30 + PART 40 Changes Not Related To Oral Fluid Drug Testing

Effective June 1, 2023; DOT final rule on oral fluid includes the amendment of some provisions of Part 40 to harmonize with the United States Department of Health and Human Services (HHS) urine and oral fluid Mandatory Guidelines. This included clarifications, removal of unnecessary provisions, and modification of a few substantive provisions to address issues that have arisen in practice. This post outlines Part 40 changes, additions, amendments or clarifications not specifically related to DOT oral fluid drug testing.

Items of change, modification, addition or clarification to Part 40 specifically related to oral fluid drug testing are included here: 49 CFR Part 40 Changes & Updates Oral Fluid

What are the 49 CFR Part 40 changes and updates effective June 1, 2023?  

Some clarifications and definitions are not listed as some of these change are not substantive and designed to conform Part 40’s wording with that of the HHS guidelines. Many sections of Part 40 have been redesignated to allow for the oral fluid drug testing information and other clarifications, removal of unnecessary provisions, and modification of a few substantive provisions to address issues that have arisen in practice.   

The main change to Part 40 is the inclusion of oral fluid drug testing as an option for DOT required drug testing. More information about DOT oral fluid drug testing is included on our web page entitled: DOT Oral Fluid Drug Testing, Collections & Mocks. 

PART 40 Changes Not Specifically Related To Oral Fluid Drug Testing

Some sections of Part 40 have been redesignated in addition there are other clarifications, removal of unnecessary provisions, additions, amendments and modification of a few substantive provisions to address issues that have arisen in practice. These that are not specifically related to the DOT oral fluid drug testing are listed below.

1. Added definitions for “oral fluid specimen” and “urine specimen.”
2. Employer Designated Employer Representative (DER) name and phone # must now be included on the drug testing CCF form in Step 1A. It is not required that this information be pre-printed on the CCF.
3. Reminder that DER’s have always been required to be available to collectors 24-7, this is even more important now.
4. Changes adopted to remind C/TPAs for motor carrier owner/operators of the C/TPA’s respective nondelegable duty to make a determination of whether a refusal has occurred when the owner/operator fails to timely report for a test that is not for pre-employment. Changes adopted and similar language added to remind employers of their duty to make a determination on refusals; the final determination is the DER’s.  
5. New section 40.191(d) emphasizes the role of the collector in a refusal is to notify the employer about the circumstances the collector believes constitute a refusal, but the employer must decide whether a refusal occurred – “the employer has the sole responsibility to decide whether a refusal occurred.”
6. A second sentence added to 40.191(c) and 40.261(b) reminds the employee and employer that the consequences specified under DOT agency regulations for a violation cannot be overturned or set aside by an arbitration, grievance or State court tasked with adjudicating the personnel decisions the employer decides to take against the employee. 
7. Addition of the defined term – “alternate specimen” as an authorized specimen of a type other than the one previously collected (e.g., in a case where the initial collection was urine, oral fluid would be an alternate specimen).
8. Clarification and new definition of “SSN or Employee No.” which is the identifying number used for an applicant or employee in the drug & alcohol testing program. The new definition will allow a collector, MRO, SAP, Breath Alcohol Technician (BAT), Screening Test Technician (STT) or other service agent or employer to utilize only the CDL number and State of issuance for FMCSA regulated drivers tested under Part 382, and to allow the CDL number to be used as an option on tests conducted under the authority of the other DOT agencies. The definition also allows any other State- or federally issued identification number to fulfill the Part 40 requirement for a unique identification number. 
9. Modification to 40.40, if an MRO, laboratory, employer or any DOT staff need to speak with the collector, the telephone number provided on the CCF must give access directly to that collector and/or the collector’s supervisor during the collection site’s business hours. The collector must not provide a number for a call center.
10. Modification to 40.40(c)(2)   – “Fax numbers may be included but are not required.”
11. Change to 40.33(F) to clarify that a collector is not subject to the time and costs of retraining for errors outside the collection process, such as in transportation process events 
12. ODAPC will provide an ODAPC Oral Fluid Specimen Collection Guidelines document, separate from their Urine Specimen Collection Guidelines document 
13. Substances Abuse Professionals (SAP) will be allowed to conduct evaluations either in-person or remotely, with specific criteria as conditions for remote evaluations.
14. A requirement for a party seeking to reverse a cancellation to consult ODAPC if the decision is being made more than 60 days after the cancellation,
15. New paragraph added to 40.13 to specify that a drug or alcohol test administered as directed by a medical examiner, exclusively as part of a medical examination required for an employee to qualify for a certificate or license, is not a DOT drug or alcohol test under Part 40 and related DOT agency drug and alcohol testing rules. 
16. A new paragraph added to 40.13 to further emphasize that DOT drug and alcohol tests are authorized to be conducted only on safety-sensitive employees as designated in the agency drug and alcohol testing regulations. DOT-regulated tests must not be conducted on non-regulated persons (i.e., those who do not perform  DOT regulated safety-sensitive duties). 
17. Clarification and addition to 40.21 referring to stand down; new paragraph to prevent the employer to send an employee back in for another test using a different specimen type after receiving a verified negative result. 
18. Addition to 40.23 regarding invalid specimen requiring subsequent direct observation collection to be either be an oral fluid collection or a urine collection under direct observation. 
19. Clarification of 40.25 regarding previous employer checks which differ for FMCSA regulated employers due to the FMCSA Clearinghouse query requirement. However, since the Clearinghouse does not include drug and alcohol violations committed by employees of other DOT agency-regulated employers, FMCSA-regulated employers must continue to comply with the requirements of § 40.25 when hiring an employee who has been employed by another DOT agency-regulated employer.  
20. Amendment to 40.61(e)  to instruct the collector to tell the employee they can find instructions for completing the CCF on specific HHS and DOT websites.
21. Revision to 40.65 to ensure that when an immediate re-collection under direct observation is needed (e.g., because the temperature of a urine specimen is out of range or there are signs of tampering), regardless of whether the first specimen was urine or oral fluid, the required directly observed collection could be either urine or oral fluid
22. Revision to 40.67(a)(4) to include permission for an employer to send an employee in for an immediate recollection if the employer discovered a direct observation should have been conducted but was not.
23. Added language to 40.67(g)(3); stating that even if an employer does not usually utilize oral fluid testing, that employer should have agreements or arrangements either directly, or through its C/TPA, for oral fluid testing to be used for directly observed collections of transgender or nonbinary employees. 
24. Modification to 40.71(b)(1) regarding instructing the collector of a urine specimen to check both the boxes for “urine” and “split specimen” on the CCF; the words “after the collection” have been added for the purpose of reminding the collector to check the boxes under Step 2 after the collection takes place. 
25. Amendment to 40.79(a)(1) to note that the employee must provide all information required in Step 5 of the revised CCF. The collector has a duty to attempt to get the employee to provide the information or note in the remarks section that this was not done.
26. A new sentence to § 40.159(a)(5)(ii), which would require re-collection when an invalid test is cancelled. The added sentence directs that an alternate specimen be collected if practicable (e.g., oral fluid, if the specimen was urine).

Medical Review Officer (MRO) Specific Changes, Additions, Clarification

1. MRO change to 40.129(b) – cancelled tests do not require both Copies 1 and 2, as the other verified non-negative results listed would require. The MRO will be able to use either copy or to issue a report, if Copy 1, Copy 2, or both are missing.
2. MRO requirement to consult ODAPC if the reversal of a test cancellation occurs more than 60 days after the test was cancelled.
3. 40.141(b) has been changed to allow MRO assistants (staff) to contact pharmacies to verify a prescription that an employee has cited as a potential legitimate medical explanation for a laboratory-confirmed positive test. No part of the MRO’s verification interview of the donor will change, only the subsequent checking with the pharmacy to authenticate the prescription. Additional language added to set a performance standard for MROs to ensure oversight and quality control measures. 
4. 40.327 adds a clarification requiring MROs not to use the CCF to transmit information about safety concerns to employers or other authorized parties. Rather, a separate communication (e.g., secure email or letter) must be used and will specify whether the MRO’s safety concern relates to the use of a medication, the type of medical condition for which such a medication is typically prescribed, or some combination of the two.

Learn more on our upcoming webinars: DOT Oral Fluid Drug Testing – What you Need to Know!