SGC-49-13-00014-A To Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo Medrol) in Standardbred Racing

1/21/15 N.Y. St. Reg. SGC-49-13-00014-A

NEW YORK STATE REGISTER

VOLUME XXXVII, ISSUE 03

January 21, 2015

RULE MAKING ACTIVITIES

NEW YORK STATE GAMING COMMISSION

NOTICE OF ADOPTION

 

I.D No. SGC-49-13-00014-A

Filing No. 1115

Filing Date. Dec. 31, 2014

Effective Date. Apr. 01, 2015

To Limit the Use of the Corticosteroid Methylprednisolone Acetate (e.g., Depo Medrol) in Standardbred Racing

PURSUANT TO THE PROVISIONS OF THE State Administrative Procedure Act, NOTICE is hereby given of the following action:

Action taken:

Amendment of section 4120.2(e)(9); and addition of sections 4120.2, (e)(21), (m) and 4120.3(a)(15) to Title 9 NYCRR.

Statutory authority:

Racing, Pari-Mutual Wagering and Breeding Law, sections 103(2), 104(1), (19) and 122

Subject:

To limit the use of the corticosteroid methylprednisolone acetate (e.g., Depo Medrol) in standardbred racing.

Purpose:

To enhance the integrity and safety of standardbred horse racing with new corticosteroid rules.

Text of final rule:

Paragraph (15) would be added to subdivision (a) of the proposed new section 4120.3 as follows:

§ 4120.3. Equine drug thresholds; per se

(a) A horse shall have raced in violation of this section if any of the following substances is found, by the laboratory conducting tests for the commission, to be present in a race-day urine or blood sample taken from such horse at a concentration in excess of a threshold listed below. The test result of such laboratory shall include an assessment of the measurement uncertainty and imprecision of the quantitative threshold for the substance.

(15) Methylprednisolone: 100 pg/ml in plasma

Subdivision (e) of Section 4120.2 would be amended as follows:

(e) The following substances are permitted to be administered by any means until 48 hours before the scheduled post time of the race in which the horse is to compete:

***

(9) hormones and non-anabolic steroids, e.g., progesterone, estrogens, chorionic gonadotropin, glucocorticoids [(e.g., Prednisolone, Depomedrol)], except in joint injections as restricted in subdivision (i) of this section;

***

(21) notwithstanding paragraph (9) of this subdivision, the corticosteroid methylprednisolone (e.g., Depo Medrol) is not a substance that is permitted to be administrated by any means until 48 hours before the scheduled post time of the race in which the horse is to compete.

A new subdivision (m) would be added to section 4120.2 as follows:

(m) A horse may not race after an administration of any formulation of methylprednisolone (e.g., Depo Medrol) unless such horse subsequently tests below the threshold set forth in section 4120.3 of this Part for such drug in a test conducted by or for the commission at the sole expense of the trainer of the horse, and is released to race by the presiding judge.

Final rule as compared with last published rule:

Nonsubstantive changes were made in sections 4120.2(e)(25), (l) and 4120.3(a).

Text of rule and any required statements and analyses may be obtained from:

Kristen Buckley, Acting Secretary, New York State Gaming Commission, 1 Broadway Center, PO Box 7500, Schenectady, NY 12305-7500, [phone], email: [e-mail]

Revised Regulatory Impact Statement, Regulatory Flexibility Analysis, Rural Area Flexibility Analysis and Job Impact Statement

The changes made to the rulemaking proposal do not require a revised RIS, RFA, RAFA or JIS as they are non-substantive in nature; therefore, the impact on small businesses, local governments, jobs, or rural areas remains the same as presented in the rule as originally proposed in the State Register on December 4, 2013.

The non-substantive changes were to renumber the proposed Section 4120.2(e)(25) as 4120.2(e)(21), the proposed Section 4120.2(l) as 4120.2(m), and the proposed Section 4120.3(a)(22) as 4120.3(a)(15), and to reword the technical description of laboratory test results (e.g., changing the word “evaluation” to “assessment”) in Section 4120.3(a).

Initial Review of Rule

As a rule that does not require a RFA, RAFA or JIS, this rule will be initially reviewed in the calendar year 2019, which is no later than the 5th year after the year in which this rule is being adopted.

Assessment of Public Comment

The Commission received public comments that are included in the record of its duly noticed legislative rulemaking public hearing held on January 21, 2014. Standardbred industry representatives stated that joint injections with corticosteroids, one such corticosteroid being methylprednisolone (e.g., Depo-Medrol), should not be regulated with thresholds and restrictions that prevent their use with a horse that races on the industry-standard weekly basis. Many testified from personal experience or statistical data that standardbred horses are very unlikely to experience a catastrophic injury as a result of a corticosteroid treatment, corticosteroids provide effective treatment of joint soreness, failing to treat joint soreness may cause a catastrophic injury as a horse shifts too much weight to other limbs, and the financial considerations faced by standardbred owners if banned from using any corticosteroid joint injections with a horse racing on a weekly basis may result in turning to other treatments that are dangerous to the health of the horse and the integrity of racing. One practicing veterinarian noted that the Commission had proposed thresholds for five corticosteroids but none for other commonly used corticosteroids, and observed that thresholds that did not account for the treatment of multiple joints between races were too strict and would cause inadvertent threshold violations. Representatives of the Racing Medication and Testing Consortium (“RMTC”) recognized special concerns with RMTC’s recommended threshold and withdrawal guideline for joint administrations with Depo-Medrol, for which research was based on treating only one or two joints using just one (e.g., a dose calculated by a horse’s weight) clinically accepted veterinary practice. RMTC indicated, including in its written materials for the public hearing, that this corticosteroid could not be used intramuscularly without greatly extending its withdrawal time, that its clearance time more than doubled when the research joint injection dose was increased from 100 to 200 mg, and that a large number of threshold violations occurred at first when the proposed threshold had been adopted in one state. RMTC further indicated that while the proposed threshold for this drug was derived for a pre-selected withdrawal period of seven days, to provide a sufficient period of time before entering to race for a thoroughbred horse to be evaluated after its treatment, a test result in excess of this threshold would not prove an administration of the drug occurred within such time period. Rather, a test result not in excess of the proposed threshold for this drug is consistent with no methylprednisolone having been administered within seven days of the horse’s race.

The Commission has concluded that further study is appropriate before adopting its proposed lengthier restricted time periods for all corticosteroid joint and systemic administrations and four corresponding thresholds, but methylprednisolone causes further concern because it has a serious potential degenerative effect with long-term use. The adoption of the proposed national threshold for methylprednisolone and a protective use restriction, accordingly, is appropriate to curtail the widespread use of this drug, allowing its use in circumstances when a trainer and veterinarian find its efficacy is sufficiently valuable to off-set a period of race ineligibility, while imposing no similar restrictions on the use of other common corticosteroids (e.g., joint therapy with betamethasone or triamcinolone acetonide, systemic use of dexamethasone or prednisolone) that present a much lower risk of joint degeneration. The use restriction for methylprednisolone performs the essential function of providing a simple instruction for trainers to follow for when it is permissible to race a horse after the administration of this drug and ensures that a trainer who complies will not incur a threshold violation with the drug.

A further assessment of the public comments is provided in the following official Fact Findings in regard to this legislative rulemaking proposal that the Commission, based on decades of institutional knowledge and close supervision of thoroughbred horse racing in New York, the veterinary expertise of Equine Medical Director Scott Palmer, D.V.M., and consultation with internationally-renowned equine pharmacologist, toxicologist, and equine practices scientific consultant, George A. Maylin, D.V.M., M.S., Ph.D, made on December 22, 2014.

The Commission made the following rulemaking fact findings with regard to this rulemaking:

Agency Finding L:

Methylprednisolone is a corticosteroid that the Commission finds requires the strictest regulation because of various factors, e.g., (1) the drug can be particularly harmful to the long term health of treated joints and tissues, (2) the drug has the potential to affect race performance for an unusually long period of time, (3) the drug will persist in the bodily system of a horse for an unusually long period of time, particularly if some of the drug is injected outside of the joint capsule. Methylprednisolone is a particularly harmful corticosteroid in terms of potential degenerative effect from long-term use, and the needless degeneration of joints aided by injudicious use of methylprednisolone is a serious equine health and safety concern. There are several other corticosteroids that widely used for treating race horses that are not as long-lasting or potentially degenerative, e.g., joint therapy with betamethasone or triamcinolone acetonide, systemic use of dexamethasone or prednisolone, and that present a much lower risk of joint degeneration. Even when administered systemically, methylprednisolone can circulate into joint capsules and contribute to potential joint degeneration. The adoption of the proposed threshold and use restriction for methylprednisolone is appropriate to curtail the widespread use of this drug, allowing its use in circumstances when a trainer and veterinarian find its efficacy is sufficiently valuable to off-set a period of race ineligibility.

Agency Finding M:

The following threshold for methylprednisolone is reasonable because it is consistent with proscribing the administration of even a small clinical dose in a single joint within seven days before a horse’s next race and prevents the clinical use of this particular corticosteroid in a regularly (weekly) racing standardbred horse. The Commission lacks sufficient scientific data to create a threshold for methylprednisolone that is violated only by an administration within such time period because of various factors, e.g., (1) multiple joints are often treated; (2) certain joints are interconnected; (3) various size doses are consistent with accepted veterinary practice; (4) other substances may be included with a corticosteroid in a joint injection. The most reasonable threshold for standardbred racing for methylprednisolone is a threshold that at least proscribes the efficacious use of clinical doses of the drug within seven days of racing.

15. Methylprednisolone: 100 pg/ml in plasma

Agency Finding N:

The Commission’s use restrictions for each drug are designed to provide the horseperson with an assurance that a horse will not incur a positive laboratory finding following an administration of the drug in a regimen that is consistent with accepted veterinary practice, e.g., the administration of a clinical dose. The new threshold for methylprednisolone requires, in order for the use restriction for such drug to provide such an assurance, that the administration of any formulation of methylprednisolone results in the horse being ineligible to race until the horse tests below the threshold and is released to race by the presiding judge. A clinical dose of this drug may result in a positive test for more than 50 days after some joint injections, yet a small clinical dose in a different joint may result in a concentration in the horse’s plasma below the threshold value within seven days. As a result, a single restricted time period may be unreasonable for this drug. The Commission also lacks sufficient scientific data to formulate a reasonably precise restricted time period that can protect regulated parties in all circumstances; there are too many unknown variables to adopt a specific time period for this drug. The use of this drug is particularly harmful to the potential long-term health of a horse, and the prohibition of the use of this drug is one reasonable alternative. Rather than prohibit all together the use of this drug, whose use might be the best therapeutic option in some circumstances, a use restriction that the horse must test negative and be released to race by the presiding judge will limit the use of this drug to such circumstances and will provide the Commission and regulated parties with a use restriction that is reasonable to apply.