HISA Anti-Doping and Medication Control Rule

Federal RegisterOct 28, 2022

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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.

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 August 17, 2022 and supplemented on October 13, 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 text and explanation, and it seeks public comment on whether the Commission should approve or disapprove the proposed rule.

DATES:

If approved, the HISA proposed rule would become effective January 1, 2023. Comments must be received on or before November 14, 2022.

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

https://www.regulations.gov.

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

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.

15 U.S.C. 3051 through 3060.

15 U.S.C. 3053(b)(2).

15 U.S.C. 3053(b)(1).

15 U.S.C. 3053(c)(1).

Pursuant to Section 3053(a) of the Horseracing Integrity and Safety Act of 2020 and Commission Rule 1.142, notice is hereby given that, on August 17, 2022, and as supplemented on October 13, 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.

The Commission publishes this document to solicit comments on the proposed rule from interested persons.

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).

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.”

15 U.S.C. 3053(a)(2)-(3), (8)-(10).

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.

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 Document.

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 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 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.

[Technical document insert]

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

www.hisaus.org/regulations

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

https://www.regulations.gov.

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.

With the approval of the Commission, the Protocol will go into effect on January 1, 2023. 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 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 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 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 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).

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 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, 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 β2-agonists, formoterol and salbutamol on cancellous bone of ovariectomized (OVX) rat: With the banning of anabolic steroids, those seeking an anabolic effect turned to β2-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 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 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 at its December 2022 meeting, and it is anticipated that the international community will adopt a withdrawal interval strategy similar to the one proposed by HISA.

ii. 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 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

https://www.arci.com/model-rules-standards/.

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

https://www.wada-ama.org/en/resources/.

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 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:

www.wada-ama.org/en/resources/.

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 ILAC standards are available at:

https://ilac.org/publications-and-resources/ilac-guidance-series/.

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 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 (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,

https://www.hisausregs.org/,

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

https://www.regulations.gov.

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 (11:59 p.m.) 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 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 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.

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 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 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.

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

If approved by the Commission, this proposed rule will become effective January 1, 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

https://www.regulations.gov.

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 proposed rule or modification is consistent with—(A) this chapter; and (B) applicable rules approved by the Commission.”

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.

15 U.S.C. 3053(c)(2).

Although the Commission must approve the proposed rule if the Commission finds that the proposed rule is consistent with the Act and the Commission's procedural rule, the Commission may consider broader questions about the health and safety of horses or the integrity of horseraces and wagering on horseraces in another context: “The Commission may adopt an interim final rule, to take effect immediately, . . . if the Commission finds that such a rule is necessary to protect—(1) the health and safety of covered horses; or (2) the integrity of covered horseraces and wagering on those horseraces.”

The Commission may exercise its power to issue an interim final rule 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 that bear on protecting the health and safety of horses or the integrity of horseraces and wagering on horseraces but do not discuss whether HISA's proposed rule on Registration is consistent with the Act or the applicable rules, they should not submit a comment here. Instead, they are encouraged to submit a petition requesting that the Commission issue an interim final rule addressing the subject of interest. The petition must meet all the criteria established in the Rules of Practice (Part 1, Subpart D);

if it does, the petition will be published in the

Federal Register

for public comment. In particular, the petition for an interim final rule must “identify the problem the requested action is intended to address and explain why the requested action is necessary to address the problem.”

As relevant here, the petition should provide sufficient information for the public to comment on, and for the Commission to find, that the requested interim final rule is “necessary to protect—(1) the health and safety of covered horses; or (2) the integrity of covered horseraces and wagering on those horseraces.”

15 U.S.C. 3053(e).

16 CFR 1.31;

see

Fed. Trade Comm'n, Procedures for Responding to Petitions for Rulemaking, 86 FR 59851 (Oct. 29, 2021).

16 CFR 1.31(b)(3).

15 U.S.C. 3053(e).

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 November 14, 2022. 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

https://www.regulations.gov.

Because of the public health emergency in response to the COVID-19 outbreak 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

https://www.regulations.gov

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 § 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 § 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 § 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

https://www.regulations.gov

—as legally required by FTC Rule § 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 § 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 November 14, 2022. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see

https://www.ftc.gov/siteinformation/privacypolicy.

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;

(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;

(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 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 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(

), 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 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 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 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 January 1, 2023.

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 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

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, 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(

) 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 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 r

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