[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65683-65686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20631]


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FEDERAL TRADE COMMISSION

[File No. P222100]


Horseracing Integrity and Safety Authority Anti-Doping and 
Medication Control Rule Modification

AGENCY: Federal Trade Commission

ACTION: Notice of Horseracing Integrity and Safety Authority (HISA) 
proposed rule modification; request for public comment.

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SUMMARY: As required by the Horseracing Integrity and Safety Act of 
2020, the Federal Trade Commission (``FTC'' or ``Commission'') 
publishes a proposed rule modification related to the equine Anti-
Doping and Medication Control Program of the Horseracing Integrity and 
Safety Authority (``HISA'' or the ``Authority''). Specifically, the 
proposed rule modification would designate iron dextran as a banned 
substance and thereby prohibit its use. This publication contains the 
Authority's proposed rule's text and explanation, and it seeks public 
comment on whether the Commission should approve the proposed rule.

DATES: The Commission must approve or disapprove the proposed 
modification on or before November 24, 2023. If approved, the proposed 
rule modification would be effective immediately. Comments must be 
filed on or before October 10, 2023.

ADDRESSES: Interested parties may file a comment online or on paper by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section. Write ``HISA Anti-Doping and 
Medication Control Rule Modification'' on your comment and file your 
comment online at https://www.regulations.gov by following the 
instructions on the web-based form. 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 H), Washington, DC 20580.

FOR FURTHER INFORMATION CONTACT: John H. Seesel (202-326-2702), 
Associate General Counsel, Office of the General Counsel, Federal Trade 
Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: On July 8, 2023, pursuant to section 3053(a) 
of the Horseracing Integrity and Safety Act of 2020 (``Act'') \1\ and 
FTC Rule 1.142,\2\ the Horseracing Integrity and Safety Authority 
(``HISA'' or the ``Authority'') filed with the Commission a proposed 
modification of the Authority's anti-doping rules to include iron 
dextran as a banned substance. Sections I and II below set forth the 
Authority's proposal. The Commission is publishing this document to 
solicit comments on the proposed rule modification from interested 
persons.
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    \1\ 15 U.S.C. 3051 through 3060.
    \2\ 16 CFR 1.142.
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    The proposed modification would insert the following row for Iron 
Dextran into the ``Technical Document--Prohibited Substances'' appendix 
to the Prohibited List (Rule Series 4000), between the row for 
Irbesartan and the row for Isoaminile.

[[Page 65684]]



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                                                                                                                                                                       Screening limit (unless
                                                   Penalty subclassification                                            Commercial name(s)                            otherwise designated as a
         HISA listed as            HISA status     (specified Substances are         Substance            Action          (developmental         Detection time       threshold). Where no value
                                                      designated with `x')                                                    names)                                    is listed for serum or
                                                                                                                                                                         plasma the substance
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                                                                                          * * * * * * *
BANNED.........................              S6  .............................  Iron Dextran,       Iron deficiency     Nonemic,
                                                                                 Colloquial Name:    anemia treatment.   Ferrextran,
                                                                                 Pig Iron.                               Imposil, Uniferon.
 
                                                                                          * * * * * * *
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* * * * *

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

    The Horseracing Integrity and Safety Act of 2020 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. The Act mandates and empowers the Authority to establish a 
uniform anti-doping and controlled medication program (``ADMC 
Program'') to improve the integrity and safety of horseracing in the 
United States. The Authority developed the proposed rules that 
constitute the ADMC Program and filed the proposed rules with the 
Commission on December 28, 2022. The proposed rules were published in 
the Federal Register on January 26, 2023,\3\ and were subsequently 
approved by the Commission by Order dated March 27, 2023.\4\
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    \3\ See FTC, HISA Anti-Doping and Medication Control Rule, 88 FR 
5070 (Jan. 26, 2023).
    \4\ Order Approving the Anti-Doping and Medication Control Rule 
Proposed by the Horseracing Integrity and Safety Authority (Mar. 27, 
2023), https://www.ftc.gov/system/files/ftc_gov/pdf/P222100CommissionOrderAntiDopingMedication.pdf.
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    As part of the ADMC Program, the Authority developed the Rule 
Series 4000 Prohibited List. This includes a list of permitted and 
prohibited medications, substances, and methods, including allowable 
limits of permitted medications, substances, and methods. The 
Prohibited List uses 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.
    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 Authority'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 ``Technical Document--Prohibited Substances'' (``Technical 
Document''), as an appendix to the Prohibited List (Rule Series 4000), 
supplements the Prohibited List and sets out additional detail 
concerning Prohibited Substances. The Technical Document 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 Authority proposes to modify the Technical Document to 
add iron dextran as a Banned Substance (S6).\5\ The proposed rule 
modification is described in detail in Section II of this publication.
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    \5\ Iron dextran is colloquially referred to as ``pig iron.''
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    In compliance with 16 CFR 1.142(a), the Authority states that the 
reason for adopting the proposed rule modification is to protect 
Covered Horses against the use of iron dextran. Use of iron dextran 
poses significant risks to the safety and welfare of Covered Horses, as 
outlined in the supporting documentation it attached as exhibits to its 
submission to the FTC.\6\ The designation of iron dextran as a Banned 
Substance will prohibit the use of iron dextran in Covered Horses.
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    \6\ Those exhibits are available as a supporting document on the 
docket for this matter at https://www.regulations.gov.
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    The Authority is careful to consider all reasonable alternatives to 
a proposed rule modification. In this case, however, the obvious and 
only course available to protect Covered Horses from the hazards 
involved in the use of iron dextran is to ban its use.
    The Equine Anti-Doping and Controlled Medication Protocol 
(``Protocol'') will affect Covered Persons, Covered Horses, and Covered 
Horseraces. The proposed rule modification will help to ensure that 
Covered Horseraces are 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 will 
be secured by a rule that strictly prohibits the administration and 
possession of iron dextran, by categorizing it as a Banned Substance 
(S6). All Covered Persons will be subject to sanctions set forth in the 
Rule 3000 Series for failure to comply with the new ban.
    To ensure this proposed rule modification is consistent with the 
Act and the rules and regulations applicable to the Authority, the 
Authority took the following principles and mandates into 
consideration. In accordance with 15 U.S.C. 3055(a)(2), which directs 
the Authority to consider the unique characteristics of any breed made 
subject to the Act by election of a State

[[Page 65685]]

Racing Commission or breed governing organization, the Authority notes 
that proposed rule modification is applicable only to Thoroughbred 
horses, because other breeds are not currently subject to the 
jurisdiction of the Authority as Covered Horses. The supporting 
documentation submitted to the Commission along with this proposed rule 
modification sets forth the need for the prohibition of iron dextran 
because of its documented effect upon Thoroughbred horses in 
particular. In developing the proposed rule modification, the Authority 
accounted for the unique characteristics of Thoroughbred horses.
    The Authority also considered the seven factors set forth in 15 
U.S.C. 3055(b) and concluded that they support the addition of iron 
dextran to the list of Prohibited Substances.\7\
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    \7\ Those seven factors are: (1) ``Covered Horses should compete 
only when they are free from the influence of medications, other 
foreign substances, and methods that affect their performance''; (2) 
``Covered Horses that are injured or unsound should not train or 
participate in Covered Horseraces, 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''; (3) ``Rules, standards, procedures, and protocols 
regulating medication and treatment methods for Covered Horses and 
Covered Horseraces should be uniform and uniformly administered 
nationally''; (4) ``Consideration should be given to international 
anti-doping and medication control standards of the IFHA 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 an 
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 examination and diagnostic process''; and (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.'' See the supporting documents on 
the docket at www.regulations.gov for the Authority's complete 
discussion of how these factors relate to the proposed rule 
modification concerning iron dextran.
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    With reference to the baseline standards in 15 U.S.C. 
3055(g)(2)(a), none of them address the regulation of iron dextran. The 
proposed rule modification would not render any rule in the Protocol 
less stringent than previously, because no rule in the Protocol 
currently addresses the regulation of iron dextran.
    Due to the need to act quickly to preserve the safety of Covered 
Horses, the Authority did not solicit informal public comments in 
advance of submitting this proposed rule modification to the 
Commission. However, the Authority did consult with Dr. Dionne Benson, 
Chief Veterinary Officer for The Stronach Group, whose letter in 
support of the proposed rule modification \8\ can be found in the 
supporting documents section of the public docket for this publication 
on www.regulations.gov.
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    \8\ Letter to HISA from Dionne Benson, DVM, JD, Chief Veterinary 
Officer for The Stronach Group, available among the supporting 
documents at www.regulations.gov.
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    With the review, input, and ultimate approval of the Authority's 
Board of Directors, the proposed rule modification to the Rule 4000 
Series Technical Document is submitted for Commission approval. As 
required by 15 U.S.C. 3053(b)(2), the proposed rule modification is 
consistent with the Act and the rules approved by the Commission. The 
Authority has consulted with the Horseracing Integrity and Welfare Unit 
(``HIWU''), the anti-doping and medication control enforcement agency 
with which the Authority has contracted to enforce the Protocol 
pursuant to 15 U.S.C. 3054(e)(1)(b). The HIWU has participated in the 
development of the proposed rule modification and approves of it.

II. Self-Regulatory Organization's Statement of the Terms of Substance 
of the Proposed Rule Modification

    The Authority submits the proposed rule modification to the 
Technical Document to designate iron dextran and other iron dextran 
containing products as Banned Substances under the ADMC Program.
    The risk of serious and potentially fatal adverse reactions to iron 
dextran products, together with its testing limitations, presents a 
risk of misuse and abuse in Covered Horses. Iron dextran products have 
Food and Drug Administration (``FDA'') approval only for the treatment 
and prevention of iron-deficiency anemia in swine. Iron and other 
blood-building supplements nonetheless are often administered to horses 
to maximize red blood cell count, with the belief that they will 
improve energy, stamina, and athletic performance. While the Animal 
Medicinal Drug Use Clarification Act of 1994, 21 U.S.C. 360b, is 
permissive of the extralabel use of FDA-approved products, the 
documented health risk of iron dextran to Covered Horses warrants its 
designation as a Banned Substance under the ADMC Program.
    Iron dextran carries an increased risk of anaphylaxis and death in 
Thoroughbred racehorses, which has prompted some racetracks to ban 
possession of these substances. See Benson Letter at 1, supra 
(``Gulfstream Park and Palm Meadows recently prohibited the possession 
and/or use of injectable iron and injectable iron containing substances 
on track property. This occurred following the sudden death of several 
horses in the past two years across all Stronach Group properties 
shortly after they had been administered injectable iron 
supplements.''); see also Thomas Tobin, MRCVS, Steven G. Kamerling, 
Ph.D., Iron: Its Functions and Metabolism in the Horse, 1986 (``Iron 
dextran injections should not be used to supplement iron. One author 
reported that two Thoroughbreds died within 15 hours of parenteral iron 
dextran injections, and in another case three horses died after the 
intramuscular injection of iron dextran. Similarly, the administration 
of supplements containing iron to neonatal foals has been suggested as 
a cause of death.'').\9\ Iron dextran may also pose a risk to a horse's 
tissues and immune system. See Tobin et al., supra. Oral iron 
supplementation has not been associated with the same risk of 
anaphylaxis in horses as intramuscular injections.\10\
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    \9\ Supporting documents referenced in this publication can be 
found in the public docket for this publication on 
www.regulations.gov.
    \10\ See Natalie Voss, As Gulfstream Prohibits Injectable Iron, 
a Look at the Use of ``Iron Shots,'' Paulick Report (Jan. 12, 2023), 
available at https://paulickreport.com/horse-care-category/as-gulfstream-prohibits-injectable-iron-a-look-at-the-use-of-iron-shots/.
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    Further, to the extent anemia occurs in horses, it is likely 
associated with blood loss or an underlying health condition, as 
opposed to a primary iron deficiency. Thus, equine veterinary experts 
recommend identifying and treating the source of the anemia before 
administering an iron supplement and returning the horse to racing and 
training activities only after the anemia and its cause have resolved. 
See Benson Letter, supra.
    Finally, monitoring and testing for iron dextran products in 
Covered Horses pose significant challenges, as iron is an endogenous 
mineral in the body. See Benson Letter, supra. Thus, it is critical 
that possession of iron dextran products be prohibited under the rules. 
By categorizing iron dextran as a Banned Substance under the ADMC 
Program, it will be prohibited under the Rule 3000 Series.
    All the changes in the proposed rule modification are intended to 
enhance the Rule 4000 Series Technical Document in a manner consistent 
with the Act. The proposed rule modification

[[Page 65686]]

is carefully tailored to the unique character of horseracing and to the 
regulation of Prohibited Substances in Covered Horses.

III. Date of Effectiveness of the Proposed Rule Change and Timing for 
Commission Action

    The Commission must approve or disapprove the proposed modification 
on or before November 24, 2023. If approved, the proposed rule 
modification would be effective immediately.

IV. Request for Comment

    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before October 10, 
2023. Write ``HISA Anti-Doping and Medication Control Rule 
Modification'' on your comment. Your comment--including your name and 
your state--will be placed on the public record of this proceeding, 
including the https://www.regulations.gov website.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we strongly encourage you 
to submit your comments online. To make sure the Commission considers 
your online comment, you must file it at https://www.regulations.gov, 
by following the instructions on the web-based form.
    If you file your comment on paper, write ``HISA Anti-Doping and 
Medication Control Rule Modification'' 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 H), Washington, DC 20580. If possible, please submit 
your paper comment to the Commission by overnight service.
    Because your comment will be placed on the publicly accessible 
website at https://www.regulations.gov, you are solely responsible for 
making sure your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
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 ``any trade secret or any commercial or 
financial information . . . which is privileged or confidential.'' 15 
U.S.C. 46(f); see FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In 
particular, your comment should not include 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), 16 CFR 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), 16 CFR 4.9(c), and the General Counsel grants 
that request.
    Visit the FTC website to read this publication and the news release 
describing it. The FTC Act and other laws 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 October 10, 2023. 
For information on the Commission's privacy policy, including routine 
uses permitted by the Privacy Act, see https://www.ftc.gov/site-information/privacy-policy.

April J. Tabor,
Secretary.
[FR Doc. 2023-20631 Filed 9-22-23; 8:45 am]
BILLING CODE 6750-01-P