80_FR_35038 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

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)

Page Range34921-34922
FR Document2015-14964

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 Issue 117 (Thursday, June 18, 2015) 
[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

Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices 34921 69. Taege A. (2013). Organ DEPARTMENT OF HEALTH AND Division of Workplace Programs, 1 transplantation and HIV progress or HUMAN SERVICES Choke Cherry Road, Room 7–1029, success? A review of current status. Rockville, MD 20850. To deliver your Curr Infect Dis Rep, 15, 67–76. Substance Abuse and Mental Health comments to the Rockville address, call 70. Tector A.J., Mangu R.S., Chestovich Services Administration telephone number (240) 276–2600 in P., et al. (2006). Use of extended advance to schedule your delivery with criteria livers decreases wait time Mandatory Guidelines for Federal one of our staff members. Because for liver transplantation without Workplace Drug Testing Programs; access to the interior of the Substance adversity impacting posttransplant Request for Information Regarding Abuse and Mental Health Services survival. Ann Surg, 244, 439–450. Specific Issues Related to the Use of Administration Building is not readily the Hair Specimen for Drug Testing available to persons without federal 71. Terrault, N.A., Roland, M.E., Schiano, T., Dove, L., Wong, M.T., AGENCY: Substance Abuse and Mental government identification, commenters Poordad, F., et al. (2012). Outcomes Health Services Administration are encouraged to either schedule your of liver transplant recipients with (SAMHSA), Department of Health and drop off or leave your comments with hepatitis C and human Human Services (DHHS). the security guard in the main lobby of immunodeficiency virus ACTION: Request for information. the building. coinfection. Liver Transpl, 18(6), FOR FURTHER INFORMATION CONTACT: 716–726. SUMMARY: This document is a request for Sean Belouin, Division of Workplace 72. Touzot, M., Pillebout, E., Matignon, information regarding specific aspects of Programs, Center for Substance Abuse M., Tricot, L., Viard, J.P., Rondeau, the regulatory policies and standards Prevention (CSAP), SAMHSA, 1 Choke E., et al. (2010). Renal that may be applied to the Mandatory Cherry Road, Room 7–1029, Rockville, transplantation in HIV-infected Guidelines for Federal Workplace Drug Maryland 20857, (240) 276–2716 patients: The Paris experience. Am Testing Programs (hair specimen). The (phone), (240) 276–2610 (Fax), or email J Transplant, 10(10), 2263–2269. original comment close date was June at sean.belouin@samhsa.hhs.gov. 73. Uriel N., Jorde U.P., Cotarlan V., et 29, 2015. We are extending the date to SUPPLEMENTARY INFORMATION: Inspection al. (2009). Heart transplantation in July 29, 2015 to allow for additional of Public Comments: All comments human immunodeficiency virus- comments. received before the close of the positive patients. J Heart Lung DATES: Comment Close Date: To be comment period are available for Transplant, 28, 667–669. assured consideration, comments must viewing by the public, including any 74. Uriel N., Nahumi N., Colombo P.C., be received at one of the addresses personally identifiable or confidential et al. (2014). Advance heart failure provided below on or before July 29, business information that is included in in patients infected with human 2015. a comment. We post all comments immunodeficiency virus: Is there ADDRESSES: Because of staff and received before the close of the equal access to care? J Heart Lung resource limitations, we cannot accept comment period on the following Web Transplant (in press, online). comments by facsimile (FAX) site as soon as possible after they have 75. Wada, N., Jacobson, L.P., Cohen, M., transmission. You may submit been received: http:// French, A., Phair, J., & Munoz, A. comments in one of four ways (please www.regulations.gov. Follow the search (2013). Cause-specific life choose only one of the ways listed): instructions on that Web site to view expectancies after 35 years of age Electronically: You may submit public comments. Comments received for human immunodeficiency electronic comments to http:// by the deadline will also be available for syndrome-infected and human www.regulations.gov. Follow ‘‘Submit a public inspection at the Substance immunodeficiency syndrome- comment’’ instructions. Abuse and Mental Health Services negative individuals followed By regular mail: You may mail written Administration, Division of Workplace simultaneously in long-term cohort comments to the following address only: Programs, 1 Choke Cherry Road, studies, 1984–2008. Am J Substance Abuse and Mental Health Rockville, MD 20850, Monday through Epidemiol, 177(2), 116–125. Services Administration, Attention: Friday of each week from 8:30 a.m. to 76. Wada, N., Jacobson, L.P., Cohen, M., Division of Workplace Programs, 1 4 p.m. To schedule an appointment to French, A., Phair, J., & Munoz, A. Choke Cherry Road, Room 7–1029, view public comments, phone (240) (2014). Cause-specific mortality Rockville, MD 20857. Please allow 276–2716. among HIV-infected individuals, by sufficient time for mailed comments to I. Background: The Department of CD4 (+) cell count at HAART be received before the close of the Health and Human Services (HHS) initiation, compared with HIV- comment period. establishes the standards for Federal uninfected individuals. AIDS, 28(2), By express or overnight mail: You Workplace Drug Testing Programs under 257–265. may send written comments to the the authority of Section 503 of Public 77. Yoon, S.C., Hurst, F.P., Jindal, R.M., following address only: Substance Law 100–71, 5 U.S.C. Section 7301, and George, S.A., Neff, R.T., Agodoa, Abuse and Mental Health Services Executive Order No. 12564. As required, L.Y., et al. (2011). Trends in renal Administration, Attention: Division of HHS published the Mandatory transplantation in patients with Workplace Programs, 1 Choke Cherry Guidelines for Federal Workplace Drug human immunodeficiency virus Road, Room 7–1029, Rockville, MD Testing Programs (Guidelines) in the infection: An analysis of the United 20850. Federal Register on April 11, 1988 [53 States renal data system. By hand or courier: Alternatively, you FR 11979]. SAMHSA subsequently tkelley on DSK3SPTVN1PROD with NOTICES Transplantation, 91(8), 864–868. may deliver (by hand or courier) your revised the Guidelines on June 9, 1994 written comments only to the following [59 FR 29908], September 30, 1997 [62 Dated: June 12, 2015 FR 51118], November 13, 1998 [63 FR address prior to the close of the Francis S. Collins, comment period: 63483], April 13, 2004 [69 FR 19644], Director, National Institutes of Health. For delivery in Rockville, MD: and on November 25, 2008 [73 FR [FR Doc. 2015–15034 Filed 6–17–15; 8:45 am] Substance Abuse and Mental Health 71858]. On May 15, 2015, HHS BILLING CODE 4140–01–P Services Administration, Attention: published a notice of proposed revisions VerDate Sep<11>2014 16:53 Jun 17, 2015 Jkt 235001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1

34922 Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices to the mandatory guidelines which accident, other (fitness for duty, return reveal adulteration and/or substitution? would provide federal executive branch to duty, etc.))? What are the acceptability criteria for agencies with the option of collecting these biomarkers or tests? Collection and testing an oral fluid specimen in • Is the ‘‘invalid’’ result category addition to urine specimen. The • What training should a collector reasonable for hair testing? If so, what comment period concludes on July 14, receive prior to collecting the hair criteria are acceptable to classify a 2015. specimen? specimen result as invalid? Section 503 of Public Law 100–71, 5 • What is the best protocol to collect the hair specimen? Testing U.S.C. Section 7301 note, required the • Should the hair collection protocol • What technologies are available to Department to establish scientific and be standardized, including specific perform initial and confirmatory testing technical guidelines and amendments in instructions on how close to cut the hair on hair specimens? accordance with Executive Order 12564 and to publish Mandatory Guidelines specimen to the skin, how to determine • What is the best sample for valid the authenticity of the hair specimen, quality control/proficiency testing which establish comprehensive what cutting instruments to use, how to material? How should this quality standards for all aspects of laboratory ensure the cutting instruments are control/proficiency testing material be drug testing and procedures, including decontaminated, and whether the use of prepared? What is the best method to standards that require the use of the best collection kits should be required? prepare a contaminated hair sample available technology for ensuring the • What is the minimum amount of full reliability and accuracy of drug tests versus a sample that represents drug hair that should be collected? use? and strict procedures governing the chain of custody of specimens collected Specimen Preparation Janine Cook, for drug testing. These revisions to the • What are acceptable protocols for Chemist, Division of Workplace Programs, Mandatory Guidelines promote and hair specimen preparation, such as Center for Substance Abuse and Prevention, establish standards that use the best cutting/powdering, initial washing, SAMHSA. available technology for ensuring the decontamination, and pre-extraction [FR Doc. 2015–14964 Filed 6–17–15; 8:45 am] full reliability and accuracy of drug (i.e., digestion, micro pulverization, BILLING CODE 4162–20–P tests, while reflecting the ongoing etc.)? process of review and evaluation of • Should the washing and legal, scientific, and societal concerns. decontamination procedures be analyte DEPARTMENT OF HOMELAND SAMHSA’s chartered CSAP Drug specific? SECURITY Testing Advisory Board (DTAB) is the • What criteria should be used to vehicle to provide recommendations to determine the acceptability of a specific Coast Guard the SAMHSA Administrator for wash and decontamination procedure? Are there published research studies, [Docket No. USCG–2010–1066] proposed changes to the Mandatory Guidelines for Federal Workplace Drug with experimental data included, that Recreational Boating Safety Projects, Testing Programs. The DTAB process demonstrate that a particular wash Programs, and Activities Funded involves evaluating the scientific procedure is effective at removing Under Provisions of the Transportation supportability of any considered external contaminants while not Equity Act for the 21st Century; Fiscal change. To assist the DTAB, we are significantly affecting the amount of Year 2014 soliciting written comments and incorporated drug related to drug use? statements from the general public and • If washing steps are used for ACTION: Notice. industry stakeholders regarding a decontamination, should adjustments be variety of issues related to hair made for drug concentrations detected SUMMARY: In 1999, the Transportation specimen drug testing, including the in the wash fluids? What calculations Equity Act for the 21st Century made $5 hair specimen, its collection, specimen are recommended for these million per year available for the preparation, analytes/cutoffs, specimen adjustments? payment of Coast Guard expenses for validity, and initial and confirmatory personnel and activities directly related Analytes/Cutoffs testing. to coordinating and carrying out the II. Solicitation of Comments: We are • What analytes should be measured national recreational boating safety seeking additional information to in hair by the initial and confirmatory program. In 2005, the law was amended, inform potential use of hair specimens tests? and the amount was increased to $5.5 • What initial and confirmation million. The Coast Guard is publishing for drug testing, specifically on the cutoffs should be used for the various this notice to satisfy a requirement of following questions: hair drug testing analytes? the Act that a detailed accounting of the Hair Specimen • For each analyte/drug, what criteria projects, programs, and activities (cutoff) should be used to distinguish • What are the acceptable body funded under the national recreational external contamination from drug use? boating safety program provision of the locations from which to collect hair for • What unique metabolites or other workplace drug testing? What should be Act be published annually in the biomarkers exist to confirm use and to Federal Register. This notice specifies done if head hair is not available for distinguish drug use from external collection? the funding amounts the Coast Guard contamination for which the drugs are has committed, obligated, or expended • What hair treatments (i.e., shampoo, currently tested? during fiscal year 2014, as of September tkelley on DSK3SPTVN1PROD with NOTICES conditioning, perm, relaxers, coloring, bleaching, straightening, hair transplant) Specimen Validity 30, 2014. influence drug concentration in hair and • Are biomarkers or tests needed to FOR FURTHER INFORMATION CONTACT: For to what degree? verify that the specimen is authentic questions on this notice, call Jeff • What are the acceptable reasons for human hair? Ludwig, Regulations Development hair testing (i.e., pre-employment, • Are there appropriate biomarkers or Manager, telephone 202–372–1061. random, reasonable suspicion, post- tests for the hair specimen that would SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:53 Jun 17, 2015 Jkt 235001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 E:\FR\FM\18JNN1.SGM 18JNN1


Document Created: 2018-02-22 11:12:11
Document Modified: 2018-02-22 11:12:11
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionRequest for information.
DatesComment Close Date: To be assured consideration, comments must
ContactSean 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]
FR Citation80 FR 34921 
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