DOT Regulation Changes.
There are some DOT Regulation changes that may be on the horizon. The DOT published a Notice of Proposed Rule Making (NPRM) on January 23, 2017, proposing revisions to the current Part 40 drug and alcohol testing regulations. A major revision is intended to harmonize the DOT regulations with new HHS regulations that were published on the same date. DOT is proposing a few changes to the regulations that are not required by the new HHS regulations, and is also using the revision to clean up some typos and some outdated sections of the regulations. Here’s what you need to know for now.
What do HHS “Mandatory Guidelines for Federal Workplace Drug Testing Programs” have to do with the 49 CFR Part 40 DOT regulations? The answer is that the HHS Mandatory Guidelines are directed towards drug testing of Federal employees; they do not apply to DOT drug testing. However, DOT is required to follow HHS Mandatory Guidelines for the categories of drugs for which DOT tests. Therefore, when HHS changes the drugs to be tested, DOT must make a corresponding change in the Part 40 regulations.
What is an NPRM, or Notice of Proposed Rule Making? Does this mean that the proposed rules will become the final rule? Federal agencies are required to issue NPRM in order to give notice and to solicit feedback from those affected by the proposed rules, prior to issuing final regulations. Historically, DOT has made at least a few modifications to proposed rules when issuing final regulations.
When will the final regulation be implemented? We don’t know. The deadline for submitting comments for this NPRM is March 24, 2017. DOT will take some time to review all the comments and then write a final regulation. Our guess is that DOT will publish a final regulation sometime later this year. The final regulation will give an effective date sometime in the future to allow adequate time for affected parties, in particular laboratories, to make the necessary changes to implement the new regulation. However, because laboratories must already be prepared to comply with the October 1, 2017 effective date of the HHS Mandatory Guidelines, it is conceivable that DOT may also make their final regulation effective on October 1, 2017 as well.
What are the proposed rules that I need to know about? There is a fairly long list of changes in the NPRM, many of which are relatively minor. We’ll focus on just a few of the more significant changes.
Expanded Synthetic Opiates Testing
Perhaps the most significant HHS change is testing for synthetic opiates. HHS recognizes that we are in what some call an opioid epidemic, and has responded by requiring testing for hydrocodone, hydromorphone, oxycodone, and oxymorphone to the existing opiate panel. The new panel will be called “opioids.” This is the change in HHS regulations that DOT is required to implement. The DOT NPRM includes all the HHS changes regarding synthetic opiates.
Removal for Blind Specimen Testing
Another significant proposed change is to do away with the requirement for employers and C/TPAs to submit blind specimens. DOT gives several reasons for this proposed change. There are adequate laboratory quality control measures already in place; in 17 years there have been no documented false positives by laboratories; the “B” specimen bottle provides adequate safeguards for the accuracy of laboratory testing; and DOT, as with all Federal agencies, has a mandate to reduce the regulatory burden if possible. DOT projects a savings of $3.1 million with this change.
Collectors, MROs, STTs, BATs, and SAPs required to subscribe to the ODAPC list-serve
The list-serve sends automatic email notifications whenever DOT announces a change in the regulations and/or wants to bring issues of importance to service agents – for example, the notice about the NPRM. Although the current regulations require that each individual keep up to date on any changes to the regulations, the regulations don’t spell out how this is to be done.
New reason for a Public Interest Exclusion (PIE)
Under the title of “Prohibition against use of federal branding” the NPRM proposes a rule that permits a Public Interest Exclusion for a service agent that falsely represents that “the service agent or its activities is approved or certified by the Department or a DOT agency.” The NPRM gives examples such as the use of a DOT or a DOT agency logo, title or emblem.
The links below will take you to the NPRM where you can learn about the other proposed changes. The preamble and discussion of the proposed rules are probably more informative than just reading the proposed rules.
Will the CCF change?
HHS will publish a revised Federal CCF to accommodate the additional synthetic opioid drugs, and plans to make the revised CCF effective on October 1, 2017, the same date as the HHS Mandatory Guidelines. DOT uses the Federal CCF.
Is there anything in the revised HHS Mandatory Guidelines that DOT chose not to include in the NPRM?
Observed Collection Change
One notable change in the new HHS Mandatory Guidelines concerns observed collections. HHS Guidelines will require the observer be the same gender as the donor’s “gender identity,” which may be different than the gender assigned at birth. Just to be clear, DOT is not proposing to implement this change.