1. DOT Drug Testing What’s New? What’s the Same?
Dr. Donna Smith
Regulatory Compliance Officer

2. 49 CFR Part 40 Final Rule Nov 13, 2017 What is Part 40?
49 CFR Part 40 is the procedural regulation that governs how drug and alcohol testing programs must be conducted under anti-drug and alcohol use prevention program regulations of the DOT agencies
6 DOT agency regulations require drug/alcohol testing of safety-sensitive employees—FAA, FMCSA, FRA, FTA, PHMSA, and USCG
When did he final rule go into effect?
January 1, 2018
What does the final rule change for employers’ DOT-mandated drug testing programs?
DOT drug panel is expanded to include additional opioid drugs—hydrocodone, hydromorphone, oxycodone and oxymorphone
DOT drug testing panel no longer includes MDEA, but continues to test for the designer amphetamines MDMA and MDA
Blind specimen submissions to the laboratories are no longer required

3. Expanded Drug Panel
Is the DOT drug panel still considered a 5-drug panel?
Yes. The 5 drug classes are Marijuana (THC),Cocaine, Amphetamines, Opioids, and PCP
The term used for the Opiates class of drugs has been changed to used the broader term “Opioids”.
This class of drugs will now include testing for morphine, codeine, 6-AM (heroin) and the expanded drugs, hydrocodone, hydromorphone, oxycodone, and oxymorphone
Why did the DOT expand the testing panel to include these drugs—all of which have legal medical uses?
The opioid drugs included on the panel are controlled substances and can be legally prescribed by physicians and HCPs, however they are also drugs that are diverted to the illegal drug market, are abused, and have potential adverse effects on workplace safety.

4. Expanded Drug Panel
What are the cut-off levels for these additional drugs?

5. Expanded Drug Panel
What type of medications will cause a positive test for the additional opioid drugs?
Controlled substance medications containing oxycodone, oxymorphone, hydrocodone or hydromorphone. They must be prescribed; not available as OTC medications
Some common names for these semi-synthetic opioids include OxyContin®, Percodan®, Percocet®, Vicodin®, Lortab®, Norco®, Dilaudid®, Exalgo®.
These medications are generally prescribed as medications for acute or chronic moderate to severe pain. They are often written as PRN—or use when needed
Will the opioid testing detect methadone, fentanyl, or Tramadol or any of the tranquillizers? No
If the employee has a prescription for an opioid drug that is detected in his/her specimen, how will the MRO report it?
Opioid positive tests will be handled like any other non-negative laboratory result
If acceptable prescription documentation is presented by the employee, the MRO will report the test as Negative

6. Safety & Fitness for Duty
Are there safety issues for a DOT-covered employee taking a prescribed opioid medication?
Possibly. The MRO will evaluate the potential for adverse impact on safety as part of the verification interview with the employee.
If the MRO believes there is a significant safety risk with the employee’s continued use of the opioid drug(s), the MRO will instruct the employee to have his/her prescribing HCP contact the MRO to discuss possible change to or discontinuance of the medication(s).
If the prescribing HCP does not contact the MRO within 5 days, the MRO will report a safety concern to the employer
If the prescribing HCP discontinues the medication or changes the medication to one that does not present a significant safety risk, the MRO will not report a safety concern
If the prescribing HCP contacts the MRO and states that the medication is not being changed or discontinued, the MRO will report a safety-concern and recommend a fitness-for-duty evaluation of the employee
NOTE: The DOT rule now specifies that the MRO must report the Negative result to the employer and then wait before reporting a medication “safety-concern” until the above process is complete

7. Safety & Fitness for Duty
Will the opioid testing be able to determine if an employee is taking medications as prescribed or is abusing or misusing them?
No. As with any urine drug testing, the opioid result does not have a relationship to the dose used, the timing of the use, or frequency of use.
The test result does not establish if an employee was “under the influence” or impaired by the drug at the time the specimen was collected.
Can the MRO make a fitness for duty assessment or determination based on the test result or information gathered during the MRO interview with the employee?
No. Fitness for duty determinations based on the employee’s use of medications should be made by the employee’s personal physician or an occupational health physician who examines and interacts in-person with the employee.

8. DOT Notice to Employees: Expanded Panel
DOT published a notice to all safety-sensitive employees on December 11, concerning the expanded drug panel
Explains the testing for the semi-synthetic opioids
Discusses employees’ obligations to inform employers and/or medical qualification examiners of medications they are taking
Reminds employees of their obligation to have a conversation with their prescribing physician(s) to discuss their safety-sensitive work. 
Explains reporting of medication safety-concerns to the employer or other third party by the MRO.
Employee will have up to five days to have his/her prescribing physician contact the MRO. 
Employee is responsible for facilitating the contact between the MRO and the prescribing physician. 
Employee’s prescribing physician should be willing to state to the MRO that employee can safely perform his/her safety-sensitive functions while taking the medication(s), or consider changing the medication to one that does not make the employee medically unqualified or does not pose a significant safety risk.
Notice posted at:

9. DOT Notice to Employers: Policy Requirements December 1, 2017
No need for employers to make any changes if their current DOT policies refer to adhering to “... Part 40.” However, there are exceptions when an employer’s DOT policy lists the following optional information:
If sub-categories of drugs tested under the 5-panel are listed – for example, if a policy lists "Opiates (codeine, heroin, & morphine)" then “Opiates“ needs to change to “Opioids (codeine, heroin, morphine, oxycodone, oxymorphone, hydrocodone, hydromorphone.  If however, employers would like to delete the sub-categories of drugs, doing so will also be acceptable.
Likewise, if cut-off levels are listed in current policies, employers must update those cut-off levels. Again, employers may simply delete the cut-off levels completely and be in compliance if the DOT policy refers to adhering to “... Part 40.”
While these DOT Agencies and USCG suggest that employers provide written notice to employees about their updated DOT policies, doing so is an employer's prerogative.

10. MRO Safety Concern on DOT Verified Negative Test
Will be reported up to 5 days after Negative has been reported to employer
DOT states that MRO cannot indicate to employer that safety-concern determination is pending; nor can the MRO delay reporting the verified negative until medication safety concerns have been determined by the MR
What will the MRO reveal in reporting a medication safety concern?
General statement that MRO believes continued performance of safety-sensitive functions by the employee using prescribed (or OTC medications) presents a significant safety risk
Specific information naming the medication(s) considered by the MRO to constitute a safety risk
General safety concern notice with statement that medical professional conducting a fitness for duty evaluation/assessment may contact the MRO for more specific information
Employer must decide what action(s) to take when safety-concern notice is given by MRO
Remove employee from performing safety-sensitive functions until medication safety concern is resolved/addressed.
Have employee sign a “disclaimer” stating that his prescribing HCP’s are aware of all medications he/she is using and is aware of his/her job functions and has determined that the employee can safely work.

11. Employer Actions on MRO Safety Concern
Options for resolving/addressing MRO safety-concerns
If employee is subject to DOT medical qualification standards (CMV driver, pilot, mariner), require employee to return to an examiner, provide all medication information to examiner and undergo re-examination.
Have prescribing physician provide statement that employee is able to perform safety-sensitive duties while taking medications
Have employee undergo “fitness for duty” evaluation by employer designated physician (recommended--Occupational Medicine physician)
Important for employer to have medication policy and procedures in place
MRO cannot make “fitness for duty” recommendation based on donor interview and urine drug test result

12. Medications and Drug Testing
Urine drug testing cannot identify medication abuse/misuse
Amount of drug detected in urine cannot be correlated to dosage, frequency of use, impairment or date/time of last use.
If employee has a legitimate prescription (in his/her name, legally dispensed, etc.), that explains the drug test result, the MRO, under federal rules is expected to report the test as negative.
There is no “expiration date” for controlled substance medications.
The MRO cannot question the prescribing physician’s “appropriateness” in prescribing the medication
MRO process will not necessarily identify multiple prescriptions obtained from more than one HCP
There is no way for an MRO to interpret a UDS in terms of normal therapeutic range for medications prescribed
DOT does not consider marijuana, CBD oils & products, hemp products as “medication”, thus use of these substances, even in states where “medically authorized” is NOT considered a legitimate medical explanation for a THC positive urine test.

13. Additional Laboratory Testing Changes
The DOT testing panel will no longer detect and report MDEA, one of the analogue amphetamines.
MDMA (Ecstasy) and MDA (also a metabolite of MDMA) will continue to be detected and reported for DOT drug testing
The laboratory will report a specimen as adulterated—abnormal pH when the pH is less than 4. This is a change from the previous adulterated pH value of 3.
Adulterated specimens, after MRO verification are generally reported as Refusal to Test
There are three additional “fatal flaws” that will cause the laboratory to reject a specimen for testing
These flaws involve the receipt of a specimen without a CCF, receipt of a CCF without a specimen, and receipt of two specimen collections with only one CCF.
These will reported by the MRO as test cancelled—fatal flaw

14. Specimen Collection Changes
The Final Rule clarifies that a collector shall not send a “questionable or suspect” specimen to the laboratory unless there is second specimen collected under direct observation that is sent to the laboratory
A “questionable or suspect” specimen is one that shows signs of tampering or manipulation by the donor (e.g. temperature out of range, abnormal color, odor or physical appearance)
If the attempt to collect the second specimen under direct observation ends in a “shy bladder” or the donor leaves the collection site before providing an adequate D.O. specimen, the first specimen is discarded. On the CCF documenting the attempt to collect the second specimen the collector shall enter remarks stating that the first specimen was discarded.
The CCF copies documenting the “shy bladder” or donor refusal (e.g. leaving collection site) are distributed to the DER and the MRO. The DER must be informed immediately (usually via phone) that the attempt to collect the second specimen was unsuccessful

15. New 2017 Federal Custody & Control Form (CCF)
Is there a new CCF for DOT drug testing?
Yes. The government issued a revised CCF for federal drug testing in August, 2017.
This CCF replaces the current 2013 version of the federal CCF & is very similar.
The 2017 CCF added hydrocodone, hydromorphone, oxycodone,& oxymorphone to Section 5A (primary specimen report) on CCF copy 1 and changed Section 1D to have only one block checked for a DOT agency test
Can the “old” (2013) CCF be used for DOT testing after Jan 1 and will the expanded panel be used by the laboratories for those tests?
Yes. The 2013 CCF can be used until June 30, Any specimen arriving at the laboratory with a federal CCF marked as a DOT test in Step 1 D will be tested for the expanded drug panel and in compliance with Part 40 Final Rule requirements
There is no requirement for statement of correction needed when a 2013 CCF is used. After June 30, a statement of correction detailing why an expired CCF was used will be requested by the laboratory.
Can MROs report positives for the expanded opioid drugs after January 1,2018 using the “old” CCF copy 2.
Yes, the MRO Sections (Step 6 & 7) of CCF Copy 2 remain the same on the 2017 CCF. The MRO writes in the name of the drug(s) the specimen is verified positive for.

17. What’s the Same?
Medical marijuana is still not accepted as an explanation for a positive THC drug test
Regardless of state or local laws, or a physician’s “prescription” for marijuana, “medical marijuana” or “legal marijuana” use is not acceptable as an explanation for a positive THC test
Use of CBD oils or other “hemp oil” products cannot be considered a legitimate medical explanation for a positive THC test.
Only urine specimens can be used for DOT drug testing—no oral fluids or hair specimens permitted
DOT also does not permit “instant” or “rapid result” Point of Collection Testing (POCT). All specimens must be tested at a DHHS certified laboratory
No DNA testing permitted on DOT urine specimens
MRO cannot order testing for drugs not on the DOT panel (e.g. fentanyl, methadone, etc.)
MROs can order further testing on methamphetamine positives to determine the chiral isomers (d & l) and on THC positives to determine if THC-V metabolite is present to distinguish pharmaceutical THC (e.g. Marinol) use from smoking marijuana

18. What’s Ahead?
FMCSA National Clearinghouse for drug and alcohol violations by Commercial Drivers Licensed (CDL) employees
49 CFR Part 382 was amended to include requirements for a national database tracking positives and refusals to test on CDL applicants/employees
Implementation and requirements for reporting to the Clearinghouse are effective January 6, 2020.
SAMHSA is working to include oral fluid testing for federally mandated drug testing.
Final revisions to the DHHS Mandatory Guidelines are expected in 2018
DOT would need to engage in rulemaking in order to allow oral fluid testing for DOT mandated drug testing
Trucking (Motor Carrier) Associations are advocating hair testing for DOT- mandated pre-employment drug testing
SAMHSA is studying the efficacy of hair testing for drugs of abuse as a potential specimen for use in DOT and other federally mandated drug testing.