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Changes to the Mandatory Guidelines for US Federal Workplace Drug Testing Programs Using Urine.

The US Department of Health and Human Services (HHS) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (HHS Guidelines), effective October 1, 2017 [1]. This article summarizes the major changes to the previous HHS Guidelines, which were effective October 1, 2010.

Background

The US Government prohibits illicit drug use by federal employees, whether on- or off-duty. Federal law requires each executive federal agency to have a Drug-Free Workplace Plan stating the agency's objectives, policies, procedures, and implementation guidelines to prevent illicit drug use by their employees and to provide support to employees with substance abuse problems. Drug testing is an essential component of each agency's comprehensive program to ensure a drug-free federal workplace. HHS is responsible for establishing the scientific and technical guidelines for federal drug testing programs as well as the National Laboratory Certification Program (NLCP), the accreditation program for forensic toxicology laboratories to become certified to test federal agency workplace specimens. Within HHS, these responsibilities are assigned to the Division of Workplace Programs in the Substance Abuse and Mental Health Services Administration (SAMHSA).

Federal agencies must conduct random drug tests of employees in safety-sensitive positions. The frequency of and criteria for such testing depend on the agency's mission and goals, as well as the potential threat to public health, safety, or national security should the employee fail to discharge their duties. Agencies must also have a program for voluntary employee drug testing, and must test employees for illegal drug use when there is a reasonable suspicion that an employee is using drugs, after an accident, or following counseling or rehabilitation for illegal drug use. In addition, agencies are authorized to conduct pre-employment drug tests of applicants for any agency position.

General Requirements

The HHS Guidelines address all areas of a drug testing program, from collection through laboratory testing to medical review officer (MRO) review and verification of results. First published in 1988, the HHS Guidelines have become the gold standard for workplace drug testing programs. All federal agencies are required to follow the HHS Guidelines. In addition, the Department of Transportation (DOT) is required by law to follow the HHS scientific and technical guidelines in its drug testing regulations for transportation industries, and DOT-regulated testing must be conducted only by HHS-certified laboratories [2]. The Nuclear Regulatory Commission, many states, and private employers have chosen to use some or all aspects of the HHS Guidelines in their workplace drug testing programs.

Specimens submitted for testing under the HHS Guidelines must undergo initial drug testing, and those specimens with positive initial test results must undergo a confirmatory test to identify and quantify specific drug analyte(s). The HHS Guidelines specify the drugs that a federal agency may test routinely (i.e., in all specimens), and specify the initial and confirmatory drug test analytes and cutoff concentrations. A federal agency may test all workplace specimens for the specified drugs or, at a minimum, must test specimens for marijuana and cocaine. An agency is also authorized to test postaccident and reasonable suspicion specimens for any drug classified as Schedule I or II under the Controlled Substances Act [3]. In addition, an agency may request a waiver from HHS to test all specimens for any Schedule I or II drug.

In addition to testing for drugs, the HHS Guidelines specify the specimen validity tests that must be performed for each specimen, to identify specimens that are not valid for testing and those that may have been adulterated or substituted by the donor. The required specimen validity tests include determining creatinine concentration, determining the specific gravity of each specimen with creatinine less than 20 mg/dL, determining pH, and performing tests for one or more oxidizing adulterant (e.g., nitrite, chromium, a halogen).

At this time, urine remains the only authorized specimen type for federal workplace drug testing programs. On May 15, 2015, HHS published two Federal Register Notices with proposed HHS Guidelines: the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG) and the Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG) [4,5]. This article addresses the final UrMG, published in the Federal Register January 23, 2017, with an effective date of October 1, 2017. HHS has not yet published the final OFMG authorizing the use of oral fluid in federal workplace drug testing programs.

Summary of Major Changes

Alternate Technology Initial Drug Tests. Since the original HHS Guidelines were issued in 1988, HHS had required immunoassay as the sole initial drug test method. The UrMG allows the use of other technologies (e.g., spectrometry, spectroscopy) for initial drug tests. HHS also added cross-reactivity criteria for an immunoassay for "grouped analytes" such as opioids or amphetamines.

The UrMG (Section 3.4) defines grouped analytes as "two or more analytes that are in the same drug class and have the same initial test cutoff." The laboratory must calibrate the immunoassay with the analyte identified by the kit manufacturer as the target analyte. The cross-reactivity to all other "nontarget" analytes in the group must be 80% or greater. If an analyte does not exhibit at least 80% crossreactivity, the laboratory must use a different immunoassay or multiple immunoassay kits. The intent was to enable consistent treatment of specimens tested using immunoassay and those tested using an alternate technology.

Drug Test Analytes. The UrMG includes a table specifying the initial and confirmatory drug test analytes and cutoff concentrations for the authorized drugs (see Table 1).

In the UrMG, HHS has added four semisynthetic opioids (i.e., oxycodone, oxymorphone, hydrocodone, and hydromorphone) to the drugs that may be routinely tested by federal agencies. The addition of these four prescription opioids to the testing panel is consistent with the federal government's actions to combat the current opioid epidemic in the US. Information assembled by HHS shows that, in 2015, 12.5 million people misused prescription opioids, 2 million people had prescription opioid use disorder, and 15,281 deaths were attributed to overdosing on commonly prescribed opioids [6]. The economic cost of the opioid epidemic was estimated as $78.5 billion, based on 2013 data. HHS strongly recommended that all federal agencies implement testing for these opioids on October 1, 2017.

In the 2010 HHS Guidelines, HHS added methylenedioxymethamphetamine (MDMA) as an initial test analyte, with MDMA, methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA) as confirmatory test analytes. In the UrMG, HHS included MDA as both an initial test and a confirmatory test analyte. Due to the low incidence of MDEA positives in federal workplace drug testing programs, HHS removed MDEA from the list of drugs authorized for routine testing. Because MDEA is a Schedule I drug, a federal agency may still test postaccident or reasonable suspicion specimens for MDEA on a case-by-case basis, or may request a waiver from HHS to test all specimens for this drug.

pH Cutoffs--Invalid and Adulterated. HHS requires agencies to test the pH of each urine specimen, to identify those specimens that are invalid for testing or are adulterated. The criteria address specimens with abnormally low or high pH. HHS raised the lower pH cutoff for adulteration from 3.0 to 4.0. As stated in the preamble to the proposed and final UrMG, the reason for this change was that "the physiologically minimum achievable urine pH that can be produced by the kidneys is about pH 4.5." HHS also noted that the Department was unaware of any medical conditions or medications that would cause urine pH to be less than 4.5. The adulteration-cutoff change necessitated raising the lower pH range for an invalid specimen from "equal to or greater than 3 and less than 4.5" to "equal to or greater than 4 and less than 4.5."

Medical Review Officer Requalification. MRO review of laboratory-reported results is an essential element of federal workplace drug testing programs. Only licensed physicians who meet HHS requirements, including specific training and a passing score on an HHS-approved examination, are allowed to serve as MROs for federal agencies. In the UrMG, HHS added requirements for MROs to complete requalification training and pass a requalification examination at least every five years after initial certification. In addition, certified MROs must complete training by an HHS-approved certification entity on any revisions to the HHS Guidelines prior to their effective date, to continue serving as an MRO for federal agency specimens.

Authorized Specimen Types. Some revisions to the previous HHS Guidelines will allow for the use of specimen types other than urine in the future. For example, some UrMG sections refer to collections of an alternative specimen type "as authorized by the federal agency" or to "another authorized specimen type (e.g., oral fluid)." All UrMG references to other specimen types will become effective only when HHS issues final HHS Guidelines for another specimen type. As noted above, urine remains the only specimen authorized for use in federal agency workplace programs at this time.

Additional Information. SAMHSA provides additional information on Drug-Free Workplace Programs and the HHS Guidelines on its website, https://www.samhsa.gov/workplace. Resources include the HHS Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs and the HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs, both of which have been updated to reflect the HHS Guidelines changes effective October 1, 2017. The SAMHSA website also includes a link to a proof of the 2017 Federal Custody and Control Form (CCF) and to the guidance for using the form. Information on the NLCP is also available on the SAMHSA website or from the NLCP contractor, RTI International, by E-mail (nlcp@rti.org) or phone (919 541-7242).

References

1. US Department of Health and Human Services: Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine; Fed Reg 82:7920; 2017.

2. US Department of Transportation: Procedures for Transportation Workplace Drug and Alcohol Testing Programs; 49 CFR Part 40, Final Rule; Fed Reg 82:52229; 2017.

3. US Department of Justice: Schedules of Controlled Substances; 21 CFR [section]1308; 2017.

4. US Department of Health and Human Services: Proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine; Fed Reg 80:28101; 2015.

5. US Department of Health and Human Services: Proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid; Fed Reg 80:28054; 2015.

6. US Department of Health and Human Services: The Opioid Epidemic in the U.S.; 2017; https://www.hhs.gov/sites/default/files/2017-opioids-infographics.pdf (Accessed December 1, 2017).

Susan Crumpton, John Mitchell

Center for Forensic Sciences RTI International Research Triangle Park, North Carolina United States of America

+1 919 541 7242; nlcp@rti.org
Table 1. Text analytes and cutoff concentrations (from Section 3.4 of
the Mandatory Guidelines for Federal Workplace Drug Testing Programs
Using Urine [1]

Initial test analyte                  Initial test
                                      cutoff concentration (1)

Marijuana metabolites (THCA) (2)         50 ng/mL (3)
Cocaine metabolite (Benzoylecgonine)    150 ng/mL (3)
Codeine/Morphine                      2,000 ng/mL

Hydrocodone/Hydromorphone               300 ng/mL

Oxycodone/Oxymorphone                   100 ng/mL

6-Acetylmorphine                         10 ng/mL
Phencyclidine                            25 ng/mL
Amphetamine/Methamphetamine             500 ng/mL

MDMA (4)/MDA (5)                        500 ng/mL


Initial test analyte                  Confirmatory test
                                      analyte

Marijuana metabolites (THCA) (2)      THCA
Cocaine metabolite (Benzoylecgonine)  Benzoylecgonine
Codeine/Morphine                      Codeine
                                      Morphine
Hydrocodone/Hydromorphone             Hydrocodone
                                      Hydromorphone
Oxycodone/Oxymorphone                 Oxycodone
                                      Oxymorphone
6-Acetylmorphine                      6-Acetylmorphine
Phencyclidine                         Phencyclidine
Amphetamine/Methamphetamine           Amphetamine
                                      Methamphetamine
MDMA (4)/MDA (5)                      MDMA
                                      MDA

Initial test analyte                  Confirmatory test
                                      cutoff concentration

Marijuana metabolites (THCA) (2)         15 ng/mL
Cocaine metabolite (Benzoylecgonine)    100 ng/mL
Codeine/Morphine                      2,000 ng/mL
                                      2,000 ng/mL
Hydrocodone/Hydromorphone               100 ng/mL
                                        100 ng/mL
Oxycodone/Oxymorphone                   100 ng/mL
                                        100 ng/mL
6-Acetylmorphine                         10 ng/mL
Phencyclidine                            25 ng/mL
Amphetamine/Methamphetamine             250 ng/mL
                                        250 ng/mL
MDMA (4)/MDA (5)                        250 ng/mL
                                        250 ng/mL

(1) For grouped analytes (i.e., two or more analytes that are in the
same drug class and have the same initial test cutoff):
Immunoassay: The test must be calibrated with one analyte from the
group identified as the target analyte. The crossreactivity 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.
(2) An immunoassay must be calibrated with the target analyte,
[DELTA]-9-tetrahydrocannabinol-9-carboxylic acid (THCA).
(3) Alternate technology (THCA and benzoylecgonine): The confirmatory
test cutoff must be used for an alternate technology initial test that
is specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL
for benzoylecgonine).
(4) Methylenedioxymethamphetamine (MDMA).
(5) Methylenedioxyamphetamine (MDA).
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Title Annotation:FORENSIC SCIENCE AROUND THE WORLD
Author:Crumpton, Susan; Mitchell, John
Publication:Forensic Science Review
Geographic Code:1USA
Date:Jan 1, 2018
Words:2173
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