Introduction: My name is Joseph H. Autry III, M.D. I bring you greetings from Dr. Nelba
Chavez Ph.D., Administrator of the Substance Abuse and Mental Health Services Administration
(SAMHSA), United States U.S. Department of Health and Human Services (HHS), who regrets she is
not able to testify today due to previous commitments. On behalf of Dr. Chavez and myself, I
wish to thank you for your invitation to testify at this Hearing of the House Commerce
Subcommittee on Oversight and Investigations, related to Federal drug testing programs and
policy.
I am currently serving as the Acting Deputy Director for the Center for Substance Abuse
Prevention (CSAP), within SAMHSA, and for the past eight years, have served as the permanent
Director of the Division of Workplace Programs (DWP), in CSAP. That Division, as a part of
our workplace related duties, is responsible for the day-to-day oversight of the Drug-Free
Federal Workplace, and the quality assurance of the related drug testing program. It is largely
because of the work of the division over the past 12 years that the Federal program has
maintained the scientific and legal credibility and integrity needed to ensure a comprehensive
drug-free workplace program. From the very beginning, this highly successful and
often emulated national model has always used Mandatory Technical and Administrative
Guidelines that underscore the principles of fairness, confidentiality, and above all, the use of
scientifically validated technologies and procedures. Coupled with constant quality assurance to
maintain the accuracy, reliability and interpretation of drug testing results, the updates to these
Mandatory Guidelines and their day-to-day implementation have served the nation well, while
maintaining the privacy and liberties of Federal employees.
I am prepared to address the expressed concerns of the Subcommittee about the recent changes in
the Mandatory Guidelines to raise the testing cut off levels for opiate metabolites and our
continued efforts to further improve the program. Dr. Edward Cone, from the National Institute
on Drug Abuse, will also address many of these issues today. Together with Dr. Cone and
our other expert witnesses, I am also prepared to discuss the ongoing scientific review and the
current state of the science of other technologies for detecting the use of drugs including saliva,
sweat, and hair. Although addressed in detail in the written testimony submitted for
the record, I will only present the highlights in oral testimony. Because of the expressed interest
of the Subcommittee regarding hair testing, I have included a current bibliography of scientific
publications on the subject, and have included a list of documents that we have delivered to
the Subcommittee today. In conclusion, I will seek to clarify for the Subcommittee, why the
Drug-Free Federal Workplace Program must continue to rely on urine drug testing until critical
gaps in our current knowledge of these alternative or complementary technologies and specimens
are scientifically addressed. At the conclusion of my remarks, I would be pleased to answer
questions.
Background
On September 15, 1986, President Ronald Reagan signed Executive Order 12564 establishing
the goal of a Drug-Free Federal Workplace. The Order required the head of each Executive
agency to establish a program to test for the use of illegal drugs by Federal employees in
sensitive positions and required the Secretary of Health and Human Services to promulgate
scientific and technical guidelines for drug testing programs. The Executive Order also required
the U.S. Department of Health and Human Services (HHS) to assist the Office of Personnel
Management to develop and improve training programs for Federal supervisors and managers on
illegal drug use and to mount an intensive drug awareness campaign throughout the Federal
work force.
Public Law 100-71 (July 11, 1987) requires HHS to do the following: (1) certify that each
agency has developed a plan for achieving a drug-free workplace in accordance with Executive
Order 12564 and applicable provisions of law; and (2) publish Mandatory Guidelines which (a)
establish comprehensive standards for all aspects of laboratory drug testing and laboratory
procedures to be applied in carrying out the Executive Order, including standards which require
the use of the best available technology for ensuring the full reliability and accuracy of drug tests
and strict procedures governing the chain of custody of specimens collected for drug testing; (b)
specify the drugs for which Federal employees may be tested; and establish standards and
procedures for periodic review of laboratories and criteria for certification and revocation of
certification of laboratories to perform drug testing in carrying out the Executive Order.
The Mandatory Guidelines for Federal Workplace Drug Testing Programs initially published by
HHS in the Federal Register on April 11, 1988 (53 FR 11970-11989) and extensively revised in
the Federal Register on June 9, 1994 (59 FR 29908-29931) establish scientific and technical
guidelines for Federal drug testing programs, as well as standards for certification of
laboratories engaged in urine drug testing for Federal agencies. A second revision to the
Mandatory Guidelines regarding opiate testing was published in the Federal Register on
September 30, 1997 (62 FR 51118-51119), and will be discussed in depth later in this testimony.
The Mandatory Guidelines also establish the National Laboratory Certification Program (NLCP),
with comprehensive standards for the testing of specimens, quality assurance and quality control,
chain of custody, personnel, and confidentiality in the reporting of results. Quality
assurance is addressed for the entire testing process from specimen collection through reporting
of the results to the employer. Specifically, the Mandatory Guidelines requires the Department
to: inspect each certified laboratory at least twice a year to document its overall performance;
conduct quarterly proficiency challenges for all certified laboratories; and support an external
blind control specimen program, with quality control specimens submitted by employers as
though they were actual donor specimens. False positive or negative errors in any of these quality
assurance components, or serious problems identified in the laboratory inspections form the basis
for program action that may range from mandatory remedial action to correct the deficiency,
partial suspension, or revocation of laboratory certification to perform testing for Federal
agencies.
For the past 12 years, the Division of Workplace Programs has maintained continuous day to day
oversight of the Drug-Free Federal Workplace Program and the related mandatory technical and
administrative guidelines. There are currently 72 certified laboratories in HHS National
Laboratory Certification Program (NLCP), including three within Canada. These
laboratories have been certified to permit testing of urine specimens from approximately 120
Federal agencies, that employ nearly 1.8 million civilian Federal employees. Over the past eight
years, the mandatory use of NLCP certified laboratories has been required for the testing of urine
specimens from transportation industries regulated by the Department of Transportation, nuclear
licensees regulated by the Nuclear Regulatory Commission, and companies regulated by the
Department of Energy. Last, nearly half of the 25 million drug tests per year conducted in these
laboratories, come from non-regulated public and private sector workplaces, who have chosen to
use the Mandatory Guidelines and NLCP certified laboratories, and are not federally mandated to
conduct employee drug testing.
Revision to Opiates Testing
In our ongoing efforts to ensure fairness in our workplace programs, the Department has revised
the Mandatory Guidelines for opiate testing. When implemented later this year, the revision will
increase the initial and confirmatory testing cutoff concentrations for morphine and codeine from
300 ng/mL to 2,000 ng/mL and operationalize the new requirement to test for 6-acetylmorphine
(6-AM), a metabolite that comes only from heroin, using a 10 ng/mL confirmatory cutoff
concentration when morphine is present at 2,000 ng/mL or greater. When the Federal Workplace
Drug Testing Program was first established, HHS adopted the same 300 ng/mL testing cutoff
concentrations for opiates that were used by the Department of Defense for testing their
uniformed service members. These initial opiate test concentrations were selected in an attempt
to provide the greatest opportunity to identify anyone who may have used heroin; however, at the
300 ng/mL concentration, many who have not used heroin but had taken a prescribed codeine or
morphine medication, including over the counter products, or eaten normal dietary amounts of
poppy seeds have also tested positive.
The primary purpose of the Federal workplace-based drug testing program is to deter use of
illegal substance of abuse in large groups of individuals subject to testing, and detect those
individuals clearly using illicit drugs. Revising the testing cutoff concentrations for opiates to
2,000 ng/mL and adding the requirement to detect 6-AM will eliminate the laboratory
identification to Medical Review Officers (MROs) of most persons legitimately using
opiate-containing pharmaceuticals available by medical prescription or in over-the-counter
preparations, or those who have ingested poppy seeds. Effective April 1, 1994, because of similar
concerns and its program experience over the previous 5 years, the Uniformed Services Drug
Testing Program for the Department of Defense also adopted increases to 2,000 ng/mL in the
initial assay testing cutoff concentrations for opiates, with increases in confirmation testing to
4,000 ng/mL for morphine, 2,000 ng/mL for codeine, and the addition of 10 ng/mL for
6-acetylmorphine.
By monitoring a subset of MROs and laboratories as we implement the revisions to opiate
testing, we fully expect to see a significant reduction in the large number of laboratory positives
that are currently verified negative by MROs. In this single, well studied revision to the
Mandatory Guidelines, it will be possible to reduce the added stress and unfairness to most of
those individuals who currently test positive for opiates; significantly reduce the employer costs
for opiate confirmation testing and subsequent MROs review, especially the millions in the
transportation regulated industries; and gain the benefit of identifying a much higher percent of
heroin users of those individuals tested in the future.
The process used by the Department to study the opiate testing issue before revising the
Mandatory Guidelines is a model of how to use scientific data and consensus to inform the
development of public policy. As part of this process, the Department has evaluated results on
over 1.1 million urine specimens tested for opiates in 5 certified laboratories and approximately
317,500 specimens that were reviewed by 3 different MRO groups. Each laboratory and MRO
group was asked to furnish information on results reported from January 1, 1992, to March 31,
1993. Based on the information obtained from the MROs, 87% of all opiate positives reported by
the laboratories were verified negative by the MRO based on the use of prescription medications,
poppy seed consumption, no clinical evidence of heroin use (such as "needle tracks"), or other
reason. It is clear that the current opiate testing cutoff concentration are not properly identifying
opiate drug abusers.
The study results from the laboratories indicate that of the approximate 1.1 million specimens
tested, 7294 specimens were reported positive for codeine and/or morphine. Of these positive
specimens, 5931 had codeine and/or morphine concentrations less than 2,000 ng/mL. Within the
group of 7294 opiate positives, 848 were also tested for 6-acetylmorphine (6-AM) with only 16
of these 848 being reported positive for 6-AM. Additionally, 14 of these 16 6-AM positives had
morphine concentrations greater than 2,000 ng/mL. When comparing information from other
published studies, there was agreement that the presence of 6-AM is highly associated with
morphine concentrations in excess of 2,000 ng/mL. Since 6-AM has a very short half-life (i.e.,
detectable for only a few hours after heroin use), it is essential that a laboratory use a sensitive
analytical procedure to test for 6-AM. From the data available, it appears that 10 ng/mL is the
lowest testing level that can reasonably be used at this time to consistently and accurately
identify and quantitate the presence of 6-AM. Additionally, the 10 ng/mL confirmatory test
cutoff concentration for 6-AM is currently used by many laboratories that test for 6-AM after a
MRO submits a request.
After thorough study, the Department has concluded that the mandatory requirement to test for
6-AM will not increase the workload for a laboratory because setting the initial test level for
opiate metabolites at 2,000 ng/mL will significantly reduce the number of specimens that will
need to be confirmed for morphine, codeine, and 6-AM.
Additionally, after thorough study, the Department has concluded that raising the testing cutoff
concentrations for opiates and establishing a requirement to test for 6-AM does not reduce the
deterrent value of the Federal Workplace Drug Testing Program, but rather shifts the emphasis of
opiate testing back to the original primary focus to deter use of illicit drugs, including heroin, in
entire workforces subject to testing, and detect individuals where there is a clear pattern of use.
The change in the testing cutoff concentrations, in conjunction with the addition of 6-AM
testing, should provide more than adequate protection that actual heroin users will be detected.
The testing expense to Federal agencies will be monitored to determine the extent of decrease,
since there will be fewer specimens screened positive hence, a reduction in the number of
specimens sent to confirmatory testing. The laboratories will be reporting fewer opiate positives
which will also reduce the time and cost for MROs to discuss use of legitimately obtained opiate
containing preparations with individuals who have been tested positive by the laboratory.
Current Ongoing Review of Alternative Specimens
At the very center of our mandate to maintain the integrity of the entire Drug-Free Federal
Workplace is our commitment to identify and use the most accurate, reliable and valid tests that
are available. We seek to accomplish that goal through ongoing scientific and program
collaboration among Federal regulators, researchers, the testing industry, and both public and
private sector employers that ultimately pay for these testing programs.
One primary example follows that underscores our continuing search for ways to improve the
process without undermining the integrity of the system; shows how we rely on experts in the
various scientific fields associated with drug testing in development of consensus for changes;
and how that process is currently being used to evaluate the potential roles of saliva, sweat and
hair for future use in Federal drug testing programs. Through this ongoing process, we have also
identified a requirement to evaluate similar areas for urine, as part of our comprehensive review.
This example is only the most recent in our 12 year program history, and began with a 3-day
scientific meeting held in April 1997, to discuss the drug testing of alternative specimens and
technologies as they apply to workplace drug testing programs. The entire meeting was open to
the public.
The first two days consisted of presentations on the principles and criteria of workplace drug
testing program requirements and industry representatives discussing alternative
specimens/technologies (urine, hair, saliva, sweat, and non-instrument based on-site tests). The
presentations focused on the following seven areas for each alternative specimen/technology: (1)
specimen collection and chain of custody, (2) initial test reagents and procedures, (3)
confirmatory test procedures, (4) internal quality control program, (5) reporting test results, (6)
interpreting test results, and (7) an external quality assurance program. Industry coordinators
selected the presenters for the alternative specimens and technologies to ensure a thoroughly
unbiased review based on the science available. On the third day, the public was given an
opportunity to make official statements or comments. A transcript of the meeting was
prepared and has been made available on the Internet at the HHS funded National Clearing
House for Drug and Alcohol Information (NCADI) website: (www.health.org/workpl.htm).
Dr. Edward Cone, a Commissioned Corps Officer in the United State Public Health Service, who
is assigned to the Addiction Research Center, National Institute on Drug Abuse, gave the first
scientific presentation in which he outlined the forensic and scientific requirements for a
workplace drug testing program that would apply to any alternative specimen or technology.
Dr. Yale Caplan, the former Chief Toxicologist for the State of Maryland, and current national
drug testing expert consultant to HHS and the Department of Transportation then provided an
overview of the current understanding of alternative specimens and technologies as applied to
workplace programs. These presentations were followed by a series of seven panels consisting of
one speaker for each type of specimen and on-site urine testing, chosen by the respective industry
coordinators, that focused attention on the topic for each panel. After the presentations were
made by the panel members, the DTAB members were given an opportunity to ask the panel
members questions regarding the information presented.
The third day of the April 1997 meeting included comments and statements made by public
attendees, that included employers, laboratory representatives and others.. This was followed by
panel members being given an opportunity to respond to any issues raised by the Board members
and/or the public, and to set expectations for the second meeting.
The next DTAB scientific meeting on special alternative specimens and technologies was
convened for two days, in September 1997, and continued discussion from the first meeting. As
with the previous special DTAB meeting, this one was also open to the public, and the transcript
was made available on the Internet at the NCADI website: (www.health.org/workpl.htm).
The second meeting began with a brief review of the April 28-30 DTAB meeting and described
the Board's activities that had occurred since that meeting. After the April meeting, the Board
members participated in independent working groups to identify the specific requirements
necessary for the scientific, administrative, and procedural integrity of a workplace drug testing
program, which all alternative specimens and technologies would have to meet. The Board
members also reviewed the voluminous materials that were presented to them at the April
meeting and additional materials sent to them upon their request by the industry coordinators
(specific representatives of a particular testing industry chosen to represent that industry as a
group) of alternative specimen/drug testing technologies.
The DTAB Board members reconceptualized the entire process of evaluating the information
that they had been presented, and created a new framework that displayed the requirements for a
forensic workplace drug testing program in the form of a matrix. This new format listed the
elements required for any program and then a corresponding grid that indicated how each of the
specimens (saliva, sweat, hair, urine) and on-site testing satisfy those requirements. Possible
entries for cells in the matrix grid were coded as "I"= Insufficient Information, "P"= Possible,
[Blank]= Can satisfy requirement, and "N"= Cannot satisfy requirement. It became clear
by using the matrix that first time, that each of the studied specimens and technologies had
differing gaps in our knowledge or documentation, including urine. As new information is
received and considered by the DTAB, revisions to this matrix will continue. Discussions at
subsequent DTAB meetings have already resulted in consensus that has changed the entry for
some specific grid cells, with more changes sure to follow. Examples from the attached copy of
the current grid include: (Section D. - Specimen) our knowledge of whether the size/volume of
the specimen is adequate for multiple tests is recorded as insufficient information "I" for saliva
and sweat; possible "P" for hair; and can satisfy requirement [Blank] for onsite and laboratory
urine testing. (Section G. - Laboratory Testing) our knowledge about ability to identify
adulterated/substituted specimens is recorded as insufficient information "I" for saliva, sweat,
hair and urine. At the end of the matrix we have included a brief description of the
factors required for reliable workplace drug testing, that corresponds with each of the sections in
the matrix.
After the Board's new matrix was presented and discussed, Dr. Carl Selavka, now affiliated with
the Massachusetts State Police Crime Laboratory, Sudbury, Massachusetts, gave an overview of
the information that had been submitted by the industry coordinators in response to the issues
that were identified during the April meeting.
Additional presentations were then made, at the request of the Board, regarding the sweat patch,
on-site urine drug testing, and hair testing for drugs of abuse. Specifically, Robert Fogerson,
PharmChem Labs, Menlo Park, California, presented a recently completed analytical study on
the performance of the sweat patch for drug testing a Federal probation/parole population in
collaboration with the Administrative Office of the US Courts; Dr. Robert Willette, Duo
Research, Denver, Colorado, presented a recently completed study of 15 hand held,
noninstrument based on-site urine drug testing devices also in collaboration with the
Administrative Office of the US Courts; Dr. Ray Kelly, Associated Pathology Labs, Las Vegas,
Nevada, and Dr. Christine Moore, U.S. Drug Testing Laboratories, Des Plaines, Illinois,
presented their approach and methods used to conduct hair testing for drugs of abuse; and Dr.
Bruce Goldberger, University of Florida, Gainesville, Florida, presented a summary of the
challenges faced in developing and implementing a proficiency testing program for drugs of
abuse testing in hair as required by Florida State law.
Dr. Steve Gutman, from the Food and Drug Administration, described the process for
manufacturers to obtain FDA clearance for medical devices.
Throughout the meeting, Board members and public attendees were given the
opportunity to ask questions and make comments.
The second meeting ended with the statement that the assessment of the alternative specimens
and on-site testing is an ongoing process and we will continue the dialogue in future DTAB
meetings as time permits.
Examples of subsequent public comments to the matrix included: for on-site testing it is
unnecessary and cost prohibitive to require that the analyst does not know the identity of the
donor or that the result be verified by a second analyst; what type of certification program would
be required for on-site analysts; that some of the incomplete information "I"s in the table
should be replaced with a different letter to indicate that we have received all the information we
will ever get; FDA will require clearance of collection kits if HHS (and the DTAB) requires it for
workplace programs; comparison of on-site urine testing was made to saliva alcohol
testing which is permitted under the DOT regulations.
Working with the products of the two special DTAB meetings, and the matrix, Dr. Walter Vogl,
of our Division of Workplace Programs, developed a draft document that presented the available
information in the form of an "expanded " Mandatory Guidelines for Urine and Alternative
Specimens and Technologies. The purpose was to show where we were missing critical
information that would need to be addressed in any actual new expanded Mandatory Guidelines.
For example, the expanded background section focused on the new knowledge collected during
the two special DTAB meetings over the past year and the purpose for these guidelines. Added
information and policy guidance is needed, regarding alternative test and specimen applicability.
Would alternative specimens and on-site urine testing be used in only specific situations or for all
the same reasons to test for which urine testing is currently used? Also, there is a requirement to
define additional terms not used in the current urine testing program. In the specimen collection
procedure section, paragraphs on collection site, security, chain of custody, access to authorized
personnel, and privacy are essentially unchanged; however, there is a need to write a detailed
step-by-step collection procedure for each alternative specimen and the device used to collect it.
For on-site urine testing, the urine specimen procedure is essentially the same, but consideration
must be given to when the on-site test is to be performed (that is, before or after sealing the
specimen bottle). The laboratory personnel section does not have any changes. Under laboratory
requirements, most subsections are unchanged except for establishing appropriate testing cutoff
concentrations for both initial tests and confirmatory tests as well as the analytes (i.e.,
drugs/metabolites) to be detected. Continuing through the draft, there are concerns with reporting
results, long term storage of specimens, retesting issues, quality control criteria, external blind
samples, MRO training, and a laboratory certification program (inspections and Proficiency
Testing (PT) programs).
The draft document was placed on our website, and the public invited to submit comments. The
document was also sent directly to the industry representatives who were involved in the April
and September DTAB meetings and they were specifically requested to provide the needed
information. Current Efforts to Obtain Required Information From Industry and Research
Sources
On March 27, 1998, the draft document for alternative specimens and technologies was sent to
the industry coordinators that participated at the previous scientific meetings. We also sent this
draft to the other speakers at the April and September 1997 DTAB meetings and put the draft on
our website (www.health.org/workpl.htm) for public comment. The letters requested the industry
coordinators to provide information in several areas for which no or limited information has been
provided. The following areas were specifically mentioned: (1) applicability of using that type of
specimen; (2) a detailed collection procedure, including the possibility for splits (if needed), how
to prevent tampering/contamination, any special handling requirements; (3) cutoff concentrations
and analytes; (4) long term storage of specimens; (5) retesting of specimens; (6) laboratory
quality control criteria for initial and confirmatory tests; (7) external blind samples; (8) Medical
Review Officer interpreting results/training; and (9) laboratory certification program (inspections
and PT program, and PT performance criteria).
On July 1, we sent a second request to the industry coordinators for all alternative specimens
reminding them of our need to obtain this additional information and to submit it by July 17. On
July 21, we received supplemental information from the hair testing industry coordinator, and
other industry coordinators expect to submit more information on the remaining alternative
specimens within the next few weeks. This information will be shared among the industry
coordinators, the public and will be discussed at future DTAB meetings, where the Board will
develop recommendations for incorporation within the Federal drug testing program.
Forthcoming Workshop to Address Critical Testing Questions
In October, in conjunction with the annual meeting of the Society of Forensic Toxicologists, we
are sponsoring a workshop on hair testing entitled "Is Hair Analysis Racially Biased?" The
co-chairs for the workshop are Dr. Werner Baumgartner, Psychemedics Corporation, Culver
City, California, and Dr. David Kidwell, a Department of Navy research scientist,
Washington, D.C..
In an effort to gather information for this important workshop, we have funded development of a
comprehensive bibliography of publications relating to all aspects of hair testing. A preliminary
copy of the bibliography is one of the documents submitted with this written testimony.
In conclusion, we are committed to continuing our efforts to scientifically assess currently used
and alternative drug testing technologies and specimens in the spirit of collaboration, with
ongoing and open exchange of new scientific information. To that end, it is our intention to also
make this document available on our website, with links to as many of the supporting documents
as possible. We believe that the process of openness and scientific review is vital to the
development of sound national public policy in the important area of testing for the illicit use of
substances of abuse.
While our mission focuses on workplace applications of drug testing, specifically for federal
workplaces and certain federally regulated workforces, we believe that our scientific process,
including peer review and consensus, can serve as a model to others in both public and private
sectors.
This concludes my testimony. I would be pleased to answer questions. Thank you.
