Hisa Reg Jan 3 1106 Am

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Horseracing Integrity and Safety Authority

HISA REGULATIONS
Definitions
AAEP: American Association of Equine Practitioners

Act: The Horseracing Integrity and Safety Act of 2020.

Administration: Providing, supplying, supervising, facilitating, or otherwise participating in the Use or Attempted Use in a
Covered Horse by a Covered Person of a Prohibited Substance or Prohibited Method.

Adverse Analytical Finding: A report from a Laboratory that, consistent with the Laboratory Standards establishes in a
Sample the presence of a Prohibited Substance or its Metabolites or Markers or evidence of the Use of a Prohibited
Method

Adverse Passport Finding: A report identified as an Adverse Passport Finding as described in the applicable Policies.

Agency: The United-States Anti-Doping Agency or any entity contracted by the Authority to fulfill the responsibilities under
the Protocol and the Act.

Aggravating Circumstances: Circumstances involving, or actions by, a Covered Person which may justify the imposition of
a period of Ineligibility greater than otherwise imposed. Such circumstances and actions shall include, but are not limited
to: administration that is detrimental to the health and welfare of the horse or is designed to deceive the betting public; the
Covered Person Possessing, Administering, or Trafficking multiple Prohibited Substances or Prohibited Methods; the
Covered Person Possessing, Administering, or Trafficking a Prohibited Substance or Prohibited Method on multiple
occasions or committing multiple other anti-doping or medication control rule violations; a Covered Horse or Covered
Person would be likely to enjoy the performance-enhancing effects or consequences of the performance-enhancing
effects of the anti-doping or medication control rule violation(s) beyond the otherwise applicable period of Ineligibility; the
Covered Person engaged in deceptive or obstructive conduct to avoid the detection or adjudication of an anti-doping or
medication control rule violation; or the Covered Person engaged in Tampering during Results Management. For the
avoidance of doubt, the examples of circumstances and conduct described herein are not exclusive and other similar
circumstances or conduct may also justify Aggravating Circumstances and the imposition of a longer period of Ineligibility.

Aliquot: A portion of the Sample of biological fluid (e.g., urine, blood) obtained from the Covered Horse used in the
analytical process.

Analyte: Also known as or referred to as a substance, compound or measurand, which is analyzed and/or determined in a
biological matrix using an Analytical Testing Procedure performed under controlled analytical and laboratory conditions.
For anti-doping and medication control purposes, an Analyte may be a Prohibited Substance, a Metabolite of a
Prohibited Substance, or a Marker of the Use of a Prohibited Substance or Prohibited Method.

Analytical Method: Analytical Testing Procedure, Test Method.

Analytical Testing Procedure: A Fit-for-Purpose procedure, as demonstrated through method validation, and used to
detect, identify and/or quantify Analytes in a Sample for Doping Control purposes in accordance with the Laboratory
Standards and relevant Technical Document(s), Technical Letter(s), or Laboratory Guidelines. An Analytical Testing
Procedure is also referred to or known as an Analytical Method or Test Method.

Analytical Testing Restriction (ATR): Restriction on a Laboratory’s application of specified Analytical Testing Procedure(s)
or the analysis of a particular class(es) of Prohibited Substances or Prohibited Methods to Samples, as determined by
the Agency.

Analytical Testing: The parts of the Doping Control process performed at the Laboratory, which include Sample handling,
analysis and reporting of results.

Anti-Doping Stewards Panel: Impartial stewards or former stewards appointed by the Agency to hear Minor Infractions
cases on a rotating basis pursuant to Article 8.2 (a).

Arbitration Procedures: The arbitration procedures for the Equine Anti-Doping and Medication Control Protocol
developed pursuant to the Act and the Protocol, which are Standards.

Association Veterinarian: A Veterinarian employed by an Association.

Association: Shall have the same definition as Racetrack

Attempt: Purposely engaging in conduct that constitutes a substantial step in a course of conduct planned to culminate in
the commission of an anti-doping or medication control rule violation. Provided, however, there shall be no anti-doping or
medication control rule violation based solely on an Attempt to commit a violation if the Person renounces the Attempt

Horseracing Integrity and Safety Authority


prior to it being discovered by a third party not involved in the Attempt.

Attending Veterinarian: A Veterinarian hired by the Trainer and/or Owner

Atypical Finding: A report from a Laboratory which requires further investigation as provided by the Laboratory Standards
or related Technical Documents prior to the determination of an Adverse Analytical Finding.

Atypical Passport Finding: A report described as an Atypical Passport Finding as described in the Policies.

Authority: The Horseracing Integrity and Safety Authority.

Batch: A set of Samples processed as a group.

Bias: Deviation of a measured result from the expected or reference value when using the complete measurement
procedure.

Billing Standards: The Standards governing compensation for arbitrators and stewards under the Arbitration Procedures.

Bled: the observation of blood from one or both nostrils as a result of exercise induced pulmonary hemorrhage

Blood Collection Officer (BCO): An official who is a veterinarian or a veterinary technician and has been authorized by the
Agency to collect a blood Sample from a Covered Horse.

Breeder: A Person who is in the business of breeding Covered Horses

Certified Reference Material (CRM): Reference Material (RM), characterized by a metrologically valid procedure for one
or more specified properties, which is accompanied by a certificate that provides the value of the specified property, its
associated uncertainty, and a statement of metrological traceability.

Chain of Custody: The sequence of individuals or organizations who have responsibility for the custody of a Sample.

Chaperone: An official who is suitably trained and authorized by the Agency to carry out the responsibilities given to
Chaperones in the Testing and Investigations Standards and/or by the DCO.

Claiming Race: A race in which a horse after leaving the starting gate may be claimed (purchased for a designated
amount) in accordance with State Racing Commission rules

Commission: The Federal Trade Commission

Concussion: An injury to the brain that results in temporary loss of normal brain function

Confirmation Procedure (CP): An Analytical Testing Procedure that has the purpose of confirming the presence and/or,
when applicable, confirming the concentration/ratio/score and/or establishing the origin (exogenous or endogenous) of
one or more specific Prohibited Substances, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method in a Sample.

Consequences of Anti-Doping and Medication Control Rule Violations (“Consequences”): Covered Person’s violation of
an anti-doping rule may result in one or more of the following: (a) Disqualification means the results in a particular Race
are invalidated, with all resulting Consequences including forfeiture of any purses, points, and prizes; (b) Ineligibility means
the Covered Horse or Covered Person is barred on account of an anti-doping or medication control rule violation for a
specified period of time from participating in any Covered Horserace or activity involving Covered Horses or Racetracks
as set forth in Article 10.12; (c) Provisional Suspension means the Covered Horse or Covered Person is barred
temporarily from participating in any Covered Horserace or activity involving Covered Horses or Racetracks as set forth in
Article 10.12 (Status During Ineligibility or Provisional Suspension) prior to the final decision pursuant to Article 8; (d) Fine
means a financial sanction imposed for an anti-doping or medication control rule violation or to recover costs associated
with an anti-doping or medication control rule violation that shall be paid to the Authority; and (e) Public Disclosure means
the dissemination or distribution of information to the general public or Persons beyond those Persons entitled to earlier
notification in accordance with the Protocol.

Contaminated Product: A product (other than normal feed or water) that contains a Prohibited Substance that is not
disclosed on the product label or in information available in a reasonable internet search.

Cooperate: Failure by the Responsible Person to properly or truthfully file or timely update designations as to the identity
of the Responsible Person for a Covered Horse or properly maintain Treatment records for a Covered Horse as
described in Article 16 of the Protocol. Failure by the Owner to properly or truthfully file or timely update ownership or
property interests in a Covered Horse or the identity of the managing Owner. And with respect to any matter under the
Agency’s authority, a Covered Person’s failure to respond promptly, truthfully, and completely to written and oral inquiries
from the Agency or adjudication body as well as to subpoenas issued by the Agency or Authority. At the request of the
Agency, a Covered Person’s failure to (a) make available any facility, office, stall, equipment, feed, medicine, etc.; (b)
submit to under oath transcribed interviews; (c) provide immediate access to records related to any Covered Horse; and
(d) provide immediate access to electronically stored data, including emails, computers, and mobile phones and devices
without alteration.

Horseracing Integrity and Safety Authority


Corrective Action Report (CAR): A report describing the Root Cause Analysis investigation of a detected nonconformity
and the corrective actions implemented to rectify it. If appropriate, it shall also describe the improvements adopted to
minimize the risk of recurrence of the nonconformity.

Coverage Factor k: A numerical value from statistical tables or computation that is used to compute the expanded
measurement uncertainty associated with a method. For example, a coverage factor of 3 confers a certain level of
statistical certainty for the measurement uncertainty value. Larger values of the Coverage Factor k increase the certainty
of the measurement uncertainty estimate.

Covered Horse: Any thoroughbred horse, or any other horse made subject to this Protocol by election of the applicable
State Racing Commission or the breed governing organization for such horse beginning on the earlier of (1) the date of
the horse’s first timed and reported Workout at a Racetrack; (2) the date of the horse’s first timed and reported workout at
a Training Facility; (3) the date of the horse’s entry in a Covered Horserace; or (4) the date of the horse’s nomination for a
Covered Horserace, and ending on the date on which the Agency receives written notice that the horse has been retired in
accordance with the Protocol. A Covered Horse that has been fatally injured or dies prior to retirement remains subject to
Agency jurisdiction, including Sample collection, after notification of retirement.

Covered Horserace: Any horserace event involving Covered Horses from the official opening of such event through the
conclusion of all the Sample collection process for all Covered Horses in connection with the event.

Covered Persons: All Trainers, Owners, Breeders, Jockeys, Racetracks, Veterinarians, and Persons licensed by a State
Racing Commission, and the agents, assigns, and employees of such persons and other horse support personnel who
are engaged in the care, training, or racing of Covered Horses.

Decision Limit: The value of the result for a Threshold Substance in a Sample, above which an Adverse Analytical Finding
shall be reported, as defined in the Laboratory Standards

Disqualification: See Consequences of Anti-Doping and Medication Rule Violations above.

Doping Control Officer (DCO): An official who has been trained and authorized by the Agency to carry out the
responsibilities given to DCOs in the Testing and Investigations Standards.

Doping Control: All steps and processes from test distribution planning through to ultimate disposition of any appeal and
the enforcement of Consequences, including all steps and processes in between, including but not limited to, Testing,
investigations, whereabouts, Sample collection and handling, Laboratory analysis, Results Management and
investigations and proceedings relating to violations of Article 10.12 (Status During Ineligibility or Provisional
Suspension).

Epistaxis: Blood from one or both nostrils as a result of exercise induced pulmonary hemorrhage

Equine Ambulance: A vehicle for the transport of an injured horse

Equine Biological Passport: The program and methods of gathering and collating data as described in the Testing and
Investigations Standards and Laboratory Standards.

Equine Constituencies: Collectively, Owners, Breeders, Trainers, Racetracks, Veterinarians, State Racing Commissions,
and Jockeys who are engaged in the care, training, or racing of Covered Horses.

Equine Passport Management Unit (EPMU): A unit composed of a person or persons that is responsible for the timely
management of Equine Biological Passports on behalf of the Agency.

Expanded Measurement Uncertainty: The Expanded Measurement Uncertainty is calculated by multiplying the Coverage
Factor (q.v.) by the Measurement Uncertainty (q.v.).

External Quality Assessment Scheme (EQAS): Program for quality assessment of Laboratory performance, which
includes the periodical distribution of urine, blood or other Samples to Laboratories and probationary laboratories by the
Agency, to be analyzed for the presence or absence of Prohibited Substances and/or their Metabolite(s), or Marker(s) of
Use of Prohibited Substances or Prohibited Methods. EQAS samples may be open (i.e., educational; in such cases the
content may be indicated), blind or double-blind (in such cases the content is unknown to the Laboratories).

Failure to Comply: A term used to describe anti-doping rule violations under Articles 2.3 and/or 2.5 of the Protocol.

Fault: Fault is any breach of duty or any lack of care appropriate to a particular situation. For a Fault reduction in
connection with an Adverse Analytical Finding, the Covered Person must establish the source of an Adverse Analytical
Finding. Factors to be taken into consideration in assessing a Covered Person’s degree of Fault include, for example, the
Covered Person’s experience, special considerations such as impairment, the degree of risk that should have been
perceived by the Covered Person and the level of care and investigation exercised by the Covered Person in relation to
what should have been the perceived level of risk. With respect to supervision, factors to be taken into consideration are
the degree to which the Covered Person vetted, monitored, and educated subordinates and created and maintained
systems to ensure compliance with the anti-doping rules. In assessing the Covered Person’s degree of Fault, the
circumstances considered must be specific and relevant to explain the Covered Person’s departure from the expected

Horseracing Integrity and Safety Authority


standard of behavior. Thus, for example, the fact that the Covered Person would lose the opportunity to earn large sums of
money during a period of Ineligibility, or the fact that the Covered Person only has a short time left in a career, or the timing
of the racing calendar, would not be relevant factors to be considered in reducing the period of Ineligibility under Article
10.6.

Fine: See Consequences of Anti-Doping and Medication Control Rule Violations above.

Fit(ness)-for-Purpose: Suitable for the intended purpose and in conformity with the ISO/IEC 17025 or ISO 15189, as
applicable, ILAG-G7, the Laboratory Standards and relevant Technical Document(s) and Technical Letter(s).

Flexible Scope of ISO/IEC 17025 Accreditation: Status of laboratory accreditation, which allows a Laboratory to make
and implement restricted modifications in the Scope of ISO/IEC 17025 Accreditation, as applicable, prior to the
assessment by the Accreditation Body.

Further Analysis: Further Analysis occurs when a Laboratory conducts additional analysis on an “A” Sample or a “B”
Sample after an analytical result for that “A” Sample or that “B” Sample has been reported by the Laboratory. There is no
limitation on a Laboratory’s authority to conduct repeat or confirmation analysis, or to analyze a Sample with additional
Analytical Methods, or to perform any other type of additional analysis on an “A” Sample or “B” Sample prior to reporting
an analytical result on that Sample. That is not considered Further Analysis.

Groom: A Covered Person who is not an Owner, Veterinarian, Trainer, or assistant Trainer but is involved in the care of a
Covered Horse.

Ineligibility: See Consequences of Anti-Doping and Medication Control Rule Violations above

Initial Testing Procedure (ITP): An Analytical Testing Procedure whose purpose is to identify those Samples which may
contain a Prohibited Substance, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method or an elevated quantity of a Prohibited Substance, Metabolite(s) of a Prohibited
Substance, or Marker(s) of the Use of a Prohibited Substance or Prohibited Method.

Intermediate Precision (sw): Variation in results observed when one or more factors, such as time, equipment, or operator
are varied within a Laboratory. It is also referred to as inter-batch/inter-run precision.

Jockey: A rider of a Covered Horse in Covered Horseraces

Laboratory Documentation Package (LDP): The material (physical or electronic) produced by a Laboratory upon reporting
of an Adverse Analytical Finding or requested by the Agency, as set forth in the Technical Document , to support an
analytical result such as an Adverse Analytical Finding or an Atypical Finding. This includes abbreviated Laboratory
Documentation Packages.

Laboratory Expert Group (LabEG): Group of laboratory experts responsible for providing advice, recommendations, and
guidance to the Agency with respect to the overall management of anti-doping and medication control Laboratory
accreditation, Laboratory disciplinary action, re-accreditation, and approval processes as well as Laboratory monitoring
activities.

Laboratory Guidelines (LGs): Recommendations of Laboratory best practices provided by the Agency to address specific
Laboratory operations or to provide technical requirements and guidance on interpretation and reporting of results for the
analysis of specific Prohibited Substance(s), Metabolites, or Markers, and/or Prohibited Method(s) or on the application
of specific Laboratory procedures.

Laboratory Internal Chain of Custody: Documentation maintained within the Laboratory to record the chronological
traceability of custody (by Person(s) or upon storage) and actions performed on the Sample and any Aliquot of the
Sample taken for Analytical Testing. Laboratory Internal Chain of Custody is generally documented by a written or
electronic record of the date, location, action taken, and the Person performing an action with a Sample or Aliquot.

Laboratory Standards: The Equine Laboratory Standards developed pursuant to the Act and the Protocol.

Laboratory: An Agency-accredited, or Agency-approved international laboratory applying Test Methods and processes to
provide evidentiary data for the detection and/or identification of Prohibited Substances, Metabolites, Markers, or
Prohibited Methods on the Prohibited List and, if applicable, quantification of a Threshold Substance in Samples of urine
and other biological matrices in the context of Doping Control activities.

Limit of Detection (LOD): Analytical parameter of assay technical performance. Lowest concentration of an Analyte in a
Sample that can be routinely detected, but not necessarily identified or quantified, under the stated Test Method
conditions.

Limit of Identification (LOI): Analytical parameter of technical performance for chromatographic-mass spectrometric
Confirmation Procedures. The LOI is estimated during method validation to evaluate the rate of false negative results at a
certain concentration level. The LOI of a Test Method, at 5% false negative rate, for an Analyte (for which a Reference
Material is available) shall be less than the MRPL. Since the LOI is an estimation of the false negative rate, Laboratories
may report findings below the estimated LOI as Adverse Analytical Findings or Atypical Findings, as applicable, when the
Analyte is identified in the Sample according to the criteria established in the Technical Document.

Horseracing Integrity and Safety Authority


Limit of Quantification (LOQ): Analytical parameter of assay technical performance. Lowest concentration of an Analyte in
a Sample that can be quantitatively determined with acceptable precision and accuracy (i.e., acceptable Measurement
Uncertainty) under the stated Test Method conditions.

Major Infractions: Anti-doping and medication control rule violations under this Protocol by a Covered Person that are not
Minor Infractions.

Marker: A compound, group of compounds or biological variable(s) that indicates the Use of a Prohibited Substance or
Prohibited Method.

Measurement Uncertainty (MU): Parameter associated with a measurement result that characterizes the dispersion of
quantity values attributed to the measure and provides confidence in the validity of the measured result.

Metabolite: Any substance produced from a Prohibited Substance by a biotransformation process.

Minimum Reporting Levels: The estimated concentration of a Prohibited Substance or its Metabolite(s) or Marker(s) in a
Sample below which Laboratories should not report that Sample as an Adverse Analytical Finding.

Minimum Required Performance Level (MRPL): Minimum analytical criterion of Laboratory technical performance
established by the Agency. Minimum concentration at which a Laboratory is expected to consistently detect and confirm a
Prohibited Substance or Metabolite of a Prohibited Substance or Marker of a Prohibited Substance or Prohibited Method
in the routine daily operation of the Laboratory. Individual Laboratories may and are expected to achieve better
performance.

Minor Infractions: Article 2.1 Presence, Article 2.2 Use, Article 2.7 Possession, and Article 2.9.3 Administration violations
of this Protocol involving a Secondary Substance or a Secondary Method and for which the Agency does not allege
Aggravating Circumstances. Additionally, an Article 2.5 failure to Cooperate violation; an Article 2.12 medication control
rule violation; Ineligibility of a Covered Horse stemming from a violation involving a Secondary Substance or a Secondary
Method; Disqualification of a Covered Horse’s competitive results stemming from a violation involving a Secondary
Substance or a Secondary Method only; and Ineligibility resulting from intractability.

Negative Finding: A Test result from a Laboratory which, in accordance with the effective Laboratory Standards and/or
relevant Technical Document(s) and/or Technical Letter(s), concludes that no Prohibited Substance(s) or its Metabolite(s)
or Marker(s) or evidence of the Use of a Prohibited Method(s), included in the requested Analytical Testing menu, were
found in a Sample based on the applied Initial Testing Procedure(s) or Confirmation Procedure(s).

No Advance Notice Testing: Sample collection that takes place with no advance warning to the Covered Persons, other
than to grant immediate access to the Covered Horse, and where the Covered Horse is continuously chaperoned or in a
secure location (a stall, for example) from the moment of notification through Sample provision.

No Fault or Negligence: The Covered Person’s establishing that they did not know or suspect and could not reasonably
have known or suspected even with the exercise of utmost caution, that they had caused a Covered Horse to Use or be
administered the Prohibited Substance or Prohibited Method or otherwise violate an anti-doping rule. For any violation of
Article 2.1 of the Protocol, the Covered Person must also establish how the Prohibited Substance entered the Covered
Horse’s system.

Nominated Person: A Person nominated by a Responsible Person at the time of notification or through a Whereabouts
Filing to assist, witness, and consent to the Sample collection of a Covered Horse. If the Responsible Person is not
present to nominate a Person, or the Nominated Person designated in the applicable Whereabouts Filing is not present
or willing to assist with Sample collection, anyone employed at the stable where the Covered Horse is located by the
Responsible Person or Owner (or their designees or agents) shall be the Nominated Person for that Sample collection. If
no Nominated Person is promptly identified as described above, the Person who has custody or control of the Covered
Horse or granted the DCO or Chaperone access to the Covered Horse shall be the Nominated Person for that Sample
collection.

Non-Threshold Substance: A substance listed on the Prohibited List for which the identification, in compliance with any
applicable Technical Document(s), constitutes an Adverse Analytical Finding.

Official Veterinarian: A Veterinarian employed, contracted, or appointed by a State Racing Commission or the Agency,
who, among other things, is tasked with monitoring the health and welfare of Covered Horses during Covered Horseraces.

Out-of-Competition: Any period which is not during Race Day.

Owner: A Person or entity who holds an ownership or property interest in one or more Covered Horses. The term also
includes the managing Owner. When an Owner is a partnership, corporation, limited liability company, syndicate or other
association or entity, a managing Owner shall hold an ownership interest in the applicable Covered Horse and be
designated as the individual who is liable under this Protocol as the Owner. In all circumstances in which an individual
owns greater than 50% stake in a Covered Horse, that individual shall be the managing Owner. Each individual with a
three percent or greater ownership or property interest in a Covered Horse must register with the Authority as an Owner of
the Covered Horse. For Covered Horses claimed in a Claiming Race, the pre-claim Owner shall remain liable, to the
same extent the Owner would have been liable if the Covered Horse had not been claimed, for any anti-doping or

Horseracing Integrity and Safety Authority


medication control rule violation resulting from a Sample collected on Race Day post-claim Race.

Paddock Judge: A person, licensed by the State Racing Commission as an official to perform the duties of a Paddock
Judge

Person: A natural person or an organization or other entity

Policy: A document approved by the Commission in support of the Protocol. Compliance with a Policy (as opposed to
another alternative standard, practice or procedure) shall be sufficient to conclude that the procedures addressed by the
Policy were performed properly. Policies shall include any Standards and Technical Documents issued pursuant to the
Act or Protocol.

Pony Horse: Any horse that accompanies a racehorse on the racetrack

Possession: The actual, physical Possession, or the constructive Possession (which shall be found only if the Person has
exclusive control or intends to exercise control over the Prohibited Substance or Prohibited Method or the premises in
which a Prohibited Substance or Prohibited Method exists); provided, however, that if the Person does not have exclusive
control over the Prohibited Substance or Prohibited Method or the premises in which a Prohibited Substance or
Prohibited Method exists, constructive Possession shall only be found if the Person knew about the presence of the
Prohibited Substance or Prohibited Method and intended to exercise control over it. There shall be no anti-doping rule or
medication control violation based solely on Possession if, prior to receiving notification of any kind that the Person has
committed an anti-doping or medication control rule violation, the Person has taken concrete action demonstrating that the
Person never intended to have Possession and has renounced Possession by explicitly declaring it to an Agency.
Notwithstanding anything to the contrary in this definition, the purchase (including by any electronic or other means) of a
Prohibited Substance or Prohibited Method constitutes Possession by the Person who makes the purchase.

Post-Mortem Veterinary Examination: Examination conducted following the fatality of a horse

Presumptive Adverse Analytical Finding (PAAF): The status of a Sample test result from the Initial Testing Procedure
which represents a suspicious finding, but for which a Confirmation Procedure to render a conclusive test result has not
yet been performed.

Primary Method: See Regulation 4.2 (b)

Primary Substance: See Regulation 4.2 (b)

Prohibited List: The Equine Prohibited List identifying the Prohibited Substances and Prohibited Methods.

Prohibited Method: Any method so described on the Prohibited List.

Prohibited Substance: Any substance, or class of substances, so described on the Prohibited List.

Protocol: The Equine Anti-Doping and Medication Control Protocol.

Provisional Hearing: For purposes of Article 7, an expedited, abbreviated hearing occurring prior to an adjudication under
Article 8 to resolve a challenge to a Provisional Suspension.

Provisional Suspension: See Consequences of Anti-Doping and Medication Control Rule Violations above. With respect
to Laboratories, the temporary Suspension of a Laboratory’s HISA Equine Analytical Laboratory accreditation by the
Agency pending a final decision by the Agency regarding the Laboratory’s accreditation status.

Publicly Disclose: See Consequences of Anti-Doping and Medication Control Rule Violations above.

Race Day: The day commencing at 12:00 a.m. on the day a Covered Horse starts a Race or Workout or the Responsible
Person or Nominated Person is notified for Sample collection on the day the Covered Horse is scheduled to start a Race
or Workout (and prior to the Covered Horse being removed from the Race or Workout) through the end of such Race or
Workout and any post-Race Sample collection process related to such Race or Workout.

Race Period: The period commencing 48 hours prior to a Covered Horse’s start in any Race or Workout through the end
of such Race or Workout and the Sample collection process related to such Race or Workout.

Race: A single competition in the Covered Horserace.

Racetrack: An organization licensed by a State Racing Commission to conduct Covered Horseraces.

Reference Collection (RC): A collection of samples or isolates of known origin that may be used in the determination of
the identity of an unknown substance. For example, a well-characterized sample obtained from a controlled administration
or from in vitro studies in which the presence of the substance of interest has been established.

Reference Material (RM): Reference Substance or Reference Standard, which is sufficiently characterized, homogeneous
and stable with respect to one or more specified properties and that has been established to be fit for its intended use in
an Analytical Testing Procedure.

Horseracing Integrity and Safety Authority


Registered Testing Pool: The pool of all Covered Horses, which are subject to focused Testing at all times, including
outside of Race Day, as part of the Agency’s test distribution plan and therefore are required to provide whereabouts
information as provided in the Protocol and the Testing and Investigations Standards.

Regulatory Veterinarian: A Veterinarian employed by a State Racing Commission that has elected to enter into an
agreement with the Authority.

Repeatability (sr): Variability of results obtained within a Laboratory using the same method, over a short time, using a
single operator, item of equipment, etc. It is also referred to as intra-batch/intra-run precision.

Reproducibility (sR): Variability of results obtained when different Laboratories analyze Aliquots of the same Sample.
Reproducibility is a property of the results obtained and represents a measurable agreement of analytical results between
different Laboratories.

Responsible Person: One person (not an entity) shall be designated in the registration with the Authority as the
Responsible Person. For a Covered Horse that has not yet done its first Workout (or competed in a Race, whichever is
earlier), the Responsible Person shall be the Owner of the Covered Horse unless the horse is in training in another
country. Once in training, the Responsible Person shall be the licensed Trainer for the Covered Horse who shall be
designated and filed with the Authority. Trainer designations must be kept current with the Authority. Designation transfers
must be in writing and on record with the Authority prior to the effective date, except for Claiming Races in which transfers
must be recorded the same day. For Covered Horses claimed in a Claiming Race, the pre-claim Responsible Person
shall remain strictly liable, to the same extent the Responsible Person would have been liable if the Covered Horse had
not been claimed, for any anti-doping or medication control rule violation resulting from a Sample collected on Race Day
post-claim Race. If a Covered Horse stops training for a period of time, the designation may be transferred to the Owner
prior to the effective date. If the Owner is an entity, the managing Owner shall be named.

Results Management: The process encompassing the timeframe between notification, or in certain cases (e.g., Atypical
Finding, Equine Biological Passport, Whereabouts Failure), such pre-notification investigation and review, through the
charge until the final resolution of the matter, including the end of the first instance adjudication process and any appeals
(if an appeal was lodged).

Revocation: The permanent withdrawal of a Laboratory’s HISA Equine Analytical Laboratory accreditation by the Agency.

Risk Assessment: The assessment of risk of doping and medication misuse conducted by the Agency used to effectively
conduct test distribution planning and/or Target Testing.

ROAP – the Racing Officials Accreditation Program

Root Cause Analysis (RCA): An investigation to identify one or more fundamental cause(s) of a nonconformity based on
the collection of objective evidence from an assessment of the likely factors that led to the nonconformity. The removal of a
root cause factor prevents the recurrence of the nonconformity; in contrast, removing a causal factor can improve the
outcome, but it does not prevent the recurrence of the problem with certainty.

Safety Officer: A person responsible for ensuring that all activities and practices involving the training and racing of horses
at the track meet required safety standards and regulatory guidelines

Sample Collection Equipment: A and B bottles, kits or containers, collection vessels, tubes or other apparatus used to
collect, hold, or store a Sample at any time during and after Doping Control.

Sample Collection Personnel: A collective term for qualified officials (including, among others, DCOs, BCOs, and
Chaperones) authorized by the Agency to carry out or assist with duties during Doping Control. An individual may be
authorized by the Agency to hold one or more positions during Doping Control.

Sample Collection Session: All of the sequential activities that directly involve the Covered Horse from the point that initial
contact is made with the Responsible Person or Nominated Person until the Covered Horse provides a Sample and
leaves the Test Barn or is otherwise discharged from Sample collection obligations.

Sample or Specimen: Any biological material collected for the purposes of Doping Control.

Scratch Time: The time set by the association for the closing of applications requesting permission of the stewards to
withdraw from a Race.

Scratch: The act of withdrawing an entered horse from a Race.

Secondary Method: See Regulation 4.2 (b)

Secondary Substance: See Regulation 4.2 (b)

Selectivity: The ability of the Analytical Testing Procedure to detect or identify, as applicable, the substance of interest in
the Sample.

Horseracing Integrity and Safety Authority


Special Event: A series of individual national Covered Horseraces conducted together under an organizing body (e.g.,
TOBA Graded Stakes Committee, Triple Crown Productions, Breeders’ Cup Limited) and for which a significant increase
of resources and Sample analyzing capacity may be required as determined by the Agency.

Stakes Race: Any Race so designated by the Racetrack at which such race is run, including, without limitation, the races
comprising the Breeders’ Cup World Championships and the races designated as graded stakes by the American
Graded Stakes Committee of the Thoroughbred Owners and Breeders Association

Standard: See Policy.

Starting Gate Personnel: Any person licensed as an assistant starter or any person who handles a horse in the starting
gate

State Racing Commission: The regulatory body established or recognized by a state or the federal government that has
jurisdiction over the conduct of horseracing within the applicable State with authority to regulate, approve, or license
Covered Persons and Covered Horses.

Steward: A duly appointed racing official with powers and duties specified by statute or rules

Strict Liability: The rule which provides that under Article 2.1 and Article 2.2 it is not necessary that intent, Fault,
negligence, or knowing Use be demonstrated by the Agency in order to establish an anti-doping or medication control rule
violation.

Substantial Assistance: For purposes of Article 10.7.1, a Person providing Substantial Assistance must: (1) fully disclose
in a signed written statement or recorded interview all information they possesses in relation to anti-doping or medication
control rule violations or other proceeding described in Article 10.7, and (2) fully Cooperate with the investigation and
adjudication of any case or matter related to that information, including, for example, providing an affidavit, presenting
testimony at a hearing, etc., if requested to do so by an Agency or adjudication body. Further, the information provided
must be credible and must comprise an important part of any case or proceeding which is initiated or, if no case or
proceeding is initiated, must have provided a sufficient basis on which a case or proceeding could have been brought.

Suspension: The temporary withdrawal of a Laboratory’s the Agency accreditation.

Tamper Evident: Refers to having one or more indicators or barriers to entry incorporated into or, if applicable, included
with the Sample Collection Equipment, which, if breached or missing or otherwise compromised, can provide visible
evidence that Tampering or Attempted Tampering of Sample Collection Equipment has occurred.

Tampering: Intentional conduct which subverts the Doping Control process, but which would not otherwise be included in
the definition of Prohibited Methods. Tampering shall include, without limitation, offering or accepting a bribe to perform or
fail to perform an act, preventing the collection of a Sample, affecting or making impossible the analysis of a Sample,
falsifying documents submitted to an Agency or committee or adjudication body, procuring false testimony from
witnesses, committing any fraudulent act upon the Agency or adjudication body to affect Results Management or the
imposition of Consequences, and any other similar interference or Attempted interference with any aspect of Doping
Control. Tampering shall include, absent a compelling justification, the failure of a prospective Responsible Person (or
Responsible Person) to disclose to the Agency or Authority, prior to a horse becoming a Covered Horse the Use or
Attempted Use of a Prohibited Substance or Prohibited Method prohibited at all times in accordance with Article 5.4 of
the Protocol.

Target Testing: Selection of specific Covered Horses for Testing based on criteria set forth in the Equine Testing and
Investigations Standards.

Technical Document (TD): A document published containing mandatory technical requirements provided by the Agency
for Laboratories on specific anti-doping and medication control topics.

Technical Letter (TL): A document published containing mandatory technical requirements provided by the Agency from
time to time (ad-hoc) to address particular issues on the analysis, interpretation, and reporting of specific Prohibited
Substance(s), Metabolites, Markers, and/or Prohibited Method(s) or on the application of specific Laboratory procedures.

Technical Note (TN): Technical guidance provided by the Agency to Laboratories on the performance of specific
Laboratory methods or procedures.

Test Barn: A designated facility (or location) where the collection of Samples takes place by Sample Collection
Personnel, typically on Race Day.

Test Method: Analytical Testing Procedure, Analytical Method.

Testing and Investigations Standards: The Equine Testing and Investigations Standards developed pursuant to the Act
and the Protocol.

Testing: The parts of the Doping Control process involving test distribution planning, Sample collection, Sample handling,
and Sample transport to the Laboratory.

Horseracing Integrity and Safety Authority


Threshold Substance: A Prohibited Substance, Metabolite or Marker of a Prohibited Substance that fulfills the criteria for
a Threshold, for which the identification and quantitative determination (e.g., concentration, ratio, score) in excess of a
pre-determined Decision Limit, or, when applicable, the establishment of an exogenous origin, constitutes an Adverse
Analytical Finding.

Threshold: The maximum permissible level of the concentration, ratio, or score for a Threshold Substance in a Sample.
The Threshold is used to establish the Decision Limit for reporting an Adverse Analytical Finding or Atypical Finding for a
Threshold Substance. Thresholds can only be adopted for (i) substances endogenous to the horse, and (ii) substances
arising from plants traditionally grazed or harvested as equine feed.

Trafficking: Selling, giving, transporting, sending, delivering or distributing (or Possessing for any such purpose) a
Prohibited Substance or Prohibited Method (either physically or by any electronic or other means) by a Covered Person to
any third party; provided, however, this definition shall not include the actions of bona fide medical personnel involving a
Prohibited Substance used for genuine and legal therapeutic purposes or other acceptable justification, and shall not
include actions involving Prohibited Substances which are prohibited on Race Day only unless the circumstances as a
whole demonstrate such Prohibited Substances are not intended for genuine and legal therapeutic purposes or are
intended to impact sport performance.

Trainer: A Person engaged in the training of Covered Horses

Training Facility: A location that is not a Racetrack licensed by a State Racing Commission that operates primarily to
house Covered Horses and conduct Workouts

Treatment: Any substance, medication, supplement, feed additive, etc. that is not normal food or water.

Unsuccessful Attempt Report: A detailed report of an unsuccessful attempt to collect a Sample from a Covered Horse
setting out the date of the attempt, the location visited, the exact arrival and departure times at the location, the steps
taken at the location to try to find the Covered Horse (including details of any contact made with Persons), and any other
relevant details about the attempt.

Use: The utilization, application, ingestion, injection, or consumption by any means whatsoever of any Prohibited
Substance or Prohibited Method in a Covered Horse.

Veterinarian: A licensed veterinarian who provides veterinarian services to Covered Horses and who, as a prerequisite to
providing veterinarian services to Covered Horses, has registered with the Authority.

Whereabouts Failure: The Failure to Comply with the Whereabouts Policy by failing to timely, accurately, and completely
provide and update the required whereabouts information and/or for a Covered Horse being unavailable for Testing due
to inaccurate information provided in a Whereabouts Filing.

Whereabouts Filing: Information provided by or on behalf of a Covered Horse in the Registered Testing Pool that sets out
the Covered Horse’s whereabouts as described in the Whereabouts Policy.

Whereabouts Policy: The Equine Whereabouts Policy developed pursuant to the Act and the Protocol.

Workout: An official timed running of a Covered Horse over a predetermined distance not associated with a Race,
including a Covered Horse’s first qualifying Race.

Horseracing Integrity and Safety Authority


Anti-Doping and Medication Control Protocol (Not Submitted to FTC)
1 DEFINITION OF ANTI-DOPING AND MEDICATON CONTROL RULE VIOLATIONS

1.1 Medication control rule violations are defined as the occurrence of one or more violations of Article 2.15 or one
or more violations of Articles 2.4 or 2.5 involving only Secondary Substances. Medication control rule violations must
also be Minor Infractions. Anti-Doping rule violations are defined as the occurrence of one or more of the violations
set forth in Article 2.4 through Article 2.15 that are not medication control rule violations.

2 ANTI-DOPING AND MEDICATION CONTROL RULE VIOLATIONS

2.1 The purpose of Article 2 is to specify the circumstances and conduct which constitute anti-doping and
medication control rule violations. Cases will be initiated based on the assertion that one or more of these specific
rules have been violated

2.10 Possession of a Primary Substance or a Primary Method by a Covered Person

2.11 Trafficking or Attempted Trafficking in any Prohibited Substance or Prohibited Method by a Covered Person

2.12 Administration

2.12 (a) Administration or Attempted Administration to any Covered Horse of any Primary Substance or any
Primary Method by a Covered Person.

2.12 (b) Administration or Attempted Administration to any Covered Horse of any Secondary Substance or
any Secondary Method by a Covered Person where the circumstances as a whole demonstrate that such
Prohibited Substances are not intended for genuine and legal therapeutic purposes or are intended to impact
sport performance.

2.12 (c) Administration or Attempted Administration to any Covered Horse of any Secondary Substance or
any Secondary Method by a Covered Person during the Race Period restricted period specified in the
Prohibited List.

2.13 Complicity or Attempted Complicity by a Covered Person

2.13 (a) Assisting, encouraging, aiding, abetting, conspiring, covering up or any other type of intentional
complicity or Attempted complicity involving an anti-doping or medication control rule violation, Attempted anti-
doping or medication control rule violation, or violation of Article 10.12 (a) by a Covered Person.

2.14 Acts by a Covered Person to Discourage or Retaliate Against Reporting to Authorities

2.14 (a) Where such conduct does not otherwise constitute a violation of Article 2.9:

2.14 (a) (1) Any act which threatens or seeks to intimidate another Person with the intent of discouraging
the Person from the good faith reporting of information that relates to an alleged anti-doping or
medication control rule violation or alleged non-compliance with the Protocol to the Agency, the
Authority, a State Racing Commission, law enforcement, a regulatory or professional disciplinary body,
an Article 8 or Article 11 adjudication body, or any Person conducting an investigation for the Agency,
the Authority, or a State Racing Commission.

2.14 (a) (2) Retaliation against a Person who, in good faith, has provided evidence or information that
relates to an alleged anti-doping or medication control rule violation or alleged non-compliance with the
Protocol to the Agency, the Authority, a State Racing Commission, law enforcement, regulatory or
professional disciplinary body, an Article 8 or Article 11 adjudication body, or Person conducting an
investigation for the Agency, the Authority, or a State Racing Commission.

2.14 (b) For purposes of Article 2.14, retaliation, threatening, and intimidation does not include an act taken
against such Person in good faith and that is a proportionate response.

Horseracing Integrity and Safety Authority


2.15 Medication Control Violation

2.15 (a) Covered Persons must ensure that all otherwise permitted medication administered to a Covered
Horse in their care is the minimum necessary to address the diagnosed health concerns, recommended by a
Veterinarian, justified by the Covered Horse’s medical condition(s) as diagnosed by a Veterinarian, and given
in the best interests of the Covered Horse’s health and welfare.

2.15 (b) Possession of otherwise permitted medication for a Covered Horse by a Covered Person must be in
compliance with state and federal law.

2.15 (c) The Responsible Person (or Owner, if there is no Responsible Person) is strictly liable for a violation
of this Article 2.15, i.e., a medication control violation. Other Covered Persons have committed a medication
control violation if they had knowledge or should have had knowledge that for 2.15 (a) the medication was not
the minimum necessary to treat the diagnosed medical condition(s), was not recommended by a Veterinarian,
was not justified by the Covered Horse’s medical condition(s) as diagnosed by a Veterinarian, or was not
given in the best interests of the Covered Horse’s health and welfare and for 2.15 (b) the Possession of the
medication was not in compliance with state or federal law.

2.2 The anti-doping and medication control rule violations described in this Article 2 may only be committed by
Covered Persons. The Consequences of Anti-Doping and Medication Control Rule Violations under this Protocol
shall apply to both Covered Persons and Covered Horses. Covered Persons shall be responsible for knowing what
constitutes an anti-doping and medication control rule violation and the Prohibited Substances and Prohibited
Methods which have been included on the Prohibited List.

2.3 To establish a Covered Person other than a Veterinarian committed a violation under this Protocol, other than an
Article 2.4, 2.5, 2.7, or 2.15 violation, the Agency must demonstrate that the elements of a violation by a Covered
Person have been established and the Covered Person intended the conduct that constituted or resulted in a
violation. To establish a Veterinarian committed a violation, the Agency must demonstrate the elements of a
violation and that the Veterinarian knew or should have known that their conduct constituted a rule violation

2.4 Presence of a Prohibited Substance or its Metabolites or Markers in a Covered Horse’s Sample

2.4 (a) It is the Responsible Persons’ duty to ensure that no Prohibited Substance enters their Covered
Horses’ bodies. Responsible Persons are responsible for any Prohibited Substance or its Metabolites or
Markers found to be present in Covered Horses’ Samples. Responsible Persons are strictly liable for the
presence of a Prohibited Substance, or its Metabolites or Markers, in their Covered Horse. Accordingly, it is
not necessary that intent, Fault, negligence or knowing Use be demonstrated in order to establish an anti-
doping or medication control rule violation under Article 2.4 by a Responsible Person. In the event there is no
Responsible Person for a Covered Horse, the responsibilities and principle of Strict Liability described under
Article 2.4 shall be applied to the Covered Horse’s Owner.

2.4 (b) Sufficient proof of an anti-doping or medication control rule violation under Article 2.4 is established by
any of the following:

2.4 (b) (1) presence of a Prohibited Substance or its Metabolites or Markers in the Covered Horse’s A
Sample where the Responsible Person (or Owner, if there is no Responsible Person) waives analysis of
the B Sample and the B Sample is not analyzed;

2.4 (b) (2) where the Covered Horse’s B Sample is analyzed and the analysis of the B Sample confirms
the presence of the Prohibited Substance or its Metabolites or Markers found in the A Sample; or

2.4 (b) (3) when the Laboratory splits the A or B Sample into two parts in accordance with the Laboratory
Standards and the analysis of the second part of the split Sample confirms the presence of the
Prohibited Substance or its Metabolites or Markers found in the first part of the split Sample or the
Responsible Person (or Owner, if there is no Responsible Person) waives analysis of the second part of
the split Sample.

2.4 (c) Subject to the terms of Article 2.4 (a)

2.4 (c) (1) sufficient proof of an anti-doping or medication control rule violation under Article 2.4 by a
Covered Person who is not a Responsible Person (or Owner if there is no Responsible Person) is
established by any of the criteria set forth in Article 2.4 (b)

2.4 (c) (2) demonstration by the Agency that the Covered Person had knowledge or should have had
knowledge that a Prohibited Substance was administered or was planned to be administered to a
Covered Horse

Horseracing Integrity and Safety Authority


2.4 (d) Excepting those substances for which a Minimum Reporting Level, Threshold, or Decision Limit is
specifically identified in the Prohibited List or a Technical Document, the presence of any reported quantity of
a Prohibited Substance or its Metabolites or Markers in a Covered Horse’s Sample shall constitute an anti-
doping or medication control rule violation.

2.4 (e) As an exception to the general rule of Article 2.4, the Prohibited List, Policies, or Technical Documents
may establish special criteria for reporting or the evaluation of certain Prohibited Substances.

2.4 (f) In the event a Responsible Person discloses to the Agency or Authority the Use or Attempted Use of
any Prohibited Substance or Prohibited Method prohibited at all times by a horse in accordance with Article
5.4, then the presence or evidence of Use of such disclosed substance or method in the Covered Horse’s
Sample shall not be considered an anti-doping or medication control rule violation if it is determined by the
Agency to have resulted from Use of the Prohibited Substance or Prohibited Method prior to the horse
becoming a Covered Horse.

2.5 Use or Attempted Use in a Covered Horse of a Prohibited Substance or a Prohibited Method

2.5 (a) It is a Responsible Person’s duty to ensure that no Prohibited Substance enters their Covered Horses’
bodies and that no Prohibited Method is Used. Responsible Persons are responsible for any Use of a
Prohibited Substance or Method in a Covered Horse. Responsible Persons are strictly liable for the Use of a
Prohibited Substance in their Covered Horse. Accordingly, it is not necessary that intent, Fault, negligence or
knowledge of Use be demonstrated in order to establish an anti-doping or medication control rule violation for
Use of a Prohibited Substance or a Prohibited Method with respect to Responsible Persons. In the event there
is no Responsible Person for a Covered Horse, the responsibilities and principle of Strict Liability described
under Article 2.5 shall be applied to the Owner.

2.5 (b) Subject to the terms of Article 2.5 (a), to establish an anti-doping or medication control rule violation for
Use of a Prohibited Substance or a Prohibited Method in a Covered Horse, by the Covered Person who is not
a Responsible Person (or Owner if there is no Responsible Person), the Agency must demonstrate that the
Covered Person had knowledge or should have had knowledge of the Use of the Prohibited Substance in the
Covered Horse.

2.5 (c) The impact of the Use or Attempted Use of a Prohibited Substance or Prohibited Method as it relates
to the Covered Horse’s performance is not material. It is sufficient that the Prohibited Substance or Prohibited
Method was Used or Attempted to be Used for an anti-doping or medication control rule violation to be
committed.

2.6 Evading, Refusing or Failing to Submit a Covered Horse to Sample Collection

2.6 (a) Evading Sample collection or refusing or failing to submit the Covered Horse to Sample collection by a
Covered Person without compelling justification.

2.6 (b) If a Covered Horse is intractable, and thereby fails to provide the Sample sought, no violation will be
found on this basis, but the Covered Horse shall not be permitted to participate in a Race until the
Responsible Person notifies the Agency that the Covered Horse is no longer intractable, and the Agency
successfully collects a Sample. [see end note 1]

2.7 Whereabouts Failures regarding a Covered Horse

2.7 (a) Any combination of three Whereabouts Failures, as defined in the Whereabouts Policy, within a twelve-
month period regarding a single Covered Horse constitutes an anti-doping rule violation for the Responsible
Person and results in Ineligibility for the Covered Horse as described in 10.1 (b)

2.7 (a) (1) If the Responsible Person changes with respect to a Covered Horse with Whereabouts
Failures, the Whereabouts Failures of the Covered Horse remain with the Covered Horse for purposes
of Article 2.7 (a) but do not count against the Whereabouts Failures for the new Responsible Person as
described in Articles 2.7 (a) and 2.7 (b)

2.7 (a) (2) In the circumstance described in Article 2.7 (a) (1) if a Covered Horse accrues three
Whereabouts Failures in a twelve-month period but the new Responsible Person has not accrued three
Whereabouts Failures with respect to that Covered Horse, an Article 2.7 (a) violation has been
committed and the Agency shall initiate the case against the new Responsible Person on behalf of the
Covered Horse. However, such Responsible Person shall not receive a violation or period of Ineligibility.
The Covered Horse shall receive Consequences consistent with the Protocol.

Horseracing Integrity and Safety Authority


2.7 (b) Any combination of six Whereabouts Failures, as defined in the Whereabouts Policy, within a twelve-
month period for every 50 Covered Horses per Responsible Person on average annually, as described more
fully in the Whereabouts Policy, constitutes an anti-doping rule violation.

2.7 (c) It is the Responsible Person’s responsibility to provide accurate and up to date whereabouts
information regarding a Covered Horse in accordance with the Whereabouts Policy and this Protocol unless
the Covered Horse has no Responsible Person, in which case all whereabouts responsibilities shall be
applied to the Owner of the Covered Horse.

2.8 Failure by a Covered Person to Cooperate with the Agency

2.9 Tampering or Attempted Tampering with any part of Doping Control by a Covered Person

3 PROOF OF DOPING AND MEDICATION CONTROL

3.1 Burdens and Standards of Proof

3.1 (a) The Agency shall have the burden of establishing that an anti-doping or medication control rule violation
has occurred. The standard of proof shall be whether the Agency has established an anti-doping or
medication control rule violation by a preponderance of the evidence. This standard of proof in all cases shall
be that the Article 8 or Article 11 (except as otherwise described in the Act) adjudication body must be
satisfied that, based on the evidence, the occurrence of the anti-doping or medication control rule violation
was more probable than not. Similarly, where the Protocol places the burden of proof upon the Covered
Person alleged to have committed an anti-doping or medication control rule violation to rebut a presumption or
establish specified facts or circumstances the standard of proof also shall be by a preponderance of the
evidence.

3.2 Methods of Establishing Facts and Presumptions

3.2 (a) Facts related to anti-doping or medication control rule violations may be established by any reliable
means, including admissions. The following rules of proof shall be applicable in doping and medication control
cases:

3.2 (a) (1) Analytical Methods, Minimum Reporting Levels, Thresholds, Screening Limits, Decision
Limits, or any other Laboratory reporting requirements approved by the Commission are presumed to
be scientifically valid and shall not be subject to challenge unless required by applicable law.

3.2 (a) (2) Laboratories are presumed to have conducted Sample analysis and custodial procedures in
accordance with the Laboratory Standards. A Covered Person may rebut this presumption by
establishing that a departure from the Laboratory Standards occurred that could reasonably have
caused the Adverse Analytical Finding.

3.2 (a) (2) (i) If the Covered Person rebuts the preceding presumption by showing that a departure
from the Laboratory Standards occurred which could reasonably have caused the Adverse
Analytical Finding, then the Agency shall have the burden to establish that such departure did not
cause the Adverse Analytical Finding.

3.2 (a) (3) Departures from any other Standards or procedures of the Agency shall not invalidate
analytical results or other evidence of an anti-doping or medication control rule violation, and shall not
constitute a defense to an anti-doping or medication control rule violation; provided, however, if the
Covered Person establishes that a departure from one of the specific Standards listed below could
reasonably have caused an anti-doping or medication control rule violation, then the Agency shall have
the burden to establish that such departure did not cause the Adverse Analytical Finding or other anti-
doping or medication control rule violation, as follows:

3.2 (a) (3) (i) a departure from the Testing and Investigations Standards related to Sample
collection or Sample handling that could reasonably have caused an anti-doping or medication
control rule violation based on an Adverse Analytical Finding, in which case the Agency shall have
the burden to establish that such departure did not cause the Adverse Analytical Finding;

3.2 (a) (3) (ii) a departure from this Protocol or Testing and Investigations Standards related to an
Adverse Passport Finding which could reasonably have caused an anti-doping or medication
control rule violation, in which case the Agency shall have the burden to establish that such

Horseracing Integrity and Safety Authority


departure did not cause the anti-doping or medication control rule violation;

3.2 (a) (3) (iii) a departure from this Protocol related to the requirement to provide notice to the
Responsible Person and Owner of the B Sample opening which could reasonably have caused an
anti-doping rule violation based on an Adverse Analytical Finding, in which case the Agency shall
have the burden to establish that such departure did not cause the Adverse Analytical Finding; or

3.2 (a) (3) (iv) a departure from this Protocol related to Responsible Person and Owner notification
which could reasonably have caused an anti-doping rule violation based on a Whereabouts
Failure, in which case the Agency shall have the burden to establish that such departure did not
cause the Whereabouts Failure.

3.2 (a) (4) Non-appealable and final factual findings of a court, or administrative body of competent
jurisdiction shall be irrebuttable evidence against the Covered Person to whom the decision pertained of
those facts unless the Covered Person establishes that the decision violated principles of due process.

3.2 (a) (5) The Steward, arbitrator, or hearing body under Article 11 reviewing an alleged anti-doping or
medication control rule violation may draw an inference adverse to the Covered Person who is asserted
to have committed an anti-doping or medication control rule violation based on the Covered Person’s
refusal to Cooperate with the Agency and/or their failure to appear and respond to questioning by the
Agency, arbitrator, and hearing body (as applicable) at any hearing contemplated under the Protocol.
This inference is independent from the Covered Person being found to have committed a violation for
failing to Cooperate.

4 THE PROHIBITED LIST

4.1 Publication and Revision of the Prohibited List

4.1 (a) This Protocol hereby incorporates by reference the Prohibited List. Unless provided otherwise in the
Prohibited List and/or a revision thereof, the Prohibited List and revisions shall go into effect under this
Protocol three months after approval by the Commission and publication, without requiring any further action.
Revisions will be made from time to time. All Covered Person shall be bound by the Prohibited List and any
revisions thereto, from the date they go into effect, without further formality. It is the responsibility of all Covered
Persons to familiarize themselves with the most up-to-date version of the Prohibited List and all revisions
thereto.

4.2 Prohibited Substances and Prohibited Methods Identified on the Prohibited List

4.2 (a) Prohibited Substances and Prohibited Methods

4.2 (a) (1) The Prohibited List shall identify those Prohibited Substances and Prohibited Methods which
are prohibited at all times because the Commission has determined in its sole discretion that the
medical, veterinary, or other scientific evidence or experience supports: [see end note 2]

4.2 (a) (1) (i) Their actual or potential to impact performance in future Covered Horseraces;

4.2 (a) (1) (ii) Their actual or potential masking properties; and/or

4.2 (a) (1) (iii) Their actual or potential detrimental impact on horse welfare.

4.2 (a) (2) The Prohibited List applies whether Prohibited Substances and Prohibited Methods are used
alone or in combination with other substances or methods. The Prohibited List further identifies those
substances and methods which are prohibited on Race Day. Substances and methods prohibited on
Race Day are also prohibited from Administration and Attempted Administration during the Race
Period.

4.2 (a) (3) Prohibited Substances and Prohibited Methods may be included in the Prohibited List by
general category (e.g., anabolic agents) or by specific reference to, or example of, a particular
substance or method.

Horseracing Integrity and Safety Authority


4.2 (b) Primary Substances, Secondary Substances, Primary Methods, and Secondary Methods

4.2 (b) (1) For purposes of application of Articles 7.4 and 10, the Prohibited List shall identify which
Prohibited Substances are Primary Substances or Secondary Substances and which Prohibited
Methods are Primary Methods or Secondary Methods

4.3 The Prohibited List

4.3 (a) The Commission’s approval of the Prohibited Substances and Prohibited Methods that will be included
on the Prohibited List, the classification of substances and methods into categories on the Prohibited List, the
classification of a substance or method as prohibited at all times, prohibited on Race Day only and prohibited
from Administration and Attempted Administration during the Race Period, the classification of a substance or
method as a Primary Substance or Secondary Substance, or as a Primary Method or Secondary Method are
presumed valid, final, and not subject to any challenge by a Covered Person based on an argument that the
substance or method did not have the potential to be a masking agent, did not have the potential to impact
performance, or did not have the potential to impact the horse’s welfare.

4.4 Monitoring Program

4.4 (a) The Authority may approve a monitoring program regarding substances which are not on the
Prohibited List, but which the Agency wishes to monitor in order to detect potential patterns of misuse in
horseracing. In addition, the monitoring program may include substances that are on the Prohibited List, but
which are to be monitored under certain circumstances—e.g., Use at all times of some substances prohibited
on Race Day only or the combined Use of multiple substances at low doses (“stacking”)—in order to establish
prevalence of Use or to be able to implement adequate decisions in regard to their analysis by Laboratories
or their Prohibited List status. Laboratories will report the instances of reported Use or detected presence of
these substances to the Agency. Nothing in this paragraph prevents a Laboratory from sharing information
with the Agency requested for any anti-doping or medication control purpose or other purpose authorized by
the Act. The monitoring program list of substances should be reviewed annually.

5 TESTING AND INVESTIGATIONS

5.1 Purpose of Testing and Investigations

5.1 (a) Testing and investigations may be undertaken for any anti-doping or medical control purpose, including
for identifying the horse, or other purpose authorized by the Act.

5.2 Authority to Test

5.2 (a) Any Covered Horse may be required by the Agency to provide a Sample at any time and at any place
by the Agency.

5.2 (b) The Agency may delegate Testing authority to third parties, including but not limited to State Racing
Commissions that elect to enter into an agreement to carry out such Testing. Such third parties shall follow the
Testing and Investigations Standards

5.2 (c) The Agency may Test or direct the Testing of any Covered Horse which has not retired via official
notification of retirement provided to the Agency. A Covered Horse that has been fatally injured or dies prior to
retirement remains subject to Agency jurisdiction, including Sample collection.

5.2 (d) The Agency may test or direct the Testing of any Covered Horse during a Covered Horse’s period of
Ineligibility.

5.3 Testing Requirements

5.3 (a) The Agency shall conduct Test distribution planning and Testing as required by the Testing and
Investigations Standards.

Horseracing Integrity and Safety Authority


5.4 Disclosure Requirements

5.4 (a) The prospective Responsible Person (or Responsible Person) shall at the time of registering with the
Authority (and prior to competing in any Race) declare in writing to the Agency or Authority all Use or
Attempted Use of Prohibited Substances and Prohibited Methods prohibited at all times prior to a horse
becoming a Covered Horse. The Agency may request Treatment records for the horse prior to it becoming a
Covered Horse. Upon declaration of a Prohibited Substance or Prohibited Method prohibited at all times, the
Agency, in its sole discretion, may require the Covered Horse to sit out (i.e., not compete in a Race) for a
period up to the period of Ineligibility applicable for the Prohibited Substance or Prohibited Method for
Covered Horses and provide one or more negative Samples. [see end note 3]

5.5 Covered Horse Whereabouts Information

5.5 (a) Whereabouts information for Covered Horses shall be provided in the manner specified in the
Whereabouts Policy and shall be subject to Consequences for Article 2.7 violations as provided in Article 10.3
(a) (2). The Agency shall coordinate the identification of such Covered Horses and the collection of their
whereabouts information. Whereabouts information shall be maintained by the Agency in accordance with the
Whereabouts Policy.

5.6 Retired Covered Horses Returning to Covered Horseraces

5.6 (a) If an Owner wishes to retire a Covered Horse, then written notice of such retirement shall be provided to
the Agency. If a Covered Horse is retired and then the Owner wishes to return the Covered Horse to active
participation in Covered Horseraces, the Covered Horse shall not be entered in a Covered Horserace until the
Covered Horse has been made available for Testing, by giving six months prior written notice to the Agency.

5.6 (b) If a Covered Horse is retired from horseracing while subject to a period of Ineligibility, the Owner must
notify the Agency in writing of such retirement. If the Owner then wishes to return the Covered Horse to active
competition in Covered Horseraces, the Owner shall provide the Agency with six months written notice and the
Covered Horse shall not be entered in Covered Horseraces until the Covered Horse has been made available
for Testing for at least six months or the remainder of the Covered Horse’s period of Ineligibility, whichever is
longer.

5.7 Investigations and Intelligence Gathering

5.7 (a) The Agency shall have the capability to conduct, and shall conduct, investigations and gather
intelligence as required by the Testing and Investigations Standards.

6 ANALYSIS OF SAMPLES

6.1 Samples collected pursuant to this Protocol and the Testing and Investigations Standards shall be the property
of the Agency. No Covered Person or any third party shall have a right to access or use of a Sample. Samples shall
be analyzed in accordance with the following principles:

6.1 (a) Use of Accredited, Approved Laboratories, and Other Laboratories

6.1 (a) (1) For purposes of directly establishing an Adverse Analytical Finding under Article 2.4,
Samples shall be analyzed only in Laboratories. The choice of the Laboratory used for the Sample
analysis shall be determined in accordance with the Testing and Investigations Standards and
Laboratory Standards.

6.1 (a) (2) As provided in Article 3.2, facts related to anti-doping or medication control rule violations
may be established by any reliable means. This would include, for example, reliable Laboratory or other
forensic Testing conducted outside of accredited or approved laboratories.

6.1 (b) Purpose of Analysis of Samples and Data

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6.1 (b) (1) Samples, related analytical data, and Doping Control information shall be analyzed to detect
Prohibited Substances and Prohibited Methods identified on the Prohibited List and other substances
as may be directed pursuant to Article 4.4, or to assist the Agency in profiling relevant parameters in a
Covered Horse’s urine, blood, hair, or other matrix, including for DNA or genomic profiling, or for any
other legitimate anti-doping or medical control purpose.

6.1 (c) Research on Samples and Data

6.1 (c) (1) Samples, related analytical data, and Doping Control information may be used for anti-doping
or medication control research purposes. Samples and related analytical data or Doping Control
information used for research purposes shall first be processed in such a manner as to prevent Samples
and related analytical data or Doping Control information being traced back to a particular Covered
Horse or Covered Person.

6.1 (d) Standards for Sample Analysis and Reporting

6.1 (d) (1) Laboratories shall analyze Samples and report results in conformity with the Laboratory
Standards.

6.1 (d) (2) At the time of initial analysis, laboratories at their own initiative and expense may analyze
Samples for Prohibited Substances or Prohibited Methods prohibited at all times that are not included
on the Agency’s standard Sample analysis menu, or as requested by the Agency. For all other
Prohibited Substances and Prohibited Methods laboratories must notify and receive approval from the
Agency prior to reporting an Adverse Analytical Finding for a substance not included on the Agency’s
standard Sample analysis menu. Results from any analysis for substances prohibited at all times or
approved analysis for all other substances shall be reported to the Agency and have the same validity
and Consequences as any other analytical result.

6.1 (e) Further Analysis of a Sample

6.1 (e) (1) There shall be no limitation on the authority of a Laboratory to conduct repeat or additional
analysis on a Sample at any time, whether

6.1 (e) (1) (i) prior to the time the Agency notifies a Covered Person that the Sample is the basis
for an Article 2.4 anti-doping or medication control rule violation or that the Sample is negative or

6.1 (e) (1) (ii) after a Sample has been reported as negative or has otherwise not resulted in an
anti-doping or medication control rule violation. In any case, once a Sample has been collected by
the Agency, it may be stored and subjected to Further Analyses for the purpose of Article 6.1 (b) at
any time exclusively at the direction of the Agency. Further Analysis of Samples shall conform with
the requirements of the Laboratory Standards.

6.1 (f) Split of A or B Sample

6.1 (f) (1) Where the Agency and/or a Laboratory (with approval from the Agency) wishes to split an A or
B Sample for the purpose of using the first part of the split Sample for an A Sample analysis and the
second part of the split Sample for B confirmation, then the procedures set forth in the Laboratory
Standards shall be followed.

7 RESULTS MANAGEMENT

7.1 Results Management for Testing initiated by the Agency

7.1 (a) Results Management for Tests initiated by the Agency or its designee shall proceed as set forth below.
The results from all analyses must be sent to the Agency via secure transmission, in a report signed by an
authorized representative of the Laboratory. All communication must be conducted confidentially.

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7.1 (b) Adverse Analytical Finding Reports

7.1 (b) (1) Upon receipt of an A Sample Adverse Analytical Finding, the Agency shall conduct a review
to determine whether there is any apparent departure from the Testing and Investigations Standards or
Laboratory Standards that caused the Adverse Analytical Finding. Subject to Article 7.1 (b) (2) the
Agency may, but need not, communicate with the Responsible Person and Owner during such review.

7.1 (b) (2) If the initial review of an Adverse Analytical Finding under Article 7.1 (b) (1) does not reveal a
departure that caused the Adverse Analytical Finding, then the Agency shall, promptly give written notice
of the potential anti-doping rule violation to the Responsible Person, Owner, Authority, and applicable
State Racing Commission after the State Racing Commission elects to enter into an agreement
incorporating the confidentiality provisions of Article 12.2 (a) Written notice from the Agency pursuant to
this Article 7.1 (b) (2) shall include the information described in Article 12.1 (a) (1) (i), as well as notify the
Responsible Person and Owner of:

7.1 (b) (2) (i) the Adverse Analytical Finding;

7.1 (b) (2) (ii) the specific potential Protocol violation;

7.1 (b) (2) (iii) the Responsible Person’s and Owner’s opportunity to promptly provide an
explanation regarding the Adverse Analytical Finding within a short deadline;

7.1 (b) (2) (iv) for those substances identified in the Laboratory Standards or Technical Documents
for which immediate analysis of the B Sample is authorized in order to preserve the scientific
integrity of the Sample in accordance with the Laboratory Standards, that the B Sample has been
Tested;

7.1 (b) (2) (v) if the B Sample has not been Tested, the date, time, and place where the B Sample
will be Tested and amount the Responsible Person or Owner must pay to have the B Sample
tested and Laboratory Documentation Package prepared, failing such payment by the date
indicated by the Agency, the B Sample analysis may be deemed irrevocably waived in the
Agency’s sole discretion; and

7.1 (b) (2) (vi) any Provisional Suspension imposed. The Agency shall promptly provide the
Responsible Person and Owner an abbreviated A Sample documentation package at no charge.
Upon receipt of the complete A Sample documentation package from the Laboratory, the Agency
shall provide such to the Responsible Person and Owner, containing all information required by the
Laboratory Standards.

7.1 (b) (3) Except for when the B Sample has been analyzed in accordance with Article 7.1 (b) (2) (iv),
where paid for by the Responsible Person, Owner, or the Agency, arrangements shall be made for
Testing the B Sample within the time-period specified in the Laboratory Standards, or such longer time
as may be reasonably required under the circumstances without undue delay. A Responsible Person
and Owner accept the A Sample analytical results by waiving the requirement for B Sample analysis. If
waived, the Agency may nonetheless elect to proceed with the B Sample analysis.

7.1 (b) (4) If the B Sample proves negative, then, unless the Agency takes the case as an anti-doping or
medication control rule violation under Article 2.5, the entire Test shall be considered negative, and the
Responsible Person and Owner shall be so informed.

7.1 (b) (5) If a Prohibited Substance or the Use of a Prohibited Method is identified (i.e., if the B Sample
analysis confirms the presence—and quantity, if applicable—of a Prohibited Substance or Prohibited
Method in the Sample), or the B Sample analysis is waived (in accordance with this Protocol), the
Responsible Person (or Owner, if no Responsible Person) shall be charged with an anti-doping rule
violation and the Responsible Person and Owner shall be given written notice of:

7.1 (b) (5) (i) the Protocol violation being asserted;

7.1 (b) (5) (ii) the basis of that assertion,

7.1 (b) (5) (iii) the additional information set forth in Article 12.1 (a) (1) (i);

7.1 (b) (5) (iv) the maximum Consequences that the Agency may seek to impose;

7.1 (b) (5) (v) the Responsible Person’s (or Owner’s, if no Responsible Person) right within ten
calendar days [see end note 4] of the notice, to challenge the violation and Consequences in
accordance with the Arbitration Procedures; and

7.1 (b) (5) (vi) that, if the Responsible Person(or Owner, if no Responsible Person) does not
request review by a steward or arbitrator within the time limit indicated in subsection 7.1 (b) (5) (v)

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of this Article, the Consequences will be imposed immediately. If not already provided to the
Responsible Person and Owner, once received by the Agency, the Agency shall promptly provide
the Responsible Person and Owner with copies of the complete A and B Sample Laboratory
Documentation Packages that include all information required by the Laboratory Standards. The
Agency shall not be required to provide the complete A and B Sample documentation if the
Responsible Person and Owner waive analysis of its B Sample. The Agency shall send a copy of
the charge to the Authority and to the applicable State Racing Commission upon the State Racing
Commission electing to enter into an agreement incorporating the confidentiality provisions of
Article 12.2 (a)

7.1 (b) (6) If the B Sample analysis does not confirm the presence of a Prohibited Substance or
Prohibited Method in the Sample, the Agency may, under appropriate circumstances (e.g., evidence the
B Sample did not confirm due to microbial degradation), still charge Covered Person with an anti-
doping rule violation under Article 2.5 and the Agency shall notify the applicable Covered Person in
accordance with Article 7.1 (b) (5).

7.1 (b) (7) After notification of a potential anti-doping rule violation, if at any point during the Results
Management process described in Article 7.1, the Agency decides not to move forward with an anti-
doping rule violation charge, it will notify the Covered Person, State Racing Commission (if prior notice
was given), and the Authority of the Agency’s decision.

7.1 (b) (8) Notification to a Covered Person by the Agency, for all purposes of this Protocol, may be
accomplished either through actual or constructive notice. Constructive notice is sufficient for all
purposes for which notification is required under this Protocol and shall be effective when delivered by
third-party courier or U.S. postal mail to the Covered Person’s most recent mailing address on file with
the Authority or by email to the Covered Person’s most recent email address on file with the Authority.
Actual notice may be accomplished by any other means.

7.1 (c) Atypical Findings Reports

7.1 (c) (1) When a Sample analysis is reported as an Atypical Finding, then the Agency shall do an
investigation and decide whether to treat the Atypical Finding as an Adverse Analytical Finding. The
Agency may, but need not, communicate with the Responsible Person and Owner during such
investigation. If the Agency decides to not treat the matter as an Adverse Analytical Finding, then the
Agency may, but need not, communicate with the applicable Responsible Person and Owner. If the
Agency decides to move forward with the matter as an Adverse Analytical Finding, then the Agency shall
communicate with the Responsible Person and Owner as set forth in Article 7.1 above.

7.1 (d) Atypical Passport Findings and Adverse Passport Findings Reports (when available)

7.1 (d) (1) Review of Atypical Passport Findings and Adverse Passport Findings shall take place as
provided in this Protocol and the Laboratory Standards.

7.1 (d) (2) At such time as the Agency is satisfied that an anti-doping or medication control rule violation
has occurred, it shall promptly charge the Responsible Person (or Owner, if no Responsible Person) as
provided in Article 7.1 (b) (5), as applicable. The Agency shall also send the Owner a copy of the charge
sent to the Responsible Person.

7.2 Results Management for Anti-Doping and Medication Control Rule Violations Not Covered by Article 7.1

7.2 (a) The Agency shall conduct any follow-up investigation required into any potential anti-doping or
medication control rule violation not covered by Article 7.1. At such time as the Agency is satisfied that an anti-
doping or medication control rule violation has occurred, it shall promptly charge the applicable Covered
Person, providing information as identified in Article 7.1 (b) (5) as applicable.

7.3 Identification of Prior Anti-Doping and Medication Control Rule Violations

7.3 (a) Before giving a Covered Person written notice of an asserted anti-doping or medication control rule
violation as provided above, the Agency shall attempt to determine whether any prior anti-doping or
medication control rule violation under this Protocol exists.

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7.4 Provisional Suspensions

7.4 (a) Provisional Suspension.

7.4 (a) (1) For each alleged violation of Articles 2.4 and/or 2.5 involving a Primary Substance or Primary
Method and in connection with one or more Covered Horses, the Agency shall, at the time of notification
(or charge, if no notification), impose a Provisional Suspension on such Covered Horses for no longer
period than the Ineligibility period designated for the particular substance or category of substance in the
Prohibited List.

7.4 (a) (2) For each alleged Article 2.7 violation in which a Covered Horse accrues three Whereabouts
Failures in a twelve-month period, the Agency may impose a Provisional Suspension on such Covered
Horse.

7.4 (a) (3) For each alleged violation of Articles 2.4 and/or 2.5 involving a Primary Substance or Primary
Method, the Agency shall, at the time of notification (or charge, if no notification), impose a Provisional
Suspension on Covered Person who were notified of the alleged violation (or charged, if no notification)
against them.

7.4 (a) (4) For all other violations, the Agency may impose a Provisional Suspension on the Covered
Person who was notified of the alleged violation (or charge, if no notification) against them.

7.4 (b) Where a Provisional Suspension is imposed pursuant to Article 7.4 (a), the applicable Covered
Person, which is the Responsible Person with respect to a Covered Horse, shall be given either: (a) an
opportunity for a Provisional Hearing either before or on a timely basis after imposition of the Provisional
Suspension; or (b) an opportunity for an expedited final adjudication in accordance with Article 8 on a timely
basis after imposition of the Provisional Suspension.

7.4 (b) (1) Provisional Hearings shall be conducted by a single arbitrator for a Major Infraction or a
member of the Anti-Doping Stewards Panel for a Minor Infraction and heard via telephone or video
conference call within the time frame specified by the Agency and in accordance with the Arbitration
Procedures. The sole issue to be determined by the arbitrator at such a hearing will be whether the
Agency’s decision that a Provisional Suspension should be imposed shall be upheld.

7.4 (b) (2) The Agency’s decision to impose a Provisional Suspension shall be upheld if probable cause
exists for the Agency to proceed with a charge of an anti-doping or medication control rule violation
against a Covered Person. It shall not be necessary, however, for any B Sample analysis to have been
completed in order to establish probable cause.

7.4 (c) If a Provisional Suspension is imposed based on an A Sample Adverse Analytical Finding and
subsequent analysis of the B Sample does not confirm the A Sample analysis, then the Covered Horse and
Covered Person shall not be subject to any further Provisional Suspension on account of a violation of Article
2.4.

7.4 (d) In all cases where a Covered Person has been notified of an anti-doping or medication control rule
violation (or charged, if no notification), but a Provisional Suspension has not been imposed on them, the
Covered Person shall be offered the opportunity to accept a Provisional Suspension voluntarily pending the
resolution of the matter.

7.5 Resolution or Imposition of Consequences

7.5 (a) A Covered Person against whom an anti-doping or medication control rule violation is asserted may
admit that violation at any time, expressly waive their right to adjudicate the matter pursuant to Article 8 and
Article 11 and accept the Consequences that have been offered by the Agency.

7.5 (b) Alternatively, if the Covered Person against whom an anti-doping or medication control rule violation is
asserted fails to inform the Agency in writing that they dispute a charged anti-doping or medication control rule
violation within ten calendar days of the Agency sending the charge, then the Covered Person shall be
deemed to have admitted the violation, to have waived their rights under Article 8 and Article 11, and to have
accepted the Consequences that have been offered by the Agency.

7.5 (c) In cases where Article 7.5. (a) or Article 7.5 (b) applies, an adjudication under Article 8 shall not be
required. Instead, the Agency shall promptly issue a release confirming the commission of the anti-doping

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and/or medication control rule violation(s) and the Consequences imposed as a result and setting out a brief
summary of the reasons for any period of Ineligibility imposed unless doing so could compromise an ongoing
investigation or proceeding. The Agency shall Publicly Disclose that release in accordance with Article 12.2
(b)

7.6 Retirement

7.6 (a) If a Covered Horse is retired or is deceased or a Covered Person retires or otherwise becomes
unlicensed while the Agency is conducting the Results Management process, including the investigation of any
Adverse Analytical Finding, Atypical Finding, Atypical Passport Finding, or potential non-analytical violation,
the Agency retains jurisdiction to complete its Results Management process. If a Covered Horse is retired or
is deceased or a Covered Person retires before any Results Management process has begun, and the
Agency had jurisdiction over the Covered Horse or Covered Person at the time the anti-doping or medication
control rule violation was committed, the Agency has authority to conduct Results Management in respect of
that anti-doping or medication control rule violation.

8 RIGHT TO A FAIR PROCESS AND REASONED DECISION

8.1 For any Covered Person who is asserted to have committed an anti-doping or medication control rule violation,
the Agency shall provide the Covered Person the opportunity for resolution before an impartial steward or arbitrator
as set forth below. A timely reasoned decision specifically including an explanation of the reason(s) for any period of
Ineligibility and Disqualification of results shall be Publicly Disclosed as provided in Article 12.2.

8.2 Procedures for Minor Infractions

8.2 (a) Where a Covered Person is alleged to have committed a Minor Infraction under this Protocol, the
Covered Person shall be entitled to submit in writing all arguments and evidence to a member of the Anti-
Doping Stewards Panel in compliance with this Protocol and accompanying Arbitration Procedures. The
member of the Anti-Doping Review Steward Panel shall issue a reasoned decision, including the period of
Ineligibility and other Consequences imposed, if any, to the Agency and the Covered Person within fourteen
calendar days after the final written submission. Subject to the terms of Article 11, decisions rendered
pursuant to this Article 8.2 shall be final and binding.

8.3 Procedures for Major Infractions

8.3 (a) Where a Covered Person is alleged to have committed a Major Infraction under this Protocol, the
Covered Person shall be entitled to a hearing before an impartial arbitrator as set forth in this Protocol and
accompanying Arbitration Procedures. The arbitrator’s reasoned hearing decision, including the period of
Ineligibility and other Consequences imposed, if any, shall be provided by the arbitrator to the Agency and the
Covered Person within fourteen calendar days after the conclusion of the Major Infraction hearing. Subject to
the terms of Article 11, decisions rendered pursuant to this Article 8.3 shall be final and binding.

8.4 Expedited Matters

8.4 (a) For matters involving Major Infractions or Minor Infractions and for which the Covered Horse or Covered
Person is not Provisionally Suspended and the Covered Horse or Covered Person that is not Provisionally
Suspended is likely to participate in a Covered Horserace within forty-five calendar days, the Agency may
address the case in an expedited basis and shorten any deadlines in this Protocol and/or Arbitration
Procedures proportionately to ensure resolution of the matter prior to the Covered Horserace.

9 AUTOMATIC DISQUALIFICATION OF COVERED HORSE’S RESULTS

9.1 An anti-doping or medication control rule violation, arising from a Race Day Test or that occurred on the Race
Day or for purposes of Prohibited Method M5 only in the fourteen calendar days preceding Race Day, automatically
leads to Disqualification of the result in the Race obtained by the Covered Horse(s) connected with the violation with
all resulting Consequences, including forfeiture of any trophies, points, rankings, prizes, purses, and other
compensation.

Horseracing Integrity and Safety Authority


10 SANCTIONS

10.1 Ineligibility of Covered Horses

10.1 (a) For each violation involving any Prohibited Substance or Prohibited Method involving a Covered
Horse, such Covered Horse shall be Ineligible for the time designated for the particular substance or category
of substance in the Prohibited List and may be required to submit a negative Sample prior to returning from
Ineligibility. Unless otherwise indicated in the Prohibited List, there shall be no Ineligibility for Covered Horses
based on violations involving one or more Secondary Substances or Secondary Methods.

10.1 (b) For a violation of Article 2.7 in which a Covered Horse accrues three Whereabouts Failures in a
twelve-month period or a violation of Article 2.6 regarding a specific Covered Horse, such Covered Horse
shall be Ineligible for twelve months and may be required to submit a negative Sample prior to returning from
Ineligibility.

10.1 (c) Under this Protocol, the Responsible Person is the sole representative of interests in a Covered
Horse with respect to Ineligibility and/or retaining competitive results and shall be the sole party representing
the interests of the Covered Horse in any adjudication under Article 8 or Article 11.

10.10 Allocation of Collected Forfeited Purses

10.10 (a) If a Covered Horse has results Disqualified under the Protocol, all purses, other prizes, and trophies
must be repaid or surrendered as applicable to the Race organizer and the other Covered Horses’ positions
adjusted accordingly.

10.11 Multiple Violations for Covered Persons

10.11 (a) Second or Third Major Infractions

10.11 (a) (1) For a Covered Person’s second Major Infraction that qualifies in accordance with Article
10.11 (d), the period of Ineligibility shall be the greater of:

10.11 (a) (1) (i) a six-month period of Ineligibility; or

10.11 (a) (1) (ii) a period of Ineligibility in the range between: i.) the sum of the period of Ineligibility
imposed for the first violation plus the period of Ineligibility otherwise applicable to the second
violation treated as if it were a first violation, not taking into account any reduction under Article
10.7 for either violation, and ii.) twice the period of Ineligibility otherwise applicable to the second
violation treated as if it were a first violation, not taking into account any reduction under Article
10.7.

10.11 (a) (2) The period of Ineligibility within its range shall be determined based on the entirety of the
circumstances and the Covered Person’s degree of Fault with respect to the second violation.

10.11 (a) (3) A third (or greater) Major Infraction will result in a period of Ineligibility of a minimum of
double the period of Ineligibility that would apply if it were a second violation up to a lifetime Ineligibility.

10.11 (a) (4) The period of Ineligibility established may then be further reduced by the application of
Article 10.7.

10.11 (b) Multiple Minor Infractions

10.11 (b) (1) A Covered Person’s second and third Minor Infraction that qualifies shall be treated the
same as a first violation. The Agency in its discretion may require additional education for Covered
Persons who have committed one or more Minor Infractions.

10.11 (b) (2) A Covered Person’s fourth Minor Infraction that qualifies shall be treated as a first Major
Infraction for all purposes under this Protocol and each subsequent Minor Infraction shall be treated as
an additional Major Infraction for all purposes under this Protocol. And a Covered Person’s Minor
Infraction for which the Agency alleges Aggravating Circumstances shall be treated as a Major Infraction
for all purposes under this Protocol.

Horseracing Integrity and Safety Authority


10.11 (c) Additional Rules for Certain Potential Multiple Violations

10.11 (c) (1) For purposes of imposing sanctions under Article 10, an anti-doping or medication control
rule violation will only be considered a second violation if the Agency can establish that the Covered
Person committed the additional anti-doping or medication control rule violation after they received
notice of the first anti-doping or medication control rule violation pursuant to Article 7, or after the Agency
made reasonable efforts to give notice of the first anti-doping or medication control rule violation. If the
Agency cannot establish this, the violations shall be considered together as one single first violation, and
the sanction imposed shall be based on the violation that carries the more severe sanction.

10.11 (c) (2) If, after the imposition of a sanction for a first anti-doping or medication control rule
violation, the Agency discovers facts involving an anti-doping or medication control rule violation by the
Covered Person that occurred prior to notification regarding the first anti-doping or medication control
rule violation, then the Agency may seek imposition of an additional sanction based on the sanction that
could have been imposed if the two violations had been adjudicated at the same time. Results in all
Races dating back to the earlier anti-doping or medication control rule violation will be Disqualified as
provided in Article 10.9.

10.11 (d) Multiple Anti-Doping or Medication Control Rule Violations Qualification

10.11 (d) (1) For purposes of Article 10, each Major Infraction must take place within the same ten-year
period in order to be considered multiple violations, and each Minor Infraction must take place within the
same five-year period in order to be considered multiple violations.

10.12 Status During Ineligibility or Provisional Suspension

10.12 (a) Prohibition against Participation during Ineligibility or Provisional Suspension [see end note 6]

10.12 (a) (1) No Covered Horse which has been declared Ineligible or is the subject of a Provisional
Suspension may, during a period of Ineligibility or Provisional Suspension, participate in any capacity in
a Race, Workout, and any activity at a Racetrack. [see end note7]

10.12 (a) (2) No Covered Person who has been declared Ineligible or is subject to a Provisional
Suspension may, during a period of Ineligibility or Provisional Suspension participate in any capacity in
a Race, Workout, any activity (other than authorized anti-doping education or rehabilitation programs) at
a Racetrack, and any activity involving Covered Horses or have an individual participate in any capacity
on their behalf in any prohibited activity.

10.12 (a) (3) Covered Horses shall remain subject to Testing and the requirement to provide
whereabouts information during a period of Ineligibility.

10.12 (b) Violation of the Prohibition of Participation during Ineligibility or Provisional Suspension

10.12 (b) (1) Where a Covered Horse or Covered Person which has been declared Ineligible violates
the prohibition against participation during Ineligibility described in Article 10.12 (a), the results of such
participation shall be Disqualified and a new period of Ineligibility equal in length to the original period of
Ineligibility shall be added to the end of the original period of Ineligibility for the Covered Horse and the
Covered Person.

10.12 (b) (2) If a Covered Horse violates the prohibition against participation during Ineligibility, the
Responsible Person for the Covered Horse shall also receive a new period of Ineligibility equal in length
to the original period of Ineligibility added to the end of the original period of Ineligibility. If the original
period of Ineligibility already expired, the new period of Ineligibility shall start on the date of acceptance
or imposition. If the Responsible Person did not serve an original period of Ineligibility, the period of
Ineligibility for violating the prohibition against participation shall range from a reprimand to one year.

10.12 (b) (3) The new period of Ineligibility, including, but not limited to, a reprimand and no period of
Ineligibility, may be adjusted based on the Covered Person’s degree of Fault and other circumstances of
the case. The determination of whether there has been a violation of the prohibition against participation,
and whether an adjustment is appropriate, shall be made by the Agency. This decision may be appealed
under Article 11.

Horseracing Integrity and Safety Authority


10.12 (c) A Covered Horse or Covered Person which violates the prohibition against participation during a
Provisional Suspension described in Article 10.12 (a) shall receive no credit for any period of Provisional
Suspension served and the results of such participation shall be Disqualified.

10.12 (d) Where a Covered Person other than the Responsible Person assists a Covered Horse or Covered
Person in violating the prohibition against participation during Ineligibility or a Provisional Suspension, the
Agency shall impose sanctions for a violation of Article 2.13 for such assistance.

10.13 Automatic Publication of Sanction

10.13 (a) A mandatory part of each sanction shall include automatic publication, as provided in Article 12.2.

10.2 Ineligibility of Covered Person for Presence, Use, or Attempted Use or Possession of a Prohibited Substance
or Prohibited Method

10.2 (a) The period of Ineligibility for a violation of Article 2.4, 2.5, or 2.10 shall be as follows, subject to
potential elimination, reduction, or suspension pursuant to Article 10.8, 10.9, or 10.10.

10.2 (a) (1) The period of Ineligibility shall be two years where:

10.2 (a) (1) (i) The anti-doping rule violation involves a Primary Substance or Primary Method.

10.2 (a) (1) (ii) The anti-doping rule violation involves a Secondary Substance or Secondary
Method, and the Agency establishes the existence of Aggravating Circumstances pursuant to
Article 10.4

10.2 (a) (1) (iii) The anti-doping rule violation involves a Secondary Substance or Secondary
Method, and it is the Covered Person’s fourth (or greater) violation pursuant to Article 10.11 (b).

10.2 (a) (2) If Article 10.2.(a) does not apply, the Consequences shall range between a reprimand, a
Fine, and no period of Ineligibility and a Fine and a 30-day period of Ineligibility as described in Article
10.6 (a) (2).

10.3 Ineligibility of Covered Person for Other Anti-Doping and Medical Control Rule Violations

10.3 (a) The period of Ineligibility for anti-doping and medication control rule violations other than as provided
in Article 10.1 shall be as follows, subject to potential reduction pursuant to Articles 10.6 and 10.7:

10.3 (a) (1) For violations of Article 2.6 2.9, 2.11, 2.12 (a), 2.12. (b), 2.13, or 2.14, the period of
Ineligibility shall be two years.

10.3 (a) (2) For violations of Article 2.7, the period of Ineligibility shall be one year.

10.3 (a) (3) For violations of Article 2.8, 2.12 (c), or 2.15, the period of Ineligibility shall be the same as
described in 10.2, except not subject to elimination pursuant to Article 10.5. For purposes of applying
Article 10.2, a medication control violation shall be treated the same as if it was a violation involving a
Secondary Substance or Secondary Method.

10.4 Aggravating Circumstances

10.4 (a) If the Agency establishes in an individual case that Aggravating Circumstances are present that justify
the imposition of a period of Ineligibility greater than the standard sanction, then the period of Ineligibility
otherwise applicable for a Major Infraction shall be increased by an additional period of Ineligibility of up to two
years depending on the seriousness of the violation and the nature of the Aggravating Circumstances, and if
Aggravating Circumstances are alleged in a Minor Infraction case, that case shall be processed as if it was a
Major Infraction.

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10.5 No Violation where there is No Fault or Negligence

10.5 (a) If a Covered Person establishes in an individual case that they bear No Fault or Negligence, then
there shall be no violation. Notwithstanding the foregoing, the Covered Horse shall still be Ineligible in
accordance with Article 10.1 and have results Disqualified in accordance with Article 9 even where the
Covered Person is determined to be without Fault. [see end note 5]

10.6 Reduction of a Covered Person’s Period of Ineligibility based on degree of Fault

10.6 (a) Reduction of Sanctions for Violations of Articles 2.4, 2.5, and 2.10 Based on Degree of Fault

10.6 (a) (1) Where an anti-doping rule violation involves a Primary Substance, Primary Method, or
Aggravating Circumstances, the period of Ineligibility shall range between three months and two years,
depending on the Covered Person’s degree of Fault.

10.6 (a) (2) Where an anti-doping rule violation involves a Secondary Substance and no Aggravating
Circumstances, the period of Ineligibility shall range between a reprimand and Fine and a 30-day period
of Ineligibility, depending on the Covered Person’s degree of Fault.

10.6 (a) (3) Contaminated Products: In cases where the Covered Person establishes that the Prohibited
Substance came from a Contaminated Product, then the period of Ineligibility shall be in the range
between a reprimand and a one-year period of Ineligibility, depending on the Covered Person’s degree
of Fault.

10.6 (b) Reduction of Sanctions for Other Anti-Doping and Medication Control Rule Violations Based on Fault

10.6 (b) (1) Article 2.7 Violations

10.6 (b) (1) (i) Where the anti-doping rule violation is based on Article 2.7 (Whereabouts Failures),
the period of Ineligibility shall range between six months and one year, depending on the
Responsible Person’s degree of Fault. The flexibility regarding the period of Ineligibility in this
Article is not available to a Responsible Person where a pattern of last-minute whereabouts
changes or other conduct raises a serious suspicion that the Responsible Person was trying to
avoid the Covered Horse being available for Testing

10.6 (b) (2) Other Anti-Doping and Medication Control Rule Violations

10.6 (b) (2) (i) The period of Ineligibility for anti-doping and medication control rule violations not
covered by Article 10.6 (a) and 10.6 (b) (1) may be reduced from two years to six months based
on the Covered Person’s degree of Fault.

10.6 (b) (2) (ii) Contaminated Products: In cases where the Covered Person establishes that the
Prohibited Substance came from a Contaminated Product, then the period of Ineligibility shall be
in the range between a reprimand and a one-year period of Ineligibility, depending on the Covered
Person’s degree of Fault.

10.7 Elimination, Reduction, or Suspension of Period of Ineligibility or Other Consequences for a Covered Person
for Reasons Other than Fault

10.7 (a) Substantial Assistance in Discovering or Establishing Other Violations

10.7 (a) (1) The Agency, in its sole discretion, may suspend all or part of the period of Ineligibility
imposed on a Covered Person in a case where the Covered Person has provided Substantial
Assistance to the Agency, a criminal authority, or a professional disciplinary body, including without
limitation the Authority or a State Racing Commission, which results in:

10.7 (a) (1) (i) the Agency discovering or bringing forward an anti-doping or medication control rule
violation by another Covered Person; or

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10.7 (a) (1) (ii) which results in a criminal or disciplinary body discovering or bringing forward a
sport-related criminal offense or the breach of professional or sports rules by another Person,
including without limitation, offenses arising out of a sport integrity violation or sport safety
violation, or the violation of any rule or requirement in the Act, and the information provided by the
Covered Person providing Substantial Assistance is made available to the Agency or as directed
to a third party by the Agency; or

10.7 (a) (1) (iii) which results in the Agency initiating a proceeding against a Laboratory for non-
compliance with the Protocol, a Policy, or Technical Document. The extent to which the otherwise
applicable period of Ineligibility may be Suspended shall be based on the seriousness of the anti-
doping or medication control rule violation committed by the Covered Person and the significance
of the Substantial Assistance provided by the Covered Person described in subsections (i) – (iii)
above. If the Covered Person fails to continue to Cooperate and provide the complete, accurate,
and credible Substantial Assistance upon which a suspension of the period of Ineligibility was
based, the Agency shall reinstate the original period of Ineligibility and other Consequences. The
Agency’s decisions in the context of this Article 10.7.1 are not subject to challenge.

10.7 (a) (2) Admission of an Anti-Doping or Medication Control Rule Violation in the Absence of Other
Evidence

10.7 (a) (2) (i) Where a Covered Person voluntarily admits the commission of an anti-doping or
medication control rule violation before having received notice of a Sample collection which could
establish an anti-doping or medication control rule violation (or, in the case of an anti-doping or
medication control rule violation other than Article 2.4, before receiving first notice of the admitted
violation pursuant to Article 7) and that admission is the only reliable evidence of the violation at
the time of admission, then the period of Ineligibility may be reduced, but not below one-half of the
period of Ineligibility otherwise applicable after reduction pursuant to Article 10.6.

10.8 Commencement of Ineligibility Period

10.8 (a) Except as provided below, the period of Ineligibility shall start on the date of the Article 8 decision
providing for Ineligibility or on the date Ineligibility is accepted or otherwise imposed. Where a Covered
Person or Covered Horse is already serving a period of Ineligibility for an anti-doping or medication control
rule violation, any new period of Ineligibility shall commence on the first day after the current period of
Ineligibility has been served. All competitive results achieved during the period of Ineligibility, including
retroactive Ineligibility, shall be Disqualified.

10.8 (a) (1) Credit for Provisional Suspension or Period of Ineligibility Served

10.8 (a) (1) (i) If a Provisional Suspension is imposed on, or voluntarily accepted by, a Covered
Person/Covered Horse and that Provisional Suspension is respected by the Covered
Person/Covered Horse, then the Covered Person/Covered Horse shall receive a credit for such
period of Provisional Suspension against any period of Ineligibility which may ultimately be
imposed.

10.8 (a) (1) (ii) Except as provided for in 10.8 (a) (2), no credit against a period of Ineligibility shall
be given for any time period before the effective date of the Provisional Suspension regardless of
whether the Covered Person/Covered Horse elected not to participate.

10.8 (a) (2) Where there have been substantial delays in the adjudication process or other aspects of
Doping Control that go well beyond the standard timeframes for Laboratory analyses and the timeframes
for Results Management set forth in the applicable rules, and the Covered Person (which is the
Responsible Person with respect to a Covered Horse) can establish that such delays are not attributable
to the Covered Person, the body imposing the sanction may start the period of Ineligibility at an earlier
date commencing as early as the date of Sample collection or the date on which an alleged anti-doping
or medication control rule violation last occurred.

10.9 Disqualification of Results in Races Subsequent to Sample Collection or Commission of an Anti-Doping or

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Medication Control Rule Violation

10.9 (a) In addition to the automatic Disqualification of the results in the Race provided for under Article 9, all
other competitive results of the Covered Horse obtained from the date an anti-doping or medication control
rule violation first occurred (which for a violation under Article 2.7 is the date of the third Whereabouts Failure)
through the commencement of any Provisional Suspension or Ineligibility period for the Covered Horse, shall,
unless fairness requires otherwise, be Disqualified with all of the resulting Consequences including forfeiture
of any trophies, points, rankings, prizes, purses, and other compensation.

11 APPEAL OF ARTICLE 8 DECISIONS

11.1 Decisions Subject to Review

11.1 (a) Any final decision by a Steward or arbitrator under Article 8 may be appealed by the Covered Person
found to have committed the anti-doping or medication control rule violation or by the Responsible Person on
behalf of the Covered Horse which has been given a period of Ineligibility. Decisions made under this Protocol
may be appealed as set forth below in Articles 11.2 - 11.3 or as otherwise provided in the Protocol or
Policies. Such decisions shall remain in effect while under appeal unless the appellate body orders otherwise.

11.2 Review by Administrative Law Judge

11.2 (a) With respect to the decisions described in Article 11.1, on application which shall include the opening
brief by the Commission, the Agency, or the Covered Person not later than 30 calendar days after the date on
which the decision was issued, the decision shall be subject to de novo review by an administrative law judge.
All administrative law judge hearings shall be conducted within 30 calendar days of a request for review
pursuant to this Article 11. The administrative law judge shall determine whether a Covered Person has
engaged in the anti-doping or medication control rule violation asserted, whether the Covered Person’s
conduct violates this Protocol or the Act, and whether the decision rendered pursuant to Article 8 was arbitrary,
capricious, an abuse of discretion, or otherwise not in accordance with law. The administrative law judge’s
reasoned hearing decision, including the decision to affirm, reverse, modify, set aside, or remand for further
proceedings, in whole or in part, shall be provided to the Agency and the Covered Person within 60 calendar
days after the conclusion of the hearing. Subject to the terms of Article 11.3 below, decisions rendered by the
administrative law judge pursuant to this Article 11.2 shall be final and binding.

11.3 Review by the Commission

11.3 (a) The Commission may, on its own motion not later than 30 calendar days after the date on which the
administrative law judge issues his or her decision, or on petition for Commission review by the Agency or the
Covered Person not later than 30 calendar days after the date on which the administrative law judge issues his
or her decision, review the administrative law judge’s decision which was rendered pursuant to Article 11.2. If
the Commission denies an application for review by the Agency or the applicable Covered Person, which the
Commission may do in its discretion, the decision of the administrative law judge shall constitute the final
decision of the Commission. In considering whether to review the administrative law judge’s decision, the
Commission shall consider whether any of the following circumstances exists:

11.3 (a) (1) a prejudicial error was committed in the conduct of the proceeding conducted pursuant to
Article 11.2,

11.3 (a) (2) the decision involved an erroneous application of the Protocol, or

11.3 (a) (3) an exercise of discretion or a decision of law or Policy warrants review by the Commission.
In the event the Commission decides a review pursuant to this Article 11.3 is warranted, such de novo
review shall be conducted on the record before the administrative law judge as it relates to the factual
findings and conclusions of law made by the administrative law judge. By motion of the Commission on
its own accord or at the request of the Agency or Covered Person who is the subject of the anti-doping
or medication control rule violation, the Commission may consider additional evidence which is material
and for which reasonable grounds exist for the failure by a party to submit such evidence. The
Commission may accept such additional evidence in writing or through testimony, or the Commission
may remand the proceeding to the administrative law judge for the consideration of such additional
evidence, in the Commission’s discretion. The Commission’s reasoned decision, including the decision
to affirm, reverse, modify, set aside, or remand for further proceedings, in whole or in part, the decision
of the administrative law judge, shall be provided to the Agency and the Covered Person within 30
calendar days after the conclusion of any hearing conducted pursuant to this Article 11.3 or final written
submission. Decisions rendered by the Commission pursuant to this Article 11.3 shall be final and

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binding.

12 CONFIDENTIALITY AND REPORTING

12.1 Information Concerning Adverse Analytical Findings, Atypical Findings, and other Asserted Anti-Doping or
Medication Control Rule Violations

12.1 (a) Notice of Anti-Doping or Medication Control Rule Violations to Covered Persons

12.1 (a) (1) Notice to Covered Person of anti-doping or medication control rule violations asserted shall
occur under Articles 7 and 12.1 (a) (1) (i) of this Protocol.

12.1 (a) (1) (i) The contents of an anti-doping or medication control rule violation notice shall
include, at a minimum, the Covered Horse’s and Covered Person’s name, whether the violation
was in connection with a particular Race, whether the Test was conducted on Race Day or
otherwise, the date of Sample collection, the analytical result reported by the Laboratory, or, for
anti-doping or medication control rule violations other than Article 2.4, the rule violated and the
basis of the asserted violation. The failure to properly identify the Race, if any, with which a
violation may be connected shall not invalidate the notice or affect the Disqualification of results
under this Protocol. Any defect in notification may be corrected by the Agency and shall not
invalidate the notice or affect the Disqualification of results under this Protocol.

12.1 (b) Notice of Protocol Violations to State Racing Commissions

12.1 (b) (1) The Agency must notify the applicable State Racing Commission of the assertion of an anti-
doping or medication control rule violation after the State Racing Commission elects to enter into an
agreement incorporating the confidentiality provisions of Article 12.2 (a). The Agency may in its sole
discretion delay notice to the State Racing Commission for case- or investigation-related reasons.

12.1 (c) Status Reports

12.1 (c) (1) When the Agency has given notice of an anti-doping or medication control rule violation
under Article 12.1 (b) the Agency shall provide a written notice of the resolution of the matter to any State
Racing Commission which has been notified and to the Authority.

12.2 Public Disclosure

12.2 (a) After notice of an anti-doping or medication control rule violation has been provided to the Covered
Person in accordance with Article 7 and Article 12, the Agency or Covered Person may Publicly Disclose
information about the alleged violation as it deems appropriate, including but not limited to:

12.2 (a) (1) the identity of any Covered Person who is notified of a potential anti-doping or medication
control rule violation and the applicable Covered Horse,

12.2 (a) (2) the Prohibited Substance or Prohibited Method and nature of the violation involved, and

12.2 (a) (3) whether the Covered Person and Covered Horse are subject to a Provisional Suspension.
The Authority and the State Racing Commission(s) shall not Publicly Disclose information about an
alleged violation unless the information has been previously publicly disclosed by the Agency or Covered
Person or the Agency gives written authorization for the Authority or State Racing Commission to
publicly disclose the information.

12.2 (b) No later than twenty calendar days after a decision pursuant to Article 8, a resolution has been
reached between the Agency and Covered Person, the assertion of an anti-doping or medication control rule
violation has not otherwise been timely challenged, or a new period of Ineligibility or reprimand has been

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imposed under Article 10.12 (b) the Agency must Publicly Disclose the disposition of the anti-doping or
medication control matter including the anti-doping or medication control rule violated (if any), the name of the
Covered Person who committed the violation and any Covered Horse affected by the violation, the Prohibited
Substance or Prohibited Method involved (if any), the Consequences imposed, and reasoned decision under
Article 8 (if any), unless doing so could compromise an ongoing investigation or proceeding. The Agency must
also Publicly Disclose within twenty calendar days the results of appellate decisions concerning anti-doping or
medication control rule violations, including the information described above.

12.2 (c) Publication shall be accomplished at a minimum by placing the required information on the Agency’s
website and leaving the information up for the period by which it may be the basis for multiple violations under
Article 10.11.

12.3 Other Reporting

12.3 (a) The Agency may publish general statistical reports of its Doping Control activities. The Agency may
also publish reports showing the name of any Covered Horses Tested and the date of each Testing.

12.4 Data Privacy

12.4 (a) The Agency may collect, store, process or disclose personal information relating to Covered Person
and Covered Horses where necessary and appropriate to conduct their anti-doping and medication control
activities under the Protocol but shall take appropriate steps to maintain its confidentiality and to maintain such
information in compliance with applicable law.

13 APPLICATION AND RECOGNITION OF DECISIONS

13.1 Any decision regarding a violation of the Protocol shall be recognized by all Covered Person and such
Covered Persons shall take all necessary action to render such decision under this Protocol effective. The Agency
shall recognize and implement other anti-doping and medication control decisions rendered by organizations with
jurisdiction over Covered Persons and Covered Horses if the Agency finds that the decision purports to be within
the authority of that body and the anti-doping and medication control rules of that body in relevant part are otherwise
consistent with this Protocol.

14 STATUTE OF LIMITATIONS

14.1 No anti-doping or medication control rule violation proceeding may be commenced unless the Covered Person
has been notified of the anti-doping or medication control rule violation as provided in Article 7, or notification has
been reasonably attempted, within ten years from the date the violation is asserted to have occurred; however, a
Covered Person’s past conduct that occurred more than ten years prior to an anti-doping or medication control
charge may be admitted as pattern and practice evidence in connection with the anti-doping or medication control
rule violation for conduct committed after the Effective Date.

15 EDUCATION

15.1 The Agency shall plan, implement, evaluate and monitor information, education, and prevention programs for
responsible medication use and doping-free horseracing and shall support active participation by Covered Persons
in such programs. Covered Persons are required to complete Agency provided education yearly prior to registration
with the Authority.

16 ADDITIONAL ROLES AND RESPONSIBILITIES OF COVERED PERSONS

16.1 Owners’ Responsibilities (when not also Responsible Person)

16.1 (a) No matter how many owners, there must be one representative on file with the Authority to receive
communication on behalf of all ownership interests.

16.1 (b) Update changes in ownership interests prior to the effective date.

16.1 (c) Owners accept decisions made removing their Covered Horse from Races in accordance with these
rules and delegate their interest in their Covered Horse adhering to these rules to the Responsible Person.

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16.1 (d) Owners accept that the Responsible Person for the Covered Horse represents the owners’ rights and
interests in the adjudication of alleged anti-doping or medication control rule violations under these rules,
stemming from one or more Prohibited Substances being found in their Covered Horse’s Sample.

16.1 (e) Understand the anti-doping and medication control rules and what conduct constitutes an anti-doping
or medication control rule violation.

16.1 (f) Cooperate with the Agency.

16.1 (g) Provide truthful information to the Authority and Agency in all interactions and filings.

16.1 (h) Not engage in improper, insulting, or obstructive behavior toward Agency personnel in relation to their
duties.

16.1 (i) Not engage in any acts intended to intimidate, threaten, discourage, or retaliate against an individual
who has or intends to report alleged violations of this Protocol to authorities or Cooperate with investigations
regarding violations of this Protocol.

16.2 Responsible Persons’ Responsibilities

16.2 (a) Update designations as to the identity of the Responsible Person for a Covered Horses prior to the
effective date.

16.2 (b) Treatment Records: Keep updated Treatment records in an electronic database designated by the
Agency or in any other form designated by the Agency. The records must include the name of the Covered
Horse, and all Treatments administered to any of the Responsible Person’s Covered Horse(s). The records
must detail the date and time of Administration, the name of the substance, route of Administration, amount,
duration (if multiple dosing), name of person administering and authorizing Administration, the reason for
Administration (such as procedure and diagnosis), and any other information prudent to the health and welfare
of the Covered Horse. These records must be updated within 24 hours of Administration and will be kept for at
least a term determined at the Agency’s sole discretion.

16.2 (c) Ensure that all treatments and medications administered to a Covered Horse for which they are
responsible are given in the best interests of the Covered Horse’s health and welfare, justified by the horse’s
medical condition upon advice from a licensed veterinarian, and do not contain a Prohibited Substance or
Prohibited Method.

16.2 (d) File and update whereabouts information in accordance with the Whereabouts Policy for Covered
Horses for which they are responsible.

16.2 (e) Ensure a Nominated Person is available when a Covered Horse is selected for Sample collection
and ensure the Nominated Person is eighteen years or older and is a Covered Person or has the requisite
information or education to adequately represent the Responsible Person through the Sample Collection
Session.

16.2 (f) Provide truthful information to the Authority and Agency in all interactions and filings.

16.2 (g) Make Covered Horses for which they are responsible available for sample collection at any time and
any place.

16.2 (h) Take responsibility for what a Covered Horse for which they are responsible ingest and Use.

16.2 (i) Ensure no Prohibited Substance or Prohibited Method is ingested or Used by their Covered Horse,
and ensure no Prohibited Substance is found in their Covered Horses’ Samples.

16.2 (j) Understand the anti-doping and medication control rules and what conduct constitutes an anti-doping
or medication control rule violation.

16.2 (k) Immediately notify the Authority in writing with information on when a female Covered Horse has been
bred, is determined to be pregnant, and is no longer pregnant.

16.2 (l) Immediately notify the Authority when a Covered Horse dies.

16.2 (m) Provide Agency access to treatment records on Covered Horses.

16.2 (n) Supervise assistance, keepers, subordinate Trainers by vetting at the time of hire, monitoring
activities related to Covered Horses, ensuring they understand their responsibilities under the anti-doping and
medication control rules, and creating and maintaining systems to ensure subordinates compliance with the
anti-doping and medication control rules.

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16.2 (o) Inform medical personnel, including without limitation Veterinarians, of their obligations to ensure that
Use of Prohibited Substances and Prohibited Methods in Covered Horses for which they are responsible
does not occur.

16.2 (p) Cooperate with the Agency.

16.2 (q) For all purposes under the Protocol, represent the interests in a Covered Horse for which they are
responsible retaining competitive results and/or not receiving a period of Ineligibility.

16.2 (r) Not engage in improper, insulting, or obstructive behavior toward Agency personnel in relation to their
duties.

16.2 (s) Not engage in any acts intended to intimidate, threaten, discourage, or retaliate against an individual
who has or intends to report alleged violations of this Protocol to authorities or Cooperate with investigations
regarding violations of this Protocol.

16.3 Veterinarians' Responsibilities

16.3 (a) Immediately notify the Authority in writing with information on when a female Covered Horse has been
bred, is determined to be pregnant, and is no longer pregnant.

16.3 (b) Cooperate with the Agency.

16.3 (c) Treatment Records: Keep updated Treatment records in an electronic database designated by the
Agency or in any other form designated by the Agency. The records must include the name of the Covered
Horse, and all Treatments administered or prescribed to any Covered Horse by the Veterinarian. The records
must detail the date and time of Administration (if applicable), the name of the substance, route of
Administration, amount, duration, name of person administering (if applicable) and authorizing Administration,
the reason for Administration (such as procedure and diagnosis), and any other information prudent to the
health and welfare of the Covered Horse. These records must be updated within 24 hours of Administration
and will be kept for at least a term determined at the Agency’s sole discretion.

16.3 (d) Provide Agency access to medical records on Covered Horses.

16.3 (e) Provide truthful information to the Authority and Agency in all interactions and filings.

16.3 (f) Understand the anti-doping and medication control rules and what conduct constitutes an anti-doping
or medication control rule violation.

16.3 (g) Ensure that all Treatment and medication administered to a Covered Horse by or at the direction or
approval of the Veterinarian is given in the best interests of the Covered Horse’s health and welfare and
justified by the horse’s medical condition.

16.3 (h) Not engage in any acts intended to intimidate, threaten, discourage, or retaliate against an individual
who has or intends to report alleged violations of this Protocol to authorities or Cooperate with investigations
regarding violations of this Protocol.

16.4 Other Covered Persons’ Responsibilities

16.4 (a) Understand the anti-doping and medication control rules and what conduct constitutes an anti-doping
or medication control rule violation.

16.4 (b) Cooperate with the Agency.

16.4 (c) Provide truthful information to the Authority and Agency in all interactions and filings.

16.4 (d) Ensure no Prohibited Substance or Prohibited Method is ingested or Used by a Covered Horse in
their care.

16.4 (e) Not engage in improper, insulting, or obstructive behavior toward Agency personnel in relation to their
duties.

16.4 (f) Make Covered Horses under their care available for sample collection at any time and any place.

16.4 (g) Not engage in any acts intended to intimidate, threaten, discourage, or retaliate against an individual
who has or intends to report alleged violations of this Protocol to authorities or Cooperate with investigations
regarding violations of this Protocol.

Horseracing Integrity and Safety Authority


17 WAIVER AND RELEASE

17.1 As a condition of participating in or preparing for a Race or working with a Covered Horse which is
participating in or preparing for a Race, Covered Persons agree to release and hold harmless the Agency, the
Authority, and all other Equine Constituencies and their designees from any claim, demand or cause of action,
known or unknown, now or hereafter arising, including attorney’s fees, resulting from acts or omissions which
occurred in good faith.

18 AMENDMENT AND INTERPRETATION OF THIS PROTOCOL

18.1 This Protocol, the Prohibited List, and the Policies may be amended from time to time by the Commission.

18.2 This Protocol shall be interpreted as an independent and autonomous text and not by reference to existing law
or statutes.

18.3 The headings used for the various parts and Articles of this Protocol are for convenience only and shall not be
deemed part of the substance of this Protocol or to affect in any way the language of the provisions to which they
refer.

18.4 The World Anti-Doping Code (“Code”), the comments annotating various provisions of the Code, and Policies
shall be used to interpret this Protocol. If there is a conflict, this Protocol shall prevail.

18.5 This Protocol shall not apply retroactively to matters pending before the Effective Date.

18.5 (a) A Presence violation after the Effective Date stemming from Use or Administration prior to the
Effective Date shall not be a violation for the Covered Horse, the Responsible Person, and any related
Covered Persons.

18.5 (b) The relevant State Racing Commission retains authority prior to the Effective Date.

19 TRANSITIONAL PROVISIONS

19.1 General Application of the 2022 Protocol

19.1 (a) The 2022 Protocol shall apply in full as of July 1, 2022 (the “Effective Date”).

19.2 Additional Protocol Amendments

19.2 (a) Any additional Protocol amendments shall go into effect as provided in Article 18.1.

Prohibited List (Not Submitted to FTC)


20 Prohibited at All Times (Race Day and Out-of-Competition)

20.1 Prohibited Substance(s)

20.1 (a) S0 Non-approved Substances

20.1 (a) (1) Any pharmacological substance which is not addressed by any of the subsequent sections
of the List and with no current approval by any governmental regulatory health authority for veterinary or
human therapeutic use (e.g., drugs under pre-clinical or clinical development or discontinued, designer
drugs) or any substance not universally recognized by veterinary regulatory authorities as a valid
veterinary therapeutic Treatment is prohibited at all times.

20.1 (b) S1 Anabolic Agents - The following substances, and other substances with similar chemical structure
or similar biological effect(s), are prohibited.

Horseracing Integrity and Safety Authority


20.1 (b) (1) Anabolic Androgenic Steroids (when administered exogenously), including but not limited to:

20.1 (b) (1) (i) 1-Androstenediol (5α-androst-1-ene-3β, 17β-diol)

20.1 (b) (1) (ii) 1-Androstenedione (5α-androst-1-ene-3, 17-dione)

20.1 (b) (1) (iii) 1-Androsterone (3α-hydroxy-5α-androst-1- ene-17-one)

20.1 (b) (1) (iv) 1-Epiandrosterone (3β-hydroxy-5α-androst- 1-ene-17-one)

20.1 (b) (1) (ix) 7α-hydroxy-DHEA

20.1 (b) (1) (l) Norethandrolone

20.1 (b) (1) (li) Oxabolone

20.1 (b) (1) (lii) Oxandrolone

20.1 (b) (1) (liii) Oxymesterone

20.1 (b) (1) (liv) Oxymetholone

20.1 (b) (1) (lix) Stenbolone

20.1 (b) (1) (lv) Prasterone (dehydroepiandrosterone, DHEA, 3β-hydroxyandrost-5-en-17-one)

20.1 (b) (1) (lvi) Prostanozol (17β-[(tetrahydropyran-2-yl) oxy]-1’H-pyrazolo[3,4:2,3]-5α-androstane)

20.1 (b) (1) (lvii) Quinbolone

20.1 (b) (1) (lviii) Stanozolol

20.1 (b) (1) (lx) Testosterone

20.1 (b) (1) (lxi) Tetrahydrogestrinone (17-hydroxy-18a- homo-19-nor-17α-pregna-4,9,11-trien-3-


one)

20.1 (b) (1) (lxii) Tibolone

20.1 (b) (1) (lxiii) Trenbolone (17β-hydroxyestr-4,9,11-trien-3- one

20.1 (b) (1) (v) 1-Testosterone (17β-hydroxy-5α-androst-1- en-3-one)

20.1 (b) (1) (vi) 4-Androstenediol (androst-4-ene-3β,17β- diol)

20.1 (b) (1) (vii) 4-Hydroxytestosterone (4,17β-dihydroxyandrost-4-en-3-one)

20.1 (b) (1) (viii) 5-Androstenedione (androst-5-ene-3,17- dione)

20.1 (b) (1) (x) 7β-hydroxy-DHEA

20.1 (b) (1) (xi) 7-Keto-DHEA

20.1 (b) (1) (xii) 19-Norandrostenediol (estr-4-ene-3,17-diol)

20.1 (b) (1) (xiii) 19-Norandrostenedione (estr-4-ene-3,17- dione)

20.1 (b) (1) (xiv) Androstanolone (5α-dihydrotestosterone, 17β-hydroxy-5α-androstan-3-one)

20.1 (b) (1) (xix) Boldione (androsta-1,4-diene-3,17-dione)

20.1 (b) (1) (xl) Methyl-1-testosterone (17β-hydroxy-17α- methyl-5α-androst-1-en-3-one)

20.1 (b) (1) (xli) Methylclostebol

20.1 (b) (1) (xlii) Methyldienolone (17β-hydroxy-17α- methylestra-4,9-dien-3-one)

20.1 (b) (1) (xliii) Methylnortestosterone (17β-hydroxy-17α- methylestr-4-en-3-one)

20.1 (b) (1) (xliv) Methyltestosterone

20.1 (b) (1) (xlix) Norclostebol (4-chloro-17β-ol-estr-4-en-3- one)

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20.1 (b) (1) (xlv) Metribolone (methyltrienolone, 17β-hydroxy- 17α-methylestra-4,9,11-trien-3-one)

20.1 (b) (1) (xlvi) Mibolerone

20.1 (b) (1) (xlvii) Nandrolone (19-nortestosterone)

20.1 (b) (1) (xlviii) Norboletone

20.1 (b) (1) (xv) Androstenediol (androst-5-ene-3β,17β-diol)

20.1 (b) (1) (xvi) Androstenedione (androst-4-ene-3,17- dione)

20.1 (b) (1) (xvii) Bolasterone

20.1 (b) (1) (xviii) Boldenone

20.1 (b) (1) (xx) Calusterone

20.1 (b) (1) (xxi) Clostebol

20.1 (b) (1) (xxii) Danazol ([1,2]oxazolo[4’,5’:2,3]pregna-4-en- 20-yn-17α-ol)

20.1 (b) (1) (xxiii) Dehydrochlormethyltestosterone (4-chloro- 17β-hydroxy-17α-methylandrosta-1,4-


dien- 3-one)

20.1 (b) (1) (xxiv) Desoxymethyltestosterone (17α-methyl-5α- androst-2-en-17β-ol and 17α-methyl-


5α- androst-3-en-17β-ol)

20.1 (b) (1) (xxix) Ethylestrenol (19-norpregna-4-en-17α-ol)

20.1 (b) (1) (xxv) Drostanolone

20.1 (b) (1) (xxvi) Epiandrosterone (3β-hydroxy-5α-androstan- 17-one)

20.1 (b) (1) (xxvii) Epi-dihydrotestosterone (17β-hydroxy-5β- androstan-3-one)

20.1 (b) (1) (xxviii) Epitestosterone

20.1 (b) (1) (xxx) Fluoxymesterone

20.1 (b) (1) (xxxi) Formebolone

20.1 (b) (1) (xxxii) Furazabol (17α-methyl [1,2,5] oxadiazolo[3’,4’:2,3]-5α-androstan-17β-ol)

20.1 (b) (1) (xxxiii) Gestrinone

20.1 (b) (1) (xxxiv) Mestanolone

20.1 (b) (1) (xxxix) Methasterone (17β-hydroxy-2α,17α- dimethyl-5α-androstan-3-one)

20.1 (b) (1) (xxxv) Mesterolone

20.1 (b) (1) (xxxvi) Metandienone (17β-hydroxy-17α- methylandrosta-1,4-dien-3-one)

20.1 (b) (1) (xxxvii) Metenolone

20.1 (b) (1) (xxxviii) Methandriol

20.1 (b) (2) Other Anabolic Agents, including but not limited to:

20.1 (b) (2) (i) Clenbuterol, Selective androgen receptor modulators [SARMs, e.g., andarine, LGD-
4033 (ligandrol) enobosarm (ostarine), RAD140, AC-262536, GW 501516, YK-11, BMS-564,929,
S-23, LGD-121071, LY-245247, GSK 2881078, LGD-2226, S-40503, TFM-4AS-1 and LGD-
3033], Zeranol, Zilpaterol, Ractopamine

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20.1 (c) S2 Peptide Hormones, Growth Factors, Related Substances, and Mimetics -The following
substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited.

20.1 (c) (1) Erythropoietins (EPO) and Agents affecting erythropoiesis, including but not limited to:

20.1 (c) (1) (i) Erythropoietin-Receptor Agonists, including but not limited to: Darbepoetins
(dEPO), Erythropoietins (EPO), EPO-based constructs [e.g., EPO-Fc, methoxy polyethylene
glycol-epoetin beta (CERA)], EPO-mimetic agents and their constructs (e.g., CNTO-530,
peginesatide)

20.1 (c) (1) (ii) Hypoxia-Inducible Factor (HIF) Activating Agents, including but not limited to:
Cobalt, Daprodustat (GSK1278863), IOX2, Molidustat (BAY 85-3934), Roxadustat (FG-4592),
Vadadustat (AKB-6548), Xenon, Argon

20.1 (c) (1) (iii) Exceptions: a.) Injectable Cobalt: maximum 1mg over 24 hours period (recognized,
legitimate Treatment) b.) Oral Cobalt: maximum 5mg over 24 hours period (nutritional supplement)

20.1 (c) (1) (iv) GATA Inhibitors, including but not limited to: K-11706

20.1 (c) (1) (v) Transforming Growth Factor-beta (TGF-β) signalling inhibitors, including but not
limited to: Luspatercept, Sotatercept

20.1 (c) (1) (vi) Innate Repair Receptor Agonists, including but not limited to: Asialo EPO,
Carbamylated EPO (CEPO)

20.1 (c) (2) Peptide Hormones and their Releasing Factors, including but not limited to:

20.1 (c) (2) (i) Chorionic Gonadotrophin (CG) and Luteinizing Hormone (LH) and their Releasing
Factors in Males and Geldings, including but not limited to: Buserelin, Deslorelin, Gonadorelin,
Goserelin, Leuprorelin, Nafarelin, Triptorelin

20.1 (c) (2) (ii) Corticotrophins and their Releasing Factors, including but not limited to:
Corticorelin

20.1 (c) (2) (iii) Growth Hormone (GH), its analogues and fragments, including but not limited to:
Growth hormone analogues, e.g., lonapegsomatropin, somapacitan, and somatrogon; Growth
hormone fragments, e.g., AOD-9604 and hGH 176-191

20.1 (c) (2) (iv) Growth hormone releasing factors, including but not limited to: Growth hormone-
releasing hormone (GHRH) and its analogues, e.g., CJC-1293, CJC-1295, sermorelin and
tesamorelin; Growth hormone secretagogues (GHS), e.g., lenomorelin (ghrelin) and its mimetics,
MK-677 (ibutamoren), anamorelin, ipamorelin, macimorelin and tabimorelin; GH-releasing
peptides (GHRPs), e.g., alexamorelin, GHRP-1, GHRP-2 (pralmorelin), GHRP-3, GHRP-4, GHRP-
5, GHRP-6, and examorelin (hexarelin)

20.1 (c) (3) Growth factors and growth factor modulators, including but not limited to:

20.1 (c) (3) (i) Fibroblast growth factors (FGFs)

20.1 (c) (3) (ii) Hepatocyte growth factor (HGF)

20.1 (c) (3) (iii) Insulin-like growth factor 1 (IGF-1) and its analogues

20.1 (c) (3) (iv) Mechano growth factors (MGFs)

20.1 (c) (3) (v) Platelet-derived growth factor (PDGF)

20.1 (c) (3) (vi) Thymosin-β4 and its derivatives e.g., TB-500

20.1 (c) (3) (vii) Vascular endothelial growth factor (VEGF)

20.1 (c) (3) (viii) and other growth factors or growth factor modulators affecting muscle, tendon or
ligament protein synthesis/degradation, vascularisation, energy utilization, regenerative capacity or
fibre type switching.

Horseracing Integrity and Safety Authority


20.1 (d) S3 Beta-2 Agonists - The following substances, and other substances with similar chemical structure
or similar biological effect(s), are prohibited.

20.1 (d) (1) All selective and non-selective beta-2 agonist, including all optical isomers, are prohibited,
including but not limited to:

20.1 (d) (1) (i) Arformoterol

20.1 (d) (1) (ii) Fenoterol

20.1 (d) (1) (iii) Formoterol

20.1 (d) (1) (iv) Higenamine

20.1 (d) (1) (ix) Indacaterol

20.1 (d) (1) (v) Levosalbutamolt

20.1 (d) (1) (vi) Olodaterol

20.1 (d) (1) (vii) Procaterol

20.1 (d) (1) (viii) Reproterol

20.1 (d) (1) (x) Salbutamol

20.1 (d) (1) (xi) Salmeterol

20.1 (d) (1) (xii) Terbutaline

20.1 (d) (1) (xiii) Tretoquinol (trimetoquinol)

20.1 (d) (1) (xiv) Tulobuterol

20.1 (d) (1) (xv) Vilanterol

20.1 (d) (2) Exceptions:

20.1 (d) (2) (i) Inhaled beta-2 agonists e.g., albuterol (salbutamol) when prescribed by a
veterinarian as a bronchodilator at an appropriate dose.

20.1 (e) S4 Hormone and Metabolic Modulators - The following substances, and other substances with similar
chemical structure or similar biological effect(s), are prohibited.

20.1 (e) (1) Aromatase Inhibitors, including but not limited to:

20.1 (e) (1) (i) 2-Androstenol (5α-androst-2-en-17-ol)

20.1 (e) (1) (ii) 2-Androstenone (5α-androst-2-en-17-one)

20.1 (e) (1) (iii) 3-Androstenol (5α-androst-3-en-17-ol)

20.1 (e) (1) (iv) 3-Androstenone (5α-androst-3-en-17-one)

20.1 (e) (1) (ix) 4-Androstene-3,6,17 trione (6-oxo)

20.1 (e) (1) (v) Aminoglutethimide

20.1 (e) (1) (vi) Anastrozole

20.1 (e) (1) (vii) Androsta-1,4,6-triene-3,17-dione (androstatrienedione)

20.1 (e) (1) (viii) Androsta-3,5-diene-7,17-dione (arimistane)

20.1 (e) (1) (x) Exemestane

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20.1 (e) (1) (xi) Formestane

20.1 (e) (1) (xii) Letrozole

20.1 (e) (1) (xiii) Testolactone

20.1 (e) (2) Anti-estrogenic substances [Anti-estrogens and selective estrogen receptor modulators
(SERMS)], including but not limited to:

20.1 (e) (2) (i) Bazedoxifene

20.1 (e) (2) (ii) Clomifene

20.1 (e) (2) (iii) Cyclofenil

20.1 (e) (2) (iv) Fulvestrant

20.1 (e) (2) (v) Ospemifene

20.1 (e) (2) (vi) Raloxifene

20.1 (e) (2) (vii) Tamoxifen

20.1 (e) (2) (viii) Toremifene

20.1 (e) (3) Agents preventing activin receptor IIB activation, including but not limited to:

20.1 (e) (3) (i) Activin A-neutralizing antibodies

20.1 (e) (3) (ii) Activin receptor IIB competitors such as: Decoy activin receptors (e.g., ramatercept
(ACE-031), dalantercept (ACE-041))

20.1 (e) (3) (iii) Anti-activin receptor IIB antibodies (e.g., bimagrumab)

20.1 (e) (3) (iv) Myostatin inhibitors such as: Agents reducing or ablating myostatin expression,
Myostatin-binding proteins (e.g., follistatin, myostatin propeptide), Myostatin-neutralizing
antibodies (e.g., domagrozumab, landogrozumab, stamulumab)

20.1 (e) (4) Metabolic Modulators

20.1 (e) (4) (i) Activators of the AMP-Activated Protein Kinase (AMPK), including but not limited to:
AICAR, SR9009, Peroxisome proliferator-activated receptor delta (PPARδ) agonists, e.g., 2-(2-
methyl-4-((4-methyl-2-(4-(trifluoromethyl)phenyl)thiazol-5-yl)methylthio)phenoxy) acetic acid
(GW1516, GW501516)

20.1 (e) (4) (ii) Insulins and Insulin-Mimetics

20.1 (e) (4) (iii) Meldonium

20.1 (e) (4) (iv) Trimetazidinet

20.1 (e) (5) Thyroid hormone and thyroid hormone modulators, including but not limited to:

20.1 (e) (5) (i) Thyroxine

20.1 (e) (5) (ii) Tetraiodothyronine

20.1 (e) (5) (iii) Triiodothyronine

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20.1 (f) S5 Diuretics and Masking Agents

20.1 (f) (1) The following diuretics and masking agents are prohibited, as are other substances with a
similar chemical structure or similar biological effect(s), including but not limited to:

20.1 (f) (1) (i) Acetazolamide

20.1 (f) (1) (ii) Amiloride

20.1 (f) (1) (iii) Bumetanide

20.1 (f) (1) (iv) Chlortalidone

20.1 (f) (1) (ix) Canrenone

20.1 (f) (1) (v) Desmopressin

20.1 (f) (1) (vi) Etacrynic acid

20.1 (f) (1) (vii) Indapamide

20.1 (f) (1) (viii) Metolazone

20.1 (f) (1) (x) Plasma expanders, e.g., intravenous Administration of albumin, dextran,
hydroxyethyl starch and mannitol

20.1 (f) (1) (xi) Probenecid

20.1 (f) (1) (xii) Spironolactone

20.1 (f) (1) (xiii) Thiazides, e.g., bendroflumethiazide, chlorothiazide and hydrochlorothiazide

20.1 (f) (1) (xiv) Triamterene

20.1 (f) (1) (xv) Vaptans, e.g., tolvaptan

20.1 (f) (2) Exceptions:

20.1 (f) (2) (i) Drospirenone; pamabrom; and topical ophthalmic Administration of carbonic
anhydrase inhibitors (e.g., dorzolamide, brinzolamide)

20.1 (f) (2) (ii) Furosemide

20.1 (f) (2) (iii) Trichlormethiazide for treatment of edema

20.1 (f) (2) (iv) Use of any S5 agent, such as plasma expanders for procedures performed for life-
saving purposes.

20.1 (g) S6 Miscellaneous Substances - The following substances, and other substances with similar chemical
structure or similar biological effect(s), are prohibited.

20.1 (g) (1) Bisphosphonates, including but not limited to:

20.1 (g) (1) (i) Alendronate

20.1 (g) (1) (ii) Clodronic acid

20.1 (g) (1) (iii) Ibandronate

20.1 (g) (1) (iv) Pamidronate

20.1 (g) (1) (v) Risedronate

20.1 (g) (1) (vi) Tiludronic acid

20.1 (g) (1) (vii) Zoledronic acid

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20.1 (g) (1) (viii) Exceptions: Bisphosphonates administered for the purpose of diagnostic imaging
(gamma scintigraphy).

20.1 (g) (2) Toxins & Venoms of any species or derivatives of them, and their synthetic analogues,
including but not limited to:

20.1 (g) (2) (i) Alpha-cobratoxin

20.1 (g) (2) (ii) Dermorphin

20.1 (g) (2) (iii) Ziconotide

20.1 (g) (3) Altrenogest in Males or Geldings

20.1 (g) (4) Pitcher plant extract

20.2 Prohibited Method(s)

20.2 (a) M1 Manipulation of Blood and Blood Components

20.2 (a) (1) The Administration or reintroduction of any quantity of autologous, allogenic (homologous) or
heterologous blood, or red blood cell products of any origin into the circulatory system.

20.2 (a) (2) Artificially enhancing the uptake, transport or delivery of oxygen. Including, but not limited to:
Perfluorochemicals; efaproxiral (RSR13) and modified haemoglobin products, e.g., haemoglobin-based
blood substitutes and microencapsulated haemoglobin products, excluding supplemental oxygen by
inhalation.

20.2 (a) (3) Any form of intravascular manipulation of the blood or blood components by physical or
chemical means.

20.2 (a) (4) Withdrawal of blood for any purpose other than for diagnostic/Laboratory Testing
procedures.

20.2 (a) (5) Exceptions:

20.2 (a) (5) (i) Procedures performed for life-saving purposes.

20.2 (a) (5) (ii) Use of veterinary regenerative therapies (autologous conditioned serum or platelet-
rich plasma), for the treatment of musculoskeletal injury or disease.

20.2 (b) M2 Chemical and Physical Manipulation

20.2 (b) (1) Tampering, or Attempted Tampering, to alter the integrity and validity of Samples collected
during Doping Control, including, but not limited to, Sample substitution and/or adulteration, e.g.,
addition of proteases to Sample.

20.2 (b) (2) Use of chemical castration or immunocastration.

20.2 (c) M3 Gene and Cell Doping

20.2 (c) (1) The following, with the potential to enhance performance or modify the heritable genome, are
prohibited:

20.2 (c) (1) (i) The use of nucleic acids or nucleic acid analogues that may alter genome
sequences and/ or alter gene expression by any mechanism. This includes but is not limited to
gene editing, gene silencing and gene transfer technologies.

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20.2 (c) (1) (ii) The use of normal or genetically modified cells.

20.2 (c) (1) (iii) Modification of the heritable genome

21 Prohibited on Race Day

21.1 Medications administered by Official Veterinarians providing emergency medical care to a Covered Horse as
a result of an injury sustained or other adverse health event during a Covered Horserace are not prohibited.

21.2 Substances prohibited on Race Day must not be Administered during the Race Period, which commences 48
hours prior to a Covered Horse’s start in any Race or Workout.

21.3 Prohibited Substance(s)

21.3 (a) S7 Supplements and feed additives and substances capable at any time of causing an action or
effect, or both an action and effect, within one or more of the following mammalian body systems:

21.3 (a) (1) the blood system

21.3 (a) (10) the urinary system

21.3 (a) (2) the cardiovascular system

21.3 (a) (3) the digestive system

21.3 (a) (4) the endocrine system

21.3 (a) (5) the immune system

21.3 (a) (6) the musculoskeletal system

21.3 (a) (7) the nervous system

21.3 (a) (8) the reproductive system

21.3 (a) (9) the respiratory system

21.3 (b) All substances, including all optical isomers, e.g., d- and l- where relevant.

21.3 (c) Metabolites, artifacts, and isomers of S7 substances.

21.3 (d) Exceptions:

21.3 (d) (1) Normal food and water.

21.3 (d) (10) Orally administered chondroitin sulphate.

21.3 (d) (11) Orally administered glucosamine.

21.3 (d) (12) Orally administered vitamins.

21.3 (d) (13) Ranitidine.

21.3 (d) (14) Registered vaccines against infectious agents.

21.3 (d) (2) Electrolytes sodium, potassium, and chloride only.

21.3 (d) (3) Altrenogest in female horses.

21.3 (d) (4) Antimicrobials (antibiotics) and other anti-infective agents, excluding procaine penicillin or
other antimicrobial/anti-infective agents containing other Prohibited Substances.

Horseracing Integrity and Safety Authority


21.3 (d) (5) Antiparasitic/anthelmintics approved and registered for use in horses, excluding levamisole
or other antiparasitic/anthelmintics metabolising to and/or containing other Prohibited Substances.

21.3 (d) (6) Cimetidine.

21.3 (d) (7) Furosemide during Workouts

21.3 (d) (8) Furosemide administered during the Race Period in accordance with specific provisions of
the Act and/or any guidance or exceptions approved by the Authority.

21.3 (d) (9) Omeprazole.

21.3 (e) S7 substances do not include substances for which there is no current approval by any governmental
regulatory health authority for veterinary or human therapeutic use (e.g., drugs under pre-clinical or clinical
development or discontinued, designer drugs) and any substance not universally recognized by veterinary
regulatory authorities as a valid veterinary therapeutic Treatment that fall within S0 and are therefore prohibited
at all times.

21.4 Prohibited Method(s)

21.4 (a) M4 Alkalinization

21.4 (b) Exceptions:

21.4 (b) (1) Furosemide during Workouts

22 Prohibited in Workouts

22.1 The Prohibited on Race Day portion of the List is applicable for Workouts except for furosemide. See
Definition of Race Day in the Equine Program Definitions, including official timed workouts.

23 Other Prohibited Periods

23.1 Prohibited Substance(s)

23.1 (a) None

23.2 Prohibited Method(s)

23.2 (a) M5 Intra-articular Injection

23.2 (a) (1) Intra-articular injections are prohibited on Race Day, and the fourteen (14) calendar days
preceding Race Day. The Covered Horse is Ineligible to race for fourteen (14) calendar days post
Administration of the intra-articular injection.

24 Table of Ineligibility Periods for Covered Horse

24.1 S0 Non-approved Substances - 14 months

24.1 (a) Exception: human substances of abuse, e.g., cocaine, MDMA - 0 months

24.10 M3 Gene and Cell Doping - LIFE

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24.11 S7 Supplements and feed additives and substances capable at any time of causing an action or effect, or
both an action and effect, within one or more of the following mammalian body systems: the nervous system; the
cardiovascular system; the respiratory system; the digestive system; the urinary system; the reproductive system; the
musculoskeletal system; the blood system; the endocrine system; the immune system - 0 months

24.12 M4 Alkalinization - 0 months

24.2 S1 Anabolic Agents - 14 months

24.2 (a) Exception: zilpaterol/ractopamine where established no Fault ( feed contamination) - 6 months

24.3 S2 Peptide Hormones, Growth Factors, Related Substances, and Mimetics - 6 months

24.4 S3 Beta-2 Agonists - 14 months

24.5 S4 Hormone and Metabolic Modulators - 3 months

24.6 S5 Diuretics and Masking Agents - 0 months

24.7 S6 Miscellaneous Substances

24.7 (a) Bisphosphonates - LIFE

24.7 (b) Other - 0 months

24.8 M1 Manipulation of Blood and Blood Components - 6 months

24.9 M2 Chemical and Physical Manipulation - 0 months

Lab Standards (Not Submitted to FTC)


47 Introduction and Scope

47.1 The Agency Laboratory Standards

47.1 (a) Equine Standards for Laboratories (ESL)

47.1 (a) (1) In the introduction to the Horseracing Anti-Doping and Medication Control Protocol
(Protocol), the purpose and implementation of the Horseracing Anti-Doping and Medication Control
Program are summarized as follows:

47.1 (a) (2) As provided in the Horseracing Integrity and Safety Act of 2020, the purpose of the
Horseracing Anti-Doping and Medication Control Program and this Protocol is to improve the integrity
and safety of Horseracing by requiring a uniform Anti-Doping and Medication Control Program to be
developed and enforced by an independent Horseracing Anti-Doping and Medication Control Authority

47.1 (a) (3) The main purpose of the ESL is

47.1 (a) (3) (i) to ensure that Laboratories report valid test results based on reliable evidentiary
data; and

47.1 (a) (3) (ii) to facilitate harmonization in Analytical Testing of Samples by Laboratories.

47.1 (a) (4) The ESL sets out the requirements to be followed by Laboratories that wish to demonstrate
that they are technically competent, operate within an effective Management System, and can produce
forensically valid results. The ESL includes, inter alia, requirements for obtaining and maintaining HISA
Equine Analytical Laboratory (HEAL) accreditation, operating standards for the performance of
Laboratories, and a description of the accreditation and approval processes. The ESL also sets out
requirements and guidance in relation to Sample custody and storage, Analytical Testing, and some
aspects of Results Management.

47.1 (a) (5) Compliance with the ESL in effect at the time of Sample analysis (as opposed to another
alternative standard, practice, or procedure) shall be sufficient to conclude that the procedures covered

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by the ESL were performed properly. A failure by a Laboratory to follow a requirement in effect at the
time of Analytical Testing, which has subsequently been eliminated from this ESL or applicable
Technical Document(s) or Technical Letter(s) at the time of a hearing, shall not serve as a defense to an
anti-doping rule violation.

47.1 (b) Technical Documents

47.1 (b) (1) Technical Documents are drafted by the Laboratory Expert Group and Agency and
circulated for stakeholder consultation before being finalized. Technical Documents are approved by the
Agency, and Authority as appropriate and published on the Agency website. Once approved, a
Technical Document becomes an integral part of the ESL and supersedes any previous publication on a
similar topic, including Technical Letter(s) and/or the ESL.

47.1 (b) (2) Implementation of the requirements detailed in a Technical Document may occur prior to the
effective date for implementation specified in the Technical Document in accordance with the provisions
below and shall occur no later than the effective date.

47.1 (b) (3) A failure by a Laboratory to implement a Technical Document or Technical Letter by the
effective date may result in the imposition of an Analytical Testing Restriction against the Laboratory for
that Analytical Testing Procedure, or a Suspension of the Laboratory’s HEAL accreditation, respectively,
as determined by the Agency

47.1 (b) (4) If a Laboratory is not able to implement a new Technical Document by its effective date, it
shall inform the Agency as soon as possible. The Laboratory shall send a written request to the Agency
for an extension beyond the applicable effective date, providing the reason(s) for the delayed
implementation of the Technical Document, any measures taken to ensure that Samples received in the
Laboratory will be subject to Analytical Testing in compliance with the new Technical Document (for
example, by subcontracting the analysis to another Laboratory as applicable), as well as plans for the
implementation of the new Technical Document

47.1 (b) (5) The implementation of the Technical Documents requirements into the Laboratory’s
Management System is mandatory for obtaining and maintaining HEAL accreditation or approval,
respectively, and for the application of the relevant Analytical Testing Procedure(s) to the analysis of
Samples

47.1 (b) (6) In cases when a newly approved version of a Technical Document lowers a Threshold for a
Threshold Substance, a Minimum Reporting Level for a Non-Threshold Substance, or any other limit, as
applicable, the revised limits specified in the new Technical Document shall not be applied to the
reporting of analytical results for Samples collected before the effective date of the Technical Document;

47.1 (b) (7) Where the above revised limit specification does not apply, Laboratories may implement a
Technical Document as soon as it is approved by the Agency and Authority, as appropriate, provided
that the requirements of the Technical Document have been implemented and documented
appropriately by the Laboratory

47.1 (b) (8) The most recently approved Technical Document shall be applied to the Analytical Testing of
Samples prior to the effective date if it would lead to a result that benefits the Covered Person and
Covered Horse (e.g., increase of the Threshold for a Threshold Substance or of the Minimum Reporting
Level for a Non-Threshold Substance, or any other limit, establishment of more stringent identification
criteria for chromatographic-mass spectrometric or other Confirmation Procedures). Therefore, in the
case where an analytical finding does not meet the reporting criteria defined in the new Technical
Document, it shall be reported as a Negative Finding

47.1 (c) Technical Letters

47.1 (c) (1) Technical Letters are issued in letter format on an ad-hoc basis to provide direction to the
Laboratories on particular issues on the analysis, interpretation and reporting of results for specific
Prohibited Substance(s) and/or Prohibited Method(s) or on the application of specific Laboratory
procedures. Technical Letters are modified and/or withdrawn by the Agency as appropriate;

47.1 (c) (2) Technical Letters are drafted and approved by the Agency and Authority, in consultation with
relevant scientific experts, and published on the Agency’s website. Technical Letters become effective
immediately, unless otherwise specified by the Agency;

47.1 (c) (3) Once approved, a Technical Letter becomes an integral part of the ESL and supersedes any
previous publication on a similar topic, including Technical Document(s) and/or the ESL;

47.1 (c) (4) The implementation of the requirements of relevant Technical Letters into the Laboratory’s

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Management System is mandatory for obtaining and maintaining HEAL accreditation or approval,
respectively, and for the application of the relevant Analytical Testing Procedure(s) to the analysis of
Samples.

47.1 (d) Laboratory Guidelines

47.1 (d) (1) Laboratory Guidelines are issued to provide direction to the Laboratories on new Analytical
Methods or procedures approved by the Agency. Laboratory Guidelines are modified and/or deleted by
the Agency, as appropriate;

47.1 (d) (2) Laboratory Guidelines are approved by the Laboratory Expert Group (LabEG) and are
published on the Agency website;

47.1 (d) (3) Implementation of Laboratory Guidelines is not mandatory. However, Laboratories are
encouraged to follow, to the fullest extent possible, the recommendations of best practice included in
relevant Laboratory Guidelines.

47.1 (e) Technical Notes

47.1 (e) (1) Technical Notes are issued to Laboratories to provide detailed technical guidance on the
performance of specific Analytical Methods or procedures;

47.1 (e) (2) Technical Notes are approved by the LabEG. Technical Notes are provided to Laboratories
only and are not published on the Agency website;

47.1 (e) (3) Implementation of the recommendations detailed in Technical Notes is not mandatory.
However, Laboratories are encouraged to follow, to the fullest extent possible, the technical guidance
included in Technical Notes.

47.2 Sample Analysis

47.2 (a) Sample analysis is part of the Analytical Testing process and involves the detection, identification,
and in some cases demonstration of the presence above a Threshold of Prohibited Substance(s) and/or their
Metabolite(s), or Marker(s) of Use of Prohibited Substances or Prohibited Methods in an equine Sample

47.2 (b) Laboratories may accept samples for other forms of analysis, subject to the provisions of the ESL
Code of Ethics (see Article 56), which are not under the scope of HEAL accreditation. Any such testing shall
not be covered by the Laboratory's HEAL accreditation and, therefore, shall not be subject to the requirements
of the ESL, Technical Documents or Technical Letters. Test reports or other documentation or
correspondence from Laboratories shall not declare or represent that any such testing is covered under their
HEAL accreditation status.

48 Protocol provisions

48.1 Several articles in the Protocol are directly relevant to the ESL, they can be obtained by referring to the
Protocol itself.

49 Definitions and Interpretations

49.1 Definitions

49.1 (a) See Definitions.

49.2 Interpretation

49.2 (a) The comments annotating various provisions of the ESL shall be used to guide its interpretation

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49.2 (b) Unless otherwise specified, references to Sections and Articles are references to Sections and
Articles of the ESL

49.2 (c) Where the term “days” is used in the ESL, it shall mean calendar days unless otherwise specified

49.2 (d) The Annexes to the ESL have the same mandatory status as the rest of the ESL

50 Racing Medication and Testing Consortium (RMTC) Accredited Laboratories

50.1 This ESL will replace current RMTC accreditation, although a transition phase which may include RMTC
conducting the accreditation program may be agreed between the Agency and RMTC.

50.2 Where a laboratory has current RMTC accreditation, any information required as part of the HEAL application
process which has already been provided as part of their RMTC accreditation, and which the laboratory checks to
confirm it is still current and valid, may with the agreement of the parties be provided to the Agency.

51 Process and Requirements for HEAL Laboratory Accreditation

51.1 This section describes the specific requirements that a laboratory shall fulfill in the process of applying for,
obtaining, and maintaining HEAL accreditation.

51.2 Applicant Laboratory for HEAL accreditation

51.2 (a) In principle, any laboratory that satisfies the criteria listed below may apply to become a candidate
laboratory for HEAL accreditation.

51.2 (b) Submit Initial Application Form

51.2 (b) (1) The applicant laboratory shall submit a completed Application Form, provided by the
Agency, duly signed by the Laboratory Director (or equivalent position) and, if relevant, by the Director
(or equivalent position) of the host organization (e.g., university, hospital, public institution).

51.2 (c) Provision of Business Plan

51.2 (c) (1) The Agency shall request the applicant laboratory to submit a business plan summary, which
shall include market considerations (clients, number of Samples, maintenance costs, prices for analysis
etc.), facility, instrumental, staffing and training needs, and shall make a reasonable guarantee the long-
term provision of adequate financial and human resources to the laboratory.

51.3 Candidate Laboratory for HEAL accreditation

51.3 (a) The application shall be evaluated by the Agency to determine whether the applicant laboratory will be
granted the Agency candidate laboratory status and thereby continue within the HEAL accreditation process.
Additional supporting documentation may be requested by, and at the discretion of the Agency.

51.3 (b) Description of the Candidate Laboratory

51.3 (b) (1) Once approved by the Agency, the candidate laboratory shall complete a detailed
questionnaire and submit it to the Agency. The questionnaire will include, but is not limited to, the
following:

51.3 (b) (10) Status and scope of ISO/IEC 17025 accreditation, according to ILAC-G7 specifications;

51.3 (b) (11) A description of how the principles of the Code of Ethics are integrated into the laboratory
Management System. A letter of compliance with the Code of Ethics signed by the laboratory Director
shall be provided.

51.3 (b) (12) The Agency may require an update of this documentation during the process of
accreditation.

51.3 (b) (2) Staff list and their qualifications, including description of any relevant anti-doping experience

Horseracing Integrity and Safety Authority


and a list of relevant scientific publications by laboratory staff;

51.3 (b) (3) Relevant memberships and engagement with professional societies, such as the
Association of Official Racing Chemists (AORC), World Association of Anti-Doping Scientists
(WAADS), Society of Forensic Toxicologists (SOFT) and The International Association of Forensic
Toxicologists (TIAFT);

51.3 (b) (4) Description of the physical laboratory facilities, including a description of the security
considerations for Samples and records. The laboratory facilities shall include ample analytical and
administrative space to allow separate, restricted and dedicated areas for analytical and administrative
operations

51.3 (b) (4) (i) Physical Security: specific measures to maintain secure and restricted access to
the laboratory facility and a controlled internal laboratory environment (e.g., dedicated and
restricted Sample storage areas, CCTV monitoring);

51.3 (b) (4) (ii) IT Security: implementation of firewalls and other cyber security measures
consistent with best practice and any applicable governmental regulations (see Article 53.2 (c)
(5));

51.3 (b) (4) (iii) Information Technology (IT) infrastructure: implementation of a data and information
management system (e.g., LIMS), central server/intranet which allows secure data handling (see
Article 53.2(c) (5)).

51.3 (b) (5) List of actual and proposed instrumental resources and equipment, including year of
purchase and conditions for technical support (e.g., contract/access to instrument manufacturer
maintenance services);

51.3 (b) (6) List of validated Initial Testing Procedure(s) and Confirmation Procedures, including target
Analytes and Limits of Detection (LODs), Limits of Identification (LOIs) and, where applicable, Limits of
Quantification (LOQs) and estimates of Measurement Uncertainty (MU);

51.3 (b) (7) Status of method development and validation, including, at minimum, all mandatory
Analytical Methods and method validation reports (if completed and currently in use);

51.3 (b) (8) List of available Reference Materials and Reference Collections, or plans to acquire
Reference Materials or obtain Reference Collections;

51.3 (b) (9) Plans to ensure compliance with laboratory independence and impartiality requirements
before receiving HEAL accreditation (see Article 51.4 (b) (4));

51.3 (c) Payment of Initial Accreditation Fee

51.3 (c) (1) Prior to entering the probationary period, the candidate laboratory shall pay the Agency a
one-time non-refundable fee to cover the costs related to the initial accreditation process. This fee shall
be determined by the Agency and disclosed to the laboratory prior to the accreditation process
commencing. If the fee is not agreed the accreditation process will not commence.

51.3 (d) Compliance with the Code of Ethics

51.3 (d) (1) The candidate laboratory shall implement and comply with the provision(s) of the Code of
Ethics. Candidate laboratories shall not accept Samples directly from individual Covered Persons or
from individuals or organizations acting on their behalf.

51.3 (e) Pre-Probationary Testing and On-Site Assessment

51.3 (e) (1) If this is covered by other accreditation such as ISO/IEC 17025, the laboratory may refer to
this.

51.3 (e) (2) Prior to entering the probationary accredited period, the Agency shall conduct a pre-
probationary testing (PPT) and on-site assessment of the candidate laboratory at the candidate
Laboratory's expense. The purpose of this assessment is to obtain information about different aspects
of the laboratory’s competence and to clarify any issues regarding the accreditation process, which are
relevant for the HEAL accreditation.

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51.3 (e) (3) As part of the PPT, the candidate laboratory shall be required to analyze at least ten (10)
blind EQAS samples arranged by the Agency. The general composition and content of the blind EQAS
samples and the evaluation of laboratory EQAS results are described in Part Three and Five,
respectively.

51.3 (e) (4) The candidate laboratory shall report the results for the PPT blind EQAS samples to, and in
a form designated by, the Agency (in compliance with Article 52.4 (e)) within fifteen (15) days, unless
otherwise requested by the laboratory and agreed to by the Agency.

51.3 (e) (4) (i) Upon request, the candidate laboratory shall provide the Agency with a Laboratory
Documentation Package for selected EQAS samples for which there is an Adverse Analytical
Finding. Additional data may be required upon the Agency’s request. This documentation shall be
submitted within ten (10) days of the request or as otherwise indicated by the Agency;

51.3 (e) (4) (ii) For selected EQAS samples with Negative Findings, the Agency may request all or
a portion of the Initial Testing Procedure(s) data

51.3 (e) (5) After receiving the PPT EQAS results, the Agency shall inform the candidate laboratory of
the evaluation of its performance and provide guidance for improvement. Corrective actions, if any, shall
be conducted and reported by the candidate laboratory to the Agency within thirty (30) days, or as
otherwise indicated by the Agency.

51.3 (e) (6) In addition, the Agency shall provide an Assessment Report regarding the outcomes of the
on-site assessment, including any identified nonconformity(-ies), to allow the candidate laboratory to
implement the necessary improvements. Corrective actions, if requested, shall be conducted, and
reported by the candidate laboratory to the Agency within thirty (30) days, or as otherwise indicated by
the Agency.

51.3 (e) (7) The nonconformities identified in the Agency Assessment Report shall be satisfactorily
addressed and the recommendations for improvement should be implemented before the candidate
laboratory can be accepted as an Agency probationary laboratory. The candidate Laboratory's
performance in the PPT and on-site assessment will be considered in the overall review of the candidate
laboratory’s application and may affect the timeliness of the candidate laboratory’s entry into the
probationary phase of accreditation.

51.3 (f) Obtaining ISO/IEC 17025 Accreditation by the Laboratory

51.3 (f) (1) Before the Agency grants HEAL accreditation, the candidate laboratory shall obtain ISO/IEC
17025 accreditation as an animal testing laboratory from an Accreditation Body, or its equivalent as
specified in ILAC-G7, with primary reference to the interpretation and application of the ISO/IEC 17025
requirements to the analysis of Samples (see Part Four). The Accreditation Body shall be an
International Laboratory Accreditation Cooperation (ILAC) full member that is a signatory to the ILAC
Mutual Recognition Arrangement (ILAC MRA) and must comply with all requirements of the current ILAC-
G7 document (Accreditation Requirements and Operating Criteria for Horseracing Laboratories).

51.3 (f) (2) The candidate laboratory shall prepare and establish the required documentation and
Management System according to the requirements of ISO/IEC 17025 applicable to the analysis of
Samples (see Part Four). Based on this, the laboratory shall initiate and prepare for the accreditation
process by consulting with an Accreditation Body. The candidate laboratory shall correct and document
any identified nonconformities with the ISO/IEC 17025 standard within the defined timelines.

51.3 (f) (3) The Accreditation Body should send a summary of the Assessment Report and any
corrective/preventive action documentation addressing nonconformities, to the Agency. Should the
candidate laboratory prefer to send the information directly to the Agency, the laboratory shall do so
within a reasonable timeline.

51.3 (f) (4) The ISO/IEC 17025 accreditation is a critical and mandatory pre-requisite for obtaining
HEAL accreditation.

51.3 (g) Analytical Testing Procedures

51.3 (g) (1) Before the Agency grants accreditation, candidate laboratories shall provide documentation
to the Agency demonstrating that all mandatory Test Methods have been validated and included in the
Laboratory's Scope of ISO/IEC 17025 accreditation. See Technical Documents.

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51.3 (h) Laboratory Independence and Impartiality

51.3 (h) (1) Before the Agency grants accreditation, probationary laboratories shall provide
documentation to the Agency demonstrating compliance with the requirements of Laboratory
independence and impartiality established in Article 51.4 (b) (4).

51.3 (i) Professional Liability Insurance Coverage

51.3 (i) (1) Before the Agency grants accreditation, probationary laboratories shall provide
documentation to the Agency demonstrating that they have adequate provisions for self-insuring, or
professional liability risk insurance coverage has been obtained to cover liability of no less than two (2)
million USD annually.

51.4 The Agency-Accredited Laboratory

51.4 (a) Obtaining HEAL Accreditation

51.4 (a) (1) The Agency Probationary HEAL Accreditation

51.4 (a) (1) (i) Upon satisfactory completion of the candidate laboratory requirements (as per
Article 51.3), as determined by the LabEG, a candidate laboratory can be considered for entry to
the probationary phase of HEAL accreditation as an Agency probationary laboratory. Once the
Agency has determined that the laboratory has successfully completed the requirements of a
candidate laboratory, the Agency can grant the laboratory probationary accreditation status.

51.4 (a) (1) (ii) A probationary laboratory must comply with the requirements of accredited
laboratories, including the requirements for maintaining accreditation.

51.4 (a) (1) (iii) The probationary period is two (2) years, or following the analysis of 2,500
samples, whichever comes later.

51.4 (a) (2) The Agency Pre-Final Accreditation

51.4 (a) (2) (i) Once the Agency has determined that the laboratory has successfully completed the
requirements of the probationary period, the Laboratory can be granted final accreditation status.
At the Agency’s discretion, as part of the final accreditation process, a Final Accreditation Test
(FAT) and/or on-site assessment may be conducted by the Agency. Costs associated with the
Agency on-site assessment and FAT shall be disclosed and agreed to with the probationary
laboratory.

51.4 (a) (2) (ii) As part of the FAT, the probationary laboratory shall analyze a minimum of fifteen
(15) blind EQAS samples selected from the routine EQAS program. The general composition and
content of the blind EQAS samples and the evaluation of laboratory EQAS results are described in
Part Three and Five, respectively.

51.4 (a) (2) (iii) Compliance with the defined requirements in the Application of ISO/IEC 17025 to
the analysis of Samples, the ESL and other Agency Laboratory Standards (Technical Documents,
Technical Letters), and the practice and documentation of the laboratory will be assessed. The
FAT shall assess both the scientific competence and the capability of the probationary laboratory
to manage multiple Samples.

51.4 (a) (2) (iv) The probationary laboratory shall successfully report the results for the blind EQAS
samples in the FAT to the Agency in accordance with Article 52.4 (e) within fifteen (15) days of
opening the samples, unless otherwise requested by the laboratory and agreed to by the Agency:

51.4 (a) (2) (v) Upon request, the probationary laboratory shall provide the Agency with a
Laboratory Documentation Package for selected EQAS samples for which there is an Adverse
Analytical Finding. Additional data may be required upon the Agency’s request. This
documentation shall be submitted within ten (10) days of the Agency request or as otherwise
indicated by the Agency;

51.4 (a) (2) (vi) For EQAS samples with Negative Findings, the Agency may request all or a

Horseracing Integrity and Safety Authority


portion of the Initial Testing Procedure(s) data.

51.4 (a) (2) (vii) After receiving the FAT EQAS results, the Agency shall inform the probationary
laboratory of the evaluation of its performance. Corrective actions, if any, shall be conducted and
reported by the probationary laboratory to the Agency within thirty (30) days, or as otherwise
indicated by the Agency.

51.4 (a) (2) (viii) The Agency shall provide an Assessment Report with the outcomes of the
accreditation assessment, including any identified nonconformities for the probationary laboratory
to implement the necessary improvements. Corrective actions, if any, shall be conducted and
reported by the probationary laboratory to the Agency within thirty (30) days, or as otherwise
indicated by the Agency. The nonconformities identified in the FAT EQAS and the Assessment
Report shall be satisfactorily addressed by the laboratory and the recommendations for
improvement should be implemented before accreditation can be granted.

51.4 (a) (3) The Agency Recommendation for Accreditation

51.4 (a) (3) (i) Based on the relevant documentation received from the probationary laboratory, the
Assessment Report(s) from the Agency and from the relevant Accreditation Body, the Agency shall
evaluate the probationary laboratory’s progress in meeting all the requirements outlined in Articles
51.3 and 51.4.

51.4 (a) (3) (ii) Once as determined by the Agency in the Agency’s sole discretion that all
accreditation requirements have been satisfactorily met by the probationary laboratory, the Agency
will grant accreditation to the laboratory.

51.4 (a) (3) (iii) However, if following the FAT and on-site assessment, and the review of any
resulting Corrective Action Reports submitted by the probationary laboratory, the Agency
determines that the probationary laboratory should not be accredited, the laboratory will have a
maximum of six (6) additional months to correct and improve any pending nonconformity(-ies). The
provision of documentation, the analysis of additional EQAS samples and/or an additional
assessment (on-site, remotely or as a documentary audit, as determined by the Agency), may be
required, and conducted at the probationary laboratory’s expense. A probationary laboratory that
fails to provide satisfactory improvements, as determined by the Agency after six (6) months may
be required to renew its candidacy as described in Article 51.3 or to re- start the probationary
phase of accreditation in accordance with Article 51.4 (a) (1).

51.4 (a) (4) Issuing and Publishing of HEAL Accreditation Certificate

51.4 (a) (4) (i) An Accreditation Certificate signed by a duly authorized representative of the
Agency shall be issued in recognition of the HEAL accreditation. It shall specify probationary or
final accreditation status. Such Accreditation Certificate shall specify the name of the Laboratory
and the period for which the Accreditation Certificate is valid. Accreditation Certificates may be
issued after the effective date, with retroactive effect. A list of HEAL accredited laboratories,
together with internationally approved laboratories, shall be published on the Agency’s website.

51.4 (b) Maintaining HEAL accreditation

51.4 (b) (1) Maintain ISO/IEC 17025 Accreditation

51.4 (b) (1) (i) The Laboratory shall maintain accreditation to ISO/IEC 17025, with primary
reference to the analysis of Samples, granted by a relevant Accreditation Body, which is an ILAC
full member and signatory to the ILAC MRA for testing activities as defined in ISO/IEC 17025.

51.4 (b) (1) (ii) Flexible Scope of ISO/IEC 17025 Accreditation is highly desired upon HEAL
accreditation, but in any event is required by 1 January 2025.

51.4 (b) (10) Laboratory Analytical Testing Procedures and services

51.4 (b) (10) (i) Laboratories shall provide to the Agency an up-to-date list of Analytical Testing
Procedures and services, to assist the Agency in developing Test Distribution Plans. Upon
request, Laboratories should Cooperate with the Agency by providing other relevant information

Horseracing Integrity and Safety Authority


regarding Testing plans (e.g., Laboratory analytical capabilities).

51.4 (b) (11) Participating in the Agency / Accreditation Body Re-assessments and Continuous
Assessments during the Accreditation Cycle

51.4 (b) (11) (i) Accreditation Body Re-assessment and/or Continuous Assessment during the
Accreditation

51.4 (b) (11) (i) (A) The assessment team shall include at least one ESL-trained assessor
selected by the Accreditation Body for the assessment/re-assessment.

51.4 (b) (11) (i) (B) The relevant Accreditation Body, or the Laboratory, should send copies
of a summary of the Assessment Report, as well as the Laboratory responses in a timely
fashion to the Agency. Should the Laboratory prefer to provide the Assessment Report
summary directly to the Agency, it shall do so within thirty (30) days from receiving the
Accreditation Body’s Assessment Report.

51.4 (b) (11) (i) (C) The Laboratory shall provide the Agency with an updated copy of the
ISO/IEC 17025 Certificate and Scope of ISO/IEC 17025 Accreditation as soon as it is
obtained from the Accreditation Body.

51.4 (b) (11) (ii) The Agency Laboratory Assessment

51.4 (b) (11) (ii) (A) The Agency reserves the right to conduct documentary audits as well as
inspect and assess the Laboratory through on-site or remote (on-line) assessments at any
time, at the Agency’s expense. The notice of the Agency assessment will be made in writing
to the Laboratory Director. In exceptional circumstances, and at the Agency’s discretion, the
assessment may be unannounced.

51.4 (b) (11) (ii) (B) As part of an announced or unannounced Laboratory assessment, the
Agency retains the right to request copies of Laboratory documentation and/or request
Further Analysis of selected “A” and/or “B” Samples either on-site or in a Laboratory(-ies)
chosen by the Agency.

51.4 (b) (2) Flexible Scope of ISO/IEC 17025 Accreditation

51.4 (b) (2) (i) A Laboratory may modify or add Analytes to Analytical Testing Procedures, which
are included within its Scope of ISO/IEC 17025 Accreditation or develop new Analytical Testing
Procedure(s) that involve technology already included within the Scope of ISO/IEC 17025
Accreditation, without the need for approval by the Accreditation Body that provides the ISO/IEC
17025 accreditation of that Laboratory.

51.4 (b) (2) (ii) The Laboratories are not eligible to apply a Flexible Scope of ISO/IEC 17025
Accreditation to the analysis of Samples in the following scenarios:

51.4 (b) (2) (iii) - New Analytical Testing Procedures: Any Analytical Testing Procedure, which is
new to the field of anti-doping analysis, shall be approved as Fit-for-Purpose by the Agency prior
to implementation by any Laboratory. The Agency shall use whatever means deemed appropriate,
including formal consultations with scientific expert working groups, publication(s) in peer-
reviewed scientific journal(s), or participation in an inter-laboratory collaborative study or the
Agency-organized EQAS round to evaluate whether the test is Fit-for-Purpose prior to providing
approval. Before applying such a new Analytical Testing Procedure to the analysis of Samples, a
Laboratory shall obtain an extension of the Scope of ISO/IEC 17025 Accreditation by the relevant
Accreditation Body and may be required to successfully participate in an Agency EQAS, if
available;

51.4 (b) (2) (iv) The Agency-specific Analytical Testing Procedures: The Agency may require an
extension of the Scope of ISO/IEC 17025 Accreditation to include specific Analytical Testing
Procedures before application to the analysis of Samples, even if the analytical technique involved
is already incorporated in the Laboratory’s Scope of ISO/IEC 17025 Accreditation. The Agency
will communicate to the Laboratories and to the Accreditation Bodies which Analytical Testing
Procedures are included in this category. In such cases, the Analytical Testing Procedure shall be
validated by the Laboratory. The Laboratory may also be required to successfully participate in an
inter-laboratory collaborative study or the Agency-organized EQAS round to obtain an extension to

Horseracing Integrity and Safety Authority


the Scope of ISO/IEC 17025 Accreditation by a relevant Accreditation Body before introducing the
Analytical Testing Procedure to the analysis of Samples. However, once included within the scope,
limited changes to these Analytical Testing Procedures may be allowed within the boundaries of a
Flexible Scope of ISO/IEC 17025 Accreditation. Nonetheless, this flexibility does not allow the
Laboratories to introduce new Analytes within these Analytical Testing Procedures if specific
method performance and compliance decision criteria (e.g., Decision Limits) are needed and
those criteria are not yet defined in an applicable Technical Document (e.g., new target
compound(s) for GC/C/IRMS analysis).

51.4 (b) (2) (v) Inclusion of an Analytical Testing Procedure within the Laboratory’s Scope of
ISO/IEC 17025 Accreditation establishes that the Analytical Testing Procedure is Fit-for-Purpose,
and the Laboratory shall not be required to provide Analytical Method validation documentation or
EQAS performance data in support of an analytical finding.

51.4 (b) (2) (vi) Laboratories are expected to include Analytical Testing Procedures within their
Scope of ISO/IEC 17025 Accreditation prior to application to the analysis of Samples. However,
under exceptional circumstances, a Laboratory may apply a method, which has been validated in
accordance with applicable Technical Document(s), Technical Letter(s) or Laboratory Guidelines,
to the analysis of Samples before inclusion into the Laboratory’s Scope of ISO/IEC 17025
Accreditation. However, in such cases, the Laboratory does not automatically benefit from the
presumption that the method is Fit-for-Purpose, as would otherwise be the case if the Analytical
Testing Procedure is included within the Laboratory’s Scope of ISO/IEC 17025 Accreditation.
Consequently, any Adverse Analytical Findingreported by applying a Test Method, which is not
within the Laboratory’s Scope of ISO/IEC 17025 Accreditation, may require the Laboratory to
provide method validation documentation or EQAS performance data in support of that Adverse
Analytical Finding.

51.4 (b) (2) (vii) Laboratories shall not apply an Agency-specific Analytical Testing Procedure to
the analysis of Samples until such method is included in the Laboratory’s Scope of ISO/IEC 17025
Accreditation.

51.4 (b) (3) Participate in the Agency EQAS Program

51.4 (b) (3) (i) Laboratories are required to participate in the Agency EQAS on a continuous basis
and meet the performance requirements of the EQAS as described in Part Three.

51.4 (b) (4) Laboratory Independence and Impartiality

51.4 (b) (4) (i) The Laboratory shall be administratively and operationally independent from any
organization or person(s) that could exert undue pressure on the Laboratory and affect the
impartial execution of its tasks and operations.

51.4 (b) (4) (ii) In order to be administratively independent, the Laboratory cannot be administered
by, connected or subject to a State Racing Commission, sport organization or other government
body responsible for sport performance, including their Board Members, staff, State Racing
Commission members or officials. This is necessary to avoid potential conflicts of interest and
ensure full confidence in the Laboratory’s competence, impartiality, judgment and operational
integrity, in compliance with ISO/IEC 17025.

51.4 (b) (4) (iii) In order to be operationally independent, the Laboratory shall manage its own
affairs without hindrance, interference or direction from any Person. The Laboratory shall, without
limitation, control: the allocation of its budget, the procurement of equipment and other resources,
Laboratory personnel decisions, the research conducted by the Laboratory and all Sample
Analytical Testing and reporting of results. The Laboratory shall not accept money from any
Covered Person.

51.4 (b) (4) (iv) The Laboratory shall have a dedicated budget allowing the implementation of an
efficient approval process for the timely procurement of necessary Reference Materials, reagents,
consumables and essential equipment, as well as independent Laboratory management decisions
concerning the recruitment, retention and training of staff, participation in scientific meetings and
symposia, etc. This does not prevent the Laboratory from receiving research grants or other
financial support from their host organization (e.g., university, hospital, public institution), Anti-
Doping Organizations, sport organizations, government, or other sponsors, while following
applicable accounting regulations in connection with the receipt and management of those funds.

51.4 (b) (4) (v) In accordance with ISO/IEC 17025, the Laboratory shall be a legal entity, or a
defined part of a legal entity, which is legally responsible for its activities.

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51.4 (b) (5) Document Compliance with the Agency Laboratory Code of Ethics

51.4 (b) (5) (i) The Laboratory shall comply with the provision(s) of the Code of Ethics.

51.4 (b) (5) (ii) The Laboratory shall annually provide to the Agency a letter of compliance with the
provisions of the Code of Ethics, signed by the Laboratory Director. All staff employed at the
Laboratory, permanent or temporary, shall also read, agree to, and sign the Code of Ethics. The
Laboratory may be asked to provide documentation of compliance with the provisions of the Code
of Ethics.

51.4 (b) (5) (iii) The Laboratory shall establish a system requiring Laboratory staff to report any
alleged breaches of the Code of Ethics to the Laboratory Director, which the Laboratory Director
shall report to the Agency. However, if Laboratory staff suspect that the Laboratory Director may
have breached the Code of Ethics, the Laboratory staff shall report the alleged breaches of the
Code of Ethics directly to the Agency. The Laboratory Director and/or the Agency, as applicable,
shall immediately and thoroughly investigate any alleged breach of the Code of Ethics.

51.4 (b) (5) (iv) If the Laboratory’s investigation determines that a breach of the Code of Ethics
occurred, the Laboratory Director shall immediately inform the Agency of the results of the
investigation and the disciplinary actions taken. The Agency may also impose penalties as a result
of its own investigations. Penalties may range from a personal reprimand to the expulsion of the
implicated Laboratory staff member(s), the reporting of the breach to the pertinent authorities (e.g.,
law enforcement), the Suspension or Revocation of the Laboratory’s HEAL accreditation, or any
other follow up measures the Agency determines to be appropriate.

51.4 (b) (6) Document Implemented Research and Development Activities

51.4 (b) (6) (i) The Laboratory shall develop and maintain a plan for research and development in
the field of anti-doping science. The research activities can either be conducted by the Laboratory
alone or in cooperation with other Laboratories or other research organizations.

51.4 (b) (6) (ii) The Laboratory shall supply an annual progress report to the Agency documenting
research and development results in the field of anti-doping science. The Laboratory shall also
relate research and development plans for the following year.

51.4 (b) (6) (iii) The annual research summary will be evaluated and scored by the LabEG. The
Laboratory must, except where otherwise agreed by the Agency, achieve the minimum
requirement to meet accreditation research requirements (Article 57).

51.4 (b) (7) Document Implemented Sharing of Knowledge

51.4 (b) (7) (i) The Laboratory shall demonstrate its willingness and ability to share knowledge with
other Laboratories. The Laboratory shall disseminate the results of its research and development
activities to other Laboratories. The Laboratory are encouraged to make at least one (1) annual
contribution to an anti-doping symposium or conference. Laboratories are encouraged to
participate in collaborative research projects with other Laboratories, and to exchange experience,
protocols, arrange for visits of specialists and provide training to other Laboratories and
probationary laboratories in specific areas of Analytical Testing.

51.4 (b) (7) (ii) The Laboratory shall supply a report on sharing of knowledge with other
Laboratories to the Agency, if requested. A description of sharing of knowledge is provided in the
Code of Ethics.

51.4 (b) (8) Maintain Professional Liability Insurance Coverage

51.4 (b) (8) (i) Laboratories shall provide documentation to the Agency including evidence that
professional liability risk insurance coverage is maintained of no less than two (2) million USD
annually (for example, evidence of timely payment of applicable fees and premiums).

51.4 (b) (9) Maintain Minimum Number of Samples

51.4 (b) (9) (i) To maintain proficiency in Analytical Testing, Laboratories are required to analyze a

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minimum of 2,500 Samples provided annually by the Agency. The Agency will monitor the number
of Samples tested by the Laboratory. If the number of Samples falls below the minimum, the
Laboratory’s HISA accreditation may be Suspended in accordance with 55.3.

51.4 (b) (9) (ii) It is recognized that specific circumstances may affect a Laboratory’s ability to
analyze the minimum Samples annually, such as when the Laboratory is not operational for the full
calendar year. In such cases, the Agency shall require that the Laboratory implement measures to
maintain proficiency in Analytical Testing, for example by strengthening its internal Quality
Assurance Scheme (iQAS) and internal audits program. The Agency may also provide additional
EQAS samples and/or conduct a documentary audit and/or an on-site or remote (on-line)
assessment, at its discretion, to assess the status of the Laboratory’s operations.

51.5 The Agency Monitoring of Accreditation Status

51.5 (a) The Agency shall regularly review the compliance of Laboratories with the requirements listed in the
ESL and related Technical Documents and Technical Letters. In addition, the Agency shall also conduct an
annual review of EQAS results and of relevant routine Analytical Testing issues to assess the overall
performance of each Laboratory and to decide its accreditation status.

51.5 (b) Maintenance of HEAL accreditation

51.5 (b) (1) Compliance with all the requirements established in Article 51.4 (b), including satisfactory
performance by a Laboratory in the EQAS and in routine Analytical Testing, as determined by the
Agency, is a critical requirement for the maintenance of the Laboratory’s HEAL accreditation.

51.5 (c) Issuing and Publication of Accreditation Certificate

51.5 (c) (1) On an annual basis, when maintenance of accreditation is approved by the Agency, the
Laboratory shall receive a HEAL accreditation Certificate, signed by a duly authorized representative of
the Agency, which is issued in recognition of such accreditation. The Accreditation Certificate shall
specify the name of the Laboratory and the period for which the Accreditation Certificate is valid. HEAL
accreditation Certificates may be issued after the effective date, with retroactive effect. The list of the
HEAL -accredited Laboratories is maintained on the Agency’s{53}} website.

52 The Agency External Quality Assessment Scheme (EQAS)

52.1 The Agency regularly distributes External Quality Assessment Scheme (EQAS) samples to Laboratories and,
when applicable, to probationary laboratories. The Agency EQAS is designed to continually monitor the capabilities
of the Laboratories and probationary laboratories, to evaluate their proficiency, and to improve test result uniformity
between Laboratories. EQAS samples are used to assess Laboratory routine analytical capacity and performance,
reporting turn-around times and overall compliance with the Agency Laboratory standards (e.g., ESL, Technical
Documents and Technical Letters), as well as other, non-analytical performance criteria. At the same time, the
EQAS also represents, via its educational components, a source of continuous improvement for the effectiveness of
the Analytical Testing Procedures.

52.2 Types of EQAS

52.2 (a) Blind EQAS

52.2 (a) (1) The Laboratory will be aware that the sample is an EQAS sample since it is delivered by the
Agency’s EQAS sample provider. However, the Laboratory will not know the content of the sample.

52.2 (b) Double-Blind EQAS

52.2 (b) (1) The Laboratory will not be aware that the sample is an EQAS sample since it is delivered by
the Agency and is indistinguishable from routine Samples.

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52.2 (c) Educational EQAS

52.2 (c) (1) Educational EQAS samples may be provided as open (in which case the content of the
EQAS sample is known), blind or double-blind samples. This approach is used for educational purposes
or for data gathering.

52.2 (c) (2) As part of the educational EQAS, the Agency may provide Laboratories with new Reference
Materials, Reference Collections, or quality control (QC) samples for a prompt implementation of
existing or new Analytical Testing Procedures.

52.2 (c) (3) The Agency may require the successful participation of Laboratories in an educational
EQAS for the Agency-specific Analytical Testing Procedures for Laboratories to seek an extension of
the Laboratory’s Scope of ISO/IEC 17025 Accreditation by an Accreditation Body (see Article 51.4 (b)
(ii)) before the subsequent application of the Analytical Testing Procedure to the routine analysis of
Samples.

52.3 EQAS Sample Number and Composition

52.3 (a) Number of EQAS Samples

52.3 (a) (1) The actual composition and number of EQAS samples supplied to different Laboratories
may vary; however, within any calendar year, all Laboratories participating in the EQAS are expected to
have analyzed the minimum total number of EQAS samples.

52.3 (a) (2) Each year, the EQAS program will consist of:

52.3 (a) (2) (i) At least fifteen (15) blind EQAS samples, distributed by the Agency in multiple
rounds;

52.3 (a) (2) (ii) At least five (5) double-blind EQAS samples distributed by the Agency in several
rounds;

52.3 (a) (2) (iii) At least three (3) of the above EQAS samples will contain Threshold Substances.

52.3 (a) (3) As part of the Agency’s Laboratory monitoring activities, and with the main purpose of
assisting Laboratories in their continuous improvement of performance, the Agency may increase the
number of annual EQAS samples (mainly for educational purposes) for certain Laboratories, according,
but not limited, to the following criteria:

52.3 (a) (3) (i) Monitoring the effectiveness of corrective action implementation after questionable
or unsatisfactory performance in the Agency EQAS or in routine Analytical Testing;

52.3 (a) (3) (ii) Substantiated intelligence information received by the Agency indicating
questionable or unsatisfactory Laboratory performance;

52.3 (a) (3) (iii) Laboratories which do not receive enough Samples (< 100 annual Samples) for a
specific Analytical Testing Procedure, which is not part of the Laboratory’s routine Analytical
Testing menu;

52.3 (a) (3) (iv) As part of the Agency Laboratory assessments.

52.3 (b) Composition of EQAS Samples

52.3 (b) (1) EQAS Samples may or may not contain Prohibited Substance(s) and/or Metabolite(s) of
Prohibited Substance(s) and/or Marker(s) of Prohibited Substance(s) or Prohibited Method(s).

52.3 (b) (2) 6.2.2.1 Blank EQAS Samples

52.3 (b) (2) (i) EQAS Samples may or may not contain Prohibited Substance(s) and/or
Metabolite(s) of Prohibited Substance(s) and/or Marker(s) of Prohibited Substance(s) or

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Prohibited Method(s).

52.3 (b) (3) Adulterated EQAS Samples

52.3 (b) (3) (i) Adulterated EQAS Samples are those which have been deliberately adulterated by
the spiking of non-characteristic Metabolite(s) or by the addition of extraneous substances
designed to dilute or concentrate the sample, degrade or mask the Analyte prior to or during the
analytical determination. Adulterated EQAS samples may also be obtained from the controlled
Administration or the addition of non-prohibited substances, which share common Metabolite(s)
with Prohibited Substance(s).

52.3 (b) (4) EQAS Samples Containing Prohibited Substance(s), their Metabolite(s) or Marker(s), or the
Marker(s) of Prohibited Method(s)

52.3 (b) (4) (i) The concentration(s) of selected Analyte(s) are those that may be encountered in
the urine or blood after Use of Prohibited Substance(s) or Prohibited Method(s). For some
Analytes, the EQAS Sample may contain the parent Prohibited Substance and/or its Metabolite(s)
and/or its Marker(s).

52.3 (b) (4) (ii) EQAS Samples may be spiked with Prohibited Substance(s) and/or their
Metabolite(s) or Marker(s) but would be preferably prepared from controlled Administration
studies. The EQAS sample composition shall reflect as closely as possible the expected target
Analyte Metabolite pattern and concentrations usually found in Samples.

52.3 (b) (4) (iii) A EQAS Samples may contain more than one Prohibited Substance,
Metabolite(s), or Marker(s) of a Prohibited Substance or Prohibited Method. It may also contain
multiple Metabolites or Markers of a single Prohibited Substance or Markers of a Prohibited
Method, which would represent the presence of a single Prohibited Substance or the Use of a
single Prohibited Method.

52.3 (b) (4) (iv) Double-blind EQAS samples should be representative of Samples. Therefore, to
the extent possible (in consideration, for example, of technical or ethical constraints, availability of
the pharmaceutical grade substance, etc.), double-blind EQAS samples containing Prohibited
Substance(s) and/or Metabolite(s) of Prohibited Substance(s) and/or Marker(s) of Prohibited
Substance(s) or Prohibited Method(s) should be prepared from controlled Administration studies
performed in equine subjects. However, if this is not possible, then the double-blind EQAS
sample(s) may be prepared by spiking expected target Analyte(s) in the Sample matrix in
consideration of the representative metabolic profile(s).

52.3 (b) (4) (v) For Non-Threshold Substances, the concentration in the EQAS sample will be
guided by, but not limited to, one of the following criteria: Concentrations of the Prohibited
Substance and/or its Metabolite(s) or Marker(s) equal to or greater than (≥) the applicable MRPL;
Concentrations of the Prohibited Substance and/or its Metabolite(s) or Marker(s) between 50% of
the MPRL and the MRPL (applicable only to Non-Threshold Substances prohibited at all times and
with no Minimum Reporting Levels); Non-Threshold Substances with Minimum Reporting Levels or
other limits controlling them (e.g., substances prohibited on Race Day only), will normally be
present in estimated concentrations greater than (>) 120% of the applicable Minimum Reporting
Level; Concentrations of the Prohibited Substance and/or its Metabolite(s) or Marker(s) below (<)
50% of the applicable MRPL (for Non-Threshold Substances prohibited at all times with no
Minimum Reporting Levels, for educational purposes).

52.3 (b) (4) (vi) For Threshold Substances, the concentration in the EQAS sample will be guided
by, but not limited to, one of the following criteria: Greater than (>) 10% of the Threshold as
established in the relevant Technical Document(s) or Laboratory Guidelines; At less than (<) 50%
of the Threshold for those Threshold Substances specified in the TD DL whose presence shall be
reported if detected in the presence of diuretics or masking agents.

52.3 (b) (5) Laboratory Analytical Testing Procedures Used in EQAS

52.3 (b) (5) (i) All procedures associated with the Analytical Testing of the EQAS samples by the
Laboratory are to be conducted in a manner similar to that applied to routine Samples, unless
otherwise specified by the Agency. No effort shall be made to optimize instrument (e.g., change
multipliers or chromatographic columns) or method performance prior to analyzing the EQAS
samples unless it is a scheduled maintenance activity. Only validated, Fit-for-Purpose Analytical
Testing Procedures described in the Laboratory’s SOPs are to be employed in the analysis of
EQAS samples (i.e., using the Initial Testing Procedure(s)s and Confirmation Procedures applied

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in routine Analytical Testing).

52.4 Reporting of EQAS results

52.4 (a) The purpose of the EQAS program is to ensure that all Laboratories maintain proficiency in the
performance of their Analytical Testing Procedures and report valid results to the Agency in a timely manner.

52.4 (b) In the spirit of the EQAS program, a Laboratory shall not communicate with other Laboratories
regarding the identity or content of substances present in or absent from blind EQAS samples prior to the
submission of EQAS results to the Agency. This prohibition also applies to Laboratory requests for second
opinions, which shall not be requested for blind EQAS samples.

52.4 (c) Contact between Laboratories regarding any aspect of blind EQAS analysis (including the results
obtained) prior to reporting by all Laboratories to The Agency will be considered an attempt to circumvent the
quality assessment.

52.4 (d) For double-blind EQAS samples, which are indistinguishable from routine Samples, consultation
between Laboratories before reporting such EQAS results to the Agency may occur. However, such
consultation shall not involve identifying the sample as an Agency double-blind EQAS sample (in cases when,
for any reason, the Laboratory identifies the EQAS nature of the sample).

52.4 (e) Reporting Blind EQAS Results

52.4 (e) (1) The Laboratory shall report the results of blind EQAS samples to the Agency in the same
manner as specified for routine Samples (see Article 53.7 (g)) unless otherwise notified by the Agency.
For some blind EQAS samples or sample sets, additional information may be requested from the
Laboratory (e.g., LODs, LOQs, MU estimations).

52.4 (e) (2) The results of the blind EQAS shall be submitted to the Agency on or before the specified
reporting date unless an extension is granted by the Agency for valid reasons. Failure to report results of
blind EQAS samples will be considered a false Negative Finding(s).

52.4 (f) Reporting Double-Blind EQAS Results

52.4 (f) (1) The Laboratory shall report the results of double-blind EQAS samples as per Article 53.7 (g)

52.4 (f) (2) Reporting of double-blind EQAS results should occur within the same timeframe as specified
for routine Samples, unless an extension is granted by the Agency for valid reasons

52.4 (f) (3) Failure to report double-blind EQAS results within this timeframe or, subject to an extension
of this deadline granted by the Agency based on valid reasons, within the agreed or the Agency-
approved deadline, will be considered a false Negative Finding(s).

52.4 (g) Reporting Educational EQAS Results

52.4 (g) (1) The Laboratory shall report the results of open or blind educational EQAS samples on or
before the specified reporting deadline and in a format specified by the Agency. Results received after
the deadline will not be included in the assessment of EQAS results nor in the subsequent educational
EQAS report and will be considered a false Negative Finding(s).

52.4 (g) (2) For open educational and blind EQAS samples, the Laboratory shall report the LODs of the
identified Non-Threshold Substance(s) and/or Metabolite(s) and/or Marker(s), or of the identified
Marker(s) of Prohibited Method(s), as estimated during method validation of the Initial Testing
Procedure(s)

52.4 (h) Reporting Results for EQAS Samples Containing Non-Threshold Substances

52.4 (h) (1) Unless otherwise specified by the Agency (for example, for an educational EQAS), the report
of EQAS results for Non-Threshold Substances shall include all the Analytes whose presence in the
EQAS sample has been confirmed by the Laboratory in accordance with applicable Technical

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Document(s), including the Prohibited Substance(s) (e.g., parent compound(s), if applicable) and all
identified Metabolite(s) and/or Marker(s) of the Prohibited Substances or Marker(s) of Prohibited
Method(s). The Agency may also require that the Laboratory report the estimated concentrations of the
confirmed Analyte(s).

52.4 (i) Reporting Results for EQAS Samples Containing Threshold Substances

52.4 (i) (1) For educational and blind EQAS samples, the report of EQAS results for Threshold
Substances shall include the values measured for each Aliquots analyzed, whenever the measured
mean value of all replicates is greater than or equal to (≥) 50% of the applicable Threshold.

52.4 (i) (2) For double-blind EQAS samples, the Laboratory shall report the quantitative results to, and in
a form designated by, the Agency has done for routine Samples, in accordance with the relevant
Technical Document(s), Technical Letter(s) or Laboratory Guidelines.

53 Application of ISO/IEC 17025 to the Analysis of Samples

53.1 Introduction and Scope

53.1 (a) This section of the ESL is intended as an extension of the application of ISO/IEC 17025 and ILAC-G7
to the field of Doping Control. Any aspect of Analytical Testing or management not specifically discussed in
this document or in the relevant Technical Documents, Technical Letters or Laboratory Guidelines shall be
governed by ISO/IEC 17025. The application focuses on the specific parts of the processes that are critical
with regard to the quality of the laboratory’s performance as a Laboratory and are therefore significant in the
evaluation and accreditation process.

53.1 (b) This section introduces the specific performance standards for a Laboratory, as applicable. The
conduct of Laboratory Analytical Testing is considered a process within the definitions of ISO 17000.
Performance standards are defined according to a process model where the Laboratory practice is structured
into three (3) main categories of processes:

53.1 (b) (1) Structural and Resource Requirements

53.1 (b) (2) Process Requirements

53.1 (b) (3) Management Requirements

53.10 Storage of Samples

53.10 (a) Storage of Urine Samples

53.10 (a) (1) All urine Samples retained for storage in the Laboratory shall be stored frozen in a secure
location under continuous chain of custody. The Laboratory shall keep all chain of custody and other
records (either as hard-copy or in digital format) pertaining to those Samples.

53.10 (a) (1) (i) Urine Sample(s) without an Adverse Analytical Findingor Atypical Finding: The
Laboratory shall retain the “A” and “B” urine Sample(s) without an Adverse Analytical Findingor
Atypical Finding for a minimum of three (3) months after reporting the final analytical result to the
Agency, and may be discarded after this time, unless the long-term storage of the Sample(s) has
been requested, in writing or electronically, by the Agency and unless the Agency requests the
Laboratory retain the Sample for a longer period.

53.10 (a) (1) (ii) Urine Samples with Irregularities: The Laboratory shall retain the “A” and “B” urine
Sample(s) with irregularities for a minimum of three (3) months after reporting to the Agency, or for
a longer period as determined by the Agency.

53.10 (a) (1) (iii) Urine Sample(s) with an Adverse Analytical Findingor Atypical Finding: The
Laboratory shall retain the “A” and “B” urine Sample(s) with an Adverse Analytical Findingor
Atypical Finding for a minimum of six (6) months after reporting the final analytical result (for the “A”
or the “B” Sample, as applicable to, the Agency and shall not dispose without approval by the

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Agency.

53.10 (a) (1) (iv) Urine Samples under challenge, dispute or investigation: If the Laboratory has
been informed by the Agency (in writing and within the applicable storage period as defined in this
Article 53.10 (a)) that the analysis of a urine Sample is challenged, disputed or under investigation,
the Laboratory shall retain both the “A” and “B” Samples until further notice by the Agency, as
applicable.

53.10 (b) Storage of Blood Samples

53.10 (b) (1) Samples for which Analytical Testing has been performed on blood serum/plasma fraction
only (not on cellular components):

53.10 (b) (2) All serum or plasma Samples retained for storage in the Laboratory shall be stored frozen
according to established protocols in a secure location under continuous chain of custody. The
Laboratory shall keep all chain of custody and other records (either as hard-copy or in digital format)
pertaining to those Samples.

53.10 (b) (2) (i) Serum/plasma “A” and “B” Samples without an Adverse Analytical Findingor
Atypical Finding: The Laboratory shall retain the serum/plasma “A” and “B” Samples without an
Adverse Analytical Findingor Atypical Finding for a minimum of three (3) months after reporting the
final analytical result to the Agency, or for a maximum of ten (10) years after the Sample collection
date, if the long-term storage of the Sample(s) has been requested by the Agency and unless the
Agency requests the Laboratory retain the Sample for a longer period.

53.10 (b) (2) (ii) Serum/plasma “A” and “B” Samples without an Adverse Analytical Findingor
Atypical Findings, analyzed only for TCO2 shall be retained for a minimum of one (1) month, unless
otherwise requested by the Agency.

53.10 (b) (2) (iii) Serum/plasma Samples with irregularities: The Laboratory shall retain the
serum/plasma Samples with irregularities for a minimum of three (3) months after reporting the
final analytical result to the Agency, or for a longer period as determined by the Agency.

53.10 (b) (2) (iv) Plasma/serum “A” and “B” Sample(s) with an Adverse Analytical Findingor
Atypical Finding: The Laboratory shall retain “A” and “B” plasma/serum Sample(s) with an Adverse
Analytical Finding or Atypical Finding for a minimum of six (6) months after reporting the final
analytical result (for the “A” or the “B” Sample, as applicable) to the Agency and shall not dispose
without approval by the Agency.

53.10 (b) (2) (v) Plasma/serum “A” and “B” Sample(s) under challenge, dispute or investigation: If
the Laboratory has been informed by the Agency (in writing and within the applicable storage
period as defined in this Article 53.10 (b)) that the analysis of a serum/plasma Sample is
challenged, disputed or under investigation, the Laboratory shall retain both the “A” and “B”
Samples until further notice by the Agency, as applicable.

53.10 (b) (3) Samples for which Analytical Testing has been performed on cellular fractions of whole
blood.

53.10 (b) (3) (i) Whole blood “A” and “B” Samples without an Adverse Analytical Findingor Atypical
Finding: The Laboratory shall retain the whole blood Samples without an Adverse Analytical
Finding or Atypical Finding for a minimum of one (1) month after reporting the final analytical result
to the Agency.

53.10 (b) (3) (ii) Whole blood Samples with irregularities: The Laboratory shall retain the whole
blood Samples with irregularities for a minimum of one month after reporting the final analytical
results to the Agency, or for a longer period as requested by the Agency.

53.10 (b) (3) (iii) Whole blood “A” and “B” Sample(s) with an Adverse Analytical Findingor Atypical
Finding: The Laboratory shall retain “A” and “B” whole blood Sample(s) with an Adverse Analytical
Finding or Atypical Finding for a minimum of three (3) months after reporting the final analytical
result (for the “A” or the “B” Sample, as applicable) to the Agency and shall not dispose without
approval by the Agency.

53.10 (b) (3) (iv) Whole blood “A” and “B” Sample(s) under challenge, dispute or investigation: If
the Laboratory has been informed by the Agency (in writing and within the applicable storage
period as defined in this Article 53.10 (b)) that the analysis of a whole blood Sample is challenged,

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disputed or under investigation, the Laboratory shall retain both the “A” and “B” Samples until
further notice by the Agency, as applicable.

53.10 (c) Storage of Hair Samples

53.10 (c) (1) All hair Samples retained for storage in the Laboratory shall be stored in a secure location
under continuous chain of custody.

53.10 (d) Storage of Other Samples

53.10 (d) (1) All other Samples should be stored in optimal conditions based on the available
information applicable to the Sample type, and at the direction of the Agency. They shall be stored in a
secure location under continuous Chain of Custody.

53.10 (e) Long-term Storage of Samples

53.10 (e) (1) At the direction of the Agency, any urine, serum/plasma, hair or other Sample may be
stored in long-term storage after the Sample collection date for the purpose of Further Analysis, subject
to the conditions set out in Articles 53.5 (i) (22), 53.10 (a) and 53.10 (b)

53.10 (e) (2) Sample(s) may be stored in long-term storage under the custody of either a Laboratory or
another Fit-for-Purpose facility under the responsibility of the Agency, which has ownership of the
Sample(s) pursuant to the Equine Testing and Investigations Standards. the Agency shall retain the
Sample collection records pertaining to all stored Samples for the duration of Sample storage.

53.10 (e) (3) Laboratories as Sample Custodians:

53.10 (e) (3) (i) The Laboratory shall ensure that Samples are stored according to established
protocols in a secure location in the Laboratory’s permanent controlled zone and under continuous
Chain of Custody. The written request from the Agency for long-term storage of Samples shall be
properly documented.

53.10 (e) (3) (ii) Samples may also be transported for long-term storage to a specialized, secure
Sample storage facility, which is located outside the Laboratory’s permanent controlled zone and
is under the responsibility of the Laboratory or may be transported to another Laboratory. If the
external Sample storage facility is not covered by the Laboratory’s ISO/IEC 17025 accreditation,
then the subcontracted external storage facility shall be Fit-for-Purpose and have its own ISO
accreditation or certification (e.g., 17025, 20387, 9001). The transfer of the Samples to the
external long-term storage facility or Laboratory shall be recorded.

53.10 (e) (3) (iii) If Sample(s) are to be transported for storage at a location outside the secured
area of the Laboratory that first analyzed the Sample(s), the Laboratory shall secure the “A”
Sample(s) to be shipped either by re-sealing individual “A” Sample container(s) with a Tamper
Evident sealing system, which has similar capabilities for security and integrity as the original
sealing system, or by sealing the box in which the Sample(s) are shipped in a manner that
maintains Sample integrity and Chain of Custody.

53.10 (e) (3) (iv) “B” Sample(s) to be shipped shall be individually sealed, either in the original,
sealed “B” Sample container(s) or, if previously opened, by re-sealing the individual “B” Sample
container(s) with a Tamper Evident sealing system, which has similar capabilities for security and
integrity as the original sealing system.

53.10 (e) (3) (v) During transport and long-term storage, Sample(s) shall be stored at a
temperature appropriate to maintain the integrity of the Sample(s). In any anti-doping rule violation
case, the issue of the Sample’s transportation or storage temperature shall be considered where
failure to maintain an appropriate temperature could have caused the Adverse Analytical Findingor
other result upon which the anti-doping rule violation is based.

53.10 (e) (3) (vi) The Laboratory shall retain all Laboratory Internal Chain of Custody and technical
records (as per ISO/IEC 17025) pertaining to a stored Sample for the duration of Sample storage,
either as hard-copy or in digital format. In addition, the Laboratory may retain Sample analytical
data which would allow retrospective analysis of such data, for example, for the purpose of
identifying signals for novel Metabolite(s) of Prohibited Substance(s) or Marker(s) of Prohibited
Substance(s) or Prohibited Method(s) (e.g., full-scan mass spectrometry data) as detailed in

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Article 53.5 (i) (22).

53.10 (e) (3) (vii) If Sample(s) are transported to another Laboratory for long-term storage, the
Sample’s external Chain of Custody and other non-analytical records (e.g., Sample collection
documentation), available to the transferring Laboratory, shall also be transferred, immediately or
upon later request, to the Laboratory storing the Samples or to the Agency, either as originals or
copies.

53.10 (e) (4) the Agency as Sample Custodians:

53.10 (e) (4) (i) Sample(s) may also be transported for long-term storage to a Fit-for-Purpose,
secure Sample storage facility, which is under the responsibility of the Agency. In such cases, the
external storage facility shall have its own ISO accreditation or certification (e.g. 17025, 20387,
9001) and shall maintain security requirements comparable to those applicable to a Laboratory.
The Agency shall ensure that Samples are stored according to established protocols in a secure
location under continuous Chain of Custody.

53.10 (e) (4) (ii) The written request from the Agency for the transfer of the Sample(s) to long-term
storage shall be properly documented. The transfer of the Samples to the external long-term
storage facility shall also be recorded. The Laboratory shall secure the Sample(s) for
transportation to the long-term storage facility as described above.

53.10 (e) (4) (iii) The Laboratory shall retain all Laboratory Internal Chain of Custody and technical
records (as per ISO/IEC 17025) pertaining to all Samples transferred for long-term storage for the
duration of Sample storage, either as hard-copy or in digital format. In addition, the Laboratory
may retain Sample analytical data which would allow retrospective analysis of such data. The
Laboratory shall transfer the Sample’s external Chain of Custody and other non-analytical records
to the Agency, either as originals or copies, immediately or upon request.

53.11 Secondary Use or Disposal of Samples and Aliquots

53.11 (a) The Laboratory shall maintain SOP(s) pertaining to the secondary use of Samples or Aliquotss for
research or quality assurance, as well as for the disposal of Samples and Aliquots.

53.11 (b) If the Laboratory has discretion to dispose of a Sample, the Laboratory shall do one of the following
with the Sample(s) and Aliquots as soon as practicable:

53.11 (c) Disposal of the Sample(s) and Aliquotss

53.11 (c) (1) Disposal of Samples and Aliquots shall be recorded under the Laboratory Internal Chain of
Custody.

53.11 (d) Secondary use of Samples and Aliquots for Research and Quality Assurance

53.11 (d) (1) Samples and Aliquots shall be anonymized to ensure that any subsequent results cannot be
traced back to a particular Covered Person or Covered Horse (see Protocol). Only after anonymization,
may a Sample or Aliquot be used for:

53.11 (d) (1) (i) Anti-doping research. The Covered Person or their representative’s consent is not
required for these purposes.

53.11 (d) (1) (ii) Quality assurance, quality improvement of existing Test Methods, development or
evaluation of Analytical Testing Procedures for Prohibited Substances or Prohibited Methods
included in the Prohibited List at the time of Sample collection, or to establish reference population
ranges or Thresholds or other statistical purposes. The Covered Person or their representative’s
consent is not required for these purposes.

53.11 (e) The use of Samples and Aliquots for the purposes of this Article 53.11 (d) is subject to the following

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conditions:

53.11 (e) (1) The Laboratory must respect the Protocol and the ESL Code of Ethics requirements
related to research, types of permitted research, and respect of ethical standards for research or quality
assurance studies involving equine subjects;

53.11 (e) (2) The Laboratory must not make any attempt to re-identify a Covered Person and/or Covered
Horse from Samples or Aliquots used for the purposes of this Article 53.11 (d) or data arising from any
research or quality assurance analysis;

53.11 (e) (3) The Laboratory must consult the applicable national regulations, guidance, or authorities to
determine whether a study should be considered as falling under Article 53.11 (d) (1) (i) or Article 53.11
(d) (1) (ii));

53.11 (e) (4) In the event the Laboratory wishes to transfer Sample(s) or Aliquots to be used for the
purposes of this Article 53.11 (d) to another Laboratory or a third-party research institution or group, or
wishes to partner with another Laboratory or research institution or group for the purpose of an Article
53.11 (d) (1) (i) study, the Laboratory shall subject the receiving party to the conditions described in this
Article 53.11 (d) (1) (i) by way of a written agreement and shall prohibit the receiving party from further
transferring any Sample(s) or Aliquots or related data to another party.

53.12 Management Requirements

53.12 (a) Organization

53.12 (a) (1) Within the framework of ISO/IEC 17025, the Laboratory shall be considered as a testing
laboratory.

53.12 (a) (2) Management Reviews

53.12 (a) (2) (i) Management reviews will be conducted to meet the requirements of ISO/IEC
17025.

53.12 (b) Document Control

53.12 (b) (1) The control of documents that make up the Management System shall meet the
requirements of ISO/IEC 17025. The Laboratory Director (or designee) shall approve the Management
System documentation and all other documents used by Laboratory staff members involved in Analytical
Testing.

53.12 (c) Control and Storage of Technical Records

53.12 (c) (1) The Laboratory shall keep a copy of all Sample records to the extent needed to produce
Laboratory Documentation Packages or Certificates of Analysis, in accordance with the Technical
Document, in a secure storage until Sample disposal or anonymization (see Article 53.11 (d)).

53.12 (d) Cooperation with the Agency

53.12 (d) (1) Cooperation with the Agency shall be handled in accordance with ISO/IEC 17025.

53.12 (d) (2) Ensuring Responsiveness to the Agency

53.12 (d) (3) The Laboratory Director or their designee shall:

53.12 (d) (3) (i) Ensure adequate communication with the Agency in a timely manner;

53.12 (d) (3) (ii) Provide complete, appropriate and timely explanatory information as requested by
the Agency;

53.12 (d) (3) (iii) Report to the Agency any unusual circumstances or information with regard to

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Analytical Testing, patterns of irregularities in Samples, or potential Use of new substances;

53.12 (d) (3) (iv) Provide documentation to the Agency [e.g., Management System documentation,
SOPs, contracts (not including commercial or financial information) or Delegated Third Parties
working on behalf of the Agency upon request to ensure conformity with the rules established under
the Protocol as part of the maintenance of HEAL accreditation. This information shall be treated in
a confidential manner.

53.12 (d) (4) The Laboratory Director shall be familiar with the Protocol and the Prohibited List.

53.12 (d) (5) The Laboratory Director shall interact with the Agency in regard to specific timing, report
information, or other support needs. These interactions should occur in a timely manner and should
include, but are not limited to, the following:

53.12 (d) (5) (i) Communicating with the Agency concerning any significant question of Analytical
Testing needs or any unusual circumstance in the Analytical Testing process (including delays in
reporting);

53.12 (d) (5) (ii) Providing complete, timely and unbiased explanations to the Agency when
requested or when there is a potential for misunderstanding of any aspect of the Analytical Testing
process, Laboratory Test Report, Certificate of Analysis or Laboratory Documentation Package;

53.12 (d) (5) (iii) If requested by the Agency, the Laboratory shall provide advice and/or opinion
regarding the Prohibited Substances and Prohibited Methods included in the Analytical Testing
Procedures;

53.12 (d) (5) (iv) Providing evidence and/or expert testimony on any test result or report produced
by the Laboratory as required in administrative, arbitration, or legal proceedings. The requests
from such expert testimonies shall originate, in writing, from the Agency or adjudication bodies as
part of the Results Management process. The Laboratory shall not provide expert testimony to
Covered Persons or their representatives, including their legal counsels;

53.12 (d) (5) (v) Responding to any complaint submitted by the Agency concerning the Laboratory
and its operation.

53.12 (d) (5) (vi) As required by ISO/IEC 17025, the Laboratory shall actively monitor the quality of
the services provided to the Agency, including the introduction of an annual questionnaire to clients
to assess their satisfaction (or otherwise) with the performance of the Laboratory. There should be
documentation that the Agency’s concerns have been incorporated into the Laboratory’s
Management System where appropriate

53.2 Structural and Resource Requirements

53.2 (a) General

53.2 (a) (1) General structure and resource requirements shall be provided in accordance with the
requirements of ISO/IEC 17025.

53.2 (a) (2) The Laboratory shall have available the personnel, facilities, equipment, systems and
support services necessary to manage and perform its Laboratory activities.

53.2 (b) Laboratory Personnel

53.2 (b) (1) The Laboratory Director is responsible for ensuring that the Laboratory personnel are
adequately trained and have the experience and skills necessary to perform their duties.

53.2 (b) (2) All personnel shall have a thorough knowledge of their responsibilities including the security
of the Laboratory, the Code of Ethics, confidentiality of Analytical Testing results, Laboratory Internal
Chain of Custody protocols, and the Standard Operating Procedures (SOPs) for any Analytical Testing
Procedure that they perform

53.2 (b) (3) The Laboratory shall have access to records for every Person employed by, or under

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contract with, the Laboratory including a curriculum vitae or qualification form(s)/certificate(s), a job
description, records of completed and ongoing training and records of authorization to perform their
defined duties.

53.2 (b) (4) Specific criteria shall be met by the Laboratory Director, Laboratory Quality Manager,
Laboratory Certifying Scientists, and Laboratory Supervisory Personnel, as outlined below.

53.2 (b) (5) Laboratory Director

53.2 (b) (5) (i) The Laboratory shall have a qualified Person as the Laboratory Director, whose
priority is to assume and focus on the professional, organizational, educational, operational and
administrative responsibilities of the Laboratory’s operations. The Laboratory Director plays an
essential role in the anti-doping Laboratory’s operations and the HEAL accreditation is delivered
based upon such qualification as well as on the Laboratory’s operational performance. A suitably
qualified person with a Doctoral degree or equivalent would be desirable, in any event they shall
possess the necessary expertise relevant equine anti-doping and medication control.

53.2 (b) (5) (ii) Any personnel changes to the position of Laboratory Director shall be
communicated to the Agency no less than one (1) month, or as soon as practicable, prior to the
scheduled date the Laboratory Director vacates their position.

53.2 (b) (6) Laboratory Quality Manager

53.2 (b) (6) (i) The Laboratory shall have a single staff member appointed as the Laboratory
Quality Manager. The Quality Manager shall have responsibility and authority to implement and
ensure compliance with the Management System. The Quality Manager’s priority and functions
shall be focused on quality assurance and quality control activities. The Quality Manager should
remain independent, as much as possible, from routine Laboratory analytical activities. By 1
January 2025 the Quality Manger shall be independent from routine Laboratory analytical activities.
Quality control activities including ISO/IEC 17025.

53.2 (b) (7) Laboratory Certifying Scientists

53.2 (b) (7) (i) The Laboratory shall have qualified personnel to serve as Certifying Scientists to
review all pertinent analytical data, Analytical Method validation results, quality control results,
Laboratory Documentation Packages, and to attest to the validity of the Laboratory’s test results.

53.2 (b) (8) Laboratory Supervisory Personnel

53.2 (b) (8) (i) The Laboratory shall have qualified personnel to serve as Laboratory Supervisors.
All Laboratory Supervisors shall have a thorough understanding of the Laboratory’s Management
System including the review, interpretation and reporting of test results, the maintenance of
Laboratory Internal Chain of Custody, and proper implementation of corrective and preventive
actions in response to analytical problems

53.2 (c) Laboratory Facilities and Environmental Conditions

53.2 (c) (1) Laboratory Facilities

53.2 (c) (1) (i) The Laboratory shall have Fit-for-Purpose facilities including sufficient space for
dedicated administrative, Sample handling, Sample storage and analytical areas, which comply
with the security requirements outlined below:

53.2 (c) (1) (ii) A Person shall be assigned as the security officer, who has overall knowledge of
the security system and/or serves as the liaison Person with the security services of the host
organization (e.g., university, hospital, research institute);

53.2 (c) (1) (iii) The Laboratory shall have a policy for the security of its facilities, equipment and
systems against unauthorized access, which may include a threat and risk assessment performed
by expert(s) in the relevant field;

53.2 (c) (1) (iv) Two (2) main levels of access shall be defined in the Management System and

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evaluated in the threat assessment plan:

53.2 (c) (1) (iv) (A) Reception Zone: An initial point of control beyond which unauthorized
individuals shall not be permitted. The Laboratory shall have a system to register visitors and
authorized individuals to the Laboratory. They shall be supplied with an identification badge
while in the Laboratory facilities.

53.2 (c) (1) (iv) (B) Controlled Zones: Access to these areas shall be monitored (e.g., through
the use of electronic access system(s) such as biometric and/or personal identification
cards) and records of access by visitors shall be maintained; Access to the Laboratory
Controlled Zones shall be monitored and restricted to Laboratory staff and temporarily
approved/authorized personnel (e.g., maintenance engineers, auditing teams). All other
visitors to the Laboratory Controlled Zones shall be continuously escorted by Laboratory staff
member(s). Access to the Laboratory Controlled Zones shall be defined in the Laboratory’s
Management System.

53.2 (c) (1) (ix) Samples may be transported for long-term storage to a third-party, secure Sample
storage facility, which is located outside the Laboratory’s permanent controlled zone, to another
Laboratory, or to another Fit-for-Purpose facility under the responsibility of the Agency, which has
ownership of the Sample(s). Long-term storage facilities shall maintain security requirements
comparable to the security requirements applicable to a Laboratory’s short-term storage of
Samples. If the external Sample storage facility is not covered by the Laboratory’s ISO/IEC 17025
accreditation, then the subcontracted external storage facility shall have its own ISO accreditation
or accredited certification (i.e., 17025, 20387, 9001). The transfer of the Samples to the long-term
storage facility shall be recorded. The Laboratory may implement additional security measures,
which should be assessed on a case-by-case basis.

53.2 (c) (1) (v) The Laboratory shall have a dedicated and restricted area within the Controlled
Zone for Sample receipt and Aliquot preparation;

53.2 (c) (1) (vi) Access to the Laboratory’s Sample receipt and Aliquot preparation area shall be
restricted to authorized personnel, based on a risk assessment by the Laboratory.

53.2 (c) (1) (vii) The Laboratory shall have a dedicated and restricted Sample storage area;

53.2 (c) (1) (viii) Access to stored Samples shall be restricted to authorized personnel, based on a
risk assessment by the Laboratory.

53.2 (c) (1) (x) Environmental Control

53.2 (c) (2) Relocation of Laboratory Facilities

53.2 (c) (2) (i) In cases where a Laboratory is to relocate to a new physical space, on a permanent
or temporary basis, a report containing the following information shall be provided to the Agency
no later than three (3) months prior to the relocation:

53.2 (c) (2) (ii) Description of the circumstances for moving Laboratory operations into a new
space and anticipated effect on capabilities;

53.2 (c) (2) (iii) Relocation date(s) including date of closing of existing facility operations and date
of opening of future facility operations;

53.2 (c) (2) (iv) Expected date(s) of assessment of the new facilities by the Accreditation Body
(evidence of continued accreditation and/or acceptance of suitability of the new Laboratory
facilities required when made available by the Accreditation Body); and

53.2 (c) (2) (v) New Laboratory contact information and coordinates

53.2 (c) (3) Environmental Control

53.2 (c) (3) (i) The Laboratory shall have a written safety policy and compliance with Laboratory
safety policies shall be enforced.

53.2 (c) (3) (ii) The Laboratory’s storage and handling of controlled substances shall comply with
applicable national legislation.

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53.2 (c) (3) (iii) The Laboratory shall: Ensure appropriate safeguards to electrical service (for
example, by provision of an alternative power supply such as a UPS system and/or power
generators, due to costs and complexity, this could be laboratory-wide and/or instrument-specific)
and environmental conditions (space, temperature, humidity, as applicable) for all Laboratory
instrumentation and equipment critical to Laboratory operations, such that service is reasonably
maintained and any damage is minimized should there be a power interruption. Have policies in
place to ensure the integrity of refrigerated and/or frozen stored Samples in the event of an
electrical or freezer/refrigerator equipment failure.

53.2 (c) (4) Confidentiality of Data, Information and Operations

53.2 (c) (4) (i) The Laboratory should either file securely any confidential or sensitive information or
properly destroy it before disposal. Laboratory staff shall be appropriately trained to comply with
confidentially requirement.

53.2 (c) (4) (ii) To minimize any attempts of fraud or counterfeit, the Laboratory should implement a
policy to ensure that discarded urine and blood Sample containers, cannot be collected by
unauthorized Persons or recovered after disposal (for example, bottles should be recycled or
destroyed, or trash containers should be properly secured).

53.2 (c) (5) Control and Security of Electronic Data and Information

53.2 (c) (5) (i) The Laboratory shall implement all reasonable measures, based on a thorough risk
and vulnerability assessments (e.g., by a competent third party), to prevent and to detect
unauthorized access and copying of Laboratory data and information from local and/or cloud-
based computerized systems. Laboratories shall implement technical and organizational
safeguards consistent with best practice and any applicable governmental regulations.

53.2 (c) (5) (ii) Access to Laboratory computer terminals, computers, servers or other operating
equipment shall be restricted to authorized personnel (e.g., by using access passwords).

53.2 (c) (5) (iii) The Laboratory shall implement a data and information management system, a
software-based solution that supports and maintains proper traceability of Laboratory operations
(e.g., a Laboratory Information Management System, LIMS) with secure and restricted access to
stored electronic data by authorized personnel as well as information and data exchange
capabilities including between the Laboratory and the Agency.

53.2 (c) (5) (iv) The Laboratory shall utilize a secure data storage system that prevents
unauthorized access and data loss (e.g., failed hard drive, fire, flooding). The Laboratory shall
ensure that at least two (2) independent, regularly backed-up copies of all relevant
analytical/LIMS/instrument software files are available. If the Laboratory is utilizing a non-cloud-
based system, then at least one backup copy shall be stored in a restricted and secure
environment either in the Laboratory (e.g., fire and waterproof safe) or in a secure off-site location
(e.g., in a mirrored server that guarantees the integrity of the server and the stored data); If the
Laboratory is using a cloud-based system, the Laboratory data shall be, at a minimum, replicated
in two different physical locations (e.g., between two different availability zones within the same
region or between different regions) in order to minimize the possibility of data loss.

53.2 (c) (5) (v) The software utilized by the Laboratory shall prevent the changing of data and test
results, unless there is a system to record the change with audit trail capabilities which is limited to
users with authorized access. The audit trail shall record the Person performing the editing task,
the date and time of the edit, the reason(s) for the change to the original data and allow the
retention of the original data.

53.2 (c) (5) (vi) If the Laboratory utilizes third-party computerized systems or software, the
Laboratory shall ensure the provider or operator complies with all applicable requirements of the
Protocol and the ESL and shall implement and maintain technical and organizational controls
necessary to safeguard Laboratory data.

53.2 (d) Laboratory Equipment

53.2 (d) (1) The Laboratory shall have access to equipment that is required for the correct performance
of Analytical Testing activities. The Laboratory shall maintain sufficient instrumental capacity to minimize
the risk of operational delays and meet the analytical and results reporting obligations. A list of available

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equipment shall be established and maintained. All maintenance, service, and repair of equipment shall
be recorded.

53.2 (d) (2) As part of its Management System, the Laboratory shall operate a program for the
maintenance and calibration of equipment according to ISO/IEC 17025. Calibrations are only required
where the setting can change the test result. A maintenance schedule, at least in accordance with the
manufacturer’s recommendations or local regulations, if available, shall be established for general
Laboratory equipment that is used in Analytical Testing Procedure(s).

53.2 (d) (3) General Laboratory equipment (fume hoods, centrifuges, evaporators, etc.) that is not used
for analytical measurements should be maintained by visual examination, safety checks, performance
verification and cleaning, as necessary.

53.2 (d) (4) Equipment or volumetric devices used in measuring shall have periodic performance checks
and/or calibrations along with servicing, cleaning, and repair.

53.2 (e) Metrological Traceability

53.2 (e) (1) Reference Materials

53.2 (e) (1) (i) When available, Reference Materials of substances traceable to a national standard
or certified by a body of recognized status (e.g., USP, BP, Ph.Eur. WHO) or a Reference Material
producer accredited to ISO 17034 should be used.

53.2 (e) (1) (ii) When a Reference Material is not certified, the Laboratory shall verify its identity
and check its purity by comparison with published data and/or by chemical characterization.

53.2 (e) (2) Reference Collections

53.2 (e) (2) (i) Samples or isolates may be obtained from in vitro or in vivo sources [e.g., (i) an
external quality control sample, (ii) an isolate from a urine or blood sample after an authenticated
Administration, or (iii) an “in-vitro” incubation with liver cells, microsomes or biological fluids] and
be used as Reference Collections.

53.2 (e) (2) (ii) Reference Collections shall be traceable to a Prohibited Substance or a Prohibited
Method, and the analytical data shall be sufficient to establish the identity of the Analyte.

53.2 (f) Subcontracting of Analysis

53.2 (f) (1) A Laboratory shall perform all work with qualified personnel and equipment within its
accredited facility.

53.2 (f) (2) A Laboratory may subcontract an analysis to another Laboratory, in consultation and following
written approval from the Agency. The conditions that justify subcontracting include, for example:

53.2 (f) (3) A specific technology or Analyte(s) that are not within the Laboratory’s Scope of ISO/IEC
17025 Accreditation;

53.2 (f) (3) (i) An Analytical Testing Restriction decision;

53.2 (f) (3) (ii) Other justifications such as a need for higher sensitivity or specific equipment or
expertise, temporary workload or technical incapacity;

53.2 (f) (3) (iii) In exceptional circumstances, the Agency may elect to grant specific authorization
to subcontract analyses using specific methods to an ISO/IEC 17025-accredited laboratory
approved by the Agency, which has the necessary technique within its Scope of ISO/IEC 17025
Accreditation (for example, DNA analysis or genomic profiling);

53.2 (f) (3) (iv) Other specific investigations, such as, without limitation, forensic examinations
which need to be performed in the course of the Analytical Testing process may also be
subcontracted by the Laboratory.

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53.2 (f) (4) In all such cases, the Laboratory subcontracting the analysis is only responsible for the
maintenance of the appropriate chain of custody up to Sample reception by the subcontracted
Laboratory. Such arrangements shall be clearly recorded as part of the Sample’s documentation and
included in the Laboratory Documentation Package, if applicable.

53.2 (g) Purchasing of Services and Supplies

53.2 (g) (1) Chemicals and reagents shall be Fit-for-Purpose and be of appropriate purity.
Documentation indicating the purity of Reference Materials/Standards shall be obtained when available
and retained in the Management System documentation. Chemicals, reagents and kits labelled (e.g.,
“Research Only” or “Forensic Use Only”) may be utilized for the purposes of Doping Control as long as
they are demonstrated to be Fit-for-Purpose by the Laboratory and/or the Agency.

53.2 (g) (2) In the case of rare or difficult to obtain Reference Materials, or Reference Collections for use
in qualitative Analytical Testing Procedures, the expiration date can be extended if adequate
documentation exists confirming that no significant deterioration has occurred or that appropriate
purification or verification of Fitness-for-Purpose has been performed. The process to extend the
expiration date of a Reference Material, Reference Collection, or solution shall be described in the
Laboratory’s Management System documentation.

53.2 (g) (3) The Laboratory shall maintain control and proper records of use of controlled chemicals and
reagents in accordance with national laws and other relevant regulations.

53.2 (g) (4) Waste disposal shall be in accordance with national laws and other relevant regulations. This
includes biohazard materials, chemicals, controlled substances, and radioisotopes, if used.

53.2 (g) (5) Environmental health and safety policies shall be in place to protect the staff, the public, and
the environment.

53.3 Process Requirements

53.3 (a) The Laboratory shall maintain paper or (ideally) electronic Laboratory Internal Chain of Custody in
compliance with the TD.

53.3 (b) Reviewing of Requests, Tenders and Contracts

53.3 (b) (1) Review of legal documents or agreements related to Analytical Testing shall meet the
requirements of ISO/IEC 17025.

53.3 (c) Reception, Registration and Handling of Samples

53.3 (c) (1) The Laboratory may receive Samples, which have been collected, sealed and transported to
the Laboratory according to the Equine Testing and Investigations Standards.

53.3 (c) (2) The transfer of the Samples from the courier or other delivery Person shall be recorded
including, at a minimum, the date, the time of receipt, the initials or (electronic) signature of the
Laboratory representative receiving the Samples and the courier company tracking number, if
applicable. This information shall be included into the Laboratory Internal Chain of Custody record(s) of
the Sample(s).

53.3 (c) (3) The Sample transport container & each individual sample shall be inspected, and any
irregularities recorded (see Article 53.3 (e)). However, Samples transferred for long-term storage
purposes are not subject to an individual inspection by the receiving Laboratory until a Sample has been
selected for Further Analysis.

53.3 (c) (4) The Laboratory shall have a system to uniquely identify the Samples and associate each
Sample with the collection document or other external chain of custody information.

53.3 (d) Acceptance of Samples for Analysis

53.3 (d) (1) The Laboratory shall analyze each Sample received, unless, unless otherwise instructed by
the Agency.

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53.3 (d) (2) If justified by the Sample irregularities observed (see Article 53.3 (e)), the Laboratory shall
seek instructions from the Agency on the performance of Analytical Testing on the Sample. The Agency
shall inform the Laboratory in writing whether a Sample with noted irregularities should be analyzed or
not, and/or of any further measures to be taken (e.g., splitting the Sample in accordance with Article 53.3
(f), forensic analysis, DNA analysis), or that the Sample should be stored for Further Analysis. The
communication between the Laboratory and the Agency shall be recorded as part of the Sample’s
documentation.

53.3 (e) Samples with Irregularities

53.3 (e) (1) The Laboratory shall observe and document conditions that exist at the time of Sample
reception or registration that may adversely impact on the integrity of a Sample or on the performance of
Analytical Testing Procedures. Only unusual conditions shall be recorded.

53.3 (e) (2) Irregularities to be noted by the Laboratory may include, but are not limited to:

53.3 (e) (2) (i) Sample transport conditions (e.g., delivery time, temperature), which may impact the
integrity of the Sample for Analytical Testing, as determined by the Laboratory;

53.3 (e) (2) (ii) Sample collection information (including Sample identification Protocol), which is
necessary to conduct the requested Analytical Testing menu, is not provided, e.g., missing or
incomplete Sample collection documentation;

53.3 (e) (2) (iii) Sample identification is questionable. For example, the number on the Sample
container does not match the Sample identification number on the Sample collection
documentation;

53.3 (e) (2) (iv) Covered Person or Covered Horse information is visible on the Laboratory copy of
the Sample collection documentation or any other document transferred to the Laboratory;

53.3 (e) (2) (ix) The Sample contains foreign objects, such as insects;

53.3 (e) (2) (v) Sample identification numbers are different between the “A” and the “B” Sample
containers of the same Sample;

53.3 (e) (2) (vi) Tampering or adulteration of the Sample is evident;

53.3 (e) (2) (vii) Sample is not sealed with Tamper-Evident device or not sealed upon receipt;

53.3 (e) (2) (viii) Sample volume does not meet the suitable volume for analysis or is otherwise
inadequate to perform the requested Analytical Testing menu;

53.3 (e) (2) (x) The Sample condition(s) is unusual – for example: color, odor, presence of turbidity
or foam in a urine Sample; color, hemolysis, freezing or clotting of a blood Sample; unusual
differences in Sample appearance (e.g., color and/or turbidity) between the “A” and the “B”
Samples.

53.3 (e) (3) When an analysis on a Sample with documented irregularities is performed, the Laboratory
shall record the irregularities in the Test Report.

53.3 (f) Sample Splitting Procedure

53.3 (f) (1) In cases when either the “A” or “B” Sample is not suitable for the performance of the analyses
(e.g., there is insufficient Sample volume; the Sample container has not been properly sealed or has
been broken; the Sample’s integrity has been compromised in any way; the Sample is heavily
contaminated, the “A” or “B” Sample is missing), the Laboratory shall notify and seek authorization from
the Agency to split the other Sample container (“A” or “B”, as applicable), provided that it is properly
sealed. The Agency shall inform the Laboratory of its decision in writing within three (3) days of
notification by the Laboratory. If the Agency decides not to proceed with the Sample splitting procedure,
then the Laboratory shall report the Sample as Not Analyzed to, and in a form designated by, the
Agency, including the noted Sample irregularities and the documented reasons if provided by the
Agency.

53.3 (f) (2) The first fraction of the split Sample shall be considered as the “A” Sample and shall be used
for the Initial Testing Procedure(s), unless the Initial Testing Procedure(s) have already been performed,

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and the “A” Confirmation Procedure(s), if necessary. The second fraction, considered as the “B”
Sample, shall be resealed and stored frozen for “B” Confirmation Procedure(s), if necessary.

53.3 (f) (3) The process of opening and splitting the Sample and resealing of the remaining second
fraction shall be conducted in accordance with Article 53.5 (i) (13) for a customary “B” Sample opening.

53.3 (f) (4) When the splitting procedure concerns blood Samples, which have been collected for
Analytical Testing on the blood serum/plasma fraction, the sealed, intact (“A” or “B”) Sample shall be
centrifuged as soon as practical after Laboratory reception to obtain the serum or plasma fraction. The
centrifuged Sample shall be stored frozen in the sealed Sample collection tube according to established
protocols until the Sample opening/splitting procedure can be conducted. The opening of the Sample for
the splitting of the serum/plasma fraction and resealing of the second fraction shall be carried out as
described immediately above.

53.3 (g) Initial Storage and Sample Aliquoting for Analysis

53.3 (g) (1) The Aliquot preparation procedure for any Initial Testing Procedure(s) or Confirmation
Procedure shall minimize the risk of contamination of the Sample or Aliquot. The Laboratory shall use
new material(s) (e.g., new test tubes, disposable pipettes or pipettes with disposable, non-reusable tip)
to take Aliquots for Confirmation Procedures.

53.3 (g) (2) Urine Samples

53.3 (g) (2) (i) In order to maintain the stability and integrity of the urine Samples, the Laboratory
shall implement Sample storage procedures that minimize storage time at room and refrigerated
temperatures as well as Sample freeze/thaw cycles.

53.3 (g) (2) (ii) For urine Samples, the Laboratory shall obtain, following proper homogenization of
the Sample, an initial Aliquot containing enough Sample volume for all analytical procedures (all
Initial Testing Procedure(s) or all intended Confirmation Procedures, as applicable), by decanting
the Aliquot from the urine Sample container into a secondary container (e.g., a Falcon tube).
Procedure-specific Aliquot(s) shall then be taken from the secondary container.

53.3 (g) (2) (iii) The Laboratory shall measure the pH and Specific Gravity of urine Samples once,
using one Aliquot, during the Initial Testing Procedure(s) and the Confirmation Procedure(s) (“A”
and “B” Samples). Other tests that may assist in the evaluation of adulteration or manipulation may
be performed if deemed necessary by the Laboratory.

53.3 (g) (2) (iv) Urine “A” Samples should be frozen after Aliquots are taken for the Initial Testing
Procedure(s) to minimize risks of Sample microbial degradation. Urine “B” Samples shall be
stored frozen after reception until analysis, if applicable.

53.3 (g) (3) Blood Samples

53.3 (g) (3) (i) The Laboratory shall follow the applicable Technical Document(s) and Technical
Letter(s) for handling and storing blood Samples.

53.4 Selection and Validation of Analytical Testing Procedures

53.4 (a) The Laboratory shall select, validate, and document Analytical Testing Procedures, which are Fit-for-
Purpose for the analysis of representative target Analytes of Prohibited Substances and Prohibited Methods.

53.4 (b) Validation results for Analytical Testing Procedures shall be summarized in a Validation Report and
supported by the necessary documentation and analytical data. The Validation Report shall indicate whether
the Analytical Testing Procedure is Fit-for-Purpose and shall be included in a Laboratory Scope of
Accreditation.

53.4 (c) The Laboratory shall define and document the conditions that would trigger the revalidation of an
Analytical Testing Procedure (e.g., change of internal standard, modified extraction procedure or
chromatographic methodology, change in detection technique) or a partial re-assessment of the validation
process (e.g., replacement or upgrade of instrument, addition of new Analyte to the Analytical Method).

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53.4 (d) Validation of Analytical Testing Procedures for Non-Threshold Substances

53.4 (d) (1) The Laboratory shall develop, as part of the method validation process, appropriate
standard solutions for detection and/or identification and estimation of the concentration of Non-
Threshold Substances. In the absence of suitable Reference Materials, Reference Collections may be
used for detection and identification.

53.4 (d) (2) Validation of Initial Testing Procedure(s) for Non-Threshold Substances

53.4 (d) (2) (i) The Laboratory shall validate the Selectivity, carryover, reliability of detection at the
MRPL and Limit of Detection (LOD) for the Initial Testing Procedure(s) from the analysis of an
adequate number of representative samples prepared in the appropriate matrix of analysis. For
chromatographic-mass spectrometric Analytical Methods, the Initial Testing Procedure shall allow
the detection of each Non-Threshold Substance or its representative Metabolite(s) or Marker(s) at
50% or less of the Minimum Required Performance Levels (MRPL).

53.4 (d) (2) (ii) For Non-Threshold Substances with Minimum Reporting Levels (MRL), the
Laboratory shall validate and document the concentration levels that will require a Confirmation
Procedure.

53.4 (d) (2) (iii) If there is no available Reference Material, an estimate of the detection capability
of the Initial Testing Procedure(s) (i.e., the LOD) for the Non-Threshold Substance or its
representative Metabolite(s) or Marker(s) may be provided by assessing a representative
substance from the same class of Prohibited Substances with a similar chemical structure.

53.4 (d) (3) Validation of Confirmation Procedures for Non-Threshold Substances

53.4 (d) (3) (i) Factors to be investigated in the method validation procedure to demonstrate that a
Confirmation Procedure for Non-Threshold Substances is Fit-for-Purpose include, but are not
limited to:

53.4 (d) (3) (ii) Selectivity: The ability of the Confirmation Procedure to detect and identify the
Analyte of interest, taking into account interference(s) from the matrix or from other substance(s)
present in the Sample. Selectivity shall be determined and documented from the analysis of an
adequate number of representative samples prepared in the matrix of Sample analysis, in
compliance with the applicable Technical Document, Technical Letter or Laboratory Guidelines.
The Confirmation Procedure shall be able to discriminate between Analytes of closely related
structures;

53.4 (d) (3) (iii) Limit of Identification (LOI): When the analyses of Non-Threshold Substances are
based on chromatographic-mass spectrometric techniques, the Laboratory shall determine the
lowest concentration at which each Non-Threshold Substance or its representative Metabolite(s) or
Marker(s), for which a Reference Material is available, is identified at no more than 5% false
negative rate (in compliance with the applicable Technical Document, Technical Letter or
Laboratory Guidelines). The LOI shall be lower than the applicable MRPL;

53.4 (d) (3) (iv) Robustness: The Confirmation Procedure shall be demonstrated to produce
similar results with respect to minor variations in analytical conditions, which may affect the results
of the analysis. Those conditions that are critical to ensuring Reproducible results shall be
considered;

53.4 (d) (3) (v) Carryover: The conditions required to eliminate carryover of the substance of
interest from Sample to Sample during processing or instrumental analysis.

53.4 (e) Validation of Analytical Testing Procedures for Threshold Substances

53.4 (e) (1) As part of the validation process for chromatography-mass spectrometric Analytical
Methods applied to the analysis of Threshold Substances, the Laboratory shall develop acceptable
standard solutions for identification of Threshold Substances. For Confirmation Procedures, Certified
Reference Materials should be used for quantification, if available.

53.4 (e) (2) For the application of affinity-binding assays, or other methods as applicable, to the analysis
of Threshold Substances, the Laboratory shall follow the applicable Technical Document and should
follow applicable Laboratory Guidelines.

53.4 (e) (3) Validation of Initial Testing Procedure(s) for Threshold Substances

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53.4 (e) (3) (i) The Laboratory shall validate Initial Testing Procedure(s) that are Fit-for-Purpose, in
accordance with relevant Technical Document(s), Technical Letter(s) or Laboratory Guidelines

53.4 (e) (3) (ii) For chromatographic-mass spectrometric Initial Testing Procedure(s), the
Laboratory shall validate the Selectivity, LOD and dynamic range from the analysis of an adequate
number of representative samples prepared in the appropriate matrix of analysis, unless otherwise
specified.

53.4 (e) (3) (iii) Unless otherwise specified, the Laboratory shall validate and document the
concentration levels which will require quantitative Confirmation Procedure(s).

53.4 (e) (3) (iv) In order to account for a possible underestimation of concentrations of Threshold
Substances during non-quantitative Initial Testing Procedure(s), the Laboratory shall establish, and
document in the Test Method’s SOP, criteria (e.g., concentration levels), determined during the
Initial Testing Procedure method validation, to evaluate initial results as Presumptive Adverse
Analytical Findings and ensure that all potentially positive Samples are subjected to quantitative
Confirmation Procedures.

53.4 (e) (3) (v) The estimation of Measurement Uncertainty (MU) is not required during the
validation of Initial Testing Procedure(s), unless otherwise specified.

53.4 (e) (4) Validation of Confirmation Procedures for Threshold Substances

53.4 (e) (4) (i) Factors to be investigated during the method validation to demonstrate that a
quantitative Confirmation Procedure for a Threshold Substance is Fit-for-Purpose include but are
not limited to:

53.4 (e) (4) (ii) Selectivity, LOI, Robustness, Carryover (see Article 53.4 (d));

53.4 (e) (4) (iii) Limit of Quantification (LOQ): The Laboratory shall demonstrate that a quantitative
Confirmation Procedure has an established LOQ of no more than 50% of the Threshold value or in
accordance with the LOQ values required in relevant Technical Document(s) or in consideration of
Laboratory Guidelines;

53.4 (e) (4) (iv) Dynamic Range: The range of the quantitative Confirmation Procedure shall be
documented from at least 50% to 200% of the Threshold value;

53.4 (e) (4) (v) Repeatability (sr): The quantitative Confirmation Procedure shall allow for the
reliable repetition of the results over a short time, using a single operator, item of equipment, etc.
Repeatability at levels close to the Threshold shall be determined;

53.4 (e) (4) (vi) Intermediate Precision (sw): The quantitative Confirmation Procedure shall allow
for the reliable repetition of the results at different times and with different operators and
instruments, if applicable, performing the assay. Intermediate Precision at levels close to the
Threshold shall be determined;

53.4 (e) (4) (vii) Bias (b): The Bias of the measurement procedure shall be evaluated either using
Certified Reference Materials or traceable Reference Materials, if available, or from comparison
with a reference method or with the consensus values obtained from an inter-Laboratory
comparison study or EQAS participation. Bias at the levels close to the Threshold shall be
determined;

53.4 (e) (4) (viii) Measurement Uncertainty (MU): The MU associated with the results obtained with
the quantitative Confirmation Procedure shall be estimated in accordance with the applicable
Technical Document, Technical Letter or Laboratory Guidelines. At least, MU at levels close to the
Threshold shall be addressed during the validation of the quantitative Confirmation Procedure.

53.4 (e) (5) Confirmation Procedure method validation data (including the estimation of MU) is evaluated
during the assessment process for inclusion of the quantitative Confirmation Procedure within the
Laboratory’s Scope of ISO/IEC 17025 Accreditation. Therefore, for those Confirmation Procedures that
are included within the Laboratory’s Scope of ISO/IEC 17025 Accreditation, the Laboratory is not
required to produce method validation data, SOPs, or other evidence of method validation in any legal
proceeding.

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53.5 Sample Analysis

53.5 (a) Laboratories shall analyze Samples collected by the Agency using Race Day or Out-of-Competition
Analytical Testing menus to detect the presence of Prohibited Substances or Prohibited Methods only (as
defined in the Prohibited List).

53.5 (b) Covered Persons and their representatives are not permitted to be present for any aspect of Sample
analysis or processing described in the ESL, Technical Documents, Technical Letters, Laboratory Guidelines,
or Laboratory SOPs. In addition, Covered Persons are not permitted to have a Sample transferred to be
tested at a laboratory.

53.5 (c) Laboratories may analyze Samples for the following, in which case the results of the analysis shall not
be reported as an Atypical Finding or an Adverse Analytical Finding:

53.5 (c) (1) Non-prohibited substances or methods that are included in the Agency Monitoring Program
(see Protocol);

53.5 (c) (2) Non-prohibited substances for results interpretation purposes (e.g., non-prohibited
substances that share Metabolite(s) or degradation products with Prohibited Substances), if applicable;

53.5 (c) (3) Non-prohibited substances or methods requested as part of a Results Management process
by an adjudicatory body or the Agency;

53.5 (c) (4) Non-prohibited substances or methods requested by the Agency as part of its safety
Protocol, Protocol of conduct or other regulations (see comments to Protocol); or

53.5 (c) (5) Additional analyses for quality assurance/quality improvement/method development or
research purposes, in accordance with the requirements indicated in Article 53.11 (d).

53.5 (d) At minimum, all Laboratories are required to implement all mandatory Analytical Testing Procedures,
as determined by the Agency in compliance with relevant Technical Document(s) and Technical Letter(s).
Laboratories may implement additional methods for the analysis of particular Prohibited Substances or
Prohibited Methods.

53.5 (e) Analytical Testing Procedure(s) included in the Laboratory’s Scope of ISO/IEC 17025 Accreditation
shall be considered as Fit-for-Purpose and therefore the Laboratory shall not be required to provide method
validation documentation, SOPs or EQAS performance data in support of an Adverse Analytical Finding.

53.5 (f) However, if the Analytical Testing Procedure has not been included yet in the Laboratory’s Scope of
ISO/IEC 17025 Accreditation, the Laboratory shall validate the procedure in compliance with the ESL and the
applicable Technical Document(s), Technical Letter(s) or Laboratory Guidelines prior to its application to the
analysis of Samples. In such cases, the Laboratory may be required to provide method validation
documentation or EQAS performance data in support of an Adverse Analytical Finding(see Article 51.4 (b)
(ii)).

53.5 (g) Laboratories may, on their own initiative and prior to reporting a test result, apply additional Analytical
Testing Procedures to analyze Samples for Prohibited Substances or Prohibited Methods not included in the
standard Analytical Testing menu, provided that the additional work is conducted at the Laboratory’s expense
and does not significantly affect the possibility to submit the Sample, as identified by the Agency, to Further
Analysis. Results from any such analysis shall be reported to, and in a form designated by, the Agency and
have the same validity and Consequences as any other analytical result.

53.5 (h) Application of Initial Testing Procedure(s)

53.5 (h) (1) The objective of the Initial Testing Procedure is to obtain information about the potential
presence of Prohibited Substance(s) or Metabolite(s) of Prohibited Substance(s), or Marker(s) of the
Use of a Prohibited Substance or Prohibited Method. Results from Initial Testing Procedure(s) can be
included as part of longitudinal studies (e.g., endogenous steroid), provided that the method is Fit-for-
Purpose.

53.5 (h) (2) The Initial Testing Procedure(s) shall fulfil the following requirements:

53.5 (h) (2) (i) The Initial Testing Procedure(s) shall be Fit-for-Purpose;

53.5 (h) (2) (ii) The Initial Testing Procedure(s) shall be performed on Aliquot(s) taken from the
container identified as the “A” Sample;

53.5 (h) (2) (iii) The Initial Testing Procedure(s) shall be recorded, as part of the Sample (or
Sample batch) record, each time it is conducted;

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53.5 (h) (2) (iv) All batches undergoing an Initial Testing Procedure(s) shall include appropriate
negative and positive quality controls prepared in the matrix of analysis, unless otherwise
specified;

53.5 (h) (2) (v) The Initial Testing Procedure(s) for Non-Threshold Substances shall include
appropriate controls of representative substance(s) at or below the MRPL;

53.5 (h) (2) (vi) The Initial Testing Procedure(s) for Threshold Substances shall include appropriate
controls close to the Threshold, unless otherwise specified;

53.5 (h) (2) (vii) Results from Initial Testing Procedure(s) are not required to consider the
associated MU, unless otherwise specified;

53.5 (h) (2) (viii) The Laboratory shall establish criteria, based on its method validation and in
accordance with its SOP, to evaluate results from an Initial Testing Procedure(s) as a Presumptive
Adverse Analytical Finding, which would trigger confirmation analyses.

53.5 (i) Application of Confirmation Procedures

53.5 (i) (1) The objective of the Confirmation Procedure is to obtain a result, which supports or does not
support the reporting of an Adverse Analytical Findingor Atypical Finding.

53.5 (i) (10) Repetition of the “A” Confirmation Procedure

53.5 (i) (10) (i) The Laboratory may repeat the Confirmation Procedure for an “A” Sample, if
appropriate, (e.g., quality control failure, chromatographic peak interferences, inconclusive “A”
confirmation results). In that case, the previous test result shall be nullified. Each repeat
confirmation shall be performed using a new Aliquot(s) taken from the “A” Sample container and
shall be recorded.

53.5 (i) (11) “A” Confirmation Procedure for Non-Threshold Substances

53.5 (i) (11) (i) For Non-Threshold Substances without Minimum Reporting Levels, Adverse
Analytical Findingor Atypical Finding decisions for the “A” Sample shall be based on the
identification of the Non-Threshold Substance or its characteristic Metabolite(s) or Marker(s), as
applicable, in compliance with the relevant Technical Document, Technical Letter or in
consideration of Laboratory Guidelines.

53.5 (i) (11) (ii) For Non-Threshold Substances with Minimum Reporting Levels as specified in the
TD, Adverse Analytical Finding decisions for the “A” Sample should be based on the identification
of the Non-Threshold Substance or its characteristic Metabolite(s) or Marker(s), in compliance with
the TD, at an estimated concentration greater than the Minimum Reporting Level, unless there is
justification for reporting the finding at levels below the Minimum Reporting Level (e.g., if the
analysis forms part of an ongoing investigation).

53.5 (i) (12) “A” Confirmation Procedure for Threshold Substances

53.5 (i) (12) (i) For Threshold Substances, Adverse Analytical Findingor Atypical Finding
decisions for the “A” Sample shall be based on the confirmed identification (in accordance with the
TD, applicable to Confirmation Procedures based on chromatography-mass spectrometry) of the
Threshold Substance and/or its Metabolite(s) or Marker(s) and their quantitative determination in
the Sample at a level exceeding the value of the relevant Decision Limit, which is specified in the
TD DL or other applicable Technical Document(s) or Laboratory Guidelines.

53.5 (i) (12) (ii) Quantitative Confirmation Procedures for Threshold Substances shall be based on
the determination of the mean of measured analytical values (e.g., concentrations, chromatogram
peak heights or areas) or the ratio/score calculated from the mean(s) of the measured analytical
values of three (3) “A” Sample Aliquots, unless otherwise specified. If there is not enough Sample
volume to analyze three (3) Aliquots, the maximum number of Aliquots that can be prepared should
be analyzed.

53.5 (i) (12) (iii) By determining that the test result exceeds the Decision Limit, the quantitative
Confirmation Procedure establishes that the Threshold Substance or its Metabolite(s) or Marker(s)

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is present in the Sample at a level greater than the Threshold, with a statistical confidence of at
least 95% (for more information, refer to the TD DL).

53.5 (i) (12) (iv) For Threshold Substances, Markers of the “steroid profile”, or any other Prohibited
Substance that may be produced endogenously at low levels, Adverse Analytical Findingdecisions
for the “A” Sample may also be based on the application of any Fit-for-Purpose Confirmation
Procedure that establishes the exogenous origin of the Prohibited Substance or its Metabolite(s)
or Marker(s). Atypical Findings may result from non-conclusive determinations of the origin
(endogenous vs. exogenous) of the Prohibited Substance or its Metabolite(s) or Marker(s).

53.5 (i) (13) “B” Confirmation Procedure:

53.5 (i) (14) Testing Laboratory

53.5 (i) (14) (i) The “B” Confirmation Procedure shall be performed in the same Laboratory as the
“A” Confirmation Procedure, unless there are exceptional circumstances, as determined by the
Agency and with the Agency’s prior written approval, which prevent the “B” Confirmation
Procedure from being performed in the same Laboratory. A different analyst must perform the “B”
analytical procedure. The same individual(s) that performed the “A” analysis may perform
instrumental set up and performance checks and verify results.

53.5 (i) (15) Notification and Timing of “B” Confirmation Procedure

53.5 (i) (15) (i) The “B” Confirmation Procedure shall only be performed by the Laboratory upon
request by the Agency.

53.5 (i) (15) (ii) The Agency should inform the Laboratory, in writing, within fifteen (15) days
following the reporting of an “A” Sample Adverse Analytical Findingby the Laboratory, whether the
“B” Confirmation Procedure shall be conducted. This includes situations when the Covered Person
does not request the “B” Sample analysis or expressly or implicitly waives their right to the analysis
of the “B” Sample, but the Agency decides that the “B” Confirmation Procedure shall still be
performed.

53.5 (i) (15) (iii) If the “B” Confirmation Procedure is to be performed, either upon the request of
and payment by the Covered Person in accordance with the Protocol or the Agency, it should be
performed as soon as possible after the Agency has provided such notice to the Laboratory.

53.5 (i) (15) (iv) The timing of the “B” Confirmation Procedure may be strictly fixed within a very
short period of time and without any possible postponement, if circumstances so justify it. This can
notably and without limitation be the case when a postponement of the “B” Sample analysis could
significantly increase the risk of Sample degradation and/or inadequately delay the decision-
making process in the given circumstances (e.g., and without limitation, during or in view of a
Covered Horserace requiring rapid completion of the Sample analysis).

53.5 (i) (16) Opening, Aliquoting and Resealing of “B” Sample

53.5 (i) (16) (i) The “B” Confirmation Procedure shall be performed using Aliquot(s) taken from the
container defined as the “B” Sample.

53.5 (i) (16) (ii) If the “B” Sample container was not properly sealed and/or showed signs of
Tampering, or if the identifying numbers did not match those on the Sample collection
documentation, the Laboratory shall not proceed with the “B” Confirmation Procedure and will
inform the Agency immediately to obtain instructions. In such cases, the “B” Confirmation
Procedure may have to be re-scheduled.

53.5 (i) (16) (iii) The Laboratory shall ensure that the “B” Sample container is opened and Aliquots
for the “B” Confirmation Procedure are taken.

53.5 (i) (16) (iv) The Laboratory shall also ensure that, after opening and taking Aliquots for the “B”
Confirmation Procedure, the “B” Sample is properly resealed.

53.5 (i) (16) (v) At a minimum, the Laboratory Director or representative shall sign another part of
the Laboratory documentation attesting that the “B” Sample opening and aliquoting procedures
and that the “B” Sample was properly resealed.

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53.5 (i) (17) Target Analyte(s)

53.5 (i) (17) (i) If more than one (1) Prohibited Substance, Metabolite(s) of a Prohibited
Substance, or Marker(s) of the Use of a Prohibited Substance or Prohibited Method has been
confirmed in the “A” Confirmation Procedure, the Laboratory shall confirm as many of the Adverse
Analytical Findings as possible given the “B” Sample volume available. The decision on the
prioritization for the confirmation(s) shall be made to prioritize the analysis of the Prohibited
Substance(s) or Prohibited Method(s) that carry the longest potential period of Ineligibility. The
prioritization decision should be made in consultation with the Agency and documented.

53.5 (i) (18) Repetition of the “B” Confirmation Procedure

53.5 (i) (18) (i) The Laboratory may repeat the Confirmation Procedure for a “B” Sample, if
appropriate, (e.g., quality control failure, chromatographic peak interferences, inconclusive “B”
confirmation results). In that case, the previous test result shall be nullified. The Laboratory may
repeat the “B” Confirmation Procedure using the remaining volume of the same Aliquot initially
taken from the “B” Sample container. However, if there is not enough volume left of the initial
Aliquot, then the Laboratory shall use a new Aliquot(s) taken from the re-sealed “B” Sample
container. Each Aliquot used shall be documented.

53.5 (i) (19) “B” Confirmation with Negative Results

53.5 (i) (19) (i) If the final “B” confirmation results are negative, the Analytical Testing result shall be
considered a Negative Finding. The Laboratory shall notify the Agency immediately. If requested
by the Agency, the Laboratory shall conduct an internal investigation of the causes of the
discrepancy between the “A” and “B” Sample results.

53.5 (i) (2) A Confirmation Procedure for a Non-Threshold Substance with a Minimum Reporting Level,
or other control limit may also be performed if the result estimated from the Initial Testing Procedure(s) is
lower than the applicable Minimum Reporting Level, as determined by the Laboratory in accordance with
the method’s validation results, or as specifically required by the Agency.

53.5 (i) (20) “B” Confirmation Procedure for Non-Threshold Substances and exogenous Threshold
Substances

53.5 (i) (20) (i) For Non-Threshold Substances (including those with Minimum Reporting Levels as
specified in the TD) and exogenous Threshold Substances, the “B” Sample results shall only
confirm the presence of the Prohibited Substance(s) or its Metabolite(s) or Marker(s) identified in
the “A” Sample (in compliance with the TD) for the Adverse Analytical Findingto be valid, unless
otherwise specified. No quantification or estimation of concentrations of such Prohibited
Substance, or its Metabolite(s) or Marker(s) is necessary.

53.5 (i) (21) “B” Confirmation Procedure for Threshold Substances

53.5 (i) (21) (i) For Threshold Substances, Adverse Analytical Findingdecisions for the “B” Sample
results shall be based on the confirmed identification (in accordance with the TD), applicable to
Confirmation Procedures based on chromatography-mass spectrometry) of the Threshold
Substance or its Metabolite(s) or Marker(s) and their quantitative determination in the Sample at a
level exceeding the value of the relevant Threshold as specified in Technical Document(s) or
Laboratory Guidelines. Comparison of the measured value of the “B” Sample to the measured
value of the “A” Sample is not necessary to establish “B” Sample confirmation. The “B” Sample
value is only required to exceed the applicable Threshold.

53.5 (i) (21) (ii) Quantitative “B” Confirmation Procedures for Threshold Substances shall be
based on the determination of the mean of measured analytical values (e.g., concentrations,
chromatogram peak heights or areas) or the ratio/score calculated from the mean(s) of the
measured analytical values of three (3) “B” Sample Aliquots, unless otherwise specified. If there is
not enough Sample volume to analyze three (3) Aliquots, the maximum number of Aliquots that can
be prepared should be analyzed.

53.5 (i) (21) (iii) For Threshold Substances or any other Prohibited Substance that may be
produced endogenously at low levels, Adverse Analytical Findingdecisions for the “B” Sample
results may also be based on the application of any Fit-for-Purpose Analytical Testing Procedure

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that establishes the exogenous origin of the Prohibited Substance and/or its Metabolite(s) or
Marker(s). Atypical Findings may result from non-conclusive determinations of the origin
(endogenous vs. exogenous) of the Prohibited Substance or its Metabolite(s) or Marker(s).

53.5 (i) (22) Further Analysis:

53.5 (i) (23) Further Analysis of stored Samples shall, as a matter of principle, be aimed at detecting all
the Prohibited Substance(s) or Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a
Prohibited Substance or Prohibited Method included in the Prohibited List in force at the time of the
collection of the Sample(s).

53.5 (i) (24) Selection of Samples and Laboratories for Further Analysis:

53.5 (i) (24) (i) Stored Samples may be selected for Further Analysis at the discretion of the
Agency.

53.5 (i) (24) (ii) The choice of which Laboratory will conduct the Further Analysis will be made by
the Agency. Requests to the Laboratory for Further Analysis shall be made in writing and be
recorded as part of the Sample’s documentation.

53.5 (i) (24) (iii) When a Sample has been reported as a Negative Finding or Atypical Finding,
there is no limitation on the Agency to conduct Further Analysis on the Sample.

53.5 (i) (24) (iv) Further Analysis may also be performed on stored Samples, which were
previously reported as Adverse Analytical Findings. Any Prohibited Substance or Prohibited
Method detected, which was prohibited at the time of Sample collection, shall be reported.

53.5 (i) (24) (v) Previously acquired Initial Testing Procedure(s) data may also be re-evaluated for
the presence of Prohibited Substances or their Metabolite(s) or Marker(s) of Prohibited
Substances or Prohibited Methods, at the initiative the Agency or the Laboratory itself. The results
of such re-evaluation, if suspicious, shall be communicated to the Agency, and may lead to Further
Analysis.

53.5 (i) (25) Analytical Testing Procedures for Further Analysis of Stored Samples:

53.5 (i) (25) (i) Further Analysis of stored Samples shall be performed under the ESL, Technical
Documents, Technical Letters in effect at the time the Further Analysis is performed. Any
Laboratory Guidelines may also be referenced.

53.5 (i) (25) (ii) Further Analysis of stored Samples includes, notably, but without limitation, the
application of newly developed or more sensitive Analytical Testing Procedures and/or the
analysis of new target Analytes of Prohibited Substance(s) or Prohibited Method(s) [e.g.,
Metabolite(s) and/or Marker(s)], which were not known or not included in the initial Analytical
Testing of the Sample.

53.5 (i) (25) (iii) Depending on the circumstances, and to ensure an effective and targeted use of
the available Sample volume, priorities may be set, and/or the scope of the Further Analysis
restricted to specific analyses (in particular, but without limitation, to analyses based on new or
improved Analytical Testing Procedures).

53.5 (i) (26) Further Analysis of Stored Samples Process

53.5 (i) (27) Use of the “A” Sample:

53.5 (i) (27) (i) The Agency may instruct the Laboratory to use the “A” Sample for both the Initial
Testing Procedure(s) and the “A” Confirmation Procedure(s), to use it only for the Initial Testing
Procedure(s) or not to use the “A” Sample for Further Analysis at all.

53.5 (i) (27) (ii) If the Laboratory has been instructed to perform only Initial Testing Procedure(s) on
the “A” Sample, any suspicious analytical result obtained from the “A” Sample shall be considered
as a Presumptive Adverse Analytical Finding, irrespective of the Analytical Testing Procedure
applied, and shall be confirmed using the split “B” Sample (see below).

53.5 (i) (27) (iii) When a Confirmation Procedure is performed on the “A” Sample and an Adverse
Analytical Findingis reported on this basis, the “B” Confirmation Procedure shall be applicable (as
per Article 53.7 (g)).

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53.5 (i) (28) Use of the split “B” Sample:

53.5 (i) (28) (i) When the “A” Sample is used only for the Initial Testing Procedure(s) or is not used
at all during Further Analysis, the “B” Sample shall be split and used for analysis. The “B” Sample
shall be split into two fractions, in accordance with Article 53.3 (f).

53.5 (i) (28) (ii) In the event an Adverse Analytical Findingis notified based on the results of a
Confirmation Procedure of the first fraction of the “B” Sample, the second split fraction of the “B”
Sample shall be deemed as the “B” Sample. If applicable, a “B” confirmation shall be decided and
performed in accordance with Article 53.7 (g).

53.5 (i) (29) Alternative Biological Matrices

53.5 (i) (29) (i) Any negative Analytical Testing results obtained from hair, hoof, saliva or other
biological material shall not be used to counter Adverse Analytical Findings or Atypical Findings
from urine or blood (including whole blood, plasma or serum).

53.5 (i) (3) A result obtained in the Initial Testing Procedure(s) for a Threshold Substance higher than the
Threshold requires a Confirmation Procedure. A Confirmation Procedure may also be performed if the
result obtained in the Initial Testing Procedure is lower than the Threshold, as determined by the
Laboratory or as specifically required by the Agency.

53.5 (i) (4) Irregularities in the Initial Testing Procedure(s) shall not invalidate an Adverse Analytical
Finding, which is adequately established by a Confirmation Procedure.

53.5 (i) (5) The Confirmation Procedure(s) shall fulfil the following requirements:

53.5 (i) (5) (i) The Confirmation Procedure(s) shall be Fit-for-Purpose, including the estimation of
the MU associated with a quantitative Confirmation Procedure;

53.5 (i) (5) (ii) The Confirmation Procedure(s) shall be recorded, as part of the Sample (or Sample
batch) record, each time it is conducted;

53.5 (i) (5) (iii) The Confirmation Procedure shall have equal or greater Selectivity than the Initial
Testing Procedure(s) and shall provide accurate quantification results (applicable to Threshold
Substances). The Confirmation Procedure should incorporate, when possible and adequate, a
different Sample extraction protocol and/or a different analytical methodology, unless otherwise
specified;

53.5 (i) (5) (iv) All batches undergoing a Confirmation Procedure shall include appropriate
negative and positive quality controls prepared in the matrix of analysis.

53.5 (i) (6) Confirmation Procedure Methods

53.5 (i) (6) (i) Mass spectrometry (MS) coupled to chromatographic separation (e.g., gas or liquid
chromatography) is the analytical technique of choice for confirmation of most Prohibited
Substances, Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a Prohibited
Substance or Prohibited Method. These are acceptable methods for both the Initial Testing
Procedure(s) and the Confirmation Procedure.

53.5 (i) (7) “A” Confirmation Procedure:

53.5 (i) (8) Aliquots

53.5 (i) (8) (i) The “A” Confirmation Procedure shall be performed using new Aliquot(s) taken from
the container identified as the “A” Sample. At this point, the link between the Sample external
Protocol as shown in the Sample container and the Laboratory internal Sample Protocol shall be
verified.

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53.5 (i) (9) Target Analyte(s)

53.5 (i) (9) (i) If the presence of more than one (1) Prohibited Substance, Metabolite(s) of a
Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance or Prohibited Method is
detected by the Initial Testing Procedure(s), the Laboratory shall confirm as many of the
Presumptive Adverse Analytical Findings as reasonably possible (such decision should consider
the volumes available in the “A” and “B” Samples). The confirmation(s) shall prioritize the
identification and/or quantification of the Prohibited Substance(s) or Prohibited Method(s) that
carry the longest potential period of Ineligibility. The prioritization decision shall be made in
consultation with the Agency and documented.

53.6 Assuring the Validity of Analytical Results

53.6 (a) The Laboratory shall monitor its analytical performance and the validity of test results by operating
quality control schemes, which are appropriate to the type and frequency of Analytical Testing performed by
the Laboratory. The resulting data should be recorded in such a way that trends are detectable and, where
practicable, statistical techniques should be applied to review the results.

53.6 (b) All quality control procedures shall be documented by the Laboratory. The range of quality control
activities include, but are not limited to:

53.6 (b) (1) Use of appropriate quality control samples (QCs)

53.6 (b) (1) (i) Appropriate positive and negative QCs shall be included in every analytical run both
for the Initial Testing Procedure(s) and Confirmation Procedure(s), unless otherwise specified.

53.6 (b) (1) (ii) Appropriate internal standard(s) shall be used for chromatographic methods.

53.6 (b) (1) (iii) For Threshold Substances, quality control charts (QC-charts) referring to
appropriate control limits depending on the Analytical Testing Procedure employed (e.g., +/- 2SD;
+/- 3SD; +/- U95%), shall be regularly used to monitor method performance and inter-batch
variability (when applicable).

53.6 (b) (2) Implementation of an Internal Quality Assurance Scheme (iQAS)

53.6 (b) (2) (i) The Laboratory shall establish a functional and robust iQAS program, in accordance
with the requirements of ISO/IEC 17025, which challenges the entire scope of the Analytical
Testing process (i.e., from Sample accessioning through result reporting). The Laboratory shall
implement a procedure that prevents the submission of iQAS results to the Agency.

53.6 (b) (2) (ii) The iQAS plan shall include and evaluate as many Laboratory procedures as
possible, including the submission of a sufficient number of test samples on a regular basis (e.g.,
monthly) and shall incorporate as many categories of Prohibited Substances and Prohibited
Methods as possible.

53.6 (b) (2) (iii) The Laboratory shall have a dedicated SOP for the iQAS program, which
incorporates a detailed procedure for the planning, preparation, (blind and/or double-blind)
introduction of the iQAS samples and management of the iQAS results (reviewing and follow-up of
nonconformities).

53.6 (b) (3) Mandatory participation in the Agency EQAS (see relevant Section).

53.6 (b) (4) Implementation of Internal Audits:

53.6 (b) (4) (i) Internal audits shall be conducted in accordance with the requirements of ISO/IEC
17025, and shall have a dedicated SOP incorporating a detailed procedure for the planning and
performance of the audits, the training and selection of internal auditors, specification of their
auditing activities, as well as for management of the internal audit conclusions (reviewing and
follow-up of nonconformities).

53.6 (b) (4) (ii) Internal audit responsibilities may be shared amongst personnel provided that any
Laboratory staff member does not audit their own area.

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53.6 (b) (4) (iii) Internal audits shall be carried out by qualified Laboratory staff members. In
addition, qualified members of the Laboratory's host organization (e.g., university, institute,
company) may also be included in the internal auditing teams.

53.6 (b) (5) Implementation of External Audits

53.6 (b) (5) (i) Laboratories may also consider having their procedures and systems audited by
other Laboratory Directors or external auditors. However, this shall not replace the performance of
internal audits by the Laboratory.

53.7 Results Management

53.7 (a) Review of Results

53.7 (b) The Laboratory shall conduct a minimum of one (1) independent review of all Initial Testing
Procedure(s) raw data and results. The review process shall be recorded.

53.7 (c) A minimum of two (2) Certifying Scientists shall conduct an independent review of all Adverse
Analytical Findings and Atypical Findings before a test result is reported. Evidence of the review and approval
of the analytical run/batch shall be recorded.

53.7 (c) (1) Second Opinion

53.7 (c) (1) (i) The Laboratory may request a second opinion from other Laboratory(-ies) before
reporting an Adverse Analytical Findingor Atypical Finding. Such requests for second opinions
may be required by specific Technical Document(s) or Technical Letters, required by the Agency
from certain Laboratory(-ies) for all or for specific Analytical Testing Procedures under certain
conditions (e.g., following the recent obtaining of HEAL accreditation or after a period of
Suspension or Analytical Testing Restriction), or requested at the discretion of the Laboratory
(e.g., for firstly detected Analytes or for difficult to interpret findings). In any case, the request for a
second opinion shall be made in writing and the second opinion received shall be recorded as
part of the Sample’s documentation. Any transfer of data and information necessary for the second
opinion shall be made securely and respecting the confidentiality of the analytical data and any
other information.

53.7 (c) (1) (ii) The Laboratory that performed the analysis is responsible for the result and for
issuing the final Test Report.

53.7 (c) (2) Laboratory Review of Adverse Analytical Findings and Atypical Findings

53.7 (c) (2) (i) At a minimum, the review of Adverse Analytical Findings and Atypical Findings shall
include:

53.7 (c) (2) (ii) Documentation linking the Sample (as specified in the Sample collection
documentation) to the Laboratory Internal Chain of Custody Documentation;

53.7 (c) (2) (iii) Laboratory Internal Chain of Custody documentation;

53.7 (c) (2) (iv) Initial Testing Procedure(s) and Confirmation Procedure(s) analytical data and
calculations;

53.7 (c) (2) (v) Quality control data;

53.7 (c) (2) (vi) Completeness of technical and analytical documentation supporting the reported
findings; Compliance of test data with the Analytical Testing Procedure’s validation results (e.g.,
MU);

53.7 (c) (2) (vii) Assessment of the existence of significant data or information that would cast
doubt on or refute the Laboratory findings;

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53.7 (c) (3) When the Confirmation Procedure result(s) are not determined to be Adverse Analytical
Finding(s) or Atypical Finding(s) based on the results review, the reason(s) for the rejection shall be
recorded, in the laboratory test report.

53.7 (d) Traceability of Results and Documentation

53.7 (e) The Laboratory shall have documented procedures to ensure that it maintains a record related to
each Sample analyzed. In the case of an Adverse Analytical Findingor Atypical Finding, the record shall
include the data necessary to support the conclusions reported as set forth in and limited by the TD.

53.7 (e) (1) Each step of Analytical Testing shall be traceable to the staff member who performed that
step;

53.7 (e) (2) Significant deviation from a written SOP shall be recorded;

53.7 (e) (3) Where instrumental analyses are conducted, the operating parameters for each run shall be
included as part of the record;

53.7 (e) (4) Requests for information by the Agency to a Laboratory shall be made in writing;

53.7 (e) (5) Laboratory Documentation Packages and Certificates of Analysis shall be in compliance
with the TD LDOC. Laboratories are not required to produce a Laboratory Documentation Package for
a Sample in which no Prohibited Substance or Prohibited Method or their Metabolite(s) or Marker(s)
was detected, unless requested by an adjudication body as part of a Results Management process or
Laboratory disciplinary proceedings.

53.7 (f) Confidentiality of the Analytical Data and Covered Person and/or Covered Horse’s Identity

53.7 (f) (1) The Laboratory shall not make any attempt to identify a Covered Person linked to and/or the
Covered Horse that has provided a Sample.

53.7 (f) (2) Information sent by a facsimile is acceptable provided that the correct facsimile number is
verified prior to transmission and the receipt is verified after the facsimile has been transmitted.

53.7 (f) (3) Secure emails or documents shall be used for reporting or discussion of Adverse Analytical
Findings or Atypical Findings if the Covered Person and/or Covered Horse can be identified or if any
information regarding the identity of the Covered Person and/or Covered Horse is included.

53.7 (g) Reporting Test Results

53.7 (h) Reporting Times

53.7 (h) (1) Reporting of all “A” Sample results should occur to, and in a form designated by, the Agency
no later than twenty (20) days of receipt of the Sample. The reporting time required for specific
occasions may be substantially less than twenty (20) days. The reporting time may be altered by
agreement between the Laboratory and the Agency. The Agency should be informed of any delay in the
reporting of “A” Sample results.

53.7 (h) (2) In order to expedite the Results Management process, an Abbreviated Laboratory
Documentation Package should be provided at the time of reporting an Adverse Analytical Findingto the
Agency unless the Agency indicates an Abbreviated Laboratory Documentation Package is not
necessary. The Laboratory Documentation Packages and/or Certificates of Analysis should be provided
by the Laboratory only to the Agency upon request and should be provided as soon as practicable and
no later than five (5) days of the request, unless a different deadline is agreed upon with the Agency.

53.7 (i) Reporting Requirements

53.7 (i) (1) The Laboratory shall record the test result for each individual Sample from the Agency to, and
in a form designated by, the Agency.

53.7 (i) (2) When reporting test results to, and in a form designated by, the Agency, the Laboratory shall
include, in addition to the mandatory information stipulated to, and in a form designated by, the Agency,
in the relevant Technical Document(s) or Technical Letter(s), and in the ISO/IEC 17025 standard, the

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following:

53.7 (i) (2) (i) The Specific Gravity of the Sample, if applicable (Initial Testing Procedure(s) and “A”
and “B” Confirmation Procedures);

53.7 (i) (2) (ii) Relevant comments, if necessary, for proper interpretation of the test result or
recommendations to the Agency (for example, for Target Testing of the Covered Horse);

53.7 (i) (2) (iii) Specific tests performed, in addition to the Laboratory routine Analytical Testing
menu (e.g., EPO, bisphosphonates, hGH, DNA, genomic profiling);

53.7 (i) (2) (iv) Any irregularities noted on Samples;

53.7 (j) The Laboratory is not required to provide any additional Test Report, either in hard-copy or digital
format, other than the submission of test results to, and in a form designated by, the Agency. Upon request by
the Agency, the Laboratory shall report a summary of the results of analyses performed in a format specified
by the Agency. In addition, the Laboratory shall also provide any information requested by the Agency in
relation to the Monitoring Program (Protocol).

53.7 (k) The Laboratory shall qualify the result(s) of the analysis in the Agency’s Test Report as:

53.7 (k) (1) Adverse Analytical Finding;

53.7 (k) (2) Atypical Finding;

53.7 (k) (3) Negative Finding; or

53.7 (k) (4) Not Analyzed

53.7 (l) Any Sample received at the Laboratory and not subject to Analytical Testing for a valid, documented
reason (as instructed by or agreed with the Agency) such as Sample irregularities, intermediate Samples of a
Sample Collection Session, etc. (see Article 53.3 (d)).

53.7 (m) Test Report for Non-Threshold Substances

53.7 (m) (1) “A” Sample Test Report

53.7 (m) (1) (i) The Laboratory is not required to report concentrations for Non-Threshold
Substances. The Laboratory shall report the actual Prohibited Substance(s) and/or its
Metabolite(s), or Marker(s) of the Use of Prohibited Substance(s) or Prohibited Method(s) present
(i.e., identified, as per the TD) in the Sample and in accordance with the reporting requirements
established in the TD. [Comment: When applicable, the Laboratory shall record in the form
designated by the Agency Test Report the specific Metabolite(s) or Marker(s) of the Non-
Threshold Substance that were identified in the Sample.]

53.7 (m) (1) (ii) However, the Laboratory shall provide estimated concentrations when possible
and for information purposes only, upon request by the Agency, if the detected level of the Non-
Threshold Substance(s), its Metabolite(s), or Marker(s) may be relevant to the Results
Management of an anti-doping case. In such instances, the Laboratory should indicate the
estimated concentration while making it clear to the Agency that the concentration was obtained by
an Analytical Testing Procedure, which has not been validated for quantitative purposes.

53.7 (m) (2) “B” Sample Test Report

53.7 (m) (2) (i) For Non-Threshold Substances, irrespective of whether they have a Minimum
Reporting Level, the Laboratory result for the “B” Sample shall only establish the presence (i.e., the
identity) of the Prohibited Substance(s) or its Metabolite(s) or Marker(s) in accordance with the
applicable Technical Document(s). The Laboratory is not required to quantify or estimate the
concentration of such Prohibited Substance, or its Metabolite(s) or Marker(s).

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53.7 (n) Test Report for Threshold Substances

53.7 (n) (1) “A” & “B” Sample Test Report

53.7 (n) (1) (i) For Threshold Substances, the Laboratory Test Report for the “A” Sample shall
establish that the identified Prohibited Substance(s) or its Metabolite(s) or Marker(s) is present at
a concentration and/or ratio and/or score of measured analytical values greater than the Threshold,
and/or that the Prohibited Substance(s) or its Metabolite(s) or Marker(s) is of exogenous origin.

53.8 Control of Nonconformities in Analytical Testing

53.8 (a) The Laboratory shall have policies and procedures that shall be implemented when any aspect of its
Analytical Testing does not comply with set requirements.

53.8 (b) Any nonconformities in Analytical Testing shall be recorded and kept as part of the documentation of
the Sample(s) involved.

53.8 (b) (1) Risk Minimization

53.8 (b) (1) (i) Laboratories shall take corrective actions in accordance with ISO/IEC 17025 for
Corrective Action Investigation and Reporting.

53.8 (b) (1) (ii) When conducting a corrective action investigation, the Laboratory shall perform and
record a thorough Root Cause Analysis of the nonconformity.

53.8 (b) (2) Improvement

53.8 (b) (2) (i) The Laboratory shall maintain, and when appropriate improve, the effectiveness of
its Management System in accordance with ISO/IEC 17025.

53.9 Complaints

53.9 (a) Complaints shall be handled in accordance with ISO/IEC 17025.

54 EQAS Overview

54.1 The Agency system of Laboratory EQAS and routine Analytical Testing performance (see Article 57) has been
developed with the objective of setting a transparent and balanced procedure for evaluation of Laboratory
operations. It is focused on maintaining and improving Laboratory’s Analytical Testing capabilities under their HEAL
accreditation, or probationary accreditation. It is ultimately aimed at maintaining the confidence in and strengthening
of the anti-doping Laboratory system to benefit clean Covered Horses.

54.10 Overall Laboratory Evaluation

54.10 (a) The Agency shall evaluate Laboratory EQAS performance for each EQAS round, as well as
Laboratory performance for routine Analytical Testing, and assign penalties, including corrective actions or
other follow up measures in the Agency’s sole discretion.

54.10 (b) When a Laboratory’s HEAL accreditation is Suspended:

54.10 (b) (1) If a Laboratory under Suspension as a result of EQAS performance is not capable of
correcting the issue(s) before the end of the Suspension period, then the Agency may extend the
Laboratory’s Suspension for up to an additional six (6) months or until such a time when the Laboratory
can satisfactorily correct all the issues identified;

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54.10 (b) (2) If the Laboratory under Suspension fails to satisfy performance criteria during an extended
period of Suspension (beyond the initial six (6) months), then the Agency may Revoke the Laboratory’s
accreditation;

54.10 (c) When a Laboratory is subject to an Analytical Testing Restriction:

54.10 (c) (1) Laboratories under an Analytical Testing Restriction remain operational (except for the
activity(-ies) under the Analytical Testing Restriction) and, therefore, are evaluated during the Analytical
Testing Restriction as any other, fully operational Laboratory.

54.11 Probationary Period and Probationary Laboratory Evaluation

54.11 (a) The probationary EQAS is a part of the initial evaluation of a probationary laboratory seeking HEAL
accreditation. Successful participation in the Agency probationary EQAS is required before a probationary
laboratory is eligible to be considered for full HEAL accreditation. The Agency may decide, based on its
evaluation of the overall performance of the probationary laboratory, to extend the probationary period of
accreditation.

54.11 (b) Overall Probationary Laboratory Evaluation

54.11 (b) (1) The Agency will evaluate probationary laboratory EQAS performance.

54.11 (b) (2) Serious and repeated issues in the probationary EQAS shall result in the removal of the
laboratory’s status as a probationary laboratory by the Agency.

54.11 (b) (3) Any false Adverse Analytical Findingor false Negative Finding of a
technical/methodological nature reported automatically suspends a probationary laboratory from further
consideration for HEAL accreditation.

54.11 (b) (4) A Suspended probationary laboratory wishing to re-enter the probationary EQAS is
required to provide documentation of corrective and preventive action(s) no later than thirty (30) days
prior to the end of the Suspension period (unless otherwise indicated by the Agency). Failure to do so
will preclude the laboratory from participating in the probationary EQAS.

54.11 (b) (5) Lifting of the Suspension occurs only when proper corrective and preventive actions have
been implemented and reported to the Agency. The Agency may choose, at its sole discretion, to submit
additional EQAS samples to the laboratory and/or to require that the laboratory be re-assessed, at the
expense of the laboratory. Laboratories re-entering the probationary EQAS shall be considered as
candidate laboratories and are subject to provide the applicable accreditation fee and the required
documentation to the Agency (see Article 51.3).

54.12 Removal of Samples by the Agency

54.12 (a) Removal of Samples for Analysis or Further Analysis

54.12 (a) (1) Within the context of an investigation or Laboratory performance monitoring activity (for
example, during an on-site Agency Laboratory assessment), the Agency, initially at its expense, may
remove Sample(s) from a Laboratory to conduct Further Analysis, or analysis of the Sample if the
analytical results for that Sample have not yet been reported, for the purpose described in Protocol. The
Agency shall retain the right to request analysis or Further Analysis, at its expense, as permitted by
Protocol.

54.12 (a) (2) The Agency may delegate an observer to monitor the removal of the Samples, which shall
be implemented in accordance with the Agency’s instructions. During the removal of Samples, the
Agency shall be responsible for maintaining proper Sample Chain of Custody documentation and the
safety and integrity of the Samples until receipt by the other Laboratory(-ies).

54.12 (a) (3) The Agency may also require that the Laboratory transfer the Samples. In such situations,
the Laboratory shall be responsible for maintaining proper Chain of Custody documentation for all
transferred Samples and the safety and integrity of the Samples until receipt by the receiving
Laboratory(-ies).

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54.12 (a) (4) In connection with its monitoring of Laboratory performance, the Agency may direct Further
Analysis of a Sample which has resulted in a Protocol anti-doping rule violation without consent of the
Covered Person or approval from an adjudication body as provided in Protocol.

54.12 (b) Removal of Samples for Laboratory Quality Assessment

54.12 (b) (1) The Agency may also direct the re-analysis of anonymized Samples, which have met the
conditions described in Article 53.11 (d), for purposes of Laboratory quality assurance and education,
including the implementation of a system of transfer of Samples reported as Negative Findings between
Laboratories. In this regard, the number of Samples directed by the Agency for re-analysis may vary.

54.12 (b) (2)

54.2 The Agency shall inform a Laboratory in writing about the imposition of penalty, and/or corrective action and/or
other follow up measures.

54.3 Technical or methodological error

54.3 (a) If the Laboratory is able to remedy the technical or methodological error through the implementation of
satisfactory corrective actions in a timely manner, as determined by the Agency, the Laboratory will not face
any additional penalty.

54.4 Clerical/Administrative Error

54.4 (a) If the Laboratory is able to remedy the clerical or administrative error through the implementation of
satisfactory corrective actions in a timely manner, as determined by the Agency, the Laboratory will not face
any additional penalty.

54.5 Corrective Action Report

54.5 (a) A Corrective Action Report may be requested by the Agency. Where requested it shall be submitted
within the timeframe specified by the Agency in written notification about the unsatisfactory result. Failure to
submit a satisfactory Corrective Action Report or the late submission of the Corrective Action Report without
prior approval by the Agency may result in a penalty.

54.5 (b) Corrective Action Reports related, for example, to nonconformities detected during the Agency
Laboratory assessments, or to procedural or reporting nonconformities with the ESL, Technical Documents or
Technical Letters, or unsatisfactory performance in the analysis of EQAS samples (not related to a false
Adverse Analytical Findingor false Negative Finding), shall be submitted to the Agency within thirty (30) days
of the Agency’s notification to the Laboratory.

54.5 (c) Unless otherwise agreed with the Agency, the corrective and preventive action(s) reported to and
approved by the Agency shall be implemented in the routine operations of the Laboratory immediately.

54.5 (d) Corrective Action Report Review

54.5 (d) (1) The Corrective Action Report will be reviewed by the Agency as soon as practicable. If
applicable, it will establish the source of the incorrect result as either a technical/methodological error or
a clerical/administrative error.

54.5 (e) Satisfactory Corrective Action Report

54.5 (e) (1) Corrective Action Report will be considered as satisfactory when it meets the following
criteria, as determined by the Agency.

54.5 (e) (1) (i) Properly and concisely identifies the root cause(s) of the nonconformity, following an
appropriate investigation into all the factors that may have caused the problem (Root Cause
Analysis);

54.5 (e) (1) (ii) Leads to the documented implementation of effective corrective action(s) to solve

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the problem; and

54.5 (e) (1) (iii) Leads to the documented implementation of appropriate preventive actions, if
applicable, to minimize the risk of recurrence of the problem.

54.5 (e) (2) A satisfactory Corrective Action Report shall include only the necessary supporting
documentation (e.g., raw analytical data, data review files, evidence of procurement of Reference
Materials) which demonstrates the implemented actions described in the Corrective Action Report.

54.5 (f) Unsatisfactory Corrective Action Report

54.5 (f) (1) If the Laboratory’s Corrective Action Report is considered unsatisfactory by the Agency, the
Agency shall provide feedback to the Laboratory and provide it with the opportunity to resubmit a revised
Corrective Action Report within seven (7) days (or as otherwise agreed with the Agency).

54.5 (f) (2) If the Laboratory is unable to submit a satisfactory revised Corrective Action Report in a
timely manner, as determined by the Agency, the Agency may impose a penalty.

54.6 Laboratory Self-Reporting

54.6 (a) If the Laboratory must identify and report all errors in Sample analysis resulting in a false Adverse
Analytical Findingor false Negative Finding. Self-reporting will be taken into consideration by the Agency.

54.7 Evaluation of EQAS Results

54.7 (a) Satisfactory EQAS performance in single EQAS round and over a consecutive twelve (12)- month
period is necessary for maintaining HEAL accreditation.

54.7 (b) EQAS Samples for Educational Samples

54.7 (b) (1) Unsatisfactory performance in an educational EQAS for a new or the Agency-specific
Analytical Testing Procedure may prevent the Laboratory from seeking an extension of the Laboratory’s
Scope of ISO/IEC 17025 Accreditation for the Analytical Testing Procedure and from its application in
routine Analytical Testing (see Article 51.4 (b) (ii)). In such circumstances, the Laboratory may only apply
the new Agency-approved method or procedure for routine Sample analysis when it properly corrects
the deficiencies identified in the educational EQAS (as determined by the Agency) and the method is
included in the Laboratory’s Scope of ISO/IEC 17025 Accreditation.

54.7 (c) EQAS Samples Containing Non-Threshold Substances

54.7 (c) (1) When a qualitative determination of a Non-Threshold Substance has been reported, the
Laboratory result will be evaluated on the basis of the correct reporting of the finding (e.g., Adverse
Analytical Finding, Negative Finding) as intended in the preparation of the EQAS sample.

54.7 (c) (2) The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) at
concentrations greater than (>) the MRPL (or exceeding 120% of the Minimum Reporting Level, when
applicable) shall be evaluated.

54.7 (c) (3) The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) at
concentrations between 50% of the MRPL and the MRPL (or less than 120% of the Minimum Reporting
Level, when applicable) may require an internal investigation and Corrective Action Report from the
Laboratory.

54.7 (c) (4) The results for any Non-Threshold Substance and/or its Metabolite(s) and/or Marker(s) at
concentrations below (<) 50% of the applicable MRPL in an EQAS sample should report their finding(s)
if the analyses are compliant with its validation data, SOPs, the ESL and the TD IDCR. Laboratories
unable to report such substance(s) are encouraged, on receipt of the EQAS report, to consider re-
assessment of their Analytical Testing Procedure.

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54.7 (d) EQAS Samples Containing Threshold Substances

54.7 (d) (1) For EQAS samples containing Threshold Substances at levels greater than (>) 50% of the
Threshold, the quantitative determination will be statistically evaluated (e.g., z- score, degree of
equivalence analysis) to determine the compatibility of the reported result with the assigned value
(reference, nominal or consensus value, as applicable).

54.7 (d) (2) A Laboratory is to achieve a satisfactory statistical evaluation of quantitative results reported
based on the mean of three (3) replicate determinations. The overall evaluation of the quantitative
performance is based on the criteria indicated in the effective version of the TD DL or other relevant
Technical Document, Technical Letter or Laboratory Guidelines.

54.7 (d) (3) The main criterion applied for the evaluation of EQAS results for the quantification of
Threshold Substances is the compatibility of the reported Laboratory result with the assigned value.
Therefore, the incorrect reporting of an EQAS sample as a Negative Finding or as an Adverse Analytical
Finding, as applicable, when the assigned value of the Threshold Substance in the EQAS sample is
close to the Threshold, is not considered as a false Negative Finding or false Adverse Analytical
Finding, respectively, if the absolute z-score (truncated to one (1) decimal place) for the Laboratory's
quantitative result is < 3.0.

54.7 (e) Unsatisfactory Quantitative Result for Threshold Substances (absolute z-score ≥ 3.0)

54.7 (e) (1) The Laboratory shall provide the Agency with a Corrective Action Report for an
unsatisfactory quantitative result.

54.7 (f) Questionable Quantitative Result (absolute z-score > 2.0 and < 3.0)

54.7 (f) (1) The Laboratory shall perform an internal investigation to determine the root cause(s) of the
questionable result and implement appropriate corrective measures to resolve them.

54.7 (g) EQAS Evaluation of Laboratory Performance

54.7 (g) (1) Where an EQAS result is reported incorrectly the Laboratory shall provide the Agency with a
Corrective Action Report.

54.7 (h) Double-blind, Blind EQAS & Educational EQAS samples

54.7 (h) (1) Failure to report accurately, in accordance with criteria, three (3) Blind or Double-blind
EQAS, or Educational EQAS results within a continuous 12-month period may result in penalties
imposed by the Agency, including, but not limited to, potential Suspension or Revocation of HEAL
accreditation, or Analytical Testing Restrictions.

54.8 Evaluation of Laboratory Performance

54.8 (a) 8.6.1 False Adverse Analytical Findingor False Negative Finding

54.8 (a) (1) If the Laboratory discovers that it reported a false Adverse Analytical Findingor false
Negative Finding, the Laboratory shall inform the Agency immediately.

54.8 (a) (2) When the false Adverse Analytical Findingor false Negative Finding is identified by the
Agency, through the Agency’s own Results Management activities or through any other means, the
Agency shall inform the Laboratory as soon as practicable.

54.8 (a) (3) The Agency, considering the nature of the error that caused the false Adverse Analytical
Findingor false Negative Finding, may impose a penalty, including, but not limited to, potential
Suspension or Revocation of HEAL accreditation, or Analytical Testing Restrictions against the
Laboratory for a particular Analytical Testing Procedure or for the analysis of a particular class of
Prohibited Substances or Prohibited Methods, as applicable or other follow up measures. For example,
The Laboratory may be required by the Agency to analyze EQAS samples and/or to review the relevant

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analytical results and to re-analyze any relevant and available Samples previously reported as Adverse
Analytical Findings during the preceding twelve (12) months (or during a period otherwise determined by
the Agency) within seven (7) days (unless informed otherwise by the Agency). Depending on the nature
of the error that caused the false Adverse Analytical Finding or false Negative Finding, this re-analysis
may be limited to one Analyte, a class of Prohibited Substances or Prohibited Methods, or may include
any Prohibited Substance or Prohibited Method. A statement signed by the Laboratory Director shall
record this re-analysis.

54.8 (a) (3) (i) During the period of Suspension, the Laboratory shall follow the instructions
provided in Article 55.6 (b)in regard to Samples in the Laboratory’s Possession at the time of
Suspension. Alternatively, if an Analytical Testing Restriction has been imposed, the Laboratory
shall subcontract the affected analyses as provided in Articles 55.6 (a) and 53.2 (f).

54.8 (a) (3) (ii) During the Suspension or Analytical Testing Restriction period, the Agency will
conduct an assessment (preferably on-site) of the Laboratory, including the analysis of further
EQAS samples.

54.8 (a) (3) (iii) The Suspension or Analytical Testing Restriction of the Laboratory shall be lifted
only when the aforementioned conditions are satisfactorily completed, and the Laboratory provides
sufficient evidence, as determined by the Agency and in the Agency’s sole discretion, that
appropriate steps have been taken to remedy the issue(s) that resulted in the Suspension or
Analytical Testing Restriction.

54.9 Further Procedural Evaluations

54.9 (a) If the Agency considers that a Corrective Action Report is unsatisfactory, and the Laboratory is not
able to provide a satisfactory revised Corrective Action Report within a reasonable time frame after receiving
feedback from the Agency, the Laboratory may receive a penalty at the Agency’s discretion.

55 Withdrawal of HEAL accreditation

55.1 A Laboratory’s HEAL accreditation may be Suspended or Revoked, or subject to an Analytical Testing
Restriction, whenever the Laboratory fails to comply with the ESL and/or Technical Documents and/or Technical
Letters, or where the Suspension, Revocation or Analytical Testing Restriction is otherwise required to protect the
integrity of the Samples, the Analytical Testing process or the interests of the Anti- Doping Community.

55.2 The imposition of an Analytical Testing Restriction or the Suspension of a Laboratory’s HEAL accreditation
should not imply the automatic withdrawal of its ISO/IEC 17025 accreditation. The status of the Laboratory’s ISO/IEC
17025 accreditation is to be independently assessed by the relevant Accreditation Body.

55.3 Suspension of Accreditation and Analytical Testing Restriction

55.3 (a) The Agency may suspend a Laboratory’s HEAL accreditation or impose an Analytical Testing
Restriction against a Laboratory if the Agency identifies a noncompliance with the ESL and/or Technical
Documents and/or Technical Letters based on the Laboratory’s performance during the EQAS or during
routine Analytical Testing.

55.3 (b) Penalties as determined by the Agency.

55.3 (b) (1) The Laboratory may not challenge the penalty imposed by the Agency.

55.4 Noncompliance with the ESL

55.4 (a) Noncompliance with the ESL that may lead to an Analytical Testing Restriction, Suspension,
Revocation of HEAL accreditation, or other follow up measures include, but are not limited to:

55.4 (a) (1) Suspension, or withdrawal of ISO/IEC 17025 accreditation;

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55.4 (a) (10) Analysis of Samples from the Agency in violation of a Suspension or Analytical Testing
Restriction decision;

55.4 (a) (11) Failure to Cooperate with the Agency in providing documentation;

55.4 (a) (12) Noncompliance with the Code of Ethics; or

55.4 (a) (13) Any other cause that materially affects the ability of the Laboratory to ensure the full
reliability and accuracy of Analytical Testing and the accurate reporting of test results.

55.4 (a) (2) Failure to establish and/or maintain administrative and operational independence as
described in Article 51.3 (h);

55.4 (a) (3) Failure to analyze the minimum number of Samples indicated in Article 51.4 (b) (9);

55.4 (a) (4) Reporting of false Adverse Analytical Findings and/or false Negative Findings;

55.4 (a) (5) Failure to implement a Technical Document or Technical Letter by the effective date without
prior approval by the Agency;

55.4 (a) (6) Failure to Comply with any of the requirements or standards listed in the ESL and/or
Technical Documents and/or Technical Letters;

55.4 (a) (7) Noncompliance with results reporting timelines (see Article 53.7 (g));

55.4 (a) (8) Failure to take appropriate corrective action after an unsatisfactory performance during
routine Analytical Testing or in a blind EQAS or double-blind EQAS round;

55.4 (a) (9) Failure to take appropriate corrective action for ESL and/or Technical Document and/or
Technical Letter noncompliance(s) identified from the Agency Laboratory assessment(s);

55.4 (b) Laboratory staff and/or management issues, including but not limited to:

55.4 (b) (1) Major changes in senior Laboratory management positions (e.g., Laboratory Director,
Quality Manager) without proper and timely notification (usually within a month) to the Agency;

55.4 (b) (2) Failure to appoint a permanent Laboratory Director or other senior management positions
(e.g., Quality Manager) within a reasonable timeline;

55.4 (b) (3) Failure to guarantee the competence and/or proper training of scientific staff including, for
example, the qualification of analysts as Certifying Scientists and Laboratory Supervisory Personnel
(see Articles 53.2 (b) (7) and 53.2 (b) (8));

55.4 (b) (4) Significant loss or lack of experienced staff (e.g., Certifying Scientists) that affects, as
determined by the Agency, the Laboratory’s ability to ensure the full reliability and accuracy of Analytical
Testing and reporting of test results;

55.4 (b) (5) Conviction of any key personnel for any criminal offence that is determined by the Agency to
impact the operations of the Laboratory;

55.4 (b) (6) Loss of sufficient Laboratory support and resources that affects, as determined by the
Agency, the quality and/or viability of the Laboratory; or

55.4 (b) (7) Failure to Cooperate in any Agency enquiry in relation to the activities of the Laboratory.

55.4 (c) Notification of Penalty Decision

55.4 (c) (1) The Agency shall provide the Laboratory with written notice of its decision regarding
penalties. This notice shall state the following:

55.4 (c) (1) (i) That the Laboratory’s HEAL accreditation has been maintained (including warnings,
if applicable); or

55.4 (c) (1) (ii) That the Laboratory’s HEAL accreditation has been Suspended or Revoked or that
an Analytical Testing Restriction has been imposed against the Laboratory. Such notice shall
include:

55.4 (c) (1) (iii) The reason(s) for Suspension or Revocation or the imposition of an Analytical

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Testing Restriction;

55.4 (c) (1) (iv) The terms of the Suspension, Revocation, or Analytical Testing Restriction; and

55.4 (c) (1) (v) The period of Suspension or of Analytical Testing Restriction, if applicable.

55.4 (c) (1) (vi) Any corrective actions or other follow up requirements.

55.4 (d) Effective Date and Appeals

55.4 (d) (1) A Revocation, Suspension, or Analytical Testing Restriction is effective immediately upon
receipt of notification of the decision.

55.4 (d) (2) The Agency’s decision is not subject to appeal.

55.5 Public Notice

55.5 (a) The Agency shall publicly announce a change in a Laboratory’s accreditation status on its website as
soon as practicable after the Laboratory is notified by the Agency of its decision.

55.5 (b) The Agency’s website shall be updated regarding a Laboratory’s accreditation status when the
Laboratory’s HEAL accreditation is reinstated following a Suspension.

55.6 Consequences of Suspended or Revoked Accreditation or Analytical Testing Restriction

55.6 (a) Analytical Testing Restriction

55.6 (a) (1) If the Agency determines that the noncompliance(s) are limited to a class of Prohibited
Substances or Prohibited Methods or to a specific Analytical Testing Procedure, which are not included
in the standard Analytical Testing menu for Race Day or Out-of-Competition Samples received by the
Laboratory, the Agency may impose an Analytical Testing Restriction for that class of Prohibited
Substance(s) or Prohibited Method(s) or for the specific Analytical Testing Procedure in which the
noncompliance(s) occurred.

55.6 (a) (2) If the reason for the Analytical Testing Restriction was related to the reporting of false
Adverse Analytical Finding(s), all analyses employing the affected Analytical Testing Procedure(s) shall
cease immediately.

55.6 (a) (3) The Laboratory shall transfer the following Samples (“A” and “B” Samples) in the
Laboratory’s custody, which involve the analysis of the same class of Prohibited Substances or
Prohibited Methods and/or the application of the affected Analytical Testing Procedure(s) subjected to
the Analytical Testing Restriction, to another Laboratory(-ies) for the performance of the “A” and, if
needed, the “B” Confirmation Procedures (unless otherwise instructed by the Agency):

55.6 (a) (3) (i) Samples, which had been previously reported as an Adverse Analytical Finding(as
requested by the Agency);

55.6 (a) (3) (ii) Samples, which had been opened and were undergoing analysis for the Initial
Testing Procedure(s) at the time of the Analytical Testing Restriction decision;

55.6 (a) (3) (iii) Samples for which, at the time of the Analytical Testing Restriction decision, Initial
Testing Procedure(s) had been completed and had produced Presumptive Adverse Analytical
Findings requiring Confirmation Procedures, or Samples that are the subject of other Confirmation
Procedures;

55.6 (a) (3) (iv) Samples for which the “A” or “B” Confirmation Procedures had been completed,
but results of the analysis had not been reported by the Analytical Testing Restriction date, or
Samples which were undergoing “A” or “B” Confirmation Procedures at the time of the imposition
of the Analytical Testing Restriction;

55.6 (a) (3) (v) Samples which had been reported as Adverse Analytical Findings based on the “A”
Confirmation Procedure prior to the imposition of the Analytical Testing Restriction. These

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Samples shall be kept in the Laboratory under proper Laboratory Internal Chain of Custody and
appropriate storage conditions. Should a “B” Confirmation Procedure be requested during the
period of the Analytical Testing Restriction, both “A” and “B” Samples shall be transferred6 to
another Laboratory(-ies) for the “A” Confirmation Procedure to be performed again and for the
performance of the “B” Confirmation Procedure, if applicable.

55.6 (a) (4) If the Analytical Testing Restriction was caused by the reporting of false Negative Finding(s),
and further investigation reveals that other Negative Finding(s) had been reported for Samples that are
still stored in the Laboratory, the Laboratory shall inform the Agency. In such cases, both the “A” and “B”
containers of the relevant Samples shall be transferred to another Laboratory(-ies) for Further Analysis,
as determined by the Agency. These re-analyses may be applied to the class of Prohibited Substances
and/or Prohibited Methods or to the Analytical Testing Procedure(s) that were associated with the
Negative Finding(s), as determined by the Agency.

55.6 (b) Suspension

55.6 (b) (1) A Laboratory whose HEAL accreditation has been Suspended is Ineligible to perform
Analytical Testing of Samples.

55.6 (c) Suspension for Violation of the Code of Ethics

55.6 (c) (1) If the reason for the Suspension was related to a violation of the Code of Ethics, all Analytical
Testing in the suspended Laboratory shall cease immediately and the Laboratory shall transfer 7 all
Samples (both the “A” and “B” Samples) in the Laboratory’s custody to other Laboratory(-ies) chosen by
the Agency.

55.6 (d) Suspension for Reporting of False Adverse Analytical Finding(s)

55.6 (d) (1) If the reason for the Suspension was related to the reporting of false Adverse Analytical
Finding(s), all Analytical Testing shall cease immediately. In addition, the Laboratory shall transfer the
following Samples (“A” and “B” Samples) in the Laboratory’s custody to another Laboratory(-ies) for the
performance of the “A” and, if needed, the “B” Confirmation Procedures, unless otherwise instructed by
the Agency:

55.6 (d) (1) (i) Samples, which had been previously reported as an Adverse Analytical Findingfor
the same class of Prohibited Substances or Prohibited Methods when applying the same
Confirmation Procedure (as requested by the Agency);

55.6 (d) (1) (ii) Samples for which, at the time of the Suspension decision, Initial Testing
Procedure(s) had been completed and had produced Presumptive Adverse Analytical Findings
requiring Confirmation Procedures, or Samples that are the subject of other Confirmation
Procedures;

55.6 (d) (1) (iii) Samples, which had been opened and were undergoing analysis for the Initial
Testing Procedure(s) at the time of the Suspension;

55.6 (d) (1) (iv) Samples which had been received at the Laboratory but had not been opened at
the time of the Suspension [these Samples shall be kept sealed in the Laboratory under proper
Laboratory Internal Chain of Custody and appropriate storage conditions until transfer to another
Laboratory(-ies)].

55.6 (d) (1) (v) Samples for which “A” or “B” Confirmation Procedures had been completed, but
results of the analysis had not been reported by the Suspension date, or Samples which were
undergoing “A” or “B” Confirmation Procedures at the time of the Suspension;

55.6 (d) (1) (vi) Samples which had been reported as Adverse Analytical Findings based on the
“A” Confirmation Procedure prior to the Suspension.

55.6 (e) Suspension for Other Reasons

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55.6 (e) (1) A Laboratory that has had its HEAL accreditation Suspended for reasons other than a
violation of the Code of Ethics or the reporting of false Adverse Analytical Findings(s) shall take the
following steps with the Samples in the Laboratory’s custody, unless otherwise instructed by the Agency:

55.6 (e) (2) Samples which had been analyzed and reported as a Negative Finding, and which have
either been stored in the Laboratory for a period of less than three (3) months or have been placed in
long-term storage upon request by the Agency.

55.6 (e) (3) These Samples shall be kept in the Laboratory under proper Laboratory Chain of Custody
and appropriate storage conditions. The Laboratory shall inform the Agency of such actions including the
provision of the Sample Protocols.

55.6 (e) (4) If the Suspension was caused by the reporting of false Negative Finding(s), and further
investigation reveals that other Negative Finding(s) had been reported by the Laboratory, the Laboratory
shall inform the Agency. In such cases, both the “A” and “B” containers of the relevant Samples shall be
transferred to another Laboratory(-ies) for Further Analysis, as determined by the Agency. These
analyses may be applied for all the Prohibited Substances and Prohibited Methods included in the
requested Analytical Testing menu or be limited to the class of Prohibited Substances and/or Prohibited
Methods or to the Analytical Testing Procedure(s) that were associated with the Negative Finding(s), as
determined by the Agency.

55.6 (e) (5) Samples for which Initial Testing Procedure(s) had been completed, but results had not been
reported at the time of the Suspension:

55.6 (e) (5) (i) If the Initial Testing Procedure(s) produced Presumptive Adverse Analytical
Finding(s) or other Confirmation Procedures were required, both the “A” and “B” Samples shall be
transferred7 to another Laboratory(-ies) for the performance of the “A” and, if needed, the “B”
Confirmation Procedures.

55.6 (e) (5) (ii) In addition, if the Suspension was caused by the reporting of false Negative
Finding(s) and the Initial Testing Procedure(s) had produced negative results, both the “A” and “B”
Samples shall also be transferred to another Laboratory(-ies) for the repetition of the Initial Testing
Procedure(s) and, if needed, the performance of Confirmation Procedures. These analyses may
be applied for all the Prohibited Substances and Prohibited Methods included in the requested
Analytical Testing menu or be limited to the class of Prohibited Substances and/or Prohibited
Methods or to the Analytical Testing Procedure(s) that were associated with the Negative Finding,
as determined by the Agency.

55.6 (e) (5) (iii) If the reason for the Suspension was not related to the reporting of false Negative
Findings and the Initial Testing Procedure(s) had produced negative results, the Sample(s) shall
be reported to the Agency as Negative Finding(s). These Samples shall be kept in the Laboratory
under proper Laboratory Internal Chain of Custody and appropriate storage conditions until further
notice by the Agency. The Laboratory shall inform the Agency of such actions including the
provision of the Sample Protocols.

55.6 (e) (6) Samples which had been opened and were undergoing analysis for the Initial Testing
Procedure(s) at the time of the Suspension:

55.6 (e) (6) (i) If the reason for Suspension was not related to the reporting of false Negative
Finding(s), the Laboratory shall continue to analyze the relevant Samples until all Initial Testing
Procedure(s) are completed. If the Initial Testing Procedure(s) produce Negative Findings, the
Laboratory shall report these findings to, and in a form designated by, the Agency and these
Samples shall be kept in the Laboratory under proper Laboratory Chain of Custody and
appropriate storage conditions until further notice by the Agency. The Laboratory shall inform the
Agency of such actions including the provision of the Sample Protocols.

55.6 (e) (6) (ii) However, if the Initial Testing Procedure(s) produced a Presumptive Adverse
Analytical Finding, both the “A” and “B” Samples shall be transferred7 to another Laboratory(-ies)
for the performance of the “A” and, if needed, the “B” Confirmation Procedures.

55.6 (e) (6) (iii) If the Suspension was caused by the reporting of false Negative Finding(s), then
the Laboratory shall cease all Analytical Testing and have the “A” and “B” Samples transferred7 to
another Laboratory(-ies) for the performance of the “A” and, if needed, the “B” Confirmation
Procedures.

55.6 (e) (6) (iv) Samples which had been received at the Laboratory but had not been opened yet
at the time of the Suspension:

55.6 (e) (6) (v) These Samples shall be kept sealed in the Laboratory under proper Laboratory
Chain of Custody and appropriate storage conditions until transfer to another Laboratory(-ies) for

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Analytical Testing.

55.6 (e) (7) Samples for which “A” or “B” Confirmation Procedures had been completed, but results of
analysis had not been reported by the Suspension date, or Samples which were undergoing “A” or “B”
Confirmation Procedures at the time of the Suspension:

55.6 (e) (7) (i) Both the “A” and “B” Samples shall be transferred7 to another Laboratory(- ies) for
the repetition of the “A” and, if applicable, the “B” Confirmation Procedures.

55.6 (e) (8) Samples which had been reported as an Adverse Analytical Findingbased on the “A”
Confirmation Procedure prior to the Suspension:

55.6 (e) (8) (i) These Samples shall be kept in the Laboratory under proper Laboratory Internal
Chain of Custody and appropriate storage conditions. Should a “B” Confirmation Procedure be
requested during the Suspension, both “A” and “B” Samples shall be transferred7 to another
Laboratory(-ies) for the “A” Confirmation Procedure to be performed again and for the
performance of the “B” Confirmation Procedure, if applicable.

55.6 (e) (8) (ii) During a Suspension or Analytical Testing Restriction period, the Laboratory shall
continue to participate in the Agency EQAS program. The Agency may require the Laboratory to
analyze additional blind EQAS samples and/or perform a Laboratory assessment, at any time and
at the expense of the Laboratory, in order to evaluate the Laboratory’s status.

55.6 (f) Revocation

55.6 (f) (1) A laboratory whose HEAL accreditation has been Revoked is Ineligible to perform Analytical
Testing of Samples. The Laboratory Internal Chain of Custody maintained by a Revoked laboratory for
stored Samples is valid until such time that arrangements can be made, in consultation with the Agency,
for the transfer of relevant Samples to a Laboratory(-ies).

55.6 (f) (2) A laboratory whose HEAL accreditation has been Revoked shall arrange the transfer of
Samples in the laboratory’s custody to a Laboratory(-ies) chosen by the Agency, respectively, within
thirty (30) days of being notified of the decision revoking its HEAL accreditation. In such circumstances,
the Samples to be transferred shall be selected the Agency. The laboratory transferring the Samples
shall inform the Agency and provide the relevant Sample Protocols and the chosen Laboratory(-ies). In
addition, the revoked laboratory shall assist with the transfer of the relevant Sample data and records to
the Laboratory(-ies) that have been selected to receive the Samples.

55.6 (f) (3) The Revoked laboratory shall transfer all Samples in its custody for which the Analytical
Testing process has not been completed at the time of the Revocation. The Agency may also choose to
transfer additional Samples retained in the laboratory in accordance with Articles 53.10 (a)-53.10 (d), or
other Samples for which it is the owner pursuant to the Testing and Investigations Standards and that
had been analyzed and were in long-term storage at the time of the Revocation of the laboratory’s HEAL
accreditation. In addition, the Agency may identify and request that Samples be transferred to another
Laboratory(-ies).

55.6 (g) Reinstatement of Suspended Accreditation or Lifting of the Analytical Testing Restriction

55.6 (g) (1) The Agency shall lift the Suspension of the Laboratory’s HEAL accreditation or lift the
Analytical Testing Restriction only when the Laboratory provides satisfactory evidence, as determined by
the Agency, that appropriate steps have been taken to remedy the noncompliance(s) that resulted in the
Suspension of the Laboratory’s HEAL accreditation or the imposition of the Analytical Testing
Restriction, and that proper measures have been implemented to satisfactorily address the condition(s)
specified, if any, for reinstatement of HEAL accreditation.

55.6 (h) Extension of Suspension or Analytical Testing Restriction

55.6 (h) (1) If a Laboratory whose HEAL accreditation has been Suspended or has been the subject of
an Analytical Testing Restriction has not satisfactorily corrected the ESL and/or Technical Document(s)
and/or Technical Letter(s) noncompliance(s) that resulted in the Suspension or Analytical Testing

Horseracing Integrity and Safety Authority


Restriction, or if the Agency identifies any additional ESL and/or Technical Document(s) and/or
Technical Letter(s) noncompliance(s) during an Agency Laboratory assessment conducted during the
initial Suspension or Analytical Testing Restriction period, either the Suspension of the Laboratory’s
HEAL accreditation or Analytical Testing Restriction may be further extended or the Laboratory’s
accreditation shall be Revoked, as determined by the Agency. The Suspension or Analytical Testing
Restriction period may be extended up to an additional six (6) months, if the Laboratory provides
justifiable explanation(s) for the delay, as determined by the Agency, in addressing the conditions to lift
the Suspension or Analytical Testing Restriction (including the submission of satisfactory corrective
actions).

55.6 (h) (2) If applicable, a delay in the delivery of the ISO/IEC 17025 accreditation to the Laboratory by
the relevant Accreditation Body may also constitute grounds to extend the Suspension of the
Laboratory’s HEAL accreditation.

55.6 (h) (3) The decision to extend the Suspension of a Laboratory’s HEAL accreditation or the period
of the Analytical Testing Restriction shall be made in the Agency’s sole discretion.

55.6 (h) (4) If, in accordance with the terms of the extension of the Suspension of the Laboratory’s HEAL
accreditation or the terms of the extension of the Analytical Testing Restriction, the Laboratory provides
evidence determined to be satisfactory by the Agency that all of the identified ESL and/or Technical
Document and/or Technical Letter noncompliance(s) have been corrected, the Laboratory’s
accreditation shall be re-instated or the Analytical Testing Restriction may be lifted by decision of the
Agency.

55.6 (h) (5) If the Laboratory has not provided evidence determined to be satisfactory by the Agency at
the end of the extended Suspension or extended Analytical Testing Restriction period, the Agency may
Revoke the Laboratory’s accreditation.

55.6 (h) (6) The Agency will notify the Laboratory of its decision to revoke the Laboratory’s HEAL
accreditation in accordance with Article 55.4 (c).

55.6 (i) Revoked Accreditation

55.6 (i) (1) If a laboratory whose HEAL accreditation has been Revoked wishes to seek a new HEAL
accreditation, it must apply for HEAL accreditation as a new laboratory in accordance with Article 51.2.

55.6 (i) (2) When seeking a new HEAL accreditation, the laboratory may request that the Agency
expedite the laboratory re-accreditation procedure, which may be approved by the Agency. To do so the
laboratory shall provide the Agency, as part of its application for a new accreditation, information that it
considers constitutes “exceptional circumstances” as justification for modifying the requirements of
Articles 51.2 and 51.3 to expedite the entry of the laboratory into, and/or shortening the duration of, the
probationary phase of accreditation. At its sole discretion, the Agency may determine whether such
modifications are justified, and which steps must be followed prior to granting approval to the laboratory
to enter the probationary phase of accreditation.

55.6 (j) Voluntary Cessation of Laboratory Operations

55.6 (j) (1) A Laboratory may decide to voluntarily cease its anti-doping Analytical Testing operations on
either a temporary or permanent basis despite not having been found to have committed any analytical
failures or other ESL noncompliance(s) and not having been subject to an Analytical Testing Restriction
or Suspension or Revocation of its HEAL accreditation.

55.6 (j) (2) In such circumstances, the Laboratory shall inform the Agency and provide, in writing, the
reason(s) for the cessation of anti-doping Analytical Testing operations as soon as the decision is taken
to cease its operations and no later than three (3) months prior to the date on which its decision shall
take effect. The Laboratory shall also take all necessary measures to notify all its clients of the decision
to cease its operations and to arrange, in consultation with its clients, to transfer Samples to another
Laboratory(-ies) in accordance with Article 55.6 (b) (temporary closure) or 55.6 (f) (permanent closure).

55.6 (j) (3) If a Laboratory voluntarily ceases its anti-doping Analytical Testing operations on a temporary
basis, the Laboratory shall maintain satisfactory performance in the analysis of EQAS samples during
the period of inactivity. The period of temporary cessation of Analytical Testing activities shall not
exceed six (6) months, with one possible extension of up to six (6) months (as determined by the
Agency). If the Laboratory is unable to resume its Analytical Testing operations within a twelve (12)-
month period, the Agency shall revoke the Laboratory’s accreditation, unless otherwise approved by the
Agency.

55.6 (j) (4) If a Laboratory decides to cease its operations on a permanent basis, the Laboratory shall

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assist the Agency with the transfer of relevant Sample data and records to the Laboratory(-ies) that have
been selected to receive the Samples.

56 CODE OF ETHICS FOR LABORATORIES

56.1 Confidentiality

56.1 (a) Directors of Laboratories, their delegates and all Laboratory staff shall respect and comply with ESL
and Protocol.

56.2 Research in Support of Doping Control

56.2 (a) Laboratories shall participate in research programs, provided that the Laboratory Director is satisfied
with their bona fide nature and the program(s) have received proper ethical approval, if applicable. The
Laboratory shall not engage in any research activity that undermines or is detrimental to the purposes of the
Act.

56.2 (b) The Laboratories are expected to develop a research and development program to support and
expand the scientific foundation of Doping Control. This research may consist of the development of new
methods or technologies, the pharmacological characterization of a new doping agent, the characterization of
a masking agent or method, and other topics relevant to the field of Doping Control.

56.2 (c) Research on Equine (and other animal species) Subjects

56.2 (d) Laboratories shall follow institutional animal care and use guidelines and requirements regarding the
use of animal subjects in research.

56.2 (e) Covered Horses who may undergo Doping Control Testing shall not be the subjects of drug
Administration studies that include Prohibited Substances or Prohibited Methods.

56.2 (f) Controlled Substances

56.2 (g) The Laboratories are expected to comply with the relevant and applicable national laws regarding the
handling, storage and discarding of controlled (illegal) substances.

56.3 Analysis

56.3 (a) The Laboratory shall not engage in any analysis or activity that undermines or is detrimental to the
purposes of the Act.

56.3 (b) Analytical Testing for Other Anti-Doping Organizations:

56.3 (c) The Laboratories shall accept Samples for Analytical Testing only if all the following conditions have
been met:

56.3 (d) The Sample matrix is of the proper type (e.g., blood, urine, hair or other Samples) for the requested
analyses;

56.3 (d) (1) The Samples have been collected, sealed and transported to the Laboratory in accordance
with procedures equivalent to the Equine Testing and Investigations Standards; and

56.3 (d) (2) The collection is a part of a legitimate anti-doping and medication control program, as
determined by the Agency, or satisfies any of the conditions for Sample analysis indicated in Article 53.5
(i).

56.4 Analytical Testing for Covered Persons or those acting of their behalf

56.4 (a) Laboratories shall not accept Samples directly from individual Covered Persons or from individuals or
organizations acting on their behalf.

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56.5 Other Analytical Activities

56.5 (a) The Laboratory shall not provide analytical services in a Doping Control adjudication, unless
specifically requested by the Agency or an adjudication body.

56.5 (b) The Laboratory shall not engage in analyzing commercial material or preparations (e.g., dietary or
herbal supplements), unless:

56.5 (b) (1) Specifically requested by the Agency or an adjudication body as part of a Results
Management process;

56.5 (b) (2) If done as part of a legitimate anti-doping research program, as determined by the Agency;
or

56.5 (b) (3) If a request is made by a Covered Person or their representative, the Laboratory may
conduct the analysis if agreed by the Agency, which may also specify conditions that must be followed
prior to or during the analysis (e.g., verification of original sealed packages, product batch number).

56.5 (c) The Laboratory shall not provide results, documentation or advice that, in any way, could be used as
an endorsement of products or services.

56.5 (d) Analytical activities performed outside the Act will not fall under Agency-accredited status of the
laboratory and shall not negatively affect the Analytical Testing of Samples from the Agency.

56.6 Sharing of Knowledge

56.6 (a) When information on new doping substance(s), method(s), or practice(s) is known to the Laboratory,
such information shall be shared with the Agency within sixty (60) days. When possible, the Laboratories shall
share information with the Agency regarding the detection of potentially new or rarely detected doping agents
as soon as possible. Immediately after having been notified of the Use of a new substance or method as a
doping agent, the Agency will inform all Laboratories.

56.6 (b) The Laboratory Director or staff shall participate in developing standards for best practice and
enhancing uniformity of Analytical Testing in the HEAL-accredited laboratory system.

56.7 Duty to Preserve the Integrity of the Anti-Doping and Medication Control Program Contemplated in the Act and
to Avoid any Detrimental Conduct

56.7 (a) The personnel of Laboratories shall not engage in conduct or activities that undermine or are
detrimental to the anti-doping and medication control program contemplated in the Act. Such conduct could
include, but is not limited to, fraud, embezzlement, perjury, etc. that would cast doubt on the integrity of the anti-
doping and medication control program.

56.7 (b) All employees of Laboratories shall strictly respect the confidentiality of Analytical Testing results, as
well as of all other Laboratory, including information provided by the Agency under confidentiality.

56.7 (c) No employee or consultant of Laboratories shall provide counsel, advice or information to Covered
Persons or others regarding techniques or methods used to mask or avoid detection of, alter metabolism of,
or suppress excretion of a Prohibited Substance or its Metabolite(s), or Marker(s) of a Prohibited Substance
or Prohibited Method in order to avoid an Adverse Analytical Finding.

56.7 (d) No employee or consultant of Laboratories shall provide information about a Test Method to a
Covered Person, or from individuals or organizations acting on their behalf, which could be used to avoid the
detection of doping. They should instead be referred to the Agency.

56.7 (e) No staff of Laboratories shall assist a Covered Person in avoiding collection of a representative
Sample (e.g., advice on masking strategies or detection windows).

56.7 (f) [This does not prohibit the publication and/or presentation of scientific research results, general
presentations to educate Covered Persons, students, or others concerning anti-doping programs and
Prohibited Substances or Prohibited Methods.]

56.7 (g) If a staff member of a Laboratory is requested to provide evidence in anti-doping proceedings, they

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are expected to provide independent, scientifically valid expert testimony.

56.7 (h) The Laboratory shall not issue any statements related to its analytical processes or findings, unless
otherwise provided in Protocol. The responsibility for evaluation of these findings with further action and
publication, if considered necessary, shall be the sole responsibility of the responsible the Agency.

56.8 Breach and Enforceability

56.8 (a) A failure to respect any of the provisions of this Code of Ethics may result in the Laboratory being
subject to Disciplinary Proceedings instituted by the Agency to either suspend or revoke its HEAL
accreditation or its Agency approval, as applicable.

56.8 (b) In addition, a failure to respect any of the provisions of this Code of Ethics may result in staff of the
Laboratory being subject to disciplinary action by the Laboratory, respectively, resulting in consequences
beyond those stipulated under the ESL, including potential termination of employment or, where applicable,
the imposition of criminal charges.

57 RESEARCH AND DEVELOPMENT ACTIVITY REQUIREMENTS

57.1 The Laboratory must receive a minimum score of ten (10) points annually.

57.1 (a) Five (5) points for each Peer-Reviewed Manuscript;

57.1 (b) Five (5) points for the production of educational materials

57.1 (c) Three (3) points for each Funded Research Project

57.1 (d) One (1) point for each Laboratory (Internal) Method Development. Note The validation or
implementation of established anti-doping methods with only minor adjustments, or repetition of research
previously published or presented by others, is not sufficient to be considered as a research and development
activity

Testing & Investigations Standards (Not Submitted to FTC)


58 Equine Testing and Investigations Standards Introduction and Scope

58.1 The Equine Testing and Investigations Standards is developed pursuant to the Horseracing Integrity and Safety
Act of 2020 and the Equine Anti-Doping and Medication Control Protocol (“Protocol”).

58.2 The first purpose of the Equine Testing and Investigations Standards (the “Testing and Investigations
Standards”) is to plan for intelligent and effective Testing, both on Race Day and Out-of-Competition, and to
maintain the integrity and identity of the Samples collected from the point of notification of a Covered Horse’s
selection for Testing, to the point the Samples are delivered to a Laboratory for analysis. To that end, these Testing
and Investigations Standards (including its Annexes) establish protocols for test planning (including collection and
use of Covered Horse whereabouts information), notification of a Covered Horse’s selection for Testing, preparing
for and conducting Sample collection, security/post-test Administration of Samples and documentation, and
transport of Samples to Laboratories for analysis.

58.3 The second purpose of the Testing and Investigations Standards is to establish rules for the efficient and
effective gathering, assessment, and use of anti-doping and medication control intelligence and for efficient and
effective investigations into possible anti-doping and medication control rule violations.

58.4 Terms used in these Testing and Investigations Standards that are defined terms in the Equine Program
Dictionary are italicized.

59 Standards for Testing

59.1 Planning Effective Testing

59.1 (a) Objective

59.1 (a) (1) The Agency is required to plan and implement intelligent Testing on Covered Horses over

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which it has authority, and which is proportionate to the risk of doping, misuse of medication, and
effective to detect and to deter such practices. The objective of this section is to set out the steps to
develop a Risk Assessment in order to inform Testing plans that best ensure clean competition and
protect the health and welfare of Covered Horses.

59.1 (a) (2) The Agency shall ensure that Covered Persons with a conflict of interest in the outcome of
the Testing being contemplated are not involved in test planning or in the process of selection of
Covered Horses for Testing.

59.1 (a) (3) The Agency should monitor, evaluate, and update its Risk Assessment during the year/cycle
in light of changing circumstances and in implementing its Testing plans.

59.1 (b) Risk Assessment

59.1 (b) (1) The Risk Assessment shall be conducted in good faith, reviewed and updated as required,
and should take into account (if available) the following information:

59.1 (b) (1) (i) Discipline, and individual factors that may result in a higher potential for adopting
doping behavior and/or misuse of medication;

59.1 (b) (1) (ii) Available statistics and research on doping trends and/or misuse of medication,
practices, and methods;

59.1 (b) (1) (iii) Reliable information received/intelligence developed on possible doping practices;

59.1 (b) (1) (iv) The outcomes of previous test planning cycles including past testing strategies;

59.1 (b) (1) (v) Optimal times to apply specific test types (including analysis) to maximize
opportunities for detecting and deterring doping;

59.1 (b) (1) (vi) Given the structure of the racing season (including generic racing schedules and
training patterns), at what time(s) during the year a horse is most likely to be administered
Prohibited Substances or subjected to Prohibited Methods (to enhance or impair performance or
impact welfare/soundness); and

59.1 (b) (1) (vii) The Agency shall consider in good faith any Risk Assessment carried out by a
State Racing Commission or racing authority in another country and provided to the Agency for
purposes of enhancing its Risk Assessment.

59.1 (c) Prioritizing between Covered Horses, Types of Testing, and Samples

59.1 (c) (1) Only the Agency has the authority to direct Testing on any Covered Horse. All Covered
Horses shall be included in the Registered Testing Pool and therefore subject to whereabouts
requirements. The Agency should consider various factors in prioritizing the allocation of Testing
resources. In addition, the Agency will use Target Testing to focus Testing resources where they are
most needed within the overall pool of Covered Horses.

59.1 (c) (2) Factors relevant to determining which Covered Horses should be subject of Target Testing
may include (but are not limited to):

59.1 (c) (2) (i) Covered Horses serving a period of Ineligibility or a Provisional Suspension;

59.1 (c) (2) (ii) Covered Horses who were high priority for Testing before retirement and are now
returning from retirement to active participation;

59.1 (c) (2) (iii) Covered Persons’ prior anti-doping and medication control rule violations, Testing
history, including any abnormal biological Sample data (e.g., Atypical Finding reported by a
Laboratory);

59.1 (c) (2) (iv) Performance history, performance pattern, and/or high performance (e.g., Trainer
strike rate) without a commensurate Testing record;

59.1 (c) (2) (ix) Association with a third party (such as a Trainer, Veterinarian, or Owner) with a
history of involvement in doping;

59.1 (c) (2) (v) Repeated failure to meet whereabouts requirements;

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59.1 (c) (2) (vi) Suspicious Whereabouts Filing patterns;

59.1 (c) (2) (vii) Moving to or training in a remote location;

59.1 (c) (2) (viii) Suspicious withdrawal or absence from expected Covered Horserace(s);

59.1 (c) (2) (x) Injury;

59.1 (c) (2) (xi) Age/stage of career;

59.1 (c) (2) (xii) Financial incentives for improved or degraded performance, such as purse size,
unusual betting patterns, or upcoming claiming race; and/or

59.1 (c) (2) (xiii) Reliable information from a third party, or intelligence developed by or shared with
the Agency.

59.1 (c) (3) Target Testing is a priority because random Testing, or even weighted random Testing,
does not ensure that all of the appropriate Covered Horses will be sufficiently tested. Covered Horses
can be tested at any time and at any place. The Protocol does not impose any reasonable suspicion or
probable cause requirement for Target Testing or Testing.

59.1 (c) (4) Testing which is not Target Testing should be determined based on the Risk Assessment.
Testing should be conducted using a documented system for such selection, such as weighted (where
Covered Horses are ranked using pre-determined criteria to increase or decrease the chances of
selection) or completely random (where no pre-determined criteria are considered, and Covered Horses
are chosen arbitrarily from a list or pool of names). Testing that is weighted should be prioritized and be
conducted according to defined criteria which may take into account the risk factors to ensure that a
greater percentage of at risk Covered Horses are selected.

59.1 (c) (5) Based on the Risk Assessment and prioritization process described above, the Agency
should determine to what extent each of the following types of Testing is required to detect and deter
doping and medication abuse practices within the sport intelligently and effectively:

59.1 (c) (5) (i) Race Day Testing and Out-of-Competition Testing;

59.1 (c) (5) (ii) Testing of urine;

59.1 (c) (5) (iii) Testing of hair;

59.1 (c) (5) (iv) Testing of blood; and

59.1 (c) (5) (v) Testing involving other matrices or methodologies as available.

59.1 (d) Sample Analysis, Retention Strategy, and Further Analysis

59.1 (d) (1) The Agency shall ask Laboratories to analyze Samples at minimum for the standard analysis
menu based on whether the Sample was collected on Race Day or Out-of-Competition. The Agency
may also consider undertaking more extensive Sample analysis for Prohibited Substances or Prohibited
Methods based on the risk or any intelligence that the Agency may receive (e.g., specific Prohibited
Substances, gene doping).

59.1 (d) (2) The Agency should develop a system for retention of Samples and the documentation
relating to the collection of such Samples to enable the Further Analysis of such Samples at a later date
in accordance with Article 6.1 (e). Such a system should comply with the requirements of the Laboratory
Standards and should take into account the purposes of analysis of Samples set out in Protocol Article
6.1 (b), as well as (without limitation) the following elements:

59.1 (d) (3) Laboratory and Equine Passport Management Unit (“EPMU”) recommendations (when
available);

59.1 (d) (3) (i) The possible need for retroactive analysis in connection with the Equine Biological
Passport program (when available);

59.1 (d) (3) (ii) New relevant detection methods to be introduced in the future;

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59.1 (d) (3) (iii) Samples collected meeting some or all of the criteria set out at Article 4.4;

59.1 (d) (3) (iv) Any other information made available to the Agency such that it determines in its
sole discretion based on that information or random selection that long-term storage or Further
Analysis of Samples is appropriate.

59.1 (e) Coordinating with State Racing Commissions and Other Entities

59.1 (e) (1) Any Testing done must be initiated and directed by the Agency. The Agency may coordinate
its Testing efforts with State Racing Commissions (subject to the applicable State Racing Commission
electing to enter into an agreement with the Agency) by, for example, utilizing Sample Collection
Personnel employed or designated by a State Racing Commission to collect Samples how and when
directed by the Agency. Any state rule, law, or regulation preventing Sample Collection Personnel or
potential Sample Collection Personnel employed or designated by a State Racing Commission from
contracting with the Agency to collect Samples is preempted by this rule that allows for such
arrangements. Regardless of who collects a Sample, only the Agency shall receive all Sample results
directly from the Laboratory.

59.1 (e) (2) The Agency may contract with third parties to collect Samples on the Agency’s behalf and
third parties may contract with the Agency to collect additional Samples on Covered Horses consistent
with the Act and the Protocol.

59.1 (e) (3) The Agency shall consult and coordinate with law enforcement and other relevant authorities,
in obtaining, developing, and sharing information and intelligence that can be useful in informing test
planning.

59.2 Notification

59.2 (a) Objective

59.2 (a) (1) The objective is to notify the Responsible Person or Nominated Person that their Covered
Horse has been selected for Testing with no advance notice, except to grant immediate access to the
Covered Horse; that the rights of those involved in the Sample collection are maintained; that the welfare
of the Covered Horse is maintained; that there are no opportunities to manipulate the Sample; and that
the notification is documented.

59.2 (b) Requirements Prior to Notification

59.2 (b) (1) No Advance Notice Testing should be the method for Sample collection save in exceptional
and justifiable circumstances. Ideally, if the Responsible Person is with the Covered Horse at the time of
notification, the Responsible Person should be the first Person notified that the Covered Horse has been
selected for Sample collection. In order to ensure that Testing is conducted on a No Advance Notice
Testing basis, the Agency shall ensure Testing selection decisions are only disclosed in advance of
Testing to those who need to know in order for such Testing to be conducted. Any notification to a third
party shall be conducted in a secure and confidential manner to minimize the risk that the Responsible
Person or other Covered Person will receive any advance notice of a Covered Horse’s selection for
Sample collection.

59.2 (b) (2) The Agency shall appoint Doping Control Officers (“DCOs”), Chaperones, and other Sample
Collection Personnel sufficient to ensure No Advance Notice Testing and continuous observation of the
Covered Horse or confirmation the Covered Horse is in a secure location (a stall, for example)
throughout the Doping Control process. Sample Collection Personnel must be trained for their assigned
responsibilities, must not have a conflict of interest in the outcome of the Sample collection, and must not
be minors. See Article 65 for more information.

59.2 (b) (3) Sample Collection Personnel shall have official documentation, provided by the Agency,
evidencing their authority to collect a Sample from the Covered Horse, such as a credential. DCOs'
credentials shall include their name, photograph, and date of expiration or a letter of authority from the
Agency and a federal or state issued identification. The Agency may determine what information to
include on other Sample Collection Personnel’s credentials.

59.2 (b) (4) Information provided in the Covered Horse’s Whereabouts Filing and registration with the

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Authority, shall be used by Sample Collection Personnel to confirm the identity of the Covered Horse.
Confirmation of the Covered Horse’s identity by any other method or failure to confirm the identity of the
Covered Horse, shall be documented, including through photographs, and reported to the Agency.

59.2 (b) (5) The DCO shall establish the location of the selected Covered Horse and plan the approach
and timing of notification, taking into consideration the specific circumstances of the location, schedule,
and the situation in question (e.g., Race Day, training).

59.2 (c) Requirements for Notification

59.2 (c) (1) Out-of-Competition Testing

59.2 (c) (1) (i) As soon as practical, the Sample Collection Personnel shall ensure that the
Responsible Person or Nominated Person is informed:

59.2 (c) (1) (i) (A) That the Covered Horse is required to undergo a Sample collection;

59.2 (c) (1) (i) (B) That immediate access to the Covered Horse shall be granted, unless
there are valid reasons for a delay (e.g., horse is currently being exercised, cooled down);

59.2 (c) (1) (i) (C) Of the responsibilities of the Responsible Person or Nominated Person
with respect to the Covered Horse, including the requirement to: Provide a secure location
where a Sample(s) can be collected from the Covered Horse like a stall or other safe and
secure location; Ensure that the Covered Horse remains within continuous observation of
Sample Collection Personnel at all times or is in a secure location (a stall, for example) until
the completion of the Sample collection procedure; Not leave the Covered Horse unattended
once Responsible Person or Nominated Person is notified and contact is made with the
Covered Horse and until Sample(s) have been collected; Produce identification of the
Responsible Person or Nominated Person if possible and identification of the Covered
Horse if requested (pictures will be taken of the individual(s) and the Covered Horse if
identification is requested and not provided); Comply with Sample collection procedures and
Cooperate (and the Responsible Person or Nominated Person, if applicable, should be
advised of the possible Consequences of a Failure to Comply); and Ensure the Covered
Horse is not administered any medications or supplements until the completion of Sample
collection, once Responsible Person or Nominated Person is notified and contact is made
with the Covered Horse and until Sample(s) have been collected, unless there is a medical
emergency as determined by a Veterinarian.

59.2 (c) (1) (ii) The Sample Collection Personnel shall have the Responsible Person or Nominated
Person sign an appropriate form to acknowledge and accept the notification. If the Responsible
Person or Nominated Person refuses to sign that they have been notified on behalf of the Covered
Horse, or evades the notification, the Sample Collection Personnel shall, if possible, inform the
Responsible Person or Nominated Person of the Consequences of a Failure to Comply, and the
Sample Collection Personnel (if not the DCO) shall immediately report all relevant facts to the
DCO. When possible, the Sample Collection Personnel shall continue to collect a Sample. The
DCO shall document the facts in a detailed report and report the circumstances to the Agency. The
Agency shall follow the steps for a review of a Possible Failure to Comply in Part Four below.

59.2 (c) (1) (iii) From the time that the Sample Collection Personnel are granted access to the
Covered Horse until the end of the Sample Collection Session, a member of the Sample
Collection Personnel shall keep the Covered Horse under observation at all times or confirm the
Covered Horse is in a secure location (a stall, for example).

59.2 (c) (1) (iv) A Nominated Person may change during the Sample collection process upon
reasonable request to the Sample Collection Personnel so long as the new Nominated Person (a)
falls within the scope of the definition of Nominated Person, (b) completes the relevant portions of
the Sample collection paperwork, and (c) does not interfere with the Sample collection process.
Any changes of Nominated Person during the Sample collection process shall be documented by
the Sample Collection Personnel.

59.2 (c) (2) Race Day Post-Race Testing

59.2 (c) (2) (i) A member of the Sample Collection Personnel will generally tag a Covered Horse
selected for Doping Control after the Race is completed in the unsaddling area and Chaperone
the Covered Horse from the point of tagging/notification for Doping Control. Notification should be
prompt after the conclusion of a Race and in no case exceed one hour after the Race or winner’s

Horseracing Integrity and Safety Authority


circle activities are completed, if applicable.

59.2 (c) (2) (ii) While the Covered Horse is being unsaddled (or as soon as practical), a member
of the Sample Collection Personnel should inform the Responsible Person or Nominated Person
(who will normally be the Groom):

59.2 (c) (2) (ii) (A) That the Covered Horse is required to undergo a Sample collection;

59.2 (c) (2) (ii) (B) That the Covered Horse must immediately report to the Test Barn, unless
there are valid reasons for a delay;

59.2 (c) (2) (ii) (C) The location of the Test Barn (if not known to the Responsible Person or
Nominated Person);

59.2 (c) (2) (ii) (D) Of the responsibilities of the Responsible Person or Nominated Person
with respect to the Covered Horse, including the requirement to: Ensure that the Covered
Horse remains within continuous observation of the Sample Collection Personnel or in a
secure location (a stall, for example) at all times until the completion of the Sample collection
procedure; Confirm the water bucket, if provided by Sample Collection Personnel at the Test
Barn, is clean and acceptable and only for that Covered Horse during that Covered Horse’s
Sample Collection Session; Not leave the Covered Horse unattended once the Responsible
Person or Nominated Person is notified and contact is made with the Covered Horse and
until Sample(s) have been collected; Produce identification of the Responsible Person or
Nominated Person if possible and identification of the Covered Horse as described above
(pictures will be taken of the individual(s) and the Covered Horse if no identification is
provided); Comply with Sample collection procedures and Cooperate (and the Responsible
Person or Nominated Person, if applicable, should be advised of the possible
Consequences of a Failure to Comply); and Ensure the Covered Horse is not administered
any medications or supplements until the completion of Sample collection, unless there is a
medical emergency as determined by an Official Veterinarian.

59.2 (c) (2) (iii) The Sample Collection Personnel shall notify the Responsible Person or
Nominated Person and document the time and the individual notified (e.g., by taking a photograph
or by having the Responsible Person or Nominated Person sign an appropriate form) and the
Responsible Person or Nominated Person must sign an appropriate form to acknowledge and
accept the notification no later than once in the Test Barn or other secure location. If the
Responsible Person or Nominated Person refuses to sign that they have been notified on behalf of
the Covered Horse, or evades the notification, the Sample Collection Personnel shall, if possible,
inform the Responsible Person or Nominated Person of the Consequences of a Failure to Comply,
and the Sample Collection Personnel (if not the DCO) shall immediately report all relevant facts to
the DCO. When possible, the Sample Collection Personnel shall continue to collect a Sample. The
DCO shall document the facts in a detailed report and report the circumstances to the Agency. The
Agency shall follow the steps for a review of a Possible Failure to Comply in Part Four below.

59.2 (c) (2) (iv) From the time that the Covered Horse is tagged until the end of the Sample
Collection Session, the Sample Collection Personnel shall keep the Covered Horse under
observation or ensure the Covered Horse is in a secure location (a stall, for example).

59.2 (c) (2) (v) A Nominated Person may change during the Sample collection process upon
reasonable request to the Sample Collection Personnel so long as the new Nominated Person (a)
falls within the scope of the definition of Nominated Person, (b) completes the relevant portions of
the Sample collection paperwork, and (c) does not interfere with the Sample collection process.
Any changes of Nominated Person during the Sample collection process shall be documented by
the Sample Collection Personnel.

59.2 (c) (3) Requests for Delay

59.2 (c) (3) (i) The DCO may at their discretion consider any reasonable third-party request or any
request by the Responsible Person or Nominated Person for permission to delay beginning the
Sample collection process following acknowledgment and acceptance of notification. The DCO
may grant such permission if the Covered Horse can be continuously chaperoned and kept under
continuous observation by Sample Collection Personnel during the delay. Delayed reporting to the
stall or Test Barn may be permitted for the following activities:

59.2 (c) (3) (i) (A) For Race Day Testing: Participation in winner’s circle; Obtaining
necessary medical Treatment if there is a medical emergency as determined by an Official
Veterinarian; or Any other reasonable circumstances, as determined by the DCO, taking into
account any instructions of the Agency.

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59.2 (c) (3) (i) (B) For Out-of-Competition Testing: Completing a training session or a cool
down; Receiving necessary medical Treatment if there is a medical emergency as
determined by a Veterinarian; or Any other reasonable circumstances, as determined by the
DCO, taking into account any instructions of the Agency.

59.2 (c) (3) (ii) The DCO shall reject a request for delay from a Responsible Person or Nominated
Person if it will not be possible for the Covered Horse to be continuously observed or secured
during such delay, unless there is a medical emergency as described above.

59.2 (c) (3) (iii) Sample Collection Personnel shall document any reasons for delay in reporting to
the stall or Test Barn and/or reasons for leaving the stall or Test Barn that may require further
investigation by the Agency.

59.2 (c) (3) (iv) If immediate access to the Covered Horse is not granted, the DCO shall report to
the Agency a possible Failure to Comply. If at all possible, the DCO shall proceed with collecting a
Sample. The Agency shall investigate a possible Failure to Comply in accordance with Part Four
below.

59.3 Preparing for Sample Collection Session

59.3 (a) Objective

59.3 (a) (1) To prepare for the Sample Collection Session in a manner that ensures that the session can
be conducted efficiently and effectively including with sufficient resources, e.g., personnel and
equipment.

59.3 (b) Requirements for Preparing for the Sample Collection Session

59.3 (b) (1) The Agency should establish a system for obtaining all the information necessary to ensure
that the Sample Collection Session can be conducted effectively.

59.3 (b) (2) For Race Day Testing that occurs post-Race, a Test Barn should be used that, where
possible, is used solely as a Test Barn for the duration of the Doping Control and unauthorized persons
should not be permitted. Should the DCO determine the Test Barn is unsuitable, they shall seek an
alternative location.

59.3 (b) (3) Unless otherwise approved by the Agency, the Test Barn should be equipped with:

59.3 (b) (3) (i) A walk ring or area for Covered Horses to walk in or adjacent to the Test Barn that is
large enough to accommodate several horses and allow for continuous observation of the Covered
Horses;

59.3 (b) (3) (ii) Sufficient enclosed stalls (at least one) for the volume of Testing and that permit
observation of the collection process and provide for the protection of Covered Horses undergoing
Testing and space for Sample Collection Personnel and up to two Covered Persons per Covered
Horse;

59.3 (b) (3) (iii) Facilities and equipment for the collection, identification, and storage of Samples
including one refrigerator or cooler that can be locked or otherwise secured;

59.3 (b) (3) (iv) An area and appropriate facilities for a Covered Horse to be bathed;

59.3 (b) (3) (v) A table or other suitable surface;

59.3 (b) (3) (vi) Access to hot and cold running water;

59.3 (b) (3) (vii) Clean water buckets for each Covered Horse or space for a Covered Person to
provide their own water bucket for their Covered Horse; and

59.3 (b) (3) (viii) A security officer to ensure no unauthorized person is permitted in the Test Barn.

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59.3 (b) (4) For Out-of-Competition Testing, the DCO will determine a suitable location to be used for
the Sample Collection Session. If at a stable, by default the Covered Horse’s own stall should be used.

59.3 (b) (5) Sample Collection Personnel should ensure they have and use Sample Collection
Equipment provided by or approved by the Agency.

59.3 (b) (6) Sample Collection Equipment for urine, blood, and hair Samples which should, at a
minimum:

59.3 (b) (6) (i) Have a unique numbering system incorporated into all A and B bottles, containers,
tubes, or other items used to seal the Sample;

59.3 (b) (6) (ii) Have a Tamper Evident sealing system;

59.3 (b) (6) (iii) Ensure the identity of the Responsible Person and Covered Horse are not evident
from the equipment itself;

59.3 (b) (6) (iv) Ensure that all equipment is clean and sealed prior to use;

59.3 (b) (6) (ix) Have a built-in security identification feature(s) which allows verification of the
authenticity of the equipment;

59.3 (b) (6) (v) Be constructed of a material and sealing system that is able to withstand the
handling conditions and environment in which the equipment will be used or subjected to, including
but not limited to transportation, Laboratory analysis, and long-term frozen storage up to the period
of the statute of limitations;

59.3 (b) (6) (vi) Be constructed of a material and sealing system approved by the Agency that
should:

59.3 (b) (6) (vi) (A) Maintain the integrity (chemical and physical properties) of the Sample for
the analytical Testing;

59.3 (b) (6) (vi) (B) Withstand temperatures of -80 °C. Tests conducted to determine integrity
under freezing conditions shall use the matrix that will be stored in the Sample bottles,
containers, or tubes, (e.g., blood, urine);

59.3 (b) (6) (vi) (C) Be constructed of a material and with a sealing system that can withstand
a minimum of three (3) freeze/thaw cycles;

59.3 (b) (6) (vii) The bottles, containers, and tubes shall be transparent or translucent so the
Sample is visible;

59.3 (b) (6) (viii) Have a sealing system which allows verification by the Responsible Person or
Nominated Person and the DCO that the Sample is correctly sealed in the bottles or containers;

59.3 (b) (6) (x) Be compliant with the standards published by the International Air Transport
Association (IATA) for the transport of exempt specimens which includes urine and/or blood
Samples in order to prevent leakage during transportation by air;

59.3 (b) (6) (xi) Have been manufactured under the internationally recognized ISO 9001 certified
process which includes quality control management systems; and

59.3 (b) (6) (xii) Be able to be resealed after initial opening by a Laboratory to maintain the
integrity of the Sample and Chain of Custody in accordance with the requirements for long-term
storage of the Sample and Further Analysis.

59.3 (b) (6) (xiii) For urine Sample collections:

59.3 (b) (6) (xiii) (A) Have the capacity to contain a minimum of 100 mL volume of urine in
each A and B bottle or container;

59.3 (b) (6) (xiii) (B) Have a visual marking on the A and B bottles or containers and the
collection vessel, indicating: the minimum volume of urine (25 mL) required in each A and B
bottle or containers; the maximum volume levels that allow for expansion when frozen without
compromising the bottle, container, or the sealing system; and the level of suitable volume for
urine for analysis on the collection vessel.

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59.3 (b) (6) (xiv) For blood Sample collection:

59.3 (b) (6) (xiv) (A) Have the ability to collect, store and transport blood tubes in separate A
and B containers;

59.3 (b) (6) (xiv) (B) For the analysis of Prohibited Substances or Prohibited Methods in
whole blood or plasma and/or for profiling blood parameters, each A and B container must
have the capacity to contain a minimum of 30 mL of blood (e.g., three 10mL tubes);

59.3 (b) (6) (xiv) (C) For the analysis of Prohibited Substances or Prohibited Methods in
serum, each A and B tube must have the capacity to contain a minimum of 10mL of blood;
and

59.3 (b) (6) (xiv) (D) For the transport of blood Samples, ensure the storage and transport
device and temperature logger meet the requirements listed in Article 63 – Collection of
Blood Samples.

59.3 (b) (7) Sample Collection Personnel should ensure they have the necessary equipment for hair
Sample collection and any other approved Testing matrices or methodologies.

59.4 Conducting the Sample Collection Session

59.4 (a) Objective

59.4 (a) (1) To conduct the Sample Collection Session in a manner that ensures the integrity, security,
and identity of the Sample and respects the humane treatment and welfare of the Covered Horse.

59.4 (b) Requirements for Sample Collection

59.4 (b) (1) The Agency shall be responsible for the overall conduct of the Sample Collection Session,
with specific responsibilities delegated to the DCO.

59.4 (b) (10) At the conclusion of the Sample Collection Session the Responsible Person or Nominated
Person and DCO shall sign appropriate documentation to indicate their satisfaction that the
documentation accurately reflects the details of the Covered Horse’s Sample Collection Session,
including any concerns expressed by the Responsible Person or Nominated Person.

59.4 (b) (11) The Responsible Person shall be provided access to the Doping Control form for the
Covered Horse’s Sample Collection Session.

59.4 (b) (2) The following may be authorized and/or required to be present during the Sample Collection
Session:

59.4 (b) (2) (i) Sample Collection Personnel sufficient to notify, Chaperone, and collect the
required Samples;

59.4 (b) (2) (ii) The Responsible Person or Nominated Person must be present during the Sample
Collection Session. If the Responsible Person or Nominated Person is not present this will be
documented by the DCO;

59.4 (b) (2) (iii) At least one, but no more than two, Covered Persons may be present to assist
during the Sample Collection Session except in exceptional circumstances as determined by the
DCO;

59.4 (b) (2) (iv) Collection of Samples must only be performed by Sample Collection Personnel
approved by the Agency; and

59.4 (b) (2) (v) Any Person authorized by the Agency who is involved in the training or supervision
of Sample Collection Personnel.

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59.4 (b) (3) Except as provided above, the Sample Collection Personnel shall coordinate with the Test
Barn security officer to ensure that no unauthorized person is permitted in the Test Barn.

59.4 (b) (4) For Race Day post-Race Testing, the Covered Horse shall remain in the Test Barn through
the end of the Sample Collection Session.

59.4 (b) (5) Samples shall be collected in a manner that ensures:

59.4 (b) (5) (i) the Sample is of a quality and quantity that meets the relevant Sample suitability and
analytical requirements;

59.4 (b) (5) (ii) the Sample has not been manipulated, substituted, contaminated, or otherwise
tampered with in any way;

59.4 (b) (5) (iii) the Sample is clearly and accurately identified; and

59.4 (b) (5) (iv) the Sample is securely sealed in a Tamper Evident kit.

59.4 (b) (6) The Sample Collection Personnel shall collect the Sample from the Covered Horse
according to the following protocol(s) for the specific type of Sample collection:

59.4 (b) (6) (i) Article 62: Collection of Urine Samples;

59.4 (b) (6) (ii) Article 63: Collection of Blood Samples;

59.4 (b) (6) (iii) Article 64: Collection of Hair Samples;

59.4 (b) (7) Any anomalous behavior by the Responsible Person, Nominated Person, and/or Covered
Persons associated with the Covered Horse or behavior with potential to compromise the Sample
collection shall be recorded in detail by the Sample Collection Personnel. If appropriate, the Agency
shall review the possible Failure to Comply in accordance with Part Four below.

59.4 (b) (8) The DCO shall provide the Responsible Person or Nominated Person with the opportunity to
document any concerns they may have about how the Sample Collection Session was conducted.

59.4 (b) (9) The following information shall be recorded as a minimum in relation to the Sample
Collection Session:

59.4 (b) (9) (i) Date, time of notification, name and signature of notifying Sample Collection
Personnel;

59.4 (b) (9) (ii) If Race Day Testing, the arrival time of the Covered Horse to the Test Barn;

59.4 (b) (9) (iii) The name of the Covered Horse, Responsible Person, and Nominated Person (if
applicable);

59.4 (b) (9) (iv) Any changes in Nominated Person during the Sample collection process;

59.4 (b) (9) (ix) The Sample code number(s);

59.4 (b) (9) (v) The gender of the Covered Horse (male, female, gelding);

59.4 (b) (9) (vi) The color of the Covered Horse;

59.4 (b) (9) (vii) Means by which the Covered Horse identity is validated (e.g., microchip number,
tattoo or brand);

59.4 (b) (9) (viii) Nominated Person’s contact information (i.e., home address, email address, and
telephone number), if not a Covered Person or if the Covered Person’s contact information is not
readily available to the Sample Collection Personnel;

59.4 (b) (9) (x) Date and time of sealing of each Sample collected and date and time of completion
of entire Sample collection process (i.e., the time when the Responsible Person or Nominated
Person signs the declaration at the bottom of the Doping Control form);

59.4 (b) (9) (xi) Location of Doping Control (e.g., for Out-of-Competition barn name, city, and state;

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for Race Day name of event, city, and state);

59.4 (b) (9) (xii) The type of the Sample (e.g., urine, blood, hair);

59.4 (b) (9) (xiii) The type of test (Race Day, Race Day TCO2, or Out-of-Competition);

59.4 (b) (9) (xiv) The name and signature of the Sample Collection Personnel catching the urine
Sample and/or collecting hair and/or blood Sample (where applicable);

59.4 (b) (9) (xix) Any comments or concerns from the Responsible Person or Nominated Person
regarding the conduct of the Sample Collection Session;

59.4 (b) (9) (xv) Whether furosemide was administered to the Covered Horse within 48 hours
before the Race;

59.4 (b) (9) (xvi) Required Laboratory information on the Sample (e.g., for urine Sample, its
volume; for hair Sample, mane/tail and pulled/cut);

59.4 (b) (9) (xvii) For a blood Sample, the DCO shall record the information as outlined in Article
63 – Collection of Blood Samples;

59.4 (b) (9) (xviii) Any irregularities in procedures for example, if advance notice was provided or if
there were delays to arriving to the Test Barn;

59.4 (b) (9) (xx) Responsible Person or Nominated Person acknowledgment of the processing of
Sample collection data and a description of such processing; and

59.4 (b) (9) (xxi) The name of additional Persons (if any) present during the Sample Collection
Session.

59.5 Security/Post-Test Administration

59.5 (a) Objective

59.5 (a) (1) The objective is to ensure that all Samples and Sample collection documentation are
securely stored prior to transport to the Laboratory.

59.5 (b) Requirements for Security/Post-Test Administration

59.5 (b) (1) Samples should be stored by Sample Collection Personnel in a manner that protects the
integrity, identity, and security prior to transport to the Laboratory, as detailed in Article 62, 63, and 64.

59.5 (b) (2) Sample Collection Personnel are required to document who has custody of the Samples
and/or is permitted access to the Samples.

59.5 (b) (3) The Agency shall develop a system for recording the Chain of Custody of Samples and
receiving Sample Collection Session documentation to ensure that each Sample is securely handled
and the documentation for each Sample is completed.

59.6 Transport of Samples and Documentation

59.6 (a) Objective

59.6 (a) (1) The objective is to ensure that Samples and related documentation arrive at the Laboratory
that will be conducting the analysis in proper condition to do the necessary analysis and to ensure the
Sample Collection Session documentation is sent to the Agency in a secure and timely manner.

59.6 (b) Requirements for Transport and Storage of Samples and Documentation

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59.6 (b) (1) The Agency shall authorize a transport system that ensures Samples and documentation are
transported in a manner that protects their integrity, identity, and security.

59.6 (b) (2) State Racing Commissions may select a Laboratory at which Samples collected in its state
shall be analyzed. If specific analysis requested by the Agency cannot be performed at the selected
Laboratory, the Agency may have the Sample sent to another Laboratory that can conduct the requested
analysis. Each year the State Racing Commissions must make their Laboratory designation for all
Samples collected within its state on or before September 30th of the year prior to the designation
taking effect. If a State Racing Commission fails to select a Laboratory by this deadline, the Authority
shall select the Laboratory for that particular state. The Agency may allow for a State Racing
Commission to change its selection of Laboratory outside of the time-period set forth above if a
reasonable request is made.

59.6 (b) (3) Samples (both A and B bottles) shall always be transported to the Laboratory using the
Agency’s authorized transport method, as soon as reasonably practicable after the completion of the
Sample Collection Session. Samples shall be transported in a manner which minimizes the potential for
Sample degradation due to factors such as delays and extreme temperature variations.

59.6 (b) (4) The Agency shall have the ability to confirm, if necessary, that both the Sample and Sample
collection documentation arrived at their intended destinations. The Laboratory shall report any
irregularities to the Agency on the condition of Samples upon arrival in line with the Laboratory
Standards.

59.6 (b) (5) The Agency shall develop a system to ensure that, where required, instructions for the type of
analysis to be conducted are provided to the Laboratory that will be conducting the analysis. In addition,
the Agency shall provide the Laboratory with information as required for result reporting and statistical
purposes and include whether long-term Sample storage is required.

59.6 (b) (6) Documentation identifying the Covered Horse and Responsible Person or Nominated
Person shall not be included with the Samples or documentation sent to the Laboratory that will be
analyzing the Samples.

59.6 (b) (7) If the Samples with accompanying documentation or the Sample Collection Session
documentation are not received at their respective intended destinations, or if a Sample’s integrity or
identity may have been compromised during transport, the Agency shall consider whether the Samples
should be voided. The decision to void a Sample is in the sole discretion of the Agency.

59.6 (b) (8) Documentation related to a Sample Collection Session and/or an anti-doping or medication
control rule violation shall be stored by the Agency for a period of ten years or in accordance with the
Agency’s record retention policy.

59.7 Ownership of Samples

59.7 (a) Samples collected from a Covered Horse are owned by the Agency.

60 Standards for Intelligence Gathering

60.1 Objective

60.1 (a) The Agency shall ensure that it is able to obtain, assess, and process anti-doping and medication
control intelligence from all available sources to help deter and detect doping and medication abuse; to inform
effective, intelligent, and proportionate test planning; to plan Target Testing; and to conduct investigations as
required by Protocol Article 5.6. The objective of this section is to establish standards for the efficient and
effective gathering, assessment, and processing of such intelligence for these purposes.

60.2 Gathering Anti-Doping and Medication Abuse Intelligence

60.2 (a) The Agency should make every reasonable effort to ensure that it is able to capture or receive anti-
doping and medication control intelligence from all available sources, including but not limited to Covered
Persons (including through Substantial Assistance provided pursuant to Protocol Article 10.7 (a)) and
members of the public (e.g., by means of a confidential tip platform), Sample Collection Personnel (whether
via mission reports, incident reports, or otherwise), laboratories, pharmaceutical companies, the Authority,

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State Racing Commissions, law enforcement, other regulatory and disciplinary bodies, and the media (in all
its forms).

60.2 (b) The Agency shall ensure that anti-doping and medication control intelligence captured or received
from a confidential source or in a non-public fashion is handled securely and confidentially, that sources of
intelligence are protected, that the risk of leaks or inadvertent disclosure is properly addressed, and that
intelligence shared with the Agency by law enforcement, other relevant authorities and/or other third parties in
a matter intended to be confidential is processed, used, and disclosed only for legitimate legal, law
enforcement, regulatory, anti-doping, or medication control purposes.

60.2 (c) The Agency shall facilitate and encourage whistleblowers.

60.3 Assessment and Analysis of Anti-Doping and Medication Abuse Intelligence

60.3 (a) The Agency should ensure that it is able to assess all anti-doping and medication control intelligence
upon receipt for relevance, reliability, and accuracy, taking into account the nature of the source and the
circumstances in which the intelligence has been captured or received.

60.3 (b) All relevant anti-doping and medication control intelligence captured or received by the Agency should
be collated and analyzed to establish patterns, trends, and relationships that may assist the Agency in
developing an effective anti-doping and medication control strategy and/or in determining (where the
intelligence relates to a particular case) whether there is reasonable suspicion that an anti-doping or
medication control rule violation may have been committed, such that further investigation is warranted.

60.4 Intelligence Outcomes

60.4 (a) Anti-doping and medication control intelligence may be used for the following purposes (without
limitation): developing, reviewing, and revising Testing planning and/or in determining when to conduct Target
Testing, and/or to create targeted intelligence files to be referred for investigation.

60.4 (b) The Agency may share intelligence, where appropriate with State Racing Commissions and/or law
enforcement and/or other relevant regulatory or disciplinary authorities (e.g., if the intelligence suggests the
possible commission of a crime or regulatory offence or breach of other rules of conduct).

61 Standards for Investigations

61.1 Objective

61.1 (a) The objective of this section is to establish standards for the efficient and effective conduct of
investigations under the Protocol, including but not limited to:

61.1 (a) (1) The investigation of Atypical Findings, Atypical Passport Findings, and Adverse Passport
Findings, and any other Sample abnormalities reported by the Laboratory;

61.1 (a) (2) The investigation of any other analytical or non-analytical information and/or intelligence
where there is reasonable suspicion to suspect that an anti-doping or medication control rule violation
may have been committed, such as a review of a possible Failure to Comply;

61.1 (a) (3) The investigation of the circumstances surrounding and/or arising from an Adverse Analytical
Findingto gain further intelligence on the Responsible Person or other Covered Persons associated with
the Covered Horse whose Sample was positive or other methods involved in doping or medication
abuse; and

61.1 (a) (4) Where an anti-doping or medication control rule violation by a Covered Horse or
Responsible Person is alleged, the investigation into whether other Covered Persons may have been
involved in that violation.

61.1 (b) In each case, the purpose of the investigation is to achieve one of the following either:

61.1 (b) (1) to rule out a possible violation or involvement in an anti-doping or medication control rule
violation;

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61.1 (b) (2) to develop evidence that supports an anti-doping or medication control rule violation
proceeding or the initiation of such a proceeding in accordance with Protocol Article 7; or

61.1 (b) (3) to provide evidence of a breach of the Protocol, applicable law, or regulation.

61.2 Investigating Possible Anti-Doping or Medication Control Rule Violations

61.2 (a) The Agency shall direct and manage all investigations under the Protocol. The Agency shall conduct
all investigations under the Protocol unless specifically referred to a State Racing Commissions (subject to the
applicable State Racing Commission electing to enter into an agreement with the Agency) whose
investigators would continue to act at the direction of the Agency.

61.2 (b) The Agency and any State Racing Commissions to which the Agency refers investigatory tasks
(subject to the applicable State Racing Commission electing to enter into an agreement with the Agency) shall
ensure that investigations are conducted confidentially.

61.2 (c) The Agency should ensure that it effectively investigates any analytical or non-analytical information or
intelligence that indicates there is reasonable suspicion that an anti-doping or medication control rule violation
may have been committed or that indicates further inquiry might lead to the discovery of admissible evidence
of such a violation.

61.2 (d) The Agency should gather and record all relevant information and documentation as soon as
possible.

61.2 (e) The Agency shall ensure that investigations are conducted fairly, objectively, and impartially at all
times. The conduct of investigations, the evaluation of information and evidence identified in the course of that
investigation, and the outcome of the investigation, should be fully documented.

61.2 (f) Covered Persons are required under Protocol Articles 2.8 and 16 to Cooperate with investigations
conducted by Agency. If they fail to do so, the Agency may bring proceedings against them for violating
Protocol Article 2.8 (Failure of Covered Person to Cooperate with the Agency). If their conduct amounts to
subversion of the investigation process (e.g., by providing false, misleading, or incomplete information, and/or
by destroying potential evidence), the Agency may also bring proceedings against them for violating Protocol
Article 2.11 (Tampering or Attempted Tampering).

61.2 (g) It shall not be a defense in a proceeding involving an anti-doping or medication control rule violation
that an investigation should have been conducted more quickly or that any aspect of the Testing and
Investigations Standards were not followed by the Agency or State Racing Commissions except as provided
in the Protocol.

61.3 Obtaining Investigative Information

61.3 (a) The Agency should make use of all investigative resources reasonably available to it to conduct its
investigation. This may include obtaining information and assistance from law enforcement and other relevant
authorities, including other regulators, the Equine Biological Passport program (when available), investigative
powers conferred under applicable rules (including inspection, examination, and seizure; production of
documents; subpoenas; and interviews), and the power to suspend a period of Ineligibility imposed on a
Covered Person in return for Substantial Assistance in accordance with Protocol Article 10.7 (a).

61.3 (b) Without limitation, the Agency may utilize the following investigative tools in relation to investigations
and inquiries of possible violations of the Protocol:

61.3 (c) Inspection, Examination, and Seizure

61.3 (c) (1) The Agency may enter facilities, offices, stables, barns, or any other premises related to
Covered Horses which are owned, controlled, or occupied by Covered Person(s) and:

61.3 (c) (1) (i) inspect and search the premises including any books, records or property, and to
take Possession or a sample of any item or material believed to be, or that may lead to, evidence
directly or indirectly of a violation of the Protocol;

61.3 (c) (1) (ii) search any Covered Person or Covered Horse on the premises;

61.3 (c) (1) (iii) access electronically stored data, including emails, computers, and mobile phones
and devices without altering such data or device(s) other than to forward, back up, copy or make a
mirror image of such data or device(s);

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61.3 (c) (1) (iv) conduct identification and medication checks on any Covered Horse;

61.3 (c) (1) (v) inspect and take copies of any records the Covered Person is required to keep
under the Protocol;

61.3 (c) (1) (vi) request a Sample from any Covered Person; and

61.3 (c) (1) (vii) examine any Covered Horse under the care of a Covered Person and take
Samples from the Covered Horse for analysis.

61.3 (d) Production of Documents, Subpoenas

61.3 (d) (1) The Agency may:

61.3 (d) (1) (i) Require a Covered Person to provide any information, documents or records in
such form as the Agency may require, and which are held by the Covered Person or within their
power to obtain;

61.3 (d) (1) (ii) Require production of any mobile phones, computers, tablets, other electronic
devices, books, documents and records (including telephone or financial records whether currently
in the direct Possession of a Covered Person or a third person who may be directed by the
Covered Person to provide the information) that may be relevant to any investigation, inquiry,
hearing or proceeding;

61.3 (d) (1) (iii) Request the Authority issue a subpoena to a Person to appear or to answer
questions and/or produce evidence related to anti-doping and medication control matters. A
subpoena may direct the witness to appear at a specific time and place to testify; to produce
designated evidence by a specific time; or to permit inspection of premises by the Agency at a
specific time. A subpoena must be issued under the signature of a designated person from the
Authority. If the Covered Person fails to comply with a subpoena, the Agency or Authority may seek
enforcement of the subpoena in any of the district courts of the United States within the jurisdiction
of which such inquiry is carried on. Additionally, the arbitrator, steward or administrative law judge
considering a case arising under the Protocol may impose an adverse inference against a
Covered Person who fails to comply with a valid subpoena, regardless of whether a court has
been required to enforce the subpoena or has found the Covered Person in contempt.

61.3 (d) (1) (iv) This issuance of a subpoena and compliance therewith is independent of the
Agency’s powers to inspect and obtain evidence without a subpoena and Covered Persons’ duty
to Cooperate under the Protocol. In addition to a rule violation for refusal to Cooperate, a refusal to
Cooperate can result in imposition of an adverse inference against a Covered Person by an
arbitrator, steward or administrative law judge.

61.3 (d) (2) As a matter of efficient operation of the Agency’s investigative program, the following
considerations should be taken into account by the Agency (but should not be considered relevant by a
reviewing court) in determining whether a subpoena should be requested to be issued by the Authority:

61.3 (d) (2) (i) The availability of and success in using alternative methods for obtaining the
information in a timely manner;

61.3 (d) (2) (ii) The indispensability of the information to the success of the investigation or
establishing a violation; and

61.3 (d) (2) (iii) The need to protect against the destruction of records or information and to protect
the Agency’s ability to bring forward a violation of the Protocol for such destruction.

61.3 (e) Interviews

61.3 (e) (1) Covered Persons must comply with a request to be interviewed by the Agency.

61.3 (e) (2) Only if the Agency requires a Covered Person to submit to an under oath transcribed
interview, the Covered Person may request a short delay to the interview, if necessary, to seek legal

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advice. However, such delay shall only encompass the time reasonably necessary to contact and retain
counsel and shall in no case exceed seven days without the consent of the Agency.

61.3 (e) (3) An authorized Person may administer an oath or affirmation to a Covered Person appearing
for an under oath interview.

61.3 (e) (4) The only basis for refusing to answer a question in an interview is an assertion of the
attorney-client privilege or the Fifth Amendment privilege against self-incrimination.

61.3 (f) Investigation Outcomes

61.3 (f) (1) The Agency shall come to a decision efficiently and without undue delay as to whether
proceedings should be brought against a Covered Person and/or Responsible Person on behalf of a
Covered Horse asserting commission of an anti-doping or medication control rule violation.

61.3 (f) (2) Where the Agency concludes based on the results of its investigation that proceedings
should be brought against a Covered Person or a Responsible Person independently or on behalf of a
Covered Horse asserting commission of an anti-doping or medication control rule violation, it shall give
notice of that decision in the manner set out in the Protocol.

61.3 (f) (3) Where the Agency concludes, based on the results of its investigation, that proceedings
should not be brought against the Covered Person or Responsible Person independently or on behalf of
a Covered Horse asserting commission of an anti-doping or medication control rule violation, it shall
consider whether any of the intelligence obtained and/or lessons learned during the investigation should
be used for test planning, to plan Target Testing, and/or should be shared with any other body or
included in any report in accordance with these Testing and Investigations Standards.

61.3 (f) (4) The Agency may include information from its investigations in reports made to the Authority,
Congress, State Racing Commissions, or other appropriate bodies regardless of whether the
information relates to one or more rule violations. The fact that information was included in such a report
shall not be a defense in any proceeding involving a potential rule violation.

62 Collection of Urine Samples

62.1 Urine Samples may be collected and analyzed for any anti-doping analytical matrix or methodology, including
Equine Biological Passport, as determined by the Agency.

62.10 The volume of urine required for a full Sample is 50-100mL; however more should be collected if possible. On
the initial attempt, if less than 50mL is obtained, the relevant Sample Collection Personnel should try to collect
additional urine.

62.11 After reasonable attempts, if less than 50mL of urine is obtained, the entire Sample should be submitted to
the Laboratory with best efforts for a 60/40 split between A and B bottles. In the event that less than 50 mL of urine is
obtained, a blood Sample should also be collected from the Covered Horse.

62.12 Intractable Covered Horses will be handled in accordance with Protocol Article 2.6 (b).

62.13 Once the volume of urine provided by the Covered Horse is deemed sufficient, the relevant Sample Collection
Personnel will bring the Sample to the designated processing area.

62.14 The relevant Sample Collection Personnel will select the Sample collection kit and will open, inspect, and
confirm Sample codes numbers within the kit match and ask the Responsible Person or Nominated Person if they
would like to confirm the same.

62.15 In view of the Responsible Person or Nominated Person, the relevant Sample Collection Personnel will pour
and split urine Sample between A and B Sample collection bottles in accordance with the above capacity.

62.16 In view of the Responsible Person or Nominated Person, the relevant Sample Collection Personnel will seal
the A and B bottles. Once closed, the relevant Sample Collection Personnel will check that the bottles have been
properly sealed.

62.17 A DCO will complete all the required Sample collection documentation and provide the Responsible Person
access to the Doping Control form for the Covered Horse’s Sample Collection Session.

62.18 Urine should only be discarded when both the A and B bottles or containers have been filled to the maximum

Horseracing Integrity and Safety Authority


amount they can hold and have been sealed. Any excess urine should be disposed of into a drain (ground drain or
sink) or into a bin or waste pile if necessary. The Responsible Person or Nominated Person shall be given the
option to observe the disposal of any residual urine not sent to the Laboratory for analysis.

62.19 A DCO shall store the Sample in a manner that protects the integrity, identity, and security prior to transport to
the Laboratory. Specifically, urine Samples should be transported to the Laboratory as soon as possible after the
conclusion of the Sample Collection Session. If a Sample cannot be transported that same day, a DCO should store
the Sample in a secure refrigerator and document in the Chain of Custody the location and time in and time out.

62.2 The Responsible Person or Nominated Person must be given reasonable opportunity to prepare the Covered
Horse for Sample collection, for example by removing gear, washing off, and moving the Covered Horse to the
collection area, while remaining in direct observation of the Sample Collection Personnel.

62.20 Comment: If the Responsible Person or Nominated Person is not satisfied with the chosen Sample Collection
Equipment, this shall be recorded by a DCO. If a DCO does not agree with the Responsible Person or Nominated
Person that the equipment is unsatisfactory, a DCO shall inform the Responsible Person or Nominated Person that
the Sample Collection Session is proceeding. If a DCO agrees with the Responsible Person or Nominated Person
that the equipment is unsatisfactory, a DCO shall use other available equipment that the DCO determines is
satisfactory. If no such equipment is available, a DCO shall terminate the Sample Collection Session, and this shall
be recorded by a DCO.

62.3 Where Testing is conducted at any location other than a Test Barn, the Responsible Person or Nominated
Person must provide a suitable location where a Sample(s) can be collected from the Covered Horse.

62.4 The Responsible Person or Nominated Person will be instructed to examine the Sample collection vessel to
ensure it will not affect the integrity of the urine Sample.

62.5 The relevant Sample Collection Personnel will retain control of the Sample collection vessel.

62.6 The relevant Sample Collection Personnel will then open and use the selected Sample collection vessel to
collect the urine Sample in accordance with the instructions for the Sample collection vessel.

62.7 The relevant Sample Collection Personnel will wear a new pair of disposable gloves when handling the Sample
collection vessel.

62.8 The relevant Sample Collection Personnel shall ensure as unobstructed view as possible of the Sample leaving
the Covered Horse’s body and shall continue to observe the Sample after provision until the Sample is securely
sealed.

62.9 When the Covered Horse passes urine, the collection vessel should be positioned to collect as much urine as
possible.

63 Collection of Blood Samples

63.1 Blood collection shall be conducted by a Blood Collection Officer (“BCO”) who is a licensed veterinarian or
veterinary technician.

63.10 Once a complete blood Sample is obtained, a BCO or DCO will properly seal the A and B bottles.

63.11 Intractable Covered Horses will be handled in accordance with Protocol Article 2.6 (b).

63.12 A BCO or DCO will complete all the required Sample collection documentation and provide the Responsible
Person.

63.13 A DCO shall store the Sample in a manner that protects the integrity, identity, and security prior to transport to
the Laboratory. Specifically, blood Samples should be transported to the Laboratory as soon as reasonably
practical to do so after the conclusion of the Sample Collection Session. If a Sample cannot be transported that
same day, a DCO should store the Sample in a secure refrigerator and document in the Chain of Custody the
location and time in and time out. For Race Day Testing, urine Samples should be stored in a secure refrigerator
until transport is possible.

63.14 Blood Samples shall be transported to the Laboratory in a device that maintains the integrity of Samples
during transportation, in a cool and constant environment, recorded by a temperature logger. The transport device
shall be transported securely via a transportation or shipping service authorized by the Agency.

63.15 Comment: If the Responsible Person or Nominated Person is not satisfied with the chosen Sample Collection
Equipment, this shall be recorded by a DCO. If a DCO does not agree with the Responsible Person or Nominated
Person that the equipment is unsatisfactory, a DCO shall inform the Responsible Person or Nominated Person that
the Sample Collection Session is proceeding. If a DCO agrees with the Responsible Person or Nominated Person
that the equipment is unsatisfactory, a DCO shall use other available equipment that the DCO determines is

Horseracing Integrity and Safety Authority


satisfactory. If no such equipment is available, a DCO shall terminate the Sample Collection Session, and this shall
be recorded by a DCO.

63.2 Certain blood collections might be required at specific times around a Race (e.g., TCO2 Testing). If so,
Sample Collection Personnel will communicate this information to the Responsible Person or Nominated Person at
the time of notification.

63.3 Blood Samples may be collected and analyzed for any anti-doping analytical matrix or methodology, including
Equine Biological Passport, as determined by the Agency.

63.4 A DCO or BCO will select a Sample collection kit containing A and B bottles, collection tubes, and the other
necessary equipment needed to collect a blood Sample (which will include a new needle).

63.5 Once the Sample collection kit has been selected, a BCO or DCO will open, inspect, and confirm Sample
codes numbers within the kit match and ask the Responsible Person or Nominated Person if they would like to
confirm the same.

63.6 A BCO will assess the most suitable location of venipuncture. A BCO will wear a new pair of disposable
gloves.

63.7 A BCO shall dispose of used blood sampling equipment not required to complete the Sample Collection
Session in accordance with the required local standards for handling used blood draw equipment.

63.8 A BCO will collect the amount of blood that will adequately satisfy the relevant analytical requirements for the
Sample analysis to be performed. The minimum total volume requirement is 30mL whole blood for each A and B
bottle, except when blood is collected solely for TCO2 analysis in which case a lesser volume may be appropriate in
the Agency’s discretion. Anything below 30mL should still be packaged and transported to the Laboratory.

63.9 If the amount of blood that can be removed from the Covered Horse at the first attempt is insufficient, a BCO
shall repeat as necessary and appropriate to try and obtain the minimum total volume for a blood Sample, unless the
Covered Horse is intractable. Should a BCO’s attempts fail to produce a sufficient amount of blood, then a DCO
shall terminate the blood Sample Collection Session and record the reasons for terminating. Other matrices should
be considered for collection.

64 Collection of Hair Samples

64.1 Requirements

64.1 (a) A member of the Sample Collection Personnel should collect hair Samples in accordance with the
following requirements:

64.1 (a) (1) Hair should (to the extent possible) be completely dry and free of visible dirt, debris, or
foreign substances;

64.1 (a) (2) Mane hair should be collected unless tail hair is specifically requested. If for a particular
reason a mane Sample cannot be obtained (such as hogged mane), tail hair may be collected;

64.1 (a) (3) An adequate Sample should be obtained for each of the A and B Samples;

64.1 (a) (4) If the mane is less than 10cm, an additional Sample of hair may be required to ensure a
suitable volume is obtained for analysis;

64.1 (a) (5) The Sample should be secured tightly with an elastic band, or equivalent, and oriented to
clearly mark the ends cut or pulled from the Covered Horse; and

64.1 (a) (6) Hair shafts should remain aligned so that the hair does not become knotted.

64.1 (b) A DCO will complete all the required Sample collection documentation and provide the Responsible
Person a copy for their records.

64.1 (c) The Sample Collection Personnel shall store the Sample in a manner that protects the integrity,
identity, and security prior to transport to the Laboratory.

65 Sample Collection Personnel Requirements

Horseracing Integrity and Safety Authority


65.1 Objective

65.1 (a) To establish standards for training and accrediting Sample Collection Personnel to ensure that they
have adequate qualifications, are free of conflicts of interest, and have experience to conduct Doping Control.

65.2 Requirements

65.2 (a) The Agency shall establish the necessary competence, eligibility, and qualification requirements for
the positions of DCO, BCO, and Chaperone. As a minimum:

65.2 (a) (1) Sample Collection Personnel shall not be minors;

65.2 (a) (2) Sample Collection Personnel shall agree to undergo screening required by the Agency (e.g.,
background checks, conflicts of interest);

65.2 (a) (3) BCOs shall be a veterinarian or veterinary technician with the practical skills and knowledge
to perform blood collection from a vein on a horse.

65.3 Conflicts

65.3 (a) The Agency shall ensure that all Sample Collection Personnel sign an agreement regarding conflicts
of interest, confidentiality, and code of conduct.

65.3 (b) The Agency shall not appoint any Sample Collection Personnel to Testing where they have an interest
in the outcome of the Doping Control process. At a minimum, Sample Collection Personnel are deemed to
have such an interest if they are:

65.3 (b) (1) Involved, or have an immediate family member involved, in the participation or
Administration of horse racing for which Doping Control is being conducted, excluding State Racing
Commissions; however, over the first eighteen months of the program this provision will not apply to
Sample Collection Personnel who are supervised and whose actions material to the Sample Collection
Session are witnessed by Sample Collection Personnel who comply with this provision;

65.3 (b) (2) Related to, or involved in the personal affairs of, any Covered Horse and/or any Equine
Constituencies, except State Racing Commissions;

65.3 (b) (3) Are engaged in business with, have a financial interest in, or have a personal stake in a
Covered Horserace; and/or

65.3 (b) (4) Appear to have private or personal interests that detract from their ability to perform their
duties with integrity and in an independent and purposeful manner.

65.4 Training

65.4 (a) The Agency shall establish or approve written training materials for Sample Collection Personnel that
outline their respective responsibilities that adequately train them of their roles.

65.4 (b) The Agency shall ensure that DCOs have completed the necessary training program and are familiar
with the requirements before giving a credential.

65.4 (c) The training program for DCOs should include, at a minimum:

65.4 (c) (1) Comprehensive theoretical training in those Doping Control activities relevant to the DCO
position;

65.4 (c) (2) Observation of Doping Control activities that are the responsibility of the DCO as set out in
these Standards, preferably on-site; and

65.4 (c) (3) The satisfactory performance of one complete Doping Control on-site under observation by
a qualified DCO or similar.

Horseracing Integrity and Safety Authority


65.4 (d) The training program for Sample Collection Personnel responsible for the collection of blood Samples
shall also include standard precautions in veterinary settings.

65.4 (e) The training program for Chaperones shall include all relevant requirements of the Doping Control
process to carry out their responsibilities including how to handle potential Failures to Comply. DCOs may
direct a Chaperone to perform specified activities that fall within the scope of the Chaperone’s authorized
duties as determined by the Agency.

65.4 (f) The Agency should ensure that Sample Collection Personnel are adequately trained to carry out their
responsibilities in a manner respectful of any Covered Persons who are of a different race, religion, sex,
national origin, sexual orientation, age, citizenship, disability, gender identity or Veteran status to its Sample
Collection Personnel.

65.4 (g) The Agency shall establish a system for credentialing and re-credentialing DCOs.

65.4 (h) Only Sample Collection Personnel who have a credential recognized by the Agency or letter of
authority from the Agency shall be authorized to conduct Doping Control activities on behalf of the Agency.

65.4 (i) DCO credentials shall be valid for a maximum of two (2) years. DCOs should be subject to an
assessment (theoretical and/or practical) before being re-credentialed. Any DCO who has not participated in
any Doping Control activities within a year should be required to complete a re-training program.

65.4 (j) The Agency shall take steps to develop a system to monitor the performance of DCOs.

65.4 (k) The Agency shall maintain records of conflicts and training of all Sample Collection Personnel.

Arbitration Procedures (Not Submitted to FTC)


66 Applicability

66.1 These Arbitration Procedures for the Equine Anti-Doping and Medication Control Protocol (the “Adjudication
Procedures”) shall apply to adjudications arising out of the Equine Anti-Doping and Medication Control Protocol (the
“Protocol”). Terms used in the Adjudication Procedures that are defined terms from the Protocol are written in italics.

67 Delegation of Duties

67.1 Major Infractions arising out of the Protocol shall be administered by an independent arbitral body (the “Arbitral
Body”) in accordance with the Protocol and the Adjudication Procedures. The Arbitral Body is selected by mutual
agreement of the Authority and the Agency. Minor Infractions arising out of the Protocol shall be adjudicated by the
National Stewards Panel member assigned to the case in accordance with the Protocol and the Adjudication
Procedures. Notwithstanding the use of the terms “arbitrator” when referring to the impartial decision-maker in Major
Infractions cases and “steward” when referring to the impartial decision-maker in Minor Infractions cases, all cases
arising out the Protocol are intended to be arbitrations, subject to review as specified in the Protocol and the Act .
Therefore, both arbitrators and stewards are to be considered arbitrators or umpires within the meaning of the
Federal Arbitration Act, which applies arbitrations under the Protocol to the exclusion of any applicable state
arbitration and to the extent not inconsistent with the Protocol and the Act.

68 Pool of Arbitrators

68.1 The pool of arbitrators for Major Infractions arising out of the Protocol shall consist of no more than ten
members appointed by mutual agreement of the Authority and the Agency (the “Arbitrator Pool”).

68.2 The arbitrators in the Arbitrator Pool shall be appointed for four-year terms. Candidates to serve as an
arbitrator shall complete an application approved by the Authority and the Agency.

68.3 There shall be no absolute requirement that an arbitrator candidate be a member of any arbitral body or
association of arbitrators prior to appointment. Candidates shall not be or have been in the previous two years an
officer, director, trustee, employee, commission member, consultant or official or be in a policy making position for
any Equine Constituencies or the Agency. A candidate shall be required to submit to a background check before
appointment to the Arbitrator Pool. The Arbitral Body shall, if necessary, accept the candidate as a member on its
roll of arbitrators, if necessary, upon appointment to the Arbitrator Pool.

68.4 Candidates shall commit in writing to accept appointment to all cases to which they are selected except (i)
when they have been involved in the Provisional Hearing for the matter; (ii) for conflicts of interest; or (iii) for personal
hardship and shall agree to not decline appointment for personal hardship in more than two cases in any 12-month

Horseracing Integrity and Safety Authority


period.

68.5 In the event an arbitrator dies, resigns, becomes incapacitated during the arbitrator’s term, or is removed by
the Authority for an ethical breach or deficiencies in carrying out their duties, a new arbitrator shall be selected and
appointed for a full four-year term, following the procedures set forth above. Incapacity of an arbitrator is determined
solely by the Authority.

69 National Stewards Panel

69.1 The National Stewards Panel (the “Panel”) consists of impartial stewards or otherwise qualified individuals
(“stewards”) appointed by mutual agreement of the Authority and the Agency to hear Minor Infractions. The Authority
and the Agency may appoint as many individuals as necessary to resolve Minor Infractions in accordance with the
Adjudication Procedures.

69.2 Prospective stewards shall be required to submit to a background check before appointment and shall commit
in writing to accept appointment to all cases to which they are selected except: (i) when they have been involved in
the Provisional Hearing for the matter; (ii) for conflicts of interest; or (iii) for personal hardship and shall agree to not
decline appointment for personal hardship in more than two cases in any 12-month period. Stewards are appointed
for four-year terms and outside appointment to the Panel shall not have any business or economic interest with a
party in a case.

69.3 In the event a steward dies, resigns, becomes incapacitated during the steward’s term (legal incapacity is not
required), or commits an ethical breach, the Authority may remove the steward from the Panel. The Agency will
publish a list of members of the Panel on its website.

70 Training of Arbitrators and Stewards

70.1 All arbitrators in the Arbitrator Pool and stewards on the Panel shall receive at least two hours of continuing
education each year on issues related to proper and efficient handling of cases or the Protocol, Standards, Policies,
or Technical Documents. The education must be approved by the Authority. Failure to complete this required
continuing education is grounds for immediate dismissal by the Authority.

71 Initiation by USADA

71.1 Major Infractions: Arbitration proceedings shall be initiated with the Arbitral Body by the Agency after a hearing
is requested by the Covered Person(s) in response to being charged with a Major Infraction under the Protocol. If
both Major and Minor Infractions are charged against one or more Covered Persons, the procedures for Major
Infractions apply. The parties to the proceeding shall be the Agency and the Covered Person(s) charged with at
least one anti-doping or medication control rule violation(s) under the Protocol. The relevant Owner(s), provided they
are not charged with a violation under the Protocol, and the Authority shall be invited to join in the proceeding as an
observer. Subject to such limitations as may be imposed by the arbitrator, the hearing shall be open to the public via
an audio/video or audio only feed that will be provided for members of the public, but technical issues in providing
the feed shall not postpone or invalidate the hearing.

71.2 Minor Infractions: Proceedings shall be initiated with the appropriate Panel member by the Agency after the
Covered Person(s) requests review by a steward in response to being charged with a Minor Infraction under the
Protocol. The parties to the proceeding shall be the Agency and the Covered Person(s) charged with one or more
anti-doping or medication control rule violations under the Protocol. The relevant Owner(s), provided they are not
charged with a violation under the Protocol, and the Authority shall be invited to join in the proceeding as an
observer and, if accepted, receive copies of the filings in the case.

72 Changes of Claim

72.1 After the filing of a claim, if the Agency desires to make any new or different claim, it shall be made in writing
and filed with the other party or parties and the steward or arbitrator and Arbitral Body, as applicable. After the
arbitrator or steward is appointed, however, no new or different claim may be submitted except with the arbitrator's
or steward’s consent. The deadlines set forth in Article 82 and Article 83 will reset provided the Covered Person
requests review by a steward or arbitrator, as applicable, of the new or different claim.

73 Expedited Procedures

73.1 At the request of any party, any time period set forth in the Adjudication Procedures may be shortened by the
arbitrator or steward when doing so is reasonably necessary to resolve any Covered Person’s or Covered Horse’s
eligibility before a Covered Horserace, while continuing to protect the right of a Covered Person to a fair process.

73.2 The adjudication process shall be expedited according to the procedures in the Protocol and may be

Horseracing Integrity and Safety Authority


expedited in such other instances where expediting is in the interest of justice. Pursuant to Article 8.3, the Agency
may in its sole discretion shorten any deadlines within the Adjudication Procedures proportionately to ensure
resolution prior to a Covered Horserace.

73.3 If a request to expedite the adjudication process is made based on circumstances that are not addressed in
the Protocol and if the Agency does not agree to the process being expedited the arbitrator or steward shall
determine whether the adjudication process shall be expedited and the schedule pursuant to which the process shall
proceed.

74 Jurisdiction

74.1 An arbitrator or steward shall have the authority to rule on his or her own jurisdiction, including any objections
with respect to the existence, scope, or validity of the applicable rules.

74.2 The arbitrator or steward shall have the authority to determine the existence or validity of a contract of which an
arbitration clause forms a part. Such an arbitration clause shall be treated as an agreement independent of the other
terms of the contract. A decision by the arbitrator that the contract is null and void shall not for that reason alone
render invalid the arbitration clause.

74.3 A party must object to the jurisdiction of the arbitrator or steward or to the arbitrability of a claim by the Agency
no later than the filing of the answering statement to the claim that gives rise to the objection. The arbitrator or
steward may rule on such objections as a preliminary matter or as part of the final reasoned award.

75 Consolidation

75.1 Matters involving more than one Covered Person may, in the Agency’s discretion, be consolidated into a single
matter and if a Major Infraction is alleged by the Agency against any of the Covered Persons who are parties in the
consolidated matter, the process for Major Infractions will be followed.

76 Location of Hearing for Major Infractions

76.1 All hearings on Major Infractions shall take place by telephone or video conference unless the parties and the
arbitrator agree to an in-person hearing. Once the parties agree to an in-person hearing, consent to an in-person
hearing can only be withdrawn upon mutual agreement of the parties.

76.2 The situs of arbitrations and locations of in-person hearings (if agreed to by the parties) shall be in the United
States at locations determined by the arbitrator and set forth no later than in the first procedural order. The arbitrator
shall give preference to the choice of the Covered Person unless outweighed by the interests of justice.

76.3 In the event it may be necessary for enforcement of an arbitration subpoena(s) (separate from an investigative
subpoena under the Act ) that the arbitrator conduct a hearing at a particular location(s) and receive live testimony or
documents or other evidence, the arbitrator shall at the request of the party who is seeking enforcement of the
subpoena travel to that location to conduct the hearing regardless of whether the parties are participating in the
arbitration via telephone or video conference.

77 Qualifications of an Arbitrator

77.1 Any arbitrator or steward appointed pursuant to Article 78 shall be subject to Disqualification for the reasons
specified in Section 79.

78 Appointment of the Arbitrators and Stewards to Adjudicate Cases

78.1 An arbitrator shall be appointed in the following manner: Immediately after the initiation of a proceeding by the
Agency (as set forth in Article 71), the Arbitral Body shall appoint an arbitrator on a rotating basis from the Arbitrator
Pool, after confirming the arbitrator will not decline appointment due to personal hardship. The arbitrator who
handles the Provisional Hearing shall not serve as an arbitrator for the Covered Person’s arbitration concerning the
allegation that they have committed an anti-doping or medication control rule violation. The Arbitral Body shall
communicate to the parties within three calendar days of initiation by the Agency the name of the arbitrator
appointed to hear the matter.

78.2 A steward shall be appointed in the following manner: Immediately after the initiation of a proceeding by the
Agency (as set forth in Article 71), the Agency’s National Stewards Panel Coordinator shall contact a steward on a
rotating basis from the National Stewards Panel except that for violations occurring during a Race Period, a steward
should not be appointed in a particular case if they work for or previously worked for one or more years for the State
Racing Commissions in the state where the Covered Horserace relevant to the alleged violation occurred. The
steward’s written acceptance of the case from the Agency’s National Stewards Panel Coordinator constitutes

Horseracing Integrity and Safety Authority


appointment to that case. The steward shall communicate to the parties within three calendar days of initiation by the
Agency that the steward has accepted the case. The steward who handles the Provisional Hearing shall not serve
as the steward determining the merits of the allegation that the Covered Person committed an anti-doping or
medication control rule violation.

78.3 Once appointed, the arbitrator shall receive from the Arbitral Body a copy of or link to the charging letter,
Adjudication Procedures, the Protocol, and the Billing Standards. Once appointed, the steward shall receive this
same information from the Agency’s National Stewards Panel Coordinator.

79 Disclosure and Challenge Procedure

79.1 An appointed arbitrator or steward in a particular case shall disclose to the parties any circumstance likely to
affect impartiality, including any Bias or any financial or personal interest in the result of the case or any past or
present relationship with the parties or their representatives.

79.2 Upon objection of a party to the continued service of an arbitrator, the Arbitral Body shall determine whether the
arbitrator is evidently partial and the arbitrator should be Disqualified. The Arbitral Body shall inform the parties of its
decision, which shall be final and not subject to interlocutory appeal.

79.3 Upon objection of a party to the continued service of a steward, the steward shall determine whether the
steward is evidently partial and the steward should recuse themself from the case. The steward shall inform the
parties of their decision, which shall be final and not subject to interlocutory appeal.

80 Communication with Arbitrator or Steward

80.1 Once appointed, no party and no one acting on behalf of any party shall communicate unilaterally concerning
the case with an arbitrator or steward. All communications concerning the case shall include the other party or
parties and for cases before an arbitrator, a representative from the Arbitral Body.

81 Vacancies

81.1 If for any reason following assignment to the case an arbitrator becomes unable to perform their duties in a
particular case, the Arbitral Body may fill the vacancy on a rotating basis as described in these rules.

81.2 If for any reason following assignment to the case a steward becomes unable to perform their duties in a
particular case, the Agency’s National Stewards Panel Coordinator may contact a steward on a rotating basis from
the National Stewards Panel to fill the vacancy.

82 Procedures for Major Infractions

82.1 For matters involving at least one alleged Major Infraction arising from an Adverse Analytical Finding(Presence
and Use violations), each Covered Person’s pre-hearing submission must be filed with the arbitrator on or before
fourteen calendar days after submitting a request for a hearing, and the Agency’s pre-hearing submission must be
filed with the arbitrator on or before fourteen calendar days after the last Covered Person’s pre-hearing submission.
There shall be no reply pre-hearing submission, but each party may present rebuttal evidence at the hearing.

82.2 For matters involving at least one alleged Major Infraction and at least one alleged non-analytical violation (i.e.,
a violation other than Presence or Use), the Agency’s initial pre-hearing submission must be filed with the arbitrator
on or before fourteen calendar days after the last Covered Person requests a hearing or (only if a Covered Person
in the same matter has already requested a hearing) after the last Covered Person’s deadline passes with no
request for a hearing, whichever is later. Each Covered Person’s pre-hearing submission must be filed with the
arbitrator on or before fourteen calendar days after the Agency’s initial pre-hearing submission, and the Agency’s
reply pre-hearing submission must be filed with the arbitrator seven calendar days after the last Covered Person’s
pre-hearing submission.

82.3 A Covered Person’s pre-hearing submission shall include a brief not to exceed 30 double-spaced pages and
shall include all exhibits, schedules, expert reports, and all other evidence (except testimonial evidence, summaries,
and demonstrative aides) the Covered Person intends to rely upon at the hearing. The Covered Person’s pre-
hearing submission shall include a designation of witnesses providing the identity of witnesses (or name of
organization if an organization representative) expected to be called to testify at the hearing as well as a brief
summary of the expected testimony. For expert witnesses, the pre-hearing submission shall include a C.V. and
expert report, identifying all opinions to which they will testify and the facts and scientific methods upon which those
opinions are based as well as to identify all scientific treatises, studies, or articles on which the expert relies in
rendering their opinion(s), for each expert included in the witness designations.

82.4 The Agency’s initial pre-hearing submission shall include a brief not to exceed thirty double-spaced pages for
each Covered Person charged in the case and shall include all exhibits, schedules, expert reports, and all other

Horseracing Integrity and Safety Authority


evidence (except testimonial evidence, impeachment evidence, summaries, and demonstrative aides) the Agency
intends to rely upon at the hearing. The Agency’s initial pre-hearing submission shall include a designation of
witnesses providing the identity of witnesses (or name of organization if an organization representative) expected to
be called to testify at the hearing as well as a brief summary of the expected testimony. For expert witnesses, the
initial pre-hearing submission shall include a C.V. and expert report, identifying all opinions to which they will testify
and the facts and scientific methods upon which those opinions are based as well as to identify all scientific
treatises, studies, or articles on which the expert relies in rendering their opinion(s), for each expert included in the
witness designations. The Agency’s reply pre-hearing submission, when permitted under these Adjudication
Procedures, shall include all additional evidence upon which it intends to rely for rebuttal (except testimonial
evidence, impeachment evidence, summaries, and demonstrative aides) and a reply brief not to exceed fifteen
double-spaced pages for each Covered Person charged in the case.

82.5 Each party is responsible for updating its disclosures as such information becomes available. If a party should
have submitted evidence in their pre-hearing submission but did not, the arbitrator should not admit such evidence
absent good cause shown.

82.6 The hearing shall take place forty-two calendar days from the date the last Covered Person requested a
hearing in a particular case. If any of the dates described in Article 82 fall on a weekend or a federal holiday, the due
date is the next business day.

82.7 At the request of any party or at the discretion of the arbitrator or the Arbitral Body, the arbitrator may schedule
as soon as practicable a preliminary hearing with the parties and/or their representatives. The preliminary hearing
should be conducted by telephone or video conference at the arbitrator's discretion. During the preliminary hearing,
the parties and the arbitrator should discuss any preliminary matters to ensure compliance with the procedures
herein.

82.8 Upon showing of exceptional circumstances, the arbitrator may extend any of the deadlines set forth in Article
82 for the minimum time necessary to address the circumstance. If all parties agree to an alternative schedule in a
particular case, the arbitrator shall alter dates accordingly.

82.9 The arbitrator shall issue a reasoned award on or before fourteen calendar days after the close of the hearing.

83 Procedures for Minor Infractions

83.1 For matters involving alleged Minor Infractions arising from an Adverse Analytical Finding(Presence and Use
violations) and no alleged Major Infraction, each Covered Person’s submission must be filed with the arbitrator on or
before seven calendar days after submitting a request for review by a steward, and the Agency’s submission must
be filed with the arbitrator on or before seven calendar days after the last Covered Person’s submission. There shall
be no reply submission.

83.2 For matters involving at least one alleged non-analytical Minor Infraction (i.e., a violation other than Presence or
Use) and no alleged Major Infraction, the Agency’s initial submission must be filed with the arbitrator on or before
seven calendar days after the last Covered Person requests a review by a steward or (only if a Covered Person in
the same matter has already requested a review by a steward) after the last Covered Person’s deadline passes
with no request for review by a steward, whichever is later. Each Covered Person’s submission must be filed with
the arbitrator on or before seven calendar days after the Agency’s initial submission, and the Agency’s reply
submission must be filed with the arbitrator on or before seven days after the last Covered Person’s submission.

83.3 A Covered Person’s submission shall include a brief not to exceed 20 double-spaced pages and shall include
all exhibits, schedules, diagrams, charts, expert reports, affidavits, and all other evidence on which the Covered
Person relies. A C.V. and expert report, identifying all opinions to which they will testify and the facts and scientific
methods upon which those opinions are based as well as to identify all scientific treatises, studies, or articles on
which the expert relies in rendering their opinion(s), must be included for each expert relied upon by the Covered
Person.

83.4 The Agency’s initial submission shall include a brief not to exceed 20 double-spaced pages for each Covered
Person charged in the case and shall include all exhibits, schedules, summaries, diagrams, charts, expert reports,
affidavits, and all other evidence on which the Agency relies. A C.V and expert report, identifying all opinions to
which they will testify and the facts and scientific methods upon which those opinions are based as well as to identify
all scientific treatises, studies, or articles on which the expert relies in rendering their opinion(s), must be included for
each expert relied upon by the Agency. The Agency’s reply submission, when permitted under these Adjudication
Procedures, shall include all additional evidence upon which it intends to rely for rebuttal and a brief not to exceed
10 double-spaced pages for each Covered Person charged in the case.

83.5 If any of the dates described in Article 83 fall on a weekend or a federal holiday, the due date is the next
business day.

83.6 At the request of any party or at the discretion of the steward, the steward may, upon showing of exceptional
circumstances, extend any of the deadlines set forth in Article 83 for the minimum time necessary to address the
circumstance. If all parties agree to an alternative schedule in a particular case, the steward shall alter dates
accordingly.

Horseracing Integrity and Safety Authority


83.7 The steward shall render a decision based on the parties’ written submissions described above, not a hearing,
and shall issue a reasoned award on or before fourteen calendar days after the last written submission
contemplated in Article 83.

84 Exchange of Information

84.1 Information shall be exchanged electronically, unless otherwise agreed by the parties. The arbitrator and
steward are authorized to resolve any disputes concerning the exchange of information between the parties
consistent with the expedited nature of the proceedings.

85 Participation

85.1 The steward, arbitrator, and the Arbitral Body shall maintain the confidentiality of the proceedings unless in
cases before an arbitrator the hearing is open to the public as described in Article 71. An arbitrator’s or a steward’s
review may proceed without the participation of any party or representative who, after due notice, fails to be present
or make a submission. An award shall not be made solely on the default of a party. The arbitrator or steward shall
require the party who is present to submit such evidence as the arbitrator or steward may require for the making of
an award.

86 Representation

86.1 Any party may be represented by counsel. The representative shall provide a letter of representation notifying
the other party and the steward or Arbitral Body of their name, phone number, email, and address. When such a
representative requests a hearing by an arbitrator or review by a steward or responds for a party, notice is deemed
to have been given. Parties are bound by the statements made or positions taken by their representatives.

87 Oaths

87.1 Before proceeding with the first preliminary hearing, or a merits hearing if no preliminary hearing, each
arbitrator may take an oath of office and, if required by law, shall do so. An arbitrator may require witnesses to testify
under oath administered by any duly qualified person and, if it is required by law or requested by any party, shall do
so. Similarly, before issuing a reasoned award, each steward may take an oath of office and, if required by law, shall
do so.

88 Stenographic Record

88.1 Any party desiring a stenographic record of all or a portion of the hearing shall notify the other parties of the
request at least seven calendar days in advance of the start of the hearing or as required by the arbitrator. The
Agency shall identify the court reporter to be used for transcription services, and the transcript must be provided to
the arbitrator and made available to the other parties for inspection, at a date, time, and place determined by the
arbitrator with the costs of the transcription divided equally between the parties.

89 Interpreters

89.1 All proceedings shall take place in English. Any party wishing to have an interpreter present during
proceedings shall make all arrangements directly with the interpreter and shall assume the costs of the service.
Interpreters shall have no prior relationship with a party or have any interest in the proceeding and the arbitrator must
approve the interpreter. Any document which is not in English shall be officially translated by a certified translator
paid for by the party offering or relying upon the document.

90 Conduct of Hearings for Major Infractions

90.1 The Agency shall present evidence to support its claim. The Covered Person(s) charged with an anti-doping or
medication control rule violation shall then present evidence to support their defense. The Agency is then entitled to
present rebuttal evidence. Witnesses for each party shall also submit to questions from the arbitrator and the
adverse party. The arbitrator has the discretion to vary this procedure, provided that the parties are treated with
equality and that each party has the right to be heard and is given a fair opportunity to present its case.

90.2 The arbitrator shall have the power to require the sequestration of any witness, other than a party or other
essential person, during the testimony of any other witness. It shall be discretionary with the arbitrator to determine
the propriety of the attendance of any other person other than (i) a party and its representatives and (ii) those entities
identified in Article 71, which may attend the hearing as observers.

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90.3 The arbitrator, exercising his or her discretion, shall conduct the proceedings with a view to resolving the
dispute in accordance with Article 82 but may direct the order of proof, bifurcate proceedings, and direct the parties
to focus their presentations on issues the decision of which could dispose of all or part of the case.

90.4 The parties may agree to waive oral hearings in any case.

91 Evidence

91.1 The parties may offer such evidence as is relevant and material to the dispute and, unless limited by the
Protocol, Policies, Standards, or Technical Documents shall produce such evidence as the arbitrator may deem
necessary to make a determination in a case.

91.2 An arbitrator or steward may only retain an expert or seek independent evidence if agreed to by the parties and
(i) the parties agree to pay for the cost of such expert or independent evidence or (ii) the Authority agrees to pay for
the cost of such expert or independent evidence. The parties shall have the right to examine any expert retained by
the arbitrator and shall have the right to respond to any independent evidence obtained by the arbitrator.

91.3 An arbitrator or steward shall determine the admissibility, relevance, and materiality of the evidence offered,
including hearsay evidence, and may exclude evidence deemed cumulative or irrelevant. Conformity to legal rules of
evidence shall not be necessary but the federal rules of evidence may be used for guidance.

91.4 The arbitrator or steward shall apply relevant principles of legal privilege, including those involving the
confidentiality of communications between a lawyer and client and investigative privilege.

91.5 An arbitrator or steward may issue subpoenas for witnesses, documents, or other evidence upon the request of
any party, keeping in mind the expedited nature of the proceedings and the procedures set forth in 83 and 84. An
arbitrator or steward shall not issue a subpoena for a deposition as depositions, along with formal written discovery
in civil litigation, are not in keeping with the expedited nature of arbitration.

92 Inspection or Investigation

92.1 An arbitrator or steward finding it necessary to make an inspection or conduct additional investigation in
connection with a proceeding shall so advise the parties. The arbitrator or steward shall set the date and time that
shall not delay the procedures in Article 82 and 83 and shall notify the parties. Any party who so desires may be
present at such an inspection or investigation. In the event that one or all parties are not present at the inspection or
investigation, the arbitrator or steward shall make an oral or written report to the parties and afford them an
opportunity to comment.

93 Interim Measures

93.1 An arbitrator or steward may take whatever interim measures they deem necessary to provide a party an
immediate protection of rights.

94 Provisional Hearings

94.1 Hearings to resolve challenges to Provisional Suspensions shall be held in accordance with Article 7.4 (b).
With all hearings, an arbitrator or steward may admit any evidence deemed relevant and given the weight the
arbitrator or steward deems appropriate. For an avoidance of doubt, hearsay shall be admissible in a Provisional
Hearing. Arbitrator or steward decisions regarding Provisional Suspensions are not subject to an interlocutory
appeal.

95 Closing of Hearing for Major Infractions

95.1 The arbitrator shall declare the hearing closed at the conclusion of closing arguments unless a party
demonstrates that such additional proof or witness(es) are material to the controversy and good cause exists for not
providing the evidence with their pre-hearing submission. If the arbitrator agrees and the additional evidence is
allowed, the adverse party then shall have the opportunity to present rebuttal evidence. No post-hearing briefs are to
be filed. The hearing shall be declared closed as of the final date set by the arbitrator for the receipt of evidence or
receipt of the transcript. The time limit within which the arbitrator is required to issue the reasoned award shall
commence upon the closing of the hearing.

96 Reopening of Hearing for Major Infractions

96.1 To avoid manifest injustice, the hearing may be reopened on the arbitrator's initiative, or upon application of a
party, at any time before the award is made. If reopening the hearing would prevent the making of the award within

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the specific time required by Article 82, the matter may not be reopened unless the parties agree on an extension of
time.

97 Waiver of Rules

97.1 Any party who proceeds with the adjudication under these rules after knowledge that any provision or
requirement of these rules has not been complied with and who fails to state an objection in writing shall be deemed
to have waived the right to object.

98 Serving of Notice

98.1 Any papers, notices, or process necessary or proper for the initiation or continuation of a proceeding under
these rules, for any court action in connection therewith, or for the entry of judgment on any award made under these
rules may be accomplished in accordance with Article 7.1 (b) (8), including by serving a party by mail or electronic
mail addressed to the party or its representative at the last known address or by personal service in or outside the
state where the arbitration is to be held.

98.2 Unless otherwise instructed by the steward, Arbitral Body, or the arbitrator, any documents submitted by any
party to a steward, Arbitral Body, or arbitrator shall simultaneously be provided to the other party or parties to the
proceeding.

99 Form of Award

99.1 Any award shall be in writing and signed by the arbitrator or steward. In all cases, the arbitrator or steward shall
render a reasoned award.

100 Scope of Award

100.1 An arbitrator or steward may grant any remedy or relief authorized by the Protocol or the Act for the violation.

100.2 In addition to a final award, an arbitrator or steward may make other decisions, including interim, interlocutory,
or partial rulings, orders, and awards.

101 Award Upon Settlement

101.1 If the parties settle their dispute during the course of the proceeding, and if the parties so request, an
arbitrator or steward may set forth the terms of the settlement in a "consent award."

102 Delivery of Award to Parties

102.1 Parties shall accept as notice and delivery of the award the placing of the award or a true copy thereof in the
mail addressed to the parties or their representatives at the last known addresses, personal or electronic service of
the award, or the publishing of the award in accordance with the Protocol.

102.2 The award is public and shall not be considered confidential.

103 Modification of Award

103.1 Within seven days after the transmittal of an award, any party, upon notice to the other parties, may request
the steward or arbitrator, through the Arbitral Body, to correct any clerical, typographical, or computational errors in
the award. The arbitrator or steward is not empowered to redetermine the merits of any claim already decided. The
other parties shall be given five days to respond to the request. The arbitrator or steward shall dispose of the
request within five days after receipt of the request and any response thereto.

104 Release of Documents for Judicial Proceedings

104.1 The Arbitral Body and steward shall, upon the written request of a party, furnish to the party, at the party's
expense, certified copies of any papers in the Arbitral Body’s or steward’s possession that may be required in
judicial proceedings relating to the proceeding. If the matter is appealed to an administrative law judge, the Arbitral
Body and steward shall furnish copies of documents to the administrative law judge requested by the administrative
law judge in connection with that proceeding.

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105 Appeal Rights

105.1 The award may be appealed exclusively to an administrative law judge and subject to further review as
provided in the Protocol and the Act . Notwithstanding any provision set forth in these Adjudication Procedures,
nothing herein shall alter the standards of review on appeal set forth in the Protocol and the Act.

106 Applications to Court and Exclusion of Liability

106.1 Arbitration is intended to be the exclusive remedy in all cases arising under the Protocol subject to appeal as
described in the Protocol and the Act .

106.2 No civil action commenced by a party relating to the subject matter of the proceeding under the Adjudication
Procedures shall be deemed a waiver of any party's right to adjudicate their case under the Adjudication
Procedures.

106.3 Neither the Arbitral Body nor any arbitrator or steward in a proceeding under these rules is a necessary party
in judicial proceedings relating to that proceeding.

106.4 Parties to a proceeding under the Adjudication Procedures shall be deemed to have consented that judgment
upon an award that is not appealed may be entered in any federal or state court having jurisdiction, unless the party
seeks administration review pursuant to the Protocol and the Act.

106.5 Neither the Agency, the Arbitral Body nor any arbitrator or steward shall be liable to any party for any act or
omission in connection with any proceedings conducted under these rules.

107 Costs

107.1 The Arbitral Body shall prescribe filing and other administrative fees and service charges to compensate it for
the cost of providing administrative services. The fees in effect when the fee or charge is incurred shall be
applicable. The Arbitral Body’s filing fee and any other administrative fee or charge shall be split equally amongst
the parties, and the Agency’s portion shall be paid by the Authority.

107.2 The Arbitral Body shall split the costs of the proceeding before an arbitrator (including arbitrator fees and
expenses but excluding attorney, witness, and party expert fees) equally amongst the parties with the Agency’s
portion being paid by the Authority. The Arbitral Body, in its discretion, may require advanced costs be paid by the
parties to ensure payment is made.

107.3 A party’s failure to pay costs or advanced costs by the deadlines imposed by the Arbitral Body will, if not
rectified immediately, result in a waiver of claims or defense to claims as applicable and result in imposition and
publication of sanctions requested by the Agency.

107.4 The Authority shall be solely responsible for the administrative costs stemming from steward-resolved cases
as described in the Adjudication Procedures.

108 Expenses

108.1 The expenses of witnesses for any party shall be paid by the party producing such witnesses. Each party shall
bear their own attorneys’ fees and other expenses.

109 Arbitrator's Compensation

109.1 Arbitrators shall be compensated and reimbursed in a manner consistent with the Billing Standards.

109.2 If there is disagreement concerning the terms of compensation, the disagreement shall be resolved as
described in the Billing Standards.

109.3 Any arrangement for the compensation or reimbursement of an arbitrator shall be made through the Arbitral
Body and not directly between the parties and the arbitrator.

109.4 Arbitrator fees and steward fees shall be paid in accordance with 108.

110 Application of Rules

110.1 The Protocol, Standards, Policies, and Technical Documents shall be considered part of the agreement to
arbitrate and that in all instances the arbitrators and stewards are required to apply the arbitration agreement and
conform to its terms.

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Methodology for Determining Assessments (Not Submitted to FTC)
1010 Definitions

1010.1 Annual Covered Racing Starts means, for the following calendar year, the sum of: (i) fifty percent (50%) of
the number of Projected Starts; plus (ii) fifty percent (50%) of the number of Projected Purse Starts.

1010.2 Covered Horseraces is defined by 15 U.S.C. 3051(5).

1010.3 Projected Starts means the number of starters in covered horseraces in the previous twelve (12) months as
reported by Equibase, after taking into consideration alterations in the racing calendar of the relevant State(s) for the
following calendar year.

1010.4 Projected Purse Starts means: (i) the total amount of purses for covered horseraces as reported by
Equibase, after taking into consideration alterations in purses for the relevant State(s) for the following calendar
year; divided by (ii) the Projected Starts for the following calendar year.

1010.5 Racetrack is defined by 15 U.S.C. 3051(15).

1020 Annual Calculation of Amounts Required.

1020.1 If a State racing commission elects to remit fees pursuant to 15 U.S.C. 3052(f)(2), the State Racing
Commission shall notify the Authority in writing on or before May 2, 2022 of its decision to elect to remit fees.

1020.2 Not later than April 1, 2022 and not later than November 1 of each year thereafter, the Authority shall
determine and provide to each State Racing Commission the estimated amount required from each State pursuant
to the calculation set forth in Section 1020.3.

1020.3 Upon the approval of the budget for the following calendar year by the Board of the Authority, and after taking
into account other sources of Authority revenue, the Authority shall allocate the calculation due from each State
pursuant to 15 U.S.C. 3052(C)(i) proportionally by each State’s respective percentage of the Annual Covered
Racing Starts. Provided however, that no State’s allocation shall exceed ten percent (10%) of the total amount of
purses for covered horseraces as reported by Equibase in the State. All amounts in excess of the ten percent (10%)
maximum shall be allocated proportionally to all States that do not exceed the maximum, based on each State’s
respective percentage of the Annual Covered Racing Starts.

1020.4 Pursuant to 15 U.S.C. 3052(f)(2)(B), a State racing commission that elects to remit fees, shall remit fees on
a monthly basis and each payment shall equal 1/12 of the estimated annual amount required from the State for the
following year.

1020.5 If a State racing commission does not elect to remit fees pursuant to 15 U.S.C. 3052(f)(2):

1020.5 (a) The Authority shall on a monthly basis calculate and notify each Racetrack in the State of the
applicable fee per racing start for the next month based upon the following calculations:

1020.5 (a) (1) Calculate the amount due from the State as if the State had elected to remit fees pursuant
to 15 U.S.C. 3052(f)(2) (the “Annual Calculation”).

1020.5 (a) (2) Calculate the number of starters in covered horseraces in the previous twelve months as
reported by Equibase (the “Total Starts”).

1020.5 (a) (3) Calculate the number of starters in covered horseraces in the previous month as reported
by Equibase (the “Monthly Starts”).

1020.5 (a) (4) The applicable fee per racing start shall equal (i) the quotient of Monthly Starts divided by
Total Starts; (ii) multiplied by the Annual Calculation.

1020.5 (b) The Authority shall on a monthly basis calculate and notify each Racetrack in the jurisdiction of the
following calculations:

1020.5 (b) (1) Multiply the number of starters in covered horseraces in the previous month by the
applicable fee per racing start calculated pursuant to Section (1020.5)(a)(4).

1020.5 (b) (2) The calculation set forth in 15 U.S.C. 3052(f)(3)(A) shall be equal to the amount calculated
pursuant to Section (1020.5)(b)(1) (the “Assessment Calculation”).

Horseracing Integrity and Safety Authority


1020.5 (c) The Authority shall allocate the monthly Assessment Calculation proportionally based on each
Racetrack’s proportionate share in the total purses in covered horseraces in the State over the next month and
shall notify each Racetrack in the jurisdiction of the amount required from the Racetrack. Each Racetrack shall
pay its share of the Assessment Calculation to the Authority within thirty (30) days of the end of the monthly
period.

1020.5 (d) Not later than May 1, 2022 and not later than November 1 each year thereafter, each Racetrack in
the State shall submit to the Authority its proposal for the allocation of the Assessment Calculation among
covered persons involved with covered horseraces (the “Covered Persons Allocation”). On or before thirty (30)
days from the receipt of the Covered Persons Allocation from the Racetrack, the Authority shall determine
whether the Covered Persons Allocation has been allocated equitably in accordance with 15 U.S.C. 3052(f)(3)
(B) and if so, the Authority shall notify the Racetrack that the Covered Persons Allocation is approved. If a
Racetrack fails to submit its proposed Covered Person Allocation in accordance with the deadlines set forth in
this paragraph, or if the Authority has not approved the Covered Persons Allocation in accordance with this
paragraph, the Authority shall determine the Covered Persons Allocation for the Racetrack. Upon the approval
of or the determination by the Authority of the Covered Persons Allocation, the Racetrack shall collect the
Covered Person Allocation from the covered persons involved with covered horseraces.

1020.6 All notices required to be given to the Authority pursuant to the Act and these regulations shall be in writing
and shall be mailed to _________________________ and emailed to __________.

Submitted to FTC
2000 RACETRACK SAFETY PROGRAM.

2010 DEFINITIONS.

When used in the Rule 2000 Series:

Workout means an official timed running of a Covered Horse over a predetermined distance not
associated with a Race.

Veterinarian means a licensed veterinarian who provides veterinarian services to Covered Horses and
who, as a prerequisite to providing veterinarian services to Covered Horses, has registered with the
Authority.

Training Facility means a location that is not a Racetrack that operates primarily to house Covered
Horses and conduct Workouts.

Trainer means a Person engaged in the training of Covered Horses.

State Racing Commission means the regulatory body established or recognized by a state or the
federal government with authority to regulate, approve, or license Covered Persons and Covered
Horses.

Starting Gate Person means any individual licensed as an assistant starter or any individual who
handles Horses in the starting gate.

Shock Wave Therapy means extracorporeal shock wave therapy or radial pulse wave therapy.

Safety Officer means an individual designated as, and having the responsibilities of, a Safety Officer as
set forth in Rule 2136.

Safety Director means an individual designated as, and having the responsibilities of, a Safety Director
as set forth in Rule 2131.

ROAP means the Racing Officials Accreditation Program.

Responsible Person means the individual designated in the registration with the Authority as the
Responsible Person in accordance with the following:

(01) For a Covered Horse that has not yet performed its first Workout (or competed in a Race,
whichever is earlier), the Responsible Person shall be the Owner of the Covered Horse unless the
Horse is in training in another country.

(02) Once in training, the Responsible Person shall be the licensed Trainer for the Covered Horse.

Horseracing Integrity and Safety Authority


The licensed Trainer’s designation as the Responsible Person shall be filed with the Authority. The
Trainer designation must be kept current with the Authority. Designation transfers must be in
writing and on record with the Authority prior to the effective date of the transfer, except for claiming
Races in which transfers must be recorded the same day.

(03) If a Covered Horse ceases training for a period of time, the designation may be transferred to
the Owner prior to the effective date.

(04) If the Owner is an entity, the managing Owner shall be named.

Regulatory Veterinarian means a Veterinarian employed, contracted, or appointed by a State Racing


Commission, Racetrack, or the Agency, who in addition to other duties, is responsible for monitoring the
health and welfare of Covered Horses during Covered Horseraces.

Racetrack Safety and Welfare Committee means the committee established pursuant to Rule 2121.

Racetrack Safety Committee means the committee established pursuant to 15 USC 3052(c)(2).

Racetrack Safety Accreditation or Accreditation means the process for achieving, and the issuance of,
safety Accreditation to a Racetrack in accordance with the Rule 2100 Series.

Racetrack means an organization licensed by a State Racing Commission to conduct Covered


Horseraces.

Race Meet means the entire period granted by the State Racing Commission to a Racetrack for the
conduct of Covered Horseraces on the Racetrack’s premises.

Protocol means the Equine Anti-Doping and Medication Control Protocol set forth in the Rule 3000
Series.

Prohibited Substance means any substance, or class of substances, so described on the Prohibited
List.

Prohibited List means the Equine Prohibited List identifying the Prohibited Substances and Prohibited
Methods as set forth in the Rule 4000 Series.

Program Effective Date means July 1, 2022.

Person means a natural person or an organization or other entity.

Owner means a Person or entity who holds an ownership or property interest in one or more Covered
Horses.

Out-of-Competition means any period which is not during race day.

Medical Director means an individual designated as Medical Director in accordance with the provisions
of Rule 2132.

Lead Veterinarian means any Veterinarian appointed pursuant to Rule 2134(b).

Jockey means a rider of a Covered Horse in a Covered Horserace.

Groom means a Covered Person who is not an Owner, Veterinarian, Trainer, or assistant Trainer but is
involved in the care of a Covered Horse.

Covered Persons means all Trainers, Owners, breeders, Jockeys, Racetracks, Veterinarians, and
Persons licensed by a State Racing Commission, and the agents, assigns, and employees of such
persons and other Horse support personnel who are engaged in the care, training, or racing of Covered
Horses.

Covered Horserace or Race means any horserace involving Covered Horses that has a substantial
relation to interstate commerce, including any Thoroughbred horserace that is the subject of interstate
off-track or advance deposit wagers.

Unless the context otherwise requires, Horse and Covered Horse shall have correlative meanings for
purposes of this Rule 2000 Series.

Covered Horse means any thoroughbred horse, or any other horse made subject to the Act by election
of the applicable State Racing Commission or the breed governing organization for such horse,
beginning on the earlier of:

Horseracing Integrity and Safety Authority


(01) the date of the Horse’s first timed and reported workout at a Racetrack;

(02) the date of the Horse’s first timed and reported workout at a Training Facility;

(03) the date of the Horse’s entry in a Covered Horserace; or

(04) the date of the Horse’s nomination for a Covered Horserace, and ending on the date on which
the Agency receives written notice that the Horse has been retired in accordance with the Protocol.

Concussion means an injury to the brain that results in temporary loss of normal brain function.

Claiming Race means a Race in which a Horse after leaving the starting gate may be claimed in
accordance with the rules and regulations of the applicable State Racing Commission.

Claim means, in the context of a Claiming Race, the purchase of a Covered Horse for a designated
amount.

Bled means that blood from one or both nostrils of a Horse has been observed after exercise.

Authority means the Horseracing Integrity and Safety Authority.

Attending Veterinarian means a Veterinarian hired by the Trainer or Owner.

Association Veterinarian means a Veterinarian employed by a Racetrack.

Act means the Horseracing Integrity and Safety Act of 2020.

2100 RACETRACK ACCREDITATION.

2101 GENERAL.

(a) The Racetrack Safety Committee and the Authority shall oversee Racetrack Safety Accreditation in
accordance with provisions of this Rule 2100 Series. The Racetrack Safety Committee may also adopt
best practices and guidance in accordance with the Act and the rules and regulations promulgated
thereunder to provide further guidance to the Racetracks in the Accreditation Process.

(b) All Racetracks are required to seek and meet the requirements of Racetrack Safety Accreditation
with the Racetrack Safety Committee in accordance with the provisions of this Rule 2100 Series.

2110 ACCREDITATION PROCESS.

2111 INTERIM AND PROVISIONAL ACCREDITATION.

(a) Interim Accreditation.

(01) A Racetrack that is accredited by the National Thoroughbred Racing Association as of


the Program Effective Date shall be granted interim Racetrack Safety Accreditation, which
shall be effective until the later of:

(i) such time as the Racetrack Safety Committee completes an Accreditation


assessment under Rule 2112 with respect to such Racetrack; or

(ii) the time period established by the Authority under Rule 2114(a).

(b) Provisional Accreditation.

(01) A Racetrack that is not accredited by the National Thoroughbred Racing Association as
of the Program Effective Date shall be granted provisional Racetrack Safety Accreditation,
which shall be effective until the later of:

Horseracing Integrity and Safety Authority


(i) such time as the Racetrack Safety Committee completes an Accreditation
assessment under Rule 2112 with respect to such Racetrack; or

(ii) the time period established by the Authority under Rule 2114(b).

(02) The Authority may at any time upon reasonable notice require a Racetrack with
provisional Racetrack Safety Accreditation to report on its progress in achieving
Accreditation. The Authority may request any additional information from the Racetrack
necessary to make its determination and may conduct unannounced on-site inspections at
any time.

2112 ACCREDITATION ASSESSMENT.

(a) Upon the initiation of an Accreditation assessment by the Racetrack Safety Committee, the
subject Racetrack shall submit or provide access to any relevant information and documentation
requested by the Racetrack Safety Committee. The Racetrack Safety Committee may request any
additional information and documentation required for the assessment and may propound
additional written questions or inquiries to the Racetrack. The Racetrack shall respond in writing to
all additional questions and inquiries within sixty (60) days of receipt of any additional questions
and inquires.

(b) After review of all information submitted by the Racetrack under paragraph (a), the Racetrack
Safety Committee shall conduct an on-site inspection of the Racetrack. The Racetrack Safety
Committee shall then prepare a post-inspection report identifying any aspects of the Racetrack’s
operations that are not in compliance with the requirements of this Rule 2100 Series.

(c) Within sixty (60) days of the Racetrack’s receipt of the post-inspection report under paragraph
(b), the Racetrack shall respond in writing to the Racetrack Safety Committee setting forth all
actions to be taken by the Racetrack to remedy the areas of non-compliance identified in the post-
inspection report, and the timeframes necessary for implementation of such remedial actions.

(d) The Racetrack Safety Committee shall assess the Racetrack’s response and make a written
recommendation to the Authority whether to issue or deny Accreditation or provisional
Accreditation of the Racetrack.

2113 ISSUANCE OF ACCREDITATION.

(a) The Authority shall determine whether a Racetrack is entitled to Accreditation by evaluating
compliance with the requirements set forth in this Rule 2100 Series.

(b) In determining whether to grant, renew or deny Accreditation to a Racetrack, the Authority shall
review all information submitted by the Racetrack and the Racing Safety Committee’s
recommendation.

2114 EFFECTIVE PERIODS OF ACCREDITATION.

(a) Accreditation.

(01) Accreditation shall be effective for a period of three (3) years.

(02) The Authority may modify the Accreditation period to a period of one (1) to seven (7)
years if the Authority determines that such modified period will be consistent with the
requirements of Accreditation outlined in this Rule 2100 Series.

(b) Provisional Accreditation.

(01) Provisional Accreditation shall be effective for an initial period of one (1) year.

(02) Upon the expiration of the initial one (1) year period referenced in paragraph (1) above,

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provisional Accreditation may be extended for additional one (1) year periods if the Authority
determines that the subject Racetrack is continuing to undertake good faith efforts to comply
with the requirements of this Rule 2100 series and achieve Accreditation.

2115 ANNUAL REPORTING.

All Racetracks granted Accreditation under these Rules shall participate in ongoing reporting and
review to the Racetrack Safety Committee. All accredited Racetracks shall, by December 31st of
each calendar year, submit satisfactory annual reports to the Racetrack Safety Committee
demonstrating compliance with all Accreditation requirements.

2116 SUSPENSION AND REVOCATION OF ACCREDITATION.

(a) An accredited Racetrack that is in material noncompliance with the Accreditation requirements,
after having received notice of the noncompliance and been given a reasonable opportunity to
remedy the noncompliance, may have its Accreditation suspended by the Authority.

(b) A provisionally accredited Racetrack that is in material noncompliance with the provisional
Accreditation requirements, after having received notice of the noncompliance and been given a
reasonable opportunity to remedy the noncompliance, may have its provisional Accreditation
suspended by the Authority.

(c) A Racetrack under suspension shall not conduct any Covered Horserace.

(d) A suspended Racetrack that fails to remedy the noncompliance in a reasonable time may have
its Accreditation or provisional Accreditation revoked by the Authority.

2120 ACCREDITATION REQUIREMENTS.

2121 RACETRACK SAFETY AND WELFARE COMMITTEE.

(a) General. The Racetracks in each state shall form a Racetrack Safety and Welfare Committee
to review the circumstances around fatalities, injuries, and racetrack safety issues with the goal of
identifying possible contributing risk factors that can be mitigated.

(b) Composition. The composition of the Racetrack Safety and Welfare Committee may vary
among jurisdictions, provided that each Racetrack Safety and Welfare Committee shall include, at
a minimum, the following:

(01) Regulatory Veterinarian;

(02) Association Veterinarian;

(03) Medical Director;

(04) Safety Officer or steward, subject to the applicable State Racing Commission electing
to enter into an agreement with the Authority if such individual is employed by the State
Racing Commission;

(05) Horsemen’s representative;

(06) Jockey;

(07) Trainer;

(08) racing secretary, and

(09) racetrack superintendent.

(c) The Regulatory Veterinarian shall chair the Racetrack Safety and Welfare Committee.

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(d) If the Safety Director is not a committee member, the Safety Director shall be an ad hoc
member of the Racetrack Safety and Welfare Committee.

(e) Responsibilities. The Racetrack Safety and Welfare Committee shall be responsible for:

(01) Review of all equine catastrophic injuries and the circumstances surrounding those
injuries, including, at a minimum:

(i) interviews with Trainers, Jockeys, exercise riders, and Attending Veterinarians, and
when appropriate, a qualified human health provider;

(ii) examination of past performances, Workouts, pre-race inspection findings,


necropsy examination findings, and Trainer and Veterinary treatment records;

(iii) review of Race or training video footage, if applicable;

(iv) review of racetrack surface conditions and weather information;

(v) convening a meeting with connections of the Covered Horse and other interested
Persons, including, at a minimum, the Regulatory Veterinarian, Trainer, and Attending
Veterinarian, and if applicable, the Jockey, exercise rider, and racetrack
superintendent to:

(A) convey the findings of the review;

(B) acquire additional information useful for developing strategies for injury
prevention; and

(C) provide continuing education or continuing education recommendations


related to cause of equine injury, if available, to persons related to the applicable
Covered Horse.

(vi) evaluation of factors that may have contributed to injuries;

(vii) evaluation of the effectiveness of protocols and procedures for managing the
equine injury scenario; and

(viii) developing strategies to mitigate identified factors that may have contributed to
the injury.

(02) Review of all environmental factors related to racing and training that may have
contributed to human injury occurrences including:

(i) evaluation of external factors that may have contributed to injuries;

(ii) development of strategies to mitigate identified factors that may have contributed to
the injury;

(iii) evaluation of the effectiveness of protocols and procedures for managing human
injury occurrences;

(03) Consideration of Racetrack safety issues brought to the Racetrack Safety and Welfare
Committee’s attention;

(04) Summary review of all injuries and considerations to review existing practices,

(05) Development of strategies to reduce or mitigate injury occurrences,

(06) Enhancement of the identification of Horses or conditions for which intervention is


warranted; and

(07) Enhancement of racetrack safety for equine and human participants.

(08) Preparation and submission of a report that summarizes the findings of the Racetrack
Safety and Welfare Committee under this paragraph (c) to the Authority within sixty (60) days

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of the end of the applicable Race Meet, unless the Racetrack Safety Committee requires
earlier submission.

2130 REQUIRED SAFETY PERSONNEL.

2131 SAFETY DIRECTOR.

(a) The Safety Director shall oversee equine safety, racetrack safety, and risk management and
injury prevention at each Racetrack in accordance with the provisions of this Rule. The Safety
Director may at the same time serve in the applicable jurisdiction as a Regulatory Veterinarian or
Safety Officer. Subject to the approval of the Racetrack Safety Committee, the Safety Director may
be shared within and among jurisdictions.

(b) If the applicable State Racing Commission does not enter into an agreement with the Authority,
then the Racetracks in such jurisdiction shall implement the requirements set forth in this Rule,
subject to the Racetrack Safety Committee’s approval of the individual named as Safety Director.

(c) The Safety Director shall be responsible for:

(01) Creating a culture of safety for Horses, riders, and Racetrack personnel;

(02) Overseeing all aspects of equine safety, racetrack safety, and safety of personnel
working with Horses by ensuring that all activities and practices involving the training and
racing of Horses at the track meet required safety standards;

(03) Implementing a risk management and injury prevention program under the oversight of
the Racetrack Safety Committee;

(04) Providing guidance to Attending Veterinarians on safety issues;

(05) Maintaining and annually reviewing standard operating procedures and protocols;

(06) Coordinating and overseeing emergency drills that include equine injury and starting
gate malfunction;

(07) Reporting all equine injuries and fatalities to the Authority within seventy-two (72) hours
of injury; and

(08) Interacting with the Authority concerning Racetrack Safety Accreditation compliance.

2132 MEDICAL DIRECTOR.

(a) The Medical Director shall oversee the care and organization of the medical needs of Jockeys.
The Medical Director shall be either a licensed physician or a board-certified athletic trainer.
Subject to the approval of the Racetrack Safety Committee, the Medical Director may be shared
within and among jurisdictions.

(b) In any jurisdiction where the applicable State Racing Commission does not elect to enter into
an agreement with the Authority to establish a Medical Director consistent with this Rule, the
Authority shall appoint and employ a Medical Director to serve as Medical Director in that
jurisdiction. The Racetracks in the applicable jurisdiction shall reimburse the Authority for all costs
associated with the employment of the Medical Director. Such reimbursement shall be shared by
the Racetracks in such jurisdiction proportionally by total handle wagered in the applicable state in
the prior calendar year.

(c) The Medical Director shall:

(01) Identify professional medical providers and referral networks that are licensed and
certified to oversee racetrack emergency services, which may include, hospital affiliations,
nursing staff, EMT service and paramedics, internists, surgeons, family practitioners,
dentists, athletic trainers, or psychiatrists;

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(02) Make medical provider contact information readily available for ease of communication
and immediate coordination of care for any medical event;

(03) Report all human injuries to the Authority within seventy-two (72) hours of injury;

(04) Coordinate and oversee a plan for on-site medical care, including provisions for
emergency medical facilities and staffing;

(05) Implement an emergency drill for a rider injury;

(06) Coordinate and oversee a comprehensive plan for transportation of an injured rider to
the nearest Trauma Level One or Two facility;

(07) Coordinate and oversee a plan for transportation of an injured rider to the Racetrack’s
first aid facility;

(08) Ensure compliance with mandatory annual rider physical examination requirements to
indicate readiness to ride for Jockeys, and document compliance to the Authority;

(09) Exercise oversight of medical standards, including the minimum criteria for riding
fitness;

(10) Certify a rider’s fitness to resume riding after any on-track incident that may impair the
rider’s reflexes, decision-making or ability to maintain control of his or her Horse in a race;

(11) Implement the program for Concussion evaluation, rider exclusion and clearance, and
return to ride protocol;

(12) Develop in writing, subject to annual review and revision as necessary, the Racetrack’s
Emergency Action Plan, which shall include readiness for medical needs of racing
participants, workers, and spectators; and

(13) Work with local, state, and federal regulators to standardize the approach and response
to pandemic-related issues among riders, workers, and spectators.

2133 STEWARDS.

(a) In states where the applicable State Racing Commission elects to enter into an agreement with
the Authority, the stewards, in addition to their duties under state law, shall enforce the safety
regulations set forth in the Rule 2200 Series.

(b) To qualify for appointment as a steward, the appointee shall meet the experience, education,
and examination requirements necessary to be accredited by the ROAP and be in good standing
with all racing jurisdictions.

(c) The requirements of this Rule for any steward employed by a State Racing Commission are
subject to the applicable State Racing Commission electing to enter into an agreement with the
Authority. If the applicable State Racing Commission does not enter into such an agreement, the
Racetracks in the jurisdiction shall implement the requirements set forth in this Rule, subject to the
Racetrack Safety Committee’s approval of the individuals named as stewards by the Racetracks.
The stewards named by the Racetracks shall enforce only the safety regulations set forth in the
Rule 2200 Series.

2134 REGULATORY VETERINARIAN.

(a) The Regulatory Veterinarian shall:

(01) Subject to the provisions of paragraph (b) below, be employed by the State Racing
Commission or similar agency having jurisdictional authority;

(02) be licensed to practice in the applicable jurisdiction;

(03) refuse employment or payment, directly or indirectly, from any Owner or Trainer of a
Horse racing or intending to race in the jurisdiction while employed as a Regulatory
Veterinarian;

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(04) refrain from directly treating or prescribing for any Horse within the applicable
jurisdiction except in cases of emergency, accident, or injury; and

(05) Regulatory Veterinarians must be trained, and their proficiency verified, in identifying
and stabilizing common musculoskeletal injuries.

(b) In any jurisdiction where the applicable State Racing Commission does not elect to enter into
an agreement with the Authority to establish a Regulatory Veterinarian consistent with this Rule, the
Authority shall employ a Veterinarian to serve as the Lead Veterinarian in such jurisdiction. The
Lead Veterinarian shall perform all of the duties, obligations and responsibilities of the Regulatory
Veterinarian in these regulations. The Racetracks in the applicable jurisdiction shall reimburse the
Authority for all costs associated with the employment of the Lead Veterinarian. The
reimbursement shall be shared by the Racetracks in the jurisdiction proportionally by total handle
wagered in the applicable state in the prior calendar year.

2135 RESPONSIBILITIES AND DUTIES OF REGULATORY VETERINARIAN.

(a) The Regulatory Veterinarian shall have the following responsibilities and duties:

(01) notify the stewards of any Horse deemed unsafe to be raced, or a Horse that it would be
inhumane to allow to race;

(02) conduct pre-race inspections on all potential starters on race day;

(03) inspect any Horse when there is a question as to the physical condition of such Horse
independent of the Horse’s entry status;

(04) be present in the paddock during saddling, on the racetrack during the post parade, and
present at the starting gate until the Horses are dispatched from the starting gate for the
Race;

(05) scratch any Horse that is, in the opinion of the Regulatory Veterinarian, injured, ill, or
otherwise unable to compete due to a medical or health-related condition;

(06) inspect any Horse which appears to be in physical distress during the Race or at the
finish of the Race;

(07) provide emergency medical care to Horses injured while racing and effect case transfer
to the Attending Veterinarian;

(08) be authorized to euthanize, consistent with the current version of the AVMA Guidelines
for the Euthanasia of Animals, any Horse deemed to be so seriously injured that it is in the
best interests of the Horse to so act;

(09) report to the Safety Director the names of all Horses euthanized or which otherwise die
at the meeting and the reasons therefor;

(10) maintain the Veterinarians’ List of Horses ineligible to race and notify the stewards of
the identities of all Horses placed on the Veterinarians’ List; and

(11) collaborate with the Safety Director, Chief Veterinarian of the State Department of
Agriculture, and other regulatory agencies to take measures to control communicable or
reportable equine diseases.

(b) If the Regulatory Veterinarian and his or her staff are unable to fulfill any of the duties described
in paragraph (a) of this Rule, such duties may, at the request of the Regulatory Veterinarian, be
performed by an Association Veterinarian. In such case, the Association Veterinarian shall be
responsible for adhering to and upholding the rules and regulations of the Authority and the State
Racing Commission.

(c) The Regulatory Veterinarian, and any Association Veterinarian exercising duties of the
Regulatory Veterinarian as provided in paragraph (b) above, are authorized to:

(01) access any and all Horses housed on Racetrack grounds regardless of entry status;

(02) perform inspections of any Horse at any time;

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(03) observe Horses during training activities and Workouts;

(04) perform pre-Race veterinary inspections and post-Race observations; and

(05) Place a Horse on the Veterinarians’ List.

(d) The Regulatory Veterinarian shall have jurisdiction over the Attending Veterinarians within the
grounds of the Racetrack and shall review and consult with the stewards, and State Racing
Commission regarding the State Racing Commission license applications of Attending
Veterinarians, veterinary technicians or assistants, vendors of medical supplies and equipment,
and non-Veterinarian health care providers. The authority and responsibilities of the Regulatory
Veterinarian under this paragraph (d) shall not be performed by an Association Veterinarian
pursuant to paragraph (b) of this Rule.

2136 RACETRACK SAFETY OFFICER.

(a) Each Racetrack shall have a Safety Officer to ensure that all activities and practices involving
the training and racing of Horses at the Racetrack meet required safety standards and regulatory
guidelines. The Safety Officer may also be a steward.

(b) The Safety Officer shall:

(01) Monitor daily stable area activities and practices in the barn area and on the racetrack
for compliance with the applicable State Racing Commission safety regulations and the
Rules of the Authority;

(02) Conduct pre-Race Meet racetrack safety inspections;

(03) Monitor outrider compliance with Racetrack rules during morning workouts;

(04) Monitor starting gate procedures;

(05) Monitor ambulance and medical personnel protocols for Horses and riders;

(06) Assist Regulatory Veterinarians with follow-up on Horses barred from training or vanned
off during training and racing;

(07) Review ship-in and ship-out lists and undertake appropriate investigations;

(08) Conduct random license checks in the stable area;

(09) Conduct random barn inspections to monitor safety and regulatory compliance,
including fire safety regulations;

(10) Conduct random inspections to verify acceptable management, equine husbandry, and
veterinary practices;

(11) Advise stewards of all planned and random inspections;

(12) Enforce fire safety rules in the stable area;

(13) Serve as a member or ad hoc member of the Racetrack Safety and Welfare
Committee; and

(14) Make recommendations to Racetrack management and racing officials to ensure the
welfare of Horses and riders, the integrity of racing, and compliance with applicable horse
racing laws and regulations.

2140 RACEHORSE INSPECTIONS AND MONITORING.

2141 VETERINARY INSPECTIONS.

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(a) Veterinary inspections shall be performed by the Regulatory Veterinarians on all Horses
entered in a Race. Such inspections shall include the items listed in Rule 2142.

(b) If, prior to starting a Race, a Horse is determined to be unfit for competition, or if the Regulatory
Veterinarian is unable to make a determination of racing soundness, the Regulatory Veterinarian
shall notify the stewards that the Horse is scratched. Regulatory Veterinarians shall have the
unconditional authority to scratch a Covered Horse from a Race.

2142 ASSESSMENT OF RACING SOUNDNESS.

(a) Post-entry screening. The Regulatory Veterinarian shall perform post-entry screenings of
previous pre-Race inspection findings of entered Horses to identify Horses that may be at
increased risk for injury. The Regulatory Veterinarian shall review past performances, lay-ups
(more than sixty (60) days without a timed Workout or Race), last thirty (30) days medical history,
previous injury and lameness diagnostics, intra-articular corticosteroid injections, previous surgery,
and individual Horse risk factors.

(b) Pre-race veterinary inspection. Every Horse entered to participate in a Covered Horserace
shall be subjected to inspection by a Regulatory Veterinarian prior to starting in the Race for which
it is entered on race day not later than one (1) hour prior to scratch time for the Race in which the
Horse is to compete.

(01) The Trainer of each Horse or a representative of the Trainer who is knowledgeable
about the Horse and able to communicate with the Regulatory Veterinarian must present the
Horse for inspection. Horses presented for inspection must have bandages removed, and
the legs must be clean and dry. Prior to inspection, Horses may not be placed in ice and no
device or substance shall be applied to the Horse that impedes veterinary clinical
assessment.

(02) The Regulatory Veterinarian’s inspection of each Horse prior to participating in a Race
shall include, at a minimum, the following:

(i) Identification of the Horse.

(ii) Ascertainment of the sex of the Horse.

(iii) Performance of an overall inspection of the entire Horse, assessing general


appearance, behavior, disposition, posture, and body condition.

(iv) Observation of the Horse jogging in hand, moving towards and away from the
Veterinarian so that both hind-end and front-end motion can be evaluated.

(v) Performance of a digital palpation on both distal forelimbs.

(vi) Placement of the Horse on the Veterinarian’s List if the Horse does not jog sound
or warm up to the Regulatory Veterinarian’s satisfaction

(vii) Visual observation in the paddock and saddling area, during the parade to post,
and at the starting gate.

(viii) Any other inspection deemed necessary by the Regulatory Veterinarian, including
Jockey consultation for the Jockey’s mount.

(03) A report summarizing the results of a pre-Race inspection under this paragraph (a) shall
be submitted to the Authority on the day of the inspection.

(c) Post-race assessment. Post-Race visual observations shall be performed by a Regulatory


Veterinarian on all Horses leaving the racetrack at the conclusion of every Race.

(01) If a Horse is determined to have Bled or to be physically distressed, medically


compromised, injured, or unsound at any time before exiting the racetrack or leaving the test
barn, the Horse shall be placed on the Veterinarians’ List and the Regulatory Veterinarian
shall document post-race inspection findings to the Authority.

(02) If a Horse is determined to have skin lacerations, swellings, or welts that resulted from

Horseracing Integrity and Safety Authority


crop use, the stewards and Attending Veterinarian shall be notified, and the information
documented to the Authority.

(d) Training. Regulatory Veterinarians may observe Horses during training activities. Horses
deemed physically distressed, medically compromised, injured, or unsound may be placed on the
Veterinarians’ List and reported to the Authority.

2143 RACEHORSE MONITORING.

(a) All Horses, including stable ponies, entering the Racetrack grounds must have proof of health
certificate and required vaccinations, which shall include:

(01) Certificate of veterinary inspection within the prior five (5) days or fewer days if high risk
situations dictate;

(02) Verification of EEE/WEE/WNV (encephalitides), rabies, and tetanus vaccinations within


the prior twelve (12) months;

(03) Verification of Influenza and Rhinopneumonitis vaccinations within the prior 180 days or
fewer days if high risk situations dictate; and

(04) Verification of Negative Equine Infectious Anemia (Coggins) Test within the calendar
year or in a shorter period of time if high risk situations dictate.

(b) Each Racetrack shall submit the following information to the Authority with respect to each
Horse on its grounds:

(01) Horse identification;

(02) Origin of Horse;

(03) Date of entry;

(04) Verification of certificate of veterinary inspection; and

(05) Verification of vaccinations.

(c) Each Racetrack shall submit the following information to the Authority with respect to each
Horse leaving its grounds:

(01) Horse identification;

(02) Intended destination;

(03) Reason for departure;

(04) Date of exit;

(05) Vehicle license plate; and

(06) Transporter.

(d) Horses moving interstate must meet the entry requirements of the destination state, the State
Racing Commission in the destination state, and the individual Racetracks or Training Facilities to
which the horse is being shipped in the destination state.

2150 RACETRACK AND RACING SURFACE MONITORING AND MAINTENANCE.

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2151 DATA COLLECTION, RECORDKEEPING AND SUBMISSION.

(a) Racetracks shall have data collection protocols in place to assist in the proper and consistent
maintenance of all racing and training surfaces. Racing and training surface testing and
maintenance should be performed based on the Racetrack’s written standard operating
procedures which are reviewed annually and updated as needed. The Racetrack Safety
Committee, or its designees, shall develop and annually update a Racetrack Surface Standard
Practices Document.

(b) All Racetrack design records, racing and training surface maintenance records, surface
material tests, and daily tests data shall be recorded in a format acceptable to the Authority and
shall be submitted to the Authority. Any test results shall be submitted to the Authority within one (1)
week of the test results.

2152 TESTING METHODS.

(a) Surface test methods and surface material test methods must be documented and consistent
with testing standards from internationally recognized standards organizations including ASTM
International, American Society of Agricultural and Biological Engineers or other relevant
international standards, and when possible for unpublished standards, methods consistent with
those documented by the Racing Surfaces Testing Laboratory.

2153 RACETRACK FACILITIES.

The Racetrack facilities must be designed, constructed and maintained as provided in this Rule to
provide for the safety of Covered Persons and Covered Horses.

(a) Rails.

(01) Racetracks shall have inside, outside, and gap rails designed, constructed, and
maintained to provide for the safety of Jockeys and Horses.

(02) Objects within 10 feet of the inside rail shall be flexible enough to collapse upon impact
of a Horse or rider, or sufficiently padded as to prevent injury.

(03) Rails shall be inspected prior to each Race Meet and daily during training and racing
events.

(b) Gaps.

(01) All gaps must be clearly marked, must have protective padding covering any sharp
edges or unique angles, and have proper mechanisms to allow for secure closure when
needed.

(02) Main gaps and on-gaps should include signage with safety rules, Racetrack hours and
other applicable rules.

(03) For Races breaking from a chute there should be sufficient temporary rail extension to
prevent Horses from ducking in or out.

(c) Starting gate.

(01) All gates, and the vehicle that moves the gates, must be inspected pre-Race Meet and
documented to be in proper working condition.

(02) All gates must have protective padding to ensure the safety of the Horse, Jockey, and
gate personnel. Protective padding shall protect the riders and gate personnel from contact
with sharp edges and help to distribute impact loads. All padding shall be designed to
ensure durability for outdoor use and shall be capable of maintaining safety and physical
integrity during all weather conditions.

(03) Gates and the vehicle that moves the gates shall be inspected and tested each race day
before the Races and each morning before schooling to ensure proper functioning.

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(04) No personnel, other than those required for steering the gate, shall ride on the gate while
the gate is in motion or being transported.

(05) Racetracks shall have in place annually reviewed and documented standard operating
procedures for the removal of the starting gate after the start of each Race as needed in a
safe and timely manner. This plan shall also include procedures for gate removal if the
primary removal mechanism fails.

(06) Every Starting Gate Person shall wear protective gear when working on or around the
starting gate, including approved helmets and safety vests.

(07) If the starting gate becomes inoperable during racing hours, racing may not continue
until the starting gate is brought back to safe operating standards or the inoperable gate is
replaced with a properly functioning alternate gate.

(08) During racing hours, a Racetrack should ensure that sufficient assistant starters are
available to safely handle each Horse entered in a Race.

(09) A Racetrack shall make at least one starting gate and one Starting Gate Person
available for racehorse schooling during designated gate training hours.

(d) Emergency warning system.

(01) Each Racetrack shall have an operational emergency warning system on all racing and
training tracks. The emergency warning system shall be approved by the State Racing
Commission, subject to the applicable State Racing Commission electing to enter into an
agreement with the Authority. If such agreement does not exist, the emergency warning
system shall be approved by the Authority.

(02) The emergency warning system shall be tested bi-weekly before training or racing.

(03) During training, when the emergency warning system is activated, all persons on
horseback shall slow to a walk and no one on horseback shall enter the racetrack.

(04) The Racetrack announcer shall be trained to utilize the public address system to:

(i) Warn riders of potentially dangerous situations and provide direction; and

(ii) Warn patrons of potentially dangerous situations and provide direction.

2154 RACETRACK SURFACE MONITORING.

(a) Racetracks shall provide equipment and personnel necessary to maintain the racetrack surface
in a safe and consistent condition.

(b) Pre-meet inspection shall be performed on all surfaces prior to the start of each Race Meet
with sufficient time allotted to facilitate corrections of any issues prior to racing. For Race (1)
Meets spanning periods with significant weather variation, inspections shall be performed
seasonally prior to anticipated weather changes.

(01) Inspections for dirt and synthetic surfaces shall include the following elements:

(i) Determine and document race and training track configurations and geometries,
including:

(A) Geometry and slopes of straights and turns and slopes at each distance
marker pole;

(B) The accuracy of distances from the finish line to the marker poles; and

(C) cushion and base geometries.

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(ii) Base inspection, including windrowing and base survey, surface survey, ground
penetrating radar, or other method;

(iii) Mechanical properties of racing and training tracks using a biomechanical surface
tester shall be determined and documented;

(iv) Surface material samples of racing and training tracks shall be analyzed for
material composition pursuant to the Racetrack Surface Standard Practices
Document; and

(v) Corrective measures to address issues under paragraphs (i) through (iv) above.

(02) Inspections for turf surfaces shall include the following elements:

(i) Determine and document racetrack configuration and geometry, including:

(A) Geometry and slopes of straights and turns and slopes at each distance
marker pole;

(B) irrigation systems;

(C) turf profile; and

(D) ensure distances from the finish line to the marker poles are correct.

(ii) Document turf species;

(iii) Mechanical properties of racing and training tracks using a surface tester should
be determined and documented;

(iv) Surface material samples of racing and training tracks shall be analyzed for
material composition pursuant to the Racetrack Surface Standard Practices
Document;

(v) The irrigation system must be tested to evaluate function of all components and
water coverage including gaps and overlap; and

(vi) Corrective measures to address issues under paragraphs (i) through (iv) above.

(c) Daily measurements shall be taken at the beginning of all daily training and racing sessions for
racing and training tracks taken at each ¼ mile marker pole at locations 5 and 15 feet outside the
inside rail.

(01) For dirt and synthetic surfaces, such daily measurements shall include:

(i) Moisture content;

(ii) Cushion depth; and

(iii) Weather conditions and precipitation at 15-minute intervals from a national or local
weather service.

(02) For turf surfaces, such daily measurements shall include:

(i) Moisture content; and

(ii) Penetration and shear properties.

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(d) Surface equipment inventory, surface maintenance logs, and surface material addition or
renovation logs shall be maintained and submitted to the Authority.

(01) Daily surface maintenance logs should include equipment used, direction of travel,
water administration.

(02) Documentation of the source, timing, quantity, and method of all additions to the
surfaces shall be submitted to the Authority.

2160 EMERGENCY PREPAREDNESS.

2161 EMERGENCY DRILLS.

Emergency protocols shall be reviewed, and drills shall be conducted, prior to the beginning of
each Race Meet for purposes of demonstrating the Racetrack’s proficiency in managing the
following emergencies:

(a) Starting gate malfunction;

(b) Paddock emergencies;

(c) Equine injury;

(d) Jockey injury;

(e) Loose Horse;

(f) Fire;

(g) Hazardous weather condition; and

(h) Multiple injury scenarios for both Horses and Jockeys;

2162 CATASTROPHIC INJURY.

Racetracks and Training Facilities under the jurisdiction of a State Racing Commission shall have
protocols in place for instances of catastrophic injury to Horses during racing and training.
Protocols should include, but not be limited to requiring collection of biological samples in
sufficient volume, to permit comprehensive drug testing. Planning shall include appropriate means
of communication to the public

2163 FIRE SAFETY.

Racetracks and Training Facilities under the jurisdiction of a State Racing Commission shall plan
for and have protocols in place for instances of fire within their enclosures. Fire and life safety
inspections shall be performed in accordance with the local authority and appropriate National Fire
Protection Association standards and shall be conducted at the required frequency. Racetracks
shall document adherence to the applicable local fire protection authority.

2164 HAZARDOUS WEATHER.

Each Racetrack shall develop, implement, and annually review a hazardous weather protocol
which shall include:

(a) Designation of the personnel responsible for monitoring weather conditions, immediately
investigating any known impending threat of dangerous weather conditions and determining if
conditions exist which warrant delay or cancellation of training or racing and the notification to the
public of such dangerous weather conditions.

(b) Use of a designated weather watcher and a reliable source for monitoring the weather,

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including lightning strike distance/radius notifications.

(c) Implementation of a dangerous weather protocol, which includes for extreme heat and chill
factors and air quality.

(d) Designation by the Racetrack of an official responsible for monitoring weather conditions
during training and racing hours.

(e) Consideration by the Racetrack of lightning safety guidelines such as the National Athletic
Trainers’ Association Position Statement, or more recent evidence-based recommendations.

(f) Requirements that the stewards shall contact Racetrack management when weather conditions
may become hazardous, and that the stewards shall commence a racing and training delay when
weather conditions pose risks to human and equine welfare.

(g) Designation by the Racetrack of an official responsible for enforcing any weather associated
training delay.

2165 INFECTIOUS DISEASE MANAGEMENT.

(a) Plans and protocols shall be put in place by each Racetrack to manage an infectious disease
outbreak. Such protocols shall be based on guidelines recommended by the AAEP General
Biosecurity Guidelines and AAEP Healthy Horse Protocols: Biosecurity Guidelines for Racetrack
Entry and Stabling or more recent versions or developed in consultation with the appropriate State
agency or official.

(b) The Regulatory Veterinarian shall maintain written biosecurity guidelines and standard
operating procedures and train Racetrack safety personnel in basic biosecurity protocols. All
Covered Persons must report any symptoms that may be attributed to an infectious disease to the
Regulatory Veterinarian and Safety Director.

(c) During an infectious disease outbreak, the above requirements may be revised as dictated by
the circumstances, and all Covered Persons shall adhere to disease control measures
implemented by State Racing Commissions or applicable state veterinary authorities.

(d) The Safety Director, or Regulatory Veterinarian if the Safety Director is not a licensed
veterinarian, must notify the Chief Veterinarian of the relevant State Department of Agriculture (or
comparable state government official) to enable timely and accurate reporting of disease
outbreaks at the racetrack to the Equine Disease Communication Center.

2166 HUMAN AMBULANCE SUPPORT.

(a) A Racetrack shall provide a properly staffed and equipped Advanced Life Support ambulance
during training and racing hours. If the ambulance is being used to transport an individual, the
Racetrack may not conduct a race, or allow Horses with riders on the racetrack, until the
ambulance is replaced or available for service.

(b) Racetracks shall ensure the Advanced Life Support ambulance staff has been trained in
Concussion management. Any Jockey who falls or is thrown from a Horse during a race must be
examined by the Advanced Life Support staff. Advanced Life Support staff shall report their
findings to the stewards who will determine if the Jockey may continue riding.

(c) Unless otherwise approved by the State Racing Commission or the stewards, an ambulance
shall follow the field at a safe distance during the running of races.

(d) The ambulance must be parked at an entrance to the racing strip except when the ambulance
is being used to transport an individual or when it is following the field during the running of a race.

2167 ACCIDENT REPORTING SYSTEM.

(a) Racetracks shall develop standard operating procedures for the collection of data associated
with all incidents resulting in Jockey or exercise rider injuries sustained at the racetrack and submit
such information to the Authority within ten (10) days of the injury occurrence. Covered Persons
involved in, or witnesses to, the circumstances surrounding the injury shall make themselves
available to and cooperate with those individuals collecting data for the database.

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(b) Data collected shall include:

(01) name of person injured;

(02) nature of the injury;

(03) date and time of day of injury;

(04) occupation of person;

(05) cause of the incident;

(06) weather;

(07) location of the incident; and

(08) witness statements.

2168 EQUINE AMBULANCE.

A dedicated Horse ambulance with personnel trained to operate the ambulance shall at all times
be available for rapid deployment during racing and training periods. It is recommended that a
second ambulance be available in the case of multiple equine injuries or failure of the primary
Horse ambulance.

2169 PADDOCK SAFETY.

Racetracks shall have protocols in place to manage the safety of their saddling paddocks and
walking rings. Such protocols should include crowd management policies as well as emergency
response procedures for human and equine injuries. An emergency medical technician or
paramedic shall be present during saddling.

2170 NECROPSIES.

(a) All Horses that die or are euthanized on Racetrack grounds shall have an autopsy (necropsy)
examination performed.

(b) Necropsies should be performed at facilities and by personnel with capabilities and expertise
to perform necropsy examination of racehorses. Relationships and contact information shall be
included in the necropsy standard operating procedure. The Veterinarian performing the necropsy
shall not be an Attending Veterinarian of the affected Horse.

(c) Field necropsy is strongly discouraged. When a field necropsy is the only practical option
available, necropsy examinations shall be performed under direct or indirect supervision of a
board-certified pathologist including phone call guidance or video conferencing. Necropsies shall
be performed in a secure area on all Horses that die or are euthanized on Racetrack premises,
isolated from the general public. Whenever possible, the Veterinarian performing the necropsy
shall not be an Attending Veterinarian of the affected Horse.

(d) Transportation options for necropsy cases and invoicing for the transportation and necropsy
shall be identified prior to need and included in a standard operating procedure. Secure storage,
pending transport, and transportation of the body should be managed in such a way that tissue
degradation and the development of post-mortem artifacts are minimized. Care shall also be
taken to implement sound infection control practices with respect to equine infectious or zoonotic
disease.

(e) Gross necropsy examination findings must be submitted by the Regulatory Veterinarian to the
Authority within seventy-two (72) hours of receiving the necropsy report, and updates submitted to
the Authority within seventy-two (72) hours as the results of ancillary tests and the final report are
received. This workflow shall be included in the necropsy standard operating procedures.

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2180 SAFETY TRAINING AND CONTINUING EDUCATION.

2181 UNIFORM NATIONAL TRAINERS TEST.

Subject to the applicable State Racing Commission electing to enter into an agreement with the
Authority, the State Racing Commission shall require the use of a uniform National Trainers Test in
addition to any State licensing requirements. This test shall have a written component and include
practical interviews that demonstrate knowledge and proficiency in basic horsemanship skills,
knowledge of racing office protocols, state specific information, and basic equine health care.

2182 CONTINUING EDUCATION.

(a) Subject to the applicable State Racing Commission electing to enter into an agreement with
the Authority, the State Racing Commission shall identify existing, or provide locally, training
opportunities for all Racetrack employees having roles in Racetrack safety or direct contact with
Covered Horses.

(b) Required annual continuing education shall include:

(01) Regulatory Veterinarians must complete, on an annual basis, at least eight (8) hours
continuing education specific to racetrack regulatory medicine;

(02) Attending Veterinarians must complete, on an annual basis, at least eight (8) hours
continuing education specifically applicable to racetrack practice;

(03) Medical Directors must complete, on an annual basis, at least eight (8) hours continuing
education;

(04) stewards shall be either accredited or actively participating in gaining accreditation


through the ROAP and Certification Programs. Maintenance of the ROAP Accreditation
requires at least sixteen (16) hours of continuing education every two (2) calendar years.

(05) Trainers must complete, on an annual basis, at least four (4) hours annual continuing
education;

(06) assistant trainers must complete, on an annual basis, at least four (4) hours annual
continuing education;

(07) Owners must complete, on an annual basis, at least two (2) hours annually;

(08) Racetrack surface managers must complete at least eight (8) hours of continuing
education every two (2) years;

(09) Grooms must complete, on an annual basis, at least two (2) hours annual continuing
education offered in English and Spanish;

(10) outriders must complete, on an annual basis, at least two (2) hours safety and outrider
protocol training delivered locally prior to the beginning of a Race Meet.

(11) Jockeys and exercise riders must complete at least two (2) hours safety and rider
protocols delivered locally in English and Spanish prior to the beginning of a Race Meet;

(12) starters and assistant starters must complete, on an annual basis, at least two (2) hours
safety training either delivered locally prior to the beginning of a Race Meet or through the
ROAP certification; and

(13) Equipment operators must complete, on an annual basis, at least two (2) hours safety
training either delivered locally prior to the beginning of a Race Meet or through a continuing
education program.

2190 JOCKEY HEALTH.

2191 JOCKEY DRUG AND ALCOHOL TESTING.

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Subject to the applicable State Racing Commission electing to enter into an agreement with the
Authority, the State Racing Commission shall develop and implement a testing program for drugs
and alcohol for Jockeys. The program shall include provisions for medications prescribed by
licensed medical doctors that do not affect mental and physical abilities. In the event that a State
Racing Commission does not elect to enter into an agreement with the Authority, the Racetracks in
such states shall develop and implement a testing program for drugs and alcohol for Jockeys,
subject to the approval of the Authority.

2192 CONCUSSION MANAGEMENT.

State Racing Commissions, or Racetracks if the applicable State Racing Commission does not
enter into an agreement with the Authority, shall implement a Concussion management program
for Jockeys containing the following elements:

(a) Each Jockey shall acknowledge in writing that they have been made aware of the Concussion
protocols in place for the facility at which they are riding;

(b) A minimum assessment shall include a current Concussion assessment tool examination;

(c) A return-to-ride guideline shall be established in order to clear a Jockey who has been
concussed, or is believed to have been concussed, once the Jockey is declared fit-to-ride; and

(d) The stewards shall be notified when a Jockey is not permitted to ride and when the Jockey has
been authorized to return to riding.

2193 INSURANCE.

In states where workers compensation benefits are not afforded to Jockeys by state statute or
regulation, Racetracks shall maintain a minimum standard of One Million Dollars ($1,000,000) per
incident worth of accident medical expense coverage for all Jockeys.

2200 SPECIFIC RULES AND REQUIREMENTS OF RACETRACK SAFETY PROGRAM.

2210 PURPOSE AND SCOPE.

(a) The purpose of Rule Series 2200 is to establish specific safety rules and requirements designed to
enhance equine and Jockey safety in Horse racing.

(b) Violation of, or failure to comply with, the requirements of this Rule 220 Series shall result in
disciplinary action by racing officials and the Authority.

(c) Safety rules arising under State laws or regulations not preempted by 15 USC 3054(b) shall be
governed by applicable State laws and regulations.

2220 ATTENDING VETERINARIAN.

(a) Only Veterinarians licensed by the State Racing Commission may attend to Covered Horses at any
location under the jurisdiction of a State Racing Commission.

(b) Veterinarians attending at any location under the jurisdiction of a State Racing Commission are
under the authority of the Regulatory Veterinarian and the stewards.

2221 TREATMENTS BY ATTENDING VETERINARIAN.

The following limitations apply to drug treatments by Attending Veterinarians of Covered Horses
that are engaged in activities related to racing, including training:

(a) No drug shall be prescribed, dispensed, or administered except in the context of a valid
Veterinarian-client patient relationship between a Veterinarian, the Owner (who may be

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represented by the Trainer) and the Covered Horse. The Owner is not required to follow the
Veterinarian’s instructions, but no drug may be administered without a Veterinarian having
examined the Horse and provided the treatment recommendation. Such relationship requires the
following:

(01) the Veterinarian, with the consent of the Trainer (on behalf of the Owner), has accepted
responsibility for making medical judgments about the health of the Horse;

(02) the Veterinarian has sufficient knowledge of the Horse to make a preliminary diagnosis
of its medical condition;

(03) the Veterinarian has performed an examination of the Horse and is acquainted with the
keeping and care of the Horse;

(04) the Veterinarian is available to evaluate and oversee treatment outcomes, or has made
appropriate arrangements for continuing care and treatment;

(05) the relationship is maintained by veterinary visits as needed; and

(06) the medical judgments of the Veterinarian are independent and are not dictated by the
Trainer or Owner of the Horse.

(b) The Trainer and Veterinarian are both responsible for ensuring compliance with this Rule,
except that the medical judgment to recommend a drug treatment or to prescribe a drug is the
responsibility of the Veterinarian, and the decision to proceed with a drug treatment that has been
so recommended is the responsibility of the Owner (who may be represented by the Trainer or
other agent).

2230 TREATMENT RESTRICTIONS.

(a) Only Trainers or their designees shall be permitted to authorize veterinary medical treatment of
Covered Horses under their care, custody, and control at locations under the jurisdiction of the State
Racing Commission.

(b) No person other than a Veterinarian licensed to practice veterinary medicine in the State and
licensed by the State Racing Commission may prescribe medication with instructions for administration
by a Responsible Person for a Covered Horse.

(c) Attending Veterinarians shall not have contact with an entered Horse within twenty-four (24) hours
before the scheduled post time of the race in which the Horse is scheduled to compete unless approved
by the Regulatory Veterinarian, or an emergency. Any unauthorized contact may result in the Horse being
scratched from the race in which it was scheduled to compete and may result in further disciplinary
action by the stewards.

(d) The Regulatory Veterinarian may administer emergency treatment to Horses on Racetrack grounds
when the Attending Veterinarian is not present.

(e) Except as set forth in paragraph (f) below, no person shall possess a hypodermic needle, syringe
capable of accepting a needle or injectable of any kind on racetrack grounds or any facility under the
jurisdiction of the Regulatory Authority, unless otherwise approved in writing by the State Racing
Commission.

(f) At any location under the jurisdiction of the State Racing Commission, Veterinarians may use only
one-time disposable syringes, needles, IV infusion sets; and shall dispose of items in a manner
approved by the State Racing Commission and applicable state and governmental regulations.

(g) If a person has a medical condition which makes it necessary to have a syringe at any location under
the jurisdiction of the State Racing Commission, that person may request permission of the stewards or
the State Racing Commissioning in writing, shall furnish a letter from a licensed physician explaining why
it is necessary for the person to possess a syringe, and shall comply with any conditions and restrictions
set by the stewards and the State Racing Commission.

2240 VETERINARIANS’ LIST.

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(a) A Veterinarians’ List shall be maintained by the Authority of all Horses that are determined to be
ineligible to compete in a Covered Horserace in any jurisdiction until released by a Regulatory
Veterinarian.

(b) The following Horses shall be placed on the Veterinarian’s List until removed in accordance with
Rules 2241 and 2242:

(i) Horses affected by illness, physical distress, medical compromise, unsoundness, injury,
infirmity, heat exhaustion, positive test or overage, administration of a medication invoking a
mandatory stand down time, administration of Shock Wave Therapy, positive Out-of-Competition
test or any other assessment or determination by Regulatory Veterinarians that such Horse is unfit
to race.

(ii) Horses which have not started in more than 365 days; and

(iii) Horses which have not made a start prior to January 1 of their 4-year-old year.

(c) Trainers and Owners shall be notified in writing within twenty-four (24) hours that their Horse has been
placed on the Veterinarians’ List.

(d) Diagnostic testing may be required for any Horse placed on the Veterinarians’ List, at the discretion
of the Safety Director, Regulatory Veterinarian, or Association Veterinarian.

2241 DURATION OF STAY ON THE VETERINARIANS’ LIST.

Horses placed on the Veterinarian’s List in accordance with Rule 2240 shall remain on the
Veterinarian’s List as follows:

(a) Horses placed on the Veterinarians’ List for unsoundness or Epistaxis shall remain on the list
for fourteen (14) days;

(b) Horses placed on the Veterinarians’ List multiple times for unsoundness within the previous
365 days shall remain on the Veterinarians’ List for forty-five (45) days for the 2nd time, seventy-
five (75) days for the 3rd time, and shall be barred from further racing after the 4th time;

(c) Horses placed on the Veterinarians’ List multiple times for Epistaxis within the previous 365
days shall remain on the Veterinarians’ List for thirty (30) days for the 2nd time, one-hundred and
eighty (180) days for the 3rd time, and shall be barred from further racing after the 4th time;

(d) Horses placed on the Veterinarians’ List for illness shall remain on the list for seven (7) days;

(e) Horses treated with Shock Wave Therapy shall be placed on the Veterinarians’ List for thirty
(30) days; and

(f) If before, during, or after the workout for removal from the Veterinarians’ List, the Horse is
deemed to be unsound or to have Bled, the stay on the Veterinarians’ List shall be extended an
additional fourteen (14) days and further diagnostic testing may be required as determined by the
Regulatory Veterinarian.

2242 REMOVAL OF HORSES FROM THE VETERINARIANS’ LIST.

Regulatory Veterinarians may remove Horses from the Veterinarians’ List in accordance with this
Rule and shall document such removal to the Authority.

(a) A Horse placed on the Veterinarian’s List as unsound or suffering from Epistaxis may be
removed from the Veterinarian’s List upon satisfaction of paragraphs (1) through (3) below.

(01) A trainer must apply to the Regulatory Veterinarian for permission to work the Horse for
removal from Veterinarian’s List. Upon receiving such approval, the Trainer and Attending
Veterinarian must observe the Horse jog and submit to the Regulatory Veterinarian a co-
signed statement that the Horse is fit to perform a Workout.

(02) The Horse must perform a Workout under the supervision of the Regulatory Veterinarian
and demonstrate to the satisfaction of the Regulatory Veterinarian that the Horse is sound to
race.

(03) The Regulatory Veterinarian determines there is no evidence or signs of Epistaxis,


physical distress, medical compromise, unsoundness, or lameness within one (1) hour after

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the Workout conducted pursuant to paragraph (a)(2) above.

(b) A Horse placed on the Veterinarians’ List as physically distressed or medically compromised
may be removed from the Veterinarians’ List provided sound health has been declared by the
Attending Veterinarian or demonstrated to the Regulatory Veterinarian and documented to the
Authority.

(c) In addition to the requirements set forth herein and any requirements of the Protocol, if a Horse
is placed on the Veterinarians’ List for a positive test or overage of a primary substance invoking a
mandatory stand down time, a positive Out-of-Competition test, or any other veterinary
administrative withdrawal, the Horse shall be prohibited from entering a Race and may be
released from the Veterinarians’ List only after also undergoing a post-Workout inspection by the
Regulatory Veterinarian.

2250 RACEHORSE TREATMENT HISTORY AND RECORDS.

2251 VETERINARY REPORTS.

(a) All Veterinarians shall provide treatment records pursuant to Rules Series 3000. In addition to
the uses set forth therein, these records may be used by Regulatory Veterinarians in the
performance of their duties at the racetrack, for transfer of sixty (60) day medical records to the
new trainer of a claimed Horse, and for purposes of research to enhance the safety and welfare of
racehorses.

(b) In addition to the information required to be submitted by Veterinarians pursuant to Rules


Series 3000, every Veterinarian who examines or treats a Covered Horse shall, within 24 hours of
such examination or treatment, submit the following information in an electronic format designated
by the Authority:

(01) the identity of the Horse treated;

(02) the name of the Trainer of the Horse;

(03) the name of the Veterinarian;

(04) contact information for the Veterinarian (phone, email address);

(05) any information concerning the presence of unsoundness and responses to diagnostic
tests;

(06) diagnosis;

(07) condition treated;

(08) any medication, drug, substance, or procedure administered or prescribed, including


date and time of administration, dose, route of administration (including structure treated if
local administration), frequency, and duration (where applicable) of treatment;

(09) any non-surgical procedure performed (including but not limited to diagnostic tests,
imaging, and shockwave treatment) including the structures examined/treated and the date
and time of the procedure;

(10) any surgical procedure performed including the date and time of the procedure; and

(11) any other information necessary to maintain and improve the health and welfare of the
Horse.

2252 RESPONSIBLE PERSONS’ RECORDS.

(a) In addition to the information required to be submitted by Responsible Persons under Rule
Series 3000, a Responsible Person is responsible for maintaining a record of medical,
therapeutic, and surgical treatments and procedures for every Covered Horse in his or her control.

Horseracing Integrity and Safety Authority


(b) For purposes of this Rule, the term treatment:

(01) means the administration of any medication or substance containing a medication to a


Horse by a Responsible Person or his or her designee;

(02) includes the administration of medications that are prescribed by a Veterinarian but
administered by the Responsible Person or his or her designee, or medications prescribed
or administered by a Veterinarian not licensed by the State Racing Commission; and

(03) specifically excludes medications or procedures directly administered by a Veterinarian


licensed by the State Racing Commission or that Veterinarian’s employees.

(c) Records must include the information outlined in paragraphs (1) and (2) below.

(01) For medical treatments:

(i) name of the Horse (or, if unnamed, the registered name of the dam and year of
foaling);

(ii) name of Trainer;

(iii) generic name of the drug, or brand name if a non-generic drug is used;

(iv) name of the prescribing Veterinarian;

(ix) full name and contact information of the individual that administered the treatment.

(v) date of the treatment;

(vi) route of administration;

(vii) dosage administered;

(viii) approximate time (to the nearest hour) of each treatment; and

(02) For medical procedures, including but not limited to, physiotherapy, acupuncture,
chiropractic, and surgeries:

(i) name of the Horse, or, if unnamed, the registered name of the dam and year of
foaling;

(ii) name of Trainer;

(iii) diagnosis and condition being treated;

(iv) name of procedure or surgery;

(v) date of the procedure;

(vi) first and last name of the individual that administered or performed the procedure;
and

(vii) any other information necessary to maintain and improve the health and welfare of
the Horse.

(d) In addition to the uses of records set forth in the Rules Series 3000, records may be used by
Regulatory Veterinarians in the performance of their duties at the Racetrack, for transfer of sixty
(60) day medical records to the new Owner of a claimed Horse, and for purposes of research to
enhance the safety and welfare of racehorses. Records may also be accessed by the State
Racing Commission or the stewards.

Horseracing Integrity and Safety Authority


2253 RECORDS FOR HORSES SHIPPING TO THE RACETRACK.

(a) If a Horse is not stabled at a facility under the Authority’s jurisdiction for the full thirty (30) days
prior to a Race or Workout for purposes of removal from the Veterinarians’ List, the Responsible
Person shall obtain and maintain the following information for the previous thirty (30) days:

(01) name of the Horse or, if unnamed, the registered name of the dam and year of foaling;

(02) generic name of the drug, or brand name of the drug if a non-generic drug is used;

(03) date and duration of the treatment;

(04) route of administration;

(05) dosage administered;

(06) surgical procedures;

(07) non-surgical therapies and procedures; and

(08) any other information necessary to maintain and improve the health and welfare of the
Horse.

(b) If a Horse is not stabled at a facility under the Authority’s jurisdiction for sixty (60) days prior to a
Race or Workout for purposes of removal from the Veterinarians’ List, the Responsible Person
shall obtain and maintain the following information:

(01) the last thirty (30) days of exercise activity at the facility;

(02) the last thirty (30) days of treatments and procedures at the facility; and

(03) any other information necessary to maintain and improve the health and welfare of the
Horse.

2260 CLAIMING RACES.

2261 TRANSFER OF CLAIMED HORSE RECORDS.

(a) Entry of Horses subject to being claimed in a Claiming Race implies Owner (Trainer as the
agent of the Owner) consent for transfer of all Trainer and veterinary examination and treatment
records for the last sixty (60) days to the new Trainer of the claimed Horse.

(b) If a Horse is successfully claimed by a new Trainer, the previous Trainer must transfer Trainer
records and authorize transfer of veterinary records to the new Trainer within three (3) days of
transfer of the Horse to the new Trainer.

2262 VOID CLAIM.

(a) Title to a Horse which is claimed shall be vested in the successful claimant from the time the
field has been dispatched from the starting gate and the Horse becomes a starter.

(b) All claimed Horses shall go to the test barn for observation by the Regulatory Veterinarian.

(c) The claim shall be voided, and ownership of the Horse retained by the original Owner if:

(01) the Horse dies on the racing track;

(02) the Horse is euthanized before leaving the racing track;

(03) the Horse is vanned off of the racing track by discretion of the Regulatory Veterinarian;

(04) the Regulatory Veterinarian determines within one (1) hour of the race that the Horse will

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be placed on the Veterinarians’ List as Bled, physically distressed, medically compromised,
unsound, or lame before the Horse is released to the successful claimant; or

(05) the Horse has a positive test for a Prohibited Substance.

(d) The claim shall not be voided if, prior to the Race in which the Horse is claimed, the claimant
elects to claim the Horse regardless of whether the Regulatory Veterinarian determines the Horse
will be placed on the Veterinarians’ List as Bled or unsound or the Horse tests positive for a
Prohibited Substance.

2263 WAIVER CLAIMING OPTION.

(a) At time of entry into a Claiming Race an Owner or Trainer may opt to declare a Horse ineligible
to be claimed provided:

(01) the Horse has not started in 120 days;

(02) the Horse’s last start must have been for a claiming price; and

(03) the Horse is entered for a claiming price equal or greater than the price it last started
for.

2270 PROHIBITED PRACTICES AND REQUIREMENTS FOR SAFETY AND HEALTH OF JOCKEYS.

2271 PROHIBITED PRACTICES.

The following are prohibited practices:

(a) Use of physical or veterinary procedures to mask the effects or signs of injury so as to allow
training or racing to the detriment of the Horse’s health and welfare.

(b) Use of extracorporeal shock wave therapy in a manner that may desensitize any limb structures
during racing or training.

(c) Surgical or chemical neurectomy to cause desensitization of musculoskeletal structures


associated with the limbs.

(d) Thermocautery including but not limited to pin firing and freeze firing, or application of any
substance to cause vesiculation or blistering of the skin, or a counter-irritant effect.

(e) Use of a device to deliver an electrical shock to the Horse including but not limited to cattle
prods and batteries.

(f) Use of electrical medical therapeutic devices including magnetic wave therapy, laser, electro-
magnetic blankets, boots, electro-shock, or any other electrical devices that may produce an
analgesic effect within forty-eight (48) hours of a training activity or of the start of the published post
time for which a Horse is scheduled to race.

2272 SHOCK WAVE THERAPY.

(a) The use of Shock Wave Therapy shall be disclosed to the Regulatory Veterinarian no less than
forty-eight (48) hours prior to use and shall not be permitted unless the following conditions are
met:

(01) Any Shock Wave Therapy may only be performed with machines that are:

(i) registered and approved for use by the State Racing Commission; and

(iii) used at a previously disclosed location that is approved by the State Racing
Commission.

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(02) The use of Shock Wave Therapy shall be limited to licensed Veterinarians and must be
reported to the Regulatory Veterinarian within forty-eight (48) hours of treatment to the
Authority.

(03) Any treated Horse shall be placed on the Veterinarians’ List and shall not be permitted
to Race or breeze for thirty (30) days following treatment.

(b) The Veterinarian and Trainer shall be suspended from the Racetrack for a period of five (5)
days if Shock Wave Therapy has not been reported within forty-eight (48) hours of any treatment or
procedure administered to a Covered Horse. For each subsequent omission of reporting, an
additional five (5) days suspension shall be added. If there are three (3) violations in a calendar
year, the Veterinarian and Trainer shall be suspended for six (6) months in the subsequent
calendar year.

2273 OTHER DEVICES.

No electrical or mechanical device or other expedient designed to increase or retard the speed of
Covered Horse, other than the riding crop permitted under these regulations, shall be possessed
by anyone, or applied by anyone to a Covered Horse at any time on Racetrack grounds or during a
Workout.

2274 OTHER DEVICE PENALTIES.

Penalties for violations of Rule 2273 shall be as follows:

(a) The penalty for a first offense shall be loss of eligibility to obtain a racing license in all racing
jurisdictions for ten (10) years.

(b) For any subsequent violation, the penalty shall be loss of eligibility to obtain a racing license in
all racing jurisdictions for the life of the Covered Person.

2275 COMMUNICATION DEVICES.

The use of a hand-held communication device by a rider is prohibited while the rider is on the
racing track.

2276 HORSESHOES.

(a) Except for full rims 2 mm or less from the ground surface of the Horseshoe, traction devices are
prohibited on forelimb and hindlimb Horseshoes during racing and training on dirt or synthetic
racing tracks.

(b) Traction devices are prohibited on forelimb and hindlimb Horseshoes during training and
racing on the turf.

(c) Traction devices include but are not limited to rims, toe grabs, bends, jar calks and stickers.

2280 USE OF RIDING CROP.

(a) A Jockey or exercise rider who uses a crop during a Race or Workout shall do so only in a
professional manner consistent with maintaining focus and concentration of the Horse for safety of
Horses and riders, or for encouragement to achieve optimal performance.

(b) A rider may:

Horseracing Integrity and Safety Authority


(01) Use the crop on the hindquarters to activate and focus the Horse a maximum of six (6) times
during a race. The six (6) permitted uses shall be in increments of two (2) or less strikes. The rider
must allow at least two (2) strides for the Horse to respond before using the crop again.

(02) Tap the Horse on the shoulder with the crop while both hands are holding on to the reins and
both hands are touching the neck of the Horse.

(03) Show or wave the crop to the Horse without physically contacting the Horse.

(04) Use the crop to preserve the safety of Horses and riders.

(c) A rider may not:

(01) Raise the crop with the rider’s wrist above the rider’s helmet when using the crop.

(02) Injure the Horse with the crop or leave any physical marks, such as welts, bruises, lacerations.

(03) Use the crop on any part of the Horse’s body other than the shoulders or hindquarters.

(04) Use the crop during the post parade or after the finish of the race other than to avoid a
dangerous situation or preserve the safety of Horses and riders.

(05) Use the crop if the Horse has obtained its maximum placing.

(06) Use the crop persistently even though the Horse is showing no response.

(07) Use a crop on a two (2) year-old Horse in races before April 1st of each year other than to
avoid a dangerous situation or preserve the safety of Horses and riders.

(08) Strike another Horse or person with the crop.

(d) In any Race in which a Jockey will ride without a crop that fact shall be declared at entry, included in
the official program, and an announcement of that fact shall be made over the public address system.

2281 RIDING CROP SPECIFICATIONS.

(a) Riding crops are subject to inspection by the Safety Officer, stewards, and the clerk of the
scales.

(b) All riding crops must be soft-padded.

(c) Riding crops shall have a shaft and a smooth foam cylinder and must conform to the following
dimensions and construction:

(01) The maximum allowable weight shall be eight (8) ounces;

(02) The maximum allowable length, including the smooth foam cylinder attachment, shall be
thirty (30) inches;

(03) The minimum diameter of the shaft shall be three-eighths of one inch; and

(04) The shaft, beyond the grip, must be smooth, with no protrusions or raised surface, and
covered by shock absorbing material that gives a compression factor of at least one
millimeter throughout its circumference.

(05) There shall be no binding within seven (7) inches of the end of the shaft.

(06) The smooth foam cylinder is the only allowable attachment to the shaft and must meet
the following specifications:

(i) Shall have no reinforcements;

(ii) Shall have a maximum length beyond the shaft of one inch;

(iii) Shall have a minimum diameter of 0.8 inches and a maximum width of 1.6 inches;

(iv) There shall be no other reinforcements or additions beyond the end of the shaft;

Horseracing Integrity and Safety Authority


(v) Shall be made of shock absorbing material with a compression factor of at least
five millimeters throughout its circumference;

(vi) Shall be made of a waterproof, ultraviolet, and chemical resistant foam material
that is durable and preserves its shock absorption in use under all conditions; and

(vii) Shall be replaced after reasonable wear and tear is visibly evident.

(07) Riding crops shall not be altered and shall have an appropriate label or marking
designating that the riding crop meets the required standards as established by the Authority

2282 RIDING CROP VIOLATIONS AND PENALTIES.

(a) Violations of Rule 2280 shall be categorized as follows, with the exception that use of the crop
for the safety of Horse and rider shall not count towards the total crop uses:

(01) Class 3 Violation – one (1) to three (3) strikes over the limit.

(02) Class 2 Violation – four (4) to nine (9) strikes over the limit.

(03) Class 1 Violation – ten (10) or more strikes over the limit.

(b) Unless the stewards determine the merits of an individual case warrant consideration of an
aggravating or mitigating factor, the penalties for violations are as follows:

(01) Class 3 Violation –

(i) $250 or 10% of Jockey’s portion of the purse, whichever is greater;

(ii) Minimum 1-day suspension for the Jockey; and

(iii) 3 points;

(02) Class 2 Violation –

(i) $500 or 20% of Jockey’s portion of the purse, whichever is greater;

(ii) Horse disqualified from purse earnings,

(iii) Minimum 3-day suspension for the Jockey; and

(iv) 5 points;

(03) Class 1 Violation –

(i) $750 fine or 30% of Jockey’s portion of the purse, whichever is greater,

(ii) Horse disqualified from purse earnings,

(iii) Minimum 5-day suspension for the Jockey;

(iv) 10 points.

2283 MULTIPLE VIOLATIONS.

Horseracing Integrity and Safety Authority


(a) Stewards shall submit violations of Rule 2282 to the Authority to identify when multiple
violations warrant additional suspensions consistent with the following schedule:

(01) 11- 15 points – 7 days;

(02) 16-20 points – 15 days; and

(03) 21 or more points – 30 days.

(b) Points assigned under Rule 2282 shall expire according to the following schedule:

(01) Class 3 Violation - 6 months;

(02) Class 2 Violation – 9 months; and

(03) Class 1 Violation - 1 year.

(c) For purposes of paragraph (b), points are expunged from the date of final adjudication of the
violation and not from the date of the violation. Mandatory suspensions are based on points
accumulated for multiple violations and do not apply to single violations.

2290 REQUIREMENTS FOR SAFETY AND HEALTH OF JOCKEYS.

2291 JOCKEY ELIGIBILITY.

(a) A Jockey shall pass a physical examination given within the previous twelve (12) months by a
licensed physician affirming the Jockey’s fitness to participate as a Jockey, as well as a baseline
Concussion test using a current Concussion testing protocol. The results of the physical
examination and the baseline Concussion test shall be submitted to the State Racing Commission
and the Authority.

(b) The stewards may require that any Jockey be reexamined and may refuse to allow any Jockey
to ride in a race or Workout pending completion of such examination.

2292 JOCKEY AND EXERCISE RIDER MEDICAL HISTORY INFORMATION.

(a) At all times while mounted on a Horse at a Racetrack, a Jockey or exercise rider shall securely
attach to his or her safety vest one or more medical information cards describing his or her
medical history and any conditions pertinent to emergent care, including a listing of any previous
injuries, drug allergies and current medications.

(b) The stewards shall confirm compliance during their safety vest inspections at the beginning of
the season and with random inspections throughout the Race Meet.

(c) The stewards may, in their discretion, take disciplinary action against, suspend, make ineligible
to race, or fine any Jockey or exercise rider found in violation of this Rule.

2293 EQUIPMENT.

(a) Helmets.

(01) Any person mounted on a Horse or stable pony anywhere on racetrack grounds shall
wear a properly secured safety helmet at all times.

(02) All starting gate personnel shall wear a properly secured safety helmet at all times while
performing their duties or handling a Horse.

(03) The safety helmet may not be altered in any manner and the product marking shall not
be removed or defaced.

Horseracing Integrity and Safety Authority


(04) The stewards, or their designee, shall inspect safety helmets at the beginning of a Race
Meet and randomly throughout the Race Meet.

(05) The Clerk of Scales shall report to the stewards any variances of safety helmets seen
during the course of their work.

(06) The helmet must comply with one of the following minimum safety standards or later
revisions:

(i) American Society for Testing and Materials (ASTM 1163);

(ii) European Standards (EN-1384 or PAS-015 or VG1);

(iii) Australian/New Zealand Standards (AS/NZ 3838 or ARB HS 2012); or

(iv) Snell Equestrian Standard 2001.

(b) Vests.

(01) Any person mounted on a Horse or stable pony on the racetrack grounds must wear a
properly secured safety vest at all times.

(02) All starting gate personnel must wear a properly secured safety vest at all times while
performing their duties or handling a Horse.

(03) The safety vest may not be altered in any manner and the product marking shall not be
removed or defaced.

(04) The stewards shall inspect safety vests at the beginning of a Race Meet and randomly
throughout the Race Meet.

(05) The clerk of scales shall report to the stewards any variances of safety vests seen during
their course of work.

(06) The safety vest must comply with one of the following minimum standards, as the same
may be from time to time amended or revised:

(i) British Equestrian Trade Association (BETA):2000 Level 1;

(ii) iEuro Norm (EN) 13158:2000 Level 1;

(iii) American Society for Testing and Materials (ASTM) F1781-08 or F1937;

(iv) Shoe and Allied Trade Research Association (SATRA) Jockey Vest Document
M6-3; or

(v) Australian Racing Board (ARB) Standard 1.1998.

8000 Violations, Sanctions, Hearing Procedures, and Investigatory Powers

8100 Violations

Violations under this Rule shall include:

(a) Failure to cooperate with the Authority or an agent of the Authority during any investigation;

Horseracing Integrity and Safety Authority


(b) Failure to respond truthfully, to the best of a Covered Person's knowledge, to a question of the
Authority or an agent of the Authority with respect to any matter under the jurisdiction of the Authority;

(c) Tampering or attempted tampering with the application of the safety, performance, or anti-doping and
medication control rules or process adopted by the Authority, including:

(01) Intentional interference, or an attempt to interfere, with an official or agent of the Authority;

(02) Procurement or the provision of knowingly false information to the Authority or agent of the
Authority; and

(03) The intimidation of, or an attempt to intimidate, a potential witness;

(d) Assisting, encouraging, aiding, abetting, conspiring, covering up, or any other type of intentional
complicity involving a safety violation, or the violation of a period of suspension or ineligibility;

(e) Threatening or seeking to intimidate a person with the intent of discouraging the person from the
good faith reporting to the Authority, an agent of the Authority or the Commission, of information that
relates to:

(01) a suspected or alleged violation of a rule in the Rule 2200 Series; or

(02) a suspected or alleged noncompliance with a rule in the Rule 2200 Series;

(f) Failure to comply with a written order or ruling of the Authority or an agent of the Authority pertaining to
a racing matter or investigation;

(g) Failure to register with the Authority, making a knowingly false statement or omission of information in
an application for registration with the Authority, or failure to advise the Authority of material changes in
the application information as required under any provision in Authority regulations;

(h) Perpetrating or attempting to perpetrate a fraud or misrepresentation in connection with the care or
racing of a Covered Horse;

(i) Failure to remit fees as required under 15 USC 3052(f)(3); and

(j) Failure by a Racetrack to collect equitable allocation amounts among Covered Persons in conformity
with the funding provisions of 15 USC 3052(f)(3) and any rules pertaining thereto.

8200 Schedule of Sanctions for Violations; Consent Decrees; Notice of Suspected or Actual Violation

(a) Application. This Schedule shall apply to any violation of, or failure to comply with, the Act or regulations
promulgated by the Authority by a Covered Person, except for:

(01) anti-doping and medication control rule violations as established in the Rule 3000 Series; and

(02) State laws or regulations not pre-empted by 15 USC Section 3054(b).

(b) Imposition of Sanction. The Authority, the Racetrack Safety Committee, the stewards, any steward or body
of stewards selected from the National Stewards Panel, or an Arbitral Body, after any hearing required to be
conducted in accordance with the Rule 7000 Series and upon finding a violation or failure to comply with the
regulations of the Authority with the exceptions identified in paragraph (a), may impose one or more of the
following sanctions on a Covered Person for each violation of the rules of the Authority:

(01) for a violation of Rule 2271(b) or 2272 relating to the use of Shock Wave Therapy, a violation of
Rule 2280 relating to the use of the riding crop, or a violation of Rule 2273 relating to the use of other
electrical or mechanical devices, impose the penalties set forth in those Sections;

(02) impose a fine upon a Covered Person in the following amounts:

(i) up to $50,000.00 for a first violation, or

Horseracing Integrity and Safety Authority


(ii) from $50,000.00 to $100,000.00 for a second violation of the same or similar nature to a prior
violation, or any violation that due to its nature, chronicity or severity poses an actual or potential
threat of harm to the safety, health and welfare of Covered Persons, Covered Horses, or the
integrity of Covered Horseraces,

(03) deny or suspend the registration of a Covered Person for a definite period, probationary period, or
a period contingent on the performance of a particular act;

(04) revoke the registration of a Covered Person subject to reapplication at a specified date;

(05) impose a lifetime ban from registration with the Authority;

(06) bar a Covered Person from associating with all Covered Persons concerning any matter under the
jurisdiction of the Commission and the Authority during the period of a suspension;

(07) impose a temporary or permanent cease and desist order against a Covered Person;

(08) require a Covered Person as a condition of participation in horse racing to take any remedial or
other action that is consistent with the safety, welfare, and integrity of Covered Horses, Covered
Persons, and Covered Horseraces;

(09) deny or require the forfeiture of purse money, disqualify a horse, or make changes to the order of
finish in Covered Races as consistent with the safety, welfare, and integrity of Covered Horses, Covered
Persons, and Covered Horseraces;

(10) censure a Covered Person;

(11) prohibit a Racetrack from conducting any Covered Horserace; or

(12) impose any other sanction as a condition of participation in horse racing as deemed appropriate by
the Authority in keeping with the seriousness of the violation and the facts of the case, and that is
consistent with the safety, welfare, and integrity of Covered Horses, Covered Persons, and Covered
Horseraces.

(c) Consent Decrees. The Authority shall have the discretion to enter into a consent decree or other similar
agreement with a Covered Person as necessary to promote the safety, welfare, and integrity of Covered
Horses, Covered Persons, and Covered Horseraces.

(d) Notice of Suspected or Actual Violation.

(01) The Authority or the Racetrack Safety Committee may issue a Notice of Suspected or Actual
Violation to a Covered Person in any case in which the Authority has reason to believe that the Covered
Person has violated or has failed to comply any provision of regulations of the Authority. The notice shall:

(i) identify the provision or provisions which the Covered Person is believed to have violated;

(ii) specify with reasonably particularity the factual basis of the Authority’s belief that the provision
has been violated; and

(iii) provide the Covered Person at least seven (7) days to respond, or a longer period as deemed
appropriate and specified in the Notice by the Authority based upon the seriousness of the
violation or the imminence of risk.

(02) Upon receipt of the Notice of Suspected or Actual Violation, the Covered Person shall respond in
writing to the Authority within the time period specified in the notice. The Covered Person shall include in
the response:

(i) a statement by the Covered Person admitting the violation, or explaining the reasons why the
Covered Person believes that a violation has not occurred;

(ii) all relevant details concerning the circumstances of the suspected or actual violation, including
the results of any investigation undertaken by the Covered Person of the circumstances, and
identification of any persons responsible for the circumstances; and

(iii) a detailed explanation of any remedial plan the Covered Person proposes to undertake to cure
the suspected or actual violation, and the date of the expected completion of the remedial plan.

Horseracing Integrity and Safety Authority


8300 Disciplinary Hearings and Accreditation Procedures

8310 Application

An alleged violation or failure to comply with the provisions of the Rule 2200 Series and any alleged
violation of the rules set forth in Rule 8100 shall be adjudicated in accordance with this Rule 8300
Series, except that:

(a) An alleged violation of the anti-doping and medication control rule provisions in the Rule 3000
Series shall be adjudicated in accordance with the procedures set forth therein.

(b) This regulation shall not apply to the adjudication of violations arising under state laws, racing
rules and regulations not preempted under 15 USC Section 3054(b).

8320 Adjudication of Violations of Established in the Rule 2200 Series

(a) Any ruling by the stewards finding a violation of Rule 2271(b) or 2272 relating to the use of Shock
Wave Therapy, a violation of Rule 2280 relating to the use of the riding crop, or a violation of Rule 2273
relating to the use of other electrical or mechanical devices, may be appealed to the Board of the
Authority under the procedures described in Rule 8330. An appeal shall be filed in writing within ten (10)
days of the issuance of the ruling by the stewards.

(b) With regard to any matter involving an alleged violation of a rule in the Rule 2200 Series other than
those set forth in paragraph (a) above, the Racetrack Safety Committee may, at its discretion and taking
into account the seriousness of the alleged violation and the facts of the case:

(01) Refer the matter to the National Stewards Panel for adjudication in conformity with the
procedures established in the Rule 7000 Series;

(02) Refer the matter to an independent Arbitral Body for adjudication in conformity with the
procedures established in the Rule 7000 Series;

(03) Refer the matter to the stewards for adjudication in accordance with the procedures of the
applicable state jurisdiction; or

(04) Conduct a hearing upon the matter itself, under the procedures set forth in Rule 8340.

8330 Adjudication of Rule 8100 Violations

With regard to any matter involving an alleged violation of a rule established in Rule 8100, the Board of
the Authority may at its discretion and taking into account the seriousness of the violation and the facts of
the case:

(a) Refer the matter to the National Stewards Panel for adjudication in conformity with the
procedures established in the Rule 7000 Series;

(b) Refer the matter to an independent Arbitral Body for adjudication in conformity with the
procedures established in the Rule 7000 Series;

(c) Refer the matter to the stewards for adjudication in accordance with the procedures of the
applicable state jurisdiction; or

(d) Conduct a hearing upon the matter itself, under the procedures set forth in Rule 8340.

Horseracing Integrity and Safety Authority


8340 Initial Hearings Conducted Before the Racetrack Safety Committee or the Board of the Authority

(a) An initial hearing before the Board shall be conducted by a panel of three Board members. The
Board chair shall appoint the panel members and shall also designate one of them as the chair of the
panel.

(b) An initial hearing before the Racetrack Safety Committee shall be heard by a quorum of the
Racetrack Safety Committee. The Racetrack Safety Committee chair shall act as the chair of the
hearing panel unless the Chair is unavailable, in which case the Racetrack Safety Committee chair shall
designate a member of the quorum to act as the chair of the panel.

(c) Persons entitled to notice of a hearing before the Board or the Racetrack Safety Committee shall be
informed not less than twenty (20) days prior to the hearing of:

(01) the time, place, and nature of the hearing;

(02) the legal authority and jurisdiction under which the hearing is to be held;

(03) a description of the alleged violation, specifying by number the rule allegedly violated; and

(04) a statement of the factual basis of the alleged violation in sufficient detail to provide adequate
opportunity to prepare for the hearing.

(d) At any time prior to, during, or after the hearing, the Board or the Racetrack Safety Committee in its
discretion may require the submission of written briefs or other information as will assist in the hearing of
the matter.

(e) All testimony in proceedings before the Board or the Racetrack Safety Committee shall be given
under oath.

(f) The burden of proof shall be on the party alleging the violation to show, by a preponderance of the
evidence, that the Covered Person has violated or failed to comply with a provision of or is responsible
for a violation of a provision of the Authority’s regulations.

(g) The Board or the Racetrack Safety Committee shall allow a full presentation of evidence and shall not
be bound by the technical rules of evidence. However, the Board or the Racetrack Safety Committee
may disallow evidence that is irrelevant or unduly repetitive of other evidence. The Board or the
Racetrack Safety Committee shall have the authority to determine, in its sole discretion, the weight and
credibility of any evidence or testimony. The Board or the Racetrack Safety Committee may admit
hearsay evidence if it determines the evidence is of a type that is commonly relied on by reasonably
prudent people. Any applicable rule of privilege shall apply in hearings before the Board or the
Committee.

(h) A party is entitled to present his case or defense by oral or documentary evidence, to submit rebuttal
evidence, and to conduct such limited cross-examination as may be required for a full and true
disclosure of the facts.

(i) The Board or the Racetrack Safety Committee shall issue to all parties within thirty days (30) of the
close of the hearing a written decision setting forth findings of fact, conclusions of law and the disposition
of the matter including any penalty imposed. If the thirtieth day falls on a Saturday, Sunday, or holiday,
then the written decision shall be issued on the next working day immediately following the Saturday,
Sunday, or holiday.

8350 Appeal to the Board

(a) Any decision rendered by the Racetrack Safety Committee, the stewards, the National Stewards
Panel, or an Arbitral Body, may be appealed on the record to the Board. The decision may be appealed
by a party to the decision, or the decision may be reviewed upon the Board’s own initiative and at its
discretion.

(b) Any decision rendered by an initial Board hearing panel may be appealed on the record to the
Board, to be heard by a quorum of the Board which shall not include the Board members who were on
the panel in the initial hearing. The decision may be appealed by a party to the decision, or the decision
may be reviewed upon the Board’s own initiative and at its discretion.

(c) An appeal shall not automatically stay the decision. A party may request the Board to stay the
decision. The Board shall order a stay for good cause shown.

Horseracing Integrity and Safety Authority


(d) A party to the decision may appeal to the Board by filing with the Board a written request for an
appeal within ten days after receiving a written order. The appeal request shall contain the following
information:

(01) the name, address, and telephone number, if any, of the appellant;

(02) a description of the objections to the decision;

(03) a statement of the relief sought; and

(04) whether the appellant desires to be present in person at the hearing of the appeal.

(e) The Board shall set a date, time, and place for the hearing. Notice shall be given to the appellant in
writing and shall set out the date, time, and place of the hearing, and shall be served personally or sent
by electronic or U.S. mail to the last known address of the appellant. If the appellant objects to the date of
the hearing, the appellant may obtain a continuance, but the continuance shall not automatically stay
imposition of a sanction or prolong a stay issued by the Board.

(f) Upon review of the decision which is the subject of the appeal, the Board shall uphold the decision
unless it is clearly erroneous or not supported by the evidence or applicable law.

(g) Upon completing its review, the Board may:

(01) Accept the decision;

(02) Reject or modify the decision, in whole or in part;

(03) Remand the matter, in whole or in part, to the stewards, Racetrack Safety Committee, the
National Stewards Panel, or an Arbitral Body, as the case may be, for further proceedings as
appropriate; or

(04) Conduct further proceedings on the matter as appropriate, including but not limited to
requiring the submission of written briefs or, in extraordinary circumstances and at the Board’s
discretion, the taking of additional testimony before the Board under oath.

(h) The Board shall issue its written decision based on the record and any further proceedings or
testimony. A copy of the Board’s decision shall be served upon all parties by first class mail, electronic
mail, or personal service.

(i) The decision of the Board shall be the final decision of the Authority agency decision.

8360 Accreditation Procedures

(a) Any decision issued by the Authority denying or revoking racetrack accreditation may:

(01) Be appealed within ten (10) days by the Racetrack to the Authority for a de novo hearing
reviewing the Authority’s decision; or

(02) Reviewed by the Authority on its own initiative.

(b) The Authority’s order revoking accreditation shall be stayed automatically pending review of the
decision by the Authority.

(c) At its discretion, the Authority may request and consider any additional information from any source
that may assist in the review.

(d) The Racetrack may request to make a presentation before the Authority concerning racetrack safety
and any remedial efforts proposed to be undertaken by the Racetrack. At its discretion, the Authority
may permit the Racetrack to make such presentation.

(e) In conducting its review, that Authority may consider all factors that it deems appropriate, including
but not limited to:

Horseracing Integrity and Safety Authority


(01) The extent and magnitude of any deficiencies in racetrack operations conducted at the
Racetrack;

(02) The threat posed by the deficiencies to the safety and integrity of horse racing conducted at
the Racetrack;

(03) The adequacy of the efforts the Racetrack proposes to undertake or has undertaken to
remedy all deficiencies at the Racetrack;

(04) The likelihood and timeframe within which compliance will be achieved by the Racetrack,
given the resources available to the Racetrack and the past record of the Racetrack in achieving
and maintaining compliance with the rules of the Authority; and

(05) Any other factors the Authority deems relevant to its review.

(f) Upon completing its review, the Authority may take one or more of the following actions:

(01) Order that the Racetrack’s accreditation be denied or revoked, upon a vote in favor of denial
or revocation by two-thirds (2/3) of a quorum of the members of the Authority;

(02) Reinstate accreditation subject to any requirements the Authority deems necessary to ensure
that horse racing will be conducted in a manner consistent with racetrack safety and integrity. The
Authority may also impose a fine upon reinstatement in amount not to exceed $50,000.00. The
Authority may require the Racetrack to report at prescribed intervals on the status of racetrack
safety operations and remedial efforts to improve safety pursuant to the Authority’s racetrack
safety rules; or

(03) Prohibit a Racetrack from conducting any Covered Horserace.

8370 Final Civil Sanction

Any decision rendered by the Board of the Authority under Rule 8350, or the Authority under Rule 8360,
shall constitute a final civil sanction subject to appeal and review in accordance with the provisions of 15
USC 3058.

8400 Investigatory Powers

(a) The Commission, the Authority or their designees:

(01) Shall have free access to the books, records, offices, racetrack facilities, and other places of
business of Covered Persons that are used in the care, treatment, training, and racing of Covered
Horses, and to the books, records, offices, facilities, and other places of business of any person who
owns a Covered Horse or performs services on a Covered Horse; and

(02) May seize any medication, drug, substance, paraphernalia, object, or device in violation or
suspected violation of any provision of 15 USC Chapter 57A or the regulations of the Authority.

(b) A Covered Person shall:

(01) Cooperate with the Commission, the Authority or their designees during any investigation; and

(02) Respond truthfully to the best of the Covered Person’s knowledge if questioned by the Commission,
the Authority, or their designees about a racing matter.

(c) A Covered Person or any officer, employee or agent of a Covered Person shall not hinder a person who is
conducting an investigation under or attempting to enforce or administer any provision of 15 USC Chapter
57A or the regulations of the Authority.

Horseracing Integrity and Safety Authority


(d) The Commission or the Authority may issue subpoenas for the attendance of witnesses in proceedings
within their jurisdiction, and for the production of documents, records, papers, books, supplies, devices,
equipment, and all other instrumentalities related to matters within the jurisdiction of the Commission or the
Authority.

(e) Failure to comply with a subpoena or with the other provisions of this Rule may be penalized by the
imposition of one or more penalties set forth in Rule 8200.

(f) The Commission or the Authority may administer oaths to witnesses and require witnesses to testify under
oath in matters within the jurisdiction of the Commission or the Authority.

Horseracing Integrity and Safety Authority


End Notes
1. Comment to Article 2.3.2: This Article does not apply to a Covered Horse that does not provide a urine Sample due to
the lack of need to urinate. Any challenge based on Intractability will be adjudicated in accordance with the procedures for
Minor Infractions.
2. Comment to Article 4.2.1: Additional guidance on the use of therapeutic substances is available through the Agency’s
website.
3. Any challenge to a sit out period based on Article 5.4 will be adjudicated in accordance with the procedures for Minor
Infractions
4. If a deadline set forth in the Protocol falls on a weekend or federal holiday, the deadline will be the next business day
5. Comment to Article 10.5: This Article will only apply in truly exceptional circumstances, for example, where a Covered
Person could prove that, despite all due care, they or their Covered Horse were sabotaged by a competitor or a Covered
Horse ingested feed contaminated at the time of manufacture, growth, or harvest. Conversely, No Fault or Negligence
would not apply, for example, in the following circumstances: (a) a positive test resulting from a mislabeled or
contaminated supplement; (b) the Administration of a Prohibited Substance by someone employed, supervised, or
contracted, or requested by any Covered Person associated with the Covered Horse to provide care, training, or other
services to a Covered Horse; and (c) sabotage or contamination of the Covered Horse’s food or drink by a Covered
Person associated with the Covered Horse.
6. Comment to Article 10.12.1: The Agency expect that State Racing Commission will determine the impact a period of
Ineligibility has on a license to ensure compliance with the Protocol
7. Comment to Article 10.12.1.1: The Responsible Person, or Owner if no Responsible Person, has three business days
to arrange for the Covered Horse to leave the Racetrack

Horseracing Integrity and Safety Authority

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