[Federal Register: April 13, 2004 (Volume 69, Number 71)]
[Notices]               
[Page 19673-19732]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13ap04-143]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

 
Proposed Revisions to Mandatory Guidelines for Federal Workplace 
Drug Testing Programs

AGENCY: Substance Abuse and Mental Health Services Administration, HHS.

ACTION: Notice of proposed revisions to mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') is proposing to establish scientific and technical 
guidelines for the testing of hair, sweat, and oral fluid specimens in 
addition to urine specimens; scientific and technical guidelines for 
using on-site tests to test urine and oral fluid at the collection 
site; requirements for the certification of instrumented initial test 
facilities; and added standards for collectors, on-site testers, and 
medical review officers.

DATES: Submit comments on or before July 12, 2004.

ADDRESSES: You may submit comments, identified by (insert docket number 
and/or RIN number), by any of the following methods:
     E-mail: wvogl@samhsa.gov. Include docket number 
and/or RIN number in the subject line of the message.
     Fax: 301-443-3031
     Mail: 5600 Fishers Lane, Rockwall II, Suite 815, 
Rockville, Maryland 20857.
     Hand Delivery/Courier: 5515 Security Lane, Suite 
815, Rockville, Maryland 20852.
     Information Collection Requirements: Submit 
comments to the Office of Information and Regulatory Affairs, OMB, New 
Executive Office Building, 725 17th Street, NW., Washington, DC 20502, 
Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, 
comments may also be sent to 202-395-6974 (fax).
    Instructions: All submissions received must include the agency name 
and docket number or Regulatory Information Number (RIN) for this 
rulemaking. All comments will be available for public review at 5515 
Security Lane, Suite 815, Rockville, Maryland 20852.

FOR FURTHER INFORMATION CONTACT: Walter F. Vogl, Ph.D., Drug Testing 
Section, Division of Workplace Programs, CSAP, 5600 Fishers Lane, 
Rockwall II, Suite 815, Rockville, Maryland 20857, 301-443-6014 
(voice), 301-443-3031 (fax), wvogl@samhsa.gov (e-mail).

SUPPLEMENTARY INFORMATION: 

Background

    The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Guidelines) were first published in the Federal Register on 
April 11, 1988 (53 FR 11970), and have since been revised in the 
Federal Register on June 9, 1994 (59 FR 29908), and on September 30, 
1997 (62 FR 51118). The Guidelines establish the scientific and 
technical guidelines for Federal workplace drug testing programs and 
establish standards for certification of laboratories engaged in urine 
drug testing for Federal agencies under authority of Pub. L. 100-71, 5 
U.S.C. section 7301 note, and E.O. 12564.
    In developing and organizing the proposed revisions to the 
Guidelines, there are a number of issues presented in this preamble, 
that include the rationale for the order and manner of presentation of 
what is proposed and why. These issues are first presented by general 
topic area, and later presented in summary, as they appear in the text 
of the proposed Guidelines.

History of the HHS Certification Program for Federal Employee Drug 
Testing Programs, and Related Knowledge

    Since the beginning of the program in 1988, many challenges have 
been overcome and lessons learned from the specific and rigorous HHS 
certification of laboratories to perform forensic workplace testing for 
job applicants and Executive Branch Federal employees.
    The initial Guidelines were published for a 60-day public comment 
period, and were first published as a final notice in the Federal 
Register in April of 1988. Originally, it was believed that fewer than 
10 laboratories would apply for HHS certification under the Guidelines 
to conduct Federal employee drug testing, and that the Department would 
not require even that many to test the urine specimens from all Federal 
agencies.
    This situation changed very quickly when the Department of 
Transportation (DOT) published a final drug testing rule (54 FR 49854) 
in December 1989 for its regulated transportation industries. DOT 
required its regulated industries to use drug testing laboratories that 
were certified by HHS. This requirement began a close relationship 
between HHS and DOT. Additionally, the Nuclear Regulatory Commission 
(NRC) in its Fitness for Duty program contained in 10 CFR Part 26 
requires its licensees to use drug testing laboratories certified by 
HHS.

[[Page 19674]]

    As the Guidelines received both public and judicial support, the 
private sector chose to incorporate the requirement to use only a 
laboratory that has HHS certification under the Guidelines, for 
employee drug testing. Between July 1988 and early 1990, 50 
laboratories had received HHS certification under the Guidelines, while 
another 100 laboratories were awaiting certification.
    In developing the preamble for the proposed expansion and revision 
of the Guidelines, it has been very helpful to keep in sight important 
areas of consideration that have remained visible as the program 
matured over the ensuing fifteen years. These include, but are not 
limited to, custody and control that ensures donor specimen identity 
and integrity, specimen collection procedures, analytical testing 
methods, quality control and quality assurance, reporting results, the 
role of the medical review officer (MRO), and HHS certification issues 
that include testing site inspections and performance testing (PT) 
samples.
    The Department has remained committed to maintaining the integrity 
of the entire Drug-Free Federal Workplace Program by identifying and 
using the most accurate, reliable drug testing technology available. To 
accomplish that goal, the Department collaborates with the DOT, NRC, 
Federal regulators, researchers, the testing industry, and both public 
and private sector employers on an on-going basis on scientific and 
program matters. As the number and types of commercial workplace drug 
testing products and testing options have increased over the past 
decade, the Department, through SAMHSA's Drug Testing Advisory Board 
(DTAB), has expressed increasing interest in assessing these new 
products and procedures for possible use in Federal agency employee 
testing programs.
    Laboratory-based testing using automated screening tests at 
instrumented initial test facilities (IITFs) was proposed by the same 
group of individuals that developed the Guidelines as an area of 
interest immediately after the Guidelines were first published in 1988. 
At that time, the industries regulated by the NRC began using this 
approach as part of their Fitness for Duty programs to allow job 
applicants access to nuclear power plants. A study of 10 sites 
(including both NRC licensee and other private sector sites) was 
conducted where such an IITF was used. Point of collection test (POCT) 
devices were also being developed, but with non-instrumented, visually 
read end-points. By 1997, the Department began, as discussed below, a 
dedicated assessment of drug testing using alternative specimens and 
drug testing technologies, including head hair, oral fluid (saliva), 
and sweat, for possible application in Federal workplace drug testing 
programs.

The Added Specimens--Major Change

    The Department proposes to expand the kinds of specimens that may 
be tested under Federal agency workplace drug testing programs. The 
proposed addition of head hair, oral fluid, and sweat specimens are the 
result of a directed Department process that began with a 3-day 
scientific meeting of the DTAB held in April 1997 to discuss drug 
testing of alternative specimens and using new testing 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 (hair, oral fluid, sweat as well as urine) and technologies 
(non-instrument based on-site tests). The presentations focused on the 
following areas for each specimen/technology: specimen collection and 
chain of custody, initial test reagents and procedures, confirmatory 
test procedures, internal quality control program, reporting test 
results, interpreting test results, and 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.
    Following this meeting, the DTAB members continued reviewing the 
large amount of information presented at the meeting. Their efforts 
resulted in the identification of specific requirements necessary for 
the scientific, administrative, and procedural integrity of a 
comprehensive workplace drug testing program, which includes 
alternative specimens and technologies. They developed a chart 
summarizing workplace drug testing program requirements, reviewed the 
technical materials submitted to them, and identified the necessary 
workplace drug testing requirements for each alternative specimen/
testing technology.
    The DTAB has continued its evaluation of the information submitted 
by the industry representatives on alternative specimens and 
technologies since September 1997. The first working draft of the new 
Guidelines was presented at the June 2000 DTAB meeting. The initial, 
work-in-progress draft Guidelines were placed on our web site and the 
public was invited to submit supplemental information and informal 
comments to help improve our knowledge base. Twenty-eight separate 
commenters submitted comments on the first working draft. The comments 
were summarized and presented at the next DTAB meeting held in 
September 2000. At the September 2000 DTAB meeting, the second working 
draft of the Guidelines was presented and, again, comments were 
requested from all interested parties. At the December 2000 DTAB 
meeting, the public comments submitted were used to prepare the third 
working draft of the Guidelines.
    As the DTAB continued to work on the Guidelines, the Department 
initiated a voluntary pilot PT program. PT samples were developed and 
produced at government expense. The PT samples were sent to several 
laboratories for testing at the laboratories' own expense, using the 
procedures that they routinely use to test head hair, oral fluid, and 
sweat specimens. This pilot PT program began in April 2000 and was 
necessary for two reasons. First, it was necessary to determine if it 
was possible to prepare stable and accurate PT samples for the 
different types of specimens that would be needed as part of a 
laboratory certification program. Second, the results reported by the 
laboratories would indicate if the PT program could establish 
credibility, precision, accuracy, and reliability in drug testing with 
alternative specimens. Based on the information obtained from four 
rounds of PT samples, it appears that valid PT samples can be prepared, 
although some further refinement is needed, and that over time some 
laboratories testing alternative specimens have been able to achieve 
performance levels approaching those levels applied to urine testing 
laboratories. The criteria for laboratory-based hair, oral fluid, and 
sweat testing, and for POCT urine and oral fluid tests have been 
developed and proposed by the industry-lead working groups.
    Although performance in the pilot PT program has been encouraging, 
with individual laboratory and group performance improving over time, 
there are still three serious concerns. First, the data from the pilot 
PT program to date show that not all participants have developed the 
capability to test for all required drug classes, nor to perform such 
tests with acceptable accuracy. Second, some drug classes are more 
difficult to detect than others, for any given type of specimen. Third, 
the specific drug classes that are difficult to

[[Page 19675]]

detect varies by the type of specimen. That means that special 
awareness will be required to select the most appropriate type of 
specimen to be collected from a specific donor, when use of a specific 
drug is suspected. This public comment period is intended to provide an 
opportunity for all interested parties to review the testing criteria 
and associated specimen-specific procedures, to be sure that required 
performance is achievable and sustainable when implemented.

Alternative Specimens

    The use of specimens other than urine in workplace drug testing 
programs have become a frequent topic in scientific meetings worldwide. 
This includes organizations such as the Society of Forensic 
Toxicologists, The International Association of Forensic Toxicologists, 
the Society of Hair Testing, and the American Academy of Forensic 
Sciences. The most frequently discussed specimens are hair, oral fluid, 
and sweat. Until recently it was considered too soon for the forensic 
community to apply these alternative specimens to workplace drug 
testing. Current scientific literature provides much of the information 
that was not previously available in peer reviewed literature. Addition 
of these specimens to the Federal Workplace Drug Testing Program would 
complement urine drug testing and aid in combating the threat from 
industries devoted to suborning drug testing through adulteration, 
substitution, and dilution.
    The preamble provides a list of scientific studies that were used 
in making the policy decisions. The Department asks whether commenters 
are aware of any other studies or data that would cast more light on 
the appropriateness of using any of the alternative specimens or on 
limitations on how the specimens should be used.

Hair

    The Department is proposing that hair testing be included in the 
Federal Workplace Drug Testing Program. Hair testing increases the time 
period over which drug use can be detected as compared to urine, sweat, 
or oral fluid. Hair is easily collected, transported and stored, is 
less likely to transmit bio-organisms than urine or oral fluid, and is 
more difficult to adulterate than urine. As separation techniques and 
detection sensitivity and specificity have improved, scientists are now 
able to detect and quantify drugs and/or metabolites in hair at 
picogram levels. Like other drug testing specimens, drugs in hair are 
initially detected using an immunoassay technique and results are 
confirmed with a more sophisticated technique, most frequently by gas 
chromatography/mass spectrometry (GC/MS). Tandem mass spectrometry (MS/
MS) using GC or liquid chromatography (LC) separation has emerged in 
recent years as the testing method of choice in order to increase 
sensitivity and selectivity and to analyze polar compounds without 
derivitization.\10,15,16\
    Hair consists of a hair follicle and hair shaft. At the base of the 
follicle (bulb) are highly vascularized matrix cells. As matrix cells 
in the dermis of the skin move outward during growth, they form layers 
of a hair shaft that include the outer protectant cuticle, central 
cortex and inner medulla. Hair grows in three stages: about 85 percent 
of hair follicles are in active growth (anagen), while the others are 
in a transition phase (catagen) before the resting phase (telogen). At 
the vertex region of the scalp, the average growth rate of hair is 
about 0.4 millimeters per day or approximately 1 centimeter per 
month.\1\ The Department is proposing to permit agencies as part of 
their Federal workplace program to test hair with lengths of about 1.5 
inches long, representing a time period of 90 days, and to use these 
specimens for pre-employment, random, return-to-duty, or follow-up 
testing.
    Analytes for the regulated drugs tested in hair are marijuana 
metabolite (delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA)), 
cocaine (parent drug and metabolites (benzoylecgonine, norcocaine, and 
cocaethylene)), phencyclidine (parent drug (PCP)), opiates (codeine, 
morphine, and heroin metabolite (6-acetylmorphine (6-AM)), and 
amphetamines (amphetamine, methamphetamine, 
methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), 
and methylenedioxyethylamphetamine (MDEA)).
    Drugs and drug metabolites may be incorporated into hair by several 
different pathways.1,3-7 As drugs and their metabolites 
travel through the body in blood, they passively diffuse from the 
bloodstream into the base of the hair follicle. Drugs and/or 
metabolites are embedded into the hair as bands during the growth 
process. The amount of drug in the hair band is proportional to the 
concentration in the blood when the hair was formed. The distance of 
the drug bands from the skin can estimate the time of drug use. Drugs 
and/or metabolites may also be incorporated into hair via secretions of 
the apocrine sweat glands and sebaceous glands, which are in close 
contact with hair as it develops in and emerges from the skin. Sweat 
and sebum can deposit drugs and/or metabolites on the hair shaft that 
in turn are absorbed into the hair shaft during and after its 
formation. Sweat can be responsible for drug incorporation at distal 
segments of hair which does not correspond to the time of drug 
ingestion.
    There are a number of factors that may influence the amount of drug 
incorporated into hair (e.g., drug dose, length of exposure, drug 
chemical structure, charge). Of particular concern are environmental 
contamination and the role of hair color.
    Concern has been raised about environmental contamination where a 
person may claim, for example, that the drug is present because the 
individual was in a room where others were using marijuana or cocaine. 
While washing the hair sample may remove some of the contamination, 
ultimately we can differentiate environmental contamination from actual 
use because of the presence of the metabolite, which is not present 
when environmental contamination is the source of the drug.
    The role of hair color is also a major concern. Melanin, which is 
responsible for pigmentation in hair, is produced in the hair bulb and 
incorporated into the cells that form the cortex and medulla during 
growth of the hair shaft. Melanin is a polyanionic polymer of two 
types: eumelanin and pheomelanin, the quantity of each determine hair 
color. Eumelanin concentration is highest in black hair and lowest in 
red hair while pheomelanin concentration is highest in red hair and 
lowest in black hair.\2\ Melanin is absent in white hair.
    Animal studies have shown that hair color influences drug 
incorporation with black hair containing the most and yellow (non-
pigmented) hair the least.\7\ In vitro studies in which black, brown, 
and blond hair from drug-free human subjects were placed in a solution 
of benzoylecgonine showed the highest concentration of the drug in 
black hair and the least in blond.\8\ Although there have been a 
limited number of human clinical controlled studies, data show that 
higher concentrations of some drugs are found in dark hair when 
compared to blond or red hair (e.g., codeine\2\, cocaine\9\, 
amphetamine\10\). The limited population studies published in peer 
reviewed literature at this time do not indicate a significant 
association between hair color or race and drug analyte.\11-13\ In one 
study, 1852 people that classified themselves as ``black'' or ``white'' 
showed no evidence of a group adversely affected by hair testing, 
compared to urine

[[Page 19676]]

testing, for cocaine and marijuana testing.\11\ The examination of 500 
positive hair samples for each of three drugs (cannabinoids, cocaine, 
and amphetamine) revealed little statistical evidence of selective 
binding of drugs to hair of a particular color.\12\ Statistical 
examination of 2791 data points that include heroin and its 
metabolites, cocaine and its metabolites, MDMA and its analogs, and 
amphetamine and methamphetamine failed to detect a significant hair 
color effect.\13\
    Despite these suspected limitations, the Department still proposes 
to go forward with incorporation of this new technology as an 
alternative to urine for Federal agencies who may find it useful in 
certain missions and tasks that only individual Federal agencies can 
identify. Though there continues to be some question about the effect 
of hair color on the amount of a drug or its metabolite present in 
hair, there is no question about the fact that the drug or metabolite 
is present. The purpose of the Federal Workplace Drug Testing Program 
is to ensure the safety of the workplace which it does in two ways. 
First, it identifies individuals in security or safety sensitive 
positions who have been using drugs, and second, it acts as a deterrent 
for people who might otherwise use drugs lest they be detected. Hair 
testing can improve the success of the program because it increases the 
time period over which drug use can be detected as compared to urine; 
it is easily collected, transported and stored; it is less likely to 
transmit bio-organisms than urine; and is more difficult to adulterate.

Oral Fluid

    Testing methods for drugs in oral fluid have been developed in 
recent years and have been extensively used in some tested populations 
(e.g., therapeutic drug monitoring, risk assessment in the insurance 
industry, and non-Federal workplace testing).17-19 Many 
studies support the use of oral fluid as a specimen for forensic drug 
testing.\20,21\
    Oral fluid offers some advantages over other types of 
specimens.\22\ Oral fluid is readily accessible and its collection is 
perceived as less invasive than a urine specimen collection. Oral fluid 
collections can easily be observed and, therefore, the specimen is less 
susceptible to adulteration or substitution by the donor. Drugs can be 
detected in oral fluids within one hour of use making oral fluids 
useful in detecting very recent drug use.\27\
    Substitution can be identified by measuring an endogenous component 
(IgG) in the specimen. Although the specimen volumes and amount of drug 
are lower in oral fluid than in urine specimens, current analytical 
methods (e.g., immunoassay, GC/MS, GC/MS/MS, LC/MS/MS) have the 
required sensitivity to be used for oral fluid specimen 
testing.23-26
    As with the other relatively new test specimens for drugs of abuse 
testing, less is known about the pharmacokinetics and disposition of 
drugs into oral fluid as compared to urine.3,28-30 Science 
shows that opiates, PCP, amphetamines and cocaine and most drugs 
including prescription medications enter oral fluid through passive 
diffusion of the drug from the blood stream into the oral fluid. 
However, the active component of marijuana (delta-9-
tetrahydrocannabinol (THC)) does not diffuse into oral fluid.\26,31,32\ 
The only way to detect marijuana use is through the presence of the 
parent drug (THC) in the oral fluid because the parent drug was present 
in the oral cavity. Unfortunately, further scientific study is needed 
to be able to differentiate between whether the parent drug was present 
in the oral cavity due to drug use or environmental contamination, i.e. 
the individual was present in a room when others smoked marijuana, for 
example.
    In order to protect Federal workers from incorrect test results for 
marijuana, the Department proposes that a second biological specimen, a 
urine specimen, will need to be collected under the current Guidelines 
at the same time the oral fluid specimen is obtained, primarily for the 
purpose of testing for marijuana when the oral fluid specimen is 
positive for marijuana. The Department will revise the Guidelines when 
the science is available to differentiate between actual use and 
environmental contamination.
    Analytes for the regulated drugs tested in oral fluid are marijuana 
(parent drug (THC)), cocaine (parent drug or metabolite 
benzoylecgonine), PCP (parent drug), opiates (codeine, morphine, and 6-
AM), and amphetamines (amphetamine, methamphetamine, MDMA, MDA, MDEA).
    The pH of oral fluid can affect incorporation of some 
drugs.33-35 Salivary pH ranges from about 6.2 to 7.4. 
Increased saliva flow rate raises the pH up to a maximum of 8.0 due to 
higher bicarbonate levels. Oral fluid collection devices cause some 
stimulation of saliva flow. Studies have found that concentrations of 
drugs (e.g., cocaine and its metabolites) in non-stimulated oral fluid 
specimens were greater than the concentrations of specimens collected 
using other methods.\34\ Mechanical saliva stimulation (i.e., chewing 
gum) can also lower drug concentrations in oral fluid.\33\ To avoid 
saliva stimulation some recommend spitting into a cup, but some donors 
may be opposed to spitting, especially when observed, and may 
experience dry mouth.
    The Department finds that the collection difficulties associated 
with oral fluid collection procedures are not functionally different 
than other specimen collection difficulties currently encountered with 
urine. Therefore, despite these known limitations, the Department 
proposes to incorporate this new technology as an optional selection 
for Federal agencies because oral fluid testing may be useful in 
certain missions and tasks that only individual Federal agencies can 
identify.

Sweat

    The incorporation of drugs into sweat is poorly understood but 
possible mechanisms appear to be passive diffusion of drugs from blood 
into sweat gland and transdermal migration of drugs to the skin 
surface, where it is dissolved in sweat.\3,36,37\ The time interval 
between drug consumption and detection in sweat depends on the nature 
of the particular drug or drug metabolite and the sensitivity of 
analytical method used.\3,36,38\
    Sweat may be collected as liquid perspiration,\38\ on sweat 
wipes,\20,39\ or with a sweat patch.40-44 Sweat collection 
is a non-invasive procedure \37,38\ and privacy during collection does 
not appear to be a concern.\38\ Commercially available sweat patches 
may be worn for an extended period of time, are waterproof, and are 
generally accepted by patients.\39\ Currently, there are a limited 
number of commercially available collection devices,\20,39\ only one of 
which is FDA-cleared. Attempts to remove or tamper with the FDA-cleared 
sweat patch are usually visible to personnel trained to remove 
them.\3,37\ Sweat patch contamination issues continue to be a 
concern.\3,39,45\ For example, one study suggests that sweat patches 
are susceptible to contamination by a drug that is on the skin before 
the sweat patch is applied and by absorption into the patch through the 
surface of the protecting membrane.\39\ Other studies indicate that the 
polyurethane (outer) layer is impermeable to molecules larger than 
dimer water.\45\ Based on that information, the Department believes 
that external absorption of any drugs through the outer layer is not 
possible under normal circumstances. With regard to contamination from 
a drug

[[Page 19677]]

present on the skin before applying the sweat patch, the Department 
proposes that the skin area be washed with soap and cool water or with 
a disposable towelette. Then the collector must thoroughly clean the 
skin area where the patches will be worn with alcohol wipes prior to 
application. However, the Department encourages researchers to conduct 
further research in this area.
    The Department knows from direct experience both at the National 
Institute on Drug Abuse and the Substance Abuse and Mental Health 
Services Administration that some individuals may not be able to wear 
the sweat patch for the optimal period of time. Skin sensitivity and 
rash are factors that can only be known after the patch is applied for 
the first time.
    The Department also knows from direct experience that if the patch 
is applied in a normally visible area of the body, such as the upper 
arm, that there could be a stigmatizing effect on the wearer.
    Despite these known limitations, the Department proposes to 
incorporate this new technology as an optional selection for Federal 
agencies because sweat testing may be useful in certain missions and 
tasks that only individual Federal agencies can identify.
    Unlike urine, head hair, or oral fluid, the use of a sweat patch 
detects drug use that occurred shortly before the patch is applied and 
while the device remains applied to the skin.\3,20,37,46\ The window of 
detection for the sweat patch is for as long as the patch remains on 
the skin and is a cumulative measure of drug ingestion.\3,37\
    Unlike urine, primarily the parent drug is found in sweat; however, 
some drug metabolites may also be detected.\3,20,36,37,47\ Some drugs 
and drug metabolites that have been detected in sweat are THC,\51\ 
amphetamine, methamphetamine,\20,48\ codeine, morphine, 6-AM, 
heroin,\40,43,45,47,49,50\ PCP,\72\ and cocaine, benzoylecgonine, 
ecgonine methylester.\20,44,47,52\ Investigations to compare the 
detection of drugs in sweat to other specimens are 
ongoing.38-41,47,48,51,53,54
    Analytes for the regulated drugs tested in sweat are marijuana 
(parent drug (THC)), cocaine (parent drug or metabolite 
benzoylecgonine), PCP (parent drug), opiates (codeine, morphine, and 6-
AM), and amphetamines (amphetamine, methamphetamine, MDMA, MDA, and 
MDEA).
    The amount of sweat excreted is variable for each person and 
between individuals and is dependent upon their daily activities, 
emotional state, and environment.\39\ The amount of sweat collected for 
testing is small and the drug concentration low. Therefore, the 
analytical procedures used for measurement of drugs and/or their 
metabolites in sweat must be very sensitive. Confirmation of drug 
analytes in sweat are routinely confirmed by GC/MS \54\ and sometimes 
with LC/MS/MS.\38\
    Currently, sweat testing is used in the private sector for 
monitoring drug use during substance abuse treatment \37\ and is also 
used in the criminal justice system.\17\ Sweat also appears to be well 
suited for return-to-duty and follow-up testing for workplace 
testing.\3,20\

The Added Types of Testing Options and Locations--Major Change

Instrumented Initial Test Facility (IITF)

    The Department proposes to include IITF options in the Guidelines. 
An IITF is basically the screening part of a screening and confirmatory 
laboratory, but established in locations to potentially more quickly 
and economically meet special local testing needs. The Department has 
learned a great deal from the experience of the NRC, where such urine-
based facilities were permitted beginning in 1990. These IITFs were 
intended to support the periodic large testing needs of nuclear-fueled 
electrical power generating facilities, whenever facility maintenance 
and fuel rod replacements were needed, at which time hundreds of 
maintenance workers needed to be allowed timely access into the secured 
areas of the nuclear power plant.
    The numbers and fixed locations of IITFs make them more ``like'' 
laboratories. Presently there are fewer than 60 laboratories HHS-
certified to perform workplace urine drug testing for Federal agencies. 
With the rigorous certification, performance testing, and inspection 
requirements proposed for the IITF, it is unlikely that the total 
number of laboratory and laboratory ``like'' facilities will increase 
very much, or even double to 120 in total. Thus, the IITF could be 
certified in much the same fashion as a laboratory with inspections and 
PT, with the focus exclusively on initial drug and validity testing.
    The Department proposes that IITFs should: (1) Be at a permanent 
location, (2) meet program forensic standards, (3) participate in open 
and blind proficiency testing, (4) have a rigorous quality assurance 
program, (5) be subject to site inspections, (6) use instrumented 
immunoassay tests for drugs which meet FDA requirements for commercial 
distribution, (7) conduct required specimen validity tests, (8) use HHS 
cutoffs, and (9) submit all non-negative specimens to a full service 
HHS-certified laboratory for required additional testing. In meeting 
these criteria, the IITF will meet Guideline requirements of the 
initial test section of an HHS-certified laboratory.

POCT for Drugs

    POCT devices for drugs of abuse were first available in the early 
1990s. POCTs include non-instrumented devices with visually read 
endpoints as well as semi-automated or automated instrumented testing 
devices with machine read endpoints. Drug tests conducted with these 
devices utilize competitive binding immunoassays, the same scientific 
principle as the initial tests conducted in certified laboratories.
    The development and commercial availability of POCT products has 
evolved to include both urine and oral fluid specimens at this time, 
with more specimens likely to be added in the future. The Department 
has learned a great deal from collaboration with the National Institute 
on Drug Abuse, the Administrative Office of the U.S. Courts, the 
Federal Probation and Parole Office, and the Department of Defense 
(DoD) Armed Forces drug testing program office. Collectively, these 
collaborations and the results of actual product assessments \58\ have 
provided the experience and knowledge to propose procedures in the 
Guidelines to more uniformly assess the on-going performance of these 
devices in Federal drug testing applications.
    Non-instrumented POCT for urine testing have been subjected to 
evaluations by investigators independent of the manufacturers and found 
to perform similar to that of the instrumented immunoassay tests in 
certified laboratories.55-58 These tests were conducted on 
both spiked and donor specimens with and without drug analytes. Little 
difference in the performance of these devices was observed between 
tests conducted by laboratory technicians and laymen who had been 
trained in the proper procedures for conducting and reading the 
tests.\55,56\
    Non-instrumented POCTs for oral fluid have been characterized by 
only one group of independent investigators.\59\ Their study was 
performed on spiked oral fluid at concentrations consistent with the 
proposed cutoffs. This study found device variability and difficulty in 
detecting cannabinoids, but suggests the rapid evolution of the 
technology should overcome current problems relating to targeted 
analyte and

[[Page 19678]]

manufacturer's cutoff and provide an assay consistent with proposed HHS 
cutoffs. The investigators felt that ``there is every reason to be 
optimistic about the future for drug testing using oral fluid matrix.'' 
\59\ Presently, there are no POCT devices that have received FDA 
clearance for drugs of abuse in hair or sweat.
    POCTs could potentially be employed almost anywhere, with hundreds, 
if not thousands of testing sites possible. The value and utility of 
the POCT is that it provides quick, negative drug results and validity 
test results and has the added benefit of not requiring a fixed 
facility, expensive test equipment, and highly trained testing 
personnel; moreover, POCTs could be run in low numbers, infrequently, 
and at any given location, as needed. These factors make it very 
difficult, if not impossible to use a laboratory ``like'' inspection 
and quality assurance process. The use of highly trained laboratory 
personnel provides no specific or added value to any oversight process, 
beyond the actual testing of sample POCT devices. Further, the sheer 
potential number and diverse locations of sites where POCT devices 
might be used by choice, make large-scale, routine, or scheduled on-
site inspections a logistic and budgeting nightmare.
    In order to provide an equivalent program of on-going quality 
assurance for POCT devices, the Department proposes a certification 
process under which POCT device manufacturers would provide tests for 
evaluation to be placed on the list of SAMHSA-certified devices 
published by the Secretary. This would be followed by periodic 
additional testing as new lots of manufactured tests become available 
as well as PT sample requirements, training of POCT testers, and on-
going quality assurance requirements. This is a complex area that will 
benefit from public comments now, and from lessons learned over time.

Advantages of POCTs

    POCT products could potentially be employed almost anywhere. The 
value and utility of the FDA-cleared and SAMHSA-certified POCT is that 
it will provide quick, negative drug and specimen validity test 
results. Those specimens that test presumptively positive for drugs or 
indicate that additional specimen validity testing is necessary would 
then be referred for confirmatory testing.
    POCT testing of urine is most suited for situations that require 
quick, negative drug and specimen validity test results such as in 
emergency/crisis management. It may be least suited for pre-employment, 
return to duty and follow-up testing.
    POCT testing of oral fluid is most suited for situations that 
require quick, negative results such as in emergency/crisis management. 
It is most suited for reasonable suspicion/cause and post-accident. It 
may be least suited for random testing. Oral fluid is not suited for 
return to duty, follow-up testing and pre-employment. In order to 
protect Federal workers from incorrect test results for marijuana, a 
second biological specimen, a urine specimen, will need to be collected 
at the same time the oral fluid specimen is obtained.

POCT for Specimen Validity Testing

    Specimen validity POCT devices for the detection of substitution 
and the presence of adulterants have become more widely used in the 
past three years. Specimen validity POCTs include non-instrumented 
devices with visually read endpoints as well as semi-automated or 
automated instrumented testing devices with machine read end points. 
Specimen validity tests conducted with these devices utilize 
colorimetric assays, the same scientific principle as the initial tests 
conducted in certified laboratories.
    Non-instrumented specimen validity POCT for urine testing have been 
subjected to evaluations by independent investigators and were able to 
detect abnormal urine specimens.60-62 These tests were 
conducted on spiked specimens with drug analytes. Results from these 
preliminary studies are variable; however, they demonstrate the ability 
of the devices to detect adulterants and creatinine. This is why the 
Department will incorporate the evaluation of the accuracy and 
reliability of specimen validity testing as part of the POCT device 
evaluation process.

Urine Specimen Validity Testing

    On August 21, 2001, HHS published a notice in the Federal Register 
(66 FR 43876), proposing that the Mandatory Guidelines be revised to 
include specific standards for determining the validity of urine 
specimens collected by Federal agencies under the Federal Workplace 
Drug Testing Program. The Department has issued a final revision with 
comments to the Mandatory Guidelines as they currently exist 
implementing the urine specimen validity testing requirements. These 
requirements have been incorporated in this revision.

Manner of Presentation and the Use of Plain Language--Major Change

    Although the order of presentation in the proposed revisions to the 
Guidelines has been retained, the manner of presentation has been 
totally revised. This ``improved'' process has been based on the 
experience and very positive public feedback that other Federal 
agencies have had when they used a similar process. The goal of the HHS 
process was to revise the manner of presentation to use ``plain 
language,'' and address complex issues by using simple questions to 
identify each specific topic. Unfortunately, these Guidelines are 
scientifically based and the answers are often complex.
    Wherever possible, the questions and answers have been organized as 
a group for a specific specimen, testing option, or related topic. The 
Department understands that such organization may produce some 
repetition, for example when reading about head hair, oral fluid, or 
sweat, and seeing identical information presented for collection site, 
donor identification, or confidentiality, as repeated text. Because 
this change in format is significantly different than the current 
Guidelines, major changes from the current Guidelines will be noted in 
the discussion of each subpart.

Organization of Draft Guidelines--No Major Change

    Within the text for the proposed revisions to the Guidelines, the 
order of presentation of topics follows the existing Guidelines, with 
expanded details to address the added specimens (head hair, oral fluid, 
sweat), testing options (IITF and POCT), and related issues. This seems 
to be the most appropriate way to permit those already familiar with 
the existing Guidelines to do a detailed comparison with what is being 
proposed. For those relatively few first-time readers of the 
Guidelines, they may wish to first review the current Guidelines so as 
to understand the current proposal. Where there are no changes to 
specific sections in the proposed revisions to the Guidelines, that has 
been stated in the preamble.

HHS Contractor--No Major Change

    In accordance with current practice, the HHS contractor performs 
certain functions on behalf of the Department. These functions include 
maintaining a laboratory inspection program and a PT program that 
satisfy the requirements described in the Guidelines. These activities 
include, but are not limited to, reviewing inspection reports submitted 
by inspectors, reviewing PT results

[[Page 19679]]

submitted by laboratories, preparing inspection and PT result reports, 
and making recommendations to the Secretary regarding certification, 
continued certification, or suspension/revocation of laboratories' 
certification. It is important to note that while the contractor 
gathers and evaluates information provided to it by inspectors or 
laboratories, all final decisions regarding laboratory certification, 
suspension or revocation of certification status is retained within the 
Department.
    In addition, the contractor has historically collected certain fees 
from the laboratories for services related to the certification 
process, specifically for laboratory application and inspection and PT 
activities for laboratories applying to become HHS-certified, and in 
the process of maintaining HHS-certification. All fees that are 
collected by the contractor are applied to its costs under the 
contract.
    This same process, which has been used since the inception of the 
laboratory certification program, will also be used by the HHS 
contractor to collect similar fees from laboratories that seek, 
achieve, and continue HHS-certification for testing additional types of 
specimens (e.g., hair, oral fluid, sweat), and from IITFs that seek, 
achieve, and continue HHS-certification to test hair, oral fluid, 
sweat, or urine.
    The Department also contributes funds to this contract for purposes 
not directly related to laboratory certification activities, such as 
evaluating the technologies and instruments and providing an assessment 
of their potential applicability to workplace drug testing programs.

Subpart A--Applicability

    Sections 1.1, 1.2, 1.3, and 1.4 contain the same policies as 
described in the current Guidelines with regard to who is covered by 
the Guidelines, who is responsible for the development and 
implementation of the Guidelines, how a Federal agency requests a 
change from these Guidelines, and how these Guidelines are revised.
    In section 1.5, where terms are defined, the Department proposes to 
add or revise several of the definitions contained in the Guidelines. 
These include, for example, new or revised definitions for adulterated 
specimen, certifying scientist, collector, confirmatory validity test, 
dilute specimen, failed to reconfirm, follow-up test, initial validity 
test, IITF, invalid result, non-negative specimen, oxidizing 
adulterant, POCT facility, post-accident test, pre-employment, random 
test, reasonable suspicion/cause test, reconfirmed, rejected for 
testing, responsible person, responsible technician, return to duty 
test, specimen, split specimen, substituted specimen, and standard. 
Every effort has been made to define terms such that they would apply 
to each type of specimen collected, as appropriate.
    Section 1.6 specifies what an agency is required to do to protect 
employee records. It is the same policy as described in the current 
Guidelines except it has been amended to include records at IITFs, POCT 
sites, specimen collection sites, and records produced and maintained 
by medical review officers.

Subpart B--Specimens--Major Change

    In section 2.1, the Department proposes to expand the urine drug 
testing program for Federal agencies to permit testing head hair, oral 
fluid, and sweat specimens. The Department wants to make it very clear 
to agencies that there is no requirement that they use hair, saliva or 
sweat as part of their drug testing program, but rather that agencies 
may use those specimens. If they choose to use these alternative 
specimens then agencies are required to follow these Guidelines.
    In section 2.2, in order to guide Federal agencies, the Department 
has added to the Guidelines a chart indicating in what circumstances 
each specimen can be collected.

Urine

    Laboratory based urine testing has traditionally been used for pre-
employment, random, reasonable suspicion/cause, post-accident, return-
to-duty, and follow-up testing.
    Drug ingestion for a 3-5 day interval preceding the specimen 
collection can usually be identified in urine. Based on the detection 
window, urine is most suited for random, return to duty and follow-up 
testing.
    Because of the increasingly evident potential that Federal agency 
workplace urine-based drug testing has the potential for being 
seriously compromised by clandestine products and procedures intended 
to mask current drug use, especially when given sufficient time to 
obtain these products, urine drug testing may be least suited for pre-
employment.

Oral Fluid

    Drug detection times for the regulated analytes in oral fluid range 
from less than one to approximately 24 hours. Drugs may be detected in 
urine longer after drug use than in oral fluid. This makes oral fluid 
useful in detecting very recent drug use. Based on the detection 
window, oral fluid is most suited for reasonable suspicion/cause and 
post-accident. It may be least suited for random testing if prior 
notice (greater than 24 hours) is given. Because of the short detection 
window, oral fluid is not suited for return to duty, and follow-up 
testing. In order to protect Federal workers from incorrect test 
results for marijuana, a second biological specimen, a urine specimen, 
will need to be collected at the same time the oral fluid specimen is 
obtained.

Hair

    Hair is useful for detecting drug use for longer time intervals, 
i.e., weeks (7-10 days) to months. Based on the detection 
window, hair is most suited for pre-employment and random testing. The 
window of detection is much longer than that of urine. Hair may be used 
for return to duty and follow-up testing depending on the time of last 
known drug use. Hair is not suited for reasonable suspicion/cause and 
post-accident because it takes 7-10 days for drug or drug metabolites 
to appear in hair.

Sweat Patch

    The window of detection for the sweat patch is for as long as the 
patch remains on the skin and is a cumulative measure of drug 
ingestion. The sweat patch may not be useful for pre-employment, 
random, reasonable suspicion/cause and post accident drug testing 
because it must be worn for days after its application. The sweat patch 
is best used for return to duty and follow-up testing.
    The Department is specifically requesting public comment on the 
appropriateness of the reasons for defining and limiting the selection 
of specimens for the different types of testing proposed in this 
notice. Commenters are requested to submit supporting documentation if 
recommending that other reasons for testing would be appropriate for 
some of the types of specimens being collected.
    In section 2.3, the Department proposes to prohibit routinely 
collecting more than one type of specimen from a donor at the same time 
except when an oral fluid specimen is collected. This restriction is 
appropriate because it prevents Federal agencies from expecting an 
individual to provide multiple specimens each time he or she is 
selected for a drug test and then attempting to compare results from 
different types of specimens. It is expected that different results 
would be obtained for the different types of specimens because the 
windows of

[[Page 19680]]

detection are different, as explained above. If a problem occurs during 
the collection of one type of specimen (e.g., shy bladder for a urine 
specimen, insufficient specimen available), permission can be obtained 
from the Federal agency to collect an alternative specimen.
    In section 2.4, the Department proposes to establish the 
requirement for all specimens to be collected as split specimens, and 
in section 2.5 to establish a minimum quantity that must be collected 
for each type of specimen. For hair, 100 mg of head hair was the 
quantity recommended by the hair testing industry. For oral fluid, the 
Department is proposing that 2 mL be collected in a collection tube 
rather than allowing oral fluid to be collected directly into a 
collection device that does not provide an accurate measurement of the 
volume of oral fluid collected. This approach allows establishing 
specific cutoffs for oral fluid testing. For sweat, since the ``sweat 
patch'' is the only FDA-cleared device currently available, the 
quantity of sweat collected is determined by the length of time the 
patch is worn. Requiring that the patch be worn at least 3 days but no 
more than 7 days ensures that a sufficient amount of sweat is collected 
that could possibly contain a measurable amount of drugs or drug 
metabolites. For urine, the Department is proposing to eliminate the 
single specimen collection procedure and to require each Federal agency 
to use the split specimen collection procedure. The 45 mL requirement 
ensures that each Federal employee is offered the same opportunity to 
have the split specimen tested by a second laboratory.

Subpart C--Drug and Validity Tests--Major Change

    Section 3.1 contains the same policy that is in the current 
Guidelines regarding which tests must be performed on a specimen. A 
Federal agency is required to test each specimen for marijuana and 
cocaine, and is authorized to also test for opiates, amphetamines, and 
phencyclidine. The Department realizes that most Federal agencies 
already test for all five drug classes authorized by the existing 
Guidelines, but has not made this a mandatory requirement. The 
Department will continue to rely on the individual agencies and 
departments to determine their testing needs above the minimum. The one 
new requirement is that each Federal agency is required to ensure that 
each specimen is tested to determine if it is a valid specimen.
    The policy in section 3.2 remains unchanged. Any Federal agency 
that wishes to routinely test its specimens for any drug not included 
in the Guidelines must obtain approval from the Department before 
expanding its program. A specimen may be tested for any drug listed in 
Schedule I or II of the Controlled Substances Act when there is 
reasonable suspicion/cause to believe that a donor may have used a drug 
not included in these Guidelines. When reasonable suspicion/cause 
exists to test for another drug, the Department is proposing that a 
Federal agency must document the possibility that the use of another 
drug exists, attach the documentation to the original Federal drug 
testing custody and control form (Federal CCF), and ensure that the 
HHS-certified laboratory has the capability to test for the additional 
drug. The HHS-certified laboratory is expected to validate the test 
methods for this additional drug and to use the same quality control 
criteria that are used for the other drug analyses described in the 
Guidelines. The Department believes this proposed policy is sufficient 
to ensure that this testing for an additional drug would be 
forensically and scientifically supportable.
    Section 3.3 restates the policy in the current Guidelines that 
specimens may not be used for any unauthorized purposes.
    Sections 3.4, 3.5, 3.6, and 3.7 list the proposed cutoff 
concentrations for each type of specimen collected. As previously 
stated in this preamble, the Department is proposing to adopt the 
cutoff concentrations that were recommended by the industry working 
groups. Based on the results from the PT testing program, it appears 
that some industry proposed cutoff concentrations for the alternative 
specimens are currently set at what appears to be approaching a limit 
of quantitation that reflect the analytical capabilities of one or two 
laboratories to detect extremely low drug concentrations. The 
Department believes that each laboratory testing a specific type of 
specimen for a particular drug must be able to accurately determine the 
concentration for a drug or drug metabolite that is less than the 
cutoff concentration, as well as concentrations equal to or greater 
than the cutoff. The Department is specifically requesting comments on 
the appropriateness of these cutoff concentrations and the ability of 
laboratories to meet this requirement.
    Since the late 1980's, a number of recommendations have been made 
that additional drugs be considered for inclusion in workplace drug 
testing. Over the past decade, MDMA and its analogues have become 
increasingly prevalent in the workplace. The 2002 National Survey on 
Drug Use and Health (NSDUH)) (available on the Internet at http://www.samhsa.gov/oas/nhsda.htm
 \63\) indicates that the estimated number 

of people using ecstasy, the generic name for MDMA, within the past 
year and within the month before the survey was taken, exceeded that 
found for heroin, crack cocaine, LSD, and PCP. This is further 
supported by Drug Abuse Warning Network (DAWN) data \64\ which finds 
that MDMA was on the list of the top 10 drugs mentioned in emergency 
room visits, just below methamphetamine and was one of the top ten of 
drugs seized and sent to Federal, State and municipal crime 
laboratories, as noted in the National Forensic Laboratory Information 
System (NFLIS) 2002 Annual Report.\65\ In 2000, the prevalence of MDMA 
found in active duty Army personnel exceeded that of 
methamphetamine.\66\ Thus, Federal agencies may elect to test for 
additional drugs including MDMA, under section 3.2(a) of the Mandatory 
Guidelines.
    The Department is specifically interested in obtaining information 
on the ability of the various immunoassay test kits to detect MDMA, 
within the amphetamine class of drugs. The Department is aware that DoD 
drug tests members of the uniformed services for MDMA using an 
additional initial test focused on that drug. Based on this experience 
from DoD, if drug testing is proposed at the cutoffs in this document, 
the Department believes that the only sensitive and specific manner to 
perform the initial test for methamphetamine, amphetamine, and MDMA is 
to use two separate initial tests, one for methamphetamine and 
amphetamine and a second initial test for MDMA. Recommendations on 
using a single amphetamine test kit or the need to use separate test 
kits are requested.
    The Department periodically reviews the cutoff for all drugs 
authorized for workplace drug testing and revises those cutoffs as 
necessary to maximize the deterrent effect of the program. As a result 
of this review, the initial test cutoff for marijuana was lowered in 
1994 and both the initial test and confirmatory test cutoff for opiates 
was raised in 1998. These changes were instituted after review of the 
science supporting the change, the technical capabilities of the 
certified laboratories and the effect of the change on the deterrent 
intent of workplace drug testing.
    The Department proposes to lower the cutoff concentration for 
cocaine and amphetamine analytes. Reductions in

[[Page 19681]]

initial and confirmatory cutoffs for most drugs in urine will increase 
the time period in which those drugs will be found.\67\ The proposed 
lower cutoffs will produce an increase in the number of urine specimens 
that are identified as containing cocaine metabolites and 
amphetamines.68-70 The cutoff reductions proposed in this 
revision are estimated to identify 10-20 percent more urine specimens 
containing cocaine metabolites 68,69 and 5-24 percent more 
urine specimens containing amphetamines.\70\ Data provided by currently 
certified laboratories are consistent with these estimates and will 
increase the deterrent effect of the program and allow early 
identification of substance use by individuals. The lowering of these 
cutoffs should not result in increased claims of passive exposure.\71\
    The capability of HHS-certified laboratories to respond to these 
changes has been evaluated. Since the beginning of this program, 
laboratories certified by HHS have exhibited significantly less 
quantitative variability when analyzing PT samples than applicant 
laboratories. Evaluations of their performance since 1990 have also 
shown that the quantitative variability of the certified laboratory 
population has continued to decrease for all drugs. Evaluations of 
performance for the testing of cocaine and amphetamines have found that 
certified laboratories have demonstrated the precision and accuracy 
necessary for the proposed cutoff revisions. Certified laboratories 
demonstrated their ability to meet current Guideline requirements 
through the testing of quarterly PT samples containing amphetamine, 
methamphetamine, and benzoylecgonine. Documentation of their 
capabilities with method validations has demonstrated the precision and 
accuracy of the method down to 40 percent of the current cutoffs. In 
addition, laboratories have been challenged quarterly with PT samples 
which contained drug concentrations at 40 percent of the current cutoff 
and higher.
    For urine, the Department proposes to lower the initial test cutoff 
concentration for cocaine metabolites from 300 ng/mL to 150 ng/mL with 
a corresponding decrease of the confirmatory test cutoff concentration 
from 150 ng/mL to 100 ng/mL. Additionally, the initial test cutoff 
concentration for amphetamines would be decreased from 1000 ng/mL to 
500 ng/mL and the confirmatory test cutoff concentration decreased from 
500 ng/mL to 250 ng/mL. The Department continues to require the 
presence of amphetamine at a concentration below cutoff in order to 
report a specimen positive for methamphetamine. This ``methamphetamine 
reporting rule'' is retained because of concerns and experience that 
extremely high concentrations of pseudoephedrine and/or ephedrine in a 
urine specimen can still lead to inappropriate reporting of a 
methamphetamine positive result when in fact there is no 
methamphetamine present at a concentration above the cutoff. 
Additionally, this requirement to confirm the presence of amphetamine 
at a concentration below the cutoff is included for reporting a hair, 
oral fluid, or sweat patch methamphetamine positive result. The 
confirmatory testing for amphetamines would be expanded to test for 
MDMA, MDA, and MDEA. The Department believes that the certified 
laboratories have the capability to accurately test urine specimens 
using these revised cutoff concentrations. Additionally, the revised 
cutoff concentrations will increase the windows of detection for these 
drugs, thereby, increasing the number of specimens that may be reported 
positive.
    In sections 3.8, 3.9, and 3.10, the Department is proposing which 
validity tests must be conducted on head hair, oral fluids and sweat 
patches. In section 3.11, the Department then reiterates which validity 
tests must be conducted on a urine specimen. The Department believes 
these policies are necessary to identify those individuals who are 
attempting to suborn a drug test. There are many products marketed on 
the Internet and in highly publicized market-focused publications that 
offer different approaches to suborn drug tests. At this time, many 
products are focused on defeating the well-established, mature urine 
drug testing program. The Department believes as alternative specimens 
become increasingly used, attempts to suborn alternative specimen drug 
tests will increase. The Department also recognizes that validity 
testing proposed for alternative specimens is not as robust as for 
urine, but is confident that this testing will be refined over time.
    In sections 3.12, 3.13, 3.14, and 3.15, the Department reiterates 
the criteria that a laboratory will use to report a urine specimen as 
adulterated and proposes the criteria that a laboratory will use to 
report a head hair, oral fluid, and sweat patch, respectively, as 
adulterated.
    Section 3.16 describes the proposed requirements to report an oral 
fluid specimen as substituted. The Department also reiterates the 
current requirements with regard to a urine specimen being reported as 
substituted.
    Section 3.18 reiterates the criteria to report a urine specimen as 
dilute.
    Sections 3.19, 3.20, 3.21, and 3.22 reiterate the criteria that 
will be used to report a urine specimen as an invalid result and 
propose the criteria that will be used to report a head hair, oral 
fluid, and sweat patch, respectively, as an invalid result. The 
Department believes these proposed criteria for each type of specimen 
collected are appropriate to ensure that each specimen is a valid 
specimen.

Subpart D--Collectors--Major Change

    In section 4.1, the Department is proposing to expand the 
requirements for donor confidentiality for collectors.
    Section 4.2 describes what specific training requirements 
individuals are required to have before they may serve as a collector.
    Section 4.3 proposes that another person, such as another employee 
of the organization or company responsible for providing collection 
site services, must provide the training for an individual to become a 
collector and specifies the qualifications for this individual to be a 
trainer.
    In section 4.4, the Department proposes what an organization must 
do before it allows an individual to serve as a collector. The 
Department believes these proposed expanded requirements are necessary 
to ensure that a collector knows the entire collection procedure, how 
to interact with the donor, how to maintain chain of custody, how to 
complete the Federal CCF, and how to transfer the specimen for testing.

Subpart E--Collection Sites

    The collection site requirements in this subpart are essentially 
the same as those described in the current Guidelines, with variations 
for specimen collection that would vary around privacy issues required 
for the collection of a urine specimen, that would not be required for 
head hair, oral fluid, or sweat specimens, based on the experience and 
input from participating industry-led working groups for each type of 
specimen.
    In sections 5.5, 5.6, 5.7, and 5.8, the Department is proposing 
specific privacy requirements when collecting head hair, oral fluid, 
sweat patch, and urine specimens, respectively. The privacy 
requirements for urine are the same as those described in the current 
Guidelines.
    For hair, the Department proposes that head hair is the only type 
of hair to collect for a hair sample. The Department believes this is 
appropriate because collecting hair only from the

[[Page 19682]]

head is the least invasive area to collect a hair sample and affords 
the donor the most privacy. If head hair is not available, the 
Department believes it is more appropriate to conduct a drug test using 
a different specimen rather than attempting to collect hair from 
another body site.
    For sweat, the Department proposes that the sweat patch may only be 
applied to the donor's upper arm, or back. The primary site for a sweat 
patch is the upper arm; however, applying a patch to a donor's chest or 
back is reasonable if the donor prefers to use these alternative sites 
to conceal the fact that they are wearing a sweat patch.
    For oral fluid, the Department proposes that the donor provide an 
oral fluid specimen directly into an appropriate container. This 
approach will ensure that a minimum amount of oral fluid is collected 
and can then be split for on-site testing or sent to a laboratory for 
both initial and confirmatory testing.
    For each type of specimen collected, the collector and the donor 
are the only individuals present while the specimen is being collected, 
except when a direct observed collection is used to collect a urine 
specimen and the observer is present with the donor.

Subpart F--Federal Drug Testing Custody and Control Forms

    The requirement to collect a Federal agency specimen using an OMB-
approved form is the same as in the current Guidelines. An OMB-approved 
Federal CCF must be used for each type of specimen collected. The form 
for each type of specimen will be developed with the assistance of each 
industry working group and Federal agencies and approval will be 
requested from OMB and comment sought from the public prior to these 
Guidelines being implemented. The Department seeks comments on whether 
it would be preferable, and practical, to have a single Federal CCF 
that could be used for all the various specimens, rather than a 
multiplicity of forms. The Department also seeks comment on whether it 
would be useful to add a requirement that employees and others could 
not alter the Federal CCF in any way, e.g., could not write comments on 
it.

Subpart G--Collection Device

    Section 7.1 describes what is considered to be the collection 
device that is used to collect each type of specimen.
    In section 7.2, the Department describes the proposed policy on 
which devices may be used to collect a specimen. If the FDA has cleared 
a collection device, it has been determined that the device does not 
affect the specimen collected. If the FDA has not cleared a collection 
device, the Federal agency must only use a collection device that does 
not affect the specimen collected. This requirement arises from 
incidents in the past where specimen containers themselves, or liners 
in the lids of specimen containers were found to absorb drugs present 
in a urine specimen. This means that the actual drug concentration in 
the specimen was reduced simply by its presence in that particular type 
of specimen container. Since the Department is proposing drug testing 
using alternative specimens and technologies, it is reasonable to 
believe that new and different specimen collection devices will be used 
to collect Federal employee drug test specimens. The Department 
requests specific comments on this requirement.

Subpart H--Specimen Collection Procedure--Major Change

    In section 8.1, the Department is proposing to establish the basic 
requirements that would apply to collecting any type of specimen. This 
includes a requirement for the collector to provide identification to 
the donor if the donor asks, explain the basic collection procedures to 
the donor, request that the donor read the instructions on the back of 
the Federal CCF, and answer any reasonable and appropriate questions 
the donor may have regarding the collection procedure.
    In sections 8.2, 8.3, 8.4, and 8.5, the Department is proposing the 
collection procedure to be used to collect each type of specimen. The 
collection procedure for urine is essentially the same as that 
described in the current Guidelines. The major change is that a split 
specimen collection would be required for all specimen collections, 
including urine.
    In section 8.6, the Department is proposing to require that a 
Federal agency conduct an annual inspection of each collection site 
that is used for its workplace drug testing program. If several Federal 
agencies are using the same collection site, then only one Federal 
agency is required to conduct an inspection. The Department believes 
this requirement will ensure that collectors and collection sites 
satisfy all the collection requirements in these Guidelines for each 
type of specimen collected. For the Department to directly carry out 
this responsibility for a Federal agency, the Department would incur 
substantial financial and administrative costs. However, to the extent 
that Federal agencies lack the clinical or technical expertise required 
to fulfill their requirements under this proposal, they are free to 
enter into Economy Act transfers with the Department.

Subpart I--HHS Certification of Laboratories and IITFs--Major Change

    Section 9.1 reaffirms the goals and objectives of the certification 
program that are the same as those described in the current Guidelines.
    Section 9.2 describes who has the authority to certify laboratories 
or IITFs to conduct testing for Federal agencies. This is the same 
policy as in the current Guidelines.
    Section 9.3 describes the process that a laboratory or IITF must 
follow to become certified to conduct testing for a Federal agency. The 
Department believes that including a description of the certification 
process will be extremely helpful to those laboratories or IITFs that 
are interested in applying for certification. It is also important to 
understand that a laboratory or IITF needs to be certified for each 
sample type it wants to test (e.g., hair, oral fluid, sweat, urine) 
since the testing procedures are different for each.
    Section 9.5 describes the specifications for the PT samples. The 
requirements in this section are the same as in the current Guidelines.
    Sections 9.6, 9.7, 9.8, and 9.9 describe the proposed PT 
requirements for an applicant laboratory to conduct testing for each 
type of specimen. The performance testing requirements for the urine 
testing program are the same as those in the current Guidelines and the 
Department is proposing that similar requirements apply to the other 
types of specimens.
    Sections 9.10, 9.11, 9.12, and 9.13 describe the proposed PT 
requirements that apply to a certified laboratory for each type of 
specimen. The PT requirements for the urine testing program are the 
same as those in the current Guidelines and the Department is proposing 
that similar requirements apply to the other types of specimens.
    Sections 9.14, 9.15, 9.16, and 9.17 describe the proposed PT 
requirements for an applicant IITF to become certified for each type of 
specimen tested. The Department is including requirements for an IITF 
in this section because of the similarity of an IITF to the part of a 
laboratory that performs initial testing. Thus, the same requirements 
will apply to an IITF as to that portion of a laboratory which performs 
initial testing.
    Sections 9.18, 9.19, 9.20, and 9.21 describe the proposed PT 
requirements

[[Page 19683]]

for an HHS-certified IITF to remain certified to test each type of 
specimen.
    Section 9.22 describes the inspection requirements for an applicant 
laboratory or IITF to become certified. As noted above, the Department 
is including requirements for an IITF in this section because of the 
similarity of an IITF to the part of a laboratory that performs initial 
testing. Thus, the same requirements will apply to an IITF as to that 
portion of a laboratory which performs initial testing.
    Section 9.23 describes the inspection requirements for an HHS-
certified laboratory or IITF to remain certified. The Department 
proposes to change the requirement that a certified laboratory or IITF 
be inspected by a team of three inspectors to a requirement that a 
certified laboratory or IITF be inspected by at least one inspector. 
The number of inspectors used for maintenance inspections would vary 
depending on the size of the laboratory. The Department believes that 
one trained inspector may be sufficient to conduct a thorough 
inspection of extremely small laboratories.
    In section 9.24, the Department is proposing the requirements for 
an individual to serve as an inspector for the HHS-certification 
program. The proposed requirements have been used for the past several 
years and are being incorporated into the Guidelines. An individual may 
serve as an inspector for the Secretary if he or she has experience and 
an educational background similar to that required for either the 
responsible person or the certifying scientist as described in subpart 
K for a laboratory, or as a responsible technician as described in 
subpart M, has read and thoroughly understands the policies and 
requirements contained in these Guidelines and in other guidance 
consistent with these Guidelines provided by the Secretary, submits a 
resume and documentation of qualifications to HHS, attends approved 
training, and submits an acceptable inspection report and performs 
acceptably as a trainee inspector on an inspection.
    Section 9.25 describes what happens when an applicant laboratory or 
IITF fails to satisfy the PT requirements or the inspection 
requirements. The consequences are the same as currently apply to 
laboratories in the current Guidelines.
    Sections 9.27, 9.28, and 9.29 apply the same requirements that are 
in the current Guidelines regarding the factors used to revoke the 
certification of a laboratory or an IITF, directing a laboratory or 
IITF to immediately suspend testing, and the issuance of a notice 
regarding these actions. It is possible for a laboratory or IITF to 
lose certification for one sample type while retaining certification to 
test another type. This is because the kinds of testing procedures used 
to test one type of sample can be very different from procedures and 
equipment used to test another sample type.
    Section 9.31 restates the policy in the current Guidelines that a 
list of HHS-certified laboratories and IITFs will be published monthly 
in the Federal Register. The list will also indicate the types of 
specimens for which each laboratory or IITF is certified to test.

Subpart J--Blind Samples Submitted by an Agency

    Section 10.1 continues to require the supplier of a blind sample to 
ensure that the contents have been validated and are stable until the 
expiration date. Additionally, the Department proposes that drug 
positive blind samples must have concentrations sufficiently above the 
cutoff concentrations used to give a positive result. This requirement 
ensures that sample degradation will not affect the blind sample and 
the laboratory will always report a positive result. The Department 
also proposes that blind samples for the urine testing program contain 
adulterants or satisfy substitution criteria to challenge a 
laboratory's capability to identify adulterated or substituted 
specimens. The specific requirement for urine specimens is based on the 
donor privacy issue associated with providing a urine specimen, where 
direct observation is not used, and the potential exists for an 
adulterant to be added to the collected specimen before it is turned 
over to the collector. There are no similar donor privacy issues 
associated with the collection of head hair, oral fluid, or sweat.
    The Department seeks comment on whether the proposed reduction of 
the blind sample rate to one percent will be sufficient to achieve the 
objectives of sending blind samples to laboratories especially with 
respect to the newer specimens with which laboratories, collectors and 
others are less familiar at this time.
    In section 10.2, the Department is proposing to reduce the 20 
percent requirement for blind samples, for each type of specimen to be 
tested (i.e., urine, head hair, oral fluid, or sweat) to 3 percent 
during the initial 90-day period of a new Federal agency program 
because the 20 percent requirement is excessive and redundant. Since 
the beginning of the urine testing program, there has never been any 
evidence to suggest that each Federal agency needs to challenge each 
laboratory with 20 percent blind samples to determine if a laboratory 
is making either administrative or technical errors in the testing of 
specimens.
    In section 10.3, the Department is proposing how a blind sample is 
to be submitted to a laboratory. This section provides more detail on 
how to complete the Federal CCF and ensure proper submission of the 
blind samples to the laboratory or IITF.
    In section 10.4, the Department is proposing the procedure to be 
used to investigate errors associated with blind samples. This proposed 
procedure provides direction and detail on how to evaluate information 
on what led to an inconsistent result.

Subpart K--Laboratory--Major Change

    This subpart has basically the same requirements that are contained 
in the current Guidelines with the following changes.
    Section 11.4 describes a new policy for when the responsible person 
(RP) leaves a certified laboratory. As stated in the current 
Guidelines, the RP assumes professional, organizational, educational, 
and administrative responsibility for the laboratory's drug testing 
facility. The Department believes it is essential to ensure that drug 
testing is routinely performed under the direction and supervision of 
an individual with such qualifications. In this section, the Department 
proposes requirements to ensure this takes place. Additionally, the 
Secretary will begin the process of suspension or revocation in 
accordance with the Guidelines if the RP leaves and no RP is approved 
within 180 days. This requirement is essential to protect the interests 
of the United States and its employees to ensure that an HHS-certified 
laboratory has an individual that can fully attest to the forensic and 
scientific supportability of the laboratory's testing program.
    Section 11.9 requires that a laboratory must be HHS-certified 
separately for each type of specimen that it wants to test for a 
Federal agency. The separate certification is necessary because of the 
differences among urine, head hair, oral fluid, and sweat specimens in 
all phases of collection, testing, reporting and on-going inspection 
and performance testing. An HHS certification for a laboratory 
performing urine tests would provide no quality assurance about that 
laboratory performing testing on other specimens.
    In section 11.15, the Department proposes to allow the use of 
additional analytical procedures for the confirmatory drug tests. For 
some of the types of specimens, the confirmatory

[[Page 19684]]

drug tests may be performed by LC/MS, GC/MS/MS, and LC/MS/MS in 
addition to the GC/MS that has been traditionally used to test urine 
specimens. The Department believes these additional confirmatory 
methods are scientifically valid, based on on-going reviews of the 
scientific and forensic literature, and the assessment of a DTAB 
working group that has studied these newer instruments and 
technologies. These additional confirmatory methods are the methods and 
instruments that have been identified by the industry-led working 
groups that must be used to successfully detect and report the cutoff 
concentrations proposed in subpart C.
    In sections 11.18, 11.19, 11.20, and 11.21, the Department is 
proposing to use the same analytical and quality control requirements 
for conducting validity tests for each type of specimen collected. The 
Department has intentionally proposed to use the same requirements for 
each type of specimen based on the established requirements for a urine 
specimen; however, information may become available during the public 
comment period to suggest that the requirements for each type of 
specimen should be different.
    In sections 11.22, 11.23, 11.24, and 11.25, the Department 
reiterates the specific analytical requirements to conduct each 
validity test for a urine specimen and proposes the specific analytical 
requirements to conduct each validity test for head hair, oral fluid, 
and sweat patch specimen collected. The Department believes these 
requirements will ensure that the validity test results reported by a 
laboratory are scientifically supportable.
    Sections 11.26, 11.27, 11.28, and 11.29 describe in detail how a 
certified laboratory is required to report test results to MROs for 
each type of specimen collected. These sections include the details of 
urine specimen validity testing, and also propose that laboratories 
report drug and/or metabolite concentrations to the MROs on all 
specimens reported as positive. The Department understands that the 
data exist, and can be reported electronically as part of the normal 
workflow, and no longer pose a barrier or significant burden to 
laboratories. In fact, the Department believes that requiring MROs to 
request concentrations by exception would create an extra burden to the 
MRO and the laboratory, and slow the reporting of the final test result 
by the MRO to the Federal agency. The Department encourages public 
comment on the appropriateness of this proposed requirement.
    In section 11.33, the Department has revised the summary report 
that a laboratory must provide to a Federal agency to include validity 
test results. Additionally, the frequency of the report has been 
significantly reduced from monthly to semiannually. The Department 
believes that a semiannual report is sufficient to track the 
effectiveness of an agency's program.
    In section 11.34, the Department is proposing a more detailed 
description of what information a donor is entitled to receive upon 
request through the MRO and the Federal agency. The Department believes 
access to the proposed information is appropriate and sufficient.
    Section 11.35 describes the information a certified laboratory must 
provide to its private sector clients when it is using procedures to 
test its specimens that are different than those used to test Federal 
agency specimens.

Subpart L--Point of Collection Test (POCT)--Major Change

    Employees of Federal agencies are in some cases located in remote 
areas of the country if they are serving with the Department of 
Interior, or overseas if they are serving with the Department of State. 
They are often in locations with few employees as is often the case 
when they are serving on American Indian reservations or in embassies 
in small foreign countries. It is often unrealistic to expect that a 
drug testing program in such places would operate in the same fashion 
as one that serves employees in the Washington, DC, area. It is in 
these circumstances and in cases where it is critical to receive an 
immediate test result that POCT tests play an important role.
    Yet a POCT offers a particular challenge to the Federal drug 
testing program because the device that is used to produce a negative 
test result is really equivalent to a laboratory test to which the 
normal laboratory procedures and requirements cannot readily apply. 
Thus, while the sections of the Guidelines related to specimens, 
collection procedures, collections sites, chain of custody, drug and 
validity testing and others do apply, it is necessary to establish 
requirements particular to POCTs. In addition, it presents logistical 
problems on how to ensure compliance with the requirements of these 
Guidelines and thus ensure the integrity of the program when any one 
agency choosing to use POCT may have many remote sites all over the 
United States and in many cases all over the world.
    To address the logistical problem, the Department considered 
several options including establishing a new organization to oversee 
compliance, to do inspections, and to maintain the PT requirements. As 
we did so, however, logistical challenges developed that could not be 
readily overcome.
    Instead, the Department is adopting a principle that if a Federal 
agency chooses to use POCTs, then it accepts some of the same 
responsibilities for ensuring compliance within their agency as the 
Department currently maintains for the laboratory-based Federal drug 
testing program. The specifics of these requirements are addressed 
below.
    Section 12.2 establishes criteria for the Secretary to certify a 
POCT for use in the Federal drug testing program. The device must be 
FDA-cleared for the purposes of detecting drugs of abuse and it must be 
determined by the Secretary that it effectively determines the presence 
or absence of drugs and the validity of a specimen, either as an 
integral function of the POCT device or as a set of compatible devices 
or procedures. The second standard is applied because FDA's premarket 
notification clearance process ensures that a device is substantially 
equivalent to a legally marketed device, but does not ensure that the 
device will satisfy minimum performance requirements that are necessary 
for its use in the Federal drug testing program.
    Section 12.4 identifies the two types of POCTs currently available, 
both of which could be considered for Secretarial certification: non-
instrumented devices where end results are determined visually or 
instrumented devices where results are obtained by instrumental 
evaluation.
    Section 12.5 provides manufacturers a list of what they must 
provide the Secretary in order to have their device or devices included 
on the list of SAMHSA-certified devices. Among the requirements, the 
manufacturer must provide 100 POCT devices and related testing 
procedures so that the Secretary may analyze the devices for 
effectiveness when testing for drugs and specimen validity.
    Section 12.7 indicates that to remain on the list of SAMHSA-
certified devices, the manufacturer must agree to provide to the 
Secretary any design changes or alterations that have been made to the 
device so that the Secretary may determine if additional testing is 
necessary to ensure effectiveness and 50 POCTs as outlined so that the 
Secretary can ensure the continued quality of the device.
    Section 12.8 is critical to the use of POCTs within the Federal 
drug testing program. This section lays out the

[[Page 19685]]

responsibilities of the Federal agency in order for it to use POCT.
    If a Federal agency chooses to use POCT, then it must use only 
POCTs that are on the list of SAMHSA-certified devices, ensure that 
only trained testers are used and provide them with a standard 
operating procedures manual, ensure that the requirements of the 
regulation are fulfilled, accomplish the inspection of the POCT test 
sites, accomplish proficiency testing, maintain records on the trainers 
as well as inspections, investigate failures, make available all 
Federal agency records for the POCT-related activities for periodic 
inspection by the Secretary, and other responsibilities. For the 
Department to directly carry out this responsibility for the Federal 
agency, the Department would incur substantial administrative and 
financial costs. However, to the extent that Federal agencies lack the 
clinical or technical expertise required to fulfill their requirements 
under this proposal, they are free to enter into Economy Act transfers 
within the Department.
    With regard to performance testing, the Federal agency will provide 
sets of HHS-contractor prepared PT samples periodically to the POCT 
testing sites to ensure reliability and integrity of the system. The 
results of the proficiency tests will be forwarded to the Federal 
agency. Where errors have occurred the Federal agency must act to 
investigate the cause of the error and determine whether it was an 
error in procedure or a failure of the device. If the error was a 
procedural one, the Federal agency must assess the reason for error and 
take corrective action to ensure compliance with the Guidelines in the 
future.
    If the error is with the device, the Federal agency must 
immediately notify the Secretary who may suspend the use of the device 
within the agency. The Department, after considering the information, 
may suspend the use of the device throughout the Federal drug testing 
program by informing the agencies through the Federal Register and 
notifying the manufacturer of the problem. The manufacturer then has 30 
days to provide information for the Secretary's consideration at which 
time the Secretary will decide what action needs to be taken. 
Additionally, the Secretary will notify the FDA of any error with a 
device so that the FDA can evaluate whether an action under the Food, 
Drug, and Cosmetic Act is necessary.
    The Secretary is also authorized to remove a device from the list 
of SAMHSA-certified devices in the absence of a suspension. A 
manufacturer may resubmit the device for approval but in so doing must 
provide a statement to the Secretary describing what has been done to 
address the problem that led to the device's removal.
    To further ensure the integrity of the system, the Guidelines 
require that one of every 10 negative samples must be sent to an HHS-
certified laboratory for confirmation. The results of this process will 
be given to the Federal agency.
    To date, POCT tests have only been developed for oral fluid and 
urine. If, in the future, POCTs are developed for hair and/or sweat and 
the POCTs are cleared by the FDA, the Department will review the 
devices to evaluate, among other things, whether they use the cutoff 
identified by these Guidelines, what their performance is around that 
cutoff, and whether the observed lot to lot variability is appropriate 
for the program's needs. Section 12.11 identifies the responsibility of 
the Secretary to inspect a Federal agency using POCT. These 
responsibilities include, but are not limited to, conducting a 
semiannual inspection of each Federal agency that uses POCT. These 
inspections will include a review of the Federal agency's records, 
standard operating procedure manual, POCT tester training records, POCT 
device quarterly PT results, and POCT quality assurance data maintained 
by each POCT tester and site.
    Section 12.16 presents the requirements that a POCT tester must 
meet. It should be kept in mind that the individual is not just a 
collector but in some capacity functions as a technician in so far as 
the individual must perform the POCT test, determine specimen validity, 
perform analysis on periodic PT challenges, interpret and document test 
results, and when required, forward the specimens with non-negative 
test results to an HHS-certified laboratory for confirmatory testing. 
Thus the training and experience requirements reflect this additional 
responsibility.
    To ensure that the process is carried out appropriately the 
Department has in section 12.18 outlined how a POCT should be conducted 
step by step. These procedures should be part of the Federal agency 
standard operating procedure manual. Again the process pays special 
attention to the integrity of the test results and the specimen, chain 
of custody, collection procedures, recordkeeping, and reporting.
    The Guidelines for a POCT mirror the provision in subparts K and M 
in that they discuss how a negative result should be reported as well 
as what must happen to a specimen with non-negative results. The 
Guidelines further discuss reporting requirements, what information is 
available to the donor, and what type of relationship is prohibited 
between a manufacturer of a POCT device or a POCT site operation and a 
Medical Review Officer. Also, what type of relationship can exist 
between a manufacturer of a POCT device or a POCT site operation and an 
HHS-certified laboratory is discussed.

Subpart M--Instrumented Initial Test Facility (IITF)--Major Change

    In this subpart, the Department proposes the requirements for a new 
type of facility. It is being called an instrumented initial test 
facility (IITF). An IITF is essentially a laboratory that only conducts 
initial tests for drugs and validity tests. The facility is at a 
permanent location and uses instrumented initial tests. An IITF must 
satisfy most of the same requirements as if it were the section of a 
laboratory that performs only initial drug and validity testing and was 
located in an HHS-certified laboratory. An IITF is certified under the 
same provisions as a laboratory as indicated above in subpart I. One 
significant difference is that the IITF is managed by a responsible 
technician (RT) whose qualifications are described in section 13.6, and 
differ slightly from those of a responsible person as required for 
laboratories.
    An IITF may be certified to test head hair, oral fluid, sweat, and/
or urine specimens as stated in section 13.2. It is also important to 
understand that an IITF needs to be certified for each sample type it 
wants to test (e.g., hair, oral fluid, sweat, urine), since the testing 
procedures are different for each.
    An IITF must test specimens using the same drug cutoff 
concentrations as used for the initial tests conducted by the HHS-
certified laboratories as stated in section 13.3. The Department is 
including these requirements for an IITF in this section because of the 
similarity of an IITF to the part of a laboratory that performs initial 
testing. Thus, the same requirements will apply to an IITF as that 
portion of laboratory.
    Section 13.8 describes a new policy for when the responsible 
technician (RT) leaves a certified laboratory. The RT assumes 
professional, organizational, educational, and administrative 
responsibility for the IITF drug testing. The Department believes it is 
essential to ensure that drug testing is routinely performed under the 
direction and supervision of an individual with such qualifications. In 
this section, the Department proposes requirements to ensure this takes 
place. Additionally, the Secretary will begin the process of suspension 
or revocation in accordance with the Guidelines if the

[[Page 19686]]

RT leaves and no RT is approved within 180 days. This requirement is 
essential to protect the interests of the United States and its 
employees to ensure that an HHS-certified IITF has an individual that 
can fully attest to the forensic and scientific supportability of the 
IITF testing program.
    The Department proposes in section 13.16 that an IITF be required 
to retain records for a period of 2 years, which is the same period 
required for laboratories.
    The Department proposes in section 13.17 that an IITF submit a 
semiannual report on the numbers of specimens tested for Federal 
agencies, again the same requirement as for laboratories.
    In section 13.18, the Department proposes what information would be 
available to a donor from an IITF, again the same requirement as for 
laboratories.
    In sections 13.19 and 13.20, the Department proposes to prohibit 
and permit the same types of relationships between the IITF and the MRO 
as between the laboratory and the MRO.
    The Department proposes in section 13.21 that an IITF report a 
negative result to an MRO within 3 working days of receipt of the 
specimen and that negative results may be reported electronically. 
Reporting a negative result electronically is the same requirement as 
for a specimen that is determined to be negative on an initial test 
conducted by a certified laboratory.
    In section 13.22, the Department proposes how a specimen that is 
presumptive drug positive, adulterated, substituted, or invalid must be 
shipped to an HHS-certified laboratory for confirmatory testing.

Subpart N--Medical Review Officer (MRO)--Major Change

    In Section 14.1, the Department establishes who may serve as an 
MRO, including the requirement that the individual successfully 
complete an examination administered by a nationally recognized entity 
that certifies MROs or subspecialty board for physicians performing a 
review of Federal employee drug test results, which has been approved 
by the Secretary. This section also establishes the requirements for 
nationally recognized entities that seek approval by the Secretary to 
certify MROs or for subspecialty boards for physicians performing a 
review of Federal employee drug test results to submit their 
qualifications and sample examination. Based on an annual objective 
review of the qualifications and content of the examination, the 
Secretary shall annually publish a list in the Federal Register of 
those entities and boards that have been approved.
    In section 14.2, the Department is proposing the specific training 
requirements before a physician may serve as an MRO for Federal 
agencies. This training should occur before the physician takes the 
required examination.
    In section 14.3, the Department proposes that an individual who 
works under the direct supervision of an MRO may conduct the review and 
report of a negative result. However, the MRO must review 5 percent of 
the negative results reported by staff to ensure that the staff are 
properly performing the review process.
    In sections 14.4, 14.5, 14.6, and 14.7, the Department proposes the 
procedure an MRO must follow to review the results reported for each 
type of specimen. For specimens reported as invalid by the laboratory, 
the Department proposes to allow the MRO to direct the agency to have 
another specimen collected. The Department requests comments on whether 
the same type of specimen or one of the other types of specimens should 
be collected when this occurs.
    Section 14.8 describes how the donor may request the testing of a 
split specimen.
    Section 14.9 describes how the MRO reports a primary specimen test 
result to a Federal agency.
    Section 14.10 describes the relationship that is prohibited between 
an MRO and a laboratory, POCT tester, or IITF.

Subpart O--Split Specimen Tests--Major Change

    Section 15.1 amends the current Guidelines by giving the donor the 
right to have a split specimen tested when a primary specimen was 
reported substituted or adulterated. This section also proposes to give 
a Federal agency the option to have a split specimen tested as part of 
a legal or administrative proceeding to defend an original positive, 
adulterated, or substituted result if a donor chooses not have the 
split specimen tested.
    In section 15.2, the Department is proposing the policy on how a 
second laboratory tests each type of split specimen when the primary 
specimen was reported positive for a drug(s).
    In sections 15.3, 15.4, 15.5, and 15.6, the Department is proposing 
the policies on how a second laboratory will test each type of split 
specimen when the primary specimen was reported adulterated. Similarly, 
sections 15.7 and 15.8 describe the proposed policies on how a second 
laboratory will test a split oral fluid or urine specimen when the 
primary specimen was reported substituted. It should be noted that a 
head hair or sweat patch sample cannot be reported as substituted.
    In sections 15.10, 15.11, 15.12, and 15.13, the Department is 
proposing the actions an MRO must take after receiving the split 
specimen result from the second laboratory for each type of specimen.
    Section 15.14 describes how an MRO reports the split specimen 
result to a Federal agency. It is the same procedure that is used to 
report the result on the primary specimen.
    In section 15.15, the Department proposes to require that the 
certified laboratory retain a split specimen for the same length of 
time that the primary specimen is retained.

Subpart P--Criteria for Rejecting a Specimen for Testing--Major Change

    The Department proposes to include this subpart to describe how 
laboratories, IITFs, or MROs are to handle errors or discrepancies that 
arise with the use of the Federal CCF. They were not contained in the 
current Guidelines; however, most of the policies were previously 
established in guidance documents. The Department believes there is a 
need to establish specific guidance on how a laboratory, IITF, or MRO 
must handle discrepancies. Since the forms used to transfer the custody 
of a specimen from the collector to the POCT tester have not yet been 
developed, the Department cannot propose a specific list of possible 
errors or discrepancies that would need to be corrected and included in 
this section. The Department, however, fully expects to include this 
list when the final Guidelines are developed.
    In section 16.1, the Department proposes those discrepancies that 
are considered to be fatal flaws, that is, the laboratory or IITF must 
not test a specimen when one of the fatal flaws occurs. The Department 
is specifically requesting comments on any additional fatal flaws that 
may apply to the collection of head hair, sweat, and oral fluid or 
fatal flaws that may occur when the collector transfers the specimen to 
a POCT tester (if the POCT tester is not the collector).
    Section 16.2 identifies only two errors that the Department 
believes must be corrected (recovered) by obtaining a memorandum for 
record (MFR) from the collector before the laboratory or IITF can 
report a test result to the MRO. The Department is specifically 
requesting comments on any additional correctable errors that may apply 
to the collection of head hair, sweat, and oral fluid or

[[Page 19687]]

correctable errors that may occur when the collector transfers the 
specimen to a POCT tester (if the POCT tester is not the collector).
    Section 16.3 describes the types of omissions and discrepancies 
that occasionally occur on the Federal CCF. When an omission or 
discrepancy occurs that is considered to be insignificant, the 
laboratory or IITF may proceed with testing the specimen and reporting 
a result without taking any action to recover or correct the error, 
omission, or discrepancy. Although each of these errors, omissions, or 
discrepancies are considered insignificant, the Department believes 
that requiring collectors to be trained and certified will 
significantly reduce the occurrence of such errors, omissions, or 
discrepancies. However, when a collector, laboratory, or IITF makes an 
error, omission, or discrepancy more than once a month, the Department 
is proposing that the MRO contacts the collector, laboratory, or IITF 
and directs the collector or laboratory to take immediate action to 
prevent the recurrence of the error, omission, or discrepancy. The 
Department is requesting specific comments on the proposal to have the 
MRO track these types of problems as well as identifying other 
insignificant omissions or discrepancies that have not been included 
for the Federal CCF. Public comments are requested for possible 
omissions or discrepancies that may occur when completing a Federal CCF 
to document collecting head hair, sweat, and oral fluid specimens or 
insignificant types of discrepancies that may occur when the collector 
transfers the specimen to a POCT tester (if the POCT tester is not the 
collector).
    In section 16.4, the Department proposes to identify those 
discrepancies that must be corrected before an MRO can report a test to 
the Federal agency. If one of these errors occurs and it is not 
corrected by obtaining an MFR from the collector, IITF, or laboratory, 
the MRO is required to cancel the test. The Department is requesting 
specific comments on any other errors that must be corrected before the 
MRO can report a test result or discrepancies that may occur and must 
be corrected when the collector transfers the specimen to a POCT tester 
(if the POCT tester is not the collector).

Subpart Q--Laboratory/IITF Suspension/Revocation Procedures

    In this subpart, the Department is retaining the procedures that 
were described in the current Guidelines to suspend or revoke the HHS-
certification of laboratories and simply expanding them to include 
IITFs.

Electronic Technology Applications

    The Department is aware that there has been a great deal of 
discussion in recent years concerning the application of electronic 
technology to the operation of drug testing programs. Electronic 
signatures on documents, electronic storage and transmission of 
records, and appropriate security precautions for confidential 
information are all issues of substantial interest as applied to 
Federal testing programs. The Department seeks comment on the extent to 
which this discussion should be reflected in the new version of the 
guidelines, and on whether specific provisions concerning electronic 
technology applications to Federal drug testing programs should be 
included.

Impact of These Guidelines on Government Regulated Industries

    The Department is well aware that these proposed changes to the 
Guidelines may impact the DOT and NRC regulated industries depending on 
their decisions to incorporate the final Guidelines into their programs 
under their own authorities.

Issues of Special Interest

    The Department requests public comment on all aspects of this 
notice. However, the Department is providing the following list of 
issues or areas for which specific comments are requested.
    In the preamble discussion on alternative specimen issues, there 
are conflicting studies that hair color affects the amount of drug 
deposited into the hair. In other words, some studies purport that a 
drug user with dark hair is more likely to test positive because a drug 
is more likely to be deposited in black hair as compared to blond hair 
while other studies refute these findings. The Department is requesting 
specific comments on this hair color bias issue as it applies to the 
testing of individuals in a workplace environment.
    With regard to testing oral fluid specimens for marijuana, there is 
scientific evidence that the parent marijuana compound (THC) in oral 
fluid is not from plasma, but is residual THC present either from 
smoking a marijuana cigarette or from oral contamination. To ensure 
that a THC result on an oral fluid specimen is from active exposure, 
the Department is proposing to always collect a urine specimen with an 
oral fluid specimen that would be available if the oral fluid specimen 
was positive for THC. The Department is requesting comments on this 
proposed policy.
    Again with regard to oral fluids, the preamble mentions a 
possibility of an individual having a ``dry mouth.'' The Department 
would appreciate any comments on whether the Department should adopt a 
specific procedure for ``dry mouth'' as it has for ``shy bladder'' 
under urine.
    With regard to proper cleansing of the skin prior to the 
application of a sweat patch, the Department is requesting comment on 
the proposal that the skin area be washed with soap and cool water or 
with a disposable towelette followed by a thorough cleaning of the skin 
area where the patches will be worn with alcohol wipes.
    The Department defines in section 1.5 both ``confirmatory validity 
test'' and ``confirmatory drug test.'' The confirmatory validity test 
means putting a different aliquot of the specimen through the same 
analytical method. A confirmatory drug test involves a second 
analytical procedure performed on a different aliquot. The Department 
requests comments on whether the utilization of these procedures is 
sufficient.
    In section 2.2, the Department is proposing to limit the use of 
alternative specimens for only those reasons listed. The Department is 
requesting comments on the appropriateness of the reasons listed and 
supporting documentation if recommending changes.
    In section 2.5, the Department requires that a sweat patch should 
be worn at least three days and no more than 7 days. While the 
Department believes that this is an adequate time period, the 
Department seeks comments and additional science on whether the 
permitted time period should be longer or shorter, and what time frame 
should be used in specific circumstances.
    Sections 3.4, 3.5, 3.6, and 3.7 list the proposed cutoff 
concentrations for each type of specimen collected. The Department is 
specifically requesting comments on the appropriateness of these 
proposed cutoffs and the changes in the cutoffs for urine. 
Additionally, the Department is interested in obtaining information on 
the ability of the various immunoassay test kits to detect MDMA within 
the amphetamine class of drugs.
    In section 7.2, the Department is requiring a Federal agency to 
only use a collection device that does not affect the specimen 
collected. The Department is requesting specific comments on this 
requirement.
    In section 11.13, the Department establishes criteria for 
laboratories validating an initial drug test. These criteria are 
significantly different from those that are currently in the

[[Page 19688]]

Guidelines and thus the Department specifically seeks comments on this 
change.
    In sections 11.18, 11.19, 11.20, and 11.21, the Department is 
proposing to use the same analytical and quality control requirements 
for conducting validity tests for each type of specimen collected. The 
Department is requesting specific comments on this proposed policy.
    Sections 11.26, 11.27, 11.28, and 11.29 propose to allow a 
laboratory to report quantitative values for non-negative specimens 
rather than waiting for the MRO to request the information. The 
Department is requesting comments on this change in reporting test 
results.
    In sections 14.4, 14.5, 14.6, and 14.7, the Department is proposing 
to allow the MRO to direct the agency to have another specimen 
collected when an invalid test result is reported. The Department is 
requesting comments on whether the same type of specimen or another 
type of specimen should be collected.
    In sections 16.1, 16.2, and 16.3, the Department is requesting 
specific comments on any additional fatal flaws, correctable errors, 
omissions or discrepancies that may apply to the collection of head 
hair, sweat, and oral fluid or that may occur when the collector 
transfers a specimen to a point of collection test (POCT) tester. 
Additionally, the Department is requesting comments on the requirement 
that MROs track these types of problems.
    In section 16.4, the Department is requesting specific comment on 
any other errors that must be corrected before an MRO can report a 
test.

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Spiehler V. (1996). Detection of methamphetamine in sweat by EIA and 
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impaired drivers. J Anal Toxicol, 24:557.
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drivers. J Forensic Sci, 47:1380.
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Brookhuis K.A., Verstraete A.G., and Riedel W.J. (2002). Plasma, 
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J.M. (2002). A field evaluation of five on-site drug-testing 
devices. J Anal Toxicol, 26:493.
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evaluation of four on-site drug-testing devices for detection of 
drugs of abuse in urine. J Anal Toxicol, 24:589.
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three on-site adulterant detection devices for urine specimens. J 
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Its detection and effects on urine drug screens. Abstract: Society 
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Presentation Society of Forensic Toxicologists.

Executive Order 12866: Economic Impact

    In accordance with Executive Order 12866, the agency has submitted 
the Guidelines for review by the Office of Management and Budget. 
However, because the Mandatory Guidelines will not have an annual 
impact of $100 million or more, and will not have a material adverse 
effect on the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local or tribal 
governments, they are not subject to the detailed analysis requirements 
of section 6(a)(3)(C) of Executive Order 12866.

Paperwork Reduction Act of 1995

    These proposed revised Mandatory Guidelines contain information 
collections which are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 
U.S.C. 3507(d)). The title, description and respondent description of 
the information collections are shown in the following paragraphs with 
an estimate of the annual reporting, disclosure and recordkeeping 
burden. Included in the estimate is the time for reviewing 
instructions, searching existing data sources, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    Title: Proposed Revisions to the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs.
    Description: The Mandatory Guidelines establish the scientific and 
technical guidelines for Federal drug testing programs and establish 
standards for certification of laboratories engaged in drug testing for 
Federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301 
note, and Executive Order 12564. Federal drug testing programs test 
applicants to sensitive positions, individuals involved in accidents, 
individuals for cause, and random testing of persons in sensitive 
positions. The program has depended on urine testing since 1988; the 
reporting, recordkeeping and disclosure requirements associated with 
urine testing are approved under OMB control number 0930-0158. Since 
1988 several products have appeared on the market making it easier for 
individuals to adulterate the urine sample. The proposed changes to the 
Guidelines address this concern. Also, scientific advances in the use 
of head hair, sweat,

[[Page 19690]]

and oral fluid in detecting drugs have made it possible for these 
specimens to be used in Federal programs with the same level of 
confidence that has been applied to the use of urine. The proposed 
changes establish when these alternative specimens may be used, the 
procedures that must be used in collecting a sample, and the 
certification process for approving a laboratory to test these 
alternative specimens.
    In an effort to s