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.

DOT Drug and Alcohol Testing - Past, Present and Future

Well, this is the start of a new year and a time to reassess where we have been, where we are, and where we are going. Last year, 2009, was a year that concentrated primarily on one item in the DOT drug-testing program – direct observation testing for return-to-duty and follow-up testing. All the energies and efforts of the DOT were spent defending their decision – and they were ultimately successful in the courts.

Interestingly enough, although this seemed a controversial subject, there really was little fallout from this policy decision – collection sites seemed to accept the fact that they now had to do direct observation collections in these situations (something that employers had an option to do anyway under the previous policy) and employers seemed to accept this change as the price of doing business. Other then that and the fact that the economy was taking a hit, 2009 was a dull year.

Current status? Employers must continue to meet the Federal regulatory requirements for conducting drug and alcohol testing; the program is not going away. As the economy improves, employers must not forget that drug testing is one of those operational necessities that must be in place – no different than other personnel and operational policies and procedures that they have to have in place to meet Federal and other legislative requirements to stay in business. As employers return to a hiring posture, more pre-employment drug and alcohol testing will have to take place and employers need to plan for this added cost increase.

The future – since no one can predict it – is a lot more fun! What will happen is any ones guess. However, there are a few indicators that the program will get a little more complicated and require more diligence to implement. Two things will be happening within the next few months. On November 25, 2008, the Department of Health and Human Services (HHS) published a revision of their Mandatory Guidelines for Federal Drug Testing Programs, which will become effective May 1, 2010. This Final Notice addresses collection and testing of urine specimens, the requirements for the certification of Instrumented Initial Test Facilities (IITFs), the role of and standards for collectors and Medical Review Officers (MROs), and adds additional drugs to those currently being tested. A copy of the revised guidelines is available at: http://workplace.samhsa.gov/DrugTesting/Files_Drug_Testing/Federal/frmanguide2008.pdf.

Proposed Revisions to the Mandatory Guidelines addressing the use of point of collection testing (POCT), oral fluid testing, sweat patch testing, hair testing, and associated issues will be published at a later date. According to the HHS, with regard to the use of alternative specimens including hair, oral fluid, and sweat patch specimens in Federal Workplace Drug Testing Programs, significant issues have been raised by Federal agencies during the review process, which require further examination, and may require additional study and analysis. When and if HHS approves use of alternative specimens, then the whole landscape of Federal drug testing will change. Employers will have major changes to contend with and a staggering amount of new procedures to implement.

The second item of interest is that HHS published a Notice of Proposed Revisions to the Federal Custody and Control Form (CCF), revising the form to conform to the revised Mandatory Guidelines, which will expand the drug testing profile to include new drug analytes:

• methylenedioxymethamphetamine (MDMA) commonly known as ``ecstasy,''
• methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA) which are close chemical analogues of MDMA.
  
  

A major change is to discontinue recording split specimen test results on Copy 1 of the Federal CCF. Instead, Step 5b of Copy 1 will be used to identify the split testing laboratory (i.e., laboratory name, city, and State), to indicate that the split specimen was tested, and to refer to a separate laboratory report for the split specimen test results. These new regulatory actions will require that the Federal CCF be modified to accommodate the new rule changes. Employers, and especially collection sites and MROs are encouraged to review this document and provide their input to HHS by January 19, 2010. (A copy of the Notice is available at http://edocket.access.gpo.gov/2009/pdf/E9-27371.pdf.)

So, what does all this have to do with the DOT drug testing requirements? Good question and here is the final answer – everything. The Omnibus Transportation Employee Testing Act of 1991, requires the DOT to use the laboratories certified by, and testing procedures of, the U.S. Department of Health and Human Services to ensure ``the complete reliability and accuracy of controlled substances tests.'' Since Congress specifically limited the scientific testing methodology upon which the DOT can rely in making its drug and alcohol testing regulations, The DOT must follow the HHS scientific and technical guidelines, including the amendments to their Mandatory Guidelines. However, the DOT has some options on procedural aspects of the program and these may, in fact, be different from those published by the HHS.

What does this mean in the long run? Well, the DOT will have to publish interim guidelines or interim rule making, give the public time for comments, and then publish a final rule. All of this will take time and the DOT will probably set up reasonable time frames to accomplish these changes. Forewarned is forearmed; employers will have to be aware of these upcoming changes and in some cases, like the additional drugs for testing, will have to add these changes to their current policies.

Bottom line: stay tuned to this publication and we will keep you up to date. Lets hope that 2010 will be a more productive year for everyone.

Medical Marijuana and the DOT

U.S. Department of Justice Guidance on Medical Marijuana and Its Impact on DOT Drug Testing

On October 19, 2009, the U.S. Department of Justice (DOJ), Office of the Deputy Attorney General, issued a memorandum providing guidance to prosecutors in states that have authorized the use of medical marijuana. Because laws vary in their substantive provisions and in the extent of state regulatory oversight, both among the enacting states and among local jurisdictions within those states, DOJ felt that rather than develop different guidelines for every possible variant of state and local law, uniform guidance to federal investigators and prosecutors in these states would provide consistent and uniform enforcement. To a large degree, the memorandum was intended to address the shortfall of resource allocation in the field.

Part of the memorandum states, “The prosecution of significant traffickers of illegal drugs, including marijuana, and the disruption of illegal drug manufacturing and trafficking networks continues to be a core priority in the Department's efforts against narcotics and dangerous drugs, and the Department's investigative and prosecutorial resources should be directed towards these objectives. As a general matter, pursuit of these priorities should not focus federal resources in your States on individuals whose actions are in clear and unambiguous compliance with existing state laws providing for the medical use of marijuana. For example, prosecution of individuals with cancer or other serious illnesses who use marijuana as part of a recommended treatment regimen consistent with applicable state law, or those caregivers in clear and unambiguous compliance with existing state law who provide such individuals with marijuana, is unlikely to be an efficient use of limited federal resources.”

This, of course, generated a myriad of questions from transportation employers, employees, and the general public. The core of the questions was does this guidance in any way now “authorize” or sanction the use of medical marijuana and how are employers to treat employees in those states that have legalized medical marijuana?

The DOT Office of Drug and Alcohol Policy and Compliance in a recent statement indicated that they have also received several inquiries about whether the DOJ advice to Federal prosecutors regarding pursuing criminal cases will have an impact upon the Department of Transportation’s longstanding regulation about the use of marijuana by safety-sensitive transportation employees – pilots, school bus drivers, truck drivers, train engineers, subway operators, aircraft maintenance personnel, transit fire-armed security personnel, ship captains, and pipeline emergency response personnel, among others.

DOT made it clear that the DOJ guidelines will have no bearing on the Department of Transportation’s regulated drug testing program. DOT will not change their regulated drug-testing program based upon these guidelines to Federal prosecutors. The Department of Transportation’s Drug and Alcohol Testing Regulation – 49 CFR Part 40, at 40.151(e) – does not authorize “medical marijuana” under a state law to be a valid medical explanation for a transportation employee’s positive drug test result.

That section states:
§ 40.151 What are MROs prohibited from doing as part of the verification process?
As an MRO, you are prohibited from doing the following as part of the verification process:

(e) You must not verify a test negative based on information that a physician recommended that the employee use a drug listed in Schedule I of the Controlled Substances Act. (e.g., under a state law that purports to authorize such recommendations, such as the “medical marijuana” laws that some states have adopted.)

Therefore, Medical Review Officers will not verify a drug test as negative based upon information that a physician recommended that the employee use “medical marijuana.” DOT also noted that marijuana remains a drug listed in Schedule I of the Controlled Substances Act. It remains unacceptable for any safety-sensitive employee subject to drug testing under the Department of Transportation’s drug testing regulations to use marijuana.

So much for the legal parameters surrounding this issue. What is the average employer to do when he/she is challenged by an employee that a drug positive result should be overturned because the employee was told by a physician to us marijuana and that even the Department of Justice is no longer considering it a “crime”. Well, for starters, you should try to nip this issue in the bud. Ensure that your drug and alcohol policy (if it does not already state this) specifically indicate that use of “medical marijuana” is not an acceptable medical explanation for a drug positive result. You may even want to state that even if the employee has “not been charged” with the crime – use of marijuana – that still does not supercede the DOT position. Any use of marijuana, even if it is unintentional – someone slipped me marijuana-laced brownies – is not an acceptable medical explanation.

Going back to the DOJ memorandum, we need to look at the following: “Indeed, this memorandum does not alter in any way the Department's authority to enforce federal law, including laws prohibiting the manufacture, production, distribution, possession, or use of marijuana on federal property. This guidance regarding resource allocation does not "legalize" marijuana or provide a legal defense to a violation of federal law, nor is it intended to create any privileges, benefits, or rights, substantive or procedural, enforceable by any individual, party or witness in any administrative, civil, or criminal matter. Nor does clear and unambiguous compliance with state law or the absence of one or all of the above factors create a legal defense to a violation of the Controlled Substances Act. Rather, this memorandum is intended solely as a guide to the exercise of investigative and prosecutorial discretion.”

Bottom line is that the DOJ memorandum has absolutely no impact on the DOT drug and alcohol program nor does it impact on an employer’s enforcement of the current drug testing requirements.