Horseracing Integrity and Safety Authority Anti-Doping and Medication Control Rule Modification, 65683-65686 [2023-20631]
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Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices
NYSHEX technology council meetings,
and other discussions relevant to the
management of NYSHEX in addition to
participating in NYSHEX Board
meetings. The Amended would also
remove Ocean Network Express Pte.
Ltd. (ONE) and add Mediterranean
Shipping Company SA.
Proposed Effective Date: 10/30/2023.
Location: https://www2.fmc.gov/
FMC.Agreements.Web/Public/
AgreementHistory/2064.
Dated: September 20, 2023.
Carl Savoy,
Federal Register Alternate Liaison Officer,
Federal Maritime Commission.
[FR Doc. 2023–20674 Filed 9–22–23; 8:45 am]
BILLING CODE 6730–02–P
Carl Savoy,
Federal Register Alternate Liaison Officer,
Federal Maritime Commission.
FEDERAL MARITIME COMMISSION
[Docket No. 23–05]
[FR Doc. 2023–20642 Filed 9–22–23; 8:45 am]
Rahal International Inc., Complainant
v. Hapag-Lloyd AG, Hapag-Lloyd
(America), LLC, and Hapag-Lloyd USA,
LLC, Respondents and Third-Party
Complainants v. Maher Terminals,
LLC, GCT New York LP, and GCT
Bayonne LP, Third-Party Respondents;
Notice of Filing of Third-Party
Complaint; Correction
Federal Maritime Commission.
Notice; correction.
AGENCY:
ACTION:
On September 8, 2023, the
Federal Maritime Commission (FMC)
published a document in the Federal
Register of September 15, 2023,
concerning a third-party complaint filed
in Docket No. 23–05. This document
incorrectly designated Hapag-Lloyd
USA, LLC as a Third-Party
Complainant.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
ddrumheller on DSK120RN23PROD with NOTICES1
Amy Strauss, Acting Secretary, (202)
523–5725 or secretary@fmc.gov.
SUPPLEMENTARY INFORMATION: In the
Federal Register of September 15, 2023,
on page 63575:
1. in the first column remove the
document title and replace with the
following: Rahal International Inc.,
Complainant v. Hapag-Lloyd AG,
Hapag-Lloyd (America), LLC, and
VerDate Sep<11>2014
20:11 Sep 22, 2023
Hapag-Lloyd USA, LLC, Respondents
and Hapag-Lloyd AG and Hapag-Lloyd
(America), LLC, Third-Party
Complainants v. Maher Terminals, LLC,
GCT New York LP, and GCT Bayonne
LP, Third-Party Respondents; Notice of
Filing of Third-Party Complaint
2. in the second column, both times
it appears, remove ‘‘Hapag-Lloyd AG,
Hapag-Lloyd (America), LLC, and
Hapag-Lloyd USA, LLC’’ and replace
with the following: Hapag-Lloyd AG
and Hapag-Lloyd (America), LLC
3. in the second column, remove the
following paragraph: Respondent and
Third-Party Complainant Hapag-Lloyd
USA, LLC is a United States subsidiary
and agent of Hapag-Lloyd AG with its
office located in Atlanta, Georgia.
Jkt 259001
BILLING CODE 6730–02–P
65683
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.
DATES:
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 antidoping 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.
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.
FOR FURTHER INFORMATION CONTACT:
FEDERAL TRADE COMMISSION
[File No. P222100]
Horseracing Integrity and Safety
Authority Anti-Doping and Medication
Control Rule Modification
Federal Trade Commission
Notice of Horseracing Integrity
and Safety Authority (HISA) proposed
rule modification; request for public
comment.
AGENCY:
ACTION:
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.
SUMMARY:
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1 15
2 16
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U.S.C. 3051 through 3060.
CFR 1.142.
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Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices
HISA listed as
HISA status
*
BANNED ...........
S6
*
ddrumheller on DSK120RN23PROD with NOTICES1
*
*
*
Penalty subclassification
(specified Substances
are designated with ‘x’)
*
*
.........................................
*
*
*
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/
P222100CommissionOrder
AntiDopingMedication.pdf.
20:11 Sep 22, 2023
Jkt 259001
Iron Dextran,
Colloquial
Name: Pig
Iron.
*
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 antidoping 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
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
VerDate Sep<11>2014
Substance
Commercial
name(s)
(developmental
names)
Action
*
Iron deficiency
anemia treatment.
*
*
Nonemic,
Ferrextran,
Imposil,
Uniferon.
*
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
5 Iron
dextran is colloquially referred to as ‘‘pig
iron.’’
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Detection time
Screening limit (unless
otherwise designated
as a threshold).
Where no value is listed for serum or plasma
the substance
*
*
*
*
described in detail in Section II of this
publication.
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.
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
6 Those exhibits are available as a supporting
document on the docket for this matter at https://
www.regulations.gov.
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Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
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.
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.
VerDate Sep<11>2014
20:11 Sep 22, 2023
Jkt 259001
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.
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 antidoping 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 irondeficiency 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
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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65685
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
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
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/asgulfstream-prohibits-injectable-iron-a-look-at-theuse-of-iron-shots/.
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65686
Federal Register / Vol. 88, No. 184 / Monday, September 25, 2023 / Notices
is carefully tailored to the unique
character of horseracing and to the
regulation of Prohibited Substances in
Covered Horses.
ddrumheller on DSK120RN23PROD with NOTICES1
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 webbased 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
VerDate Sep<11>2014
20:11 Sep 22, 2023
Jkt 259001
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]
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GENERAL SERVICES
ADMINISTRATION
[Notice–Q–2023–04; Docket No. 2023–0002;
Sequence No. 33]
Federal Secure Cloud Advisory
Committee; Notification of Upcoming
Meeting
Federal Acquisition Service
(Q), General Services Administration
(GSA).
ACTION: Meeting notice.
AGENCY:
As stipulated by the Federal
Advisory Committee Act (FACA), GSA
is hereby giving notice of a series of four
(4) open public meetings of the Federal
Secure Cloud Advisory Committee
(FSCAC). Information on attending and
providing public comment is under the
SUPPLEMENTARY INFORMATION section.
DATES: The open public meetings will
be held on Thursday, October 19, 2023,
from 1:00 p.m. to 3:00 p.m., Eastern
Daylight Time (EDT); Thursday, October
26, 2023, from 1:00 p.m. to 3:00 p.m.,
EDT; Thursday, November 2, 2023, from
1:00 p.m. to 3:00 p.m., EDT; and
Thursday, November 9, 2023, from 1:00
p.m. to 3:00 p.m., EST. The agendas for
the meetings will be made available
prior to the October 19, 2023 meeting
online at https://gsa.gov/fscac.
ADDRESSES: The meetings will be
accessible via webcast. Registrants will
receive the webcast information before
the meeting.
FOR FURTHER INFORMATION CONTACT:
Michelle White, Designated Federal
Officer (DFO), FSCAC, GSA, 703–489–
4160, fscac@gsa.gov. Additional
information about the Committee,
including meeting materials and
agendas, will be available online at
https://gsa.gov/fscac.
SUPPLEMENTARY INFORMATION:
SUMMARY:
Background
GSA, in compliance with the
FedRAMP Authorization Act of 2022,
established the FSCAC, a statutory
advisory committee in accordance with
the provisions of FACA (5 U.S.C. 10).
The Federal Risk and Authorization
Management Program (FedRAMP)
within GSA is responsible for providing
a standardized, reusable approach to
security assessment and authorization
for cloud computing products and
services that process unclassified
information used by agencies.
The FSCAC will provide advice and
recommendations to the Administrator
of GSA, the FedRAMP Board, and
agencies on technical, financial,
programmatic, and operational matters
regarding the secure adoption of cloud
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]]>Agencies
[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
