Notice2023-00957
HISA Anti-Doping and Medication Control Rule
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
January 26, 2023
Effective
March 27, 2023
Issuing agencies
Federal Trade Commission
Abstract
The Horseracing Integrity and Safety Act of 2020 recognizes a self-regulatory nonprofit organization, the Horseracing Integrity and Safety Authority, which is charged with developing proposed rules on a variety of subjects. Those proposed rules and later proposed rule modifications take effect only if approved by the Federal Trade Commission. The proposed rules and rule modifications must be published in the Federal Register for public comment. Thereafter, the Commission has 60 days from the date of publication to approve or disapprove the proposed rule or rule modification. The Authority submitted to the Commission a proposed rule on Anti-Doping and Medication Control on December 30, 2022. The Office of the Secretary of the Commission determined that the proposal complied with the Commission's rule governing such submissions. This document publicizes the Authority's proposed rule's text and explanation, and it seeks public comment on whether the Commission should approve or disapprove the proposed rule. This document is substantially similar to the document published on October 28, 2022, as corrected on November 4, 2022, and the Commission will consider all comments filed in response to that document as well as all comments filed in response to this document.
Full Text
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<title>Federal Register, Volume 88 Issue 17 (Thursday, January 26, 2023)</title>
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[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5070-5201]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-00957]
[[Page 5069]]
Vol. 88
Thursday,
No. 17
January 26, 2023
Part II
Federal Trade Commission
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HISA Anti-Doping and Medication Control Rule; Notice
Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 /
Notices
[[Page 5070]]
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FEDERAL TRADE COMMISSION
[Matter No. P222100]
HISA Anti-Doping and Medication Control Rule
AGENCY: Federal Trade Commission.
ACTION: Notice of Horseracing Integrity and Safety Authority (HISA)
proposed rule; request for public comment.
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SUMMARY: The Horseracing Integrity and Safety Act of 2020 recognizes a
self-regulatory nonprofit organization, the Horseracing Integrity and
Safety Authority, which is charged with developing proposed rules on a
variety of subjects. Those proposed rules and later proposed rule
modifications take effect only if approved by the Federal Trade
Commission. The proposed rules and rule modifications must be published
in the Federal Register for public comment. Thereafter, the Commission
has 60 days from the date of publication to approve or disapprove the
proposed rule or rule modification. The Authority submitted to the
Commission a proposed rule on Anti-Doping and Medication Control on
December 30, 2022. The Office of the Secretary of the Commission
determined that the proposal complied with the Commission's rule
governing such submissions. This document publicizes the Authority's
proposed rule's text and explanation, and it seeks public comment on
whether the Commission should approve or disapprove the proposed rule.
This document is substantially similar to the document published on
October 28, 2022, as corrected on November 4, 2022, and the Commission
will consider all comments filed in response to that document as well
as all comments filed in response to this document.
DATES: If approved, the HISA proposed rule would take effect
immediately, and the Commission must approve or disapprove the rule by
March 27, 2023. Comments must be received on or before February 9,
2023.
ADDRESSES: Interested parties may file a comment online or on paper by
following the instructions in the Comment Submissions part of the
SUPPLEMENTARY INFORMATION section below. Write ``HISA Anti-Doping and
Medication Control'' on your comment and file your comment online at
<a href="https://www.regulations.gov">https://www.regulations.gov</a> under docket number FTC-2023-0009. If you
prefer to file your comment on paper, mail your comment to the
following address: Federal Trade Commission, Office of the Secretary,
600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC
20580.
FOR FURTHER INFORMATION CONTACT: Austin King (202-326-3166), Associate
General Counsel for Rulemaking, Office of the General Counsel, Federal
Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Self-Regulatory Organization's Statement of the Background,
Purpose of, and Statutory Basis for, the Proposed Rule
a. Background and Purpose
b. Statutory Basis
II. Self-Regulatory Organization's Statement of the Terms of
Substance of the Proposed Rule and Discussion of Alternatives
III. Self-Regulatory Organization's Summary of Comments Received
Pre-Submission and Its Responses to Those Comments
IV. Legal Authority
V. Effective Date
VI. Request for Comments
VII. Comment and Submissions
VIII. Communications by Outside Parities to the Commissioners or
Their Advisors
IX. Self-Regulatory Organization's Proposed Rule Language
Background
The Horseracing Integrity and Safety Act of 2020 \1\ recognizes a
self-regulatory nonprofit organization, the Horseracing Integrity and
Safety Authority, which is charged with developing proposed rules on a
variety of subjects. Those proposed rules and later proposed rule
modifications take effect only if approved by the Federal Trade
Commission.\2\ The proposed rules and rule modifications must be
published in the Federal Register for public comment.\3\ Thereafter,
the Commission has 60 days from the date of publication to approve or
disapprove the proposed rule or rule modification.\4\
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\1\ 15 U.S.C. 3051 through 3060.
\2\ 15 U.S.C. 3053(b)(2).
\3\ 15 U.S.C. 3053(b)(1).
\4\ 15 U.S.C. 3053(c)(1).
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Pursuant to Section 3053(a) of the Horseracing Integrity and Safety
Act of 2020 and Commission Rule Sec. 1.142, notice is hereby given
that, on December 30, 2022, the Horseracing Integrity and Safety
Authority (``HISA'' or the ``Authority'') filed with the Federal Trade
Commission a proposed Anti-Doping and Medication Control rule and
supporting documentation as described in Items I, II, III, IV, and IX
below, which Items have been prepared by HISA. The Office of the
Secretary of the Commission determined that the filing complied with
the Commission's rule governing such submissions.\5\ The Commission
publishes this Notice to solicit comments on the proposed rule from
interested persons. This document is substantially similar to the
document published on October 28, 2022, 87 FR 65292, as corrected on
November 4, 2022, 87 FR 66705, and the Commission will consider all
comments filed in response to that document as well as all comments
filed in response to this document.
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\5\ 16 CFR 1.140 through 1.144; see also Fed. Trade Comm'n,
Procedures for Submission of Rules Under the Horseracing Integrity
and Safety Act, 86 FR 54819 (Oct. 5, 2021).
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I. Self-Regulatory Organization's Statement of the Background, Purpose
of, and Statutory Basis for, the Proposed Rule
a. Background and Purpose
The Act recognizes that the establishment of a national set of
uniform standards for racetrack safety and medication control will
enhance the safety and integrity of horseracing. As part of this
endeavor, section 3053(a) of the Act directs the Authority to develop
proposed rules relating to ``(2) a list of permitted and prohibited
medications, substances, and methods, including allowable limits of
permitted medications, substances, and methods; (3) laboratory
standards for accreditation and protocols; [. . .] (8) a description of
safety, performance, and anti-doping and medication control rule
violations applicable to covered horses and covered persons; (9) a
schedule of civil sanctions for violations; and (10) a process or
procedures for disciplinary hearings.'' \6\
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\6\ 15 U.S.C. 3053(a)(2)-(3), (8)-(10).
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With the review, input, and ultimate approval of the Anti-Doping
and Medication Control Standing Committee (``ADMC'') and the
Authority's Board of Directors, the proposed rules: (1) set forth a
list of anti-doping and controlled medication rules; (2) set forth a
list of prohibited substances and methods; (3) set forth a framework
for the testing of covered horses and the investigation of possible
rule violations by the Horseracing Integrity and Welfare Unit (the
``Agency''); (4) set forth a framework by which laboratories will be
accredited and will analyze samples for prohibited substances and
markers of prohibited methods; (5) specify the civil sanctions that
apply to anti-doping and controlled medication violations; (6) create
procedures for disciplinary hearings, tailored to the nature of the
charge. The Agency participated in the development of the proposed rule
and approves of the rules as filed.
[[Page 5071]]
In compliance with 16 CFR 1.142(a), the Authority states that the
reason for adopting the Protocol is that the Horseracing Integrity and
Safety Act of 2020 (``Act'') mandates and empowers the Horseracing
Integrity and Safety Authority (the ``Authority'') to establish a
uniform anti-doping and controlled medication program to improve the
integrity and safety of horseracing in the United States (``Program'').
The Equine Anti-Doping and Controlled Medication Protocol
(``Protocol'') has been developed and issued by the Authority as part
of that mandate. It contains or incorporates by reference rules,
standards, and procedures to improve and protect the integrity and
safety of horseracing in the United States by deterring and penalizing
the improper administration or application of Prohibited Substances and
Prohibited Methods to Covered Horses. The Protocol is split into five
chapters: (1) the purpose, scope, and organization of the Protocol; (2)
the Prohibited List, rules of proof, and testing and investigations;
(3) the Equine Anti-Doping Rules; (4) the Equine Controlled Medication
Rules; and (5) other violations and general procedure/administration.
The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except if specified otherwise.
The Protocol and related rules are intended to address the need for
uniformity in horseracing, to protect the welfare of Covered Horses, to
safeguard the integrity of horseracing, and to ensure the confidence of
stakeholders (including the betting public) in the sport. Prior to the
implementation of the Authority, horseracing has been regulated in the
United States by the States. By its nature, this results in a lack of
uniformity in the rules of horseracing, including in many vital areas
of equine safety and the proper regulation of the use of prohibited
substances. Congress acted to impose a comprehensive program that would
effectively regulate horseracing with a common set of rules. The
Protocol was developed in collaboration with industry experts and
stakeholders who brought to the endeavor an unparalleled depth of
equine safety, anti-doping, veterinary medicine, sports integrity, and
compliance experience. The Protocol will provide one standard set of
rules that apply to doping and medication control, laboratory drug
testing methods and techniques, sample collection procedures,
investigatory procedures, and hearing and adjudication procedures that
will enhance the effective regulation of horse safety and medication
issues.
In considering reasonable alternatives to the proposed rule or
modification that may accomplish the stated objective, it is important
to underline that the Authority and the development of the Protocol is
unprecedented. As a consequence, there are of course countless
``alternatives'' on various issues, but the Authority has sought to
combine the best practice elements from various sources, including
rules and practices developed by the global anti-doping community,
horseracing authorities (national and international), and other equine
sport organizations.
The Protocol will affect Covered Persons, Covered Horses, and
Covered Horseraces by ensuring that horseracing is conducted in a
manner that is consistent with the highest standards of integrity and
that prioritizes the safety of Covered Horses and Covered Persons. The
welfare of Covered Horses is secured by rules that strictly ban and
penalize the use of doping substances and methods, and that sanction
the misuse of therapeutic medications. All Covered Persons are required
to comply with the Protocol and related rules, and to cooperate with
the Authority and the Agency in relation to all aspects of doping and
medication control, including sample collection, testing, and
investigation procedures. The manner in which the Protocol implements
these requirements is outlined in detail in Item II of this Notice.
In developing the Protocol and related rules in a manner that is
consistent with the Act and the rules and regulations applicable to the
Authority, the Authority took the following principles and mandates
into consideration, as directed by section 3055(b) of the Act:
(1) Covered Horses should compete only when they are free from the
influence of medications, other foreign substances, and methods that
affect their performance. The entire Protocol is dedicated to this
principle, and the elaborate anti-doping and controlled medication
rules work toward the objective of ensuring that Covered Horses compete
in a manner that is free of the influence of doping substances,
medications, and methods that affect their performance. The Prohibited
List and related Technical Document prescribe the substances and
methods that are prohibited and permitted under certain circumstances.
The Standards (Rules 5000 and 6000 Series) set out comprehensive
investigatory and sample collection provisions and an accreditation
system that ensures accurate laboratory testing, and the Arbitration
Procedures establish a set of disciplinary procedures to deal fairly
but firmly with violations of the rules.
(2) Covered Horses that are injured or unsound should not train or
participate in covered races, and the use of medications, other foreign
substances, and treatment methods that mask or deaden pain in order to
allow injured or unsound horses to train or race should be prohibited.
In the Protocol, Rule 3111 operates together with the Prohibited List
to ban substances and methods for which there exists medical,
veterinary, or other scientific evidence or experience to a support
their actual or potential masking properties (``Banned Substances'' and
``Banned Methods'') and to restrict the use of medications during the
Race Period (``Controlled Medication Substances'' and ``Controlled
Medication Methods''). Certain Controlled Medication Substances are
also prohibited during workouts, as set out in the Prohibited List. The
Protocol also operates in conjunction with the Rule 2000 Racetrack
Safety Program, which sets forth stringent rules for placing Covered
Horses on the Veterinarians' List and requires the Regulatory
Veterinarian to oversee removal from the list. These processes help to
ensure that injured and unsound horses do not train or participate in
Covered Horseraces. It should also be noted that Rule 2271 in the
Racetrack Safety Program prohibits the ``[u]se 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.''
(3) Rules, standards, procedures, and protocols regulating
medication and treatment methods for Covered Horses and Covered
Horseraces should be uniform and uniformly administered nationally. The
Protocol preempts state laws and provides instead a uniform set of
comprehensive rules that embrace all of the areas previously addressed
in state anti-doping and medication
[[Page 5072]]
control regulation schemes. The entire scheme will be administered
nationally by the Authority and the Agency to ensure uniform and
consistent application of the law. The Protocol and related rules will
create a comprehensive program that is unprecedented in horseracing as
previously conducted and regulated in the United States.
(4) Consideration should be given to international anti-doping and
medication control standards of the International Federation of
Horseracing Authorities (``IFHA'') and the Principles of Veterinary
Medical Ethics of the American Veterinary Medical Association. As
directed by the Act, the ADMC has scrutinized the IFHA standards and
rules very closely and also considered the Principles of Veterinary
Medical Ethics of the American Veterinary Medical Association in
preparing the Protocol. The World Anti-Doping Code also provided much
of the inspiration for the Protocol, adapted as necessary for
horseracing, taking into account national and international horseracing
rules and Equine Anti-Doping and Controlled Medication Regulations of
the International Equestrian Federation (i.e., the global governing
body for equestrian sport).
(5) The administration of medications and treatment methods to
Covered Horses should be based upon an examination and diagnosis that
identifies an issue requiring treatment for which the medication or
method represents an appropriate component of treatment. The Protocol
addresses the requirement for a sound diagnosis as a prerequisite for
treatment and the need for such treatment not to be administered in a
manner contrary to horse welfare. Specifically, Rule 3040(b)(3) states
that it is the personal responsibility of each Responsible Person to
ensure that treatments and medications administered to his or her
Covered Horses (i) are administered only on the advice of a
Veterinarian or (if a prescription is not required) following
sufficient due diligence regarding the treatment or medication; (ii)
are not administered in a manner detrimental or contrary to horse
welfare; (iii) are the minimum necessary to address the diagnosed
health concerns identified during the veterinary examination and
diagnostic process; (iv) do not contain a Banned Substance or involve a
Banned Method; and (v) do not otherwise violate the Protocol. Further,
Rule 3314 penalizes use of a Controlled Medication Substance or Method
in a manner that is contrary to horse welfare. In particular, Rule
3314(a) specifically mandates that any use of a Controlled Medication
Substance or a Controlled Medication Method on a Covered Horse must
``(i) be justified by the Covered Horse's medical condition(s) as
diagnosed by a Veterinarian, (ii) have been recommended by a
Veterinarian in the context of a valid veterinarian-patient-client
relationship, (iii) go no further than the minimum necessary to address
the diagnosed health concerns, and (iv) be in the best interests of the
Covered Horse's health and welfare.'' Rule 3314(b) also states that it
is ``the personal and non-delegable duty of the Responsible Person'' to
ensure the above requirements in Rule 3314(a) are complied with. The
Protocol also establishes in Rules 3227 and 3327 that an aggravating
circumstance that may be taken into account in assessing sanctions for
a rule violation may include ``administration of a Controlled
Medication Substance that is detrimental to the health and welfare of
the horse or is designed to deceive the betting public.'' It should
also be noted that Rule 2221 (of the previously approved Racetrack
Safety Rule) also establishes examination and diagnoses requirements in
the context of the veterinarian-client-patient relationship.
(6) The amount of therapeutic medication that a Covered Horse
receives should be the minimum necessary to address the diagnosed
health concerns identified during the examination and diagnostic
process. As noted above, Rule 3040(b)(3) and Rule 3314 specifically
address the requirement that any use of a Controlled Medication
Substance or a Controlled Medication Method on a Covered Horse must go
no further than ``the minimum necessary to address the diagnosed health
concerns.''
(7) The welfare of Covered Horses, the integrity of the sport, and
the confidence of the betting public require full disclosure to
regulatory authorities regarding the administration of medications and
treatments to Covered Horses. The Protocol addresses this issue in
several ways. It requires all Covered Persons to cooperate promptly and
completely with the Authority and the Agency in the exercise of their
respective powers under the Act and the Protocol and related rules
(Rule 3040(a)). Each Responsible Persons is required to maintain
accurate, complete, and up-to-date treatment records of his or her
Covered Horses in a form specified by the Agency, and to provide the
records on request to the Agency (Rule 3040(b)(8)). Responsible Persons
must declare to the Agency any use of Banned Substances or Banned
Methods on a horse prior to it becoming a Covered Horse (Rule
3040(b)(9)). To facilitate out-of-competition testing, Responsible
Persons must file whereabouts information if their Covered Horses are
moved to a private facility (Rule 3040(b)(10)). Attending Veterinarians
must keep updated treatment records in an electronic database
designated by the Agency or in any other form designated by the Agency
and must provide access on request to copies of these records (Rule
3040(d)). Refusal or failure to cooperate with the Authority or the
Agency, or the commission of a Whereabouts Failure, constitutes a
violation of the Protocol under Rule 3510. Several provisions in the
Rule 2000 Series complement the Protocol's disclosure requirements.
Rule 2551, for example, requires every Veterinarian who examines or
treats a Covered Horse to submit to the Authority, within 24 hours of
such examination or treatment medications, treatment records with
details as prescribed in the Rule.
In further compliance with the Act, the Protocol establishes a
comprehensive set of violations and hearing procedures to prohibit
certain conduct, to provide a process for determining the existence of
a violation; of charging a Covered Person with a violation; and with
resolving the matter in a full and fair hearing process. The Protocol
authorizes the imposition of sanctions that comport with the severity
of the violation. Consistent with 15 U.S.C. 3057(d)(2), the violation
and sanction system is tailored to the unique aspects of horseracing in
that it has the power to declare a Covered Person or Covered Horse
ineligible to race for a specified time, imposes substantial fines upon
Covered Persons, and establishes a points system to implement a system
of penalties for multiple violations of the Protocol. These penalties
are common in the adjudication and sanction of violations in the world
of horseracing. The sanctions also include forfeiture of purse,
disqualification of horses, and changes to the order of finish in horse
races. The elaborate hearing procedures and penalty rules ensure that
violations are consistently and fairly penalized, which in turn deters
future violations, and maintains the integrity and conduct of fair and
transparent horseraces. Effective sample collection and testing
techniques, as set forth in Rule Series 5000 and 6000 also serve to
enhance successful prosecution of violations, which deter future
violations. The goal of transparency is also served by operation of the
public disclosure rules in the Protocol, which
[[Page 5073]]
mandate that the public be informed of information concerning specific
cases as the cases are adjudicated or otherwise resolved.
The components of the Protocol and related rules comport with the
baseline standards in 15 U.S.C. 3055(g)(2)(a), which include: (1) the
lists of permitted and prohibited substances (including drugs,
medications, and naturally occurring substances and synthetically
occurring substances) in effect for the International Federation of
Horseracing Authorities, including the International Federation of
Horseracing Authorities International Screening Limits for urine, dated
May 2019, and the International Federation of Horseracing Authorities
International Screening Limits for plasma, dated May 2019; (2) the
World Anti-Doping Agency International Standard for Laboratories
(version 10.0), dated November 12, 2019; (3) the Association of Racing
Commissioners International out-of-competition testing standards, Model
Rules of Racing (version 9.2); and (4) the Association of Racing
Commissioners International penalty and multiple medication violation
rules, Model Rules of Racing (version 6.2). Any deviations from the
baseline standards have been approved by the Authority and the Agency
following detailed consideration and adoption of an approach that is
either stricter or more consistent with horseracing.
b. Statutory Basis
The Horseracing Integrity and Safety Act of 2020, 15 U.S.C. 3051
through 3060.
II. Self-Regulatory Organization's Statement of the Terms of Substance
of the Registration Proposed Rule and Discussion of Alternatives
a. Existing Standards
Anti-doping and controlled medication rules currently vary from
State to State, but the overall structure of the rules governing
horseracing is generally consistent among the States. In particular,
the rules of horseracing center around a number of common subject
areas, including the licensing of racing associations and of individual
participants in horseracing, medication control rules, pari-mutuel
wagering rules, the operation of various incentive funds, rules
concerning the running of the race, and rules establishing disciplinary
measures and hearing procedures. The basic precepts of many of the
rules pertaining to violations, sanctions, hearing procedures, and
investigatory powers have been in force in racing states for many
years, and the Authority has reviewed and considered key provisions
from numerous states in developing these rules.
The Association of Racing Commissioners International (``ARCI'')
sets forth standards and protocols in its Model Rules of Racing (``ARCI
Rules''). Relying upon the collective expertise of regulatory personnel
in member jurisdictions in consultation with regulated entities,
industry stakeholders, and individuals, ARCI committees regularly
consider ways to improve and enhance the regulation of racing. The
Authority considered the ARCI Model Rules of Racing when developing the
Protocol and related rules. Likewise, the Authority considered rules
from other racing jurisdictions such as the British Horseracing
Authority's Rules of Racing.
The Authority also considered and relied heavily on international
anti-doping standards, including the World Anti-Doping Code (applicable
to human athletes) and the International Equestrian Federation
(``FEI'') Equine Anti-Doping and Controlled Medication Regulations
(applicable at the international level to various equestrian
disciplines). Those regulations provide a robust anti-doping framework
that has been tested before arbitration tribunals for many years, and
that has generated a well-developed body of precedent and guidance for
interpreting the provisions in those frameworks.
The Authority, in consultation with the ADMC and the Agency,
reviewed these existing standards and tailored them to the Authority's
regulatory structure and goals, and to the specificities of
horseracing.
The provisions of these Series were made publicly available on the
Authority website at <a href="http://www.hisaus.org/regulations">www.hisaus.org/regulations</a> on June 1, 2022. A
number of stakeholder comments were received, which are addressed
further in Item III below. Additionally, the Authority consulted
directly with a number of industry officials and participants in
obtaining feedback on the proposed rules. The Authority is submitting
those comments along with this Notice of Filing as Exhibit A, which is
available for public inspection at the corresponding docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Furthermore, all the important source materials on
which the Authority relied in developing its proposed rule are also
collected at that docket as Exhibit B.
b. Terms of Substance: Rule Series 3000--Equine Anti-Doping and
Controlled Medication Protocol
1. Purpose, Scope, and Organization--Rules 3010-3090
Chapter I of the Protocol has been developed taking account of the
requirements of the Act, including, in particular, those set out at
sections 3054 and 3055 of the Act.
The Protocol will go into effect if and when the Commission
approves the proposed rule. The Protocol contains or incorporates by
reference rules, standards, and procedures to improve and protect the
integrity and safety of horseracing in the United States by deterring
and penalizing the improper administration or application of Prohibited
Substances and Prohibited Methods to Covered Horses. The Protocol is
divided into five substantive chapters: (1) the purpose, scope, and
organization of the Protocol; (2) the Prohibited List, rules of proof,
and testing and investigations; (3) the Equine Anti-Doping Rules; (4)
the Equine Controlled Medication Rules; and (5) other violations and
general procedure/administration.
The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except if specified otherwise. This division accords with international
best practices. However, the two distinct processes share many common
features and rules, and therefore the Protocol is streamlined to make
the processes consistent with each other wherever possible.
The Protocol will be implemented and enforced on behalf of the
Authority by the Agency, which has created an entity designated as the
Horseracing Integrity and Welfare Unit (``Agency''). In addition, and
only where so agreed, State Racing Commissions acting under the
delegated authority of the Authority
[[Page 5074]]
or the Agency (Rule 3010(e)) may also assist in implementation.
In accordance with section 3055(a)(1) of the Act, the Protocol
applies to all Covered Horses, Covered Persons, and Covered Horseraces
(Rule 3020). Pursuant to section 3054 of the Act, Covered Persons must
register with the Authority.
In developing the Protocol, the Authority reviewed and considered
various anti-doping and controlled medication rules, including:
Exhibit B.2. ARCI Model Rules of Racing, including, in particular, the
penalty provisions and rules on multiple medication violation.
Exhibit B.3. FEI Equine Anti-Doping & Controlled Medication
Regulations.
Exhibit B.4. FEI Atypical Findings Policy.
Exhibit B.5. World Anti-Doping Code.
Exhibit B.6. British Horseracing Authority Equine Anti-Doping Rules.
2. Prohibited List, Rules of Proof, and Testing and Investigations--
Rules 3110-3140
The Protocol incorporates the Prohibited List, which identifies the
Banned Substances and Banned Methods that are prohibited at all times
on the basis of the Agency's determination that medical, veterinary, or
other scientific evidence or experience supports their actual or
potential (i) ability to enhance the performance in Covered Horses,
(ii) masking properties, or (iii) detrimental impact on horse welfare.
The Prohibited List also identifies Controlled Medication Substances
and Controlled Medication Methods, which are prohibited for Use on or
Administration to a Covered Horse during the Race Period and must not
be present in a Post-Race Sample or Post-Work Sample, except as
specified otherwise. In other words, the phrase ``Prohibited Substances
and Prohibited Methods'' refers to Banned Substances and Banned Methods
as well as Controlled Substances and Controlled Medication Methods that
are only restricted during the Race Period. The Prohibited List will be
published at least annually (Rule 3112).
The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances
that fall into the general categories listed in the Prohibited List and
sets forth detection times, screening limits, and thresholds for those
Prohibited Substances. The Technical document also designates certain
Prohibited Substances as Specified Substances, which are those that
pose a higher risk of being the result of contamination and that are,
therefore, subject to more flexible sanctions.
In disciplinary cases brought under the Protocol, the Agency will
have the burden of establishing that a violation of the Protocol has
occurred to the comfortable satisfaction of the hearing panel, bearing
in mind the seriousness of the allegation made (Rule 3121), and facts
may be established by any reliable means (Rule 3122). The ``comfortable
satisfaction'' standard of proof is greater than a mere balance of
probability (i.e., a preponderance of the evidence) but less than clear
and convincing evidence or proof beyond a reasonable doubt (Rule 3121).
Only the Agency (and those authorized by the Agency) may initiate
and direct testing on any Covered Horse. The Agency will have broad
authority to conduct testing both in and out of competition (Rule
3132), and samples collected will be owned by the Authority (Rule
3135). Samples obtained from Covered Horses will be analyzed primarily
to detect the presence of Prohibited Substances (Rule 3137).
State Racing Commissions, Racetracks, Race Organizers, and Training
Facilities shall not initiate or direct any Testing of Covered Horses.
However, they may request that the Agency initiate and direct enhanced
or additional Testing (e.g., in relation to a particular Covered
Horserace). The Agency may accept or decline such request at its
absolute discretion. Where the Agency accepts the request, the costs of
Sample collection and analysis shall be borne by the entity requesting
the additional or enhanced Testing. The Agency may conduct the Testing
itself or delegate the Testing to the relevant State Racing Commission.
(Rule 3132).
3. Equine Anti-Doping Rules--Rules 3210-3260
The Equine Anti-Doping Rules set out in Chapter III of the Protocol
apply to conduct involving Banned Substances or Banned Methods, i.e.,
substances and methods prohibited at all times. The violations set out
in this Chapter are included as directed by section 3057(a)(2) of the
Act, and are also substantively modelled on World Anti-Doping Code
violations. The violations prohibit use, possession, trafficking, and
administration to a Covered Horse of Banned Substances or Banned
Methods (Rules 3213 and 3214). It is a violation to evade, refuse or
fail to submit a Covered Horse to sample collection (Rule 3215), and
the presence of a Banned Substance in a sample collected from a Covered
Horse is also a violation (Rule 3212). In accordance with section
3057(a)(2) of the Act, presence and use violations are strict liability
offenses for the Responsible Person, although other Covered Persons may
also be liable to the same extent if they are complicit in the
violation. Other prohibited conduct includes tampering with doping
control, complicity with another person's violation, associating with a
person who is banned, and improper retaliation against actual or
potential whistle-blowers or intimidation of witnesses (Rule 3216).
Attempts to commit Anti-Doping Rule Violations are also sanctionable.
As directed by the Act, the Authority has developed a list of civil
sanctions for Anti-Doping Rule Violations. The Protocol and Prohibited
List establish uniform rules imposing civil sanctions against Covered
Persons and Covered Horses for Anti-Doping Rule Violations (and also
for Controlled Medication Rule Violations, addressed under chapter IV
of the Protocol), as directed by section 3057(d) of the Act. The range
of civil sanctions (a) take into account the unique aspects of
horseracing; (b) are designed to ensure fair and transparent Covered
Horseraces; and (c) are intended to deter violations. The severity of
the sanctions depends on the nature of the violation, and allows an
opportunity for adjustment in penalty depending on the violation and
facts involved.
A mandatory part of each sanction will include Public Disclosure of
relevant information, including the Covered Person's name, the
violation, and consequences imposed (Rules 3231 and 3620).
If the violation arises from a Post-Race Sample or occurs during
the Race Period, the Covered Horse's results at that Covered Horserace
will automatically be disqualified, because the horse competed with a
Banned Substance in its system, irrespective of the reason why the
Banned Substance was there or any degree of fault on the part of the
Covered Person (Rule 3221(a)). Subsequent results may also be
disqualified (Rule 3221(b)) and in any case of disqualification, all
purses and other compensation, prizes, trophies, points, and rankings
are forfeited and must be repaid or surrendered to the race organizer,
and the results of the other Covered Horses in the race in question
must be adjusted accordingly (Rule 3221(c)).
The Protocol now also specifies what happens to the race
classification pending the outcome of the disciplinary proceedings
(Rules 3221 and 3321). Further, Rule 3221(a) allows for the Agency, the
Responsible Person, and the
[[Page 5075]]
Owner of the Covered Horse in question to agree (or to ask the
Arbitral) to apply Rule 3221 immediately, i.e., prior to adjudication
of any other issue.
In presence or use cases, the Covered Horse will be subject to a
period of ineligibility, the length of which depends on the particular
Banned Substance(s) detected, as set out in the Prohibited List. During
any period of ineligibility, the Covered Horse shall not participate in
any Workout or Covered Horserace, but will remain subject to testing
(Rule 3229).
The Covered Person will be sanctioned with a period of
ineligibility commensurate to his or her level of fault, in accordance
with a detailed sanctioning framework. The starting point for presence,
use, possession, or administration violations is a period of
ineligibility of two years, subject to elimination or reduction if the
Covered Person can demonstrate that he or she bears no or no
significant fault or negligence, or subject to increase if aggravating
circumstances are present (Rules 3223(b), 3224, and 3225). For other
violations, the rules specify other starting points or ranges for the
applicable period of ineligibility that reflect the seriousness of the
violation (Rule 3223(b)). The rules also provide the Authority with the
ability to eliminate or reduce an applicable period of ineligibility in
circumstances where a Covered Person provides Substantial Assistance or
admits the violation early or in the absence of other evidence (Rule
3226). There are also increased sanctions for repeat offenders (Rule
3228). During any period of ineligibility, the Covered Person shall not
participate in any capacity in any activity involving Covered Horses or
in any other activity (other than authorized anti-doping education or
rehabilitation programs) taking place at a Racetrack or Training
Facility; nor shall he or she permit anyone to participate in any
capacity on his or her behalf in any such activities (Rule 3229(a)).
The Covered Horse(s) of an Owner or Trainer subject to a Provisional
Suspension or period of Ineligibility shall also be subject to
restrictions (Rule 3229(b)).
The Covered Person may also be required to pay a fine, depending on
the violation, and some or all of the Agency's legal costs (Rule
3223(b)).
Where a Covered Person is found based on the same facts to have
committed a violation involving both (i) one or more Banned
Substance(s) or Banned Method(s), and (ii) one or more Controlled
Medication Substance(s) or Controlled Medication Method(s), the Covered
Person shall be considered to have committed one Anti-Doping Rule
Violation and the sanction imposed shall be based on the Banned
Substance or Banned Method that carries the most severe sanction. Rule
3227 (Aggravating Circumstances) may also be applied to increase the
sanction imposed (Rule 3228(d)).
The Equine Anti-Doping Rules provide a framework for the results
management of potential anti-doping rule violations, as directed by the
Act. Different types of Samples may be collected from Covered Horses,
including urine, blood, and hair. Unless specified otherwise in the
rules, at the time of collection, the Sample will be divided into an
``A'' and a ``B'' Sample. Review of ``A Sample'' adverse analytical
findings or other evidence leads to an initial notification by the
Agency to the Covered Person that he or she may have committed an anti-
doping rule violation (Rule 3245). In some cases, the Covered Person
will be provisionally suspended pending determination of the matter
(Rule 3247), and the ``B Sample'' may be tested (Rule 3246). The
Covered Person is entitled to respond to the Agency's initial
notification, and if he or she does, the Agency will take any comments
and additional information into account before deciding whether to
formally charge the Covered Person with an anti-doping rule violation
and request a more formal response (Rule 3248)).
The Covered Person is entitled to have the charge determined by the
Arbitral Body (the panel hearing will consist of either one or three
impartial arbitrators) in accordance with the Arbitration Procedures
(Series 7000). The final decision of the Arbitral Body is subject to
review in accordance with the Act (Rule 3264). The rules also provide
for the Agency and Covered Person to agree to a resolution to the
charge without a hearing (Rule 3249).
4. Equine Controlled Medication Rules--Rules 3310-3360
The Equine Controlled Medication Rules set out in Chapter IV of the
Protocol apply to conduct involving Controlled Medication Substances or
Controlled Medication Methods (i.e., substances prohibited for use on
or administration to a Covered Horse during the Race Period and
prohibited to be present in a Post-Race Sample or Post-Work Sample,
except as otherwise specified in the Prohibited List). The violations
set out in this Chapter are drawn from similar provisions to those
relating to Anti-Doping Rule Violations, modified to reflect the
differing approaches to the use of Controlled Medication Substances and
Controlled Medication Methods, as opposed to Banned Substances and
Banned Methods. The violations include the use, possession, or
administration to a Covered Horse of Controlled Medication Substances
or Controlled Medication Methods during the Race Period (Rules 3313 and
3315). Other violations include use of a Controlled Medication
Substance that is not justified by the horse's medical condition or
does not meet other criteria (Rule 3314), tampering with medication
control (Rule 3316), and the presence of a Controlled Medication
Substance in a sample collected from a Covered Horse (Rule 3312). In
accordance with section 3057(a)(2) of the Act, presence and use
violations are considered strict liability offenses. Attempts to commit
Controlled Medication Rule Violations are also sanctionable.
As directed by the Act, the Authority has developed a list of civil
sanctions for Controlled Medication Rule Violations. The Protocol and
Prohibited List establish uniform rules imposing civil sanctions
against Covered Persons and Covered Horses for Controlled Medication
Rule Violations, as directed by section 3057(d) of the Act. The range
of civil sanctions (a) take into account the unique aspects of
horseracing; (b) are designed to ensure fair and transparent Covered
Horseraces; and (c) are intended to deter violations. The severity of
the sanctions depends on the nature of the violation, and allows an
opportunity for adjustment depending on the violation and facts
involved.
A mandatory part of each sanction will include Public Disclosure of
relevant information, including the Covered Person's name, the
violation, and consequences imposed (Rules 3331 and 3620).
If the violation arises from a Post-Race Sample or occurs during
the Race Period, the Covered Horse's results at that Covered Horserace
will automatically be disqualified, with all resulting consequences,
because the horse competed with a Controlled Medication Substance in
its system. The results will be automatically disqualified irrespective
of the reason why the Controlled Medication Substance was detected or
of any degree of fault on the part of the Covered Person (Rule
3321(a)). Subsequent results will not be disqualified (Rule 3321(b)).
The Covered Horse will not be subject to a period of ineligibility
if the violation involves a Controlled Medication Substance, but may be
subject to a period of ineligibility if the violation involves a
Controlled Medication Method as specified in the Prohibited List (Rule
3322).
[[Page 5076]]
Covered Persons shall be sanctioned for any Controlled Medication
Rule Violations in accordance with Rule 3323(b), depending on the
category or class of the violation, and the number of violations
committed within that same category/class in the previous two-year
period. Presence, use, and administration violations are divided into
three different classes (Class A, Class B, Class C) with Class A
carrying the more severe sanctions. The sanctions for Controlled
Medication Rule Violations are subject to elimination (Rule 3324),
reduction (Rules 3325 and 3326), or increase (Rule 3327), depending on
the violation in issue and the specific circumstances of the case.
The Protocol also establishes a multiple medication violation
penalty points system for repeat offenders which takes account of
violations committed in different categories/classes (Rule 3328). As
directed by section 3055(g) of the Act, the Authority used the
Association of Racing Commissioners International penalty and multiple
medication violation rules, Model Rules of Racing, as a baseline for
the multiple violations penalty points system. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the ADMC and the Agency in accordance with section
3055(g)(3) of the Act.
The penalty points system is not a substitute for the consequences
that apply to the underlying Controlled Medication Rule Violations.
Rather, the penalty points system is intended to apply additional
uniform Consequences where the Covered Person is a repeat offender and
exceeds the permissible number of points. Where the relevant cumulative
point threshold is exceeded, the Covered Person shall receive an
automatic additional period of ineligibility as specified in Rule
3328(c). Penalty points are assigned automatically depending on the
category/class of violation in issue, save where specified otherwise in
Rule 3328. Penalty points and the additional period of Ineligibility
shall be applied automatically at the conclusion of the proceeding on
the underlying violation, without any additional hearing or right of
review. Penalty points shall be applied retroactively to start on the
date on which the Controlled Medication Rule Violation occurred and
shall expire after 2 years (Rule 3328(d)).
During any period of Ineligibility or Provisional Suspension,
Covered Persons shall be prohibited from the same activities as anyone
banned for an Anti-Doping Rule Violation. As for Anti-Doping Rule
Violations, the Covered Horses of a suspended Trainer or Owner may not
participate in any Timed and Reported Workout or Covered Horserace, but
in contrast to Anti-Doping Rule Violations, they may participate in a
Covered Horserace if they were entered in the race before the Trainer
was notified of the Provisional Suspension or the period of
Ineligibility was imposed (whichever is earlier) (Rule 3320(b)).
Further, in contrast to Anti-Doping Rule Violations, the Covered Horses
of a suspended Trainer must only be transferred to another Covered
Person if the period of ineligibility imposed on the Trainer is more
than 30 days (Rule 3329(b)).
The Covered Person may also be required to pay a fine depending on
the category of the violation, and some or all of the Agency's legal
costs (Rule 3323(b)).
The Equine Controlled Medication Rules provide a framework for the
results management of potential controlled medication rule violations
as directed by the Act, from review of ``A Sample'' adverse analytical
findings or other evidence leading to an initial notification by the
Agency to the Covered Person that he or she may have committed a
controlled medication rule violation (Rule 3345). The Covered Person
will not be provisionally suspended pending determination of the matter
unless he or she voluntarily accepts a provisional suspension (Rule
3347), and the B Sample may be tested (Rule 3346). The Covered Person
is entitled to respond to the Agency's initial notification, and if he
or she does, the Agency will take any comments and additional
information into account before deciding whether to formally charge the
Covered Person with a controlled medication rule violation and request
a more formal response (Rule 3348).
The Covered Person is entitled to request a hearing before the
Internal Adjudication Panel. The hearing will ordinarily be conducted
before a single member of the Internal Adjudication Panel, though three
members may be assigned to hear the case where appropriate. The
Internal Adjudication Panel may decide in its sole discretion to
determine the matter on the written submissions alone without a hearing
if the Internal Adjudication Panel considers itself sufficiently well-
informed to render a decision on the written submissions alone. The
Internal Adjudication Panel will issue a final decision, subject to
review in accordance with the Act (Rules 3361-3364).
The rules also provide for the Agency and Covered Person to agree
to a resolution to the charge without a hearing (Rule 3349).
5. Other Violations and General Procedure/Administration--Rules 3500-
3800
Chapter V sets out additional disciplinary offenses that do not
fall within the chapters on Equine Anti-Doping Rules or Equine
Controlled Medication Rules (Rule 3510), and also prescribes sanctions
(periods of ineligibility and fines) for those violations (Rule 3520).
Those violations include engaging in disruptive or offensive conduct
towards doping control personnel, refusing/failing to cooperate in full
with the Authority or Agency in the discharge of his or her respective
responsibilities under this Protocol, and committing a whereabouts
failure (in effect, failing to provide the necessary information to
enable a Covered Horse to be located for testing). Alleged violations
will be determined by the Internal Adjudication Panel (Rule 3361).
In accordance with section 3057(c)(2) of the Act, the rules provide
guidelines for confidentiality and public reporting of decisions (Rules
3610-3630). Rule 3710 also provides for the recognition of decisions by
recognized, official third parties, for example, national horseracing
authorities in other countries applying substantially similar rules
(Rule 3700).
c. Terms of Substance: Rule Series 1000--General Provisions
The Protocol and other Series are supported by the general rules of
interpretation (Rule 1010) and a list of defined terms (Rule 1020) to
assist with clarity of meaning.
d. Terms of Substance: Rule Series 4000--Prohibited List
As directed by sections 3053 and 3055 of the Act, the Authority has
developed a list of permitted and prohibited medications, substances,
and methods, including allowable limits of permitted medications,
substances, and methods, using as a baseline the lists of permitted and
prohibited substances (including drugs, medications, and naturally
occurring substances and synthetically occurring substances) in effect
for the International Federation of Horseracing Authorities (``IFHA''),
including the IFHA International Screening Limits for urine and the
IFHA International Screening Limits for plasma. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the
[[Page 5077]]
ADMC and the Agency in accordance with section 3055(g)(3) of the Act.
The Prohibited List identifies Prohibited Substances and Prohibited
Methods that are: (a) prohibited at all times (``Banned Substances''
and ``Banned Methods'') on the basis of the Agency's determination that
medical, veterinary, or other scientific evidence or experience
supports their actual or potential (i) ability to enhance the
performance in Covered Horses, (ii) masking properties, or (iii)
detrimental impact on horse welfare; or (b) prohibited for Use on or
Administration to a Covered Horse during the Race Period and prohibited
to be present in a Post-Race Sample (which includes samples collected
following a Covered Horserace or Vets' List Workout) or Post-Work
Sample (which includes samples collected following a Timed and Reported
Workout), except as otherwise specified in the Prohibited List
(``Controlled Medication Substances'' and ``Controlled Medication
Methods''). Prohibited Substances and Prohibited Methods may be
included in the Prohibited List by general category (e.g., anabolic
steroids) or by specific reference to a particular substance or method.
The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances
that fall into the general categories listed in the Prohibited List and
sets forth detection times, screening limits, and thresholds for those
Prohibited Substances. The Technical Document also designates certain
Prohibited Substances as Specified Substances, which are those that
pose a higher risk of being the result of contamination and that are
therefore subject to more flexible sanctions.
In accordance with section 3055(d) of the Act, the use or
administration of Controlled Medication Substances and Controlled
Medication Methods is prohibited during the ``Race Period'' (i.e., 48
hours prior to post-time) except where expressly provided otherwise in
the Prohibited List or Protocol. Responsible Persons are strictly
liable for any substance found to be present in a Post-Race Sample or
Post-Work Sample, even if such substance was used or administered
before the Race Period. As specified in section 3055(e) and (f) of the
Act, certain exemptions apply to furosemide (i.e., Lasix/Salix), which
are set out in the Prohibited List.
The Prohibited List and supporting Technical Document were prepared
in consultation with the ADMC and the Agency, and approved by the
Authority, as directed by section 3055(c)(5) of the Act. In preparing
the Prohibited List and the ``Technical Document--Prohibited
Substances,'' the Authority considered lists of prohibited substances
and methods published by other organizations, including the ARCI, World
Anti-Doping Agency (``WADA''), the FEI, and the British Horseracing
Association. Documents considered in preparing the Prohibited List are
exhibited below:
Exhibit B.7. IFHA International Screening Limits for urine.
Exhibit B.8. IFHA International Screening Limits for plasma.
Exhibit B.9. ARCI Uniform Classification Guidelines for Foreign
Substances and Recommended Penalties Model Rule.
Exhibit B.10. WADA 2022 Prohibited List.
Exhibit B.11. 2022 FEI Equine Prohibited Substances List.
Exhibit B.12. British Horseracing Association Equine Prohibited List
Code (2022).
Exhibit B.13. British Horseracing Association Published Detection Times
(June 2019).
Exhibit B.14. Hong Kong Jockey Club Medication and Prohibited
Substances.
The ADMC also considered a number of scientific papers when
developing the Prohibited List and supporting Technical Document:
Exhibit B.15. AAS 16 Detection of Some Designer Steroids in Horse
Urine: Identifies the integrity risks associated with the use of
anabolic steroids in racehorses.
Exhibit B.16. AAS 29 Anabolic Effects of [beta]2-agonists, formoterol
and salbutamol on cancellous bone of ovariectomized (OVX) rat: With the
banning of anabolic steroids, those seeking an anabolic effect turned
to [beta]2-agonists. Their misuse has been well-documented in horses
engaged in racing and training.
Exhibit B.17. ACA 01 Effects of intravenous aminocaproic acid on
exercise-induced pulmonary haemorrhage (EIPH): Although this drug has
extensive anecdotal support for effect in mitigating EIPH, this article
demonstrates no effect on the condition. While not regulated in human
sport, the illicit use of this substance, particularly in races where
furosemide is prohibited, represents an integrity threat.
Exhibit B.18. AU 04 Disposition of the anti-ulcer medications
ranitidine, cimetidine, and omeprazole following administration of
multiple doses to exercised Thoroughbred horses. The results of
multiple RMTC administration studies supporting the use of anti-ulcer
medications up to 24 hours prior to a horse's race.
Exhibit B.19. Bicarb 08 Sodium Bicarbonate as an Ergogenic Aid:
Supports the use of alkalinizing agents as a Prohibited Method.
Exhibit B.20. BP Gen 04 Bisphosphonate Therapy in Equine Sports
Medicine: While having legitimate use in human medicine, the documented
pharmacologic effect of this class of drug (blocking remodeling) on
bone represents a significant increased risk for fracture development
in the racehorse.
Exhibit B.21. Cobalt 01 The Disparate Roles of Cobalt in
Erythropoiesis, and Doping Relevance: Establishes the relevance of the
administration of cobalt salts as a doping threat and justifies the
controls established in the Prohibited List.
Exhibit B.22. Comp 18 The Disparate Roles of Cobalt in Erythropoiesis,
and Doping Relevance: Published by the American Veterinary Medical
Association, this document clarifies what constitutes legal compounding
of drugs as the ethical use of compounded medications is important to
maintaining equine health. However, the compounding or administration
of illicitly compounded substances to circumvent Food and Drug
Administration (``FDA'') oversight represents a substantial risk to
horse health and racing integrity.
Exhibit B.23. EIPH 33 Exercise-induced pulmonary hemorrhage (EIPH):
mechanistic bases and therapeutic interventions: Describes this
condition (rarely, but occasionally, experienced by human athletes)
that affects virtually every race horse at some point(s) in its racing
and training career.
Exhibit B.24. Furos 15 Efficacy of furosemide in the treatment of
exercise-induced pulmonary hemorrhage in Thoroughbred racehorses: The
seminal study that demonstrated the efficacy of furosemide in
mitigating or preventing episodes of EIPH in the racing Thoroughbred.
While not submitted as a justification for the continued use of
furosemide, this study did establish furosemide as the only medication
having efficacy for controlling EIPH and why the WADA total ban on
furosemide cannot be, at this time, applied to horseracing. This
article also then justifies the Prohibited List's exclusion for the use
of furosemide in training exercise.
Exhibit B.25. PAG 13 Intra-Articular Polyacrylamide Hydrogel Injections
[[Page 5078]]
Are Not Innocent: While the use of polyacrylamide hydrogels have a
history of use in human joint disease, their introduction into the
equine market as medical devices, is relatively recent, and the lack of
documented method of action causes reservations about its use in that
it may have the potential to mask pain and allow the progression of
orthopedic disease to the overall detriment of the horse.
Exhibit B.26. PBZ 05 Effectiveness of administration of phenylbutazone
alone or concurrent administration of phenylbutazone and flunixin
meglumine to alleviate lameness in horses: Establishes justification
for the prohibition on ``stacking'' of NSAIDs--medications that are not
controlled in human sport, but require control in equine sport for
safety reasons and ethical considerations.
Exhibit B.27. Ract 04 Effects of Ractopamine HCl on Physical and
Reproductive Parameters in the Horse: This anabolic agent is not
addressed in human sport but has been detected in post-race and out of
competition samples derived from racehorses. Its presence has been both
the result of contamination of commercial feed at the processing site
as well as deliberate administration.
Exhibit B.28. Thyro 07 A randomised, controlled trial to determine the
effect of levothyroxine on Standardbred racehorses: This prescription
medication had widespread use for the (scientifically unsupported)
treatment of a multitude of conditions--other than hypothyroidism which
is exceedingly rare in the horse. This article elucidates the health
risk in its use and justifies the ban as established in the Prohibited
List.
Exhibit B.29. Tryp 03 Effects of a commercial dose of L-tryptophan on
plasma tryptophan concentrations and behaviour in horses: An example of
unregulated, over the counter oral nutraceuticals that have the
potential to impact a horse's health, behavior, or mental state--thus
exerting a drug-like effect while evading regulation by the FDA. It is
for this reason that the Prohibited List is not permissive of the use
of these substances during the race period, to be consistent with FDA-
approved drugs having similar effects.
1. Banned Substances and Banned Methods--Rule Series 4100
Banned Substances and Banned Methods are set out in categories,
including anabolic agents, peptide hormones and growth factors, beta-2
agonists, hormone and metabolic modulators, and diuretics and masking
agents (Rule 4110). Banned Methods include blood manipulation, chemical
castration or immunocastration, and gene and cell doping (Rule 4120).
2. Controlled Medication Substances and Controlled Medication Methods
and Exceptions--Rule Series 4200
Subject to exceptions specified in the Prohibited List (Rule 4212),
only feed, hay, and water are permitted during the Race Period (Rule
4211(a)). Accordingly, subject to Rule 4212, any substance administered
during the Race Period or present in a Post-Race Sample (including any
metabolite(s), artifact(s), and isomer(s) of such substance(s)) that
does not otherwise qualify as a Banned Substance shall constitute a
prohibited Controlled Medication Substance. In addition, certain
Controlled Medication Substances are prohibited from presence in a
Post-Work Sample (Rule 4211(b)). Exceptions are provided in Rule 4212
for emergency veterinary care, for certain substances that are
permitted up to 24 hours prior to Post-Time (e.g., anti-ulcer
medications), electrolyte solutions consumed by the horse by free
choice, furosemide (i.e., Lasix/Salix), and for supplements or feed
additives that do not have an action or effect on listed mammalian body
systems.
Controlled Medication Methods include alkalinization, intra-
articular injections, and use of a nasogastric tube within specified
time periods (Rule 4220).
3. Ineligibility Periods for Covered Horses--Rule Series 4300
Consistent with section 3057(d) of the Act, Rule 4300 establishes
uniform rules setting out the periods of ineligibility that apply to
Covered Horses implicated in Anti-Doping Rule Violations or Controlled
Medication Rule Violations. The Ineligibility period ranges from zero
months to lifetime bans, depending on the category of the substance or
method.
Violations involving Controlled Medication Substances will not
result in a period of Ineligibility for the Covered Horse. However, the
Covered Horse shall be placed on the Veterinarians' List and a Vets'
List Workout must be scheduled (at which the horse may be subject to
Sample collection). Violations involving Controlled Medication Methods
may result in a period of Ineligibility for the Covered Horse where
specified in the Prohibited List at Rule 4320.
Covered Horses are not subject to increased Ineligibility periods
if they are involved in multiple violations.
4. Rule Series 4000 Appendix: Technical Document--Prohibited Substances
The ``Technical Document--Prohibited Substances'' supplements the
Prohibited List (Rule Series 4000) and sets out additional detail
concerning Prohibited Substances. The ``Technical Document--Prohibited
Substances,'' enumerates specific Prohibited Substances that fall into
the general categories listed in the Prohibited List and sets forth
detection times, screening limits, and thresholds for those Prohibited
Substances. The Technical Document also designates certain Prohibited
Substances as Specified Substances, which are those that pose a higher
risk of being the result of contamination and that are therefore
subject to more flexible sanctions. The following paragraphs describe
the rules and specifications applicable to certain categories of
medications that vary from the baseline standards enumerated in 15
U.S.C. 3055(g).
i. Anti-Ulcer Medications (Cimetidine, Omeprazole, Ranitidine)
The IFHA has published a restricted administration period that
prohibits administration of anti-ulcer medications within 48 hours of
the post time for the race in which the horse is entered. HISA in the
Protocol recommends a 24-hour restricted administration period.
The basis for this deviation is two-fold: (1) Withdrawal intervals
of greater than 24 hours have been identified as an equine welfare
issue. Published research demonstrates a rebound effect when anti-ulcer
medications are withdrawn for more than 24 hours with resultant ulcers
more severe than those originally treated. (2) The IFHA's Advisory
Council on Prohibited Substances and Practices will be revisiting the
control of these substances, and it is anticipated that the
international community will adopt a withdrawal interval strategy
similar to the one proposed by HISA.
ii. Non-Steroidal Anti-Inflammatory Drugs (``NSAIDs'') (Flunixin,
Ketoprofen, Phenylbutazone)
The IFHA has published a 48-hour Detection Time (DT) for a single
NSAID--meclofenamic acid. There is no FDA-approved product containing
meclofenamic acid commercially available in the United States. (It is
important to note that a Detection Time is the foundation for
determining a withdrawal interval, but under no circumstances should
the Detection Time be equated with withdrawal guidance. The withdrawal
interval is decided by the veterinarian in
[[Page 5079]]
consultation with the responsible person for the horse in consideration
of their level of risk aversion and their knowledge of the specific
horse's health, management, other medications or foreign substances co-
administered, and other relevant factors. The withdrawal interval
should always be longer than the Detection Time, and in most cases this
means adding 24 hours (at a minimum) to the Detection Time.)
The HISA Protocol establishes Screening Limits corresponding to a
48-hour Detection Time for 3 commercially available NSAIDs having FDA-
approval for use in the horse. The Protocol allows the veterinarian to
select one NSAID that can be administered using a withdrawal interval
based on the 48-hourr Detection Time. All other NSAIDs are then
controlled applying IFHA Detection Times and Screening Limits, and the
detection of more than one NSAID in a horse's sample is a violation.
This is philosophically consistent with the IFHA and represents a far
more restrictive approach to the use of NSAIDs than currently exists in
the United States.
iii. Methocarbamol/Glycopyrrolate
The IFHA is silent on these substances. However, the Asian Racing
Federation (a signatory to the IFHA's International Agreement on
Breeding, Racing, and Wagering (IABRW)) has published a Screening Limit
for methocarbamol. So there is precedent for establishing Screening
Limits in addition to those provided by the IFHA. Further, the IFHA's
IABRW references the adoption of Screening Limits and advises that a
regulatory authority may elect to publish Detection Times.
The Screening Limits and Detection Times for methocarbamol and
glycopyrrolate were derived after reviewing the Racing Medication and
Testing Consortium's administration study pharmacokinetic data. The
elected Screening Limits and corresponding Detection Times ensure
withdrawal intervals of sufficient length to prevent the substances
from having any potential to impact a horse's racing performance.
iv. Ciclesonide/Lidocaine
The Protocol adheres to IFHA Screening Limits, but, consistent with
the requirements of IABRW Article 6, HISA has elected to adopt
Detection Times that vary from those of the IFHA. In the case of
ciclesonide, the Detection Time is consistent with that used by Racing
Australia (also an IFHA member). For lidocaine, HISA elected to use a
lower dose in determining a Detection Time, as it believed that IFHA's
dosing is too permissive and potentially allows illicit low-dose use on
Race Day, which may be undetectable by laboratory testing.
v. Procaine Penicillin
The European Horseracing Scientific Liaison Committee (EHSLC) has
established a detection time of 240 hours (10 days) for procaine
penicillin. (The EHSLC is the scientific body that the IFHA consults
when developing medication control policy.) HISA has determined that
the 240-hour detection time could negatively impact horse welfare,
through the withholding of appropriate medical treatment. HISA has
elected instead to adopt the current ARCI controls, which allow for the
use of this safe and effective antibiotic up to 48 hours prior to a
race, while still effectively controlling against the illicit use of
procaine as a local anesthetic.
e. Terms of Substance: Rule Series 5000--Equine Standards for Testing
and Investigation
In accordance with section 3055 of the Act, the Authority has
developed Equine Standards for Testing and Investigations to manage
test distribution planning (including intelligence-based testing), the
sample collection process, and in-competition and out-of-competition
testing. The Authority considered the Association of Racing
Commissioners International out-of-competition testing standards as a
baseline, but also relied in large part on the WADA International
Standard for Testing and Investigations, given the comprehensive nature
of that standard. All adjustments and modifications to the baseline
rules were approved by the Authority in consultation with the ADMC and
the Agency in accordance with section 3055(g)(3) of the Act.
In preparing the standards, the Authority consulted with the
Agency, the ADMC, and experts in the field to tailor the standards to
horseracing. The Authority considered and relied significantly on the
following rules:
Exhibit B.2. The ARCI out-of-competition testing standards, Model Rules
of Racing (version 11.0). The Authority notes that the Act refers to
version 9.2, but the model rules have since been updated. The most
recent versions of the ARCI documents are available at <a href="https://www.arci.com/model-rules-standards/">https://www.arci.com/model-rules-standards/</a>.
Exhibit B.30. WADA International Standard for Testing and
Investigations dated January 1, 2021. The most recent versions of the
WADA documents are available at <a href="https://www.wada-ama.org/en/resources/">https://www.wada-ama.org/en/resources/</a>.
1. Testing--Rules 5100-5500 and 5800
The Testing and Investigations Standards sets out how the Agency
will plan effective testing by using risk assessments and prioritizing
between Covered Horses and types of testing (Rule 5100). As directed by
section 3055(c)(4)(C) of the Act, Sample Collection Personnel will
notify the Responsible Person or Nominated Person without advance
notice that his or her Covered Horse has been selected for testing
(Rule 5200), following--as applicable--the procedure set out at Rule
5220 depending on when the sample is collected.
Sample Collection Sessions will be conducted by suitably qualified
personnel (Rule 5450), using suitable equipment (Rule 5320), in a
suitable ``test barn'' environment (Rule 5310). Samples will be
collected in accordance with Rule 5400, in particular to ensure that
the sample is of suitable quality and quantity, is clearly and
accurately identified, is sealed in a tamper evident kit, and has not
been manipulated or tampered with. Further specific procedures and
requirements apply to the collection of urine samples (Rule 5420),
blood samples (Rule 5430), and hair samples (Rule 5440).
Once collected, Samples will be stored and transported by Sample
Collection Personnel in a manner that protects the integrity, identity,
and security of the Samples (Rules 5510 and 5520).
2. Investigations--Rule 5600-5700
As directed by the Act, the Agency will put in place internal
processes and procedures to ensure it is able to gather, analyze, and
process anti-doping and medication control intelligence from all
available sources in order to help deter and detect doping and
medication abuse, to inform effective, intelligent, and proportionate
test distribution planning, to plan intelligence-based Target Testing,
and to conduct investigations (Rule 5600).
Further, the Agency will conduct efficient and effective
investigations into (among other things) atypical findings and other
sample abnormalities, and other analytical or non-analytical
information or intelligence. The purpose of such investigations is to
either rule out or develop evidence that supports an anti-doping or
controlled medication rule violation or other violation of the Protocol
(Rule 5710). The Agency will make use of all investigative resources
available to it, which may include obtaining information from law
enforcement authorities and other
[[Page 5080]]
regulators (Rule 5730). The Agency may also exercise the investigative
powers conferred under applicable rules, including powers of
inspection, examination, seizure, production of documents, request to
the Authority for the issuance of subpoenas, and the conduct of
interviews). All Covered Persons are required to cooperate with the
Agency's investigations in the manner set forth in the rules, and
failure to cooperate may result in the imposition of sanctions (Rule
5720(f)).
f. Terms of Substance: Rule Series 6000--Equine Standards for
Laboratories and Accreditation
As directed by sections 3053, 3055, and 3057 of the Act, the
Authority has developed the Equine Standards for Laboratories and
Accreditation (``Laboratory Standards'') using the WADA International
Standard for Laboratories as a baseline. All adjustments and
modifications to the baseline rules were approved by the Authority in
consultation with the ADMC and the Agency in accordance with section
3055(g)(3) of the Act.
Exhibit B.31. WADA International Standard for Laboratories dated
January 1, 2021. The Authority notes that the Act refers to the WADA
International Standard for Laboratories (version 10.0) dated November
12, 2019, but that version has since been updated by WADA. The most
recent versions of the WADA documents are available at: <a href="http://www.wada-ama.org/en/resources/">www.wada-ama.org/en/resources/</a>.
As directed by the Act at section 3057(b), the Laboratory Standards
establish standards of accreditation for laboratories involved in
testing samples from Covered Horses; the process for achieving and
maintaining accreditation; and the standards and protocols for testing
of such samples. The Laboratory Standards will be supported by
technical documents, letters, notes, and laboratory guidelines, as
appropriate.
The Laboratory Standards also cross refer in a number of places to
the ISO/IEC 17025 standard. Laboratories must obtain ISO/IEC 17025
accreditation before receiving HISA Equine Analytical Laboratory
(``HEAL'') accreditation.
Exhibit B.32. ISO/IEC 17025:2017. The Authority consulted with
laboratory experts in order to tailor the Laboratory Standards to
horseracing laboratories and to reflect the specificities of equine
sport. As part of its review, the Authority considered the ILAC-G7:04/
2021 Accreditation Requirements and Operating Criteria for Horseracing
Laboratories, which may inform subsequent Technical Documents.
Exhibit B.33. ILAC-G7:04/2021 Accreditation Requirements and
Operating Criteria for Horseracing Laboratories. The most recent
versions of the International Laboratory Accreditation Cooperation
(``ILAC'') standards are available at: <a href="https://ilac.org/publications-and-resources/ilac-guidance-series/">https://ilac.org/publications-and-resources/ilac-guidance-series/</a>.
1. Laboratory Accreditation--Rule Series 6100 and 6500
In accordance with sections 3055(c) and 3057(b) of the Act, the
Laboratory Standards establish the requirements for obtaining HISA
Equine Analytical Laboratory (``HEAL'') accreditation, and the
requirements and standards for maintenance of HEAL accreditation. The
rules set out a procedure by which laboratories may achieve HEAL
accreditation, starting with an application and the granting of
``candidate laboratory'' status. The candidate laboratory must provide
specified information to the Agency, perform pre-probationary testing
to identify prohibited substances in samples, and complete an on-site
assessment. The Agency will assess the outcomes of those processes and
any non-conformities identified, and the candidate laboratory will have
a specified period of time to remedy those non-conformities with
corrective actions (Rule 6110).
If a candidate laboratory is granted probationary accreditation
status, it will be accredited by the Agency, with a probationary period
of two years or until analysis of 2,500 samples has been performed,
whichever occurs first. If the probationary period is successfully
completed and the laboratory successfully completes a final
accreditation test, the Agency will grant accreditation to the
laboratory (Rule 6120).
The rules impose continuing obligations on each laboratory that
must be satisfied in order to maintain HEAL accreditation (Rule 6130),
including maintenance of ISO/IEC 17025 accreditation, satisfactory
participation in the Agency External Quality Assessment Scheme
(``EQAS'') whereby laboratories are sent samples to be analyzed (blind
or for specified substances), compliance with the code of ethics (which
is set out in full at Rule 6600), and continued research and
development activities and sharing of knowledge.
The Agency will regularly monitor and review the compliance of each
laboratory with its ongoing accreditation obligations (Rule 6140). A
laboratory's HEAL accreditation may be suspended or revoked, or
subjected to specified analytical testing restrictions if (among other
things) the laboratory fails to comply with the Laboratory Standards or
other Agency requirements (Rules 6510 and 6520). The rules set out the
effects of such decisions on Agency-related laboratory activity and the
transfer of samples to other laboratories pending resolution of the
matter (Rule 6560), and provide for reinstatement of the laboratory if
it has remedied the non-compliance that resulted in the Agency's
decision.
2. Laboratory Quality Monitoring--Rule Series 6200, 6400, and 6600
The Agency will regularly distribute External Quality Assessment
Scheme (EQAS) samples in order to monitor the capabilities of
laboratories and probationary laboratories, evaluate their proficiency,
and improve test result uniformity between laboratories (Rule 6210).
Some of these samples are blind (the laboratory will know it is an EQAS
sample but will not know its contents), some are double-blind (the
laboratory will not know it is an EQAS sample or know its contents),
and some are educational (the laboratory will know it is an EQAS sample
and will know its contents) (Rule 6220). EQAS samples should be
analyzed in a manner substantially similar to that applied to routine
samples, unless otherwise specified by the Agency, and results reported
to the Agency (Rules 6250 and 6260).
The Agency will evaluate laboratory EQAS results and, as necessary
and appropriate, inform the laboratory of any technical,
methodological, or clerical errors that should be remedied. If such
errors are remedied, no penalty will be imposed (Rule 6410). The Agency
may request corrective action reports that detail actions taken to
correct any non-conformity or other issue (Rule 6420). The annual EQAS
evaluation will be a factor in assessment of HEAL accreditation and
maintenance of HEAL accreditation.
3. Analysis of Samples--Rule Series 6300
The Laboratory Standards set out a process for the withdrawal of
accreditation if the relevant requirements and standards are not met.
The Laboratory Standards also ensure that laboratories report valid
test results based on reliable evidentiary data and facilitate
harmonization in analytical testing of Samples by laboratories.
The rules also contain detailed standards for the analysis of
samples (section 6300). When analyzing a sample, the laboratory will
prepare an aliquot, select the analytical testing
[[Page 5081]]
procedure, and conduct the initial testing procedure, with the
objective of obtaining information about the potential presence of
prohibited substances in the sample (Rule 6308). The laboratory will
then conduct the confirmation procedure to obtain a result that either
supports or does not support the reporting of an adverse analytical
finding or atypical finding, in particular, by identifying and
sometimes quantifying--for example in the case of a threshold
substance--a prohibited substance in the sample (Rules 6309 and 6311).
The laboratory must conduct a detailed review of the analysis (Rule
6315) and report all results to the Agency (Rule 6316).
An important amendment to the baseline rules is that any B sample
analysis will be conducted by a different laboratory than the one that
performed the A sample analysis, unless the Agency considers that is
not possible due to due to (i) reasonable concerns over Sample
integrity or unstable analytes; or (ii) because no other Laboratory is
available to perform the B Sample procedure within a reasonable period
of time (Rule 6312).
If the laboratory reports an adverse analytical finding for the A
sample, and the Covered Person requests or the Agency orders that the B
sample be analyzed, the laboratory will promptly transfer the B sample
to the laboratory specified by the Agency, and that (second) laboratory
will perform the B sample procedure and analysis (Rule 6312). The
samples will be stored and may be subject to further analysis if
directed by the Agency (Rules 6313 and 6319).
e. Terms of Substance: Rule Series 7000--Arbitration Procedures
In accordance with sections 3053(a)(10) and 3057(c) of the Act, the
Arbitration Procedures set out a disciplinary process for the hearing
and adjudication of Anti-Doping Rule Violations, Controlled Medication
Rule Violations, and other related offenses. As directed by section
3057(c)(3), the procedures were developed to provide for adequate due
process, including impartial hearing panels commensurate with the
seriousness of the alleged violation. Different procedures apply to
Anti-Doping Rule Violations (heard by the Arbitral Body) as compared to
Controlled Medication Rule Violations (heard by the Internal
Adjudication Panel, which may adjudicate the matter on written
submissions alone.
1. Dispute Resolution Frameworks--Rules 7010-7050
The arbitrators on the Arbitral Body will be appointed by the
Agency for four-year terms (Rule 7030). Members of the Internal
Adjudication Panel will be appointed by the Agency for four-year terms
(Rule 7040). Members of the Arbitral Body and Internal Adjudication
Panel will receive mandatory annual training and education on issues
relating to the proper handling of cases (Rule 7050).
2. Initiating Proceedings--Rules 7060-7160
If a Covered Person is charged with an Anti-Doping Rule Violation
or Controlled Medication Rule Violation, proceedings will be initiated
with the appropriate adjudicator by the Agency. The adjudicator will be
appointed by the arbitral body or by the coordinator of the Internal
Adjudication Panel, as applicable (Rule 7130), and the rules establish
a process by which parties may challenge the adjudicator's appointment
in appropriate circumstances. The adjudicator has broad powers to
manage the proceedings, including the power to issue orders for
expedited procedures, rule on their own jurisdiction, and consolidate
proceedings.
3. Hearings and Evidence--Rules 7170-7330
In cases involving Anti-Doping Rule Violations or related
violations, the rules set out a procedure for the exchange of written
submissions and evidence (Rule 7170), and for the conduct of hearings
(Rule 7250). The Arbitral Body has broad discretion to determine the
admissibility, relevance and materiality of evidence offered, and may,
if necessary and appropriate, order production (Rule 7260 and 7270) or
interim measures (Rule 7280) or resolve challenges to provisional
suspensions at a provisional hearing (Rule 7290).
In cases involving Controlled Medication Rule Violations and
related violations, and other violations of the Protocol, a more
streamlined and flexible process applies (Rule 7180).
4. Decisions--Rules 7240-7450
In all cases, a final decision will be issued and the adjudicator
may grant any remedy or relief authorized by the Protocol (Rule 7340-
7350). Final decisions issued by the Arbitral Body or Internal
Adjudication Panel are subject to review as specified in section 3058
of the Act (Rule 7400).
III. Self-Regulatory Organization's Summary of Comments Received Pre-
Submission and Its Responses to Those Comments
As encouraged by the Commission's procedural rule, the Authority,
before finalizing this submission to the Commission, made a draft of
the Anti-Doping and Medication Control proposed rule available to the
public for review and comment on the HISA website, <a href="https://www.hisausregs.org/">https://www.hisausregs.org/</a>, beginning on June 1, 2022. Comments on the Anti-
Doping and Medication Control proposed rule were received from various
individuals and groups in the horseracing industry.
The stakeholder feedback received was constructive and well-
considered. All submitted comments were carefully reviewed by the
Authority as well as by the ADMC and the Agency. Those collected
comments are available as Exhibit A on the docket at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. The Authority also engaged with a number of
stakeholders through follow-up conference calls to further analyze
their comments and discuss any questions raised. The stakeholder
comments informed a number of adjustments and modifications to the
proposed rules, as explained in more detail below. The open
consultation process and stakeholder engagement is an important process
and one that is intended to build consensus where possible within the
industry.
The following is a summary of the substance of the comments
received. The following also summarizes the Authority's response to the
significant issues raised in the comments, and the manner in which the
Authority has addressed those comments in developing the proposed rules
submitted to the Commission. In a few instances the Authority declined
to make a suggested change, though the Authority will consider the
suggestions made in the course of future rulemaking.
1000 Series--General Provisions
The Authority revised the definition of ``Race Day'' based on
comments received, amending it so that the period will end one hour
after the end of the Official Workout or Covered Horserace or at the
end of any Sample collection process, whichever is later, instead of
ending at 23:59 (11:59pm) on the day of the Official Workout/Covered
Horserace as previously stated. This revision was made to take account
of horse welfare, recognizing in particular that once a horse has been
subject to sample collection, or it has been decided that a
[[Page 5082]]
horse will not be selected for sample collection, the horse should not
be prohibited from receiving any necessary therapeutic treatments post-
race that are permitted outside the Race Period. The end of the ``Race
Day'' now also coincides with the end of the ``Race Period.''
The definition of ``Tampering'' was adjusted to make clear that it
does not include the actions of bona fide veterinary personnel
involving a Controlled Medication Substance or Controlled Medication
Method used for genuine and legal therapeutic purposes or other
acceptable justification. This addition mirrors the wording used in the
definition of ``Administration,'' which includes the same important
carve-out.
3000 Series--Equine Anti-Doping and Controlled Medication Protocol
Some commenters expressed the strong opinion that there is a
material difference between the use of doping substances to unfairly
affect the performance of horses, as opposed to errors in the
administration of recognized therapeutic substances. The Authority
agrees that this is a vital distinction, and the Protocol recognizes
the distinction in the penalty structure and other provisions
throughout the Protocol.
Further detail on the meaning of ``Owner'' has been provided to
take account of the varied and sometimes complex ownership structures
in horseracing (Rule 3020(c)).
The term ``Responsible Person'' defined in Rule 3030 has been
simplified to make clear that the trainer of a Covered Horse is the
Responsible Person for that horse. In circumstances where the horse
does not have a Trainer, the Owner is the Responsible Person. The
Responsible Person is personally liable for his or her Covered
Horse(s). However, other Covered Persons (including veterinarians,
among others) who made a relevant decision about the Covered Horse may
be found to be complicit in a violation and may be liable to the same
extent as the Responsible Person.
In response to comments received, the Authority removed the
disciplinary provisions concerning hypodermic needles, because
equivalent provisions are included in the Rule 2000 Series (Racetrack
Safety Program).
Some commenters proposed increasing the sanctions applicable to
repeat medication violation offenders and lengthening the period of
time that such violations would remain on their ``official record.''
The limitation period and roll-off period for Controlled Medication
Rule Violations has been increased from one to two years, and a
multiple violation penalty points system, modelled on the ARCI system,
has been added. As a consequence, in addition to any sanction received
for the underlying Controlled Medication Rule Violation, a Covered
Person will also receive a certain number of penalty points which
accumulate over a two-year period. When the points thresholds are
exceeded, additional sanctions will be imposed (in a manner similar to
the points system in the driver's licensing violation system).
A number of commenters requested that Controlled Medication
Substances be stratified into different classes, with individual
screening limits prescribed for each category. The Authority has done
so by classifying Controlled Medication Substances into Classes A to C
in the Technical Document-Prohibited Substances, which supplements the
Prohibited List. The sanctions in the Protocol in turn depend on the
class of substance in issue.
Commenters requested clarification of the requirement that a
Responsible Person make a Covered Horse available for testing ``at any
time and place.'' The Protocol was clarified to specify that the
Covered Horse must be available for testing at any time and place where
the horse is located (e.g., Racetrack, Training Facility, private
facility). The Protocol was also clarified to specify that Responsible
Persons shall ensure that the Covered Horse is produced for Sample
collection immediately upon notification by a duly authorized Person,
or, if the horse is not available at the location for Testing, within 6
hours of notification by a duly authorized Person (or if the Agency
agrees to extend that time period due to extenuating circumstances,
then within such extended time period). Failure to produce a Covered
Horse for Sample collection within six hours (or any extended period
agreed by the Agency) shall constitute a violation of Rule 3215
(evasion, or refusal or failure to submit to Sample collection). Sample
collection shall ordinarily be conducted where the Covered Horse is
located (e.g., Racetrack, Training Facility, or private facility),
unless the Agency agrees that the Covered Horse may be transported to
another agreed location (e.g., a nearby Racetrack).
In response to comments received, the Authority extended the period
of inactivity of a Covered Horse from 12 to 18 months, after which the
horse may be retired by the Authority, subject to an objection by the
Owner of the horse. This change was based on the rationale that horses
may suffer injuries that require a 12-month recovery period (such as
tendon injuries).
The Protocol was modified to clarify that where a horse's Sample
reveals the presence of more than one Controlled Medication Substance
above the applicable thresholds (if any), each substance may be treated
as a separate presence violation.
The Protocol was revised to clarify that Covered Persons may
request clearance testing to be conducted on their Covered Horses by a
Laboratory, but only if such request is authorized by the Authority in
advance and paid for by the Covered Person, and provided that such
samples will be treated in the same way as official Post-Race Samples,
such that any violation detected may be pursued by the Agency.
Some concerns were expressed regarding how cases involving
environmental contamination would be handled and publicized. The
Authority has incorporated an ``Atypical Findings Policy'' as Appendix
1 to the Rule 3000 Series. The Policy allows for certain substances to
be investigated first as Atypical Findings before being pursued as
Adverse Analytical Findings. If further to such investigation it is
determined that the positive test was the result of environmental
contamination, the matter will not be pursued as an Adverse Analytical
Finding, and the Atypical Finding will not be publicly disclosed.
The Authority has added provisions to the Protocol to clarify the
provisions on claimed horses. Some commenters expressed the concern
that testing every horse in a claiming race would be excessive. In
particular, Rule 3060 provides that a claimed horse may be subject to
Sample collection at a claiming race if elected (and paid for) by the
claimant. If the analysis of such Sample(s) results in an Anti-Doping
Rule Violation or Controlled Medication Rule Violation, the claim may
be voided at the option of the claimant and the claimant shall be
entitled to return of all sums paid for the claimed horse and of all
expenses incurred after the date of the claim.
Commenters also expressed the opinion that use of Lasix should not
be prohibited during training. The Protocol does not prohibit the use
of Lasix during training (see Rule 4212(d)).
4000 Series--Prohibited List
The key change made based on comments received was the development
of the ``Technical Document--Prohibited Substances,'' which supplements
the Prohibited List. The Technical Document provides additional detail
concerning the
[[Page 5083]]
Prohibited Substances that fall into the general categories established
in the Prohibited List, and sets forth detection times, screening
limits, and thresholds for those Prohibited Substances. The Technical
Document also designates certain Prohibited Substances as Specified
Substances. Specified Substances are those substances that pose a
higher risk of being the result of contamination, and that are
therefore subject to more flexible sanctions.
Comments were also received urging that anti-ulcer medications
should be permitted within 24 hours prior to a race. The ADMC
considered that proposition further, including the scientific paper
referenced below, which shows that the pH of gastric fluids returns to
baseline 24 hours after treatment with Omeprazole (an anti-ulcer
medication). Given that pH directly affects the development of ulcers,
the paper supports the use of anti-ulcer medications up to 24 hours
prior to Post-Time. To require a longer withdrawal interval means that
the stomach lining of a horse could be vulnerable to the recrudescence
of gastric ulceration.
Exhibit B.34. Jessica Wise et al., Pharmacokinetic and
pharmacodynamic effects of 2 registered omeprazole preparations and
varying dose rates in horses, J. Veterinary Internal Medicine (Nov.
2020), <a href="https://doi.org/10.1111/jvim.15971">https://doi.org/10.1111/jvim.15971</a>.
5000 Series--Equine Testing and Investigations Standards
In addition to a number of minor revisions based on the comments
received, the Authority added a section to address procedures for total
carbon dioxide (``TCO2'') testing, i.e., testing blood samples for
total carbon dioxide as evidence of use or administration of the
Controlled Medication Method M4 (alkalinization or use/administration
of an alkalinizing agent) (see Rule 5430).
6000 Series--Equine Standards for Laboratories and Accreditation
A number of minor revisions were made based on the detailed
comments received and further consultation with laboratory experts.
Some duplication with ISO/IEC 17025 was also removed, in particular in
section 6300.
7000 Series--Arbitration Procedures
Some commenters expressed confusion concerning the role of racing
stewards in the adjudication body previously designated as the
``National Stewards Panel.'' The body is now designated as the
``Internal Adjudication Panel,'' with individual members referred to as
Internal Adjudication Panel (``IAP'') members instead of ``stewards.''
The procedure for Controlled Medication Rule Violations was
developed partly in response to requests by commenters to provide for a
simplified hearing process for Covered Persons charged with a
violation. The procedures allow the IAP members adjudicating the case
to dispense with written filings and permit the Covered Person to make
an oral presentation in a hearing context. This procedure allows the
adjudication process to dispense where appropriate with certain of the
more formal and costly aspects of legal proceedings.
The Arbitration Procedures were also clarified to specify that
hearings regarding alleged breaches of the Protocol will not be open to
the media or the public, and to specify the Owners who may attend
hearings involving Covered Horses when the horse is owned by multiple
persons or entities.
The Arbitration Procedures were also clarified to specify that
while document production requests may be permitted, discovery or other
wide-ranging document requests are not permitted.
Minor Corrections Made to October 2022 Proposed Rule
Based on stakeholder comments and further review, the Authority has
made a few minor corrections to the proposed rule previously filed with
the Commission. Minor corrections were made to the Technical Document,
including (i) correcting certain references to thresholds throughout
the Technical Document, to ensure consistency with the approach taken
by the IFHA; (ii) correcting a typographical error regarding the
threshold for ketoprofen, which is 2ng/ml, as approved by the ADMC, as
noted in a correction published November 4, 2022, 87 FR 66705; (iii)
adding a comment about pemoline that was mistakenly deleted from the
previous version; (iv) correcting certain minor typographical errors in
the spelling of substance names; (v) capitalizing defined terms; and
(vi) other minor amendments to ensure consistency across the document,
including deletion of duplicate entries.
Certain other minor corrections were made to the proposed rule,
including (i) clarifying, in the definition of ``Aggravating
Circumstances,'' that one or both of an additional period of
ineligibility or fine may be imposed; (ii) correcting Rule 3346(a) to
clarify that the Responsible Person and Owner and one representative
each may attend the Laboratory to witness the opening and
identification of the B sample; (iii) adding ``to the extent possible''
in Rule 5220(b)(iv)(B) for consistency with other similar provisions;
(iv) specifying in Rule 5320 that sample collection equipment must be
able to withstand -20[deg]C rather than -80[deg]C, consistent with
industry standard; (v) removing the requirement for a signature in Rule
5410(i)(1) because the personnel tagging the horse at the end of the
race will not accompany the horse to the Test Barn and the signing of
the doping control documentation will occur at a later stage in the
sample collection process (see Rule 5410(i)(10)); (vi) minor
corrections to Rules 5420(j) and 5430(e) by striking ``within the
kit,'' as it was not consistent with collection kits available in the
industry; (vii) amending references to the ``BCO or DCO'' in Rule
5430(e) to ``relevant Sample Collection Personnel'' for consistency
with other similar provisions; (viii) amending Rules 5420(n) and
5430(k) to clarify that copies of doping control documentation will be
sent to the Responsible Person subsequently and not instantaneously;
and (ix) adding a reference to ``or refrigerator'' in Rule 5510(b)(1)
because, if urine samples are not shipped on the day of collection,
they will be refrigerated rather than frozen.
Minor typographical errors, such as extra spaces, spelling errors,
and punctuation, were corrected as well.
IV. Legal Authority
This rule is proposed by the Authority for approval or disapproval
by the Commission under 15 U.S.C. 3053(c)(1).
V. Effective Date
This rule would take effect upon approval by the Commission, and
the Commission must approve or disapprove the rule by March 27, 2023.
VI. Request for Comments
Members of the public are invited to comment on the Authority's
proposed rule. The Commission requests that factual data on which the
comments are based be submitted with the comments. The supporting
documentation referred to in the Authority's filing, as well as the
written comments it received before submitting the proposed rule to the
Commission, are available for public inspection at <a href="https://www.regulations.gov">https://www.regulations.gov</a> under docket number FTC-2023-0009.
The Commission seeks comments that address the decisional criteria
provided by the Act. The Act gives the Commission two criteria against
which to measure proposed rules and rule modifications: ``The
Commission shall approve a proposed rule or modification if the
Commission finds that the
[[Page 5084]]
proposed rule or modification is consistent with--(A) this chapter; and
(B) applicable rules approved by the Commission.'' \7\ In other words,
the Commission will evaluate the proposed rule for its consistency with
the specific requirements, factors, standards, or considerations in the
text of the Act as well as the Commission's procedural rule.
---------------------------------------------------------------------------
\7\ 15 U.S.C. 3053(c)(2).
---------------------------------------------------------------------------
Although the Commission evaluates the Authority's proposed rule for
its consistency with the Act and the Commission's procedural rule, the
Commission may consider broader questions--about the health and safety
of horses and jockeys, the integrity of horseraces and wagering on
horseraces, and the administration of the Authority itself--in another
context: ``The Commission . . . may abrogate, add to, or modify the
rules of the Authority promulgated in accordance with this Act as the
Commission finds necessary or appropriate to ensure the fair
administration of the Authority, to conform the rules of the Authority
to requirements of this Act and applicable rules approved by the
Commission, or otherwise in furtherance of the purposes of this Act.''
\8\ The Commission may exercise this rulemaking power on its own
initiative or in response to a petition from a member from the public.
If members of the public wish to provide comments to the Commission
about its use of the rulemaking power, they are encouraged to submit a
petition requesting that the Commission issue a rule addressing the
subject of interest. The petition must meet all the criteria
established in the Rules of Practice (part 1, subpart D); \9\ if it
does, the petition will be published in the Federal Register for public
comment. In particular, the petition for a rulemaking must ``identify
the problem the requested action is intended to address and explain why
the requested action is necessary to address the problem.'' \10\
---------------------------------------------------------------------------
\8\ 15 U.S.C. 3053(e) (as amended by the Consolidated
Appropriations Act, 2023, H.R. 2617, 117th Cong., Division O, Title
VII (2022)).
\9\ 16 CFR 1.31; see Fed. Trade Comm'n, Procedures for
Responding to Petitions for Rulemaking, 86 FR 59851 (Oct. 29, 2021).
\10\ 16 CFR 1.31(b)(3).
---------------------------------------------------------------------------
VII. Comment Submissions
You can file a comment online or on paper. For the Commission to
consider your comment, we must receive it on or before February 9,
2023. Write ``HISA Anti-Doping and Medication Control'' on your
comment. Your comment--including your name and your State--will be
placed on the public record of this proceeding, including, to the
extent practicable, on the website <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Because of public health measures and the Commission's heightened
security screening, postal mail addressed to the Commission will be
subject to delay. We strongly encourage you to submit your comments
online through the <a href="https://www.regulations.gov">https://www.regulations.gov</a> website. To ensure that
the Commission considers your online comment, please follow the
instructions on the web-based form.
If you file your comment on paper, write ``HISA Anti-Doping and
Medication Control'' on your comment and on the envelope, and mail your
comment to the following address: Federal Trade Commission, Office of
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B),
Washington, DC 20580.
Because your comment will be placed on the public record, you are
solely responsible for making sure that your comment does not include
any sensitive or confidential information. In particular, your comment
should not contain sensitive personal information, such as your or
anyone else's Social Security number; date of birth; driver's license
number or other State identification number or foreign country
equivalent; passport number; financial account number; or credit or
debit card number. You are also solely responsible for making sure your
comment does not include any sensitive health information, such as
medical records or other individually identifiable health information.
In addition, your comment should not include any ``[t]rade secret or
any commercial or financial information which * * * is privileged or
confidential''--as provided in Section 6(f) of the FTC Act, 15 U.S.C.
46(f), and FTC Rule Sec. 4.10(a)(2), 16 CFR 4.10(a)(2)--including in
particular competitively sensitive information such as costs, sales
statistics, inventories, formulas, patterns, devices, manufacturing
processes, or customer names.
Comments containing material for which confidential treatment is
requested must be filed in paper form, must be clearly labeled
``Confidential,'' and must comply with FTC Rule Sec. 4.9(c), 16 CFR
4.9(c). In particular, the written request for confidential treatment
that accompanies the comment must include the factual and legal basis
for the request and must identify the specific portions of the comment
to be withheld from the public record. See FTC Rule Sec. 4.9(c). Your
comment will be kept confidential only if the General Counsel grants
your request in accordance with the law and the public interest. Once
your comment has been posted publicly at <a href="https://www.regulations.gov">https://www.regulations.gov</a>--
as legally required by FTC Rule Sec. 4.9(b), 16 CFR 4.9(b)--we cannot
redact or remove your comment, unless you submit a confidentiality
request that meets the requirements for such treatment under FTC Rule
Sec. 4.9(c), and the General Counsel grants that request.
Visit the FTC website to read this document and the news release
describing it. The FTC Act and other laws that the Commission
administers permit the collection of public comments to consider and
use in this proceeding as appropriate. The Commission will consider all
timely and responsive public comments it receives on or before February
9, 2023. For information on the Commission's privacy policy, including
routine uses permitted by the Privacy Act, see <a href="https://www.ftc.gov/siteinformation/privacypolicy">https://www.ftc.gov/siteinformation/privacypolicy</a>.
VIII. Communications by Outside Parties to the Commissioners or Their
Advisors
Written communications and summaries or transcripts of oral
communications respecting the merits of this proceeding, from any
outside party to any Commissioner or Commissioner's advisor, will be
placed on the public record. See 16 CFR 1.26(b)(5).
IX. Self-Regulatory Organization's Proposed Rule Language
1000. General Provisions
Rule 1010. Rules of Interpretation
Unless specified otherwise:
(a) words in the singular include the plural, and words in the
plural include the singular;
(b) references to any ``Rule'' or ``Rule Series'' are references to
the rules or rule series approved by the Commission pursuant to section
3053 of the Act;
(c) any Appendices to a Rule Series form an integral part of such
Rule Series;
(d) any reference to a provision in rules, protocols, policies,
standards, guidelines, or similar includes any modifications or
successor provisions made or issued from time to time;
(e) any reference to legislation includes any modification or re-
enactment of legislation enacted in substitution of that legislation,
and any regulation or other instrument from time to time issued or made
under that legislation;
(f) any term defined in this Rule 1000 Series shall supersede the
definition of that term in the Rule 2000 Series;
[[Page 5085]]
(g) a reference to ``writing,'' ``write,'' or ``written'' includes
communications transmitted by email;
(h) a reference to ``may'' means ``in the sole and absolute
discretion of such person or body'';
(i) a reference to a ``day'' means any day of the week and is not
limited to working days;
(j) any time limits shall begin from the day after which the
relevant notification is received (or the day after the relevant
notification is sent, if sent by email). Official holidays and non-
working days are included in the calculation of time limits. The time
limits fixed under this Protocol are respected if the communications by
the parties are sent before midnight (U.S. Eastern time) on the last
day on which such time limits expire. If the last day of the time limit
is an official holiday or a non-business day in the state or country
where the notification has been made, the time limit shall expire at
the end of the first subsequent business day;
(k) a reference to a ``person'' (with no initial capital letter)
means a natural person; and
(l) any words following the terms ``including,'' ``include,'' ``in
particular,'' ``such as,'' ``for example,'' or any similar expression,
are illustrative only, and do not limit the sense of the words,
description, definition, phrase, or term preceding those terms.
Rule 1020. Definitions
Act means the Horseracing Integrity and Safety Act of 2020 (15
U.S.C. 3051-3060), as amended from time to time.
ADMC means the Anti-Doping and Medication Control Standing
Committee of the Authority.
Administration means providing, supplying, supervising,
facilitating, or otherwise participating in the Use or Attempted Use in
a Covered Horse of a Prohibited Substance or Prohibited Method.
However, this definition shall not include the actions of bona fide
veterinary personnel involving a Controlled Medication Substance or
Controlled Medication Method used for genuine and legal therapeutic
purposes or other acceptable justification.
Adverse Analytical Finding (``AAF'') means 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.
Agency means the anti-doping and controlled medication enforcement
agency known as the Horseracing Integrity and Welfare Unit.
Aggravating Circumstances means circumstances involving, or actions
by, a Covered Person that may justify the imposition of one or both of
a period of Ineligibility or fine greater than the otherwise applicable
standard sanction. Such circumstances and actions include those set
forth in Rule 3227 or Rule 3327 (as applicable).
Aliquot means a portion of the Sample obtained from the Covered
Horse.
Analyte means a substance, compound, or measurand that is analyzed
or determined in a biological matrix using an Analytical Testing
Procedure performed under controlled analytical and laboratory
conditions. For anti-doping and controlled medication 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 has the same meaning as Analytical Testing
Procedure.
Analytical Testing means the parts of the Doping Control or
Medication Control process performed at the Laboratory, which includes
Sample handling, analysis, and the reporting of results.
Analytical Testing Procedure means a Fit-for-Purpose procedure, as
demonstrated through method validation, that is used to detect,
identify or quantify Analytes in a Sample in accordance with the
Laboratory Standards and relevant Technical Document(s), Technical
Letter(s), Technical Note(s), or Laboratory Guidelines. Unless the
context otherwise requires, Analytical Testing Procedure is also
referred to or known as an Analytical Method or Test Method.
Analytical Testing Restriction (``ATR'') means a restriction on a
Laboratory's application of specified Analytical Testing Procedure(s)
or on the analysis of a particular class(es) of Prohibited Substances
or Prohibited Methods to Samples, as determined by the Agency.
Anti-Doping Rule Violation (``ADRV'') means an anti-doping rule
violation under the Protocol.
Arbitral Body has the meaning given to it in the Rule 7000 Series.
Arbitration Procedures means the arbitration procedures set forth
in the Rule 7000 Series.
Assistant Trainer means a person engaged in the training of Covered
Horses, under the direct or indirect supervision of a Trainer.
Association Veterinarian means a Veterinarian employed by a
Racetrack.
Attempt means purposely engaging in conduct that constitutes a
substantial step in a course of conduct planned to culminate in the
commission of an Anti-Doping Rule Violation or Controlled Medication
Rule Violation; provided, however, that there shall be no Anti-Doping
Rule Violation or Controlled Medication Rule Violation based solely on
an Attempt to commit a violation if the Covered Person renounces the
Attempt prior to it being discovered by a third party not involved in
the Attempt.
Attending Veterinarian means a Veterinarian providing treatment or
services to Covered Horses hired or otherwise authorized by the Trainer
or Owner or his or her respective designee.
Atypical Finding means a report from a Laboratory that requires
further investigation in accordance with the Atypical Findings Policy
set out at Appendix 1 to the Protocol, prior to the determination of
whether it is an Adverse Analytical Finding.
Atypical Findings Policy means the policy set out at Appendix 1 to
the Protocol.
Authority means the Horseracing Integrity and Safety Authority
designated by section 3052(a) of the Act.
Banned Method has the meaning given to it in Rule 3111.
Banned Substance has the meaning given to it in Rule 3111.
Batch means a set of Samples processed as a group.
Bias means deviation of a measured result from the expected or
reference value when using the complete measurement procedure.
Billing Standards means the standards governing compensation for
arbitrators and stewards under the Arbitration Procedures.
Blood Collection Officer (``BCO'') means a Veterinarian or a
veterinary technician who has been authorized by the Agency (or its
delegate) to collect blood Samples from a Covered Horse.
Breeder means a Person who is in the business of breeding Covered
Horses.
Certified Reference Material (``CRM'') means Reference Material
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.
Certifying Scientists means personnel appointed by a Laboratory 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.
Chain of Custody means the sequence of individuals or organizations
who
[[Page 5086]]
have responsibility for the custody of a Sample from the provision of
the Sample until the Sample has been delivered to the Laboratory for
analysis.
Chaperone means a person authorized by the Agency (or its delegate)
to carry out the responsibilities given to Chaperones in the Testing
and Investigations Standards or by the DCO.
Charge Letter has the meaning given to it in (as the context
requires) Rule 3248 or Rule 3348.
Claim means, in the context of a Claiming Race, the purchase of a
Covered Horse for a designated amount.
Claiming Race means a Covered Horserace in which a Covered Horse
after leaving the starting gate may be claimed in accordance with the
rules and regulations of the applicable State Racing Commission.
Code of Ethics means the Code of Ethics for Laboratories set forth
at Rule 6610.
Commission means the Federal Trade Commission.
Confirmation Procedure (``CP'') means an Analytical Testing
Procedure that has the purpose of confirming the presence in a Sample--
or, when applicable, confirming the concentration, ratio, or score, 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.
Consequences means the penalties resulting from the occurrence of
one or more violations of the Protocol, as set forth in the Rule 3000
Series. The Consequences for an Anti-Doping Rule Violation or a
Controlled Medication Rule Violation may include one or more of the
following:
(1) Disqualification;
(2) Ineligibility;
(3) Provisional Suspension;
(4) financial penalties; and
(5) Public Disclosure.
Contaminated Product means a product other than feed, hay, or
water, that contains a Prohibited Substance that (i) is not disclosed
on the product label, and (ii) a Veterinarian or Trainer would not
otherwise reasonably be aware might be included in the product.
Controlled Medication Method means any method so described on the
Prohibited List.
Controlled Medication Rule Violation has the meaning given to it in
Rule 3311(a).
Controlled Medication Substance means any substance so described on
the Prohibited List or the Technical Document-Prohibited Substances.
Corrective Action Report (``CAR'') means a report describing the
Root Cause Analysis of a 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.
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 under
section 3054(l), during the period: (A) beginning on the date of the
horse's first Timed and Reported Workout at a Racetrack that
participates in Covered Horseraces or at a training facility; and (B)
ending on the date on which the horse is deemed retired pursuant to
Rule 3050(b).
Covered Horserace 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.
Covered Person means all Trainers, Owners, Breeders, Jockeys,
Racetracks, Veterinarians, Persons licensed by a State Racing
Commission, and the agents, assigns, and employees of such Persons; any
other Persons required to be registered with the Authority; and any
other horse support personnel who are engaged in the care, treatment,
training, or racing of Covered Horses.
Decision Limit means the value of the result for a Threshold
Substance in a Sample, above which an Adverse Analytical Finding shall
be reported.
Designated Owner has the meaning given to it in Rule 3020(c).
Detection Time means the interval after a medication is
administered during which it is detectable in a specific matrix (serum,
plasma, urine, or hair) from any member(s) of a group of test horses.
Detection times are determined from analysis of samples collected at
specific time points following an administration of a medication to
group of, potentially as few as 2, test horses. A detection time is not
the same as a withdrawal time. The withdrawal time for a medication
must be decided upon by a Veterinarian (in consultation with the
Responsible Person) and is likely to be based on the Detection Time and
an added safety margin. This margin should be determined using
professional judgment and discretion to take into account the
variability that could be expected to normally occur in a larger
population by considering individual differences between horses, such
as size, metabolism, fitness, health, or recent illness or disease. The
withdrawal interval used for a medication should always be longer than
its Detection Time.
Disqualification means the results of a Covered Horse in a
particular Covered Horserace are invalidated, with all resulting
consequences, including forfeiture of any purses and other
compensation, prizes, trophies, points, and rankings associated with
such Covered Horserace.
Doping Control means all steps and processes from test distribution
planning through to ultimate disposition of any adjudication and review
process pursuant to the Protocol and the Act involving an Anti-Doping
Rule Violation and the enforcement of Consequences, including all steps
and processes in between, including Testing, investigations,
whereabouts program, Sample collection and handling, Laboratory
analysis, Results Management, hearings and reviews, and investigations
and proceedings relating to Anti-Doping Rule Violations not arising
from or related to Testing or violations of Rule 3229.
Doping Control Officer (``DCO'') means an official who has been
authorized by the Agency (or its delegate) to carry out the
responsibilities given to DCOs in the Testing and Investigations
Standards and any related Agency procedures.
EAD Notice has the meaning given to it in Rule 3245.
EAD Violations means Anti-Doping Rule Violations arising out of the
Rule 3000 Series and violations of Rule 3229.
ECM Notice has the meaning given to it in Rule 3345.
ECM or Other Violations means Controlled Medication Rule Violations
arising out of the Rule 3000 Series, violations of Rule 3329, or
violations of Rule 3510.
Equibase means the official database for Thoroughbred horseracing.
Equine Constituencies means, collectively, Owners, Breeders,
Trainers, Racetracks, Veterinarians, State Racing Commissions, and
Jockeys who are engaged in the care, training, or racing of Covered
Horses.
Equine Industry Representative means an organization regularly and
significantly engaged in the equine industry, including organizations
that represent the interests of, and whose membership consists of,
Owners, Breeders, Trainers, Racetracks, Veterinarians, State Racing
Commissions, or Jockeys.
Expanded Measurement Uncertainty means the multiplication of the
coverage factor (q.v.) by the Measurement Uncertainty (q.v.).
External Quality Assessment Scheme (``EQAS'') means a program for
quality
[[Page 5087]]
assessment of Laboratory performance, which includes the periodic
distribution of urine, blood, hair, or other samples to Laboratories
and probationary laboratories by the Agency, to be analyzed for the
presence or absence of Prohibited Substances 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).
Fault means any breach of duty or any lack of care appropriate to a
particular situation. Factors to be taken into consideration in
assessing a Covered Person's degree of Fault include (but are not
limited to) the Covered Person's experience and 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
conducted appropriate due diligence, educated, supervised, and
monitored Covered Persons (including Veterinarians), employees,
personnel, agents, and other Persons involved in any way with the care,
treatment, training, or racing of his or her Covered Horses, and
created and maintained systems to ensure compliance with the Protocol.
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 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 or Covered Horse only has a short time left in
a career, or the timing of the horseracing calendar, would not be
relevant factors to be considered in reducing the period of
Ineligibility based on degree of Fault.
Fit(ness)-for-Purpose means suitable for the intended purpose and
in conformity with the ISO/IEC 17025, ILAC-G7, the Laboratory
Standards, and relevant Technical Document(s) and Technical Letter(s).
Further Analysis means additional analysis conducted by a
Laboratory on an A Sample or a B Sample after it has reported an
analytical result for that A Sample or that B Sample, save that it
excludes (and, therefore, there is no limitation on a Laboratory's
authority to conduct) repeat or confirmation analysis, and analysis
with additional or different Analytical Methods.
IAP member means a member of the Internal Adjudication Panel.
Immediate Family Member means a spouse, domestic partner, mother,
father, aunt, uncle, sibling, or child.
Ineligibility means the Covered Horse or Covered Person is barred
for a specified period of time from participating in specified
activities, as further particularized in the provisions of the Protocol
relating to Ineligibility.
Initial Testing Procedure (``ITP'') means an Analytical Testing
Procedure whose purpose is to identify those Samples that 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.
Interested Party means the Authority, the Owner of the Covered
Horse, the Trainer of the Covered Horse, and the relevant State Racing
Commission (provided that such State Racing Commission has entered into
an agreement incorporating required confidentiality provisions).
Intermediate Precision (sw) means variation in results observed
when one or more factors, such as time, equipment, or operator, are
varied within a Laboratory, and may also be referred to as inter-batch
or inter-run precision.
Internal Adjudication Panel has the meaning given to it in the Rule
7000 Series. The Internal Adjudication Panel shall have the same
meaning as the National Stewards Panel in any other rules approved by
the Commission.
Jockey means a rider or driver of a Covered Horse in Covered
Horseraces.
Laboratory means a laboratory approved by the Agency, applying Test
Methods and processes to provide evidentiary data for the detection or
identification of Prohibited Substances, Metabolites, Markers, or
Prohibited Methods, and, if applicable, quantification of a Threshold
Substance in Samples of urine, blood, hair, and other biological
matrices in the context of Doping Control or Medication Control
activities.
Laboratory Director means a person appointed by a Laboratory to be
responsible for overseeing the professional, organizational,
educational, operational, and administrative responsibilities of the
Laboratory's operations in accordance with the Laboratory Standards.
Laboratory Documentation Package (``LDP'') means the physical or
electronic material produced by a Laboratory upon reporting of an
Adverse Analytical Finding or as requested by the Agency to support an
analytical result such as an Adverse Analytical Finding or an Atypical
Finding.
Laboratory Expert Group (``LabEG'') means the group of laboratory
experts responsible for providing advice, recommendations, and guidance
to the Agency with respect to the overall management of Laboratory
accreditation, disciplinary action, re-accreditation, approval
processes, and monitoring activities.
Laboratory Guidelines (``LGs'') means recommendations of Laboratory
best practices that may be 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, or Prohibited
Method(s), or on the application of specific Laboratory procedures.
Laboratory Internal Chain of Custody means documentation maintained
within the Laboratory to record the chronological traceability of
custody 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 means the Equine Standards for Laboratories
and Accreditation set forth in the Rule 6000 Series.
Laboratory Supervisory Personnel means personnel appointed by a
Laboratory to serve as Laboratory supervisors.
Limit of Detection (``LOD'') means the analytical parameters 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 used.
Limit of Identification (``LOI'') means 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
[[Page 5088]]
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 a Technical Document.
Limit of Quantification (``LOQ'') means the 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.
Management System refers to the Laboratory's quality system to deal
with control of management system documents and records and with
actions to address risk, test improvements, corrective actions, and
ongoing management reviews.
Managing Owner has the meaning given to it in Rule 3020(c).
Marker means a compound, group of compounds, or biological
variable(s) that indicates the Use of a Prohibited Substance or
Prohibited Method.
Measurement Uncertainty (``MU'') means the 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.
Medication Control means all steps and processes from test
distribution planning through to ultimate disposition of any
adjudication and review process pursuant to the Protocol and the Act
involving a Controlled Medication Rule Violation and to enforcement of
Consequences, including all steps and processes in between, including
Testing, investigations, whereabouts program, Sample collection and
handling, Laboratory analysis, Results Management, hearings and
reviews, and investigations and proceedings relating to Controlled
Medication Rule Violations not arising from or related to Testing or
violations of Rule 3329.
Metabolite means any substance produced from a Prohibited Substance
by a biotransformation process.
Minimum Reporting Level means the estimated concentration of a
Prohibited Substance or its Metabolite(s) or Marker(s) in a Sample
below which Laboratories will not report that Sample as an Adverse
Analytical Finding.
Minimum Required Performance Level (``MRPL'') means minimum
analytical criterion of Laboratory technical performance established by
the Agency, including the minimum concentration at which a Laboratory
is expected to consistently detect and confirm a Prohibited Substance,
Metabolite of a Prohibited Substance, or Marker of a Prohibited
Substance or Prohibited Method in the routine daily operation of the
Laboratory.
Minor means a natural person who has not reached the age of 18
years.
National Stewards Panel means the Internal Adjudication Panel.
Negative Finding means a test result from a Laboratory that, in
accordance with the Laboratory Standards and any relevant Technical
Document(s) and 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 Fault or Negligence means the Covered Person establishing that
he or she did not know or suspect, and could not reasonably have known
or suspected, even with the exercise of utmost caution, that he or she
had administered to the Covered Horse (or that the Covered Horse's
system otherwise contained) a Banned Substance or a Controlled
Medication Substance, or that he or she had Used on the Covered Horse a
Banned Method or a Controlled Medication Method, or otherwise committed
an Anti-Doping Rule Violation or Controlled Medication Rule Violation.
For any violation of Rule 3212 or Rule 3312, the Covered Person must
also establish how the Prohibited Substance entered the Covered Horse's
system in order to establish No Fault or Negligence.
No Significant Fault or Negligence means the Covered Person
establishing that his or her fault or negligence, when viewed in the
totality of the circumstances and taking into account the criteria for
No Fault or Negligence, was not significant in relationship to the
Anti-Doping Rule Violation or Controlled Medication Rule Violation in
question. For any violation of Rule 3212 or 3312, the Covered Person
must also establish how the Prohibited Substance entered the Covered
Horse's system in order to establish No Significant Fault or
Negligence.
Nominated Person means a person nominated by a Responsible Person
at the time of notification or through a whereabouts filing to assist,
consent to, and witness Sample collection from a Covered Horse. If the
Responsible Person is not present to nominate a person, or the
designated Nominated Person is not present or willing to assist with
Sample collection, anyone employed by the Responsible Person or Owner
at the stable where the Covered Horse is located 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, BCO, or Chaperone access to the
Covered Horse shall be the Nominated Person for that Sample collection.
In each case, the Nominated Person shall be 18 years or older.
Non-Threshold Substance means a Prohibited Substance for which the
identification, in compliance with any applicable Technical
Document(s), constitutes an Adverse Analytical Finding.
Owner means a person who holds an ownership interest in one or more
Covered Horses.
Person means a natural person or an organization or other entity.
Possession means actual, physical possession, or constructive
possession (which shall be found only if the Covered Person has
exclusive control or intends to exercise exclusive control over the
Prohibited Substance or Prohibited Method or the premises in which a
Prohibited Substance or Prohibited Method exists). If the Covered
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 Covered 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 or Controlled Medication Rule
violation based solely on Possession if, prior to receiving
notification of any kind of any violation, the Covered Person has taken
concrete action demonstrating that the Covered Person never intended to
have possession and has renounced possession by explicitly declaring it
to the Agency. Notwithstanding anything to the contrary in this
definition, the act of purchasing (including by any electronic or other
means) a Banned Substance or Banned Method constitutes Possession by
the Covered Person who makes the purchase, whether or not the Banned
Substance or Banned Method purchased is ever delivered to the Covered
Person.
Post-Race Sample means a Sample collected by or on behalf of the
Agency from a Covered Horse where notification of such Sample
collection takes place no more than 1 hour after the end of a Covered
Horserace in which a Covered Horse participates or is entered, or the
[[Page 5089]]
end of a Vets' List Workout in which a Covered Horse participates. All
Banned Substances and all Controlled Medication Substances are
prohibited from being present in a Post-Race Sample.
Post-Time means the start time of a Covered Horserace in which a
Covered Horse participates or is entered, or the start time of a Vets'
List Workout in which a Covered Horse participates.
Post-Work Sample means a Sample collected by or on behalf of the
Agency from a Covered Horse where notification of such Sample
collection takes place no more than 1 hour after the end of a Timed and
Reported Workout. All Banned Substances and any Controlled Medication
Substances specifically identified on the Prohibited List as prohibited
during Timed and Reported Workouts are prohibited from being present in
a Post-Work Sample.
Presumptive Adverse Analytical Finding (``PAAF'') means 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.
Program means the anti-doping and medication control program
established under section 3055(a) of the Act.
Program Effective Date means the date on which the Commission
approves the proposed rule.
Prohibited List means the list identifying Prohibited Substances
and Prohibited Methods set forth in the Rule 4000 Series.
Prohibited Method means any method so described on the Prohibited
List.
Prohibited Substance means any substance or class of substances so
described on the Prohibited List or the Technical Document-Prohibited
Substances.
Protocol means the Rule 3000 Series (Equine Anti-Doping and
Controlled Medication Protocol), as amended from time to time.
Provisional Hearing means an expedited abbreviated hearing to
resolve a challenge to a Provisional Suspension, occurring prior to the
adjudication of the violation in issue.
Provisional Suspension means the Covered Horse or Covered Person is
barred temporarily from participating in any Timed and Reported Workout
or Covered Horserace in accordance with Rules 3229 or 3329 (as
applicable).
Public Disclosure means the dissemination or distribution of
information by the Authority or the Agency to the general public.
Quality Manager means the staff member appointed by a Laboratory to
perform that role in accordance with the Laboratory Standards.
Race Day means the period commencing at 12:01 a.m. on the day of a
Vets' List Workout or Covered Horserace and ending (i) 1 hour after the
end of such Vets' List Workout or Covered Horserace or (ii) at the end
of any Sample Collection Session conducted at that Vets' List Workout
or Covered Horserace when the Covered Horse is released from the Test
Barn, whichever is later.
Race Organizer means any Person that arranges, organizes, and has
administrative responsibility for a Covered Horserace.
Race Period means the period:
(a) commencing 48 hours prior to the Post-Time of either (i) any
Vets' List Workout in which the Covered Horse participates or (ii) any
Covered Horserace that the Covered Horse has been entered in, whether
or not the Covered Horse actually starts; and
(b) ending (i) 1 hour after the end of such Vets' List Workout or
Covered Horserace or (ii) at the end of any Sample collection process
conducted at that Vets' List Workout or Covered Horserace when the
Covered Horse is released from the Test Barn, whichever is later.
However, the Prohibited List may specify a Race Period that is
shorter or longer in duration than the above period for certain
Controlled Medication Substances or Controlled Medication Methods.
Racetrack means an organization licensed by a State Racing
Commission to conduct Covered Horseraces.
Racetrack Safety Program means the program set forth in Rule 2000
Series, established pursuant to section 3056(a) of the Act.
Reference Collection (``RC'') means 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'') means a Reference Substance or
Reference Standard that 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.
Regulatory Veterinarian means a Veterinarian who is employed,
contracted, or appointed by a State Racing Commission, Racetrack, the
Authority, or the Agency to monitor the health and welfare of Covered
Horses, in addition to any other duties assigned to him or her by the
Authority or the Agency.
Repeatability (sr) means 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) means 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 has the meaning given to it in Rule 3030.
Results Management means the process encompassing the timeframe
from provision of an EAD Notice or ECM Notice through the charge until
the final resolution of the matter, including the end of any
adjudication and review process pursuant to the Protocol and the Act.
Revocation means the permanent withdrawal of a Laboratory's Equine
Analytical Laboratory accreditation by the Agency.
Risk Assessment means the assessment of risk of doping and
controlled medication misuse conducted by the Agency and used to
effectively conduct test distribution planning or Target Testing.
RMTC has the meaning given to it in Rule 6070(a).
Root Cause Analysis (``RCA'') means an investigation to identify
one or more fundamental causes 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.
Sample means any biological material collected for the purposes of
Doping Control or Medication Control, including urine, blood, and hair.
Sample Collection Equipment means A and B bottles, kits,
containers, collection vessels, tubes, or other apparatus used to
collect, hold, or store a Sample at any time during or after a Sample
Collection Session.
Sample Collection Personnel means all qualified officials
authorized by the Agency to carry out or assist with duties during
Doping Control or Medication Control, including, but not limited to,
Blood Collection Officers, Doping
[[Page 5090]]
Control Officers, and Chaperones. An individual may be authorized by
the Agency to carry out one or more roles during Doping Control or
Medication Control.
Sample Collection Session means all of the sequential activities
that directly involve the collection of a Sample from a 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 is
discharged from Sample collection obligations.
Screening Limit means a concentration to be used by Laboratories
when screening for certain Non-Threshold Substances during the Initial
Testing Procedure, below which a Laboratory will not pursue the
possible presence of a Prohibited Substance. When the concentration of
an Analyte subject to a Screening Limit exceeds the Screening Limit as
determined by the Initial Testing Procedure, qualitative confirmatory
analysis by mass spectrometry Confirmation Procedure is required to
confirm the presence or absence of the Prohibited Substance.
Quantification is not required. A Screening Limit is not a Limit of
Detection, a Limit of Identification, or a Limit of Quantification.
Selectivity means the ability of the Analytical Testing Procedure
to detect or identify (as applicable) the substance of interest in the
Sample.
Specified Substance has the meaning given to it in Rule 3111(c).
Stacking Violation has the meaning given to it in Rule 3312(e).
Stakes Race means any race so designated by the Racetrack at which
such race is run, including, without limitation, the races the
Breeders' Cup World Championships comprises and the races designated as
graded stakes by the American Graded Stakes Committee of the
Thoroughbred Owners and Breeders Association.
Standard Operating Procedure means a document setting out
prescribed methods or procedures to be followed when performing certain
routine operations.
Standards means the Testing and Investigations Standards and the
Laboratory Standards. Compliance with a Standard (as opposed to another
alternative standard, practice, or procedure) shall be sufficient to
conclude that the procedures addressed by the Standard were performed
properly. Standards shall include any Technical Documents issued
pursuant to the Standards.
State Racing Commission means an entity designated by State law or
regulation that has jurisdiction over the conduct of horseracing within
the applicable state.
Substantial Assistance means, for purposes of Rule 3226(a) and Rule
3326(a), a Covered Person providing the following assistance:
(1) fully disclosing in a signed written statement or recorded
interview all information the Covered Person possesses in relation to
violations of the Protocol; and
(2) fully cooperating with the investigation and adjudication of
any case or matter related to that information, including, for example,
by providing an affidavit and presenting testimony at a hearing if
requested to do so by the 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.
Tamper Evident means to have one or more indicators or barriers to
entry included with or incorporated into the Sample Collection
Equipment, which, if breached, missing, or otherwise compromised, can
provide visible evidence that Tampering or Attempted Tampering of
Sample Collection Equipment has occurred.
Tampering means intentional conduct that subverts the Doping
Control or Medication Control process, but that would not otherwise be
included in the definition of Prohibited Methods. Tampering includes
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 the Agency
(or a committee or adjudication body), procuring false testimony from
witnesses, committing any other fraudulent act upon the Agency (or
committee 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 or Medication
Control. However, this definition shall not include the actions of bona
fide veterinary personnel involving a Controlled Medication Substance
or Controlled Medication Method used for genuine and legal therapeutic
purposes or other acceptable justification.
Target Testing means selection of specific Covered Horses for
Sample collection based on criteria set forth in the Testing and
Investigations Standards.
Technical Document (``TD'') means a document adopted and published
by the Authority from time to time containing requirements or guidance
on specific anti-doping or medication control topics.
Technical Letter (``TL'') means a document published containing
mandatory technical requirements provided by the Agency from time to
time to address particular issues on the analysis, interpretation, and
reporting of specific Prohibited Substance(s), Metabolites, Markers, or
Prohibited Method(s), or on the application of specific Laboratory
procedures.
Technical Note (``TN'') means technical guidance provided by the
Agency to Laboratories on the performance of specific Laboratory
methods or procedures.
Test Barn means the location where Sample collection is conducted
on Race Day.
Test Barn Veterinarian means a Veterinarian who is employed,
contracted, or appointed by a State Racing Commission, Racetrack, the
Authority, or the Agency to monitor the health and welfare of Covered
Horses subject to Sample collection in the Test Barn.
Testing means the parts of the Doping Control or Medication Control
process involving Sample collection, Sample handling, and Sample
transport to the Laboratory.
Testing and Investigations Standards means the Equine Testing and
Investigations Standards set forth in the Rule 5000 Series.
Test Method has the same meaning as Analytical Testing Procedure.
Thoroughbred means a horse that is registered in The American Stud
Book or in a foreign stud book approved by the Jockey Club or the
International Stud Book Committee.
Threshold means 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 may only be adopted for (i) substances endogenous to the
horse or (ii) substances arising from plants traditionally grazed or
harvested as equine feed.
Threshold Substance means a Prohibited Substance, or Metabolite or
Marker of a Prohibited Substance, for which the identification and
quantitative determination, including, for example, concentration,
ratio, or score, in excess of a pre-determined Decision Limit, or, when
applicable, the establishment of an exogenous origin,
[[Page 5091]]
constitutes an Adverse Analytical Finding.
Timed and Reported Workout means an officially timed and published
running of a Thoroughbred horse over a predetermined distance that is
not a horserace, as reported by Equibase or any official supplier of
racing information and statistics recognized by the Authority. Official
timed workouts shall have the same meaning as Timed and Reported
Workouts. Any official timed workout by a Thoroughbred horse in any
other jurisdiction shall be deemed a Timed and Reported Workout upon
the earliest to occur of the following: (i) the horse is brought to the
United States for purposes of participating in any Covered Horserace;
or (ii) the horse is nominated for a Covered Horserace.
Trafficking means a Covered Person selling, giving, transporting,
sending, delivering, or distributing by any means a Banned Substance or
Banned Method to any other Person, or Possessing a Banned Substance or
Banned Method for any such purpose; provided, however, that Trafficking
shall not include the actions of Veterinarians or other licensed
medical personnel involving a Prohibited Substance used for genuine and
legal therapeutic purposes or other acceptable justification.
Trainer means an individual engaged in the training of Covered
Horses.
Training Facility means a location that is not a Racetrack licensed
by a State Racing Commission that operates primarily to house Covered
Horses and conduct Timed and Reported Workouts.
Use means the utilization, application, ingestion, injection, or
consumption by any means whatsoever of any Prohibited Substance or
Prohibited Method in relation to a Covered Horse.
Veterinarian means a licensed veterinarian who provides veterinary
services to Covered Horses.
Veterinarians' List has the meaning given to it in Rule 2000 Series
(Racetrack Safety Program).
Vets' List Workout means an officially timed running of a Covered
Horse over a predetermined distance that is not a Covered Horserace but
is overseen by a Regulatory Veterinarian or Racetrack steward.
Whereabouts Failure means a failure by the Responsible Person to do
any of the following: (i) provide notice to the Agency that his or her
Covered Horse has been moved from a Racetrack or Training Facility to a
private facility (i.e., a facility not under the jurisdiction of the
Authority/Agency) before such move occurs; (ii) provide whereabouts
information about his or her Covered Horse(s) upon request by the
Agency; (iii) provide sufficient information about the Covered Horse's
whereabouts to enable the Agency to Test the Covered Horse at any time;
or (iv) update any whereabouts information provided to the Agency if it
changes.
Without Prejudice Agreement means a written agreement between the
Agency and a Covered Person that allows the Covered Person to provide
information to the Agency in a defined time-limited setting with the
understanding that, if an agreement for Substantial Assistance or a
case resolution agreement is not finalized, the information provided by
either party may not be used by the other party in any Results
Management proceeding under this Protocol. Such an agreement shall not
preclude the parties from using any information or evidence gathered
from any source.
Workout means a timed running of a horse over a predetermined
distance not associated with a race or its first qualifying race, if
such race is made subject to the Act by election under section 3054(l)
of the Act of the horse's breed governing organization or the
applicable State Racing Commission.
3000. Equine Anti-Doping and Controlled Medication Protocol
3000. General Provisions
Rule 3010. Introduction
(a) The Horseracing Integrity and Safety Act of 2020 (``Act'')
mandates and empowers the Horseracing Integrity and Safety Authority
(``Authority'') to establish a uniform anti-doping and controlled
medication program to improve the integrity and safety of horseracing
in the United States (``Program'').
(b) This Equine Anti-Doping and Controlled Medication Protocol
(``Protocol'') has been developed and issued by the Authority as part
of that mandate. It contains or incorporates by reference rules,
standards, and procedures to improve and protect the integrity and
safety of horseracing in the United States by deterring and penalizing
the improper administration or application of Prohibited Substances and
Prohibited Methods to Covered Horses. The Protocol is split into five
chapters:
(1) the purpose, scope, and organization of the Protocol;
(2) the Prohibited List, rules of proof, and testing and
investigations;
(3) the Equine Anti-Doping Rules;
(4) the Equine Controlled Medication Rules; and
(5) other violations and general procedure/administration.
(c) The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into
separate chapters to reflect the Authority's view that the treatment of
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods,
which are substances/methods that should never be in a horse's system
or used on a horse as they serve no legitimate treatment purpose.
Conversely, Controlled Medication Rule Violations involve Controlled
Medication Substances or Controlled Medication Methods, which are
substances/methods that have been determined to have appropriate and
therapeutic purposes, and so may be used outside the Race Period,
except as otherwise provided in the Prohibited List. For the avoidance
of doubt, the Protocol does not regulate the use of drugs or
medications by human participants in Covered Horseraces.
(d) The Protocol reflects and implements the following principles
set out in section 3055(b) of the Act that:
(1) Covered Horses should compete only when they are free from the
influence of medications, other foreign substances, and treatment
methods that affect their performance;
(2) Covered Horses that are injured or unsound should not train or
participate in Covered Horseraces, and that medications, other foreign
substances, and treatment methods that mask or deaden pain in order to
allow injured or unsound horses to train or race should be prohibited;
(3) rules, standards, procedures, and protocols regulating
medication and treatment methods for Covered Horses and Covered
Horseraces should be uniform and uniformly administered throughout the
United States;
(4) to the extent consistent with the Act, consideration should be
given to international anti-doping and medication control standards of
the International Federation of Horseracing Authorities and the
Principles of Veterinary Medical Ethics of the American Veterinary
Medical Association;
(5) the administration of medications and treatment methods to
Covered Horses should be based upon a veterinary examination and
diagnosis that identifies an issue requiring treatment for which the
medication or method represents an appropriate component of treatment;
(6) the amount of therapeutic medication that a Covered Horse
receives should be the minimum necessary to address the diagnosed
[[Page 5092]]
health concerns identified during the veterinary examination and
diagnostic process; and
(7) the welfare of Covered Horses, the integrity of the sport of
horseracing, and the confidence of its stakeholders (including the
betting public) require full disclosure to regulatory authorities
regarding the administration of medications and treatments to Covered
Horses.
(e) The Protocol will be implemented and enforced on behalf of the
Authority by:
(1) an anti-doping and controlled medication enforcement agency
known as the Horseracing Integrity and Welfare Unit (``Agency''); and
(2) where agreed in accordance with 3060 of the Act, by State
Racing Commissions acting under the delegated authority of the
Authority or the Agency (and references to the Authority or the Agency
in the Protocol will be deemed to encompass such commissions as the
context requires, subject to and consistent with the scope of their
delegated authority).
(f) In accordance with section 3054(b) of the Act, the rules of the
Authority promulgated in accordance with the Act shall preempt any
provision of State law or regulation with respect to matters within the
jurisdiction of the Authority under the Act. Among other things, the
Protocol:
(1) identifies the conduct that will constitute an Anti-Doping Rule
Violation (Rules 3211 to 3216), a Controlled Medication Rule Violation
(Rules 3311 to 3315), or a related violation (Rules 3229, 3329, and
3510);
(2) establishes evidentiary and other rules for proving violations
of the Protocol (Rules 3121 to 3122);
(3) provides for the creation, maintenance, and updating of a
Prohibited List and related Technical Document that identify Prohibited
Substances and Prohibited Methods (Rules 3111 to 3113);
(4) empowers the Agency to perform and manage test distribution
planning and Testing of Covered Horses both in and out of competition,
in accordance with the Testing and Investigations Standards (Rule
3133);
(5) empowers the Agency to gather intelligence and investigate
potential violations of the Protocol, in accordance with the Testing
and Investigations Standards, which incorporate uniform rules and
procedures in accordance with section 3054(c) of the Act (Rule 3133);
(6) empowers the Agency to accredit testing laboratories in
accordance with the Laboratory Standards and to monitor, test, and
audit approved Laboratories to ensure continuing compliance with the
Laboratory Standards; and provides for all samples collected pursuant
to the Protocol to be analyzed at approved Laboratories in accordance
with the Laboratory Standards or by other laboratories, such as
international laboratories accredited by the International Federation
of Horseracing Authorities, in accordance with Rule 3136(d) (Rule
3136);
(7) sets out uniform rules and procedures for the Agency's
management of the results of testing and investigations, and for its
prosecution of any charges that Covered Persons have violated the
Protocol, including incorporating the Arbitration Procedures to ensure
the fair adjudication of those charges;
(8) sets out the sanctions that may be applied in case of
violations of the Protocol, including, but not limited to,
Disqualification of results, forfeiture of prizes and purses, fines,
payment of costs, periods of Ineligibility for Covered Horses or
Covered Persons (including additional periods of Ineligibility for
repeat offenders), and Public Disclosure (sections 3220 and 3320); and
requires the Authority, Racetracks, Race Organizers, Training
Facilities, all Covered Persons, and all other relevant Persons to
recognize, respect, enforce, and give full force and effect to final
decisions issued under the Protocol within their respective spheres of
authority (Rule 3710);
(9) regulates the public reporting and disclosure of cases, and
permits and facilitates statistical reporting to the Authority and to
the U.S. Congress, the Commission, State Racing Commissions, and other
Federal or State governmental bodies or agencies having jurisdiction
over the sport of horseracing in the United States (section 3600); and
(10) empowers the Agency to undertake and commission education and
research activities designed to advance the integrity and safety of
horseracing in the United States (Rule 3810).
(g) The Protocol comes into force on the Program Effective Date and
will apply in full as from that date. In accordance with section
3054(k)(1) of the Act, the Protocol only has prospective effect, i.e.,
it does not apply to, and does not give the Authority or Agency
authority to investigate, prosecute, adjudicate, or penalize conduct
that occurred before the Program Effective Date (Rule 3080).
(h) The Protocol incorporates by reference the supporting rules and
documents approved by the Commission and issued by the Authority,
including Rule 1000 Series (General Provisions), Rule 2000 Series
(Racetrack Safety Program), Rule 4000 Series (Prohibited List), Rule
5000 Series (Testing and Investigations Standards), Rule 6000 Series
(Laboratory Standards), Rule 7000 Series (Arbitration Procedures), Rule
8000 Series (Enforcement Rule), Rule 8500 Series (Methodology for
Determining Assessments), and Rule 9000 Series (Registration of Covered
Persons and Covered Horses).
(i) In accordance with section 3055(c)(4) of the Act, the Agency
may develop further rules, protocols, policies, and guidelines for
approval by the Authority to support the implementation of the
Protocol. These materials will be developed in consultation with the
Anti-Doping and Medication Control Standing Committee (ADMC) of the
Authority and will be consistent with international best practices.
(j) Nothing in the Protocol or in any of its associated rules,
protocols, policies, and guidelines:
(1) is intended to constrain or limit in any way the powers of the
Authority or the Agency under the Act; or
(2) shall be interpreted or applied in a manner that has the effect
of constraining or limiting those powers in any way.
(k) Unless specified otherwise, words and terms in the Protocol
that are capitalized are defined terms that have the meaning given to
them in Rule 1020.
(l) The rules of interpretation included at Rule 1010 and Rule 3070
shall be used as an aid to interpretation of the Protocol.
Rule 3020. Application
(a) The Protocol applies to and is binding on:
(1) 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
(each, a Covered Horserace);
(2) 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 under section 3054(l), during the
period: (A) beginning on the date of the horse's first Timed and
Reported Workout at a racetrack that participates in Covered Horseraces
or at a Training Facility; and (B) ending on the date on which the
horse is deemed retired pursuant to Rule 3050(b) (each, a Covered
Horse); and
(3) the following persons (each, a Covered Person): all Trainers,
Owners,
[[Page 5093]]
Breeders, Jockeys, Racetracks, Veterinarians, Persons licensed by a
State Racing Commission, and the agents, assigns, and employees of such
Persons; any other Persons required to be registered with the
Authority; and any other horse support personnel who are engaged in the
care, treatment, training, or racing of Covered Horses.
(b) Pursuant to section 3054 of the Act, Covered Persons must
register with the Authority. However, they are bound by the Protocol by
undertaking the activity (or activities) that make(s) them a Covered
Person, whether or not they register with the Authority.
(c) Owners. Covered Horses may be owned by a sole individual,
multiple individuals, or one or more entities. As a consequence of the
various ownership structures and property interests of Covered Horses,
it is necessary to identify which Person shall be responsible as the
Owner for purposes of registration, communication, personal liability,
and other requirements under the Protocol and related rules.
Accordingly:
(1) For purposes of mandatory registration with the Authority, any
Covered Person who owns a 5% or greater ownership or property interest
in a Covered Horse shall register with the Authority as an Owner.
(2) The following person shall be responsible as the Owner for any
communication, notification, and reporting requirements under the
Protocol:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the individual designated in the
Authority's database as the representative for the other owners of the
Covered Horse authorized to receive communications or notifications and
fulfill any reporting requirements on their behalf in respect of the
Covered Horse (Designated Owner).
(3) If Rule 3030 makes the Owner the Responsible Person for a
Covered Horse, that shall mean that the following person is personally
liable for violations involving that Covered Horse:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the individual who manages the Covered
Horse as a matter of fact (Managing Owner). If an individual owns more
than a 50% stake in a Covered Horse or where the entity that owns the
Covered Horse has designated an individual with an ownership interest
in the Covered Horse as the individual who will be personally liable
under the Protocol as the Owner of the Covered Horse, that individual
will be presumed to be the Managing Owner. If an individual with an
ownership or property interest in the Covered Horse who is not the
Managing Owner makes a relevant decision about the Covered Horse that
leads to a violation of the Protocol, that person shall be jointly and
severally liable with the Managing Owner for such decision as an Owner
of the Covered Horse.
(4) Only the following persons may attend hearings under the
Protocol as the Owner of the Covered Horse, unless otherwise agreed by
the hearing panel:
(i) if the Covered Horse is owned by one individual, that
individual; or
(ii) if the Covered Horse is owned by more than one individual or
by a partnership, corporation, limited liability company, syndicate, or
other association or entity, the Designated Owner or Managing Owner.
(5) Unless the context requires otherwise, the individual owner or
Managing Owner of the Covered Horse (as applicable) shall be
responsible for discharging any other requirements imposed on an Owner
under the Protocol or related rules.
Rule 3030. Responsible Persons
(a) ``Responsible Person'' means the Trainer of the Covered Horse.
If the Covered Horse does not have a Trainer, the Responsible Person
shall be the Owner of the Covered Horse. The Responsible Person shall
be personally liable for his or her Covered Horse(s) as set out under
the Protocol. Other Covered Persons who make a relevant decision about
the Covered Horse may also be liable depending on the facts and
circumstances.
(b) If a Covered Horse is claimed in a Claiming Race, the person
designated as the Responsible Person prior to that Claiming Race shall
be liable for any violation resulting from a Sample collected on Race
Day. The person who claims the Covered Horse in the Claiming Race shall
not be liable for such violation, unless he or she was complicit in the
violation.
(c) The Responsible Person shall register their designation as the
Responsible Person for a Covered Horse with the Authority and shall
keep such designation and registration up-to-date. Any transfer of the
Responsible Person designation to another Covered Person shall be done
with the Authority in accordance with its procedures prior to the
effective date of the transfer, except that if a Covered Horse is
claimed in a Claiming Race, the transfer shall be done on the day of
the Claiming Race.
(d) The Responsible Person for a Covered Horse shall be the sole
representative for the interests of that Covered Horse in any matter
arising under the Protocol. The Owner (if not the Responsible Person)
may attend any hearing concerning a violation of the Protocol involving
his or her Covered Horse(s) in accordance with the Arbitration
Procedures.
Rule 3040. Core Responsibilities of Covered Persons
(a) Responsibilities of All Covered Persons
It is the personal responsibility of each Covered Person:
(1) to be knowledgeable of and to comply with the Protocol and
related rules at all times. All Covered Persons shall be bound by the
Protocol and related rules, 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 Protocol and related rules and all
revisions thereto;
(2) to cooperate promptly and completely with the Authority and the
Agency in the exercise of their respective powers under the Act and the
Protocol and related rules, including:
(i) in relation to the Testing program and in relation to the
investigation of potential violations of the Protocol;
(ii) by providing complete and accurate information to the
Authority and the Agency in all interactions and filings; and
(iii) on request by the Agency:
(A) making available for inspection any facility, office, stall, or
equipment or other relevant location that is used in the care,
treatment, training, or racing of Covered Horses, or any feed,
medicine, or other item given to Covered Horses;
(B) submitting to under-oath transcribed interviews about his or
her dealings with or in relation to Covered Horses;
(C) providing immediate and unfettered access to any and all data,
documents, and records used in the care, treatment, training or racing
of any Covered Horse (including, but not limited to, data, documents
and records existing in electronic form, e.g., on computers, mobile
phones, or other devices); and
(D) permitting the Agency to review or make and take away copies of
any such data, documents, or records for analysis, investigation, and
potential
[[Page 5094]]
use as evidence of a violation of the Protocol by a Covered Person;
Failure to cooperate promptly and completely with the Agency may
constitute a violation pursuant to Rule 3510(b); and
(3) not to engage in offensive conduct towards any Sample
Collection Personnel or any representative of the Agency or the
Authority (including engaging in improper, insulting, or obstructive
conduct, or recording any Sample Collection Session contrary to Rule
5410). Failure to comply may constitute a violation pursuant to Rule
3510(a) or Tampering or Attempted Tampering, depending on the
circumstances of the case.
(b) Additional Responsibilities of Responsible Persons
In addition to the duties under Rule 3040(a), it is the personal
responsibility of each Responsible Person:
(1) to ensure that Covered Horses for which he or she is the
Responsible Person are made available for Sample collection at any time
and any place where they are located (e.g., Racetrack, Training
Facility, private facility) upon request by the Agency (or its
delegate). In particular, without limiting the generality of the
foregoing:
(i) The Responsible Person shall ensure that the Covered Horse is
produced for Sample collection immediately upon notification by a duly
authorized person in accordance with the Agency's procedures if the
Covered Horse is present at the location where notification is
attempted. If the Covered Horse is present at the location where
notification is attempted, failure to produce a Covered Horse
immediately upon valid notification shall constitute an Anti-Doping
Rule Violation under Rule 3215.
(ii) If the Covered Horse is not present at the location where
notification is attempted (including due to a Whereabouts Failure), the
Responsible Person shall ensure that the Covered Horse is produced for
Sample collection within 6 hours of notification by a duly authorized
Person in accordance with the Agency's procedures, except that the
Agency may extend the 6-hour period if it determines that extenuating
circumstances justify doing so. If the Covered Horse is not present at
the location where notification is attempted or if a Covered Horse
cannot be located by the Agency, failure to produce a Covered Horse for
Sample collection within 6 hours (or any extended period agreed by the
Agency) of valid notification period shall constitute an Anti-Doping
Rule Violation under Rule 3215.
(2) to either be present during a Sample collection involving his
or her Covered Horse and comply with all Sample collection procedure
requirements, or (if not present) to ensure that a Nominated Person who
is 18 years or older is present to represent him or her and complies
with all Sample collection procedure requirements;
(3) to ensure that treatments and medications administered to his
or her Covered Horses:
(i) are administered only on the advice of a Veterinarian or (if a
prescription is not required) following sufficient due diligence
regarding the treatment or medication;
(ii) are not administered in a manner detrimental or contrary to
horse welfare;
(iii) are the minimum necessary to address the diagnosed health
concerns identified during the veterinary examination and diagnostic
process;
(iv) do not contain a Banned Substance or involve a Banned Method;
and
(v) do not otherwise violate the Protocol;
(4) to inform all Covered Persons (including Veterinarians),
employees, personnel, agents, and other Persons involved in any way
with the care, treatment, training, or racing of his or her Covered
Horses of their respective obligations under the Protocol (including,
in particular, those specified in Rule 3040(a));
(5) to adequately supervise all Covered Persons (including
Veterinarians), employees, personnel, agents, and other Persons
involved in any way with the care, treatment, training, or racing of
his or her Covered Horses, including by (without limitation):
(i) conducting appropriate due diligence in the hiring process
before engaging their services;
(ii) clearly communicating to such Persons that compliance with the
Protocol is a condition of employment or continuing engagement in the
care, treatment, training, or racing of his or her Covered Horses;
(iii) creating and maintaining systems to ensure that those Persons
comply with the Protocol; and
(iv) adequately monitoring and overseeing the services provided by
those Persons in relation to the care, treatment, training, or racing
of his or her Covered Horses;
(6) to bear strict liability for any violations of the Protocol by
such Covered Persons (including Veterinarians), employees, personnel,
agents, and other Persons involved in the care, treatment, training, or
racing of his or her Covered Horses;
(7) to file and update as necessary with the Authority information
identifying what Covered Horses he or she is the Responsible Person
for;
(8) to maintain accurate, complete, and up-to-date treatment
records (including, without limitation, records of medical,
therapeutic, and surgical treatments and procedures, including
diagnostics) of his or her Covered Horses in an electronic or other
form specified by the Agency, and to provide the Agency with access to
those records upon request and without delay so that it may inspect and
make and retain copies of them for purposes of monitoring and ensuring
compliance with the requirements of the Protocol. The records must
include the details required under Rule 2251(b). The Responsible Person
must retain copies of such treatment records for a period of no less
than 3 years, although the Responsible Person is advised to retain them
for the duration of the limitation periods under Rule 3090;
(9) at the time of registering a horse with the Authority and prior
to such horse competing in any Timed and Reported Workout or Covered
Horserace, the Responsible Person shall declare in writing to the
Agency all administrations of Banned Substances and Banned Methods to
the horse since the Responsible Person first owned the horse (or, if
not the Owner, since the Owner at the time of registration first owned
the horse) or since the Program Effective date, whichever is earlier.
On request by the Agency, the Responsible Person shall provide any
related treatment records for the horse during that period. If a Banned
Substance or Banned Method has been administered in that period, the
Agency may impose a stand down period for the horse of up to the period
of Ineligibility that would be applicable for the relevant Banned
Substance or Banned Method and require that (at the Responsible
Person's cost) the Covered Horse provide one or more negative Samples
before subsequently being eligible to participate in a Timed and
Reported Workout or a Covered Horserace. Failure by a Responsible
Person to comply with this Rule 3040(b)(9) may constitute a violation
of Rule 3510(b);
(10) if any Covered Horse is moved from a Racetrack or Training
Facility to a private facility (i.e., a facility not under the
jurisdiction of the Authority or the Agency), the Responsible Person
shall provide sufficient information about the Covered Horse's
whereabouts so that the Agency remains able to collect Samples from the
Covered Horse
[[Page 5095]]
at any time. The Responsible Person shall also provide any further
information about the whereabouts of a Covered Horse that is
specifically requested by the Agency. Failure to do so may constitute a
violation of Rule 3510(d);
(11) to notify the Authority in writing within 7 days of becoming
aware that any of his or her Covered Horses:
(i) is pregnant;
(ii) was pregnant but has foaled or is no longer pregnant;
(iii) has been castrated or hemicastrated (including chemical
castration or immunocastration); or
(iv) has suffered a fatal condition.
In each case, the Responsible Person shall state the name of the
Covered Horse, the date of the event triggering the notice, and (for
paragraph (iv) above) a summary explanation regarding the cause of the
fatal condition.
(c) Additional Responsibilities of Owners
In addition to the duties under Rule 3040(a):
(1) each person with a 5% percent or greater ownership or property
interest in a Covered Horse shall register with the Authority as an
Owner of the Covered Horse, and ensure that any transfer of ownership
is registered with the Authority in accordance with its procedures; and
(2) if a Covered Horse is owned by multiple Owners, they shall
ensure that the Agency is notified in writing of one Designated Owner
authorized to receive communications and notifications and fulfil any
reporting requirements on their behalf.
(d) Additional Responsibilities of Attending Veterinarians
In addition to the duties under Rule 3040(a), and the further
duties and requirements imposed under the Rule 2000 Series (Racetrack
Safety Program), it is the personal responsibility of each Attending
Veterinarian to act in strict compliance with the Protocol and keep
updated treatment records (including, without limitation, records of
medical, therapeutic, and surgical treatments and procedures, including
diagnostics) in an electronic database designated by the Agency or in
any other form designated by the Agency and provide access to the
Agency upon request and without delay to or copies of such treatment
records. The records must include the details required under Rule
2251(b) and must be submitted in an electronic format designated by the
Authority within the deadline specified in that same provision.
Attending Veterinarians must retain copies of such treatment records
for a period of no less than 3 years, or for the retention period
required by the relevant state veterinary practice act, whichever is
longer.
Rule 3050. Retirement and Equine Fatalities
(a) Covered Persons.
(1) Each Responsible Person who wishes to no longer be bound by the
Protocol shall give written notice to the Authority of his or her
retirement from the position that made him or her a Responsible Person.
In each case, the Responsible Person shall be deemed to have retired
(and to be no longer subject to the Protocol) on the later of (i) the
date given in the written notice of retirement and (ii) the date the
notice is received.
(2) Any other Covered Person will continue to be bound by and
required to comply with the Protocol and related rules unless and until
he or she unregisters with the Authority.
(3) If a Covered Person ceases to be subject to the Protocol while
the Agency is conducting a Results Management process in respect of
that person, the Agency retains jurisdiction to complete its Results
Management process. If a Covered Person retires or ceases to be subject
to the Protocol before any Results Management process has begun, and
the Agency had jurisdiction over the Covered Person at the time the
Anti-Doping Rule Violation or Controlled Medication Rule Violation was
committed, the Agency retains jurisdiction to conduct Results
Management in respect of that violation.
(4) If a Covered Person retires while subject to a period of
Ineligibility, he or she must give written notice of such retirement to
the Authority. The Covered Person may not return to the sport (i.e.,
carry out any of the activities prohibited during the period of
Ineligibility pursuant to Rules 3229 and 3329) unless the Covered
Person has given 4 months' prior written notice (or notice equivalent
to the period of Ineligibility remaining as of the date the Covered
Person retired, if that period was longer than 4 months) to the
Authority of his or her intent to return to the sport.
(5) The Agency may forward notifications of retirement of Covered
Persons to Interested Parties or other Persons with a need to know.
(b) Covered Horses.
(1) If an Owner wishes to retire a Covered Horse such that it is no
longer made available for Testing, the Owner must provide written
notice of such retirement to the Agency, in accordance with its
procedures.
(2) A Covered Horse that has been retired in accordance with the
previous clause may not participate in a Timed and Reported Workout or
be entered in a Covered Horserace until the Covered Horse has been made
available for Testing at least 4 months prior to notice being given to
the Agency (in accordance with its procedures) of the intention to
unretire the Covered Horse.
(3) If a Covered Horse is retired from horseracing or suffers a
fatal condition while the Agency is conducting a Results Management
process in respect of it, the Agency retains jurisdiction to complete
its Results Management process. If a Covered Horse is retired or
suffers a fatal condition before any Results Management process has
begun, and the Agency had jurisdiction over the Covered Horse at the
time the Anti-Doping Rule Violation or Controlled Medication Rule
Violation was committed, the Agency retains jurisdiction to conduct
Results Management in respect of that violation. If a Covered Horse
suffers a fatal condition, the Agency retains Testing authority over
that horse in accordance with Rule 3132(d).
(4) 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 wishes that horse to return to
participation in Covered Horseraces or Timed and Reported Workouts, the
Owner must first provide the Agency with written notice and make the
Covered Horse available for Testing for at least 4 months prior to such
participation or for the remainder of the Covered Horse's period of
Ineligibility, whichever is longer.
(5) In order to manage the number of Covered Horses registered with
the Authority, the Agency may retire a Covered Horse based on
inactivity (i.e., where the Covered Horse does not participate in a
Timed and Reported Workout or Covered Horserace for 18 months or more,
excluding periods of inactivity due to a Provisional Suspension or
period of Ineligibility) by sending written notice thereof to the
Authority and the Owner in accordance with the Agency's procedures. If
the Owner disputes that retirement, while the dispute is pending the
Covered Horse may not participate in any Timed and Reported Workout or
Covered Horserace but must be made available for Testing. Upon
resolution of the dispute, the Authority will notify the Agency whether
the horse is retired and, therefore, no longer subject to Testing. If
the Owner wishes to return the Covered Horse to participation in Timed
and Reported Workouts or Covered
[[Page 5096]]
Horseraces, the Owner must first provide the Agency with written notice
and make the Covered Horse available for Testing for at least 4 months
prior to such participation.
(6) The Agency may reduce the 4-month notice period in Rule 3050(b)
to 2 months where the Owner of the Covered Horse submits an application
establishing good cause to do so, and where the Agency approves such
application based on a review conducted in accordance with the
objectives of the Protocol.
(7) The Agency may forward notifications of retirement of Covered
Horses to Interested Parties or other Persons with a need to know.
Rule 3060. Claiming Races and Voidable Claims
(a) Subject to Rule 3132(b), a claimed horse may be subject to
Sample collection at a Claiming Race if requested (and paid for) by the
claimant as part of the claiming procedure on the day of the Claim. If
a Sample collected from the claimed horse results in an Anti-Doping
Rule Violation or Controlled Medication Rule Violation, the Claim may
be voided at the option of the claimant, and the claimant shall be
entitled to the return from the seller of all sums paid for the claimed
horse and of all reasonable expenses incurred after the date of the
Claim. While awaiting test results, a claimant shall: (i) exercise due
care in maintaining and boarding a claimed horse; and (ii) not
materially alter a claimed horse.
(b) Any voided claim shall be recorded in Equibase.
Rule 3070. Amendment and Interpretation of the Protocol
(a) The Authority may amend the Protocol from time to time, as
necessary to ensure that it remains fit for purpose, in accordance with
section 3057(e) of the Act. Unless provided otherwise, any amendments
will come into force on the date specified or (if no date is specified)
on the date the amendment is approved by the Commission.
(b) Subject to Rule 3070(d), the Protocol shall be interpreted as
an independent and autonomous text and not by reference to existing law
or statutes.
(c) The Protocol has been adopted pursuant to the Act and shall be
interpreted, where applicable, in a manner that is consistent with
applicable provisions of the Act and the other rules in Rule 1000-9000
Series. In the event of any conflict between the Act and the Protocol,
the Act shall prevail. In the event of any conflict between the
Protocol and any other rules in Rule 1000-9000 Series, the Protocol
shall prevail.
(d) The World Anti-Doping Code and related International Standards,
procedures, documents, and practices (WADA Code Program), the comments
annotating provisions of the WADA Code Program, and any case law
interpreting or applying any provisions, comments, or other aspects of
the WADA Code Program, may be considered when adjudicating cases
relating to the Protocol, where appropriate.
Rule 3080. Transitional Provisions
(a) The Protocol shall not apply retroactively to matters pending
before the Program Effective Date.
(b) A presence violation under Rule 3212 or Rule 3312 that occurs
after the Program Effective Date as a result of Use or Administration
prior to the Program Effective Date shall not constitute a violation of
the Protocol.
(c) The relevant State Racing Commission retains authority
(including results management) in relation to any anti-doping or
controlled medication matters taking place prior to the Program
Effective Date.
(d) Changes to substances or methods covered by the Prohibited List
or related Technical Document--Prohibited Substances shall not, unless
they specifically provide otherwise, be applied retroactively. However,
a Responsible Person or other Covered Person who is serving a period of
Ineligibility on account of a Prohibited Substance or Prohibited Method
that is later subject to a change in status (either because it is no
longer prohibited or subject to lesser sanctions) may apply to the
Agency for consideration of a reduction in the period of Ineligibility
in light of that change in status. The Responsible Person may also
apply to the Agency for consideration of a reduction in the period of
Ineligibility applicable to his or her Covered Horse(s).
Rule 3090. Statute of Limitations
(a) No charge may be brought against a Covered Person or in
relation to a Covered Horse in respect of an Anti-Doping Rule Violation
unless the Covered Person or Responsible Person for the Covered Horse
has been given notice, or notification has been reasonably attempted,
within 10 years of the date the Anti-Doping Rule Violation is asserted
to have occurred. Any violation of Rule 3229 is also subject to a 10-
year limitation period.
(b) No charge may be brought against a Covered Person or in
relation to a Covered Horse in respect of a Controlled Medication Rule
Violation unless the Covered Person or Responsible Person for the
Covered Horse has been given notice, or notification has been
reasonably attempted, within 2 years of the date the Controlled
Medication Rule Violation is asserted to have occurred. Any violation
of Rule 3329 is also subject to a 2-year limitation period.
(c) Any violation of Rule 3510 is subject to a 4-year limitation
period.
3110. The Prohibited List
Rule 3111. Prohibited Substances and Prohibited Methods
(a) The Prohibited List identifies Prohibited Substances and
Prohibited Methods that are:
(1) prohibited at all times (Banned Substances and Banned Methods)
on the basis of the Agency's determination that medical, veterinary, or
other scientific evidence or experience supports their actual or
potential (i) ability to enhance the performance of Covered Horses,
(ii) masking properties, or (iii) detrimental impact on horse welfare;
or
(2) prohibited for Use or Administration in relation to a Covered
Horse during the Race Period and prohibited to be present in a Post-
Race Sample or Post-Work Sample, except as otherwise specified in the
Prohibited List (Controlled Medication Substances and Controlled
Medication Methods).
(b) Prohibited Substances and Prohibited Methods may be included in
the Prohibited List by general category (e.g., anabolic steroids) or by
specific reference to a particular substance or method.
(c) The Prohibited List is supplemented by the ``Technical
Document--Prohibited Substances,'' which provides guidance on the
Prohibited Substances that fall into the general categories listed in
the Prohibited Lis
[…truncated; see source link]Indexed from Federal Register on January 26, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.