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.
