Administrative Rule of the Month - 71 IAC 8-1-1 Medication (Expired)

This month, IBOP's Administrative Rule of the Month takes a look at an administrative rule that the Indiana Horse Racing Commission (IHRC) has allowed to expire as of January 1, 2013. ‘71 IAC 8-1-1 Medication,’ which is a standardbred racing rule, has expired and is no longer in effect. For a little background, administrative rules in Indiana expire on January 1st following their sixth year anniversary of their approval unless they are modified or readopted. ‘71 IAC 8-1-1’ was last modified in 2006. The equivalent administrative rule in the flat racing rulebook, ‘71 IAC 8.5-1-1 Medication’ was last readopted in 2007 so its expiration date will be January 1, 2014 unless modified prior to then. Here's how the standardbred ‘Medication’ rule looked prior to its expiration:

71 IAC 8-1-1 Medication
Authority: IC 4-31-3-9
Affected: IC 4-31-12
Sec. 1. (a) No horse participating in a race or entered in a race shall carry in its body any foreign substance as defined in 71 IAC 1, except as provided for in this rule.
(b) No substance, foreign or otherwise, shall be administered to a horse entered to race by:
(1) injection;
(2) jugging;
(3) oral administration;
(4) tube;
(5) rectal infusion or suppository;
(6) inhalation; or
(7) any other means;
within twenty-four (24) hours prior to the scheduled post time for the first race except furosemide as provided for in this rule. The prohibition [sic., prohibitions] in this section include, but are not limited to, injection or jugging of vitamins, electrolyte solutions, and amino acid solutions. The prohibition also includes, but is not limited to, the administration of breathing compounds for oral and nasal dosing, such as Traileze, Vapol, Vicks vapor-rub, wind-aid, exhale ease, or containing methylsalicylate, camphor, or potassium iodide.
(c) Substances or metabolites thereof which are contained in equine feed or feed supplements that do not contain pharmacodynamic or chemotherapeutic agents are not considered foreign substances if consumed in the course of normal dietary intake (eating and drinking).
(d) The prohibition in subsection (b) notwithstanding, the use of nebulizers are permitted on an entered horse within twentyfour (24) hours of the scheduled post time for the horse's race until the horse's arrival in the paddock provided their use is restricted to water and saline solutions only.
(e) Topical dressings such as leg paints, liniments, ointments, salves, hoof dressings, and antiseptics which do not contain anesthetics or a pharmacodynamic or a chemotherapeutic agent may be administered at any time prior to a horse's arrival in the paddock. Products containing "caine" derivatives or dimethylsulfoxide (DMSO) are foreign substances and are prohibited. (Indiana Horse Racing Commission; 71 IAC 8-1-1; emergency rule filed Feb 10, 1994, 9:20 a.m.: 17 IR 1168; emergency rule filed Mar 25, 1996, 10:15 a.m.: 19 IR 2078; emergency rule filed Feb 13, 1998, 10:00 a.m.: 21 IR 2410; readopted filed Oct 30, 2001, 11:50 a.m.: 25 IR 899; emergency rule filed Feb 21, 2003, 4:15 p.m.: 26 IR 2384; emergency rule filed Mar 10, 2006, 11:00 a.m.: 29 IR 2217; errata filed Apr 10, 2006, 2:00 p.m.: 29 IR 2546)

Here’s how the standardbred rulebook will look as soon as the Indiana Register is updated to note the expiration:

71 IAC 8-1-1 Medication (Expired)
Sec. 1. (Expired under IC 4-22-2.5, effective January 1, 2013.)

So, why would the IHRC allow '71 IAC 8-1-1 Medication' to expire? What does the IHRC have to gain by allowing an administrative rule to expire? The better question is what does the IHRC hope to avoid by allowing this rule to expire? The answer is that the IHRC is attempting to avoid going through the regular rulemaking process with this rule. The ‘why’ to this expiration actually began on January 24, 2012 when the IHRC added ’71 IAC 8-1-4.2 Threshold levels’ which established a specific threshold for the use of DMSO and a few other medications. You’ll notice in the text above 71 IAC 8-1-1(e) states, “Products containing "caine" derivatives or dimethylsulfoxide (DMSO) are foreign substances and are prohibited.” What the IHRC had done was create conflicting rules where one allowed for the use of DMSO while another prohibited the use of DMSO.

IBOP brought this conflict to the IHRC’s attention on April 27, 2012 with a petition under IHRC rules to have the conflicting language removed. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/04/on-april-27-2012-following-was-sent-to.html .) This conflict also became a major point within our Administrative Rule of the Month for May, 2012: http://ibopindy.blogspot.com/2012/04/administrative-rule-of-month-dimethyl.html. By not covering this conflict at their June or August meetings, the IHRC allowed racing to take place throughout 2012 knowing that there were problems with their medication rules. In advance of their October 12, 2012 meeting, on October 2, 2012, IBOP submitted a “second request” to the IHRC. (To view this email, please follow this link: http://ibopindy.blogspot.com/2012/10/second-request-to-modify-medication.html .) As part of the New Business portion of the October 12th meeting, ‘71 IAC 8-1-1 Medication’ was considered. However, since the rule was due to expire on January 1, 2013 the commissioners approved the rule’s readoption without fixing the conflict regarding DMSO use! This, of course, made no logical sense.

According to the approved minutes for that October 12, 2012 meeting, “General Counsel Ellingwood presented two rules (71 IAC 8-1-1 and 71 IAC 8-1-5.6) to the Commission that are scheduled to sunset at the end of 2012. Commission unanimously voted to begin the process for re-adoption of 71 IAC 8-1-1 and 71 IAC 8-1-5.6.” Using the emergency rulemaking process to fix the DMSO oversight actually made perfect sense. Instead, on October 17, 2012 the IHRC staff filed a ‘Notice of Intent to Readopt” both rules which can be found at this link:
http://www.in.gov/legislative/iac/20121017-IR-071120572RNA.xml.pdf. (Please note that 71 IAC 8-1-5.6 was another unrelated expiring rule that allows for use of anti-ulcer medications.)

For additional background, Indiana statue, under IC 4-22-2.5-4(a) which is copied below allows for multiple rules to be readopted at the same time with one readoption notice. If you read the notice from the link above, you will also see the following, “Requests for any part of this readoption to be separate from this action must be made in writing within 30 days of this publication.” Indiana law, under IC 4-22-2.5-4(b) copied below provides for requests to be made to have a rule or rules be considered separately from the submitted readoption notice. So, knowing that the conflicting language regarding DMSO needed to be fixed, and citing that conflict, on November 1, 2012 IBOP filed a request under IC 4-22-2.5-4(b) to have 71 IAC 8-1-1 be considered separately. Based upon the language in the statute, “....the agency must” readopt the rule separately and “follow the procedure for adoption…..under IC 4-22-2 with respect to the rule.”

IC 4-22-2.5-4
Request for separate readoption of rules
Sec. 4. (a) Except as provided in subsection (b) and subject to section 3.1 of this chapter, an agency may readopt all rules subject to expiration under this chapter under one (1) rule that lists all rules that are readopted by their titles and subtitles only. A rule that has expired but is readopted under this subsection may not be removed from the Indiana Administrative Code.
(b) If, not later than thirty (30) days after an agency's publication of notice of its intention to adopt a rule under IC 4-22-2-23 using the listing allowed under subsection (a), a person submits to the agency a written request and the person's basis for the request that a particular rule be readopted separately from the readoption rule described in subsection (a), the agency must:
(1) readopt that rule separately from the readoption rule described in subsection (a); and
(2) follow the procedure for adoption of administrative rules under IC 4-22-2 with respect to the rule.
(c) If the agency does not receive a written request under subsection (b) regarding a rule within thirty (30) days after the agency's publication of notice, the agency may:
(1) submit the rule for filing with the publisher under IC 4-22-2-35; or
(2) elect the procedure for readoption under IC 4-22-2.
As added by P.L.17-1996, SEC.7. Amended by P.L.188-2005, SEC.7; P.L.215-2005, SEC.10; P.L.1-2006, SEC.76; P.L.123-2006, SEC.18.

To fully grasp the impact of IBOP’s request to have 71 IAC 8-1-1 be considered separately, you have to understand that IC 4-22-2 prohibits the readoption of an administrative rule by use of the emergency rulemaking process. Therefore, the IHRC can’t simply approve the rule then file it with the Indiana Register as a final or readopted rule. According to Indiana statute, the IHRC “must” go through the regular rulemaking process which includes, among other steps, a public hearing, approval by the attorney general, and approval by the governor. In the history of the IHRC, the regular rulemaking process has never been used to establish or readopt one single rule. So, their scramble began.

On November 15, 2012, we were informed by IHRC’s General Counsel Lea Ellingwood via an email that our second request to amend ‘71 IAC 8-1-1 Medication’ and the flat racing version, 71 IAC 8.5-1-1, was tentatively scheduled to be considered at the IHRC’s next meeting on December 14, 2012. Now, all of a sudden, IBOP’s petition to amend these rules seems very important to the IHRC staff. In that email, we were asked to provide the IHRC a “redlined version” of the rule with our proposed changes. This seemed like a strange request as IBOP has submitted (and successfully had modified) four other pairs of administrative rules in 2012 without being asked to provide a redlined (edited) version. There was no mention of our request to have 71 IAC 8-1-1 considered separately through the regular rulemaking process. We immediately withdrew our petition to have 71 IAC 8-1-1 amended via emergency rulemaking stating, “We will provide appropriate comments when 71 IAC 8-1-1 is considered separately from the Notice of Intent to Readopt filed by the commission on October 17, 2012.”

To our surprise, when the agenda for the IHRCs December 14, 2012 meeting was posted one of the agenda items was “Consideration of emergency rule re: 71 IAC 8-1-1 and 71 IAC 8.5-1-1, Medication.” Upon arriving at the December 14th meeting, sure enough, one of the hand-outs was IBOP’s petition to modify both of 'Medication' rules and our redlined versions of each. Of course, there was no mention of the withdrawal of our petition to amend 71 IAC 8-1-1 or the fact that a request was made to have 71 IAC 8-1-1 considered separately through the regular rulemaking process.

Unfortunately, due to the length of the meeting, the consideration of the ‘Medication’ emergency rules was pushed back to the IHRC’s next meeting. Essentially, what the IHRC was attempting to do is readopt 71 IAC 8-1-1 via an emergency rulemaking process, which is prohibited by Indiana statute, rather than be forced to go through the regular rulemaking process. They had eight months to fix the DMSO conflict, but chose not to do so. And, only when faced with being required to go through the regular rulemaking process for the first time did fixing the rule make sense. What we fully expect is that at their first meeting in 2013 the IHRC will use their emergency rulemaking authority to replace the ‘Medication’ rules with a different version and/or take a different approach with overall medication rules as a cover. We fully expect the readoption of 71 IAC 8-1-1 through the regular rulemaking process, as required under Indiana statute, to be ignored.

The question that remains unanswered is who is making these decisions? The commissioners approved the readoption of 71 IAC 8-1-1 at their public meeting on October 12, 2012. Only a majority vote of the commissioners can change a prior IHRC action. With IBOP’s request, Indiana statute appears to compel the readoption of 71 IAC 8-1-1 via the regular rulemaking process. Yet, we don’t see that happening. In fact, with the expiration, 71 IAC 8-1-1 can never be used in the Indiana Administrative Code ever again. Nor, can ‘71 IAC 8-1-5.6 Anti-ulcer medications,’ the other administrative rule that was readopted by the IHRC on October 12, 2012, be used. As we always say, ‘we couldn’t make this stuff up even if we tried.”