DOT PUBLISHES NOTICE OF PROPOSED RULEMAKING FOR DRUG & ALCOHOL TESTING

Those of you who read the January issue of this publication may remember the comment that the U.S. Department of Transportation (DOT) was going to publish a notice of proposed rulemaking (NPRM) in the near future. Well, here it is; on February 4, 2010, DOT published the NPRM for 49 CFR Part 40. A copy may be obtained from the Federal Register web site at: http://edocket.access.gpo.gov/2010/pdf/2010-2315.pdf

Why is DOT doing this? As mentioned last month, DOT is required by The Omnibus Transportation Employee Testing Act of 1991, to use laboratories certified by, and testing procedures of, the U.S. Department of Health and Human Services (HHS) to ensure ``the complete reliability and accuracy of controlled substances tests.'' Since Congress specifically limited the scientific testing methodology upon which the DOT can base its drug and alcohol testing regulations, the DOT must follow the HHS scientific and technical guidelines. The NPRM is an attempt by the DOT to amend certain provisions of its drug testing program to create consistency with the new technical requirements established by the HHS Mandatory Guidelines.

The major changes that the DOT is proposing are as follows:

1. The DOT proposes changing some of the definitions and adding a few new ones to make them consistent with the HHS definitions.

2. The DOT proposes to allow employers to have the option to choose between using a full service drug testing laboratory and an Instrumented Initial Test Facility (IITF).

3. The DOT wants to add IITF’s to the laboratory section of their regulation and spell-out how an IITF should perform urine drug testing.

4. The DOT is proposing to adopt the following additional HHS laboratory testing requirements:

- Conduct initial testing for methylenedioxymethamphetamine (MDMA) commonly known as ``ecstasy,''
- Conduct confirmatory testing for methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA), which are close chemical analogues of MDMA,
- Conduct initial testing for 6-Acetylmorphines (Heroin),
- Lower the initial test and confirmatory test cutoff concentrations for Amphetamines; and
- Lower the initial test and confirmatory test cutoff concentrations for Cocaine.

5. The DOT is also proposing to amend Appendix B so that IITF’s will be required to report semi-annual test results to employers and Appendix C so that IITF’s would report semi-annual test data to the DOT.

6. The HHS Mandatory Guidelines will require that nationally recognized Medical Review Officer (MRO) certification entities or subspecialty boards for medical practitioners must have their qualifications, training programs, and examinations approve by the HHS on an annual basis. The DOT is seeking comments on whether Part 40 should also require these groups to be approved.

There are a number of other issues that the DOT also addresses in the NPRM. Many of these are related to the HHS procedural requirements, some of which the DOT does not want to adopt. For example, the DOT does not propose to require observers to receive advanced formalized training to learn about the steps necessary to perform a direct observation collection. The DOT does not propose to change their current requirement that a collector need not obtain prior approval from a collection site supervisor before performing a directly observed collection. Also, the DOT will continue to require collection sites to keep Copy 3 of the Custody and Control Form for only 30 days versus the new HHS requirement to keep the form for two years.

Other issues are related to the HHS requirement to audit 5 percent or a maximum of 50 collection sites; a 3 percent level of blind specimen testing versus current DOT 1 percent requirement; MRO record retention time frame and type of records that MROs maintain; and limits on IITF and MRO relationships.

A few of the issues may be of interest to employers. For example, what exactly is an Instrumented Initial Test Facility (IITF)? It is a mouthful, but the answer is relatively simple. The HHS published Proposed Revisions to their Mandatory Guidelines in the Federal Register on April 13, 2004. At that time, they proposed establishing permanent locations where initial testing, reporting of results, and record keeping were to be performed under the supervision of a responsible technician. These facilities would be certified by the HHS, but would not have the full capabilities to conduct confirmation testing. Any non-negative results would have to be forwarded to one of the current certified laboratories. The assumption was that some laboratories might want to establish IITFs to be closer to their customers and provide faster negative results to employers.

At this point, there are no IITFs established, so it is difficult to state how effective and how widely they will be used. As mentioned, the DOT will give an employer the option to use an IITF or a “regular” laboratory. One scenario, which may require watching, is whether or not use of IITFs will increase the lag time for reports related to non-negative results. In other words, if an IITF comes up with a non-negative result, they must package the specimens and forward them to the laboratory that can conduct confirmation testing. Will this increase the length of time for reporting non-negative results remains to be seen?

Although not clearly stated, another issue of interest is that the HHS will require initial testing for 6-Acetylmorphines without waiting for the MRO to request this test. The presence of this metabolite is proof of heroin use and the MRO does not have to find clinical evidence of illegal drug use. Of importance to employers is the fact that most of these changes – which may change again after comments from the public – will need to be added to their current drug and alcohol policies.

The DOT is requesting comments to their NPRM by April 5, 2010. Although the proposed changes do not seem to be dramatic or extensive, nevertheless, it behooves employers to read the NPRM and provide input to the DOT. Procedures on how to provide comments are listed in the NPRM.