Drug Testing

DRUG TESTING ADVISORY BOARD OPEN SESSION December 4, 2001

Agenda Item: Welcome

MR. STEPHENSON (Chairman, HHS): Good morning. Thank you for coming to this open session of the Drug Testing Advisory Board meeting. This is a relatively short open session. We have a lot of work to do in the closed session.

Agenda Item: HHS Update

DR. VOGL (HHS): After the last DTAB meeting, the public comment period ended on our Federal Register notice where we proposed changes to the specimen validity testing policy. As usual, most comments were received on the 21st and the 22nd of October.

A total of 23 separate submissions were received from individuals, organizations, labor, management, and laboratories. As promised, after the 22nd of October we scanned every submission in pdf format and put it on our web site. This allowed us to make the comments available to as many people as possible.

We did send hard copies of the comments to the Board members, DOT, and RTI. I believe there was also an email sent to individuals who normally attend the DTAB to make them aware that they can look on our web site and review the comments.

We are working diligently on preparing the final Federal Register notice with the SVT testing policy. The process is to review the comments and decide which comments will be accepted and which will be rejected. We then prepare a preamble, which is the first part of the Federal Register notice. In the preamble, we discuss the comments submitted and give the Department's position. The Department's position will impact on the Federal Register notice itself and any changes that would need to be made. When the notice is published, we are planning to publish the entire revised guidelines rather than just the final changes to sections or paragraphs, and will also include the change we made in the opiate cutoffs. Currently, the revised opiate cutoffs is a separate notice which is attached to the '94 guidelines.

The implementation of the final SVT policy will be several months after publishing the notice. We need to give laboratories a reasonable amount of time to implement the policy.

MR. STEPHENSON: That's a good segue right into the next subject, the status of the alternative specimens.

DR. VOGL: This is somewhat similar to what we have been doing with SVT. At the last DTAB meeting, we presented Draft 4 of the guidelines relating to alternative specimen testing. It is on our web site.

After the meeting we prepared the Federal Register notice, again with a preamble that describes our position on different issues with regard to alternative specimen testing and the justification for establishing certain policies. The guidelines are in the question-answer format and currently have the proposed SVT testing policy. This would change based on what we are doing with the SVT policy development.

The notice has been sent to our Office of General Counsel and they are reviewing the preamble and the guidelines themselves. I hope to receive their feedback on the entire draft by the end of the calendar year. I have received some feedback on the preamble at this time. It will be relatively easy to address them by adding some additional information.

We hope to make those changes and begin the process of officially sending the notice to the Secretary's office for signature and publication in the Federal Register. It has to go through the Office of Management and Budget, and that's an area where we have limited control over the time it will take to review the notice and to address concerns they may have.

We will do our best to keep this package going. I am always optimistic about when all this will be accomplished. I hope to publish the notice for public comment by next summer. The public comment period will probably be about 120 days. It would have to be a rather long public comment period, similar to what DOT had for their Part 40, in that it's so different than the current guidelines and all the other issues that we're discussing with regard to alternative specimens, on-site testing, etcetera.

We would expect to receive a significant number of public comments. Again, we would use the same approach of scanning the comments and putting them on our web site. Hopefully, we will get those over of a regular period of time rather than on the last day of the public comment period.

Just to make you aware, we did make two changes in the draft guidelines that have been sent forward for review. The first one involves collectors. For some time, we have proposed certifying organizations that would actually certify or license collectors. We decided not to certify organizations. The proposed requirements for collectors are now essentially the same as those described the DOT Part 40. It did not make sense to go beyond what is in Part 40.

The second change has to do with MRO certification. We decided not to recognize MRO certification organizations and to simply propose requirements similar to those described in the DOT Part 40. In other words, the proposed requirements for MROs would stop short of actually recognizing organizations that would issue MRO certifications.

As of this time, these were the only changes in the draft sent to the Office of the General Counsel.

MR. STEPHENSON: Just to emphasize what Walt was saying, the issue of certification is a case of working with DOT to standardize the program against a larger population. We have very limited numbers of MRO's and collectors that function inside the federal agencies. The guidance that would be specific to our federal agency program was not cost or time-effective. Since there has been a long development process, we do coordinate with DOT on these issues.

I think it's a good revision. It's less onerous than it would have been otherwise. It would have been very hard for us to set the standards and get all of the players to work together.

Agenda Item: DOT Update

MR. EDGELL (DOT): I am still the Acting Director of the Office of Drug and Alcohol Compliance. At DOT, we do have all of our candidates requiring to go through the political confirmation process either in or through that pipeline and now are in the process of appointing what we refer to in the Federal Government as Schedule C's, those political appointees who can be appointed simply directly from the appointment of the Secretary of Transportation with White House concurrence. We are moving down to that level now, but there's no change in our office. As a matter of fact, I don't even have a rumor of a good rumor in that area to report to you.

In September, the sixth of our final conforming rules for the Research and Special Programs Administration was published in the Federal Register. Those conforming rules, as you know, brought the motor rules in line with the changes that we had made and incorporated into our one DOT policy that affected all of the modes.

DOT had opened for comment and the comment period closed and is in the process of making its report to Congress. This is a report that was required by the Motor Carrier Safety Act of 1999 on the feasibility of medical review officers reporting drug test results to a national database. The Department received approximately 70 rather lengthy comments on the feasibility of this database.

The vast majority of the commenters supported the feasibility of this database and most of them got in line with similar comments, in that it should not be limited just to drug positive, it should also include alcohol results as well as the substitutions, the substituted and refusal, adulterated and refusal to test as well. That report is in process now and is due this month to Congress.

We are establishing a federal advisory committee to evaluate the security and the transmission of electronic data both for drugs and alcohol. There are nominations that were submitted to the Secretary of Transportation and the names came from two previous meetings that DOT, HHS, and OMB had in the year 2000. The nominations are submitted to the Secretary. He is in the process of selecting this federal advisory committee and we hope to have the selection completed very soon, to meet in early 2002 to establish specifications, parameters for the handling of electronic data, both the security, transmission and storage of.

Lastly, the current MIS reporting requirements that are owned by each one of the DOT operating administrations does not match the new standard five-part drug testing custody and control form. We are in the process of designing for public comment and putting out a notice of proposed rulemaking a one-DOT MIS form which will consolidate the information, simplify it.

We have six modes and, counting the EZ form, a possible 12 different forms that the different transportation employers can submit their MIS data on. Our goal is to reduce that to one form that will be used by all of the modes. Hopefully, we can get this NPRM out this month.

We also will be proposing a web-based reporting capability. I think that with the small businesses that we have we will always have to maintain the ability to report on paper. I heard a report last week, I think it was put out by AOL, that some 75 percent of Americans use the Internet now. Certainly the capability does exist out there for transportation employers to use the Internet to report their data. But still, we do have to maintain the presence to accept paper. That is something we are working on now. The way that would be presented to the transportation community would be through a notice of proposed rulemaking.

Agenda item: NRC Update

DR. WEST (NRC): We have just started the process for a proposed rule for the fitness for duty area. This is 10 CFR Part 26 of our regulations. We had a meeting back about the middle of last month. That was our initial meeting since we received guidance in this area from the Commission. We have scheduled a meeting for this Thursday and we are just at the beginning of the planning stages.

Just to give you a flavor of it, we are talking with our stakeholders relative to -- the last meeting, we talked at the level of goals, sort of high level. This next meeting we will get down to the specifics of basically an outline of major sections of what the rule will look like.

Then we were anticipating and still anticipate a rather aggressive schedule, trying to meet maybe on the order of maybe every other week. Our intent is to move along as quickly as we can to actually craft the language of the rule, and we are probably about six months from actually getting the first draft of the proposed rule, then about six months from that time frame, totally about a year, for the proposed rule being issued in the Federal Register for public comment.

I think, since we are now about at the timing of the validity testing guidelines coming out from HHS, that is certainly something we plan to fold into our proposed rule. Not that we don't have a section in there already in that area, but what we plan to do is to update the policy relative to the HHS guidelines.

Agenda Item: September 11th

MR. STEPHENSON: We are going to make available the microphone for public comments here in just a minute and go around the table and ask if there are any other issues that members of the Board want to address in the open session.

One of the things I want to do -- this is heartfelt. This hasn't been scripted out and it hasn't been written down in a way that's going to sound good, but it's coming from the heart, so I hope you'll accept the way it is.

Every one of us as individuals, families, businesses, and communities have been profoundly affected by what has happened on September the 11th and since. In the business world and in the world that involves drug testing that we're all involved in, there have been tremendous changes in the amount of work, the level of employment being found by everybody in each of the sectors, whether it's the labs and the medical review officers and so on.

People have kind of gone on hold on making a lot of decisions. There have been a lot of layoffs, hopefully temporary. The labor force we think will rebound and come back strong, and we're already beginning to see a little of that in the stock market and I hope it continues. We certainly had a surge in auto sales and we've had a tremendous upswing in confidence in purchasing toward the holiday season.

Why am I saying this? Well, because I want to remind all of us that we've gone through an event that every one of us will remember. It's become a part of our lives and it's a part of the process. Part of what we can bring back into that new world is our awareness of alcohol and substance abuse issues, and what happens when people are under great stress? People don't have to be bad actors or criminals or people that are just deviant to be affected by stress in ways that they'll try to deal with as individuals.

Businesses have begun to realize this with the work forces they still have present. We've had a national summit in New York City from the 14th to the 16th of November addressing issues of substance abuse and mental health services in responding to terrorism. From that I can tell you that there is a great awareness about issues of depression, post-traumatic stress disorder, and so on.

But one of the underlying things that's still there is the issue of substance abuse, how it may act out and how it might be used by ordinary people like you and me. What we do as employers, as people that are part of this system, is to understand that in a holistic manner, make sure that every time we perform a test it's accurate, make sure we do it with absolute due diligence in terms of process and speed and correct interpretation of results, but do it in a way that's a part of rebuilding this country and holding the fibers together.

We're going to have 30,000 new people that are going to become federal employees. My understanding is most of them are going to be in testing-designated positions that will require drug testing in the Transportation Security Administration, a new agency that's being created to help restore confidence in air travel and in other travel.

Just remember that we've had a long history. I will say I think in some ways we've become a little complacent. Some of our guidances have become more actuarial in nature and perhaps driven by legal or profit concerns, not always unbalanced from the other, but to the extent that I think we need to go back to that and remind ourselves: We are on a war footing in a different world today than we were before September the 11th.

Everything that we do here plays an important part, maybe more important than some of us realize on a day to day basis. But just take what I said as honesty. It's not something that I can guarantee you is going to go down in anybody's mission as memorable, but it's something I thought was important to share.

DR. BUSH: In the context of "One SAMHSA," we hear the "One DOT" concept a lot and we are on the "One SAMHSA" concept also. Just as a refresher, Substance Abuse and Mental Health Administration is made up of three centers: The Center for Mental Health Services, the Center for Substance Abuse Treatment, and the Center for Substance Abuse Prevention, of which we are a division.

The Center for Mental Health Services is a world leader in capability. Just as you look gratefully at us as leaders in the drug testing arena, our Center for Mental Health Services has equal footing and equally capable and qualified people in that arena. What we are finding is they are being deluged with requests to help with recovery efforts for people to try to resume normal life again after September 11th.

So I suggest -- and I'm using this as a vehicle for you -- many of you in your businesses may be asked, or part of -- drug testing is just one part of a big holistic process and many times mental health services, EAP's, are part also of the processes that you market and use. So CMHS is quite a leader in that area and, while they're being asked many, many times to step up to the plate and provide the best current services, call them again. You get in line to call them, because they have resources that are available and can help you, too.

So in the "One SAMHSA" concept, please utilize our Center for Mental Health Services as a follow-up and continuum to what Bob said.

Agenda Item: Public Comments

MS. SHELTON (DATIA): I just have a question on the alternative specimen guidelines. At the time the original drafts were written, they required FDA clearance of on-site testing kits. Do you have any comments on what your intention for those requirements were now that FDA has intended to implement a draft guidance requiring over-the-counter clearance and bundling of confirmation testing?

MR. STEPHENSON: At this time, we are aware of the issues in terms of letters of comment and notice by Congress. We are aware of the issues that are going on at the FDA. But I think it is too early for us. I think we owe it to the industries, to the public, to professional organizations like yours, to have an opportunity to make your own independent comments and input during the time when we are going to have the alternative specimen guidelines out for public comment.

I think it would prejudice the process if we were to say anything one way or the other. I think we all are aware of the balancing act that goes on of having FDA participate and being involved in a clearance process. There are issues we still have not addressed about specimen validity testing being pulled into the collection site activity. Those are things that someone may address during the public comment period. So, let's wait.

The open session was adjourned at 9:09 a.m.