Notice2023-20631
Horseracing Integrity and Safety Authority Anti-Doping and Medication Control Rule Modification
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 25, 2023
Issuing agencies
Federal Trade Commission
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 184 (Monday, September 25, 2023)</title>
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[Federal Register Volume 88, Number 184 (Monday, September 25, 2023)]
[Notices]
[Pages 65683-65686]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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), <a href="https://www.ftc.gov/system/files/ftc_gov/pdf/P222100CommissionOrderAntiDopingMedication.pdf">https://www.ftc.gov/system/files/ftc_gov/pdf/P222100CommissionOrderAntiDopingMedication.pdf</a>.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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 <a href="http://www.regulations.gov">www.regulations.gov</a> 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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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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
<a href="http://www.regulations.gov">www.regulations.gov</a>.
\10\ See Natalie Voss, As Gulfstream Prohibits Injectable Iron,
a Look at the Use of ``Iron Shots,'' Paulick Report (Jan. 12, 2023),
available at <a href="https://paulickreport.com/horse-care-category/as-gulfstream-prohibits-injectable-iron-a-look-at-the-use-of-iron-shots/">https://paulickreport.com/horse-care-category/as-gulfstream-prohibits-injectable-iron-a-look-at-the-use-of-iron-shots/</a>.
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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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>,
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>, 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 <a href="https://www.ftc.gov/site-information/privacy-policy">https://www.ftc.gov/site-information/privacy-policy</a>.
April J. Tabor,
Secretary.
[FR Doc. 2023-20631 Filed 9-22-23; 8:45 am]
BILLING CODE 6750-01-P
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This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.