Mandatory Guidelines for Federal Workplace Drug Testing Programs

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:

Revised Mandatory Guidelines by the Secretary of Health and Human Services.

SUMMARY:

The Department of Health and Human Services (“HHS” or “Department”) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines), 73 FR 71858 (November 25, 2008) for urine testing.

DATES:

Effective Date:

October 1, 2017.

FOR FURTHER INFORMATION CONTACT:

Charles LoDico, M.S., F-ABFT, Division of Workplace Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA mail to: 5600 Fishers Lane, Room 16N03A, Rockville, MD 20857, telephone (240) 276-2600 or email at

charles.lodico@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION:

In particular, these revised Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) allow federal executive branch agencies to test for additional Schedule II drugs of the Controlled Substances Act (

i.e.,

oxycodone, oxymorphone, hydrocodone and hydromorphone) in federal drug-free workplace programs, remove methylenedioxyethylamphetamine (MDEA) from the authorized drugs in Section 3.4, add methylenedioxyamphetamine (MDA) as an initial test analyte, raise the lower pH cutoff from 3 to 4 for identifying specimens as adulterated, require MRO requalification training and re-examination at least every five years after initial MRO certification, and allow federal agencies to authorize collection of an alternate specimen (

e.g.,

oral fluid) when a donor in their program is unable to provide a sufficient amount of urine specimen at the collection site. Many of the wording changes and reorganization of the UrMG were made for clarity, to use current scientific terminology or preferred grammar, and for consistency with the OFMG.

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

The proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) published in the

Federal Register

on May 15, 2015 (80 FR 28101) include revisions to the initial and confirmatory drug test analytes and methods for urine testing, the cutoff for reporting a urine specimen as adulterated based on low pH, and the requalification requirements for individuals serving as Medical Review Officers (MROs) and, where appropriate, include references to the use of an alternate specimen in federal workplace drug testing programs. References to an alternate specimen are not applicable until final Guidelines are implemented for the use of the alternative specimen matrix. The Department published a separate Notice in the May 15, 2015

Federal Register

(80 FR 28054) proposing Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) to allow federal agencies to collect and test oral fluid specimens in their workplace drug testing programs. There was a 60-day public comment period for both

Federal Register

Notices, during which 125 commenters submitted comments on the proposed changes to the Guidelines. These commenters were comprised of individuals, organizations, and private sector companies. The comments are available for public view at

http://www.regulations.gov/.

All comments were reviewed and taken into consideration in the preparation of the revised Guidelines. The issues and concerns raised in the public comments for the UrMG are set out below. Similar comments are considered together in the discussion.

Summary of Public Comments and HHS's Response

The following comments were directed to the information and questions in the preamble.

Costs and Benefits

The Department requested comments on costs and benefits. One commenter disagreed that the cost increase for laboratories to add analytes to regulated testing will be minimal, stating that significant costs would be incurred for information technology (IT) development, as well as incremental costs for additional immunoassays (if required); for additional calibrators, controls, and internal standards; and for increased confirmatory testing costs (including data review and result certification) based on an expected increased positivity rate for opioids. One commenter disagreed with the Department's estimated 3% cost increase for Medical Review Officers (MROs) and estimated that the increase will be 10%. The commenters did not provide any substantive evidence or data to support these comments. The Department recognizes that there will be start-up costs to laboratories to implement testing for the additional analytes for regulated specimens including administrative costs, and agrees that the estimated increased costs for some MROs may exceed the 3% estimate. The Department's cost analysis was based on information provided by multiple HHS-certified laboratories and MROs, as well as the estimated number of additional positives resulting from the inclusion of the new opioid analytes. Costs are expected to vary among individual laboratories and MROs, depending on their processes and testing populations. Additional information on the estimated costs associated with these Guidelines is included under

Regulatory Impact and Notices

below.

Proposed New Analytes: Oxycodone, Oxymorphone, Hydrocodone, and Hydromorphone

Seven commenters specifically agreed with the addition of these drugs to the Guidelines. Two commenters expressed concerns over the added drugs, indicating that individuals who follow their physician's treatment plan of taking legally prescribed medication would produce positive tests, leading to greater reliance on MROs to determine whether tests are truly positive (as a result of illegal use) or are positive due to prescribed usage of the drugs, and a greater number of workers will be subject to scrutiny and their medical

records examined at length. One of the commenters maintained that such testing would exceed the legal mandate under Executive Order No. 12564 and the promulgation of scientific Guidelines by HHS pursuant to it. The Guidelines include requirements to protect individuals' privacy while maintaining public safety, including procedures for MRO review to verify legitimate drug use and maintain the confidentiality of donor drug testing records. The Department provides additional guidance in the Medical Review Officer Manual for Federal Workplace Drug Testing Programs. The inclusion of these additional drugs in the Guidelines is within the scope of the Department's regulatory authority to test for illegal drug use under Section 503(a)(1)(A)(ii)(II) of Public Law 100-71 and Executive Order No. 12564.

New Analytes—Cutoff Concentrations

Eight commenters addressed the proposed cutoffs for the added drugs: Three commenters agreed with the proposed cutoffs; four disagreed with the cutoffs for one or more of the added drugs. Of these, three commenters stated that the cutoffs are too low: Two of these commenters believe that these cutoffs will unnecessarily identify workers using prescription drugs and one commenter noted that these cutoffs will affect accurate quantitation in routine specimens. The Department recognizes that the added analytes will result in an increased number of positive opioid results requiring MRO review, and has incorporated requirements for MRO requalification and retraining at least every five years. Additional guidance and information on the added drugs will be provided in the Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs. The Department disagrees that the cutoffs will affect accurate quantitation in routine specimens. Information from HHS-certified laboratories indicates that testing at these cutoffs can be accomplished with current instrumentation. However, the Department has raised the confirmatory test cutoffs for oxycodone and oxymorphone from 50 ng/mL to 100 ng/mL. These higher cutoffs are supported by a single dose study which showed similar detection rates for oxycodone and oxymorphone using either a 50 ng/mL or 100 ng/mL cutoff.

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Use of the 100 ng/mL confirmatory test cutoffs is expected to be less analytically challenging for laboratories.

One commenter suggested changing the oxycodone and oxymorphone initial test cutoff to 300 ng/mL and changing the hydrocodone and hydromorphone initial test cutoff to 100 ng/mL, to equate the detection times for these drugs. One commenter requested that the Department provide the justification and data used to determine the cutoff levels for the added opioids. The Department raised the oxycodone and oxymorphone confirmatory test cutoffs to 100 ng/mL as described above. The Department has evaluated the comments and has concluded that no further change is needed. The selection of cutoff concentration is not based solely on the factor of detection times and must take into consideration a variety of factors, both pharmacological and chemical. Drug potency, disposition in urine, impact and prevalence must be considered. For example, oxycodone is approximately twice as potent as hydrocodone and may be prescribed in lower doses, thus a cutoff lower than that for hydrocodone is warranted. Therefore, in selecting the cutoffs, the Department considered the detection times of equipotent doses as well as dispositional patterns of each drug in urine. Data on the disposition of hydrocodone and oxycodone in urine following administration of a single dose can be found in two recently published scientific articles.

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Medical Review Officer (MRO) Requalification—Continuing Education Units (CEUs)

The Department requested comments on requiring MRO requalification continuing education units (CEUs) and on the optimum number of credits and the appropriate CEU accreditation bodies should CEUs be required as part of MRO requalification. Three commenters agreed with requiring MRO recertification, but disagreed with the addition of CEU requirements to the Guidelines. Two commenters disagreed with specifying the number of CEUs required. Two commenters indicated that certification entities already enforce training requirements and recommended that acceptance of CEUs be handled by MRO certification boards, not the Department. Two commenters recommended a requirement of annual CEUs: One suggested 16 CEUs and the other recommended three CEUs. One commenter recommended 12 CEUs prior to initial certification, eight CEUs every five years, and also recommended two CEUs related to the new requirements/topics within two years of implementation of the revised Guidelines. The Department has evaluated the comments and has concluded that requirements for continuing education units will remain with the MRO certification entities and will not be included in the Guidelines. The Department has removed references to MRO training entities in Sections 13.2 and 13.3, because training documentation is maintained by MRO certification entities. The Department agrees with the comment that MROs should receive training on revisions to the Guidelines, and has added item Section 13.3(b) to require such training prior to the effective date of revised Guidelines.

Discussion of Sections

The Department has not included a discussion in the preamble of any sections for which public comments were not submitted or where minor typographical or grammatical changes were made.

Subpart A—Applicability

1.5 What do the terms used in these Guidelines mean?

One commenter disagreed with the definition for “dilute specimen” because it does not include numerical values for creatinine and specific gravity. The Department has concluded that no change is needed; the analytical (numerical) criteria for a dilute specimen are provided in Section 3.8.

One commenter requested that “external service provider” be defined, because this is a new term included in the proposed Guidelines. The Department agrees and has added the definition.

The Department has added the definition for “gender identity” to Section 1.5. This term is now used in Guidelines sections addressing observed and monitored collections as described in this preamble under Sections 4.4, 8.1, 8.10, and 8.12. Gender identity means an individual's internal sense of being male or female, which may be different from an individual's sex assigned at birth.

Two commenters disagreed with the proposed definition for “invalid result” which indicated that an invalid result was reported only when an HHS-certified laboratory could not complete testing or obtain a valid drug test result. The Department agrees with the commenters and has reinstituted the definition from the Guidelines effective October 1, 2010 (73 FR 71858).

To address comments described in this preamble under Section 13.1, the Department deleted the definition for “non-medical use of a drug.”

Two commenters found the definition of “specimen” confusing, because the term “sample” used in the definition was also defined as a representative portion of a donor's specimen. The

Department agrees, and has reinstituted some wording for the definition of “specimen” from the Guidelines effective October 1, 2010 (73 FR 71858) for clarity.

1.6 What is an agency required to do to protect employee records?

One commenter suggested that the non-applicability of the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) should be clearly stated in the Guidelines. The Department has evaluated the comment and has concluded that the applicability of HIPAA and other relevant privacy laws is clearly stated in Section 1.6. Accordingly, except for minor rewording for clarity, no further revisions are necessary.

1.7 What is a refusal to take a federally regulated drug test?

One commenter noted that, per Sections 8.4(c) and 8.9(b), when a collector finds an adulterant or substitution product or observes an attempt to substitute a urine specimen, this prompts a direct observed collection, not a refusal to test. The commenter suggested bringing an adulterant or a substitution product to the collection should be a refusal to test. The Department has evaluated the comment, and agrees that the collector must report a refusal to test when a donor brings materials for adulterating, substituting, or diluting the specimen to the collection site, or when the collector observes a donor's clear attempt to tamper with a specimen. The Department has revised Sections 1.7, 8.3(h), 8.4(c), and 8.9(b) accordingly.

One commenter noted that the collector does not report a refusal to test when a donor leaves the collection site before the collection process begins for a pre-employment test. The commenter recommended defining the beginning of the pre-employment test collection process as the point at which the donor is asked to present photo identification. The Department agrees with the suggestion to define the beginning of the collection process specifically for this situation. However, the Department has designated the beginning as the step described in Section 8.4(a), when the collector provides or the donor selects a specimen collection container. The Department has revised Sections 1.7(a)(2) and (3) to include a reference to this section. All subsequent items in Section 1.7(a) (

i.e.,

items 4-13) apply once the donor has arrived for the pre-employment test collection.

1.8 What are the potential consequences for refusing to take a federally regulated drug test?

The Department reworded Section 1.8(b) to clarify that the requirements in this section apply to donors who fail to appear at the collection site in a reasonable time for any test (except a pre-employment test), as described in Section 1.7(a)(1).

Subpart B—Urine Specimens

2.1 What type of specimen may be collected?

Two commenters requested clarification on the collection/testing scenario where the federal agency authorizes collection of an oral fluid specimen, but the contracted laboratory does not perform oral fluid testing. The Department has evaluated the comments and has concluded that no change is needed. This will be addressed in the federal agency plan.

2.2 Under what circumstances may a urine specimen be collected?

One commenter suggested that the cost of mandatory random drug and alcohol testing among airline pilots outweighs the benefit. The Department has evaluated the comment and has concluded that no change is needed. Airline pilots are subject to drug and alcohol testing under DOT regulations. Therefore, this public comment is not relevant to the Guidelines. In regard to drug testing of federal agency employees and applicants, each federal agency establishes its agency plan based on its mission, its employees' duties, and the potential consequences to the public health and safety or national security that could result from the failure of an employee to adequately perform their duties and responsibilities.

Subpart C—Urine Specimen Tests

3.1 Which tests are conducted on a urine specimen?

One commenter suggested changing the term “opiates” to “opioids” in the Guidelines. The Department agrees with the commenter and has changed the term “opiates” to “opioids” where appropriate to refer to oxycodone, oxymorphone, hydrocodone, and hydromorphone in addition to codeine, morphine, and 6-acetylmorphine (6-AM).

3.2 May a specimen be tested for additional drugs?

The Department reworded Section 3.2(a) to clarify the additional drug tests that may be performed on federal employee specimens.

3.3 May any of the specimens be used for other purposes?

Section 3.3 states that specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines may not be used for purposes other than drug and validity testing in accordance with Subpart C of the Guidelines. One commenter disagreed with prohibiting employees from using their drug test specimens for other purposes (

e.g.,

deoxyribonucleic acid, DNA, testing). The Department has evaluated this comment and has concluded that no change is needed. While the Guidelines do not authorize the release of urine 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. For example, see Sections 8.5(b), 8.8, and 15.1(a).

In addition, under Public Law 100-71, Section 503(a)(1)(A)(ii)(I), HHS is mandated to establish “strict procedures governing the chain of custody of specimens collected for drug testing . . . .” Sections 11.7(a) and 11.20(a) also provide that an “HHS-certified laboratory must control access to the drug testing facility, specimens, aliquots, and records,” and must retain specimens that, among other things, have been reported “drug positive” for a minimum of one year. Therefore, the release of specimens to employees, or to an employee's designee, is inconsistent with the mandates of the federal drug testing process, and could significantly compromise a specimen's integrity, security, and an HHS-certified laboratory's ability to fulfill its regulatory duties under the Guidelines.

One commenter requested further clarification of the phrase “unless authorized in accordance with [applicable] federal law” in Section 3.3. The phrase “unless otherwise authorized in accordance with applicable law in Section 3.3(a) does not represent a significant change from the intent of the prior Guidelines language. Section 3.3, among others, is intended to prohibit the use of specimens for purposes other than those specifically authorized by the Guidelines. However, there may be circumstances in which federal law authorizes an HHS-certified laboratory to handle a specimen in a manner that differs from the Guidelines. Therefore, the phrase “unless authorized in accordance with applicable federal law” in Section 3.3 of the Guidelines is intended to avoid conflict with other applicable federal law.

It should be noted that Section 3.3 specifically prohibits conducting deoxyribonucleic acid (DNA) testing on urine specimens, unless authorized in accordance with applicable federal law.

3.4 What are the drug test cutoff concentrations for urine?

The Department proposed methylenedioxyamphetamine (MDA) and methylenedioxyethylamphetamine (MDEA) as initial test analytes. Three commenters disagreed with the addition of MDA and MDEA as target analytes, stating this change would require modification of current immunoassay reagents, laboratory processes, or both. The commenters noted that this imposes an unnecessary burden for compounds with such low incidence in workplace testing. The Department has evaluated the comments and has removed MDEA from the Guidelines (

i.e.,

MDEA is no longer included as an authorized drug in Section 3.4). The number of positive MDEA specimens reported by HHS-certified laboratories (

i.e.,

information provided to the Department through the NLCP) does not support testing all specimens for MDEA in federal workplace drug testing programs. Because MDEA is a Schedule I drug, a federal agency may test specimens for MDEA in accordance with Section 3.2 (

i.e.,

on a case-by-case basis for reasonable suspicion or post accident testing, routinely with a waiver from the Secretary). The Department understands that MDA and some other analytes also have a low incidence, but believes that continued testing for these analytes is warranted in a deterrent program. In particular, inclusion of MDA as an initial and confirmatory test analyte is warranted because, in addition to being a drug of abuse, it is a metabolite of MDEA and MDMA.

An HHS-certified laboratory or Instrumented Initial Test Facility (IITF) may group analytes for initial testing. For clarity, the Department has defined the term “grouped analytes” where used in footnote 1 of the table in Section 3.4: “(

i.e.,

two or more analytes that are in the same drug class and have the same initial test cutoff).”

The Department proposed criteria for immunoassays for grouped analytes such as opioids and amphetamines, specifying the minimum cross-reactivity to the other analyte(s) within the group. Two commenters disagreed with the added cross-reactivity requirements, noting this section should not attempt to provide equivalence between immunoassay and other initial testing technologies. One of these commenters suggested the Department develop separate requirements for initial test methods using an alternate technology or, alternatively, require the combined cross-reactivity of low-reacting compounds (

e.g.,

hydrocodone and hydromorphone for an opiate assay; MDA and MDEA for an amphetamines assay) to be equal to or greater than the cutoff. The other commenter recommended not allowing methods other than immunoassay for urine initial testing. One commenter stated that cross-reactivity specifications for hydromorphone are not necessary, based on their non-regulated testing results (

i.e.,

confirmatory test concentrations detected after using an immunoassay with 60% cross-reactivity for hydromorphone). The Department has evaluated the comments and has concluded that no change is needed for immunoassay cross-reactivity requirements. The requirements in Section 3.4 are necessary to ensure consistency in testing among laboratories using different immunoassay kits, as well as those using different test methods for initial drug testing. Cross-reactivity must be demonstrated and documented by the manufacturer (

e.g.,

package insert) and by the HHS-certified laboratory or IITF (

i.e.,

assay validation studies, reagent lot verification, and batch quality control for any analyte that exhibits less than 100% cross-reactivity). The Department will continue to allow the use of methods other than immunoassay for initial testing.

However, the Department has revised Section 3.4 regarding the use of alternate technology initial tests for THCA and benzoylecgonine. Depending on the technology, the confirmatory test cutoff (

i.e.,

15 ng/mL for THCA, 100 ng/mL for benzoylecgonine) must be used as the cutoff for an initial test using an alternate technology to ensure consistent treatment of specimens. For these analytes, the immunoassay test is not specific for the target analyte for the confirmatory test. For example, immunoassays for cannabinoids react with multiple compounds that are excreted as a result of marijuana use. Therefore, it is necessary to use an immunoassay cutoff higher than that of the confirmatory test in order to detect the target analyte (THCA) at or above the confirmatory test cutoff. An initial test using an alternate technology with specificity comparable to the confirmatory test requires use of the confirmatory test cutoff.

Also in Section 3.4, the Department did not specify the target analyte to be used to calibrate an initial test for grouped analytes such as amphetamines or opioids. Three commenters noted that when an immunoassay is calibrated with a low-reacting drug, other analytes may exhibit high cross-reactivity, leading to false initial test positives. Two of these commenters also noted that this may result in possibly different cross-reactivity profiles for some structurally unrelated and concomitantly used prescription and/or over the counter drugs. One commenter noted that the option to “include a control containing the lowest reacting analyte at its cutoff concentration in each batch” was described in the preamble to the proposed Guidelines, but was not specified in Section 3.4 of the Guidelines. It was not the Department's intent for the laboratory or IITF to calibrate an immunoassay test using an analyte other than that specified by the manufacturer. In the preamble to the proposed UrMG, the Department described using a control containing the lowest reacting analyte at its cutoff concentration to establish the decision point (

i.e.,

when an immunoassay for grouped analytes did not demonstrate at least 80% cross-reactivity to each analyte). The Department has determined that this approach is not necessary, and will not be permitted. There are current immunoassays that meet the requirements of this section for two or more analytes in a group (

i.e.,

analytes in the same drug class that have the same initial test cutoff). As indicated in Section 3.4, the laboratory or IITF may use multiple test kits or a single kit to meet the requirements.

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)?

One commenter recommended that HHS maintain a list of allowable additional tests and reporting criteria (

e.g.,

threshold for reporting as positive, adulterated, substituted, and/or invalid, and a limit of detection as appropriate), to ensure consistency among laboratories and within the testing program. The Department has evaluated the comment and has concluded that no change is needed. The Department does not want to limit the analytes that may be tested, and will provide guidance to laboratories as needed. It is also noted that the section requires all tests to meet appropriate validation and quality control requirements. The procedures and specimen records for such tests will be reviewed at NLCP inspections. The Department will continue to maintain a list of HHS-certified laboratories that choose to perform additional tests for regulated specimens.

One commenter asked whether an MRO could submit a blanket request to perform additional testing (

e.g.,

additional opioid metabolites) for all confirmatory specimens (

i.e.,

would laboratories be permitted to monitor the additional compounds in all confirmatory test assays?). The Department believes that testing all specimens for additional analytes may not be appropriate for some tests, especially hydrocodone, hydromorphone, oxycodone and oxymorphone. Recent studies show that testing for norhydrocodone and or noroxycodone is not necessary for the interpretation of all results.

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Norhydrocodone and noroxycodone metabolites may be helpful for the MRO to interpret test results only when a donor's prescription does not support the test results. For example, a hydrocodone dose may result in urine concentrations of only hydromorphone metabolite above the cutoff. The presence of norhydrocodone metabolite would support the use of hydrocodone and validate the donor's prescription. The same could be said for interpreting test results following an oxycodone dose. The presence of noroxycodone metabolite would support the use of oxycodone when only oxymorphone was reported as positive. The Department will provide guidance on these and other additional tests that may provide useful information for the MRO in the Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs. The Department has revised Section 3.5 to clarify that HHS-certified laboratories are authorized to perform additional tests upon MRO request on a case-by-case basis, but are not authorized to routinely perform such tests without prior authorization from the Secretary or designated HHS representative, with the exception of the determination of D,L stereoisomers of amphetamine and methamphetamine. The Department will continue to allow HHS-certified laboratories to test for D,L amphetamine and methamphetamine routinely or upon MRO request. The Department will provide guidance on these and other additional tests that may provide useful information for the MRO (

e.g.,

tetrahydrocannabivarin) in the Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs.

Additional drug and specimen validity testing under Section 3.5 does not include DNA testing.

3.6 What criteria are used to report a urine specimen as adulterated?

Two commenters agreed and one disagreed with raising the lower pH cutoff from 3.0 to 4.0 for identifying specimens as adulterated. One commenter advised caution in changing specimen validity test cutoffs, and indicated that the proposed change will require updates to computer systems for reporting, calibrators, and controls. One commenter indicated that previous review of data (more than 10 years ago) indicated this change would have more than doubled the number of low pH/adulterated results reported. The commenter that disagreed with changing the pH cutoff believes HHS does not have enough scientific evidence supporting the change. The Department has evaluated the comments and has concluded that no change is needed to the proposed cutoff (

i.e.,

4.0). As stated in the preamble to the proposed Guidelines (80 FR 28101), this decision is based on the fact that the physiologically minimum achievable urine pH that can be produced by the kidneys is about pH 4.5. Furthermore, the Department is not aware of any medical conditions or medications that would cause urine pH to be less than 4.5.

3.8 What criteria are used to report a urine specimen as dilute?

One commenter suggested removing the three-decimal place criteria for reporting a specimen as dilute. One commenter indicated that the criteria for reporting a specimen as dilute in Section 3.8 and 11.19(f) were not consistent, and that Section 3.8 does not address the situation when creatinine is between 5 and 20 mg/dL and the specific gravity is less than 1.0020. This section was intended to clarify that only HHS-certified laboratories (and not HHS-certified IITFs) may report a specimen as dilute when the creatinine concentration is greater than or equal to 2.0 mg/dL and less than or equal to 5 mg/dL, and the laboratory must use a four-decimal place refractometer for the specific gravity test. The Department will retain the three-decimal place criteria in Section 3.8(a) because both HHS-certified IITFs and laboratories may use a three-decimal place refractometer for a specific gravity screening test when the creatinine concentration is greater than 5 mg/dL and less than 20 mg/dL. However, the Department agrees that this section did not address all situations, so has revised the wording in Section 3.8(b) to be consistent with the wording in 11.19(f).

3.9 What criteria are used to report an invalid result for a urine specimen?

One commenter suggested increasing the acceptable pH range upper end from 9.0 to 9.5 due to heat during summer months. One commenter recommended that the Department define requirements to be met before a new validity marker is implemented. One commenter suggested that additional biomarkers used to support a result of invalid should be standardized across all HHS-certified laboratories and one solution to donor subversion might be random assignment of collection of alternative specimens. The Department has evaluated the comments and has concluded that no change is needed. A 2006 study on the stability of regulated drug analytes in urine slightly below and within the high pH invalid range supports the pH 9.0 decision point due to the loss of drug analytes at a pH between 9.0 and 9.5.

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Subpart D—Collectors

4.4 What are the requirements to be an observer for a direct observed collection?

One commenter disagreed with the requirement for an observer to be the same gender as the donor, and suggested that a physician or health care professional (regardless of gender) should be allowed to function as an observer. The commenter indicated that gender determination can be challenging (

i.e.,

transgender employees). The Department has evaluated these comments and agrees that all observed collections must be conducted in a professional manner that minimizes discomfort to the donor. The Department has revised Sections 4.4(b), 8.1(b), and 8.10 to allow the donor to be observed by a person whose gender matches the donor's gender, which is determined by the donor's gender identity (defined in Section 1.5). The donor's gender identity may be the same as or different from the donor's sex assigned at birth. The Department also revised Sections 8.1(b) and 8.12 for monitored collections, to allow the donor to be monitored by a person whose gender matches the donor's gender, unless the monitor is a medical professional (as described in Section 8.12).

The Department disagrees with the commenter's suggestion to allow an individual to serve as an observer based solely on their credentials as a physician or health care professional. Such credentials alone would not guarantee that these individuals could appropriately perform the functions of an observer (

i.e.,

as specified in Section 4.4).

The same commenter expressed concerns over the requirement for an observer to have received training, indicating that this would require

documentation and may make finding short notice observers more difficult. The Department disagrees with this comment. These are the same requirements as in the Guidelines effective October 1, 2010 (73 FR 71858). As stated in the preamble to those Guidelines, the training elements are included to ensure that the observer interacts with the donor in a professional manner, respecting the donor's modesty and privacy, and that the collector maintains the confidentiality and integrity of collection information.

Subpart F—Federal Drug Testing Custody and Control Form (CCF)

6.1 What federal form is used to document custody and control?

Two commenters recommended that the Department provide instructions on recording results for the added drugs on the CCF until the Federal CCF is revised. Three commenters recommended that the CCF be revised to address the addition of the oral fluid specimen matrix. One commenter encouraged SAMHSA to modify the CCF to account for collections where multiple specimens are collected during a single collection event. The Department will publish a

Federal Register

Notice with the revised Federal CCF, including changes for the added analytes, with the same effective date as these Guidelines. Guidance on the use of the revised Federal CCF will be posted on the SAMHSA Web site

http://www.samhsa.gov/workplace.

In regard to when the collector submits multiple urine specimens (

i.e.,

different voids) collected during the same testing event, the Department has concluded that no change is needed; the collector must use a separate Federal CCF for each specimen.

6.2 What happens if the correct OMB approved Federal CCF is not available or is not used?

One commenter questioned the purpose of a Memorandum for the Record (MFR) obtained from the collector when an incorrect CCF was used for the collection. The commenter suggested that if certain information is required to be in the MFR, these requirements should be specified in the Guidelines. The commenter suggested that if the purpose of the MFR is to correct the collector's behavior (

i.e.,

using an incorrect form), then it would be more effective to reject the specimen upon receipt and indicate that it was rejected due to the use of an incorrect form. The Department has evaluated the comments and has concluded that no change is needed. Section 6.2 describes the information required in the MFR from the collector. However, the Department reworded items 6.2(b) and (c) for clarity.

Subpart H—Urine Specimen Collection Procedure

8.1 What privacy must the donor be given when providing a urine specimen?

As described in this preamble under Section 4.4, the Department has revised Section 8.1(b) to require that the gender of the observer matches the donor's gender, and that the gender of the monitor matches the donor's gender unless the monitor is a medical professional as described in Section 8.12.

8.3 What are the preliminary steps in the urine specimen collection procedure?

One commenter was concerned that the Guidelines do not mention alcohol testing, which was added to the Department of Transportation (DOT) program in 1991. Alcohol testing is outside of the scope of the Department's regulatory authority granted by Executive Order 12564 and Public Law 100-71.

In response to comments described under Sections 1.7 and 8.4 in this preamble, the Department revised Section 8.3(h) to require the collector to report a refusal to test when a donor brings materials for adulterating, substituting, or diluting a specimen to the collection site.

8.4 What steps does the collector take in the collection procedure before the donor provides a urine specimen?

The proposed section included the same requirement as the Guidelines effective October 1, 2010 (73 FR 71858) for the collector to perform an observed collection when the donor exhibits conduct that clearly indicates an attempt to tamper with a specimen (

e.g.,

substitute urine in plain view or an attempt to bring into the collection site an adulterant or urine substitute). One commenter stated that if the collector finds an adulterant or substitution product or observes the donor attempt to substitute a urine specimen, this should be a refusal to test. As noted under Section 1.7 in this preamble, the Department agrees that the collector must report a refusal to test when a donor brings materials for adulterating, substituting, or diluting a specimen to the collection site, or when the collector observes a donor's clear attempt to tamper with a specimen. The Department has revised Section 8.4 accordingly.

8.5 What steps does the collector take during and after the urine specimen collection procedure?

8.6 What procedure is used when the donor states that they are unable to provide a urine specimen?

Comments on these two sections are addressed here. Numerous commenters expressed concern with the Department's urine collection policy, stating that 7 to 10% of Americans have a condition (“paruresis”), described as a social anxiety disorder which prevents a person from producing urine on demand or in the presence of other people. These commenters stated that if the government wants to seek the largest group of qualified applicants, the Guidelines should specify that a diagnosis of paruresis means non-urine (

i.e.,

oral fluid) testing will automatically be provided, and that donors should not have to attempt to provide a urine specimen first. The Department has evaluated the comments and has concluded that no change is needed. The Guidelines will allow a federal agency to use any authorized specimen types (

e.g.,

urine, oral fluid, or both) in their drug testing programs. The Guidelines will continue to require that the donor be allowed reasonable attempts to provide a urine specimen as described in Sections 8.5 and 8.6, and allow collection of an authorized alternate specimen (

i.e.,

oral fluid).

Three commenters disagreed with the requirement for the collector to contact the agency representative for authorization to collect an alternate specimen each time a donor is unable to provide a sufficient volume. These commenters suggested that the Guidelines allow this to be addressed in established standard protocols for the agency. The Department agrees with the commenters. Each federal agency may decide whether to require notification in each case or whether to provide a standard protocol for collectors to follow. Sections 8.5 and 8.6 have been revised accordingly.

Also in regard to Section 8.6, one commenter indicated that some employers may wish to retain urine testing as the primary test due to a longer detection window. This commenter raised concern that some donors may claim they are unable to provide a urine specimen so that an alternative specimen (

i.e.,

OF) with a shorter detection window will be collected. The commenter suggested that the Guidelines be changed to indicate that an alternative specimen

may be collected when a donor is physiologically unable to provide a urine specimen, and not just when the donor states that they are unable to provide a urine specimen. The Department disagrees; collectors are not qualified to conduct a medical evaluation to verify or refute the donor's claim. It will be the agency's decision to collect urine or an authorized alternate specimen, and Sections 13.6 and 13.7 include procedures for medical evaluation as needed during the MRO review process.

The Department reworded Section 8.5(d) to clarify that the collector must record comments on both CCFs when two specimens from the same collection event are forwarded to a laboratory.

8.7 If the donor is unable to provide a urine specimen, may another specimen type be collected for testing?

The Department proposed within Section 8.7 that when the donor is unable to provide a urine specimen, another specimen type may be collected only if specifically authorized by the agency. One commenter disagreed with the Guidelines as written and suggested that when a donor cannot provide the primary specimen type, an alternate specimen should be collected immediately. The commenter cited the additional time and cost (evaluation of donor for “shy bladder”) as well as the fact that the collector may not know the agency's policy on alternate specimen types. The Department has concluded that no change is needed for Section 8.7 in response to this comment. The Guidelines will continue to require that the donor be allowed reasonable attempts to provide a urine specimen as described in Sections 8.5 and 8.6. The Department has revised those sections to allow a federal agency to either require notification in each case or provide a standard protocol for collectors to follow when the donor is unable to provide a urine specimen. The Department has reworded this section to state “Yes, if . . .” rather than “No, unless . . . .” in response to a federal agency's comment and to enhance clarity. The meaning of this section remains the same.

8.8 How does the collector prepare the urine specimens?

In response to a federal agency comment, the Department deleted a sentence in item 8.8(h) that required the collector to send a copy of the Federal CCF to the HHS-certified laboratory or IITF. The Department agreed with the federal agency that this instruction is redundant because item 8.8(g) instructs the collector to distribute copies of the Federal CCF as required.

8.9 When is a direct observed collection conducted?

The proposed section included requirements for the collector to perform an observed collection when the donor exhibits conduct that clearly indicates an attempt to tamper with a specimen or the collector observed materials brought by the donor to the collection site for the purpose of adulterating, substituting, or diluting the specimen. One commenter stated that if the collector finds an adulterant or substitution product or observes the donor attempt to substitute a urine specimen, this should be a refusal to test. As noted in this preamble under Sections 1.7 and 8.4, the Department agrees that the collector must report a refusal to test when a donor brings materials for adulterating, substituting, or diluting the specimen to the collection site, or when the collector observes a donor's clear attempt to tamper with a specimen. The Department has revised Section 8.9 accordingly.

8.10 How is a direct observed collection conducted?

To address a comment described in this preamble under Section 4.4, the Department has revised Section 8.10 to allow the donor to be observed by an observer whose gender matches the donor's gender. At the beginning of the observed collection, the collector requests that the donor document the donor's gender on the Federal CCF and initial the annotation. An observer of the same gender is provided, and the collector records the name and gender of the observer on the Federal CCF.

8.12 How is a monitored collection conducted?

To address a comment described in this preamble under Section 4.4, the Department has revised Section 8.12 to allow the donor to be monitored by a monitor whose gender matches the donor's gender, unless the monitor is a medical professional (

e.g.,

nurse, doctor, physician's assistant, technologist, or technician licensed or certified to practice in the jurisdiction in which the collection takes place). As described in Section 8.10, at the beginning of the monitored collection, the collector follows the same procedure as for observer selection in Section 8.10(b). That is, the collector requests that the donor document the donor's gender on the Federal CCF and initial the annotation. A monitor of the same gender is provided, and the collector records the name and gender of the monitor on the Federal CCF. A medical professional may serve as the monitor, regardless of gender.

Subpart I—HHS Certification of Laboratories and IITFs

9.5 What are the qualitative and quantitative specifications of performance testing (PT) samples?

One commenter noted that, because proposed initial test requirements allow calibration with a low-reacting analyte, PT schemes would likely need to be designed based on the specific implementation at each laboratory. The commenter provided an example: When an immunoassay is calibrated with a drug/metabolite that exhibits 50% cross-reactivity, the intended target analyte (“calibrant”) at the cutoff concentration would elicit a response well in excess of the cutoff. This could result in inaccurate initial test results (

i.e.,

a positive initial test result for a specimen containing the calibrant at a concentration below the cutoff). The commenter stated that this result could be scored as a “false positive” PT result. The Department has evaluated the comment and has concluded that no change is needed. As noted above regarding Section 3.4, it was not the Department's intent for the laboratory or IITF to calibrate an immunoassay test using an analyte other than that specified by the manufacturer. NLCP PT schemes are designed based on known cross-reactivity profiles of the initial tests used by HHS-certified laboratories.

Also in regard to proposed Section 9.5, one commenter suggested that the Guidelines use the same wording as in the Guidelines effective October 1, 2010 (73 FR 71858) for retest PT sample specifications (

i.e.,

“. . . may be as low as . . .” rather than the proposed wording “. . . may be less than. . .”). The Department agrees and has reinstituted wording from Section 9.3 of the Guidelines effective October 1, 2010 (73 FR 71858) into Section 9.5(a)(1)(ii).

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 or IITFs?

Two commenters disagreed with the proposed limit to the number of blind samples required (

i.e.,

a maximum of 400 blind samples per year) in Section 10.1(b). The commenters indicated that for a large agency, there is a very large difference between 3% and 400 samples and suggested keeping only the 3% requirement. Another commenter disagreed with the 3% requirement for

blind samples and requested that the amount to be lowered to 1% to lessen the burden on employers. One commenter suggested that the wording be modified to clarify that employers are responsible for ensuring blind samples are sent to the laboratories, but that collectors are tasked with submitting the blind samples. The Department has evaluated the comments and has concluded that no change is needed. The 400 sample limit was added to reduce the burden on large agencies based on the Department's review of agencies' blind testing programs. The wording in Section 10.1(a) clearly describes the responsibilities of the federal agency and the role of the collector in blind sample submission; however, the Department reworded Section 10.3(a) for clarity as described below.

10.3 How is a blind sample submitted to an HHS-certified laboratory?

The Department has reworded Section 10.3(a) to clarify that the collector sends a blind sample to a laboratory or IITF as a split specimen (

i.e.,

Bottle A and Bottle B).

Subpart K—Laboratory

11.10 What are the requirements for an initial drug test?

One commenter noted that HHS previously required initial and confirmatory testing using different techniques, and asked whether this requirement had been removed with allowance of technologies other than immunoassay for initial testing. The commenter expressed concern that an error in the initial drug test could be repeated in the confirmatory drug test using the same method. The Department has evaluated the comments and has concluded that no change is needed. The Guidelines maintain the requirement for initial and confirmatory tests on two separate aliquots to report a result other than negative. The NLCP will review validation and quality control records, as well as specimen records, to ensure that the initial and confirmatory testing methods meet Guidelines requirements and provide scientifically and forensically supportable results.

Also in regard to the proposed Section 11.10, one commenter asked whether non-FDA cleared immunoassays were included in the category of alternate initial drug test technology. The Department has evaluated the comment and has concluded that no change is needed. This section clearly distinguishes initial tests using immunoassay from those using an alternate technology. Furthermore, Section 1.5 includes the definition for “alternate technology initial drug test.”

11.11 What must an HHS-certified laboratory do to validate an initial drug test?

One commenter noted that an immunoassay initial test calibrated with a low-reacting analyte may not be able to meet Guidelines requirements for performance of the test around the cutoff concentration. The Department has evaluated the comments and has concluded that no change is needed. All tests must be validated by the HHS-certified laboratory to meet the requirements prior to use for regulated drug testing.

One commenter noted that the requirement in section 11.11(b) for reagent verification prior to use is an operational, not a validation, requirement. The Departments agrees with the commenter but has concluded that no change is needed. While this section addresses initial drug test validation requirements, the verification of each new reagent lot is essential to verify that lot-to-lot differences have not significantly affected assay performance as demonstrated and documented during validation. Therefore, this is the most appropriate section of the Guidelines to include the requirement.

11.12 What are the batch quality control requirements when conducting an initial drug test?

One commenter noted that this and other sections use inconsistent terminology when describing quality controls samples relative to the cutoff concentration (

i.e.,

“25 percent above the cutoff,” “75 percent of the cutoff”). The commenter suggested that the Department use one version consistently. The Department has considered the comment and has concluded that no change is needed. These terms have been used in the Guidelines, in NLCP documents, and in other guidance to HHS-certified laboratories without issue.

One commenter asked whether the added analytes affect quality control content requirements. The Department has evaluated the comment and has concluded that no change is needed. The initial drug test quality control requirements in the Guidelines apply to each analyte used to calibrate the test (

i.e.,

immunoassay or alternate technology initial drug test). When a single immunoassay test is used for two or more analytes in a drug class, the HHS-certified laboratory or IITF must include a control in accordance with item 11.12(a)(2) for each analyte that has less than 100% cross-reactivity with the assay, to demonstrate that the requirement for at least 80% cross-reactivity has been met.

11.12 What are the batch quality control requirements when conducting an initial drug test?

11.15 What are the batch quality control requirements when conducting a confirmatory drug test?

Comments on these two sections are addressed here. One commenter requested clarification for the requirement for a drug-free control in initial and confirmatory drug test batches (

i.e.,

whether the control should contain no drug or whether the control should not contain the specific analyte for that test). The Department has evaluated the comment and has concluded that no change is needed. These Guidelines sections list the requirement for “at least one control certified to contain no drug or drug metabolite,” meaning that the control must contain no regulated drug analytes.

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

One commenter found the wording of Section 11.16(a) to be confusing, noting that a specimen would not be subjected to a second specimen validity test when the first test was in the acceptable range. The Department agrees with the comment and has revised Section 11.16(a) to correctly reflect requirements.

11.18 What are the requirements for conducting each specimen validity test?

One commenter noted that the proposed changes in the lower pH cutoff for identifying adulterated specimens and lower pH decision point for identifying invalid specimens may cause additional costs for manufacturers and laboratories. The Department has evaluated the comment and has concluded that no change is needed. The Department recognizes that the revised cutoff will necessitate changes by HHS-certified laboratories as well as by manufacturers of commercial quality control samples; however, the 4.0 pH cutoff is supported by scientific studies and workplace drug testing data, and is expected to reduce the incidence of undetected attempts to subvert the drug test.

11.19 What are the requirements for an HHS-certified laboratory to report a test result?

One commenter suggested that the Department remove the requirement for

an executed CCF as the official report for “non-negative” specimens and permit the use of an electronic report with the required information. The Department has evaluated the comment and has concluded that no change is needed. The Federal CCF serves as the chain of custody for the specimen from the time of collection until receipt by the laboratory and also contains the certification statement signed by the certifying scientist. The Federal CCF may be paper or electronic.

11.21 How long must an HHS-certified laboratory retain records?

In Section 11.21, the Department proposed that laboratories be allowed to convert hardcopy records to electronic records for storage and then discard the hardcopy records after six months. One commenter stated their assumption that this section did not require laboratories to convert electronic records to hardcopy records and maintain them for six months. This assumption is correct; the intent is to allow laboratories to maintain records in electronic format for the required storage period. The Department has concluded that no change is needed.

11.22 What statistical summary reports must an HHS-certified laboratory provide for urine testing?

One commenter asked why the proposed Guidelines include a requirement for a copy of the semiannual statistical summary report to be sent to the Secretary or designated HHS representative. The Department included the requirement in Section 11.22 (and in Section 12.19 for IITFs) to facilitate compilation of statistical information for the federal drug-free workplace program. This will not place an additional burden on the test facilities other than transmission of the report. The Department will continue to evaluate the effectiveness of this requirement.

Subpart M—Medical Review Officer (MRO)

13.1 Who may serve as an MRO?

Three commenters disagreed with the term “nonmedical use of a drug” used in Section 13.1 (and defined in Section 1.5) and indicated that the term changes the role of an MRO from review, verify and “report a non-negative result” to review, verify and “interpret before reporting a result as negative or nonmedical use of a drug.” Two commenters disagreed with use of “interpretation of results” to supplant “alternative medical explanation.” One commenter noted that this perceived change in the MRO's role represents an unjustified shifting of risk to the MRO. One commenter believes the term presents a possible legal flaw to the Guidelines, stating that this term is legally different from “safety concern” and places MROs in the position of being in conflict with the prescribing physician and subject to lawsuits. This commenter stated that even a lack of a finding of nonmedical use could be an issue if the donor subsequently had an accident after using the drug. The same commenter submitted five recommendations related to inclusion of prescription drugs in federal workplace drug testing programs, to address the commenter's concerns with the proposed Guidelines. These five specific recommendations pertain to matters that are outside the scope of these Guidelines, and therefore are not addressed in the Department's response below.

The responsibilities of an MRO to interpret results have largely remained the same between the Guidelines effective October 1, 2010 (73 FR 71858) and these Guidelines. As stated in Section 13.5(c) of these Guidelines, “if the donor provides a legitimate medical explanation (

e.g.,

a valid prescription) for the positive result, the MRO reports the test result as negative to the agency.” Accordingly, the intent of the Guidelines, in this context, is to confirm whether a positive drug test is the result of drug use under a valid prescription. Furthermore, the term “alternate medical explanation” has never been used in the Guidelines, but has been used in the HHS Medical Review Officer Manual for Federal Workplace Drug Testing Programs.

For the reasons above, the Department believes that the definition of “nonmedical use of a drug” and the requirement for a physician serving as an MRO to have knowledge of this topic do not fundamentally change the MRO's responsibilities. However, to address the commenters' concerns, the Department has removed this term from the Guidelines (

i.e.,

revised Sections 1.5 and 13.1).

The Department proposed within Section 13.1 who may serve as an MRO. One commenter requested clarification that it is the federal agency's burden to ensure that the MRO is certified. One commenter asked how the laboratory will be informed that an MRO has met requirements for re-qualification. The Department evaluated the comments and concluded that no change is needed. The MRO is an employee or a contractor of the agency. Therefore, it is the agency's responsibility to ensure that the MRO meets the Guidelines qualification requirements.

Two commenters disagreed with the requirement for MRO recertification every five years, and recommended that MROs complete training every three years. Five commenters stated support for five year requalification and examination requirements. The Department has evaluated the comments and has concluded that no change is needed. The Department will keep the five-year recertification requirement as proposed.

13.2 How are nationally recognized entities or subspecialty boards that certify MROs approved?

One commenter agreed with MRO certification/training entities submitting the delivery method and content of the MRO examination as applicable along with other required documents. One commenter agreed with extending time from one to two years for approved MRO certification/training entities' resubmission of qualifications for HHS approval. The commenter noted that they would support further extension to 3 years. One commenter recommended that approval of MRO educational courses and content be at the discretion of the MRO certification entities, not HHS. Since the certification entities and their examinations are subject to HHS oversight and approval, the commenter noted that it may be burdensome for HHS to review and approve the courses and content, and be a disincentive to development of new courses. One commenter recommended that examinations be allowed to be in-person or online with appropriate security precautions for each delivery method. The Department has evaluated the comments and agrees that the submission of training materials to HHS would possibly discourage the development of new training courses. Therefore, the review of MRO educational courses and content will not be part of the approval process for MRO certification entities. As described under

Medical Review Officer (MRO) requalification—continuing education units (CEUs)

in this preamble, the Department has removed references to MRO training entities in Section 13.2, because training documentation is maintained by MRO certification entities. The Department will only require the MRO certification entities to submit their examination and any other necessary supporting examination materials (

e.g.,

answers, examination statistics or background information on questions) that will help in the Department's evaluation of the examination. The Department will

review and evaluate the examination delivery method (

e.g.,

in-person or online) when reviewing submitted training materials to ensure that the delivery method employs appropriate security and identification procedures.

13.3 What training is required before a physician may serve as an MRO?

Five commenters disagreed and one commenter agreed with the added requirement for MRO training to include information about how to discuss substance misuse and abuse and how to access those services. The Department has evaluated the comments and has revised Section 13.3 to remove this requirement. Federal agencies may provide this information to employees and applicants to facilitate their access to effective treatment and support recovery. The Department provides information to the public on help and treatment for substance misuse and abuse, and how to access those services, on the SAMHSA Web site

http://www.samhsa.gov/.

One commenter stated that the Department should add a requirement for MRO training on what constitutes a refusal to test. One commenter suggested that the Department should add a requirement for MRO training on when and how to report safety concerns to employers when prescription and/or over-the-counter medications may affect performance. The Department has evaluated the comments and has concluded that no change is needed. Criteria for reporting a refusal to test are covered under the topics listed in Section 13.3 such as items (a)(4) training on the Guidelines and (a)(5) procedures for interpretation, review, and reporting of results. When a donor provides a legitimate medical explanation for a positive drug test result (

e.g.,

a valid prescription), the Guidelines do not require MROs to contact federal agency employers for the purpose of reporting a safety concern. Accordingly, MRO training related to reporting “safety concerns” does not relate to a mandatory function under the Guidelines and, therefore, is not an essential component of required MRO training. The Department will provide additional guidance in the HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs.

In addition, the Department revised Section 13.3 as described under

Medical Review Officer (MRO) requalification—continuing education units (CEUs)

in this preamble. The Department removed references to MRO training entities, because training documentation is maintained by MRO certification entities, and added item 13.3(b) to require MRO training on revised Guidelines prior to their effective date.

13.4 What are the responsibilities of an MRO?

One commenter suggested creating a subset of medical professionals trained specifically to determine fitness for duty since an MRO cannot determine fitness for duty over the telephone. The Department has evaluated the comment and has concluded that no change is needed. Fitness for duty evaluations fall outside the purview of the Guidelines.

13.5 What must an MRO do when reviewing a urine specimen's test results?

The Department has revised Section 13.5(d)(1) to include an example of documentation to support a medical explanation for a positive drug test result.

Three commenters disagreed with MRO procedures for “a positive result for opiates” (

i.e.,

requirement for clinical evidence of illegal use in addition to positive result) and noted that the proposed Guidelines wording was not changed to clarify that the described procedures do not apply to the added opioids. The Department agrees with the commenters and has revised Section 13.5(d) to clarify that the procedures do not apply to the added opioid analytes. Wording in Section 13.5(d)(2)(i) regarding “clinical evidence of illegal use” was also edited for clarity and for consistency with the wording in the OFMG.

One commenter disagreed with requirements concerning two separate specimens collected at a single test event and sent to the laboratory for testing (

e.g.,

a urine specimen outside the acceptable temperature range and the subsequently collected specimen). The proposed Guidelines require that, when one of the two specimens is negative and other is not, the MRO reports only the verified result other than negative. This commenter suggested that the MRO cancel the negative result. The Department has evaluated the comments and has concluded no change is needed. Cancellation of the test may be confusing in the situation referenced by the commenter and lead to inappropriate specimen recollection. Both the MRO and the federal agency employer will receive their Federal CCF copies with explanatory collector remarks in Step 2 including the specimen identification number of the associated specimen, and the MRO may provide additional comment in the MRO's report.

The Department also revised Section 13.5(d) to reflect the policy of the Department that passive exposure to marijuana smoke and ingestion of food products containing marijuana are not acceptable medical explanations for a positive drug test result. Individuals who are passively exposed to marijuana smoke or who consume food products containing marijuana can pose public safety and/or security risks.

4 5

Marijuana is listed as a Schedule I drug under the Controlled Substances Act.

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

One commenter suggested the Guidelines define “appropriate expertise” of a physician with a list of conditions and an appropriate type of physician in an appendix. The same commenter requested medical referral information on the employer's actions when a donor could not provide a urine specimen and then could not provide an oral fluid specimen. The Department has evaluated the comments and has concluded that no change is needed. A physician who is a trained MRO will have the knowledge necessary to identify another physician with appropriate expertise for the medical evaluation. The Department will provide additional guidance in the HHS Medical Review Officer Guidance Manual for Federal Workplace Drug Testing Programs as appropriate when alternate specimen types (

e.g.,

oral fluid) are allowed in federal workplace drug testing programs.

The Department clarified the definition of “permanent or long-term medical conditions” in Section 13.6(b)(1) based on a federal agency comment.

Subpart O—Criteria for Rejecting a Specimen for Testing

15.1 What discrepancies require an HHS-certified laboratory or an HHS-certified IITF to report a specimen as rejected for testing?

The Department revised wording in items a and b of this section, and included three additional fatal flaws as items f-h, to reflect fatal flaws for regulated donor specimens that have been identified by HHS-certified laboratories. These fatal flaws were addressed in NLCP guidance sent to all HHS-certified and applicant laboratories and IITFs on August 9, 2016. In addition, the Department revised this section to include an additional item i to allow a laboratory or IITF to reject a specimen when they identify a flaw that

prevents testing or affects the forensic defensibility of the drug test, and cannot be corrected. This general item enables laboratories and IITFs to reject specimens with fatal flaws that may be rare, but do occur. It is not possible to list all such flaws in the Guidelines.

15.3 What discrepancies are not sufficient to require an HHS-certified laboratory or an HHS-certified IITF to reject a urine specimen for testing or an MRO to cancel a test?

Two commenters indicated that inclusion of some items as insignificant discrepancies contradicts guidance provided to HHS-certified laboratories and IITFs in NLCP Notices, which required laboratories to attempt to recover missing information. One of these commenters suggested that if these items are important, they should be removed from the “insignificant” list. Two commenters disagreed with the Guidelines designating the listed omissions and discrepancies as “insignificant only when they occur no more than once per month.” The Department has evaluated the comments. The listed discrepancies would not result in rejection or cancellation. NLCP Notices requiring laboratory action are consistent with this section. However, the Department has reworded section 15.3 to not classify these errors as insignificant. While these types of errors do not warrant laboratory rejection of a specimen or MRO cancellation of a test, as noted in section 15.3(c), corrective action must be initiated when they occur more than once a month.

The commenters indicated that this section implies that the MRO must keep a log of insignificant errors by laboratory and by collection site in order to track frequency. The commenters noted that this is an unenforceable policy, that this should be a duty of inspectors of laboratories and collection sites, and that requiring MROs to keep these types of logs would create significant extra costs. One commenter suggested that item 15.3(c) be modified for the MRO to advise the collector or laboratory to retrain staff on relevant procedures to ensure that collections are completed correctly (rather than directing them to immediately take corrective action). The Department has evaluated the comments and has concluded that no change is needed. This section is the same as in the Guidelines effective October 1, 2010 (73 FR 71858).

One commenter suggested modifying 15.3(a)(5) to read “donor identification number” which would include a social security number or an employee identification number since many employers no longer use social security numbers for employee identification. The Department agrees and has revised Section 15.3(a)(5) to include “employee identification number” in addition to “Social Security Number.”.

15.4 What discrepancies may require an MRO to cancel a test?

One commenter suggested adding the scenario where the donor did not sign the CCF because the collector forgot to ask the donor to sign, rather than the donor's refusal to sign. The Department has evaluated the comment and has concluded that no change is needed. As stated in Section 15.4, the MRO contacts the collector “to obtain a statement to verify that the donor refused to sign the MRO copy.”

Regulatory Impact and Notices

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 presents 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 Guidelines under Executive Order 12866, which directs federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).

According to Executive Order 12866, a regulatory action is “significant” if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million; adversely affecting in a material way a sector of the economy, competition, or jobs; or if it raises novel legal or policy issues. The 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. However, the statute under which the mandatory guidelines were created (Pub. L. 100-71, section 503(a)(3)) required notice and comment apart from the APA. This provision provides the following:

(3) Notwithstanding any provision of chapter 5 of title 5, United States Code, the mandatory guidelines to be published pursuant to subsection (a)(l)(A)(ii) shall be published and made effective exclusively according to the provisions of this paragraph. Notice of the mandatory guidelines proposed by the Secretary of Health and Human Services shall be published in the

Federal Register

, and interested persons shall be given not less than 60 days to submit written comments on the proposed mandatory guidelines. Following review and consideration of written comments, final mandatory guidelines shall be published in the

Federal Register

and shall become effective upon publication.

The Department included a Regulatory Impact and Notices section with cost and benefits analysis and burden estimates in the May 15, 2015

Federal Register

Notice for the proposed UrMG (80 FR 28101), and requested public comment on all figures and assumptions. The Department's projections were developed using information from current HHS-certified urine testing laboratories, with input from DOT and the Nuclear Regulatory Commission (NRC), and cost analysis was based on information provided by multiple HHS-certified laboratories and MROs. The Department received no substantive data or evidence through public comments in favor of changing the estimated costs and benefits provided in the Department's May 2015

Federal Register

Notice for the UrMG, and therefore, has retained the analysis and estimates provided in that notice below. Comments that related to the costs and benefits of this rule are summarized and discussed above in the Summary of Public Comments and

HHS's Response under the heading

Costs and Benefits.

Need for Revisions to the Guidelines

The inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone in the URMG was recommended by the DTAB, reviewed by the Department's Prescription Drug Subcommittee of the Behavioral Health Coordinating Committee, and approved by the SAMHSA Administrator in January 2012. This action is supported by various data, described in this preamble.

1-4

In addition, in 2008, 12 percent of military personnel admitted to the illicit use of prescription medications. Prevalence testing by the Department of Defense (DoD) in 2009 indicated that prescription drug abuse exceeded illegal drug abuse. Because of this, hydrocodone and hydromorphone testing was added to the regular DoD drug testing panel in 2011.

Costs

Costs associated with the implementation of testing for oxycodone, oxymorphone, hydrocodone and hydromorphone will be minimal because the Department has determined that all HHS certified laboratories testing specimens from federal agencies are currently conducting tests for one or more of these analytes on non-regulated urine specimens. Likewise, there will be minimal costs associated with changing initial testing to include MDA since the current immunoassays can be adapted to test for this analyte. Laboratory personnel are currently trained and test methods have been implemented. However, there will be some administrative costs associated with adding these analytes. Prior to being allowed to test regulated specimens for these compounds, HHS certified laboratories will be required to demonstrate that their performance meets Guideline requirements by testing three (3) groups of PT samples. The Department will provide the PT samples through the National Laboratory Certification Program (NLCP) at no cost to the certified laboratories. Based on costs charged for specimen testing, laboratory costs to conduct the PT testing would range from $900 to $1,800 for each certified laboratory.

In Section 3.4, the Department included criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specified the cross-reactivity of the immunoassay to the other analytes(s) within the group. These Guidelines allow the use of methods other than immunoassay for initial testing. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.

For the added opiate analytes, the two immunoassays currently used for oxycodone and oxymorphone meet the requirements, and two of the three existing opiate immunoassays used in certified laboratories meet the requirements for hydrocodone and hydromorphone analysis. The opiate immunoassay that does not have sufficient cross-reactivity would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, hydromorphone, is used to establish a decision point. Therefore, the Department assumes that all certified laboratories will elect to use existing immunoassays. Thus, the costs associated with implementing the initial tests for these analytes is expected to be

de minimis.

For amphetamines, one of the three existing methylenedioxymethamphetamine (MDMA) immunoassays used in certified laboratories meets the requirements. The remaining two exhibit insufficient cross-reactivity for MDA. These two immunoassays would be acceptable as an initial test under these Guidelines when the lowest-reacting analyte, MDA, is used to establish a decision point. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance. Again, the Department assumes that certified laboratories will use the existing immunoassays and incur

de minimis

costs.

Once the testing has been implemented, the cost per specimen for initial testing for the added analytes will range from $.06 to $0.20 due to reagent costs. Current costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported positive, due to sample preparation and analysis costs. Based on information from non-regulated workplace drug testing for these analytes and testing performed by the Department on de-identified federally regulated specimens in 2011, approximately 1% of the submitted specimens is expected to be confirmed as positive for the added analytes. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This would indicate that the cost per specimen submitted for testing will increase by $0.11-$0.30. Annual recurring testing costs in the table below are based on an estimated number of 6,145,500 specimens.

The addition of the Schedule II prescription medications will require MRO review to verify legitimate drug use. Based on the positivity rates from non-regulated workplace drug testing for these analytes and the additional review of specimens confirmed positive for prescription medications, MRO costs are estimated to increase by approximately 3%. The burden of this 3% cost increase is expected to shift gradually from MROs to agencies as agencies' existing contracts expire and they renegotiate the terms of new contracts, with an increase to the total cost of a federal drug test over time to between $0.60-$1.35. This cost would indicate a total cost of $3,687,300 to $8,296,425 in the urine testing program. A federal agency may also incur additional costs (

e.g.,

additional managerial effort to arrange substitute workers) when an employee tests positive for a prescription medication and is removed from duties during the MRO verification process.

The additional costs for testing and MRO review will be incorporated into the overall cost for the federal agency submitting the specimen to the laboratory. The estimation of costs incurred is based upon overall cost to the federal agency because the review of positive specimens is usually based on all specimens submitted from an agency, rather than individual specimen testing costs or MRO review of positive specimens. Agencies may also incur some costs for training of federal employees such as drug program coordinators due to implementation of the revised Guidelines. Based on current training modules offered to drug program coordinators, and other associated costs including travel for 90% of drug program coordinators, the estimated total training cost for a one-day training session would be between $108,000 and $138,000 (

i.e.,

assuming 8 hours of time multiplied by a GS 12/13 wage including benefits and overhead adjustments). The Department will offer the choice of online or in-person training. This will eliminate travel costs for those federal agencies who choose to use online training.

Recurring Annual Costs Summary Table

Lower bound

Upper bound

Reagent Costs

$368,730.00

$1,229,100.00

Additional Confirmatory tests

307,275.00

614,550.00

MRO Costs

3,687,300.00

8,296,425.00

Total annual costs

4,363,305.00

10,140,075.00

Upfront (One-Time) Costs Summary Table

Lower bound

Upper bound

Performance Testing

$27,900.00

$55,800.00

Training

108,000

138,000

Total

135,900.00

193,800.00

Benefits

The potential benefits of deterring use of oxycodone, oxymorphone, hydrocodone and hydromorphone are the prevention of their side effects (

e.g.,

anxiety, dizziness, drowsiness, fatigue, and other neurological effects), which will result in a healthier and more alert workforce as well as avoid the issues associated with addiction and rehabilitation. Since the personnel tested under this program are in positions that are safety sensitive, potential benefits include decreased risk of transportation accidents, decreased risk of low-probability high consequence events, more responsible workforce in positions of public trust, and potentially reducing individuals' dependence or addiction and the personal benefits associated with those conditions.

Considering the potential health and performance costs of narcotic abuse, the benefits to the federal workplace and the individuals within that workplace justify the inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone in Federal Workplace Drug Testing programs.

Regulatory Flexibility Analysis

For the reasons outlined above, the Secretary has determined that the 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 UrMG will not require addition expenditures. Therefore, a final regulatory flexibility analysis is not required for this notice.

The Secretary has determined that the 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 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 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 UrMG. 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 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 revised the standards for certification of laboratories engaged in urine fluid drug testing for federal agencies and the use of urine 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 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. Information collection and recordkeeping requirements which would be imposed on MROs engaged in drug testing services for federal agencies concern drug testing result review and reports as set out in subparts 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 will submit the information collection and recordkeeping requirements contained in the Guidelines to OMB for review and approval prior to the effective date of the final Guidelines. Information collections changed by these Guidelines are not effective until approved by OMB.

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 Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine 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 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 Guidelines do not have tribal implications. The Guidelines will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175.

Information Collection/Record Keeping Requirements

The information collection requirements (

i.e.,

reporting and recordkeeping) in the current Guidelines (73 FR 71858) 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 these final Guidelines are effective and OMB approves the revised information collection. OMB will assign a new control number to account for changes associated with the final Guidelines.

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 Urine Specimens

Description:

The Mandatory 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.

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, 30 urine specimen testing laboratories, 1 IITF, and 100 MROs.

Estimate of Annual Reporting Burden

Section

Purpose

Number of

respondents

Responses/

respondent

Hours/

response

Total hours

9.2(a)(1)

Laboratory or IITF

1

required to submit application for certification

10

1

3

30

9.12(a)(3)

Materials to submit to become an HHS inspector

10

1

2

20

11.3(a)

Laboratory submits qualifications of RP to HHS

10

1

2

20

11.4(c)

Laboratory submits information to HHS on new RP or alternate RP

10

1

2

20

11.22

Specifications for laboratory semi-annual statistical report of test results to each federal agency

10

5

0.5

25

12.3(a)

IITF

1

submits qualifications of RT to HHS

1

1

1

1

12.4(c)

IITF

1

submits information to HHS on new RT or alternate RT

1

1

1

1

12.19

Specifications for IITF

1

semi-annual statistical report of test results to each federal agency

1

1

1

1

13.9 and 14.7

Specifies that MRO must report all verified primary and split specimen test results to the federal agency

100

14

0.05 (3 min)

70

16.1(b) & 16.5(a)

Specifies content of request for informal review of suspension/proposed revocation of certification

1

1

3

3

16.4

Specifies information appellant provides in first written submission when laboratory suspension/revocation is proposed

1

1

0.5

0.5

16.6

Requires appellant to notify reviewing official of resolution status at end of abeyance period

1

1

0.5

0.5

16.7(a)

Specifies contents of appellant submission for review

1

1

50

50

16.9(a)

Specifies content of appellant request for expedited review of suspension or proposed revocation

1

1

3

3

16.9(c)

Specifies contents of review file and briefs

1

1

50

50

Total

159

295

1

Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not received any IITF applications for certification to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The following reporting requirements are also in the Guidelines, but have not been addressed in the above reporting burden table: Collector must report any unusual donor behavior or refusal to participate in the collection process on the Federal CCF [Sections 1.8, 8.9]; collector annotates the Federal CCF when a sample is a blind sample [Section 10.3(a)]; MRO notifies the federal agency and HHS when an error occurs on a blind sample [Section 10.4(c)]; Section 13.5 describes the actions an MRO takes to report a primary specimen result; Section 14.6 describes the actions an MRO takes to report a split specimen result; and Sections 13.6 and 13.7 describe the actions an MRO takes for the medical evaluation of a donor who cannot provide a urine specimen. 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

Section

Purpose

Number of

respondents

Responses/

respondent

Hours/

response

Total hours

8.3(a), 8.5(f)(2) (iii), 8.6(b)(2)

Collector must contact federal agency point of contact

100

1

0.05 (3 min)

5

11.23, 11.24

Information on drug test that laboratory must provide to federal agency upon request or to donor through MRO

50

10

3

1,500

12.20, 12.21

Information on drug test that IITF

1

must provide to federal agency upon request or to donor through MRO

1

1

1

1

13.8(b)

MRO must inform donor of right to request split specimen test when a positive, adulterated, or substituted result is reported

100

14

3

4,200

Total

211

5,706

1

Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not certified any IITFs to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The following disclosure requirements are also included in the 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(e) and (g)]. 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

Section

Purpose

Number of

respondents

Responses/

respondent

Hours/

response

Total hours

8.3, 8.5, 8.8

Collector completes Federal CCF for specimen collected

100

380

0.07 (4 min)

2,534

8.8(d) & (f)

Donor initials specimen labels/seals and signs statement on the Federal CCF

38,000

1

0.08 (5 min)

3,167

11.8(a) & 11.19

Laboratory completes Federal CCF upon receipt of specimen and before reporting result

10

3,800

0.05 (3 min)

1,900

12.8(a) & 12.15

IITF

1

completes Federal CCF upon receipt of specimen and before reporting result

1

1

1

1

13.4(d)(4),13.9(c),14.7(c)

MRO completes Federal CCF before reporting the primary or split specimen result

100

380

0.05 (3 min)

1,900

14.1(b)

MRO documents donor's request to have split specimen tested

300

1

0.05 (3 min)

15

Total

38,511

9,517

1

Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not certified any IITFs to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes.

The 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)]. Because this is required by the current Guidelines and is consistent with general forensic requirements, 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(c), 8.5(d)(2), 8.5(e)(1) and (2)] requires collectors to enter any information on the Federal CCF of any unusual findings during the urine 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. Subpart K describes a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records [

i.e.,

Sections 11.1(a) and (d); 11.2(b), (c), and (d); 11.6(b); 11.7(c); 11.8; 11.11(a); 11.14(a); 11.17; 11.21(a), (b), and (c); 11.22; 11.23(a) and 11.24. These recordkeeping requirements are necessary for any laboratory to conduct forensic drug testing and to ensure the scientific supportability of the test results. Therefore, they are considered to be standard business practice and are not considered a burden for this analysis.

Thus the total annual response burden associated with the testing of urine specimens by the laboratories and IITFs is estimated to be 15,518 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 submitted a copy of these proposed Guidelines to OMB for its review. Comments on the information collection requirements were 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.

References

1. Cone, E.J., Heltsley, R., Black, D.L., Mitchell, J.M., LoDico, C.P., Flegel, R.R, 2013. Prescription opioids. I. metabolism and excretion patterns of oxycodone in urine following controlled single dose administration.

J. Anal. Toxicol,

37, 255-264.

2. Cone, E.J., Heltsley. R., Black, D.L., Mitchell, J.M., LoDico, C.P., Flegel, R.R, 2013. Prescription opioids. II. metabolism and excretion patterns of hydrocodone in urine following controlled single dose administration.

J. Anal. Toxicol,

37, 486-494.

3. Esposito, F.M., Mitchell, J.M., Baylor, M.R., Bush, D.M, 2006. Influence of basic pH on federal regulated drugs in urine at room temperature. Poster presented at the Society of Forensic Toxicologists (SOFT) Annual Meeting, Austin, TX. October 2006.

4. Cone, E.J., Bigelow, G.E., Herrmann, E.S., Mitchell, J.M., LoDico, C., Flegel, R., Vandrey, R, 2015. Nonsmoker exposure to secondhand cannabis smoke. III. oral fluid and blood concentrations and corresponding subjective effects.

J. Anal. Toxicol,

39, 497-509.

5. Hermann, E.S, Cone, E.J., Mitchell, J.M., Bigelow, G.E., LoDico, C., Flegel, R., Vandrey, R., 2016. Non-smoker exposure to secondhand cannabis smoke II: Effect of room ventilation on the physiological, subjective, and behavioral/cognitive effects. Drug alcohol depend, 151, 194-202.

Dated: January 11, 2017.

Kana Enomoto,

Acting Deputy Assistant Secretary for Mental Health and Substance Use, SAMHSA.

Dated: January 11, 2017.

Sylvia M. Burwell

Secretary.

The Mandatory Guidelines using Urine Specimens as revised are hereby adopted in accordance with section 503 of Public Law 100-71 and Executive Order 12564.

Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine 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—Urine Specimens

2.1 What type of specimen may be collected?

2.2 Under what circumstances may a urine specimen be collected?

2.3 How is each urine specimen collected?

2.4 What volume of urine is collected?

2.5 How does the collector split the urine specimen?

2.6 When may an entity or individual release a urine specimen?

Subpart C—Urine Specimen Tests

3.1 Which tests are conducted on a urine 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 urine?

3.5 May an HHS-certified laboratory perform additional drug and/or specimen validity tests on a specimen at the request of the Medical Review Officer (MRO)?

3.6 What criteria are used to report a urine specimen as adulterated?

3.7 What criteria are used to report a urine specimen as substituted?

3.8 What criteria are used to report a urine specimen as dilute?

3.9 What criteria are used to report an invalid result for a urine 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 an observer for a direct observed collection?

4.5 What are the requirements to be a trainer for collectors?

4.6 What must a federal agency do before a collector is permitted to collect a specimen?

Subpart E—Collection Sites

5.1 Where can a collection for a drug test take place?

5.2 What are the requirements for a collection site?

5.3 Where must collection site records be stored?

5.4 How long must collection site records be stored?

5.5 How does the collector ensure the security and integrity of a specimen at the collection site?

5.6 What are the privacy requirements when collecting a urine 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—Urine Specimen Collection Containers and Bottles

7.1 What is used to collect a urine specimen?

7.2 What are the requirements for a urine collection container and specimen bottles?

7.3 What are the minimum performance requirements for a urine collection container and specimen bottles?

Subpart H—Urine Specimen Collection Procedure

8.1 What privacy must the donor be given when providing a urine specimen?

8.2 What must the collector ensure at the collection site before starting a urine specimen collection?

8.3 What are the preliminary steps in the urine specimen collection procedure?

8.4 What steps does the collector take in the collection procedure before the donor provides a urine specimen?

8.5 What steps does the collector take during and after the urine specimen collection procedure?

8.6 What procedure is used when the donor states that they are unable to provide a urine specimen?

8.7 If the donor is unable to provide a urine specimen, may another specimen type be collected for testing?

8.8 How does the collector prepare the urine specimens?

8.9 When is a direct observed collection conducted?

8.10 How is a direct observed collection conducted?

8.11 When is a monitored collection conducted?

8.12 How is a monitored collection conducted?

8.13 How does the collector report a donor's refusal to test?

8.14 What are a federal agency's responsibilities for a collection site?

Subpart I—HHS Certification of Laboratories and IITFs

9.1 Who has the authority to certify laboratories and IITFs to test urine specimens for federal agencies?

9.2 What is the process for a laboratory or IITF to become HHS-certified?

9.3 What is the process for a laboratory or IITF to maintain HHS certification?

9.4 What is the process when a laboratory or IITF 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 urine laboratory?

9.8 What are the PT requirements for an applicant IITF?

9.9 What are the PT requirements for an HHS-certified IITF?

9.10 What are the inspection requirements for an applicant laboratory or IITF?

9.11 What are the maintenance inspection requirements for an HHS-certified laboratory or IITF?

9.12 Who can inspect an HHS-certified laboratory or IITF and when may the inspection be conducted?

9.13 What happens if an applicant laboratory or IITF does not satisfy the minimum requirements for either the PT program or the inspection program?

9.14 What happens if an HHS-certified laboratory or IITF does not satisfy the minimum requirements for either the PT program or the inspection program?

9.15 What factors are considered in determining whether revocation of a laboratory's or IITF's HHS certification is necessary?

9.16 What factors are considered in determining whether to suspend a laboratory's or an IITF's HHS certification?

9.17 How does the Secretary notify an HHS-certified laboratory or IITF that action is being taken against the laboratory or IITF?

9.18 May a laboratory or IITF that had its HHS certification revoked be recertified to test federal agency specimens?

9.19 Where is the list of HHS-certified laboratories and IITFs 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 or IITFs?

10.2 What are the requirements for blind samples?

10.3 How is a blind sample submitted to an HHS-certified laboratory or IITF?

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 test(s) does an HHS-certified laboratory conduct on a urine specimen received from an IITF?

11.10 What are the requirements for an initial drug test?

11.11 What must an HHS-certified laboratory do to validate an initial drug test?

11.12 What are the batch quality control requirements when conducting an initial drug test?

11.13 What are the requirements for a confirmatory drug test?

11.14 What must an HHS-certified laboratory do to validate a confirmatory

drug test?

11.15 What are the batch quality control requirements when conducting a confirmatory drug test?

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

11.17 What must an HHS-certified laboratory do to validate a specimen validity test?

11.18 What are the requirements for conducting each specimen validity test?

11.19 What are the requirements for an HHS-certified laboratory to report a test result?

11.20 How long must an HHS-certified laboratory retain specimens?

11.21 How long must an HHS-certified laboratory retain records?

11.22 What statistical summary reports must an HHS-certified laboratory provide for urine testing?

11.23 What HHS-certified laboratory information is available to a federal agency?

11.24 What HHS-certified laboratory information is available to a federal employee?

11.25 What types of relationships are prohibited between an HHS-certified laboratory and an MRO?

11.26 What type of relationship can exist between an HHS-certified laboratory and an HHS-certified IITF?

Subpart L—Instrumented Initial Test Facility (IITF)

12.1 What must be included in the HHS-certified IITF's standard operating procedure manual?

12.2 What are the responsibilities of the responsible technician (RT)?

12.3 What qualifications must the RT have?

12.4 What happens when the RT is absent or leaves an HHS-certified IITF?

12.5 What qualifications must an individual have to certify a result reported by an HHS-certified IITF?

12.6 What qualifications and training must other personnel of an HHS-certified IITF have?

12.7 What security measures must an HHS-certified IITF maintain?

12.8 What are the IITF chain of custody requirements for specimens and aliquots?

12.9 What are the requirements for an initial drug test?

12.10 What must an HHS-certified IITF do to validate an initial drug test?

12.11 What are the batch quality control requirements when conducting an initial drug test?

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

12.13 What must an HHS-certified IITF do to validate a specimen validity test?

12.14 What are the requirements for conducting each specimen validity test?

12.15 What are the requirements for an HHS-certified IITF to report a test result?

12.16 How does an HHS-certified IITF handle a specimen that tested positive, adulterated, substituted, or invalid at the IITF?

12.17 How long must an HHS-certified IITF retain a specimen?

12.18 How long must an HHS-certified IITF retain records?

12.19 What statistical summary report must an HHS-certified IITF provide?

12.20 What HHS-certified IITF information is available to a federal employee?

12.21 What types of relationships are prohibited between an HHS-certified IITF and an MRO?

12.22 What type of relationship can exist between an HHS-certified IITF and an HHS-certified laboratory?

Subpart M—Medical Review Officer (MRO)

13.1 Who may serve as an MRO?

13.2 How are nationally recognized entities or subspecialty boards that certify MROs approved?

13.3 What training is required before a physician may serve as an MRO?

13.4 What are the responsibilities of an MRO?

13.5 What must an MRO do when reviewing a urine 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 urine for a drug test?

13.7 What happens when an individual is unable to provide a sufficient amount of urine 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 or an HHS-certified IITF?

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 primary (A) specimen was reported positive?

14.3 How does an HHS-certified laboratory test a split (B) urine specimen when the primary (A) specimen was reported adulterated?

14.4 How does an HHS-certified laboratory test a split (B) urine specimen when the primary (A) specimen was reported substituted?

14.5 Who receives the split (B) specimen result?

14.6 What action(s) does an MRO take after receiving the split (B) urine specimen result from the second HHS-certified laboratory?

14.7 How does an MRO report a split (B) specimen test result to an agency?

14.8 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 or an HHS-certified IITF to report a specimen as rejected for testing?

15.2 What discrepancies require an HHS-certified laboratory or an HHS-certified IITF 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 or an HHS-certified IITF to reject a urine 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 or IITF Suspension/Revocation Procedures

16.1 When may the HHS certification of a laboratory or IITF 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 and instrumented initial test facilities (IITFs) 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 HHS 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 49 U.S.C. 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 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 Responsible Technician.

The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified IITF when the responsible technician 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 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 Container.

A receptacle used to collect a urine specimen.

Collection Site.

The location where specimens are collected.

Collector.

A person trained to instruct and assist a donor in providing a specimen.

Confirmatory Drug Test.

A second analytical procedure performed on a separate aliquot of a specimen to identify and quantify a specific drug or drug metabolite.

Confirmatory Specimen Validity Test.

A second test performed on a separate aliquot of a specimen to further support 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.

Dilute Specimen.

A urine specimen with creatinine and specific gravity values that are lower than expected but are still within the physiologically producible ranges of human urine.

Donor.

The individual from whom a specimen is collected.

External Service Provider.

An independent entity that performs services related to federal workplace drug testing on behalf of a federal agency, a collector/collection site, an

HHS‐certified laboratory, a Medical Review Officer (MRO), or, for urine, an HHS‐certified Instrumented Initial Test Facility (IITF).

Failed to Reconfirm.

The result reported for a split (B) specimen when a second HHS-certified laboratory is unable to corroborate the result reported for the primary (A) specimen.

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.

Gender Identity.

Gender identity means an individual's internal sense of being male or female, which may be different from an individual's sex assigned at birth.

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 in accordance with the criteria established in Section 3.9 when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.

Laboratory.

A permanent location where initial and confirmatory drug testing, reporting of results, and recordkeeping are performed under the supervision of a responsible person.

Limit of Detection.

The lowest concentration at which the analyte (

e.g.,

drug or drug metabolite) can be identified.

Limit of Quantification.

For quantitative assays, the lowest concentration at which the identity and concentration of the analyte (

e.g.,

drug or drug metabolite) can be accurately established.

Lot.

A number of units of an item (

e.g.,

reagents, quality control material) manufactured from the same starting materials within a specified period of time for which the manufacturer ensures that the items have essentially the same performance characteristics and expiration date.

Medical Review Officer (MRO).

A licensed physician who reviews, verifies, and reports a specimen test result to the federal agency.

Negative Result.

The result reported by an HHS-certified laboratory or (for urine) an HHS-certified IITF to an MRO when a specimen contains no drug and/or drug metabolite; or the concentration of the drug or drug metabolite is less than the cutoff for that drug or drug class.

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) 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.

Responsible Technician (RT).

The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of an HHS-certified IITF.

Sample.

A performance testing sample, calibrator or control used during testing, or a representative portion of a donor's specimen.

Secretary.

The Secretary of the U.S. Department of Health and Human Services.

Specimen.

Fluid or material collected from a donor at the collection site for the purpose of a drug test.

Split Specimen Collection (for Urine).

A collection in which the specimen collected is divided into a primary (A) specimen and a split (B) specimen, which are independently sealed in the presence of the donor.

Standard.

Reference material of known purity or a solution containing a reference material at a known concentration.

Substituted Specimen.

A specimen that has been submitted in place of the donor's urine, as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine.

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, IITFs, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of Section 503 of Public Law 100-71. Each federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, Subparts A and E, may be applicable to certain health care providers with whom a federal agency may contract. If a health care provider is a HIPAA covered entity, the provider must protect the individually identifiable health information it maintains in accordance with the requirements of the Rule, which includes not using or disclosing the information except as permitted by the Rule and ensuring there are reasonable safeguards in place to protect the privacy of the information. For more information regarding the HIPAA Privacy Rule, please visit

http://www.hhs.gov/ocr/hipaa.

Section 1.7 What is a refusal to take a federally regulated drug test?

(a) As a donor for a federally regulated drug test, you have refused to take a federally regulated drug test if you:

(1) Fail to appear for any test (except a pre-employment test) within a

reasonable time, as determined by the federal agency, consistent with applicable agency regulations, after being directed to do so by the federal agency;

(2) Fail to remain at the collection site until the collection process is complete with the exception of a donor who leaves the collection site before the collection process begins for a pre-employment test as described in section 8.4(a);

(3) Fail to provide a specimen (

e.g.,

urine 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 as described in section 8.4(a);

(4) In the case of a direct observed or monitored collection, fail to permit the observation or monitoring of your provision of a specimen when required as described in Sections 8.9 and 8.10;

(5) Fail to provide a sufficient amount of urine when directed, and it has been determined, through a required medical evaluation, that there was no legitimate medical explanation for the failure as determined by the process described in Section 13.6;

(6) Fail or decline to participate in an alternate specimen collection (

e.g.,

oral fluid) as directed by the federal agency or collector (

i.e.,

as described in Section 8.6);

(7) 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;

(8) Fail to cooperate with any part of the testing process (

e.g.,

refuse to empty pockets when directed by the collector, disrupt the collection process, fail to wash hands after being directed to do so by the collector);

(9) For an observed collection, fail to follow the observer's instructions related to the collection process;

(10) Bring materials to the collection site for the purpose of adulterating, substituting, or diluting the specimen;

(11) Attempt to adulterate, substitute, or dilute the specimen;

(12) Possess or wear a prosthetic or other device that could be used to interfere with the collection process; or

(13) Admit to the collector or MRO that you have adulterated or substituted the specimen.

Section 1.8 What are the potential consequences for refusing to take a federally regulated drug test?

(a) As a federal agency employee or applicant, a refusal to take a test may result in the initiation of disciplinary or adverse action, up to and including removal from, or non-selection for, federal employment.

(b) When a donor has refused to participate in a part of the collection process, including failing to appear in a reasonable time for any test except a pre-employment test as described in Section 1.7(a)(1), the collector must terminate the collection process and take action as described in Section 8.13. Required action includes immediately notifying 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 and, if a Federal CCF has been initiated, documenting the refusal on the Federal CCF, signing and dating the Federal CCF, and sending 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—Urine Specimens

Section 2.1 What type of specimen may be collected?

A federal agency may collect urine 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 urine must follow these Guidelines.

Section 2.2 Under what circumstances may a urine specimen be collected?

A federal agency may collect a urine 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 urine specimen collected?

Each urine specimen is collected as a split specimen as described in Section 2.5.

Section 2.4 What volume of urine is collected?

A donor is expected to provide at least 45 mL of urine for a specimen.

Section 2.5 How does the collector split the urine specimen?

The collector pours at least 30 mL into a specimen bottle that is designated as A (primary) and then pours at least 15 mL into a specimen bottle that is designated as B (split).

Section 2.6 When may an entity or individual release a urine 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—Urine Drug and Specimen Validity Tests

Section 3.1 Which tests are conducted on a urine specimen?

A federal agency:

(a) Must ensure that each specimen is tested for marijuana and cocaine metabolites as provided under Section 3.4;

(b) Is authorized to test each specimen for opioids, amphetamines, and phencyclidine, as provided under Section 3.4; and

(c) Must ensure that the following specimen validity tests are conducted on each urine specimen:

(1) Determine the creatinine concentration on every specimen;

(2) Determine the specific gravity on every specimen for which the creatinine concentration is less than 20 mg/dL;

(3) Determine the pH on every specimen; and

(4) Perform one or more specimen validity tests for oxidizing adulterants on every specimen.

(d) If a specimen exhibits abnormal characteristics (

e.g.,

unusual odor or color, semi-solid characteristics), causes reactions or responses characteristic of an adulterant during initial or confirmatory drug tests (

e.g.,

non-recovery of internal standard, unusual

response), or contains an unidentified substance that interferes with the confirmatory analysis, 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. 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 urine?

Initial test analyte

Initial test cutoff

1

Confirmatory test analyte

Confirmatory test

cutoff concentration

Marijuana metabolites (THCA)

2

50 ng/mL

3

THCA

15 ng/mL.

Cocaine metabolite (Benzoylecgonine)

150 ng/mL

3

Benzoylecgonine

100 ng/mL.

Codeine/Morphine

2,000 ng/mL

Codeine

Morphine

2,000 ng/mL.

2,000 ng/mL.

Hydrocodone/Hydromorphone

300 ng/mL

Hydrocodone

Hydromorphone

100 ng/mL.

100 ng/mL.

Oxycodone/Oxymorphone

100 ng/mL

Oxycodone

Oxymorphone

100 ng/mL.

100 ng/mL.

6-Acetylmorphine

10 ng/mL

6-Acetylmorphine

10 ng/mL.

Phencyclidine

25 ng/mL

Phencyclidine

25 ng/mL.

Amphetamine/Methamphetamine

500 ng/mL

Amphetamine

Methamphetamine

250 ng/mL.

250 ng/mL.

MDMA

4

/MDA

5

500 ng/mL

MDMA

MDA

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 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.

2

An immunoassay must be calibrated with the target analyte, Δ-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).

Section 3.5 May an HHS-certified laboratory perform additional drug and/or specimen validity tests on a specimen at the request of the Medical Review Officer (MRO)?

An HHS-certified laboratory is authorized to perform additional drug and/or specimen validity tests on a case-by-case basis as necessary to provide information that the MRO would use to report a verified drug test result (

e.g.,

tetrahydrocannabivarin, specimen validity tests using biomarkers). An HHS-certified laboratory is not authorized to routinely perform additional drug and/or specimen validity tests at the request of an MRO without prior authorization from the Secretary or designated HHS representative, with the exception of the determination of D,L stereoisomers of amphetamine and methamphetamine. All tests must meet appropriate validation and quality control requirements in accordance with these Guidelines.

Section 3.6 What criteria are used to report a urine specimen as adulterated?

An HHS-certified laboratory reports a primary (A) specimen as adulterated when:

(a) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;

(b) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (

e.g.,

multi-wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on the second aliquot;

(c) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (

e.g.,

multi-wavelength spectrophotometry, ion chromatography, atomic absorption spectrophotometry, capillary electrophoresis, inductively coupled plasma-mass spectrometry) with the chromium (VI) concentration equal to or greater than the limit of quantitation (LOQ) of the confirmatory test on the second aliquot;

(d) The presence of halogen (

e.g.,

bleach, iodine, fluoride) is verified using either a general oxidant colorimetric test (with an equal to or great than 200 mcg/mL nitrite-equivalent cutoff or an equal to or great than 50 mcg/mL chromium (VI)-equivalent cutoff) or halogen colorimetric test (halogen concentration equal to or greater than the LOQ) for the initial test on the first aliquot and a different confirmatory test (

e.g.,

multi-wavelength spectrophotometry, ion chromatography, inductively coupled plasma-mass spectrometry) with a specific halogen concentration equal to or greater than the LOQ of the confirmatory test on the second aliquot;

(e) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (

e.g.,

GC/MS) for the confirmatory test with the glutaraldehyde concentration equal to or greater than the LOQ of the analysis on the second aliquot;

(f) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (

e.g.,

GC/MS) for the confirmatory test with the pyridine concentration equal to or greater than the LOQ of the analysis on the second aliquot;

(g) The presence of a surfactant is verified by using a surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (

e.g.,

multi-wavelength spectrophotometry) with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff on the second aliquot; or

(h) The presence of any other adulterant not specified in paragraphs (b) through (g) of this section is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.

Section 3.7 What criteria are used to report a urine specimen as substituted?

An HHS-certified laboratory reports a primary (A) specimen as substituted when the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests on two separate aliquots (

i.e.,

the same colorimetric test may be used to test both aliquots) and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200 on both the initial and confirmatory specific gravity tests on two separate aliquots (

i.e.,

a refractometer is used to test both aliquots).

Section 3.8 What criteria are used to report a urine specimen as dilute?

A dilute result may be reported only in conjunction with the positive or negative drug test results for a specimen.

(a) An HHS-certified laboratory or an HHS-certified IITF reports a primary (A) specimen as dilute when the creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is equal to or greater than 1.002 but less than 1.003 on a single aliquot.

(b) In addition, an HHS-certified laboratory reports a primary (A) specimen as dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030.

Section 3.9 What criteria are used to report an invalid result for a urine specimen?

An HHS-certified laboratory reports a primary (A) specimen as an invalid result when:

(a) Inconsistent creatinine concentration and specific gravity results are obtained (

i.e.,

the creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests and the specific gravity is greater than 1.0010 but less than 1.0200 on the initial and/or confirmatory specific gravity test, the specific gravity is less than or equal to 1.0010 on both the initial and confirmatory specific gravity tests and the creatinine concentration is equal to or greater than 2 mg/dL on either or both the initial or confirmatory creatinine tests);

(b) The pH is equal to or greater than 4 and less than 4.5 or equal to or greater than 9 and less than 11 using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;

(c) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial (first) test and the second test or using either initial test and the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL for a different confirmatory test (

e.g.,

multi-wavelength spectrophotometry, ion chromatography, capillary electrophoresis) on two separate aliquots;

(d) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial (first) test and the second test on two separate aliquots;

(e) The possible presence of a halogen (

e.g.,

bleach, iodine, fluoride) is determined using the same halogen colorimetric test with a cutoff equal to or greater than the LOQ for both the initial (first) test and the second test on two separate aliquots or relying on the odor of the specimen as the initial test;

(f) The possible presence of glutaraldehyde is determined by using the same aldehyde test (aldehyde present) or characteristic immunoassay response on one or more drug immunoassay tests for both the initial (first) test and the second test on two separate aliquots;

(g) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen concentration is equal to or greater than the LOQ) for both the initial (first) test and the second test on two separate aliquots;

(h) The possible presence of a surfactant is determined by using the same surfactant colorimetric test with an equal to greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial (first) test and

the second test on two separate aliquots or a foam/shake test for the initial test;

(i) 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);

(j) Interference with the drug confirmatory assay occurs on two separate aliquots of the specimen and the laboratory is unable to identify the interfering substance;

(k) The physical appearance of the specimen (

e.g.,

viscosity) is such that testing the specimen may damage the laboratory's instruments; or

(l) The specimen has been tested and the appearances of the primary (A) and the split (B) specimens (

e.g.,

color) are clearly different; or

(m) The concentration of a biomarker is not consistent with that established for human urine for both the initial (first) test and the second test on two separate aliquots.

Subpart D—Collectors

Section 4.1 Who may collect a specimen?

(a) A collector who has been trained to collect urine specimens in accordance with these Guidelines.

(b) The immediate supervisor of a federal employee donor may only collect that donor's specimen when no other collector is available. The supervisor must be a trained collector.

(c) The hiring official of a federal agency applicant may only collect that federal agency applicant's specimen when no other collector is available. The hiring official must be a trained collector.

Section 4.2 Who may not collect a specimen?

(a) A federal agency employee who is in a testing designated position and subject to the federal agency drug testing rules must not be a collector for co-workers in the same testing pool or who work together with that employee on a daily basis.

(b) A federal agency applicant or employee must not collect their own drug testing specimen.

(c) An employee working for an HHS-certified laboratory or IITF 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 they fulfill the following conditions:

(1) Is knowledgeable about the collection procedure described in these Guidelines;

(2) Is knowledgeable about any guidance provided by the federal agency's Drug-Free Workplace Program and additional information provided by the Secretary relating to these Guidelines;

(3) Is trained and qualified to collect a urine specimen. Training must include the following:

(i) All steps necessary to complete a urine 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 pro

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