Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Synthetic Opiates and Minor Amendments
2017-03-17 2017-01-30 2017-03-27 2017-03-23 2017-03-09 2017-03-24 2017-03-24 2017-03-27 2017-01-25 2017-02-22
DOT-OST-2016-0189-0037 DOT-OST-2016-0189-0009 DOT-OST-2016-0189-0070 DOT-OST-2016-0189-0054 DOT-OST-2016-0189-0032 DOT-OST-2016-0189-0056 DOT-OST-2016-0189-0064 DOT-OST-2016-0189-0068 DOT-OST-2016-0189-0003 DOT-OST-2016-0189-0025
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https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0037 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0009 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0070 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0054 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0032 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0056 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0064 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0068 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0003 https://api.regulations.gov/v4/comments/DOT-OST-2016-0189-0025
Heather Dajuan Edward Lisa Miguel Esther Lena Josephine Teresa Thomas
Healy Leavell Reiskin Bradley Lopez Miller Hess Kenney Creasy Haj
Comments from the Association of Flight Attendants-CWA, AFL-CIO   I Dajuan Leavell a previous employee under the federal Department Of Transportation in Toledo, Ohio will love to comment on the 49 rule of shy bladder. I think that the MRO evaluation process under the shy bladder situation is not reasonable at all.I understand that an individual could hold his or her urine in for 3 hours due to them knowing the results will be positive. Although what about the ones that are negative without a medical history and documentations of urinating problems? They do not get to prove there innocents and they could also loose there livelihood. This is very unfair! its almost like robbery of your career to a existingmedical condition that was currently discovered. There has got to be a better way to prove your innocents in this situation. Its hard to believe the MRO will consider a highly probable condition without medical documentation. I even offered blood and a hair test. YOU LOOSE GOODRELIABLE EMPLOYEES this way. I had never failed a drug test in my life. It hurts so bad its like being convicted of a crime you didnt do. I committed 5 years to my employer no call offs and worked when the needed me, no discipline nothing on my file or record. And this shy bladder situation is a joke when you dont look further into the situation. It could be somethingthat an employee will find out when its too late and lost there job!! You guys have to do better than that!! Thank You for taking the time out to here me out. Please feel free to give feedback. My email is dajuanleavell23@gmail.com March 24, 2017   VIA Federal eRulemaking Portal   Docket Management Facility U.S. Department of Transportation 1200 New Jersey Ave., SE West Building Ground Floor Room W12-140 Washington, DC 20590-0001   Subject: Docket No. DOT-OST-2016-0189   Dear Docket Clerk,   The San Francisco Municipal Transportation Agency (SFMTA) appreciates the opportunity to review the U.S. Department of Transportations (DOT) proposal to revise its drug testing program regulations as follows: Align DOTs regulated-industry drug testing with the Department of Health and Human Services (HHS) laboratory drug testing requirements; Add clarification to certain existing drug-testing provisions; Remove outdated information from DOTs current regulation; and, Remove the requirement for employers and C/TPAs to submit blind specimens.We are in agreement and support the proposed changes. SFMTA would also like to take this opportunity to express its interest in commenting on other aspects of the DOT regulations that are not currently open as part of this proposed rulemaking, such as post-accident testing, definition of an accident, and when drug testing is deemed appropriate. For example, we believe that the current definition of accident may not be broad enough to encompass other situations for which testing may be appropriate, such as serious safety violations, e.g., signal violations.   Specifically, we would welcome an opportunity to comment formally on the following sections of the Code of Federal Regulations (CFR): 49 CFR 655.4: Definitions, Accident; 49 CFR 655.43: Reasonable Suspicion Testing; and, 49 CFR 655.44: Post-Accident Testing.    We strongly encourage DOT to initiate a formal discussion on these issues as soon as possible. If you have any questions or require additional information, please do not hesitate to contact me at 415.701.4720 or Ed.Reiskin@sfmta.com.   Sincerely, Edward D. ReiskinDirector of Transportation   Comment provided by: Lisa Bradley; Certified Training SolutionsRE: DOT-OST-2016-0189-0038We would like to express a similar opinion regarding 40.33, commented by SAPAA.The concern is the requirement for all collectors, BATs, STTs, SAPs, and MROs to subscribe to the free ODAPC list-serve.  This is an excellent idea, and we stress to our trainees that they need to sign up for updates online and that it is their responsibility to keep up with Regulation changes.  However, please consider allowing more time (beyond the October 1, 2017 effective date) for all of these service agents to subscribe to the email updates list.  We intend to communicate to our clients that they must subscribe to the list; however, we believe there will be many service agents that may not be aware of the requirement in such a short time (and thereby, be out of compliance once the Rule takes effect).   We believe that allowing a bit more time for more service agents to hear about the Rule will result in a higher compliance rate once it goes into effect.Some of our clients in covered industries have also expressed concern, since they are responsible for ensuring they use only compliant service agents.  A question to consider is:  Who is responsible for ensuring that all of these BATs, Collectors, etc. actually are on the email updates list and how will it be enforced? Example:  A trucking company uses a collection site/clinic for their urine drug collections, and the DER initially checks to ensure that all currently-employed collectors and BATs are subscribed to ODAPCs list-serve.  However, there is often a lot of turnover in these types of positions at clinics and collection facilities.  If every DER at every covered-company has to call every service agent (and document) frequently -possibly even daily to truly ensure full compliance - this will create significant new costs and record-keeping burdens on covered employers that may not have been considered in the new language.Thank you for the opportunity to comment. I believe that all drivers, in any instance, need to be tested for any kind of drug in their system because it is very unsafe to drive, specially, commercial vehicles under the influence of drugs because these drugs do not let people react as the normally would. Dear Regulators, Ive worked over 20 years in this industry as a marketing rep for a SAMHSA certified lab, a collector-trainer and for a TPA. In my job, I communicate with labs, collection sites, TPAs, BAT techs and employers on the DOT regulations and collection requirements. I agree in the addition of the synthetic opioids and believe this would greatly increase safety for the public and help provide intervention to those who suffer with drug addiction. I also agree with the minor changes mentioned. I do feel the collector training should include the following scenarios for mock collections as a minimum: 1. Standard mock collection (no errors)  2. Shy bladder   A. The normal scenario where the donor eventually provides a full specimen within range  B. The unusual scenario where the donor stays all 3 hours, is compliant, but does not provide a specimen.  3. A specimen offered where the specimen is either temp out of range or appears to be tampered and the donor agrees to the 2nd observed collection. #4 would be the 2nd observed collection, also talking about the other scenarios when an observed collection may be ordered and 5. A refusal to test (being disruptive, not follow collection instruction, etc.) and 5B: Items a donor can refuse to do (i.e. not initial bottles seals or sign the COC form or provide a full SS #, that does not cancel the test when the donor follows all other guidelines. I find when you cover all of these items with mock collections, there are less errors and better retention. I also have found some SAMHSA certified labs have found the ability to test beyond the limited description for substitute specimens in order to capture the use of synthetic urine, (which is a real problem, and needs to be addressed). I believe the actual DOT positive drug test rate is far higher than reported. Labs should be able to use proprietary methods without having to fully disclose what they are except to the MRO who views the test result and the SAMSHA certified labs who would do a secondary confirmation test to verify the same result. Its a little like computer viruses and hackers, labs are always trying to stay one step ahead of the bad guys who would tamper with a test, but under the current DOT regulations, they have to give out the formula on how to do it. This really is a 2nd subject that deserves its own rulemaking. There are currently SAMSHA certified labs that have effectively shut down the majority of use of these kind of tampering agents with NON-DOT tests, the same should be true for DOT testing since the technology is available. I would not advise not adding this subject to the existing recommendations as this would only delay the opioid panels from being added.   The current DOT collector guidelines do not address electronic chain of custody forms in either training guidelines or in practice guidelines. Its recommended that the collector must go through the DOT collector training using standard paper chain of custody forms, and that if the collector will be using electronic chain of custody forms, must have additional training from the vendor on how to properly process the electronic chain of custody form on-line. In addition, common errors include the collector dismissing the donor without providing a specimen without fully allowing for the 3 hour time frame because they are closing for lunch or for the day. This should be a collector error and fatal flaw. I also think unless the site can reliably provide male and female collectors, they should not be able to offer to do a DOT collection, since some observed collections will be initiated during the collection (i.e. specimen temp out of range) which cannot be predicted in advance. I think its also a disservice to claim to offer DOT breath alcohol without having the confirmation(i.e. breath alcohol test) available at the site. The reason is while the clear majority of alcohol saliva tests are negative, when one is positive it most likely is for reasonable cause or post-accident scenario where the outcome is critical. It would also be helpful to include in the observed collection procedure on how to handle a transgender collection. Most collectors agree that the legal sex that is registered on the donors drivers license, however this is a thorny issue with many opinions, so would further recommend this subject have its own rule-making period.  I would also recommend that the opioid panel be flexible enough that the employer and/or MRO can order additional opioid testing not in the expanded panel (i.e. Fentanyl) as the drugs of abuse are constantly evolving and users will continue to change their drugs of abuse in order to avoid detection.  March 24, 2017Anthony R. FoxxSecretary of TransportationAttention: DOT-OST-2016-0189U. S. Department of Transportation1200 New Jersey Avenue, SE.West Building Ground Floor Room W12-140Washington, DC 20590-0001Re: DOT-OST-2016-0189 Procedures for Transportation Workplace Drug and Alcohol Testing Programs: Addition of Certain Schedule II Drugs to the Department of Transportations Drug-Testing Panel and Certain Minor AmendmentsDear Secretary Foxx:As a registered nurse, doctorate student of family nursing practice at the University of Minnesota, and a member of Minnesota Advance Practiced Registered Nurse (APRN) Coalition, I appreciate the opportunity to comment on the 1/23/2017 proposed rule (DOT-OST-2016-0189) regarding the amendment to the Department of Transportations drug-testing panel, as part of the drug-testing program regulation, to include four additional opioids, namely oxycodone, oxymorphone, hydrocodone, and hydromorphone. Advanced practice registered nurses (APRN) strive to improve patient access to quality, cost-effective health care, and work in collaboration with patients to optimize health, concurrently managing multiple health conditions and morbidities, including painful manifestations requiring analgesic therapy.  The choice of analgesic is based on accurate evaluation and diagnosis of the origin of pain, some which require the use of opioids to treat moderate-to-severe pain.  While practitioners strive for judicious and appropriate opioid prescription, opioid over-prescription is still a very real problem affecting our health care system (Centers for Disease Control and Prevention [CDC], 2016).   As you are aware, nearly 250,000 opioid prescriptions were written in the U. S. in 2013, and nearly two million Americans were dependent on or abused opioid prescriptions in 2014 (CDC, 2016).   1.Modification of the drug-testing panelThe amendment proposes to include four additional opioid medications to the list of the Department of Transportations drug-testing panel, including oxycodone, oxymorphone, hydrocodone, and hydromorphone.  As a future APRN, I support this proposal, as these medications are among some of the most abused, resulting in approximately 91 opioid overdose-induced deaths every day in this country (CDC, 2016).  As you know, opioids have depressant effects which result in pain relief, but also can potentiate a state of euphoria, making them subject to misuse (Strain, 2017).  Prescription opioids including those listed in the referenced proposal, have a high risk of developing tolerance, dependence, addiction, and abuse (CDC, 2016). Those who have developed a tolerance may show no external signs of effect despite having opioid use, and may maintain employment and daily functioning (Strain, 2017), yet can still have side effects such as sedation and blunting of cognitive function (McAllister 2016).  As you know, blunted senses can affect an individuals ability to operate machinery including motor vehicles, affecting those using this type of transportation.  While opioid medications have valid and appropriate use to treat moderate-to-severe pain, the degree to which they are abused or are the cause of substance dependence supports the proposed addition to the drug-testing panel for the Department of Transportation.  I support the proposed change in language from opiates to opioids as defined by the description within the proposal, delineating the difference between these two umbrella terms, and expanding the definition to include opiates and semi-synthetic compounds identified above.  The definition of opioids is supported by experts in the field, and therefore, I have no recommendations to modify the language further (National Alliance of Advocates for Buprenorphine Treatment [NAABT], n.d.). Thank you for considering my comments on this important proposed rule.  I look forward to collaborating efforts to continue to improve public health and transportation industry safety for our citizens. Sincerely,Lena Hess, BSN, RN, DNP student References:Centers for Disease Control and Prevention [CDC]. (2016). Injury prevention  control: Opioid overdose.   Retrieved from https://www.cdc.gov/drugoverdose/epidemic/index.html McAlister, M. J. (2016). Treating chronic pain. Retrieved from http://www.instituteforchronicpain.org/treating-common-pain/tolerance-to-opioid-pain-medications National Alliance of Advocates for Buprenorphine Treatment [NAABT]. (n.d.). Opiates/opioids. Retrieved from https://www.naabt.org/education/opiates_opioids.cfmStrain, E. (2017). Opioid use disorder: Epidemiology, pharmacology, clinical manifestations, course, screening, assessment, and diagnosis.  Retrieved from https://www.uptodate.com/contents/opioid-use-disorder-epidemiology-pharmacology-clinical-manifestations-course-screening-assessment-and-diagnosis?source=search_resultsearch=opioid%20toleranceselectedTitle=1~43 NPRM Comments submitted on behalf of First Advantage. With a BS in Business, 25+ years of Human Resources, Safety and Compliance work experience, I have worked for several companies who employ commercial drivers and operate under DOT regulations. The DOT Drug  Alcohol Program has included the same 5-panel drugs for as long as I can remember. As everyone knows, over time new prescription drugs are invented, approved and prescribed by Doctors. In my experience, Commercial Drivers are one group of employees who seem to a) have access to and b) desire the use of narcotic (specifically opiate) class drugs. This may be due to the need/desire to drive longer hours (stay awake), boredom, or actual medical conditions caused from sitting in a truck for hours on end, over many years.The new proposal for Transportation Workplace Drug  Alcohol Testing to add the most abused drugs is essential to the safety of everyone. From an employers standpoint, I can assure you that most commercial drivers are well aware of the drugs which will test positive in a urine screening, and those which are not tested. It is very frustrating to employers when use and possible misuse of certain prescription drugs, such as opiates, is present, but not included as part of the drug screening guidelines.  Personally, I think it would be a wise decision of the USDOT to include language with the new proposed rule to include a three to five year review period, allowing the DOT to review the program and add certain drugs, such as opiates, based on the most abused drugs at each time period. Without the ability to review and include new prescription drugs with known dangerous side effects when operating a vehicle or equipment, this issue will be a never-ending struggle to protect drivers, passengers and the public.As the Safety Manager of a Motor Carrier, I speak for several companies who are happy with the new proposed rule. Anyone who does not want the safety of commercial drivers and the public to be the first goal, either do not care about safety or have a hidden agenda. It is important to remember, prescribed drugs, including opiates are legal if used correctly; it is unlawful to consume a prescription drug without a prescription; which should be enforced the same as for all employees, regardless of his/her position within a company, or self-employed.  Lastly, I think it would be very beneficial for the DOT to investigate the misuse of methadone, suboxone, and other opiate-blocking medications, which are becoming the most widely desired and misused type of drug. These drugs require special testing and commercial drivers (and employees) are aware these drugs are not tested as part of the Drug  Alcohol Program (both Workplace and DOT). These drugs are extremely powerful and include long-lasting, dangerous side effects. I am aware of several vehicle accidents, one involving a death, caused by one driver consuming methadone and passing out while operating the vehicle. Many doctors are prescribing these drugs to offset the abuse of some opiates, but unfortunately, they include the same side effects, especially when misused. Thank you for your time,Teresa Creasy Please excuse me if this is a duplicate comment, since I have no record of a previous contact. I am commenting on the DOT workplace drug testing change which would remove any non-urine testing in the area of paruresis (shy bladder) cases. I am hoping that this change would in no way weaken the shy bladder protocol currently in effect. Of course, allowing oral fluid drug testing as an alternate to urine-only would alleviate this problem and ensure honesty in all those who are being tested.