November 22, 2017
Patrice M. Kelly
Director, Office of Drug and Alcohol Policy and Compliance
1200 New Jersey Avenue, SE
Washington, DC 20590
RE: Docket Number DOT-OST-2016-0189 Recently Published Final Rule Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Certain Schedule II Drugs to the Department of Transportation's Drug-Testing Panel and Certain Minor Amendments
Dear Director Kelly:
The American College of Occupational and Environmental Medicine (ACOEM) is providing comments regarding certain provisions of the recently published Final Rule regarding changes to CFR Part 40. Specifically, the Final Rule includes a change in MRO procedures that was not announced in the Notice of Proposed Rulemaking. We are asking for reconsideration of this change, especially as it has not yet gone through the regulatory process including public review and comment.
ACOEM has received considerable feedback from its MRO members indicating concern and surprise regarding the revised requirements that mandate that an MRO institute a five-day pause before reporting medication-related safety concern. We would like to point out the following issues:
Expressed Concern of MRO “Disruption”
We understand from reading the Final Rule explanations that DOT received public comments expressing concern that MROs would cause disruption by flagging prescription medication as safety issues. In response, DOT has modified Part 40 with the intent that MROs be able to reconcile their safety concerns by discussion with the prescribers rather than involving the employer or other responsible party. In the preamble, DOT explains that it prefers “to ensure that the employee is not caught by surprise by an MRO’s decision to report the medical information regarding a legally valid prescription to a third party.”
ACOEM is surprised by this assertion. MROs have held to protocols and procedures that are time-honored and have worked well. We believe that during our interview processes that are held with donors when potential safety sensitive issues arise, that MROs adhere to their training whereby clear instructions are conveyed to the donor that such safety sensitive concerns will be shared with the employer and why. MROs have long held a duty to the general safety of the public, and we believe that our responsibilities include enhancing this public safety by expressing these concerns as early as possible to the employer or other responsible party so that employees in safety-sensitive positions can be evaluated promptly and appropriately by local specialists. We fail to understand how delaying reporting for 5 days reduces “disruption” in this process; rather we offer that the introduction of this 5-day delay will instead increase disruption to the confidence employers will have in placing safety-sensitive employees in positions during this 5-day period (after the negative drug test report is received but before the MRO notification of a safety- sensitive concern is received).
MRO Practice Changes and Concerns
Our members have indicated that they will need to change their day-to-day practices because of these final rule changes. Not only are they unprepared to make these changes in a timely fashion given that the time between the Final Rule published date and initiation date is less than 60 days, but many feel that it will be an undue burden that has not been taken into consideration by the Department.
There can be no question that the addition of synthetic opioid testing will create an increase in the amount of MRO work in reviewing laboratory positive results due to the widespread use (both legally and illegally) of these medications within the United States. While MROs have been well prepared for this to occur, and have been supportive of these additions, adding additional staff and changing processes by January 1, 2018 in order to meet the requirements of this 5-day pause rule was unanticipated and will prove difficult. Systems will need to be set in place so that the MRO does not forget to report at the appropriate time (5 days later) where prior the reporting of the negative result and the safety sensitive concern could be done concurrently.
There will also need to be systems placed by MROs to deal with the 5-day delay reporting requirement if the MRO who made the initial negative determination and safety sensitive concern is not available 5 days into the future to then make the report to the employer. This occurs often in MRO practices, especially those in larger practices where MROs may not be available due to illness, scheduled time away, vacations, etc.
The MRO Role is to Determine Whether There is a Legitimate Medical Explanation for a Laboratory Result, Not to Serve as Fitness for Duty Evaluators
The DOT drug testing programs are not intended to address medical fitness for duty. Although ACOEM clearly understands that determining medical fitness is important in the process of determining qualification for safety sensitive positions, we have advocated keeping a clear delineation between the role of an MRO and the role of a health care provider making fitness for duty determinations.
Safety is best assured by the MRO alerting the employer and/or employer’s local occupational health provider. Those individuals are in the best position to review the job duties and the company’s policies. The local occupational health provider can meet with the donor, get signed releases as needed, and more thoroughly and reliably address and monitor the safety concern. While it is possible that a donor could have his/her prescriber contact the MRO and resolve the concerns, this rarely happens.
In the preamble to the Final Rule, DOT assumes that the pause will reduce the number of safety concerns that MROs report. This assumption overestimates the ability of MROs to resolve safety concerns and stop donors from taking addictive drugs. Even if the donor’s physician tells the MRO that he/she will stop prescribing hydrocodone or oxycodone, a donor who has been taking large amounts of opioids will probably keep taking them. If the donor’s physician stops prescribing opioids, the donor will probably get them from somewhere else. For example, if the truck driver is prescribed large amounts of opioids and the prescriber tells the MRO he will stop prescribing them, does that really eliminate the safety concern?
MRO Liability Concerns
ACOEM has received considerable communication from its MRO members regarding responsibility for liability in the situation whereby an accident occurs within the 5-day window that occurs after the negative drug test is reported (which triggers the employer to give the green light to their employees operating in safety sensitive positions) and when a safety-sensitive concern is raised. The Final Rule places the MRO in a precarious position: legally being directed to withhold safety-sensitive concerns for 5 days while knowing that a donor could be at even extremely high risk of causing an incident.
We do not see in the Final Rule any language to protect the MRO in this situation. For this reason, we believe that the 5-day pause rule is a very bad idea and that the process should continue as it currently does with the MRO having the ability to disclose a safety-sensitive concern as soon as possible.
Discordance Between 5-Day Pause for Safety Sensitive Medication Concern v. Other Medical Concern
There seems to be an inconsistency within the new language in Part 40.135 as it singles out the 5-day pause rule for medications but does not address a pause notification for other medical conditions where a safety sensitive issue might occur. MROs are authorized under Part 40.327 to notify the employer or other responsible party of medical information that raises qualification or safety concerns. The term “medical information” means more than just medications. For example, an MRO may learn that a truck driver is taking seizure medication, and will then seek assurance that the employer’s NRCME medical examiner knows that the driver has a seizure disorder, which is a disqualifying condition for truck driving. The five-business day pause applies to medication-related safety concerns only according to Part 40.135. We do not understand how it could apply for medications but not for medical conditions.
In conclusion, we ask the Department of Transportation to rescind this portion of the Final Rule, or if it is indeed desired, to propose the change and seek public comment, perform a cost analysis, and reconsider the implementation period.
Charles M. Yarborough III, MD, MPH, FACOEM