DOT Update: Proposed Revisions to the CFR Part 40

The Department of Health and Human Services has proposed numerous revisions for the CFR Part 40, including the following:

Proposed Urine Mandatory Guidelines (UrMG):

Add opiate analytes oxycodone, oxymorphone, hydrocodone, and hydromorphone as screening and confirmation analytes.
Include MDA and MDEA as initial tests and confirmatory test analytes. The current guidelines have these two drugs as confirmatory analytes only.
- These proposed guidelines would allow for alternative methods for initial testing other than immunoassay.
The addition of the Schedule 2 prescription medications will require MRO Review to verify legitimate drug use.
Screen oxycodone and oxymorphone at 100 ng/mL and confirm at 50 ng/mL.
Screen hydrocodone and hydromorphone at 300 ng/mL and confirm at 100 ng/mL.
Screen MEA and MDEA at 500 ng/mL and confirm at 250 ng/mL.

Include oral fluid as an alternate collection specimen, revising terms and definitions as needed.

Additional testing for grouped analytes such as opiates and amphetamines, and specification of the cross-reactivity of the immunoassay to the other analyte(s) within the group. The Drug Testing Advisory Board (DTAB) recommends that due to current drugs of abuse trends, the additional opiates Oxycodone, Oxymorphone, Hydrocodone and Hydromorphone should be added to the federal program.

Revise pH adulteration criteria from less than 3 pH to less than 4 pH, as there is no known medical condition that causes urine to have a pH of less than 4.5.

Allow reporting an invalid result when the specimen is not consistent with human urine, as evidenced by additional specimen validity test results (i.e., testing for uric acid to distinguish human urine from synthetic).

Clarify that collection site records must be stored at a secure site designated by the collector or the collector’s employer. Additionally, that Section 5.4 allows hard-copy records to be discarded 6 months after they have been converted to electronic records.

Subpart H Revisions

Allow federal agencies to authorize the collection of oral fluid when a donor does not provide an adequate urine specimen.

Require an assessment of potential interferences during assay validation. Include additional requirements for alternate technology initial drug tests based on the characteristics of these technologies.

To allow use of external service providers, remove the requirement for laboratories to report results directly to MROs. This will reduce MROs’ recordkeeping burden, which is expected to increase following the implementation of Electronic CCFs.

Require regular re-qualification training and re-examination given the inclusion of Schedule 2 drugs. This does not include having to obtain continuing education units (CEUs). MRO training must now include information about how to discuss substance misuse and abuse and how to access rehabilitation services.

Addresses MRO procedures for multiple specimens from the same testing event (e.g., TOR sample and the subsequent test).