STATEMENT
BY
JOSEPH H. AUTRY III, M.D.
ACTING DEPUTY DIRECTOR
CENTER FOR SUBSTANCE ABUSE PREVENTION
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
COMMITTEE ON COMMERCE
U.S. HOUSE OF REPRESENTATIVES
JULY 23, 1998
RELEASE ONLY UPON DELIVERY
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 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
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 (c) 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:
(http://ncadi.samhsa.gov/workpl.aspx).
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: (http://ncadi.samhsa.gov/workpl.aspx).
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 (ncadi.samhsa.gov/workpl.aspx) 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.
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