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 December 30, 2022. The Office of the Secretary of the Commission determined that the proposal complied with the Commission's rule governing such submissions. This document publicizes the Authority's proposed rule's text and explanation, and it seeks public comment on whether the Commission should approve or disapprove the proposed rule. This document is substantially similar to the document published on October 28, 2022, as corrected on November 4, 2022, and the Commission will consider all comments filed in response to that document as well as all comments filed in response to this document.

DATES:

If approved, the HISA proposed rule would take effect immediately, and the Commission must approve or disapprove the rule by March 27, 2023. Comments must be received on or before February 9, 2023.

ADDRESSES:

Interested parties may file a comment online or on paper by following the instructions in the Comment Submissions part of the SUPPLEMENTARY INFORMATION section below. Write “HISA Anti-Doping and Medication Control” on your comment and file your comment online at https://www.regulations.gov under docket number FTC-2023-0009. If you prefer to file your comment on paper, mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT:

Austin King (202-326-3166), Associate General Counsel for Rulemaking, Office of the General Counsel, Federal Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Self-Regulatory Organization's Statement of the Background, Purpose of, and Statutory Basis for, the Proposed Rule

a. Background and Purpose

b. Statutory Basis

II. Self-Regulatory Organization's Statement of the Terms of Substance of the Proposed Rule and Discussion of Alternatives

III. Self-Regulatory Organization's Summary of Comments Received Pre-Submission and Its Responses to Those Comments

IV. Legal Authority

V. Effective Date

VI. Request for Comments

VII. Comment and Submissions

VIII. Communications by Outside Parities to the Commissioners or Their Advisors

IX. Self-Regulatory Organization's Proposed Rule Language

Background

The Horseracing Integrity and Safety Act of 2020 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.

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 December 30, 2022, the Horseracing Integrity and Safety Authority (“HISA” or the “Authority”) filed with the Federal Trade Commission a proposed Anti-Doping and Medication Control rule and supporting documentation as described in Items I, II, III, IV, and IX below, which Items have been prepared by HISA. The Office of the Secretary of the Commission determined that the filing complied with the Commission's rule governing such submissions. The Commission publishes this Notice to solicit comments on the proposed rule from interested persons. This document is substantially similar to the document published on October 28, 2022, 87 FR 65292, as corrected on November 4, 2022, 87 FR 66705, and the Commission will consider all comments filed in response to that document as well as all comments filed in response to this document.

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.”

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 Notice.

In developing the Protocol and related rules in a manner that is consistent with the Act and the rules and regulations applicable to the Authority, the Authority took the following principles and mandates into consideration, as directed by section 3055(b) of the Act:

(1) Covered Horses should compete only when they are free from the influence of medications, other foreign substances, and methods that affect their performance. The entire Protocol is dedicated to this principle, and the elaborate anti-doping and controlled medication rules work toward the objective of ensuring that Covered Horses compete in a manner that is free of the influence of doping substances, medications, and methods that affect their performance. The Prohibited List and related Technical Document prescribe the substances and methods that are prohibited and permitted under certain circumstances. The Standards (Rules 5000 and 6000 Series) set out comprehensive investigatory and sample collection provisions and an accreditation system that ensures accurate laboratory testing, and the Arbitration Procedures establish a set of disciplinary procedures to deal fairly but firmly with violations of the rules.

(2) Covered Horses that are injured or unsound should not train or participate in covered races, and the use of medications, other foreign substances, and treatment methods that mask or deaden pain in order to allow injured or unsound horses to train or race should be prohibited. In the Protocol, Rule 3111 operates together with the Prohibited List to ban substances and methods for which there exists medical, veterinary, or other scientific evidence or experience to a support their actual or potential masking properties (“Banned Substances” and “Banned Methods”) and to restrict the use of medications during the Race Period (“Controlled Medication Substances” and “Controlled Medication Methods”). Certain Controlled Medication Substances are also prohibited during workouts, as set out in the Prohibited List. The Protocol also operates in conjunction with the Rule 2000 Racetrack Safety Program, which sets forth stringent rules for placing Covered Horses on the Veterinarians' List and requires the Regulatory Veterinarian to oversee removal from the list. These processes help to ensure that injured and unsound horses do not train or participate in Covered Horseraces. It should also be noted that Rule 2271 in the Racetrack Safety Program prohibits the “[u]se of physical or veterinary procedures to mask the effects or signs of injury so as to allow training or racing to the detriment of the Horse's health and welfare.”

(3) Rules, standards, procedures, and protocols regulating medication and treatment methods for Covered Horses and Covered Horseraces should be uniform and uniformly administered nationally. The Protocol preempts state laws and provides instead a uniform set of comprehensive rules that embrace all of the areas previously addressed in state anti-doping and medication 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.

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.

The Protocol will go into effect if and when the Commission approves the proposed rule. The Protocol contains or incorporates by reference rules, standards, and procedures to improve and protect the integrity and safety of horseracing in the United States by deterring and penalizing the improper administration or application of Prohibited Substances and Prohibited Methods to Covered Horses. The Protocol is divided into five substantive chapters: (1) the purpose, scope, and organization of the Protocol; (2) the Prohibited List, rules of proof, and testing and investigations; (3) the Equine Anti-Doping Rules; (4) the Equine Controlled Medication Rules; and (5) other violations and general procedure/administration.

The Protocol has intentionally divided the regulation of Anti-Doping Rule Violations and Controlled Medication Rule Violations into separate chapters to reflect the Authority's view that the treatment of such violations should be separate and distinct from each other. Anti-Doping Rule Violations involve Banned Substances or Banned Methods, which are substances/methods that should never be in a horse's system or used on a horse as they serve no legitimate treatment purpose. Conversely, Controlled Medication Rule Violations involve Controlled Medication Substances or Controlled Medication Methods, which are substances/methods that have been determined to have appropriate and therapeutic purposes, and so may be used outside the Race Period, except if specified otherwise. This division accords with international best practices. However, the two distinct processes share many common features and rules, and therefore the Protocol is streamlined to make the processes consistent with each other wherever possible.

The Protocol will be implemented and enforced on behalf of the Authority by the Agency, which has created an entity designated as the Horseracing Integrity and Welfare Unit (“Agency”). In addition, and only where so agreed, State Racing Commissions acting under the delegated authority of the Authority 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, World Anti-Doping Agency (“WADA”), the FEI, and the British Horseracing Association. Documents considered in preparing the Prohibited List are exhibited below:

Exhibit B.7. IFHA International Screening Limits for urine.

Exhibit B.8. IFHA International Screening Limits for plasma.

Exhibit B.9. ARCI Uniform Classification Guidelines for Foreign Substances and Recommended Penalties Model Rule.

Exhibit B.10. WADA 2022 Prohibited List.

Exhibit B.11. 2022 FEI Equine Prohibited Substances List.

Exhibit B.12. British Horseracing Association Equine Prohibited List Code (2022).

Exhibit B.13. British Horseracing Association Published Detection Times (June 2019).

Exhibit B.14. Hong Kong Jockey Club Medication and Prohibited Substances.

The ADMC also considered a number of scientific papers when developing the Prohibited List and supporting Technical Document:

Exhibit B.15. AAS 16 Detection of Some Designer Steroids in Horse Urine: Identifies the integrity risks associated with the use of anabolic steroids in racehorses.

Exhibit B.16. AAS 29 Anabolic Effects of 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 Food and Drug Administration (“FDA”) oversight represents a substantial risk to horse health and racing integrity.

Exhibit B.23. EIPH 33 Exercise-induced pulmonary hemorrhage (EIPH): mechanistic bases and therapeutic interventions: Describes this condition (rarely, but occasionally, experienced by human athletes) that affects virtually every race horse at some point(s) in its racing and training career.

Exhibit B.24. Furos 15 Efficacy of furosemide in the treatment of exercise-induced pulmonary hemorrhage in Thoroughbred racehorses: The seminal study that demonstrated the efficacy of furosemide in mitigating or preventing episodes of EIPH in the racing Thoroughbred. While not submitted as a justification for the continued use of furosemide, this study did establish furosemide as the only medication having efficacy for controlling EIPH and why the WADA total ban on furosemide cannot be, at this time, applied to horseracing. This article also then justifies the Prohibited List's exclusion for the use of furosemide in training exercise.

Exhibit B.25. PAG 13 Intra-Articular Polyacrylamide Hydrogel Injections Are Not Innocent: While the use of polyacrylamide hydrogels have a history of use in human joint disease, their introduction into the equine market as medical devices, is relatively recent, and the lack of documented method of action causes reservations about its use in that it may have the potential to mask pain and allow the progression of orthopedic disease to the overall detriment of the horse.

Exhibit B.26. PBZ 05 Effectiveness of administration of phenylbutazone alone or concurrent administration of phenylbutazone and flunixin meglumine to alleviate lameness in horses: Establishes justification for the prohibition on “stacking” of NSAIDs—medications that are not controlled in human sport, but require control in equine sport for safety reasons and ethical considerations.

Exhibit B.27. Ract 04 Effects of Ractopamine HCl on Physical and Reproductive Parameters in the Horse: This anabolic agent is not addressed in human sport but has been detected in post-race and out of competition samples derived from racehorses. Its presence has been both the result of contamination of commercial feed at the processing site as well as deliberate administration.

Exhibit B.28. Thyro 07 A randomised, controlled trial to determine the effect of levothyroxine on Standardbred racehorses: This prescription medication had widespread use for the (scientifically unsupported) treatment of a multitude of conditions—other than hypothyroidism which is exceedingly rare in the horse. This article elucidates the health risk in its use and justifies the ban as established in the Prohibited List.

Exhibit B.29. Tryp 03 Effects of a commercial dose of L-tryptophan on plasma tryptophan concentrations and behaviour in horses: An example of unregulated, over the counter oral nutraceuticals that have the potential to impact a horse's health, behavior, or mental state—thus exerting a drug-like effect while evading regulation by the FDA. It is for this reason that the Prohibited List is not permissive of the use of these substances during the race period, to be consistent with FDA-approved drugs having similar effects.

1. Banned Substances and Banned Methods—Rule Series 4100

Banned Substances and Banned Methods are set out in categories, including anabolic agents, peptide hormones and growth factors, beta-2 agonists, hormone and metabolic modulators, and diuretics and masking agents (Rule 4110). Banned Methods include blood manipulation, chemical castration or immunocastration, and gene and cell doping (Rule 4120).

2. Controlled Medication Substances and Controlled Medication Methods and Exceptions—Rule Series 4200

Subject to exceptions specified in the Prohibited List (Rule 4212), only feed, hay, and water are permitted during the Race Period (Rule 4211(a)). Accordingly, subject to Rule 4212, any substance administered during the Race Period or present in a Post-Race Sample (including any metabolite(s), artifact(s), and isomer(s) of such substance(s)) that does not otherwise qualify as a Banned Substance shall constitute a prohibited Controlled Medication Substance. In addition, certain Controlled Medication Substances are prohibited from presence in a Post-Work Sample (Rule 4211(b)). Exceptions are provided in Rule 4212 for emergency veterinary care, for certain substances that are permitted up to 24 hours prior to Post-Time ( e.g., anti-ulcer medications), electrolyte solutions consumed by the horse by free choice, furosemide ( i.e., Lasix/Salix), and for supplements or feed additives that do not have an action or effect on listed mammalian body systems.

Controlled Medication Methods include alkalinization, intra-articular injections, and use of a nasogastric tube within specified time periods (Rule 4220).

3. Ineligibility Periods for Covered Horses—Rule Series 4300

Consistent with section 3057(d) of the Act, Rule 4300 establishes uniform rules setting out the periods of ineligibility that apply to Covered Horses implicated in Anti-Doping Rule Violations or Controlled Medication Rule Violations. The Ineligibility period ranges from zero months to lifetime bans, depending on the category of the substance or method.

Violations involving Controlled Medication Substances will not result in a period of Ineligibility for the Covered Horse. However, the Covered Horse shall be placed on the Veterinarians' List and a Vets' List Workout must be scheduled (at which the horse may be subject to Sample collection). Violations involving Controlled Medication Methods may result in a period of Ineligibility for the Covered Horse where specified in the Prohibited List at Rule 4320.

Covered Horses are not subject to increased Ineligibility periods if they are involved in multiple violations.

4. Rule Series 4000 Appendix: Technical Document—Prohibited Substances

The “Technical Document—Prohibited Substances” supplements the Prohibited List (Rule Series 4000) and sets out additional detail concerning Prohibited Substances. The “Technical Document—Prohibited Substances,” enumerates specific Prohibited Substances that fall into the general categories listed in the Prohibited List and sets forth detection times, screening limits, and thresholds for those Prohibited Substances. The Technical Document also designates certain Prohibited Substances as Specified Substances, which are those that pose a higher risk of being the result of contamination and that are therefore subject to more flexible sanctions. The following paragraphs describe the rules and specifications applicable to certain categories of medications that vary from the baseline standards enumerated in 15 U.S.C. 3055(g).

i. Anti-Ulcer Medications (Cimetidine, Omeprazole, Ranitidine)

The IFHA has published a restricted administration period that prohibits administration of anti-ulcer medications within 48 hours of the post time for the race in which the horse is entered. HISA in the Protocol recommends a 24-hour restricted administration period.

The basis for this deviation is two-fold: (1) Withdrawal intervals of greater than 24 hours have been identified as an equine welfare issue. Published research demonstrates a rebound effect when anti-ulcer medications are withdrawn for more than 24 hours with resultant ulcers more severe than those originally treated. (2) The IFHA's Advisory Council on Prohibited Substances and Practices will be revisiting the control of these substances, and it is anticipated that the international community will adopt a withdrawal interval strategy similar to the one proposed by HISA.

ii. Non-Steroidal Anti-Inflammatory Drugs (“NSAIDs”) (Flunixin, Ketoprofen, Phenylbutazone)

The IFHA has published a 48-hour Detection Time (DT) for a single NSAID—meclofenamic acid. There is no FDA-approved product containing meclofenamic acid commercially available in the United States. (It is important to note that a Detection Time is the foundation for determining a withdrawal interval, but under no circumstances should the Detection Time be equated with withdrawal guidance. The withdrawal interval is decided by the veterinarian in 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 International Laboratory Accreditation Cooperation (“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 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 (11:59pm) on the day of the Official Workout/Covered Horserace as previously stated. This revision was made to take account of horse welfare, recognizing in particular that once a horse has been subject to sample collection, or it has been decided that a 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.

Exhibit B.34. Jessica Wise et al., Pharmacokinetic and pharmacodynamic effects of 2 registered omeprazole preparations and varying dose rates in horses, J. Veterinary Internal Medicine (Nov. 2020), https://doi.org/10.1111/jvim.15971 .

5000 Series—Equine Testing and Investigations Standards

In addition to a number of minor revisions based on the comments received, the Authority added a section to address procedures for total carbon dioxide (“TCO2”) testing, i.e., testing blood samples for total carbon dioxide as evidence of use or administration of the Controlled Medication Method M4 (alkalinization or use/administration of an alkalinizing agent) (see Rule 5430).

6000 Series—Equine Standards for Laboratories and Accreditation

A number of minor revisions were made based on the detailed comments received and further consultation with laboratory experts. Some duplication with ISO/IEC 17025 was also removed, in particular in section 6300.

7000 Series—Arbitration Procedures

Some commenters expressed confusion concerning the role of racing stewards in the adjudication body previously designated as the “National Stewards Panel.” The body is now designated as the “Internal Adjudication Panel,” with individual members referred to as Internal Adjudication Panel (“IAP”) members instead of “stewards.”

The procedure for Controlled Medication Rule Violations was developed partly in response to requests by commenters to provide for a simplified hearing process for Covered Persons charged with a violation. The procedures allow the IAP members adjudicating the case to dispense with written filings and permit the Covered Person to make an oral presentation in a hearing context. This procedure allows the adjudication process to dispense where appropriate with certain of the more formal and costly aspects of legal proceedings.

The Arbitration Procedures were also clarified to specify that hearings regarding alleged breaches of the Protocol will not be open to the media or the public, and to specify the Owners who may attend hearings involving Covered Horses when the horse is owned by multiple persons or entities.

The Arbitration Procedures were also clarified to specify that while document production requests may be permitted, discovery or other wide-ranging document requests are not permitted.

Minor Corrections Made to October 2022 Proposed Rule

Based on stakeholder comments and further review, the Authority has made a few minor corrections to the proposed rule previously filed with the Commission. Minor corrections were made to the Technical Document, including (i) correcting certain references to thresholds throughout the Technical Document, to ensure consistency with the approach taken by the IFHA; (ii) correcting a typographical error regarding the threshold for ketoprofen, which is 2ng/ml, as approved by the ADMC, as noted in a correction published November 4, 2022, 87 FR 66705; (iii) adding a comment about pemoline that was mistakenly deleted from the previous version; (iv) correcting certain minor typographical errors in the spelling of substance names; (v) capitalizing defined terms; and (vi) other minor amendments to ensure consistency across the document, including deletion of duplicate entries.

Certain other minor corrections were made to the proposed rule, including (i) clarifying, in the definition of “Aggravating Circumstances,” that one or both of an additional period of ineligibility or fine may be imposed; (ii) correcting Rule 3346(a) to clarify that the Responsible Person and Owner and one representative each may attend the Laboratory to witness the opening and identification of the B sample; (iii) adding “to the extent possible” in Rule 5220(b)(iv)(B) for consistency with other similar provisions; (iv) specifying in Rule 5320 that sample collection equipment must be able to withstand −20°C rather than −80°C, consistent with industry standard; (v) removing the requirement for a signature in Rule 5410(i)(1) because the personnel tagging the horse at the end of the race will not accompany the horse to the Test Barn and the signing of the doping control documentation will occur at a later stage in the sample collection process (see Rule 5410(i)(10)); (vi) minor corrections to Rules 5420(j) and 5430(e) by striking “within the kit,” as it was not consistent with collection kits available in the industry; (vii) amending references to the “BCO or DCO” in Rule 5430(e) to “relevant Sample Collection Personnel” for consistency with other similar provisions; (viii) amending Rules 5420(n) and 5430(k) to clarify that copies of doping control documentation will be sent to the Responsible Person subsequently and not instantaneously; and (ix) adding a reference to “or refrigerator” in Rule 5510(b)(1) because, if urine samples are not shipped on the day of collection, they will be refrigerated rather than frozen.

Minor typographical errors, such as extra spaces, spelling errors, and punctuation, were corrected as well.

IV. Legal Authority

This rule is proposed by the Authority for approval or disapproval by the Commission under 15 U.S.C. 3053(c)(1).

V. Effective Date

This rule would take effect upon approval by the Commission, and the Commission must approve or disapprove the rule by March 27, 2023.

VI. Request for Comments

Members of the public are invited to comment on the Authority's proposed rule. The Commission requests that factual data on which the comments are based be submitted with the comments. The supporting documentation referred to in the Authority's filing, as well as the written comments it received before submitting the proposed rule to the Commission, are available for public inspection at https://www.regulations.gov under docket number FTC-2023-0009.

The Commission seeks comments that address the decisional criteria provided by the Act. The Act gives the Commission two criteria against which to measure proposed rules and rule modifications: “The Commission shall approve a proposed rule or modification if the Commission finds that the 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.

Although the Commission evaluates the Authority's proposed rule for its consistency with the Act and the Commission's procedural rule, the Commission may consider broader questions—about the health and safety of horses and jockeys, the integrity of horseraces and wagering on horseraces, and the administration of the Authority itself—in another context: “The Commission . . . may abrogate, add to, or modify the rules of the Authority promulgated in accordance with this Act as the Commission finds necessary or appropriate to ensure the fair administration of the Authority, to conform the rules of the Authority to requirements of this Act and applicable rules approved by the Commission, or otherwise in furtherance of the purposes of this Act.” The Commission may exercise this rulemaking power on its own initiative or in response to a petition from a member from the public. If members of the public wish to provide comments to the Commission about its use of the rulemaking power, they are encouraged to submit a petition requesting that the Commission issue a rule addressing the subject of interest. The petition must meet all the criteria established in the Rules of Practice (part 1, subpart D); if it does, the petition will be published in the Federal Register for public comment. In particular, the petition for a rulemaking must “identify the problem the requested action is intended to address and explain why the requested action is necessary to address the problem.”

VII. Comment Submissions

You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before February 9, 2023. Write “HISA Anti-Doping and Medication Control” on your comment. Your comment—including your name and your State—will be placed on the public record of this proceeding, including, to the extent practicable, on the website https://www.regulations.gov .

Because of public health measures and the Commission's heightened security screening, postal mail addressed to the Commission will be subject to delay. We strongly encourage you to submit your comments online through the 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 February 9, 2023. 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. See16 CFR 1.26(b)(5).

IX. Self-Regulatory Organization's Proposed Rule Language

1000. General Provisions

Rule 1010. Rules of Interpretation

Unless specified otherwise:

(a) words in the singular include the plural, and words in the plural include the singular;

(b) references to any “Rule” or “Rule Series” are references to the rules or rule series approved by the Commission pursuant to section 3053 of the Act;

(c) any Appendices to a Rule Series form an integral part of such Rule Series;

(d) any reference to a provision in rules, protocols, policies, standards, guidelines, or similar includes any modifications or successor provisions made or issued from time to time;

(e) any reference to legislation includes any modification or re-enactment of legislation enacted in substitution of that legislation, and any regulation or other instrument from time to time issued or made under that legislation;

(f) any term defined in this Rule 1000 Series shall supersede the definition of that term in the Rule 2000 Series;

(g) a reference to “writing,” “write,” or “written” includes communications transmitted by email;

(h) a reference to “may” means “in the sole and absolute discretion of such person or body”;

(i) a reference to a “day” means any day of the week and is not limited to working days;

(j) any time limits shall begin from the day after which the relevant notification is received (or the day after the relevant notification is sent, if sent by email). Official holidays and non-working days are included in the calculation of time limits. The time limits fixed under this Protocol are respected if the communications by the parties are sent before midnight (U.S. Eastern time) on the last day on which such time limits expire. If the last day of the time limit is an official holiday or a non-business day in the state or country where the notification has been made, the time limit shall expire at the end of the first subsequent business day;

(k) a reference to a “person” (with no initial capital letter) means a natural person; and

(l) any words following the terms “including,” “include,” “in particular,” “such as,” “for example,” or any similar expression, are illustrative only, and do not limit the sense of the words, description, definition, phrase, or term preceding those terms.

Rule 1020. Definitions

Act means the Horseracing Integrity and Safety Act of 2020 (15 U.S.C. 3051-3060), as amended from time to time.

ADMC means the Anti-Doping and Medication Control Standing Committee of the Authority.

Administration means providing, supplying, supervising, facilitating, or otherwise participating in the Use or Attempted Use in a Covered Horse of a Prohibited Substance or Prohibited Method. However, this definition shall not include the actions of bona fide veterinary personnel involving a Controlled Medication Substance or Controlled Medication Method used for genuine and legal therapeutic purposes or other acceptable justification.

Adverse Analytical Finding (“AAF”) means a report from a Laboratory that, consistent with the Laboratory Standards, establishes in a Sample the presence of a Prohibited Substance or its Metabolites or Markers or evidence of the Use of a Prohibited Method.

Agency means the anti-doping and controlled medication enforcement agency known as the Horseracing Integrity and Welfare Unit.

Aggravating Circumstances means circumstances involving, or actions by, a Covered Person that may justify the imposition of one or both of a period of Ineligibility or fine greater than the otherwise applicable standard sanction. Such circumstances and actions include those set forth in Rule 3227 or Rule 3327 (as applicable).

Aliquot means a portion of the Sample obtained from the Covered Horse.

Analyte means a substance, compound, or measurand that is analyzed or determined in a biological matrix using an Analytical Testing Procedure performed under controlled analytical and laboratory conditions. For anti-doping and controlled medication purposes, an Analyte may be a Prohibited Substance, a Metabolite of a Prohibited Substance, or a Marker of the Use of a Prohibited Substance or Prohibited Method.

Analytical Method has the same meaning as Analytical Testing Procedure.

Analytical Testing means the parts of the Doping Control or Medication Control process performed at the Laboratory, which includes Sample handling, analysis, and the reporting of results.

Analytical Testing Procedure means a Fit-for-Purpose procedure, as demonstrated through method validation, that is used to detect, identify or quantify Analytes in a Sample in accordance with the Laboratory Standards and relevant Technical Document(s), Technical Letter(s), Technical Note(s), or Laboratory Guidelines. Unless the context otherwise requires, Analytical Testing Procedure is also referred to or known as an Analytical Method or Test Method.

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

Anti-Doping Rule Violation (“ADRV”) means an anti-doping rule violation under the Protocol.

Arbitral Body has the meaning given to it in the Rule 7000 Series.

Arbitration Procedures means the arbitration procedures set forth in the Rule 7000 Series.

Assistant Trainer means a person engaged in the training of Covered Horses, under the direct or indirect supervision of a Trainer.

Association Veterinarian means a Veterinarian employed by a Racetrack.

Attempt means purposely engaging in conduct that constitutes a substantial step in a course of conduct planned to culminate in the commission of an Anti-Doping Rule Violation or Controlled Medication Rule Violation; provided, however, that there shall be no Anti-Doping Rule Violation or Controlled Medication Rule Violation based solely on an Attempt to commit a violation if the Covered Person renounces the Attempt prior to it being discovered by a third party not involved in the Attempt.

Attending Veterinarian means a Veterinarian providing treatment or services to Covered Horses hired or otherwise authorized by the Trainer or Owner or his or her respective designee.

Atypical Finding means a report from a Laboratory that requires further investigation in accordance with the Atypical Findings Policy set out at Appendix 1 to the Protocol, prior to the determination of whether it is an Adverse Analytical Finding.

Atypical Findings Policy means the policy set out at Appendix 1 to the Protocol.

Authority means the Horseracing Integrity and Safety Authority designated by section 3052(a) of the Act.

Banned Method has the meaning given to it in Rule 3111.

Banned Substance has the meaning given to it in Rule 3111.

Batch means a set of Samples processed as a group.

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

Billing Standards means the standards governing compensation for arbitrators and stewards under the Arbitration Procedures.

Blood Collection Officer (“BCO”) means a Veterinarian or a veterinary technician who has been authorized by the Agency (or its delegate) to collect blood Samples from a Covered Horse.

Breeder means a Person who is in the business of breeding Covered Horses.

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

Certifying Scientists means personnel appointed by a Laboratory to review all pertinent analytical data, Analytical Method validation results, quality control results, Laboratory Documentation Packages, and to attest to the validity of the Laboratory's test results.

Chain of Custody means the sequence of individuals or organizations who have responsibility for the custody of a Sample from the provision of the Sample until the Sample has been delivered to the Laboratory for analysis.

Chaperone means a person authorized by the Agency (or its delegate) to carry out the responsibilities given to Chaperones in the Testing and Investigations Standards or by the DCO.

Charge Letter has the meaning given to it in (as the context requires) Rule 3248 or Rule 3348.

Claim means, in the context of a Claiming Race, the purchase of a Covered Horse for a designated amount.

Claiming Race means a Covered Horserace in which a Covered Horse after leaving the starting gate may be claimed in accordance with the rules and regulations of the applicable State Racing Commission.

Code of Ethics means the Code of Ethics for Laboratories set forth at Rule 6610.

Commission means the Federal Trade Commission.

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

Consequences means the penalties resulting from the occurrence of one or more violations of the Protocol, as set forth in the Rule 3000 Series. The Consequences for an Anti-Doping Rule Violation or a Controlled Medication Rule Violation may include one or more of the following:

(1) Disqualification;

(2) Ineligibility;

(3) Provisional Suspension;

(4) financial penalties; and

(5) Public Disclosure.

Contaminated Product means a product other than feed, hay, or water, that contains a Prohibited Substance that (i) is not disclosed on the product label, and (ii) a Veterinarian or Trainer would not otherwise reasonably be aware might be included in the product.

Controlled Medication Method means any method so described on the Prohibited List.

Controlled Medication Rule Violation has the meaning given to it in Rule 3311(a).

Controlled Medication Substance means any substance so described on the Prohibited List or the Technical Document-Prohibited Substances.

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

Covered Horse means any Thoroughbred horse, or any other horse made subject to the Act by election of the applicable State Racing Commission or the breed governing organization for such horse under section 3054( l), during the period: (A) beginning on the date of the horse's first Timed and Reported Workout at a Racetrack that participates in Covered Horseraces or at a training facility; and (B) ending on the date on which the horse is deemed retired pursuant to Rule 3050(b).

Covered Horserace means any horserace involving Covered Horses that has a substantial relation to interstate commerce, including any Thoroughbred horserace that is the subject of interstate off-track or advance deposit wagers.

Covered Person means all Trainers, Owners, Breeders, Jockeys, Racetracks, Veterinarians, Persons licensed by a State Racing Commission, and the agents, assigns, and employees of such Persons; any other Persons required to be registered with the Authority; and any other horse support personnel who are engaged in the care, treatment, training, or racing of Covered Horses.

Decision Limit means the value of the result for a Threshold Substance in a Sample, above which an Adverse Analytical Finding shall be reported.

Designated Owner has the meaning given to it in Rule 3020(c).

Detection Time means the interval after a medication is administered during which it is detectable in a specific matrix (serum, plasma, urine, or hair) from any member(s) of a group of test horses. Detection times are determined from analysis of samples collected at specific time points following an administration of a medication to group of, potentially as few as 2, test horses. A detection time is not the same as a withdrawal time. The withdrawal time for a medication must be decided upon by a Veterinarian (in consultation with the Responsible Person) and is likely to be based on the Detection Time and an added safety margin. This margin should be determined using professional judgment and discretion to take into account the variability that could be expected to normally occur in a larger population by considering individual differences between horses, such as size, metabolism, fitness, health, or recent illness or disease. The withdrawal interval used for a medication should always be longer than its Detection Time.

Disqualification means the results of a Covered Horse in a particular Covered Horserace are invalidated, with all resulting consequences, including forfeiture of any purses and other compensation, prizes, trophies, points, and rankings associated with such Covered Horserace.

Doping Control means all steps and processes from test distribution planning through to ultimate disposition of any adjudication and review process pursuant to the Protocol and the Act involving an Anti-Doping Rule Violation and the enforcement of Consequences, including all steps and processes in between, including Testing, investigations, whereabouts program, Sample collection and handling, Laboratory analysis, Results Management, hearings and reviews, and investigations and proceedings relating to Anti-Doping Rule Violations not arising from or related to Testing or violations of Rule 3229.

Doping Control Officer (“DCO”) means an official who has been authorized by the Agency (or its delegate) to carry out the responsibilities given to DCOs in the Testing and Investigations Standards and any related Agency procedures.

EAD Notice has the meaning given to it in Rule 3245.

EAD Violations means Anti-Doping Rule Violations arising out of the Rule 3000 Series and violations of Rule 3229.

ECM Notice has the meaning given to it in Rule 3345.

ECM or Other Violations means Controlled Medication Rule Violations arising out of the Rule 3000 Series, violations of Rule 3329, or violations of Rule 3510.

Equibase means the official database for Thoroughbred horseracing.

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

Equine Industry Representative means an organization regularly and significantly engaged in the equine industry, including organizations that represent the interests of, and whose membership consists of, Owners, Breeders, Trainers, Racetracks, Veterinarians, State Racing Commissions, or Jockeys.

Expanded Measurement Uncertainty means the multiplication of the coverage factor (q.v.) by the Measurement Uncertainty (q.v.).

External Quality Assessment Scheme (“EQAS”) means a program for quality 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 the date on which the Commission approves the proposed rule.

Prohibited List means the list identifying Prohibited Substances and Prohibited Methods set forth in the Rule 4000 Series.

Prohibited Method means any method so described on the Prohibited List.

Prohibited Substance means any substance or class of substances so described on the Prohibited List or the Technical Document-Prohibited Substances.

Protocol means the Rule 3000 Series (Equine Anti-Doping and Controlled Medication Protocol), as amended from time to time.

Provisional Hearing means an expedited abbreviated hearing to resolve a challenge to a Provisional Suspension, occurring prior to the adjudication of the violation in issue.

Provisional Suspension means the Covered Horse or Covered Person is barred temporarily from participating in any Timed and Reported Workout or Covered Horserace in accordance with Rules 3229 or 3329 (as applicable).

Public Disclosure means the dissemination or distribution of information by the Authority or the Agency to the general public.

Quality Manager means the staff member appointed by a Laboratory to perform that role in accordance with the Laboratory Standards.

Race Day means the period commencing at 12:01 a.m. on the day of a Vets' List Workout or Covered Horserace and ending (i) 1 hour after the end of such Vets' List Workout or Covered Horserace or (ii) at the end of any Sample Collection Session conducted at that Vets' List Workout or Covered Horserace when the Covered Horse is released from the Test Barn, whichever is later.

Race Organizer means any Person that arranges, organizes, and has administrative responsibility for a Covered Horserace.

Race Period means the period:

(a) commencing 48 hours prior to the Post-Time of either (i) any Vets' List Workout in which the Covered Horse participates or (ii) any Covered Horserace that the Covered Horse has been entered in, whether or not the Covered Horse actually starts; and

(b) ending (i) 1 hour after the end of such Vets' List Workout or Covered Horserace or (ii) at the end of any Sample collection process conducted at that Vets' List Workout or Covered Horserace when the Covered Horse is released from the Test Barn, whichever is later.

However, the Prohibited List may specify a Race Period that is shorter or longer in duration than the above period for certain Controlled Medication Substances or Controlled Medication Methods.

Racetrack means an organization licensed by a State Racing Commission to conduct Covered Horseraces.

Racetrack Safety Program means the program set forth in Rule 2000 Series, established pursuant to section 3056(a) of the Act.

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

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

Regulatory Veterinarian means a Veterinarian who is employed, contracted, or appointed by a State Racing Commission, Racetrack, the Authority, or the Agency to monitor the health and welfare of Covered Horses, in addition to any other duties assigned to him or her by the Authority or the Agency.

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

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

Responsible Person has the meaning given to it in Rule 3030.

Results Management means the process encompassing the timeframe from provision of an EAD Notice or ECM Notice through the charge until the final resolution of the matter, including the end of any adjudication and review process pursuant to the Protocol and the Act.

Revocation means the permanent withdrawal of a Laboratory's Equine Analytical Laboratory accreditation by the Agency.

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

RMTC has the meaning given to it in Rule 6070(a).

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

Sample means any biological material collected for the purposes of Doping Control or Medication Control, including urine, blood, and hair.

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

Sample Collection Personnel means all qualified officials authorized by the Agency to carry out or assist with duties during Doping Control or Medication Control, including, but not limited to, Blood Collection Officers, Doping Control Officers, and Chaperones. An individual may be authorized by the Agency to carry out one or more roles during Doping Control or Medication Control.

Sample Collection Session means all of the sequential activities that directly involve the collection of a Sample from a Covered Horse from the point that initial contact is made with the Responsible Person or Nominated Person until the Covered Horse provides a Sample and is discharged from Sample collection obligations.

Screening Limit means a concentration to be used by Laboratories when screening for certain Non-Threshold Substances during the Initial Testing Procedure, below which a Laboratory will not pursue the possible presence of a Prohibited Substance. When the concentration of an Analyte subject to a Screening Limit exceeds the Screening Limit as determined by the Initial Testing Procedure, qualitative confirmatory analysis by mass spectrometry Confirmation Procedure is required to confirm the presence or absence of the Prohibited Substance. Quantification is not required. A Screening Limit is not a Limit of Detection, a Limit of Identification, or a Limit of Quantification.

Selectivity means the ability of the Analytical Testing Procedure to detect or identify (as applicable) the substance of interest in the Sample.

Specified Substance has the meaning given to it in Rule 3111(c).

Stacking Violation has the meaning given to it in Rule 3312(e).

Stakes Race means any race so designated by the Racetrack at which such race is run, including, without limitation, the races the Breeders' Cup World Championships comprises and the races designated as graded stakes by the American Graded Stakes Committee of the Thoroughbred Owners and Breeders Association.

Standard Operating Procedure means a document setting out prescribed methods or procedures to be followed when performing certain routine operations.

Standards means the Testing and Investigations Standards and the Laboratory Standards. Compliance with a Standard (as opposed to another alternative standard, practice, or procedure) shall be sufficient to conclude that the procedures addressed by the Standard were performed properly. Standards shall include any Technical Documents issued pursuant to the Standards.

State Racing Commission means an entity designated by State law or regulation that has jurisdiction over the conduct of horseracing within the applicable state.

Substantial Assistance means, for purposes of Rule 3226(a) and Rule 3326(a), a Covered Person providing the following assistance:

(1) fully disclosing in a signed written statement or recorded interview all information the Covered Person possesses in relation to violations of the Protocol; and

(2) fully cooperating with the investigation and adjudication of any case or matter related to that information, including, for example, by providing an affidavit and presenting testimony at a hearing if requested to do so by the Agency or adjudication body.

Further, the information provided must be credible and must comprise an important part of any case or proceeding which is initiated or, if no case or proceeding is initiated, must have provided a sufficient basis on which a case or proceeding could have been brought.

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

Tampering means intentional conduct that subverts the Doping Control or Medication Control process, but that would not otherwise be included in the definition of Prohibited Methods. Tampering includes offering or accepting a bribe to perform or fail to perform an act, preventing the collection of a Sample, affecting or making impossible the analysis of a Sample, falsifying documents submitted to the Agency (or a committee or adjudication body), procuring false testimony from witnesses, committing any other fraudulent act upon the Agency (or committee or adjudication body) to affect Results Management or the imposition of Consequences, and any other similar interference or attempted interference with any aspect of Doping Control or Medication Control. However, this definition shall not include the actions of bona fide veterinary personnel involving a Controlled Medication Substance or Controlled Medication Method used for genuine and legal therapeutic purposes or other acceptable justification.

Target Testing means selection of specific Covered Horses for Sample collection based on criteria set forth in the Testing and Investigations Standards.

Technical Document (“TD”) means a document adopted and published by the Authority from time to time containing requirements or guidance on specific anti-doping or medication control topics.

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

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

Test Barn means the location where Sample collection is conducted on Race Day.

Test Barn Veterinarian means a Veterinarian who is employed, contracted, or appointed by a State Racing Commission, Racetrack, the Authority, or the Agency to monitor the health and welfare of Covered Horses subject to Sample collection in the Test Barn.

Testing means the parts of the Doping Control or Medication Control process involving Sample collection, Sample handling, and Sample transport to the Laboratory.

Testing and Investigations Standards means the Equine Testing and Investigations Standards set forth in the Rule 5000 Series.

Test Method has the same meaning as Analytical Testing Procedure.

Thoroughbred means a horse that is registered in The American Stud Book or in a foreign stud book approved by the Jockey Club or the International Stud Book Committee.

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

Threshold Substance means a Prohibited Substance, or Metabolite or Marker of a Prohibited Substance, for which the identification and quantitative determination, including, for example, concentration, ratio, or score, in excess of a pre-determined Decision Limit, or, when applicable, the establishment of an exogenous origin, constitutes an Adverse Analytical Finding.

Timed and Reported Workout means an officially timed and published running of a Thoroughbred horse over a predetermined distance that is not a horserace, as reported by Equibase or any official supplier of racing information and statistics recognized by the Authority. Official timed workouts shall have the same meaning as Timed and Reported Workouts. Any official timed workout by a Thoroughbred horse in any other jurisdiction shall be deemed a Timed and Reported Workout upon the earliest to occur of the following: (i) the horse is brought to the United States for purposes of participating in any Covered Horserace; or (ii) the horse is nominated for a Covered Horserace.

Trafficking means a Covered Person selling, giving, transporting, sending, delivering, or distributing by any means a Banned Substance or Banned Method to any other Person, or Possessing a Banned Substance or Banned Method for any such purpose; provided, however, that Trafficking shall not include the actions of Veterinarians or other licensed medical personnel involving a Prohibited Substance used for genuine and legal therapeutic purposes or other acceptable justification.

Trainer means an individual engaged in the training of Covered Horses.

Training Facility means a location that is not a Racetrack licensed by a State Racing Commission that operates primarily to house Covered Horses and conduct Timed and Reported Workouts.

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

Veterinarian means a licensed veterinarian who provides veterinary services to Covered Horses.

Veterinarians' List has the meaning given to it in Rule 2000 Series (Racetrack Safety Program).

Vets' List Workout means an officially timed running of a Covered Horse over a predetermined distance that is not a Covered Horserace but is overseen by a Regulatory Veterinarian or Racetrack steward.

Whereabouts Failure means a failure by the Responsible Person to do any of the following: (i) provide notice to the Agency that his or her Covered Horse has been moved from a Racetrack or Training Facility to a private facility ( i.e., a facility not under the jurisdiction of the Authority/Agency) before such move occurs; (ii) provide whereabouts information about his or her Covered Horse(s) upon request by the Agency; (iii) provide sufficient information about the Covered Horse's whereabouts to enable the Agency to Test the Covered Horse at any time; or (iv) update any whereabouts information provided to the Agency if it changes.

Without Prejudice Agreement means a written agreement between the Agency and a Covered Person that allows the Covered Person to provide information to the Agency in a defined time-limited setting with the understanding that, if an agreement for Substantial Assistance or a case resolution agreement is not finalized, the information provided by either party may not be used by the other party in any Results Management proceeding under this Protocol. Such an agreement shall not preclude the parties from using any information or evidence gathered from any source.

Workout means a timed running of a horse over a predetermined distance not associated with a race or its first qualifying race, if such race is made subject to the Act by election under section 3054( l) of the Act of the horse's breed governing organization or the applicable State Racing Commission.

3000. Equine Anti-Doping and Controlled Medication Protocol

3000. General Provisions

Rule 3010. Introduction

(a) The Horseracing Integrity and Safety Act of 2020 (“Act”) mandates and empowers the Horseracing Integrity and Safety Authority (“Authority”) to establish a uniform anti-doping and controlled medication program to improve the integrity and safety of horseracing in the United States (“Program”).

(b) This Equine Anti-Doping and Controlled Medication Protocol (“Protocol”) has been developed and issued by the Authority as part of that mandate. It contains or incorporates by reference rules, standards, and procedures to improve and protect the integrity and safety of horseracing in the United States by deterring and penalizing the improper administration or application of Prohibited Substances and Prohibited Methods to Covered Horses. The Protocol is split into five chapters:

(1) the purpose, scope, and organization of the Protocol;

(2) the Prohibited List, rules of proof, and testing and investigations;

(3) the Equine Anti-Doping Rules;

(4) the Equine Controlled Medication Rules; and

(5) other violations and general procedure/administration.

(c) The Protocol has intentionally divided the regulation of Anti-Doping Rule Violations and Controlled Medication Rule Violations into separate chapters to reflect the Authority's view that the treatment of such violations should be separate and distinct from each other. Anti-Doping Rule Violations involve Banned Substances or Banned Methods, which are substances/methods that should never be in a horse's system or used on a horse as they serve no legitimate treatment purpose. Conversely, Controlled Medication Rule Violations involve Controlled Medication Substances or Controlled Medication Methods, which are substances/methods that have been determined to have appropriate and therapeutic purposes, and so may be used outside the Race Period, except as otherwise provided in the Prohibited List. For the avoidance of doubt, the Protocol does not regulate the use of drugs or medications by human participants in Covered Horseraces.

(d) The Protocol reflects and implements the following principles set out in section 3055(b) of the Act that:

(1) Covered Horses should compete only when they are free from the influence of medications, other foreign substances, and treatment methods that affect their performance;

(2) Covered Horses that are injured or unsound should not train or participate in Covered Horseraces, and that medications, other foreign substances, and treatment methods that mask or deaden pain in order to allow injured or unsound horses to train or race should be prohibited;

(3) rules, standards, procedures, and protocols regulating medication and treatment methods for Covered Horses and Covered Horseraces should be uniform and uniformly administered throughout the United States;

(4) to the extent consistent with the Act, consideration should be given to international anti-doping and medication control standards of the International Federation of Horseracing Authorities and the Principles of Veterinary Medical Ethics of the American Veterinary Medical Association;

(5) the administration of medications and treatment methods to Covered Horses should be based upon a veterinary examination and diagnosis that identifies an issue requiring treatment for which the medication or method represents an appropriate component of treatment;

(6) the amount of therapeutic medication that a Covered Horse receives should be the minimum necessary to address the diagnosed health concerns identified during the veterinary examination and diagnostic process; and

(7) the welfare of Covered Horses, the integrity of the sport of horseracing, and the confidence of its stakeholders (including the betting public) require full disclosure to regulatory authorities regarding the administration of medications and treatments to Covered Horses.

(e) The Protocol will be implemented and enforced on behalf of the Authority by:

(1) an anti-doping and controlled medication enforcement agency known as the Horseracing Integrity and Welfare Unit (“Agency”); and

(2) where agreed in accordance with 3060 of the Act, by State Racing Commissions acting under the delegated authority of the Authority or the Agency (and references to the Authority or the Agency in the Protocol will be deemed to encompass such commissions as the context requires, subject to and consistent with the scope of their delegated authority).

(f) In accordance with section 3054(b) of the Act, the rules of the Authority promulgated in accordance with the Act shall preempt any provision of State law or regulation with respect to matters within the jurisdiction of the Authority under the Act. Among other things, the Protocol:

(1) identifies the conduct that will constitute an Anti-Doping Rule Violation (Rules 3211 to 3216), a Controlled Medication Rule Violation (Rules 3311 to 3315), or a related violation (Rules 3229, 3329, and 3510);

(2) establishes evidentiary and other rules for proving violations of the Protocol (Rules 3121 to 3122);

(3) provides for the creation, maintenance, and updating of a Prohibited List and related Technical Document that identify Prohibited Substances and Prohibited Methods (Rules 3111 to 3113);

(4) empowers the Agency to perform and manage test distribution planning and Testing of Covered Horses both in and out of competition, in accordance with the Testing and Investigations Standards (Rule 3133);

(5) empowers the Agency to gather intelligence and investigate potential violations of the Protocol, in accordance with the Testing and Investigations Standards, which incorporate uniform rules and procedures in accordance with section 3054(c) of the Act (Rule 3133);

(6) empowers the Agency to accredit testing laboratories in accordance with the Laboratory Standards and to monitor, test, and audit approved Laboratories to ensure continuing compliance with the Laboratory Standards; and provides for all samples collected pursuant to the Protocol to be analyzed at approved Laboratories in accordance with the Laboratory Standards or by other laboratories, such as international laboratories accredited by the International Federation of Horseracing Authorities, in accordance with Rule 3136(d) (Rule 3136);

(7) sets out uniform rules and procedures for the Agency's management of the results of testing and investigations, and for its prosecution of any charges that Covered Persons have violated the Protocol, including incorporating the Arbitration Procedures to ensure the fair adjudication of those charges;

(8) sets out the sanctions that may be applied in case of violations of the Protocol, including, but not limited to, Disqualification of results, forfeiture of prizes and purses, fines, payment of costs, periods of Ineligibility for Covered Horses or Covered Persons (including additional periods of Ineligibility for repeat offenders), and Public Disclosure (sections 3220 and 3320); and requires the Authority, Racetracks, Race Organizers, Training Facilities, all Covered Persons, and all other relevant Persons to recognize, respect, enforce, and give full force and effect to final decisions issued under the Protocol within their respective spheres of authority (Rule 3710);

(9) regulates the public reporting and disclosure of cases, and permits and facilitates statistical reporting to the Authority and to the U.S. Congress, the Commission, State Racing Commissions, and other Federal or State governmental bodies or agencies having jurisdiction over the sport of horseracing in the United States (section 3600); and

(10) empowers the Agency to undertake and commission education and research activities designed to advance the integrity and safety of horseracing in the United States (Rule 3810).

(g) The Protocol comes into force on the Program Effective Date and will apply in full as from that date. In accordance with section 3054(k)(1) of the Act, the Protocol only has prospective effect, i.e., it does not apply to, and does not give the Authority or Agency authority to investigate, prosecute, adjudicate, or penalize conduct that occurred before the Program Effective Date (Rule 3080).

(h) The Protocol incorporates by reference the supporting rules and documents approved by the Commission and issued by the Authority, including Rule 1000 Series (General Provisions), Rule 2000 Series (Racetrack Safety Program), Rule 4000 Series (Prohibited List), Rule 5000 Series (Testing and Investigations Standards), Rule 6000 Series (Laboratory Standards), Rule 7000 Series (Arbitration Procedures), Rule 8000 Series (Enforcement Rule), Rule 8500 Series (Methodology for Determining Assessments), and Rule 9000 Series (Registration of Covered Persons and Covered Horses).

(i) In accordance with section 3055(c)(4) of the Act, the Agency may develop further rules, protocols, policies, and guidelines for approval by the Authority to support the implementation of the Protocol. These materials will be developed in consultation with the Anti-Doping and Medication Control Standing Committee (ADMC) of the Authority and will be consistent with international best practices.

(j) Nothing in the Protocol or in any of its associated rules, protocols, policies, and guidelines:

(1) is intended to constrain or limit in any way the powers of the Authority or the Agency under the Act; or

(2) shall be interpreted or applied in a manner that has the effect of constraining or limiting those powers in any way.

(k) Unless specified otherwise, words and terms in the Protocol that are capitalized are defined terms that have the meaning given to them in Rule 1020.

(l) The rules of interpretation included at Rule 1010 and Rule 3070 shall be used as an aid to interpretation of the Protocol.

Rule 3020. Application

(a) The Protocol applies to and is binding on:

(1) any horserace involving Covered Horses that has a substantial relation to interstate commerce, including any Thoroughbred horserace that is the subject of interstate off-track or advance deposit wagers (each, a Covered Horserace);

(2) any Thoroughbred horse, or any other horse made subject to the Act by election of the applicable State Racing Commission or the breed governing organization for such horse under section 3054( l), during the period: (A) beginning on the date of the horse's first Timed and Reported Workout at a racetrack that participates in Covered Horseraces or at a Training Facility; and (B) ending on the date on which the horse is deemed retired pursuant to Rule 3050(b) (each, a Covered Horse); and

(3) the following persons (each, a Covered Person): all Trainers, Owners, Breeders, Jockeys, Racetracks, Veterinarians, Persons licensed by a State Racing Commission, and the agents, assigns, and employees of such Persons; any other Persons required to be registered with the Authority; and any other horse support personnel who are engaged in the care, treatment, training, or racing of Covered Horses.

(b) Pursuant to section 3054 of the Act, Covered Persons must register with the Authority. However, they are bound by the Protocol by undertaking the activity (or activities) that make(s) them a Covered Person, whether or not they register with the Authority.

(c) Owners. Covered Horses may be owned by a sole individual, multiple individuals, or one or more entities. As a consequence of the various ownership structures and property interests of Covered Horses, it is necessary to identify which Person shall be responsible as the Owner for purposes of registration, communication, personal liability, and other requirements under the Protocol and related rules. Accordingly:

(1) For purposes of mandatory registration with the Authority, any Covered Person who owns a 5% or greater ownership or property interest in a Covered Horse shall register with the Authority as an Owner.

(2) The following person shall be responsible as the Owner for any communication, notification, and reporting requirements under the Protocol:

(i) if the Covered Horse is owned by one individual, that individual; or

(ii) if the Covered Horse is owned by more than one individual or by a partnership, corporation, limited liability company, syndicate, or other association or entity, the individual designated in the Authority's database as the representative for the other owners of the Covered Horse authorized to receive communications or notifications and fulfill any reporting requirements on their behalf in respect of the Covered Horse (Designated Owner).

(3) If Rule 3030 makes the Owner the Responsible Person for a Covered Horse, that shall mean that the following person is personally liable for violations involving that Covered Horse:

(i) if the Covered Horse is owned by one individual, that individual; or

(ii) if the Covered Horse is owned by more than one individual or by a partnership, corporation, limited liability company, syndicate, or other association or entity, the individual who manages the Covered Horse as a matter of fact (Managing Owner). If an individual owns more than a 50% stake in a Covered Horse or where the entity that owns the Covered Horse has designated an individual with an ownership interest in the Covered Horse as the individual who will be personally liable under the Protocol as the Owner of the Covered Horse, that individual will be presumed to be the Managing Owner. If an individual with an ownership or property interest in the Covered Horse who is not the Managing Owner makes a relevant decision about the Covered Horse that leads to a violation of the Protocol, that person shall be jointly and severally liable with the Managing Owner for such decision as an Owner of the Covered Horse.

(4) Only the following persons may attend hearings under the Protocol as the Owner of the Covered Horse, unless otherwise agreed by the hearing panel:

(i) if the Covered Horse is owned by one individual, that individual; or

(ii) if the Covered Horse is owned by more than one individual or by a partnership, corporation, limited liability company, syndicate, or other association or entity, the Designated Owner or Managing Owner.

(5) Unless the context requires otherwise, the individual owner or Managing Owner of the Covered Horse (as applicable) shall be responsible for discharging any other requirements imposed on an Owner under the Protocol or related rules.

Rule 3030. Responsible Persons

(a) “Responsible Person” means the Trainer of the Covered Horse. If the Covered Horse does not have a Trainer, the Responsible Person shall be the Owner of the Covered Horse. The Responsible Person shall be personally liable for his or her Covered Horse(s) as set out under the Protocol. Other Covered Persons who make a relevant decision about the Covered Horse may also be liable depending on the facts and circumstances.

(b) If a Covered Horse is claimed in a Claiming Race, the person designated as the Responsible Person prior to that Claiming Race shall be liable for any violation resulting from a Sample collected on Race Day. The person who claims the Covered Horse in the Claiming Race shall not be liable for such violation, unless he or she was complicit in the violation.

(c) The Responsible Person shall register their designation as the Responsible Person for a Covered Horse with the Authority and shall keep such designation and registration up-to-date. Any transfer of the Responsible Person designation to another Covered Person shall be done with the Authority in accordance with its procedures prior to the effective date of the transfer, except that if a Covered Horse is claimed in a Claiming Race, the transfer shall be done on the day of the Claiming Race.

(d) The Responsible Person for a Covered Horse shall be the sole representative for the interests of that Covered Horse in any matter arising under the Protocol. The Owner (if not the Responsible Person) may attend any hearing concerning a violation of the Protocol involving his or her Covered Horse(s) in accordance with the Arbitration Procedures.

Rule 3040. Core Responsibilities of Covered Persons

(a) Responsibilities of All Covered Persons

It is the personal responsibility of each Covered Person:

(1) to be knowledgeable of and to comply with the Protocol and related rules at all times. All Covered Persons shall be bound by the Protocol and related rules, and any revisions thereto, from the date they go into effect, without further formality. It is the responsibility of all Covered Persons to familiarize themselves with the most up-to-date version of the Protocol and related rules and all revisions thereto;

(2) to cooperate promptly and completely with the Authority and the Agency in the exercise of their respective powers under the Act and the Protocol and related rules, including:

(i) in relation to the Testing program and in relation to the investigation of potential violations of the Protocol;

(ii) by providing complete and accurate information to the Authority and the Agency in all interactions and filings; and

(iii) on request by the Agency:

(A) making available for inspection any facility, office, stall, or equipment or other relevant location that is used in the care, treatment, training, or racing of Covered Horses, or any feed, medicine, or other item given to Covered Horses;

(B) submitting to under-oath transcribed interviews about his or her dealings with or in relation to Covered Horses;

(C) providing immediate and unfettered access to any and all data, documents, and records used in the care, treatment, training or racing of any Covered Horse (including, but not limited to, data, documents and records existing in electronic form, e.g., on computers, mobile phones, or other devices); and

(D) permitting the Agency to review or make and take away copies of any such data, documents, or records for analysis, investigation, and potential use as evidence of a violation of the Protocol by a Covered Person;

Failure to cooperate promptly and completely with the Agency may constitute a violation pursuant to Rule 3510(b); and

(3) not to engage in offensive conduct towards any Sample Collection Personnel or any representative of the Agency or the Authority (including engaging in improper, insulting, or obstructive conduct, or recording any Sample Collection Session contrary to Rule 5410). Failure to comply may constitute a violation pursuant to Rule 3510(a) or Tampering or Attempted Tampering, depending on the circumstances of the case.

(b) Additional Responsibilities of Responsible Persons

In addition to the duties under Rule 3040(a), it is the personal responsibility of each Responsible Person:

(1) to ensure that Covered Horses for which he or she is the Responsible Person are made available for Sample collection at any time and any place where they are located ( e.g., Racetrack, Training Facility, private facility) upon request by the Agency (or its delegate). In particular, without limiting the generality of the foregoing:

(i) The Responsible Person shall ensure that the Covered Horse is produced for Sample collection immediately upon notification by a duly authorized person in accordance with the Agency's procedures if the Covered Horse is present at the location where notification is attempted. If the Covered Horse is present at the location where notification is attempted, failure to produce a Covered Horse immediately upon valid notification shall constitute an Anti-Doping Rule Violation under Rule 3215.

(ii) If the Covered Horse is not present at the location where notification is attempted (including due to a Whereabouts Failure), the Responsible Person shall ensure that the Covered Horse is produced for Sample collection within 6 hours of notification by a duly authorized Person in accordance with the Agency's procedures, except that the Agency may extend the 6-hour period if it determines that extenuating circumstances justify doing so. If the Covered Horse is not present at the location where notification is attempted or if a Covered Horse cannot be located by the Agency, failure to produce a Covered Horse for Sample collection within 6 hours (or any extended period agreed by the Agency) of valid notification period shall constitute an Anti-Doping Rule Violation under Rule 3215.

(2) to either be present during a Sample collection involving his or her Covered Horse and comply with all Sample collection procedure requirements, or (if not present) to ensure that a Nominated Person who is 18 years or older is present to represent him or her and complies with all Sample collection procedure requirements;

(3) to ensure that treatments and medications administered to his or her Covered Horses:

(i) are administered only on the advice of a Veterinarian or (if a prescription is not required) following sufficient due diligence regarding the treatment or medication;

(ii) are not administered in a manner detrimental or contrary to horse welfare;

(iii) are the minimum necessary to address the diagnosed health concerns identified during the veterinary examination and diagnostic process;

(iv) do not contain a Banned Substance or involve a Banned Method; and

(v) do not otherwise violate the Protocol;

(4) to inform all Covered Persons (including Veterinarians), employees, personnel, agents, and other Persons involved in any way with the care, treatment, training, or racing of his or her Covered Horses of their respective obligations under the Protocol (including, in particular, those specified in Rule 3040(a));

(5) to adequately supervise all Covered Persons (including Veterinarians), employees, personnel, agents, and other Persons involved in any way with the care, treatment, training, or racing of his or her Covered Horses, including by (without limitation):

(i) conducting appropriate due diligence in the hiring process before engaging their services;

(ii) clearly communicating to such Persons that compliance with the Protocol is a condition of employment or continuing engagement in the care, treatment, training, or racing of his or her Covered Horses;

(iii) creating and maintaining systems to ensure that those Persons comply with the Protocol; and

(iv) adequately monitoring and overseeing the services provided by those Persons in relation to the care, treatment, training, or racing of his or her Covered Horses;

(6) to bear strict liability for any violations of the Protocol by such Covered Persons (including Veterinarians), employees, personnel, agents, and other Persons involved in the care, treatment, training, or racing of his or her Covered Horses;

(7) to file and update as necessary with the Authority information identifying what Covered Horses he or she is the Responsible Person for;

(8) to maintain accurate, complete, and up-to-date treatment records (including, without limitation, records of medical, therapeutic, and surgical treatments and procedures, including diagnostics) of his or her Covered Horses in an electronic or other form specified by the Agency, and to provide the Agency with access to those records upon request and without delay so that it may inspect and make and retain copies of them for purposes of monitoring and ensuring compliance with the requirements of the Protocol. The records must include the details required under Rule 2251(b). The Responsible Person must retain copies of such treatment records for a period of no less than 3 years, although the Responsible Person is advised to retain them for the duration of the limitation periods under Rule 3090;

(9) at the time of registering a horse with the Authority and prior to such horse competing in any Timed and Reported Workout or Covered Horserace, the Responsible Person shall declare in writing to the Agency all administrations of Banned Substances and Banned Methods to the horse since the Responsible Person first owned the horse (or, if not the Owner, since the Owner at the time of registration first owned the horse) or since the Program Effective date, whichever is earlier. On request by the Agency, the Responsible Person shall provide any related treatment records for the horse during that period. If a Banned Substance or Banned Method has been administered in that period, the Agency may impose a stand down period for the horse of up to the period of Ineligibility that would be applicable for the relevant Banned Substance or Banned Method and require that (at the Responsible Person's cost) the Covered Horse provide one or more negative Samples before subsequently being eligible to participate in a Timed and Reported Workout or a Covered Horserace. Failure by a Responsible Person to comply with this Rule 3040(b)(9) may constitute a violation of Rule 3510(b);

(10) if any Covered Horse is moved from a Racetrack or Training Facility to a private facility ( i.e., a facility not under the jurisdiction of the Authority or the Agency), the Responsible Person shall provide sufficient information about the Covered Horse's whereabouts so that the Agency remains able to collect Samples from the Covered Horse at any time. The Responsible Person shall also provide any further information about the whereabouts of a Covered Horse that is specifically requested by the Agency. Failure to do so may constitute a violation of Rule 3510(d);

(11) to notify the Authority in writing within 7 days of becoming aware that any of his or her Covered Horses:

(i) is pregnant;

(ii) was pregnant but has foaled or is no longer pregnant;

(iii) has been castrated or hemicastrated (including chemical castration or immunocastration); or

(iv) has suffered a fatal condition.

In each case, the Responsible Person shall state the name of the Covered Horse, the date of the event triggering the notice, and (for paragraph (iv) above) a summary explanation regarding the cause of the fatal condition.

(c) Additional Responsibilities of Owners

In addition to the duties under Rule 3040(a):

(1) each person with a 5% percent or greater ownership or property interest in a Covered Horse shall register with the Authority as an Owner of the Covered Horse, and ensure that any transfer of ownership is registered with the Authority in accordance with its procedures; and

(2) if a Covered Horse is owned by multiple Owners, they shall ensure that the Agency is notified in writing of one Designated Owner authorized to receive communications and notifications and fulfil any reporting requirements on their behalf.

(d) Additional Responsibilities of Attending Veterinarians

In addition to the duties under Rule 3040(a), and the further duties and requirements imposed under the Rule 2000 Series (Racetrack Safety Program), it is the personal responsibility of each Attending Veterinarian to act in strict compliance with the Protocol and keep updated treatment records (including, without limitation, records of medical, therapeutic, and surgical treatments and procedures, including diagnostics) in an electronic database designated by the Agency or in any other form designated by the Agency and provide access to the Agency upon request and without delay to or copies of such treatment records. The records must include the details required under Rule 2251(b) and must be submitted in an electronic format designated by the Authority within the deadline specified in that same provision. Attending Veterinarians must retain copies of such treatment records for a period of no less than 3 years, or for the retention period required by the relevant state veterinary practice act, whichever is longer.

Rule 3050. Retirement and Equine Fatalities

(a) Covered Persons.

(1) Each Responsible Person who wishes to no longer be bound by the Protocol shall give written notice to the Authority of his or her retirement from the position that made him or her a Responsible Person. In each case, the Responsible Person shall be deemed to have retired (and to be no longer subject to the Protocol) on the later of (i) the date given in the written notice of retirement and (ii) the date the notice is received.

(2) Any other Covered Person will continue to be bound by and required to comply with the Protocol and related rules unless and until he or she unregisters with the Authority.

(3) If a Covered Person ceases to be subject to the Protocol while the Agency is conducting a Results Management process in respect of that person, the Agency retains jurisdiction to complete its Results Management process. If a Covered Person retires or ceases to be subject to the Protocol before any Results Management process has begun, and the Agency had jurisdiction over the Covered Person at the time the Anti-Doping Rule Violation or Controlled Medication Rule Violation was committed, the Agency retains jurisdiction to conduct Results Management in respect of that violation.

(4) If a Covered Person retires while subject to a period of Ineligibility, he or she must give written notice of such retirement to the Authority. The Covered Person may not return to the sport ( i.e., carry out any of the activities prohibited during the period of Ineligibility pursuant to Rules 3229 and 3329) unless the Covered Person has given 4 months' prior written notice (or notice equivalent to the period of Ineligibility remaining as of the date the Covered Person retired, if that period was longer than 4 months) to the Authority of his or her intent to return to the sport.

(5) The Agency may forward notifications of retirement of Covered Persons to Interested Parties or other Persons with a need to know.

(b) Covered Horses.

(1) If an Owner wishes to retire a Covered Horse such that it is no longer made available for Testing, the Owner must provide written notice of such retirement to the Agency, in accordance with its procedures.

(2) A Covered Horse that has been retired in accordance with the previous clause may not participate in a Timed and Reported Workout or be entered in a Covered Horserace until the Covered Horse has been made available for Testing at least 4 months prior to notice being given to the Agency (in accordance with its procedures) of the intention to unretire the Covered Horse.

(3) If a Covered Horse is retired from horseracing or suffers a fatal condition while the Agency is conducting a Results Management process in respect of it, the Agency retains jurisdiction to complete its Results Management process. If a Covered Horse is retired or suffers a fatal condition before any Results Management process has begun, and the Agency had jurisdiction over the Covered Horse at the time the Anti-Doping Rule Violation or Controlled Medication Rule Violation was committed, the Agency retains jurisdiction to conduct Results Management in respect of that violation. If a Covered Horse suffers a fatal condition, the Agency retains Testing authority over that horse in accordance with Rule 3132(d).

(4) If a Covered Horse is retired from horseracing while subject to a period of Ineligibility, the Owner must notify the Agency in writing of such retirement. If the Owner wishes that horse to return to participation in Covered Horseraces or Timed and Reported Workouts, the Owner must first provide the Agency with written notice and make the Covered Horse available for Testing for at least 4 months prior to such participation or for the remainder of the Covered Horse's period of Ineligibility, whichever is longer.

(5) In order to manage the number of Covered Horses registered with the Authority, the Agency may retire a Covered Horse based on inactivity ( i.e., where the Covered Horse does not participate in a Timed and Reported Workout or Covered Horserace for 18 months or more, excluding periods of inactivity due to a Provisional Suspension or period of Ineligibility) by sending written notice thereof to the Authority and the Owner in accordance with the Agency's procedures. If the Owner disputes that retirement, while the dispute is pending the Covered Horse may not participate in any Timed and Reported Workout or Covered Horserace but must be made available for Testing. Upon resolution of the dispute, the Authority will notify the Agency whether the horse is retired and, therefore, no longer subject to Testing. If the Owner wishes to return the Covered Horse to participation in Timed and Reported Workouts or Covered Horseraces, the Owner must first provide the Agency with written notice and make the Covered Horse available for Testing for at least 4 months prior to such participation.

(6) The Agency may reduce the 4-month notice period in Rule 3050(b) to 2 months where the Owner of the Covered Horse submits an application establishing good cause to do so, and where the Agency approves such application based on a review conducted in accordance with the objectives of the Protocol.

(7) The Agency may forward notifications of retirement of Covered Horses to Interested Parties or other Persons with a need to know.

Rule 3060. Claiming Races and Voidable Claims

(a) Subject to Rule 3132(b), a claimed horse may be subject to Sample collection at a Claiming Race if requested (and paid for) by the claimant as part of the claiming procedure on the day of the Claim. If a Sample collected from the claimed horse results in an Anti-Doping Rule Violation or Controlled Medication Rule Violation, the Claim may be voided at the option of the claimant, and the claimant shall be entitled to the return from the seller of all sums paid for the claimed horse and of all reasonable expenses incurred after the date of the Claim. While awaiting test results, a claimant shall: (i) exercise due care in maintaining and boarding a claimed horse; and (ii) not materially alter a claimed horse.

(b) Any voided claim shall be recorded in Equibase.

Rule 3070. Amendment and Interpretation of the Protocol

(a) The Authority may amend the Protocol from time to time, as necessary to ensure that it remains fit for purpose, in accordance with section 3057(e) of the Act. Unless provided otherwise, any amendments will come into force on the date specified or (if no date is specified) on the date the amendment is approved by the Commission.

(b) Subject to Rule 3070(d), the Protocol shall be interpreted as an independent and autonomous text and not by reference to existing law or statutes.

(c) The Protocol has been adopted pursuant to the Act and shall be interpreted, where applicable, in a manner that is consistent with applicable provisions of the Act and the other rules in Rule 1000-9000 Series. In the event of any conflict between the Act and the Protocol, the Act shall prevail. In the event of any conflict between the Protocol and any other rules in Rule 1000-9000 Series, the Protocol shall prevail.

(d) The World Anti-Doping Code and related International Standards, procedures, documents, and practices (WADA Code Program), the comments annotating provisions of the WADA Code Program, and any case law interpreting or applying any provisions, comments, or other aspects of the WADA Code Program, may be considered when adjudicating cases relating to the Protocol, where appropriate.

Rule 3080. Transitional Provisions

(a) The Protocol shall not apply retroactively to matters pending before the Program Effective Date.

(b) A presence violation under Rule 3212 or Rule 3312 that occurs after the Program Effective Date as a result of Use or Administration prior to the Program Effective Date shall not constitute a violation of the Protocol.

(c) The relevant State Racing Commission retains authority (including results management) in relation to any anti-doping or controlled medication matters taking place prior to the Program Effective Date.

(d) Changes to substances or methods covered by the Prohibited List or related Technical Document—Prohibited Substances shall not, unless they specifically provide otherwise, be applied retroactively. However, a Responsible Person or other Covered Person who is serving a period of Ineligibility on account of a Prohibited Substance or Prohibited Method that is later subject to a change in status (either because it is no longer prohibited or subject to lesser sanctions) may apply to the Agency for consideration of a reduction in the period of Ineligibility in light of that change in status. The Responsible Person may also apply to the Agency for consideration of a reduction in the period of Ineligibility applicable to his or her Covered Horse(s).

Rule 3090. Statute of Limitations

(a) No charge may be brought against a Covered Person or in relation to a Covered Horse in respect of an Anti-Doping Rule Violation unless the Covered Person or Responsible Person for the Covered Horse has been given notice, or notification has been reasonably attempted, within 10 years of the date the Anti-Doping Rule Violation is asserted to have occurred. Any violation of Rule 3229 is also subject to a 10-year limitation period.

(b) No charge may be brought against a Covered Person or in relation to a Covered Horse in respect of a Controlled Medication Rule Violation unless the Covered Person or Responsible Person for the Covered Horse has been given notice, or notification has been reasonably attempted, within 2 years of the date the Controlled Medication Rule Violation is asserted to have occurred. Any violation of Rule 3329 is also subject to a 2-year limitation period.

(c) Any violation of Rule 3510 is subject to a 4-year limitation period.

3110. The Prohibited List

Rule 3111. Prohibited Substances and Prohibited Methods

(a) The Prohibited List identifies Prohibited Substances and Prohibited Methods that are:

(1) prohibited at all times (Banned Substances and Banned Methods) on the basis of the Agency's determination that medical, veterinary, or other scientific evidence or experience supports their actual or potential (i) ability to enhance the performance of Covered Horses, (ii) masking properties, or (iii) detrimental impact on horse welfare; or

(2) prohibited for Use or Administration in relation to a Covered Horse during the Race Period and prohibited to be present in a Post-Race Sample or Post-Work Sample, except as otherwise specified in the Prohibited List (Controlled Medication Substances and Controlled Medication Methods).

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

(c) The Prohibited List is supplemented by the “Technical Document—Prohibited Substances,” which provides guidance on the Prohibited Substances that fall into the general categories listed in the Prohibited List and on Screening Limits, Thresholds, or Detection Times for those Prohibited Substances (as applicable), and also designates certain Prohibited Substances as Specified Substances, which are those that pose a higher risk of being the result of contamination and, therefore, are subject to more flexible sanctions.

(d) Certain Prohibited Substances may first be reported as Atypical Findings requiring further investigation before being declared as Adverse Analytical Findings, in accordance with the Atypical Findings Policy set out at Appendix 1 to the Protocol.

Rule 3112. Review and Publication of the Prohibited List and Related Technical Documents

The Agency will publish the Prohibited List on its website at least annually, following an opportunity for stakeholder comment. The Agency will review and consider such stakeholder comment and will provide recommended revisions to the Authority. Each new version of the Prohibited List will also be sent to the State Racing Commissions.

The Authority (on recommendation of the ADMC, in consultation with the Agency) may revise the Prohibited List from time to time, subject to approval by the Commission. Revisions to the Prohibited List will go into effect on the date specified in the revised Prohibited List (which will not be any earlier than 90 days following its publication). The Agency will also publish any Technical Documents supplementing the Prohibited List (including the Technical Document—Prohibited Substances) on its website at least annually, following an opportunity for public comment. Any revisions to such Technical Documents will go into effect on the date specified in the revised Technical Document.

All Covered Persons shall be bound by the Prohibited List and related Technical Documents (including the Technical Document—Prohibited Substances), and any revisions thereto, from the date they go into effect, without further formality. It is the responsibility of all Covered Persons to familiarize themselves with the most up-to-date version of the Prohibited List and related Technical Documents (including the Technical Document—Prohibited Substances) and all revisions thereto.

Rule 3113. Validity of the Prohibited List and Related Technical Documents

The following decisions are final and shall not be subject to any challenge by any Covered Person or other Person on any basis, including any challenge based on an argument that the substance or method is not a masking agent or does not have the potential to enhance the performance of Covered Horses or have a detrimental impact on horse welfare:

(a) the Authority's determination of the Prohibited Substances and Prohibited Methods included on the Prohibited List or Technical Document—Prohibited Substances;

(b) the approval of the Prohibited List or Technical Document—Prohibited Substances by the Commission or the Authority;

(c) the classification of substances and methods into categories or classes on the Prohibited List or Technical Document—Prohibited Substances;

(d) the classification of a substance or method as a Banned Substance or Banned Method as opposed to a Controlled Medication Substance or Controlled Medication Method;

(e) the periods during which Prohibited Substances or Prohibited Methods are prohibited; and

(f) the classification of Prohibited Substances as either Specified Substances or non-Specified Substances.

Rule 3114. Monitoring Program

The Agency may approve a monitoring program regarding substances that are not on the Prohibited List or Technical Document—Prohibited Substances, if the Agency wishes to research or monitor such substances, including to identify potential patterns of misuse in horseracing. Laboratories will report the instances of reported Use or detected presence of monitored substances to the Agency, but the results of any such analyses shall not constitute an Anti-Doping Rule Violation or Controlled Medication Rule Violation. Nothing in this Rule 3114 or elsewhere in the Protocol prevents a Laboratory from sharing information with the Agency for any anti-doping or controlled medication purpose or other purpose authorized by the Act. The list of substances in the monitoring program will be reviewed annually by the Agency.

3120. Proof of Violations

Rule 3121. Burden and Standard of Proof

(a) The Agency shall 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 that is made. This standard of proof in all cases 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.

(b) Where the Protocol places the burden of proof on a Covered Person to rebut a presumption or to establish specified facts or circumstances, the standard of proof shall be by a balance of probability ( i.e., a preponderance of the evidence), except as provided in Rules 3122(c) and 3122(d).

Rule 3122. Methods of Establishing Facts and Presumptions

Facts related to violations may be established by any reliable means, including admissions. The following rules of proof shall apply:

(a) Analytical methods, Minimum Reporting Levels, Thresholds, Screening Limits, Decision Limits, and any other Laboratory reporting requirements approved by the Commission are presumed to be scientifically valid.

(b) Compliance with the Standards (as opposed to an alternative standard, practice, or procedure) will be sufficient to conclude that the procedures addressed by those Standards were performed properly.

(c) Laboratories are presumed to have conducted Sample analysis and custodial procedures in accordance with the Laboratory Standards. A Covered Person who is alleged to have committed a violation may rebut this presumption by establishing that a departure from the Laboratory Standards occurred that could reasonably have caused the Adverse Analytical Finding or other factual basis for any other violation asserted. Where the presumption is rebutted, the Agency shall have the burden of establishing that such departure did not cause the Adverse Analytical Finding or other factual basis for the violation asserted.

(d) Departures from any other Standards or any provisions of the Protocol shall not invalidate analytical results or other evidence of a violation, and shall not constitute a defense to a charge of such violation; provided, however, that if the Covered Person establishes that a departure from any other Standards or any provisions of the Protocol could reasonably have caused the Adverse Analytical Finding or other factual basis for the violation charged, the Agency shall have the burden to establish that such departure did not cause the Adverse Analytical Finding or other factual basis for the violation.

(e) Non-appealable and final factual findings of a court, arbitral tribunal, professional disciplinary body, or administrative body of competent jurisdiction shall be irrebuttable evidence against the Covered Person to whom the decision pertained of those facts, unless the Covered Person establishes that the decision did not respect due process.

(f) A hearing panel may draw an inference adverse to a Covered Person who is asserted to have committed a violation of the Protocol based on the Covered Person's refusal to cooperate with the Agency, including any refusal to respond to questions put to him or her as part of an investigation or to appear at the hearing (either in person or remotely) and to answer questions put by the Agency or the hearing panel.

3130. Testing and Investigations

Rule 3131. Purpose of Testing and Investigations

Testing and investigations may be undertaken to assist in the effective policing and enforcement of the Protocol, including to obtain evidence regarding potential violations of the Protocol.

Rule 3132. Authority To Test

(a) Only the Agency (and those authorized by the Agency) may initiate and direct Testing on Covered Horses. The Agency has authority to conduct Testing both in and out of competition.

(b) No other entity (including State Racing Commissions, Racetracks, Race Organizers, and Training Facilities) may initiate or direct any Testing on Covered Horses. However, a State Racing Commission, Racetrack, Race Organizer, or other third party 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 Testing (or aspects thereof) to the relevant State Racing Commission, subject to the applicable State Racing Commission electing to enter into an agreement with the Agency.

(c) Covered Horses may be subject to Testing at any time and any place where they are located by or on behalf of the Agency.

(d) A Covered Horse that is subject to a Provisional Suspension or period of Ineligibility, or that sustains a fatal condition, remains subject to Testing.

(e) In accordance with the Racetrack Safety Program, a Covered Horse may be required to submit to Sample collection (at the Owner's cost) following a Vets' List Workout in order to be released from the Veterinarians' List. Any Sample collected following a Vets' List Workout constitutes a Post-Race Sample, and, as a result, is subject to all of the same requirements that apply to Sample collection at Covered Horseraces. To schedule a Vets' List Workout, the Responsible Person or the Owner of the Covered Horse shall make a request to a Regulatory Veterinarian who shall, in turn, notify the Agency in order to make any necessary arrangements. The Agency must be given a minimum of 48 hours' notice of any Vets' List Workout.

Rule 3133. Requirements

(a) Testing. The Agency shall conduct test distribution planning and Testing in accordance with the Testing and Investigations Standards. The Agency may delegate authority to third parties, including State Racing Commissions (see Rule 3132), to conduct Testing (or aspects thereof) in accordance with the Testing and Investigations Standards under its supervision.

(b) Investigations and intelligence gathering. The Agency shall gather intelligence and conduct investigations, or delegate to third parties to do so under its supervision, in accordance with the Testing and Investigations Standards, which incorporate uniform rules and procedures in accordance with section 3054 of the Act providing for:

(1) access for the Agency to books, records, offices, racetrack facilities, and other places of business of Covered Persons that are used in the care, treatment, training, or racing of Covered Horses;

(2) the issuance and enforcement of subpoenas and subpoenas duces tecum by the Authority at the request of the Agency;

(3) the exercise of other investigatory powers similar in nature and scope to those exercised by State Racing Commissions before the Program Effective Date; and

(4) the coordination and sharing of intelligence and information with the Authority, law enforcement (authorized by any government, including Federal, State, or international), State Racing Commissions, Racetracks, Race Organizers, Training Facilities, Laboratories, anti-doping organizations, equine regulatory bodies, or other relevant regulatory or disciplinary authorities.

Rule 3134. Sample Analysis

Samples shall be analyzed in accordance with the principles set forth in Rules 3135 through 3139.

Rule 3135. Ownership of Samples

Samples collected under the Protocol are the property of the Authority, and the Authority is entitled (subject to Rule 3138(b)) to determine all matters regarding access to and the analysis and disposal of such Samples.

Rule 3136. Use of Approved Laboratories and Other Laboratories

(a) The Agency will publish a list of approved Laboratories, which may be revised from time to time.

(b) Subject to paragraph (d) below, Samples collected by or on behalf of the Agency pursuant to the Protocol will be analyzed by approved Laboratories. Only approved Laboratories may declare an Adverse Analytical Finding.

(c) Selection of Laboratories

(1) Subject to paragraph (2) below, a State Racing Commission may select a Laboratory to analyze A Samples or TCO2 Samples collected in its State. If a State Racing Commission does not select a Laboratory, the selection of the Laboratory to analyze such Samples shall be determined exclusively by the Agency.

(2) The Agency shall have the authority to require specific Samples to be directed to and analyzed by Laboratories having special expertise in the required analysis.

(3) The selection of the Laboratory for any B Sample analysis shall be determined exclusively by the Agency. The B Sample analysis (if applicable) will be performed in a different Laboratory from the A Sample analysis, except if provided otherwise in the Laboratory Standards.

(d) In accordance with Rule 3122, facts related to violations of the Protocol may be established by any reliable means. This would include, for example, laboratory analysis or other forensic testing conducted reliably outside of Agency-approved laboratories.

Rule 3137. Purpose of Sample Analysis

(a) General. Samples, related analytical data, Doping Control information, and Medication Control information shall be analyzed (1) to detect the presence of Prohibited Substances and Prohibited Methods identified on the Prohibited List (or Technical Document—Prohibited Substances) and other substances as may be directed pursuant to Rule 3114, (2) to assist the Agency in profiling relevant parameters in a Covered Horse's urine, blood, hair, or other matrix, including for DNA or genomic profiling, or (3) for any other legitimate purpose.

(b) Research on Samples and Data. Samples, related analytical data, Doping Control information, and Medication Control information may be used for anti-doping or medication control research purposes. However, the results of any analyses performed for such research purposes may not be used as the basis for pursuing an Anti-Doping Rule Violation or Controlled Medication Rule Violation.

Rule 3138. Standards for Sample Analysis and Reporting

(a) General. Laboratories may not accept or analyze any Samples from Covered Horses that were not collected by or on behalf of the Agency or otherwise authorized by the Agency. Laboratories shall analyze Samples and report results in accordance with the Laboratory Standards. The results of all Sample analyses must be sent exclusively to the Agency via secure transmission in a form designated by the Agency. All communications must be conducted in such a way that the results of the Sample analyses are kept confidential.

(b) Further Analysis of a Sample prior to or during Results Management. Further Analyses may be conducted, without limitation, on a Sample prior to the time that it is reported as negative or prior to the time that the Agency notifies a Covered Person that the Sample is the basis for an Anti-Doping Rule Violation or Controlled Medication Rule Violation. If the Agency notifies a Covered Person that the Sample is the basis for an Anti-Doping Rule Violation or Controlled Medication Rule Violation, and the Agency wishes to conduct Further Analyses on that Sample after such notification, it may do so only with the consent of the Covered Person or the approval of the hearing panel adjudicating the case against the Covered Person.

(c) Further Analysis of a Sample after it has been reported as negative or has otherwise not resulted in an Anti-Doping Rule Violation or Controlled Medication Rule Violation. A Sample that has been reported as negative or has otherwise not resulted in a charge may be stored and subjected to Further Analyses for the purpose described in Rule 3137 at any time exclusively at the direction of the Agency. Any Sample storage and Further Analysis initiated by the Agency shall be at the Agency's expense. Further Analysis of Samples shall be conducted in accordance with the Laboratory Standards.

(d) Split of A or B Sample. Where, in exceptional circumstances, the Laboratory (on instruction from the Agency) is required to further split an A or B Sample for the purpose of using the first part of the resulting split Sample for an A Sample analysis and the second part of the resulting split Sample for B confirmation, the procedures and analysis shall be conducted in accordance with the Laboratory Standards.

Rule 3139. The Agency's Right To Take Possession of Samples and Related Data

The Agency may at any time, with or without prior notice, take physical possession of any Sample collected by or on behalf of the Agency and any related analytical data or information in the possession of a Laboratory. Upon request by the Agency, the Laboratory in possession of the Sample or related data shall grant access to and enable the Agency to take physical possession of the Sample or data as soon as possible.

Rule 3140. Clearance Testing

Clearance testing for a Covered Horse at the request of a Covered Person ( i.e., testing to determine if Controlled Medications Substances have cleared the horse's system) may be performed by a Laboratory only if in advance of such testing (1) the Agency approves such request (which approval may be subject to conditions determined by the Agency), and (2) the Covered Person pays for all of the costs of Sample collection and analysis. The Agency may pursue any violation of the Protocol that is evidenced by the results of the clearance testing.

3210. Anti-Doping Rule Violations

Rule 3211. Definition of Anti-Doping Rule Violation and Responsibility for Violations

(a) Doping cases will be initiated based on the assertion that one or more of Rules 3212 through 3216 has been violated (each, an Anti-Doping Rule Violation).

(b) The Anti-Doping Rule Violations described below may only be committed by Covered Persons, but the Consequences for Anti-Doping Rule Violations may apply to both the Covered Person(s) who commit(s) the violation and any Covered Horse(s) implicated by the violation.

(c) All Covered Persons are responsible for knowing what constitutes an Anti-Doping Rule Violation and what Banned Substances and what Banned Methods are included on the Prohibited List and Technical Document—Prohibited Substances.

Rule 3212. Presence of a Banned Substance

(a) It is the personal and non-delegable duty of the Responsible Person to ensure that no Banned Substance is present in the body of his or her Covered Horse(s). The Responsible Person is therefore strictly liable for any Banned Substance or its Metabolites or Markers found to be present in a Sample collected from his or her Covered Horse(s). Accordingly, it is not necessary to demonstrate intent, Fault, negligence, or knowing Use on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3212 Anti-Doping Rule Violation.

(b) Sufficient proof of a Rule 3212 Anti-Doping Rule Violation is established by any of the following:

(1) the presence of a Banned Substance or its Metabolites or Markers in the Covered Horse's A Sample where the Responsible Person waives analysis of the B Sample and the B Sample is not analyzed;

(2) the Covered Horse's B Sample is analyzed and the analysis of the B Sample confirms the presence of the Banned Substance or its Metabolites or Markers found in the A Sample; or

(3) where, in exceptional circumstances, the Laboratory (on instruction from the Agency) further splits the A or B Sample into two parts in accordance with the Laboratory Standards, the analysis of the second part of the resulting split Sample confirms the presence of the same Banned Substance or its Metabolites or Markers as were found in the first part of the split Sample, or the Responsible Person waives analysis of the second part of the split Sample.

(c) The general rule is that the presence of any amount of a Banned Substance or its Metabolites or Markers in a Sample collected from a Covered Horse constitutes an Anti-Doping Rule Violation by the Responsible Person of that Covered Horse.

(d) As an exception to the general rule of Rule 3212(c), the Prohibited List, Standards, or Technical Documents may establish special criteria for the reporting or the evaluation of certain Banned Substances, including a Minimum Reporting Level, Screening Limit, Threshold, or Decision Limit.

Rule 3213. Use or Attempted Use of a Banned Substance or a Banned Method

(a) Subject to Rule 3213(c), the Use or Attempted Use of a Banned Substance or Banned Method in relation to a Covered Horse constitutes an Anti-Doping Rule Violation. The success or failure of that Use or Attempted Use is not material. For a Rule 3213 violation to be committed, it is sufficient that the Banned Substance or Banned Method was Used or Attempted to be Used.

(b) It is the personal and non-delegable duty of the Responsible Person to ensure that no Banned Substance or Banned Method is Used in relation to his or her Covered Horse. The Responsible Person is therefore strictly liable for any Use of a Banned Substance or Banned Method in relation to his or her Covered Horse(s). Accordingly, it is not necessary to demonstrate intent, Fault, negligence, or knowing Use on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3213 Anti-Doping Rule Violation of Use. However, in accordance with the definition of Attempt, it is necessary to show intent on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3213 Anti-Doping Rule Violation of Attempted Use.

(c) The presence of a Prohibited Substance or of evidence of Use of a Prohibited Method in the Covered Horse's Sample or other evidence of Use of such Prohibited Substance or Prohibited Method shall not be considered an Anti-Doping Rule Violation if it is determined to have resulted from Use of the Banned Substance or Banned Method prior to the horse becoming a Covered Horse. However, any such Use is subject to Rule 3040(b)(9) and may be reported to the relevant State Racing Commission.

Rule 3214. Other Anti-Doping Rule Violations Involving Banned Substances or Banned Methods

The following acts and omissions constitute Anti-Doping Rule Violations by the Covered Person(s) in question:

(a) Possession of a Banned Substance or a Banned Method, unless there is compelling justification for such Possession.

(b) Trafficking or Attempted Trafficking in any Banned Substance or Banned Method.

(c) Administration or Attempted Administration to a Covered Horse of any Banned Substance or any Banned Method.

Rule 3215. Evading Collection of a Sample From a Covered Horse; Refusing or Failing Without Compelling Justification To Submit a Covered Horse to Sample Collection; or Refusing or Failing To Comply With All Sample Collection Procedure Requirements

(a) Except as provided in Rule 3215(d), each of the following constitutes an Anti-Doping Rule Violation: (1) evading collection of a Sample from a Covered Horse, (2) refusing or failing without compelling justification to submit a Covered Horse to Sample collection after notification by a duly authorized person, or (3) refusing or failing to comply with all Sample collection procedure requirements.

(b) Responsible Persons are responsible for ensuring compliance with Rules 3040(b)(1) and 3040(b)(2). A Responsible Person may delegate the submission and supervision of the Covered Horse to a third party, but the Responsible Person remains responsible for the Covered Horse throughout the Sample collection process and for the acts and omissions of his or her delegate. Therefore, the Responsible Person shall be deemed liable for any evasion by his or her delegate of Sample collection, any refusal or failure by his or her delegate without compelling justification to submit the Covered Horse to Sample collection, or any refusal or failure by his or her delegate to comply with all Sample collection procedure requirements.

(c) 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).

(d) No violation occurs where a Covered Horse is made available for Sample collection, but a Sample is not collected because the Covered Horse is intractable.

Rule 3216. Other Anti-Doping Rule Violations

The following acts and omissions constitute Anti-Doping Rule Violations by the Covered Person(s) in question:

(a) Tampering or Attempted Tampering by a Covered Person with any part of Doping Control or Medication Control;

(b) a Covered Person assisting, encouraging, aiding, abetting, conspiring, covering up, or engaging in any other type of intentional complicity or Attempted complicity involving (1) an Anti-Doping Rule Violation or Attempted Anti-Doping Rule Violation, or (2) a violation of Rule 3229 by another Covered Person.

(c) Prohibited Association:

(1) Association by a Covered Person in a professional or sport-related capacity with any Person who:

(i) is serving a period of Ineligibility imposed pursuant to the Protocol or is serving a period of ineligibility imposed pursuant to anti-doping rules administered by any other equine regulatory body or anti-doping organization; or

(ii) has been found in a criminal, disciplinary, or professional proceeding to have engaged in conduct that would have constituted a violation of the Protocol if it had been applicable to such Person at the relevant time. The disqualifying status of such Person shall last for the longer of:

(A) 6 years from the criminal, professional, or disciplinary decision; and (B) the duration of the criminal, disciplinary, or professional sanction imposed; or

(iii) is serving as a front or intermediary for an individual falling within paragraph (i) or (ii) above.

(2) To establish a violation of Rule 3216(c), the Agency must establish that the Covered Person knew at the relevant time of the Person's disqualifying status. It is presumed that any association with the Person described in Rules 3216(c)(1)(i) and (ii) is in a professional or sport-related capacity, and the burden shall be on the Covered Person to rebut that presumption.

(3) It shall be a defense to a charge of violation of Rule 3216 if the Covered Person establishes that the association with the Person could not have been reasonably avoided.

(d) Acts by a Covered Person to discourage or retaliate against reporting to authorities.

(1) Where such conduct does not otherwise constitute a violation under Rule 3216(a) (Tampering or Attempted Tampering), each of the following constitutes an Anti-Doping Rule Violation under this Rule 3216(d):

(i) any act that threatens or seeks to intimidate another Person with the intent of discouraging that Person from the good faith reporting of information that relates to an alleged Anti-Doping Rule Violation or other alleged non-compliance with the Protocol to the Agency or other appropriate Person; and

(ii) retaliation against a Person who, in good faith, has provided evidence or information that relates to an alleged Anti-Doping Rule Violation or other alleged non-compliance with the Protocol to the Agency or other appropriate entity or Person.

(2) For purposes of Rule 3216(d), threatening or seeking to intimidate a Person, and retaliation against a Person, include an act taken against such Person that lacks a good faith basis or is a disproportionate response.

3220. Sanctions

Rule 3221. Disqualification of the Covered Horse's Results

(a) Automatic Disqualification of results.

(1) An Anti-Doping Rule Violation that arises from a Post-Race Sample, or that occurs during the Race Period, automatically leads to Disqualification of the results of the Covered Horse obtained on the Race Day(s) that fall(s) within the Race Period, even if any other sanction for the violation is eliminated or reduced under Rules 3224, 3325, or 3226.

(2) In circumstances where an EAD Notice has been sent as required under Rule 3245, and the B Sample analysis confirms the A Sample analysis, or the right to request the analysis of the B Sample is waived, the Agency, the Responsible Person, and the Owner of the Covered Horse in question may agree to apply Rule 3221 immediately, i.e., prior to adjudication of any other issue, or (in the absence of such agreement) any one of them may request that the Arbitral Body apply Rule 3221 immediately.

(b) Disqualification of subsequent results.

(1) Subject to paragraph (2), in addition to the automatic Disqualification of results under Rule 3221(a), any other results that the Covered Horse obtained from the date the Anti-Doping Rule Violation first occurred, as well as during any period of retroactive Ineligibility, shall be Disqualified, unless it is established by the Responsible Person that fairness requires otherwise.

(2) If the Anti-Doping Rule Violation occurs in relation to a Claiming Race in which the Covered Horse is claimed, Rule 3221(b)(1) shall not apply to any results obtained by the Covered Horse under the new ownership.

(c) Consequence of Disqualification of results:

(1) If a Covered Horse has results Disqualified under the Protocol, all purses and other compensation, prizes, trophies, points, and rankings are forfeited and must be repaid or surrendered (as applicable) to the Race Organizer, and the results of the other Covered Horses in the race(s) in question must be adjusted accordingly and the purses, prizes, and trophies redistributed. Purses, prizes, trophies, and other compensation shall (where possible) be withheld for the Covered Horse in issue pending resolution of the relevant charge.

(2) The Covered Horses that participated in a Covered Horserace involving an alleged Anti-Doping Rule Violation are often entered in other Covered Horseraces prior to the final adjudication of the violation. The ultimate Disqualification of a Covered Horse in connection with final adjudication of a violation shall only impact that horse's conditions for eligibility. By way of example, a maiden that is Disqualified after finishing first in a maiden race shall remain a maiden until it has won another race, but the runner-up in the disputed Covered Horserace shall not be considered the winner for purposes of its future condition eligibility. The adjustment to the Disqualified horse's condition eligibility shall only occur once the violation has been finally adjudicated.

Rule 3222. Ineligibility for Covered Horses

(a) For a violation of Rule 3212 (presence), 3213 (Use or Attempted Use), or Rule 3214(c) (Administration or Attempted Administration), the Covered Horse involved shall be Ineligible for the period designated in the Prohibited List for the Banned Substance or Banned Method in issue.

(b) For a violation of Rule 3215 involving evasion of Sample collection, the Covered Horse shall be Ineligible for 18 months. For a violation of Rule 3215 involving refusal or failure to submit to Sample collection, or refusal or failure to comply with all Sample collection procedure requirements, the Covered Horse shall be Ineligible for 18 months, unless it is established by the Responsible Person that fairness requires otherwise, in which case the period of Ineligibility may be reduced, depending on the specific circumstances of the case and considerations of horse welfare.

(c) Rule 3228 on increased periods of Ineligibility for repeat offenders does not apply to Covered Horses.

(d) The period of Ineligibility for a Covered Horse shall be deemed to commence on the date that the violation occurred (which, in the case of a Rule 3212 violation, shall be the date that the positive Sample was collected, even if the Covered Horse has participated in Timed and Reported Workouts or Covered Races after that date).

Rule 3223. Ineligibility and Financial Penalties for Covered Persons

(a) General.

(1) The periods of Ineligibility and financial penalties set out in this Rule 3223 apply to the Covered Person's first doping offense. Where an offense is not the Covered Person's first doping offense, Rule 3228 applies.

(2) Unless specified otherwise, the periods of Ineligibility set out in this Rule 3223 are subject to potential elimination, reduction, or suspension pursuant to Rules 3224 to 3226 or potential increase pursuant to Rule 3227.

(3) In accordance with Rule 3247(i), any period of Provisional Suspension served by the Covered Person shall be credited against the period of Ineligibility ultimately imposed on that Covered Person for the violation in question.

(b) Consequences.

Subject to Rule 3223(a), and in addition to any other Consequences that apply under the Protocol (including Disqualification), the periods of Ineligibility and financial penalties specified below shall apply to a Covered Person for his or her first Anti-Doping Rule Violation:

(c) Commencement of the period of Ineligibility for a Covered Person.

(1) Except as otherwise provided in this Rule 3223, the period of Ineligibility imposed on any Covered Person shall start on the date the period of Ineligibility is accepted or otherwise imposed in accordance with the Protocol.

(2) Where a Covered Person is already serving a period of Ineligibility for another violation of the Protocol, any new period of Ineligibility shall start to run the day after the original period of Ineligibility ends.

(3) Where there have been substantial delays in the adjudication process or other aspects of Doping Control that go well beyond the standard timeframes for Laboratory analyses and Results Management, and the Covered Person can establish that such delays are not attributable to him or her, the start date of the period of Ineligibility may be deemed back-dated to reflect such delays, but in no event may it be deemed back-dated to a date before the Anti-Doping Rule Violation last occurred. All competitive results achieved during the period of Ineligibility by the Covered Person or Covered Horse in issue, including retroactive Ineligibility, shall be Disqualified, unless it is established by the Covered Person that fairness requires otherwise.

Rule 3224. Elimination of the Period of Ineligibility Where There Is No Fault or Negligence

(a) If a Covered Person establishes in an individual case that he or she bears No Fault or Negligence for the Anti-Doping Rule Violation(s) charged, the otherwise applicable period of Ineligibility and other Consequences for such Covered Person shall be eliminated (except for those set out in Rule 3221(a) and Rule 3620). When the violation is of Rule 3212 (presence of a Banned Substance), the Covered Person must also establish how the Banned Substance entered the Covered Horse's system as a pre-condition to application of this Rule 3224(a). In the event the period of Ineligibility otherwise applicable is eliminated pursuant to this Rule 3224, the Anti-Doping Rule Violation shall not be considered a prior violation for the purpose of Rule 3228.

(b) Rule 3224 only applies in exceptional circumstances. In particular, it will not apply where the Banned Substance found to be present in a Sample: (1) came from a mislabeled or contaminated supplement; or (2) was administered to the Covered Horse by veterinary or other support personnel without the knowledge of the Responsible Person.

(c) A finding that the Covered Person bears No Fault or Negligence for an Anti-Doping Rule Violation shall not affect the Consequences of that violation that apply to the Covered Horse ( i.e., Ineligibility in accordance with Rule 3222(a) and Disqualification of results in accordance with Rule 3221).

Rule 3225. Reduction of the Period of Ineligibility Where There Is No Significant Fault or Negligence

Reductions under this Rule 3225 are mutually exclusive and not cumulative, i.e., no more than one of them may be applied in a particular case.

(a) General rule.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Anti-Doping Rule Violation in question, then (unless Rule 3225(b) or 3225(c) applies) the period of Ineligibility shall be fixed between 3 months and 2 years, depending on the Covered Person's degree of Fault.

(b) Specified Substances.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Anti-Doping Rule Violation in question, and the violation involves only a Specified Substance, the period of Ineligibility shall be, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, 2 years of Ineligibility, depending on the Covered Person's degree of Fault.

(c) Contaminated Products or other contamination.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Anti-Doping Rule Violation in question and that the Banned Substance in question came from a Contaminated Product or from another form of contamination, the period of Ineligibility shall be, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, 2 years of Ineligibility, depending on the Covered Person's degree of Fault.

Rule 3226. Elimination, Reduction, or Suspension of Period of Ineligibility or Other Consequences for Reasons Unrelated to Degree of Fault

(a) Substantial Assistance. The Agency may suspend all or part of the Consequences imposed on a Covered Person in an individual doping case—other than Disqualification of results pursuant to Rule 3221—based on the following:

(1) The Covered Person provides Substantial Assistance to the Agency, the Authority, or a State Racing Commission, a criminal authority, or a professional disciplinary body that results in:

(i) the Agency discovering or bringing forward an Anti-Doping Rule Violation or a Controlled Medication Rule Violation by another Covered Person; or

(ii) a criminal or disciplinary body discovering or bringing forward a sport-related criminal offense or the breach of professional or sports rules by another Person, including offenses arising out of a sport integrity violation or sport safety violation, or the violation of any rule or requirement in the Act, and the information provided by the Covered Person providing Substantial Assistance is also made available to the Agency.

(2) The extent to which the otherwise applicable period of Ineligibility may be suspended shall be based on the seriousness of the Anti-Doping Rule Violation committed by the Covered Person and the degree to which the Substantial Assistance provided by the Covered Person assists the effort to promote doping-free racing, compliance with the Protocol, or the integrity of racing. In any event, no more than three-quarters of the otherwise applicable period of Ineligibility may be suspended. If the otherwise applicable period of Ineligibility is a lifetime, the non-suspended period under this section must be no less than 8 years. For purposes of this Rule 3226, the otherwise applicable period of Ineligibility shall not include any period of Ineligibility that could be added under Rule 3228(c)(2).

(3) If so requested, the Agency shall allow the Covered Person who seeks to provide Substantial Assistance to provide the information to the Agency subject to a Without Prejudice Agreement.

(4) If the Covered Person fails to continue to cooperate or fails to provide the complete, accurate, and credible Substantial Assistance promised, the Agency shall reinstate the original Consequences. That decision is not subject to review.

(b) Voluntary Admission of an Anti-Doping Rule Violation in the absence of other evidence. If (1) the Covered Person voluntarily admits the commission of an Anti-Doping Rule Violation before receiving the EAD Notice or (in the case of a Rule 3212 violation) before having received notice of a Sample collection that could establish the Anti-Doping Rule Violation, and (2) that admission is the only reliable evidence of the violation at the time the admission is made, the otherwise applicable period of Ineligibility may be reduced by up to one-half.

(c) Application of multiple grounds for reduction of a sanction. If the Covered Person establishes entitlement to a reduction or suspension of the period of Ineligibility under 2 or more of Rules 3224, 3225, or 3226, the otherwise applicable period of Ineligibility shall be determined in accordance with Rules 3223, 3224, and 3225 before applying any reduction or suspension under Rule 3226. If the Covered Person establishes entitlement to a reduction or suspension of the period of Ineligibility under Rule 3226, up to three-quarters of the otherwise applicable period of Ineligibility may be reduced or suspended.

(d) Reductions for certain Anti-Doping Rule Violations based on early admission and acceptance of sanction.

(1) If the Agency notifies a Covered Person of a potential Anti-Doping Rule Violation that carries an asserted period of Ineligibility of 4 or more years (including any period of Ineligibility asserted under Rule 3227), if the Covered Person admits the violation and accepts the asserted period of Ineligibility no more than 7 days after receiving the Charge Letter, the period of Ineligibility to be served will be automatically reduced by 1 year (but no further reduction shall be allowed under any other Rule).

(2) If the Agency notifies a Covered Person of a potential Anti-Doping Rule Violation that carries an asserted period of Ineligibility of 2 years or more years, but less than 4 years (including any period of Ineligibility asserted under Rule 3227), if the Covered Person admits the violation and accepts the asserted period of Ineligibility no more than 7 days after receiving the Charge Letter, the period of Ineligibility to be served will be automatically reduced by 6 months (but no further reduction shall be allowed under any other Rule).

Rule 3227. Aggravating Circumstances

(a) In an individual case involving an Anti-Doping Rule Violation that is not a Rule 3214(b) violation (Trafficking or Attempted Trafficking) or a Rule 3216(d) violation (acts to discourage or retaliate against reporting), if the Agency establishes that Aggravating Circumstances are present, the period of Ineligibility otherwise applicable shall be increased by up to 2 years, depending on the seriousness of the Aggravating Circumstances, unless the Covered Person establishes that he or she did not knowingly commit the Anti-Doping Rule Violation. Where the period of Ineligibility is increased pursuant to this Rule, an additional fine of up to $10,000 or an additional 10% of the total purse (whichever is greater) may also be imposed.

(b) Actions and circumstances constituting Aggravating Circumstances include:

(1) Administration of a Banned Substance or Use of a Banned Method that is detrimental to the health and welfare of the horse or is designed to deceive the betting public;

(2) the presence in the Covered Horse's Sample of a combination of Banned Substance(s) and Controlled Medication Substance(s);

(3) prior violations under the Protocol; or

(4) the Covered Person engaged in deceptive or obstructive conduct to avoid the detection or adjudication of an Anti-Doping Rule Violation or a Controlled Medication Rule Violation, for which the Covered Person has not been separately sanctioned for Tampering.

(c) For the avoidance of doubt, the examples set out in Rule 3227(b) are not exhaustive and other similar circumstances or conduct may also be deemed to amount to Aggravating Circumstances that justify the imposition of a longer period of Ineligibility.

Rule 3228. Increased Sanctions for Repeat Offenders

(a) For purposes of this Rule 3228, the following prior Anti-Doping Rule Violations shall be disregarded: (1) violations that occurred more than 10 years prior to the violation now being sanctioned; and (2) violations for which the Covered Person was found to bear No Fault or Negligence.

(b) Subject to Rule 3228(a), and in addition to any other Consequences that apply under the Protocol (including Disqualification), the periods of Ineligibility and financial penalties specified below shall apply to any Covered Person who commits a second or subsequent Anti-Doping Rule Violation:

(c) Additional rules for certain multiple violations.

(1) Multiple violations for the same Banned Substance/Method incurred by a Covered Person in relation to the same Covered Horse prior to delivery of an EAD Notice may (at the Agency's discretion) be treated together as a single Anti-Doping Rule Violation, unless the facts demonstrate that there was more than one administration. Multiple violations for the same Banned Substance/Method incurred by a Covered Person in relation to different Covered Horses prior to delivery of an EAD Notice may (at the Agency's discretion) each be treated as a first Anti-Doping Rule Violation. Where multiple Banned Substances are detected in a single Post-Race Sample or Post-Work Sample, each Banned Substance may (at the Agency's discretion) be treated as a separate violation.

(2) If the Agency establishes that, prior to receiving an EAD Notice in respect of one Anti-Doping Rule Violation, the Covered Person committed an additional Anti-Doping Rule Violation that occurred 12 months or more before or after the violation asserted in that EAD Notice, the period of Ineligibility for the additional violation shall be calculated as if the additional violation were a stand-alone first violation, and that period of Ineligibility will run consecutively to (rather than concurrently with) the period of Ineligibility imposed for the first-notified violation. Where this Rule applies, the violations taken together will constitute a single violation for purposes of Rule 3228.

(3) If a Doping Control process results in the assertion of an Anti-Doping Rule Violation, and the Agency establishes that the Covered Person committed an independent violation of Rule 3216(a) (Tampering) in connection with that Doping Control process, the Rule 3216(a) (Tampering) violation shall be treated as a stand-alone violation and the period of Ineligibility for such violation shall be served consecutively to, rather than concurrently with, the period of Ineligibility imposed for the other Anti-Doping Rule Violation. Where this Rule 3228(c)(3) is applied, the violations taken together shall constitute a single violation for purposes of Rule 3228.

(4) If the Agency establishes that the Covered Person has committed a further violation of the Protocol during a period of Ineligibility, any new period of Ineligibility shall start to run the day after the original period of Ineligibility ends.

(d) Violations involving both a Banned Substance or Method and a Controlled Medication Substance or Method.

Where a Covered Person is found, based on a common set of facts, to have committed a (1) violation involving one or more Banned Substance(s) or Banned Method(s), and (2) a violation involving one or more Controlled Medication Substance(s) or Controlled Medication Method(s), they shall be treated as separate violations, but shall be adjudicated together in consolidated proceedings pursuant to the procedure that applies to Anti-Doping Rule Violations under the Arbitration Procedures.

Rule 3229. Status During Provisional Suspension or Ineligibility

(a) While serving a Provisional Suspension or period of Ineligibility for an Anti-Doping Rule Violation:

(1) a Covered Horse may not participate in any Timed and Reported Workout or Covered Horserace, but shall remain subject to Testing;

(2) a Covered Person may 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, except to the extent that the Covered Person is an Owner and the activity is necessary to ensure the safekeeping and wellbeing of the horse during the period of such Owner's Provisional Suspension or Ineligibility.

(b) The Covered Horse(s) of an Owner or Trainer who is subject to a Provisional Suspension or period of Ineligibility shall be subject to the following restrictions:

(1) The Covered Horse(s) of a Trainer who is subject to a Provisional Suspension or period of Ineligibility may not participate in any Timed and Reported Workout or Covered Horserace unless and until they have been transferred to another Covered Person. For the “transfer” to be valid, (i) the transfer must be registered with the Authority in accordance with its procedures, and (ii) the Covered Horses must also be physically relocated to facilities under the care or control of a Covered Person who is not affiliated with the suspended Trainer (and failure to comply may constitute an Anti-Doping Rule Violation under Rule 3216(c), i.e., Prohibited Association).

(2) The Covered Horse(s) of an Owner who is subject to a Provisional Suspension or period of Ineligibility may not participate in any Timed and Reported Workout or Covered Horserace unless and until they have been transferred in a bona fide transaction to a different Owner. If an Immediate Family Member has any ownership or property interest in the Covered Horse(s) following such transfer, the transfer shall not constitute a bona fide transaction to a different Owner.

Rule 3230. Consequences for Violation of the Prohibition on Participation During Ineligibility or Provisional Suspension Under Rule 3229

(a) Consequences for violation of the prohibition on participation during Ineligibility.

(1) If a Covered Person violates the prohibition against participation during Ineligibility described in Rule 3229, any results obtained from such participation shall be Disqualified and a new period of Ineligibility equal in length to the original period of Ineligibility shall be added to the end of the Covered Person's original period of Ineligibility.

(2) If a Covered Horse participates in any Timed and Reported Workout or Covered Horserace in violation of the prohibition against participation during Ineligibility described in Rule 3229, any results obtained from such participation shall be Disqualified and the Responsible Person for that Covered Horse shall receive the following period of Ineligibility:

(i) if the Responsible Person was subject to an original period of Ineligibility, a new period of Ineligibility equal in length to the original period of Ineligibility shall be added to the end of the original period of Ineligibility. If the original period of Ineligibility has already expired, the new period of Ineligibility shall start on the date that it is accepted or imposed; or

(ii) if the Responsible Person was not subject to an original period of Ineligibility, the period of Ineligibility for violating Rule 3229 shall be from a reprimand to 1 year, depending on the Covered Person's degree of Fault.

(b) Consequences for violation of the prohibition on participation during Provisional Suspension.

(1) A Covered Person who violates the prohibition against participation during a Provisional Suspension shall receive no credit for any period of Provisional Suspension served and the results of such participation shall be Disqualified.

(2) If a Covered Horse participates in any Timed and Reported Workout or Covered Horserace in violation of the prohibition against participation during a Provisional Suspension described in Rule 3229, the Responsible Person for that Covered Horse and the Covered Horse shall receive no credit for any period of Provisional Suspension served and the results of such participation shall be Disqualified.

(c) The consequence of Disqualification under this Rule 3230 shall be the same as set out in Rule 3221(c).

(d) The Arbitral Body (or the Agency, if the Covered Person admits the violation and accepts the consequences) shall determine whether there has been a violation of the prohibition against participation during Provisional Suspension or Ineligibility and apply the appropriate consequences pursuant to Rule 3261.

Rule 3231. Automatic Public Disclosure

A mandatory part of each sanction shall include automatic Public Disclosure in accordance with Rule 3620.

Rule 3232. Conditions Precedent to Reinstatement for Covered Persons

(a) To be reinstated after commission of an Anti-Doping Rule Violation, the Covered Person must have respected his or her period of Ineligibility (Rule 3229); and repaid or surrendered any purses and other compensation, prizes, trophies, points, and rankings forfeited pursuant to Rule 3221, and paid any fines and reimbursed any costs imposed or accepted to the Agency, unless an installment plan was established pursuant to Rule 3232(b), in which case the Covered Person must have made all payments due under that plan. If any installment(s) subsequently become(s) overdue under that plan ( i.e., after reinstatement), the Covered Person and the Covered Horses under his or her ownership or training may not participate in any Timed and Reported Workout or Covered Horserace until such overdue installment(s) is/are paid in full.

(b) Where fairness requires, the Agency or the Arbitral Body may establish an installment plan for repayment of amounts due to be paid or reimbursed under the Protocol. The payment schedule may extend beyond any period of Ineligibility imposed upon the Covered Person.

Rule 3233. Conditions Precedent to Reinstatement for Covered Horses

(a) A Covered Horse shall be reinstated once its period of Ineligibility ends, provided that (1) the Ineligibility has been respected in full throughout that period in accordance with Rule 3229, (2) the Covered Horse has been made available for Testing during that period in accordance with Rule 3132(d), and (3) the Covered Horse has completed any Vets' List Workout(s) required by the Racetrack Safety Program or the Agency (for the avoidance of doubt, such workouts may be scheduled prior to the expiry of the period of Ineligibility and will not constitute a violation of Rule 3229).

(b) Any reinstatement pursuant to this Rule 3233 is without prejudice to any rest or stand down period that may be imposed on the Covered Horse ( e.g., due to injuries), and any requirements for release from the Veterinarians' List, pursuant to the Racetrack Safety Program.

3240. Results Management

Rule 3241. General

Where there is evidence of a potential Anti-Doping Rule Violation(s), the Agency will conduct Results Management in accordance with this section 3240 and the Testing and Investigations Standards.

Rule 3242. Review of Adverse Analytical Findings

(a) Upon receipt of an Adverse Analytical Finding in relation to an A Sample, the Agency will conduct a review of the Laboratory certificate of analysis supporting the Adverse Analytical Finding and the relevant Sample collection documentation and Testing documents to determine whether the Adverse Analytical Finding was caused by any apparent departure from the Testing and Investigations Standards, the Laboratory Standards, or any provision of the Protocol. Subject to Rule 3242(b), the Agency may, but does not have to, communicate with the Responsible Person and Owner during such review.

(b) If the review under Rule 3242(a) reveals an apparent departure that caused the Adverse Analytical Finding, the entire test shall be considered negative, and the Agency shall promptly inform the Responsible Person and each Interested Party of that fact.

(c) If the initial review of an Adverse Analytical Finding under Rule 3242(a) does not reveal an apparent departure that caused the Adverse Analytical Finding, the Agency shall promptly send an EAD Notice to the Responsible Person and each Interested Party in accordance with Rule 3245.

Rule 3243. Review of Atypical Findings Relating to Banned Substances

(a) In certain circumstances, Laboratories may report the presence of certain Banned Substances as “Atypical Findings” in accordance with the Atypical Findings Policy set out at Appendix 1. Upon receipt of an A Sample Atypical Finding, the Agency will conduct a review to determine whether the Atypical Finding was caused by a departure from the Testing and Investigations Standards, the Laboratory Standards, or any provision of the Protocol. If that review does not reveal any departure that caused the Atypical Finding, the Agency will conduct an investigation (including directing any Further Analysis) or take any other steps required to decide whether the Atypical Finding should be brought forward as an Adverse Analytical Finding, in accordance with the Atypical Findings Policy.

(b) The Agency may, but does not have to, provide notice of an Atypical Finding to anyone until it has made that decision unless one of the following circumstances exists:

(1) if the Agency determines that the B Sample should be analyzed prior to the conclusion of its investigation, the Agency may conduct the B Sample analysis after notifying the Responsible Person and the Owner, with such notice to include a description of the Atypical Finding and the information described in Rule 3245; or

(2) if the Atypical Finding is likely connected to a serious pathology that requires urgent veterinary attention.

(c) If the Agency ultimately decides not to pursue the Atypical Finding as an Adverse Analytical Finding, the Agency may, but does not have to, communicate that fact to the Responsible Person and Owner unless he or she has previously received notice of the Analytical Finding pursuant to Rule 3243(b).

(d) If the Agency decides to move forward with the matter as an Adverse Analytical Finding, the Agency shall promptly send an EAD Notice to the Responsible Person and each Interested Party.

Rule 3244. Review of Other Evidence of a Potential Anti-Doping Rule Violation

The Agency shall conduct any follow-up investigation required into any potential Anti-Doping Rule Violation not covered by Rules 3242 or 3243. At such time as the Agency is satisfied that it has sufficient evidence to establish that an Anti-Doping Rule Violation occurred, it shall promptly send an EAD Notice to the relevant Covered Person and each Interested Party.

Rule 3245. EAD Notice

(a) Where it is determined that a Covered Person may have committed one or more Anti-Doping Rule Violations, the Agency will promptly notify the Covered Person and each Interested Party in writing of the following (the EAD Notice):

(1) the alleged Anti-Doping Rule Violation and the Consequences if it is agreed or determined to have been committed;

(2) the Adverse Analytical Finding (with a copy of the Laboratory certificate of analysis in a form designated by the Agency) or a brief summary of the facts relied on by the Agency to assert the alleged violation (including, where applicable, the name of the Covered Horse implicated in the alleged violation, whether the alleged violation was in connection with a particular Covered Horserace, and the date of Sample collection or of the other relevant facts said to give rise to the violation);

(3) if applicable, the right of the Responsible Person and the Owner to receive copies of the A Sample Laboratory Documentation Package after the B Sample analysis has been completed or after such analysis is waived;

(4) if applicable, the following details regarding the B Sample analysis:

(i) that the B Sample has been (or will be) analyzed because the Agency has authorized immediate analysis to preserve the scientific integrity of the Sample;

(ii) if the B Sample has not been analyzed, the Responsible Person's and Owner's right to promptly request the analysis of the B Sample within no more than 5 days or (failing such request) that the B sample analysis shall be deemed to be waived;

(iii) an explanation that, where the Responsible Person or Owner requests the B Sample analysis within the applicable deadline, or where the Agency decides to proceed with the B Sample analysis, the Agency will notify the Responsible Person and Owner of the date, time, and place where the B Sample will be analyzed and (where the analysis is requested by the Responsible Person or Owner) the amount that the Responsible Person or Owner must pay to have the B Sample tested and B Sample Laboratory Documentation Package prepared, and the date by which such payment must be received, failing which the B Sample analysis shall be deemed to have been waived; and

(5) the opportunity for the Covered Person to provide an explanation within a short deadline set by the Agency;

(6) the opportunity to provide Substantial Assistance, to admit the Anti-Doping Rule Violation, or to seek to resolve the matter without a hearing under Rule 3249;

(7) all relevant details relating to any Provisional Suspension (including, if applicable, the possibility to accept a voluntary Provisional Suspension) in accordance with Rule 3247; and

(8) if applicable, the ability for the automatic Disqualification of results to be applied immediately in accordance with Rule 3221(a)(2).

(b) Before sending an EAD Notice, for purposes of Rule 3228, the Agency shall seek to determine whether the Covered Person in question has committed any prior violations under the Protocol.

(c) Any defect in the EAD Notice (including a failure to identify the Covered Horseraces implicated in the alleged violation, if any) may be corrected by the Agency and shall not in any event invalidate the EAD Notice or affect the due application of the provisions of the Protocol (including the Disqualification provisions) in relation to that violation.

Rule 3246. B Sample Analysis

(a) Arrangements shall be made for analysis of the B Sample without undue delay, in accordance with the Protocol and the Laboratory Standards. Subject to Rule 3246(b), the Responsible Person or Owner must pay the costs of the B Sample analysis in advance, but, if the B Sample analysis does not confirm the A Sample analysis, they will be reimbursed that cost by the Agency. The Responsible Person and Owner or one representative each may attend the Laboratory to witness the opening and identification of the B Sample. They do not have any right to witness the analysis of the B Sample.

(b) The Responsible Person and Owner may (if they both agree) waive analysis of the B Sample (in which case they shall be deemed to accept the A Sample analytical results). If waived, the Agency may nonetheless elect to proceed with the B Sample analysis at its own expense.

(c) If the B Sample proves negative, the entire Test shall be considered negative, and the Responsible Person and Owner shall be so informed. In such circumstances, unless the Agency asserts an Anti-Doping Rule Violation under Rule 3213 (Use), the EAD Notice will be withdrawn, any Provisional Suspensions imposed shall be deemed automatically vacated with immediate effect (without the need for any order from the Arbitral Body), and no further disciplinary action will be taken against the Responsible Person, other Covered Person, or Covered Horse by the Agency in relation to the original Adverse Analytical Finding (provided, however, that the Agency may investigate why the B Sample did not match the A Sample). If the Agency asserts that a Rule 3213 (Use) violation has occurred, it shall send a Charge Letter to the Responsible Person and other Covered Person(s), with a copy to each Interested Party.

(d) If the presence of a Banned Substance or the Use of a Banned Method is confirmed by the B Sample analysis, or the B Sample analysis is waived, the Agency shall send a Charge Letter to the Responsible Person and any other relevant Covered Person(s), with a copy to each Interested Party, asserting that a Rule 3212 (presence) violation or a Rule 3213 (Use) violation (as applicable) has occurred.

Rule 3247. Provisional Suspensions

(a) Provisional Suspensions shall be imposed as follows:

(1) For each alleged violation of Rule 3212 (presence), 3213 (Use), or 3214(c) (Administration or Attempted Administration) that involves a Banned Substance that is not a Specified Substance, the Agency shall impose a Provisional Suspension, effective from the date specified by the Agency in the EAD Notice or in further correspondence up to and including the Charge Letter, on (i) the Covered Horse, (ii) the Responsible Person, and (iii) any other Covered Person charged with the violation.

(2) For each alleged violation of Rule 3215 (evading Sample collection; refusing or failing to submit to Sample collection; or refusing or failing to comply with all Sample collection procedure requirements), the Agency may impose a Provisional Suspension, effective from the date specified by the Agency in the EAD Notice or in further correspondence up to and including the Charge Letter, on (i) the Covered Horse, (ii) the Responsible Person, or (iii) any other Covered Person charged with the violation.

(3) For all other alleged Anti-Doping Rule Violations, the Agency may impose a Provisional Suspension, effective from the date specified by the Agency in the EAD Notice or in further correspondence up to and including the Charge Letter, on the Responsible Person, or any other Covered Person alleged to be implicated in the violation, but not on the Covered Horse.

(b) Where a Provisional Suspension is imposed pursuant to Rule 3247(a), the Responsible Person (on his or her own behalf and on behalf of the Covered Horse) and any other Covered Person made subject to the Provisional Suspension shall be given:

(1) an opportunity for a Provisional Hearing before imposition of the Provisional Suspension;

(2) an opportunity for a Provisional Hearing on a timely basis after imposition of the Provisional Suspension; or

(3) an opportunity for an expedited final adjudication in accordance with Rule 3262 on a timely basis after imposition of the Provisional Suspension.

(c) Provisional Hearings shall be conducted by the Arbitral Body and heard via telephone or video conference call within the time frame specified in accordance with the Arbitration Procedures. The sole issue to be determined by the Arbitral Body will be whether the Agency's decision to impose a Provisional Suspension shall be maintained. The Agency's decision to impose a Provisional Suspension shall be maintained unless the Responsible Person/Covered Person requesting the lifting of the Provisional Suspension establishes that:

(1) the allegation that an Anti-Doping Rule Violation has been committed has no reasonable prospect of being upheld, e.g., because of a material defect in the evidence on which the allegation is based;

(2) the Responsible Person/Covered Person charged bears No Fault or Negligence for the Anti-Doping Rule Violation that is alleged to have been committed, so that any period of Ineligibility that might otherwise be imposed for such offense would be completely eliminated by application of Rule 3224. (This ground does not apply in respect of any Provisional Suspension imposed on a Covered Horse);

(3) Rule 3225 applies and the Responsible Person/Covered Person bears No Significant Fault or Negligence and he or she will likely be given a period of Ineligibility that is not longer than the period for which he or she has already been provisionally suspended (this ground does not apply in respect of any Provisional Suspension imposed on a Covered Horse); or

(4) exceptional circumstances exist that make it clearly unfair, taking into account all of the circumstances of the case, to impose a Provisional Suspension prior to the final hearing on the merits. This ground is to be construed narrowly and applied only in truly exceptional circumstances. For example, the fact that the Provisional Suspension would prevent the Responsible Person, Covered Person, or Covered Horse from participating in a particular Timed and Reported Workout, Covered Horserace, or other activity shall not qualify as exceptional circumstances for these purposes.

(d) If the application is made before the Provisional Suspension comes into effect, the Provisional Suspension will not come into effect pending the decision on the application. If the application is made after the Provisional Suspension has come into effect, the Provisional Suspension will remain in place pending the decision on the application.

(e) If it considers it appropriate to do so on the specific facts of the case, the Agency may lift the Provisional Suspension.

(f) If the application to have a Provisional Suspension not imposed/lifted is not granted, a further application may not be made to lift the Provisional Suspension unless: (i) it is based on new and material evidence that the Responsible Person or other Covered Person was not aware of and could not reasonably have been aware of at the time he or she made the original application; or (ii) there has been some other significant and material change in circumstances since the original application was decided. If the Responsible Person or other Covered Person makes a further application that does not meet either of these requirements, costs may be awarded against him or her.

(g) Voluntary Provisional Suspension.

(1) In all cases where a Responsible Person/Covered Person has been notified of or charged with an Anti-Doping Rule Violation, but no Provisional Suspension has been imposed on him or her or on the Covered Horse, that person may (on his or her own behalf and, if the Responsible Person, on behalf of the Covered Horse) voluntarily accept a Provisional Suspension at any time by written notice to the Agency. A copy of the voluntary Provisional Suspension shall promptly be provided to each Interested Party.

(2) A Provisional Suspension that is voluntarily accepted will have effect (in the same manner as if the Provisional Suspension had been imposed under Rule 3247(a)) from the date that written notice of its acceptance is received by the Agency.

(h) No admission will be inferred, or other adverse inference drawn, from the decision of a Covered Person: (1) not to make an application to lift a Provisional Suspension; or (2) to accept a voluntary Provisional Suspension.

(i) If a Provisional Suspension is imposed or voluntarily accepted, and that Provisional Suspension is respected, then the Responsible Person/Covered Person and Covered Horse in question shall receive a credit for such period of Provisional Suspension against any period of Ineligibility that may ultimately be imposed. If the Responsible Person/Covered Person or Covered Horse does not respect a Provisional Suspension, the Responsible Person/Covered Person or Covered Horse shall receive no credit for any period of Provisional Suspension served. If a period of Ineligibility is served pursuant to a decision that is subsequently subject to review, the Responsible Person/Covered Person or Covered Horse shall receive a credit for such period of Ineligibility served against any period of Ineligibility that may ultimately be imposed on review.

(j) Notwithstanding any other provision in this Rule 3247 or elsewhere in the Protocol, any Provisional Suspension imposed on a Covered Horse will be automatically lifted (without the need for any hearing) if it has been in place for a period equal to the period of Ineligibility specified in the Protocol or Prohibited List.

Rule 3248. Charge Letter

If, after receipt of the Covered Person's explanation, or expiry of the deadline to provide such explanation, the Agency remains satisfied that the Covered Person has committed an Anti-Doping Rule Violation(s), the Agency shall promptly charge the Covered Person with the asserted Anti-Doping Rule Violation(s). In this letter of charge (Charge Letter), which will be copied to each Interested Party, the Agency shall:

(a) set out the Anti-Doping Rule Violation(s) that the Covered Person is charged with having committed;

(b) provide a summary of the relevant facts upon which the charge is based, enclosing a copy of the A Sample Laboratory Documentation Package and (if applicable and if requested) the B Sample Laboratory Documentation Package;

(c) specify the Consequences that will apply if the charge is upheld;

(d) grant a deadline of not more than 7 days from receipt of the Charge Letter (unless otherwise agreed by the Agency) for the Covered Person to either:

(1) admit the Anti-Doping Rule Violation(s) charged and:

(i) accept the Consequences proposed by the Agency, in which case the Agency will issue a decision under Rule 3249(b);

(ii) seek to agree to mitigated Consequences with the Agency pursuant to Rule 3249, failing which the Consequences may still be disputed at a hearing; or

(iii) dispute or seek to mitigate the proposed Consequences at a hearing in accordance with Rule 3261 and the Arbitration Procedures; or

(2) deny the Anti-Doping Rule Violation charged and dispute the proposed Consequences at a hearing in accordance with Rule 3261 and Arbitration Procedures;

(e) indicate that, if the Covered Person does not challenge the Agency's assertion of an Anti-Doping Rule Violation or the proposed Consequences within the prescribed deadline, the Covered Person shall be deemed to have waived his or her right to a hearing, admitted the Anti-Doping Rule Violation(s) charged, and accepted the Consequences specified by the Agency in the Charge Letter (without any mitigation of those Consequences);

(f) give the opportunity to provide Substantial Assistance in accordance with Rule 3226(a); and

(g) provide all relevant details relating to any Provisional Suspensions (including, if applicable, the possibility to accept a voluntary Provisional Suspension) in accordance with Rule 3247.

Rule 3249. Case Resolution Without a Hearing

(a) At any time prior to a final decision under the Arbitration Procedures: (1) the Agency may withdraw a Charge Letter for good cause, in which case any Provisional Suspension will be automatically lifted and (absent the emergence of new information) no further steps will be taken in relation to the violations alleged in the Charge Letter; or (2) the Covered Person may agree to admit the Anti-Doping Rule Violation(s) charged (or any other violation of the Protocol) and accede to specified Consequences consistent with the Protocol. In any such case, an adjudication under the Arbitration Procedures will not be required.

(b) In the event that the Covered Person admits the Anti-Doping Rule Violation(s) charged and accedes to Consequences specified by the Agency (or is deemed to have done so in accordance with Rule 3248(a)(5)), the Agency will (1) promptly issue a final decision confirming the commission of the Anti-Doping Rule Violation(s) and setting out the factual basis for the decision and all of the Consequences to be imposed (including a brief summary of the reasons for any period of Ineligibility imposed, unless doing so could compromise an ongoing investigation or proceeding), and (2) send notice of the decision to each Interested Party. The Agency will also Publicly Disclose the decision (or a summary thereof, at the discretion of the Agency) in accordance with Rule 3620.

(c) In the event that the Agency withdraws the Charge Letter, it will (1) promptly issue a summary decision confirming the withdrawal of the Charge Letter, (2) send notice of the decision to the Covered Person concerned, with a copy to each Interested Party, and (3) Publicly Disclose the decision (or a summary thereof, at the discretion of the Agency) in accordance with Rule 3620.

Rule 3250. Notification Requirements

(a) Notification of Anti-Doping Rule Violations will take place as set out in Rule 3245 and Rule 3248. If at any point after an EAD Notice has been provided the Agency decides not to move forward with the charge, it will notify the Covered Person(s) concerned and each Interested Party of that decision.

(b) Notification to a Covered Person by the Agency, for all purposes of the Protocol, may be accomplished either through actual or constructive notice. Actual notice may be accomplished by any means. Constructive notice shall be deemed to have been given when the information in question is delivered by third-party courier or U.S. postal mail to the Covered Person's most recent mailing address on file with the Authority or by email or text message to the Covered Person's most recent email address or mobile telephone number on file with the Authority.

3260. Hearings and Review of Final Decisions

Rule 3261. Hearing Before the Arbitral Body

Where a Covered Person is alleged to have committed an Anti-Doping Rule Violation or to have violated Rule 3229, the Covered Person shall be entitled to a hearing before the Arbitral Body in accordance with the Arbitration Procedures. A copy of the final decision of the Arbitral Body shall be sent to the Covered Person(s) concerned, with a copy to the Agency and each Interested Party. The decision (or a summary thereof, at the discretion of the Agency) shall be Publicly Disclosed as provided in Rule 3620. If an individual case involves allegations that both an Anti-Doping Rule Violation and a Controlled Medication Rule Violation have been committed, the matter shall be referred to and adjudicated by the Arbitral Body in accordance with the Arbitration Procedures.

The Arbitral Body may also adjudicate any other matter referred to it under the Protocol, and any other matter that might arise from time to time under the Protocol that the Agency considers should be determined by the Arbitral Body.

Rule 3262. Expedited Hearing

In Anti-Doping Rule Violation cases where the Covered Horse or Covered Person in question is not Provisionally Suspended and is likely to participate in a Covered Horserace within 45 days, the Agency may (if it sees fit) address the case on an expedited basis and shorten any deadlines in the Protocol or Arbitration Procedures proportionately to ensure resolution of the matter prior to the Covered Horserace.

Rule 3263. Finality

Subject to Rule 3264, decisions rendered by the Arbitral Body under the Protocol shall be final and binding.

Rule 3264. Review of Final Decisions

Any final decision by the Agency or the Arbitral Body is subject to review in accordance with section 3058 of the Act. Any final decision under review shall remain in effect pending resolution of the review unless ordered otherwise.

3310. Controlled Medication Rule Violations

Rule 3311. Definition of Controlled Medication Rule Violation and Responsibility for Violations

(a) Controlled medication cases will be initiated based on the assertion that one or more of Rules 3312 through 3315 has been violated (each, a Controlled Medication Rule Violation).

(b) The Controlled Medication Rule Violations described below may only be committed by Covered Persons, but the Consequences for Controlled Medication Rule Violations may apply to both the Covered Person(s) who commit(s) the violation and any Covered Horse(s) implicated by the violation.

(c) All Covered Persons are responsible for knowing what constitutes a Controlled Medication Rule Violation and what Controlled Medication Substances and what Controlled Medication Methods are included on the Prohibited List and Technical Document-Prohibited Substances.

Rule 3312. Presence of a Controlled Medication Substance

(a) It is the personal and non-delegable duty of the Responsible Person to ensure that no Controlled Medication Substance is present in the Post-Race Sample of his or her Covered Horse(s), and that no Controlled Medication Substance specifically identified on the Prohibited List as prohibited during Timed and Reported Workouts is present in the Post-Work Sample of his or her Covered Horse(s). The Responsible Person is therefore strictly liable for any Controlled Medication Substance or its Metabolites or Markers found to be present in a Post-Race Sample collected from his or her Covered Horse(s), and for any specifically prohibited Controlled Medication Substance or its Metabolites or Markers found to be present in a Post-Work Sample collected from his or her Covered Horse(s). Accordingly, it is not necessary to demonstrate intent, Fault, negligence, or knowing Use on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3312 Controlled Medication Rule Violation.

(b) Sufficient proof of a Rule 3312 Controlled Medication Rule Violation is established by any of the following:

(1) the presence of a Controlled Medication Substance or its Metabolites or Markers in the Covered Horse's A Sample where the Responsible Person waives analysis of the B Sample and the B Sample is not analyzed;

(2) the Covered Horse's B Sample is analyzed and the analysis of the B Sample confirms the presence of the Controlled Medication Substance or its Metabolites or Markers found in the A Sample; or

(3) where, in exceptional circumstances, the Laboratory (on instruction from the Agency) further splits the A or B Sample into two parts in accordance with the Laboratory Standards, the analysis of the second part of the resulting split Sample confirms the presence of the same Controlled Medication Substance or its Metabolites or Markers as were found in the first part of the split Sample, or the Responsible Person waives analysis of the second part of the split Sample.

(c) The general rule is that the presence of any amount of a Controlled Medication Substance or its Metabolites or Markers in a Post-Race Sample or Post-Work Sample collected from a Covered Horse constitutes a Controlled Medication Rule Violation by the Responsible Person of that Covered Horse.

(d) As an exception to the general rule of Rule 3312(c), the Prohibited List, Standards, or Technical Documents may establish special criteria for the reporting or the evaluation of certain Controlled Medication Substances, including a Minimum Reporting Level, Screening Limit, Threshold, or Decision Limit.

(e) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and corticosteroids, which are Controlled Medication Substances prohibited during Timed and Reported Workouts and during the Race Period, are subject to Screening Limits.

(1) If one NSAID or one corticosteroid is detected in the Post-Race Sample or Post-Work Sample of a Covered Horse above the applicable Screening Limit, it constitutes a presence violation under Rule 3312.

(2) If more than one NSAID or more than one corticosteroid is detected in the Post-Race Sample or Post-Work Sample of a Covered Horse, each NSAID and each corticosteroid above the applicable Screening Limit constitutes a separate presence violation of Rule 3312.

(3) If more than one NSAID or more than one corticosteroid is detected in the Post-Race Sample or Post-Work Sample of a Covered Horse, but each are below the applicable Screening Limits (and so individually would not constitute a presence violation), they will together constitute a single presence violation under Rule 3312 (Stacking Violation).

Rule 3313. Use or Attempted Use of a Controlled Medication Substance or a Controlled Medication Method During the Race Period

(a) Subject to Rule 3313(c), the Use or Attempted Use of a Controlled Medication Substance or Controlled Medication Method in relation to a Covered Horse during the Race Period constitutes a Controlled Medication Rule Violation. The success or failure of that Use or Attempted Use is not material. For a Rule 3313 violation to be committed, it is sufficient that the Controlled Medication Substance or Controlled Medication Method was Used or Attempted to be Used on a Covered Horse during the Race Period.

(b) It is the personal and non-delegable duty of the Responsible Person to ensure that no Controlled Medication Substance or Controlled Medication Method is Used in relation to his or her Covered Horse during the Race Period. The Responsible Person is therefore strictly liable for any Use of a Controlled Medication Substance or Controlled Medication Method in relation to his or her Covered Horse(s). Accordingly, it is not necessary to demonstrate intent, Fault, negligence, or knowing Use on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3313 Controlled Medication Rule Violation of Use. However, in accordance with the definition of Attempt, it is necessary to show intent on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3313 Controlled Medication Rule Violation of Attempted Use.

(c) Use of a Controlled Medication Substance or a Controlled Medication Method outside the Race Period is not a Rule 3313 violation. However, if a Controlled Medication Substance or any of its Metabolites or Markers is still present in a Post-Race Sample or Post-Work Sample, that constitutes a Rule 3312 (presence) violation.

Rule 3314. Use of a Controlled Medication Substance or a Controlled Medication Method in a Manner Contrary to Horse Welfare

(a) Any Use of a Controlled Medication Substance or a Controlled Medication Method in relation to a Covered Horse must (1) be justified by the Covered Horse's health condition(s), (2) have been recommended by a Veterinarian in the context of a valid veterinarian-patient-client relationship or (if a prescription is not required) following sufficient due diligence regarding the substance or method, (3) go no further than the minimum necessary to address the health concerns, and (4) be in the best interests of the Covered Horse's health and welfare.

(b) It is the personal and non-delegable duty of the Responsible Person to ensure that no Controlled Medication Substance or Controlled Medication Method is Used on his or her Covered Horse in breach of the requirements set out in Rule 3314(a). The Responsible Person is therefore strictly liable for a violation of this Rule 3314. Accordingly, it is not necessary to demonstrate intent, Fault, negligence, or knowing Use on the part of the Responsible Person in order to establish that the Responsible Person has committed a Rule 3314 Controlled Medication Rule Violation.

Rule 3315. Other Controlled Medication Rule Violations Involving Controlled Medication Substances or Controlled Medication Methods

The following acts and omissions constitute Controlled Medication Rule Violations by the Covered Person(s) in question:

(a) The Administration or Attempted Administration of a Controlled Medication Substance or Controlled Medication Method by a Covered Person to a Covered Horse during the Race Period.

(b) The Possession of a Controlled Medication Substance or Controlled Medication Method by any Covered Person that is not in compliance with applicable State or Federal law.

(c) A Covered Person assisting, encouraging, aiding, abetting, conspiring, covering up, or engaging in any other type of intentional complicity or Attempted complicity involving (1) a Controlled Medication Rule Violation or Attempted Controlled Medication Rule Violation, or (2) a violation of Rule 3329 by another Covered Person.

Rule 3316. Tampering or Attempted Tampering With Medication Control

If the Agency establishes that a Covered Person committed a violation of Tampering or Attempted Tampering in connection with a Medication Control process, that will constitute an Anti-Doping Rule Violation under Rule 3216(a), and the matter will be dealt with in accordance with the procedures and Consequences applicable to Anti-Doping Rule Violations.

3320. Sanctions

Rule 3321. Disqualification of the Covered Horse's Results

(a) Automatic Disqualification of results.

(1) A Controlled Medication Rule Violation that arises from a Post-Race Sample, or that occurs during the Race Period, automatically leads to Disqualification of the results of the Covered Horse obtained on the Race Day(s) that fall(s) within the Race Period, even if any other sanction for the violation is eliminated or reduced under Rules 3324, 3325, or 3326.

(2) In circumstances where an ECM Notice has been sent as required under Rule 3345, and the B Sample analysis confirms the A Sample analysis, or the right to request the analysis of the B Sample is waived, the Agency, the Responsible Person, and the Owner of the Covered Horse in question may agree to apply Rule 3321 immediately, i.e., prior to adjudication of any other issue, or (in the absence of such agreement) any one of them may request that the Internal Adjudication Panel apply Rule 3321 immediately.

(b) No Disqualification of subsequent results.

Subsequent results obtained by the Covered Horse from the date a Controlled Medication Rule Violation first occurred through the commencement of any Provisional Suspension or Ineligibility period for the Covered Horse shall not be Disqualified.

(c) Consequence of Disqualification of results.

(1) If a Covered Horse has results Disqualified under the Protocol, all purses and other compensation, prizes, trophies, points, and rankings are forfeited and must be repaid or surrendered (as applicable) to the Race Organizer, and the results of the other Covered Horses in the race(s) in question must be adjusted accordingly and the purses, prizes, and trophies redistributed. Purses, prizes, trophies, and other compensation shall (where possible) be withheld for the Covered Horse in issue pending resolution of the relevant charge.

(2) The Covered Horses that participated in a Covered Horserace involving an alleged Controlled Medication Rule Violation are often entered in other Covered Horseraces prior to the final adjudication of the violation. The ultimate Disqualification of a Covered Horse in connection with final adjudication of a violation shall only impact that horse's conditions for eligibility. By way of example, a maiden that is Disqualified after finishing first in a maiden race shall remain a maiden until it has won another race, but the runner-up in the disputed Covered Horserace shall not be considered the winner for purposes of its future condition eligibility. The adjustment to the Disqualified horse's condition eligibility shall only occur once the violation has been finally adjudicated.

Rule 3322. Ineligibility for Covered Horses

(a) There shall be no period of Ineligibility for Covered Horses implicated in violations involving only Controlled Medication Substances.

(b) There may be a period of Ineligibility for Covered Horses implicated in violations involving Controlled Medication Methods. Where the Prohibited List specifies a period of Ineligibility, it shall be applied only prospectively ( i.e., going forward from the date that it is imposed), with no Disqualification of any results obtained by the Covered Horse before the date that the period of Ineligibility starts to run, other than as provided under Rule 3321(a)(1).

Rule 3323. Ineligibility and Financial Penalties for Covered Persons

(a) General.

(1) The periods of Ineligibility and financial penalties set out in this Rule 3323 apply to any Controlled Medication Rule Violation committed by a Covered Person. However:

(i) When determining if a Covered Person has committed multiple violations, the following prior Controlled Medication Rule Violations shall be disregarded: (A) violations that occurred more than 2 years prior to the violation now being sanctioned; and (B) violations for which the Covered Person was found to bear No Fault or Negligence.

(ii) A Controlled Medication Rule Violation will be considered a second or subsequent violation only if the Covered Person committed an offense in the same category/class in the previous 2 years. Violations in different categories will be taken into account when assigning penalty points under Rule 3328.

(iii) Unless specified otherwise, the periods of Ineligibility set out in this Rule 3323 are subject to potential elimination, reduction, or suspension pursuant to Rules 3324-3326, or increase pursuant to Rule 3327.

(2) In accordance with Rule 3347(j), any period of Provisional Suspension served by the Covered Person shall be credited against the period of Ineligibility ultimately imposed on that Covered Person for the violation in question.

(3) If a presence violation involves a Controlled Medication Substance that has not been assigned a Class A-C, the Agency shall determine the class of the substance. Any supplements or feed additives used in contravention of Rule 4211(a) of the Prohibited List that have not been assigned a class shall be designated as Class C substances, unless the Agency decides otherwise.

(4) If two or more Controlled Medication Rule Violations in the same category/class are adjudicated separately, the first violation adjudicated shall constitute the “first violation” for sanctioning purposes, the second violation adjudicated shall constitute the “second violation,” and so on, regardless of the chronological order in which those violations occurred.

(b) Consequences.

Subject to Rule 3323(a), and in addition to any other Consequences that apply under the Protocol, the periods of Ineligibility, fines, and Disqualification of results specified below shall apply to any Covered Person who commits multiple Controlled Medication Rule Violations. The Covered Person may also be required to pay some or all of the adjudication costs and the Agency's legal costs.

(c) Commencement of the period of Ineligibility for a Covered Person.

(1) Except as otherwise provided in this Rule 3323, the period of Ineligibility imposed on any Covered Person shall start on the date the period of Ineligibility is accepted or otherwise imposed in accordance with the Protocol.

(2) Where a Covered Person is already serving a period of Ineligibility for another violation of the Protocol, any new period of Ineligibility shall start to run the day after the original period of Ineligibility ends.

(3) Where there have been substantial delays in the adjudication process or other aspects of Medication Control that go well beyond the standard timeframes for Laboratory analyses and Results Management, and the Covered Person can establish that such delays are not attributable to him or her, the start date of the period of Ineligibility may be deemed back-dated to reflect such delays, but in no event may it be deemed back-dated to a date before the Controlled Medication Rule Violation last occurred.

(d) Additional rules for certain multiple violations.

(1) Multiple violations for the same Controlled Medication Substance/Method incurred by a Covered Person in relation to the same Covered Horse prior to delivery of an ECM Notice may (at the Agency's discretion) be treated together as a single Controlled Medication Rule Violation, unless the facts demonstrate that there was more than one administration. Multiple violations for the same Controlled Medication Substance/Method incurred by a Covered Person in relation to different Covered Horses prior to delivery of an ECM Notice may each be treated as a first Controlled Medication Rule Violation within the relevant category/class. Where multiple Controlled Medication Substances are detected in a single Post-Race Sample or Post-Work Sample, each Controlled Medication Substance may be treated as a separate violation and assigned separate penalty points.

(2) If the Agency establishes that prior to receiving an ECM Notice in respect of one Controlled Medication Rule Violation the Covered Person committed an additional Controlled Medication Rule Violation that occurred 12 months or more before or after the violation asserted in that ECM Notice, the period of Ineligibility for the additional violation shall be calculated as if the additional violation were a stand-alone first violation, and that period of Ineligibility will run consecutively to (rather than concurrently with) the period of Ineligibility imposed for the first-notified violation. Where this Rule applies, the violations taken together will constitute a single violation for purposes of Rule 3323(b).

(3) If the Agency establishes that the Covered Person has committed a further violation of the Protocol during a period of Ineligibility, any new period of Ineligibility shall start to run the day after the original period of Ineligibility ends.

(e) Violations involving both a Banned Substance or Method and a Controlled Medication Substance or Method.

Where a Covered Person is found, based on a common set of facts, to have committed a (1) violation involving one or more Banned Substance(s) or Banned Method(s), and (2) a violation involving one or more Controlled Medication Substance(s) or Controlled Medication Method(s), they shall be treated as separate violations, but shall be adjudicated together in consolidated proceedings pursuant to the procedure that applies to Anti-Doping Rule Violations under the Arbitration Procedures.

Rule 3324. Elimination of the Period of Ineligibility Where There Is No Fault or Negligence

(a) If a Covered Person establishes in an individual case that he or she bears No Fault or Negligence for the Controlled Medication Rule Violation(s) charged, the otherwise applicable period of Ineligibility and other Consequences for such Covered Person shall be eliminated (except for those set out in Rule 3321 and Rule 3620). When the violation is of Rule 3312 (presence of a Controlled Medication Substance), the Covered Person must also establish how the Controlled Medication Substance entered the Covered Horse's system as a pre-condition to application of this Rule 3324. In the event the period of Ineligibility otherwise applicable is eliminated pursuant to this Rule 3324, the Controlled Medication Rule Violation shall not be considered a prior violation for the purpose of Rule 3323(b).

(b) Rule 3324 only applies in exceptional circumstances. In particular, it will not apply where the Controlled Medication Substance found to be present in a Sample: (1) came from a mislabeled or contaminated supplement; or (2) was administered to the Covered Horse by veterinary or other support personnel without the knowledge of the Responsible Person.

(c) A finding that the Covered Person bears No Fault or Negligence for a Controlled Medication Rule Violation shall not affect the Consequences of that violation that apply to the Covered Horse ( i.e., Ineligibility in accordance with Rule 3322(b) and Disqualification of results in accordance with Rule 3321).

Rule 3325. Reduction of the Period of Ineligibility Where There Is No Significant Fault or Negligence (Limited to Class A/B or Equivalent)

This Rule applies only to Controlled Medication Rule Violations involving Class A or Class B substances or a category of violation with sanctions equivalent to Class A or Class B substances. Reductions under this Rule 3325 are mutually exclusive and not cumulative, i.e., no more than one of them may be applied in a particular case.

(a) General rule.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Controlled Medication Rule Violation in question, then (unless Rule 3325(b) or 3325(c) applies) the period of Ineligibility may be reduced, depending on the Covered Person's degree of Fault, but the reduced period of Ineligibility may not be less than one-half of the otherwise applicable period of Ineligibility.

(b) Specified Substances.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Controlled Medication Rule Violation in question, and the violation involves only a Specified Substance, the period of Ineligibility shall be, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, the otherwise applicable period of Ineligibility, depending on the Covered Person's degree of Fault.

(c) Contaminated Products or other contamination.

Where the Covered Person establishes that he or she bears No Significant Fault or Negligence for the Controlled Medication Rule Violation in question and that the Controlled Medication Substance in question came from a Contaminated Product or from another form of contamination, the period of Ineligibility shall be, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, the otherwise applicable period of Ineligibility, depending on the Covered Person's degree of Fault.

Rule 3326. Elimination, Reduction, or Suspension of Period of Ineligibility or Other Consequences for Reasons Unrelated to Degree of Fault

(a) Substantial Assistance. The Agency may suspend all or part of the Consequences imposed on a Covered Person in an individual Controlled Medication Rule Violation case—other than Disqualification of results pursuant to Rule 3321—based on the following:

(1) The Covered Person provides Substantial Assistance to the Agency, the Authority, or a State Racing Commission, a criminal authority, or a professional disciplinary body that results in:

(i) the Agency discovering or bringing forward an Anti-Doping Rule Violation or a Controlled Medication Rule Violation by another Covered Person; or

(ii) a criminal or disciplinary body discovering or bringing forward a sport-related criminal offense or the breach of professional or sports rules by another Person, including offenses arising out of a sport integrity violation or sport safety violation, or the violation of any rule or requirement in the Act, and the information provided by the Covered Person providing Substantial Assistance is also made available to the Agency.

(2) The extent to which the otherwise applicable period of Ineligibility may be suspended shall be based on the seriousness of the Controlled Medication Rule Violation committed by the Covered Person and the degree to which the Substantial Assistance provided by the Covered Person assists the effort to promote doping-free racing, compliance with the Protocol, or the integrity of racing. In any event, no more than three-quarters of the otherwise applicable period of Ineligibility may be suspended. For purposes of this Rule 3326, the otherwise applicable period of Ineligibility shall not include any period of Ineligibility that could be added under Rule 3323(d)(2).

(3) If so requested, the Agency shall allow the Covered Person who seeks to provide Substantial Assistance to provide the information to the Agency subject to a Without Prejudice Agreement.

(4) If the Covered Person fails to continue to cooperate or fails to provide the complete, accurate, and credible Substantial Assistance promised, the Agency shall reinstate the original Consequences. That decision is not subject to review.

(b) Voluntary Admission of a Controlled Medication Rule Violation in the absence of other evidence. If (1) the Covered Person voluntarily admits the commission of a Controlled Medication Rule Violation before receiving the ECM Notice or (in the case of a Rule 3312 violation) before having received notice of a Sample collection that could establish the Controlled Medication Rule Violation, and (2) that admission is the only reliable evidence of the violation at the time the admission is made, the otherwise applicable period of Ineligibility may be reduced by up to one-half.

(c) Application of multiple grounds for reduction of a sanction. If the Covered Person establishes entitlement to a reduction or suspension of the period of Ineligibility under 2 or more of Rules 3324, 3325, or 3326, the otherwise applicable period of Ineligibility shall be determined in accordance with Rules 3323, 3324, and 3325 before applying any reduction or suspension under Rule 3326. If the Covered Person establishes entitlement to a reduction or suspension of the period of Ineligibility under Rule 3326, up to three-quarters of the otherwise applicable period of Ineligibility may be reduced or suspended.

(d) Reductions for certain Controlled Medication Rule Violations based on early admission and acceptance of sanction. If the Covered Person admits the violation and accepts the asserted period of Ineligibility no more than 7 days after receiving the Charge Letter, the period of Ineligibility to be served will be automatically reduced by one-half (but no further reduction shall be allowed under any other Rule).

Rule 3327. Aggravating Circumstances

(a) If the Agency establishes in an individual Controlled Medication Rule Violation case that Aggravating Circumstances are present, the period of Ineligibility otherwise applicable shall be increased by up to 6 months depending on the seriousness of the Aggravating Circumstances, unless the Covered Person establishes that he or she did not knowingly commit the Controlled Medication Rule Violation. Where the period of Ineligibility is increased pursuant to this Rule, an additional fine of up to $5,000 or an additional 5% of the total purse (whichever is greater) may also be imposed.

(b) Actions and circumstances constituting Aggravating Circumstances include:

(1) Administration of a Controlled Medication Substance or Use of a Controlled Medication Method that is detrimental to the health and welfare of the horse or is designed to deceive the betting public;

(2) prior violations under the Protocol; or

(3) the Covered Person engaged in deceptive or obstructive conduct to avoid the detection or adjudication of a Controlled Medication Rule Violation, for which the Covered Person has not been separately sanctioned for Tampering.

(c) For the avoidance of doubt, the examples set out in Rule 3327(b) are not exhaustive and other similar circumstances or conduct may also be deemed to amount to Aggravating Circumstances that justify the imposition of a longer period of Ineligibility.

Rule 3328. Penalty Points System for Multiple Controlled Medication Rule Violations

(a) The penalty points system established in this Rule 3328 does not replace or lessen in any way the Consequences that apply to the underlying Controlled Medication Rule Violation. 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.

(b) Covered Persons shall be assigned penalty points as set out in the table below for each Controlled Medication Rule Violation that they commit. The imposition of the specified penalty points is automatic, without any consideration of mitigating or aggravating circumstances, except that:

(1) no points shall be assigned for any violations (i) where the Covered Person was found to bear No Fault or Negligence, or (ii) resulting from environmental contamination;

(2) fewer or no points may be assigned where the Covered Person provides Substantial Assistance in accordance with Rule 3326; and

(3) the penalty points for a complicity or Attempted complicity violation may be adjusted if there are mitigating or aggravating circumstances.

(c) In addition to the Consequences applicable to the underlying Controlled Medication Rule Violation, the following Consequences shall be imposed based on the cumulative points contained in the Covered Person's official record:

(d) 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.

(e) The additional period of Ineligibility imposed based on penalty points shall run consecutive to any period of Ineligibility imposed for the underlying Controlled Medication Rule Violation.

(f) A Covered Person's official record of cumulative penalty points shall be maintained by the Agency.

Rule 3329. Status During Provisional Suspension or Ineligibility

(a) While serving a Provisional Suspension or period of Ineligibility for a Controlled Medication Rule Violation:

(1) a Covered Horse may not participate in any Timed and Reported Workout or Covered Horserace, but shall remain subject to Testing;

(2) a Covered Person may 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, except to the extent that the Covered Person is an Owner and the activity is necessary to ensure the safekeeping and wellbeing of the horse during the period of such Owner's Provisional Suspension or Ineligibility.

(b) The Covered Horse(s) of an Owner or Trainer who is subject to a Provisional Suspension or period of Ineligibility shall be subject to the following restrictions:

(1) The Covered Horse(s) of a Trainer who is subject to a Provisional Suspension or period of Ineligibility may not participate in any Timed and Reported Workout or Covered Horserace unless and until they have been transferred to another Covered Person, except that such Covered Horses 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 or accepted (whichever is earlier). For the “transfer” to be valid, (i) the transfer must be registered with the Authority in accordance with its procedures, and (ii) if the Trainer is subject to a period of Ineligibility of more than 30 days, the Covered Horses must also be physically relocated to facilities under the care or control of a Covered Person who is not affiliated with the suspended Trainer (and failure to comply may constitute an Anti-Doping Rule Violation under Rule 3216(c), i.e., Prohibited Association).

(2) The Covered Horse(s) of an Owner who is subject to a Provisional Suspension or period of Ineligibility may not participate in any Timed and Reported Workout or Covered Horserace unless and until they have been transferred in a bona fide transaction to a different Owner. If an Immediate Family Member has any ownership or property interest in the Covered Horse(s) following such transfer, the transfer shall not constitute a bona fide transaction to a different Owner.

Rule 3330. Consequences for Violation of the Prohibition on Participation During Ineligibility or Provisional Suspension Under Rule 3329

(a) Consequences for violation of the prohibition on participation during Ineligibility.

(1) If a Covered Person violates the prohibition against participation during Ineligibility described in Rule 3329, any results obtained from such participation shall be Disqualified and a new period of Ineligibility equal in length to the original period of Ineligibility shall be added to the end of the Covered Person's original period of Ineligibility.

(2) If a Covered Horse participates in any Timed and Reported Workout or Covered Horserace in violation of the prohibition against participation during Ineligibility described in Rule 3329, any results obtained from such participation shall be Disqualified, and the Responsible Person for that Covered Horse shall receive the following period of Ineligibility:

(i) if the Responsible Person was subject to an original period of Ineligibility, a new period of Ineligibility equal in length to the original period of Ineligibility shall be added to the end of the original period of Ineligibility. If the original period of Ineligibility has already expired, the new period of Ineligibility shall start on the date that it is accepted or imposed; or

(ii) if the Responsible Person was not subject to an original period of Ineligibility, the period of Ineligibility for violating Rule 3329 shall be from a reprimand to 1 year, depending on the Covered Person's degree of Fault.

(b) Consequences for violation of the prohibition on participation during Provisional Suspension.

(1) A Covered Person who violates the prohibition against participation during a Provisional Suspension shall receive no credit for any period of Provisional Suspension served and the results of such participation shall be Disqualified.

(2) If a Covered Horse participates in any Timed and Reported Workout or Covered Horserace in violation of the prohibition against participation during a Provisional Suspension described in Rule 3329, the Responsible Person for that Covered Horse and the Covered Horse shall receive no credit for any period of Provisional Suspension served and the results of such participation shall be Disqualified.

(c) The consequence of Disqualification under this Rule 3330 shall be the same as set out in Rule 3321(c).

(d) The Internal Adjudication Panel (or the Agency, if the Covered Person admits the violation and accepts the consequences) shall determine whether there has been a violation of the prohibition against participation during Provisional Suspension or Ineligibility and apply the appropriate consequences pursuant to Rule 3361.

Rule 3331. Automatic Public Disclosure

A mandatory part of each sanction shall include automatic Public Disclosure in accordance with Rule 3620.

Rule 3332. Conditions Precedent to Reinstatement for Covered Persons

(a) To be reinstated after commission of a Controlled Medication Rule Violation, the Covered Person must have respected his or her period of Ineligibility (Rule 3329); and repaid or surrendered any purses and other compensation, prizes, trophies, points, and rankings forfeited pursuant to Rule 3321, and paid any fines and reimbursed any costs imposed or accepted to the Agency, unless an installment plan was established pursuant to Rule 3332(b), in which case the Covered Person must have made all payments due under that plan. If any installment(s) subsequently become(s) overdue under that plan ( i.e., after reinstatement), the Covered Person and the Covered Horses under his or her ownership or training may not participate in any Timed and Reported Workout or Covered Horserace until such overdue installment(s) is/are paid in full.

(b) Where fairness requires, the Agency or the Internal Adjudication Panel may establish an installment plan for repayment of amounts due to be paid or reimbursed under the Protocol. The payment schedule may extend beyond any period of Ineligibility imposed upon the Covered Person.

Rule 3333. Conditions Precedent to Reinstatement for Covered Horses

(a) A Covered Horse shall be reinstated once its period of Ineligibility ends, provided that (1) the Ineligibility has been respected in full throughout that period in accordance with Rule 3329, (2) the Covered Horse has been made available for Testing during that period in accordance with Rule 3132(d), and (3) the Covered Horse has completed any Vets' List Workout(s) required by the Racetrack Safety Program or the Agency (for the avoidance of doubt, such workouts may be scheduled prior to the expiry of the period of Ineligibility and will not constitute a violation of Rule 3329).

(b) Any reinstatement pursuant to this Rule 3333 is without prejudice to any rest or stand down period that may be imposed on the Covered Horse ( e.g., due to injuries), and any requirements for release from the Veterinarians' List, pursuant to the Racetrack Safety Program.

3340. Results Management

Rule 3341. General

Where there is evidence of a potential Controlled Medication Rule Violation(s), the Agency will conduct Results Management in accordance with this section 3340 and the Testing and Investigations Standards.

Rule 3342. Review of Adverse Analytical Findings

(a) Upon receipt of an Adverse Analytical Finding in relation to an A Sample, the Agency will conduct a review of the Laboratory certificate of analysis supporting the Adverse Analytical Finding and the relevant Sample collection documentation and Testing documents to determine whether the Adverse Analytical Finding was caused by any apparent departure from the Testing and Investigations Standards, the Laboratory Standards, or any provision of the Protocol. Subject to Rule 3342(b), the Agency may, but does not have to, communicate with the Responsible Person and Owner during such review.

(b) If the review under Rule 3342(a) reveals an apparent departure that caused the Adverse Analytical Finding, the entire test shall be considered negative, and the Agency shall promptly inform the Responsible Person and each Interested Party of that fact.

(c) If the initial review of an Adverse Analytical Finding under Rule 3342(a) does not reveal an apparent departure that caused the Adverse Analytical Finding, the Agency shall promptly send an ECM Notice to the Responsible Person and each Interested Party in accordance with Rule 3345.

Rule 3343. Review of Atypical Findings Relating to Controlled Medication Substances

(a) In certain circumstances, Laboratories may report the presence of certain Controlled Medication Substances as “Atypical Findings” in accordance with the Atypical Findings Policy set out at Appendix 1. Upon receipt of an A Sample Atypical Finding, the Agency will conduct a review to determine whether the Atypical Finding was caused by a departure from the Testing and Investigations Standards, the Laboratory Standards, or any provision of the Protocol. If that review does not reveal any departure that caused the Atypical Finding, the Agency will conduct an investigation (including directing any Further Analysis) or take any other steps required to decide whether the Atypical Finding should be brought forward as an Adverse Analytical Finding, in accordance with the Atypical Findings Policy.

(b) The Agency may, but does not have to, provide notice of an Atypical Finding to anyone until it has made that decision unless one of the following circumstances exists:

(1) if the Agency determines that the B Sample should be analyzed prior to the conclusion of its investigation, the Agency may conduct the B Sample analysis after notifying the Responsible Person and the Owner, with such notice to include a description of the Atypical Finding and the information described in Rule 3345; or

(2) if the Atypical Finding is likely connected to a serious pathology that requires urgent veterinary attention.

(c) If the Agency ultimately decides not to pursue the Atypical Finding as an Adverse Analytical Finding, the Agency may, but does not have to, communicate that fact to the Responsible Person and Owner unless he or she has previously received notice of the Analytical Finding pursuant to Rule 3343(b).

(d) If the Agency decides to move forward with the matter as an Adverse Analytical Finding, the Agency shall promptly send an ECM Notice to the Responsible Person and each Interested Party.

Rule 3344. Review of Other Evidence of a Potential Controlled Medication Rule Violation

The Agency shall conduct any follow-up investigation required into any potential Controlled Medication Rule Violation not covered by Rules 3342 or 3343. At such time as the Agency is satisfied that it has sufficient evidence to establish that a Controlled Medication Rule Violation occurred, it shall promptly send an ECM Notice to the relevant Covered Person and each Interested Party.

Rule 3345. ECM Notice

(a) Where it is determined that a Covered Person may have committed one or more Controlled Medication Rule Violations, the Agency will promptly notify the Covered Person and each Interested Party in writing of the following (the ECM Notice):

(1) the alleged Controlled Medication Rule Violation and the Consequences if it is agreed or determined to have been committed;

(2) the Adverse Analytical Finding (with a copy of the Laboratory certificate of analysis in a form designated by the Agency) or a brief summary of the facts relied on by the Agency to assert the alleged violation (including, where applicable, the name of the Covered Horse implicated in the alleged violation, whether the alleged violation was in connection with a particular Covered Horserace, and the date of Sample collection or of the other relevant facts said to give rise to the violation);

(3) if applicable, the right of the Responsible Person and the Owner to receive copies of the A Sample Laboratory Documentation Package after the B Sample analysis has been completed or after such analysis is waived;

(4) if applicable, the following details regarding the B Sample analysis:

(i) that the B Sample has been (or will be) analyzed because the Agency has authorized immediate analysis to preserve the scientific integrity of the Sample;

(ii) if the B Sample has not been analyzed, the Responsible Person's and Owner's right to promptly request the analysis of the B Sample within no more than 5 days or (failing such request) that the B sample analysis shall be deemed to be waived;

(iii) an explanation that where the Responsible Person or Owner requests the B Sample analysis within the applicable deadline, or where the Agency decides to proceed with the B Sample analysis, the Agency will notify the Responsible Person and Owner of the date, time, and place where the B Sample will be analyzed and (where the analysis is requested by the Responsible Person or Owner) the amount that the Responsible Person or Owner must pay to have the B Sample tested and B Sample Laboratory Documentation Package prepared, and the date by which such payment must be received, failing which the B Sample analysis shall be deemed to have been waived; and

(5) the opportunity for the Covered Person to provide an explanation within a short deadline set by the Agency;

(6) the opportunity to provide Substantial Assistance, to admit the Anti-Doping Rule Violation, or to seek to resolve the matter without a hearing under Rule 3349;

(7) all relevant details relating to any Provisional Suspension (including, if applicable, the possibility to accept a voluntary Provisional Suspension) in accordance with Rule 3347; and

(8) if applicable, the ability for the automatic Disqualification of results to be applied immediately in accordance with Rule 3321(a)(2).

(b) Before sending an ECM Notice, for purposes of Rule 3323, the Agency shall seek to determine whether the Covered Person in question has committed any prior violations under the Protocol.

(c) Any defect in the ECM Notice (including a failure to identify the Covered Horseraces implicated in the alleged violation, if any) may be corrected by the Agency and shall not in any event invalidate the ECM Notice or affect the due application of the provisions of the Protocol (including the Disqualification provisions) in relation to that violation.

Rule 3346. B Sample Analysis

(a) Arrangements shall be made for analysis of the B Sample without undue delay, in accordance with the Protocol and the Laboratory Standards. Subject to Rule 3346(b), the Responsible Person or Owner must pay the costs of the B Sample analysis in advance, but, if the B Sample analysis does not confirm the A Sample analysis, they will be reimbursed that cost by the Agency. The Responsible Person and Owner and one representative each may attend the Laboratory to witness the opening and identification of the B Sample. They do not have any right to witness the analysis of the B Sample.

(b) The Responsible Person and Owner may (if they both agree) waive analysis of the B Sample (in which case they shall be deemed to accept the A Sample analytical results). If waived, the Agency may nonetheless elect to proceed with the B Sample analysis at its own expense.

(c) If the B Sample proves negative, the entire Test shall be considered negative, and the Responsible Person and Owner shall be so informed. In such circumstances, unless the Agency asserts a Controlled Medication Rule Violation under Rules 3313 or 3314 (Use), the ECM Notice will be withdrawn, any Provisional Suspensions imposed shall be deemed automatically vacated with immediate effect (without the need for any order from the Internal Adjudication Panel), and no further disciplinary action will be taken against the Responsible Person, other Covered Person, or Covered Horse by the Agency in relation to the original Adverse Analytical Finding (provided, however, that the Agency may investigate why the B Sample did not match the A Sample). If the Agency asserts that a Rule 3313 or 3314 (Use) violation has occurred, it shall send a Charge Letter to the Responsible Person and other Covered Person(s), with a copy to each Interested Party.

(d) If the presence of a Controlled Medication Substance or the Use of a Controlled Medication Method is confirmed by the B Sample analysis, or the B Sample analysis is waived, the Agency shall send a Charge Letter to the Responsible Person and any other relevant Covered Person(s), with a copy to each Interested Party, asserting that a Rule 3312 (presence) violation or a Rule 3313 (Use) violation (as applicable) has occurred.

Rule 3347. Provisional Suspensions

(a) The Agency shall not impose a Provisional Suspension on a Covered Horse for a Controlled Medication Rule Violation, unless the violation involves a Controlled Medication Method for which the Prohibited List specifies a period of Ineligibility.

(b) The Agency may impose a Provisional Suspension on a Covered Person for a Controlled Medication Rule Violation where it considers it appropriate to do so in the circumstances of the case, including where (1) the Covered Person admits the Controlled Medication Rule Violation and is likely to be subject to a period of Ineligibility, (2) there is an Adverse Analytical Finding for more than one Controlled Medication Substance and those substances are not Specified Substances, (3) the Covered Person has a pending Anti-Doping Rule Violation or Controlled Medication Rule Violation or prior violation that is likely to result in an increased period of Ineligibility, or (4) the individual represents a threat to the health, safety, or welfare of horses or the integrity of the sport of horseracing.

(c) Where a Provisional Suspension is imposed pursuant to Rule 3347(a) or (b), the Responsible Person (on his or her own behalf and on behalf of the Covered Horse) and any other Covered Person made subject to the Provisional Suspension shall be given:

(1) an opportunity for a Provisional Hearing before imposition of the Provisional Suspension;

(2) an opportunity for a Provisional Hearing on a timely basis after imposition of the Provisional Suspension; or

(3) an opportunity for an expedited final adjudication in accordance with Rule 3362 on a timely basis after imposition of the Provisional Suspension.

(d) Provisional Hearings shall be conducted by the Internal Adjudication Panel and heard via telephone or video conference call within the time frame specified in accordance with the Arbitration Procedures, except where the Internal Adjudication Panel decides to determine the matter based solely on the written submissions without a hearing. The sole issue to be determined by the Internal Adjudication Panel will be whether the Agency's decision to impose a Provisional Suspension shall be maintained. The Agency's decision to impose a Provisional Suspension shall be maintained unless the Responsible Person/Covered Person requesting the lifting of the Provisional Suspension establishes that:

(1) the allegation that a Controlled Medication Rule Violation has been committed has no reasonable prospect of being upheld, e.g., because of a material defect in the evidence on which the allegation is based;

(2) the Responsible Person/Covered Person charged bears No Fault or Negligence for the Controlled Medication Rule Violation that is alleged to have been committed, so that any period of Ineligibility that might otherwise be imposed for such offense would be completely eliminated by application of Rule 3324. (This ground does not apply in respect of any Provisional Suspension imposed on a Covered Horse);

(3) Rule 3325 applies and the Responsible Person/Covered Person bears No Significant Fault or Negligence and he or she will likely be given a period of Ineligibility that is not longer than the period for which he or she has already been provisionally suspended. (This ground does not apply in respect of any Provisional Suspension imposed on a Covered Horse); or

(4) exceptional circumstances exist that make it clearly unfair, taking into account all of the circumstances of the case, to impose a Provisional Suspension prior to the final hearing on the merits. This ground is to be construed narrowly and applied only in truly exceptional circumstances. For example, the fact that the Provisional Suspension would prevent the Responsible Person, Covered Person, or Covered Horse from participating in a particular Timed and Reported Workout, Covered Horserace, or other activity shall not qualify as exceptional circumstances for these purposes.

(e) If the application is made before the Provisional Suspension comes into effect, the Provisional Suspension will not come into effect pending the decision on the application. If the application is made after the Provisional Suspension has come into effect, the Provisional Suspension will remain in place pending the decision on the application.

(f) If it considers it appropriate to do so on the specific facts of the case, the Agency may lift the Provisional Suspension.

(g) If the application to have a Provisional Suspension not imposed/lifted is not granted, a further application may not be made to lift the Provisional Suspension unless: (1) it is based on new and material evidence that the Responsible Person or other Covered Person was not aware of and could not reasonably have been aware of at the time he or she made the original application; or (2) there has been some other significant and material change in circumstances since the original application was decided. If the Responsible Person or other Covered Person makes a further application that does not meet either of these requirements, costs may be awarded against him or her.

(h) Voluntary Provisional Suspension.

(1) In all cases where a Responsible Person/Covered Person has been notified of or charged with a Controlled Medication Rule Violation, but no Provisional Suspension has been imposed on him or her or on the Covered Horse, that person may (on his or her own behalf and, if the Responsible Person, on behalf of the Covered Horse where it might be subject to a period of Ineligibility), voluntarily accept a Provisional Suspension at any time by written notice to the Agency. A copy of the voluntary Provisional Suspension shall promptly be provided to each Interested Party.

(2) A Provisional Suspension that is voluntarily accepted will have effect (in the same manner as if the Provisional Suspension had been imposed under Rule 3347(a)) from the date that written notice of its acceptance is received by the Agency.

(i) No admission will be inferred, or other adverse inference drawn, from the decision of a Covered Person: (1) not to make an application to lift a Provisional Suspension; or (2) to accept a voluntary Provisional Suspension.

(j) If a Provisional Suspension is imposed or voluntarily accepted, and that Provisional Suspension is respected, then the Responsible Person/Covered Person and Covered Horse in question shall receive a credit for such period of Provisional Suspension against any period of Ineligibility that may ultimately be imposed. If the Responsible Person/Covered Person or Covered Horse does not respect a Provisional Suspension, the Responsible Person/Covered Person or Covered Horse shall receive no credit for any period of Provisional Suspension served. If a period of Ineligibility is served pursuant to a decision that is subsequently subject to review, the Responsible Person/Covered Person or Covered Horse shall receive a credit for such period of Ineligibility served against any period of Ineligibility that may ultimately be imposed on review.

(k) Notwithstanding any other provision in this Rule 3347 or elsewhere in the Protocol, any Provisional Suspension imposed on a Covered Horse will be automatically lifted (without the need for any hearing) if it has been in place for a period equal to the period of Ineligibility specified in the Protocol or Prohibited List.

Rule 3348. Charge Letter

If, after receipt of the Covered Person's explanation, or expiry of the deadline to provide such explanation, the Agency remains satisfied that the Covered Person has committed a Controlled Medication Rule Violation(s), the Agency shall promptly charge the Covered Person with the asserted Controlled Medication Rule Violation(s). In this letter of charge (Charge Letter), which will be copied to each Interested Party, the Agency shall:

(a) set out the Controlled Medication Rule Violation(s) that the Covered Person is charged with having committed;

(b) provide a summary of the relevant facts upon which the charge is based, enclosing a copy of the A Sample Laboratory Documentation Package and (if applicable and if requested) the B Sample Laboratory Documentation Package;

(c) specify the Consequences that will apply if the charge is upheld;

(d) grant a deadline of not more than 7 days from receipt of the Charge Letter (unless otherwise agreed by the Agency) for the Covered Person to either:

(1) admit the Controlled Medication Rule Violation(s) charged and:

(i) accept the Consequences proposed by the Agency, in which case the Agency will issue a decision under Rule 3349,

(ii) seek to agree mitigated Consequences with the Agency pursuant to Rule 3349 failing which the Consequences may still be disputed at a hearing; or

(iii) dispute or seek to mitigate the proposed Consequences at a hearing in accordance with Rule 3361 and the Arbitration Procedures; or

(2) deny the Controlled Medication Rule Violation charged and dispute the proposed Consequences at a hearing in accordance with Rule 3361 and Arbitration Procedures;

(e) indicate that if the Covered Person does not challenge the Agency's assertion of a Controlled Medication Rule Violation or the proposed Consequences within the prescribed deadline, the Covered Person shall be deemed to have waived his or her right to a hearing, admitted the Controlled Medication Rule Violation(s) charged, and accepted the Consequences specified by the Agency in the Charge Letter (without any mitigation of those Consequences);

(f) give the opportunity to provide Substantial Assistance in accordance with Rule 3326(a); and

(g) provide all relevant details relating to any Provisional Suspensions (including, if applicable, the possibility to accept a voluntary Provisional Suspension) in accordance with Rule 3347.

Rule 3349. Case Resolution Without a Hearing

(a) At any time prior to a final decision under the Arbitration Procedures: (1) the Agency may withdraw a Charge Letter for good cause, in which case any Provisional Suspension will be automatically lifted and (absent the emergence of new information) no further steps will be taken in relation to the violations alleged in the Charge Letter; or (2) the Covered Person may agree to admit the Controlled Medication Rule Violation(s) charged (or any other violation of the Protocol) and accede to specified Consequences consistent with the Protocol. In any such case, an adjudication under the Arbitration Procedures will not be required.

(b) In the event that the Covered Person admits the Controlled Medication Rule Violation(s) charged and accedes to Consequences specified by the Agency (or is deemed to have done so in accordance with Rule 3348(a)(5)), the Agency will (1) promptly issue a final decision confirming the commission of the Controlled Medication Rule Violation(s) and setting out the factual basis for the decision and all of the Consequences to be imposed (including a brief summary of the reasons for any period of Ineligibility imposed, unless doing so could compromise an ongoing investigation or proceeding), and (2) send notice of the decision to each Interested Party. The Agency will also Publicly Disclose the decision (or a summary thereof, at the discretion of the Agency) in accordance with Rule 3620.

(c) In the event that the Agency withdraws the Charge Letter, it will (1) promptly issue a summary decision confirming the withdrawal of the Charge Letter, (2) send notice of the decision to the Covered Person concerned, with a copy to each Interested Party, and (3) Publicly Disclose the decision (or a summary thereof, at the discretion of the Agency) in accordance with Rule 3620.

Rule 3350. Notification Requirements

(a) Notification of Controlled Medication Rule Violations will take place as set out in Rule 3345 and Rule 3348. If at any point after an ECM Notice has been provided the Agency decides not to move forward with the charge, it will notify the Covered Person(s) concerned and each Interested Party of that decision.

(b) Notification to a Covered Person by the Agency, for all purposes of the Protocol, may be accomplished either through actual or constructive notice. Actual notice may be accomplished by any means. Constructive notice shall be deemed to have been given when the information in question is delivered by third-party courier or U.S. postal mail to the Covered Person's most recent mailing address on file with the Authority or by email or text message to the Covered Person's most recent email address or mobile telephone number on file with the Authority.

3360. Hearings and Review of Final Decisions

Rule 3361. Procedure Before the Internal Adjudication Panel

Where a Covered Person is alleged to have committed a Controlled Medication Rule Violation, a violation of Rule 3329, or any violation of Rule 3510, the Covered Person shall be entitled to request a hearing before the Internal Adjudication Panel in accordance with the Arbitration Procedures. However, the Internal Adjudication Panel may decide, in its sole discretion, to determine the matter based solely on the written submissions without a hearing if the Internal Adjudication Panel considers itself sufficiently well-informed to render a decision on the written submissions alone. A copy of the final decision of the Internal Adjudication Panel shall be sent to the Agency and the Covered Person(s) concerned. Where the Agency considers it necessary or appropriate to do so, a copy of the decision may be sent to any Interested Party. The decision (or a summary thereof, at the discretion of the Agency) shall be Publicly Disclosed as provided in Rule 3620. The Internal Adjudication Panel may also adjudicate any other matter referred to it under the Protocol, and any other matter that might arise from time to time under the Protocol that the Agency considers should be determined by the Internal Adjudication Panel.

Rule 3362. Expedited Hearing

In Controlled Medication Rule Violation cases where the Covered Horse or Covered Person in question is not Provisionally Suspended and is likely to participate in a Covered Horserace within 45 days, the Agency may (if it sees fit) address the case on an expedited basis and shorten any deadlines in the Protocol or Arbitration Procedures proportionately to ensure resolution of the matter prior to the Covered Horserace.

Rule 3363. Finality

Subject to Rule 3364, decisions rendered by the Internal Adjudication Panel under the Protocol shall be final and binding.

Rule 3364. Review of Final Decisions

Any final decision by the Agency or the Internal Adjudication Panel is subject to review in accordance with section 3058 of the Act. Any final decision under review shall remain in effect pending resolution of the review unless ordered otherwise.

3500. Other Violations

Rule 3510. Other Violations Under the Protocol

Where a Covered Person:

(a) engages in disruptive or offensive conduct towards a Doping Control official or other Person involved in Doping Control that does not rise to the level of Tampering;

(b) refuses or fails to cooperate promptly and completely with the Authority or the Agency in the exercise of their respective powers under the Act and the Protocol and related rules, including any refusal or failure to comply with Rule 3040(a)(2);

(c) commits a Whereabouts Failure; or

(d) refuses or fails without compelling justification to comply with any other provision of the Protocol (where such refusal or failure does not constitute an Anti-Doping Rule Violation);

the Covered Person will not be deemed to have committed an Anti-Doping Rule Violation or Controlled Medication Rule Violation. However, disciplinary proceedings may be brought against him or her before the Internal Adjudication Panel in accordance with the Arbitration Procedures or resolved without a hearing applying the rules of proof set out in Rule 3120 and following the procedures set out in section 3360 (in each case, mutatis mutandis, i.e., amended as required to reflect the different context). The Agency will send the Covered Person at issue a notice of the alleged violation, setting out a summary of the relevant facts upon which the charge is based, and giving the Covered Person the opportunity to provide an explanation within a short deadline. If the Internal Adjudication Panel finds the violation alleged to be proven, or if the Covered Person admits the violation alleged and does not request a hearing to determine the consequences, the Internal Adjudication Panel or the Agency (as applicable) may impose sanctions on Covered Persons as set out in Rule 3520.

Rule 3520. Sanctions for Other Violations Under the Protocol

(a) For a violation of Rule 3510(a) (disruptive or offensive conduct), the Covered Person shall be subject to, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, 30 days of Ineligibility, depending on the seriousness of the violation. A fine of up to $5,000 may also be imposed.

(b) For a violation of Rule 3510(b) (refusal or failure to cooperate), the Covered Person shall be subject to, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, a period of Ineligibility of up to 2 years, depending on the seriousness of the violation. A fine of up to $15,000 may also be imposed. A failure to comply with Rule 3040(b)(7) will be considered a particularly serious violation that will ordinarily warrant the imposition of the maximum sanction.

(c) For a violation of Rule 3510(c) (Whereabouts Failures), the Covered Person shall not be subject to any penalty for the first Whereabouts Failure, but shall be subject to a fine of $250 for the second Whereabouts Failure, and a fine of $500 for the third Whereabouts Failure. For any subsequent Whereabouts Failures, the fine will increase by $500 each time ( i.e., $1,000 for the fourth failure, $1,500 for the fifth failure, etc.).

(d) For a first violation of Rule 3510(d) (refusal or failure to comply with any other provision of the Protocol), the Covered Person shall be subject to, at a minimum, a reprimand and no period of Ineligibility, and, at a maximum, 30 days of Ineligibility, as well as a fine of up to $2,500, depending on the seriousness of the violation.

(e) For any second or subsequent Rule 3510 violation, the maximum potential Ineligibility and potential fine will be double what the maximum potential Ineligibility and potential fine was for the previous violation.

(f) Where a violation of Rule 3510 is alleged and the Covered Person represents a threat to the health, safety, or welfare of horses or the integrity of the sport of horseracing, the Agency may impose a Provisional Suspension on the Covered Person concerned pending resolution of the charge. The Covered Person may challenge the Provisional Suspension in accordance with Rule 3347 (which shall apply mutatis mutandis, i.e., amended as required to reflect the different context).

3600. Confidentiality and Reporting

Rule 3610. Notice of Violations and Confidentiality

(a) Notice.

(1) Notice of Anti-Doping Rule Violation or Controlled Medication Rule Violations shall be sent to the Covered Persons concerned, with a copy to each Interested Party, as set out in Rules 3245/3248 and 3345/3348.

(2) Notice of other violations shall be sent to the Covered Persons concerned. The Agency may send a copy to any Interested Party where it considers it necessary or appropriate to do so in the circumstances.

(3) State Racing Commissions shall only be entitled to receive notice of violations of the Protocol as Interested Parties if they first enter into an agreement with the Agency incorporating confidentiality provisions required by the Agency pursuant to the Act or the Protocol. The Agency may, in its sole discretion, delay notice to the State Racing Commission for case- or investigation-related reasons.

(b) Confidentiality and public reporting.

(1) Subject to the other provisions of this paragraph (b), the Agency will use its reasonable endeavors to ensure that Persons under its control do not publicly identify Covered Horses or Covered Persons who are alleged to have committed a violation under the Protocol, unless and until (i) in presence cases, the B Sample confirms the results of the A Sample analysis, or the B Sample analysis is waived, (ii) a Provisional Suspension has been imposed or voluntarily accepted, (iii) a charge has been brought, or (iv) a violation has been admitted, whichever is earlier.

(2) In such circumstances, subject to paragraph (3) below, the Agency shall publicly report:

(i) the identity of any Covered Person who is the subject of the alleged violation;

(ii) the identity of any relevant Covered Horse(s); and

(iii) the rule violated and, where appropriate, the basis of the asserted violation.

(3) The Agency shall not be required to publicly report a matter under this paragraph (b) if it would risk compromising an ongoing investigation or proceeding. When the Agency determines that an ongoing investigation or proceeding will no longer be compromised by public reporting, the Agency shall at such time make any public reporting required under this Rule.

(4) The mandatory public reporting under Rule 3610(b) shall not be required where the Covered Person who is alleged to have committed a violation is a Minor. Any optional public reporting in a case involving a Minor shall be proportionate to the facts and circumstances of the case.

(5) If at any time information pertaining to an alleged violation is publicly reported by a Person not affiliated with the Authority or the Agency, the Agency may respond to such public comment as it considers necessary.

(6) The Agency may publicly report any relevant information at any time, including prior to delivery of notice of a violation, if the Agency determines that such disclosure:

(i) concerns a violation or circumstance that poses a serious and imminent risk of harm to any Covered Person(s), Covered Horse(s), State Racing Commission(s), Racetrack(s), Race Organizer(s), Training Facilities, or the public; or

(ii) is otherwise in the best interest of horseracing conducted at Covered Horseraces.

(7) The Agency may at any time disclose to other Persons such information as the Agency considers necessary or appropriate to facilitate administration or enforcement of the Protocol (including Interested Parties and other Persons with a need to know), provided that each Person provides assurance satisfactory to the Agency that the organization will maintain all such information in confidence.

(8) Interested Parties and other Persons may not publicly report any information about an alleged violation unless the information has been publicly reported by the Agency or the Covered Person(s) concerned, or the Agency gives written authorization for him or her to publicly report the information.

Rule 3620. Public Disclosure

(a) The Agency shall Publicly Disclose the resolution of an alleged violation of the Protocol no later than 20 calendar days after:

(1) the final decision;

(2) a resolution between the Agency and the Covered Person; or

(3) the withdrawal of a charge or a final decision finding of no violation.

(b) Public Disclosure shall include:

(1) the name of the Covered Person who committed the violation(s) and any Covered Horse(s) implicated by the violation;

(2) the Rule(s) violated;

(3) the Prohibited Substance(s) or Prohibited Method(s) involved, if any;

(4) the Consequences imposed;

(5) any final decision or a summary thereof, unless publishing that decision could compromise an ongoing investigation or proceeding, and excluding decisions made by the Agency with respect to Atypical Findings pursuant to Appendix 1; and

(6) any review rights available in respect of the decision.

(c) The mandatory Public Disclosure required by this 3620 shall not be required where the Covered Person who has been found to have committed a violation is a Minor. Any optional Public Disclosure in a case involving a Minor shall be proportionate to the facts and circumstances of the case.

(d) Publication shall be accomplished by, at a minimum, placing the required information on the Agency's website.

Rule 3630. General Reporting

The Agency may publish general statistical reports of its Doping Control and Medication Control activities and may report as necessary on its activities to the U.S. Congress, the Commission, the Authority, the State Racing Commissions, and other federal or state governmental bodies or agencies having jurisdiction over the sport of horseracing in the United States. The Agency may also publish reports showing the names of any Covered Horses Tested and the date of each Sample collection.

Rule 3640. Data Privacy

The Agency may collect, store, process, or disclose personal information relating to Covered Persons, Covered Horses, or other Persons and horses where necessary and appropriate to discharge its responsibilities under the Protocol, but shall take appropriate steps to maintain that information and its confidentiality in compliance with applicable law.

3700. Implementation of Decisions

Rule 3710. Application and Recognition of Decisions

(a) Any final decision issued pursuant to the Protocol that a violation of the Protocol has taken place and imposing Consequences or other sanctions for that violation shall be automatically and immediately recognized, respected, enforced and given full force and effect by the Authority, Racetracks, Race Organizers, Training Facilities, all Covered Persons, and all other relevant Persons within their respective spheres of authority.

(b) Where a third party with its own jurisdiction over Covered Persons or Covered Horses imposes consequences on them for violation of anti-doping or controlled medication rules that are consistent with the Protocol or the World Anti-Doping Code, that decision, upon review and acceptance by the Authority and the Agency, shall be immediately recognized, respected, enforced and given full force and effect by the Agency, the Authority, Racetracks, Race Organizers, all Covered Persons, and all other relevant Persons within their respective spheres of authority.

3800. Education

Rule 3810. Education Programs

The Agency shall plan, implement, evaluate, and monitor education programs for responsible medication use and doping-free horseracing.

Rule Series 3000 Appendix 1: Atypical Finding Policy

Overview

1. Atypical Findings occur when the Laboratory provides the results of its analysis of a Sample to the Agency and more investigation or review is needed to determine whether or not it should be treated as an Adverse Analytical Finding. This Atypical Findings Policy (Atypical Findings Policy) sets out the process by which the Agency will decide whether or not Atypical Findings will be pursued as Adverse Analytical Findings.

Prohibited Substances To Be Treated as Atypical Findings

2. If detected in the Sample of a Covered Horse, the following Prohibited Substances shall be investigated or reviewed as Atypical Findings:

(a) Specified Substances;

(b) endogenous substances;

(c) ractopamine; and

(d) zilpaterol.

3. The Laboratory may also report other Atypical Findings in relation to substances that are not specifically listed in the Prohibited List or Technical Document-Prohibited Substances.

Decisions Regarding Atypical Findings

4. The Agency is responsible for issuing a decision regarding whether or not an Atypical Finding will be pursued as an Adverse Analytical Finding.

5. Subject to the notification requirements set out below, the deliberations of the Agency shall be confidential.

Preliminary Steps

6. Initial review.

The Agency will first conduct a review to determine whether there is any apparent departure from any Standards or any provisions of the Protocol that caused the Atypical Finding. If that review does not reveal any departure that caused the Atypical Finding, the Agency will conduct the required investigation in accordance with this Atypical Findings Policy. The precise nature of the investigation will depend on basis for the Atypical Finding, including the Prohibited Substance(s) associated with the Atypical Finding (if applicable), and the level of cooperation of the Responsible Person.

7. Notification.

The Agency will promptly inform the Responsible Person and Interested Parties in writing of the Atypical Finding and any relevant information, such as the Covered Horserace to which the Atypical Finding relates, and the Responsible Person will have the opportunity to provide any information that he or she believes might assist the Agency in deciding whether or not to pursue the Atypical Finding as an Adverse Analytical Finding, as set forth in the criteria below. Such information must be provided to the Agency by the deadlines set by the Agency in order for it to be considered by the Agency.

8. Additional information.

The Agency may request such additional information or explanations from the Responsible Person as it considers necessary to evaluate the Atypical Finding, and the Responsible Person must comply fully and promptly with any such requests.

Criteria

In deciding whether or not an Atypical Finding should be pursued as an Adverse Analytical Finding, the Agency will consider the following criteria:

9. Proving source of the Prohibited Substance(s) as a precondition.

(a) The Responsible Person has the burden of proving how the Prohibited Substance(s) entered the body of the Covered Horse. If the Responsible Person is unable to discharge that burden, the Atypical Finding must be pursued as an Adverse Analytical Finding. If the Responsible Person proves the source, the Agency will determine whether or not the Analytical Finding should be pursued as an Adverse Analytical Finding.

(b) The Agency will take a number of factors into account when considering whether or not the source of the Atypical Finding has been established including, but not limited to:

(i) if there were Atypical Findings for the same Prohibited Substance(s) arising from other Samples collected at the relevant Covered Horserace;

(ii) if there were Atypical Findings for the same Prohibited Substance(s) arising from other Samples collected at previous Covered Horseraces held at the same Racetrack or in the same region;

(iii) if Samples taken from feed or bedding at the relevant Covered Horserace (if such samples are available) test positive for the Prohibited Substance(s) in question;

(iv) if there were other (non-Atypical Finding) Prohibited Substance(s) in the Sample; and

(v) the concentration level of the particular Prohibited Substance(s) in the Sample.

(c) In addition, the Agency may, in accordance with Rules 3246 and 3346 of the Protocol, request the B Sample analysis.

(d) If the Atypical Finding concerns a Prohibited Substance(s) that is an endogenous substance, the Agency will request that the Responsible Person provide any veterinary information that would assist in establishing if the result is due to a physiological or pathological condition, and such information shall be taken into account by the Agency.

(e) When trying to establish the source of the Prohibited Substance(s) in question, the Agency may consult, as necessary, with one or more experts to obtain further information on the Prohibited Substance(s) in order to assess whether or not: (i) the explanations provided by the Responsible Person (if any) are plausible; or (ii) the presence of the Prohibited Substance(s) in the Sample is likely to be due to contamination.

(f) The Agency will consider any measures the Responsible Person has in place to prevent Prohibited Substances entering the body of his or her Covered Horse(s), including:

(i) whether or not the Responsible Person keeps up-to-date treatment records;

(ii) whether or not the Responsible Person keeps a record of the feed and supplements given to his or her Covered Horses, and whether samples of such feed or supplements have been stored for potential analysis;

(iii) the security measures put in place by the Responsible Person at his or her stables and when travelling to or attending Covered Horseraces; and

(iv) other measures taken by the Responsible Person to prevent Prohibited Substances inadvertently entering the body of his or her Covered Horses.

10. Other factors.

The Agency may also have regard to other factors that it considers necessary or relevant, including, but not limited to:

(a) the security measures in place at the relevant Covered Horserace;

(b) the report(s) of the Veterinarians or stewards at the relevant Covered Horserace;

(c) the prevalence of the use of the Prohibited Substance(s); and

(d) whether or not the Responsible Person has any prior Anti-Doping Rule Violation(s) or Controlled Medication Rule Violation(s) (excluding any violations where the Responsible Person was found to bear No Fault or Negligence).

Conclusion of the Investigation and Notification

11. Following the Agency's investigation of the Atypical Finding in accordance with the criteria above, the Agency shall decide whether or not the Atypical Finding should be pursued as an Adverse Analytical Finding. The Agency shall issue a written decision, with a short summary of the basis for that decision. The decision of the Agency is final and is not subject to review. The Agency will send a copy of its decision to the Responsible Person.

12. If the Agency determines that the Atypical Finding should not be pursued as an Adverse Analytical Finding, no further action will be taken, and no case will be opened against the Responsible Person.

13. If the Agency determines that the Atypical Finding should be pursued as an Adverse Analytical Finding, the Agency will follow the notification procedure set out in Rules 3250 and 3350 and will refer the matter for adjudication in accordance with the Arbitration Procedures (unless the matter is resolved by agreement without a hearing as permitted under the Protocol). The Agency may rely on any information submitted or obtained when investigating the Atypical Finding in the subsequent Adverse Analytical Finding case.

Publication of Atypical Findings

14. At the end of each year, the Agency may publish a report setting out the following information, on an anonymised basis:

(a) how many Atypical Findings were reported by Laboratories that year;

(b) how many Atypical Findings were pursued as Adverse Analytical Findings, and the Prohibited Substances in question;

(c) how many Atypical Findings were not pursued as Adverse Analytical Findings, and the Prohibited Substances in question; and

(d) how many Atypical Findings remain under investigation.

Public Comment

15. Unless there are compelling reasons (as determined by the Agency), no Person may make any public comment on the specific details of an Atypical Finding while the investigation is ongoing. If such a disclosure is made by a Person not affiliated with the Authority or the Agency, the Authority or the Agency may respond to such public comment as it considers necessary.

16. If an Atypical Finding is not pursued as an Adverse Analytical Finding, no Person may make any public comment on the details of that Atypical Finding without the prior consent of the Responsible Person. If such a disclosure is made by a Person not affiliated with the Authority or the Agency, the Authority or the Agency may respond to such public comment as it considers necessary.

4000. Prohibited List

4010. Purpose

In accordance with Rule 3111, the Prohibited List identifies substances and methods that are prohibited at all times (Banned Substances and Banned Methods) and those that are prohibited for Use or Administration in relation to a Covered Horse during the Race Period and prohibited to be present in a Post-Race Sample or Post-Work Sample, except as otherwise specified in the Prohibited List (Controlled Medication Substances and Controlled Medication Methods). In accordance with the definition of “Race Period” (see Rule 1020), the Prohibited List may specify that, for certain specified Controlled Medication Substances and Controlled Medication Methods, the Race Period shall be shorter or longer in duration. 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 provides guidance on the Prohibited Substances that fall into the general categories listed in the Prohibited List and on the Screening Limits, Thresholds, or Detection Times for those Prohibited Substances (as applicable), and also designates certain Prohibited Substances as Specified Substances, which are those that pose a higher risk of being the result of contamination and, therefore, are subject to more flexible sanctions. Certain Prohibited Substances might also first be reported as Atypical Findings requiring further investigation before being declared as Adverse Analytical Findings, in accordance with the Atypical Findings Policy set out as Appendix 1 to the Protocol. The Prohibited List also sets out the periods of Ineligibility applicable to Covered Horses for Anti-Doping Rule Violations and Controlled Medication Rule Violations (see Rule 4300).

4100. Banned Substances and Banned Methods

4110. Banned Substances

Rule 4111. S0 Non-Approved Substances

Any pharmacological substance that (i) is not addressed by Rules 4112 through 4117, (ii) has no current approval by any governmental regulatory health authority for veterinary or human use, and (iii) is not universally recognized by veterinary regulatory authorities as a valid veterinary use, is prohibited at all times. For the avoidance of doubt, compounded products compliant with the Animal Medicinal Drug Use Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 (also known as Compounding Animal Drugs from Bulk Drug Substances) are not prohibited under this section S0.

Rule 4112. S1 Anabolic Agents

The following substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited at all times:

(a) anabolic androgenic steroids when administered exogenously;

(b) other anabolic agents, including, but not limited to:

(1) Selective Androgen Receptor Modulators (SARMs);

(2) Zeranol;

(3) Zilpaterol; and

(4) Ractopamine.

Rule 4113. S2 Peptide Hormones, Growth Factors, Related Substances, and Mimetics

The following substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited at all times:

(a) Erythropoietins (EPO) and agents affecting erythropoiesis, including, but not limited to:

(1) erythropoietin-receptor agonists;

(2) Hypoxia-Inducible Factor (HIF) activating agents;

(3) GATA (Erythroid Transcription Factor) inhibitors;

(4) Transforming Growth Factor-beta (TGF-β) signaling inhibitors; and

(5) innate repair receptor agonists.

(b) Peptide Hormones and their releasing factors, including, but not limited to:

(1) Chorionic Gonadotrophin (CG) and Luteinizing Hormone (LH) and their releasing factors in stallions, ridglings, and geldings;

(2) corticotrophins and their releasing factors (excluding ACTH if administered outside the Race Period);

(3) Growth Hormone (GH) and its analogues and fragments; and

(4) Growth Hormone (GH) releasing factors.

(c) Growth factors and growth factor modulators affecting muscle, tendon, or ligament protein synthesis/degradation, vascularization, energy utilization, regenerative capacity, or fiber type switching.

Rule 4114. S3 Beta-2 Agonists

The following substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited at all times: all selective and non-selective beta-2 agonists, including all optical isomers. Notwithstanding the above, the following are not prohibited under this section S3:

(a) inhaled beta-2 agonists ( e.g., albuterol, salbutamol) when prescribed by a Veterinarian (in the context of a valid veterinarian-patient-client relationship) as a bronchodilator; and

(b) clenbuterol when prescribed by a Veterinarian (in the context of a valid veterinarian-patient-client relationship) for a duration not to exceed 30 days in a 6-month period and provided that, following administration of clenbuterol, the Covered Horse shall be placed on the Veterinarians' List and shall not be eligible to participate in any Timed and Reported Workout or Covered Horserace until a urine and a blood Sample have been collected from it by or on behalf of the Agency, and analysis by a Laboratory of those Samples does not detect the presence of clenbuterol or its Metabolites or Markers.

Rule 4115. S4 Hormone and Metabolic Modulators

The following substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited at all times:

(a) aromatase inhibitors;

(b) anti-estrogenic substances, anti-estrogens, and selective estrogen receptor modulators (SERMS);

(c) agents preventing activin receptor IIB activation, including, but not limited to, myostatin inhibitors;

(d) metabolic modulators, including, but not limited to:

(1) insulins and insulin-mimetics;

(2) meldonium; and

(3) trimetazidine; and

(e) thyroid hormone and thyroid hormone modulators.

Rule 4116. S5 Diuretics and Masking Agents

(a) Diuretics and masking agents, and other substances with a similar chemical structure or similar biological effect(s), are prohibited at all times.

(b) Notwithstanding the above, the following are not prohibited under this section S5:

(1) drospirenone, pamabrom, and topical ophthalmic administration of carbonic anhydrase inhibitors ( e.g., dorzolamide, brinzolamide);

(2) trichlormethiazide for treatment of edema;

(3) plasma expanders for life-saving procedures; and

(4) furosemide (also known as Lasix/Salix), subject to the limitations set out in Rule 4212(d).

Rule 4117. S6 Miscellaneous Substances

The following substances, and other substances with similar chemical structure or similar biological effect(s), are prohibited at all times:

(a) bisphosphonates (except that bisphosphonates may be administered for the purpose of diagnostic imaging, i.e., gamma scintigraphy);

(b) toxins ( e.g., botulinum toxin, botox);

(c) venoms of any species, their synthetic analogs, or derivatives thereof;

(d) altrenogest in stallions, ridglings, or geldings;

(e) pitcher plant extract (Sarapin); and

(f) perfluorocarbons.

4120. Banned Methods

Rule 4121. M1 Manipulation of Blood and Blood Components

The following are prohibited at all times:

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

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

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

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

(e) Notwithstanding the above, manipulation of blood or blood components is not prohibited under this section M1:

(1) procedures performed for life-saving purposes; and

(2) use of veterinary regenerative therapies ( i.e., autologous conditioned serum or platelet-rich plasma) for the treatment of musculoskeletal injury or disease.

Rule 4122. M2 Chemical Castration or Immunocastration

In case of chemical castration or immunocastration, the Covered Horse shall remain designated as an intact male. Designating a Covered Horse that has had chemical castration or immunocastration as a gelding constitutes Use of a Prohibited Method.

Rule 4123. M3 Gene and Cell Doping

The following, which have the potential to enhance performance or modify the heritable genome, are prohibited at all times:

(a) the use of nucleic acids or nucleic acid analogues that might alter genome sequences or alter gene expression by any mechanism. This includes, but is not limited to, gene editing, gene silencing, and gene transfer technologies;

(b) the use of normal or genetically modified cells; and

(c) modification of the heritable genome.

4200. Controlled Medication Substances and Controlled Medication Methods

4210. Controlled Medication Substances

Rule 4211. S7 Controlled Medication Substances

(a) Subject to Rule 4212, only feed, hay, and water are permitted during the Race Period. 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.

(b) The following Controlled Medication Substances are prohibited from presence in a Post-Work Sample:

(1) analgesics;

(2) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs);

(3) local anesthetics; and

(4) corticosteroids.

(c) S7 Controlled Medication Substances exclude those substances that fall under section S0, which are Banned Substances.

Rule 4212. Exceptions to Rule 4211

(a) Medications administered or authorized by a Regulatory Veterinarian or Test Barn Veterinarian to provide medical care to a Covered Horse as a result of an injury sustained, or other adverse health event, during the Race Period are not prohibited.

(b) The following may be administered up to 24 hours prior to Post-Time:

(1) orally administered vitamins;

(2) licensed vaccines against infectious agents;

(3) anti-ulcer medications ( e.g., Cimetidine, Omeprazole, and Ranitidine);

(4) unsupplemented isotonic electrolyte solutions by oral or intravenous administration;

(5) altrenogest in female horses;

(6) antimicrobials (antibiotics) and other anti-infective agents, excluding procaine penicillin or other antimicrobial/anti-infective agents containing or metabolizing to Prohibited Substances; and

(7) antiparasitic/anthelmintics approved and registered for use in horses, excluding levamisole or other antiparasitic/anthelmintics metabolizing to or containing other Prohibited Substances.

(c) Unsupplemented isotonic electrolyte solutions may be consumed by the horse's free choice at any time (but may not be administered except as provided in paragraph (b) above).

(d) Furosemide (also known as Lasix or Salix):

(1) is permitted during Timed and Reported Workouts and Vets' List Workouts; and

(2) may be administered during the Race Period in accordance with specific provisions of the Act and any guidance or exceptions approved by the Authority, but shall not be administered within the 4 hours prior to Post-Time.

(e) The Use or Administration of supplements or feed additives during the Race Period shall not be prohibited if the Responsible Person or Covered Person establishes, or the Agency expressly accepts, that such substances are not capable at any time of causing an action or effect, or both an action and effect, within one or more of the following mammalian body systems:

(1) the blood system;

(2) the urinary system;

(3) the cardiovascular system;

(4) the digestive system;

(5) the endocrine system;

(6) the immune system;

(7) the musculoskeletal system;

(8) the nervous system;

(9) the reproductive system; or

(10) the respiratory system.

4220. Controlled Medication Method(s)

In addition to any prohibited practices set forth in the Rule 2000 Series (Racetrack Safety Program):

Rule 4221. M4 Alkalinization or Use/Administration of an Alkalinizing Agent

Alkalinization or Use/Administration of an alkalinizing agent is prohibited on Race Day. A threshold concentration of total carbon dioxide (TCO2) in the blood in excess of 37 mmol constitutes prima facie evidence of alkalinization or Use/Administration of an alkalinizing agent.

Rule 4222. M5 Intra-Articular Injections

Intra-articular injections are prohibited on Race Day; within 14 days prior to Post-Time; and within 7 days prior to any Timed and Reported Workout.

Rule 4223. M6 Nasogastric Tube

The use of a nasogastric tube for any purpose is prohibited within 24 hours prior to Post-Time.

Rule 4224. M7 Intra-Articular Injections of Polyacrylamide Hydrogels

Intra-articular injections of polyacrylamide hydrogels are prohibited within 180 days prior to Post-Time.

Rule 4225. Modification of Race Period

The start of the “Race Period” shall be modified for each of the Controlled Medication Methods above ( i.e., each of M4-M7) based on the restricted administration time period specified for such method ( e.g., the Race Period for M7 shall start180 days prior to Post-Time).

4300. Ineligibility Periods for Covered Horse

4310. Violations Involving Prohibited Substances

The period of Ineligibility of a Covered Horse resulting from a violation involving a Prohibited Substance shall be as set forth in Table 1 below:

4320. Violations Involving Prohibited Methods

The period of Ineligibility of a Covered Horse resulting from a violation involving a Prohibited Method shall be as set forth in Table 2 below:

4330. Other Violations Leading to a Period of Ineligibility for the Covered Horse

The period of Ineligibility of a Covered Horse resulting from a violation of Rule 3215 shall be as set forth in Table 3 below:

Appendix 1 to Rule Series 4000: Technical Document—Prohibited Substances