[Federal Register Volume 85, Number 176 (Thursday, September 10, 2020)]
[Proposed Rules]
[Pages 56108-56151]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-16432]



[[Page 56107]]

Vol. 85

Thursday,

No. 176

September 10, 2020

Part IV





Department of Health and Human Services





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42 CFR Chapter I





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Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Proposed Rule

  Federal Register / Vol. 85 , No. 176 / Thursday, September 10, 2020 / 
Proposed Rules  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

42 CFR Chapter I


Mandatory Guidelines for Federal Workplace Drug Testing Programs

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

ACTION: Notification of mandatory guidelines.

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SUMMARY: The Department of Health and Human Services (``HHS'' or 
``Department'') is proposing to establish scientific and technical 
guidelines for the inclusion of hair specimens in the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (Guidelines).

DATES: Submit comments on or before November 9, 2020.

ADDRESSES: In commenting, please refer to file code [SAMHSA-2020-0001]. 
Because of staff and resource limitations, SAMHSA cannot accept 
comments by facsimile (fax) transmission.
    You may submit comments in one of four ways (please choose only one 
of the ways listed):
    Electronically. You may submit electronic comments on this 
regulation to http://www.regulations.gov. Follow ``Submit a comment'' 
instructions.
    By regular mail. You may mail written comments to the 
following address: SAMHSA, Center for Substance Abuse Prevention 
(CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room 
16N02, Rockville, MD 20857. Please allow sufficient time for mailed 
comments to be received before the close of the comment period.
    By express or overnight mail. You may send written comments 
to the following address: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 
16N02, Rockville, MD 20857.
    By hand or courier. You may deliver your written comments 
by hand or courier to the following address prior to the close of the 
comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02, 
Rockville, MD 20857. If you intend to deliver your comments to the 
Rockville address, please call (240) 276-2600 in advance to schedule 
your arrival with one of our staff members. Because access to the 
SAMHSA building is secure, persons without federal government 
identification are encouraged to schedule their delivery or to leave 
comments with the security guard at the front desk located in the main 
lobby of the building.
    All comments received before the close of the comment period will 
be available for viewing by the public. Please note that all comments 
are posted in their entirety, including personal or confidential 
business information that is included in the comment. SAMHSA will post 
all comments before the close of the comment period on the following 
website: http://www.regulations.gov. Use the website's search function 
to view the associated comments.
    Comments received before the close of the comment period will also 
be available for public inspection as they are received, generally 
beginning approximately three weeks after publication of a document, at 
SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday 
through Friday of each week, excluding federal holidays, from 8:30 a.m. 
to 4:00 p.m. To schedule an appointment to view public comments, please 
call (240) 276-2600.

FOR FURTHER INFORMATION CONTACT: Eugene D. Hayes, Ph.D., MBA, SAMHSA, 
CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by 
telephone (240) 276-1459 or by email: [email protected].

SUPPLEMENTARY INFORMATION:

Executive Summary

    This notice of proposed Mandatory Guidelines for Federal Workplace 
Drug Testing Programs using Hair (HMG) will allow federal executive 
branch agencies to collect and test a hair specimen as part of their 
drug testing programs with the limitation that hair specimens be used 
for pre-employment (i.e., for applicants applying for federal testing 
designated positions) and random testing. A federal agency choosing to 
test hair specimens must authorize collection and testing of at least 
one other specimen type (e.g., urine or oral fluid) that is authorized 
under the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs, and provide procedures whereby the alternate specimen is used 
in the event that a donor is unable to provide a sufficient amount of 
hair for faith-based or medical reasons, or due to an insufficient 
amount or length of hair. The proposed HMG require collection of an 
alternate authorized drug testing specimen in addition to the hair 
specimen, either simultaneously (i.e., at the same collection event) or 
when directed by the Medical Review Officer (MRO) after review and 
verification of laboratory-reported results for the hair specimen. This 
alternate specimen would be tested and reported in place of a donor's 
positive hair specimen only in certain circumstances, as described 
below.
    These proposed HMG establish standards and technical requirements 
for hair collection and collection materials, initial hair drug test 
analytes and methods, confirmatory hair drug test analytes and methods, 
processes for review by an MRO, standards for certification of 
laboratories engaged in hair drug testing for federal agencies' drug-
free workplace programs, and requirements for federal agency actions 
that are covered by these Guidelines. The HMG provide flexibility for 
federal agency workplace drug testing programs to address testing needs 
by allowing hair as an alternative specimen type.
    The Department of Health and Human Services, pursuant to the 
Department's authority under Section 503 of Public Law 100-71, 5 U.S.C. 
Section 7301, and Executive Order No. 12564, establishes the scientific 
and technical guidelines for federal workplace drug testing programs 
and establishes standards for certification of laboratories engaged in 
drug testing for federal agencies.

Summary of the Major Provisions of the Proposed HMG

    The promulgation of the HMG allows federal agencies to collect and 
test hair specimens in their workplace drug testing programs. The 
collection process provides that the specimen will be collected by a 
trained collector under direct observation. The HMG collection 
procedure requires that a single hair specimen be obtained from the 
donor's head and divided into two specimens (A and B). The collector 
places the A and B specimens into separate specimen collection 
containers. Unlike the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Urine (UrMG), the HMG do not allow Instrumented 
Initial Test Facilities (IITFs), primarily because of the limited 
amount of hair collected from the donor.
    The Department is proposing that an alternate authorized drug 
testing specimen be collected (i.e., simultaneously collected or 
collected and tested at the direction of the MRO after verification of 
a positive hair test result). As described in greater detail below, 
this two-test approach is intended to protect federal workers from 
issues that have been identified as limitations of hair testing, and 
related legal deficiencies identified in Jones v. City of Boston, 845 
F.3d 28 (1st Cir. 2016) and Thompson v. Civil Service Com'n, 90 
Mass.App.Ct. 462 (Oct. 7, 2016). Both cases indicate that an employment 
action taken on the basis of a positive hair test alone, without other 
corroborating evidence, may be

[[Page 56109]]

vulnerable to legal challenge. The Department is specifically 
requesting comments, including support from recent peer-reviewed 
scientific literature, on advances in the science of hair testing that 
adequately address these limitations and elucidate the extent to which 
hair color, external contamination and other factors (e.g., hair 
treatments, hygiene) will affect hair tests and the interpretation of 
hair drug test results. The Department will continue to monitor the 
science of hair testing and will carefully review peer-reviewed 
literature and other valid scientific information submitted by federal 
agencies and the public for scientific support of hair testing. Based 
on this evaluation, the Department will decide whether performance 
standards can be established to mitigate identified limitations and 
obviate the requirement to collect an alternate authorized specimen. 
The Department is also soliciting public comment on the potential added 
burden to federal agencies and specimen donors should an alternate 
specimen be necessary. As noted under Executive Orders 13563 and 12866 
in the Regulatory Impact and Notices section of this Notice, the 
Department does not find these proposed mandatory guidelines to be a 
significant burden for federal agencies or incur a significant cost. In 
addition, a federal agency is not required to adopt hair testing in 
their Drug-free Workplace Programs. However, comments provided by the 
public on the subject of potential added burden could be useful to 
federal agencies deciding whether to test hair in addition to other 
specimen types in their federal workplace drug testing programs.
    In addition, the Department is specifically requesting comments, 
including support from the recent scientific literature, on whether 
hair tests that are positive for the marijuana analyte, delta-9-
tetrahydrocannabinol-9-carboxylic acid (THCA), should be excluded from 
the requirement to test an alternate authorized specimen (i.e., MROs 
would report verified positive THCA hair results to the federal 
agency).

Costs and Benefits

    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS-certified laboratories, the Department estimates that 
275,000 urine specimens are tested annually by federal agencies. HHS 
projects that approximately 1% (or 2,750) of the 275,000 specimens 
tested per year will be hair specimens and 89% (or 244,750) will be 
urine specimens, with the remaining approximately 10% being oral fluid 
specimens (27,500). The approximate annual numbers of regulated 
specimens for the Department of Transportation (DOT) and the Nuclear 
Regulatory Commission (NRC) are 6.1 million and 150,000, respectively. 
It should be noted that the NRC-related information in this notice only 
pertains to individuals subject to drug testing conducted pursuant to 
10 CFR part 26, ``Fitness for Duty Programs'' (i.e., employees of 
certain NRC-regulated entities). Should DOT and NRC allow hair testing 
in their regulated workplace programs, the estimated annual numbers of 
specimens for DOT would be 50% (3,050,000) hair specimens for pre-
employment testing, 7% (427,000) oral fluid specimens, and 43% 
(2,623,000) urine specimens; and numbers of specimens for NRC would be 
10% (15,000) hair, 7% (10,500) oral fluid, and 83% (124,500) urine. 
These projected numbers are based on existing annual pre-employment 
testing in the regulated industries and hair testing currently 
conducted in the private sector for commercial drivers.
    An HHS-certified laboratory may group analytes for initial testing 
as shown in the table in Section 3.4 (i.e., use a single test for two 
or more analytes that are in the same drug class and have the same 
initial test cutoff), or may use multiple tests. In Section 3.4, the 
Department is proposing criteria for calibrating initial tests for 
grouped analytes and is specifying the minimum cross-reactivity of the 
immunoassay to the non-target analytes(s) within the group (i.e., those 
not used for calibration). An immunoassay manufacturer may incur costs 
if they choose to alter their existing product and resubmit the 
immunoassay for Food and Drug Administration (FDA) clearance.
    Costs associated with hair testing are greater than for urine or 
oral fluid testing based on information from commercial laboratories 
currently testing hair specimens. Costs of initial testing will not 
pose a significant increase for laboratories currently testing hair if 
the laboratory can use currently available immunoassay testing kits 
cleared by the FDA for hair testing. All confirmatory testing can be 
achieved using commercially available instrumentation. Prior to testing 
regulated hair specimens, laboratories must be specifically certified 
for hair testing by the Department through the National Laboratory 
Certification Program (NLCP). Laboratories choosing to apply for HHS 
certification may incur additional costs associated with adding the 
matrix and/or validating and implementing assays using different 
cutoffs and analytes. The estimated laboratory cost to complete and 
submit a certification application is $3,000 and the estimated cost for 
the Department to process the application is $10,200. The initial HHS 
hair testing certification includes the requirement for the laboratory 
to demonstrate that their performance meets Guidelines analytical 
requirements by testing three (3) sets of performance testing (PT) hair 
samples. The Department will provide the three groups of PT samples 
through the NLCP at no cost to laboratories participating in the NLCP 
Pilot Proficiency Testing Program for hair. This pilot PT program is 
described in the History and Proposed Changes to the HHS Mandatory 
Guidelines for Federal Workplace Drug Testing Programs section below. 
Based on estimated fees charged for hair specimen testing, laboratory 
costs to conduct the PT testing would range from $3,000 to $3,375 for 
each applicant laboratory.
    Based on information from current commercial hair testing 
laboratories, once hair testing is implemented, the average cost per 
specimen will range from $40.00 to $45.00. Information from current 
HHS-certified laboratories indicates that the average cost of testing a 
urine specimen ranges from approximately $6.50 to $11.00 per specimen. 
Once hair testing is implemented, the estimated cost per specimen for 
each initial test will range from $2.50 to $6.00 including costs for 
initial test reagents and sample preparation (e.g., washing, 
digestion). Estimated additional costs for each confirmatory test will 
range from $20.00 to $35.00, primarily due to the costs of sample 
preparation (including decontamination procedures as defined in Section 
1.5) and analysis. Therefore, the estimated cost of a commercial hair 
testing laboratory using both initial testing with confirmation will 
range from $40.00 to $80.00 per specimen. These costs for the 
laboratories or federal agencies choosing to use hair in their drug 
testing programs will be incorporated into the overall testing cost for 
the federal agency submitting the specimen to the laboratory.
    As described earlier, a federal agency choosing to use hair for 
pre-employment and/or random testing may collect an alternate specimen 
type at the same collection event or later, at the direction of the 
MRO. Agencies choosing not to collect an alternate specimen at the same 
time as hair would save upfront collection and handling costs, and 
would pay for alternate specimen collection and testing only when 
directed by the MRO (i.e., when the donor has no legitimate medical

[[Page 56110]]

explanation for a positive hair test, when the hair specimen was 
reported by the laboratory as invalid or rejected, or when the donor 
requests testing of the split specimen and the split specimen cannot be 
tested). A federal agency that chooses to collect an alternate specimen 
type at the same time as hair for a pre-employment or random test would 
incur additional upfront costs for collection and handling of the 
alternate specimen, but would only pay for testing of those alternate 
specimens when directed by the MRO, and would save time on recollection 
in those instances. Agencies choosing to use hair in their drug testing 
programs may also incur some costs for training of federal employees 
such as drug program coordinators.
    As explained in more detail below, hair testing potentially offers 
several benefits when compared to urine, including directly observed 
collections, ease of transport and storage, increased specimen 
stability, and a longer window of drug detection. The Department 
believes these benefits justify pursuing hair testing in federal 
workplace programs.

Background

    The Department of Health and Human Services, pursuant to the 
Department's authority under Section 503 of Public Law 100-71, 5 U.S.C. 
Section 7301, and Executive Order No. 12564, establishes the scientific 
and technical guidelines for federal workplace drug testing programs 
and establishes standards for certification of laboratories engaged in 
drug testing for federal agencies. As required, HHS originally 
published the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs (Guidelines) in the Federal Register [FR] on April 11, 1988 
[53 FR 11979]. The Substance Abuse and Mental Health Services 
Administration (SAMHSA) subsequently revised the Guidelines on June 9, 
1994 [59 FR 29908], September 30, 1997 [62 FR 51118], November 13, 1998 
[63 FR 63483], April 13, 2004 [69 FR 19644], and November 25, 2008 [73 
FR 71858]. SAMHSA published the revised Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine (UrMG) on January 
23, 2017 [82 FR 7920] and published the proposed Mandatory Guidelines 
for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on 
May 15, 2015 [80 FR 28054].
    On December 4, 2015, the President signed the Fixing America's 
Surface Transportation (FAST) Act, which required HHS to ``issue 
scientific and technical guidance for hair testing as a method of 
detecting the use of a controlled substance for purposes of section 
31306 of title 49, United States Code.'' Public Law 114-94, section 
5402(b).

History and Proposed Changes to the HHS Mandatory Guidelines for 
Federal Workplace Drug Testing Programs

    A focus of the HHS mission is to maintain the integrity and ensure 
the quality of federal drug-free workplace programs by a commitment to 
identify and mandate the use of the most accurate, reliable drug tests 
and testing methods available. To accomplish these goals, the 
Department implements ongoing scientific reviews and program 
collaboration with federal regulators, researchers, drug testing 
laboratories, and public and private sector employers. As the use of 
alternative specimens (other than urine) and new analytical test 
technologies increased over the previous years, the Department, through 
SAMHSA's Center for Substance Abuse and Prevention (CSAP) Drug Testing 
Advisory Board (DTAB), responded by reviewing new technologies and 
assessing drug testing using other specimen types, such as oral fluid 
(saliva), hair, and sweat for possible use in federal agency workplace 
testing programs.
    The proposed HMG are the result of a directed Departmental 
assessment that began in 1997 with a 3-day scientific meeting of the 
DTAB. During that public meeting, DTAB members discussed drug testing 
using alternative specimens and the use of new and developing drug 
testing technologies with potential applicability to workplace drug 
testing programs. Following the initial meeting, members of the DTAB 
continued to review and analyze all available information on 
alternative specimens and testing technologies. These efforts 
identified specific scientific, administrative, and procedural 
requirements necessary for a comprehensive federal workplace drug 
testing program that included alternative specimens and technologies.
    The first working draft of new Guidelines that included the testing 
of alternative specimens including hair was presented at the June 2000 
DTAB meeting. These ``work-in-progress'' draft Guidelines were placed 
on the SAMHSA website and the public was invited to submit information 
and comments to improve the draft document and further SAMHSA's 
knowledge of the analysis of alternative specimens. Twenty-eight 
separate comments were received. Those comments were summarized, 
incorporated into the draft Guidelines and the updated document was 
presented at the DTAB meeting in September 2000. Again, comments were 
requested from all interested parties. At the December 2000 DTAB 
meeting, a third working draft of the Guidelines was presented that 
included public comments resulting from the September meeting. SAMHSA, 
in consultation with subject matter experts including researchers and 
drug testing industry professionals, continued to assess the scientific 
supportability of testing alternative specimens in the Drug-Free 
Workplace Program (DFWP). Areas of specimen collection, specimen 
validity, initial testing, confirmation, medical review, and 
performance testing were examined to evaluate the integrity, 
reliability, and defensibility of drug testing using alternate 
matrices.
    To assess laboratory performance and utility of alternative 
specimen testing in federal drug-free workplace programs, the 
Department initiated a voluntary pilot proficiency testing (PT) program 
for hair. The Hair Pilot PT program ran from 2000 to 2007 and resumed 
in 2014 based on DTAB's recommendation. The program was developed, and 
the samples were prepared using government funding. This pilot PT 
program was established to determine if it was possible to prepare 
stable and accurate hair PT samples, and to develop criteria for the PT 
program. Participating laboratories used their established procedures 
to test the PT samples and shared their results with SAMHSA. Based on 
data obtained from the pilot PT program, it appeared that valid and 
stable hair PT samples could be prepared. The results of the pilot PT 
program showed that the technology used by participant laboratories for 
confirmatory testing could meet requirements for sensitivity and 
specificity. Also, inter-laboratory precision improved during the pilot 
PT program for most drug analytes.
    Based on the pilot PT results from 2000 to 2003 and input from 
subject matter experts for all alternate matrices, the Department 
issued a Federal Register notice [69 FR 19673] on April 13, 2004 
proposing inclusion of oral fluid, hair, and sweat specimens in federal 
workplace drug testing programs. Following publication of the proposed 
Guidelines, the public and federal agencies identified significant 
scientific, legal, and public policy concerns about the use of the 
alternative specimens. As a result of the review, the Department issued 
a Final Notice of Revisions to the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs on November 25, 2008 [73 FR 71858] that 
concluded the scientific, technical, and legal information for the

[[Page 56111]]

testing of alternative specimens (oral fluid, hair, and sweat) was 
insufficient to include these specimens in the federal programs at that 
time. As noted above, the purposes of the Hair Pilot PT Program were to 
determine if it was possible to prepare stable and accurate hair PT 
samples, and to develop criteria for the PT program. Many of the issues 
raised by commenters (e.g., concerns over external contamination) were 
not addressed in the pilot PT program. The Department committed to 
monitoring developments in alternative specimen testing and has 
continued to do so since 2008.
    The complexity of responses to the 2004 notice made it clear that 
if the Department were to subsequently authorize alternative specimens 
for the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs, each specimen matrix would need a separate set of Guidelines. 
Additionally, the Department proposed to stagger the timeline for the 
review and potential incorporation of alternative specimens, and to 
begin with oral fluid. The decision to begin with oral fluid was 
supported by fewer legal and policy concerns, and current peer-reviewed 
literature that existed with oral fluid. The Department published the 
proposed OFMG on May 15, 2015 [80 FR 28054].
    Since 2004, methodology developed for non-regulated private sector 
workplace alternate matrix testing has evolved, leading to enhanced 
analytical sensitivity and specificity for hair testing. The scientific 
literature for hair testing and interpretation of results has grown. 
Many non-regulated private sector organizations have incorporated hair 
testing into their workplace drug testing programs.
    At the open session of the January 2012 DTAB meeting, SAMHSA shared 
updated information on hair testing with DTAB and the public. During 
the meeting, experts made scientific presentations concerning hair 
specimens for workplace drug testing, including physiological 
composition of hair, tested drugs and cutoffs, wash procedures, 
decontamination procedures, hair testing results and best practices in 
laboratory methodologies (initial and confirmatory testing). Wash 
procedures consisted of a rinse with organic solvents to remove oils 
and residue on the hair prior to initial testing. Decontamination 
procedures were more extensive methods (e.g., multiple organic and 
aqueous washes) designed to remove drug present due to environmental 
contamination prior to confirmatory testing.
    In May 2015, SAMHSA solicited comments regarding the science and 
practice of hair testing via a Request for Information (RFI) [80 FR 
30689], and subsequently extended the due date for comments [80 FR 
34921]. The notice requested comments from the public and industry 
stakeholders regarding a variety of hair testing issues (e.g., 
specimens, collection, specimen preparation, analytes/cutoffs, specimen 
validity, and testing methods). The RFI gave the public and industry 
stakeholders an opportunity to provide information and comments for 
consideration during the development of the proposed Guidelines for 
hair testing. The Department received 37 comments from drug testing 
laboratories, MROs, manufacturers, drug testing industry associations, 
and the public. All submitted comments were reviewed and were presented 
to the DTAB members for consideration during SAMHSA's continuing 
assessment of hair as an alternative specimen.
    Following the August 2015 meeting of the DTAB, the Board submitted 
the following recommendation to SAMHSA: ``Based on the review of the 
science, DTAB recommends that SAMHSA pursue hair as an alternative 
specimen in the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs, including performance standards that sufficiently address 
external contamination and hair color impact.''
    Thereafter, SAMHSA continued to critically review the state-of-the-
science and technology for forensic drug testing of hair and the 
utility of hair as a specimen in federal workplace drug testing 
programs. SAMHSA also consulted subject matter experts with expertise 
in biochemistry, toxicology, laboratory operations, MRO practices and 
workplace policy. The input of these experts was considered along with 
Department officials at quarterly DTAB meetings.

Rationale for Pursuing Hair Testing in the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs

    Hair has been used in non-regulated testing programs including the 
transportation and casino industries (i.e., for pre-employment and 
random testing), and other situations when longer detection periods may 
be needed. Corresponding developments have led to analytical 
technologies that provide the needed sensitivity and accuracy for 
testing hair specimens at the levels required to determine a positive 
test result, as demonstrated in the Hair Pilot PT Program.
    Hair and urine pre-employment test results have been shown to be 
somewhat dissimilar because each matrix has a different time window of 
drug detection. Typically, positivity rates are higher in hair due to 
hair's longer window of detection.\1\ Hair is easily collected, 
transported and stored, and is also more difficult to substitute and/or 
adulterate than urine since collections are performed under direct 
observation. Separation, detection, and identification techniques have 
improved such that scientists are now able to detect and quantify drugs 
and/or metabolites in hair at picogram per milligram (pg/mg) 
concentrations. A forensic workplace testing program for hair can be 
modeled after the existing federal program: Specimens are first tested 
using an initial test (e.g., immunoassay or an alternate technology), 
and specimens with positive initial test results are confirmed using 
mass spectrometric identification.

What is hair?

    Unlike urine and oral fluid, hair is a solid, heterogenous matrix 
that is exposed to the environment. Hair color and structure differ by 
individual and within the same individual. 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 in the 
posterior vertex region of the head are in active growth phase 
(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.2-5 The Department is 
proposing to permit agencies as part of their federal drug-free 
workplace programs to test head hair specimens between 0.5 and 1.0 
inches (approximately 2.5 cm) long, representing a detection time 
period of approximately 30-60 days, for pre-employment and random 
testing.

What is the mechanism of drug disposition in hair?

    Drugs and drug metabolites may be incorporated into hair by several 
pathways.6-10 As drugs and their metabolites travel through 
the body in blood, they diffuse from the bloodstream into the base of 
the hair follicle. The amount of drug in the hair is related to the 
drug concentration in the blood when the hair was formed and depends on 
the chemical structure of the drug or metabolite. Drugs and/or 
metabolites may also be incorporated

[[Page 56112]]

into hair via secretions of the sweat glands and sebaceous glands, 
which are in close contact with hair as it develops and emerges from 
the skin. Sweat and sebum can deposit drugs and/or metabolites on the 
hair shaft that are absorbed into the hair during and after its 
formation. As hair grows and emerges from the skin, the location of 
drug and metabolite in the hair shaft can be used to generally assess 
the timeframe of drug use. However, sweat can contribute to drug and/or 
metabolite incorporation across the entire length of the hair. 
Therefore, segmental analysis (i.e., analysis of multiple short 
longitudinal segments to determine a time profile of use) must be done 
with caution and is not recommended for workplace drug testing. 
6-10

What are some of the known issues with drug testing using hair?

    Numerous factors influence the amount of drug incorporated into 
hair (e.g., drug dose, length of exposure, physical and chemical 
properties of hair, and factors associated with the chemical structure 
of the drug). Of concern are environmental contamination, the impact of 
natural hair color on drug incorporation, and the effects of hygiene 
and cosmetic hair treatments. These issues may confound the results and 
interpretation of hair tests as explained in more detail below.

Environmental Contamination and Decontamination

    Concerns have been raised over environmental contamination of 
hair.2 4 11-15 There can be opportunities for hair to be 
contaminated from drugs in the environment.\14\ For example, a donor 
may claim they tested positive for a drug because they were in the 
presence of others using the drug, or were in an environment in which 
drug particulates were in the air or on contaminated surfaces.
    Effective decontamination procedures are a key issue in hair 
testing, because the inability to rule out external contamination 
presents legal challenges. In one relevant case, a state court upheld a 
state commission's finding that hair testing did not adequately rule 
out the possibility of a false positive drug test resulting from 
external contamination such that an employer could rely on hair testing 
as the sole basis for an employee's termination. See Thompson v. Civil 
Service Com'n, 90 Mass.App.Ct. 462 (Oct. 7, 2016). Notably, the court 
in Thompson v. Civil Service Com'n stated the following regarding the 
reliability of hair testing:

    A threshold issue before the commission was the scientific 
reliability of the hair testing, and its ability to distinguish 
between voluntary ingestion and environmental exposure. The ten 
officers and the department held competing views as to whether the 
testing alone was reliable enough to establish just cause supporting 
the officers' terminations . . . . Ultimately, the commission found 
that the hair testing methodology was not sufficiently reliable to 
be the sole basis for an officer's termination, concluding that 
``[a] reported positive test result . . . is not necessarily 
conclusive of ingestion and, depending on the preponderance of 
evidence in a particular case, may or may not justify termination or 
other appropriate discipline of a tenured [department] officer.'' 
Nonetheless, the commission found that hair testing is an 
appropriate tool to enforce the department's substance abuse policy 
and that hair test results could be used as some evidence of drug 
use.

Id. at 465--466 (internal citations omitted) (emphasis added). The 
Thompson court also stated that:

    Here, after an exhaustive inquiry on the scientific reliability 
of the . . . hair testing methodology, the commission reached the 
conclusion that a positive test was not conclusive on the question 
of voluntary ingestion, as the positive test may also represent 
sample contamination by environmental exposure. In other words, the 
commission found that the risk of a false positive test was great 
enough to require additional evidence to terminate an officer for 
just cause. That conclusion is well supported by the record, which 
includes evidence of shifting cutoff levels through the years since 
the testing had been implemented, a lack of general acceptance in 
the scientific and law enforcement communities, and a lack of 
universally recognized industry standards.

Id. at 467--468. The Thompson court went on to hold that, ``the 
evidence amply supported the commission decision.'' Id. at 470.
    Many laboratories use wash procedures to remove oils and residue on 
the hair prior to initial testing. Approximately 90% of specimens are 
negative upon initial testing, and are subsequently reported 
negative.\16\ Depending upon the analyte, external contamination is of 
the most concern for the remaining 10% of hair specimens submitted for 
confirmation testing. Therefore, some laboratories use decontamination 
procedures designed to remove drug present due to environmental 
contamination prior to performing confirmatory testing.
    Decontamination procedures that adequately remove externally 
deposited drug and drug metabolites prior to confirmation testing are 
the subject of much scientific inquiry. It is likely that hair from 
individuals who use drugs is also externally 
contaminated.6 17 In other words, drugs and some drug 
metabolites (e.g., benzoylecgonine) detected during testing of a drug 
user's hair can be from drug ingestion and/or external contamination. 
This is mainly because of drug users' exposure to drugs in their 
environment as well as drugs and/or metabolites in the individual's own 
sweat and sebum coming into contact with their hair.
    A variety of decontamination procedures have been reported in the 
literature with varying effectiveness.11-13 Decontamination 
procedures employing multiple washes with analysis of the final wash 
solution may be a useful tool to identify external 
contamination.11 12 15 However, it has been shown that some 
externally deposited drug may remain, even after extensive washing.\11\ 
To address this issue, some laboratories have developed procedures 
employing a wash ``factor'' for some drugs (e.g., cocaine), whereby the 
concentration of the final wash solution is multiplied by a factor to 
simulate the effect of additional washes and the product is subtracted 
from the concentration of the drug measured in the hair.\12\ The factor 
used in these calculations varies and is dependent upon the drug and 
the laboratory. For some drugs (e.g., cocaine), the factor alone was 
not found to be effective at discriminating external contamination from 
drug use, so laboratories have employed additional criteria (e.g., 
presence of multiple metabolites, metabolite to parent drug 
ratios).\12\ One study proposed using a wash-to-hair concentration 
ratio to designate results as either indicative of drug use, indicative 
of drug use in combination with external contamination or indicative 
that the source of the drug was external contamination and inconclusive 
as to drug use.\15\ In that study, 11% of all test results had ratios 
indicative of external contamination and inconclusive for drug use. 
While the use of wash factors or ratios has shown promise in mitigating 
the effect of external contamination on hair drug testing, the 
Department is not proposing that such procedures be used in federal 
agency testing programs, in part because of the difficulty in 
development of performance testing samples to assess their 
effectiveness in the certified laboratories.
    Laboratories that have researched the validity and efficacy of 
decontamination procedures recommend utilizing aqueous and organic 
solvents in these decontamination procedures.\11\ Both the Society of 
Hair Testing and United Nations Office of Drugs and Crime recommend a 
hair decontamination procedure that includes both an organic and 
aqueous washing step, whereas the European Workplace Drug Testing

[[Page 56113]]

Society recommends an organic and/or aqueous wash. The proposed 
inclusion of both organic and aqueous solvent wash steps is in 
accordance with current peer reviewed literature. As opposed to 
requiring a single method for decontamination to be used by all testing 
laboratories, SAMHSA proposes that minimum performance standards be 
established for the efficacy of decontamination procedures that are 
followed in all HHS-certified hair drug testing laboratories.
    However, although there is scientific evidence that suggests that 
wash and decontamination procedures may be effective in ensuring that 
the outer protectant cuticle and inner medulla portions of the hair 
shaft are decontaminated, there are no published studies that prove 
that external contamination cannot reach the central cortex of the 
hair. Further, one published study concludes that drug-contaminated 
hair when washed with water and methanol is indistinguishable from drug 
user hair because the drug migrates into the cortex and medulla due to 
swelling effects of these solvents.\13\ If this issue is not addressed, 
a donor may claim that, even if hair is washed and decontaminated in 
accordance with the most vigorous washing methodologies utilized by 
laboratories, a hair test result could remain influenced by 
contamination and potentially result in a false positive test. 
Therefore, more time and research are needed for the development of 
performance standards that address this and other issues. The 
Department is currently in the process of developing performance 
standards for decontamination of hair and is seeking public comment on 
what such standards should be and how performance test samples could be 
developed to assess these standards. When the decontamination 
performance standards are fully developed, it is the Department's 
intention to add them to the HMG through the notice and comment process 
rather than delay publishing of the proposed HMG until such standards 
are developed. Compliance with these mandatory minimum standards, when 
fully developed and included in these Guidelines, will be evaluated 
through the NLCP Performance Testing (PT) program.
    After relevant performance testing standards are developed, the HMG 
require laboratories to perform a valid and effective decontamination 
procedure prior to confirmatory drug testing in order to address the 
external contamination issue. The Department is requesting comments and 
information about decontamination procedures that remove drug present 
as a result of external contamination. All decontamination and test 
methods must meet the validation, quality control, and review 
requirements specified by the HMG. Furthermore, the NLCP Performance 
Testing (PT) program would challenge those methods using drug user 
hair, hair contaminated with drug analytes, hair subjected to cosmetic 
treatments, and blind quality controls. The laboratories will also be 
required to prepare decontamination controls that challenge their 
decontamination procedures and are analyzed with each confirmatory drug 
analysis. The Department is specifically requesting comments on the 
types of samples to be included in the hair PT program and procedures 
used to prepare decontamination controls.

Identification of Unique Metabolites

    Identification of a unique drug metabolite would distinguish drug 
use from environmental contamination as long as strict criteria for 
defining a unique metabolite are established.\11\ The proposed HMG 
define a unique metabolite as ``a drug metabolite present in a hair 
specimen only as a result of biotransformation following drug use'' and 
which ``does not occur as a contaminant in licit and illicit drug 
products and is not produced from the drug as an artifact.''
    To date, only one unique metabolite (i.e., THCA) meets the above 
definition and has been included for the proposed drugs. However, while 
the use of a unique metabolite addresses the external contamination 
issue, the Department is not aware of any controlled dosing studies 
that demonstrate the lack of a hair color impact on THCA results. See 
additional discussion on the impact of hair color on hair test results 
below. Accordingly, the Department is requesting comments including 
support from the scientific literature on whether THCA positive hair 
tests can be excluded from the requirement to test an alternate 
authorized specimen (i.e., MROs would report verified positive THCA 
hair results to the federal agency).
    The Department is also requesting information including, at a 
minimum, support from the scientific literature about unique 
metabolites that can be analyzed on a stand-alone basis for the other 
proposed drugs listed in Section 3.4. For example, one recent study 
analyzing opioids in hair indicates that unique glucuronide metabolites 
of opioid drugs may be reliably detected in hair.\18\ In addition, 
although hydroxylated metabolites of cocaine and benzoylecgonine do not 
meet the Guidelines definition of a unique metabolite for hair, these 
analytes have been touted in the literature as being diagnostic of 
cocaine use when ratio criteria are applied to the quantitative 
results.12 19-22 Hydroxy-metabolites of cocaine were 
originally thought to be unique metabolites as defined in the HMG, 
until these compounds were identified in street cocaine samples and 
found to be produced during hair treatment experiments.21 22 
More recently, hydroxy-metabolites of benzoylecgonine were identified 
in hair and thought to represent a new opportunity to reliably identify 
cocaine use.19-21 However, these analytes also have been 
detected in a limited study of street cocaine samples, and were found 
to form and increase in concentration over a period of eight weeks 
after contamination of seven subjects' hair with cocaine.\20\ To 
compensate for these issues, researchers have proposed the use of 
ratios and criteria schemes (i.e., detection of multiple metabolites at 
or above proposed cutoff concentrations and within certain ratios to 
each other).20 21 These schemes require the analysis of 
cocaine and multiple hydroxylated metabolites to be effective, thereby 
increasing the costs of testing and the NLCP performance testing used 
to monitor the accuracy and reliability of laboratory results.

Impact of Hair Color on Hair Test Results

    The natural color of human hair ranges from shades of black, brown, 
red, yellow, gray and white. Hair color is controlled, in part, by the 
biochemistry of two major groups of melanin pigments. The eumelanins 
are black to brown and the pheomelanins are reddish in color.\23\ The 
presence of eumelanin appears to be the major determinant of drug 
binding and incorporation of drug into the hair shaft. One of the 
postulated mechanisms for drug uptake in hair is ionic binding of drugs 
containing basic nitrogen moieties in their molecular structure (e.g., 
amphetamines, cocaine, opioids, and phencyclidine) with melanins.\24\ 
Neutral and acidic drugs appear to bind to hair by other poorly 
understood means. Direct evidence of binding of various drugs with 
melanin and with human hair has been demonstrated.25-27 In 
one in vitro study, cocaine binding experiments with black, brown, and 
blonde human hair demonstrated up to 34-fold differences in cocaine 
binding with dark hair as compared to blonde hair.\26\ These findings 
have raised concerns that selective drug binding with the wide 
variation of color

[[Page 56114]]

pigments distributed amongst the population may introduce bias in drug 
test results.
    A number of laboratory animal studies indicate that some drugs are 
differentially incorporated into hair based on color. Following 
administration of the same dose, higher drug concentrations were 
demonstrated in dark hair versus light hair in animals administered 
amphetamine,\28\ methamphetamine,\29\ methadone,\30\ and 
phencyclidine.\31\ Several controlled dosing studies in humans are 
consistent with the findings in animals.
    In one human study, administration of the same dose of isotopically 
labeled cocaine to Caucasians (hair color primarily brown) and non-
Caucasians (hair color primarily black) resulted in approximately 2.7 
times more cocaine being incorporated into non-Caucasian hair than 
Caucasian hair.\32\ In another study, codeine was administered to male 
and female participants with black (Caucasians, non-Caucasian, American 
Indian, Hispanic, Asian), brown (Caucasians), blond (Caucasians) and 
red hair (Caucasians).\33\ Codeine concentrations in black hair were 
seven-fold higher than those in brown hair and 14-15-fold higher than 
those in blond hair. Using the proposed confirmatory cutoff of 200 pg/
mg, 100% of subjects with black hair and 50% subjects with brown hair 
in this study would have been reported as positive. In contrast, 
subjects with blond or red hair would have tested negative. The authors 
suggested a direct relationship between codeine concentration and 
melanin concentration in hair. In another study of codeine 
administration to participants with different hair colors, a strong 
correlation was observed between codeine concentrations in hair and 
melanin concentrations.\34\
    Some of these investigators conducting controlled drug dosing 
studies measured melanin pigments as well as the amount of drug 
incorporation in hair and suggested that normalization of drug 
concentration to pigment content would effectively reduce potential 
bias in test results.33 34
    However, it remains unclear how the effect of pigmentation 
differences on drug amount in hair translates to a broader population 
as a whole, given the many other sources of variability (e.g., 
individual differences in amount and frequency of drug use and rates of 
drug metabolism and disposition). Epidemiology studies have suggested 
no significant hair color impact exists for THCA,\35\ heroin, cocaine, 
and amphetamines.\36\ The THCA result is consistent with studies of 
other acidic and neutral drugs and metabolites in hair. However, the 
Department is unaware of any controlled dosing studies that evaluated 
THCA in hair and therefore without this objective data the question of 
whether THCA exhibits a hair color impact remains. As noted earlier, 
the Department is requesting comments including support from the recent 
scientific literature on whether THCA positive hair tests should be 
excluded from the requirement to test an alternate authorized specimen 
(i.e., MROs would report verified positive THCA hair results to the 
federal agency). It is unknown for the other drugs whether the absence 
of an objective and scientific measure of hair color and differences in 
how hair color was categorized between these epidemiological and 
controlled human dosing studies played a role in the lack of 
concordance in results. Another study found that black arrestees tested 
positive for cocaine more often than white arrestees in both urine and 
hair.\37\ The authors suggested that, given the consistency between 
self-reported cocaine use and test outcome, there was no bias in the 
hair or urine tests based on racial group. A recent prepublication 
article by researchers from the University of Arkansas was provided to 
the Department for review. Similar to the Mieczkowski studies 
referenced above, the article attempts to consider hair pigmentation 
difference by dividing donors into ethnic groups and comparing urine 
and hair specimen testing results. The authors suggest that ethnic 
groups are significantly different irrespective of testing procedure. 
As noted, the Department wishes to solicit feedback on scientific 
studies comparing drug results and hair color and results comparing 
urine to hair.
    In addition, in vitro binding studies, animal studies, and 
controlled human dosing studies for certain drug classes (i.e., 
amphetamines, cocaine, opioids, and phencyclidine) provide scientific 
evidence that melanin pigments may influence the amount of drug 
incorporated into hair. However, it is unclear whether this influence 
would lead to significant bias in different populations of workers 
undergoing drug tests, given variabilities described herein, that could 
be introduced into test results from other sources and within the time 
frame of 30-60 days based on a 0.5 to 1.0 inch hair test. The 
Department is requesting information, including support from the recent 
scientific literature to address the impact of hair color on drug test 
results.
    The hair color impact/bias issue also presents legal challenges. It 
should be highlighted in this regard that the United States Court of 
Appeals for the First Circuit found that certain African-American 
police officers who were terminated from their positions on the basis 
of hair testing results were able to prove a ``prima facie case of 
disparate impact under Title VII.'' See Jones v. City of Boston, 752 
F.3d 38, 60 (1st Cir. 2014).) The First Circuit reiterated this finding 
in a subsequent 2016 proceeding and remanded the matter to the district 
court for further proceedings on the remaining prongs of the disparate 
impact analysis. See Jones v. City of Boston, 845 F.3d 28 (1st Cir. 
2016). The First Circuit held that:

    [t]he record contains sufficient evidence from which a 
reasonable factfinder could conclude that hair testing plus a 
follow-up series of random urinalysis tests for those few officers 
who tested positive on the hair test would have been as accurate as 
the hair test alone at detecting the non-presence of cocaine 
metabolites while simultaneously yielding a smaller share of false 
positives in a manner that would have reduced the disparate impact 
of the hair test. We also think that, on the present record, a 
reasonable factfinder could conclude that the [Boston Police] 
Department in 2003 refused to adopt this alternative.

Jones v. City of Boston, 845 F.3d 28, 38 (1st Cir. 2016).
    Thus, the First Circuit characterized ``a follow-up series of 
random urinalysis tests'' for officers who tested positive using hair 
as being just ``as accurate as the hair test alone at detecting the 
non-presence of cocaine metabolites while simultaneously yielding a 
smaller share of false positives in a manner that would have reduced 
the disparate impact of the hair test.'' Id. Accordingly, the 
Department is proposing to include testing using an alternate specimen 
when directed by the MRO for individuals who test positive on a hair 
test, unless the donor has a legitimate medical explanation for the 
positive test or the MRO has corroborating evidence to support the 
positive hair test (i.e., donor admission of illicit drug use). In 
addition, testing of an alternative matrix could also prove to be an 
effective measure to mitigate the external contamination issue because 
it would supply additional evidence to support an adverse action when 
premised on a positive drug test, which the Thompson court found to be 
needed when hair specimens are used for drug testing. As noted earlier, 
the Department is specifically requesting comments, including support 
from recent peer-reviewed scientific literature, on advances in the 
science of hair testing that may mitigate the requirement for an 
alternate authorized specimen in place of a donor's positive hair 
specimen in certain circumstances. The Department

[[Page 56115]]

is also seeking comments from the public on the potential for added 
burden should the alternate specimen requirement be necessary. 
Specifically, the Department is soliciting comments on potential burden 
that this approach could place on the federal agency employers and 
specimen donors. Information from the public could be useful to federal 
agencies evaluating hair testing as compared to using urine or oral 
fluid testing in their workplace drug testing programs.

Effects of Cosmetic Hair Treatments

    Hair treatments such as bleaching, straightening, relaxing, 
frequent washing, and vigorous brushing may; (1) decrease the hair 
concentrations of incorporated drug, (2) have effects that are drug, 
metabolite, target marker and profile dependent, and (3) because of the 
physical and chemical damage caused by these processes, they may 
increase the susceptibility of the hair to environmental 
contamination.38-42 The Department is proposing that each 
laboratory have a scientifically validated method to identify hair that 
has been damaged to the extent a drug test may be affected. One method 
for identification of damaged or porous hair has been published in the 
scientific literature but further information on this topic is 
needed.\43\ Therefore, the Department is requesting information 
including, at a minimum, support from the scientific literature to 
address these issues. Examples of requested information might include 
published scientific studies, internal laboratory study procedures or 
protocols, or reviews conducted by outside stakeholders to identify 
damaged hair. The Department is also requesting comments on whether 
this testing should be performed routinely on all specimens, or only on 
certain specimens (e.g., based on initial test results). The Department 
is also seeking comment on the extent to which (based upon scientific 
studies) hair specimens can be impacted by hair treatments and whether 
such specimens should be reported as invalid and an alternate specimen 
be collected and tested.

Rationale for Hair for Pre-Employment and Random Testing

    The Department is proposing the use of hair for pre-employment and 
random drug testing. Because drugs/metabolites are not detected in hair 
for 5 to 7 days after ingestion, it is not an appropriate specimen to 
detect recent use. Thus, hair is not an appropriate specimen for post-
accident and reasonable suspicion testing. The Department is requesting 
comments on whether hair may be used for follow-up or return to duty 
testing.

How were analytes and cutoffs selected?

    The selection of analytes for testing was based on known drug 
disposition patterns in hair. Analytes for the regulated drugs tested 
in hair are marijuana metabolite (delta-9-tetrahydrocannabinol-9-
carboxylic acid, THCA), cocaine (parent drug and metabolite, 
benzoylecgonine), phencyclidine (PCP), opioids (codeine, morphine, 
hydrocodone, hydromorphone, oxycodone, oxymorphone), heroin metabolite 
(6-acetylmorphine, 6-AM), and amphetamines (amphetamine, 
methamphetamine, methylenedioxymethamphetamine [MDMA], and 
methylenedioxyamphetamine [MDA]).
    Cutoffs were based on those proposed by the Department in 2004 (69 
FR 19673). The Department has added the same prescription opioids 
(i.e., hydrocodone, hydromorphone, oxycodone, and oxymorphone) 
specified in the UrMG and OFMG, with the same hair cutoffs as proposed 
for codeine and morphine. The codeine and morphine cutoffs are 
consistent with those recommended by the European Workplace Drug 
Testing Society and the Society of Hair Testing.44 45

Will there be specimen validity tests for hair?

    The Department is not aware of any objective methods in use to 
assess hair specimen validity (e.g., to distinguish synthetic from 
human hair or to identify hair that has been damaged to the extent a 
drug test result may be affected). As noted earlier, the Department is 
proposing that each laboratory use a validated method to identify 
damaged hair; therefore, the Department is seeking information on such 
methods and comments on whether all or only certain hair specimens 
should be subjected to such testing. The Department is also seeking 
comments on whether other validity testing is necessary for hair and, 
if so, what tests could be used.

National Laboratory Certification Program (NLCP)

    The functions of the National Laboratory Certification Program 
include maintaining laboratory inspection and PT programs as described 
in these Guidelines. Activities within these functions also include, 
but are not limited to, reviewing inspection reports and PT results, 
preparing summary reports of inspection and PT results, and making 
decisions regarding laboratory certification, suspension or revocation.

Organization of Proposed Guidelines

    This preamble describes the differences between the UrMG and the 
proposed HMG. In addition, it provides the rationale for the 
differences between the two Guidelines. The preamble also presents a 
number of issues raised during the development of the HMG. These issues 
are presented first in summary form as they appear in the proposed HMG 
and second as issues for which the Department is seeking specific 
public comment.
    References to Instrumented Initial Test Facilities (IITFs) have 
been removed in multiple sections, because IITFs are not practical for 
hair testing and will not be allowed to test hair specimens (see 
discussion under Subpart L, section 12.1 below).

Subpart A--Applicability

    Section 1.1 contains the same policies as described in the UrMG 
regarding who is covered by the Guidelines, except that instrumented 
initial test facilities will not be allowed to test hair specimens.
    Sections 1.2, 1.3, and 1.4 contain the same policies as described 
in the UrMG regarding 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 terms that apply specifically to hair (e.g., artificial hair, false 
hair, wash procedures, decontamination, unique metabolite).
    Section 1.6 contains the same policies as described in the UrMG 
regarding what an agency is required to do to protect federal applicant 
and employee records.
    Section 1.7 contains the conditions that constitute a refusal to 
take a federally regulated drug test. The Department has removed UrMG 
items that are not applicable to hair (e.g., situations involving 
observed or monitored urine collections) and is proposing conditions 
specific to hair. For example, in the event a donor is unable to 
provide a sufficient amount of hair for faith-based or medical reasons, 
or due to an insufficient amount or length of hair, the federal agency 
would be required to collect another authorized specimen type (e.g., 
urine, oral fluid). In addition, the Department is proposing in Section 
8.4 that the collector ask the donor whether the donor is wearing false 
hair (i.e., artificial or natural hair that is not the donor's

[[Page 56116]]

own such as a wig, weave, or extensions). If the donor states that they 
are wearing false hair, or the collector otherwise identifies its 
presence, this does not constitute a refusal to test. If the collector 
can collect a sufficient amount of the donor's own hair, the collector 
will proceed with the hair test. If the donor is unable to provide a 
sufficient amount of hair because of the false hair or for faith-based 
or medical reasons, or due to an insufficient amount or length of hair, 
the collector will collect an alternate authorized specimen.
    Section 1.8 contains the same policies as described in the UrMG 
with regard to the consequences of a refusal to take a federally 
regulated drug test.

Subpart B--Hair Specimen

    In section 2.1, the Department proposes to expand the drug testing 
program for federal agencies to permit the use of hair specimens. There 
is no requirement for federal agencies to use hair as part of their 
program. A federal agency may choose to use urine, oral fluid, hair, or 
any combination of authorized specimen types in their drug testing 
program. However, any agency choosing to use hair is required to follow 
the HMG. For example, for pre-employment or random drug tests, an 
agency program can randomly assign individuals for urine, oral fluid, 
or hair collection. The Department is proposing to allow federal 
agencies the option to collect an alternate authorized specimen (e.g., 
urine, oral fluid) either: (1) At the same time as the hair specimen or 
(2) at the direction of the MRO, following verification of a hair test 
as positive or invalid, or when the laboratory rejected the hair 
specimen. Under both options, the MRO would direct testing of the 
alternate specimen after completing the review and verification of the 
hair test results. Under these procedures, MROs would only be 
authorized to report a positive result for a hair test when the donor 
admits illicit use of the drug(s) that caused the positive test. To be 
clear, the results of a positive hair test cannot be reported to a 
federal agency without this corroborating evidence to support the 
positive test result. This hair testing approach best addresses the 
current disparate impact and external contamination legal issues 
discussed in the Jones v. City of Boston and Thompson v. Civil Service 
Com'n. cases. As noted earlier, the Department is specifically 
requesting comments including support from the scientific literature on 
advances in the science of hair testing that address these issues and 
obviate the need for the alternate specimen collection, as well as 
whether THCA should be excluded from this requirement (i.e., MROs would 
report verified positive THCA hair results to the federal agency). In 
the event a donor was unable to provide a sufficient amount of head 
hair for faith-based or medical reasons, or due to an insufficient 
amount or length of hair, the federal agency would be required to 
collect an alternate authorized specimen.
    Section 2.2 describes the circumstances under which a hair specimen 
may be collected. The Department proposes that hair tests be used in 
the pre-employment and random drug testing contexts only. Because drug 
analytes do not appear in hair for 5-7 days after use, hair is not an 
appropriate specimen to detect recent use. The Department is proposing 
to allow hair testing for pre-employment and random testing, and is 
requesting comments on whether hair may be used for follow-up or return 
to duty testing. In addition, due to different growth rates and drug 
detection windows based on the location of hair on the body, as well as 
privacy concerns, the Department is proposing to limit collection to 
head hair only and require federal agencies to authorize another 
specimen type for collection when head hair cannot be collected.
    Section 2.3 describes how each hair specimen is collected for 
testing. This section is consistent with the established requirement 
for all specimens to be collected as a split specimen. The Department 
proposes that the collector subdivide the collected hair specimen into 
the primary (A) and split (B) specimens.
    Section 2.4 establishes the amount of hair that must be collected 
for each specimen.
    Section 2.5 describes how a hair specimen is split.
    Section 2.6 includes the same requirement as the UrMG, that all 
entities and individuals identified in Section 1.1 of these Guidelines 
are prohibited from releasing specimens collected under the federal 
workplace drug testing program to any individual or entity unless 
expressly authorized by these Guidelines or in accordance with 
applicable federal law.
    While the HMG do not authorize the release of specimens, or 
portions thereof, to donors, the Guidelines afford donors a variety of 
protections that ensure the identity, security and integrity of their 
specimens from the time of collection through final disposition of the 
specimen. There are also procedures that allow donors to request the 
retesting of their specimen (for drugs or adulteration) at a different 
certified laboratory. Furthermore, the Guidelines grant donors access 
to a wide variety of information and records related to the testing of 
their specimens, including a documentation package that includes, among 
other items, a copy of the Federal Custody and Control Form (CCF) with 
any attachments, internal chain of custody records for the specimen, 
and any memoranda generated by the laboratory regarding the donor's 
drug test.
    Therefore, the procedures in these Guidelines offer federal 
employees and federal agencies transparent and definitive evidence of a 
specimen's identity, security, control and chain of custody. However, 
the Guidelines do not entitle employees to access the specimen itself 
or a portion thereof. The reason for this prohibition is that specimens 
collected under the Guidelines are for the purpose of drug testing 
only. They are not intended or designed to be used for other purposes 
such as deoxyribonucleic acid (DNA) testing. Furthermore, conducting 
additional testing outside the parameters of the Guidelines would not 
guarantee incorporation of the safeguards, quality control protocols, 
and the exacting scientific standards developed under the Guidelines to 
ensure the security, reliability and accuracy of the drug testing 
process.

Subpart C--Hair Specimen Tests

    Section 3.1 describes the tests to be performed on each hair 
specimen. This is the same policy that is in the UrMG regarding which 
drug tests must be performed on a specimen. A federal agency is 
required to test all specimens for marijuana and cocaine and is 
authorized to also test specimens for opioids, amphetamines, and 
phencyclidine. The Department realizes that most federal agencies 
typically test for all five drug classes authorized by the existing 
Guidelines, but has not made this a mandatory requirement, and will 
continue to rely on the individual agencies and departments to 
determine their testing needs above the required minimum. The 
Department is not aware of any currently used hair tests for a 
biomarker or specific adulterant. However, the HMG authorize specimen 
validity testing (e.g., for a biomarker, for a specific adulterant) 
upon request of the MRO as is allowed in the URMG. All tests must be 
properly validated and include appropriate quality control samples in 
accordance with these Guidelines. Specimen validity testing methods 
must be reviewed and approved by SAMHSA prior to use with federally 
regulated specimens. The Department is seeking comments on

[[Page 56117]]

whether validity testing is necessary for hair and, if so, what tests 
could be used.
    The policy in Section 3.2 does not differ from that for urine 
testing in that an agency may test a donor's hair specimen for 
additional drugs on a case-by-case basis. For reasons outlined above, 
hair may be used for pre-employment and random testing purposes but 
cannot be used for other reasons (e.g., reasonable suspicion and post-
accident testing). A federal agency must consider collecting another 
authorized specimen type (e.g., urine or oral fluid) in such cases.
    The Department has included the same policy as the UrMG for a 
federal agency that wishes to routinely test its specimens for any drug 
not included in the Guidelines, in that the agency must obtain approval 
from the Department before expanding its program. The HHS-certified 
laboratory performing such additional testing must validate the test 
methods and meet the quality control requirements as described in the 
Guidelines for the other drug analyses.
    Section 3.3 states that specimens must only be tested for drugs and 
to determine their validity in accordance with Subpart C of these 
Guidelines. Additional explanation is provided above, in the 
description of Section 2.6.
    The table in Section 3.4 lists the proposed analytes and cutoff 
concentrations for hair. Most of the analytes and cutoffs are the same 
as those proposed in 2004. The Department has added the same 
prescription opioids (i.e., hydrocodone, hydromorphone, oxycodone, and 
oxymorphone) as the UrMG, with the same hair cutoffs as codeine and 
morphine. The codeine and morphine cutoffs are consistent with those 
recommended by the European Workplace Drug Testing Society and the 
Society of Hair Testing.44 45 The Department is specifically 
requesting comments on the appropriateness of these analytes and 
cutoffs.
    Due to issues of possible external contamination and possible 
concerns of hair color impact, SAMHSA is continuing to evaluate 
standards regarding these issues. The Department is soliciting 
comments, with supporting scientific information, on unique metabolites 
as defined in these Guidelines that show use, or ingestion, of a drug, 
thereby eliminating external contamination as a concern.
    Other footnotes in the Section 3.4 table include the same 
calibration and immunoassay cross-reactivity requirements as the UrMG 
for the initial tests. This includes the requirement for a laboratory 
to use the confirmatory test cutoff as the cutoff for an alternate 
technology initial test that is specific for THCA. Immunoassays for 
cannabinoids react with multiple compounds that may be incorporated 
into hair as a result of marijuana use. Therefore, it is necessary to 
use an immunoassay cutoff higher than that of the confirmatory test in 
order to detect the target analyte (THCA) at or above the confirmatory 
test cutoff. An initial test using an alternate technology with 
specificity comparable to the confirmatory test requires use of the 
confirmatory test cutoff.
    Section 3.5 has the same policy as the UrMG regarding additional 
tests to provide information that the MRO would use to report a 
verified drug test result. HHS-certified laboratories are authorized to 
perform additional tests upon MRO request on a case-by-case basis, but 
are not authorized to routinely perform such tests without prior 
authorization from the Secretary or designated HHS representative, with 
the exception of the determination of D, L stereoisomers of amphetamine 
and methamphetamine. The Department is requesting comments including 
supporting data from the scientific literature on specimen validity 
tests and tests for additional analytes (e.g., metabolites) that may be 
performed on a case-by-case basis or routinely upon MRO request.
    Section 3.6 includes criteria for reporting a hair specimen as 
adulterated. While there are no known hair adulterants at this time, 
the Department is proposing to establish criteria similar to that for 
urine specimens, to ensure procedures that are forensically acceptable 
and scientifically sound, while allowing laboratories the flexibility 
necessary to develop specific testing requirements for an adulterant.
    Section 3.7 includes criteria applicable for reporting a hair 
specimen as substituted (i.e., the laboratory has identified physical 
or chemical characteristics inconsistent with human hair).
    Section 3.8 incorporates criteria from the UrMG that are applicable 
for reporting an invalid result for a hair specimen and includes 
additional criteria specific for hair specimens. As noted previously, 
the Department is proposing that laboratories subject each confirmatory 
drug test specimen to a validated and effective decontamination 
procedure prior to testing for the confirmatory test analyte(s) listed 
in Section 3.4. If a laboratory has used its validated decontamination 
procedure for a specimen with a positive confirmatory drug test and was 
unable to distinguish external contamination from drug ingestion based 
on its test results, the laboratory would report the specimen as 
invalid. Additionally, a hair specimen may be damaged to the extent 
that the drug test is invalid (i.e., the damaged hair is susceptible to 
incorporation of drug from external contamination or to loss of 
incorporated drug). Therefore, the Department is also proposing that 
each laboratory use a validated specimen validity test to identify 
damaged specimens and report specimens as invalid when the damage may 
affect the drug test result. The Department is requesting comments on 
whether testing for hair damage should be routinely performed on all 
specimens or only on certain specimens (e.g., based on initial test 
results).

Subpart D--Collectors

    Sections 4.1 through 4.5 contain the same policies as described in 
the UrMG regarding who may or may not collect a specimen, the 
requirements to be a collector, the requirements to be a trainer for 
collectors, and what a federal agency must do before a collector is 
permitted to collect a specimen.

Subpart E--Collection Sites

    Sections 5.1 through 5.6 address requirements for collection sites, 
collection site records, how a collector ensures the security and 
integrity of a specimen at the collection site, and the privacy 
requirements when collecting a specimen. These are the same 
requirements as in the UrMG.

Subpart F--Federal Drug Testing Custody and Control Form

    Sections 6.1 and 6.2 are the same as in the UrMG, requiring the 
OMB-approved Federal CCF be used to document custody and control of 
each specimen at the collection site, and specifying what should occur 
if the correct OMB-approved CCF is not used.

Subpart G--Hair Specimen Collection Materials

    Section 7.1 describes the collection materials that must be used to 
collect a hair specimen. The Department is proposing that either 
single-use or reusable scissors may be used to cut the hair. If 
reusable scissors are used, the collector must use an individually 
packaged isopropyl alcohol wipe to clean the scissors in the presence 
of the donor. Materials also must include two specimen guides, as 
defined in Section 1.5, and two sealable collection containers for the 
A and B specimens.
    Section 7.2 describes specific requirements for the hair collection 
materials, to maintain the integrity of the specimen. All collection 
materials that come into contact with the hair

[[Page 56118]]

must not substantially affect the composition of drug and/or drug 
metabolites in the specimen. The specimen guides and containers must be 
sufficiently transparent to enable an objective assessment of specimen 
appearance and identification of abnormal physical characteristics 
without opening the container. This is the same requirement as in the 
UrMG for urine collection bottles.
    Section 7.3 details the minimum performance requirements for hair 
collection materials. Specimen guides must be capable of holding the 
hair specimen as positioned by the collector, and have an indication of 
the orientation (i.e., root or distal end) of the hair specimen 
collected. The specimen guides or the containers must have graduated 
markings or guides for collectors to verify the minimum width (i.e., 
0.5 inches wide) and length (i.e., 1.0 inch, approximately 2.5 cm, 
long) of hair that would equate to 100 mg of hair or 50 mg of hair in 
each container labeled A and B.

Subpart H--Hair Specimen Collection Procedure

    This subpart addresses the same topics, in the same order, as the 
UrMG procedures for urine specimen collection, but excludes UrMG 
requirements that are specific for observed or monitored urine 
collection.
    Section 8.1 includes the procedures required to provide privacy for 
the hair donor during the collection procedure.
    Sections 8.2 through 8.5 describe the responsibilities and 
procedures the collector must follow before, during, and after a hair 
collection. Sections 8.3 and 8.5 specify how hair is to be selected, 
collected, and packaged. Section 8.3 requires the collector to stop the 
collection if lice or a similar infestation is present in the donor's 
hair and Section 8.4 requires the collector to stop the collection if 
the donor has false hair and the collector cannot collect a sufficient 
amount of the donor's own hair. In these cases, the collector proceeds 
with collection of another specimen type authorized by the federal 
agency. Section 8.5 specifies that only head hair should be collected.
    Section 8.6 describes the procedures the collector must follow when 
a donor is unable to provide a hair specimen (i.e., as described in 
Sections 2.1, 8.3, and 8.4). In these cases, the collector proceeds 
with collection of another specimen type authorized by the federal 
agency.
    Section 8.7 requires collection of an alternate specimen when a 
donor is unable to provide a sufficient amount of hair for faith-based 
or medical reasons, or due to an insufficient amount or length of hair. 
As noted earlier, if a federal agency authorizes the collection of hair 
specimens in its workplace drug testing program, it must also authorize 
the collection of one or more alternate specimen types in the event 
that hair cannot be collected, in accordance with the Mandatory 
Guidelines for the alternate specimen type. Enabling collection of 
another specimen without delay should facilitate the pre-employment 
process and may help reduce attempts to subvert the drug test.
    Section 8.8 describes how the collector prepares the hair 
specimens, including the description of the hair split specimen 
collection.
    Section 8.9 specifies how a collector is to report a refusal to 
test. The procedures are the same as in the UrMG.
    Section 8.10 is the same as that in the UrMG in regard to federal 
agency responsibilities for ensuring that each collection site complies 
with all provisions of the Mandatory Guidelines. An example of 
appropriate action that may be taken in response to a reported 
collection site deficiency is self-assessment using the Collection Site 
Checklist for the Collection of Hair Specimens for Federal Agency 
Workplace Drug Testing Programs. This document will be available on the 
SAMHSA website http://www.samhsa.gov/workplace/drug-testing.

Subpart I--HHS-Certification of Laboratories

    This subpart addresses the same topics for HHS certification of 
laboratories to test hair specimens, as are included in the UrMG for 
HHS certification of laboratories to test urine specimens.
    Sections 9.1 through 9.4 contain the same policies as in the UrMG 
for laboratories to become HHS-certified and to maintain HHS 
certification to conduct hair testing for a federal agency, as well as 
what a laboratory must do when certification is not maintained.
    Section 9.5 contains specifications for NLCP PT samples, Section 
9.6 contains PT requirements for an applicant laboratory, and Section 
9.7 contains PT requirements for an HHS-certified laboratory. These 
sections incorporate the applicable requirements from the current UrMG, 
but exclude UrMG requirements that are specific for urine testing. In 
Sections 9.6 and 9.7, the Department also added a requirement for 
laboratories to correctly identify a sample that has been contaminated 
with one or more drugs.
    As noted earlier, the Department plans to use multiple types of 
head hair (e.g., drug user hair, hair contaminated with drug analytes, 
hair subjected to cosmetic treatments, bleached hair) in the NLCP PT 
Program. These samples will be used to challenge the laboratories' 
abilities to identify and quantify drug analytes, to remove external 
contamination, and to identify damaged hair. The Department will use 
additional PT materials (e.g., spiked reference materials) as part of a 
multi-pronged approach to assess accuracy and precision of HHS 
certified hair testing laboratories. The Department is specifically 
requesting comments on the types of samples and multi-pronged approach 
to be included in the hair PT program.
    The remaining Sections 9.8 through 9.17 contain the same policies 
as the UrMG. These sections address inspection requirements for 
applicant and HHS-certified laboratories, inspectors, consequences of 
an applicant or HHS-certified laboratory failing to meet PT or 
inspection performance requirements, factors considered by the 
Secretary in determining the revocation or suspension of HHS-
certification, the procedure for notifying a laboratory that adverse 
action (e.g., suspension or revocation) is being taken by HHS, and the 
process for re-application once a laboratory's certification has been 
revoked by the Department.
    Section 9.17 states that a list of laboratories certified by HHS to 
conduct forensic drug testing for federal agencies will be published 
monthly in the Federal Register. The list will indicate the type of 
specimens (e.g., hair, oral fluid, and/or urine) that each laboratory 
is certified to test.

Subpart J--Blind Samples Submitted by an Agency

    This subpart (Sections 10.1 through 10.4) describes the same 
policies for federal agency blind samples as the UrMG, with two 
exceptions. Hair blind samples that challenge specimen validity tests 
are not required, and the concentration of drug positive blind samples 
must be at least 1.5 times the initial drug test cutoff concentration 
(i.e., no upper limit as in the UrMG).

Subpart K--Laboratory

    This subpart addresses the same topics, in the same order, as the 
UrMG procedures for laboratories testing urine specimens. As 
appropriate, the section includes requirements that are specific for 
hair testing.
    Sections 11.1 through 11.8 include the same requirements that are 
contained in the UrMG for the laboratory standard operating procedure

[[Page 56119]]

(SOP) manual; responsibilities and scientific qualifications of the 
responsible person (RP); procedures in the event of the RP's extended 
absence from the laboratory; qualifications of the certifying 
scientists, certifying technicians, and other HHS-certified laboratory 
staff; security; and chain of custody requirements for specimens and 
aliquots.
    A new Section 11.9 has been added to describe how an HHS-certified 
laboratory processes the alternate authorized specimen that was 
collected at the same time as a hair specimen in accordance with 
Section 8.5(e).
    A new Section 11.10 has been added to describe the amount of hair 
tested. This section specifies that 1.0 inch of the hair specimen from 
the root end is tested, when the collector has identified the root end.
    Sections 11.11 through 11.16 include the same requirements as in 
the UrMG in regard to initial and confirmatory drug test requirements, 
validation, and batch quality control as described in each section 
below.
    Section 11.11 describes the requirements for the initial drug test 
which permit the use of an immunoassay or alternate technology (e.g., 
spectrometry or spectroscopy).
    Sections 11.12 and 11.13 cover validation and quality control 
requirements for the initial tests.
    Section 11.14 describes the same requirements for a confirmatory 
drug test as the UrMG with one exception. This section requires 
laboratories to perform a decontamination procedure prior to 
confirmatory drug testing.
    Sections 11.15 and 11.16 cover validation and quality control 
requirements for the confirmatory tests. Section 11.15 includes the 
requirement to demonstrate and document the effectiveness of 
decontamination procedures and Section 11.16 requires at least one 
control in each batch to monitor the effectiveness of the 
decontamination procedure.
    Sections 11.17 and 11.18 address specimen validity tests that a 
laboratory performs for hair specimens. The Department is proposing 
that each laboratory have a validated specimen validity test that 
identifies hair that has been damaged to the extent that a drug test 
may be affected. The HMG allow, but do not require, other specimen 
validity testing for hair. The HMG collection procedures greatly 
minimize the risks of donor attempts to tamper with the specimen. To 
avoid prohibiting use of scientifically supportable hair biomarker or 
adulterant tests that may become available, the Department is 
authorizing specimen validity testing upon request of the Medical 
Review Officer as described in Sections 3.1 and 3.5. All tests must be 
properly validated and include appropriate quality control samples in 
accordance with these Guidelines. Specimen validity testing methods 
must be approved by SAMHSA prior to use with federally regulated 
specimens. As noted earlier, the Department is requesting information 
on procedures to identify damaged hair and other specimen validity 
tests for hair. The Department is also requesting comments on whether 
testing for hair damage should be routinely performed on all specimens 
or only on certain specimens (e.g., based on initial test results).
    Section 11.19 describes in detail, requirements for how a certified 
laboratory reports test results to the MRO for hair specimens. This 
section has requirements specific to hair.
    Sections 11.20 and 11.21 contain the same requirements as the UrMG 
for length of time of specimen and record retention and specifies that 
hair specimens must be stored at room temperature and out of direct 
light. As noted in Section 11.9, the collector forwards the alternate 
authorized specimen collected at the same time as the hair specimen to 
a laboratory that is certified by HHS for that specimen type. Section 
11.20 also requires that alternate authorized specimens (e.g., urine, 
oral fluid) be retained under appropriate storage conditions as 
specified by the Mandatory Guidelines for that specimen type, for the 
same period of time that the associated hair specimen is retained.
    Section 11.22 describes the statistical summary report that a 
laboratory must provide to a federal agency for hair testing. This 
section is comparable to the same section in the UrMG, differing only 
in that the statistical report elements are specific for hair testing.
    Section 11.23 addresses the laboratory information to be made 
available to a federal agency and describes the contents of a standard 
laboratory documentation package. This is the same policy as in the 
UrMG.
    Section 11.24 addresses the laboratory information to be made 
available to an applicant or employee upon written request through the 
MRO, and clarifies that specimens are not a part of the information 
package that donors can receive from HHS-certified laboratories. This 
is the same policy as in the UrMG.
    The remaining section, Section 11.25, describes the relationships 
that are prohibited between an HHS-certified laboratory and an MRO. 
These are the same as in the UrMG.

Subpart L--Instrumented Initial Test Facility (IITF)

    This subpart emphasizes that federal agencies may choose to use 
IITFs for urine testing but not for hair testing. Section 12.1 clearly 
states that only HHS-certified laboratories are authorized to test hair 
specimens for federal agency workplace drug testing programs. 
Instrumented Initial Test Facilities will not be allowed, primarily 
because of the limited amount of hair collected from the donor.

Subpart M--Medical Review Officer (MRO)

    MROs play a key role in the federal safety program and maintain the 
balance between the safety and privacy objectives of the program. This 
subpart addresses the same topics, in the same order, as the UrMG 
procedures for MROs.
    The proposed requirements in Section 13.1 through 13.3 are the same 
as in the UrMG, including training requirements in Section 13.3 for a 
physician to receive training on the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs for all authorized specimen types prior 
to serving as an MRO, and for a certified MRO to complete training on 
any revisions to the Guidelines prior to their effective date, to 
continue serving as an MRO for federal agency specimens. Section 13.4 
includes the same requirements as the UrMG except the HMG do not permit 
an MRO to conduct a medical evaluation or review the examining 
physician's findings to determine clinical evidence of opioid abuse 
when codeine or morphine is positive below a specified concentration in 
hair. Because of the longer detection time for hair, the medical 
evaluation would not be useful after limited drug use (e.g., injection 
site healing). Furthermore, this requirement would have significant 
effects on the costs of the program and the turnaround time of the 
result. The Department would like to clarify that the Mandatory 
Guidelines, including the HMG, authorize testing that detects illicit 
drug use, not drug ``abuse.'' Therefore, an MRO's inquiry in this 
context is limited to whether a legitimate medical explanation exists 
for the positive result, not whether the donor has ``abused'' opioids.
    Section 13.5 describes an MRO's actions when reviewing a hair 
specimen's test results. This section includes procedures that are 
specific to hair specimen results. The review and verification 
procedures for negative, adulterated, and substituted results are the 
same as those for urine. The review

[[Page 56120]]

and verification procedures for invalid results and rejected specimens 
are the same as those for urine, except that the HMG specifically 
requires testing of an alternate specimen type in these cases. MRO 
actions required for a positive hair test are described below.
    When an HHS-certified laboratory reports a positive result for the 
primary (A) hair specimen, the MRO must contact the donor to determine 
if there is an explanation for the positive test. If the donor provides 
a legitimate medical explanation (e.g., a valid prescription), the MRO 
reports the hair test result as negative to the federal agency. If the 
donor admits illicit use of the drug(s) that caused the positive test, 
the MRO reports the hair test result as positive to the federal agency. 
If the donor is unable to provide a legitimate medical explanation and 
does not admit illicit drug use, the MRO cancels the test and directs 
testing of an alternate authorized specimen from the donor.
    If an alternate authorized specimen was collected at the same time 
as the hair specimen, the MRO directs (in writing) the laboratory who 
has custody of the specimen to proceed with testing. If an alternate 
specimen was not collected, the MRO directs the agency to collect an 
alternate authorized specimen from the donor. The collector, 
laboratory, and MRO must follow the applicable Mandatory Guidelines for 
Federal Workplace Drug Testing Programs for that specimen type.
    The MRO would also direct testing of the alternate authorized 
specimen for invalid and rejected for testing hair results.
    The Department had considered specifying a morphine or codeine 
confirmatory concentration that could be used as a decision point to 
rule out consumption of food products as a legitimate explanation for 
the donor having morphine or codeine at or above the specified 
concentration in his or her hair. There is limited information in the 
scientific literature on the codeine and/or morphine concentrations 
seen in hair after consumption of poppy seed food products. One study 
found morphine concentrations ranging from 0.05 -0.48 ng/10 mg (5.0-
48.0 pg/mg) in the hair of 10 poppy seed consumers.\46\ The Department 
had chosen a conservative concentration of 2000 pg/mg (i.e., 10 times 
the confirmatory test cutoff) as the decision point. Because the HMG 
require testing of an alternate specimen when a hair test is positive 
(i.e., unless the donor has a legitimate medical explanation or admits 
illicit drug use), the additional decision point for codeine and 
morphine results is not needed. However, in the event that this is 
needed in the final HMG, the Department specifically requests public 
comment on the appropriateness of this concentration.
    Section 13.6 describes what an MRO must do when the collector 
reports that a donor did not provide a sufficient amount of hair for a 
drug test. In the event a donor was unable to provide a sufficient 
amount of hair, the collector should direct the donor to submit another 
authorized specimen type consistent with the respective federal 
agency's policies and procedures.
    Sections 13.7 and 13.8 are similar to the UrMG, addressing who may 
request a test of the split (B) specimen and how an MRO reports a 
primary (A) specimen result. However, because the MRO does not report 
positive hair test results to the federal agency without corroborating 
evidence (i.e., donor admission of illicit drug use); the split 
specimen is not tested to reconfirm a positive hair test result. Split 
hair specimens are only retested to reconfirm adulterated or 
substituted results at the donor's request.
    Section 13.9 is the same as in the UrMG, addressing the types of 
relationships that are prohibited between an MRO and an HHS- certified 
laboratory.

Subpart N--Split Specimen Tests

    Section 14.1 includes the same policies as the UrMG in regard to 
when a split (B) specimen may be tested. As noted previously in this 
preamble, because the MRO does not report positive hair test results to 
the federal agency without corroborating evidence (i.e., donor 
admission of illicit drug use), split specimens are not tested to 
reconfirm positive hair test results. A split hair specimen may be 
tested only to reconfirm an adulterated or substituted result reported 
for the primary hair specimen.
    Section 14.2 specifies how the split testing laboratory tests a 
split (B) hair specimen when the primary (A) specimen was reported as 
adulterated. As noted previously in this Preamble, the Department is 
not aware of any adulterants being used for hair specimens, but has 
included policies in these Guidelines to allow for the testing and 
reporting of adulterants in hair.
    Section 14.3 specifies how the split testing laboratory tests a 
split (B) hair specimen when the primary (A) specimen was reported as 
substituted. As noted previously in this Preamble, the Department is 
requesting information from the public on specimen validity tests for 
hair, and has included policies in these Guidelines to allow for the 
testing and reporting of hair as substituted.
    Section 14.4 includes the same policy as the UrMG, requiring the 
laboratory to report the split (B) specimen result to the MRO.
    In Section 14.5, the Department is proposing the actions an MRO 
must take after receiving the split (B) specimen result. This section 
is analogous to the corresponding section in the UrMG with differences, 
where applicable, for hair specimen reports.
    Section 14.6 is the same as the UrMG in regard to how an MRO 
reports a split (B) specimen result to an agency.
    Section 14.7 is the same as the UrMG, requiring the HHS-certified 
laboratory to retain a split hair specimen for the same length of time 
that the primary specimen is retained.

Subpart O--Criteria for Rejecting a Specimen for Testing

    Section 15.1 specifies the same fatal flaws as the UrMG that 
require the laboratory to reject the specimen, with one addition 
specific to hair specimens. Section 15.1, item (i) requires the 
laboratory to reject the specimen when the physical characteristics of 
the primary (A) and split (B) specimen are clearly different (i.e., 
could not be from the same individual). An example of a hair specimen 
that would be rejected is a short straight hair sample labeled as A and 
a long curly hair labeled as B. However, this requirement does not 
apply to A and B specimens that only have different hair color, because 
an individual may have different colored hair. Sections 3.8(c) and 
11.19(e) address reporting as invalid when A and B specimens have 
clearly different colors, and the A specimen has been tested.
    Section 15.3 lists those discrepancies that would not affect either 
testing or reporting of a hair specimen result. These are similar to 
the corresponding section in the UrMG, with differences where 
applicable for hair specimens.
    The other sections in this Subpart (i.e., Sections 15.2 and 15.4) 
contain the same policies as the UrMG concerning correctable 
discrepancies and fatal flaws that may require the MRO to cancel the 
test.

Subpart P--Laboratory Suspension/Revocation Procedures

    In this subpart, the Department proposes the same procedures that 
are described in the UrMG to revoke or suspend the HHS certification of 
laboratories.

[[Page 56121]]

Impact of These Guidelines on Government Regulated Industries

    The Department is aware that these proposed new Guidelines may 
impact the Department of Transportation (DOT) and Nuclear Regulatory 
Commission (NRC) regulated industries depending on these agencies' 
decisions to incorporate the final HMG into each of their programs 
under their own authority.

Topics of Special Interest

    The Department requests public comment on all aspects of this 
notice. However, the Department is providing the following list of 
areas for which specific comments are requested.
    The continuing questions and concerns on the impact of hair color 
on drug test results are discussed in this preamble. The Department is 
requesting information including, at a minimum, support from the 
scientific literature to address the impact of hair color on hair drug 
test results.
    To address the potential issues of both disparate impact and 
external contamination, Section 2.1 includes the requirement to collect 
a second biological specimen (i.e., urine or other authorized specimen 
type) at the same time as the hair specimen or as directed by the MRO 
after verification of a hair specimen as positive, invalid, or when the 
laboratory rejected the hair specimen. Under these procedures, MROs 
would only be authorized to report the results of a positive hair test 
to an agency when the donor admits to the MRO the illicit use of the 
drug(s) that caused the positive test. The Department is specifically 
requesting comments including support from the recent scientific 
literature on advances in the science of hair testing that adequately 
address these issues and elucidate the extent to which hair color, 
external contamination as well as other factors (e.g., hair treatments, 
hygiene) will affect hair tests and the interpretation of hair drug 
test results. The Department is also requesting comment with scientific 
support on whether THCA positive hair tests should be excluded from the 
requirement to test an alternate authorized specimen (i.e., MROs would 
report verified positive THCA hair results to the federal agency) and 
information on other unique metabolites that can be analyzed on a 
stand-alone basis for the other proposed drugs listed in Section 3.4.
    Section 2.2 describes the circumstances under which a hair specimen 
may be collected. The Department proposes to limit the reasons for 
testing to pre-employment and random. Because drug analytes do not 
appear in hair for 5-7 days after use, hair is not an appropriate 
specimen to detect recent use. However, the longer window of detection 
makes hair an appropriate choice for pre-employment and random. The 
Department is requesting comments on whether hair may be used for other 
reasons (e.g., return to duty, follow-up,).
    In Sections 3.1 and 3.5, the Department allows laboratories to 
perform specimen validity testing for hair specimens. The Department is 
seeking comments on whether validity testing is necessary for hair and, 
if so, what tests could be used.
    Section 3.4 lists the proposed test analytes and cutoff 
concentrations. The Department is specifically requesting comments on 
the appropriateness of these analytes and cutoffs.
    Section 3.5 allows laboratories to perform additional tests to 
provide information that the MRO would use to report a verified drug 
test result. The Department is specifically requesting comments 
including supporting data from the scientific literature on additional 
analytes (e.g., metabolites) that may be tested on a case-by-case basis 
or routinely upon MRO request.
    Section 9.5 contains the specifications for PT samples. The 
Department is specifically requesting comments on the types of samples 
and the multi-pronged approach that should be included in a hair PT 
program.
    In Section 11.14, the Department is proposing that laboratories 
implement procedures to distinguish external contamination from drug 
use using a validated and effective decontamination procedure prior to 
confirmatory testing. The Department is requesting comment on (1) 
decontamination procedures that remove drug present as a result of 
external contamination, (2) procedures used to prepare decontamination 
controls, and (3) drug metabolites that are uniquely found in hair 
after drug use.
    In Section 11.17, the Department is proposing that laboratories 
implement procedures to identify damaged hair specimens. The Department 
is requesting information including, at a minimum, support from the 
scientific literature, on procedures to identify damaged hair. The 
Department is also requesting comments on whether testing for hair 
damage should be routinely performed on all specimens or only on 
certain specimens (e.g., based on initial test results).
    In Section 13.5, the Department had considered a concentration 
equal to or greater than 2000 pg/mg morphine or codeine be used by the 
MRO to report a positive hair test result for these drugs in the 
absence of a legitimate medical explanation (i.e., prescription), to 
rule out the possibility of a positive result due to consumption of 
food products. The proposal for testing an alternate specimen type for 
all positive hair tests negates the need for this procedure. However, 
the Department is requesting specific comments on this proposed 
concentration if it is included in the final HMG.

Regulatory Impact and Notices

    The Department welcomes public comment on all figures and 
assumptions described in this section.

Executive Orders 13563 and 12866

    Executive Order 13563 of January 18, 2011 (Improving Regulation and 
Regulatory Review) states ``Our regulatory system must protect public 
health, welfare, safety, and our environment while promoting economic 
growth, innovation, competitiveness, and job creation.'' Consistent 
with this mandate, Executive Order 13563 requires agencies to tailor 
``regulations to impose the least burden on society, consistent with 
obtaining regulatory objectives.'' Executive Order 13563 also requires 
agencies to ``identify and consider regulatory approaches that reduce 
burdens and maintain flexibility and freedom of choice'' while 
selecting ``those approaches that maximize net benefits.'' This notice 
proposes a regulatory approach that will reduce burdens to providers 
and to consumers while continuing to provide adequate protections for 
public health and welfare.
    The Secretary has examined the impact of the proposed Guidelines 
under Executive Order 12866, which directs federal agencies to assess 
all costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity).
    According to Executive Order 12866, a regulatory action is 
``significant'' if it meets any one of a number of specified 
conditions, including having an annual effect on the economy of $100 
million; adversely affecting in a material way a sector of the economy, 
competition, or jobs; or if it raises novel legal or policy issues. The 
proposed Guidelines do establish additional regulatory requirements and 
allow an activity that was otherwise prohibited. While this is a 
significant regulatory action as defined

[[Page 56122]]

by Executive Order 12866, the Secretary finds that it does not confer 
significant costs to regulated entities warranting a regulatory 
flexibility analysis. Therefore, the Department does not find these 
proposed mandatory guidelines to be a significant burden for federal 
agencies or incur a significant cost. In addition, a federal agency is 
not required to adopt hair testing in their Drug-free Workplace 
Programs.

Regulatory Flexibility Analysis

    For the reasons outlined above, the Secretary has determined that 
the proposed Guidelines will not have a significant impact upon a 
substantial number of small entities within the meaning of the 
Regulatory Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by 
the HMG will not require additional expenditures. Therefore, an initial 
regulatory flexibility analysis is not required for this notice.

Need for Regulation

Enhances Flexibility

    The proposed Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Hair (HMG) will provide flexibility to address 
workplace drug testing needs of federal agencies and federally 
regulated entities while continuing to promulgate established standards 
to ensure the full reliability and accuracy of drug test results.

Enhances Versatility

    Medical conditions exist that may prevent a federal employee or 
applicant from providing sufficient urine or oral fluid for a drug 
test. When the HMG are implemented, in the event that an individual is 
unable to provide a urine or oral fluid specimen, the federal agency 
may authorize the collection of a hair specimen. In the event a federal 
agency adopts hair testing and the donor is unable to provide a hair 
specimen for faith-based or medical reasons, or due to an insufficient 
amount or length of hair, the federal agency would be required to 
collect an alternate specimen. Thus, the inclusion of hair in federal 
workplace drug testing programs will reduce both the need to reschedule 
collections and the need for the Medical Review Officer (MRO) to 
arrange a medical evaluation of a donor's inability to provide a urine 
or oral fluid specimen.
    Urine collection requires use of a specialized collection facility, 
secured restrooms, observers of the same gender as the donor for 
observed collections, and other special requirements. Hair may be 
collected in various settings and may not necessarily require a 
specialized collection facility, but if a second authorized specimen is 
collected at the same time then the collection facility must meet the 
requirements for a collection facility for the alternate specimen. An 
acceptable hair collection site must allow the collector to observe the 
donor, maintain control of the collection materials during the process, 
maintain record storage, and protect donor privacy.

Decreases Invalid Tests

    Hair collections will occur under direct observation, which should 
substantially lessen the risks of invalid results due to specimen 
substitution and adulteration. The Department is also proposing that 
each laboratory have a method to identify damaged hair as invalid 
specimens, which would further decrease the risk of invalid results.

Saves Time

    The requirement to collect a urine or oral fluid specimen in the 
event that the donor cannot provide a hair specimen (and vice versa) 
will reduce both the need to reschedule a collection and the need for 
the MRO to arrange a medical evaluation of a donor's inability to 
provide a urine or oral fluid specimen.

Versatility in Detection

    The time course of drugs and metabolites differs between hair, 
urine, and oral fluid, resulting in some differences in analytes and 
detection times. A federal agency may wish to pursue hair testing if 
they want to use a longer detection window and retain the ability to 
use other specimen types for circumstances necessitating more recent 
use, such as post-accident situations.

Current Testing in the Drug-Free Workplace Program

    Urine was the original specimen of choice for forensic workplace 
drug testing, and urine testing is expected to remain an established 
and reliable component of federal workplace drug testing programs. 
Urine testing provides scientifically accurate and legally defensible 
results and has proven to be an effective deterrent to drug use in the 
workplace. However, urine testing is not observed in all cases. Hair 
testing, like oral fluid testing, is observed, and therefore, less 
susceptible to substitution or adulteration.

Time Horizon of this Analysis

    The transition to the testing of hair will be gradual over the 
course of four years, when it should plateau. By that time, it is 
expected that hair tests will account for 25-30% of all regulated drug 
testing. This estimate is based on the current percentage of regulated 
pre-employment and random tests using urine and the non-regulated 
sector's time course of the testing of hair, oral fluid, and urine in 
the past four years.

Cost and Benefit

    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS certified laboratories, the Department estimates that 
275,000 specimens are will be tested annually by federal agencies. HHS 
projects that approximately 1% (or 2,750) of the 275,000 specimens 
tested per year will be hair specimens and 92% (or 253,000) will be 
urine specimens, with the remainder being oral fluid specimens 
(19,250). The approximate annual number of regulated specimens for the 
Department of Transportation (DOT) and Nuclear Regulatory Commission 
(NRC) is 6.1 million and 150,000, respectively. Should DOT and NRC 
allow hair testing in their regulated workplace programs, the estimated 
annual numbers of specimens for DOT would be 25% (1.53 million) hair 
specimens for pre-employment, 7% (427,000) oral fluid specimens and 68% 
(4.15 million) urine, and numbers of specimens for NRC would be 10% 
(15,000) hair, 7% (10,500) oral fluid and 83% (124,500) urine. These 
projected numbers are based on existing annual pre-employment testing 
that currently occurs in the regulated industries and current hair 
testing being conducted.
    In Section 3.4, the Department is proposing criteria for 
calibrating initial tests for grouped analytes such as opiates and 
amphetamines, and specifying the cross-reactivity of the immunoassay to 
the other analytes(s) within the group. These proposed Guidelines allow 
the use of methods other than immunoassay for initial testing. An 
immunoassay manufacturer may incur costs if they choose to alter their 
existing product and resubmit the immunoassay for FDA clearance.
    Costs associated with the addition of hair testing and testing for 
oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal 
based on information from some HHS-certified laboratories currently 
testing non-regulated hair specimens. Likewise, there will be minimal 
costs associated with changing initial testing to include MDA and MDMA 
since current immunoassays can be adapted to test for these analytes. 
Prior to being allowed to test regulated hair specimens, laboratories 
must be certified by the Department through the NLCP. Estimated 
laboratory costs to complete and submit the application are $3,000, and 
estimated costs for the Department to process the application are 
$10,200.

[[Page 56123]]

These estimates are based on the NLCP fee schedule and historical 
costs. The initial certification process includes the requirement to 
demonstrate that their performance meets Guidelines requirements by 
testing three (3) groups of PT samples. The Department will provide the 
three groups of PT samples through the NLCP at no cost to laboratories 
participating in the NLCP Hair Pilot PT Program. Based on costs charged 
for urine specimen testing, laboratory costs to conduct the PT testing 
would range from $900 to $1,800 for each applicant laboratory.
    Agencies choosing to use hair in their drug testing programs may 
also incur some costs for training of federal employees such as drug 
program coordinators. Based on current training modules offered to drug 
program coordinators, and other associated costs including travel for 
90% of drug program coordinators, the estimated total training cost for 
a one-day training session would be between $108,000 and $138,000 
(i.e., assuming 8 hours of time multiplied by a GS 12/13 wage including 
benefits and overhead adjustments). This training cost is included in 
the costs of the proposed HMG. The Department will offer the choice of 
online or in-person training. This will eliminate travel costs for 
those federal agencies who choose to use online training.

Summary of One-Time Costs

 
----------------------------------------------------------------------------------------------------------------
                                                                    Lower bound     Upper bound       Primary
----------------------------------------------------------------------------------------------------------------
Cost of Application *...........................................  ..............  ..............      $12,000.00
Application Processing *........................................  ..............  ..............       40,800.00
Performance Testing *...........................................       $3,600.00       $7,200.00
Training *......................................................       54,000.00       69,000.00
                                                                 -----------------------------------------------
    Total.......................................................      110,400.00      129,000.00
----------------------------------------------------------------------------------------------------------------
* Estimated using costs presented above multiplied by the number of laboratories (4).

Costs and Benefits

    Thus, the Department estimates one-time, upfront costs of between 
$110,400 and $129,000 for hair testing laboratories. While the 
Department has only monetized a small portion of the benefits to a 
small subset of the workplace drug testing programs that could be 
affected by the HMG (i.e., federal employee testing programs and not 
drug testing programs conducted under NRC and DOT regulations), the 
Department is confident that the benefits would outweigh the one-time 
upfront costs. Even if NRC and DOT do not implement hair testing, the 
benefits to federal workplace testing programs could be a cost savings, 
which would recur on annual basis.

Regulatory Flexibility Analysis

    For the reasons outlined above, the Secretary has determined that 
the proposed Guidelines will not have a significant impact upon a 
substantial number of small entities within the meaning of the 
Regulatory Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by 
the HMG will not require addition expenditures. Therefore, an initial 
regulatory flexibility analysis is not required for this notice.
    As mentioned in the section on Executive Orders 13563 and 12866, 
the Secretary anticipates that there will be no reduction in costs if 
drug testing is expanded under the HMG. The costs to implement this 
change to regulations are negligible. The added flexibility will permit 
federal agencies to select the specimen type best suited for their 
needs and to authorize collection of an alternate specimen type when an 
applicant or employee is unable to provide the originally authorized 
specimen type. The added flexibility will also benefit federal 
applicants and employees, who should be able to provide one of the 
specimen types, thereby facilitating the drug test required for their 
employment.

Unfunded Mandates

    The Secretary has examined the impact of the proposed Guidelines 
under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). 
This notice does not trigger the requirement for a written statement 
under section 202(a) of the UMRA because the proposed Guidelines do not 
impose a mandate that results in an expenditure of $100 million 
(adjusted annually for inflation) or more by either state, local, and 
tribal governments in the aggregate or by the private sector in any one 
year.

Environmental Impact

    The Secretary has considered the environmental effects of the HMG. 
No information or comments have been received that would affect the 
agency's determination there would be a significant impact on the human 
environment and that neither an environmental assessment nor an 
environmental impact statement is required.

Executive Order 13132: Federalism

    The Secretary has analyzed the proposed Guidelines in accordance 
with Executive Order 13132: Federalism. Executive Order 13132 requires 
federal agencies to carefully examine actions to determine if they 
contain policies that have federalism implications or that preempt 
state law. As defined in the Order, ``policies that have federalism 
implications'' refer to regulations, legislative comments or proposed 
legislation, and other policy statements or actions that have 
substantial direct effects on the states, on the relationship between 
the national government and the states, or on the distribution of power 
and responsibilities among the various levels of government.
    Because the Mandatory Guidelines govern standards applicable to the 
management of federal agency personnel, there should be little, if any, 
direct effect on the states, on the relationship between the national 
government and the states, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
the Secretary has determined that the Guidelines do not contain 
policies that have federalism implications.

Paperwork Reduction Act of 1995

    The proposed Guidelines contain information collection requirements 
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)]. Information collection and recordkeeping requirements which 
would be imposed on laboratories engaged in drug testing for federal 
agencies concern quality assurance and quality control documentation, 
reports, performance testing, and inspections as

[[Page 56124]]

set out in subparts H, I, K, L, M and N. To facilitate ease of use and 
uniform reporting, a Federal CCF for each type of specimen collected 
will be developed as referenced in Section 6.1. The Department has 
submitted the information collection and recordkeeping requirements 
contained in the proposed Guidelines to OMB for review and approval.

Privacy Act

    The Secretary has determined that the Guidelines do not contain 
information collection requirements constituting a system of records 
under the Privacy Act. The Federal Register notice announcing the 
proposed Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Hair is not a system of records as noted in the 
information collection/recordkeeping requirements below.
    Note the collection of information on the Federal Chain of Custody 
Form as required by the Mandatory Guidelines are discussed below under 
information collection and record keeping and are a separate submission 
and approval by the Office of Management and Budget.

Executive Order 13175: Consultation and Coordination With Indian Tribal 
Governments

    Executive Order 13175 (65 FR 67249, November 6, 2000) requires 
SAMHSA to develop an accountable process to ensure ``meaningful and 
timely input by tribal officials in the development of regulatory 
policies that have tribal implications.'' ``Policies that have tribal 
implications'' as defined in the Executive Order, include regulations 
that have ``substantial direct effects on one or more Indian tribes, on 
the relationship between the federal government and the Indian tribes, 
or on the distribution of power and responsibilities between the 
federal government and Indian tribes.'' The proposed Guidelines do not 
have tribal implications. The Guidelines will not have substantial 
direct effects on tribal governments, on the relationship between the 
federal government and Indian tribes, or on the distribution of power 
and responsibilities between the federal government and Indian tribes, 
as specified in Executive Order 13175.

Information Collection/Record Keeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines (82 FR 7920 for urine, 84 FR 
57554 for oral fluid), which establish the scientific and technical 
guidelines for federal workplace drug testing programs and establish 
standards for certification of laboratories engaged in urine and oral 
fluid drug testing for federal agencies under authority of 5 U.S.C. 
7301 and Executive Order 12564, are approved by the Office of 
Management and Budget (OMB) under control number 0930-0158. The Federal 
Drug Testing Custody and Control Form used to document the collection 
and chain of custody of urine and oral fluid specimens at the 
collection site, for laboratories to report results, and for Medical 
Review Officers to make a determination; the National Laboratory 
Certification Program (NLCP) application; the NLCP Laboratory 
Information Checklist; and recordkeeping requirements in the current 
Guidelines, as approved under control number 0930-0158, will be revised 
for the use of hair specimens when the final Guidelines using hair are 
issued.
    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: The Mandatory Guidelines for Federal Workplace Drug Testing 
Programs using Hair.
    Description: The 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 No. 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 specimen testing since 
1988; the reporting, recordkeeping and disclosure requirements 
associated with urine specimen 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 or substitute the 
urine specimen. Scientific advances in the use of hair in detecting 
drugs have made it possible for this alternative specimen to be pursued 
in federal programs. The proposed Guidelines establish when hair 
specimens may be collected, the procedures that must be used in 
collecting a hair specimen, and the certification process for approving 
a laboratory to test hair specimens.
    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, 10 hair specimen testing 
laboratories, and 100 MROs.

                                                           Estimate of Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
9.2(a)(1)......................................  Laboratory required to submit                        10               1               3              30
                                                  application for certification.
9.10(a)(3).....................................  Materials to submit to become an HHS                 10               1               2              20
                                                  inspector.
11.3...........................................  Laboratory submits qualifications of RP              10               1               2              20
                                                  to HHS.
11.4(c)........................................  Laboratory submits information to HHS                10               1               2              20
                                                  on new RP or alternate RP.
11.21..........................................  Specifications for laboratory semi-                  10               5             0.5              25
                                                  annual statistical report of test
                                                  results to each federal agency.
14.7...........................................  Specifies that MRO must report all                  100               5    0.05 (3 min)              25
                                                  verified split specimen test results
                                                  to the federal agency.
16.1(b) & 16.5(a)..............................  Specifies content of request for                      1               1               3               3
                                                  informal review of suspension/proposed
                                                  revocation of certification.
16.4...........................................  Specifies information appellant                       1               1             0.5             0.5
                                                  provides in first written submission
                                                  when laboratory suspension/revocation
                                                  is proposed.

[[Page 56125]]

 
16.6...........................................  Requires appellant to notify reviewing                1               1             0.5             0.5
                                                  official of resolution status at end
                                                  of abeyance period.
16.7(a)........................................  Specifies contents of appellant                       1               1              50              50
                                                  submission for review.
16.9(a)........................................  Specifies content of appellant request                1               1               3               3
                                                  for expedited review of suspension or
                                                  proposed revocation.
16.9(c)........................................  Specifies contents of review file and                 1               1              50              50
                                                  briefs.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  .......................................             156  ..............  ..............             247
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 refusal to 
participate in the collection process on the Federal CCF (Sections 1.8, 
8.9); collector annotates the Federal CCF when a sample is a blind 
sample (Section 10.3(a)); MRO notifies the federal agency and HHS when 
an error occurs on a blind sample (Section 10.4(d)); Section 13.5 
describes the actions an MRO takes to report a primary specimen result; 
and Section 14.6 describes the actions an MRO takes to report a split 
specimen result. 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of      Responses/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(a) & 8.6...................................  Collector must contact federal agency               100               1    0.05 (3 min)               5
                                                  point of contact.
11.23 & 11.24..................................  Information on drug test that                        10              10               3             300
                                                  laboratory must provide to federal
                                                  agency upon request or to donor
                                                  through MRO.
13.7(b)........................................  MRO must inform donor of right to                   100               5               3           1,500
                                                  request split specimen test when an
                                                  adulterated or substituted result is
                                                  reported.
                                                --------------------------------------------------------------------------------------------------------
    Total......................................  .......................................             210  ..............  ..............           1,805
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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 
8.3(h), and must review the procedures for the hair specimen collection 
materials used with the donor (Section 8.4(c)). SAMHSA believes having 
the collector explain the collection procedure to the donor and answer 
any questions is a standard business practice and not a disclosure 
burden.

                                                         Estimate of Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                               Number of      Responses/
                 Section                               Purpose                respondents     respondent           Hours/ response          Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.4, & 8.8.........................  Collector completes Federal CCF              100             380  0.07 (4 min)................           2,534
                                           for specimen collected.
8.8(c) & (e)............................  Donor initials specimen labels/           38,000               1  0.08 (5 min)................           3,167
                                           seals and signs statement on
                                           the Federal CCF.
11.8(a) & 11.18.........................  Laboratory completes Federal CCF              10           3,800  0.05 (3 min)................           1,900
                                           upon receipt of specimen and
                                           before reporting result.
13.4(d) (4), 13.8 (c), & 14.7(c)........  MRO completes Federal CCF before             100             380  0.05 (3 min)................           1,900
                                           reporting the result.
14.1(b).................................  MRO documents donor's request to             300               1  0.05 (3 min)................              15
                                           have split hair specimen tested.
                                         ---------------------------------------------------------------------------------------------------------------
    Total...............................  ................................          38,510  ..............  ............................           9,516
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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)(3)] and 
the documentation must be maintained in the collector's training file 
[Section 4.3(c)]. 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

[[Page 56126]]

recordkeeping burden. Subpart H [Sections 8.3 (f), and 8.4 (d), (f)] 
requires collectors to enter any information on the Federal CCF of any 
unusual findings during the hair 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. Subpart K 
describes a number of recordkeeping requirements for laboratories 
associated with their testing procedures, maintaining chain of custody, 
and keeping records (i.e., Sections 11.1(a) and (d); 11.2(b), (c), and 
(d); 11.6(b); 11.7(c); 11.8; 11.12(a); 11.15(a); 11.18; 11.19(a), (b), 
and (c); 11.22; 11.23, and 11.24. These recordkeeping requirements are 
necessary for any laboratory 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.
    Thus, the total annual response burden associated with the testing 
of hair specimens by the laboratories is estimated to be 13,268 hours 
(that is, the sum of the total hours from the above tables). This is in 
addition to the 1,788,809 hours currently approved by OMB under control 
number 0930-0158 for urine testing under the current Guidelines.
    As required by Section 3507(d) of the PRA, the Secretary has 
submitted a copy of these proposed 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, 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).

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32. Henderson GL, Harkey MR, Zhou C, Jones RT, Jacob P III. 1998. 
Incorporation of isotopically labeled cocaine into human hair: race 
as a factor. J Anal Toxicol. 22:156-165.
33. Rollins DE, Wilkins DG, Krueger GG, Augsburger MP, Mizuno A, 
O'Neal C, Borges CR, Slawson MH. 2003. The effect of hair color on 
the incorporation of codeine into human hair. J Anal Toxicol. 27, 
545-551.
34. Kronstrand R, Forstberg-Peterson S, Kagedal B, Ahlner J, Larson 
G. 1999. Codeine concentration in hair after oral administration is 
dependent on melanin content. Clin Chem. 45:1485-1494.
35. Mieczkowski T. 2003. Assessing the potential of a ``color 
effect'' for hair analysis of 11-nor-9-carboxy-delta(9)-
tetrahydrocannabinol: analysis of a large sample of hair specimens. 
Life Sci. 74:463-469.
36. Mieczkowski T, Newel R. 2000. Statistical examination of hair 
color as a potential biasing factor in hair analysis. Forensic Sci. 
Int. 107:13-38.
37. Mieczkowski T, Newel R. 1993. An evaluation of patterns of 
racial bias in hair assays for cocaine: black and white arrestees 
compared. Forensic Sci. Int. 63:85-98.
38. Cuypers E, Flinders B., Bosman IJ, Lusthof KJ, Van Asten AC, 
Tytgat J, Heeren RMA. 2014. Hydrogen peroxide reactions on cocaine 
in hair using imaging mass spectrometry. Forens Sci Int. 242:103-
110.
39. Tanaka S, Iio R, Takayama N., Hayakawa K. 2001. Identification 
of reaction products of methamphetamine and hydrogen peroxide in 
hair dye and decolorant treatments by high performance liquid 
chromatography/mass spectrometry. Biomed Chromatgr. 15;45-49.
40. Pritchett JS, Phinney KW. 2015. Influence of chemical 
straightening on the stability of drugs of abuse in hair. J Anal 
Toxicol. 39:13-16.
41. Baeck S, Han E, Chung H, Pyo M. 2011. Effects of repeated hair 
washing and a single hair dyeing on concentrations of 
methamphetamine and amphetamine in human hairs. Forens Sci Int. 
206:77-80.
42. Kidwell DA, Smith FP, Shepherd AR. 2015. Ethnic hair care 
products may increase false positives in hair drug testing. Forens 
Sci Int. 257:160-164.
43. Hill V, Loni E, Cairns T, Sommer J, Schaffer M. 2014. 
Identification and analysis of damaged or porous hair. Drug Test 
Anal. 6:42-54.
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guidelines for workplace drug and alcohol testing in hair. 2015-11-
01 Version 2.0. Retrieved from http://www.ewdts.org/.
45. Cooper GAA, Kronstrand R, Kintz P. 2012. Society of hair testing 
guidelines for drug testing in hair. Forens Sci Int. 218:20-24.
46. Hill V, Cairns T, Cheng CC, Schaffer M. 2005. Multiple aspects 
of hair analysis for opiates: methodology, clinical and workplace 
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29:696-703.

Summary

    The Department believes that the benefits of pursuing the proposed 
Mandatory Guidelines using Hair outweigh the costs to include this 
additional specimen type in federal workplace drug testing programs. 
There is no requirement for federal agencies to use hair as part of 
their drug testing program. A federal agency may choose to use urine, 
oral fluid, hair or any combination of specimen types in accordance 
with the Mandatory Guidelines for each matrix in their program based on 
the agency's mission, its employees' duties, and the danger to the 
public health and safety or to national security that could result from 
an employee's failure to carry out the duties of his or her position.

    Dated: July 20, 2020.
Elinore F. McCance-Katz,
Assistant Secretary for Mental Health and Substance Use, Substance 
Abuse and Mental Health Services Administration.
    Approved: July 23, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.


0
The Mandatory Guidelines using Hair are hereby proposed to be adopted 
in accordance with section 503 of Public Law 100-71 and Executive Order 
12564.

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using 
Hair

Subpart A--Applicability
1.1 To whom do these Guidelines apply?
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?
1.7 What is a refusal to take a federally regulated drug test?
1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?
Subpart B--Hair Specimens
2.1 What type of specimen may be collected?
2.2 Under what circumstances may a hair specimen be collected?
2.3 How is each hair specimen collected?
2.4 What amount of hair is collected?
2.5 How does the collector split the hair specimen collected?
2.6 When may an entity or individual release a hair specimen?
Subpart C--Hair Specimen Tests
3.1 Which tests are conducted on a hair specimen?
3.2 May a hair specimen be tested for additional drugs?
3.3 May any of the specimens be used for other purposes?
3.4 What are the drug test cutoff concentrations for hair?
3.5 May an HHS-certified laboratory perform additional drug and/or 
specimen validity tests on a specimen at the request of the Medical 
Review Officer (MRO)?
3.6 What criteria are used to report a hair specimen as adulterated?
3.7 What criteria are used to report a hair specimen as substituted?
3.8 What criteria are used to report an invalid result for a hair 
specimen?
Subpart D--Collectors
4.1 Who may collect a specimen?
4.2 Who may not collect a specimen?
4.3 What are the requirements to be a collector?
4.4 What are the requirements to be a trainer for collectors?

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4.5 What must a federal agency do before a collector is permitted to 
collect a specimen?
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 Where must collection site records be stored?
5.4 How long must collection site records be stored?
5.5 How does the collector ensure the security and integrity of a 
specimen at the collection site?
5.6 What are the privacy requirements when collecting a hair 
specimen?
Subpart F--Federal Drug Testing Custody and Control Form
6.1 What federal form is used to document custody and control?
6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?
Subpart G--Hair Specimen Collection Materials
7.1 What is used to collect a hair specimen?
7.2 What are the requirements for hair collection materials?
7.3 What are the minimum performance requirements for hair 
collection materials?
Subpart H--Hair Specimen Collection Procedure
8.1 What privacy must the donor be given when providing a hair 
specimen?
8.2 What must the collector ensure at the collection site before 
starting a hair specimen collection?
8.3 What are the preliminary steps in the hair specimen collection 
procedure?
8.4 What steps does the collector take in the collection procedure 
before the donor provides a hair specimen?
8.5 What steps does the collector take during and after the hair 
specimen collection procedure?
8.6 What procedure is used when the donor is unable to provide a 
hair specimen?
8.7 If the donor is unable to provide a hair specimen, may another 
specimen type be collected for testing?
8.8 How does the collector prepare the hair specimens?
8.9 How does the collector report a donor's refusal to test?
8.10 What are a federal agency's responsibilities for a collection 
site?
Subpart I--HHS Certification of Laboratories
9.1 Who has the authority to certify laboratories to test hair 
specimens for federal agencies?
9.2 What is the process for a laboratory to become HHS-certified?
9.3 What is the process for a laboratory to maintain HHS 
certification?
9.4 What is the process when a laboratory does not maintain its HHS 
certification?
9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?
9.6 What are the PT requirements for an applicant laboratory that 
seeks to perform hair testing?
9.7 What are the PT requirements for an HHS-certified hair 
laboratory?
9.8 What are the inspection requirements for an applicant 
laboratory?
9.9 What are the maintenance inspection requirements for an HHS-
certified laboratory?
9.10 Who can inspect an HHS-certified laboratory and when may the 
inspection be conducted?
9.11 What happens if an applicant laboratory does not satisfy the 
minimum requirements for either the PT program or the inspection 
program?
9.12 What happens if an HHS-certified laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?
9.13 What factors are considered in determining whether revocation 
of a laboratory's HHS certification is necessary?
9.14 What factors are considered in determining whether to suspend a 
laboratory's HHS certification?
9.15 How does the Secretary notify an HHS-certified laboratory that 
action is being taken against the laboratory?
9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?
9.17 Where is the list of HHS-certified laboratories 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?
10.2 What are the requirements for blind samples?
10.3 How is a blind sample submitted to an HHS-certified laboratory?
10.4 What happens if an inconsistent result is reported for a blind 
sample?
Subpart K--Laboratory
11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?
11.2 What are the responsibilities of the responsible person (RP)?
11.3 What scientific qualifications 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 personnel of an 
HHS-certified laboratory have?
11.7 What security measures must an HHS-certified laboratory 
maintain?
11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?
11.9 How must an HHS-certified laboratory process an alternate 
specimen that was collected at the same time as a hair specimen?
11.10 What amount of hair is tested?
11.11 What are the requirements for an initial drug test?
11.12 What must an HHS-certified laboratory do to validate an 
initial drug test?
11.13 What are the batch quality control requirements when 
conducting an initial drug test?
11.14 What are the requirements for a confirmatory drug test?
11.15 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
11.16 What are the batch quality control requirements when 
conducting a confirmatory drug test?
11.17 What are the analytical and quality control requirements for 
conducting specimen validity tests?
11.18 What must an HHS-certified laboratory do to validate a 
specimen validity test?
11.19 What are the requirements for an HHS-certified laboratory to 
report a test result?
11.20 How long must an HHS-certified laboratory retain specimens?
11.21 How long must an HHS-certified laboratory retain records?
11.22 What statistical summary reports must an HHS-certified 
laboratory provide for hair testing?
11.23 What HHS-certified laboratory information is available to a 
federal agency?
11.24 What HHS-certified laboratory information is available to a 
federal employee?
11.25 What types of relationships are prohibited between an HHS-
certified laboratory and an MRO?
Subpart L--Instrumented Initial Test Facility (IITF)
12.1 May an IITF test hair specimens for a federal agency's 
workplace drug testing program?
Subpart M--Medical Review Officer (MRO)
13.1 Who may serve as an MRO?
13.2 How are nationally recognized entities or subspecialty boards 
that certify MROs approved?
13.3 What training is required before a physician may serve as an 
MRO?
13.4 What are the responsibilities of an MRO?
13.5 What must an MRO do when reviewing a hair specimen's test 
results?
13.6 What action does the MRO take when the collector reports that 
the donor did not provide a sufficient amount of hair for a drug 
test?
13.7 Who may request a test of a split (B) hair specimen?
13.8 How does an MRO report a primary (A) specimen test result to an 
agency?
13.9 What types of relationships are prohibited between an MRO and 
an HHS-certified laboratory?
Subpart N--Split Specimen Tests
14.1 When may a split (B) hair specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) hair 
specimen when the primary (A) specimen was reported adulterated?

[[Page 56129]]

14.3 How does an HHS-certified laboratory test a split (B) hair 
specimen when the primary (A) specimen was reported substituted?
14.4 Who receives the split (B) specimen result?
14.5 What action(s) does an MRO take after receiving the split (B) 
hair specimen result from the second HHS-certified laboratory?
14.6 How does an MRO report a split (B) specimen test result to an 
agency?
14.7 How long must an HHS-certified laboratory retain a split (B) 
specimen?
Subpart O--Criteria for Rejecting a Specimen for Testing
15.1 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing?
15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?
15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject a hair specimen for testing or an MRO 
to cancel a test?
15.4 What discrepancies may require an MRO to cancel a test?
Subpart P--Laboratory Suspension/Revocation Procedures
16.1 When may the HHS certification of a laboratory be suspended?
16.2 What definitions are used for this subpart?
16.3 Are there any limitations on issues subject to review?
16.4 Who represents the parties?
16.5 When must a request for informal review be submitted?
16.6 What is an abeyance agreement?
16.7 What procedures are used to prepare the review file and written 
argument?
16.8 When is there an opportunity for oral presentation?
16.9 Are there expedited procedures for review of immediate 
suspension?
16.10 Are any types of communications prohibited?
16.11 How are communications transmitted by the reviewing official?
16.12 What are the authority and responsibilities of the reviewing 
official?
16.13 What administrative records are maintained?
16.14 What are the requirements for a written decision?
16.15 Is there a review of the final administrative action?

Subpart A--Applicability

Section 1.1 To whom do these Guidelines apply?
    (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 Executive Order 
12333, is subject to these Guidelines only to the extent agreed to by 
the head of the affected agency;
    (5) Laboratories that provide drug testing services to the federal 
agencies;
    (6) Collectors who provide specimen collection services to the 
federal agencies; and
    (7) Medical Review Officers (MROs) who provide drug testing review 
and interpretation of results services to the federal agencies.
    (b) These 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.
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) To ensure the full reliability and accuracy of specimen 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 signs the Federal Drug Testing 
Custody and Control Form at the time of specimen receipt at the HHS-
certified laboratory or (for urine) the HHS-certified IITF.
    Adulterated Specimen. A specimen that has been altered, as 
evidenced by test results showing either a substance that is not a 
normal constituent for that type of specimen or showing an abnormal 
concentration of a normal constituent (e.g., nitrite in urine).
    Aliquot. A portion of a specimen used for testing.
    Alternate Responsible Person. The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of the HHS-certified laboratory when the 
responsible person is unable to fulfill these obligations.
    Alternate Technology Initial Drug Test. An initial drug test using 
technology other than immunoassay to differentiate negative specimens 
from those requiring further testing.
    Artificial hair. A weave or other synthetic forms of hair, as well 
as animal substitutes.
    Batch. A number of specimens or aliquots handled concurrently as a 
group.
    Biomarker. An endogenous substance used to validate a biological 
specimen.
    Blind Sample. A sample submitted to an HHS-certified test facility 
for quality assurance purposes, with a fictitious identifier, so that 
the test facility cannot distinguish it from a donor specimen.
    Calibrator. A sample of known content and analyte concentration 
prepared in the appropriate matrix used to define expected outcomes of 
a testing procedure. The test result of the calibrator is verified to 
be within established limits prior to use.
    Cancelled Test. The result reported by the MRO to the federal 
agency when a specimen has been reported to the MRO as an invalid 
result (and the donor has no legitimate explanation), the specimen has 
been rejected for testing, when a hair specimen has been reported as 
positive and the MRO directs testing of the alternate specimen for the 
donor, when a split specimen fails to reconfirm, or when the MRO 
determines that a fatal flaw or unrecovered correctable flaw exists in 
the forensic records (as described in Sections 15.1 and 15.2).
    Carryover. The effect that occurs when a sample result (e.g., drug 
concentration) is affected by a preceding sample during the preparation 
or analysis of a sample.
    Certifying Scientist (CS). The individual responsible for verifying 
the chain of custody and scientific

[[Page 56130]]

reliability of a test result reported by an HHS-certified laboratory.
    Certifying Technician (CT). The individual responsible for 
verifying the chain of custody and scientific reliability of negative, 
rejected for testing, and (for urine) negative/dilute results reported 
by an HHS-certified laboratory or (for urine) an HHS-certified IITF.
    Chain of Custody (COC) Procedures. Procedures that document the 
integrity of each specimen or aliquot from the point of collection to 
final disposition.
    Chain of Custody Documents. Forms used to document the control and 
security of the specimen and all aliquots. The document may account for 
an individual specimen, aliquot, or batch of specimens/aliquots and 
must include the name and signature of each individual who handled the 
specimen(s) or aliquot(s) and the date and purpose of the handling.
    Collection Container. A receptacle used to collect a donor's drug 
test specimen.
    Collection Site. The location where specimens are collected.
    Collector. A person trained to instruct and assist a donor in 
providing a specimen.
    Confirmatory Drug Test. A second analytical procedure performed on 
a separate aliquot of a specimen to identify and quantify a specific 
drug or drug metabolite.
    Confirmatory Specimen Validity Test. A second test performed on a 
separate aliquot of a specimen to further support an initial specimen 
validity test result.
    Control. A sample used to evaluate whether an analytical procedure 
or test is operating within predefined tolerance limits.
    Cutoff. The analytical value (e.g., drug or drug metabolite 
concentration) used as the decision point to determine a result (e.g., 
negative, positive, adulterated, invalid, or substituted) or the need 
for further testing.
    Decontamination. The removal of external contamination (i.e., 
environmentally-deposited drug) in or on a hair specimen.
    Donor. The individual from whom a specimen is collected.
    External Service Provider. An independent entity that performs 
services related to federal workplace drug testing on behalf of a 
federal agency, a collector/collection site, an HHS[hyphen]certified 
laboratory, a Medical Review Officer (MRO), or, for urine, an HHS-
certified Instrumented Initial Test Facility (IITF).
    Failed to Reconfirm. The result reported for a split (B) specimen 
when a second HHS-certified laboratory is unable to corroborate the 
result reported for the primary (A) specimen.
    False Hair. Hair that is not the donor's hair. False hair may be 
artificial or human in origin.
    Federal Drug Testing Custody and Control Form (Federal CCF). The 
Office of Management and Budget (OMB) approved form that is used to 
document the collection and chain of custody of a specimen from the 
time the specimen is collected until it is received by the test 
facility (i.e., HHS-certified laboratory or, for urine, HHS-certified 
IITF). It may be a paper (hardcopy), electronic, or combination 
electronic and paper format (hybrid). The form may also be used to 
report the test result to the Medical Review Officer.
    HHS. The Department of Health and Human Services.
    Initial Drug Test. An analysis used to differentiate negative 
specimens from those requiring further testing.
    Initial Specimen Validity Test. The first analysis used to 
determine if a specimen is invalid, adulterated, or substituted.
    Instrumented Initial Test Facility (IITF). A permanent location 
where (for urine) initial testing, reporting of results, and 
recordkeeping are performed under the supervision of a responsible 
technician.
    Invalid Result. The result reported by an HHS-certified laboratory 
in accordance with the criteria established in Section 3.8 when a 
positive, negative, adulterated, or substituted result cannot be 
established for a specific drug or specimen validity test.
    Laboratory. A permanent location where initial and confirmatory 
drug testing, reporting of results, and recordkeeping are performed 
under the supervision of a responsible person.
    Limit of Detection. The lowest concentration at which the analyte 
(e.g., drug or drug metabolite) can be identified.
    Limit of Quantification. For quantitative assays, the lowest 
concentration at which the identity and concentration of the analyte 
(e.g., drug or drug metabolite) can be accurately established.
    Lot. A number of units of an item (e.g., reagents, quality control 
material) manufactured from the same starting materials within a 
specified period of time for which the manufacturer ensures that the 
items have essentially the same performance characteristics and 
expiration date.
    Medical Review Officer (MRO). A licensed physician who reviews, 
verifies, and reports a specimen test result to the federal agency.
    Negative Result. The result reported by an HHS-certified laboratory 
or (for urine) an HHS-certified IITF to an MRO when a specimen contains 
no drug and/or drug metabolite; or the concentration of the drug or 
drug metabolite is less than the cutoff for that drug or drug class.
    Performance Testing (PT) Sample. A program-generated sample sent to 
a laboratory or (for urine) to an IITF to evaluate performance.
    Positive Result. The result reported by an HHS-certified laboratory 
when a specimen contains a drug or drug metabolite equal to or greater 
than the confirmation cutoff concentration.
    Reconfirmed. The result reported for a split (B) specimen when the 
second HHS-certified laboratory corroborates the original result 
reported for the primary (A) specimen.
    Rejected for Testing. The result reported by an HHS-certified 
laboratory or (for urine) an HHS-certified IITF when no tests are 
performed on a specimen because of a fatal flaw or an unrecovered 
correctable error (see Sections 15.1 and 15.2)
    Responsible Person (RP). The person who assumes professional, 
organizational, educational, and administrative responsibility for the 
day-to-day management of an HHS-certified laboratory.
    Sample. A performance testing sample, calibrator or control used 
during testing, or a representative portion of a donor's specimen.
    Secretary. The Secretary of the U.S. Department of Health and Human 
Services.
    Specimen. Fluid or material collected from a donor at the 
collection site for the purpose of a drug test.
    Specimen guide. An item that holds the hair specimen as positioned 
by the collector, and has an indication of the orientation (i.e., root 
or distal end) of the hair specimen collected.
    Split Specimen Collection (for Hair). A collection in which the 
specimen collected is divided into a primary (A) specimen and a split 
(B) specimen, which are independently sealed in the presence of the 
donor.
    Standard. Reference material of known purity or a solution 
containing a reference material at a known concentration.
    Substituted Specimen. A specimen with physical or chemical 
characteristics that are not consistent with those observed in human 
hair.
    Wash procedures. A rinse with organic solvents to remove oils and 
residue on the hair prior to initial testing.

[[Page 56131]]

    Unique metabolite. A drug metabolite present in a hair specimen 
only as a result of biotransformation following drug use, and whose 
detection by a confirmatory drug test distinguishes drug use from 
external contamination. A unique metabolite does not occur as a 
contaminant in licit and illicit drug products and is not produced from 
the drug as an artifact and only results from biotransformation 
following drug use.
Section 1.6 What is an agency required to do to protect employee 
records?
    Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency 
contracts with laboratories, collectors, and MROs must require that 
they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the 
contracts must require compliance with employee access and 
confidentiality provisions of Section 503 of Public Law 100-71. Each 
federal agency must establish a Privacy Act System of Records or modify 
an existing system or use any applicable Government-wide system of 
records to cover the records of employee drug test results. All 
contracts and the Privacy Act System of Records must specifically 
require that employee records be maintained and used with the highest 
regard for employee privacy.
    The Health Insurance Portability and Accountability Act of 1996 
(HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, Subparts A and 
E, may be applicable to certain health care providers with whom a 
federal agency may contract. If a health care provider is a HIPAA 
covered entity, the provider must protect the individually identifiable 
health information it maintains in accordance with the requirements of 
the Rule, which includes not using or disclosing the information except 
as permitted by the Rule and ensuring there are reasonable safeguards 
in place to protect the privacy of the information. For more 
information regarding the HIPAA Privacy Rule, please visit http://www.hhs.gov/ocr/hipaa.
Section 1.7 What is a refusal to take a federally regulated drug test?
    (a) As a donor for a federally regulated drug test, you have 
refused to take a federally regulated drug test if you:
    (1) Fail to appear for any test (except a pre-employment test) 
within a reasonable time, as determined by the federal agency, 
consistent with applicable agency regulations, after being directed to 
do so by the federal agency;
    (2) Fail to remain at the collection site until the collection 
process is complete with the exception of a donor who leaves the 
collection site before the collection process begins for a pre-
employment test as described in Section 8.5(d);
    (3) Fail to provide a hair specimen for any drug test required by 
these Guidelines or federal agency regulations with the exception of a 
donor who leaves the collection site before the collection process 
begins for a pre-employment test as described in Section 8.5(d); or a 
donor who is unable to provide a sufficient amount of hair for faith-
based or medical reasons, or due to an insufficient amount or length of 
hair; or when the collector identifies lice or a similar infestation in 
the hair.
    (4) Fail or decline to participate in an alternate specimen 
collection (e.g., urine, oral fluid) as directed by the federal agency 
or collector (i.e., as described in Section 8.5);
    (5) Fail to cooperate with any part of the testing process (e.g., 
disrupt the collection process; refuse to allow the collector to 
collect a sufficient amount of hair; fail to provide a split specimen);
    (6) Bring materials to the collection site for the purpose of 
adulterating or substituting the specimen;
    (7) Attempt to adulterate or substitute the specimen; or
    (8) Admit to the collector or MRO that you have adulterated or 
substituted the specimen.
Section 1.8 What are the potential consequences for refusing to take a 
federally regulated drug test?
    (a) As a federal agency employee or applicant, a refusal to take a 
test may result in the initiation of disciplinary or adverse action, up 
to and including removal from, or non-selection for, federal 
employment.
    (b) When a donor has refused to participate in a part of the 
collection process, the collector must terminate the collection process 
and take action as described in Section 8.9; immediately notify the 
federal agency's designated representative by any means (e.g., 
telephone or secure facsimile [fax] machine) that ensures that the 
refusal notification is immediately received, document the refusal on 
the Federal CCF, sign and date the Federal CCF, and send all copies of 
the Federal CCF to the federal agency's designated representative.
    (c) When documenting a refusal to test during the verification 
process as described in Sections 13.4 and 13.5, the MRO must complete 
the MRO copy of the Federal CCF to include:
    (1) Checking the refusal to test box;
    (2) Providing a reason for the refusal in the remarks line; and
    (3) Signing and dating the MRO copy of the Federal CCF.

Subpart B--Hair Specimens

Section 2.1 What type of specimen may be collected?
    a. Only specimen types authorized by Mandatory Guidelines for 
Federal Workplace Drug Testing Programs may be collected.
    b. A federal agency may collect hair and/or an alternate specimen 
type for its workplace drug testing program, but may not implement hair 
testing as the exclusive means of drug testing. A federal agency using 
hair testing must follow these Guidelines.
    c. A federal agency that collects hair specimens for its workplace 
drug testing program must also authorize an alternate specimen type to 
be collected either:
    (1) At the time that a donor's hair specimen is collected, or
    (2) at the direction of the MRO, following verification of a hair 
test as positive or invalid, or when the laboratory rejected the hair 
specimen.
    Alternate specimens collected under Section 2.1(c)(1) and (2) can 
be tested only if an MRO directs, in writing, that such specimens be 
tested and following the MRO's receipt and verification of a positive, 
invalid, or rejected hair test result from a laboratory (see Section 
13.5).
    d. A federal agency that collects hair specimens for its workplace 
drug testing program must also authorize the collection of one or more 
alternative specimen types when a donor is unable to provide a 
sufficient amount of hair for faith-based or medical reasons, or due to 
an insufficient amount or length of hair.
Section 2.2 Under what circumstances may a hair specimen be collected?
    A federal agency may only collect a hair specimen for federal 
agency pre-employment and random testing purposes, and may not use hair 
specimens for reasonable suspicion/cause, post accident, return to 
duty, or follow-up testing purposes (i.e., for purposes other than pre-
employment or random testing).
Section 2.3 How is each hair specimen collected?
    Each hair specimen is collected as a split specimen as described in 
Sections 2.5 and 8.8.
Section 2.4 What amount of hair is collected?
    At least 100 mg of hair is collected, as described in Section 8.5.

[[Page 56132]]

Section 2.5 How does the collector split the hair specimen collected?
    The collector subdivides the collected hair into 2 specimens 
designated as ``A'' (primary) and ``B'' (split) as described in Section 
8.5.
Section 2.6 When may an entity or individual release a hair specimen?
    Entities and individuals subject to these Guidelines under Section 
1.1 may not release specimens collected pursuant to Executive Order 
12564, Public Law 100-71 and these Guidelines to donors or their 
designees. Specimens also may not be released to any other entity or 
individual unless expressly authorized by these Guidelines or by 
applicable federal law. This section does not prohibit a donor's 
request to have a split (B) specimen tested in accordance with Section 
13.9.

Subpart C--Hair Drug and Specimen Validity Tests

Section 3.1 Which tests are conducted on a hair specimen?
    A federal agency:
    (a) Must ensure that each specimen is tested for marijuana and 
cocaine as provided under Section 3.4;
    (b) Is authorized to test each specimen for opioids, amphetamines, 
and phencyclidine, as provided under Section 3.4;
    (c) Is authorized to test hair specimens for damage that may affect 
drug test results;
    (d) Is authorized upon a Medical Review Officer's request to test a 
hair specimen to determine specimen validity, using, for example, a 
test for a biomarker or a test for a specific adulterant; and
    (e) May perform additional testing if a specimen exhibits abnormal 
characteristics, causes reactions or responses characteristic of an 
adulterant during initial or confirmatory drug tests (e.g., non-
recovery of internal standard, unusual response), or contains an 
unidentified substance that interferes with the confirmatory analysis.
Section 3.2 May a hair specimen be tested for additional drugs?
    For approval to routinely test for any drugs listed in Schedule I 
or II of the Controlled Substances Act that are not listed in Section 
3.1, a federal agency must petition the Secretary in writing. Such 
approval must be limited to the use of the appropriate science and 
technology. If an initial test procedure is not available upon request 
for a Schedule I or Schedule II drug, the HHS-certified laboratory must 
test for the drug using the confirmatory analytical method. For any 
specimen with a positive result, the laboratory must test a separate 
aliquot of the specimen in a separate testing batch using the same 
confirmatory analytical method. Additionally, the split (B) specimen 
will be available for testing if the donor requests a retest at another 
HHS-certified laboratory.
Section 3.3 May any of the specimens be used for other purposes?
    (a) Specimens collected pursuant to Executive Order 12564, Public 
Law 100-71, and these Guidelines must only be tested for drugs and to 
determine their validity in accordance with Subpart C of these 
Guidelines. Use of specimens by donors, their designees or any other 
entity, for other purposes (e.g., deoxyribonucleic acid, DNA, testing) 
is prohibited unless authorized in accordance with applicable federal 
law.
    (b) These Guidelines are not intended to prohibit federal agencies, 
specifically authorized by law to test a specimen for additional 
classes of drugs in its workplace drug testing program.
Section 3.4 What are the drug test cutoff concentrations for hair?

----------------------------------------------------------------------------------------------------------------
                                                                                                   Confirmatory
             Initial test analyte                Initial test       Confirmatory test analyte       test cutoff
                                                  cutoff \1\                                       concentration
----------------------------------------------------------------------------------------------------------------
Marijuana Metabolites (THCA) \2\..............     \3\ 1 pg/mg  THCA............................      0.05 pg/mg
Cocaine/Benzoylecgonine.......................   \3\ 500 pg/mg  Cocaine Benzoylecgonine.........       500 pg/mg
                                                                                                        50 pg/mg
Codeine/......................................       200 pg/mg  Codeine.........................       200 pg/mg
Morphine/.....................................  ..............  Morphine........................       200 pg/mg
6-Acetylmorphine..............................  ..............  6-Acetylmorphine................       200 pg/mg
Hydrocodone/..................................       200 pg/mg  Hydrocodone.....................       200 pg/mg
Hydromorphone.................................  ..............  Hydromorphone...................       200 pg/mg
Oxycodone/....................................       200 pg/mg  Oxycodone.......................       200 pg/mg
Oxymorphone...................................  ..............  Oxymorphone.....................       200 pg/mg
Phencyclidine.................................       300 pg/mg  Phencyclidine...................       300 pg/mg
Amphetamine/..................................   \3\ 500 pg/mg  Amphetamine.....................       300 pg/mg
Methamphetamine \4\...........................  ..............  Methamphetamine.................       300 pg/mg
MDMA \5\/MDA \6\..............................   \3\ 500 pg/mg  MDMA............................       300 pg/mg
                                                ..............  MDA.............................       300 pg/mg
----------------------------------------------------------------------------------------------------------------
\1\ For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial
  test cutoff):
Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The
  cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if
  not, separate immunoassays must be used for the analytes within the group.
Alternate technology: Either one analyte or analytes as grouped in the table above must be used for calibration,
  depending on the technology. At least one analyte within the group must have a concentration equal to or
  greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or
  greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial
  test cutoff.
\2\ An immunoassay must be calibrated with the target analyte, L-[Delta]-9-tetrahydrocannabinol-9-carboxylic
  acid (THCA).
\3\ Alternate technology (THCA): The confirmatory test cutoff (i.e., 0.05 pg/mg) must be used for an alternate
  technology initial test that is specific for THCA).
\4\ An immunoassay must be calibrated with the target analyte, D-amphetamine or D-methamphetamine.
\5\ Methylenedioxymethamphetamine (MDMA).
\6\ Methylenedioxyamphetamine (MDA).


[[Page 56133]]

Section 3.5 May an HHS-certified laboratory perform additional drug 
and/or specimen validity tests on a specimen at the request of the 
Medical Review Officer (MRO)?
    An HHS-certified laboratory is authorized to perform additional 
drug and/or specimen validity tests on a case-by-case basis as 
necessary to provide information that the MRO would use to report a 
verified drug test result (e.g., specimen validity tests using 
biomarkers). An HHS-certified laboratory is not authorized to routinely 
perform additional drug and/or specimen validity tests at the request 
of an MRO without prior authorization from the Secretary or designated 
HHS representative, with the exception of the determination of D, L 
stereoisomers of amphetamine and methamphetamine. All tests must meet 
appropriate validation and quality control requirements in accordance 
with these Guidelines.
Section 3.6 What criteria are used to report a hair specimen as 
adulterated?
    An HHS-certified laboratory reports a hair specimen as adulterated 
when the presence of an adulterant is verified using an initial test on 
the first aliquot and a different confirmatory test on the second 
aliquot.
Section 3.7 What criteria are used to report a hair specimen as 
substituted?
    An HHS-certified laboratory documents and reports a hair specimen 
as substituted if it has physical or chemical characteristics 
inconsistent with those observed in human hair. Such documentation 
should briefly describe the physical or chemical characteristics that 
are inconsistent with human hair.
Section 3.8 What criteria are used to report an invalid result for a 
hair specimen?
    An HHS-certified laboratory reports a primary (A) hair specimen as 
an invalid result when:
    (a) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (b) Interference with the confirmatory drug assay occurs on two 
separate aliquots of the specimen and the laboratory is unable to 
identify the interfering substance;
    (c) The specimen has been tested and the color of the primary (A) 
and the split (B) specimens are clearly different;
    (d) The laboratory determines the hair is damaged (i.e., using a 
validated method) to the extent that the drug test result may be 
affected; or
    (e) The laboratory obtains a positive confirmatory drug test result 
and is unable to definitively remove external contamination from the 
specimen (i.e., using a validated decontamination procedure).

Subpart D--Collectors

Section 4.1 Who may collect a specimen?
    (a) A collector who has been trained to collect hair specimens in 
accordance with these Guidelines.
    (b) The immediate supervisor of a federal employee donor may only 
collect that donor's specimen when no other collector is available. The 
supervisor must be a trained collector.
    (c) The hiring official of a federal agency applicant may only 
collect that federal agency applicant's specimen when no other 
collector is available. The hiring official must be a trained 
collector.
Section 4.2 Who may not collect a specimen?
    (a) A federal agency employee who is in a testing designated 
position and subject to the federal agency drug testing rules must not 
be a collector for co-workers in the same testing pool or who work 
together with that employee on a daily basis.
    (b) A federal agency applicant or employee must not collect his or 
her own drug testing specimen.
    (c) An employee working for an HHS-certified laboratory must not 
act as a collector if the employee could link the identity of the donor 
to the donor's drug test result.
    (d) To avoid a potential conflict of interest, a collector must not 
be related to the employee (e.g., spouse, ex-spouse, relative) or a 
close personal friend (e.g., fianc[eacute]e).
Section 4.3 What are the requirements to be a collector?
    (a) An individual may serve as a collector if they fulfill the 
following conditions:
    (1) Is knowledgeable about the collection procedure described in 
these Guidelines;
    (2) Is knowledgeable about any guidance provided by the federal 
agency's Drug-free Workplace Program and additional information 
provided by the Secretary relating to these Guidelines;
    (3) Is trained and qualified to collect a hair specimen. Training 
must include the following:
    (i) All steps necessary to complete a hair collection;
    (ii) Completion and distribution of the Federal CCF;
    (iii) Problem collections;
    (iv) Fatal flaws, correctable flaws, and how to correct problems in 
collections; and
    (v) The collector's responsibility for maintaining the integrity of 
the collection process, ensuring the privacy of the donor, ensuring the 
security of the specimen, and avoiding conduct or statements that could 
be viewed as offensive or inappropriate.
    (4) Has demonstrated proficiency in collections by completing five 
consecutive error-free mock collections.
    (i) The five mock collections must include two uneventful 
collection scenarios, one insufficient specimen quantity scenario, one 
scenario in which the donor refuses to sign the Federal CCF, and one 
scenario in which the donor refuses to initial the specimen container 
tamper-evident seal.
    (ii) A qualified trainer for collectors must monitor and evaluate 
the individual being trained, in person or by a means that provides 
real-time observation and interaction between the trainer and the 
trainee, and the trainer must attest in writing that the mock 
collections are ``error-free.''
    (b) A trained collector must complete refresher training at least 
every five years that includes the requirements in paragraph (a) of 
this section.
    (c) The collector must maintain the documentation of his or her 
training and provide that documentation to a federal agency when 
requested.
    (d) An individual may not collect specimens for a federal agency 
until his or her training as a collector has been properly documented.
Section 4.4 What are the requirements to be a trainer for collectors?
    (a) Individuals are considered qualified trainers for collectors 
and may train others to collect hair specimens when they have completed 
the following:
    (1) Qualified as a trained collector and regularly conducted hair 
drug test collections for a period of at least one year or
    (2) Completed a ``train the trainer'' course given by an 
organization (e.g., manufacturer, private entity, contractor, federal 
agency).
    (b) A qualified trainer for collectors must complete refresher 
training at least every five years in accordance with the collector 
requirements in Section 4.3(a).
    (c) A qualified trainer for collectors must maintain the 
documentation of his or her training and provide that documentation to 
a federal agency when requested.

[[Page 56134]]

Section 4.5 What must a federal agency do before a collector is 
permitted to collect a specimen?
    A federal agency must ensure the following:
    (a) The collector has satisfied the requirements described in 
Section 4.3;
    (b) The collector, who may be self-employed, or an organization 
(e.g., third party administrator that provides a collection service, 
collector training company, federal agency that employs its own 
collectors) maintains a copy of the training record(s); and
    (c) The collector has been provided the name and telephone number 
of the federal agency representative.

Subpart E--Collection Sites

Section 5.1 Where can a collection for a drug test take place?
    (a) A collection site may be a permanent or temporary facility 
located either at the work site or at a remote site.
    (b) In the event that an agency-designated collection site is not 
accessible and there is an immediate requirement to collect a hair 
specimen, another site may be used for the collection, providing the 
collection is performed by a trained hair specimen collector.
Section 5.2 What are the requirements for a collection site?
    The facility used as a collection site must have the following:
    (a) Provisions to ensure donor privacy during the collection (as 
described in Section 8.1);
    (b) A suitable and clean surface area that is not accessible to the 
donor for handling the specimens and completing the required paperwork;
    (c) A secure temporary storage area to maintain specimens until the 
specimen is transferred to an HHS-certified laboratory;
    (d) A restricted access area where only authorized personnel may be 
present during the collection;
    (e) A restricted access area for the storage of collection 
supplies; and
    (f) A restricted access area for the secure storage of records.
Section 5.3 Where must collection site records be stored?
    Collection site records must be stored at a secure site designated 
by the collector or the collector's employer.
Section 5.4 How long must collection site records be stored?
    Collection site records (e.g., collector copies of the OMB-approved 
Federal CCF) must be stored securely for a minimum of 2 years. The 
collection site may convert hardcopy records to electronic records for 
storage and discard the hardcopy records after 6 months.
Section 5.5 How does the collector ensure the security and integrity of 
a specimen at the collection site?
    (a) A collector must do the following to maintain the security and 
integrity of a specimen:
    (1) Not allow unauthorized personnel to enter the collection area 
during the collection procedure;
    (2) Perform only one donor collection at a time;
    (3) Restrict access to collection supplies before, during, and 
after collection;
    (4) Ensure that only the collector and the donor are allowed to 
handle the unsealed specimen;
    (5) Ensure the chain of custody process is maintained and 
documented throughout the entire collection, storage, and transport 
procedures;
    (6) Ensure that the Federal CCF is completed and distributed as 
required; and
    (7) Ensure that specimens transported to an HHS-certified 
laboratory are sealed and placed in transport containers designed to 
minimize the possibility of damage during shipment (e.g., specimen 
boxes, padded mailers, or other suitable shipping container), and those 
containers are securely sealed to eliminate the possibility of 
undetected tampering.
    (b) Couriers, express carriers, and postal service personnel are 
not required to document chain of custody since specimens are sealed in 
packages that would indicate tampering during transit to the HHS-
certified laboratory.
Section 5.6 What are the privacy requirements when collecting a hair 
specimen?
    The collector collects hair from the donor (as described in Section 
8.5). The donor must be allowed privacy while the collector obtains the 
hair specimen. Collections must be performed at a site that provides 
reasonable privacy (as described in Section 8.1).

Subpart F--Federal Drug Testing Custody and Control Form

Section 6.1 What federal form is used to document custody and control?
    The OMB-approved Federal CCF must be used to document custody and 
control of each specimen at the collection site.
Section 6.2 What happens if the correct OMB-approved Federal CCF is not 
available or is not used?
    (a) The use of a non-federal CCF or an expired Federal CCF is not, 
by itself, a reason for the HHS-certified laboratory to automatically 
reject the specimen for testing or for the MRO to cancel the test.
    (b) If the collector does not use the correct OMB-approved Federal 
CCF, the collector must document that it is a federal agency specimen 
collection and provide the reason that the incorrect form was used. 
Based on the information provided by the collector, the HHS-certified 
laboratory must handle and test the specimen as a federal agency 
specimen.
    (c) If the HHS-certified laboratory or MRO discovers that the 
collector used an incorrect form, the laboratory or MRO must obtain a 
memorandum for the record from the collector describing the reason the 
incorrect form was used. If a memorandum for the record cannot be 
obtained, the laboratory reports a rejected for testing result to the 
MRO and the MRO cancels the test. The HHS-certified laboratory must 
wait at least 5 business days while attempting to obtain the memorandum 
before reporting a rejected for testing result to the MRO.

Subpart G--Hair Specimen Collection Materials

Section 7.1 What is used to collect a hair specimen?
    Collection materials include a means (i.e., single-use or reusable 
scissors) to cut the hair, individually packaged isopropyl alcohol wipe 
(i.e., to clean reusable scissors), two specimen guides (items that 
hold the hair specimen as positioned by the collector), and two 
sealable collection containers (e.g., envelopes) labelled A for the 
primary (A) and B for the split (B) specimens.
Section 7.2 What are the requirements for hair collection materials?
    (a) The specimen guides and the collection containers must not 
substantially affect the composition of drugs and/or drug metabolites 
in the hair specimen.
    (b) All collection items (e.g., scissors, clip) that come into 
contact with the hair must be single-use items or must be cleaned 
before each use, as described in section 8.4.
    (c) The specimen guides and containers must maintain the integrity 
of the specimen during storage and transport so that the specimen 
contained therein can be tested in an HHS-certified laboratory for the

[[Page 56135]]

presence of drugs and/or their metabolites.
    (d) The specimen guides and containers must be sufficiently 
transparent to enable an assessment of specimen appearance and 
identification of abnormal physical characteristics without opening the 
container.
Section 7.3 What are the minimum performance requirements for hair 
collection materials?
    (a) The specimen guides must be capable of holding the hair 
specimen as positioned by the collector, and have an indication of the 
orientation (i.e., root or distal end) of the hair specimen collected.
    (b) The specimen guides or containers must have graduated markings 
or guides for collectors to verify the minimum width and length of hair 
that would equate to 100 mg of hair or 50 mg of hair in each container 
labeled A and B.

Subpart H--Hair Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing a hair 
specimen?
    The following privacy requirements apply when a donor is providing 
a hair specimen:
    (a) Only authorized personnel and the donor may be present in the 
restricted access area where the collection takes place.
    (b) The collector is not required to be the same gender as the 
donor.
Section 8.2 What must the collector ensure at the collection site 
before starting a hair specimen collection?
    The collector must take all reasonable steps to prevent the 
adulteration or substitution of a hair specimen at the collection site.
Section 8.3 What are the preliminary steps in the hair specimen 
collection procedure?
    The collector must take the following steps before beginning a hair 
specimen collection:
    (a) If a donor fails to arrive at the collection site at the 
assigned time, the collector must follow the federal agency policy or 
contact the federal agency representative to obtain guidance on action 
to be taken.
    (b) When the donor arrives at the collection site, the collector 
should begin the collection procedure without undue delay. For example, 
the collection should not be delayed because an authorized employer or 
employer representative is late in arriving.
    (c) The collector requests the donor to present photo 
identification (e.g., driver's license; employee badge issued by the 
employer; an alternative photo identification issued by a federal, 
state, or local government agency). If the donor does not have proper 
photo identification, the collector shall contact the supervisor of the 
donor or the federal agency representative who can positively identify 
the donor. If the donor's identity cannot be established, the collector 
must not proceed with the collection.
    (d) The collector asks the donor to remove any unnecessary outer 
garments such as a coat or jacket and any hat or hood.
    (e) If, at any point in the collection, the collector sees any item 
that appears to have been brought by the donor to the collection site 
with the intent to adulterate or substitute the specimen, this is 
considered a refusal to test. The collector must stop the collection 
and report the refusal to test as described in Section 8.9.
    (f) If, at any point in the collection, the collector sees any 
evidence that the donor has lice or similar infestation in his or her 
hair, the collector immediately stops the collection procedure. The 
collector records the reason for not collecting a hair specimen on the 
Federal CCF, contacts the federal agency's designated representative 
for authorization to collect an alternate specimen, and assuming proper 
authorization is provided, begins the collection procedure for the 
alternate specimen (see Section 8.7) in accordance with the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using the 
alternate specimen. The collector sends the appropriate copies of the 
Federal CCF used for the hair specimen to the MRO and to the federal 
agency's designated representative. The federal agency may choose to 
provide the collection site with a standard protocol to follow in lieu 
of requiring the collector to contact the agency's designated 
representative for authorization in each case.
    (g) The collector must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (h) The collector explains the basic collection procedure to the 
donor.
    (i) The collector informs the donor that the instructions for 
completing the Federal Custody and Control Form are located on the 
Federal CCF (e.g., on the back of Copy 5 or on a separate page) or are 
available upon request.
    (j) The collector answers any reasonable and appropriate questions 
the donor may have regarding the collection procedure.
Section 8.4 What steps does the collector take in the collection 
procedure before the donor provides a hair specimen?
    (a) At the beginning of the collection, the collector must put on 
single-use gloves that are clean and unused. The collector must remove 
the gloves from the package in the presence of the donor.
    (b) The collector will provide or the donor may select specimen 
collection materials that are clean, unused, and wrapped/sealed in 
original packaging. The specimen collection materials will be opened in 
view of the donor. Specimen collection materials must be single-use, 
with the exception of scissors and/or clips which may be either single-
use or reusable (as described in item 2 below).
    (1) Both the donor and the collector must keep the unwrapped 
collection materials in view at all times until the container 
containing the donor's hair specimen has been sealed and labeled.
    (2) Scissors and/or clips may be reused provided that the collector 
cleans such items in the presence of the donor with an isopropyl 
alcohol wipe prior to use in the hair collection. If single-use items 
are used, the collector is not required to clean the item before use 
assuming such use is the first use of the item.
    (c) The collector reviews with the donor the procedures required 
for hair specimen collection as stated in the instructions for the 
specimen collection kit.
    (d) The collector asks the donor whether they have false hair 
(i.e., artificial or natural hair that is not their own such as a wig, 
weave, or extensions). If the donor admits the presence of false hair 
or the collector identifies false hair after the donor denies having 
false hair, this does not constitute a refusal to test. If the 
collector can collect a sufficient amount of the donor's own hair, the 
collector proceeds with the collection.
    (e) If the collector is unable to collect the donor's hair, the 
collector immediately stops the collection procedure. The collector 
records the reason for not collecting a hair specimen on the Federal 
CCF, contacts the federal agency's designated representative for 
authorization to collect the alternate specimen, and assuming proper 
authorization is provided, begins the collection procedure for the 
alternate specimen (see Section 8.7) in accordance with the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using the 
alternate specimen. The collector sends the

[[Page 56136]]

appropriate copies of the Federal CCF used for the hair specimen to the 
MRO and to the federal agency's designated representative. The federal 
agency may choose to provide the collection site with a standard 
protocol to follow in lieu of requiring the collector to contact the 
agency's designated representative for authorization in each case.
    (f) The collector notes any unusual behavior or appearance of the 
donor on the Federal CCF. If the collector detects any conduct that 
clearly indicates an attempt to tamper with a specimen, the collector 
must report a refusal to test in accordance with Section 8.9.
Section 8.5 What steps does the collector take during and after the 
hair specimen collection procedure?
    Integrity and Identity of the Specimen. The collector must take the 
following steps during and after the donor provides the hair specimen:
    (a) The collector shall be present and maintain visual contact with 
the donor during the procedures outlined in this section.
    (b) The collector cuts a portion of the donor's hair that is 
approximately one-half (0.5) inches wide and at least one (1.0) inch 
long on the crown (i.e., posterior vertex) of the head and as close to 
the scalp as possible.
    (1) The collector must ensure that at least 100 mg of hair is 
collected for testing.
    (2) If the donor's hair is sparse or is short (i.e., between one-
half and one inch long), the collector may collect hair from multiple 
sites on the posterior vertex and back of the head, avoiding the front 
and side regions.
    (3) If the donor's hair is less than one-half inch long or if the 
collector cannot collect at least 100 mg from the posterior vertex or 
back of the head, the collector stops the collection and takes actions 
described in Section 8.6.
    (c) The collector subdivides the hair specimen into two 
approximately equal specimens (A and B), and places specimen A in the 
first specimen guide and specimen B in the second specimen guide. If 
possible, the collector aligns the hairs with the root end identified 
as indicated on the specimen guide. For short hair (between one-half 
and one inch long), the collector is not required to identify the root 
end. The collector secures the hair in each specimen guide (e.g., folds 
the guide).
    (d) If the donor fails to remain present through the completion of 
the collection, fails to follow the instructions for the collection, 
refuses to allow the collector to collect sufficient hair as required 
in step (b) above for reasons other than those described in Section 
2.1, or refuses to provide an alternate specimen when directed to do 
so, the collector stops the collection and reports the refusal to test 
in accordance with Section 8.9.
    (e) If the federal agency requires collection of an alternate 
specimen at the same time as the hair collection, the collector should 
collect the hair specimen first, and then collect the other authorized 
specimen (e.g., urine or oral fluid) using the applicable collection 
procedures described in the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs using the alternate specimen.
    (i) The collector must record a comment on the Federal CCF for each 
specimen with sufficient information to link the two specimens 
(including the unique specimen identification number of the associated 
specimen).
    (ii) The collector must also record a comment on the Federal CCF 
for the alternate specimen noting that the laboratory is to hold the 
specimen for testing pending the MRO's request for testing.
    (iii) The collector must forward the hair specimen to an HHS-
certified hair testing laboratory. The collector forwards the alternate 
specimen, if one is authorized to be collected at the same time as the 
hair specimen, to a laboratory that is certified by HHS for that 
specimen type. The laboratory will accession and store the alternate 
specimen under appropriate storage conditions in the event that the MRO 
requests testing as described in Section 13.5.
Section 8.6 What procedure is used when the donor is unable to provide 
a hair specimen?
    If the donor is unable to provide a hair specimen (i.e., as 
described in sections 2.1, 8.3, and 8.4), the collector records the 
reason for not collecting a hair specimen on the Federal CCF, contacts 
the federal agency's designated representative for authorization to 
collect an alternate specimen, and assuming proper authorization is 
provided, begins the collection procedure for the alternate specimen 
authorized by the federal agency (see Section 8.7) in accordance with 
the Mandatory Guidelines for Federal Workplace Drug Testing Programs 
using the alternate specimen. The collector sends the appropriate 
copies of the Federal CCF used for the hair specimen to the MRO and to 
the federal agency's designated representative. The federal agency may 
choose to provide the collection site with a standard protocol to 
follow in lieu of requiring the collector to contact the agency's 
designated representative for authorization to collect an alternate 
specimen in each case.
Section 8.7 If the donor is unable to provide a hair specimen, may 
another specimen type be collected for testing?
    Yes. A federal agency that elects to implement hair testing is 
required to authorize collections of one or more alternate specimen 
types authorized by Mandatory Guidelines for Federal Workplace Drug 
Testing Programs.
Section 8.8 How does the collector prepare the hair specimens?
    (a) All federal agency collections are to be split specimen 
collections.
    (b) After placing the A and B hair specimens (i.e., in the specimen 
guides) into separate envelopes, in the presence of the donor, the 
collector places a tamper-evident label/seal from the Federal CCF on 
each envelope. The collector records the date of the collection on the 
tamper-evident labels/seals.
    (c) The collector instructs the donor to initial the tamper-evident 
labels/seals on each specimen envelope. If the donor refuses to initial 
the labels/seals, the collector notes the refusal on the Federal CCF 
and continues with the collection process.
    (d) The collector must ensure that all the information required on 
the Federal CCF is provided.
    (e) The collector asks the donor to read and sign a statement on 
the Federal CCF certifying that the specimens identified were collected 
from him or her. If the donor refuses to sign the certification 
statement, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (f) The collector signs and prints his or her name on the Federal 
CCF, completes the Federal CCF, and distributes the copies of the 
Federal CCF as required.
    (g) The collector seals the specimens (A and B) in a package and, 
within 24 hours or during the next business day, sends them to the HHS-
certified laboratory that will be testing the primary (A) hair 
specimen.
    (h) If the specimen and Federal CCF are not immediately transported 
to an HHS-certified laboratory, they must remain under direct control 
of the collector or be appropriately secured under proper specimen 
storage conditions until transported.
Section 8.9 How does the collector report a donor's refusal to test?
    If there is a refusal to test as defined in Section 1.7, the 
collector stops the collection, discards any hair specimen

[[Page 56137]]

collected and reports the refusal to test by:
    (a) Notifying the federal agency by means (e.g., telephone, email, 
or secure fax) that ensures that the notification is immediately 
received,
    (b) Documenting the refusal to test including the reason on the 
Federal CCF. In the event that a donor is unable to provide a 
sufficient amount of hair for faith-based or medical reasons, or due to 
an insufficient amount or length of hair, the collector must specify 
the circumstances, and
    (c) Sending all copies of the Federal CCF to the federal agency's 
designated representative.
Section 8.10 What are a federal agency's responsibilities for a 
collection site?
    (a) A federal agency must ensure that collectors and collection 
sites satisfy all requirements in subparts D, E, F, G, and H.
    (b) A federal agency (or only one federal agency when several 
agencies are using the same collection site) must inspect 5 percent or 
up to a maximum of 50 collection sites each year, selected randomly 
from those sites used to collect agency specimens (e.g., virtual, 
onsite, or self-evaluation).
    (c) A federal agency must investigate reported collection site 
deficiencies (e.g., specimens reported ``rejected for testing'' by an 
HHS-certified laboratory) and take appropriate action which may include 
a collection site self-assessment (i.e., using the Collection Site 
Checklist for the Collection of Hair Specimens for Federal Agency 
Workplace Drug Testing Programs) or an inspection of the collection 
site. The inspections of these additional collection sites may be 
included in the 5 percent or maximum of 50 collection sites inspected 
annually.

Subpart I--HHS Certification of Laboratories

Section 9.1 Who has the authority to certify laboratories to test hair 
specimens for federal agencies?
    (a) The Secretary has broad discretion to take appropriate action 
to ensure the full reliability and accuracy of drug testing and 
reporting, to resolve problems related to drug testing, and to enforce 
all standards set forth in these Guidelines. The Secretary has the 
authority to issue directives to any HHS-certified laboratory, 
including suspending the use of certain analytical procedures when 
necessary to protect the integrity of the testing process; ordering any 
HHS-certified laboratory to undertake corrective actions to respond to 
material deficiencies identified by an inspection or through 
performance testing; ordering any HHS-certified laboratory to send 
specimens or specimen aliquots to another HHS-certified laboratory for 
retesting when necessary to ensure the accuracy of testing under these 
Guidelines; ordering the review of results for specimens tested under 
the Guidelines for private sector clients to the extent necessary to 
ensure the full reliability of drug testing for federal agencies; and 
ordering any other action necessary to address deficiencies in drug 
testing, analysis, specimen collection, chain of custody, reporting of 
results, or any other aspect of the certification program.
    (b) A laboratory is prohibited from stating or implying that it is 
certified by HHS under these Guidelines to test hair specimens for 
federal agencies unless it holds such certification.
Section 9.2 What is the process for a laboratory to become HHS-
certified?
    (a) A laboratory seeking HHS certification must:
    (1) Submit a completed OMB-approved application form (i.e., the 
applicant laboratory provides detailed information on both the 
administrative and analytical procedures to be used for federally 
regulated specimens);
    (2) Have its application reviewed as complete and accepted by HHS;
    (3) Successfully complete the PT challenges in 3 consecutive sets 
of initial PT samples;
    (4) Satisfy all the requirements for an initial inspection; and
    (5) Receive notification of certification from the Secretary before 
testing specimens for federal agencies.
Section 9.3 What is the process for a laboratory to maintain HHS 
certification?
    (a) To maintain HHS certification, a laboratory must:
    (1) Successfully participate in both the maintenance PT and 
inspection programs (i.e., successfully test the required quarterly 
sets of maintenance PT samples, undergo an inspection 3 months after 
being certified, and undergo maintenance inspections at a minimum of 
every 6 months thereafter);
    (2) Respond in an appropriate, timely, and complete manner to 
required corrective action requests if deficiencies are identified in 
the maintenance PT performance, during the inspections, operations, or 
reporting; and
    (3) Satisfactorily complete corrective remedial actions, and 
undergo special inspection and special PT sets to maintain or restore 
certification when material deficiencies occur in either the PT 
program, inspection program, or in operations and reporting.
Section 9.4 What is the process when a laboratory does not maintain its 
HHS certification?
    (a) A laboratory that does not maintain its HHS certification must:
    (1) Stop testing federally regulated specimens;
    (2) Ensure the security of federally regulated specimens and 
records throughout the required storage period described in Sections 
11.20, 11.21, and 14.7;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.23 and 11.24 and Subpart P; and
    (4) Follow the HHS suspension and revocation procedures when 
imposed by the Secretary, follow the HHS procedures in Subpart P that 
will be used for all actions associated with the suspension and/or 
revocation of HHS certification.
Section 9.5 What are the qualitative and quantitative specifications of 
performance testing (PT) samples?
    (a) PT samples used to evaluate drug tests will be prepared using 
the following specifications:
    (1) PT samples may contain one or more of the drugs and drug 
metabolites in the drug classes listed in Section 3.4. The PT samples 
must satisfy one of the following parameters:
    (i) The concentration of a drug or metabolite will be at least 20 
percent above the initial test cutoff concentration for the drug or 
drug metabolite;
    (ii) The concentration of a drug or metabolite may be as low as 40 
percent of the confirmatory test cutoff concentration when the PT 
sample is designated as a retest sample; or
    (iii) The concentration of drug or metabolite may differ from 
9.5(a)(1)(i) and 9.5(a)(1)(ii) for a special purpose.
    (2) A PT sample may contain an interfering substance or other 
substances for special purposes.
    (3) A PT sample may be prepared in various ways (e.g., using drug 
user hair, hair externally contaminated with drug analytes, hair 
subjected to cosmetic treatments) to challenge the laboratory's 
decontamination and test procedures.
    (4) A negative PT sample will not contain a measurable amount of a 
target analyte.
    (b) The laboratory must (to the greatest extent possible) handle, 
test, and report a PT sample in a manner identical to that used for a 
donor specimen, unless otherwise specified.

[[Page 56138]]

Section 9.6 What are the PT requirements for an applicant laboratory 
that seeks to perform hair testing?
    (a) An applicant laboratory that seeks certification under these 
Guidelines to perform hair testing must satisfy the following criteria 
on three consecutive sets of PT samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over the three sets of PT samples;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over the three sets of PT samples;
    (4) For the confirmatory drug tests, correctly determine the 
concentrations [i.e., no more than 20 percent or 2 standard deviations (whichever is larger) from the appropriate 
reference or peer group means] for at least 80 percent of the total 
drug challenges over the three sets of PT samples;
    (5) For the confirmatory drug tests, must not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group mean;
    (6) For each confirmatory drug test, correctly identify and 
determine the concentrations [i.e., no more than 20 percent 
or 2 standard deviations (whichever is larger) from the 
appropriate reference or peer group means] for at least 50 percent of 
the drug challenges for an individual drug over the three sets of PT 
samples;
    (7) For each confirmatory drug test, correctly identify a sample 
that has been contaminated with one or more drugs;
    (b) Failure to satisfy these requirements will result in the denial 
of the laboratory's application for HHS certification to perform hair 
testing.
Section 9.7 What are the PT requirements for an HHS-certified hair 
laboratory?
    (a) A laboratory certified under these Guidelines to perform hair 
testing must satisfy the following criteria on the maintenance PT 
samples:
    (1) Have no false positive results;
    (2) Correctly identify, confirm, and report at least 90 percent of 
the total drug challenges over two consecutive PT cycles;
    (3) Correctly identify at least 80 percent of the drug challenges 
for each initial drug test over two consecutive PT cycles;
    (4) For the confirmatory drug tests, correctly determine that the 
concentrations for at least 80 percent of the total drug challenges are 
no more than 20 percent or 2 standard 
deviations (whichever is larger) from the appropriate reference or peer 
group means over two consecutive PT cycles;
    (5) For the confirmatory drug tests, must not obtain any drug 
concentration that differs by more than 50 percent from the 
appropriate reference or peer group means;
    (6) For each confirmatory drug test, correctly identify and 
determine that the concentrations for at least 50 percent of the drug 
challenges for an individual drug are no more than 20 
percent or 2 standard deviations (whichever is larger) from 
the appropriate reference or peer group means over two consecutive PT 
cycles;
    (7) For each confirmatory drug test, correctly identify a sample 
contaminated with one or more drugs;
    (b) Failure to participate in all PT cycles or to satisfy these 
requirements may result in suspension or revocation of an HHS-certified 
laboratory's certification.
Section 9.8 What are the inspection requirements for an applicant 
laboratory?
    (a) An applicant laboratory is inspected by a team of two 
inspectors.
    (b) Each inspector conducts an independent review and evaluation of 
all aspects of the laboratory's testing procedures and facilities using 
an inspection checklist.
Section 9.9 What are the maintenance inspection requirements for an 
HHS-certified laboratory?
    (a) An HHS-certified laboratory must undergo an inspection 3 months 
after becoming certified and at least every 6 months thereafter.
    (b) An HHS-certified laboratory is inspected by two or more 
inspectors. The number of inspectors is determined according to the 
number of specimens to be reviewed. Additional information regarding 
inspections is available from SAMHSA.
    (c) Inspectors conduct an independent evaluation and review of the 
HHS-certified laboratory's procedures, records, and facilities using 
guidance provided by the Secretary.
    (d) To remain certified, an HHS-certified laboratory must continue 
to satisfy the minimum requirements as stated in these Guidelines.
Section 9.10 Who can inspect an HHS-certified laboratory and when may 
the inspection be conducted?
    (a) An individual may be selected as an inspector for the Secretary 
if they satisfy the following criteria:
    (1) Has experience and an educational background similar to that 
required for either a responsible person or a certifying scientist for 
an HHS-certified laboratory as described in Subpart K;
    (2) 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;
    (3) Submits a resume and documentation of qualifications to HHS;
    (4) Attends approved training; and
    (5) Performs acceptably as an inspector on an inspection of an HHS-
certified laboratory.
    (b) The Secretary or a federal agency may conduct an inspection at 
any time.
Section 9.11 What happens if an applicant laboratory does not satisfy 
the minimum requirements for either the PT program or the inspection 
program?
    If an applicant laboratory fails to satisfy the requirements 
established for the initial certification process, the laboratory must 
start the certification process from the beginning.
Section 9.12 What happens if an HHS-certified laboratory does not 
satisfy the minimum requirements for either the PT program or the 
inspection program?
    (a) If an HHS-certified laboratory fails to satisfy the minimum 
requirements for certification, the laboratory is given a period of 
time (e.g., 5 or 30 working days depending on the nature of the 
deficiency) to provide any explanation for its performance and evidence 
that all deficiencies have been corrected.
    (b) A laboratory's HHS certification may be revoked, suspended, or 
no further action taken depending on the seriousness of the 
deficiencies and whether there is evidence that the deficiencies have 
been corrected and that current performance meets the requirements for 
certification.
    (c) An HHS-certified laboratory may be required to undergo a 
special inspection or to test additional PT samples to address 
deficiencies.
    (d) If an HHS-certified laboratory's certification is revoked or 
suspended in accordance with the process described in Subpart P, the 
laboratory is not permitted to test federally regulated specimens until 
the suspension is lifted or the laboratory has successfully completed 
the certification requirements as a new applicant laboratory.
Section 9.13 What factors are considered in determining whether 
revocation of a laboratory's HHS certification is necessary?
    (a) The Secretary shall revoke certification of an HHS-certified

[[Page 56139]]

laboratory in accordance with these Guidelines if the Secretary 
determines that revocation is necessary to ensure fully reliable and 
accurate drug test results and reports.
    (b) The Secretary shall consider the following factors in 
determining whether revocation is necessary:
    (1) Unsatisfactory performance in analyzing and reporting the 
results of drug tests (e.g., an HHS-certified laboratory reporting a 
false positive result for an employee's drug test);
    (2) Unsatisfactory participation in performance testing or 
inspections;
    (3) A material violation of a certification standard, contract 
term, or other condition imposed on the HHS-certified laboratory by a 
federal agency using the laboratory's services;
    (4) Conviction for any criminal offense committed as an incident to 
operation of the HHS-certified laboratory; or
    (5) Any other cause that materially affects the ability of the HHS-
certified laboratory to ensure fully reliable and accurate drug test 
results and reports.
    (c) The period and terms of revocation shall be determined by the 
Secretary and shall depend upon the facts and circumstances of the 
revocation and the need to ensure accurate and reliable drug testing.
Section 9.14 What factors are considered in determining whether to 
suspend a laboratory's HHS certification?
    (a) The Secretary may immediately suspend (either partially or 
fully) a laboratory's HHS certification to conduct drug testing for 
federal agencies if the Secretary has reason to believe that revocation 
may be required and that immediate action is necessary to protect the 
interests of the United States and its employees.
    (b) The Secretary shall determine the period and terms of 
suspension based upon the facts and circumstances of the suspension and 
the need to ensure accurate and reliable drug testing.
Section 9.15 How does the Secretary notify an HHS-certified laboratory 
that action is being taken against the laboratory?
    (a) When a laboratory's HHS certification is suspended or the 
Secretary seeks to revoke HHS certification, the Secretary shall 
immediately serve the HHS-certified laboratory with written notice of 
the suspension or proposed revocation by fax, mail, personal service, 
or registered or certified mail, return receipt requested. This notice 
shall state the following:
    (1) The reasons for the suspension or proposed revocation;
    (2) The terms of the suspension or proposed revocation; and
    (3) The period of suspension or proposed revocation.
    (b) The written notice shall state that the laboratory will be 
afforded an opportunity for an informal review of the suspension or 
proposed revocation if it so requests in writing within 30 days of the 
date the laboratory received the notice, or if expedited review is 
requested, within 3 days of the date the laboratory received the 
notice. Subpart P contains detailed procedures to be followed for an 
informal review of the suspension or proposed revocation.
    (c) A suspension must be effective immediately. A proposed 
revocation must be effective 30 days after written notice is given or, 
if review is requested, upon the reviewing official's decision to 
uphold the proposed revocation. If the reviewing official decides not 
to uphold the suspension or proposed revocation, the suspension must 
terminate immediately and any proposed revocation shall not take 
effect.
    (d) The Secretary will publish in the Federal Register the name, 
address, and telephone number of any HHS-certified laboratory that has 
its certification revoked or suspended under Section 9.13 or Section 
9.14, respectively, and the name of any HHS-certified laboratory that 
has its suspension lifted. The Secretary shall provide to any member of 
the public upon request the written notice provided to a laboratory 
that has its HHS certification suspended or revoked, as well as the 
reviewing official's written decision which upholds or denies the 
suspension or proposed revocation under the procedures of Subpart P.
Section 9.16 May a laboratory that had its HHS certification revoked be 
recertified to test federal agency specimens?
    Following revocation, a laboratory may apply for recertification. 
Unless otherwise provided by the Secretary in the notice of revocation 
under Section 9.15 or the reviewing official's decision under Section 
16.9(e) or 16.14(a), a laboratory which has had its certification 
revoked may reapply for HHS certification as an applicant laboratory.
Section 9.17 Where is the list of HHS-certified laboratories published?
    (a) The list of HHS-certified laboratories is published monthly in 
the Federal Register. This notice is also available on the internet at 
http://www.samhsa.gov/workplace.
    (b) An applicant laboratory is not included on the list.

Subpart J--Blind Samples Submitted by an Agency

Section 10.1 What are the requirements for federal agencies to submit 
blind samples to HHS-certified laboratories?
    (a) Each federal agency is required to submit blind samples for its 
workplace drug testing program. The collector must send the blind 
samples to the HHS-certified laboratory that the collector sends 
employee specimens.
    (b) Each federal agency must submit at least 3 percent blind 
samples along with its donor specimens based on the projected total 
number of donor specimens collected per year (up to a maximum of 400 
blind samples). Every effort should be made to ensure that blind 
samples are submitted quarterly.
    (c) Approximately 75 percent of the blind samples submitted each 
year by an agency must be negative and 25 percent must be positive for 
one or more drugs.
Section 10.2 What are the requirements for blind samples?
    (a) Drug positive blind samples must be validated by the supplier 
using appropriate initial and confirmatory tests.
    (1) Drug positive blind samples must contain one or more of the 
drugs or metabolites listed in Section 3.4.
    (2) Drug positive blind samples must contain concentrations of 
drugs at least 1.5 times the initial drug test cutoff concentration.
    (b) Drug negative blind samples (i.e., certified to contain no 
drugs) must be validated by the supplier as negative using appropriate 
initial and confirmatory tests.
    (c) The supplier must provide information on the blind samples' 
content, validation, expected results, and stability to the collection 
site/collector sending the blind samples to the laboratory, and must 
provide the information upon request to the MRO, the federal agency for 
which the blind sample was submitted, or the Secretary.
Section 10.3 How is a blind sample submitted to an HHS-certified 
laboratory?
    (a) A blind sample must be submitted as a split specimen (specimens 
A and B) with the current Federal CCF that the HHS-certified laboratory 
uses for donor specimens. The collector provides the required 
information to ensure that the Federal CCF has been properly completed 
and provides fictitious

[[Page 56140]]

initials on the specimen label/seal. The collector must indicate that 
the specimen is a blind sample on the MRO copy where a donor would 
normally provide a signature.
    (b) A collector should attempt to distribute the required number of 
blind samples randomly with donor specimens rather than submitting the 
full complement of blind samples as a single group.
Section 10.4 What happens if an inconsistent result is reported for a 
blind sample?
    If an HHS-certified laboratory reports a result for a blind sample 
that is inconsistent with the expected result (e.g., a laboratory 
reports a negative result for a blind sample that was supposed to be 
positive, a laboratory reports a positive result for a blind sample 
that was supposed to be negative):
    (a) The MRO must contact the laboratory and attempt to determine if 
the laboratory made an error during the testing or reporting of the 
sample;
    (b) The MRO must contact the blind sample supplier and attempt to 
determine if the supplier made an error during the preparation or 
transfer of the sample;
    (c) The MRO must contact the collector and determine if the 
collector made an error when preparing the blind sample for transfer to 
the HHS-certified laboratory;
    (d) If there is no obvious reason for the inconsistent result, the 
MRO must notify both the federal agency for which the blind sample was 
submitted and the Secretary; and
    (e) The Secretary shall investigate the blind sample error. A 
report of the Secretary's investigative findings and the corrective 
action taken in response to identified deficiencies must be sent to the 
federal agency. The Secretary shall ensure notification of the finding 
as appropriate to other federal agencies and coordinate any necessary 
actions to prevent the recurrence of the error.

Subpart K--Laboratory

Section 11.1 What must be included in the HHS-certified laboratory's 
standard operating procedure manual?
    (a) An HHS-certified laboratory must have a standard operating 
procedure (SOP) manual that describes, in detail, all HHS-certified 
laboratory operations. When followed, the SOP manual ensures that all 
specimens are tested using the same procedures.
    (b) The SOP manual must include at a minimum, but is not limited 
to, a detailed description of the following:
    (1) Chain of custody procedures;
    (2) Accessioning;
    (3) Security;
    (4) Quality control/quality assurance programs;
    (5) Analytical methods and procedures;
    (6) Equipment and maintenance programs;
    (7) Personnel training;
    (8) Reporting procedures; and
    (9) Computers, software, and laboratory information management 
systems.
    (c) All procedures in the SOP manual must be compliant with these 
Guidelines and all guidance provided by the Secretary.
    (d) A copy of all procedures that have been replaced or revised and 
the dates on which the procedures were in effect must be maintained for 
at least 2 years.
Section 11.2 What are the responsibilities of the responsible person 
(RP)?
    (a) Manage the day-to-day operations of the HHS-certified 
laboratory even if another individual has overall responsibility for 
alternate areas of a multi-specialty laboratory.
    (b) Ensure that there are sufficient personnel with adequate 
training and experience to supervise and conduct the work of the HHS-
certified laboratory. The RP must ensure the continued competency of 
laboratory staff by documenting their in-service training, reviewing 
their work performance, and verifying their skills.
    (c) Maintain a complete and current SOP manual that is available to 
all personnel of the HHS-certified laboratory and ensure that it is 
followed. The SOP manual must be reviewed, signed, and dated by the 
RP(s) when procedures are first placed into use and when changed or 
when a new individual assumes responsibility for the management of the 
HHS-certified laboratory. The SOP must be reviewed and documented by 
the RP annually.
    (d) Maintain a quality assurance program that ensures the proper 
performance and reporting of all test results; verify and monitor 
acceptable analytical performance for all controls and calibrators; 
monitor quality control testing; and document the validity, 
reliability, accuracy, precision, and performance characteristics of 
each test and test system.
    (e) Initiate and implement all remedial actions necessary to 
maintain satisfactory operation and performance of the HHS-certified 
laboratory in response to the following: Quality control systems not 
within performance specifications; errors in result reporting or in 
analysis of performance testing samples; and inspection deficiencies. 
The RP must ensure that specimen results are not reported until all 
corrective actions have been taken and that the results provided are 
accurate and reliable.
Section 11.3 What scientific qualifications must the RP have?
    The RP must have documented scientific qualifications in analytical 
toxicology.
    Minimum qualifications are:
    (a) Certification or licensure as a laboratory director by the 
state in forensic or clinical laboratory toxicology, a Ph.D. in one of 
the natural sciences, or training and experience comparable to a Ph.D. 
in one of the natural sciences with training and laboratory/research 
experience in biology, chemistry, and pharmacology or toxicology;
    (b) Experience in forensic toxicology with emphasis on the 
collection and analysis of biological specimens for drugs of abuse;
    (c) Experience in forensic applications of analytical toxicology 
(e.g., publications, court testimony, conducting research on the 
pharmacology and toxicology of drugs of abuse) or qualify as an expert 
witness in forensic toxicology;
    (d) Fulfillment of the RP responsibilities and qualifications, as 
demonstrated by the HHS-certified laboratory's performance and verified 
upon interview by HHS-trained inspectors during each on-site 
inspection; and
    (e) Qualify as a certifying scientist.
Section 11.4 What happens when the RP is absent or leaves an HHS-
certified laboratory?
    (a) HHS-certified laboratories must have multiple RPs or one RP and 
an alternate RP. If the RP(s) are concurrently absent, an alternate RP 
must be present and qualified to fulfill the responsibilities of the 
RP.
    (1) If an HHS-certified laboratory is without the RP and alternate 
RP for 14 calendar days or less (e.g., temporary absence due to 
vacation, illness, or business trip), the HHS-certified laboratory may 
continue operations and testing of federal agency specimens under the 
direction of a certifying scientist.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all specimens if the 
laboratory does not have an RP or alternate RP for a period of more 
than 14 calendar days. The suspension will be lifted upon the

[[Page 56141]]

Secretary's approval of a new permanent RP or alternate RP.
    (b) If the RP leaves an HHS-certified laboratory:
    (1) The HHS-certified laboratory may maintain certification and 
continue testing federally regulated specimens under the direction of 
an alternate RP for a period of up to 180 days while seeking to hire 
and receive the Secretary's approval of the RP's replacement.
    (2) The Secretary, in accordance with these Guidelines, will 
suspend a laboratory's HHS certification for all federally regulated 
specimens if the laboratory does not have a permanent RP within 180 
days. The suspension will be lifted upon the Secretary's approval of 
the new permanent RP.
    (c) To nominate an individual as an RP or alternate RP, the HHS-
certified laboratory must submit the following documents to the 
Secretary: The candidate's current resume or curriculum vitae, copies 
of diplomas and licensures, a training plan (not to exceed 90 days) to 
transition the candidate into the position, an itemized comparison of 
the candidate's qualifications to the minimum RP qualifications 
described in the Guidelines, and have official academic transcript(s) 
submitted from the candidate's institution(s) of higher learning. The 
candidate must be found qualified during an on-site inspection of the 
HHS-certified laboratory.
    (d) The HHS-certified laboratory must fulfill additional inspection 
and PT criteria as required prior to conducting federally regulated 
testing under a new RP.
Section 11.5 What qualifications must an individual have to certify a 
result reported by an HHS-certified laboratory?
    (a) A certifying scientist must have:
    (1) At least a bachelor's degree in the chemical or biological 
sciences or medical technology, or equivalent;
    (2) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (3) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.
    (b) A certifying technician must have:
    (1) Training and experience in the analytical methods and forensic 
procedures used by the HHS-certified laboratory relevant to the results 
that the individual certifies; and
    (2) Training and experience in reviewing and reporting forensic 
test results and maintaining chain of custody, and an understanding of 
appropriate remedial actions in response to problems that may arise.
Section 11.6 What qualifications and training must other personnel of 
an HHS-certified laboratory have?
    (a) All HHS-certified laboratory staff (e.g., technicians, 
administrative staff) must have the appropriate training and skills for 
the tasks they perform.
    (b) Each individual working in an HHS-certified laboratory must be 
properly trained (i.e., receive training in each area of work that the 
individual will be performing, including training in forensic 
procedures related to their job duties) before they are permitted to 
work independently with federally regulated specimens. All training 
must be documented.
Section 11.7 What security measures must an HHS-certified laboratory 
maintain?
    (a) An HHS-certified laboratory must control access to the drug 
testing facility, specimens, aliquots, and records.
    (b) Authorized visitors must be escorted at all times, except for 
individuals conducting inspections (i.e., for the Department, a federal 
agency, a state, or other accrediting agency) or emergency personnel 
(e.g., firefighters and medical rescue teams).
    (c) An HHS-certified laboratory must maintain records documenting 
the identity of the visitor and escort, date, time of entry and exit, 
and purpose for access to the secured area.
Section 11.8 What are the laboratory chain of custody requirements for 
specimens and aliquots?
    (a) HHS-certified laboratories must use chain of custody procedures 
(internal and external) to maintain control and accountability of 
specimens from the time of receipt at the laboratory through completion 
of testing, reporting of results, during storage, and continuing until 
final disposition of the specimens.
    (b) HHS-certified laboratories must use chain of custody procedures 
to document the handling and transfer of aliquots throughout the 
testing process until final disposal.
    (c) The chain of custody must be documented using either paper copy 
or electronic procedures.
    (d) Each individual who handles a specimen or aliquot must sign and 
complete the appropriate entries on the chain of custody form when the 
specimen or aliquot is handled or transferred, and every individual in 
the chain must be identified.
    (e) The date and purpose must be recorded on an appropriate chain 
of custody form each time a specimen or aliquot is handled or 
transferred.
Section 11.9 How must an HHS-certified laboratory process an alternate 
specimen that was collected at the same time as a hair specimen?
    When an alternate specimen is collected at the same time as a hair 
specimen, the collector must forward the hair specimen to an HHS-
certified hair testing laboratory and forward the alternate specimen to 
a laboratory that is certified by HHS for that specimen type. Section 
8.5(e) requires the collector to record a comment on each Federal CCF 
with sufficient information (including the associated specimen's unique 
specimen identification number) to enable the laboratory to identify 
that there is an associated hair specimen.
    (a) When a laboratory receives a specimen that it is not certified 
by HHS to test, the laboratory must contact the federal agency 
representative to select a laboratory with the appropriate HHS 
certification to test the specimen, and must forward the specimen to 
the selected laboratory.
    (b) The laboratory certified to test the alternate specimen must 
accession and hold the specimen under the storage conditions specified 
by the Mandatory Guidelines for Federal Workplace Drug Testing Programs 
for that specimen type. The laboratory does not test the alternate 
specimen unless an MRO submits a signed request for testing.
    (c) Upon receipt of a written MRO request for testing of the 
alternate specimen, the laboratory tests and reports the specimen in 
accordance with its standard operating procedures for that specimen 
type.
Section 11.10 What amount of hair is tested?
    The laboratory prepares an aliquot of the hair specimen of the 
specified weight needed for the test. If the root end is identified, 
the laboratory uses the first one inch of the hair from the root end.
Section 11.11 What are the requirements for an initial drug test?
    (a) An initial drug test may be:
    (1) An immunoassay or
    (2) An alternate technology (e.g., spectrometry, spectroscopy).
    (b) An HHS-certified laboratory must validate an initial drug test 
before testing specimens.

[[Page 56142]]

    (c) Initial drug tests must be accurate and reliable for the 
testing of specimens when identifying drugs or their metabolites.
    (d) An HHS-certified laboratory may conduct a second initial drug 
test using a method with different specificity, to rule out cross-
reacting compounds. This second initial drug test must satisfy the 
batch quality control requirements specified in Section 11.12.
Section 11.12 What must an HHS-certified laboratory do to validate an 
initial drug test?
    (a) An HHS-certified laboratory must demonstrate and document the 
following for each initial drug test:
    (1) The ability to differentiate negative specimens from those 
requiring further testing;
    (2) The performance of the test around the cutoff concentration, 
using samples at several concentrations between 0 and 150 percent of 
the cutoff concentration;
    (3) The effective concentration range of the test (linearity);
    (4) The potential for carryover;
    (5) The potential for interfering substances; and
    (6) The potential matrix effects if using an alternate technology.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) Each initial drug test using an alternate technology must be 
re-verified periodically or at least annually.
Section 11.13 What are the batch quality control requirements when 
conducting an initial drug test?
    (a) Each batch of specimens must contain the following controls:
    (1) At least one control certified to contain no drug or drug 
metabolite;
    (2) At least one positive control with the drug or drug metabolite 
targeted at a concentration 25 percent above the cutoff;
    (3) At least one control with the drug or drug metabolite targeted 
at a concentration 75 percent of the cutoff; and
    (4) At least one control that appears as a donor specimen to the 
analysts.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.
Section 11.14 What are the requirements for a confirmatory drug test?
    (a) The analytical method must use mass spectrometric 
identification [e.g., gas chromatography/mass spectrometry (GC/MS), 
liquid chromatography/mass spectrometry (LC/MS), GC/MS/MS, LC/MS/MS] or 
equivalent.
    (b) A confirmatory drug test must be validated before it can be 
used to test federally regulated specimens.
    (c) Confirmatory drug tests must be accurate and reliable for the 
testing of a hair specimen when identifying and quantifying drugs or 
their metabolites.
    (d) The laboratory must subject each confirmatory drug test 
specimen to a validated and effective decontamination procedure prior 
to testing.
Section 11.15 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
    (a) An HHS-certified laboratory must demonstrate and document the 
following for each confirmatory drug test:
    (1) The linear range of the analysis;
    (2) The limit of detection;
    (3) The limit of quantification;
    (4) The accuracy and precision at the cutoff concentration;
    (5) The accuracy (bias) and precision at 40 percent of the cutoff 
concentration;
    (6) The potential for interfering substances;
    (7) The potential for carryover;
    (8) The effectiveness of the decontamination procedure; and
    (9) The potential matrix effects if using liquid chromatography 
coupled with mass spectrometry.
    (b) Each new lot of reagent must be verified prior to being placed 
into service.
    (c) HHS-certified laboratories must re-verify each confirmatory 
drug test method periodically or at least annually.
Section 11.16 What are the batch quality control requirements when 
conducting a confirmatory drug test?
    (a) At a minimum, each batch of specimens must contain the 
following calibrators and controls:
    (1) A calibrator at the cutoff concentration;
    (2) At least one control certified to contain no drug or drug 
metabolite;
    (3) At least one positive control with the drug or drug metabolite 
targeted at 25 percent above the cutoff;
    (4) At least one control targeted at or less than 40 percent of the 
cutoff; and
    (5) At least one control contaminated with drug analyte to monitor 
the effectiveness of the decontamination procedure.
    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.
Section 11.17 What are the analytical and quality control requirements 
for conducting specimen validity tests?
    An HHS-certified laboratory must perform specimen validity testing 
to identify hair that has been damaged to the extent that the drug test 
may be affected, and may perform other specimen validity tests in 
accordance with Sections 3.1 and 3.5.
    (a) Each invalid, adulterated, or substituted specimen validity 
result must be based on an initial specimen validity test on one 
aliquot and a confirmatory specimen validity test on a second aliquot;
    (b) The HHS-certified laboratory must establish acceptance criteria 
and analyze calibrators and controls as appropriate to verify and 
document the validity of the test results; and
    (c) Controls must be analyzed concurrently with specimens.
Section 11.18 What must an HHS-certified laboratory do to validate a 
specimen validity test?
    An HHS-certified laboratory must demonstrate and document for each 
specimen validity test the appropriate performance characteristics of 
the test, and must re-verify the test periodically, or at least 
annually. Each new lot of reagent must be verified prior to being 
placed into service.
Section 11.19 What are the requirements for an HHS-certified laboratory 
to report a test result?
    (a) Laboratories must report a test result to the agency's MRO 
within an average of 5 working days after receipt of the specimen. 
Reports must use the Federal CCF and/or an electronic report, as 
described in items (l) and (m) below. Before any test result can be 
reported, it must be certified by a certifying scientist or a 
certifying technician (as appropriate).
    (b) A primary (A) specimen is reported negative when each initial 
drug test is negative or if the specimen is negative upon confirmatory 
drug testing, and the specimen does not meet invalid criteria as 
described in items (e)(1) through (e)(5) below.
    (c) A primary (A) specimen is reported positive for a specific drug 
or drug metabolite when both the initial drug test is positive and the 
confirmatory drug test is positive in accordance with Section 3.4.
    (d) For a specimen that has an invalid result for one of the 
reasons stated in items (e)(1) or (e)(2) below, the HHS-certified 
laboratory shall contact the MRO and both will decide if testing by 
another HHS-certified laboratory would be useful in being able to 
report a positive, adulterated, or substituted result. If no further 
testing is necessary, the HHS-certified laboratory then reports the 
invalid result to the MRO.

[[Page 56143]]

    (e) A primary (A) hair specimen is reported as an invalid result 
when:
    (1) The color of the A and B specimens are clearly different (note: 
A is tested);
    (2) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (3) Interference with the confirmatory drug test occurs on at least 
two separate aliquots of the specimen and the HHS-certified laboratory 
is unable to identify the interfering substance;
    (4) The hair is damaged to the extent that the drug test result may 
be affected (i.e., based on at least two separate aliquots of the 
specimen tested using a validated method to assess damage); or
    (5) The laboratory obtains a positive confirmatory drug test result 
and is unable to definitively remove external contamination from the 
specimen using a validated decontamination procedure.
    (f) An HHS-certified laboratory shall reject a primary (A) specimen 
for testing when a fatal flaw occurs as described in Section 15.1 or 
when a correctable flaw as described in Section 15.2 is not recovered. 
The HHS-certified laboratory will indicate on the Federal CCF that the 
specimen was rejected for testing and provide the reason for reporting 
the rejected for testing result.
    (g) An HHS-certified laboratory must report all positive, 
adulterated, substituted, and invalid test results for a hair specimen, 
with the exceptions noted below. For example, a specimen can be 
positive for a drug and invalid because of interference on the 
confirmatory test for a different drug analyte. The following 
exceptions apply:
    (1) When a specimen is positive and invalid because the hair is 
damaged as described in item (e)(4) above, the laboratory does not 
report the positive result.
    (2) When a specimen is invalid because the laboratory cannot 
definitively remove a drug present from external contamination as 
described in item (e)(5) above, the laboratory does not report the 
positive result for that drug. If the specimen is also positive for 
another drug and the laboratory was able to remove external 
contamination for that drug, the laboratory reports that positive 
result in addition to the invalid result.
    (h) An HHS-certified laboratory must report the confirmatory 
concentration of each drug or drug metabolite reported for a positive 
result.
    (i) An HHS-certified laboratory must report numerical values of the 
specimen validity test results that support an adulterated, 
substituted, or invalid result (as appropriate).
    (j) When the concentration of a drug or drug metabolite exceeds the 
validated linear range of the confirmatory test, HHS-certified 
laboratories may report to the MRO that the quantitative value exceeds 
the linear range of the test or that the quantitative value is greater 
than ``insert the actual value for the upper limit of the linear 
range,'' or laboratories may report a quantitative value above the 
upper limit of the linear range that was obtained by diluting an 
aliquot of the specimen to achieve a result within the method's linear 
range and multiplying the result by the appropriate dilution factor.
    (k) HHS-certified laboratories may transmit test results to the MRO 
by various electronic means (e.g., teleprinter, fax, or computer). 
Transmissions of the reports must ensure confidentiality and the 
results may not be reported verbally by telephone. Laboratories and 
external service providers must ensure the confidentiality, integrity, 
and availability of the data and limit access to any data transmission, 
storage, and retrieval system.
    (l) HHS-certified laboratories must fax, courier, mail, or 
electronically transmit a legible image or copy of the completed 
Federal CCF and/or forward a computer-generated electronic report. The 
computer-generated report must contain sufficient information to ensure 
that the test results can accurately represent the content of the 
custody and control form that the MRO received from the collector. HHS-
certified laboratories must use the drug/metabolite names in Section 
3.4 and/or the drug/metabolite abbreviations on the Federal CCF on 
computer-generated electronic reports.
    (m) For positive, adulterated, substituted, invalid, and rejected 
specimens, laboratories must fax, courier, mail, or electronically 
transmit a legible image or copy of the completed Federal CCF.
Section 11.20 How long must an HHS-certified laboratory retain 
specimens?
    (a) An HHS-certified laboratory must retain specimens that were 
reported as positive, adulterated, or as an invalid result for a 
minimum of 1 year.
    (b) Retained hair specimens must be kept in secured storage at room 
temperature and out of direct light, to ensure their availability for 
retesting during an administrative or judicial proceeding.
    (c) Alternate specimens (i.e., urine or oral fluid) must be kept in 
appropriate long-term storage conditions, as specified by the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs for that 
specimen type.
    (d) The laboratory must retain the alternate specimen for the same 
period of time that the associated hair specimen is retained.
    (e) Federal agencies may request that the HHS-certified laboratory 
retain a specimen for an additional specified period of time and must 
make that request within the 1-year period following the laboratory's 
receipt of the specimen.
Section 11.21 How long must an HHS-certified laboratory retain records?
    (a) An HHS-certified laboratory must retain all records generated 
to support test results for at least 2 years. The laboratory may 
convert hardcopy records to electronic records for storage and then 
discard the hardcopy records after 6 months.
    (b) A federal agency may request the HHS-certified laboratory to 
maintain a documentation package (as described in Section 11.23) that 
supports the chain of custody, testing, and reporting of a donor's 
specimen that is under legal challenge by a donor. The federal agency's 
request to the laboratory must be in writing and must specify the 
period of time to maintain the documentation package.
    (c) An HHS-certified laboratory may retain records other than those 
included in the documentation package beyond the normal 2-year period 
of time.
Section 11.22 What statistical summary reports must an HHS-certified 
laboratory provide for hair testing?
    (a) HHS-certified laboratories must provide to each federal agency 
for which they perform testing a semiannual statistical summary report 
that must be submitted by mail, fax, or email within 14 working days 
after the end of the semiannual period. The summary report must not 
include any personally identifiable information. A copy of the 
semiannual statistical summary report will also be sent to the 
Secretary or designated HHS representative. The semiannual statistical 
report contains the following information:
    (1) Reporting period (inclusive dates);
    (2) HHS-certified laboratory name and address;
    (3) Federal agency name;
    (4) Number of specimen results reported;
    (5) Number of specimens collected by reason for test;
    (6) Number of specimens reported negative;
    (7) Number of specimens rejected for testing because of a fatal 
flaw;

[[Page 56144]]

    (8) Number of specimens rejected for testing because of an 
uncorrected flaw;
    (9) Number of specimens tested positive by each initial drug test;
    (10) Number of specimens reported positive;
    (11) Number of specimens reported positive for each drug and drug 
metabolite;
    (12) Number of specimens reported adulterated;
    (13) Number of specimens reported substituted; and
    (14) Number of specimens reported as invalid result.
    (b) An HHS-certified laboratory must make copies of an agency's 
test results available when requested to do so by the Secretary or by 
the federal agency for which the laboratory is performing drug-testing 
services.
    (c) An HHS-certified laboratory must ensure that a qualified 
individual is available to testify in a proceeding against a federal 
employee when the proceeding is based on a test result reported by the 
laboratory.
Section 11.23 What HHS-certified laboratory information is available to 
a federal agency?
    (a) Following a federal agency's receipt of a positive, 
adulterated, or substituted drug test report, the federal agency may 
submit a written request for copies of the records relating to the drug 
test results or a documentation package or any relevant certification, 
review, or revocation of certification records.
    (b) Standard documentation packages provided by an HHS-certified 
laboratory must contain the following items:
    (1) A cover sheet providing a brief description of the procedures 
and tests performed on the donor's specimen;
    (2) A table of contents that lists all documents and materials in 
the package by page number;
    (3) A copy of the Federal CCF with any attachments, internal chain 
of custody records for the specimen, memoranda (if any) generated by 
the HHS-certified laboratory, and a copy of the electronic report (if 
any) generated by the HHS-certified laboratory;
    (4) A brief description of the HHS-certified laboratory's initial 
drug (and specimen validity, if applicable) testing procedures, 
instrumentation, and batch quality control requirements;
    (5) Copies of the initial test data for the donor's specimen with 
all calibrators and controls and copies of all internal chain of 
custody documents related to the initial tests;
    (6) A brief description of the HHS-certified laboratory's 
confirmatory drug (and specimen validity, if applicable) testing 
procedures, instrumentation, and batch quality control requirements;
    (7) Copies of the confirmatory test data for the donor's specimen 
with all calibrators and controls and copies of all internal chain of 
custody documents related to the confirmatory tests; and
    (8) Copies of the r[eacute]sum[eacute] or curriculum vitae for the 
RP(s) and the certifying technician or certifying scientist of record.
Section 11.24 What HHS-certified laboratory information is available to 
a federal applicant or employee?
    Federal applicants or employees who are subject of a workplace drug 
test may submit a written request through the MRO and/or the federal 
agency requesting copies of any records relating to their drug test 
results or a documentation package as described in Section 11.23(b) and 
any relevant certification, review, or revocation of certification 
records. Federal applicants or employees, or their designees, are not 
permitted access to their specimens collected pursuant to Executive 
Order 12564, Public Law 100-71, and these Guidelines.
Section 11.25 What types of relationships are prohibited between an 
HHS-certified laboratory and an MRO?
    An HHS-certified laboratory must not enter into any relationship 
with a federal agency's MRO that may be construed as a potential 
conflict of interest or derive any financial benefit by having a 
federal agency use a specific MRO.
    This means an MRO may be an employee of the agency or a contractor 
for the agency; however, an MRO shall not be an employee or agent of or 
have any financial interest in the HHS-certified laboratory for which 
the MRO is reviewing drug testing results. Additionally, an MRO shall 
not derive any financial benefit by having an agency use a specific 
HHS-certified laboratory or have any agreement with an HHS-certified 
laboratory that may be construed as a potential conflict of interest.

Subpart L--Instrumented Initial Test Facility (IITF)

Section 12.1 May an IITF test hair specimens for a federal agency's 
workplace drug testing program?
    No, only HHS-certified laboratories are authorized to test hair 
specimens for federal agency workplace drug testing programs in 
accordance with these Guidelines.

Subpart M--Medical Review Officer (MRO)

Section 13.1 Who may serve as an MRO?
    (a) A currently licensed physician who has:
    (1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) 
degree;
    (2) Knowledge regarding the pharmacology and toxicology of illicit 
drugs;
    (3) The training necessary to serve as an MRO as set out in Section 
13.3;
    (4) Satisfactorily passed an initial examination administered by a 
nationally recognized entity or subspecialty board that has been 
approved by the Secretary to certify MROs; and
    (5) At least every five years from initial certification, completed 
requalification training on the topics in Section 13.3 and 
satisfactorily passed a requalification examination administered by a 
nationally recognized entity or a subspecialty board that has been 
approved by the Secretary to certify MROs.
Section 13.2 How are nationally recognized entities or subspecialty 
boards that certify MROs approved?
    All nationally recognized entities or subspecialty boards which 
seek approval by the Secretary to certify physicians as MROs for 
federal workplace drug testing programs must submit their 
qualifications, a sample examination, and other necessary supporting 
examination materials (e.g., answers, previous examination statistics 
or other background examination information, if requested). Approval 
will be based on an objective review of qualifications that include a 
copy of the MRO applicant application form, documentation that the 
continuing education courses are accredited by a professional 
organization, and the delivery method and content of the examination. 
Each approved MRO certification entity must resubmit their 
qualifications for approval every two years. The Secretary shall 
publish at least every two years a notice in the Federal Register 
listing those entities and subspecialty boards that have been approved. 
This notice is also available on the internet at http://www.samhsa.gov/workplace/drug-testing.
    Section 13.3 What training is required before a physician may serve 
as an MRO?
    (a) A physician must receive training that includes a thorough 
review of the following:

[[Page 56145]]

    (1) The collection procedures used to collect federal agency 
specimens;
    (2) How to interpret test results reported by HHS-certified IITFs 
and laboratories (e.g., negative, negative/dilute, positive, 
adulterated, substituted, rejected for testing, and invalid);
    (3) Chain of custody, reporting, and recordkeeping requirements for 
federal agency specimens;
    (4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing 
Programs for all authorized specimen types; and
    (5) Procedures for interpretation, review (e.g., donor interview 
for legitimate medical explanations, review of documentation provided 
by the donor to support a legitimate medical explanation), and 
reporting of results specified by any federal agency for which the 
individual may serve as an MRO.
    (b) Certified MROs must complete training on any revisions to these 
Guidelines prior to their effective date, to continue serving as an MRO 
for federal agency specimens.
Section 13.4 What are the responsibilities of an MRO?
    (a) The MRO must review all positive, adulterated, rejected for 
testing, invalid, and substituted test results.
    (b) Staff under the direct, personal supervision of the MRO may 
review and report negative and (for urine) negative/dilute test results 
to the agency's designated representative. The MRO must review at least 
5 percent of all negative results reported by the MRO staff to ensure 
that the MRO staff are properly performing the review process.
    (c) The MRO must discuss potential invalid results with the HHS-
certified laboratory, as addressed in Section 11.19(d) to determine 
whether testing at another HHS-certified laboratory may be warranted.
    (d) After receiving a report from an HHS-certified laboratory or 
(for urine) HHS-certified IITF, the MRO must:
    (1) Review the information on the MRO copy of the Federal CCF that 
was received from the collector and the report received from the HHS-
certified laboratory or HHS-certified IITF;
    (2) Interview the donor when required;
    (3) Make a determination regarding the test result; and
    (4) Report the verified result to the federal agency.
    (e) The MRO must maintain records for a minimum of 2 years while 
maintaining the confidentiality of the information. The MRO may convert 
hardcopy records to electronic records for storage and discard the 
hardcopy records after 6 months.
Section 13.5 What must an MRO do when reviewing a hair specimen's test 
results?
    (a) When the HHS-certified laboratory reports a negative result for 
the primary (A) hair specimen, the MRO reports a negative result to the 
agency.
    (b) When the HHS-certified laboratory reports multiple results for 
the primary (A) hair specimen, the MRO must follow the verification 
procedures described in 13.5(c) through (g) and:
    (1) The MRO reports all verified refusal to test results to the 
federal agency.
    (2) If an invalid result was reported in conjunction with a 
positive, adulterated, or substituted result, the MRO does not report 
the verified invalid result to the federal agency at this time. The MRO 
takes action for the verified invalid result(s) for the primary (A) 
specimen as described in 13.5(f) only when:
    (i) The MRO verifies the positive or adulterated result as negative 
based on a legitimate medical explanation as described in 13.5(c)(2) 
and 13.5(d)(1); or
    (ii) The split (B) specimen is tested and reported as a failure to 
reconfirm the adulterated or substituted result reported for the 
primary (A) specimen as described in Section 14.5(b) and 14.5(c).
    (c) When the HHS-certified laboratory reports a positive result for 
the primary (A) specimen, the MRO must contact the donor to determine 
if there is an explanation for the positive result.
    (1) If the donor admits illicit use of the drug(s) that caused the 
positive result, the MRO reports the test result as positive to the 
agency.
    (2) If the donor provides documentation (e.g., a valid 
prescription) to support a legitimate medical explanation for the 
positive result, the MRO reports the test result as negative to the 
agency.
    (i) Passive exposure to a drug (e.g., exposure to marijuana smoke) 
is not a legitimate medical explanation for a positive drug test 
result.
    (ii) Ingestion of food products containing marijuana is not a 
legitimate medical explanation for a positive marijuana test result.
    (3) If the donor is unable to provide a legitimate medical 
explanation and there is no admission of illicit use supporting the 
positive hair test result, the MRO reports a test cancelled result to 
the agency and takes actions as follows:
    (i) If an alternate specimen was collected at the same time as the 
hair specimen, the MRO directs (in writing) the laboratory who has 
custody of the donor's alternate specimen to test the specimen. The 
laboratory and MRO follow the procedures in the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs for that specimen type.
    (ii) If an alternate specimen was not collected at the same time as 
the hair specimen, the MRO directs the agency to immediately collect an 
alternate specimen from the donor. The collector, laboratory and MRO 
follow the procedures in the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs for the alternate specimen type.
    (d) When the HHS-certified laboratory reports an adulterated result 
for the primary (A) hair specimen, the MRO contacts the donor to 
determine if the donor has a legitimate medical explanation for the 
adulterated result.
    (1) If the donor provides a legitimate medical explanation, the MRO 
reports a negative result to the federal agency.
    (2) If the donor is unable to provide a legitimate medical 
explanation, the MRO reports a refusal to test to the federal agency 
because the hair specimen was adulterated.
    (e) When the HHS-certified laboratory reports a substituted result 
for the primary (A) hair specimen, the MRO reports a refusal to test to 
the federal agency because the hair specimen was substituted.
    (f) When the HHS-certified laboratory reports an invalid result for 
the primary (A) hair specimen, the MRO reports a test cancelled result 
to the agency and takes action as follows:
    (1) If an alternate specimen was collected at the same time as the 
hair specimen, the MRO directs (in writing) the laboratory who has 
custody of the donor's alternate specimen to test the specimen. The 
laboratory and MRO follow the procedures in the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs for the alternate specimen 
type.
    (2) If an alternate specimen was not collected at the same time as 
the hair specimen, the MRO directs the agency to immediately collect an 
alternate specimen from the donor. The collector, laboratory and MRO 
follow the procedures in the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs for the alternate specimen type.
    (g) When the HHS-certified laboratory reports a rejected for 
testing result for the primary (A) specimen, the MRO reports a test 
cancelled result to the agency and takes action as follows:
    (1) If an alternate specimen was collected at the same time as the 
hair

[[Page 56146]]

specimen, the MRO directs (in writing) the laboratory who has custody 
of the donor's alternate specimen to test the specimen. The laboratory 
and MRO follow the procedures in the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs for the alternate specimen type.
    (2) If an alternate specimen was not collected at the same time as 
the hair specimen, the MRO directs the agency to immediately collect an 
alternate specimen from the donor. The collector, laboratory and MRO 
follow the procedures in the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs for the alternate specimen type.
Section 13.6 What action does the MRO take when the collector reports 
that the donor did not provide a sufficient amount of hair for a drug 
test?
    (a) When another specimen type (e.g., urine, oral fluid) was 
collected in accordance with section 8.6, the MRO reviews and reports 
the alternate specimen's test result in accordance with the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using the 
alternate specimen.
    (b) If the donor is unable to provide a sufficient amount of the 
alternate specimen authorized by the federal agency, the MRO consults 
with the federal agency. The federal agency follows the required 
procedures in the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using the alternate specimen. This includes 
immediately directing the donor to obtain, within five days, an 
evaluation from a licensed physician, acceptable to the MRO, who has 
expertise in the medical issues raised by the donor's failure to 
provide a specimen. The MRO may perform this evaluation if the MRO has 
appropriate expertise.
Section 13.7 Who may request a test of a split (B) hair specimen?
    (a) For an adulterated or substituted result reported on a primary 
(A) hair specimen, a donor may request through the MRO that the split 
(B) specimen be tested by a second HHS-certified laboratory to verify 
the result reported by the first HHS-certified laboratory.
    (b) The donor has 72 hours (from the time the MRO notified the 
donor that his or her specimen was reported adulterated or substituted 
to request a test of the split (B) specimen. The MRO must inform the 
donor that the donor has the opportunity to request a test of the split 
(B) specimen when the MRO informs the donor that an adulterated or 
substituted result is being reported to the federal agency on the 
primary (A) specimen.
Section 13.8 How does an MRO report a primary (A) specimen test result 
to an agency?
    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, fax, or computer). Transmissions of the 
reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all 
adulterated and substituted results.
    (d) The MRO must not disclose numerical values of drug test results 
to the agency.
Section 13.9 What types of relationships are prohibited between an MRO 
and an HHS-certified laboratory?
    An MRO must not be an employee, agent of, or have any financial 
interest in an HHS-certified laboratory for which the MRO is reviewing 
drug test results.
    This means an MRO must not derive any financial benefit by having 
an agency use a specific HHS-certified laboratory or have any agreement 
with the HHS-certified laboratory that may be construed as a potential 
conflict of interest.

Subpart N--Split Specimen Tests

Section 14.1 When may a split (B) hair specimen be tested?
    (a) The donor may request, verbally or in writing, through the MRO 
that the split (B) hair specimen be tested at a different (i.e., 
second) HHS-certified laboratory when the primary (A) specimen was 
determined by the MRO to be adulterated or substituted.
    (b) A donor has 72 hours to initiate the request after being 
informed of the result by the MRO. The MRO must document in the MRO's 
records the verbal request from the donor to have the split (B) 
specimen tested.
    (c) If a split (B) hair specimen cannot be tested by a second HHS-
certified laboratory (e.g., insufficient specimen, lost in transit, 
split not available, no second HHS-certified laboratory to perform the 
test), the MRO reports a cancelled test to the federal agency and takes 
action as follows:
    (i) If an alternate specimen was collected at the same time as the 
hair specimen, the MRO directs (in writing) the laboratory who has 
custody of the donor's alternate specimen to test the specimen. The 
laboratory and MRO follow the procedures in the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs for the alternate specimen 
type.
    (ii) If an alternate specimen was not collected at the same time as 
the hair specimen, the MRO directs the agency to collect an alternate 
specimen from the donor. The collector, laboratory and MRO follow the 
procedures in the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs for the alternate specimen type.
    (d) If a donor chooses not to have the split (B) specimen tested by 
a second HHS-certified hair laboratory, a federal agency may have a 
split (B) specimen retested as part of a legal or administrative 
proceeding to defend an original adulterated or substituted result.
Section 14.2 How does an HHS-certified laboratory test a split (B) hair 
specimen when the primary (A) specimen was reported adulterated?
    (a) The HHS-certified laboratory must use its confirmatory specimen 
validity test at an established limit of quantification (LOQ) to 
reconfirm the presence of the adulterant.
    (b) The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
adulterated result reported by the first HHS-certified laboratory.
Section 14.3 How does an HHS-certified laboratory test a split (B) hair 
specimen when the primary (A) specimen was reported substituted?
    The second HHS-certified laboratory may only conduct the 
confirmatory specimen validity test(s) needed to reconfirm the 
substituted result reported by the first HHS-certified laboratory.
Section 14.4 Who receives the split (B) specimen result?
    The second HHS-certified laboratory must report the result to the 
MRO.
Section 14.5 What action(s) does an MRO take after receiving the split 
(B) hair specimen result from the second HHS-certified laboratory?
    The MRO takes the following actions when the second HHS-certified

[[Page 56147]]

laboratory reports the result for the split (B) hair specimen as:
    (a) Reconfirmed adulteration and/or substitution result. The MRO 
reports reconfirmed to the agency.
    (b) Failed to reconfirm adulteration or substitution. The MRO 
reports to the agency a failed to reconfirm result (specify adulterant 
or not substituted) and cancels both tests. The MRO shall notify the 
HHS office responsible for coordination of the Drug Free Workplace 
Program regarding the test results for the specimen.
    (c) Failed to reconfirm an adulterated result and failed to 
reconfirm a substituted result. The MRO reports to the agency a failed 
to reconfirm result [(specify adulterant) and not substituted]. The MRO 
shall notify the HHS office responsible for coordination of the Drug 
Free Workplace Program regarding the test results for the specimen.
    (d) Failed to reconfirm an adulterated result and reconfirmed a 
substituted result. The MRO reports to the agency a reconfirmed result 
(substituted) and a failed to reconfirm result (specify adulterant). 
The MRO tells the agency that it may take action based on the 
substituted result although Laboratory B failed to reconfirm the 
adulterated result.
    (e) Failed to reconfirm a substituted result and reconfirmed an 
adulterated result. The MRO reports to the agency a reconfirmed result 
(adulterated) and a failed to reconfirm result (not substituted). The 
MRO tells the agency that it may take action based on the adulterated 
result although Laboratory B failed to reconfirm the substituted 
result.
Section 14.6 How does an MRO report a split (B) specimen test result to 
an agency?
    (a) The MRO must report all verified results to an agency using the 
completed MRO copy of the Federal CCF or a separate report using a 
letter/memorandum format. The MRO may use various electronic means for 
reporting (e.g., teleprinter, fax, or computer). Transmissions of the 
reports must ensure confidentiality. The MRO and external service 
providers must ensure the confidentiality, integrity, and availability 
of the data and limit access to any data transmission, storage, and 
retrieval system.
    (b) A verified result may not be reported to the agency until the 
MRO has completed the review process.
    (c) The MRO must send a copy of either the completed MRO copy of 
the Federal CCF or the separate letter/memorandum report for all split 
specimen results.
    (d) The MRO must not disclose the numerical values of the drug test 
results to the agency.
Section 14.7 How long must an HHS-certified laboratory retain a split 
(B) specimen?
    A split (B) specimen is retained for the same period of time that a 
primary (A) specimen is retained and under the same storage conditions, 
in accordance with Section 11.20. This applies even for those cases 
when the split (B) specimen is tested by a second HHS-certified 
laboratory and the second HHS-certified laboratory does not confirm the 
original result reported by the first HHS-certified laboratory for the 
primary (A) specimen.

Subpart O--Criteria for Rejecting a Specimen for Testing

Section 15.1 What discrepancies require an HHS-certified laboratory to 
report a hair specimen as rejected for testing?
    The following discrepancies are considered to be fatal flaws. The 
HHS-certified laboratory must stop the testing process, reject the 
specimen for testing, and indicate the reason for rejecting the 
specimen on the Federal CCF when:
    (a) The specimen ID number on the primary (A) or split (B) specimen 
label/seal does not match the ID number on the Federal CCF, or the ID 
number is missing either on the Federal CCF or on either specimen 
label/seal;
    (b) The primary (A) specimen label/seal is misapplied, broken or 
shows evidence of tampering and the split (B) specimen cannot be re-
designated as the primary (A) specimen;
    (c) The collector's printed name and signature are omitted on the 
Federal CCF;
    (d) There is an insufficient amount of specimen for analysis in the 
primary (A) specimen unless the split (B) specimen can be re-designated 
as the primary (A) specimen; or
    (e) The accessioner failed to document the primary (A) specimen 
seal condition on the Federal CCF at the time of accessioning, and the 
split (B) specimen cannot be re-designated as the primary (A) specimen.
    (f) The specimen was received at the HHS-certified laboratory 
without a CCF;
    (g) The CCF was received at the HHS-certified laboratory without a 
specimen;
    (h) The collector performed two separate collections using one CCF;
    (i) The physical appearances (other than color) of the primary (A) 
and split (B) specimen are clearly different;
    (j) The laboratory identifies lice or a similar infestation in the 
hair; or
    (k) The HHS-certified laboratory identifies a flaw (other than 
those specified above) that prevents testing or affects the forensic 
defensibility of the drug test and cannot be corrected.
Section 15.2 What discrepancies require an HHS-certified laboratory to 
report a specimen as rejected for testing unless the discrepancy is 
corrected?
    The following discrepancies are considered to be correctable:
    (a) If a collector failed to sign the Federal CCF, the HHS-
certified laboratory must attempt to recover the collector's signature 
before reporting the test result. If the collector can provide a 
memorandum for record recovering the signature, the HHS-certified 
laboratory may report the test result for the specimen. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot recover the collector's signature, the laboratory 
must report a rejected for testing result and indicate the reason for 
the rejected for testing result on the Federal CCF.
    (b) If a specimen is submitted using a non-federal form or an 
expired Federal CCF, the HHS-certified laboratory must test the 
specimen and also attempt to obtain a memorandum for record explaining 
why a non-federal form or an expired Federal CCF was used and ensure 
that the form used contains all the required information. If, after 
holding the specimen for at least 5 business days, the HHS-certified 
laboratory cannot obtain a memorandum for record from the collector, 
the laboratory must report a rejected for testing result and indicate 
the reason for the rejected for testing result on the report to the 
MRO.
Section 15.3 What discrepancies are not sufficient to require an HHS-
certified laboratory to reject a hair specimen for testing or an MRO to 
cancel a test?
    (a) The following omissions and discrepancies on the Federal CCF 
that are received by the HHS-certified laboratory should not cause an 
HHS-certified laboratory to reject a hair specimen or cause an MRO to 
cancel a test:
    (1) An incorrect laboratory name and address appearing at the top 
of the form;
    (2) Incomplete/incorrect/unreadable employer name or address;
    (3) MRO name is missing;
    (4) Incomplete/incorrect MRO address;

[[Page 56148]]

    (5) A transposition of numbers in the donor's Social Security 
Number or employee identification number;
    (6) A telephone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``drug tests to be performed'' box is not marked;
    (9) A ``specimen collection'' box is not marked;
    (10) The collection site address is missing;
    (11) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (13) The time of collection is not indicated;
    (14) The date of collection is not indicated;
    (15) Incorrect name of delivery service;
    (16) The collector has changed or corrected information by crossing 
out the original information on either the Federal CCF or specimen 
label/seal without dating and initialing the change; or
    (17) The donor's name inadvertently appears on the HHS-certified 
laboratory copy of the Federal CCF or on the tamper-evident labels used 
to seal the specimens.
    (b) The following omissions and discrepancies on the Federal CCF 
that are made at the HHS-certified laboratory should not cause an MRO 
to cancel a test:
    (1) The testing laboratory fails to indicate the correct name and 
address in the results section when a different laboratory name and 
address is printed at the top of the Federal CCF;
    (2) The accessioner fails to print his or her name;
    (3) The certifying scientist or certifying technician fails to 
print his or her name;
    (4) The certifying scientist or certifying technician accidentally 
initials the Federal CCF rather than signing for a specimen reported as 
rejected for testing;
    (c) The above omissions and discrepancies should occur no more than 
once a month. The expectation is that each trained collector and HHS-
certified laboratory will make every effort to ensure that the Federal 
CCF is properly completed and that all the information is correct. When 
an error occurs more than once a month, the MRO must direct the 
collector or HHS-certified laboratory (whichever is responsible for the 
error) to immediately take corrective action to prevent the recurrence 
of the error.
Section 15.4 What discrepancies may require an MRO to cancel a test?
    (a) An MRO must attempt to correct the following errors:
    (1) The donor's signature is missing on the MRO copy of the Federal 
CCF and the collector failed to provide a comment that the donor 
refused to sign the form;
    (2) The certifying scientist failed to sign the Federal CCF for a 
specimen being reported adulterated, invalid, or substituted; or
    (3) The electronic report provided by the HHS-certified laboratory 
does not contain all the data elements required for the HHS standard 
laboratory electronic report for a specimen being reported adulterated, 
invalid result, or substituted.
    (b) If error (a)(1) occurs, the MRO must contact the collector to 
obtain a statement to verify that the donor refused to sign the MRO 
copy. If, after at least 5 business days, the collector cannot provide 
such a statement, the MRO must cancel the test.
    (c) If error (a)(2) occurs, the MRO must obtain a statement from 
the certifying scientist that they forgot to sign the Federal CCF, but 
did, in fact, properly conduct the certification review. If, after at 
least 5 business days, the MRO cannot get a statement from the 
certifying scientist, the MRO must cancel the test.
    (d) If error (a)(3) occurs, the MRO must contact the HHS-certified 
laboratory. If, after at least 5 business days, the laboratory does not 
retransmit a corrected electronic report, the MRO must cancel the test.

Subpart P--Laboratory Suspension/Revocation Procedures

Section 16.1 When may the HHS certification of a laboratory be 
suspended?
    These procedures apply when:
    (a) The Secretary has notified an HHS-certified laboratory in 
writing that its certification to perform drug testing under these 
Guidelines has been suspended or that the Secretary proposes to revoke 
such certification.
    (b) The HHS-certified laboratory has, within 30 days of the date of 
such notification or within 3 days of the date of such notification 
when seeking an expedited review of a suspension, requested in writing 
an opportunity for an informal review of the suspension or proposed 
revocation.
Section 16.2 What definitions are used for this subpart?
    Appellant. Means the HHS-certified laboratory which has been 
notified of its suspension or proposed revocation of its certification 
to perform testing and has requested an informal review thereof.
    Respondent. Means the person or persons designated by the Secretary 
in implementing these Guidelines.
    Reviewing Official. Means the person or persons designated by the 
Secretary who will review the suspension or proposed revocation. The 
reviewing official may be assisted by one or more of the official's 
employees or consultants in assessing and weighing the scientific and 
technical evidence and other information submitted by the appellant and 
respondent on the reasons for the suspension and proposed revocation.
Section 16.3 Are there any limitations on issues subject to review?
    The scope of review shall be limited to the facts relevant to any 
suspension or proposed revocation, the necessary interpretations of 
those facts, the relevant Mandatory Guidelines for Federal Workplace 
Drug Testing Programs, and other relevant law. The legal validity of 
these Guidelines shall not be subject to review under these procedures.
Section 16.4 Who represents the parties?
    The appellant's request for review shall specify the name, address, 
and telephone number of the appellant's representative. In its first 
written submission to the reviewing official, the respondent shall 
specify the name, address, and telephone number of the respondent's 
representative.
Section 16.5 When must a request for informal review be submitted?
    (a) Within 30 days of the date of the notice of the suspension or 
proposed revocation, the appellant must submit a written request to the 
reviewing official seeking review, unless some other time period is 
agreed to by the parties. A copy must also be sent to the respondent. 
The request for review must include a copy of the notice of suspension 
or proposed revocation, a brief statement of why the decision to 
suspend or propose revocation is wrong, and the appellant's request for 
an oral presentation, if desired.
    (b) Within 5 days after receiving the request for review, the 
reviewing official will send an acknowledgment and advise the appellant 
of the next steps. The reviewing official will also send a copy of the 
acknowledgment to the respondent.

[[Page 56149]]

Section 16.6 What is an abeyance agreement?
    Upon mutual agreement of the parties to hold these procedures in 
abeyance, the reviewing official will stay these procedures for a 
reasonable time while the laboratory attempts to regain compliance with 
the Guidelines or the parties otherwise attempt to settle the dispute. 
As part of an abeyance agreement, the parties can agree to extend the 
time period for requesting review of the suspension or proposed 
revocation. If abeyance begins after a request for review has been 
filed, the appellant shall notify the reviewing official at the end of 
the abeyance period, advising whether the dispute has been resolved. If 
the dispute has been resolved, the request for review will be 
dismissed. If the dispute has not been resolved, the review procedures 
will begin at the point at which they were interrupted by the abeyance 
agreement with such modifications to the procedures as the reviewing 
official deems appropriate.
Section 16.7 What procedures are used to prepare the review file and 
written argument?
    The appellant and the respondent each participate in developing the 
file for the reviewing official and in submitting written arguments. 
The procedures for development of the review file and submission of 
written argument are:
    (a) Appellant's Documents and Brief. Within 15 days after receiving 
the acknowledgment of the request for review, the appellant shall 
submit to the reviewing official the following (with a copy to the 
respondent):
    (1) A review file containing the documents supporting appellant's 
argument, tabbed and organized chronologically, and accompanied by an 
index identifying each document. Only essential documents should be 
submitted to the reviewing official.
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining why respondent's decision to suspend or propose revocation 
of appellant's certification is wrong (appellant's brief).
    (b) Respondent's Documents and Brief. Within 15 days after 
receiving a copy of the acknowledgment of the request for review, the 
respondent shall submit to the reviewing official the following (with a 
copy to the appellant):
    (1) A review file containing documents supporting respondent's 
decision to suspend or revoke appellant's certification to perform drug 
testing, which is tabbed and organized chronologically, and accompanied 
by an index identifying each document. Only essential documents should 
be submitted to the reviewing official.
    (2) A written statement, not exceeding 20 double-spaced pages in 
length, explaining the basis for suspension or proposed revocation 
(respondent's brief).
    (c) Reply Briefs. Within 5 days after receiving the opposing 
party's submission, or 20 days after receiving acknowledgment of the 
request for review, whichever is later, each party may submit a short 
reply not to exceed 10 double-spaced pages.
    (d) Cooperative Efforts. Whenever feasible, the parties should 
attempt to develop a joint review file.
    (e) Excessive Documentation. The reviewing official may take any 
appropriate step to reduce excessive documentation, including the 
return of or refusal to consider documentation found to be irrelevant, 
redundant, or unnecessary.
Section 16.8 When is there an opportunity for oral presentation?
    (a) Electing Oral Presentation. If an opportunity for an oral 
presentation is desired, the appellant shall request it at the time it 
submits its written request for review to the reviewing official. The 
reviewing official will grant the request if the official determines 
that the decision-making process will be substantially aided by oral 
presentations and arguments. The reviewing official may also provide 
for an oral presentation at the official's own initiative or at the 
request of the respondent.
    (b) Presiding Official. The reviewing official or designee will be 
the presiding official responsible for conducting the oral 
presentation.
    (c) Preliminary Conference. The presiding official may hold a 
prehearing conference (usually a telephone conference call) to consider 
any of the following: simplifying and clarifying issues, stipulations 
and admissions, limitations on evidence and witnesses that will be 
presented at the hearing, time allotted for each witness and the 
hearing altogether, scheduling the hearing, and any other matter that 
will assist in the review process. Normally, this conference will be 
conducted informally and off the record; however, the presiding 
official may, at their discretion, produce a written document 
summarizing the conference or transcribe the conference, either of 
which will be made a part of the record.
    (d) Time and Place of the Oral Presentation. The presiding official 
will attempt to schedule the oral presentation within 30 days of the 
date the appellant's request for review is received or within 10 days 
of submission of the last reply brief, whichever is later. The oral 
presentation will be held at a time and place determined by the 
presiding official following consultation with the parties.
    (e) Conduct of the Oral Presentation.
    (1) General. The presiding official is responsible for conducting 
the oral presentation. The presiding official may be assisted by one or 
more of the official's employees or consultants in conducting the oral 
presentation and reviewing the evidence. While the oral presentation 
will be kept as informal as possible, the presiding official may take 
all necessary steps to ensure an orderly proceeding.
    (2) Burden of Proof/Standard of Proof. In all cases, the respondent 
bears the burden of proving by a preponderance of the evidence that its 
decision to suspend or propose revocation is appropriate. The 
appellant, however, has a responsibility to respond to the respondent's 
allegations with evidence and argument to show that the respondent is 
wrong.
    (3) Admission of Evidence. The Federal Rules of Evidence do not 
apply and the presiding official will generally admit all testimonial 
evidence unless it is clearly irrelevant, immaterial, or unduly 
repetitious. Each party may make an opening and closing statement, may 
present witnesses as agreed upon in the prehearing conference or 
otherwise, and may question the opposing party's witnesses. Since the 
parties have ample opportunity to prepare the review file, a party may 
introduce additional documentation during the oral presentation only 
with the permission of the presiding official. The presiding official 
may question witnesses directly and take such other steps necessary to 
ensure an effective and efficient consideration of the evidence, 
including setting time limitations on direct and cross-examinations.
    (4) Motions. The presiding official may rule on motions including, 
for example, motions to exclude or strike redundant or immaterial 
evidence, motions to dismiss the case for insufficient evidence, or 
motions for summary judgment. Except for those made during the hearing, 
all motions and opposition to motions, including argument, must be in 
writing and be no more than 10 double-spaced pages in length. The 
presiding official will set a reasonable time for the party opposing 
the motion to reply.
    (5) Transcripts. The presiding official shall have the oral 
presentation transcribed and the transcript shall be

[[Page 56150]]

made a part of the record. Either party may request a copy of the 
transcript and the requesting party shall be responsible for paying for 
its copy of the transcript.
    (f) Obstruction of Justice or Making of False Statements. 
Obstruction of justice or the making of false statements by a witness 
or any other person may be the basis for a criminal prosecution under 
18 U.S.C. 1505 or 1001.
    (g) Post-hearing Procedures. At their discretion, the presiding 
official may require or permit the parties to submit post-hearing 
briefs or proposed findings and conclusions. Each party may submit 
comments on any major prejudicial errors in the transcript.
Section 16.9 Are there expedited procedures for review of immediate 
suspension?
    (a) Applicability. When the Secretary notifies an HHS-certified 
laboratory in writing that its certification to perform drug testing 
has been immediately suspended, the appellant may request an expedited 
review of the suspension and any proposed revocation. The appellant 
must submit this request in writing to the reviewing official within 3 
days of the date the HHS-certified laboratory received notice of the 
suspension. The request for review must include a copy of the 
suspension and any proposed revocation, a brief statement of why the 
decision to suspend and propose revocation is wrong, and the 
appellant's request for an oral presentation, if desired. A copy of the 
request for review must also be sent to the respondent.
    (b) Reviewing Official's Response. As soon as practicable after the 
request for review is received, the reviewing official will send an 
acknowledgment with a copy to the respondent.
    (c) Review File and Briefs. Within 7 days of the date the request 
for review is received, but no later than 2 days before an oral 
presentation, each party shall submit to the reviewing official the 
following:
    (1) A review file containing essential documents relevant to the 
review, which is tabbed, indexed, and organized chronologically; and
    (2) A written statement, not to exceed 20 double-spaced pages, 
explaining the party's position concerning the suspension and any 
proposed revocation. No reply brief is permitted.
    (d) Oral Presentation. If an oral presentation is requested by the 
appellant or otherwise granted by the reviewing official, the presiding 
official will attempt to schedule the oral presentation within 7-10 
days of the date of appellant's request for review at a time and place 
determined by the presiding official following consultation with the 
parties. The presiding official may hold a prehearing conference in 
accordance with Section 16.8(c) and will conduct the oral presentation 
in accordance with the procedures of Sections 16.8(e), (f), and (g).
    (e) Written Decision. The reviewing official shall issue a written 
decision upholding or denying the suspension or proposed revocation and 
will attempt to issue the decision within 7-10 days of the date of the 
oral presentation or within 3 days of the date on which the transcript 
is received or the date of the last submission by either party, 
whichever is later. All other provisions set forth in Section 16.14 
will apply.
    (f) Transmission of Written Communications. Because of the 
importance of timeliness for these expedited procedures, all written 
communications between the parties and between both party and the 
reviewing official shall be by fax, secured electronic transmissions, 
or overnight mail.
Section 16.10 Are any types of communications prohibited?
    Except for routine administrative and procedural matters, a party 
shall not communicate with the reviewing or presiding official without 
notice to the other party.
Section 16.11 How are communications transmitted by the reviewing 
official?
    (a) Because of the importance of a timely review, the reviewing 
official should normally transmit written communications to either 
party by fax, secured electronic transmissions, or overnight mail in 
which case the date of transmission or day following mailing will be 
considered the date of receipt. In the case of communications sent by 
regular mail, the date of receipt will be considered 3 days after the 
date of mailing.
    (b) In counting days, include Saturdays, Sundays, and federal 
holidays. However, if a due date falls on a Saturday, Sunday, or 
federal holiday, then the due date is the next federal working day.
Section 16.12 What are the authority and responsibilities of the 
reviewing official?
    In addition to any other authority specified in these procedures, 
the reviewing official and the presiding official, with respect to 
those authorities involving the oral presentation, shall have the 
authority to issue orders; examine witnesses; take all steps necessary 
for the conduct of an orderly hearing; rule on requests and motions; 
grant extensions of time for good reasons; dismiss for failure to meet 
deadlines or other requirements; order the parties to submit relevant 
information or witnesses; remand a case for further action by the 
respondent; waive or modify these procedures in a specific case, 
usually with notice to the parties; reconsider a decision of the 
reviewing official where a party promptly alleges a clear error of fact 
or law; and to take any other action necessary to resolve disputes in 
accordance with the objectives of these procedures.
Section 16.13 What administrative records are maintained?
    The administrative record of review consists of the review file; 
other submissions by the parties; transcripts or other records of any 
meetings, conference calls, or oral presentation; evidence submitted at 
the oral presentation; and orders and other documents issued by the 
reviewing and presiding officials.
Section 16.14 What are the requirements for a written decision?
    (a) Issuance of Decision. The reviewing official shall issue a 
written decision upholding or denying the suspension or proposed 
revocation. The decision will set forth the reasons for the decision 
and describe the basis therefore in the record. Furthermore, the 
reviewing official may remand the matter to the respondent for such 
further action as the reviewing official deems appropriate.
    (b) Date of Decision. The reviewing official will attempt to issue 
their decision within 15 days of the date of the oral presentation, the 
date on which the transcript is received, or the date of the last 
submission by either party, whichever is later. If there is no oral 
presentation, the decision will normally be issued within 15 days of 
the date of receipt of the last reply brief. Once issued, the reviewing 
official will immediately communicate the decision to each party.
    (c) Public Notice. If the suspension and proposed revocation are 
upheld, the revocation will become effective immediately and the public 
will be notified by publication of a notice in the Federal Register. If 
the suspension and proposed revocation are denied, the revocation will 
not take effect and the suspension will be lifted immediately. Public 
notice will be given by publication in the Federal Register.

[[Page 56151]]

Section 16.15 Is there a review of the final administrative action?
    Before any legal action is filed in court challenging the 
suspension or proposed revocation, respondent shall exhaust 
administrative remedies provided under this subpart, unless otherwise 
provided by Federal Law. The reviewing official's decision, under 
Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe 
for judicial review as of the date of the decision.

[FR Doc. 2020-16432 Filed 9-4-20; 4:15 pm]
BILLING CODE 4162-20-P