Mandatory Guidelines for Federal Workplace Drug Testing Programs, 28053-28101 [2015-11523]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Substance Abuse and Mental Health Services Administration

[Federal Register Volume 80, Number 94 (Friday, May 15, 2015)]
[Notices]
[Pages 28053-28101]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11523]



[[Page 28053]]

Vol. 80

Friday,

No. 94

May 15, 2015

Part II





Department of Health and Human Services





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Substance Abuse and Mental Health Services Administration





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Mandatory Guidelines for Federal Workplace Drug Testing Programs; 
Notice

Federal Register / Vol. 80 , No. 94 / Friday, May 15, 2015 / 
Notices

[[Page 28054]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Mandatory Guidelines for Federal Workplace Drug Testing Programs

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

ACTION: Notice of the mandatory guidelines proposed by the Secretary of 
Health and Human Services.

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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 oral fluid specimens in the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs (Guidelines).

DATES: Submit comments on or before July 14, 2015.

ADDRESSES: In commenting, please refer to file code SAMHSA-2015-2. 
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 https://www.regulations.gov. Follow ``Submit a comment'' 
instructions.
     By regular mail. You may mail written comments to the 
following address ONLY: SAMHSA, Attention Division of Workplace 
Programs (DWP), 1 Choke Cherry Rd., Room 7-1045, Rockville, MD 20850. 
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 ONLY: SAMHSA, Attention DWP, 1 Choke 
Cherry Rd., Room 7-1045, Rockville, MD 20850.
     By hand or courier. Alternatively, you may deliver (by 
hand or courier) your written comments ONLY to the following address 
prior to the close of the comment period: SAMHSA, Attention DWP, 1 
Choke Cherry Rd., Room 7-1045, Rockville, MD 20850. If you intend to 
deliver your comments to the Rockville address, call telephone number 
(240) 276-2600 in advance to schedule your arrival with one of our 
staff members. Because access to the interior of the SAMHSA building is 
not readily available to persons without federal government 
identification, commenters are encouraged to schedule their delivery or 
to leave comments with the security guard front desk located in the 
main lobby of the building. Comments erroneously mailed to the address 
indicated as appropriate for hand or courier delivery may be delayed 
and received after the comment period.

FOR FURTHER INFORMATION CONTACT: Charles LoDico, M.S., DABFT, Division 
of Workplace Programs, Center for Substance Abuse Prevention (CSAP), 
SAMHSA mail to: 1 Choke Cherry Road, Room 7-1045, Rockville, MD 20850, 
telephone (240) 276-2600, fax (240) 276-2610, or email at 
charles.lodico@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

    This notice of proposed revisions to the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs (Guidelines) will allow federal 
executive branch agencies to collect and test an oral fluid specimen as 
part of their drug testing programs. In addition, some agencies, such 
as the Department of Transportation, are required to follow these 
guidelines in developing drug testing programs for their regulated 
industries, whereas others, such as the Nuclear Regulatory Commission 
(NRC), use the guidelines as part of the regulatory basis for their 
federal drug testing programs. These proposed Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) 
establish standards and technical requirements for oral fluid 
collection devices, initial oral fluid drug test analytes and methods, 
confirmatory oral fluid drug test analytes and methods, processes for 
review by a Medical Review Officer (MRO), and requirements for federal 
agency actions.
    These Guidelines provide flexibility for federal agency workplace 
drug testing programs to address testing needs and remove the 
requirement to collect only a urine specimen, which has existed since 
the Guidelines were first published in 1988. Federal agencies, MROs, 
and regulated industries using these Guidelines will continue to adhere 
to all other federal standards established for workplace drug testing 
programs. These proposed OFMG provide the same scientific and forensic 
supportability of drug test results as the Mandatory Guidelines for 
Federal Workplace Drug Testing Programs using Urine (URMG).
    The Department of Health and Human Services, by authority of 
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 urine drug testing for 
federal agencies. These proposed OFMG establish standards for 
certification of laboratories engaged in oral fluid drug testing for 
federal agencies and the use of oral fluid testing in federal drug-free 
workplace programs.

Summary of the Major Provisions of the Proposed OFMG

    The promulgation of the OFMG allows federal agencies to collect and 
test oral fluid specimens in their workplace drug testing programs. The 
collection process for oral fluids provides that the specimen 
collection will be under observation. The OFMG enable split specimen 
testing by requiring two specimens to be obtained from the donor, 
either concurrently or serially, using separate collection devices or a 
single collection device that can be split into two separate specimens. 
Unlike the urine Mandatory Guidelines for Federal Workplace Drug 
Testing Programs (UrMG), Instrumented Initial Test Facilities are not 
practical and will not be allowed due primarily to the limited sample 
volume of oral fluid collected from the donor. With the exception of 6-
acetylmorphine, a metabolite of heroin, and benzoylecgonine, a 
metabolite of cocaine, the analytes detected in oral fluids are 
primarily parent compounds. The OFMG analyte cutoffs are much lower 
than those specified for urine in the UrMG because drug analyte 
concentrations in oral fluid are much lower than urine concentrations. 
The Department is proposing that all specimens be tested for either 
albumin or Immunoglobulin G (IgG) to determine whether the specimen is 
valid. In the event that an individual is unable to provide an oral 
fluid specimen, the federal agency may authorize the collection of a 
urine specimen. With the inclusion of oral fluid testing in federal 
agency workplace programs, medical review of drug test results will 
become more complex. The MRO must interpret laboratory reported drug 
test results for both urine and oral fluid specimens. To ensure that 
MROs remain up-to-date on drug testing issues, pharmacological and 
toxicological information, and federal agency rules and regulations, 
the OFMG require MRO requalification training and reexamination on a 
regular basis (i.e., every five years).

Costs and Benefits

    Using data obtained from the Federal Workplace Drug Testing 
Programs and HHS certified laboratories, the Department estimates the 
number of specimens tested annually for federal

[[Page 28055]]

agencies to be 150,000. HHS projects that approximately 7% (or 10,500) 
of the 150,000 specimens tested per year will be oral fluid specimens 
and 93% (or 139,500) will be urine specimens. The approximate annual 
numbers of regulated specimens for the Department of Transportation 
(DOT) and Nuclear Regulatory Commission (NRC) are 6 million and 
200,000, respectively. Should DOT and NRC allow oral fluid testing in 
regulated industries' workplace programs, the estimated annual numbers 
of specimens for DOT would be 180,000 oral fluid and 5,820,000 urine, 
and numbers of specimens for NRC would be 14,000 oral fluid and 186,000 
urine.
    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. In 
addition, these proposed Guidelines include an alternative for 
laboratories to continue to use existing FDA-cleared immunoassays which 
do not have the specified cross-reactivity, by establishing a decision 
point with the lowest-reacting analyte. 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 oral fluid testing and 
testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will 
be minimal based on information from some HHS certified laboratories 
currently testing non-regulated oral fluid specimens. Likewise, there 
will be minimal costs associated with changing initial testing to 
include methylenedioxyamphetamine (MDA) and 
methylenedioxyethylamphetamine (MDEA) since current immunoassays can be 
adapted to test for these analytes. Prior to being allowed to test 
regulated oral fluid specimens, laboratories must be certified by the 
Department through the National Laboratory Certification Program 
(NLCP). Laboratories choosing to apply for HHS certification will incur 
some administrative costs associated with adding the matrix and these 
analytes. However, laboratories performing urine and oral fluid drug 
testing have trained personnel, drug testing methods, and the 
infrastructure (e.g., secured facilities, computer systems, and 
electronic reporting methods) in place. Estimated laboratory costs to 
complete and submit the application are $2,000, and estimated costs for 
the Department to process the application are $7,200. 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. 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.
    The following estimated costs are based on current costs for urine 
testing. Once oral fluid testing has been implemented, the cost per 
specimen for each initial test will range from $.06 to $0.20, due to 
reagent costs. Estimated costs for each confirmatory test range from 
$5.00 to $10.00 for each specimen reported as positive, due to costs of 
sample preparation and analysis. Based on information from non-
regulated workplace drug testing, approximately 1% of the submitted 
specimens is expected to be confirmed as positive for one or more of 
the following analytes: Oxycodone, oxymorphone, hydrocodone, and/or 
hydromorphone. Therefore, the added cost for confirmatory testing will 
be $0.05 to $0.10 per submitted specimen. This would indicate that the 
total cost per specimen submitted for testing will increase by $0.11-
$0.30. These costs for the laboratories or federal agencies choosing to 
use oral fluid in their drug testing programs will be incorporated into 
the overall testing cost for the federal agency submitting the specimen 
to the laboratory. Agencies choosing to use oral fluid in their drug 
testing programs may also incur some costs for training of federal 
employees such as drug program coordinators.
    Based on current figures, approximately 7% (or 10,500) of the 
150,000 specimens tested per year for HHS will be oral fluid, 180,000 
oral fluid specimens for DOT, and 14,000 oral fluid specimens for NRC.
    The federal agencies choosing to use oral fluid in their drug 
testing program may see many benefits including a reduction in time of 
the collection process; an observed collection method leading to 
reductions in rejected, invalid, substituted, and adulterated 
specimens; and an effective tool in post-accident testing identifying 
the parent or active drug. Productivity for federal agencies related to 
the drug free workplace program is expected to improve. For example, 
administrative data indicates it takes, on average, about 4 hours from 
the start of the notification of the drug test to the actual time a 
donor reports back to the worksite. Since oral fluid collection does 
not have the same privacy concerns as urine collection, onsite 
collections are likely, thereby reducing the time a donor is away from 
the worksite. The Department estimates the time savings to be between 1 
and 3 hours. The Department believes the cost reduction as outlined in 
this Preamble will benefit the federal agencies and drug free workplace 
program.
    Inspection of Public Comments: All comments received before the 
close of the comment period are 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 a 
comment. SAMHSA will post all comments before the close of the comment 
period on the following Web site as soon as possible after they have 
been received: https://www.regulations.gov. Follow the search 
instructions on that Web site to view public 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 the 
Substance Abuse and Mental Health Services Administration, Division of 
Workplace Programs, 1 Choke Cherry RD., Rockville, MD, 20850, Monday 
through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an 
appointment to view public comments, call (240) 276-2600.

Background

    The Department of Health and Human Services (HHS) by the authority 
of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and 
Executive Order No. 12564 has established the scientific and technical 
guidelines for federal workplace drug testing programs and established 
standards for certification of laboratories engaged in urine 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] with an effective date of May 1, 2010 (correct effective date 
published on December 10, 2008; [73 FR 75122]). The effective date of 
the Guidelines was

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further changed to October 1, 2010 on April 30, 2010 [75 FR 22809].

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 methods available. To accomplish that goal, the Department has 
implemented an ongoing scientific review and program collaboration with 
federal regulators, researchers, the drug testing industry, and public 
and private sector employers. As the use of alternative specimens 
(other than urine), analytical test technologies, and types of 
commercial workplace drug testing products have increased over the past 
decade in the private sector, the Department, through SAMHSA's Drug 
Testing Advisory Board (DTAB), has responded by review of these new 
products and began a dedicated assessment of drug testing using 
alternative specimens, such as oral fluid (saliva), hair and sweat for 
possible application in federal agency workplace testing programs.
    The following OFMG are the result of a directed Departmental 
assessment that began in 1997 with a 3-day scientific meeting of the 
DTAB. During that meeting, the DTAB members discussed drug testing 
using alternative specimens and the use of new and developing drug 
testing technologies that could be applicable to workplace drug testing 
programs. The DTAB meeting was open to the public. Following the 
initial meeting, members of the DTAB continued to review and analyze 
all available information on alternative specimens and testing 
technologies. These efforts resulted in identifying specific 
scientific, administrative, and procedural requirements necessary for a 
comprehensive federal workplace drug testing program that included 
alternative specimens and technologies.
    For more than 15 years, the DTAB has continued to evaluate the 
science and information submitted by industry representatives on 
alternative specimens and technologies. The following section presents 
a chronology of meetings and events leading to these proposed 
Guidelines for the testing of oral fluid.
    The first working draft of new guidelines, including the testing of 
alternative specimens, was presented at the June 2000 DTAB meeting. 
These initial, ``work-in-progress'' guidelines were placed on the 
SAMHSA Web site and the public was invited to submit supplemental 
information and informal comments to improve the draft and further 
SAMHSA's knowledge base. Twenty-eight separate comments were submitted. 
All comments were summarized, incorporated into the draft Guidelines 
and presented at the next DTAB meeting held in September 2000. At that 
DTAB meeting, a second working (revised) draft of the Guidelines was 
presented and, again, comments were requested from all interested 
parties. At the December 2000 DTAB meeting, the public comments 
submitted were used to prepare the third working draft of the 
Guidelines. Concurrently, SAMHSA organized three expert groups [Oral 
Fluid, Hair, and Sweat] that included members from science and 
industry.
    To assess laboratory performance and utility of alternative 
specimen testing for use in federal workplace programs, the Department 
initiated a voluntary pilot proficiency testing (PT) program. This 
pilot program provides PT samples, developed and prepared at government 
expense, to a number of laboratories for testing. Participating 
laboratories used their routine procedures to test oral fluid, hair and 
sweat specimens and shared their PT results with SAMHSA. This pilot PT 
program was established for two reasons. The first was to determine if 
it was possible to prepare stable and accurate PT samples for the 
proposed specimen type that could be used in a laboratory certification 
program. Second, the PT results reported by the laboratories could be 
used to help establish criteria for the analysis of alternative 
specimens.
    Based on data obtained from the pilot PT program, it appeared that 
valid PT samples could be prepared but refinement was needed. The 
results in the pilot PT program were encouraging, and both individual 
laboratory and collective performance improved over time; however, 
there remained some concern about the performance differences among the 
participating laboratories, and the applicability of some testing 
technologies used by the laboratories. By 2004, the working groups 
reached consensus and proposed standards for laboratory-based oral 
fluid, hair, and sweat testing procedures.
    In April 2004, the Department issued a Federal Register notice [69 
FR 19673] on the proposed inclusion of oral fluid, hair, and sweat 
specimens in federal workplace drug testing programs. Public comments 
and issues raised by federal agencies during the internal review of the 
proposed changes identified significant scientific, legal, and public 
policy concerns about the use of the alternative specimens. As a result 
of the internal review, the Department issued a Final Notice of 
Revisions to the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs in November of 2008 [73 FR 71858] that concluded the 
scientific, technical, and legal information for the testing of 
alternative specimens (oral fluid, hair, and sweat) was insufficient to 
include these specimens in the federal programs at that time. However, 
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.
    Methods developed since 2004 offer enhanced analytical sensitivity 
and specificity for testing drugs in oral fluid. The scientific 
literature base for oral fluid testing and interpretation of results 
has grown substantially. Many non-regulated private sector 
organizations have incorporated oral fluid testing into their workplace 
programs. Also, during this period, SAMHSA funded a review of a Medical 
Review Officer (MRO) database of laboratory-reported results for urine 
and alternative specimens from both regulated and non-regulated 
workplaces. The study showed a dramatic increase in the use of oral 
fluid testing from 2003 to 2009.
    At the open session of the January 2011 DTAB meeting, SAMHSA shared 
with DTAB and the public the most current information on the oral fluid 
specimen. During the meeting, experts made scientific presentations 
concerning oral fluid as a specimen for workplace drug testing, 
including: Physiological composition of oral fluid, tested drugs and 
cutoffs, collection devices, and best practices laboratory 
methodologies (initial and confirmatory testing). At approximately the 
same time, SAMHSA entered into an Interagency Agreement (IAA) with the 
Office of National Drug Control Policy (ONDCP) and received funding to 
update and expand the laboratory standards for federal forensic drug 
testing. The overall goal of this IAA was

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to determine the state of the science for oral fluid collection, 
testing, and interpretation, to support the development of these 
proposed Guidelines to include the use of the oral fluid specimen. 
Additionally, the IAA required researching additional drugs of abuse 
that warranted addition to the existing urine specimen analyte panel. 
This included investigation of prescription drugs with high abuse and 
impairment potential.
    Subsequent to the IAA and the January 2011 DTAB meeting, several 
working group meetings were held to discuss the oral fluid science and 
develop proposed Guidelines using oral fluid specimens. Working group 
members included federal partners, subject matter experts, industry 
leaders, stakeholders, and representatives from the National Laboratory 
Certification Program (NLCP).
    In June 2011, SAMHSA solicited comments regarding the science and 
practice of oral fluid testing via a Request for Information (RFI) [76 
FR 34086]. The notice requested written opinions from the public and 
industry stakeholders regarding a variety of issues related to oral 
fluid testing, including potential analytes, cutoff concentrations, 
specimen validity, specimen collection, collection devices, testing 
methods and interpretation of analytical results. The RFI was an effort 
to give the public and industry stakeholders an additional opportunity 
to provide information and comments for consideration during the 
development of the draft Guidelines for oral fluid testing. The 
Department received 18 comments from drug testing laboratories, MROs, 
oral fluid collection device manufacturers, drug testing industry 
associations, and the public [available at www.regulation.gov (docket 
SAMHSA-2011-0001)]. All submitted comments were reviewed and were 
presented to the DTAB members for consideration during SAMHSA's 
continuing assessment of oral fluid as an alternative specimen.
    At the July 2011 meeting of the DTAB, Board members voted 
unanimously for the following:

    (1) Based on review of the science, DTAB recommends that SAMHSA 
include oral fluid as an alternative specimen in the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs; and (2) DTAB 
recommends the inclusion of additional Schedule II prescription 
medications (e.g., oxycodone, oxymorphone, hydrocodone and 
hydromorphone) in the Mandatory Guidelines for Federal Workplace 
Drug Testing Programs.

    At the January 2012 DTAB meeting, the SAMHSA Administrator received 
the DTAB recommendations from the July 2011 meeting.
    The DTAB recommendations, the results from the SAMHSA-funded PT 
program, and the private sector experience have led the Department to 
conclude that oral fluid should be included in the federal program as 
an alternative specimen.

Rationale for the Inclusion of Oral Fluid in the Mandatory Guidelines 
for Federal Workplace Drug Testing Programs

    The scientific basis for use of oral fluid as an alternative 
specimen for drug testing has been broadly established.1-12 
Corresponding developments have proceeded in analytical technologies 
that provide the needed sensitivity and accuracy for testing oral fluid 
specimens.13-28
    Oral fluid and urine test results have been shown to be 
substantially similar, and oral fluid may have some inherent advantages 
as a drug test specimen. Oral fluid collection will occur under 
observation, which should substantially lessen the risk of specimen 
substitution and adulteration and, unlike direct observed urine 
collections, the collector need not be the same gender as the donor.

What is oral fluid?

    Oral fluid is the physiological fluid that can be collected from 
the oral cavity of the mouth. Oral fluid is comprised primarily of 
saliva produced by the submandibular, sublingual, and parotid 
glands.\29\ Other sources that contribute to the composition of oral 
fluid are minor salivary glands, gingival crevicular fluid (fluid from 
between the gums and teeth), cellular debris, bacteria, and food 
residues.\30\ The major constituent of oral fluid is water. Other 
components include electrolytes such as potassium, sodium, chloride, 
bicarbonates and phosphates, and organic substances such as enzymes, 
immunoglobulins, and mucins.\31\ The composition of oral fluid is 
dynamic and varies with the rate of saliva production (flow rate). The 
pH of saliva is generally acidic, but may range from 6.0 to 7.8, 
depending upon the rate of saliva flow. As saliva flow increases, 
levels of bicarbonate increase, thus increasing pH.\32\ The volume of 
saliva produced by individuals varies considerably from approximately 
500 to 1500 mL per day. The total volume of oral fluid in the mouth 
after swallowing averages about 0.9 mL for adult males and 0.8 mL for 
adult females.\33\

What is the mechanism of drug disposition in oral fluid?

    Drugs enter oral fluid primarily by diffusion from blood and from 
active drug use by oral, transmucosal, smoked, inhaled, and insufflated 
routes. Oral cavity tissues have a rich blood supply. The movement of 
drugs from blood (plasma) to oral fluid depends upon certain 
physicochemical properties of the drug. The primary restricting factors 
are drug lipophilicity, degree of ionization, and the degree of drug 
binding with plasma proteins.\34\ Lipid-soluble molecules pass through 
cell membranes more efficiently than those that are more water soluble 
(e.g., drug metabolites). Consequently, parent (unmetabolized) drug is 
frequently the predominant analyte identified in oral fluid. Biological 
membranes are not permeable to the drug fraction that is bound to 
plasma proteins or to drug that is in the ionized state; hence only 
free, non-protein bound and non-ionized drug in plasma can diffuse into 
saliva. Consequently, oral fluid drug concentrations are closely 
related to the free, unbound drug in blood (plasma). For those drugs 
that are weak bases (e.g., cocaine, opioids, amphetamines, and 
phencyclidine), concentrations in oral fluid frequently are higher than 
plasma concentrations as a result of ``ion-trapping'' due to oral 
fluid's higher acidity relative to plasma. Despite these restrictions, 
drug transfer from blood to oral fluid is a rapid process as 
demonstrated by consistent positive tests for drug in oral fluid two to 
five minutes following an intravenous injection of heroin \35\ or 
cocaine.\36\ The correlations of drug concentrations in oral fluid to 
those in plasma vary substantially from drug to drug.\4\
    Deposition of drugs in oral fluid can also occur from external 
sources. For example, drugs in food sources (e.g., morphine in poppy 
seeds) are a potential source of contamination.\37\ Drug residues can 
initially be deposited in high concentration in oral fluid during 
active drug administration by oral, transmucosal, smoked, inhaled, and 
insufflated routes.1 35 36 Generally, deposited drug 
residues disappear fairly rapidly because of inherent self-cleansing 
mechanisms of the oral cavity (e.g., saliva production and subsequent 
swallowing).
    Detection times are influenced by many pharmacological and chemical 
factors associated with the drug, dose, route of administration, 
frequency of drug use, biology of the individual, specimen type, and 
the sensitivity of the detection system. In general, detection times in 
oral fluid are somewhat shorter

[[Page 28058]]

than observed for urine. In oral fluid, drugs of abuse are detected for 
5 to 48 hours after use, whereas in urine, the detection time is 1.5 to 
4 days or longer with chronic drug use.11 38 However, as 
described below, positivity rates for oral fluid reported for non-
regulated workplace testing are the same as or higher than urine 
positivity rates. These rates demonstrate the equivalency of these 
specimen types in identifying drug use, despite differences in drug 
detection times.

How do testing positivity rates compare between oral fluid and urine?

    In the absence of paired specimen collections (i.e., urine and oral 
fluid from the same donor) in workplaces, the positivity rates of urine 
and oral fluid tests can be used to infer the relative effectiveness of 
these two specimen types.
    The workplace positivity rates for drugs in oral fluid appear to be 
generally comparable to corresponding rates reported for urine. The 
2013 Drug Testing Index (DTI) by Quest Diagnostics for drugs in the 
general workforce indicated positivity rates for oral fluid as 0.59 
percent amphetamines (combined percentages of amphetamine and 
methamphetamine), 0.31 percent cocaine, 4.0 percent marijuana, 0.88 
percent opiates, and 0.02 percent PCP and, for urine, as 0.87 percent 
amphetamines, 0.21 percent cocaine, 2.0 percent marijuana, 0.44 percent 
opiates and 0.01 percent PCP.\39\ The overall drug positivity rate for 
oral fluid was 5.5 percent compared to 4.1 percent for urine. An 
earlier study of 77,218 oral fluid specimens reported similar trends in 
the positive prevalence rates compared to the DTI for urine specimens 
collected during the same period.\40\ In that study, the overall 
combined positivity rate for oral fluid was 5.06 percent compared to 
4.46 percent for urine. Both sets of data compared positivity rates in 
two separate workplace populations over a comparable time period. The 
higher positivity rates for oral fluid are most likely due to the fact 
that oral fluid collections are performed under observation, reducing 
the ability of donors to substitute or adulterate the specimen.
    Only limited studies have compared positivity rates from ``paired'' 
specimen collections in the same population. A clinical study involving 
compliance monitoring of pain patients compared test results for oral 
fluid to urine specimens collected in ``near simultaneous fashion.'' 
\41\ The specimens were analyzed for 42 drugs and/or metabolites by 
mass spectrometric procedures. The authors evaluated two subsets of 
data related to federal workplace drug testing: 263 comparisons of 
currently tested drugs (i.e., morphine, codeine, cannabinoids, cocaine, 
amphetamine, and methamphetamine) and 491 comparisons that included 
these drugs plus hydrocodone and oxycodone. For the first data set, 
92.4 percent of the oral fluid and urine specimens had the same results 
(i.e., positive/positive or negative/negative). For the second data set 
(which included hydrocodone and oxycodone test results), 89.2 percent 
of the specimens had the same results (i.e., positive/positive or 
negative/negative). Statistically, both data sets exhibited substantial 
agreement in results between oral fluid and urine. The overall result 
discordance for the current drugs was 5.5%, of which 2.5% were positive 
in oral fluid and negative in urine, and 3% were negative in oral fluid 
and positive in urine. For hydrocodone, 9 (7.9%) analyte results were 
positive in oral fluid and negative in urine, while only 1 (0.09%) 
analyte result was negative in oral fluid and positive in urine. For 
oxycodone, 9 (7.9%) analyte results were positive in oral fluid and 
negative in urine, and 14 (12.3%) analyte results were negative in oral 
fluid and positive in urine. Differences in time courses of drugs and 
metabolites in these matrices may explain the discordant results.
    Another study compared positivity rates from paired specimens from 
45 subjects (164 paired sets of specimens) of treatment patients 
stabilized on either methadone or buprenorphine.\42\ Aside from 
methadone or buprenorphine, 595 (21.1 percent) drug analytes were 
positive and 1948 (69.0 percent) were negative for both specimens for 
an overall agreement of 90 percent. There were 82 (2.9 percent) analyte 
results that were positive in oral fluid and negative in urine, and 199 
(7.0 percent) that were negative in oral fluid and positive in urine, 
for an overall disagreement of 10 percent. Morphine was found more 
often in urine (n=66) than in oral fluid (n=48), whereas 6-
acetylmorphine was found more often in oral fluid (n=48) than in urine 
(n=20). Amphetamine and methamphetamine were found slightly more often 
in oral fluid than in urine. Benzodiazepines and cannabis were found 
more frequently in urine.
    Several studies have been reported comparing oral fluid testing to 
urinalysis for individuals under criminal justice 
supervision.43-45 In one study, the agreement rates between 
an oral fluid initial test result and confirmed urine test for 223 
probationers ranged from 90 to 99 percent.\44\ The lowest agreement 
rate (90 percent) was for marijuana, with 20 of the 23 discordant 
specimens negative by oral fluid and positive by urine testing. Two 
studies reported almost identical rates of recent cocaine and opiate 
use from either type of test, but oral fluid was less effective in 
detection of marijuana users than urinalysis.43 45

How were analytes and cutoffs selected?

    The selection of analytes for testing was based on known drug 
disposition patterns in oral fluid. Some drug disposition patterns in 
oral fluid are similar to urine and others differ in relative amounts 
of parent drug versus metabolite and in type of metabolite. The 
mechanisms of drug excretion in oral fluid are somewhat different than 
in urine. In some cases, direct deposition of parent drug in oral fluid 
may occur by oral, snorted (insufflated), transmucosal, inhaled, and 
smoked routes of administration. When this occurs, the metabolites 
generally appear later in oral fluid. For some drugs (e.g., cocaine and 
heroin), it appears that direct hydrolysis may also 
occur.35 36 The primary means of entry into oral fluid for 
most drugs (and metabolites) is by passive diffusion of un-ionized, 
non-protein bound fraction of drug from plasma. Diffusion into oral 
fluid occurs more readily for lipophilic drugs than for water-soluble 
metabolites. As a result of these mechanisms, parent (unmetabolized) 
drug is frequently the primary analyte present in oral fluid. Urinary 
excretion occurs more readily for water-soluble metabolites; lipid-
soluble drugs are frequently re-absorbed back into blood during urinary 
excretion.
    The route of administration influences the time course of both drug 
and metabolites in oral fluid.\46\ Orally administered drugs generally 
undergo some degree of metabolism in the gastrointestinal tract and 
liver prior to entering the bloodstream, whereas injected and smoked 
drugs are absorbed primarily intact without metabolite formation. Once 
drugs (and metabolites) enter the bloodstream, they rapidly diffuse 
into oral fluid by excretion from highly blood-perfused salivary 
glands. Consequently, oral fluid tests generally are positive for 
parent drug as soon as the drug is absorbed into the body. Additional 
information on analyte selection for each drug is provided below in 
Subpart C, Oral Fluid Specimen Tests. In contrast, urine tests that are 
based solely on detection of a metabolite are dependent upon the rate 
and extent of metabolite formation.

[[Page 28059]]

Will there be specimen validity tests for oral fluid?

    In regard to specimen validity testing for oral fluid, the 
Department considered measuring various oral fluid components (e.g., 
amylase, albumin, and immunoglobulins such as IgG). Given that 
collection of oral fluid specimens will occur under observation, the 
Department did not find sufficient justification for extensive validity 
testing to identify attempts to adulterate or substitute specimens. 
However, both IgG and albumin in oral fluid are currently being used in 
the industry to identify specimen collections in which insufficient 
oral fluid was collected. The Department is proposing that all oral 
fluid specimens be tested for one of these components, but specifically 
requests public comment on requiring these tests.
    Review of the literature for concentrations of albumin in oral 
fluid found that healthy subjects were characterized by concentrations 
ranging from 2.6-23.8 mg/dL \47\ and in patients with cancer and renal 
failure,48 49 the albumin concentrations ranged from 1.0-
12.2 mg/dL. These data support using the industry cutoff of 0.6 mg/dL 
as a decision point for albumin in oral fluid.
    Literature concerning the concentrations of IgG in oral fluid found 
that only predentate babies exhibited IgG concentrations below 1 mg/
L.\50\ Adults with and without teeth had a concentration mean of 19 mg/
L. The mean for elderly adults with teeth was 24 mg/L and the mean for 
edentate elderly adults was 5.2 mg/L. Young healthy adults under 
various exercise routines had IgG concentrations means ranging from 5 
mg/L to greater than 40 mg/L.\51\ These data support using the industry 
cutoff of 0.5 mg/L as a decision point for IgG in oral fluid.
    To avoid prohibiting other oral fluid specimen validity tests that 
may become available, the Department is also authorizing additional 
specimen validity testing as described in Section 3.1.d and Section 
3.5.
    The Department maintains that allowing tests for biomarkers other 
than albumin and IgG can be useful. The draft OFMG requirements are 
analogous to the current urine drug testing requirements in that 
laboratories must perform specified specimen validity tests on all 
specimens and may perform additional specimen validity tests for other 
measurands. The Department does not want to limit the testing to 
albumin and IgG, because other tests or biomarkers may be identified 
for use. The tests must be forensically acceptable and scientifically 
sound. Because OF specimen collections are observed and because oral 
fluid may be collected using a device in which the specimen is diluted 
by a buffer, a laboratory cannot definitively state that a specimen has 
been substituted. (The collector or MRO may report a refusal to test as 
described in Section 1.7 of the OFMG.) As noted in Section 13.5 of the 
OFMG, when an OF test is reported as Invalid and the donor has no 
legitimate explanation for the Invalid result, the MRO directs the 
agency to collect another specimen. The agency may decide the type of 
specimen for the recollection.

How will oral fluid be collected?

    The Department recognizes that methods for collection of oral fluid 
specimens vary by manufacturers of devices and that new, innovative 
methods may be developed that offer improvements over existing methods. 
Two basic types of collection devices currently exist: One is designed 
to collect undiluted (neat) oral fluid by expectoration; the second 
type makes use of an absorbent pad that is inserted into the oral 
cavity for specimen collection and then placed in a tube containing a 
diluent. The Department is recommending that all collection devices 
maintain the integrity of the specimen during collection, storage and 
transport to the laboratory for testing. All devices must have an 
indicator that demonstrates the adequacy of the volume of collected 
specimen; have a sealable, non-leaking container; and have components 
that ensure pre-analytical drug and drug metabolite stability; and the 
device components must not substantially affect the composition of 
drugs and drug metabolites in the oral fluid specimen.

What are the performance requirements for a collection device?

    The Department proposes that a collection device should collect 
either a minimum of 1 mL of undiluted (neat) oral fluid or, for those 
collection devices containing a diluent (or other component, process, 
or method that modifies the volume of the specimen), that the volume of 
oral fluid collected should be within 0.1 mL of the target volume and 
the volume of diluent in the device should be within 0.05 mL of the 
diluent target volume. The Department recommends that the device 
maintain stability of drug and/or drug metabolite in the oral fluid 
specimen allowing >=90 percent recovery for one week at room 
temperature (18-25 [deg]C). To ensure that collection device components 
do not substantially affect the composition of drugs and/or drug 
metabolites in the oral fluid specimen, the Department recommends that 
the device performance characteristics are such that there is >=90 
percent recovery (but no more than 120 percent) of drug and/or drug 
metabolite in the undiluted (neat) oral fluid at (or near) the initial 
test cutoff concentration. The established upper range is to minimize a 
collection device concentrating the specimen on the collection pad and/
or the device. Numerous studies of stability and recovery of drugs from 
commercial oral fluid collection devices indicate wide variability in 
performance characteristics.52-57 The recommended limits of 
>=90 percent but no more than 120 percent recovery ensure concentration 
accuracy (within experimental limits), prevent potential concentration 
of drug and/or metabolite by the device, and ensure consistency in 
specimen collections using different collection devices.
    The Department notes that these collection devices are subject to 
clearance by the FDA. The Department requests comments on whether HHS 
should publish a list of FDA-cleared oral fluid collection devices.

What are the collection procedures?

    The Department is recommending that a split specimen be collected 
either (1) as two specimens collected simultaneously or serially with 
two separate collection devices, or (2) collected with a collection 
device that subdivides the specimen into two separate collection tubes. 
If collected serially, collection of the second specimen must begin 
within two minutes after the completion of the first collection. The 
Department believes this allows sufficient time for the collector to 
begin the second specimen collection in a timely manner, to minimize 
differences in oral fluid collected using two separate collection 
devices. Oral fluid test results for delta-9-tetrahydrocannabinol (THC) 
in simultaneously collected specimens with an absorbent pad have been 
reported to be highly correlated.\58\
    In addition, the Omnibus Transportation Employee Testing Act 
(OTETA), which governs the DOT-regulated testing programs as well as 
the Federal Aviation Administration's federal employee testing program, 
requires that collected specimens must be able to be subdivided, to 
allow for additional testing upon request of the employee.
    Therefore, the Department requests comments on whether serial or 
simultaneous collection using two collection devices constitutes a 
split

[[Page 28060]]

collection, and recommendations for any other oral fluid collection 
processes that enable subdividing the collected specimen.

What new drugs are being included?

    Since the late 1980's, multiple recommendations have been made that 
additional drugs be considered for inclusion in workplace drug testing. 
These recommendations resulted in the Ecstasy-related drugs--
methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), 
and methylenedioxyethylamphetamine (MDEA)--being included for testing 
in 2008. The 2012 National Survey on Drug Use and Health (NSDUH) 
indicated that past month illicit drug use of psychotherapeutics was 
second only to marijuana in prevalence among persons aged 12 or older 
in the United States. Prescription psychotherapeutics include pain 
relievers, tranquilizers, stimulants, and sedatives.\59\ The abuse of 
narcotic pain relievers has become a serious and growing public health 
concern.
    Like heroin, many are derived from opium, but are synthetic 
analogs. Oxycodone and hydrocodone top the list of narcotic pain 
relievers causing visits to hospital emergency departments due to non-
medical use,\60\ and are among the top 10 drugs seized in law 
enforcement operations and sent to federal, state, and municipal 
forensic laboratories, ranking second and third of prescription drugs 
on the list.\61\ Because of the prevalence of their abuse, hydrocodone 
and oxycodone have been included in these proposed OFMG.
    Hydrocodone is metabolized in the body to hydromorphone and 
excreted in biological fluids.\62\ Hydromorphone is also available 
commercially as an analgesic, is more potent than hydrocodone, and 
exhibits significant abuse liability. Oxycodone is metabolized in the 
body to oxymorphone and excreted in biological fluids.\63\ Oxymorphone 
is also available commercially as an analgesic, is more potent than 
oxycodone, and exhibits significant abuse liability. For these reasons, 
hydromorphone and oxymorphone are also included in these proposed OFMG.

Provisions for the Administration of the National Laboratory 
Certification Program (NLCP)

    In accordance with the current practice, an HHS contractor will 
perform certain functions on behalf of the Department. These functions 
include maintaining laboratory inspection and PT programs that satisfy 
the requirements described in the Guidelines. These activities include, 
but are not limited to, reviewing inspection reports submitted by 
inspectors, reviewing PT results submitted by laboratories, preparing 
inspection and PT result reports, and making recommendations to the 
Department regarding certification or suspension/revocation of 
laboratories' certification. It is important to note that, although a 
contractor gathers and evaluates information provided by the inspectors 
or laboratories, all final decisions regarding laboratory 
certification, suspension or revocation of certification are made by 
the Secretary.
    In addition, a contractor has historically collected certain fees 
from the laboratories for services related to the certification 
process, specifically for laboratory application and inspection and PT 
activities for laboratories applying to become HHS-certified, and for 
inspection and PT activities for laboratories maintaining HHS 
certification. All fees collected by a contractor are applied to its 
costs under the contract.
    This same process, used since the inception of the laboratory 
certification program, will also be used by an HHS contractor to 
collect similar fees from laboratories that seek, achieve, and continue 
HHS certification to test oral fluid. The Department also contributes 
funds to this contract for purposes not directly related to laboratory 
certification activities, such as evaluating technologies and 
instruments and providing an assessment of their potential 
applicability to workplace drug testing programs.

Organization of Proposed Guidelines

    This preamble describes the differences between the Mandatory 
Guidelines for Federal Workplace Drug Testing Programs using Urine 
Specimens (UrMG) and the proposed Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using Oral Fluid Specimens (OFMG), and 
provides the rationale for the differences. In addition, the Preamble 
presents a number of the remaining issues raised during the development 
of Guidelines for oral fluid drug testing. The issues are organized and 
presented first in summary as they appear in the text of the proposed 
OFMG and later as issues of special interest for which the Department 
is seeking specific public comment.

Subpart A--Applicability

    Sections 1.1, 1.2, 1.3, and 1.4 contain the same policies as 
described in the current UrMG with regard to who is covered by the 
Guidelines, who is responsible for the development and implementation 
of the Guidelines, how a federal agency requests a change from these 
Guidelines and how these Guidelines are revised.
    In section 1.5, where terms are defined, the Department proposes to 
add terms that apply specifically to oral fluid (e.g., collection 
device, oral fluid specimen).
    Sections 1.6, 1.7, and 1.8 contain the same policies as described 
in the current UrMG with regard to what an agency is required to do to 
protect employee records, the conditions that constitute refusal to 
take a federally regulated drug test, and the consequences of a refusal 
to take a federally regulated drug test.

Subpart B--Oral Fluid Specimen

    In section 2.1, the Department proposes to expand the drug-testing 
program for federal agencies to permit the use of oral fluid specimens. 
There is no requirement for federal agencies to use oral fluid as part 
of their program. A federal agency may choose to use urine, oral fluid, 
or both specimen types in their drug testing program. However, any 
agency choosing to use oral fluid is required to follow the OFMG. For 
example, an agency program can randomly assign individuals to either 
urine or OF testing, for random or pre-employment testing. This would 
not only help reduce subversion, but would allow comparison of urine 
and OF testing outcomes for planning purposes.
    Section 2.2 describes the circumstances under which an oral fluid 
specimen may be collected. The Department has included this section to 
ensure that the circumstances described are consistent with the reasons 
for collecting a specimen as listed on the Federal Custody and Control 
Form (Federal CCF). The Department will review comments on the reasons 
that are appropriate for oral fluid testing.
    Section 2.3 describes how each oral fluid specimen is collected for 
testing. The Department is seeking comment on whether the described 
procedures are consistent with the established requirement for all 
specimens to be collected as a split specimen and recommendations for 
other processes that enable subdividing the collected specimen.
    Section 2.4 establishes a known volume that must be collected for 
each specimen.
    Section 2.5 describes how a split oral fluid specimen is collected.
    Section 2.6 clarifies that all entities and individuals identified 
in Section 1.1 of these Guidelines are prohibited from

[[Page 28061]]

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 these Guidelines do not authorize the release of specimens, 
or portions thereof, to federal employees, the Guidelines afford 
employees 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 
federal employees to request the retesting of their specimen (for drugs 
or adulteration) at a different certified laboratory. Furthermore, the 
Guidelines grant federal employees 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 CCF with any attachments, internal chain of custody 
records for the specimen, and any memoranda generated by the 
laboratory.
    Therefore, the 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 access to the specimen itself or to a portion 
thereof. The reason for this prohibition is that specimens collected 
under the Guidelines are uniquely designed for the purpose of drug and 
validity testing only. They are not designed 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--Oral Fluid Specimen Tests

    Section 3.1 describes the tests to be performed on each oral fluid 
specimen. This is the same policy that is in the current 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 opiates, 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 included requirements for federal agencies to test all oral 
fluid specimens for either albumin or IgG to determine specimen 
validity, but specifically requests public comment on requiring these 
tests.
    The policy in section 3.2 is the same as that for urine testing. 
Any federal agency that wishes to routinely test its specimens for any 
drug not included in the Guidelines must obtain approval from the 
Department before expanding its program. A specimen may be tested for 
any drug listed in Schedule I or II of the Controlled Substances Act 
when there is reasonable suspicion/cause to believe that a donor may 
have used a drug not included in these Guidelines. When reasonable 
suspicion/cause exists to test for another drug, the federal agency 
must document the possibility that the use of another drug exists, 
attach the documentation to the original Federal CCF, and ensure that 
the HHS-certified laboratory has the capability to test for the 
additional drug. 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 comments for 
Section 2.6.
    Section 3.4 lists the proposed analytes and cutoff concentrations 
for undiluted (neat) oral fluid. The table in Section 3.4 specifies 
both initial and confirmatory cutoff concentrations for each drug test 
analyte. Footnote 2 of the table addresses requirements that differ for 
initial tests using immunoassay-based technology and those using an 
``alternate'' technology. Over the last 5 years, technological advances 
have been made to techniques (e.g., methods using spectrometry or 
spectroscopy) that enable their use as efficient and cost-effective 
alternatives to the immunoassay techniques for initial drug testing 
while maintaining the required degree of sensitivity, specificity, and 
accuracy. The proposed Guidelines allow the use of alternate 
technologies provided that the laboratory validates the method in 
accordance with Section 11 and demonstrates acceptable performance in 
the PT program.
    Considerable research and discussion were conducted regarding the 
complex issues surrounding the specification of each cutoff 
concentration. The Department solicited input from laboratories, 
reagent and device manufacturers, subject matter experts, and the Food 
and Drug Administration (FDA). The cutoff concentrations are the 
outcome of the lengthy discussion process and represent the best 
approach currently available. The proposed analytes follow: Marijuana 
(Cannabis).
    The Department is proposing to test for delta-9-
tetrahydrocannabinol (THC) using a 4 ng/mL cutoff concentration for the 
initial test. For the confirmatory test, the Department is proposing to 
test for THC using a 2 ng/mL cutoff concentration.
    Marijuana (cannabis) continues to be the most prevalent drug of 
abuse in the U.S. THC is the primary psychoactive ingredient of 
marijuana and is rapidly transferred from the lungs to blood during 
smoking.\64\ THC is distributed by the blood and absorbed rapidly by 
body tissues. Apparently, very little unchanged THC is excreted in oral 
fluid as demonstrated by investigations with intravenously administered 
THC \65\ or orally administered THC (dronabinol).\66\ The major source 
of THC in oral fluid occurs from deposition in the mouth during smoking 
or oral use.\65\ THC appears at its highest concentration in oral fluid 
immediately after smoking marijuana.58 67 68 69 Initial high 
concentrations of THC in oral fluid decline rapidly within the first 30 
minutes after use and thereafter decline over time in a manner similar 
to that observed for THC in plasma \68\ and serum.\70\ It has been 
suggested that the similarity in oral fluid and plasma concentrations 
can be attributed to a physiological link involving transmucosal THC 
absorption from oral fluid into blood.\1\ One study reported 
significant correlations of oral fluid THC concentrations with 
subjective intoxication and with heart rate elevation.\71\
    Positive prevalence rates for THC in oral fluid specimens collected 
from workplace drug testing programs appear to be comparable or greater 
than 11-nor-delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA) rates 
for urine drug testing in the general workforce. A 2002 study of 77,218 
oral fluid specimens revealed a positive prevalence of 3.22 percent 
compared to a 3.17 percent positivity rate for more than 5,200,000 
urine specimens collected during the same period.\40\ The 2012 Drug 
Testing Index by Quest Diagnostics for marijuana positivity in the 
general workforce for oral fluid was 4.0 percent and for urine was 2.0 
percent.\39\
    Once absorbed and distributed to tissues, THC is ultimately 
transformed by oxidative metabolic enzymes to THCA. Further metabolism 
of THCA leads to formation of a glucuronide

[[Page 28062]]

metabolite (conjugated metabolite). Both free (unconjugated) THCA 
72-74 and conjugated THCA \75\ are excreted in oral fluid in 
low concentrations (picograms per milliliter). In a study of one 
frequent marijuana smoker,\75\ concentrations of THC were highest 
immediately following smoking and declined thereafter. In that study, 
THC concentrations in oral fluid specimens collected during three 
different smoking occasions ranged from 0 to 93 ng/mL; free THCA 
concentrations ranged from 0.027 to 0.085 ng/mL and total (conjugated 
and free) THCA concentrations ranged from 0.033 to 0.314 ng/mL. The 
ratio of conjugated THCA to free THCA ranged from 0.5 to 3.64. 
Predominantly, there was approximately twice as much conjugated THCA as 
free THCA in oral fluid specimens, indicating the need for hydrolysis 
prior to confirmatory analysis to convert conjugated THCA to free THCA, 
enabling analysis for total THCA. Urine testing programs currently use 
hydrolysis and test for total THCA, and the analytical procedures for 
oral fluid are similar to those in practice for urine.
    In contrast to urine, there is a paucity of scientific data on the 
time course of excretion or the detection window of THC, THCA, and 
conjugated THCA in oral fluid following marijuana use.\1\ This is 
especially true for occasional users. Studies of daily marijuana 
smokers indicate that THC is detectable for up to two days, but THCA 
continues to be excreted in oral fluid during abstinence for several 
weeks in daily users.\76\ As noted earlier, the mechanisms of drug 
excretion in oral fluid are somewhat different than in urine. Because 
oral fluid tests generally are positive for parent drug as soon as the 
drug is administered, the Department, for oral fluid testing, is 
considering testing and confirming for THC. THC is reliably present in 
oral fluid immediately after smoked cannabis administration and remains 
detectable for 24-30 hours or longer, whereas THCA may or may not be 
present. The risks of passive smoke exposure have been assessed. To 
date, studies have indicated that transient amounts of THC may be 
present in oral fluid for a few hours (1-3), and no THCA is detected in 
oral fluid but is detected in blood. The detection of traces of THC 
occurred only under conditions of extreme tolerated exposure. Unknowing 
or transient exposure to marijuana smoke does not appear likely to 
produce a positive THC test in oral fluid. The Department seeks comment 
on whether THCA is suitable for inclusion as a reliable test analyte 
for detection of marijuana use.
    The proposed initial test cutoff for THC (4 ng/mL) and confirmatory 
test cutoff for THC (2 ng/mL) are the same as those proposed in the 
2004 Guidelines. The detection time for THC in oral fluid appears to be 
shorter than the detection time for THCA in 
urine;58 67 76 77 78 79 consequently, a lower initial test 
cutoff concentration would enhance detection rates of marijuana use. 
For this reason, the Department is interested in receiving comments on 
lowering the cutoff concentration for delta-9-tetrahydrocannabinol 
(THC) to either 2 or 3 ng/mL for the initial test cutoff concentration 
and to 1 ng/mL for the confirmatory cutoff concentration. Lowering the 
initial and confirmatory test cutoff concentrations would lengthen the 
detection window (i.e., the number of hours after a drug is ingested by 
an individual that the concentration of the drug or drug metabolite in 
oral fluid will likely be at or above the cutoff concentration). Lower 
cutoff concentrations will increase the number of specimens that are 
identified as containing THC and, thereby, will increase the deterrent 
effect of the program and improve identification of employees using 
this illicit substance.
    The Department had considered proposing to test for THCA (i.e., 
``total'' amount following hydrolysis, as described above) using a 
0.050 ng/mL cutoff concentration for confirmation to extend the window 
of detection. However, the Department is concerned over the utility of 
confirming for this analyte as well as the ability of laboratories to 
reliably implement this test for routine analyses, based on the reasons 
provided below
    Currently, few laboratories perform confirmatory testing for THCA 
in oral fluid testing. Thus, there is limited data on the positivity 
rates for these analytes in a workplace population. In a study of 143 
specimens positive by immunoassay using the proposed 4 ng/mL initial 
test cutoff,\74\ 84 percent were confirmed positive for THC using the 
proposed 2 ng/mL confirmatory test cutoff. Only 51 percent would have 
confirmed positive for THCA using a 0.010 ng/mL cutoff.
    Also, testing for THCA requires a larger sample volume than testing 
for THC. This may affect the ability of a laboratory to perform 
additional testing as required. To avoid the risk of positive test 
results from passive exposure, some investigators have recommended that 
THCA be included in confirmatory testing.74 76 77 78 80 THCA 
occurs in oral fluid as a result of passive diffusion from blood \66\ 
and is not found in marijuana smoke.\81\ Consequently, the presence of 
THCA provides evidence of active use of products containing THC (e.g., 
marijuana, dronabinol). However, based on information provided from 
recent studies,\82\ it does not appear that THCA is reliably present in 
oral fluid specimens for some marijuana users: a marijuana user's oral 
fluid specimen may be positive for THC and negative for THCA.
    A number of passive exposure studies have been conducted under a 
variety of exposure conditions.58 67 80 83 Two studies 
reported that false results for THC were a problem if oral fluid was 
collected in a contaminated environment.67 80 One passive 
inhalation study in which oral fluid specimens were collected in a 
clean environment reported no specimens positive for THC at a 
confirmatory cutoff concentration of 1.5 ng/mL throughout an 8-hour 
monitoring period following exposure.\67\ A recent study \80\ reported 
negative results for total THCA at a limit of quantification of 0.002 
ng/mL, but found positive results for THC in oral fluid when specimens 
were collected during three hours of continuous passive exposure. 
Specimens collected 12 to 22 hours after passive exposure were negative 
for total THCA and were predominantly negative for THC; however, two of 
10 specimens contained detectable amounts of THC (1.0, 1.1 ng/mL) that 
are well below the proposed 4 ng/mL cutoff for the initial test and 2 
ng/mL cutoff for the confirmatory test.
    The Department is not aware of any studies that demonstrate passive 
exposure causing a positive oral fluid THC result when the donor would 
not be aware of that exposure. Nor does there appear to be evidence 
that incidental exposure to marijuana smoke can cause an oral fluid 
specimen to be reported positive for THC using the proposed cutoff 
levels. Therefore, passive exposure would not be a reasonable defense 
for a positive result for THC in oral fluid testing.
    The Department recognizes that THCA testing may be useful, because 
THC and THCA may be present singly or in combination in a marijuana 
user's oral fluid specimen depending on the length of time between use 
and collection. However, Current technology for conducting a 
confirmatory test for THCA at pg/mL concentrations requires the use of 
specialized materials, instrumentation, and methods.72 73 84 
In addition, a substantial portion of the oral fluid specimen may be 
consumed in the analytical process, thus making it difficult for a 
laboratory to confirm multiple initial positive drug tests or

[[Page 28063]]

reanalyze these specimens. Therefore, the Department is specifically 
interested in obtaining information on the ability of laboratories to 
conduct initial and/or confirmatory tests for THCA, as well as the cost 
of conducting the confirmatory test.

Cocaine

    The Department is proposing to test for cocaine/benzoylecgonine 
using an initial cutoff concentration of 15 ng/mL and 8 ng/mL for the 
confirmatory cutoff concentrations. Cocaine appears in oral fluid 
within minutes after use following intravenous, nasal and smoked 
administration.\36\ Cocaine is rapidly metabolized to benzoylecgonine 
that also is excreted in oral fluid. At different times after use, 
cocaine and benzoylecgonine may be present singly or in combination in 
oral fluid. The current proposed initial test cutoff for cocaine/
benzoylecgonine (15 ng/mL) is lower than that proposed in the 2004 
proposed revisions to the Guidelines (20 ng/mL). This change is 
justified because of the recognition that different combinations of 
cocaine analytes may be present at different times after use and for 
enhanced sensitivity for the detection of each analyte.
    An immunoassay initial test for cocaine/benzoylecgonine should be 
calibrated with one of the two analytes and demonstrate sufficient 
cross-reactivity with the other analyte. The Department recommends that 
the minimum cross-reactivity with either analyte be 80 percent or 
greater. If an alternate technology initial test is performed instead 
of immunoassay, either one or both analytes in the group should be used 
to calibrate, depending on the technology. The quantitative sum of the 
two analytes must be equal to or greater than 15 ng/mL. The 
quantitative sum of the two analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The 8 ng/mL confirmatory test cutoff concentration applies equally 
to cocaine and benzoylecgonine. A positive test would be comprised of 
either or both analytes with a confirmed concentration equal to or 
greater than 8 ng/mL.

Codeine/morphine

    The Department is proposing to test for codeine/morphine using a 30 
ng/mL cutoff concentration for the initial test and 15 ng/mL for the 
confirmatory test cutoff concentrations. After single oral use, codeine 
has been reported to appear in oral fluid within an hour, quickly reach 
maximum concentration and decline over a period of approximately 24 
hours.\85\ An earlier study showed that codeine appeared in urine 
within an hour of dosing, and was detectable up to four days.\86\ A 
metabolite of codeine, norcodeine, was also detected in oral fluid, but 
morphine was not detected. Although there is high variability, codeine 
oral fluid concentrations have been significantly correlated with 
plasma codeine concentrations.85 87 Codeine undergoes 
extensive metabolism in the body. Two important, but minor metabolites 
of codeine are morphine and hydrocodone.88 89 90 Morphine 
may be present in oral fluid as a result of administration of 
morphine,91 92 heroin,\35\ or ingestion of poppy seeds.\37\ 
A study of morphine levels in urine and oral fluid following ingestion 
of poppy seeds indicated that morphine was positive for a shorter 
period of time (approximately 2 hours) compared to urine (approximately 
8 hours).\37\ A study of 77,218 oral fluid specimens collected under 
workplace drug testing conditions indicated that approximately 12.5 
percent of specimens positive for morphine or codeine were positive in 
the concentration range of 30 to 39.9 ng/mL and would have been 
reported negative using a 40 ng/mL confirmatory cutoff 
concentration.\40\ The current proposed initial test cutoff 
concentration (30 ng/mL) and confirmatory test cutoff concentration (15 
ng/mL) for codeine/morphine are lower than those in the 2004 proposed 
revisions to the Guidelines (40 ng/mL for initial test and confirmatory 
test), primarily due to the enhanced sensitivity especially for the 
detection of morphine.
    An immunoassay initial test for codeine/morphine should be 
calibrated with one of the two analytes and demonstrate sufficient 
cross-reactivity with the other analyte. The Department proposes that 
the minimum cross-reactivity with either analyte be 80 percent or 
greater. If an alternate technology initial test is performed instead 
of immunoassay, either one or both analytes in the group should be used 
to calibrate, depending on the technology. The quantitative sum of the 
two analytes must be equal to or greater than 30 ng/mL. The 
quantitative sum of the two analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The 15 ng/mL confirmatory test cutoff concentration applies equally 
to codeine and morphine. A positive test would be comprised of either 
or both analytes with a confirmed concentration equal to or greater 
than 15 ng/mL.

6-Acetylmorphine

    The Department is proposing to test for 6-acetylmorphine using a 3 
ng/mL cutoff concentration for the initial test and 2 ng/mL for the 
confirmatory test cutoff concentration. 6-acetylmorphine, a unique 
metabolite of heroin, appears in oral fluid within minutes following 
smoked or injected heroin administration.\35\ A high prevalence of 6-
acetylmorphine in oral fluid specimens following heroin use has been 
reported,93-96 suggesting it may offer advantages over urine 
in workplace testing programs. An initial assay for 6-acetylmorphine 
separate from a general opiates assay is currently used in the UrMG. 
The 2004 proposed revisions to the Guidelines did not propose a 
separate initial test for 6-acetylmorphine. An initial test for 6-
acetylmorphine is proposed because of the recent recognition that 6-
acetylmorphine may be positive in oral fluid specimens that would not 
initially test positive for opiates.35 94 A study of 77,218 
oral fluid specimens collected under workplace drug testing conditions 
indicated that 12.5 percent of specimens positive for 6-acetylmorphine 
were positive in the concentration range of 3 to 3.9 ng/mL and would 
have been reported negative at a 4 ng/mL confirmatory cutoff 
concentration.\40\ The current proposed confirmatory test cutoff 
concentration (2 ng/mL) for 6-acetylmorphine is lower than in the 2004 
proposed revisions to the Guidelines (4 ng/mL), primarily for enhanced 
sensitivity.

Phencyclidine

    The Department is proposing to test for phencyclidine using a 3 ng/
mL cutoff concentration for the initial test and 2 ng/mL for the 
confirmatory test cutoff concentration. Phencyclidine has been measured 
in oral fluid following different routes of administration. 
97 98 A study of 77,218 oral fluid specimens collected under 
workplace drug testing conditions indicated that 57.1 percent of 
specimens positive for phencyclidine were positive in the concentration 
range of 1.5 to 9.9 ng/mL and would have been reported negative at a 10 
ng/mL confirmatory cutoff concentration.\40\ The current proposed 
initial test cutoff concentration (3 ng/mL) and confirmatory test 
cutoff concentration (2 ng/mL) for phencyclidine are lower than those 
in the 2004 proposed revisions to the Guidelines (10 ng/mL for initial 
test and confirmatory test), primarily for enhanced sensitivity.

[[Page 28064]]

Amphetamine/methamphetamine

    The Department is proposing to test for amphetamine/methamphetamine 
using a 25 ng/mL cutoff concentration for the initial test and 15 ng/mL 
for the confirmatory test cutoff concentration. Amphetamine appears 
rapidly in oral fluid following administration \99\ and, although 
variable, correlates with blood concentrations in drivers suspected of 
driving under the influence of drugs.\100\ Methamphetamine and its 
metabolite, amphetamine, also appear rapidly in oral fluid and plasma 
following administration. 101 102 In one study,\102\ 
concentrations of amphetamine relative to methamphetamine in oral fluid 
ranged from 16 percent to 37 percent following methamphetamine 
administration. The positivity rate for methamphetamine in oral fluid 
was highly influenced by the requirement for detection of amphetamine 
metabolite in the study. When the confirmatory cutoff concentration for 
methamphetamine was 50 ng/mL and detection of amphetamine at 2.5 ng/mL 
(limit of detection) was applied to oral fluid specimens, only 1 of 13 
individuals tested positive 24 hours after a single methamphetamine 
dose and; only 23 of 130 (18 percent) specimens tested positive within 
24 hours after dosing. The current proposed initial test cutoff 
concentration (25 ng/mL) and confirmatory test cutoff concentration (15 
ng/mL) for amphetamine/methamphetamine are lower than those in the 2004 
proposed revisions to the Guidelines (50 ng/mL for initial test and 
confirmatory test), primarily for enhanced sensitivity. There is no 
proposed reporting requirement for a methamphetamine-positive specimen 
to contain amphetamine as there is in the UrMG.
    An immunoassay initial test for amphetamine/methamphetamine should 
be calibrated with one of the two analytes and demonstrate sufficient 
cross-reactivity with the other analyte. The Department recommends that 
the minimum cross-reactivity with either analyte be 80 percent or 
greater. If an alternate technology initial test is performed instead 
of immunoassay, either one or both analytes in the group should be used 
to calibrate, depending on the technology. The quantitative sum of the 
two analytes must be equal to or greater than 25 ng/mL. The 
quantitative sum of the two analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The 15 ng/mL confirmatory test cutoff concentration applies equally 
to amphetamine and methamphetamine. A positive test would be comprised 
of either or both analytes with a confirmed concentration equal to or 
greater than 15 ng/mL.

Methylenedioxymethamphetamine (MDMA)/Methylenedioxyamphetamine (MDA)/
Methylenedioxyethylamphetamine (MDEA)

    The Department is proposing to test for MDMA/MDA/MDEA using a 25 
ng/mL cutoff concentration for the initial test and 15 ng/mL for the 
confirmatory test cutoff concentration. MDMA appears in oral fluid 
approximately 0.25-1.5 hours following oral administration and 
demonstrates similar kinetic patterns as plasma 
concentrations.103-105 MDMA is metabolized by N-
demethylation to MDA, a compound that exhibits similar psychoactive 
properties to MDMA. As a metabolite of MDMA, MDA is excreted in oral 
fluid with concentrations representing approximately 4-5 percent of 
MDMA.\104\ MDEA also is metabolized by N-dealkylation to MDA as an 
active metabolite.\106\ MDEA has been reported in oral fluid specimens 
collected from recreational drug users in concentrations ranging from 
25 to 3320 ng/mL.\105\ The current recommended initial test 
concentration (25 ng/mL) and confirmatory test cutoff concentration (15 
ng/mL) for MDMA/MDA/MDEA are lower than those in the 2004 proposed 
revisions to the Guidelines (50 ng/mL for initial test and confirmatory 
test), primarily for enhanced sensitivity.
    An immunoassay initial test for MDMA/MDA/MDEA should be calibrated 
with one of the three analytes and demonstrate sufficient cross-
reactivity with each analyte. The Department recommends that the 
minimum cross-reactivity with each analyte be 80 percent or greater. If 
an alternate technology initial test is performed instead of 
immunoassay, either one or all analytes in the group should be used to 
calibrate, depending on the technology. The quantitative sum of the 
three analytes must be equal to or greater than 25 ng/mL. The 
quantitative sum of the three analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The 15 ng/mL confirmatory test cutoff concentration applies equally 
to MDMA, MDA and MDEA. A positive test would be comprised of one or 
more of the three analytes with a confirmed concentration equal to or 
greater than 15 ng/mL.

Inclusion of Oxycodone, Oxymorphone, Hydrocodone, Hydromorphone

    Misuse and abuse of psychotherapeutic prescription drugs, including 
opoid pain relievers, are issues of concern for all populations 
regardless of age, gender, ethnicity, race, or community. Recent data 
show that opoid-related overdose deaths in the U.S. now outnumber 
overdose deaths involving all illicit drugs such as heroin and cocaine 
combined. In addition to overdose deaths, emergency department visits, 
substance abuse treatment admissions, and economic costs associated 
with opioid abuse have all increased in recent years. The Department is 
continuing to work with partners at the federal, state, and local 
levels to implement policies and programs to reduce prescription drug 
abuse and improve public health.\107\
    The Department proposes the inclusion of additional Schedule II 
prescription medications (i.e., oxycodone, oxymorphone, hydrocodone and 
hydromorphone) in the list of authorized drug tests and cutoff 
concentrations. This action was recommended by the DTAB, reviewed by 
the Department's Prescription Drug Subcommittee of the Behavioral 
Health Coordinating Committee, and received by the SAMHSA Administrator 
in January 2012. The inclusion of oxycodone, oxymorphone, hydrocodone 
and hydromorphone is supported by various data. According to the 2012 
National Survey on Drug Use and Health, which provides data on illicit 
drug use in the U.S., current (past month) nonmedical users aged 12 
years and older of prescription psychotherapeutic drugs increased from 
2003 (6.5 million) to 2012 (6.8 million).\59\ Psychotherapeutic drugs 
are defined as opioid pain relievers, tranquilizers, sedatives, and 
stimulants. The abuse of psychotherapeutic drugs non-medically is 
ranked second behind marijuana, where pain relievers represent the 
majority of the group. The Drug Abuse Warning Network (DAWN) Report, 
which provides national estimates of drug-related visits to hospital 
emergency departments (ED), showed that of the 1.2 million ED visits 
involving nonmedical use of pharmaceuticals in 2011, 46.0 percent of 
visits involved nonmedical use of pain relievers, with 29 percent being 
narcotic pain relievers.\60\ The most frequently involved narcotic pain 
relievers were oxycodone and hydrocodone. From 2004 to 2011, ED visits 
involving nonmedical use of narcotic pain

[[Page 28065]]

relievers increased by 153 percent. ED visits involving opiates/opioids 
increased by 183 percent during this period, with increases of 438 
percent for hydromorphone, 263 percent for oxycodone, and over 100 
percent for hydrocodone, as well as fentanyl and morphine. In addition, 
the National Forensic Laboratory Information System (NFLIS) found that 
oxycodone and hydrocodone were among the top ten drugs seized in law 
enforcement operations and sent to federal, state, and municipal 
forensic laboratories.\61\ Among prescription drugs, oxycodone and 
hydrocodone ranked first and second. Information on over 5 million drug 
tests in general workplace drug testing shows that the positivity rate 
for oxycodone and hydrocodone (0.96%) was second only to marijuana in 
2012.\39\
    The use of medications, specifically Schedule II drugs, without a 
prescription is a growing concern for the Department in workplace drug 
testing, and the proposal for their inclusion offers the opportunity to 
deter nonmedical use of these drugs among federal workers. The 
Department does note that in recognition of the prescription drug abuse 
issue, the Department of Defense issued a memorandum on January 30, 
2012, announcing the expansion of their drug testing panel to include 
hydrocodone and benzodiazepines starting on May 1, 2012. Similarly, the 
Department proposes that federal agencies include the testing of 
oxycodone, oxymorphone, hydrocodone, and hydromorphone in oral fluid 
specimens as described below.

Oxycodone/oxymorphone

    The Department is proposing to test for oxycodone/oxymorphone using 
a 30 ng/mL cutoff concentration for the initial test and 15 ng/mL for 
the confirmatory test cutoff concentrations. Both oxycodone and 
oxymorphone have been reported to be readily detectable in oral fluid 
specimens collected from pain patients.41 108 Oxycodone is 
metabolized in relatively minor amounts to oxymorphone.\63\ Oxymorphone 
is a potent analgesic used for pain relief orally and parenterally, and 
is primarily metabolized by conjugation.\109\
    An immunoassay initial test for oxycodone/oxymorphone should be 
calibrated with one of the two analytes and demonstrate sufficient 
cross-reactivity with the other analyte. The Department recommends that 
the minimum cross-reactivity with either analyte be 80 percent or 
greater. If an alternate technology initial test is performed instead 
of immunoassay, either one or both analytes in the group should be used 
to calibrate, depending on the technology. The quantitative sum of the 
two analytes must be equal to or greater than 30 ng/mL. The 
quantitative sum of the two analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The 15 ng/mL confirmatory test cutoff concentration applies equally 
to oxycodone and oxymorphone. A positive test would be comprised of 
either or both analytes with a confirmed concentration equal to or 
greater than 15 ng/mL.

Hydrocodone/hydromorphone

    The Department is proposing to test for hydrocodone/hydromorphone 
using a 30 ng/mL cutoff concentration for the initial test and 15 ng/mL 
for the confirmatory test cutoff concentration. Hydromorphone appears 
rapidly in oral fluid following intravenous administration and follows 
a similar kinetic profile as that observed in plasma.\110\ Both 
hydrocodone and hydromorphone have been reported to be readily 
detectable in oral fluid specimens collected from pain 
patients.41 108 Hydrocodone is metabolized in relatively 
minor amounts to hydromorphone.\62\ Hydromorphone is a potent analgesic 
used for pain relief orally and parenterally, and is primarily 
metabolized by conjugation.\111\ Hydrocodone has been reported to be a 
minor metabolite of codeine \90\ and hydromorphone has been reported to 
be a minor metabolite of morphine.112 113
    An immunoassay initial test for hydrocodone/hydromorphone should be 
calibrated with one of the two analytes and demonstrate sufficient 
cross reactivity with the other analyte. The Department proposes that 
the minimum cross-reactivity with either analyte be 80 percent or 
greater. If an alternate technology initial test is performed instead 
of immunoassay, either one or both analytes in the group should be used 
to calibrate, depending on the technology. The quantitative sum of the 
two analytes must be equal to or greater than 30 ng/mL. The 
quantitative sum of the two analytes must be based on quantitative 
values for each analyte that are equal to or above the laboratory's 
validated limit of quantification.
    The confirmatory test cutoff concentration applies equally to 
hydrocodone and hydromorphone. A positive test would be comprised of 
either or both analytes with a confirmed equal to or greater than 15 
ng/mL.
    In 2009, the U.S. Drug Enforcement Administration (DEA) asked the 
U.S. Department of Health and Human Services (HHS) for a recommendation 
regarding whether to change the schedule for hydrocodone combination 
drug products, such as Vicodin. The proposed change was from Schedule 
III to Schedule II, which would increase the controls on these 
products. Due to the unique history of this issue and the tremendous 
amount of public interest, in October 2013, the FDA Center for Drug 
Evaluation and Research announced the agency's intent to recommend to 
HHS that hydrocodone combination drug products should be reclassified 
to Schedule II. FDA stated that this determination came after a 
thorough and careful analysis of extensive scientific literature, 
review of hundreds of public comments on the issue, and several public 
meetings, during which FDA received input from a wide range of 
stakeholders, including patients, health care providers, outside 
experts, and other government entities.
    In December 2013, FDA, with the concurrence of the National 
Institute on Drug Abuse (NIDA), submitted a formal recommendation 
package to HHS to reclassify hydrocodone combination drug products into 
Schedule II. Also in December 2013, the Secretary of HHS submitted the 
scientific and medical evaluation and scheduling recommendation to the 
DEA for its consideration. On August 22, 2014, DEA published the Final 
Rule that moves hydrocodone combination drug products from Schedule III 
to Schedule II.
    Section 3.5 authorizes HHS-certified laboratories to perform 
additional tests to assist the MRO in making a determination of 
positive or negative results. The Department believes that additional 
tests can be requested by the MRO to further inform them to determine 
the veracity of the medical explanation of the donor. An example of an 
additional test currently requested by an MRO is when the laboratory 
reports a positive methamphetamine result. The MRO may request a d,l-
stereoisomer determination for methamphetamine, to determine whether 
the result could be attributed to use of an over-the-counter nasal 
inhaler. Another example of current practice is when the laboratory 
reports a positive THCA result, and the MRO requests testing for 
cannabivarin, to distinguish marijuana use from dronabinol (e.g., 
Marinol[supreg]).
    Section 3.6 includes criteria for reporting an oral fluid specimen 
as adulterated. While there are no known oral fluid 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

[[Page 28066]]

scientifically sound, while allowing laboratories the flexibility 
necessary to develop specific testing requirements for an adulterant.
    Section 3.7 incorporates criteria from the UrMG that are applicable 
for reporting an invalid result for an oral fluid specimen, and 
includes an additional criterion to enable laboratories to perform 
specimen validity testing using biomarkers other than IgG and albumin.

Subpart D--Collectors

    Sections 4.1 through 4.5 contain the same policies as described in 
the current UrMG in regard to 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 5.5 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.

Subpart F--Federal Drug Testing Custody and Control Form

    Sections 6.1 and 6.2 are the same as in the current UrMG, requiring 
an 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--Oral Fluid Specimen Collection Devices

    Section 7.1 describes the type of collection device that must be 
used to collect an oral fluid specimen. A single use device that has 
been cleared by the FDA for the collection of oral fluid must be used.
    Section 7.2 describes specific requirements for the oral fluid 
collection device, to ensure that the device provides a sufficient 
volume for laboratory analysis and maintains the integrity of the 
specimen. The Department has determined that it is essential that the 
device have a volume adequacy indicator showing that a minimum volume 
of 1 mL oral fluid has been collected; that the container be sealable 
and non-leaking; and that all components of the device ensure drug and 
metabolite stability and do not substantially affect the composition of 
drug and/or drug metabolites in the specimen.
    Section 7.3 details the minimum performance requirements for a 
collection device. Considering the variety of oral fluid collection 
devices available, the Department considers it necessary to require 
that any device used meet minimum standards to ensure the integrity of 
the specimen and the standardization of the laboratory analysis 
process.

Subpart H--Oral Fluid Specimen Collection Procedure

    This subpart addresses the same topics, in the same order, as the 
UrMG procedures for urine specimen collection.
    Section 8.1 specifies the procedures required to provide privacy 
for the oral fluid donor during the collection procedure.
    Sections 8.2 through 8.5 describe the responsibilities and 
procedures the collector must follow before, during, and after an oral 
fluid collection.
    Section 8.6 describes the procedures the collector must follow when 
a donor is unable to provide an oral fluid specimen.
    Section 8.7 prohibits collection of an alternate specimen when a 
donor is unable to provide an adequate oral fluid specimen, unless 
specifically authorized by the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs and by the federal agency.
    Section 8.8 describes how the collector prepares the oral fluid 
specimens, including the description of the oral fluid split specimen 
collection.
    Section 8.9 specifies how a collector is to report a refusal to 
test.
    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 Oral Fluid Specimens for Federal Agency 
Workplace Drug Testing Programs. This document will be available on the 
SAMHSA Web site https://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 oral fluid 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 
current UrMG for laboratories to become HHS-certified and to maintain 
HHS certification to conduct oral fluid testing for a federal agency, 
as well as what a laboratory must do when certification is not 
maintained.
    Section 9.5 contains specifications for 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 and 
include those specific for oral fluid testing.
    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 
specimen (e.g., oral fluid 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. Oral fluid blind samples that challenge specimen validity 
tests are not required, and the blind supplier must validate blind 
samples in the selected manufacturer's collection device.

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 
oral fluid testing.
    Sections 11.1 through 11.8 include the same requirements that are 
contained in the current UrMG for the laboratory standard operating 
procedure (SOP) manual; responsibilities and scientific qualifications 
of the

[[Page 28067]]

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.
    Sections 11.9 through 11.14 include the same requirements as in the 
current UrMG in regard to initial and confirmatory drug test 
requirements, validation, and batch quality control as described in 
each section below.
    Section 11.9 describes the requirements for the initial drug test 
which permit the use of an immunoassay or alternate technology (e.g., 
spectrometry or spectroscopy). The Department believes that new 
technology has advanced in the initial testing for drugs, and does not 
want to limit the testing technology to immunoassay.
    Sections 11.10 and 11.11 cover validation and quality control 
requirements for the initial test.
    Section 11.12 describes the requirements for a confirmatory drug 
test. The Department proposes to allow analytical procedures using mass 
spectrometry or other equivalent technologies. Based on ongoing reviews 
of the scientific and forensic literature, and the assessment of a DTAB 
working group that has studied newer instruments and technologies, the 
Department believes that scientifically valid confirmatory methods 
other than combined chromatographic and mass spectrometric methods can 
be used to successfully detect and report the cutoff concentrations 
proposed in Subpart C-Oral Fluid Specimen Drug Tests.
    Sections 11.13 and 11.14 cover validation and quality control 
requirements for the confirmatory tests.
    Sections 11.15 and 11.16 address specimen validity tests that a 
laboratory performs for oral fluid specimens. The Department included 
requirements in the OFMG to test all specimens for albumin or IgG and 
to allow laboratories to perform other specimen validity tests. All 
specimen validity tests must use appropriate analytical methods that 
are properly controlled and validated, to provide scientifically 
supportable and forensic acceptable results to the MRO.
    Section 11.17 describes in detail how a certified laboratory is 
required to report test results to MRO for oral fluid specimens.
    Sections 11.18 and 11.19 contain the same requirements as the UrMG 
for specimen and record retention.
    Section 11.20 describes the statistical summary report that a 
laboratory must provide to a federal agency for oral fluid testing. 
This section is comparable to the same section in the UrMG, differing 
only in that the statistical report elements are specific for oral 
fluid testing.
    Section 11.21 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 11.22 addresses the laboratory information to be made 
available to a federal 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 11.23, 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 oral fluid testing. Section 12.1 
clearly states that only HHS-certified laboratories are authorized to 
test oral fluid specimens for federal agency workplace drug testing 
programs. Instrumented Initial Test Facilities are not practical and 
will not be allowed due primarily to the limited sample volume of oral 
fluid collected from the donor.

Subpart M--Medical Review Officer (MRO)

    This subpart addresses the same topics, in the same order, as the 
UrMG procedures for Medical Review Officers (MROs).
    Section 13.1 describes who may serve as an MRO. With the inclusion 
of additional Schedule II prescription medications in the Mandatory 
Guidelines and the ever-changing field of drug testing, medical review 
of drug test results is more complex today than before. Therefore, the 
Department proposes to incorporate MRO requalification training and 
reexamination on a regular basis (at least every five years). The URMG 
and OFMG do not include a requirement for MROs to obtain continuing 
education units (CEUs). The Department understands that it would be 
difficult to determine whether CEUs obtained are related to federal 
agency drug testing. The requalification requirement every five years 
will assure agency auditors and inspectors and regulated employers that 
MROs are appropriately qualified. This requirement is not expected to 
increase costs to MROs. Current practices for MRO requirements have 
equivalent standards but vary among MRO training entities. These 
requirements will standardize the length of time each MRO is required 
to take a requalification examination. Currently, some MRO 
requalification periods are longer than five years, while others are 
less than five years. The Department assumes that the costs to those 
MROs that have requalification periods over five years will be offset 
by the cost savings to MROs that have periods shorter than five years. 
Thus, the Department has not estimated any costs associated with this 
provision, but it welcomes comment on this assumption.
    The Department anticipates that MROs will continue to obtain CEUs 
by virtue of maintaining their medical licensure requirements. In 
addition, the MRO certification/training entities provide MRO manuals 
and periodic newsletters with updates on federal drug testing program 
requirements. However, the Department is seeking comments on requiring 
MRO requalification CEUs and on the optimum number of credits and the 
appropriate CEU accreditation bodies should CEUs be required as part of 
MRO requalification.
    MROs play a key role in the federal safety program and maintain the 
balance between the safety and privacy objectives of the program. The 
MRO's role in gathering and evaluating the medical evidence and 
providing due process is imperative. These are duties that must be 
carried out by the MRO and cannot be delegated to other personnel who 
are not certified by an MRO entity.
    The MRO is charged with certain important medical and 
administrative duties. The MRO must have detailed knowledge of the 
effects of medications and other potential alternative medical 
explanations for laboratory reported drug test results. He or she is 
responsible for determining whether legitimate medical explanations are 
available to explain an employee's drug test result. This medical 
review process has become far more complex as a result of specimen 
validity testing and the myriad of medical explanations for 
adulterated, substituted, and invalid laboratory test results. These 
complexities have made MRO knowledge of the effects of drugs and 
medications even more important.
    In addition, MROs confer with prescribing physicians in making 
decisions about prescription changes so that alternative medications 
can be used that will not impact public safety. Similarly, the MRO is 
required to report

[[Page 28068]]

to employers the employees' prescription and over-the-counter 
medication use (or dangerous combinations of use) that the MRO believes 
will negatively affect duty performance. In addition, the MRO is 
required to medically assess referral physician examinations and 
evaluations in certain positive and refusal-to-test situations. These, 
too, have become more complex over time.
    Section 13.2 describes how nationally recognized entities or 
subspecialty boards that certify MROs are approved.
    Section 13.3 describes the training that is required before a 
physician may serve as an MRO. The Department has added a requirement 
for MRO training to include information about how to discuss substance 
misuse and abuse and how to access those services. MROs performing the 
review of federal employee drug test results should be aware of 
prevention and treatment opportunities for individuals and can provide 
information to the donor.
    Section 13.4 describes the responsibilities of an MRO.
    Section 13.5 describes an MRO's actions when reviewing an oral 
fluid specimen's test results. This section includes procedures that 
are specific to oral fluid specimen results.
    In Section 13.5, item c(2)(ii), the Department proposes a morphine 
or codeine confirmatory concentration that the MRO verifies as positive 
without requiring clinical evidence of illegal drug use, when the donor 
does not have a legitimate medical explanation. As in the UrMG, this 
section states that the MRO must not consider 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 oral 
fluid. There is limited information in the scientific literature on the 
codeine and/or morphine concentrations seen in oral fluid after 
consumption of poppy seed food products. Therefore, the Department is 
proposing a conservative concentration of 150 ng/mL (i.e., 10 times the 
confirmatory test cutoff) as the decision point. 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 oral fluid 
for a drug test. This section contains the same procedures as the UrMG, 
with information specific to oral fluid specimens.
    Section 13.7 describes what an MRO must do when a donor has a 
permanent or long-term medical condition that prevents him or her from 
providing a sufficient amount of oral fluid for a federal agency 
applicant/pre-employment, follow-up, or return-to-duty test. These 
procedures are the same as in the UrMG.
    The remaining sections, Sections 13.8, 13.9, and 13.10, are the 
same as in the UrMG, addressing who may request a test of the split (B) 
specimen, how an MRO reports a primary (A) specimen result, and the 
types of relationship that are prohibited between an MRO and an HHS- 
certified laboratory.

Subpart N--Split Specimen Tests

    Sections 14.1 and 14.2 include the same policies as the UrMG in 
regard to when a split (B) specimen may be tested and the testing 
requirements for a split specimen when the primary specimen was 
reported positive for a drug(s).
    Section 14.3 specifies how the split testing laboratory tests a 
split (B) oral fluid 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 oral fluid 
specimens, but has included policies in these Guidelines to allow for 
the testing and reporting of adulterants in oral fluid.
    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 oral fluid 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 oral fluid specimen for the same length of 
time that the primary specimen is retained.

Subpart O--Criteria for Rejecting a Specimen for Testing

    Sections 15.1 and 15.2 contain the same policies as the current 
UrMG for discrepancies requiring a laboratory to reject a specimen and 
for discrepancies that require a laboratory to reject a specimen unless 
the discrepancy is corrected.
    Section 15.3 lists those discrepancies that would not affect either 
testing or reporting of an oral fluid specimen result. These are 
similar to the corresponding section in the UrMG, with differences 
where applicable for oral fluid specimens.
    Section 15.4 describes the discrepancies that may require the MRO 
to cancel a test, which are the same as those in the UrMG.

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.

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 OFMG into 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.
    Section 3.1 requires federal agencies to test all oral fluid 
specimens for either albumin or IgG to determine specimen validity. The 
Department specifically requests public comment on this requirement.
    Section 3.4 lists the proposed cutoff concentrations. The 
Department is specifically requesting comments on the appropriateness 
of these proposed cutoffs.
    Regarding Section 3.4, the Department is specifically interested in 
obtaining information on the capability of laboratories to test THCA 
analyte using a cutoff of 50 pg/mL and the validity of whether THCA can 
be established as an accurate, sensitive and valid marker for oral 
fluid testing to detect marijuana use. Additionally, the Department is 
interested in obtaining information whether THCA should be used to 
extend the window of detection of marijuana use. The Department is also 
interested in receiving comments on lowering the cutoff concentration 
for delta-9-tetrahydrocannabinol (THC) to either 2 or 3 ng/mL for the 
initial test cutoff concentration and to 1 ng/mL for the confirmatory 
cutoff concentration to extend the window of detection.
    In section 7.3, the Department proposes performance requirements 
for a collection device. The Department is requesting specific comments 
on these requirements.
    In Section 13.5, the Department proposes a concentration of 150 ng/
mL morphine or codeine be used by the

[[Page 28069]]

MRO to report a positive result in the absence of a legitimate medical 
explanation (i.e., prescription), without requiring clinical evidence 
of illegal opiate use, and to rule out the possibility of a positive 
result due to consumption of food products. The Department is 
requesting specific comments on this proposed concentration.

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). In addition, the Department published a Federal Register 
notice in June 2011 to solicit comments regarding the science and 
practice of oral fluid testing via a Request for Information (RFI) [76 
FR 34086].
    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. The Administrative 
Procedure Act (APA) delineates an exception to its rulemaking 
procedures for ``a matter relating to agency management or personnel'' 
5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary 
govern federal workplace drug testing programs, HHS has taken the 
position that the Guidelines are a ``matter relating to agency 
management or personnel'' and, thus, are not subject to the APA's 
requirements for notice and comment rulemaking. This position is 
consistent with Executive Order 12564 regarding Drug-Free Workplaces, 
which directs the Secretary to promulgate scientific and technical 
guidelines for executive agency drug testing programs.

Need for regulation

Enhances Flexibility
    The proposed Mandatory Guidelines for Federal Workplace Drug 
Testing Programs using Oral Fluid (OFMG) will provide flexibility to 
address workplace drug testing needs of federal agencies 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 OFMG are implemented, in the event that an individual is 
unable to provide a urine specimen, the federal agency may authorize 
the collection of an oral fluid specimen. In the event a federal agency 
adopts oral fluid testing and the donor is unable to collect an oral 
fluid specimen, the federal agency may also authorize the collection of 
a urine specimen. This 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 
specimen.
    Urine collection requires use of a specialized collection facility, 
secured restrooms, the same gender, and other special requirements. 
Oral fluid may be collected in various settings. An acceptable oral 
fluid collection site must allow the collector to observe the donor, 
maintain control of the collection device(s) during the process, 
maintain record storage, and protect donor privacy.
Decreases Invalid Tests
    Oral fluid collections will occur under observation, which should 
substantially lessen the risks of specimen substitution and 
adulteration that has been associated with urine specimen collections, 
most of which are unobserved. All oral fluid specimens will be tested 
for either albumin or immunoglobulin G (IgG) to identify invalid 
specimens.
Saves Time
    Oral fluid collection can require less time than urine collection, 
reducing employee time away from the workplace and, therefore, reducing 
costs to the federal agency employer. Oral fluid collection does not 
require a facility that provides visual privacy during the collection. 
It is expected that many oral fluid collections will occur at or near 
the workplace, and not at a dedicated collection site, thereby reducing 
the amount of time away from the workplace. The collector is allowed to 
be in the vicinity of the donor, reducing the loss of productive time. 
The option to collect a urine specimen in the event that the donor 
cannot provide an oral fluid 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 specimen. 
Administrative data indicates it takes, on average, about 4 hours from 
the start of the notification of the drug test to the actual time a 
donor reports back to the worksite. Since oral fluid collection does 
not have the same privacy concerns as urine collection, onsite 
collections are likely, thereby reducing the time a donor is away from 
the worksite. The Department estimates the time savings to be between 1 
and 3 hours. This range reflects uncertainty around the location of the 
collection. The lower bound represents an estimate of time savings if 
the collection was conducted at an offsite location. The upper bound 
estimate represents the time savings if the collection was conducted at 
the employee's workplace, and thus incorporates travel time savings. 
Using OPM's estimate for the average annual salary of Federal employees 
converted to an hourly wage, the savings generated for the Federal 
Government would be roughly $400,000 to $1.2 million a year, or $38 to 
$114 per test.
Versatility in Detection
    The time course of drugs and metabolites differs between oral fluid 
and urine, resulting in some differences in analytes and detection 
times. Oral fluid tests generally are positive as soon as the drug is 
absorbed into the body. In contrast, urine tests that are based solely 
on detection of a metabolite are

[[Page 28070]]

dependent upon the rate and extent of metabolite formation. Thus, oral 
fluid may permit more interpretative insight into recent drug use drug-
induced effects that may be present shortly before or at the time the 
specimen is collected. A federal agency may select the specimen type 
for collection based on the circumstances of the test. For example, in 
situations where drug use at the work-site is suspected, the testing of 
oral fluid may show the presence of an active drug, which may indicate 
recent administration of the drug and be advantageous when assessing 
whether the drug contributed to an observed behavior.
Advances in Oral Fluid Drug Testing
    In the past, urine was the only permitted specimen for forensic 
workplace drug testing. However, some issues that previously deterred 
the use of oral fluid for drug testing have been resolved. The 
scientific basis for the use of oral fluid as an alternative specimen 
for drug testing has now been broadly established. For example, oral 
fluid collection devices and procedures have been developed that 
protect against biohazards, maintain the stability of analytes, and 
provide sufficient oral fluid for testing. In addition, OFMG analyte 
cutoff concentrations are much lower than those specified for urine in 
the Guidelines. Additionally, specimen volume is also much lower, 
saving time in collection and transport cost. Developments in 
analytical technologies have allowed their use as efficient and cost-
effective methods that provide the needed analytical sensitivity and 
accuracy for testing oral fluid specimens.
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.
    A major challenge to urine drug testing has been the proliferation 
of commercial products used to adulterate or substitute a donor's urine 
specimen. Due to individual privacy rights, most urine collections are 
unobserved, allowing the opportunity to use such products. As the 
Department has established requirements and laboratories have developed 
procedures to control for adulterated and substituted specimens, 
manufacturers have developed new products to avoid detection. Current 
research indicates that some current substitution products are 
indistinguishable from human urine. The use of these products is 
expected to continue.
Time Horizon of This Analysis
    The transition to the testing of oral fluids will be gradual and 
steady over the course of four years, when it should plateau. By this 
time, it is expected that oral fluid tests will account for 25-30% of 
all regulated drug testing. This estimate is based on the non-regulated 
sector's time course of the testing of 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 the 
number of specimens tested annually for federal agencies to be 150,000. 
HHS projects that approximately 7% (or 10,500) of the 150,000 specimens 
tested per year will be oral fluid specimens and 93% (or 139,500) will 
be urine specimens. The approximate annual numbers of regulated 
specimens for the Department of Transportation (DOT) and Nuclear 
Regulatory Commission (NRC) are 6 million and 200,000, respectively. 
Should DOT and NRC allow oral fluid testing in regulated industries' 
workplace programs, the estimated annual numbers of specimens for DOT 
would be 180,000 oral fluid and 5,820,000 urine, and numbers of 
specimens for NRC would be 14,000 oral fluid and 186,000 urine.
    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. In 
addition, these proposed Guidelines include an alternative for 
laboratories to continue to use existing FDA-cleared immunoassays which 
do not have the specified cross-reactivity, by establishing a decision 
point with the lowest-reacting analyte. 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 oral fluid testing and 
testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will 
be minimal based on information from some HHS certified laboratories 
currently testing non-regulated oral fluid specimens. Likewise, there 
will be minimal costs associated with changing initial testing to 
include MDA and MDEA since current immunoassays can be adapted to test 
for these analytes. Prior to being allowed to test regulated oral fluid 
specimens, laboratories must be certified by the Department through the 
NLCP. Estimated laboratory costs to complete and submit the application 
are $2,000, and estimated costs for the Department to process the 
application are $7,200. These estimates are from SAMHSA 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. 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 oral fluid 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 $54,000 and $69,000. 
This training cost is included in the costs of the revised URMG.

Summary of One-Time Costs

----------------------------------------------------------------------------------------------------------------
                                                                    Lower bound     Upper bound       Primary
----------------------------------------------------------------------------------------------------------------
Cost of Application *...........................................  ..............  ..............      $62,000.00
Application Processing *........................................  ..............  ..............      217,000.00
Performance Testing *...........................................       27,900.00       55,800.00  ..............
Training *......................................................       54,000.00       69,000.00  ..............
                                                                 -----------------------------------------------

[[Page 28071]]

 
    Total.......................................................      360,900.00      403,800.00  ..............
----------------------------------------------------------------------------------------------------------------
* Estimated using costs presented above multiplied by the number of laboratories (31).

Costs and Benefits

    Thus, the Department estimates one-time, upfront costs of between 
$360,000 and $400,000. While the Department has only monetized a small 
portion of the benefits (time savings) to a small subset of the 
workplace drug testing programs that could be affected by the OFMG 
(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 costs. Even if NRC and DOT do not 
implement oral fluid testing, the benefits to Federal workplace testing 
programs, estimated at between $400,000 and $1.2 million, 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 OFMG 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 an overall reduction in 
costs if drug testing is expanded under the OFMG. The costs to 
implement this change to regulation 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 
alternative specimen type when an employee is unable to provide the 
originally authorized specimen type. Insofar as there are costs 
associated with each drug test, this could lead to lower overall 
testing costs for federal agencies. The added flexibility will also 
benefit federal employees, who should be able to provide one of the 
specimen types, thereby facilitating the drug test required for their 
employment.
    The Secretary has determined that the proposed Guidelines are not a 
major rule for the purpose of congressional review. For the purpose of 
congressional review, a major rule is one which is likely to cause an 
annual effect on the economy of $100 million; a major increase in costs 
or prices; significant effects on competition, employment, 
productivity, or innovation; or significant effects on the ability of 
U.S.-based enterprises to compete with foreign-based enterprises in 
domestic or export markets. This is not a major rule under the Small 
Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.

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 OFMG. 
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.
    In this notice, the Secretary is proposing to establish standards 
for certification of laboratories engaged in oral fluid drug testing 
for federal agencies and the use of oral fluid testing in federal drug-
free workplace programs. The Department of Health and Human Services, 
by authority of 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 
urine drug testing for federal agencies. 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 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 Oral Fluid is not a system of records as noted in the 
information collection/recordkeeping requirements below. As required, 
HHS originally published the Mandatory Guidelines for Federal Workplace 
Drug

[[Page 28072]]

Testing Programs (Guidelines) in the Federal Register on April 11, 1988 
[53 FR 11979]. 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] with an effective date of May 1, 2010 (correct effective date 
published on December 10, 2008 [73 FR 75122]). The effective date of 
the Guidelines was further changed to October 1, 2010 on April 30, 2010 
[75 FR 22809].

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/Recordkeeping Requirements

    The information collection requirements (i.e., reporting and 
recordkeeping) in the current Guidelines, which establish the 
scientific and technical guidelines for federal workplace drug testing 
programs and establish standards for certification of laboratories 
engaged in urine drug testing for federal agencies under authority of 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 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 remain in effect until final Guidelines 
including the use of oral fluid specimens 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 Oral Fluid Specimens.
    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 the urine 
specimen. Scientific advances in the use of oral fluid in detecting 
drugs have made it possible for this alternative specimen to be used in 
federal programs with the same level of confidence that has been 
applied to the use of urine. The proposed Guidelines establish when 
oral fluid specimens may be collected, the procedures that must be used 
in collecting an oral fluid specimen, and the certification process for 
approving a laboratory to test oral fluid specimen.
    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 oral fluid specimen 
testing laboratories, and 100 MROs.

                                       Estimate of Annual Reporting Burden
----------------------------------------------------------------------------------------------------------------
                                                                       Number of    Responses/    Hours/   Total
                     Section                           Purpose        respondents   respondent   response  hours
----------------------------------------------------------------------------------------------------------------
9.2(a)(1).......................................  Laboratory                  10             1       3      30
                                                   required to
                                                   submit
                                                   application for
                                                   certification.
9.10(a)(3)......................................  Materials to                10             1       2      20
                                                   submit to become
                                                   an HHS inspector.
11.3(a).........................................  Laboratory                  10             1       2      20
                                                   submits
                                                   qualifications
                                                   of RP to HHS.
11.4(c).........................................  Laboratory                  10             1       2      20
                                                   submits
                                                   information to
                                                   HHS on new RP or
                                                   alternate RP.
11.20...........................................  Specifications              10             5     0.5      25
                                                   for laboratory
                                                   semi-annual
                                                   statistical
                                                   report of test
                                                   results to each
                                                   federal agency.
13.9 & 14.6.....................................  Specifies that             100             5   * 0.05     25
                                                   MRO must report
                                                   all verified
                                                   split specimen
                                                   test results to
                                                   the federal
                                                   agency.
16.1(b) & 16.5(a)...............................  Specifies content            1             1       3       3
                                                   of request for
                                                   informal review
                                                   of suspension/
                                                   proposed
                                                   revocation of
                                                   certification.

[[Page 28073]]

 
16.4............................................  Specifies                    1             1     0.5     0.5
                                                   information
                                                   appellant
                                                   provides in
                                                   first written
                                                   submission when
                                                   laboratory
                                                   suspension/
                                                   revocation is
                                                   proposed.
16.6............................................  Requires                     1             1     0.5     0.5
                                                   appellant to
                                                   notify reviewing
                                                   official of
                                                   resolution
                                                   status at end of
                                                   abeyance period.
16.7(a).........................................  Specifies                    1             1      50      50
                                                   contents of
                                                   appellant
                                                   submission for
                                                   review.
16.9(a).........................................  Specifies content            1             1       3       3
                                                   of appellant
                                                   request for
                                                   expedited review
                                                   of suspension or
                                                   proposed
                                                   revocation.
16.9(c).........................................  Specifies                    1             1      50      50
                                                   contents of
                                                   review file and
                                                   briefs.
                                                                    --------------------------------------------
    Total.......................................  .................          156   ............  ........  247
----------------------------------------------------------------------------------------------------------------
* 3 min.

    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 refuse 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(c)); section 13.5 
describes the actions an MRO takes to report a primary specimen result; 
and section 14.5 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(b)(2).............................  Collector must contact federal agency               100               1          * 0.05               5
                                                  point of contact.
11.21 & 11.22..................................  Information on drug test that                        10              10            3              1,500
                                                  laboratory must provide to federal
                                                  agency upon request or to donor
                                                  through MRO.
13.8(b)........................................  MRO must inform donor of right to                   100               5            3              1,500
                                                  request split specimen test when a
                                                  positive or adulterated result is
                                                  reported.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................             210  ..............  ..............           3,505
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 3 min.

    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(f) and (h), and must review the procedures for the oral fluid 
specimen collection device used with the donor (section 8.4(b)). 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/        Hours/
                    Section                                      Purpose                    respondents     respondent       response       Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3, 8.5, & 8.8................................  Collector completes Federal CCF for                 100             380          * 0.07           2,534
                                                  specimen collected.
8.8(d) & (f)...................................  Donor initials specimen labels/seals             38,000               1         ** 0.08           3,167
                                                  and signs statement on the Federal CCF.
11.8(a) & 11.17................................  Laboratory completes Federal CCF upon                10           3,800        *** 0.05           1,900
                                                  receipt of specimen and before
                                                  reporting result.
13.4(d)(4), 13.9(c), & 14.6(c).................  MRO completes Federal CCF before                    100             380        *** 0.05           1,900
                                                  reporting the result.
14.1(b)........................................  MRO documents donor's request to have               300               1        *** 0.05              15
                                                  split specimen tested.
                                                                                         ---------------------------------------------------------------

[[Page 28074]]

 
    Total......................................  .......................................          38,510  ..............  ..............           9,516
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 4 min.
** 5 min.
*** 3 min.

    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 recordkeeping burden. 
Subpart H [sections 8.4(d) and 8.5(a)(1)] requires collectors to enter 
any information on the Federal CCF of any unusual findings during the 
oral fluid 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 are included in the 
recordkeeping burden estimated to complete the Federal CCF and is, 
therefore, not considered an additional recordkeeping burden. Subparts 
K describe 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; 11.10(1); 11.13(a); 11.16; 11.17(a), (b), 
and (c); 11.20; 11.21, and 11.22. 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 oral fluid 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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2007. Oral fluid as an alternative matrix to monitor opiate and 
cocaine use in substance-abuse treatment patients. Drug Alcohol 
Depend, 87, 258-267.
96. Presley, L., Lehrer, M., Seiter, W., Hahn, D., Rowland, B., 
Smith, M., Kardos, K.W., Fritch, D., Salamone, S., Niedbala, R.S., 
Cone, E.J., 2003. High prevalence of 6-acetylmorphine in morphine-
positive oral fluid specimens. Forensic Sci Int, 133, 22-25.
97. Cook, C.E., Brine, D.R., Jeffcoat, A.R., Hill, J.M., Wall, M.E., 
Perez-Reyes, M., DiGuiseppi, S.R., 1982. Phencyclidine disposition 
after intravenous and oral doses. Clin Pharmacol Ther, 31, 625-634.
98. McCarron, M.M., Walberg, C.B., Soares, J.R., Gross, S.J., 
Baselt, R.C., 1984. Detection of phencyclidine usage by 
radioimmunoassay of saliva. J Anal Toxicol, 8, 197-201.
99. Wan, S.H., Matin, S.B., Azarnoff, D.L., 1978. Kinetics, salivary 
excretion of amphetamine isomers, and effect of urinary pH. Clin 
Pharmacol Ther, 23, 585-590.
100. Engblom, C., Gunnar, T., Rantanen,A., Lillsunde, P., 2007. 
Driving under the influence of drugs--amphetamine concentrations in 
oral fluid and whole blood samples. J Anal Toxicol, 31, 276-280.
101. Huestis, M.A., Cone, E.J., 2007. Methamphetamine disposition in 
oral fluid, plasma, and urine. Ann N Y Acad Sci, 1098, 104-121.
102. Schepers, R.J., Oyler, J.M., Joseph, R.E., Jr., Cone, E.J., 
Moolchan, E.T., Huestis, M.A., 2003. Methamphetamine and amphetamine 
pharmacokinetics in oral fluid and plasma after controlled oral 
methamphetamine administration to human volunteers. Clin Chem, 49, 
121-132.
103. Barnes, A.J., Scheidweiler, K.B., Kolbrich-Spargo, E.A., 
Gorelick, D.A., Goodwin, R.S., Huestis, M.A., 2011. MDMA and 
metabolite disposition in expectorated oral fluid after controlled 
oral MDMA administration. Ther Drug Monit, 33, 602-608.
104. Navarro, M., Pichini, S., Farre, M., Ortuno, J., Roset, P.N., 
Segura, J., de.la Torre, R., 2001. Usefulness of saliva for 
measurement of 3, 4-methylenedioxymethamphetamine and its 
metabolites: correlation with plasma drug concentrations and effect 
of salivary pH. Clin Chem, 47, 1788-1795.
105. Samyn, N., De Boeck, G., Wood, M., Lamers, C.T., De Waard, D., 
Brookhuis, K.A., Verstraete, A.G., Riedel, W.J., 2002. Plasma, oral 
fluid and sweat wipe ecstasy concentrations in controlled and real 
life conditions. Forensic Sci Int, 128, 90-97.
106. Freudenmann, R.W., Spitzer, M., 2004. The 
Neuropsychopharmacology and Toxicology of 3, 4-methylenedioxy-N-
ethyl-amphetamine (MDEA). CNS Drug Rev, 10, 89-116.
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Coordinating Committee, Prescription Drug Abuse Subcommittee, 
Addressing Prescription Drug Abuse in the United States: Current 
Activities and Future Opportunities. Department of Health and Human 
Services, 2013. https://www.cdc.gov/HomeandRecreationalSafety/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf (accessed 15 
September 2014).
108. Heltsley, R., DePriest, A., Black, D.L., Robert, T., Marshall, 
L., Meadors, V.M., Caplan, Y.H., Cone, E.J., 2011. Oral fluid drug 
testing of chronic pain patients. I. Positive prevalence rates of 
licit and illicit drugs. J Anal Toxicol,35, 529-540.
109. Cone, E.J., Darwin, W.D., Buchwald, W.F., Gorodetzky, C.W., 
1983. Oxymorphone metabolism and urinary excretion in human, rat, 
guinea pig, rabbit, and dog. Drug Metab Dispos, 11, 446-450.
110. Ritschel, W., Parab, P.V., Denson, D.D., Coyle, D.E., Gregg, 
R.V., 1987. Absolute bioavailability of hydromorphone after peroral 
and rectal administration in humans: saliva/plasma ratio and 
clinical effects. J Clin Pharmacol, 27, 647-653.
111. Cone, E.J., Phelps, B.A., Gorodetzky, C.W., 1977. Urinary 
excretion of hydromorphone and metabolites in humans, rats, dogs, 
guinea pigs, and rabbits. J Pharm Sci, 66, 1709-1713.
112. Cone, E.J., Caplan, Y.H., Moser, F., Robert, T., Black, D., 
2008. Evidence that morphine is metabolized to hydromorphone but not 
to oxymorphone. J Anal Toxicol, 32, 319-323.
113. Cone, E.J., Heit, H.A., Caplan, Y.H., Gourlay, D., 2006. 
Evidence of morphine metabolism to hydromorphone in pain patients 
chronically treated with morphine. J Anal Toxicol, 30, 1-5.

    The Department believes that the benefits of the proposed Mandatory 
Guidelines using Oral Fluid Specimens outweigh the costs to include 
this additional specimen type in federal workplace drug testing 
programs. There is no requirement for federal agencies to use oral 
fluid as part of their drug testing program. A federal agency may 
choose to use urine, oral fluid, or both specimen types 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: May 4, 2015.
Pamela S. Hyde,
Administrator, SAMHSA.
    Dated: May 7, 2015.
Sylvia M. Burwell,
Secretary.
    For reasons set forth in the preamble, the Department proposes to 
revise the Mandatory Guidelines for Federal Workplace Drug Testing 
Programs to include Mandatory Guidelines using Oral Fluid Specimens to 
read as follows:

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using 
Oral Fluid Specimens

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--Oral Fluid Specimens

2.1 What type of specimen may be collected?
2.2 Under what circumstances may an oral fluid specimen be 
collected?
2.3 How is each oral fluid specimen collected?
2.4 What volume of oral fluid is collected?
2.5 How is the split oral fluid specimen collected?
2.6 When may an entity or individual release an oral fluid specimen?

Subpart C--Oral Fluid Specimen Tests

3.1 Which tests are conducted on an oral fluid specimen?
3.2 May a 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 undiluted 
(neat) oral fluid?
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 an oral fluid specimen as 
adulterated?
3.7 What criteria are used to report an invalid result for an oral 
fluid 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?
4.5 What must a federal agency do before a

[[Page 28078]]

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 an oral fluid 
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--Oral Fluid Specimen Collection Devices

7.1 What is used to collect an oral fluid specimen?
7.2 What are the requirements for an oral fluid collection device?
7.3 What are the minimum performance requirements for a collection 
device?

Subpart H--Oral Fluid Specimen Collection Procedure

8.1 What privacy must the donor be given when providing an oral 
fluid specimen?
8.2 What must the collector ensure at the collection site before 
starting an oral fluid specimen collection?
8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?
8.4 What steps does the collector take in the collection procedure 
before the donor provides an oral fluid specimen?
8.5 What steps does the collector take during and after the oral 
fluid specimen collection procedure?
8.6 What procedure is used when the donor states that he or she is 
unable to provide an oral fluid specimen?
8.7 If the donor is unable to provide an oral fluid specimen, may 
another specimen type be collected for testing?
8.8 How does the collector prepare the oral fluid 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 oral fluid 
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?
9.7 What are the PT requirements for an HHS-certified oral fluid 
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 What are the requirements for an initial drug test?
11.10 What must an HHS-certified laboratory do to validate an 
initial drug test?
11.11 What are the batch quality control requirements when 
conducting an initial drug test?
11.12 What are the requirements for a confirmatory drug test?
11.13 What must an HHS-certified laboratory do to validate a 
confirmatory drug test?
11.14 What are the batch quality control requirements when 
conducting a confirmatory drug test?
11.15 What are the analytical and quality control requirements for 
conducting specimen validity tests?
11.16 What must an HHS-certified laboratory do to validate a 
specimen validity test?
11.17 What are the requirements for an HHS-certified laboratory to 
report a test result?
11.18 How long must an HHS-certified laboratory retain specimens?
11.19 How long must an HHS-certified laboratory retain records?
11.20 What statistical summary reports must an HHS-certified 
laboratory provide for oral fluid testing?
11.21 What HHS-certified laboratory information is available to a 
federal agency?
11.22 What HHS-certified laboratory information is available to a 
federal employee?
11.23 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 oral fluid 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 an oral fluid 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 oral fluid for a 
drug test?
13.7 What happens when an individual is unable to provide a 
sufficient amount of oral fluid for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because 
of a permanent or long-term medical condition?
13.8 Who may request a test of a split (B) specimen?
13.9 How does an MRO report a primary (A) specimen test result to an 
agency?
13.10 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) specimen be tested?
14.2 How does an HHS-certified laboratory test a split (B) specimen 
when the

[[Page 28079]]

primary (A) specimen was reported positive?
14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid specimen when the primary (A) specimen was reported 
adulterated?
14.4 Who receives the split (B) specimen result?
14.5 What action(s) does an MRO take after receiving the split (B) 
oral fluid 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 an oral fluid 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.\1\
---------------------------------------------------------------------------

    \1\ The NRC-related information in this notice 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).
    Although HHC has no authority to regulate the transportation 
industry, the Department of Transportation (DOT) does have such 
authority. DOT is required by law to develop requirements for its 
regulated industry that ``incorporate the Department of Health and 
Human Services scientific and technical guidelines dated April 11, 
1988 and any amendments to those guidelines . . .'' See, e.g., 49 
U.S.C. Sec.  20140(c)(2). In carrying out its mandate, DOT requires 
by regulation at 49 CFR Part 40 that its federally-regulated 
employers use only HHS-certified laboratories in the testing of 
employees, 49 CFR Sec.  40.81, and incorporates the scientific and 
technical aspects of the HHS Mandatory Guidelines.
---------------------------------------------------------------------------

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 an endogenous substance.
    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.
    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) or rejected

[[Page 28080]]

for testing, 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 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 Device. A product that is used to collect an oral fluid 
specimen and may include a buffer or diluent.
    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 a 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, for urine, substituted) 
or the need for further testing.
    Donor. The individual from whom a specimen is collected.
    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.
    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 (for urine) diluted 
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 
when the laboratory determines that it cannot complete testing or 
obtain a valid drug test result.
    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, oral fluid collection device) 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.
    Non-Medical Use of a Drug. The use of a prescription drug, whether 
obtained by prescription or otherwise, other than in the manner or for 
the time period prescribed, or by a person for whom the drug was not 
prescribed.
    Oral Fluid Specimen. An oral fluid specimen is collected from the 
donor's oral cavity and is a combination of physiological fluids 
produced primarily by the salivary glands.
    Oxidizing Adulterant. A substance that acts alone or in combination 
with other substances to oxidize drug or drug metabolites to prevent 
the detection of the drugs or drug metabolites, or affects the reagents 
in either the initial or confirmatory drug test.
    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. A sample collected from a donor at the collection site 
for the purpose of a drug test.
    Split Specimen Collection (for Oral Fluid). A collection in which 
two specimens [primary (A) and split (B)] are collected, concurrently 
or serially, and independently sealed in the presence of the donor.
    Standard. Reference material of known purity or a solution 
containing a

[[Page 28081]]

reference material at a known concentration.

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.
    In addition, the Health Insurance Portability and Accountability 
Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, 
Subparts A and E, is 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 https://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);
    (3) Fail to provide a specimen (e.g., oral fluid or another 
authorized specimen type) 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);
    (4) Fail or decline to participate in an alternate specimen 
collection (e.g., urine) as directed by the federal agency or collector 
(i.e., as described in Section 8.6);
    (5) Fail to undergo a medical examination or evaluation, as 
directed by the MRO as part of the verification process (i.e., Section 
13.6) or as directed by the federal agency. In the case of a federal 
agency applicant/pre-employment drug test, the donor is deemed to have 
refused to test on this basis only if the federal agency applicant/pre-
employment test is conducted following a contingent offer of 
employment. If there was no contingent offer of employment, the MRO 
will cancel the test;
    (6) Fail to cooperate with any part of the testing process (e.g., 
disrupt the collection process); or
    (7) Admit to the collector or MRO that you have adulterated or (for 
urine) 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 that portion of 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 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, 13.5, and 13.6, 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--Oral Fluid Specimens

Section 2.1 What type of specimen may be collected?

    A federal agency may collect oral fluid and/or an alternate 
specimen type for its workplace drug testing program. Only specimen 
types authorized by Mandatory Guidelines for Federal Workplace Drug 
Testing Programs may be collected. An agency using oral fluid must 
follow these Guidelines.

Section 2.2 Under what circumstances may an oral fluid specimen be 
collected?

    A federal agency may collect an oral fluid specimen for the 
following reasons:
    (a) Federal agency applicant/Pre-employment test;
    (b) Random test;
    (c) Reasonable suspicion/cause test;
    (d) Post-accident test;
    (e) Return to duty test; or
    (f) Follow-up test.

Section 2.3 How is each oral fluid specimen collected?

    Each oral fluid specimen is collected as a split specimen (i.e., 
collected either simultaneously or serially) as described in Section 
2.5.

Section 2.4 What volume of oral fluid is collected?

    A known volume of at least 1 mL of undiluted (neat) oral fluid for 
each oral fluid specimen (designated ``Tube A'' and ``Tube B'') is 
collected using a collection device.

Section 2.5 How is the split oral fluid specimen collected?

    The collector collects at least 1 mL of undiluted (neat) oral fluid 
in a collection device designated as ``A'' (primary) and at least 1 mL 
of undiluted (neat) oral fluid in a collection device designated as 
``B'' (split) either simultaneously or serially (i.e., as described in 
Section 8.8.)

Section 2.6 When may an entity or individual release an oral fluid 
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 
13.8.

Subpart C--Oral Fluid Drug and Specimen Validity Tests

Section 3.1 Which tests are conducted on an oral fluid specimen?

    A federal agency:

[[Page 28082]]

    (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 opiates, amphetamines, 
and phencyclidine, as provided under Section 3.4; and
    (c) Must ensure that the following specimen validity tests are 
conducted on each oral fluid specimen:
    (1) Determine the albumin concentration on every specimen; or
    (2) Determine the immunoglobulin G (IgG) concentration on every 
specimen.
    (d) If a specimen exhibits abnormal characteristics (e.g., unusual 
odor or color), 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, 
then additional testing may be performed.

Section 3.2 May a specimen be tested for additional drugs?

    (a) On a case-by-case basis, a specimen may be tested for 
additional drugs, if a federal agency is conducting the collection for 
reasonable suspicion or post accident testing. A specimen collected 
from a federal agency employee may be tested by the federal agency for 
any drugs listed in Schedule I or II of the Controlled Substances Act 
(other than the drugs listed in Section 3.1, or when used pursuant to a 
valid prescription or when used as otherwise authorized by law). The 
federal agency must request the HHS-certified laboratory to test for 
the additional drug, include a justification to test a specific 
specimen for the drug, and ensure that the HHS-certified laboratory has 
the capability to test for the drug and has established properly 
validated initial and confirmatory analytical methods. If an initial 
test procedure is not available upon request for a suspected Schedule I 
or Schedule II drug, the federal agency can request an HHS-certified 
laboratory to test for the drug by analyzing two separate aliquots of 
the specimen in two separate testing batches using the confirmatory 
analytical method. Additionally, the split (B) specimen will be 
available for testing if the donor requests a retest at another HHS-
certified laboratory.
    (b) A federal agency covered by these Guidelines must petition the 
Secretary in writing for approval to routinely test for any drug class 
not listed in Section 3.1. Such approval must be limited to the use of 
the appropriate science and technology and must not otherwise limit 
agency discretion to test for any drug tested under paragraph (a) of 
this section.

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 undiluted 
(neat) oral fluid?

----------------------------------------------------------------------------------------------------------------
                                                                                               Confirmatory test
                                               Initial test                                         cutoff
           Initial test analyte               cutoff (ng/mL)      Confirmatory test analyte   concentration (ng/
                                                                                                      mL)
----------------------------------------------------------------------------------------------------------------
Marijuana (THC) \1\.......................                   4  THC.........................                   2
Cocaine/Benzoylecgonine...................              \2\ 15  Cocaine.....................                   8
                                            ..................  Benzoylecgonine.............                   8
Codeine/Morphine..........................              \2\ 30  Codeine.....................                  15
                                            ..................  Morphine....................                  15
Hydrocodone/Hydromorphone.................              \2\ 30  Hydrocodone.................                  15
                                            ..................  Hydromorphone...............                  15
Oxycodone/Oxymorphone.....................              \2\ 30  Oxycodone...................                  15
                                            ..................  Oxymorphone.................                  15
6-Acetylmorphine..........................                   3  6-Acetylmorphine............                   2
Phencyclidine.............................                   3  Phencyclidine...............                   2
Amphetamine/Methamphetamine...............              \2\ 25  Amphetamine.................                  15
                                            ..................  Methamphetamine.............                  15
MDMA \4\/MDA \5\/MDEA \6\.................              \2\ 25  \3\ MDMA....................                  15
                                            ..................  \4\ MDA.....................                  15
                                            ..................  \5\ MDEA....................                  15
----------------------------------------------------------------------------------------------------------------
\1\ [Delta]-9-Tetrahydrocannabinol (THC).
\2\ 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 all analytes from the group 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.
\3\ Methylenedioxymethamphetamine (MDMA).
\4\ Methylenedioxyamphetamine (MDA).
\5\ Methylenedioxyethylamphetamine (MDEA).

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 as necessary to provide information 
that the MRO would use to report a verified drug test result [e.g., d, 
l-stereoisomers determination for methamphetamine, [Delta]-9-
tetrahydrocannabinol-9-carboxylic acid (THCA), and additional specimen 
validity tests including adulterants]. All tests must meet appropriate 
validation and quality control requirements.

Section 3.6 What criteria are used to report an oral fluid specimen as 
adulterated?

    An HHS-certified laboratory reports an oral fluid specimen as 
adulterated

[[Page 28083]]

when the presence of an adulterant is verified using an initial test on 
a first aliquot and a different confirmatory test on a second aliquot.

Section 3.7 What criteria are used to report an invalid result for an 
oral fluid specimen?

    An HHS-certified laboratory reports a primary (A) oral fluid 
specimen as an invalid result when:
    (a) The albumin concentration is less than 0.6 mg/dL for both the 
initial (first) test and the second test on two separate aliquots;
    (b) The IgG concentration is less than 0.5 mg/L for both the 
initial (first) test and the second test on two separate aliquots;
    (c) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid immunoassay or alternate technology initial drug 
test results cannot be obtained);
    (d) Interference with the drug confirmatory assay occurs on two 
separate aliquots of the specimen and the laboratory is unable to 
identify the interfering substance;
    (e) The physical appearance of the specimen (e.g., viscosity) is 
such that testing the specimen may damage the laboratory's instruments;
    (f) The specimen has been tested and the appearances of the primary 
(A) and the split (B) specimens (e.g., color) are clearly different; or
    (g) The concentration of a biomarker other than albumin or IgG is 
not consistent with that established for human oral fluid.

Subpart D--Collectors

Section 4.1 Who may collect a specimen?

    (a) A collector who has been trained to collect oral fluid 
specimens in accordance with these Guidelines and the manufacturer's 
procedures for the collection device.
    (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., fiancée).

Section 4.3 What are the requirements to be a collector?

    (a) An individual may serve as a collector if he or she fulfills 
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 use the specific oral fluid 
collection device. Training must include the following:
    (i) All steps necessary to complete an oral fluid 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 collection 
device 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 
for a specific oral fluid collection device and may train others to 
collect oral fluid specimens using that collection device when they 
have completed the following:
    (1) Qualified as a trained collector and regularly conducted oral 
fluid drug test collections using that collection device 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.

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 an oral 
fluid specimen (e.g., an accident

[[Page 28084]]

investigation), another site may be used for the collection, providing 
the collection is performed by a trained oral fluid 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) The ability to store records securely.

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 an oral 
fluid 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 for an oral fluid specimen?

    (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 uses an incorrect form, 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 an 
incorrect form was used by the collector, 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 HHS-certified laboratory must wait at least 5 
business days before the laboratory reports a rejected for testing 
result to the MRO and the MRO cancels the test.

Subpart G--Oral Fluid Specimen Collection Devices

Section 7.1 What is used to collect an oral fluid specimen?

    An FDA-cleared single-use collection device intended to collect an 
oral fluid specimen must be used. This collection device must maintain 
the integrity of such specimens during storage and transport so that 
the specimen contained therein can be tested in an HHS-certified 
laboratory for the presence of drugs or their metabolites.

Section 7.2 What are the requirements for an oral fluid collection 
device?

    An oral fluid specimen collection device must provide:
    (a) An indicator that demonstrates the adequacy of the volume of 
oral fluid specimen collected;
    (b) A sealable, non-leaking container that maintains 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 
presence of drugs or their metabolites;
    (c) Components that ensure pre-analytical drug and drug metabolite 
stability; and
    (d) Components that do not substantially affect the composition of 
drugs and/or drug metabolites in the oral fluid specimen.

Section 7.3 What are the minimum performance requirements for a 
collection device?

    An oral fluid collection device must meet the following minimum 
performance requirements.
    (a) Reliable and reproducible collection of a minimum of 1 mL of 
undiluted (neat) oral fluid;
    (b) If the collection device contains a diluent (or other 
component, process, or method that modifies the volume of the testable 
specimen):
    (1) The volume of oral fluid collected should be within 0.1 ml of 
the target volume, and
    (2) The volume of diluent in the device should be within 0.05 ml of 
the diluent target volume;
    (c) Stability (recoverable concentrations >=90 percent of the 
concentration at the time of collection) of the drugs and/or drug 
metabolites for one week at room temperature (18-25 [deg]C) and under 
intended shipping and storage conditions; and
    (d) Recover >=90 percent (but no more than 120 percent) of drug 
and/or drug metabolite in the undiluted (neat) oral fluid at (or near) 
the initial test cutoff (see Section 3.4).

[[Page 28085]]

Subpart H--Oral Fluid Specimen Collection Procedure

Section 8.1 What privacy must the donor be given when providing an oral 
fluid specimen?

    The following privacy requirements apply when a donor is providing 
an oral fluid 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 an oral fluid specimen collection?

    The collector must deter the adulteration or substitution of an 
oral fluid specimen at the collection site.

Section 8.3 What are the preliminary steps in the oral fluid specimen 
collection procedure?

    The collector must take the following steps before beginning an 
oral fluid 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 requests that the donor opens his or her mouth, 
and the collector inspects the oral cavity to ensure that it is free of 
any items that could impede or interfere with the collection of an oral 
fluid specimen (e.g., candy, gum, food, tobacco, dental retainer).
    (1) At this time, the collector starts the 10-minute wait period 
and proceeds with the steps below before beginning the specimen 
collection as described in Section 8.5.
    (2) If the donor's mouth is not free of any items that could impede 
or interfere with the collection of an oral fluid specimen immediately 
prior to collection, or the donor claims to be a tobacco user, or 
claims to have ``dry mouth,'' the donor may drink while rinsing his or 
her mouth with water (up to 4 oz.) and wait 10 minutes before beginning 
the specimen collection.
    (e) The collector must provide identification (e.g., employee 
badge, employee list) if requested by the donor.
    (f) The collector explains the basic collection procedure to the 
donor.
    (g) The collector informs the donor that the instructions for 
completing the Federal Custody and Control Form are located on the back 
of the Federal CCF or available upon request.
    (h) 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 an oral fluid specimen?

    (a) The collector will provide or the donor may select a specimen 
collection device that is clean, unused, and wrapped/sealed in original 
packaging. The specimen collection device will be opened in view of the 
donor.
    (1) Both the donor and the collector must keep the unwrapped 
collection devices in view at all times until each collection device 
containing the donor's oral fluid specimen has been sealed and labeled.
    (b) The collector reviews with the donor the procedures required 
for a successful oral fluid specimen collection as stated in the 
manufacturer's instructions for the specimen collection device.
    (1) The collector may set a reasonable time limit for specimen 
collection (based on the device used, not to exceed 15 minutes per 
device).
    (c) 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 note the conduct on the Federal CCF.

Section 8.5 What steps does the collector take during and after the 
oral fluid specimen collection procedure?

    Integrity and Identity of the Specimen. The collector must take the 
following steps during and after the donor provides the oral fluid 
specimen:
    (a) The collector shall be present and maintain visual contact with 
the donor during the procedures outlined in this section.
    (1) Under the observation of the collector, the donor is 
responsible for placing the specimen collection device in his or her 
mouth. The collector must ensure the collection is performed correctly 
and that the collection device is working properly. If the device fails 
to collect the specimen, the collector must begin the process again, 
beginning with Step 8.4(b), using a new specimen collection device (for 
both A and B specimens) and a new Federal CCF.
    (2) The donor and collector must complete the collection in 
accordance with the manufacturer instructions for the collection 
device.
    (b) If the donor fails to remain present through the completion of 
the collection, fails to follow the instructions for the collection 
device, refuses to provide a second specimen as required in step (a)(1) 
above, or refuses to provide an alternate specimen as authorized in 
Section 8.6, the collector stops the collection and reports the refusal 
to test in accordance with Section 8.9.

Section 8.6 What procedure is used when the donor states that he or she 
is unable to provide an oral fluid specimen?

    (a) If the donor states that he or she is unable to provide an oral 
fluid specimen during the collection process, the collector requests 
that the donor follow the collector instructions and attempt to provide 
an oral fluid specimen.
    (b) The donor demonstrates his or her inability to provide a 
specimen when, after 15 minutes of using the collection device, there 
is insufficient volume or no oral fluid collected using the device.
    (1) If the donor states that he or she could provide a specimen 
after drinking some fluids, the collector gives the donor a drink (up 
to 8 ounces) and waits an additional 10 minutes before beginning the 
specimen collection (a period of 1 hour must be provided or until the 
donor has provided a sufficient oral fluid specimen). If the donor 
simply needs more time before attempting to provide an oral fluid 
specimen, the donor is not required to drink any fluids during the 1 
hour wait time. The collector must inform the donor that the donor must 
remain at the collection site (i.e., in an area designated by the 
collector) during the wait period.
    (2) If the donor states that he or she is unable to provide an oral 
fluid specimen, the collector records the reason for not collecting an 
oral fluid

[[Page 28086]]

specimen on the Federal CCF, notifies the federal agency's designated 
representative for authorization of an alternate specimen to be 
collected, and sends the appropriate copies of the Federal CCF to the 
MRO and to the federal agency's designated representative. If an 
alternate specimen is authorized, the collector may begin 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 alternative specimen.

Section 8.7 If the donor is unable to provide an oral fluid specimen, 
may another specimen type be collected for testing?

    No, unless the alternate specimen type is authorized by Mandatory 
Guidelines for Federal Workplace Drug Testing Programs and specifically 
authorized by the federal agency.

Section 8.8 How does the collector prepare the oral fluid specimens?

    (a) All federal agency collections are to be split specimen 
collections.
    An oral fluid split specimen collection may be:
    (1) Two specimens collected simultaneously with two separate 
collection devices;
    (2) Two specimens collected serially with two separate collection 
devices. Collection of the second specimen must begin within two 
minutes after the completion of the first collection and recorded on 
the Federal CCF; or
    (3) Two specimens collected simultaneously using a single 
collection device that directs the oral fluid into two separate 
collection tubes.
    (b) A known volume of at least 1 mL of undiluted (neat) oral fluid 
is collected for the specimen designated as ``Tube A'' and a known 
volume of at least 1 mL of undiluted (neat) oral fluid is collected for 
the specimen designated as ``Tube B''.
    (c) In the presence of the donor, the collector places a tamper-
evident label/seal from the Federal CCF over the cap of each specimen 
tube. The collector records the date of the collection on the tamper-
evident labels/seals.
    (d) The collector instructs the donor to initial the tamper-evident 
labels/seals on each specimen tube. If the donor refuses to initial the 
labels/seals, the collector notes the refusal on the Federal CCF and 
continues with the collection process.
    (e) The collector must ensure that all the information required on 
the Federal CCF is provided.
    (f) 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.
    (g) 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.
    (h) The collector seals the specimens (Tube A and Tube 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 Tube A 
oral fluid specimen. The collector must also send a copy of the Federal 
CCF to the HHS-certified laboratory.
    (i) 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 oral fluid specimen 
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 on the Federal CCF, 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 Oral Fluid 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 oral 
fluid 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 oral fluid 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

[[Page 28087]]

    (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 
11.18, 11.19, and 14.7;
    (3) Ensure access to federally regulated specimens and records in 
accordance with Sections 11.21 and 11.22 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 and may be sent 
to the laboratory as undiluted (neat) oral fluid. 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 less than 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 negative PT sample will not contain a measurable amount of a 
target analyte.
    (b) PT samples used to evaluate specimen validity tests shall 
satisfy, but are not limited to the following criteria:
    (1) The concentration of albumin and/or IgG will be at least 20 
percent below the cutoff; or
    (2) The concentration of albumin and/or IgG may be another 
concentration for a special purpose.
    (c) 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.

Section 9.6 What are the PT requirements for an applicant laboratory?

    (a) An applicant laboratory that seeks certification under these 
Guidelines 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) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over the three sets of PT samples;
    (8) Correctly identify at least 80 percent of the challenges for 
each individual specimen validity test over the three sets of PT 
samples;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over the three 
sets of PT samples that satisfy the following criteria:
    (i) Albumin concentrations are no more than 20 percent 
or 2 standard deviations from the appropriate reference or 
peer group mean; and
    (ii) IgG values are no more than 20 percent or 2 standard deviations from the appropriate reference or peer 
group mean;
    (b) Failure to satisfy these requirements will result in 
disqualification.

Section 9.7 What are the PT requirements for an HHS-certified oral 
fluid laboratory?

    (a) A laboratory certified under these Guidelines 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, obtain no more than one drug 
concentration on a PT sample that differs by more than 50 
percent from the appropriate reference or peer group mean over two 
consecutive PT cycles;
    (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) Correctly identify at least 80 percent of the total specimen 
validity testing challenges over two consecutive PT cycles;
    (8) Correctly identify at least 80 percent of the challenges for 
each

[[Page 28088]]

individual specimen validity test over two consecutive PT cycles;
    (9) For quantitative specimen validity tests, obtain quantitative 
values for at least 80 percent of the total challenges over two 
consecutive PT cycles that satisfy the following criteria:
    (i) Albumin concentrations are no more than 20 percent 
or 2 standard deviations from the appropriate reference or 
peer group mean; and
    (ii) IgG values are no more than 20 percent or 2 standard deviations from the appropriate reference or peer 
group mean.
    (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 one or more 
inspectors. The number of inspectors is determined according to the 
number of specimens reviewed. Additional information regarding 
inspections is available from SAMHSA.
    (c) Each inspector conducts 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 he or she satisfies the following criteria:
    (1) Has experience and an educational background similar to that 
required for either an HHS-certified laboratory responsible person or 
certifying scientist 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 
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 facsimile, 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

[[Page 28089]]

    (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 
https://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 
in the selected manufacturer's collection device as to their content 
using appropriate initial and confirmatory tests.
    (1) Drug positive blind samples must be fortified with one or more 
of the drugs or metabolites listed in Section 3.4.
    (2) Drug positive blind samples must contain concentrations of 
drugs between 1.5 and 2 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 in the selected manufacturer's 
collection device 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 or IITF, 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 in the collection device 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 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:

[[Page 28090]]

    (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 
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

[[Page 28091]]

    (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 he or she is 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 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.
    (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 11.11.

Section 11.10 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 11.11 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 11.12 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 an oral fluid specimen when identifying and quantifying 
drugs or their metabolites.

Section 11.13 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; and
    (8) 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 11.14 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; and
    (4) At least one control targeted at or less than 40 percent of the 
cutoff.

[[Page 28092]]

    (b) Calibrators and controls must total at least 10 percent of the 
aliquots analyzed in each batch.

Section 11.15 What are the analytical and quality control requirements 
for conducting specimen validity tests?

    (a) Each specimen validity test result must be based on performing 
an initial specimen validity test on one aliquot and a second or 
confirmatory 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 11.16 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 11.17 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. 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)(4) 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) through (e)(4) 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 or adulterated result. If no further testing is 
necessary, the HHS-certified laboratory then reports the invalid result 
to the MRO.
    (e) A primary (A) oral fluid specimen is reported as an invalid 
result when:
    (1) Interference occurs on the initial drug tests on two separate 
aliquots (i.e., valid initial drug test results cannot be obtained);
    (2) 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;
    (3) The physical appearance of the specimen is such that testing 
the specimen may damage the laboratory's instruments;
    (4) The physical appearances of Tubes A and B are clearly different 
(note: A is tested);
    (5) The albumin concentration is less than 0.6 mg/dL for both the 
initial (first) test and the second test on two separate aliquots;
    (6) The IgG concentration is less than 0.5 mg/L for both the 
initial (first) test and the second test on two separate aliquots; or
    (7) The concentration of a biomarker other than albumin or IgG is 
not consistent with that established for human oral fluid.
    (f) An HHS-certified laboratory shall reject a primary (A) oral 
fluid 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, and invalid test results for an oral fluid specimen. For 
example, a specimen can be positive for a specific drug and 
adulterated.
    (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 a specimen that is reported 
adulterated or invalid (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, facsimile, 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 facsimile, 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.
    (m) For positive, adulterated, invalid, and rejected specimens, 
laboratories must facsimile, courier, mail, or electronically transmit 
a legible image or copy of the completed Federal CCF.

Section 11.18 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 specimens must be kept in secured frozen storage (-20 
[deg]C or less) to ensure their availability for retesting during an 
administrative or judicial proceeding.
    (c) 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.

Section 11.19 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 11.21) 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.

[[Page 28093]]

    (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 11.20 What statistical summary reports must an HHS-certified 
laboratory provide for oral fluid 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, facsimile, or email within 14 working 
days after the end of the semiannual period. The summary report must 
not include any personal identifying 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;
    (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; and
    (13) 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 11.21 What HHS-certified laboratory information is available to 
a federal agency?

    (a) Following a federal agency's receipt of a positive or 
adulterated 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 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 11.22 What HHS-certified laboratory information is available to 
a federal employee?

    A federal employee who is the subject of a workplace drug test may 
submit a written request through the MRO and the federal agency 
requesting copies of any records relating to his or her drug test 
results or a documentation package as described in Section 11.21(b) and 
any relevant certification, review, or revocation of certification 
records. Federal 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 11.23 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 oral fluid specimens for a federal 
agency's workplace drug testing program?

    No, only HHS-certified laboratories are authorized to test oral 
fluid 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 and nonmedical use of prescription 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, 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 and/or train physicians as 
MROs for federal workplace drug testing programs must submit their 
qualifications and, if

[[Page 28094]]

applicable, a sample examination. Approval will be based on an 
objective review of qualifications that include a copy of the MRO 
applicant application form, the course syllabus and materials, 
documentation that the continuing education courses are accredited by a 
professional organization, and, if applicable, the delivery method and 
content of the examination. Each approved MRO training/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 
https://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:
    (1) The collection procedures used to collect federal agency 
specimens;
    (2) How to interpret test results reported by HHS-certified 
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;
    (5) Procedures for interpretation, review (e.g., donor interview 
for legitimate medical explanations), and reporting of results 
specified by any federal agency for which the individual may serve as 
an MRO; and
    (6) Training in Substance Abuse including information about how to 
discuss substance misuse and abuse, and how individuals that test 
positive can access services.
    (b) Nationally recognized entities or subspecialty boards that 
train or certify physicians as MROs should make the MROs aware of 
prevention and treatment opportunities for individuals after testing 
positive.

Section 13.4 What are the responsibilities of an MRO?

    (a) The MRO must review all positive, adulterated, rejected for 
testing, invalid, and (for urine) 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 11.17(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.
    (f) The MRO must conduct a medical examination or a review of the 
examining physician's findings and make a determination of refusal to 
test or cancelled test when a collector reports that the donor was 
unable to provide a specimen, as addressed in Section 8.6.

Section 13.5 What must an MRO do when reviewing an oral fluid 
specimen's test results?

    (a) When the HHS-certified laboratory reports a negative result for 
the primary (A) specimen, the MRO reports a negative result to the 
agency.
    (b) When the HHS-certified laboratory reports multiple results for 
the primary (A) specimen, as the MRO, you must follow the verification 
procedures described in 13.5(c) through (f) and:
    (1) Report all verified positive and/or refusal to test results to 
the federal agency.
    (2) If an invalid result was reported in conjunction with a 
positive or adulterated result, do not report the verified invalid 
result to the federal agency at this time. The MRO reports the verified 
invalid result(s) for the primary (A) specimen only if the split 
specimen is tested and reported as a failure to reconfirm as described 
in Section 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 any legitimate medical explanation for the positive result.
    (1) If the donor provides a legitimate medical explanation for the 
positive result, the MRO reports the test result as negative to the 
agency.
    (2) If the donor is unable to provide a legitimate medical 
explanation, the MRO reports a positive result to the agency for all 
drugs except codeine and/or morphine as follows:
    (i) For codeine and/or morphine less than 150 ng/mL and no 
legitimate medical explanation: the MRO must determine if there is 
clinical evidence of illegal use (in addition to the drug test result) 
to report a positive result to the agency. If there is no clinical 
evidence of illegal use, the MRO reports a negative result to the 
agency.
    (ii) For codeine and/or morphine at or above 150 ng/mL and no 
legitimate medical explanation: the MRO reports a positive result to 
the agency. Consumption of food products must not be considered a 
legitimate medical explanation for the donor having morphine or codeine 
at or above this concentration.
    (d) When the HHS-certified laboratory reports an adulterated result 
for the primary (A) oral fluid 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 oral fluid specimen was adulterated.
    (e) When the HHS-certified laboratory reports an invalid result for 
the primary (A) oral fluid specimen, the MRO must contact the donor to 
determine if there is a legitimate explanation for the invalid result.
    (1) If the donor provides a legitimate explanation (e.g., a 
prescription medication), the MRO reports a test cancelled result with 
the reason for the invalid result and informs the federal agency that a 
recollection is not required because there is a legitimate explanation 
for the invalid result.
    (2) If the donor is unable to provide a legitimate explanation, the 
MRO reports a test cancelled result and directs the agency to collect 
another specimen from the donor.
    (i) If the second specimen collected provides a valid result, the 
MRO follows the procedures in Section 13.5(a) through (d).
    (ii) If the second specimen collected provides an invalid result, 
the MRO

[[Page 28095]]

reports this specimen as test cancelled and recommends that the agency 
collect another authorized specimen type (e.g., urine).
    (f) When the HHS-certified laboratory reports a rejected for 
testing result on the primary (A) specimen, the MRO reports a test 
cancelled result to the agency and recommends that the agency collect 
another specimen from the donor.

Section 13.6 What action does the MRO take when the collector reports 
that the donor did not provide a sufficient amount of oral fluid for a 
drug test?

    (a) When another specimen type (e.g., urine) was collected as 
authorized by the federal agency, the MRO reviews and reports the test 
result in accordance with the Mandatory Guidelines for Federal 
Workplace Drug Testing Programs using the alternative specimen.
    (b) When the federal agency did not authorize the collection of an 
alternative specimen, the MRO consults with the federal agency. The 
federal agency immediately directs 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.
    (1) For purposes of this section, a medical condition includes an 
ascertainable physiological condition. Permanent or long-term medical 
conditions are those physiological, anatomic, or psychological 
abnormalities documented as being present prior to the attempted 
collection, and considered not amenable to correction or cure for an 
extended period of time, if ever.
    (2) As the MRO, if another physician will perform the evaluation, 
you must provide the other physician with the following information and 
instructions:
    (i) That the donor was required to take a federally regulated drug 
test, but was unable to provide a sufficient amount of oral fluid to 
complete the test;
    (ii) The consequences of the appropriate federal agency regulation 
for refusing to take the required drug test;
    (iii) That, after completing the evaluation, the referral physician 
must agree to provide a written statement to the MRO with a 
recommendation for one of the determinations described in paragraph 
(b)(3) of this section and the basis for the recommendation. The 
statement must not include detailed information on the employee's 
medical condition beyond what is necessary to explain the referral 
physician's conclusion.
    (3) As the MRO, if another physician performed the evaluation, you 
must consider and assess the referral physician's recommendations in 
making your determination. You must make one of the following 
determinations and report it to the federal agency in writing:
    (i) A medical condition as defined in paragraph (b)(1) of this 
section has, or with a high degree of probability could have, precluded 
the employee from providing a sufficient amount of oral fluid, but is 
not a permanent or long-term disability. As the MRO, you must report a 
test cancelled result to the federal agency.
    (ii) A permanent or long-term medical condition as defined in 
paragraph (b)(1) of this section has, or with a high degree of 
probability could have, precluded the employee from providing a 
sufficient amount of oral fluid and is highly likely to prevent the 
employee from providing a sufficient amount of oral fluid for a very 
long or indefinite period of time. As the MRO, you must follow the 
requirements of Section 13.7, as appropriate. If Section 13.7 is not 
applicable, you report a test cancelled result to the federal agency 
and recommend that the agency authorize collection of an alternative 
specimen type (e.g., urine) for any subsequent drug tests for the 
donor.
    (iii) There is not an adequate basis for determining that a medical 
condition has or, with a high degree of probability, could have 
precluded the employee from providing a sufficient amount of oral 
fluid. As the MRO, you must report a refusal to test to the federal 
agency.
    (4) When a federal agency receives a report from the MRO indicating 
that a test is cancelled as provided in paragraph (b)(3)(i) of this 
section, the agency takes no further action with respect to the donor. 
When a test is canceled as provided in paragraph (b)(3)(ii) of this 
section, the agency takes no further action with respect to the donor 
other than designating collection of an alternate specimen type (i.e., 
authorized by the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs) for any subsequent collections, in accordance with 
the federal agency plan. The donor remains in the random testing pool.

Section 13.7 What happens when an individual is unable to provide a 
sufficient amount of oral fluid for a federal agency applicant/pre-
employment test, a follow-up test, or a return-to-duty test because of 
a permanent or long-term medical condition?

    (a) This section concerns a situation in which the donor has a 
medical condition that precludes him or her from providing a sufficient 
specimen for a federal agency applicant/pre-employment test, a follow-
up test, or a return-to-duty test and the condition involves a 
permanent or long-term disability and the federal agency does not 
authorize collection of an alternative specimen. As the MRO in this 
situation, you must do the following:
    (1) You must determine if there is clinical evidence that the 
individual is an illicit drug user. You must make this determination by 
personally conducting, or causing to be conducted, a medical evaluation 
and through consultation with the donor's physician and/or the 
physician who conducted the evaluation under Section 13.6.
    (2) If you do not personally conduct the medical evaluation, you 
must ensure that one is conducted by a licensed physician acceptable to 
you.
    (b) If the medical evaluation reveals no clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
negative test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state the basis for the determination 
that a permanent or long-term medical condition exists, making 
provision of a sufficient oral fluid specimen impossible, and for the 
determination that no signs and symptoms of drug use exist. The MRO 
recommends that the agency authorize collection of an alternate 
specimen type (e.g., urine) for any subsequent collections.
    (c) If the medical evaluation reveals clinical evidence of drug 
use, as the MRO, you must report the result to the federal agency as a 
cancelled test with written notations regarding results of both the 
evaluation conducted under Section 13.6 and any further medical 
examination. This report must state that a permanent or long-term 
medical condition [as defined in Section 13.6(b)(1)] exists, making 
provision of a sufficient oral fluid specimen impossible, and state the 
reason for the determination that signs and symptoms of drug use exist. 
Because this is a cancelled test, it does not serve the purposes of a 
negative test (e.g., the

[[Page 28096]]

federal agency is not authorized to allow the donor to begin or resume 
performing official functions because a negative test is needed for 
that purpose).

Section 13.8 Who may request a test of a split (B) specimen?

    (a) For a positive or adulterated result reported on a primary (A) 
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 positive, adulterated, or 
(for urine) substituted to request a test of the split (B) specimen. 
The MRO must inform the donor that he or she has the opportunity to 
request a test of the split (B) specimen when the MRO informs the donor 
that a positive, adulterated, or (for urine) substituted result is 
being reported to the federal agency on the primary (A) specimen.

Section 13.9 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, facsimile, 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 
positive, adulterated, and (for urine) substituted results.
    (d) The MRO must not disclose numerical values of drug test results 
to the agency.

Section 13.10 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) specimen be tested?

    (a) The donor may verbally request through the MRO that the split 
(B) specimen be tested at a different (i.e., second) HHS-certified oral 
fluid laboratory when the primary (A) specimen was determined by the 
MRO to be positive, adulterated, or (for urine) substituted.
    (b) A donor has 72 hours to initiate the verbal request after being 
informed of the result by the MRO. The MRO must document in his or her 
records the verbal request from the donor to have the split (B) 
specimen tested.
    (c) If a split (B) oral fluid 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 available to 
perform the test), the MRO reports to the federal agency that the test 
must be cancelled and the reason for the cancellation. The MRO directs 
the federal agency to ensure the immediate recollection of another oral 
fluid specimen from the donor, with no notice given to the donor of 
this collection requirement until immediately before the collection.
    (d) If a donor chooses not to have the split (B) specimen tested by 
a second HHS-certified oral fluid laboratory, a federal agency may have 
a split (B) specimen retested as part of a legal or administrative 
proceeding to defend an original positive, adulterated, or (for urine) 
substituted result.

Section 14.2 How does an HHS-certified laboratory test a split (B) 
specimen when the primary (A) specimen was reported positive?

    (a) The testing of a split (B) specimen for a drug or metabolite is 
not subject to the testing cutoff concentrations established.
    (b) The HHS-certified laboratory is only required to confirm the 
presence of the drug or metabolite that was reported positive in the 
primary (A) specimen.

Section 14.3 How does an HHS-certified laboratory test a split (B) oral 
fluid 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 14.4 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) oral fluid specimen result from the second HHS-certified 
laboratory?

    The MRO takes the following actions when the second HHS-certified 
laboratory reports the result for the split oral fluid specimen as:
    (a) Reconfirmed the drug(s) or adulteration result. The MRO reports 
reconfirmed to the agency.
    (b) Failed to reconfirm a single or all drug positive results and 
adulterated. If the donor provides a legitimate medical explanation for 
the adulteration result, the MRO reports a failed to reconfirm [specify 
drug(s)] and cancels both tests. If there is no legitimate medical 
explanation, the MRO reports a failed to reconfirm [specify drug(s)] 
and a refusal to test to the agency and indicates the adulterant that 
is present in the specimen. The MRO gives the donor 72 hours to request 
that Laboratory A retest the primary (A) specimen for the adulterant. 
If Laboratory A reconfirms the adulterant, the MRO reports refusal to 
test and indicates the adulterant present. If Laboratory A fails to 
reconfirm the adulterant, the MRO cancels both tests and directs the 
agency to immediately collect another specimen. The MRO shall notify 
the appropriate regulatory office about the failed to reconfirm and 
cancelled test.
    (c) Failed to reconfirm a single or all drug positive results and 
not adulterated. The MRO reports to the agency a failed to reconfirm 
result specify drug(s)], cancels both tests, and notifies the HHS 
office responsible for coordination of the drug-free workplace program.
    (d) Failed to reconfirm a single or all drug positive results and 
invalid result. The MRO reports to the agency a failed to reconfirm 
result [specify drug(s) and gives the reason for the invalid result], 
cancels both tests, directs the agency to immediately collect another 
specimen and notifies the HHS office responsible for coordination of 
the drug-free workplace program.
    (e) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and adulterated. The MRO reports to the agency a reconfirmed 
result [specify drug(s)] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the

[[Page 28097]]

agency that it may take action based on the reconfirmed drug(s) 
although Laboratory B failed to reconfirm one or more drugs and found 
that the specimen was adulterated. The MRO shall notify the HHS office 
official responsible for coordination of the drug-free workplace 
program regarding the test results for the specimen.
    (f) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and not adulterated. The MRO reports a reconfirmed result 
[specify drug(s)] and a failed to reconfirm result [specify drug(s)]. 
The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs. The MRO shall notify the HHS office responsible for 
coordination of the drug-free workplace program regarding the test 
results for the specimen.
    (g) Failed to reconfirm one or more drugs, reconfirmed one or more 
drugs, and invalid result. The MRO reports to the agency a reconfirmed 
result [specify drug(s)] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) although Laboratory B failed to reconfirm one or 
more drugs and reported an invalid result. The MRO shall notify the HHS 
office responsible for coordination of the Drug-free Workplace Program 
regarding the test results for the specimen.
    (h) Failed to reconfirm adulteration. The MRO reports to the agency 
a failed to reconfirm result (specify adulterant) 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.
    (i) Failed to reconfirm a single or all drug positive results and 
reconfirmed an adulterant. The MRO reports to the agency a reconfirmed 
result (specify adulterant) and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed result (adulterated) although Laboratory B failed to 
reconfirm the drug(s) result.
    (j) Failed to reconfirm a single or all drug positive results and 
failed to reconfirm the adulterant. The MRO reports to the agency a 
failed to reconfirm result [specify drug(s) and adulterant] 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.
    (k) Failed to reconfirm at least one drug and reconfirmed the 
adulterant. The MRO reports to the agency a reconfirmed result [specify 
drug(s) and adulterant] and a failed to reconfirm result [specify 
drug(s)]. The MRO tells the agency that it may take action based on the 
reconfirmed drug(s) and the reconfirmed adulterant although Laboratory 
B failed to reconfirm one or more drugs.
    (l) Failed to reconfirm at least one drug and failed to reconfirm 
the adulterant. The MRO reports to the agency a reconfirmed result 
[specify drug(s)] and a failed to reconfirm result [specify drug(s) and 
adulterant]. The MRO tells the agency that it may take action based on 
the reconfirmed drug(s) although Laboratory B failed to reconfirm one 
or more drugs and failed to reconfirm the adulterant.

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, facsimile, 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. 
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 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 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 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.

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

[[Page 28098]]

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 an oral fluid 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 are considered 
insignificant and should not cause an HHS-certified laboratory to 
reject an oral fluid 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;
    (5) A transposition of numbers in the donor's SSN;
    (6) A telephone number is missing/incorrect;
    (7) A fax number is missing/incorrect;
    (8) A ``reason for test'' box is not marked;
    (9) A ``drug tests to be performed'' box is not marked;
    (10) A ``specimen collection'' box is not marked;
    (11) The lot number of the collection device used for the 
collection is missing;
    (12) The collection site address is missing;
    (13) The collector's printed name is missing but the collector's 
signature is properly recorded;
    (14) The time of collection is not indicated;
    (15) The date of collection is not indicated;
    (16) Incorrect name of delivery service;
    (17) 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
    (18) 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 are considered 
insignificant and 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 are considered 
insignificant only when they 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 drug positive, adulterated, invalid, or (for 
urine) substituted; or
    (3) The electronic report provided by the HHS-certified oral fluid 
laboratory does not contain all the data elements required for the HHS 
standard laboratory electronic report for a specimen being reported 
drug positive, adulterated, invalid result, or (for urine) 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 he or she inadvertently 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 his or her 
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

[[Page 28099]]

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.

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 his or her 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 his or her 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

[[Page 28100]]

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 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 his or her 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 either party and the 
reviewing official shall be by facsimile, 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 facsimile, 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

[[Page 28101]]

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 
his or her 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.

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. 2015-11523 Filed 5-13-15; 4:15 pm]
 BILLING CODE 4162-20-P