80 FR 34921 - Mandatory Guidelines for Federal Workplace Drug Testing Programs; Request for Information Regarding Specific Issues Related to the Use of the Hair Specimen for Drug Testing

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

Federal Register Volume 80, Issue 117 (June 18, 2015)

This document is a request for information regarding specific aspects of the regulatory policies and standards that may be applied to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hair specimen). The original comment close date was June 29, 2015. We are extending the date to July 29, 2015 to allow for additional comments.

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34921-34922]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-14964]


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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; 
Request for Information Regarding Specific Issues Related to the Use of 
the Hair Specimen for Drug Testing

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), Department of Health and Human Services (DHHS).

ACTION: Request for information.

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SUMMARY: This document is a request for information regarding specific 
aspects of the regulatory policies and standards that may be applied to 
the Mandatory Guidelines for Federal Workplace Drug Testing Programs 
(hair specimen). The original comment close date was June 29, 2015. We 
are extending the date to July 29, 2015 to allow for additional 
comments.

DATES: Comment Close Date: To be assured consideration, comments must 
be received at one of the addresses provided below on or before July 
29, 2015.

ADDRESSES: Because of staff and resource limitations, we 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 to http://www.regulations.gov. Follow ``Submit a comment'' instructions.
    By regular mail: You may mail written comments to the following 
address only: Substance Abuse and Mental Health Services 
Administration, Attention: Division of Workplace Programs, 1 Choke 
Cherry Road, Room 7-1029, Rockville, MD 20857. Please allow sufficient 
time for mailed comments to be received before the close of the comment 
period.
    By express or overnight mail: You may send written comments to the 
following address only: Substance Abuse and Mental Health Services 
Administration, Attention: Division of Workplace Programs, 1 Choke 
Cherry Road, Room 7-1029, 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:
    For delivery in Rockville, MD: Substance Abuse and Mental Health 
Services Administration, Attention: Division of Workplace Programs, 1 
Choke Cherry Road, Room 7-1029, Rockville, MD 20850. To deliver your 
comments to the Rockville address, call telephone number (240) 276-2600 
in advance to schedule your delivery with one of our staff members. 
Because access to the interior of the Substance Abuse and Mental Health 
Services Administration Building is not readily available to persons 
without federal government identification, commenters are encouraged to 
either schedule your drop off or leave your comments with the security 
guard in the main lobby of the building.

FOR FURTHER INFORMATION CONTACT: Sean Belouin, Division of Workplace 
Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA, 1 Choke 
Cherry Road, Room 7-1029, Rockville, Maryland 20857, (240) 276-2716 
(phone), (240) 276-2610 (Fax), or email at [email protected].

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following Web site as soon as possible after they have been 
received: http://www.regulations.gov. Follow the search instructions on 
that Web site to view public comments. Comments received by the 
deadline will also be available for public inspection at the Substance 
Abuse and Mental Health Services Administration, Division of Workplace 
Programs, 1 Choke Cherry Road, Rockville, MD 20850, Monday through 
Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment 
to view public comments, phone (240) 276-2716.
    I. Background: The Department of Health and Human Services (HHS) 
establishes the standards for Federal Workplace Drug Testing Programs 
under the authority of Section 503 of Public Law 100-71, 5 U.S.C. 
Section 7301, and Executive Order No. 12564. As required, HHS published 
the Mandatory Guidelines for Federal Workplace Drug 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 on November 25, 2008 [73 FR 
71858]. On May 15, 2015, HHS published a notice of proposed revisions

[[Page 34922]]

to the mandatory guidelines which would provide federal executive 
branch agencies with the option of collecting and testing an oral fluid 
specimen in addition to urine specimen. The comment period concludes on 
July 14, 2015.
    Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 note, 
required the Department to establish scientific and technical 
guidelines and amendments in accordance with Executive Order 12564 and 
to publish Mandatory Guidelines which establish comprehensive standards 
for all aspects of laboratory drug testing and procedures, including 
standards that require the use of the best available technology for 
ensuring the full reliability and accuracy of drug tests and strict 
procedures governing the chain of custody of specimens collected for 
drug testing. These revisions to the Mandatory Guidelines promote and 
establish standards that use the best available technology for ensuring 
the full reliability and accuracy of drug tests, while reflecting the 
ongoing process of review and evaluation of legal, scientific, and 
societal concerns.
    SAMHSA's chartered CSAP Drug Testing Advisory Board (DTAB) is the 
vehicle to provide recommendations to the SAMHSA Administrator for 
proposed changes to the Mandatory Guidelines for Federal Workplace Drug 
Testing Programs. The DTAB process involves evaluating the scientific 
supportability of any considered change. To assist the DTAB, we are 
soliciting written comments and statements from the general public and 
industry stakeholders regarding a variety of issues related to hair 
specimen drug testing, including the hair specimen, its collection, 
specimen preparation, analytes/cutoffs, specimen validity, and initial 
and confirmatory testing.
    II. Solicitation of Comments: We are seeking additional information 
to inform potential use of hair specimens for drug testing, 
specifically on the following questions:

Hair Specimen

     What are the acceptable body locations from which to 
collect hair for workplace drug testing? What should be done if head 
hair is not available for collection?
     What hair treatments (i.e., shampoo, conditioning, perm, 
relaxers, coloring, bleaching, straightening, hair transplant) 
influence drug concentration in hair and to what degree?
     What are the acceptable reasons for hair testing (i.e., 
pre-employment, random, reasonable suspicion, post-accident, other 
(fitness for duty, return to duty, etc.))?

Collection

     What training should a collector receive prior to 
collecting the hair specimen?
     What is the best protocol to collect the hair specimen?
     Should the hair collection protocol be standardized, 
including specific instructions on how close to cut the hair specimen 
to the skin, how to determine the authenticity of the hair specimen, 
what cutting instruments to use, how to ensure the cutting instruments 
are decontaminated, and whether the use of collection kits should be 
required?
     What is the minimum amount of hair that should be 
collected?

Specimen Preparation

     What are acceptable protocols for hair specimen 
preparation, such as cutting/powdering, initial washing, 
decontamination, and pre-extraction (i.e., digestion, micro 
pulverization, etc.)?
     Should the washing and decontamination procedures be 
analyte specific?
     What criteria should be used to determine the 
acceptability of a specific wash and decontamination procedure? Are 
there published research studies, with experimental data included, that 
demonstrate that a particular wash procedure is effective at removing 
external contaminants while not significantly affecting the amount of 
incorporated drug related to drug use?
     If washing steps are used for decontamination, should 
adjustments be made for drug concentrations detected in the wash 
fluids? What calculations are recommended for these adjustments?

Analytes/Cutoffs

     What analytes should be measured in hair by the initial 
and confirmatory tests?
     What initial and confirmation cutoffs should be used for 
the various hair drug testing analytes?
     For each analyte/drug, what criteria (cutoff) should be 
used to distinguish external contamination from drug use?
     What unique metabolites or other biomarkers exist to 
confirm use and to distinguish drug use from external contamination for 
which the drugs are currently tested?

Specimen Validity

     Are biomarkers or tests needed to verify that the specimen 
is authentic human hair?
     Are there appropriate biomarkers or tests for the hair 
specimen that would reveal adulteration and/or substitution? What are 
the acceptability criteria for these biomarkers or tests?
     Is the ``invalid'' result category reasonable for hair 
testing? If so, what criteria are acceptable to classify a specimen 
result as invalid?

Testing

     What technologies are available to perform initial and 
confirmatory testing on hair specimens?
     What is the best sample for valid quality control/
proficiency testing material? How should this quality control/
proficiency testing material be prepared? What is the best method to 
prepare a contaminated hair sample versus a sample that represents drug 
use?

Janine Cook,
Chemist, Division of Workplace Programs, Center for Substance Abuse and 
Prevention, SAMHSA.
[FR Doc. 2015-14964 Filed 6-17-15; 8:45 am]
BILLING CODE 4162-20-P