DRUG TESTING ADVISORY BOARD
OPEN SESSION
September 4, 2002

Agenda Item: Welcome

MR. STEPHENSON (Chair): Good morning. I am the Director of the Division of Workplace Programs and the Chair of the Drug Testing Advisory Board. This is the open session of the Drug Testing Advisory Board meeting. Please make sure that you have signed in. If you are here from the public, we really want to know. Anyone who wishes to make public comments in this open session, please let a representative know so that we can allocate the time according to the number of speakers who wish to make comments.

Agenda Item: HHS UPDATE

MR. STEPHENSON: We have a few updates that we would like to provide from the Department of Health and Human Services. The first is we have had our Drug Testing Advisory Board charter renewed. It is now good through June 17, 2004. All of the charters in our Department were reauthorized with the same beginning and end dates.

The next item is an update on the status of our specimen validity testing Federal Register notice. While this might to some of us seem a never-ending process, trust me, it is in fact progressing fairly well. We have taken the advice of a number of those who use our documents and procedures in various kinds of litigations and hearings and have strengthened the logic and basic foundation included in the preface part of that document, and have had it distributed again through the Department of Transportation's Offices of General Counsel, as well as through our own HHS Department General Counsel staff. We anticipate this will be the last time that it goes out for these kind of comments before being distributed to the myriad of folks across the Federal Government who have to see it and at least acknowledge its presence and make some potential comments on it. It will be cleared through HHS and go to the Office of Management and Budget, and then we hope it will be prepared for signature by the Secretary in the near future.

DR. BUSH (HHS): While it seems like the process takes so long, it does. What we are finding repeatedly -- for those of us who are scientists and live in the scientific fishbowl every day - many times we have to take this science, which many parts of this rule are going to define new terms and new science and new technologies, things that we want to impress in the guidelines; we have to write a story about it in the preamble.

We have come to believe that that is the best way to approach this preamble, is not just a review of each and every public comment with our decision as to why we agree or disagree. Rather than just make that statement and make the change or not, we are describing in detail the reasons why we are either changing something or not changing it.

It has to do, then, for those employees who are drug tested, we feel that this document will be better understood by a comprehensive preamble that tells more of the story. The Guidelines themselves are extremely didactic and strictly speaking to the letter of what we expect to see. But then why and how, and better understood then by the employees who are drug tested, the employers who are implementing drug-free workplace programs, unions, union arbiters, administrative law judges -- anyone who has to be drug tested under these rules, use these rules for an effective drug testing program, or make decisions on how a drug-free workplace program and drug testing was implemented.

It was the attorneys who suggested that we tell a better story about the science, and so that's where we are. I don't think I've given too much away on that.

I'm trying to tell you it's going to be a very good read. We believe it will be a very good read.

MR. STEPHENSON: Status on the alternative specimen guidelines. It is progressing well, but we have had to embed parts of the specimen validity testing components first into these draft new guidelines, because they will at least address urine and the new guidelines and carry forward some basic consistent messages on specimen validity to the other specimen, too.

Therefore, we are trying to press to get the SVT out first, but we have not stopped work on the other. We have a requirement to establish a new contract for the oversight work on the national laboratory certification program within the next year and we will have new elements that will address the alternative specimens and technologies under that contract. We are basically going to quadruple the size and complexity and the numbers of issues that potentially can be gotten right or go wrong over the next several years beginning next year.

This is very important. We have not forgotten about the quality assurance and proficiency challenges that need to be developed and the specimens that need to be used for those purposes and are looking for improved technology all the time.

One of the tasks that will be included under this concept is the development, introduction, and evaluation of new technologies beyond what we are doing right now to look for a common process that we can use to address all of those new issues. It could be anything from brain scans, eye movement. We have seen some older ones, micropauses in speech some of us have even evaluated, right down to dowsing rods, which have been used to look at whether or not they can in fact find hidden drugs in a certain area. That was a fun exercise, I think our friends down at RTI would express. That is one we could even write up, not necessarily for a scientific journal, but one that we could certainly write up.

We are looking at the concept of establishing some superlab resources, ones that go beyond those elements that we see in the day to day production lab procedures, but to look at how to evaluate the new technologies and the different tests and so forth that are out there.

Our friends at NIDA have certainly done a lot of this. Our friends at AFIP certainly could do this. We have been working increasingly with the Civil Aerospace Medical Institute part of the FAA, and probably others over the next months and years. I think these are areas that we are going to have to increasingly explore and develop some partnerships with to collectively do our work better.

We have obviously addressed a lot of concerns about post 9/11. We are seeing increasing testing that is going on in certain of our security environments and are every day recognizing the need and the importance of those tests by what we are finding in the results.

One other element I think is interesting. On the 29th of August, the Office of National Drug Control Policy, a part of the White House, had published a new booklet. It was called "What You Need to Know About Drug Testing in Schools." I think most of you are probably familiar with the Earles decision in the Supreme Court that by a split decision of five to four provided that, according to the words that were used here at the very beginning, that it's an important issue for communities to look at whether or not drugs are a problem in their community and whether or not drug testing might be an issue that could be helpful. This pamphlet has put together a lot of input from various sources. It certainly identifies our resources and the work of this group and identifies it as the first of the sources for those resources.

I have a few copies here. But I, more importantly, want to address this to folks who would like to download it. This is the whitehousedrugpolicy.gov. You can certainly pick it up as a pdf file there and download it on your own computer.

How many of you saw a recent article in the U.S. News and World Report on drug testing? (A show of hands.)

Not many, so I will not spend a lot of time on it. We were one of a number of sources that was contacted and asked for input on it. The article did not reflect our policy or our issues. It was simply one of the input sources for the reporter. When we were contacted and offered an opportunity to provide fact-checking, we in fact did make some corrections, that were then not incorporated into the final effect. We apologize for any apparent glitches or issues that might be consistent with the things that you see here. This is a reflection of mainstream news across the country and, quite honestly, there are a number of issues out there that we need to look at carefully as we introduce new technologies. We are aware of it and that is our work. But for others across the country in the 15 to 16 million readership group that are reached by that magazine, maybe some of this is new.

I do not expect that will be the last article. I expect we will see more as we get closer to the new testing technologies being deployed and if and when there is an expansion of testing in the schools across the country. We will see even newer populations that will have to be educated about what this is about in terms of science.

Agenda Item: DOT UPDATE

MR. EDGELL (DOT): Since we last met, our office, the Office of Drug and Alcohol Policy and Compliance, headed a project run by Don Shatinsky. It was the organization of an electronic transfer and storage of drug testing results meeting. This was a Federal advisory committee meeting. Twenty-one members appointed by the Secretary of Transportation met in June for two days. The actual transcripts of the meeting, a list of the members, and a copy of all the documents that were reviewed by the committee are on the DOT docket and I can provide that information to anyone who's interested in it and doesn't have it.

Three committees were formed: data elements and record layout committee, chaired by Scott Grabo of EHP; a second committee, security and transmission of drug testing information and digital signatures, the chair is Eric Quilter; and the third committee, security and storage of drug testing information, chaired by Neil Fortner of PharmChem.

These subcommittees are meeting and we have tentatively planned to get back together a second time to finalize this, hopefully in early December of this year, to reconvene and finalize the work of the federal advisory committee working groups.

The second item that I want to report on is work done by the U.S. Coast Guard drug and alcohol program manager, Bob Schoening. He has a service agent listing of -- this will be live next week on the Coast Guard web site and Bob has the web site details. I also have them here for anyone who'd like to look this up. It is a listing of service agents who will be able to provide drug tests, collection, laboratory, MRO services for individual mariners who are trying to accomplish their drug testing requirements of the U.S. Coast Guard. Our friends at the Division of Workplace Programs are very happy with that.

DR. BUSH: If I could add just a little bit to that. It is one thing to call our office to get a list of certified labs. When someone is an independent mariner and they call for the list of labs and then get a phone number, they call the laboratory and say: Hey, I want to come in and provide a specimen. Well, that is not the way the business is done. Unfortunately, even with our phone call, our help with the phone call or fielding a phone call, they were not linked up properly with necessarily a collection site, with payment options, with medical review officers. We all appreciate your work.

MR. EDGELL: This is more of a soup to nuts provision for these mariners. 183 responses came in to Bob with over 260 sites around the country. We are hoping that will ease that issue.

MR. STEPHENSON: I think over the last several years we have been able to track most mariners that have a U.S. licensure issue anywhere in the world. We get calls from Australia, from Great Britain, from almost any seaport anyplace in the world. I know this resource that you have created is going to be a great help to many folks out there. It is not just taking the calls away from us. It is how it helps them. This is a big piece of work. It is not something that is easily done. It is a very unique way that you have to do business.

MR. EDGELL: Just one other item and this is more of a personal note. I read the article in U.S. News and World Report which you commented on about drug testing. The publication should be embarrassed.

MR. STEPHENSON: Absolutely.

MR. EDGELL: On the shoddiness of that, the incompleteness of that article.

MR. STEPHENSON: We had actually pondered whether or not to make a letter to the editor. But quite honestly, it did not seem like it would achieve much more than trying to extend the kind of misguided focus that was there.

There are elements of truth that are embedded in it, but the context was such that the end result was misleading and not helpful either to the process, the social goals and intents, or the individual technologies that were referenced in it. There must have been some other process at work and I cannot and will not judge what it was.

Agenda Item: NRC UPDATE

DR. WEST (NRC): We are continuing to move forward with our rulemaking effort and, as has been expressed already, it is sometimes quite slow, but we are getting there. We just completed a meeting with our stakeholders this past month, August the 28th, and our next meeting in October.

Actually, this one is going to be a three-day meeting. On the 16th of October we will have our typical meeting with our stakeholders to go over the draft language of the proposed rule. On the second day -- we are getting to the point where we are trying to move forward the regulatory analysis. We are going to have a special day just focused on the regulatory analysis.

Then the final day, on the 18th -- again, these meetings will occur on the 16th, 17th, and the 18th -- we are intending to invite some of the new categories of licensees, classes of licensees, that will be covered by this rule, in addition to our operating reactors. That will keep us quite busy, just preparing for that.

But this speaks well to the fact that we are trying to ramp down with our meetings with stakeholders. Not that we do not want to continue, and we will and our commitment is to continue to engage our stakeholders. But we get to a point where we have to move forward to put the draft language in our internal process, and we are expecting to do that, roughly speaking, around the end of this year, just to get the package pulled together. It takes us a little while to do that.

Before the October meetings, we intend as we go through our internal process, if we have any significant changes to the rulemaking package then we would make those changes known to our stakeholders on our web site. Then, if they reach a threshold where the stakeholders feel that we, or even if we make a determination on our end that we feel we have some major changes, we might schedule a meeting to get together with our stakeholders.

That's where we are. You can get access to the draft language on our web site. The general web site is www.nrc.gov. I believe it is also available even on the HHS web site at this point. We are linked currently to the HHS web site, at least in one direction. They link to the "Fitness for Duty" web site and I believe it is, our rulemaking package, the draft language, is currently available there.

MR. STEPHENSON: It is and we'll make sure that it does. Richard, check that link and make sure that we have it?

MR. LIPOV (HHS): Yes.

DR. WEST: If you have any difficulty getting on our web site so that you can ultimately get to the portion of it that speaks to our draft language, you can either email me at fitnessforduty@nrc.gov or you can give me a call at 301-415-1044. It is not as straightforward as we would like for it to be to find that path to exactly where you want to go.

That is where we are and we think we have come up with a very good product. It has been a slow process, but with these various meetings with our stakeholders we think we have come up with a really good product. Bottom line, we are due to the Commission June 2003 with a proposed rule.

Agenda Item: PILOT PT PROGRAM RESULTS FOR ALTERNATIVE MATRICES

DR. BUSH: At this time Dr. John Mitchell will make a presentation to the Board on our pilot PT program results. Our drug of choice for today will be cocaine. For those of you who were here last time, you recall that we reviewed our findings with marijuana, marijuana metabolites, alternative specimens, taking a look at urine laboratory-based drug testing, hair laboratory-based drug testing, and oral fluid laboratory-based drug testing, and literally just focusing on the confirmation side of it. Again, we are going to take a similar approach in presenting cocaine information and benzoylecgonine information to you.

MR. STEPHENSON: One of the things that we have committed to do, although we do not have handouts for you, we will place the presentation on our web site, so you will be able to download it as well as the previous one that was developed in a very similar format. They should be readable and interpretable in terms of the slide layouts and the graphics.

Note: The following presentation is found in a PowerPoint format under: Workplace Drug Testing Documents and Publications, Regulations/Guidance Under Development

DR. MITCHELL (RTI): As Donna said, we have been going through this analyte by analyte, and we talked about the analytes that can be expected in these different matrices after marijuana use the last time. This time we are going to cocaine, and we are looking at three matrices.

They are the ones that we are taking into consideration: urine, hair, and oral fluid.

Next slide.

To review a few things, in evaluating analytical values reported for cocaine and its metabolites, we are going to look only at confirmatory testing in these three matrices. Just as general background information, the urine testing is done by GC/MS, the quantitations are in nanograms per mL. Donna wanted this parts per billion, which is an indication of the relative amount or weight of the analyte that is in the particular matrix versus the weight which is the standard.

We are using -- for nanograms per mL, we are saying that the mL is one gram, so it is 10 to the minus 9 grams per gram of urine. That is what we are looking at.

In hair, most of the laboratories are using GC/MS. We had two laboratories that were using MS/MS, one is GC/MS, one is LC/MS and LC/MS/MS.

The quantitations are in picograms per milligram, which comes out to be parts per billion.

For oral fluid, mostly GC/MS with one MS/MS, and quantitations in nanograms per mL just like we have in urine, which is parts per billion. Parts per billion does not really tell you anything if you start thinking about it. It would seem like they are all working at the same type of sensitivity required.

Next slide.

I was trying to find a better way to explain this and I wanted to look at the relative sensitivity. That is, if we take the cutoff of the drug in each of the three matrices -- urine, hair, and oral fluid -- you can see they're quite different. There's 150 nanograms/mL for urine, 50 -- this is for benzoylecgonine -- 50 picograms/milligram in hair, and 8 nanograms/mL.

If we take the amount of the sample that is being analyzed in some of the labs -- and I'm trying to go down to the lowest amount. I didn't do that for urine because there are labs that are using less than one mL. But just using one mL for urine, 10 milligrams, which I think is the smallest amount that I've seen in any of the laboratories for hair, and whenever you take in all the dilutions and everything for analysis of cocaine, it comes out to 0.03 mLs of neat oral fluid that's being analyzed by one of the laboratories.

We go through all of the calculations, we find that when we go to the analysis in hair we're looking at -- I mean, in urine we are looking at 150 nanograms. In hair, we are looking at 0.5 nanograms. In oral fluids we are looking at 0.24 nanograms. That is the total amount of benzoylecgonine in the sample that they're analyzing. That gives us a relative sensitivity.

If we take urine as being 1, then it requires 300 times that sensitivity to analyze in hair and 600 times, about 600 times, to analyze in oral fluids. I think that gives us a little better sense of what the sensitivity required is.

Now, this varies. If they took twice as much oral fluid, that would make it about 300 equal to hair. Or if hair took 20, then it would be a little bit less. But this would just give us some type of sensitivity, indication of sensitivity. You would require at least 100 times the sensitivity in hair and oral fluids as you require in urine.

Next slide.

We are going to talk about variance. We are looking at the variance around the industry-agreed cutoffs. That is going to be our reference point. We are going to look at mean values that are reported by the laboratories and these mean values will represent three or more values. If we only had two or one value, that is not included in this data.

When we look at the variance, we will be looking at histograms which show the percent variation or percent of the coefficient of variation. This is also called in some circles the relative standard deviation.

When you take -- in statistics, you take a mean, you take all the samples or all the values, add them together, take the mean and divide by the number of samples which you have, that gives you an average or a mean.

You can also do a statistical analysis which is called standard deviation. It is a very simple one. You can take the standard deviation, which is an indication of the variance, and divide it by the mean, and this gives you a value which is the relative standard deviation, or in this case percent coefficient. You multiply that by 100 and that gives you a percentage. That is just a mathematical indicator and it is an easy way for us to look at the different values by the different matrices.

Next slide.

Performance around the cutoffs. Again, we are going to look at graphs which give the values, the mean values for each of the samples, and we are going to see lines which give us the plus and minus 20 percent and plus or minus 50 percent ranges. We want to look at the relative position.

When we do these, we want to look at the relative position of the cutoff to the values and also the distribution of these values below the cutoff. It is in urine which is the major matrix that we have experience at this point in time. We have required the labs to have the ability to analyze below the HHS-required cutoff. Actually, we have required them to be able to go down to at least 40 percent below that cutoff. We want to see in the graphs that we are going to present how well have these labs analyzed in all the matrices urine all the way through oral fluids and hair and how well they do in this area.

Next slide.

Our source of analytical values again for the urine will be 2 maintenance PT cycles for this past year containing all the labs that are currently certified. We have 4 hair pilot PT cycles. We took only the 6 labs that went through all 4 cycles for comparison in this data. In the 3 oral fluid PT cycles, we looked at the values from 9 labs that completed all 3 cycles.

Next slide.

Let's begin the analysis of cocaine in urine and recommended cutoffs. There is going to be a change in the new guidelines. There is going to be a change in the cutoff for the initial test and for the confirmatory test. I think if we go back, I think this change was originally suggested at the consensus conference in 1989?

We are finally dropping -- the reason that it was replaced is that the number of positives that would be gained are relatively small, maybe 10 percent or something like that, but the technology of the hair testing -- I mean, in urine -- is such that it's well within the capabilities, as we'll see, and there's no reason not to do it at this point in time.

DR. BUSH: In the early nineties there was a publication, I believe in Journal of Analytical Toxicology, with Ed Cohn as a primary author when he did work at NIDA's Addiction Research Center. He looked at passive exposure to cocaine vapors, essentially crack smoke, things like that. We were looking at passive exposure issues and not comfortable moving cutoffs until we had that definitive work on his part. That was also a contributory factor why we were hesitating to move without good science behind us.

DR. MITCHELL: Right. There are two different sides of this. There is the science behind the excretion of the drug and then there is the science behind the analysis of it. The analysis has been there for quite a while, but we had to clear up other scientific issues before we could move on.

The confirmatory test has been moved down to 100 nanograms per mL from 150.

Next slide.

In this there are occasions 61 and 62, which were in 2002. We had 56 laboratories participating, all the laboratories again using GC/MS, and in the samples they only contained benzoylecgonine. That is the analyte that we require in urine. That will become more relevant as we get to the other matrices.

Next slide.

The first slide is just a graph of the analytical values reported for benzoylecgonine in urine in the two PT cycles. All of these colored values that we see is just a mass of 56 laboratories which are placed on this one graph. We see the plus and minus 50 percent range.

If it is on this line or below, it means that the value was less than 50 percent of the mean value. If it's above, it would be equal to or greater than 50 percent of the mean value, and the blue lines represent the plus or minus 20 percent. These are -- the plus or minus 20 percent, plus or minus 50 percent, are ranges that are identical to the guidelines in the judgment of PT and that's why they are here.

You can see that we have the mean concentration on the X axis going all the way from somewhere around I believe 90 nanograms per mL all the way up to over 1400 nanograms per mL, and then the reported values are on the Y axis. You can see this is the proposed cutoff.

We do have some values below the proposed cutoff and we have a fairly large range.

Next slide.

Looking at from about 300 down to 90 nanograms per mL, you'll see that most of the values are again within the plus or minus 20 percent, none outside of 50 percent. Also, they're below the cutoff of 100. However, we have not yet challenged the laboratories at a 40 percent of the proposed cutoff, which would be down here, and that's something that we'll have to do in the future.

Next slide.

Looking at the variance, remember I was talking about the coefficient of variation, which is the percent CV. You can see that the variance is well below 10 percent of the mean for benzoylecgonine whether we are above or below the cutoff, and that is the values of the variance over the two different cycles for the whole 56 laboratories.

Next slide.

Next we take up hair, and hair's a little more complicated than urine. We took the easy one first. In hair, the initial test, the recommended cutoff is 500 picograms/milligram for the initial test with cocaine. The confirmatory test is cocaine at 500 picograms/milligram, and we have some qualifying statements: and there must be one of three, one of these three analytes present: either benzoylecgonine, cocaethylene, or norcocaine.

Now, the benzoylecgonine is probably the most complicated of the two in that the cocaine value must be at least ten times the benzoylecgonine value. If we really put it in the case of or in the terminology we use in the PT program, the cutoff for benzoylecgonine is 50, greater than or equal to 50 picograms per milligram, and that's what we would be looking at from a PT standpoint.

Next slide.

We had 4 cycles of pilot PT. We had six laboratories that made it all the way through for the cocaine analytes. Five were using MS, one was using MS/MS. Six laboratories could analyze for cocaine and benzoylecgonine. Five laboratories said that they could analyze for cocaethylene. We did not include norcocaine in any of the samples in the previous four cycles. We plan to do that in the future.

We had analytes cocaine and benzoylecgonine included in the samples in all four cycles. We had cocaethylene also included in some of the samples in cycles 1, 2, and 3.

Next slide.

Again, looking at the gross or the summary slide of the values that were reported, again we have the mean concentration, the reported value -- and this is for cocaine -- and you can see the variance of some of the values. Some are below 50, some are above 50. There's a good bit of variation here in the laboratories. Again, we only have those laboratories that reported values for this particular analyte. You see that we do not have any values below the proposed cutoff.

Next slide.

That's just reiterating. We do have considerable variation down at this lower level, but we are approaching the 500. We need to go down to at least 200 with our changes for these laboratories.

Next slide, please.

Looking at the variation in the values of cocaine, we can see that there is considerable variation throughout the cycles. We have cycle 1, 2, and in cycle 3 we had -- if you remember when we reported the values, the laboratories were asked to provide two tests of each sample. One is a not-washed, that is they did no preparatory wash of the hair before they did the analysis. They were also asked to analyze the samples washed if they had a wash procedure. Some labs do not have a wash procedure. So that makes the data in cycle 3 for washed somewhat limited and the things we can say about it are somewhat limited, but that's never stopped us from saying some things. But we'll go ahead with that.

You can see on the variance we did have one sample in which the variance was excellent in cycle 1, actually 2 was well below, was 10 percent or below, which is very good. But overall the values have been -- the variance has been pretty high. It's been 20 percent or greater.

We're not sure -- as I said last time with THC, we still are working on our samples that we're providing to the laboratories to make sure that they're valid and that they're not a contributory or not contributing to this variation in the labs. That's going to take some time for us to work out.

We have some experiments or some additional tests that we have scheduled to try to answer those questions, to look at variance of the PT samples that we are providing to the laboratories.

Next slide.

Now, looking at benzoylecgonine, you can see it's very similar to the cocaine score as far as the variance is concerned. We are looking again, mean reported values and the 50 percent errors, we can see those in there. The cutoff is down here below the values.

Next slide will blow up that area.

This gives a little bit -- we should be going down to 50 picograms/mill, but we can see we are not near there at 100. Actually, in a previous draft -- the reason we're using 100, a previous draft had the proposed cutoff of 40 percent would be at the 100 if I remember correctly. But this is the most recent draft. So we still have some work to do in this lower area and hopefully we can identify some of the problems with the variation.

You can see that some of it may well be laboratory-based. We have one lab that's high here. We have another lab that's running low. So some of the variance may be due, that we see, may be laboratory-based relative to the mean.

Next slide.

Again, the variance. Cycle 1, we were only able to get one; we only had one value. The cycles were set up so that they emphasized certain drugs, so that's why we don't have an even distribution across the four cycles. You can see cycle 3, the ones that have the brickwork are samples that contained both cocaine and benzoylecgonine. The reason I had to look at that was because in cycle 3 we had these two samples which had very high variation and the question was, is that due to the presence of cocaine and cocaine being converted to benzoylecgonine? Is that why we had the variance?

At this time, I can't say. I tried to go through it and look at it, but because of the hit and miss -- not hit and miss -- the failure of laboratories to conduct all the tests that were requested, either because they didn't have sufficient samples or something of that nature, the values are somewhat limited. So we couldn't make direct comparison in all cases.

But again, we see that with benzoylecgonine we have some relatively high variance, which again, as I said, may be due to some -- may be some laboratory-based. Yet, we still can't say that it's not sample-based at this point in time.

Next slide.

We looked at the agreement between washed and unwashed samples as far as the values that we obtained for cocaine and we can see that they agree fairly well with the theoretical line. Here it appears that they were a little bit below the line, meaning the concentration found in the unwashed was higher than the concentration in the washed. But that's based upon the means.

Next slide.

This is benzoylecgonine and, looking at the agreement between the unwashed and the washed, again we see in this range here some that are below, which might indicate if they were cocaine, if they contained cocaine, that they would be the conversion of cocaine to benzoylecgonine. Indeed, I believe these three did have some cocaine in them.

We noticed early on in some labs that there was a large amount of conversion of cocaine to benzoylecgonine. This was in the first couple of cycles. Those labs didn't make it through the process -- I mean, they didn't go through all four cycles. But still, we have to address this because, since the cocaine and benzoylecgonine concentrations are linked, then we need to make sure that we are not -- or at least have control, conversion of cocaine to benzoylecgonine.

DR. SMITH (DTAB member): If you expected a conversion, wouldn't you expect the washed values to be there?

DR. MITCHELL: Not necessarily, because it may be due to the -- the washed values to be higher? You mean the benzoylecgonine concentration?

DR. SMITH: The conversion doesn't take place in the washing step, is that what you're saying?

DR. MITCHELL: Right. I don't think the number is there. I think it's in the processing of the sample to get the cocaine and benzoylecgonine out. That's where it occurs.

Next slide, please.

I had not presented any information concerning cocaethylene even though we had it in some of the samples. The reason for that is that the points that we got, we only have one or two values and I just wanted to throw those up. What we wanted to do was look at cocaethylene and its concentration relative to washed and unwashed, and you see that it appears that the non-washed have a higher concentration than the washed samples.

But that is just very limited data. I just wanted to say that we did have some cocaethylene.

Next slide.

In oral fluids, the initial test cutoff is cocaine metabolites at 20 nanograms per mL. The confirmatory test is cocaine in 8 nanograms/mL as well as benzoylecgonine at 8 nanograms/mL.

Next slide.

In this program we have 3 cycles, 9 laboratories, seven using MS, two using MS/MS. Nine of the laboratories were able to analyze for benzoylecgonine. Five of those labs were also able to analyze for cocaine, which means that if all nine labs are going to meet the requirements they are going to have to deal with cocaine, too, in the future.

The samples -- this is a little bit clearer with this than here. We had benzoylecgonine only with samples 1 and 2 and in cycle 3 we had cocaine and benzoylecgonine in the samples.

Next slide.

Looking at the analytical values reported for benzoylecgonine in all three cycles, again the mean versus reported values of the labs, the cutoff is 8, which is down in this area. The line was so close that it was difficult in PowerPoint to put it there, so I left it out.

Next slide.

Blows up the region down near the cutoff, which is where most of our interest is. You can see that there is considerable variation in these samples around, in the values that were obtained around the cutoff. We were able to bracket the cutoff down to about 50 percent, which is what we would like.

You can see that we do have some labs that have problems, either a high bias and some with what appears to be a low bias. But at least with the benzoylecgonine we were able to look at the variability on both sides of the cutoff.

Next slide.

DR. SAMPLE (DTAB member): Are these all off-device or is it a mix of on-device, off-device?

DR. MITCHELL: Go back to the slide.

(Screen.)

Okay, this is neat. I'm sorry. Good question. This is neat. That means that they analyzed the oral fluids directly.

Next slide.

That's the device, the same data. You see we have fewer values. Not every laboratory that participated had a device to use. They were asked -- they were given the oral fluid and they were asked to pipette the theoretical amount that their device would hold onto that and then process it as if they were processing a regular specimen.

We do have some variation. We were able to go on either side of the cutoff. The values then fell a little bit high in here and we'll talk about that just a little bit later. Again, we do have some 50 percent errors, as you can see, from laboratories.

Next slide.

This is the variance. Again, those samples had cocaine in the brickwork. We had cycle 1, 2, 3, and 4. All of these are just benzoylecgonine. You can note that the overall variability of the benzoylecgonine, the variance appears to be higher where we have cocaine. I think that we'll see from the following slide that there is evidence of cocaine to benzoylecgonine in these laboratories.

I think we have reiterated everything. We said the values fell on both sides of the cutoff, and we look at both variance with benzoylecgonine -- and this is cycle 2. After cycle 1, the variance is fairly low, but then it went back up at 3. So we still have some additional PT work that we need to do.

Next slide.

Looking at cocaine, we did not manage to get concentrations directly at the cutoff or below the cutoff. We have to try to do that in the next PT cycle. We only had five labs that have given us values for cocaine. The variation -- all but one of the values is within 50 percent of the mean.

Looking at the variance, this is the neat.

Next slide.

The variance. As you can see, one sample was high, but the others were somewhere around 20 percent in the nine laboratories in cycle 3.

Next slide.

Comparison of analytical values for benzoylecgonine without cocaine in oral fluid. As you can see, the comparison, they almost fall right on the line as long as we do not have cocaine present, and this is neat.

Next slide.

With cocaine, you can see that the mean values are high, indicating that we have a conversion of cocaine to benzoylecgonine. That would be one of the -- the question is where does it occur. Does it occur in the sample before we get it or does it occur during their analytical process? We've got to figure out a way to distinguish between those two for the future.

Next slide.

Looking at cocaine, this is with the device. We see the same thing. The previous was the neat. We see the same thing with that. Benzoylecgonine concentrations are high in the presence of cocaine.

Next slide.

When we look at the theoretical for cocaine, it's lower than theoretical, which again would be consistent with the cocaine being converted to benzoylecgonine. This is neat.

Next slide.

We didn't have the other values. One of the things I did after I made these slides, I went back and looked at reference values that we had. We actually had these samples analyzed at another laboratory which did not participate in this. They indicated that there was not -- that we did not have conversion of cocaine to benzoylecgonine in our sample.

We will be looking at that a little bit closer. This laboratory where we had benzoylecgonine present, they were able to analyze it, but their analysis indicated that they were close to theoretical. So that one piece of evidence would indicate that our samples appear to be okay in the oral fluids and we have a problem with conversion.

The question that is a scientific one is: Is that significant? You remember in urine we don't analyze for cocaine even though cocaine is known to be excreted in human subjects into the urine. We may have conversion, we may not, in laboratories. That's not something that currently is being looked at in the PT program.

In the case of oral fluids, is it significant, the cocaine? Are there interpretations that require the presence, require the cocaine, in benzoylecgonine in order to interpret the results? That's something that the Board will have to consider. It's just a finding that we have.

Unlike hair, we have to make sure that there's not conversion because of the requirement there for the cocaine to be ten times the benzoylecgonine.

(Screen.)

In summary, urine, we are going to need a special PT set before we institute the initial test cutoff to make sure that they are in compliance with this cutoff. We'll also need some special PT's before the cutoff is instituted at 100 for confirmation to demonstrate the precision and accuracy at 40 percent of the proposed confirmatory cutoff.

Next slide.

With hair, again, initial testing, the same thing. We'll need to look at the initial screen -- and that's wrong. It's 500. No, it is one picogram per milligram for the initial test, excuse me. We need to do that.

Confirmatory testing, we still need to look at what is causing the high variance, whether it's laboratory-based or whether it is due to the samples. Washing, again, did not appear to affect the means compared to non-washed quantitations. That was one of the findings that we had.

Next slide.

We will need additional PT's to challenge at and below the proposed cutoff for cocaine, benzoylecgonine, cocaethylene, and over the whole range for norcocaine; and, as I said, additional PT's to investigate potential for conversion.

In any case, once hair is brought up as a matrix then it would be necessary in every PT cycle to check for that, just as we check for things within urine for potential problems or issues.

Next slide.

Oral fluids, the same thing with initial test. We need to check it. And we see that the variance is approaching for cocaine 20 percent, the variance for benzoylecgonine is high, and it appears that that's probably due to conversion of cocaine to benzoylecgonine.

Next slide.

If it is considered by the Board that the conversion is significant or a problem, then we are going to need to go back and look at that issue in the PT cycles; and also, we need additional PT's to verify performance at and below the proposed cutoff.

Any questions about this data?

VOICE: Is there any correlation between the type of spectroscopy technique to the result? You mentioned that some people used GC/MS, GC/MS/MS, or LC/MS/MS.

DR. MITCHELL: I haven't done that analysis at this point in time. What we do have is just a general feeling that the MS/MS, at least in the hair, appears to be more sensitive than, which is what we'd expect, than the MS. We really saw that with the THC, which is going another level down. It doesn't appear to be quite as critical with the cocaine analytes because the concentrations are much higher.

DR. SAMPLE: Were initial tests performed on these proficiency samples? And if so, what's your general sense of how the laboratories performed versus the cutoffs? It looked like some of the values might actually challenge at, say, 25 percent, 50 percent, 100 percent of the cutoff. Did the laboratories generally perform well or was there more variation in the ability to detect closer to the cutoff with the alternative specimen than you would see with urine?

DR. MITCHELL: We looked at that, if you remember, in the first series of this where we provided the raw data.

DR. SAMPLE: It's been a while.

DR. MITCHELL: It has been a while and I have not looked at that point. But my feeling is that most of the labs were adhering to these cutoffs. There were some possibilities that the labs had cutoffs below. I mean, the cutoff for the immunoassay that they were using was below what was at that point in time.

But relative to these cutoffs, I haven't really gone back and analyzed that data, because I'm not sure that was the same cutoff we were using at that point in time. So I'd have to go back and look at it, especially for this analyte.

MR. SHULTS (AAMRO): It looks like the graphical data looks better than the coefficient of variation would give you the sense of it. Now, if I just try and connect the dots myself, if I looked at your oral fluids data, it looked like you had one laboratory that had a high bias and one laboratory that had a low bias and one laboratory that was cut right down the middle.

So kind of by definition, when you talk about your program, you have already eliminated the bad urine laboratories because they're all part of the NLCP. So if you eliminated all the bad laboratories with the high bias and the low bias, then your coefficient of variation for some of these looked pretty good.

DR. MITCHELL: That is correct. The problem that we run into in some cases, we haven't done that analysis, number one. We haven't gone through and eliminated the big outliers, used some type of routine that would eliminate values which were obviously outside. So we haven't done it at this point in time. We will be doing that as the Board starts looking at these issues a little bit closer.

But also, variation is a function of the number of values that you have, too. So the fewer labs you have and the more widespread they are, then the variation goes up also. So where you're only dealing with five labs or nine labs versus 56 labs, you are going to see the effects of N, which is the number of labs participating, on that variation goes up, that's true.

DR. BUSH: Recall that the numbers that are included in this analysis are from laboratories who have doggedly plugged along with us through the four cycles. We have excluded some of your major outliers who recognized that they were not at the point and maybe need to refine their techniques and come back and begin participating at a later time when they feel better about it and they've refined their technique. They have weeded themselves out. Some have already weeded themselves out by not continuing to participate.

MR. SHULTS: Again, without a great deal of analysis, just connecting the dots, in your mind's eye you can see that some of these are straight lines. So if you're looking at coefficient of variation, an interpretation of that is, yes, there are differences in the precision of these laboratories, but there seems to be the technologies theoretically there.

DR. BUSH: Exactly. We are encouraged that the technology is there to do this. Thank you for the take-home message, because that's what we have been working with industry for these years to try to show and help them get better, help us get better. We've got to learn how to prepare these specimens and make good judgments about them and their acceptability: Yes, this is a good PT and, yes, this lab is performing well with it.

We keep using this overlay of the 20 percent and the 50 percent ranges that we continue to show, because they have been a part of the Mandatory Guidelines for urine drug testing from the very beginning, from April 11,1988, when the first version was published in final format, and might we need as a group to embrace a larger window of variation based on the technologies that we see?

These are questions that we need to ask. Yet, sometimes these are questions hard to even pose because since April 11, 1988, to this very day we have accepted one set of criteria and yet we may be changing that, widening it, opening it, changing it. Change is hard, no matter what you do, and trying to get people to understand what the change means. First of all, we have to understand it; and second of all, trying to get people to embrace it as a good thing will be another hurdle. We've got to understand it all.

But that variation, it's a concern, because right now if we were to write the guidelines exactly, for alternative matrices, exactly as the urine drug testing guidelines were written, you may only have one lab that meets the requirements. Wouldn't that be ironic? You need an A lab and a B lab. We always have to look at this. You always have to have at least two labs certified for each matrix because you have split specimen possibilities, etcetera, retests. So, anyway.

We want more players. Everybody is a player and we need everyone to step up who wants to be a player in this very valuable workplace exercise.

DR. MITCHELL: One thing I might add is, some of the laboratories that we have talked to recently are either purchasing or have purchased, already purchased, MS/MS instrumentation. I expect when we start the new set that we'll see some additional improvements if indeed the MS/MS is a key to this analysis, and I think it probably is in most cases.

MR. STEPHENSON: I think we'll need to have some continued discussion by the Board and perhaps look at the option of reconvening some of our industry working groups to look at some of these issues more pointedly. We need more partnership process and maybe some of those group dynamics that help drive some of the general parameters early on can be used again, rather than simply trying to drive only through the PT cycles with the length of time across.

Again, we are looking for industry development, not just certification of proficiency by single laboratory. We are looking for what we can do to improve across domains in each of these areas to help give us repeatability in different laboratories over time and good consistent results as we move into the alternative matrices.

DR. BUSH: We chose cocaine for today's presentation because, as you recall, at the last Board meeting we went over the marijuana data that we had, for two reasons: marijuana is America's favorite illegal drug and it is the sole member of the acid-based drugs that we analyze for in our program, more acid in nature than basic.

Here, cocaine is America's second favorite illegal drug, but this clearly is a basic drug. We are taking a look at laboratory performance with the instrumentation necessary many times to go down into parts per trillion with marijuana metabolites versus what we are very used to in the parts per billion range.

As John said, showing on that one slide, we are looking at sensitivity issues and how does the drug class affect that? We also have to keep our eye on the ball of keeping the program relevant to America's drug abuse problems.

I am not sure we are going to have a PCP story with a chapter this thick (indicating) for you at some time in the future, but we are going to keep our eye on the ball with marijuana and cocaine and opiates and amphetamines more so. We are going to take those first as the more representative classes.

Agenda Item: PUBLIC COMMENTS

MS. VARLOTTA: Mr. Stephenson, all members of the Drug Testing Advisory Board: My name is N.B. Varlotta. I'm a career flight attendant with an excellent employment history. In March of 1999, my employer terminated me only one month shy of my providing 20 years of faithful service. I was falsely accused of substituting a drug screen sample under the standards established by this sample. Eventually, I learned that lab findings reported my creatinine level as 2 and my specific gravity as 1.001.

Immediately, on my own initiative, I provided 7 inches of hair, an observed recollection, and a note from my physician. Shockingly, I found that nothing was accepted to prove my innocence, nor was there a statutory avenue available to prove my innocence.

In the fall of 2000, a pilot's appeal of his certificate revocation exposed egregious errors in the same laboratory that tested my sample. The accuracy of the lab's creatinine assay could not be established beyond plus or minus 8. This finding was also exposed in a trial involving another flight attendant's case -- same employer, same lab as myself.

It is my understanding that before these cutoffs of 5 creatinine and 1.001 specific gravity were established individuals in HHS and DOT were well aware that approximately 28 percent of the female population and 5 percent of the male population could test below these levels.

Additionally, Cornell University research states that there is no reference range for creatinine on a spot urine collection. In essence, ladies and gentlemen, at any given moment that creatinine content on a spot urine collection in the human body is highly variable. How can this testing procedure be approved knowing individuals will fall below the margins of the bell curve with catastrophic consequences? If falsely accused, an individual's reputation and future career can be ended and any potential employment is extremely limited, if attainable, as attested by the fact that I was unable to find employment with this stigma attached to my record.

Through fortuitous circumstances, I did return to my career in February of 2001. The investigations following the pilot's case exposed egregious errors in the test procedures in the lab. SAMHSA's emergency inspection of all certified labs gave failing marks to 40 out of 66 facilities. Yet my test and those of many others were not cancelled. Had the pilot not fought through channels outside of the drug testing regulations, I more than likely would not have ever been returned to my career.

Sadly, even today the analytical variance between the laboratories remains great. The possibility of my body testing outside of the normal cutoffs is a daily reality to me. Quite simply, that means that the nightmare could again happen at any particular urine collection, deeming me a cheater.

There is no solution in place by DOT to protect or safeguard me. Putting the testing of the laboratory aside, the ability for an innocent person to clear their name is not established. No legitimate due process exists, particularly to the non-certificate holders such as a flight attendant.

My company-selected substance abuse professional completed a fitness for duty evaluation without recommending treatment or follow-up testing. The medical review officer did not recommend follow-up testing, although my employer now claims that there is a report from the MRO on file. Regardless of the MRO's position, the Federal Aviation Regulations clearly state that follow-up testing is only warranted upon the recommendation of a substance abuse professional.

I have been subjected to nine follow-up tests since May of 2001 under the threat of termination. Essentially, I am still considered guilty and being harassed, falsely accused again by each and every one of these follow-up tests, solely because my body happens to naturally produce low levels of creatinine. Will I continue to be discriminated against simply because my body functions do not fall within the normal, non-scientifically established standards?

I am asking this Board to please discontinue this so-called validity testing immediately and until the science is foolproof. Failing such action, since the science is questionable and since human error can never be removed from the equation, I would suggest that it is incumbent on this Board to adopt specific step by step procedures acceptable to all employers which would allow any employee to clear their name in the event of a false accusation.

Thank you for your time.

MR. STEPHENSON: Do we have some comment? Are there any questions?

(No response.)

Sir, could you provide your statement, if you would, at this time. For the record, restate your name.

MR. DRAKE: My name is Richard Drake. I was a Delta flight attendant. I was previously a (inaudible) flight attendant for 35 years. I had an outstanding career, no problems whatsoever. I was terminated from my employment with Delta because they claimed that I had an adulterant in my urine sample.

This testing on my urine sample was done outside of any chain of custody. This was confirmed to Ken Edgell's office by the Inspector General of DOT. No chain of custody was used. In light of that, you would think right away they would certainly cancel the test, being that no chain of custody was used as it was shoved around to different laboratories that found it negative for adulterants, negative for adulterants, negative for adulterants.

Eventually, one laboratory said it was positive for an adulterant, but has lost and never produced, never found, any of the records of that testing. You would think right away they would cancel that test. The FAA and the DOT, even in light of the Inspector General's report, just that one basic situation that no chain of custody was used, you would think they would cancel it. You would think they would comment on why they would not.

As Ms. Varlotta already testified, there is absolutely no method for a person who is a flight attendant to in any way litigate, force, compel, direct anybody in the DOT or the FAA to do anything.

For 10 years I've fought this case through the courts and constantly, never to prove my innocence, just to be able to get a hearing, to present the evidence, which is unlimited, as to all the violations that were committed by Delta and the labs during the testing. I have been constantly told, constant rulings from the courts, that I have absolutely no rights to bring any type of action in any forum for any violation of the drug testing program that you people created.

You have falsely accused me. You have created rules that you do not enforce. You have followed procedures which are absolutely outrageous in any kind of a civilized country that has a due process system.

I would now ask this Board, since you are all here, which one of you will tell me where I could have a hearing to present the evidence that I have that my testing was done totally improperly and it was actually negative, when my employer, who wanted to get rid of me because I was the head of the union, union movement, wanted to get rid of me, used that process and has refused, refused for seven years, to even show me one piece of evidence regarding my testing.

Nothing, absolutely nothing. They would not show me any results of the testing. The labs now refuse to show any results, any process, any data, anything, regarding my testing.

Please, now tell me where I can appeal to get a hearing regarding my situation? Or any flight attendant -- Ms. Varlotta, where can she go? Ms. Smith, another flight attendant who is also totally innocent, but can find no forum to hear her complaints. Can I please have some information from this group now?

Are you Ken Edgell, by the way?

MR. EDGELL: Yes.

MR. DRAKE: Yes? Would you please comment on where, your being the head of that program, I can go to have a hearing to present my evidence that my testing was done improperly?

MR. STEPHENSON: If I could please interject here. This is an opportunity for you to make a public comment. It is not a process to engage in public dialogue. I would suggest that at the close of this public session, if you choose to have a discussion with Mr. Edgell, we'll make sure that there is a little bit of time that you can do that.

MR. DRAKE: I see. Then you're saying now that I don't even have a right to get an answer from this Board. I have no rights whatsoever. I have come here because this is a public forum. Let's tell the public: Is there a process for me to follow? Somebody here must know it. I'd like to know what it is.

Obviously, there isn't one. No one knows what it is. This is the top of the Board and none of you know what process I can use. You have created a wonderful system.

MR. STEPHENSON: Thank you for your comment, sir.

MR. DRAKE: Outrageous, outrageous.

MR. STEPHENSON: Excuse me. Are there any other public comments at this time?

(No response.)

I would like to close the open session of the Drug Testing Advisory Board. We will convene in closed session at 10:15. Thank you very much.

The open session was adjourned at 10 a.m.