Proposed Revisions to Mandatory Guidelines for Federal Workplace Drug Testing Programs

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.

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.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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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46. Spiehler V., Fay J., Fogerson R., Schoendorfer D., and Niedbala R.S. (1996). Enzyme immunoassay validation for qualitative detection of cocaine in sweat. Cl Chem, 42:34.

47. Preston L.P., Huestis M.A., Wong C.J., Umbricht A., and Goldberger B.A. (1999). Monitoring cocaine use in substance-abuse-treatment patients by sweat and urine testing. J Anal Toxicol, 23:313.

48. Suzuki S., Inoue T., Hori H., and Inayama S. (1989). Analysis of methamphetamine in hair, nail, sweat, and saliva by mass fragmentography. J Anal Toxicol, 13:176.

49. Kintz P., Tracqui A., Mangin P., and Edel Y. (1996). Sweat testing in opioid users with a sweat patch. J Anal Toxicol, 20 393.

50. Fay J., Fogerson R., Schoendorfer D., Niedbala R.S., and Spiehler V. (1996). Detection of methamphetamine in sweat by EIA and GC-MS. J Anal Toxicol, 20:398.

51. Kintz P., Cirimele V., and Ludes B. (2000). Detection of cannabis in oral fluid (saliva) and forehead wipes (sweat) from impaired drivers. J Anal Toxicol, 24:557.

52. Fogerson R. and Sutliff J. (1995). Testing for cocaine and opiate use with the PharmChek

TM

Sweat Patch, presentation Society of Forensic Toxicologists.

53. Sampyn N., DeBoeck G., and Verstrate A.G. (2002). The use of oral fluid and sweat wipes for the detection of drugs of abuse in drivers. J Forensic Sci, 47:1380.

54. Samyn N., De Boeck G., Wood M., Lamaaras C.T.J., DeWaard S., Brookhuis K.A., Verstraete A.G., and Riedel W.J. (2002). Plasma, oral fluid and sweat wipe ecstasy concentrations in controlled and real life conditions. Forensic Sci Int, 128:90.

55. Crouch D.J., Hersch R.K., Cook R.F., Frank J.F., and Walsh J.M. (2002). A field evaluation of five on-site drug-testing devices. J Anal Toxicol, 26:493.

56. Kadehjian L.J. (2001). Performance of five non-instrumented urine drug-testing devices with challenging near-cutoff specimens. J Anal Toxicol, 25:670.

57. Peace M.R, Tarnai L.D., Poklis A. (2002). Performance evaluation of four on-site drug-testing devices for detection of drugs of abuse in urine. J Anal Toxicol, 24:589.

58. SAMHSA study entitled “On-site Testing: An Evaluation of Non-Instrumented Drug Test Devices,” dated January 29, 1999, available on the Internet at

http://www.workplace.samhsa.gov/ResourceCenter/r409.htm.

59. Walsh J.M., Flegel R., Crouch D.J., Cangianelli L., Baudys J. (2003). An evaluation of rapid point-of-collection oral fluid drug-testing devices. J Anal Toxicol, 27:429.

60. Peace M.R. and Tarnai L.D. (2002). Performance evaluation of three on-site adulterant detection devices for urine specimens. J Anal Toxicol, 26:464.

61. Wong B., Nguyen P., Wong R., and Tse H. (2002). Adulterants: Its detection and effects on urine drug screens. Abstract: Society of Forensic Toxicologists 2002 Meeting.

62. Wong R. (2002). The effect of adulterants on urine screen for drugs of abuse: Detection by an on-site dipstick device. Am Clin Lab, 21:37.

63. Report entitled “2002 National Survey on Drug Use and Health (National Household Survey on Drug Abuse),” available on the Internet at

http://www.samhsa.gov/oas/nhsda.htm.

64. Report entitled “Emergency Department Trends From DAWN: Final Estimates 1995-2002,” available on the Internet at

http://dawninfo.samhsa.gov.

65. Report entitled “Year 2002 Annual Report National Forensic Laboratory Information System (NFLIS).”

66. Bruins M.R, Okano C.K., Lyons T.P., and Lukey B.J. (2002). Drug-positive rates for the army from fiscal years 1991 to 2000 and for the National Guard from fiscal years 1997 to 2000. Mil Med, 167:379.

67. Jones R.T. (1997). Pharmacokinetics of cocaine considerations when assessing cocaine use by urinalysis. NIDA Research Monograph, 175:221.

68. Wingert W.W. (1997). Lowering cutoffs for initial and confirmation testing for cocaine and marijuana: large scale study of effects on the rates of drug-positive results. Clin Chem, 43:100.

69. Cone E.J., Sampson-Cone A.H., Darwin W.D., Huestis M.A., and Oyler, J.M. (2003). Urine testing for cocaine abuse: Metabolic and excretion patterns following different routes of administration and methods for detection of false negative results. J Anal Toxicol, 27:386.

70. Oyler J.M., Cone E.J., Joseph R.E. Jr, Moolchan E.T., and Huestis M.A. (2002). Duration of detectable methamphetamine and amphetamine excretion in urine after controlled oral administration of methamphetamine to humans. Clin Chem, 48:1703.

71. Cone A.J., Yousefnejad D., Hillsgrove M.J., Holicky B., and Darwin W.D. (1995). Passive inhalation of cocaine. J Anal Toxicol, 19:399.

72. Fay J.F., and Niedbala, S. (1995). Sweat eluate analysis for phencyclidine by STC Diagnostics PCP Micro-Plate EIA and GC/MS. 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,

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 shorten the time for negative results to be reported to the Federal agency, the proposed changes also establish criteria for an IITF that will only perform initial tests and not confirmatory tests, and POCTs or on-site testing kits, as well as POCT testers.

Description of Respondents:

Individuals or households; Businesses or other for-profit; Not-for-profit institutions.

The burden estimates in the tables below are based on the following number of respondents:

38,000 donors who apply for employment in testing designated positions, 100 collectors, 50 urine testing laboratories, 10 hair testing laboratories,10 oral fluid testing laboratories, 2 sweat testing laboratories, 25 IITFs, 30 POCT manufacturers, 50 POCT testers, and 100 MROs.

Estimate of Annual Reporting Burden

Section

Purpose

No. of respondents

Responses/respondent

Hours/response

Total hours

9.3(c), 9.4(a) and (b)

Laboratory or IITF 9.4(a) and (b) required to submit application for certification

50

1

3

150

9.24(b)(3)

Materials to submit to become an HHS inspector

200

1

2

400

11.4(a)

Laboratory submits qualifications of alternate RP to HHS

50

1

2

100

11.4(d)

Laboratory submit information to HHS on new RP

25

1

2

50

11.32(a)

Specifications for laboratory semi-annual statistical report of test results to each Federal agency

72

5

0.5

180

12.5

Specifies what a POCT manufacturer must submit to HHS to be approved

30

1

1

30

12.7(a)

Specifies what a POCT manufacturer must submit to HHS to remain on approved list

30

1

0.5

15

12.14(b)

Requirements for POCT manufacturer statement of action to overcome problems that cause a device to be removed from the approved list

1

1

3

3

13.8(a)

Information an IITF must submit to HHS for an RT

25

1

2

50

13.8(d)

Information an IITF must submit to HHS for a new RT candidate

25

1

2

50

13.17(a)

Specifies contents of IITF semi-annual statistical report to Federal agencies served

25

5

0.5

63

13.22(d)

Specifies how IITF reports test results for specimen that is presumptive drug positive, adulterated, substituted or invalid

25

100

0.05 (3 min)

125

15.14

Specifies that MRO must report all verified split specimen test results to the Federal agency

100

5

0.05 (3 min)

25

17.1(b); 17.5(a)

Specifies content of request for informal review of suspension/proposed revocation of certification

1

1

3

3

17.4

Specifies information appellant provides in first written submission when laboratory or IITF suspension/revocation is proposed

1

1

0.5

0.5

17.6

Requires appellant to notify reviewing official of resolution status at end of abeyance period

1

1

0.5

0.5

17.7(a)

Specifies contents of appellant submission for review

1

1

50

50

17.9(a)

Specifies content of appellant request for expedited review of suspension or proposed revocation

1

1

3

3

17.9(c)

Specifies contents of review file and briefs

1

1

50

50

Total

456

1,358

The following reporting requirements are also in the proposed Guidelines, but have not been addressed in the above reporting burden table: collector must report any unusual donor behavior or appearance on the Federal CCF (sections 8.5(a)(8) and (14)); collector annotates the Federal CCF when a sample is a blind sample (section 10.3(a)); and MRO notifies the Federal agency and HHS when an error occurs on a blind sample (section 10.4(c)). SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to Federal agencies.

Estimate of Annual Disclosure Burden

Section

Purpose

No. of respondents

Responses/respondent

Hours/response

Total hours

4.4(c)

Collector is given name and phone of Federal agency point of contact

100

1

0.05 (3 min)

5

11.33(b)

Information on drug test that laboratory must provide to donor through MRo

50

10

3

1,500

12.24

Information related to drug test that POCT tester must provide to donor through MRO

50

10

1

500

13.18

Information related to drug test that IITF must provide to donor through MRO

25

10

2

500

14.8(b)

MRO must inform donor of right to request split specimen test when non-negative result is reported

100

5

3

1,500

Total

325

4,005

The following disclosure requirements are also included in the proposed Guidelines, but have not been addressed in the above disclosure burden table: the collector must explain the basic collection procedure to the donor and answer any questions (section 8.1(b) and (d)); and a laboratory must tell private sector clients when the laboratory is not testing their specimen under the Guidelines (section 11.35). SAMHSA believes having the collector explain the collection procedure to the donor and to answer any questions is a standard business practice and not a disclosure burden. With regard to requiring a laboratory to inform a private sector client that its specimens are not being tested under the Guidelines, this is also a standard business practice and not considered an additional burden because it ensures that a private sector client is not being mislead into believing that its specimens are being tested under the Guidelines.

Estimate of Annual Recordkeeping Burden

Section

Purpose

No. of respondents

Responses/respondent

Hours/response

Total hours

8.2-8.5

Collector completes Federal CCF for each type of specimen collected

100

380

0.07 (4 min)

2,660

11.8(a)

Laboratory completes Federal CCF upon receipt of specimen and before reporting result

50

760

0.05 (3 min)

1,900

12.18(c)

POCT tester completes Federal CCF for primary specimen and documents chain of custody

50

100

0.05 (3 min)

250

13.12(a)

IITF completes Federal CCF upon receipt of specimen and before reporting result

25

1520

0.05 (3 min)

1,900

14.3(a)(4)

MRO completes the Federal CCF before reporting the result

100

380

0.05 (3 min)

1,900

15.1(b)

Donor must request the split to be tested in writing

300

1

0.05 (3 min)

15

Total

625

8,625

The proposed Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector (section 4.3(a)) and that the documentation be maintained in the collector's training file (section 4.4(b)). SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a Federal agency specimen, the collector is required to provide a statement (section 6.2(b)) explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H (sections 8.5(a)(8) and (14)) requires collectors to enter any information on the Federal CCF of any unusual findings during the urine specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries is included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subparts K and M describe a number of recordkeeping requirements for laboratories and instrumented initial test facilities (IITFs) associated with their testing procedures, maintaining chain of custody, and keeping records (

i.e.,

sections 11.1(a), 11.1(d), 11.2(b), 11.2(c), 11.2(d), 11.7(c), 11.8(b), 11.8(c), 11.8(e), 11.13(b), 11.14(c), 11.16, 11.17(c), 11.17(d), 11.31(a), 13.4(a), 13.4(d), 13.5, 13.7(b), 13.7(c), 13.7(d), 13.10(c), 13.11(c), 13.12(b), 13.12(c), 13.12(e), 13.13, and 13.16(a)). These recordkeeping requirements are necessary for any laboratory or IITF to conduct forensic drug testing and to ensure the scientific supportability of the test results. Therefore, they are considered to be standard business practice and are not considered a burden for this analysis. This same opinion applies to the recordkeeping requirements for POCT testers in section 12.23, for IITFs in section 13.16(a), and for MROs in section 14.3(a)(5).

Thus the total annual response burden associated with the testing of these alternative specimens by the new laboratories and Instrumented Initial Test Facilities (IITFs) and Point of Collection Test sites is estimated to be 13,888 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,089 hours currently approved by OMB under control number 0930-0158 for urine testing under the existing Mandatory Guidelines.

As required by section 3507(d) of the PRA, the Secretary has submitted a copy of these proposed revised Mandatory Guidelines to OMB for its review.

Comments on the information collection requirements are specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

OMB is required to make a decision concerning the collection of information contained in these proposed Guidelines between 30 and 60 days after publication of this document in the

Federal Register.

Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment to HHS on the proposed Guidelines.

Organizations and individuals desiring to submit comments on the information collection requirements should direct them to the Office of Information and Regulatory Affairs, OMB. (address above).

Charles G. Curie,

Administrator, SAMHSA.

Dated: April 2, 2004.

Tommy G. Thompson,

Secretary.

For the reasons set forth in the preamble, the Department proposes to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs to read as follows:

Mandatory Guidelines for Federal Workplace Drug Testing Programs

Subpart A—Applicability

Sec.

1.1

Whom do these Guidelines cover?

1.2

Who is responsible for developing and implementing these Guidelines?

1.3

How does a Federal agency request a change from these Guidelines?

1.4

How are these Guidelines revised?

1.5

What do the terms used in these Guidelines mean?

1.6

What is an agency required to do to protect employee records?

Subpart B—Specimens

2.1

What types of specimens may be collected?

2.2

Under what circumstances can the different types of specimens be collected?

2.3

Can more than one type of specimen be collected at the same time from the same donor?

2.4

How is each type of specimen to be collected?

2.5

What is the minimum quantity of specimen to be collected?

Subpart C—Drug and Validity Tests

3.1

Which tests must be performed on a specimen?

3.2

Can a specimen be tested for additional drugs?

3.3

May any of the specimens be used for other purposes?

3.4

What are the cutoff concentrations for hair samples?

3.5

What are the cutoff concentrations for oral fluid specimens?

3.6

What are the cutoff concentrations for sweat patch samples?

3.7

What are the cutoff concentrations for urine specimens?

3.8

What validity tests must be performed on a hair sample?

3.9

What validity tests must be performed on an oral fluid specimen?

3.10

What validity tests must be performed on a sweat patch sample?

3.11

What validity tests must be performed on a urine specimen?

3.12

What criteria are used to report a hair sample as adulterated?

3.13

What criteria are used to report an oral fluid specimen as adulterated?

3.14

What criteria are used to report a sweat patch sample as adulterated?

3.15

What criteria are used to report a urine specimen as adulterated?

3.16

What criteria are used to report an oral fluid specimen as substituted?

3.17

What criteria are used to report a urine specimen as substituted?

3.18

What criteria are used to report a urine specimen as dilute?

3.19

What criteria are used to report a hair sample as an invalid result?

3.20

What criteria are used to report an oral fluid specimen as an invalid result?

3.21

What criteria are used to report a sweat patch sample as an invalid result?

3.22

What criteria are used to report a urine specimen as an invalid result?

Subpart D—Collectors

4.1

Who may collect a specimen?

4.2

What are the requirements to be a trained collector for a Federal agency?

4.3

How is a collector's training documented?

4.4

What must an organization do before a collector is permitted to collect specimens for a Federal agency?

Subpart E—Collection Sites

5.1

Where can a collection for a drug test take place?

5.2

What are the requirements for a collection site?

5.3

How long must collection site records be stored?

5.4

How does the collector ensure the security of a specimen at the collection site?

5.5

What are the privacy requirements when collecting a hair sample?

5.6

What are the privacy requirements when collecting an oral fluid specimen?

5.7

What are the privacy requirements when collecting a sweat patch sample?

5.8

What are the privacy requirements when collecting a urine specimen?

Subpart F—Federal Drug Testing Custody and Control Forms

6.1

What form is used for the collection of a specimen?

6.2

What happens if a Federal CCF is not available or is not used?

Subpart G—Collection Device

7.1

What is a collection device?

7.2

Which collection devices may be used?

Subpart H—Specimen Collection Procedure

8.1

What must the collector do before starting a specimen collection procedure?

8.2

What procedure is used to collect a head hair sample?

8.3

What procedure is used to collect an oral fluid specimen?

8.4

What procedure is used to collect a sweat patch sample?

8.5

What procedure is used to collect a urine specimen?

8.6

What are the responsibilities of a Federal agency that uses a collection site?

Subpart I—HHS Certification of Laboratories and IITFs

9.1

What are the goals and objectives of HHS-certification?

9.2

Who has the authority to certify laboratories and IITFs that want to test specimens for Federal agencies?

9.3

What is the process for a laboratory or IITF to become HHS-certified and to maintain that certification?

9.4

How does a laboratory or IITF apply to become HHS-certified?

9.5

What are the qualitative and quantitative specifications of a performance test (PT) sample?

9.6

What are the PT requirements for an applicant laboratory to conduct hair testing?

9.7

What are the PT requirements for an applicant laboratory to conduct oral fluid testing?

9.8

What are the PT requirements for an applicant laboratory to conduct sweat patch testing?

9.9

What are the PT requirements for an applicant laboratory to conduct urine specimen testing?

9.10

What are the PT requirements for an HHS-certified laboratory to conduct hair testing?

9.11

What are the PT requirements for an HHS-certified laboratory to conduct oral fluid testing?

9.12

What are the PT requirements for an HHS-certified laboratory to conduct sweat patch testing?

9.13

What are the PT requirements for an HHS-certified laboratory to conduct urine testing?

9.14

What are the PT requirements for an applicant IITF to conduct hair testing?

9.15

What are the PT requirements for an applicant IITF to conduct oral fluid

testing?

9.16

What are the PT requirements for an applicant IITF to conduct sweat patch testing?

9.17

What are the PT requirements for an applicant IITF to conduct urine testing?

9.18

What are the PT requirements for an HHS-certified IITF to conduct hair testing?

9.19

What are the PT requirements for an HHS-certified IITF to conduct oral fluid testing?

9.20

What are the PT requirements for an HHS-certified IITF to conduct sweat patch testing?

9.21

What are the PT requirements for an HHS-certified IITF to conduct urine testing?

9.22

What are the inspection requirements for an applicant laboratory or IITF?

9.23

What are the maintenance inspection requirements for an HHS-certified laboratory or IITF?

9.24

Who can inspect an HHS-certified laboratory or IITF and when may the inspection be conducted?

9.25

What happens if an applicant laboratory or IITF does not satisfy the minimum requirements for either the PT program or the inspection program?

9.26

What happens if an HHS-certified laboratory or IITF does not satisfy the minimum requirements for either the PT program or the inspection program?

9.27

What factors are considered in determining whether revocation of a laboratory's or IITF's certification is necessary?

9.28

What factors are considered in determining whether to suspend a laboratory or IITF?

9.29

How does the Secretary notify a laboratory or IITF that action is being taken against the laboratory or IITF?

9.30

May a laboratory or IITF that had its certification revoked be recertified to test Federal agency specimens?

9.31

Where is the list of HHS-certified laboratories and IITFs published?

Subpart J—Blind Samples Submitted by an Agency

10.1

What are the requirements for Federal agencies to submit blind samples to HHS-certified laboratories or IITFs?

10.2

What are the requirements for a blind sample?

10.3

How is a blind sample submitted to the HHS-certified laboratory or IITF?

10.4

What happens if an inconsistent result is reported on a blind sample?

Subpart K—Laboratory

11.1

What is a standard operating procedure manual?

11.2

What are the responsibilities of the responsible person (RP)?

11.3

What scientific qualifications in analytical toxicology must the RP have?

11.4

What happens when the RP is absent or leaves an HHS-certified laboratory?

11.5

What qualifications must an individual have to certify a result reported by an HHS-certified laboratory?

11.6

What qualifications and training must other laboratory personnel have?

11.7

What security measures must an HHS-certified laboratory maintain?

11.8

What are the internal laboratory chain of custody requirements for a specimen or an aliquot?

11.9

Which type of specimens may an HHS-certified laboratory test?

11.10

What test(s) does an HHS-certified laboratory conduct on a specimen received after a POCT?

11.11

What test(s) does a HHS-certified laboratory conduct on a specimen received from an IITF?

11.12

What are the requirements for an initial drug test?

11.13

What must an HHS-certified laboratory do to validate an initial drug test?

11.14

What are the batch quality control requirements when conducting an initial drug test?

11.15

What are the requirements for a confirmatory drug test?

11.16

What must an HHS-certified laboratory do to validate a confirmatory drug test method?

11.17

What are the quality control requirements when conducting a confirmatory drug test?

11.18

What are the analytical and quality control requirements for conducting validity tests on hair samples?

11.19

What are the analytical and quality control requirements for conducting validity tests on oral fluid specimens?

11.20

What are the analytical and quality control requirements for conducting validity tests on sweat patch samples?

11.21

What are the analytical and quality control requirements for conducting validity tests on urine specimens?

11.22

What are the requirements for conducting each validity test on a hair sample?

11.23

What are the requirements for conducting each validity test on an oral fluid specimen?

11.24

What are the requirements for conducting each validity test on a sweat patch sample?

11.25

What are the requirements for conducting each validity test on a urine specimen?

11.26

What are the requirements for an HHS-certified laboratory to report a hair test result?

11.27

What are the requirements for an HHS-certified laboratory to report an oral fluid test result?

11.28

What are the requirements for an HHS-certified laboratory to report a sweat patch test result?

11.29

What are the requirements for an HHS-certified laboratory to report a urine test result?

11.30

How long must an HHS-certified laboratory retain a specimen?

11.31

How long must an HHS-certified laboratory retain records?

11.32

What statistical summary report must an HHS-certified laboratory provide?

11.33

What information is available to the donor?

11.34

What type of relationship is prohibited between an HHS-certified laboratory and an MRO?

11.35

What information must an HHS-certified laboratory provide to its private sector clients?

Subpart L—Point of Collection Test (POCT)

12.1

What is the goal of this subpart?

12.2

What POCT devices may be used in a Federal Workplace Drug Testing Program?

12.3

What is the rationale for the additional requirements to use POCT devices besides FDA clearance?

12.4

What types of POCT devices are there?

12.5

What must a POCT device manufacturer submit to the Secretary to have its POCT device initially included on the list of SAMHSA-certified POCTs?

12.6

What criteria will the Secretary use to place a POCT device on the list of SAMHSA-certified POCTs?

12.7

What is required for a FDA cleared POCT device to continue on the list of SAMHSA-certified devices?

12.8

What are the responsibilities of a Federal agency that wishes to conduct POCT?

12.9

What are the qualitative and quantitative specifications for PT samples that are used to evaluate test devices submitted by manufacturers or for a Federal agency to evaluate a POCT site and tester?

12.10

What are the inspection requirements for a Federal agency wishing to use a POCT?

12.11

What is the responsibility of the Secretary to inspect a Federal agency using a POCT?

12.12

What is a failure for the purposes of the POCT?

12.13

What is the responsibility of the Secretary when a failure is reported?

12.14

How can a manufacturer apply to have a device reinstated on the list of SAMHSA-certified devices?

12.15

What types of specimens may be tested using a POCT?

12.16

What are the requirements to be a POCT tester?

12.17

What happens if a POCT site or tester does not satisfy the minimum technical requirements?

12.18

What are the requirements for conducting a POCT?

12.19

What are the quality control requirements when conducting POCTs?

12.20

What action must be taken when a POCT quality control sample fails?

12.21

What does a POCT tester do with a specimen after conducting a POCT?

12.22

How is a POCT negative result reported?

12.23

How long must records generated at the POCT site be retained?

12.24

What POCT information is available to the donor?

12.25

What statistical summary report must a Federal agency provide to the Secretary?

12.26

What type of relationship is prohibited between a manufacturer of a POCT device or a POCT site operation and an MRO?

12.27

What type of relationship can exist between a manufacturer of a POCT device or a POCT site operation and an

HHS-certified laboratory?

Subpart M—Instrumented Initial Test Facility (IITF)

13.1

What is an HHS-certified IITF?

13.2

Which types of specimens may be tested at an HHS-certified IITF?

13.3

What cutoff concentrations are used by an HHS-certified IITF for the drug tests?

13.4

What must be included in the HHS-certified IITFs standard operating procedure manual?

13.5

What must the HHS-certified IITF do to validate an initial drug test?

13.6

What qualifications must the responsible technician (RT) have?

13.7

What are the responsibilities of an RT?

13.8

What happens when an RT is absent or leaves an HHS-certified IITF?

13.9

What qualifications must an individual have to certify a test result reported by an HHS-certified IITF?

13.10

What qualifications and training must other HHS-certified IITF personnel have?

13.11

What security measures must an HHS-certified IITF maintain?

13.12

What are the internal IITF chain of custody requirements for a specimen or an aliquot?

13.13

What are the batch quality control requirements when conducting the initial tests for drugs?

13.14

What are the analytical and quality control requirements for conducting initial validity tests?

13.15

What action is taken after an HHS-certified IITF tests a specimen?

13.16

How long must an HHS-certified IITF retain records?

13.17

What statistical summary report must an HHS-certified IITF provide?

13.18

What IITF information is available to the donor?

13.19

What type of relationship is prohibited between an HHS-certified IITF and an MRO?

13.20

What type of relationship can exist between an HHS-certified IITF and an HHS-certified laboratory?

13.21

How does an HHS-certified IITF report a negative test result?

13.22

How does an HHS-certified IITF handle a specimen that is presumptive drug positive, adulterated, substituted, or invalid?

13.23

Where is the list of HHS-certified IITFs published?

Subpart N—Medical Review Officer (MRO)

14.1

Who may serve as an MRO?

14.2

What are the training requirements before a physician can serve as an MRO?

14.3

What are the responsibilities of an MRO?

14.4

What must an MRO do when reviewing a hair test result?

14.5

What must an MRO do when reviewing an oral fluid test result?

14.6

What must an MRO do when reviewing a sweat patch test result?

14.7

What must an MRO do when reviewing a urine test result?

14.8

Who may request a test of a split specimen?

14.9

How does the MRO report a primary specimen test result to an agency?

14.10

What type of relationship is prohibited between an MRO and an HHS-certified laboratory, POCT tester, or HHS-certified IITF?

Subpart O—Split Specimen Tests

15.1

When may a split specimen be tested?

15.2

How does an HHS-certified laboratory test a split hair, oral fluid, sweat, or urine specimen when the primary specimen was reported positive?

15.3

How does an HHS-certified laboratory test a split hair sample for adulterants when the primary sample was reported adulterated?

15.4

How does an HHS-certified laboratory test a split oral fluid specimen for adulterants when the primary specimen was reported adulterated?

15.5

How does an HHS-certified laboratory test a split sweat patch sample for adulterants when the primary sample was reported adulterated?

15.6

How does an HHS-certified laboratory test a split urine specimen for adulterants when the primary specimen was reported adulterated?

15.7

How does an HHS-certified laboratory test a split oral fluid specimen for substitution when the primary specimen was reported substituted?

15.8

How does an HHS-certified laboratory test a split urine specimen for substitution when the primary specimen was reported substituted?

15.9

Who receives the split specimen result?

15.10

What action(s) does the MRO take after receiving the split hair sample result from the second laboratory?

15.11

What action(s) does the MRO take after receiving the split oral fluid specimen result from the second laboratory?

15.12

What action(s) does the MRO take after receiving the split sweat patch sample result from the second laboratory?

15.13

What action(s) does the MRO take after receiving the split urine specimen result from the second laboratory?

15.14

How does an MRO report a split specimen test result to an agency?

15.15

How long must an HHS-certified laboratory retain a split specimen?

Subpart P—Criteria for Rejecting a Specimen for Testing

16.1

What discrepancies require an HHS-certified laboratory or IITF to report a hair, oral fluid, sweat, or urine specimen as rejected for testing?

16.2

What discrepancies require an HHS-certified laboratory or IITF to report a hair, oral fluid, sweat, or urine specimen as rejected for testing unless the discrepancy is corrected?

16.3

What discrepancies are not sufficient to require an HHS-certified laboratory or IITF to reject a hair, oral fluid, sweat, or urine specimen for testing or an MRO to cancel a test?

16.4

What discrepancies may require an MRO to cancel a test?

Subpart Q—Laboratory/IITF Suspension/Revocation Procedures

17.1

When may an HHS-certified laboratory or IITF be suspended?

17.2

What definitions are used for this subpart?

17.3

Are there any limitations on issues subject to review?

17.4

Who represents the parties?

17.5

When must a request for informal review be submitted?

17.6

What is an abeyance agreement?

17.7

What procedure is used to prepare the review file and written argument?

17.8

When is there an opportunity for oral presentation?

17.9

Are there expedited procedures for review of immediate suspension?

17.10

Are any types of communications prohibited?

17.11

How are communications transmitted by a reviewing official?

17.12

What is the authority and responsibilities of the reviewing official?

17.13

What administrative records are maintained?

17.14

What are the requirements for a written decision?

17.15

Is there a review of the final administrative action?

Authority:

E.O. 12564 and sec. 503 of Pub. L. 110-71.

Subpart A—Applicability

Section 1.1 Whom Do These Guidelines Cover?

(a) These Guidelines apply to:

(1) Executive Agencies as defined in 5 U.S.C. 105;

(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));

(3) Any other employing unit or authority of the Federal Government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and

(4) The Intelligence Community, as defined by E.O. 12333, are subject to these Guidelines only to the extent agreed to by the head of the affected Agency; and

(5) Laboratories, instrumented initial test facilities, and point of collection tests that provide drug testing services to the Federal agencies.

(b) The Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice system, such as, arrestees, detainees, probationers, incarcerated persons, or parolees.

1

1

Although HHS has no authority to regulate the transportation industry, the Department of Transportation (DOT) does have such authority. DOT is required by law to develop requirements for its regulated industry that “incorporate the Department of Health and Human Services

scientific and technical guidelines dated April 11, 1988, and any amendments to those guidelines * * *”

See, e.g.,

49 U.S.C. 20140(c)(2). In carrying out its mandate, DOT requires by regulation that its federally-regulated employers use only HHS-certified laboratories in the testing of employees, 49 CFR 40.81, and incorporates the scientific and technical aspects of the guidelines in its regulations. The DOT regulated industry should refer to the DOT regulations at 49 CFR part 40.

Section 1.2 Who Is Responsible For Developing and Implementing These Guidelines?

(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for Federal workplace drug testing programs.

(b) The Secretary has the responsibility to implement these Guidelines.

Section 1.3 How Does a Federal Agency Request a Change From These Guidelines?

(a) Each Federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.

(b) To obtain a waiver, a Federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.

Section 1.4 How Are These Guidelines Revised?

(a) In order to ensure the full reliability and accuracy of drug and validity tests, the accurate reporting of test results, and the integrity and efficacy of Federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.

(b) The changes will be published in final as a notice in the

Federal Register

.

Section 1.5 What Do the Terms Used in These Guidelines Mean?

The following definitions are adopted:

Accessioner.

The individual who receives the specimens at the laboratory or IITF and signs the Federal drug testing custody and control form.

Aliquot.

A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.

Adulterated.

A specimen containing either a substance that is not a normal constituent for that type of specimen or containing an endogenous substance at a concentration that is not a normal physiological concentration.

Batch.

A number of specimens that are being handled and tested as a group.

Calibrator.

A solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a test specimen aliquot/sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation. Calibrators may be used to establish a calibration curve over a range of interest.

Canceled Test.

The MRO determines that the result reported by the laboratory cannot support reporting either a positive or a negative test to the employer.

Certifying Scientist (CS).

The individual responsible for verifying the chain of custody and scientific reliability of a non-negative or invalid

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