SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

Opening Remarks - Joseph Autry, MD

Overview of Information Submitted in Response to

April DTAB Meeting - Carl Selavka, PhD

Forensic Workplace Drug Testing Program Requirements

US Probation/PharmChek Drugs of Abuse Patch Pilot

Program - Robert Fogerson

Administrative Office of the US Courts:

An Evaluation of Non-Instrumented Drugs Tests

- Robert Willette, PhD

Public Comments

Group Discussion

Public Comments

JOSEPH AUTRY, MD (Chair), CSAP, Rockville, MD

DONNA BUSH, PhD, (Exec. Secretary), CSAP, Rockville, MD

ROSEMARY BAKES-MARTIN, CDC, Chamblee, Georgia

YALE CAPLAN, PhD, Quest Diagnostics, Inc.Baltimore, Maryland

CHRISTOPHER HOLLAND, MD, HRSA, Bethesda, MD

AARON JACOBS, PhD, USAMC, Fort Sam Houston, Texas

ALAN JONES, PhD, University of Mississippi, University, MS

TAI KWONG, PhD, University of Rochester, Rochester, NY

MELANIE MALLORY, Consultant, Scottsdale, Arizona

RICHARD PINDER, PhD, Public Health and Addiction Services, Hartford, CT

DIANA WILKINS, PhD, University of Utah, Salt Lake City, Utah

ROBERT FOGERSON, VP and Laboratory Director, PharmChem Labs, Inc

BRUCE GOLDBERGER, Ph.D., Diagnostic Reference Laboratory, University of Florida College of Medicine

RAY KELLY, Ph.D., Director of Toxicology, Associated Pathology Labs

CHRISTINE MOORE, Ph.D., Associate Scientific Director, US Drug Testing Laboratories

CARL SELAVKA, Ph.D., Director, Office of Forensic Services, New York State Division of Criminal Justice Services

ROBERT WILLETTE,Ph.D., President, Duo Research

PROCEEDINGS (8:54 a.m.)

DR. BUSH: Good morning. As the Executive Secretary of the Drug Testing Advisory Board, I would like to welcome you to this meeting of the Board. We are going to continue with what we have done with the April meeting in taking a look at alternative specimens and testing technologies for workplace applications.

Dr. Autry received his bachelor's degree from Rhodes University with majors in chemistry and psychology. He received his doctorate of medicine from the University of Tennessee. He completed an internship in internal medicine at Baptist Memorial Hospital, where he ran a coronary care unit for several months. He completed his residency training in psychiatry at the National Institute of Mental Health/St. Elizabeth's Hospital Model Residency Training Program. He was board certified by the American Board of Psychiatry and Neurology in 1976. Dr. Autry had an active career as a practicing psychiatrist prior to coming to the Washington area, joining the National Institute of Mental Health and becoming the director of extramural research, taking on responsibilities for basic research, clinical research, treatment research, and applied research. He took on the challenges of directing the Office of Policy Analysis and Coordination for the National Institute of Mental Health and then for the Alcohol, Drug Abuse and Mental Health Services Administration, the parent organization for NIMH. In 1990, Dr. Autry decided to move back into research and became the director, Division of Applied Research, at the National Institute on Drug Abuse, with responsibility for research on drug-free workplace programs, workplace policies related to substance abuse and AIDS in the workplace, health services research, research on HIV infection/AIDS in the community, and oversight for the National Laboratory Certification Program which certifies laboratories to conduct drug testing for federal drug-free workplace programs and the federally regulated industries. Following the reorganization of the Alcohol, Drug Abuse and Mental Health Services Administration in 1992, Dr. Autry became director of workplace programs for the Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Prevention, and with oversight responsibility for all the federal drug-free workplace programs and the National Laboratory Certification Program for forensic urine drug testing. As the old saying goes, no good deed shall go unpunished. The reputation of his insightful leadership and his abilities to tame the wild bunch has resulted in his being assigned, at least temporarily, as the acting deputy director of the Center for Substance Abuse Prevention. Additionally, Dr. Autry continues his part-time private practice of psychiatry which he frequently describes as his link to the non-bureaucratic world and an opportunity to constantly infuse his federal research and services responsibilities with a continuing need for new knowledge to deal with the problems of mental illness and substance abuse in clinical practice. Dr. Autry.

DR. AUTRY: Good morning. It is good to see so many friends and colleagues here again. I am not quite sure what Donna meant by taming the wild bunch. I am afraid to ask. Let me apologize to you for being late this morning. I have a long and checkered history with northern Virginia. The first year I lived here I was convinced that you could not go from southeast Washington to northwest Washington without crossing the Potomac and doing a U turn in Pentagon South parking. I am now convinced that I cannot come to this side of the river without going to Pentagon City first and then going wherever it is that I am supposed to be going.

We have a very busy couple of days ahead of us. This is the second meeting of the Drug Testing Advisory Board that is focused exclusively on looking at emerging technologies and alternative specimens. It is an undertaking that we have been very pleased to do on behalf of the federal drug free workplace program. We have appreciated all your participation up to this point.

I also want to bring you greetings from Nelba Chavez and Paul Schwab, who are the Administrator and Deputy Administrator of the Agency.Unfortunately Nelba is out in Arizona and Paul is doing something down at the Department level in her stead and neither one of them could be here. They do both, however, send to you their greetings and let you know of their commitment to continue this very important undertaking.

There are a couple of housekeeping chores that we need to do. We are going to have a public comment period toward the end of this day and we would ask that you sign up in the back. We will take them on a first come, first served basis. Depending on how many people sign up, we will divide the available time by the number of people. You will probably have a period of about five minutes or so. We are also taking written questions throughout the day today and also tomorrow. Please, if there are any questions, get them up to us. We will weave them into the public comment period. We will also change the agenda slightly tomorrow afternoon to allow additional public comment and, again, ask that you sign up in advance.

In April we undertook, or started the process, I guess is a better way to say it, of looking at alternative technologies for specimens, to see how they might fit into the federal drug free workplace program. I think we were a bit optimistic at that point in time and thought that we could probably go through this pretty quickly in a couple of meetings because of the emerging science. However, I think we were quickly dissuaded of that disbelief.

Following that meeting we asked that the industry representatives coordinate getting additional information in to the board, which they did. We were scheduled to meet again in August. However, the Board needed additional time in order to go through what had been presented in April, to go through the extensive material that had been sent in following that meeting. So, the board members themselves had a meeting in August as a working group, not as a formal board. My staff and I were not involved in that.

So, we are hearing a lot of what you are hearing today, not exactly for the first time, but certainly in a more formalized way than we have had informal discussions with the board in the past. What we intend to do for this meeting is to try to take advantage of the board's work in August, the material sent in after the April meeting and the deliberations of the April meeting to come up to sort of a state of the science of where we are today with alternative specimens and technologies. Perhaps more importantly, where are we today in re-examining the underlying principles on which drug testing has been based for the past decade. I am pleased to see my predecessor, Mike Walsh, is here with us and we certainly look forward to having comments from him as we go through this meeting, too. I am not going to say anything more at this point because I think the deliberations of the board are what this meeting is all about. I will tell you that what we will try to do is at least once a year have a session in which we do look at the principles that underlie drug testing to see if they are still the gold standard. We will continue to look at all of the testing technologies and all the specimens that are available for testing on at least an annual basis. With that, I am going to ask that Skip Jones come up and talk a bit about where we are with the board's deliberations.

DR. JONES: I am going to use the floor mike. I am going to use the overhead in a little bit, so I am just going to use this mike to start with. Thank you, Dr. Autry. We are going to be passing out some efforts of the board and I am going to go over those in a few minute. I will let Donna and Laura pass them out. I have been asked to serve as spokesperson of the board, I guess, is the appropriate title this morning, to give you a little bit of an idea of what we have been doing, where we have come from, and where we are at present in our efforts. As Dr. Autry said, we started this program, this process, this trip back in April when we first had the first large open hearing and had a variety of submissions and presentations.

As a board member -- and I think I can speak for the board -- I certainly want to thank all of you who made presentations at that meeting, supplied additional information, supplied additional reading information. I think we had plenty of information to read. We had plenty of information to use in the gym to work out with as we lifted those boxes and packages of papers that you had submitted. It is that type of information that we certainly needed and we certainly appreciate your efforts in supplying all of that information. We certainly appreciate your efforts in making this meeting today. Our mission, our challenge, our charge, has probably changed.

When we started this process back in April, several of us thought -- and I think the board agreed in general -- that what we were going to do was probably have some presentations by a variety of people looking at some of the alternative technologies that are available, looking at some of the procedures and techniques that are available. Somebody was going to present a program for us and the board was going to come back and say yea or nay on that program that was presented. As we finished up the April meeting and started looking at all the material that was supplied, as we talked back and forth amongst ourselves via telephone, via fax, via conference calls, et cetera, over the following few months. Then we met in August and we have had a couple of conference calls again since then as a board, we came fairly rapidly to the position that we could not do that. We could not say yea or nay on a single technology or on a single process because we came to the realization that if we start changing and admitting or allowing one thing, then that one thing is going to impact upon the whole existing system, the system that we already have in place. So, to address that, what we did as a board, we decided that we needed to step back. Actually, we went all the way back to the April 1988 guidelines and started looking at, what are the required factors for an acceptable workplace forensic drug testing program.

We have established a series of ideas and comments and factors and that is what has been distributed to you, a table, a checklist, a measuring stick by which we are going to try to do these evaluations. I want to quickly say that this is a work in progress. This document is an evolving document and we would certainly appreciate your comments and your input as to whether or not it is complete, as to whether or not things need to be added, or whether or not things need to be deleted from it. It is a work in progress that we are attempting to establish a yardstick, a measuring device, by which we can evaluate these programs. So, with that, we came to the -- let me just spend a few minutes talking about some of these. You have all these in front of you.

What we attempted to do was identify various general characteristics, general categories of those factors that are included in a drug testing program that would be acceptable for federal workplace drug testing.

Initially we looked at this whole process. Of course, this whole process starts with the collection site. We heard issues about the collection site at the April meeting. So, collection site issues are certainly relevant to all of the methodologies. Many of my comments here today, I think, also reflect some of the deliberations of the board and reflect not only the science but the administrative aspects of a quality program. So, collection site starts the program, starts the issue. What we have tried to do is generate a matrix by which we can do evaluations of the five categories that we have indicated there.

Initially the first category is saliva, then the on-site urine testing, the sweat testing, the hair testing, and the current urine testing program that is laboratory based. We have also looked at that, and we hope to look at that. There may be issues and recommendations that need to be made for that issue as we currently have that formulated. So, we started with the collection site, looked at some characteristics of the collection site, moved on to the donor, some characteristics of the donor, and the specimen. We have included some descriptions of these characteristics. We hope that these descriptions are understandable. If there are questions, if there are issues that you see, that the clarity of the descriptor is not there, please let us know.

As I said, this is a document, a work in progress. It is certainly not etched in stone. It is the measuring stick by which we are trying to start this process. There may be some terminology that may be more appropriate in some of these. We have included in some of these descriptors, in some of these items, some parenthetical phrases that additionally elaborate on those.

We proceed on down, following the specimen into the collection device, and some characteristics of that device, and some characteristics of that device, and further then into the collector, the individual that is responsible for the collector.

Some of the things that we have included in here, and I think we have not come to closure on this by any means as a board, are such things as I have included here in the collection device.

FDA approval; that is an issue that has not been resolved. Do all the devices need to be FDA approved. Part of that is a program issue and the like.

A collector. Another issue that we have identified as an element of a quality program is collector training. How do we document that. What kind of requirements are required for documentation of the collector's training.

Certification; does that collector need to be certified, especially as we have said there in the parenthetical phrase, in the on-site arena. What kind of documentation and certification is necessary. If we are indeed to have a quality program, we want that program to be one that will stand up in litigation and arbitration hearings and court proceedings. These are types of challenges that we anticipate a program would have. That is what propagated some of these types of comments.

As we go on to the second page there, we have got some issues about the transportation. We identified some issues about the transportation of the specimen and whether or not there would be issues in this.

Then we had some issues associated with the on-site testing. What you might want to do -- and I don't have a marker -- section G only applies to on-site testing. If you want to put an X in the columns under saliva, sweat, hair and urine lab, and X those columns out, section G only applies to on-site urine testing. We recognized also that at present we are dealing with urine testing programs in the on-site mode. There may be in the future on-site protocols that are dealing with some other matrices.

There may be in the future some on-site protocols that deal with sweat, with saliva, with hair or with some other matrix that might come up. At present we are only evaluating this in the on-site mode in the urine testing. So, those other columns of section G do not apply. These are some criteria that we are discussing in terms of the on site for the on-site urine test protocol.

Some issues that we are discussing, as you will see here, are the specificity, the FDA approval again comes up on these, the documentation of the on-site test, the identity, the verification by a second certified technician; these are discussion points that are being deliberated by the board.

As you move out of the on-site mode into the laboratory mode, we are dealing with laboratory-based testing that is analogous to what we currently have, analogous to where we are there.

We felt that at least in an initial mode, that many of the protocols, many of the criteria that are currently applied to laboratory based testing should apply to all matrices.

It is that measuring stick, that evaluation, that scheme by which we are establishing this yardstick. We talk about the characteristics of the lab, the receiving, the documentation, the initial testing and the criteria of that initial testing as are delineated in the present guidelines.

Furthermore, we talk about the confirmation testing, that second protocol that is by an alternative methodology, something that is different from the initial testing methodology.

That confirmation test, again, currently the guidelines we are dealing with are GC/MS. We as a board, I think, recognize that there is a distinct possibility that the guidelines may need to be rewritten, if we start moving away from the position of these criteria that are currently established. These are the deliberations and the questions that are in the board's minds, I believe, as we go through these. The laboratory based criteria are not that distinctly different from where we currently reside as we move through there.

The quality control issues and quality assurance issues are, again, very similar to where we currently reside with the guidelines as they presently exist, internal and external QC, the documentation associated with that, and the ability to introduce blinds into the system.

Reporting, again, tries to address some of the issues. This is, I think, where we -- one of the places we first started seeing the fact that if we start moving into some of these other methodologies, that the things that are being proposed or the things that are being discussed will have an impact on the existing methodologies.

I am not attacking it in any way, but I am using as an example the on-site methodology right here, in reporting. If we allow, or if one allows, reporting of on-site test results directly to the employer or to the MRO, then what is to preclude the development of an on-site testing lab, what is to preclude the immediate results automatically coming out of an autoanalyzer in the resident lab, all of these types of things.

To have a program that is consistent and uniformly applied to all the individuals whom are affected by this program, we have to consider that.

As I said, this is one of those examples where we recognized fairly early on when we started looking at this, that if you start changing one thing, you are going to start impacting on the system as it currently exists. I think, at least in my own mind, the system that currently exists is a system in which the administrative component affords the protection to the individual that we desire, that I desire, as well as the scientific credibility of that result that I desire as an individual. So, that is one of those examples that, as I said, led us to where we are in terms of reporting.

Then finally, in terms of interpretation of those results, again, some of the challenges we face are illustrated in these elements. Certainly the issue of bias, we have talked about bias and we have heard some presentations on bias up to this point in time, the issues of cutoffs, what are the relevant cutoffs of some of these alternate methodologies, how do they relate to one another. How does an individual who is tested under a hair testing protocol or a sweat patch protocol or a saliva protocol compare to a urine protocol. We recognize that the windows of opportunity of detection with those other matrices are certainly different from urine and how does one correlate between those two. What are the pharmacokinetic and pharmacodynamic relevances of the cutoffs that are established and how are those cutoffs going to be established.

Some of the issues associated with the interpretation, looking at parent drug and/or metabolite, again, as we move into those, the guidelines that currently exist are very specific as to what the analyte would be. As we move into those other technologies, then the guidelines revisions are going to have to allow for those other potential analytes. This item four, this interpretation, this detection window we have termed there, the opportunity to detect a potential user, the contamination issue, alternate method explanation issues, all these impact upon these alternate technologies.

Then we get item seven, the source of the specimen. Are there variations in there from the source of the specimen, as to hair, as to where the patch might be selected, what the nature of the saliva might be.

Are there variations -- we know that there are variations in the source of the specimen in a urine test, what the hydration rate is on that individual, whether or not he or she might be hydrated or dehydrated. That certainly impacts upon the concentration of that, but that is variable across the population. Certainly the data suggest that it is variable across the population.Are those same types of variations going to be seen and expected across populations as we move into the other matrices.

So, we put together this chart, this matrix, this measuring stick, by which we are going to try to evaluate these specimens. As I said, as we go through the comments today, please look at this, see if we have omitted anything. If there are other items that need to be included, please let us know, please communicate with any of the board. There may be opportunities even to communicate that in the public forum, in the open hearing, in the open public questions. We want to make this as complete as we possibly can. What we did as a board to start this evaluation process is we started looking at these. This particular document, actually a version two generations prior to this because, as I said, this is a work in progress, went to all the board members.

The board members were asked to respond in each square with one of four responses. They were asked to put a Y in there, a yes, meaning that the protocols that had been described, that had been submitted to us, that we had reviewed, did meet the criteria that were established. For example, if we looked at the very first one -- flip back to the first page -- the board members were asked to place a Y into the box, that it might have been appropriate to put a Y into the box under security and privacy of the collection site for saliva testing.

Is that possible? Is that probable? Yes, so we saw Ys in there. If they didn't think it was yes, they put an N into it. A no, it can never be obtained.

So, a Y and an N were two possible responses. A third response was a P that it was probable but we didn't have the details on it, or an I, that it was incomplete, that we needed additional information to make a determination.

So, we went through this whole chart. Everybody, all participants on the board responded, and then we prepared a compilation of that. That is kind of where we are today. We had some issues and we identified some issues that we felt were still issues that we needed some additional information on. Then we also have had come out in the recent months, certainly since the last meeting, some additional review studies and multi-faceted studies that have come forward. So, we went back to staff and said, we need some more help. We need some more information. We would like some more information as we continue this deliberation process. Some individuals were identified as potential presenters, presenters of some of the summary data. We also went to staff and said, some of the summary data that have been presented in some of the summary studies that are presented here, and that is what is going to hear today and tomorrow. We also went to staff and said, we would like to have a summary of all the data that have been presented to date, from all the submissions, particularly in the April meeting, as well as submissions that came in subsequent to the April meeting. Then that was tasked out to an individual and Dr. Selavka, Carl Selavka, is going to make a presentation, a summary of that also, a little later today to the board to assist us. Even though most of us, I think all of us have had a chance to review all the documents that many of you have submitted, Carl is going to try to assemble those into some sort of a summary form for us to further work with. That is kind of where we started and where we are today. We are still looking and trying to get as much information as possible on all these various aspects. We have established this yardstick by which we are going to try to do these measurements. We certainly would like additional input from any or all of you as we go through these next two days of the session.

So, in summary, I guess that is where we are. If any of the board members that are present would like to make additional comments at this time, I would certainly be happy to hand the microphone over to them.

If anyone wants to expand or elaborate on anything I have said, please wave your hand and say so, or no.

Dr. Autry?

DR. AUTRY: Skip, are you saying that these are the criteria that any technology or specimen must satisfy in order to be acceptable for workplace testing?

DR. JONES: Yes, I would think that is the interpretation that we have put on there. Notice the title on this, factors required for reliable workplace drug testing. I think that we are at the position today that even if a new technology were to come on board, such that I could look at the number of eye blinks that might be coming out of the left eye as a result of being under the influence of a particular substance, that criteria would have to meet these factors. That is what we have tried to identify as the elements or the factors in any testing protocol that might be present.

DR. WALSH: Skip, you indicated that under some of these categories that some of these factors were still under consideration. Your last answer to Joe indicated that you had come to pretty much conclusion that these were.

DR. JONES: I guess I would respond to that, Dr. Walsh, in the following manner. As I said, these are the factors that we have identified to date.

We are at this present time in our deliberations, these are what the factors would be that we feel would be the elements of that program, of any program. As I said, I think it is a document that is a working document, that is a document in evolution. We have not made a recommendation to Dr. Autry yet as a board.That recommendation will be forthcoming sometime in the future.

DR. AUTRY: Part of what this meeting is about is to look at this document and see if it needs to be modified, scratched, whatever.

DR. JONES: So, that is why I urge you to give us your comments, to give us your feelings, to give us your input on these. I know that some of you will have some fairly strong feelings on some of the items that are here.

DR. WALSH: One last comment. In going back to the April 1988 regulations to determine what was originally intended to be the basic tenets of the program, you need to recognize that that exercise began in the fall of 1986, and at a time when my instructions from the secretary were to put together the best system of technology that was available at the time. My instructions from the Justice Department were that we needed to bend over backwards and be conservative because we knew the regulations were going to have to pass Supreme Court muster. I guess I would urge the board to remember that 10 years have passed and technology has changed significantly. Also, employee drug testing has really become a standard business practice in the United States. Some of those issues that we were dealing with back in 1986 and 1987 are no longer tenable, as being the primary focus of what we were trying to achieve at the time.

DR. JONES: And I would concur with that. I think this document here reflects not only a lot of the science, but a lot of the administrative -- if I can use that term -- issues associated with a testing program. The majority of the elements on this really are administrative and are not scientific in that sense. They are programmatic. They are organizational in nature. So, with those opening comments, then, we will proceed. We have a lot of time here. We have a lot of flexibility. When we laid this agenda out, we didn't know how long it would take to cover some of these items. But we can proceed on from where we are, Dr. Autry, Dr. Bush. Dr. Autry asked me if the board would be willing to take a few questions. I said, sure. I would ask, if you do have questions, if I can't get to you with this, use the mike in the center so that we do have a recording of this for transcript purposes. Questions and comments at this point in time? I guess I did an outstanding job. Thank you.

They were looking at the agenda. We were scheduled for a break at 9:45. Why don't we go ahead and have the break at the present time. Then we can come back and have Carl have his presentation right after the break. Is that agenda okay, Donna?

Okay, so, let's go ahead and have our break now and we will reconvene in about 15 minutes.

(Brief recess.)

DR. BUSH: Ladies and gentlemen, if you can take your seats please, the reason that we have this preliminary agenda is so that we can move presentations around as we need to, to fit the flow of the meeting. Many times what you plan ahead is not what you really need at the time. So, we are going to have Dr. Carl Selavka make his presentation at this time.

Ladies and gentlemen, I would like to introduce to you Dr. Carl Selavka. Carl Selavka is the director of forensic services for the New York State Division of Criminal Justice Services. He is responsible for coordinating the quality assurance activities of all public forensic toxicology and crime laboratories in the state, including the implementation of laboratory accreditation standards, training programs and provision of technical assistance to improve service delivery. In addition, the office of forensic services is the unit within DCJS which is responsible for insuring implementation and maintenance of the New York State DNA Identification Index. This data bank, which will be housed at the New York State Police Forensic Investigation Center, will contain the DNA records of certain convicted offenders for use in assisting criminal investigations, as well as identifying recidivistic activities. Prior to joining New York State in August 1996, De. Selavka served as the director of criminalistics at National Medical Services, a private forensic laboratory in Willow Grove, Pennsylvania from 1991 to 1996, and as the operations officer at the US Army Drug Testing Laboratory in Hawaii from 1987 through 1991. Other experience includes work with the Bureau of Alcohol, Tobacco and Firearms National Lab in Rockville, Maryland. Carl received his bachelors degree from Indiana University in 1982, and a master of science and a doctor of philosophy degrees in forensic chemistry from Northeastern University in Boston. He is a diplomate of, and serves on the board of directors for, the American Board of Criminalistics. In addition, Dr. Selavka is a fellow of the American Academy of Forensic Sciences. Carl serves on the editorial boards of several forensic science publications, and is active in organizations involved with the quality issues and standardization in forensic science. In addition, he has testified in numerous military and civilian criminal and civil trials on cases involving drug testing in urine and hair, drugs in street samples and paraphernalia, and several other areas of criminalistics. He has published and presented work on a wide variety of topics, including the forensic analysis of evidence for explosives, drugs in traditional and esoteric biological matrices, determinations of pesticides in biological samples, and leadership philosophy in the forensic laboratory. Carl lives in Chocopee, Massachusetts with his wife Carolyn, who is a veterinarian, and their assorted animals. Golf, basketball and sleeping for pleasure fill his odd hours. Dr. Selavka.

DR. SELAVKA: Thank you. I will have my mom stop writing these introductions for these talks. I can't start a talk without giving you a joke. It is not a true story, so you don't feel bad at the end. Since I have moved to New York state I have learned that the Hamptons is where the old money lives, and that funny things happen there, including Scarsdale diet things and other things.

A couple was having a dinner party and at the last minute the woman said, we need snails. We have no snails. How can we have escargot without snails.

So, she sent her husband down on the beach. He rolled up his pant cuffs and he went down to the beach and he is picking up snails and putting them into the snail pail. He looks up the beach and there is a beautiful woman off in the distance. He thinks, this snail picking up is pretty boring. I wish she would come over and talk to me. Oh, it would never happen. So, he is picking up the snails and all of a sudden a shadow crosses his path. He looks up and she is standing next to him. Not only is she a great conversationalist, but they spend the night together. The next morning he wakes up and says, geez, the dinner party, the snails, I am in deep trouble. So, he throws his clothes on and runs home, gets the snails in a pail, runs up to the doorway of their condominium on the beach.

Just at the top step, right at the landing, he trips and falls. The snails go everywhere. His wife hears the commotion and opens and door and she is just madder than heck and he can tell. He looks at her and he looks at the snails and he says, come on, fellows, we are almost home!

I did that because this is a really short talk and there is nothing else very exciting in it. A couple of weeks ago I did get a call. We have had quite a bit of information submitted to the Drug Testing Advisory Board. Quite frankly, in the years leading up to that April meeting, there is a good deal of information in the literature available for studying these alternative matrices and on-site testing methodologies in workplace testing environments or in applications thereof.

It is a pleasure to be here today. I appreciate the opportunity to do so. The usual disclaimers apply. Any attorneys in the audience will be happy I do this. Anything I am saying is from my own mouth and brain and doesn't have anything to do with anybody I have ever worked for or any of the labs I am talking about. In general, what I plan to do is very quickly give you a summary of the questions that were posed by the DTAB after the April meeting, for which information was elicited from those presenters and those that might go through those presenters to the DTAB to answer those questions.

I will go over what type of information was received, some of the responses to the questions, what got answered and what in essence didn't have answers provided in those additional materials.

The last time we talked, I was here summarizing hair testing reporting. Really we were talking as a group about thinking outside the box.

This discussion today is an ongoing part of the process of thinking outside the box of workplace drug testing. There is a flood of information available. Just in the meeting we just had -- in April you got a notebook. For those of you who surf the web, this is a double-sided down load of the verbatim transcript of the April meeting. This is half the information sent to the DTAB in response to the questions they posed. This is the other half. Today we are in a really skinny piece of documentation. So far, so good, really thin. But this is just since April. So, that is a lot of information. It is easy to drown in that information. So, what I hope to do is to take the material submitted and try to put it into a summary form that might be a little more digestible.

What I did for the board is, I presented to them about a six-page spread sheet that goes through the questions that were asked and then references a specific area of the documentation that were provided by the respondents to help them assess whether or not those questions were answered. It was not my task to decide what the information said. It would be very presumptuous for me to tell them what anything said. I did tell them where to look, in my opinion, within the package of information. Basically, there were nine formal questions and I added a 10th category or question at the end. They asked about information related to the future role of the matrix for on-site testing in workplace drug testing programs.

They looked for:

1. Correlations with urine drug testing;

2. Publications and supporting data for the alternative matrix technologies and on-site testing;

3. Proficiency testing results if they were available;

4. How the structure of the programs worked;

5. Any data that could be submitted to address lab intravariability related to that alternative matrix;

6. The preparation of calibrators and controls;

7. The issue and how it would be dealt with of sample unavailability, when a person from whom they desire a sample is unavailable to give a sample for whatever reasons are appropriate, that alternative matrix;

8. Definitions of unsuitable samples and how the technology goes about addressing those problems;

9. A summary of the best applications in the opinion of the respondent for that matrix or on-site test;

10. Then a lump at the end that I created called other significant information.

On-site testing and sweat testing packets were received from a number of organizations. The National On-site Testing Association, David Evans, submitted materials for them.

Robert Aramondo submitted materials from Roche Diagnostic Systems. Dr. Niebala sent materials from STC and sweat testing information was submitted by Neil Fortner at PharmChem Laboratories in Menlo Park, California. I didn't have a good picture for spit, so I just had to choose this one. Oral fluid testing and hair testing submissions were provided for the DTAB review. Oral fluid testing information was submitted by Dr. Niebala and Dr. Kippenberger submitted a packet from Psychomedics Corporation in California.

With respect to the first of the questions, the future role of testing and on-site testing, alternative matrix testing and on-site testing, there was material submitted by all of the alternative matrices, and on-site testing respondents. Correlations with urine tests were demonstrated in literature or information was provided in literature from all the respondents.

Additional publications and data to support the use of the testing in the workplace environment was submitted for all of them. Proficiency test information was submitted by two of the categories. Laboratory intravariability was addressed and information submitted by three of the respondents. Calibrator and control preparation information was submitted by the oral fluid and hair testing bodies. The issue of sample unavailability was addressed in information provided by all the respondents, as was unsuitable sample information. The best applications were addressed conventionally in summary format by all the respondents, as well as with some additional information provided by some. Significant information was provided by all of these respondents. There was a lot of information provided. To summarize them, basically what got answered, about seven of the 10 overall categories that I was asked to assess in the information provided to the DTAB were addressed by all the alternative matrix respondents and on-site testing respondents.

There were a few zebras outstanding, things that are not answered in the information provided to date. There are some examples herein, in these two slides. Basically, although information was not provided in the additional materials to the DTAB questions from April, there is additional information available, either in the notebook from the meeting in April or frankly, in some cases, the notebooks from the TF Soft conference that DHHS held at that time on hair testing. Of course, there is literature available that may be submitted hereafter on these questions for which information has not been provided in answer to the April questions. Proficiency testing data for sweat and oral fluid was not submitted as part of the packets that I reviewed, nor was laboratory intervariability for sweat testing. That may make sense because there really is not a large body of laboratories performing sweat testing. It may just be premature at this point.

Calibration and control information was not submitted as part of the formal follow up documents by on-site urinalysis testing organizations or sweat testers. Looking back at the information from April, the sweat testing calibrator and control preparation was described pretty thoroughly in that information. Maybe it was not needed or there was no additional information to be provided for DTAB review. Again, we are thinking of taking the urine programs and potentially augmenting them. As we do that, of course, it is easy to think that this new technology is a blast.

You don't want to get stung, and you don't want to get tied up trying to do it. So, what we really need is to take all the information, discern its critical elements and decide whether it does or does not answer the questions required for the workplace drug testing programs. In the end, as we go down the road with our future tools, we want to make sure we have the right tools available and use them appropriately.

I appreciate the opportunity to provide the service that I have to the DTAB and to be here today to present to you a very quick summary of what I did for them. Thanks very much for your attention and I will take any questions if there are any. In the absence of questions, I will give up the floor to Skip and move on. Thank you very much.

(Applause.)

DR. JONES: Thank you, Carl. That was a yoeman's task, to do that review, to summarize the elements of where many of the items are included in the packet or the packets, the volume of information that we have been supplied. That gives us a great cross reference to that.

DR. JONES: Using that type of information, as I said, what we did as a Board is to go through this matrix and start trying to fill in line by line what we did. So, I would like to share with you for the next few minutes some of the deliberations of the board and where we are as we stand right now, in that evaluation. I will be getting copies of this. Some of you asked me during the break, are you going to be able to supply us with copies of the form as you have done these deliberations. The answer to that is yes. We will give you copies of where we are at present a little bit later, and I will distribute those with all the elements filled in on the form.

What I want to do right now is just start going through that and let you know, and explain in some detail, or attempt to explain in some detail, where we are and where we feel at present there are additional information items needed and the like. To do that, I have got some more overheads here. Let me just look at them an element at a time. As we looked at the various elements, what we did, we looked at each one of these items and looked across.

We said, we asked the question, in the collection site copy, is the security, privacy, custody and control form appropriate. Are they available. Are they possible. Do we need additional information. Can we never be satisfied.

As you look across the matrices in terms of saliva, on site, sweat, hair and urine drug testing as it currently exists in the laboratory environment, all the elements of all four of these have yeses in them, have Ys in them.

Everybody agreed that the security and privacy issue was not a problem, standardization of custody and control forms of all methods would not be a problem. Furthermore, the capability for observed collection would not be a problem and the preparation of the collection site would not be a problem.

So, when you looked at the responses of everybody, these all has Ys in them. They didn't have Ns or Is or Ps. They had Ys in them. If any of you feel that is not appropriate, I am going to take the liberty of doing the following. As I go through these, I would appreciate any comments from the floor, from any of you who have any experience with these various elements and these various matrices and these various environments.

If you think that certainly there are problems, please bring them to our attention, of our evaluation status on these. Hopefully that doesn't fall into a big vicious circle, but I would certainly appreciate any comments from here.

I would ask that you need to use the microphones as we go forward with that, because it is being recorded.

MR. FRANCE: This isn't really a comment, but a question. When you say you get a yes in these boxes, there is no comparison, then, as to say whether the capability for observed collection, you know, one is easier than another. It is just yes or no?

DR. JONES: Yes. One thing, state your name, please.

MR. FRANCE: I am sorry, this is Steve France with Workplace Substance Abuse Advisory.

DR. JONES: When we put a yes in an element here, that means that that particular protocol or methodology -- that criteria can be satisfied for that particular protocol or methodology. There is no comparison between the two at the present time. That simply means that this particular matrix, saliva, can satisfy the factor that we have identified as a required element for an acceptable drug testing program. Okay, so as I said, we felt that all of these were satisfied and we had no Is or Ps or incompletes or additional information needed. As we look at the donor, those items on the donor, the only one that popped up was, positive identification can be satisfied in all issues. The only one that popped up with an I was under saliva in preparation of the donor for collection. The I means that we would like to have additional information, that we felt there was incomplete information supplied to say whether or not the procedures that would be proposed or reported would be adequate for meeting these criteria. So, an I pops up in that element, and only that element, in the donor. Again, the board members are here. As I make comments, if anyone wants to make an expanded comment, please let me know and I will hand the mike to you.

Under specimen collection, specimen collection, again we felt that we would like to have some additional information at the present time on some of these. If you look at the size of the specimen in terms of saliva, is it consistent with multiple testing. Again, I think we did not know. We need to look at that. That is a question that we had. Is the size of the specimen in terms of the sweat patch consistent with the availability of multiple specimens. As long as we are at the position that we currently find ourselves of having a requirement for multiple specimens, and it is certainly the feeling of the board at the present time that that should be an element of such a program, then sweat patch has that issue of how do you, or what is proposed, what kind of things are proposed to supply a multiple specimen to the individual, a specimen for multiple testing, I am sorry.

Again, the hair issue, how do you supply specimen of sufficient magnitude for multiple testing and what are the criteria, what are the guidelines that are there. So, those were Is that we indicated there. The site of collection we had no problem with. Split specimen capabilities, if we stay with the split specimen capabilities, what are the proposals for split specimens for these particular alternative matrices in particular. How are split specimens going to be collected. What kinds of containers, what kinds of capabilities are there for split specimens in saliva, in sweat, in hair, even in on site.

We know that on site testing is there, but it hasn't been proposed or recommendations have not been submitted to us as to how split specimens are going to be collected with on-site testing.

If we stay with split specimen technology, that is the challenge that we felt there.

Item 4, evaluation of stability and storage, again, we did not have a lot of information and we felt that we would like to have some additional information on several of these. In terms of stability and storage of the specimen, again, this is analyte specific. I am not criticizing the saliva when I say this, but basically the saliva testing was limited to one drug, the data we have.

If we move to saliva testing for multiple analytes, we are going to have to have additional data there in terms of stability, in terms of storage of that specimen. The same is true with sweat, the same is true with hair, as we identified and reviewed the information that we had submitted to us. Specimen integrity evaluation, what we were looking at there was, again, the suitability of the specimen. We had issues with hair. We talked about that at the last meeting. We have had issues of the sweat patch. We have had the question there of the impact patch, whether or not it is intact, how its integrity is validated, et cetera. So, we come up with two I elements under that, under sweat and hair.

Under the tampering issue of the specimen, we did not have any inclusions in there. So, that is where we currently are with the specimen and those specimen items. Comments? Questions?

DR. AUTRY: A point of clarification. The I is not to say that these cannot meet these criteria, but that the data you had to review was not sufficient to let you know whether they did or not.

DR. JONES: That is correct. Under the collection device, again, we have some I elements under the collection device, particularly under saliva and sweat. What kind of containers are these, the appropriateness of the container. Many of these elements, obviously, have crossed over between other elements of this matrix. For example, the container in saliva, does it contribute to the stability of the specimen or does it allow for stability testing of the specimen to be conducted. There is an obvious cross over there. The same is true with the container that would be for the sweat patch. How do you supply that inappropriate container that maintains the stability and the integrity of the item, of the patch. So, those were the elements that we felt we did not have sufficient information on in the submitted documentation. The item II, capability to secure containers, obviously we felt that that would be okay. There were no challenges, no problems there. Item III, FDA approval if required. This is in part a policy issue. Is FDA approval going to be required for these containers or not.

We are going to hear some additional information on this issue from an FDA representative about the FDA approval process during this meeting, but at the present time we include Is in the four elements there, under the FDA approval if required of the saliva, on site, hair and sweat testing protocols and the containers used therein.

MR. SHULTS: This is Ted Shults with the American Association of Medical Review Officers. My thought process has slowed me up here. I wanted to skip back to section C item number 6 under specimens. We said the criteria here is, shall deter tampering. The first thing that crossed my mind is, are we satisfied that with current practices with urine testing that we are going to have adequate control over water dilution? At best, the best case scenario in my mind is that the answer would be I. If that is the case, how can we possibly say that the question of tampering with on site urine or test or saliva or hair have been addressed? It seems to me that the best case scenario for that would be I.

DR. JONES: I appreciate your comments. I think as we looked at that as a board or as I looked at that element -- and maybe the board can comment on that -- I looked on tampering to mean external tampering, not internal dilution. I am making a distinction personally between water dilution, as you have properly pointed out. I think many of us will agree that the biggest problem we face in urine drug testing in hydration and internal dilution. So, we have looked at it right now in this sense in terms of the integrity of the specimen from external tampering. Part of that interpretation of the impact of hydration, I think, comes up in some of the later elements in the matrix.

DR. SHULTS: I think that is a worthwhile distinction between external and internal tampering. However, we are still left with the situation in legal constraints by having an unobserved collection process with urine. We also don't have, in my mind, enough experience to know whether or not, in theory or practice, you can wash the drugs off your skin or shampoo them out of your hair or chew on the next internet product to tamper with your saliva testing.

Again, I am pretty well left with a personal view that we don't have enough experience or knowledge on doing this. Of course, if you are going to say we are okay with urine, we are probably okay with the rest. Do you see what I mean?

DR. JONES: I appreciate your comments. These are the types of comments that we as a board would appreciate hearing. Originally, from our evaluation, that is where we were. Many of these items right now are collection site issues. You are right. Who is going to check the internet tomorrow and there are 14 new products out there. If you download the internet, there is a plethora of material there. Again, I appreciate your comments on that.

MS. CHILDS: I am Paula Childs. I work at Lab Corp in North Carolina. One of the challenges that labs are facing in the urine program -- and Ted brought this up and I want to just focus on this a little bit -- is the adding of things to urine specimens. Probably one of the challenges that we are all dealing with right now is a product called KLEAR. I guess what I want to say is, as quickly as the laboratories are able to identify and try to overcome the challenges that these different adulterants present, there is something new that is coming along. Although we spend lots of time sifting the internet looking for those, I would estimate there are probably 50 to 100 problems that one could use to adulterate their specimens. I am sure that as soon as there are technologies that allow one to do on-site testing, for example, those same products may work very effectively with on-site testing and with hair testing and so on. We are looking at not only removing drug but doing something to sort of interfere that you don't really know is there and how to identify that. That is really a challenge that laboratories currently face and I am sure will provide adequate financial opportunity for people who want to go out there looking for ways to advise people about ways to beat their testing, whether it is urine based or some other kind of substance we are testing, hair or saliva or others.

DR. JONES: I appreciate your comment. I guess I would say that I have always looked at this program as a deterrent based program and not a detection based program. When we go with a deterrent based program philosophy, we are going to be encountering many of those. I think that is my own evaluation of the inevitability of that. Those are challenges that are going to impact on all these matrices. We don't even know what those challenges are going to be in the future. The labs, as you have rightly pointed out, have been operating in a reactive mode, in many, many cases, rather than having had the opportunity to be proactive. They have to be reactive. I appreciate that.

Okay, going on then, if I may, in the collection devices, as I said, the elements that we have entered into the collection device elements are the I in terms of the FDA approval and the questions we have there. An issue that we have identified in this whole thing, then, in the collector as we move on down to item E, the collector on this particular page, notice that we have included in the collector documentation, the training of the collector and certification of the collector as a desirable criteria for a factor required for reliable workplace drug testing.

All of these have Ps included in all elements of documentation across all matrices because drug testing does not require certification of the drug tester at the current time. As many of us know, that is often reported as being one of the weaker links of the program, is the collection system. So, ideally it would be very desirable to have that individual to be certified, that collector. So, that is where we came from in including these two elements, the documentation and the certification of the collector on that particular one.

Similarly, we included Ps in the requirements for special handling across all elements as we moved across the matrix. There may well be conditions out there, and it is certainly possible. Much of the data that was submitted to us did not include details of these. Certainly in our evaluation of the board -- and the representation on the board is fairly diverse, coming from a variety of backgrounds and disciplines -- many of us felt that those types of elements could be included. So, we included a P on all elements in the transportation of the specimen, requirements for special handling. Not knowing what those requirements are going to be in some of these instances, as I said before, these interface with other elements.

What are the stability issues, what are the handling issues for some of these other matrices, the saliva, the sweat. As we accumulate more and more data on these particular matrices, these are going to come into play and we felt those could be fairly easily addressed.

In terms of the on-site, let me just do it this way. As I indicated in my earlier comments, the on-site testing is strictly item G, on-site initial testing for drug or adulterant is strictly limited to urine, and we did not fill in any of the matrices under saliva, sweat or hair or urine lab. As I said earlier, there may be somebody out there who wants to propose an on-site sweat test or an on-site hair test or an on-site saliva test. We are not looking at that at the present time. We are looking only an on-site urine testing program. So, we had some elements in there that we had some questions for and many of these will probably be addressed by some of the review issues that Dr. Willette is going to share with us again later at this meeting.

As we started going through there, we felt we needed additional information on the specificity of the analyte class, some questions that we did not have total information on in the submission. Again, shall it have FDA approval if required. We don't know whether it is going to be required or not. I think that is where we are and so that is why we had an I in that element. Is it going to be required to have FDA approval. We will hear, again, more about that as we look at some of our comments from our FDA presentation. The provide documentation of the collection. Certainly that is possible. We felt that was certainly an element of P. We did not have the data submitted there.

This would be very similar to, in all probability, a typical urine collection. As long as the collection of on-site is consistent with the collection of any normal laboratory-based urine program, those two are certainly very feasible and very probable. That included an elemental P in there.

Documentation of the test results. I know we are going to hear some issues, some of those discussed by Dr. Willette today.

How are these results documented. I appreciate the information that has been supplied to us, again, by various submissions from Roche and from Mr. Evans and those things that came to the board allowing us to understand some of the details of some of these devices that are there, and some of those that Carl referred to in his comments.

We would like to have some additional information on the documentation of the result. Item 5, shall provide for specimen handling issues, specimen aliquoting for on-site testing, specimen retained in the test device.Some of the devices, as you know, are all in one devices and the urine goes in there. So, how is the result retained. We feel that to have at least under our initial look to have a valid protocol here, you need a mechanism by which that record can be maintained. As many of you are well aware, those are the challenges that you often face, is the documentation of that result. So, how is that result documented. What kind of sample retention capabilities are present. So, again, we entered an I in there. Shall use the HHS approved cutoff levels for that specimen. Again, many of the on-site devices have capabilities of a variety of cutoffs and we would like additional information on those.

Certainly the on-site testing protocols that are our thoughts at the present time, if those protocols are to be used and it is a urine-based protocol, then the same cutoffs that are based in the resident lab are going to be applicable in that screening test as those that would be used in the on-site testing protocol. Shall be directed toward DHHS approved target analytes. Again, we felt that this was a P. However, there is probably some additional information that we will receive from some of the presentations today and some of the more recent data that has been submitted to us on that.

The issue item 8, shall have objective differentiation of positive and negative with or without a recording device. The challenge that many of us looked at in reviewing some of these is the ability of that device to discriminate -- if I could use terminology that comes out of the guidelines -- discriminate reliability between a positive and a negative at or around the cutoff. Those are some of the challenges that we felt were opportunities for having additional data in there.

The issue of controls, we have already talked a little bit about controls in some of our previous discussions, and suitable controls tested and documented.

Item 10, a certification program for the analyst. If we are going to -- again, this is one of those -- item 10, 11 and 12, if these are going to be programs that are consistent with the existing program, we require certification of the laboratory based program. If we are going to allow results to be coming out of an on-site testing protocol, then initially it was felt that it would be appropriate to require certification of those individuals that are doing those analyses.

Rather than looking at the certification of a lab, it appeared to us, at least initially, that it would be better to look at the certification of the analyst. In an analogous manner, I guess I could say, we looked at the certification of the collector as an opportunity to enhance the integrity of the program, the certification of the analyst. Certainly the issue of the donor being blind to the analyst, shall provide for analyst to be blind to the donor identity, that is an issue and concern. That has been a major component of the existing program. As many of you know, in regulated testing, the identity of the donor shall not be known to the lab. So, translating that over to on-site testing, then the identity of the donor should be -- there should be a blind issue between the donor and the analyst in the on-site testing as an element of the requirement. If we do not require that, then the logic of it would be to not require it in the other side of the house. At the present time, that is where we are there. Thirdly, there, shall provide for verification of the results by a certified technician, by a second individual. We require that in resident lab environments. Even if we look at urine drug testing we allow for a negative certifying scientist to exist in that environment. That individual certifies a negative result and that result comes back to the MRO. If we accept that as a minimum standard of operation then it appears logical to require a certification of that result by a second individual in the testing protocol. Again, if you do not maintain the second tier of review here, then there is little logic in the argument, in my mind, of requiring that second tier of review in the resident lab testing protocol.

So, these are again examples of those issues, as we started looking at these, of why we went all the way back and started looking at the elements of a quality program as we defined it, rather than saying that this program or that program would be acceptable. Questions on the on-site issue?

MR. PINDER: I am Richard Pinder. I would just like to reiterate something that was said earlier; that these requirements that the board had listed here that are required for reliable workplace drug testing, positioned where we are now -- and we are open for additional requirements -- maybe we should consider for a minimum requirements for reliable workplace testing, also we are open to arguments about the appropriateness of the requirements that are listed here.

MR. KUNSMAN: Ken Kunsman, STC Technologies. What data do you have to suggest that in a presumptive positive or a screening test for on-site, that having the analyst and the tester and the collector creates a problem, certainly referring to the on-site alcohol testing, where that screen is then confirmed by another individual?

DR. JONES: Speaking for myself, I don't think we have any evidence there. Where I think we find ourselves is that we have a criteria that has been placed upon the in-lab urine drug testing system. That criteria has stated that there shall be that blind component. So, if that remains acceptable, then we felt it would be appropriate to apply it to the on-site arena. If that is not acceptable, then that probably should apply across the board. That is where we find ourselves as a board, I believe. Comments from the board?

MR. KUNSMAN: I certainly wouldn't speak for Dr. Walsh, but he did mention the idea that technology has changed to the time when that was the requirement. It was just a matter of function. Was there any debate on that issue during the board deliberations?

DR. CAPLAN: Yale Caplan. I will try to comment on that somewhat and maybe also reiterate some of the philosophical things that are going on, why we really are here and why we need your input. What we are trying to do is pose the questions and ultimately come to a decision or at least a recommendation of what a policy change might be and whether there is adequate scientific information to support it. So, as Dick has said earlier, the mind of the board is open. But what we did do at the result of the last deliberations that we had and our ability to look at the information and deal with these things is really try to pose the questions. We don't necessarily have the full answer. But we did realize, I think very significantly, that whatever we look at has to work across the board. It either has to be supported before the board is going to make a recommendation to HHS by some scientific basis that we are trying to determine. We may or may not be in a position to recommend a policy change. In other words, we can say we think that is what it is and that this requires a policy change. Then that policy would need to be looked at by parties above and beyond the board. I am glad to hear the discussion we are having now. It is hard to say that we, in the short time on telephone conferences, et cetera, came to consensus on every one of these issues. I feel that we are trying to look at these things in the most comprehensive manner. There is a big distinction, I guess, in what is going on now -- I guess I will take this opportunity to reiterate it since I have got the floor right now very quickly -- some of the things that dictated where we are going. I think the audience needs to understand that and give us the input back so that this can be altered or modified. That is to say, if we are going to change, what do we need to do to affect change. Our change has to be what does the public interest require. The public interest may require things differently today, as you and Mike have said, than it did before. But that may not be our decision. We could perhaps make a recommendation, but that is going to be what the public interest desires. The second major element of consideration was, what is the impact on current programs. We have to have, no matter what we do, something that will work across the board.

What became abundantly obvious in the deliberations and the process is that we cannot take each piece of this, each idea, each technology, each altered entity and say whether that is acceptable or not. We tried that. I think we made an honest approach by looking at that the first go-round and we could not come to an effective conclusion unless we went back to basics. So, philosophically we did, quite frankly, do a bit of a reversal. We are back to basics. It has become very clear that we need to develop the guidelines or redevelop the issues that are in the guidelines to be more appropriately stated, so that they could include multiple specimens. The guidelines deal only with urine, which was favored at that time, and the guidelines need to deal with this in an effective manner. I don't think we have an answer. In fact, as you can see now, we have got many more questions than answers. I know many of you here hoped that we would have answers and it would be nice if we did. But we actually have more questions than answers today. The important thing to the people here in the next hour or so and in the course of the day is to bring forth these things. We will try to make note of it and write it down. Yes, the on-site alcohol you might consider an anomaly. We have always considered alcohol an anomaly in drug testing for a variety of reasons. It is one of the substances that we can do an initial screening and confirmation on site by what have been recognized as evidentiary devices. We don't have that in this arena. Therefore, we can't make the jump to say, if you could do it for alcohol, you could do it for drugs. Please, I am happy -- particularly the other thing Ted mentioned, we might have skipped over these things in the vast issues that were there. It doesn't mean that we skipped over something because it was unimportant, but in the realm of things, that seemed to be more of a policy decision, whether or not in a deterrent based program there should be concern, fundamental concern, about the alteration of a specimen or not. We know that we can look at that later, but since it has already been established one way for urine, the others didn't seem to be any worse off for that.

Some of you may have comments that maybe they are better. If we are able to come up with a policy that is stronger than the one we say today, that there may be other specimens that can better meet that. I am going to reiterate what Skip said. The way these are worded, these are ideas. They are concepts. Our goal at the end of this is to write each one of those into a recommendation. In other words, write a one line, two line or three line or whatever statement, to say that it is our feeling that this is important, that this should be done or perhaps this shouldn't be done. That is the goal and we do need the input of everybody here. I would say with the 10 or 12 of us that are involved in doing this, there is a much vaster experience out there.

The other thing that we are always mindful of in this process is that what this -- and Mike again may attest for this over the years, even though things have changed, but what is this program based upon. It is based upon a process of integrity, insurability, reliability, met legal challenges, and we have to be very cautious that in making changes we don't compromise that. We have had a program that had two major elements; very tight control over the processes, which we are trying to review for the other substances and procedures which might come into play, and also the independent review of these processes by third party MROs. These are the things that have been the stalwart of the success to date, and it is certainly the responsibility of the board to look at these things in such a way that we can continue to ensure them from. I guess, a philosophical point of view that is where we are, and I want to reiterate the things that Skip said. We appointed Skip spokesman. He has done a very good job, but there is a deeper thought process here and we need your assistance in that as well.

DR. JONES: Thank you, Dr. Caplan.

MR. CROUCH: I am Dennis Crouch with the Center for Human Toxicology. I apologize because I missed the first meeting. I would like the board to consider blood testing for a couple of reasons. Maybe you have discussed it, but I think it is worth looking at. The negatives about blood testing have always been that it is invasive. I think it is arguable whether it is more invasive than plucking hair or wearing a sweat patch for a week or two. Secondly, a negative about it has been the sensitivity requirement to test blood. However, the sensitivity is at least in the ballpark of that needed for sweat testing, hair testing and saliva testing. There are a number of positives about blood testing. First of all, it would be difficult to adulter a specimen. We have a wealth of information about the pharmacokinetics in most drugs and metabolites in blood. In blood, often we can detect the parent drug or metabolite that would provide a lot more qualitative information about the identification of the drug.

Some of the new immunoassays and existing immunoassays target the parent drug so that they can be used on whole blood, plasma or serum samples.

Lastly, we have a lot of information about interpretation of results. There is a wealth of information in the literature about blood and the pharmacokinetics of drugs of abuse in blood, plasma and serum that is lacking with some of these other matrices. This can give us a lot of information, at least more information than we have about interpreting impairment, time of dose or possibly the dose.

I would like to just put that out. I don't know if they have been discussed before. Some of these matrices are so new that we don't have a lot of literature on them, while blood testing has been around for a long, long time.

DR. CAPLAN: Yale Caplan again. Just to respond to that point, part of what the deliberations that we had and are doing, while they may not have been specific on blood because I guess there are no proponent groups supporting that from an industry based point of view at this time, the goal of redeveloping guidelines along the lines that we are suggesting are such that they would allow the possible inclusion of anything as it came along.

That is a major difference in the thinking, I think. So that, if we say that there are certain elements -- and you can see probably in some of the information we have for saliva it is going to parallel blood in concentrations and maybe analyte detectability -- that should there be other specimens -- and blood is the primary one -- it could be included effectively along the same lines and wouldn't have to come, again, as another afterthought. So, part of the goal of the board is to say, what do we need. Then one could propose then whether or not current things out there or things which we yet have not considered may meet those criteria.

MR. THISTLE: Bill Thistle, Psychomedics. Just to clarify the reference to hair testing in the work place, I am not aware of anyone who plucks hair for testing.

DR. JONES: Other comments on the on site issue?

MR. FORTUNA: I am Joseph Fortuna with Chemical Detection Services. I am not sure I agree with the across the board factors being applicable to all different candidate systems. What we need to do, we have to look at how they are used in the workplace. On-site testing has a lot of problems. I can see it for my clients, some of whom don't want to pay the extra money to go to a laboratory. That is where the problem really becomes for me. How do I explain to my clients the risk they are taking by not having me take the samples to the laboratory. I will do both. I can do either one. I make a little more money, actually, doing the on-site testing than the laboratory, but I prefer the laboratory. The question that really comes up to this is we have got to do it in the context of what the workplace manager desires. For small businesses -- and that is who I serve -- they are very conscious about cost. Most of these factors are very good and most of the kits have these factors. Some of them aren't there, but most of them are. The question is, do you really want to have a uniform set of factors for all systems, independent of how they are used. That is what I would like to ask as a question.

DR. CAPLAN: I guess I will play the role in answering the questions, at least maybe commenting additionally, Skip, on the position of the board. What you are proposing is certainly secondary and was considered, in that we can't do everything at once, but right now we are talking about looking at equivalents for one particular task which is a workplace based deterrent program. It certainly doesn't preclude -- I think as Dr. Autry indicated, we are in a new time now. We spent the first 10 years doing one thing and I think we are going to spend the next 10 doing a lot of different, more diverse, things. Certainly the use of these specimens for pre-designated special purposes is something to follow. But it is too big a chore to bite off all at once. The first major question that we are dealing with is, what things can we do to support the current program. We use this term, alternative specimens. I am going to coin a phrase for you today. We are talking about not necessarily alternative specimens, but specimens which are complementary. We are looking, I think, at what are the various complements or complementary processes or complementary specimens or complementary other things as go on, which can allow us to produce an effective workplace result. If it is deterrence as we have now, that is one thing. If it turns out to be for cause and other things, then there may be other recommendations to come, as various specimens and technologies and various approaches complement one another in a comprehensive program. That is longer term, though, I think.

DR. JONES: I would also add, we discussed in a variety of times the use of these complementary matrices for specified purposes. There is nothing to preclude the idea at present of some of these matrices being appropriate for post-accident, for example, or uniquely for pre-employment or uniquely applied to rehabilitation type testing. I guess one thing that we have tried to look at it as, if they are going to be looked at it as, if they are going to be used in this general context of workplace drug testing, then that is where we are with the present matrix here, in the general application of workplace drug testing programs.

DR. CONE: I just had a couple of comments. We seem to be stuck right now on the on-site testing and my comments apply equally to the on-site situation as well as some of the other matrices. One of the things I think I lack in terms of understanding is I would like to focus whenever we can. I just want to make sure we are talking about the same things. The heading for this forum says, factors required for reliable workplace drug testing. I am assuming that means reliable federal workplace drug testing and not private sector.

DR. JONES: Correct.

DR. CONE: Several comments and questions. This may be getting ahead of the game, but I would like to think that what we are hopefully moving toward with each of these matrices and test modalities is the development of a certification program similar or dissimilar, but at least in effect some kind of an oversight of these test modalities. I am wondering if that is an assumed goal behind this forum or whether it is an implicit goal of a certification program, and all the sundry of programs that go along with that. The core of the NLCP program, I think, has been the strength of the certification, the PT program and the laboratory inspections. That triumvirate of strengths has gone over the decade toward producing an incredibly reliable technology in many respects; that is, urine testing. Are we moving toward these other matrices? If we are, I think I would like to see more in terms of how do we adapt these matrices to these programs. Along those lines, it would seem to me that maybe as part of your efforts to bring some of the people in the certification program the actual nuts and bolts of making that program work and say, if we were going to set up a certification program today, how would we do it or what are we missing. Where do we stand in terms of adapting these new test modalities to an actual certification program. So, I would like to see us, at some stage of this process, address the issues of how do we implement or design a certification program. I think in doing so we might then be able to open up some of these critical questions that haven't been answered but need to be answered.

DR. JONES: Thank you, Dr. Cone. I think some of the items in item H will address at least the board's current position on where we have looked at some of those elements that you referred to, because that addresses the laboratory process. So, some of that, I think, will come clear, at least, where we are at present.

MR. MC CANN: Thank you. Bernie McCann, Labor Health and Safety Fund, North America. The last gentleman made some astute remarks, I thought. What to me is clearly obvious is when I look at section G and section H, the major difference that I see is item number one, shall employ DHHS certified laboratory. The major concern I have with on-site testing is the lack of any certification process that an on-site facility -- or in fact an on-site capacity because it isn't really a facility in my mind -- would have to go through. Given the current political climate and the capacity of the certifying authorities of going into such on-site facilities and actually doing any type of certification, you know, it is just not going to happen. Therefore, what we really have is a Volkswagen and a Mercedes Benz, to use an analogy there. That is really the crux of the matter, to me. When we get to on-site testing we are really not going to be able to compare apples to apples. There are two very, very different, even conceptually, methodologies. I just don't really see how we can even put them up against each other with any expectation that they will be able to match up. I guess that is more of a comment than it is a question. I guess what I would like to hear from the board is how they expect to be -- or maybe hear from some of the folks who are here proponents of the on-site testing. How do they actually expect to be able to have a credible product that is going to stand up next to these other methodologies. I just don't see it. Basically the certification process I think is the way that we separate the two out.

DR. JONES: Thank you for your comment. Mr. Evans.

MR. EVANS: I am Dave Evans with the National On-Site Testing Association. My first car was a Volkswagen and it was a great car. The On-Site Testing Association is moving toward developing a certification program. We support certification. We have supported legislation. For example, in Alaska we supported legislation. A bill was passed that allowed on-site testing and that bill had certification requirements in it. We welcome anybody's input on the issue of certification. Certification has to do with not only collection sites, but test operators. We are moving in that direction. Similar to the National Association of Collection Sites is moving toward certification, we now have some very good programs for certification of MROs. Ted Shults is here. Those are all private efforts that were done without the government. Not that the government shouldn't be involved; we welcome governmental involvement. We agree that certification is the way to go, training is the way to go, meeting FDA standards. These standards, I think on-site testing can meet these. We welcome anybody's input on this, including labor, on how they think the certification should go.

DR. WALSH: I am Mike Walsh. I was very fortunate to kind of be with the framers of this program, and most fortunate in that the terms or concepts, efficiency and cost effectiveness, were never a consideration in the development of this program. We were breaking new ground. Our directives were to put together a system of checks and balances and multiple redundancies that would be legally unassailable. We did that. I think the very difficult balancing act that the board is dealing with now is the reality of the day, and that is that efficiency and cost effectiveness are primary concerns. They are very much so in the federally regulated, transportation, nuclear regulatory field, and so on; also, all private sector testing that generally has leaned on the federal regulations as the gold standard.

I think the board is -- I know at the last meeting I got the feeling that in many instances much of the discussion was focusing on really administrative aspects of the program. I felt that maybe these were more within the purview of the human resources section of various organizations and really are not issues that the board should be focusing on. The Bubba issue, which kind of dominated the last meeting, it seemed to me, was one that sort of fell into that category, within the DOT alcohol program that dealt with that. I suspect that it could be dealt with equally as well in a drug testing program. The difficulty is that some of the administrative aspects of this program are critical to the overall integrity and reliability and so on. I think what the board is being asked to do in terms of alternate technologies is, can we integrate this within this system.

How many factors that were key to the original program are still necessary today. Can we, in trying to balance the cost issue, the efficiency issue, the effectiveness issue where you are going to give on the one side, you are probably going to diminish the accuracy and reliability.

How far can you go and how can we come up with a system of federally regulated system for federally regulated testing that is still going to be able to meet today's legal challenges, but be more efficient and cost effective.

It is not an easy balance and I think intermixed in all of this are some very highly charged political issues. That is, if you believe that drug testing is an extremely viable tool, as I think everybody in this room does, that on the one hand, from a political perspective, you want to increase the use of testing as much as you can. Therefore, you want to increase the efficiency and cost effectiveness of these programs.

On the other hand, the only reason that these programs have evolved from the early 1980s to where they are today -- this is an issue that I come up against in Europe all the time where people say, where did you get to where you are now from where we are. The answer is, it is not easy and it didn't happen overnight. But I truly believe that because we built this iron clad system of protections and multiple redundancies and double checks and MROs and a sense of fairness in the overall policy end of the program but also an absolute confidence in the accuracy and reliability, as Dr. Cone mentioned, of the laboratory program, which for those of you who have been around for a long time was in serious question 10 years ago, that is the reason, built on this very strong cornerstone of science and technology, that the programs have been able to grow to where they are today.

I think the charge is where -- I know Dr. Autry struggles with this -- where to focus on the science and technology and how much of the policy and the cost effectiveness and cost and efficiency of the system -- how do you accurately mix that balance to come out where we ought to be.

DR. JONES: Thank you, Mike. As you well know, we met in this hotel some number of years ago. It was in the early 1980s, in the first meeting to get all the army, navy and air force together and have a discussion of these types of things before even the executive order came out. So, we go back a long way and we have seen the genesis of this. Thank you for your comments. You recognize the challenge that we as a board face in making recommendations to Dr. Autry and that group, too. In balancing those issues, if you back off on one point, you pick up on something else, but where does that balance lie. At least in our initial efforts we are trying to share with you where we are in that balance today.

Any additional comments before I proceed on with the laboratory side? As I said, then, the laboratory analysis, the laboratory process, it is still visualized that even the on-site will send, in some manner, those specimens to a laboratory. Under the current guidance of the laboratory being a DHHS certified laboratory, then all these complementary specimens, if I can continue to use the words that Dr. Caplan used, if all of these complementary specimens are still going to be tested in a laboratory, then it is certainly feasible, it is certainly possible that the DHHS certified laboratories could handle those.

Incorporated into the entry of a P into these elements is the fact that then a particular protocol would have to be developed to challenge these laboratories in a proficiency testing, et cetera, to handle these particular matrices that are there.

That becomes more apparent as you look at the other issues associated with the laboratory, of the utilization of current DHHS criteria involving receiving of the specimen, that provide for short term storage of the specimen consistent with stability issues, and provide long-term storage of the specimen, again consistent with stability.

Those have all been included in the top three elements, two, three, and four. It is certainly possible for all of those specimens, as they come into a DHHS certified laboratory.

Where we have found that we would like to have additional information is on the initial test, as it would be imposed on any or all of these.

Again, currently the regulations say that the initial test shall be an FDA approved test and an FDA approved protocol. So, additional information is being requested for not only a saliva but for the on-site and the sweat and the urine.

We have included the I even on the on-site there. That is probably the closest one that we probably have a P in, but at present we have left it in as an I. Again, shall be directed toward the target analytes. This becomes, in part, a regulatory issue, a regulation issue. The question is, what are the analytes that are particularly present in these complementary specimens. What is present in saliva? What is present in hair? What is present with sweat?

Are those consistent with the current regulations? Of course, in some of these, we don't even know because we don't have the data on all drugs or drug classes that are currently under the guidelines. Shall use DHHS approved cutoff for that specimen. Again, we don't have the information. We don't know what those cutoffs would be. Since we don't know for sure what the analytes would be in all cases, we don't know what the cutoffs would be. So, we have included a request for additional information there.

The issue of precision around the cutoff, again, we have some data that were submitted on some semi-quantitative and quantitative basis that Carl referred to. Certainly the sensitivity of these methodologies are methodologies as they apply to these particular complementary specimens and it allows for additional information to be submitted to demonstrate that precision in and around the cutoff on the screening assay or the initial test.

In the present arena, again, the second initial test is allowed, and translating that over to the other matrices, we don't know whether a second initial test, a protocol, exists, even for a second initial test. Are the alternative immunoassays applicable to these other matrices that are currently being used in a urine drug testing program. We don't know that, and that is why we have included Is in that. Again, this goes back in part to the issue of whether or not we retain all of these elements in this checklist. As the elements currently exist, that is where this list has been generated.

So, we have a lot of Is in the initial test and we also see some Is in the confirmatory test in the laboratory based testing protocol, as well as some Ps.

The confirmation test, at present we are again at GC/MS, under the regulations. I think as many of us are well aware, there may be some alternative methodologies there that are very applicable to these drugs as we go into some other matrices. It appears that the data that have been presented to date have all utilized the GC/MS methodology as that confirmatory test.

Certainly it appears possible and probable that GC/MS methodology can be applied to all of these matrices as we expand the analytes that are included in these matrices. As you move away, of course, there may be other methodologies and there may be something else that would go on there. But that is where we are with the methodology. The target analyte in the confirmation test appears as is the target analyte in the initial test. There is some questions about what those target analytes would be.

For example, in the saliva, as we move to some of the other drugs of abuse that are included in an allowed workplace -- federally regulated workplace drug testing program, we don't know what the analytes would be.

So, we need the additional data there. That would be the same with sweat and that would be the same with hair, as we move into all those particular drugs that would be used. Again, the cutoff issue is illustrated and the linearity around the cutoff, addressing the reliability, the discrimination ability of this particular assay, this particular procedure to discriminate reliably between those specimens that are positive and those specimens that are negative at or around the cutoff.

The verbiage there is very similar to the existing guidelines.

Finally, the challenge that we are faced with in part is relating one particular methodology to another. That is certainly not our goal, to have commonality between the methodologies. We all recognize, I think, that the different methodologies give different information.

The cutoffs to be employed, we use the terminology here that they are pharmacokinetically relevant. In other words, we have a feel for example, I believe -- most of us have some sort of a feeling of what it means to have a particular cutoff in a urine drug testing program, what that means in terms of recent use, what that means in terms of past history. However, as we move into these other matrices, we don't have that feeling yet. We don't have that data. Some of the data that we have heard reference to in blood, we don't have that data yet in sweat, in saliva. Those are some of the questions we have in saliva and hair. What are the cutoffs going to be in those particular matrices.

It is certainly a concern of mine, that if one recommends that a particular protocol be acceptable for federally regulated workplace drug testing programs, then that is one of the details about which we need to know something; what is the cutoff. So, from the laboratory side of the house, that is where we stand at least at the present time. Certainly we would be adding some additional information. Certainly from the laboratory side of the house, that is where we feel that the data that have been presently supplied to the board put us at present. Any comments about the laboratory sides or issues?

DR. SELAVKA: I am curious, after the April meeting. The language in number 7 is different. I am hearing it differently at this meeting than we heard it before. That is, cutoffs shall be pharmacokinetically relevant with respect to the analytes. The way you described it, or in April it was described as driving the process of setting cutoffs. That is where pharmacologic relevance at that time, that is how it was being used. Today I hear you saying number 7 relates to the ability to understand a time window around positive findings in any matrix, based on pharmacokinetic properties. That, I think, is a very different way of interpreting pharmacokinetic relevance. I guess the ultimate question is, are 5-B and C and 6-B and C, which is the setting of cutoffs and targeting of specific analytes going to be driven by pharmacokinetic relevance to given doses of abused drugs, or will pharmacokinetic relevance merely be used to understand and interpret appropriately positive findings once cutoffs are set. I wonder where the board stands on that question.

DR. JONES: I personally would say the latter. I don't know how other board members would respond, but for my own purpose I would say the latter, for interpretation. Historically, if you look back at where we are today with the urine program, where did those cutoffs come from. They were driven by a variety of parameters, among which were pharmacokinetics. There were policy, there were politics, and the availability of the methodology. That was one of the big driving forces, the availability of the methodology to produce a result at that particular level. That was a big driving force there. I think what we are looking at here, even though those cutoffs were established with all those other parameters input to them, from my perspective, we are looking at a similar type of thing, but there should be at least some correlation, if I can use that term, between the methodologies and presentation of that result and understanding of what that result means. That is the background behind 7 in my mind. The board may want to make other comments, too.

DR. AUTRY: It also strikes me that there is another element in pharmacokinetically relevant. That is, where do you draw the cutoff to strike the balance between true positives, false positives, true negatives and false negatives.

DR. JONES: Anybody else?

DR. SELAVKA: If I could just finalize a comment on your comment. I think that is a fairer way of approaching this problem than was addressed in April. Even urinalysis, because of the historical setting of cutoffs, it couldn't meet that test and it is impossible to say that it ever really could. Thank you.

DR. JONES: Thank you. Other comments, questions?

MR. VELASCO: Javier Velasco from Poisonlab. I have a question. When you are establishing a cutoff, how are you going to account for the differences from one individual to another, like female to male in the case of sweat, or hair growth or those kinds of changes from one individual to another.

If you establish a cutoff that would be applicable to the male population, let's say, how would it be applicable to the female population or between races for some of those analytes?

DR. JONES: I think that is why we have Is in some of these elements. These are types of information that we don't know the answer to, that we want more information supplied to us as board members before making those recommendations. I am getting head shakings up here from everybody in the front row. I guess I responded correctly. Other questions or comments? Then as we move forward into quality assurance programs, again we would like to have additional information across the board, QC specimens. I realize that there are systems currently in place and part of that is what we are going to see tomorrow and today, about the introduction of quality control specimens and a quality control sufficiency testing program for some of these matrices. We heard some about that at the April meeting. We are going to hear more tomorrow. But we certainly have Is in saliva, on-site, sweat and hair at the present time. The program should contain documentation of the validation of the test results. Again, that would be the next step.

Once the QC specimens are included, the documentation of the results should be obvious, and shall provide the introduction of blinds into these systems. Again, we are going to hear more about how blinds are introduced into these systems in today's and tomorrow's program. So, we did include Is in those four elements across the board there.

If I can just go on to the reporting, since this is on the same slide, again, the final review of all the results by qualified medical personnel, as we apply the same criteria to all of these that currently exist, that means a medical review officer in the loop. That is our initial interpretation.

So, all results would go to an MRO. It is certainly possible for all these matrices, whatever the results that are generated, to go to an MRO for a final review. That is why we have the piece in there, even though we haven't heard the presentations of these. We didn't see a need to make a challenges or hurdles to be overcome as you enter into the reporting arena with any of these other matrices. Similarly, reporting in writing in a confidential manner, can be just as easily achieved there, even though we haven't had the presentation of how to do that. A standard custody and control form across a given matrix technology on which the results are reported, it is certainly conceivable that a new standard testing control form could be created. However, how long did it take us to get the one that currently exists only for urine? To go across matrices, that is going to grow exponential, not just multiple factors. It is, again, certainly feasible to do that. Then, finally, the testing control form reports. It says, the results of the test shall be certified by the appropriate trained individual. That is different from the analyst. The test results are reported are reported by analyst class, and the positive results only if the initial and confirmatory test are positive, the application of the same criteria of the two-tiered testing program that currently exists. So, all in the reporting arena, all are possibles, even though we have not seen the actual proposals. We did not foresee hurdles that would offer any real challenges there, other than the establishment of a uniform testing result form for all matrices. Comments on those two?

Finally, interpretation of results, and some of this gets into issues that Dr. Selavka was addressing there. As we go into interpretation of results, is the result independent of bias toward specific populations. Those are questions we would like additional information on. We have heard some of those discussions about bias, particularly bias in terms of the hair. We don't know about bias in terms of sweat or saliva or bias in terms of on-site.

Are we willing to allow bias in urine testing? This gets back to some of the things we heard about earlier. Water loading. That is a bias. That is a bias of a population. I recognize that as a bias of a population and is that acceptable in workplace drug testing, as Ted Shults referred to a little earlier in his comments. Are cutoffs in their relation to passive exposure relevant? We know things about some urine. We know things about there, and I don't know whether that should be an I in urine there. I think that might be a typo. I don't think we had an I under urine under passive exposure. As I said, this is a document that is a document in evolution. It is a working document. So, that is certainly one that I think probably should not be there. What is the impact of passive exposure. We have heard some about some of hair. What is sweat? What is saliva? What are those. Part of that goes back into your comment, Carl, about what is that cutoff and how is it going to be established, and those are data that are relevant there. Are the results resulted for parent drug or metabolite. Again, we get into the issue of what is the analyte there. If it is parent drug, is that consistent with regulations? Are we going to have to change the guidelines or not. We know that we are talking about cocaine in some cases and not benzoylecgonine in some cases. In some cases it is benzoylecgonine that is in the confirmation tests. Those are minor technicalities but those are issues that we are facing in terms of a regulation and a regulatory kind of overview on this.

Again, item 4 addresses some of the things that Dr. Selavka was mentioning and some of my comments earlier about that window of detection.

What is that particular matrix going to be used for? I think it is certainly consistent, as I said earlier. It may be that some of these matrices are applicable to a particular type of workplace testing. As we look at their applicability in general, we have included these types of questions and these types of elements into this large shape or this matrix.

The interpretation in terms of contamination, internal and external, again raising the issue that Ted Shults raised a little bit. You can call it water loading, excessive hydration and internal contamination if you want to. That is certainly some of the thoughts that put the I in that element over there under the urine lab issue. Alternative medical explanations for the presence of the analyte. We are always going to see those. Again, the internet is replete with a variety of products and the herbal medicines is in its growth, in its particular issue there. So, that is a challenge and that is part of the challenge that the interpretation of the results has to face. Then the source of the specimen certainly could be overcome. It is possible, even though we did not have a lot of data on this. So, we put three Ps in the elements in saliva, sweat and hair on that.

So, that is where the board, that is where we were a week ago, I guess, when we had our final conference call, when we had our final submission of these things back and forth by fax, and where we kind of started this meeting after the review of all the literature that Carl summarized for us, and all the literature that has been supplied by many of you in reviewing the comments and the transcripts of the April meeting, and the deliberation in August that we had in a working meeting and subsequent deliberations on the phone and across e mail and fax. Questions or comments or anything are welcome at this time.

MR. FORTNER: Neal Fortner with PharmChem Laboratories. I might not have understood one of the sections in number 4, pursuant to on-site testing and the blank in that section relative to urine based testing.

DR. JONES: On that last element there, that last overhead?

MR. FORTNER: Yes, sir.

DR. JONES: Let's see if I can get my colleagues on the panel and the board to explain it.

MR. FORTNER: Pursuant to a question of inference of time of use, differentiating on-site versus the laboratory based?

DR. JONES: I think that is another typo. Yes, I think that should not be there.

MR. FORTNER: I just thought I missed it. Second, as a summary comment, we provided a lot of information as did all the other alternate matrices for the April hearings and as subsequent follow up questions are requested of us. I certainly commend the board for going through and absorbing all that information, which is quite a lot. However, at this point in time you are asking for even more. Do I understand that to be correct? If so, how does the board want this facilitated? Do you want this run through the original coordinators? Certainly there is evidence there are many other people involved in the different matrices other than just those individuals who were originally approached by HHS to coordinate the presentations for the alternate matrices.

So, where do we go from here? If you had a lot of information initially, now you are bound to get volumes and volumes of subsequent information because now your questions are more specific. As the original presentations were simply overviews of, this is what an alternate matrix could or could not offer to a workplace program.

DR. JONES: I think where we are and where I stand today is, that some of the presentations today and tomorrow will address some of these specific issues that we had identified as requesting additional information. I think where we are as a board is, we are going to hopefully say to Dr. Autry that here is where we feel that additional data is warranted and it would probably be out of his office or that organization, that such a call for additional data to address those particular issues would come. It would certainly be my hope -- and I think I speak for the board -- that within a matter of a couple of months, if not maybe even sooner, there will be a finalization of this document as it exists today submitted to his office. I think that is consistent with the board's feelings. Richard?

MR. PINDER: A question about a much more specific. If the information you provide to us can be addressed to the specific issues listed, it would be very, very helpful. If you submit a publication, could you outline that portion of the publication that you feel addresses the specific issue. The material that was given to us before was voluminous and very difficult to go through and identify what in that material was helpful and what was not. It would be very helpful if you, in your responses, would address these issues in a very specific manner.

MR. FORTNER: I certainly appreciate that. My comment was, if you think the original material that was submitted to you was voluminous, you haven't seen the rest of it. I would also suggest that as the questions become more and more specific and very technically oriented, if the board would consider, after receiving this second plethora of data, to actually sit down and have question and answer discussions. While it might be possible for the entire board to independently read, digest and understand all the different questions you have asked of all the different matrices, that is a very overwhelming task.

Certainly I believe that you could get support from the alternate matrices to help facilitate your endeavor in understanding the different questions that you are asking.

DR. JONES: Thank you for recognizing the task that we have, and I want to acknowledge the fact that all the board have other full time jobs and are not exclusively dedicated to this particular task. I thank them for going through all the data that have been submitted to this point in time.

Other comments or questions? Thanks. Dr. Autry.

DR. AUTRY: Thanks, Skip. I want to thank the board for work that they have done up to this point in time. Quite literally, there is no way that HHS could pay them for the amount of time that they have put into this endeavor. I also want to thank the people who have been presenters and have sent in information. There is no way the board could have gotten that information without your help. I think what you see here is that as the board has moved along in its deliberations, we have moved into the nitty gritty scientific issues and administrative issues that are still outstanding in order to make determinations about where we stand with these complementary technologies and specimens.

What we need at this point is just what Dick was saying, and that is very specific information summarized to address the specific questions that were put out to the group at the end of the April meeting. A lot of what we have has helped in that deliberation, but it has also left a number of questions unanswered. Some of these are probably fairly easily answered, but we haven't seen proposals. Similarly, there are some that are probably not answerable because we have not had a good critique of the scientific data that is still out there and had that summarized for us. We encourage all of you to please do that, to help us in our deliberations. Some of this we will have answered by presentations that the board has requested over the next day and a half here. They have very specific questions. They knew that there were some definitive studies out there and they have asked people to come and share that information with us.

In other cases, we know that people have tried to set up QC programs and they have run into problems. We have asked them to come and share that information with us, to try to fill in some of the gaps. When I met with the board after the first meeting to give them my instructions, or what my fantasy was at that time, for their working group, I said that ideally what we would like to come out from this, or what I would like to come out from this is a grid that lays out all the principles and criteria along one axis, all the testing technologies along the other axis, and then to simply fill it in.

It says meet or doesn't meet or can't tell. Where it doesn't meet or can't tell, give me a statement about what the industry needs to do to fill in the gaps for the can't tell or doesn't meet. That has not been possible to this point. But I think what you see and what the board has done is to lay out a grid to make that possible. The charge to you is to fill in what needs to be done for the doesn't meet or can't tell. So, that is going to be part of the charge of what we do over the next day and a half and part of the charge to all of you after the end of this meeting.

Again, I want to commend the board and thank them. I am painfully aware that they have other full time jobs and that this is only a very small part of what they have to do to make a living. I can't tell you how small it is in terms of what they have to do to make a living. But I think they deserve kudos for getting us to this point and I think they have given you at least an outline or a map about where we need to go to fill in the rest of the questions.

With that, why don't we break for lunch.

(Whereupon, at 11:45 a.m. the meeting was recessed, to reconvene at 1:00 p.m., that same day.)

AFTERNOON SESSION (1:00 p.m.)

DR. BUSH: Good afternoon. Let's convene our afternoon session. Our first presenter this afternoon is Bob Fogerson.

Mr. Fogerson joined PharmChem in 1975 as a laboratory analyst and has served as laboratory supervisor, laboratory manager, director of quality assurance and director of laboratory operations. Mr. Fogerson has more than 20 years experience in forensic toxicology. He is the designated alternate responsible person for PharmChem's forensic drug testing laboratory certifications and has acted as a certified Department of Defense laboratory inspector. He is a member of the American Association of Clinical Chemistry and a member and past president of the California Association of Toxicologists, the Society of Forensic Toxicologists and the International Association of Forensic Toxicologists. Mr. Fogerson is responsible for all technical aspects of laboratory operations. He directs laboratory methods development, including methods for the PharmChek sweat patch. He also provides in-service training on drugs of abuse for PharmChem customers and testifies as an expert witness in legal proceedings regarding laboratory test results.

MR. FOGERSON: Thanks, Donna. I also wanted to extend thanks to the board for giving us the opportunity to present a little bit more data on sweat testing. This is a little bit more data than we were able to present in April because it is actually relatively new data and most of it has been generated in the months following that last meeting. What I have been asked to do is present some information on our most recent rather large-scale field use evaluation of sweat testing and its comparison with urine testing in an existing program. That is the title of this particular presentation. We did a project with the Probation Division of the United States Courts to compare drug detection with their ongoing urine testing program, to see if drug detection could be achieved with a sweat testing alternative. Before I begin, I do need to extend some special thanks to an awful lot of people. Aaron