Mandatory Guidelines for Federal Workplace Drug Testing Programs

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DEPARTMENT OF HEALTH AND HUMAN SERVICES 42 CFR Chapter I Mandatory Guidelines for Federal Workplace Drug Testing Programs AGENCY:

Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS).

ACTION:

Notification of mandatory guidelines.

SUMMARY:

The Department of Health and Human Services (“HHS” or “Department”) is proposing to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the Federal Register of January 23, 2017.

DATES:

Submit comments on or before June 6, 2022.

ADDRESSES:

In commenting, please refer to file code SAMHSA 2022-0001. Because of staff and resource limitations, SAMHSA cannot accept comments by facsimile (fax) transmission.

You may submit comments in one of four ways (please choose only one of the ways listed):

• Electronically. You may submit electronic comments on this document to https://www.regulations.gov. Follow “Submit a comment” instructions.

• By regular mail. You may mail written comments to the following address: SAMHSA, Center for Substance Abuse Prevention (CSAP), Division of Workplace Programs (DWP), 5600 Fishers Lane, Room 16N02, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.

• By express or overnight mail. You may send written comments to the following address: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02, Rockville, MD 20857.

2, Rockville, MD 20857.

• By hand or courier. You may deliver your written comments by hand or courier to the following address prior to the close of the comment period: SAMHSA, CSAP, DWP, 5600 Fishers Lane, Room 16N02, Rockville, MD 20857. If you intend to deliver your comments to the Rockville address, please call (240) 276-2600 in advance to schedule your arrival with one of our staff members. Because access to the SAMHSA building is secure, persons without Federal Government identification are encouraged to schedule their delivery or to leave comments with the security guard at the front desk located in the main lobby of the building.

All comments received before the close of the comment period will be available for viewing by the public. Please note that all comments are posted in their entirety, including personal or confidential business information that is included in the comment. SAMHSA will post all comments before the close of the comment period on the following website: https://www.regulations.gov. Use the website's search function to view the associated comments.

Comments received before the close of the comment period will also be available for public inspection as they are received, generally beginning approximately three weeks after publication of a document, at SAMHSA, CSAP, DWP, 5600 Fishers Lane, Rockville, MD 20857, Monday through Friday of each week, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, please call (240) 276-2600.

FOR FURTHER INFORMATION CONTACT:

Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276-1459 or by email at Eugene.Hayes@samhsa.hhs.gov

Rockville, MD 20857, Monday through Friday of each week, excluding Federal holidays, from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, please call (240) 276-2600.

FOR FURTHER INFORMATION CONTACT:

Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276-1459 or by email at Eugene.Hayes@samhsa.hhs.gov.

SUPPLEMENTARY INFORMATION:

Executive Summary

This notification of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) includes revisions that will: Establish a process whereby the Department annually publishes the authorized drug testing panel ( i.e., drugs, analytes, and cutoffs) to be used for Federal workplace drug testing programs; revise the definition of a substituted specimen to include specimens with a biomarker concentration inconsistent with that established for a human specimen; establish a process whereby the Department publishes an authorized biomarker testing panel ( i.e., biomarkers, analytes, and cutoffs) for Federal workplace drug testing programs; revise the confirmatory test cutoff for morphine; revise the Medical Review Officer (MRO) verification process for positive codeine and morphine specimens; and require MROs to submit semiannual reports to the Secretary or designated HHS representative on Federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative by the MRO. In addition, some wording changes have been made for clarity and for consistency with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), 84 FR 57554 (October 25, 2019), or to apply to any authorized specimen type.

The Department is publishing a separate Federal Register Notification (FRN) elsewhere in this issue of the Federal Register proposing revisions to the OFMG, including the same or similar revisions proposed for the UrMG, where appropriate

ory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG), 84 FR 57554 (October 25, 2019), or to apply to any authorized specimen type.

Background

The Department of Health and Human Services, pursuant to the Department's authority under Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order 12564, establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies. Using data obtained from the Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by 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). SAMHSA published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) on January 23, 2017 (82 FR 7920), and HHS published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554)

November 13, 1998 (63 FR 63483), April 13, 2004 (69 FR 19644), and November 25, 2008 (73 FR 71858). SAMHSA published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) on January 23, 2017 (82 FR 7920), and HHS published the current Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) on October 25, 2019 (84 FR 57554).

Proposed Revisions to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs

Authorized Drug Testing Panel

The Guidelines pertain to a matter of Federal agency personnel and, therefore, are not subject to the notice and comment procedures under the Administrative Procedures Act. In light of the potential impact on entities outside of the Federal Government, the Department has chosen to submit the Guidelines to notice and comment, and will continue to do so. In this revision, the Department is proposing to change the way a specific part of the Guidelines i.e., the drug testing panel) is published and the frequency with which it is published.

Since the original Guidelines were published in 1988, several recommendations have been made for drugs to be added to or removed from Federal workplace drug testing programs. The Department has revised the Guidelines in the past to add or remove drugs from the authorized drug testing panel and to revise test cutoffs ( i.e., Section 3.4 of the UrMG). The time required to revise the Guidelines through the Federal review process has impeded the Department's ability to respond to drug use trends. Individuals may change their drug use, and illicit drug manufacturers may change their manufacturing methods, to avoid testing positive for drugs included in proposed Guidelines, especially as the number of new drugs and drug analogues increases. A less flexible drug testing panel may delay needed drug analyte or cutoff changes based on the state of the science ( e.g., new technologies, research including dosing studies)

heir drug use, and illicit drug manufacturers may change their manufacturing methods, to avoid testing positive for drugs included in proposed Guidelines, especially as the number of new drugs and drug analogues increases. A less flexible drug testing panel may delay needed drug analyte or cutoff changes based on the state of the science ( e.g., new technologies, research including dosing studies). Therefore, the Department proposes to publish the drug testing panel in the Federal Register on at least an annual basis, including any revisions to the panel, without the need (perceived or otherwise) to undergo notice and comment. Should the Department remove a drug from the drug testing panel, a Federal agency may test specimens for that drug in accordance with Section 3.2 ( i.e., on a case-by-case basis for reasonable suspicion or post accident testing, or routinely with a waiver from the Secretary). This process is expected to improve the effectiveness of Federal agency drug testing programs in support of the Federal Drug-Free Workplace Program. The drug testing panel in Section 3.4 of the final UrMG will remain in effect until the Department publishes a separate FRN with the drug testing panel.

The Department will continue to monitor drug use trends and review information on new drugs of abuse from sources such as Federal regulators, researchers, the drug testing industry (including HHS-certified laboratories), and public and private sector employers, to determine whether drugs should be added or removed from the panel. Any changes to analytes and cutoffs made in accordance with the newly established drug testing panel publishing process will be based on a thorough review of relevant information, including the current state of the science, laboratory capabilities, cost associated with the change, and benefits of the change to Federal agencies

, to determine whether drugs should be added or removed from the panel. Any changes to analytes and cutoffs made in accordance with the newly established drug testing panel publishing process will be based on a thorough review of relevant information, including the current state of the science, laboratory capabilities, cost associated with the change, and benefits of the change to Federal agencies. The Department will set a date for the panel changes to take effect and include the effective date in the annual drug testing panel FRN in order to allow time for drug testing service providers ( e.g., immunoassay kit manufacturers) to develop or revise their products, and for HHS-certified laboratories to develop or revise assays, complete validation studies, and revise procedures. The prior version of the panel will remain in effect until the effective date of a newly published annual panel.

For consistency and to avoid misinterpretation of drug test results, the Department is requiring HHS-certified laboratories and HHS-certified instrumented initial test facilities (collectively referred to hereafter as “HHS-certified test facilities”) and Medical Review Officers (MROs) to report results using the nomenclature ( i.e., analyte names and abbreviations) published with the drug testing panel.

Authorized Biomarker Testing Panel

A biomarker is an endogenous substance used to validate a biological specimen. The purpose of a biomarker test is to determine whether a submitted specimen is a human specimen. The current UrMG (effective October 1, 2017) allow additional specimen validity testing using biomarkers upon MRO request, to provide information to assist the MRO in the verification process. The current UrMG also require HHS-certified laboratories to report a specimen as invalid when the biomarker is not present or when its concentration is not consistent with that established for human urine but does not allow these specimens to be reported as substituted

specimen validity testing using biomarkers upon MRO request, to provide information to assist the MRO in the verification process. The current UrMG also require HHS-certified laboratories to report a specimen as invalid when the biomarker is not present or when its concentration is not consistent with that established for human urine but does not allow these specimens to be reported as substituted. The Department proposes to revise the UrMG to define such specimens as substituted, and to allow only biomarker tests that have been authorized by SAMHSA for use in Federal agency workplace drug testing programs.

To ensure that scientifically valid biomarker tests, analytes, and cutoffs are standardized for Federal workplace drug testing, the Department will institute an approval process for biomarker tests, based on review of data from the scientific and/or medical literature, before authorizing the use of the biomarker test. This process is equivalent to the approval process currently in use for testing additional Schedule 1 and 2 drugs or adding new tests for a specific adulterant. The Department will accept scientific information submitted for review from various sources ( e.g., HHS-certified test facilities, drug testing industry stakeholders, researchers). The Department will include the authorized biomarker testing panel ( i.e., a table of biomarkers authorized for testing, with test analytes and cutoffs), in the FRN to be published annually (as described earlier in this preamble). Federal agencies may choose to test some or all of their workplace specimens for one or more authorized biomarkers.

An HHS-certified laboratory, or (for urine only) an HHS-certified instrumented initial test facility (IITF), may request authorization from SAMHSA to conduct a biomarker test that has not been included on the list of authorized biomarkers. The test facility must submit supporting documentation and assay validation records to the National Laboratory Certification Program (NLCP) for SAMHSA review and approval

tified laboratory, or (for urine only) an HHS-certified instrumented initial test facility (IITF), may request authorization from SAMHSA to conduct a biomarker test that has not been included on the list of authorized biomarkers. The test facility must submit supporting documentation and assay validation records to the National Laboratory Certification Program (NLCP) for SAMHSA review and approval. When a urine biomarker test is approved through this process, SAMHSA will authorize the individual HHS-certified test facility to perform the biomarker test for federally regulated specimens only upon MRO request ( i.e., a blanket request for all specimens or a case-by-case request for a specific specimen). A certified laboratory or IITF may choose to begin the process by submitting supporting documentation for review prior to assay validation, or may send supporting documentation with completed validation records. The Department will continue to include measurands and decision points for other specimen validity tests in the UrMG ( e.g., Sections 11.19 and 12.15).

Once a biomarker test has been added to the authorized biomarker panel published in the FRN, any HHS-certified laboratory or IITF may routinely conduct the test without requiring an MRO request, and only require a signed MRO request for case-by-case biomarker testing (in accordance with UrMG section 3.5). The Department will continue to require NLCP review of biomarker assay validation records before allowing an IITF or laboratory to use the test for federally regulated workplace specimens.

This process will facilitate the identification of donors who attempt to subvert their drug test, and ensure that biomarker tests used for federally regulated workplace programs are scientifically supportable and properly validated, and that all HHS-certified test facilities use the same analytes and cutoffs

owing an IITF or laboratory to use the test for federally regulated workplace specimens.

For consistency and to avoid misinterpretation of biomarker test results, the Department is requiring HHS-certified test facilities and Medical Review Officers (MROs) to report results using the nomenclature ( i.e., analyte names and abbreviations) published with the biomarker testing panel.

Medical Review Officer (MRO) Verification of Codeine and Morphine Test Results

The MRO has an essential role in federally regulated workplace drug testing programs that includes performing the review of laboratory results and supporting documentation, interviewing the donor when necessary, and making a final determination regarding the result. As described in Section 13.5d(2) of the current UrMG, when a donor has no legitimate medical explanation for a positive codeine or morphine result equal to or greater than 15,000 ng/mL, the MRO reports the specimen as positive to the agency. When a donor has no legitimate medical explanation for a positive codeine or morphine result less than 15,000 ng/mL, the MRO must determine that there is clinical evidence of illegal opioid use (in addition to the test results) to report such specimens as positive. If the MRO finds no clinical evidence of illegal opioid use, the MRO verifies the opiate results as negative. These requirements were included in the UrMG to address positive codeine and/or morphine results that may be due to poppy seed ingestion

/mL, the MRO must determine that there is clinical evidence of illegal opioid use (in addition to the test results) to report such specimens as positive. If the MRO finds no clinical evidence of illegal opioid use, the MRO verifies the opiate results as negative. These requirements were included in the UrMG to address positive codeine and/or morphine results that may be due to poppy seed ingestion. The Department proposes to remove the additional decision point for codeine and morphine, to adjust the confirmatory test cutoff for morphine from 2,000 to 4,000 ng/mL, and to remove the additional requirement for clinical evidence of illegal opioid use, as described above. The confirmatory test cutoff for codeine will remain at 2,000 ng/mL. The basis for the Department's proposed changes is described in the following paragraphs.

A review of the scientific literature, as cited below, regarding the role of poppy seed food products in producing positive urine drug tests for the opiates, codeine and morphine, was undertaken to ascertain whether the current decision point should be maintained or changed. The Department focused on studies using analytical techniques acceptable to modern forensic toxicology laboratories, for which the researchers included information on poppy seed doses and adequately described the analytical techniques. Because most common poppy variants produce morphine in great excess to codeine, morphine concentrations significantly exceeded codeine concentrations in all reviewed studies.

Studies of patients being tested for abstention from heroin use suggest that urine concentrations of morphine are often below 15,000 ng/mL and the heroin metabolite, 6-acetylmorphine (6-AM) is absent, indicating the heroin use was not within the short detection limit for 6-AM. A study by Colby et al. examined morphine concentrations in urine specimens from chronic pain patients being monitored for medication compliance

ing tested for abstention from heroin use suggest that urine concentrations of morphine are often below 15,000 ng/mL and the heroin metabolite, 6-acetylmorphine (6-AM) is absent, indicating the heroin use was not within the short detection limit for 6-AM. A study by Colby et al. examined morphine concentrations in urine specimens from chronic pain patients being monitored for medication compliance. Patients with positive 6-AM results had morphine concentrations averaging 85,000 ng/mL (±154,000 ng/mL), with 25% at or below 10,000 ng/mL and an additional 15% falling between 10,000 ng/mL and 20,000 ng/mL. (Ref. 1) However, it is well known that 6-AM is generally positive in only the first few urine specimens following heroin dosing, making it the limiting factor in unequivocal detection of heroin use. (Ref. 2 and 3) Further, in a study by Wang et al., heroin metabolites including morphine were measured in subjects seeking in-patient addiction treatment for heroin use. In 20 subjects without 6-AM positive urine specimens, the total morphine concentration ranged from 87 to 34,896 ng/mL and averaged 9,960 ng/mL. Only 30% of the subjects had specimens above the 15,000 ng/mL decision point specified by the current UrMG. Lowering the morphine cutoff to 4,000 ng/mL would identify another 30% of the heroin users in this type of cohort. (Ref. 4)

In regard to poppy seed food products, the literature is consistent in the conclusion that regular ingestion of poppy seed-containing foods (bagels, cakes, curries, etc.) rarely results in urine opiate concentrations above the 2,000 ng/mL cutoff specified in the current UrMG, and that proper handling by pre-washing and cooking the poppy seeds into food products causes loss of both morphine and codeine. Studies attempting to characterize morphine and codeine results after reasonable consumption of poppy seed food products on an acute and chronic basis reported maximum morphine concentrations ranging between 160 and 3,000 ng/mL with codeine ranging between 11 and 390 ng/mL. (Ref

proper handling by pre-washing and cooking the poppy seeds into food products causes loss of both morphine and codeine. Studies attempting to characterize morphine and codeine results after reasonable consumption of poppy seed food products on an acute and chronic basis reported maximum morphine concentrations ranging between 160 and 3,000 ng/mL with codeine ranging between 11 and 390 ng/mL. (Ref. 3 and 5-8) There is only one study in which the urine concentration of morphine exceeded 4,000 ng/mL after ingestion of regular prepared food containing poppy seeds, and the researchers reported that some subjects became ill due to the large amount of poppy seeds in the food product. (Ref. 9) The results of this study have not been duplicated in subsequent studies involving prepared food products.

Other studies used extreme exposure protocols involving intolerable or near intolerable amounts of raw and/or unwashed poppy seeds, which are known to contain much more codeine and morphine than their washed and cooked counterparts. In one such extreme study in 2015, the researchers reported that participants felt that 15 g of raw, unwashed poppy seeds was close to the bearable limit for ingestion, and the maximum urine concentration was 4,200 ng/mL for morphine and 664 ng/mL for codiene. (Ref. 7) Of note, this study also included the same dose of poppy seeds baked in a roll and maximum morphine and codeine concentrations were considerably lower at 1,400 and 194 ng/ml, respectively. This research confirms the results of extreme ingestion by three volunteers in a 2003 study by Rohrig and Moore, and the experience in a 2014 study by Smith et al. in which only 19 of 22 participants could tolerate ingestion of all planned doses. (Ref. 10 and 11) Further, in the 2014 study, seven of the 19 subjects did not produce a positive morphine result ( i.e., ≥2,000 ng/mL) until after the second extreme dose of poppy seeds, approximately eight hours after the first dose

2003 study by Rohrig and Moore, and the experience in a 2014 study by Smith et al. in which only 19 of 22 participants could tolerate ingestion of all planned doses. (Ref. 10 and 11) Further, in the 2014 study, seven of the 19 subjects did not produce a positive morphine result ( i.e., ≥2,000 ng/mL) until after the second extreme dose of poppy seeds, approximately eight hours after the first dose. At all times in this study, codeine results were below the 2,000 ng/mL cutoff. The Department finds these studies relevant to setting the cutoff limit of 4,000 ng/mL for morphine and sufficient for eliminating positives due to poppy seeds because they confirm that urine morphine concentrations exceeding 4,000 ng/mL would be very rare, transient, and a consequence of unrealistic and extreme poppy seed exposure ( i.e., ingesting barely tolerable amounts of raw and/or unwashed poppy seeds).

The Department also reviewed information on other sources of poppy seed exposure. In reaction to at least 12 deaths reported in the scientific literature associated with the use of tea prepared with unwashed poppy seeds and the availability of unwashed poppy seeds from online retailers, the Drug Enforcement Administration (DEA) issued a warning in 2019 restating that unwashed poppy seeds are a danger to the user, and their use and misuse may result in unpredictable outcomes including death when used alone or in combination with other drugs. DEA reiterated that the morphine and codeine, if present as contaminants on poppy seed material, are not exempted from the Controlled Substances Act (CSA) control. (Ref. 12)

d that the morphine and codeine, if present as contaminants on poppy seed material, are not exempted from the Controlled Substances Act (CSA) control. (Ref. 12)

In summary, the Department is not aware of any evidence that reasonable or realistic consumption of poppy seed-containing food products would cause a positive drug test using the codeine and morphine cutoffs specified by these Guidelines. Only purposeful consumption of large amounts ( e.g., 15 g or more) of raw and/or unwashed poppy seeds has been shown to result in codeine at or above 600 ng/mL or in morphine exceeding 4,000 ng/mL, and

Based on this information, the Department has decided that no additional decision point is needed for MRO verification of codeine and morphine results. Further, the Department has concluded that continued use of the current 15,000 ng/mL decision point diminishes the deterrent effect of the program by attributing codeine and morphine results between the cutoff and 15,000 ng/mL to poppy seed ingestion in the absence of a legitimate medical explanation. The Department proposes to raise the confirmatory test cutoff for morphine to 4,000 ng/mL to rule out any donor claims that consumption of poppy seed food products (on an acute or chronic basis) was the reason for a positive morphine test result. This cutoff change makes the Federal drug testing program cutoffs for codeine and morphine the same as the Department of Defense (DoD) program cutoffs, which were previously raised to these concentrations to eliminate positive tests due to poppy seeds. (Ref. 14)

Medical Review Officer (MRO) Semiannual Reports

The Department, through the NLCP, obtains information from HHS-certified laboratories that is reviewed to verify accurate reports and compliance with Guidelines requirements. The NLCP conducts statistical analysis and provides reports to the Department on federally regulated workplace testing, although the data are limited to laboratory-reported results and not the final, MRO-verified results. To obtain additional information needed to assess compliance with the Mandatory Guidelines, the Department proposes to require each MRO performing medical review services for Federal agencies to submit semiannual reports, in January and July of each year, of Federal agency specimens that were reported as positive for a drug or drug metabolite by the laboratory, and verified as negative by the MRO, along with the reason for the negative verification ( e.g., a valid prescription for a drug). The reports will not contain any personally identifiable information of the donors.

This revision to the Guidelines will enable Department oversight of MRO reporting practices and will enhance the Department's ability to verify the accuracy of MRO reports and address areas of confusion about Guidelines requirements. The information in the MRO reports will be matched to information submitted to the NLCP by HHS-certified laboratories for the same specimens. This additional information will improve statistical analyses and provide a clearer picture of illicit drug use by Federal job applicants and employees.

Proposed Revisions to the Guidelines

This preamble describes the proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), and the rationale for the changes.

Subpart A—Applicability

Section 1.5 defines terms used in the UrMG. The Department has added terms and revised definitions in this section in accordance with proposed changes to these Guidelines, and to standardize terms and definitions, where possible, to apply to all authorized specimen types

s for Federal Workplace Drug Testing Programs using Urine (UrMG), and the rationale for the changes.

Subpart A—Applicability

The Department proposes to revise the Substituted Specimen definition to include specimens tested for a biomarker, when the biomarker is absent or is present at a concentration inconsistent with that established for a human specimen. For clarity, the Department also added a reference to the reporting criteria for substitution in Section 3.7 of these Guidelines. For clarity and consistency with the revised Substituted Specimen definition, the Department proposes to edit the Adulterated Specimen definition to apply to specimens with “an abnormal concentration of a normal constituent ( e.g., nitrite in urine),” rather than “an abnormal concentration of an endogenous substance,” and to revise definitions for Cutoff and Initial Specimen Validity Test to remove the “(for urine)” specification for identifying a substituted specimen. The Department proposes to revise the Collection Container definition to apply to all authorized specimen types, by changing “a urine specimen” to “a donor's drug test specimen.” The Department has also added definitions for “Biomarker Testing Panel” and “Drug Testing Panel” consistent with the proposed publication of these testing panels in a separate FRN each year.

th the proposed publication of these testing panels in a separate FRN each year.

Section 1.7 describes what constitutes a donor's refusal to take a federally regulated drug test. Section 1.7(a) includes exceptions for a donor who fails to appear in a reasonable time for a pre-employment test and a donor who leaves the collection site before the collection process begins for a pre-employment test. The Department finds that there is no justification for altering a refusal to test based on whether the test is being conducted in the employment or pre-employment context and, therefore, proposes to remove these exceptions. The collector will report a refusal to test for any donor who fails to appear in a reasonable time or who leaves the collection site before the collection is complete, regardless of the reason for the test.

Section 1.8(a) describes the potential consequences for a refusal to test. The Department has reworded this section to clarify potential actions for a Federal employee who refuses to take a drug test, and the potential action for an applicant who refuses to take a pre-employment test.

Subpart C—Urine Specimen Tests

The Department proposes to edit Section 3.1 to reflect the proposed process for publishing drug and biomarker testing panels in an FRN each year containing a list of authorized drug analytes and biomarkers that can be tested. As described under Authorized drug testing panel and Authorized biomarker testing panel above, the time required to revise the Guidelines through the Federal review process has impeded the Department's ability to respond to drug use trends, and to make drug analyte or cutoff changes based on the state of the science ( e.g., new technologies, research including dosing studies). This new process is expected to improve the effectiveness of Federal agency drug testing programs in support of the Federal Drug-Free Workplace Program. See also Section 3.4

eral review process has impeded the Department's ability to respond to drug use trends, and to make drug analyte or cutoff changes based on the state of the science ( e.g., new technologies, research including dosing studies). This new process is expected to improve the effectiveness of Federal agency drug testing programs in support of the Federal Drug-Free Workplace Program. See also Section 3.4.

For clarity, the Department also revised the header for Section 3.2 to refer to “drugs other than those in the drug testing panel” (see above) rather than “additional drugs”.

The Department has revised the analytes and cutoffs table in Section 3.4 of the UrMG to reflect the proposed change to the confirmatory cutoff for morphine, and revised the section to describe the publication of a final notification in the Federal Register each year that will include the authorized drugs, test analytes, and cutoffs; the authorized biomarkers, test analytes, and cutoffs; and the nomenclature required for IITF, laboratory, and MRO reports. The annual notification will be posted on the SAMHSA website, https://www.samhsa.gov/workplace. The table in Section 3.4 of the final UrMG will remain in effect until the effective date of the new panels published in the separate FRN.

Section 3.7 describes the criteria used to report a specimen as substituted and Section 3.9 describes the criteria used to report an invalid result for a urine Authorized biomarker testing panel above, the purpose of a biomarker test is to determine whether a submitted specimen is a human specimen. Therefore, the Department proposes to revise these sections to require specimens to be reported as substituted, rather than invalid, based on biomarker testing. See also Section 1.5.

Subpart H—Urine Specimen Collection Procedure

The Department proposes to revise the wording in Section 8.3(f) regarding how instructions for completing the Federal Custody and Control Form (CCF) are provided to the donor

re, the Department proposes to revise these sections to require specimens to be reported as substituted, rather than invalid, based on biomarker testing. See also Section 1.5.

Subpart H—Urine Specimen Collection Procedure

The Department proposes to revise the wording in Section 8.3(f) regarding how instructions for completing the Federal Custody and Control Form (CCF) are provided to the donor. This is consistent with changes made to the Federal CCF to enable its use with both urine and oral fluid specimens.

The Department moved items under Section 8.3(h) into a new item 8.3(i) addressing the collector's request for the donor to display the contents of their pockets and subsequent collector actions. The required actions remain the same, but the Department revised wording in new items 8.3(i)(1) through 8.3(i)(4) for clarity.

In Section 8.5(a), the Department clarified that the collector must inform the donor that the donor's failure to remain at the collection site until the collection is complete will be reported as a refusal to test. This is consistent with Section 1.7.

The Department also revised wording in Section 8.9(a)(3) for clarity.

Subpart I—HHS Certification of Laboratories and IITFs

Section 9.7 describes performance test (PT) requirements for an HHS-certified laboratory and Section 9.9 describes PT requirements for an HHS-certified IITF. PT error criteria will remain the same; however, the Department is proposing to edit some items for clarity. Specifically, the Department proposes to revise Sections 9.7(a)(5), 9.7(a)(10), and 9.9(a)(6) to state clearly that quantitative values reported for drug and specimen validity tests are evaluated based on reported results for each PT cycle, not on cumulative results reported over two consecutive PT cycles. An HHS-certified test facility must not obtain a quantitative value outside the specified range for a drug or specimen validity test result, based on the appropriate reference or peer group mean

clearly that quantitative values reported for drug and specimen validity tests are evaluated based on reported results for each PT cycle, not on cumulative results reported over two consecutive PT cycles. An HHS-certified test facility must not obtain a quantitative value outside the specified range for a drug or specimen validity test result, based on the appropriate reference or peer group mean.

The Department also revised Section 9.6(a)(11) for an applicant laboratory and Section 9.7(a)(10) for an HHS-certified laboratory to address requirements for PT samples reported as substituted based on biomarker test results, in addition to those reported as substituted based on creatinine and specific gravity test results.

Subpart K—Laboratory

Section 11.19 describes the requirements for an HHS-certified laboratory to report primary (A) specimen test results to an MRO. The Department proposes to revise the requirements for reporting a specimen as substituted in item 11.19(e) to include specimens with a biomarker concentration inconsistent with that established for human urine, in addition to those reported as substituted based on creatinine and specific gravity test results (see also Sections 1.5, 3.7, and 3.9).

Section 11.19(g) addresses laboratory and MRO discussions to determine whether additional testing may be useful for specimens with certain invalid results. Because biomarker testing could be used to identify substitution, the Department has revised this section to indicate that additional testing may be useful in being able to report a substituted result, as well as positive or adulterated results.

Section 11.19(g) describes the requirements for a laboratory to report a specimen as invalid. The Department has added an item 13 addressing tests used to determine specimen validity, other than those specifically listed in this section

revised this section to indicate that additional testing may be useful in being able to report a substituted result, as well as positive or adulterated results.

The Department also proposes to add a new item 11.19(m) stating that the laboratory must use the HHS-specified nomenclature published with the drug and biomarker testing panels on reports. This change is to ensure consistency in reporting and interpretation of test results, by requiring the results of each test performed to be reported using clear and correct nomenclature for test analytes, with the same terminology and units of measurement. See also Section 3.4.

Subpart L—Instrumented Initial Test Facility (IITF)

Section 12.15 describes the requirements for an HHS-certified IITF to report primary (A) specimen test results to an MRO. The Department proposes to add a new item 12.15(e) stating that the IITF must use the HHS-specified nomenclature published with the drug and biomarker testing panels on reports. See also Section 3.4.

Subpart M—Medical Review Officer (MRO)

Section 13.4(f) describes when an MRO must conduct a medical examination or review an examining physician's findings when the collector reported that the donor was unable to provide a specimen. The Department has clarified that a medical examination is not required when an alternate specimen was collected.

Section 13.5(c)(2) describes MRO actions when a laboratory reports an invalid result in conjunction with a positive, adulterated, or substituted result

examination or review an examining physician's findings when the collector reported that the donor was unable to provide a specimen. The Department has clarified that a medical examination is not required when an alternate specimen was collected.

Section 13.5(c)(2) describes MRO actions when a laboratory reports an invalid result in conjunction with a positive, adulterated, or substituted result. The Department has added an item to this section to clarify that the MRO takes the required action for the invalid result (specified in item f of this section) only when the MRO has verified the other result(s) for the specimen ( i.e., positive, adulterated, or substituted) as negative or when the split (B) specimen was tested and reported as a failure to reconfirm.

Section 13.5(d) describes MRO actions to determine whether the donor has a legitimate medical explanation for a positive specimen test result. The Department added a new item Section 13.5(d)(1) to clarify that the MRO reports a positive result when the donor admits unauthorized use of the drug(s) that caused the positive test result, and documents the admission of unauthorized use in the MRO records and in the MRO's report to the Federal agency. A donor's admission of unauthorized use corroborates the positive test.

Currently, Section 13.5(d)(2) includes the policies of the Department that passive exposure to marijuana smoke and ingestion of food products containing marijuana are not acceptable medical explanations for a positive marijuana test result. The Department proposes to reword this section to clarify that these policies apply to any positive urine drug test results, not only positive marijuana results. Item i of this section now states that passive exposure to any drug is not an acceptable medical explanation for a positive drug test, with “exposure to secondhand marijuana smoke” as an example of passive exposure

marijuana test result. The Department proposes to reword this section to clarify that these policies apply to any positive urine drug test results, not only positive marijuana results. Item i of this section now states that passive exposure to any drug is not an acceptable medical explanation for a positive drug test, with “exposure to secondhand marijuana smoke” as an example of passive exposure. Item ii of this section now states that ingestion of food products containing a drug is not an acceptable medical explanation for a positive drug test, with “products containing marijuana” and “poppy seeds containing codeine and/or morphine” as examples. The Department also proposes to add a new item iii to this section stating that a physician's authorization or medical recommendation for a Schedule I

Section 13.5(d)(3) describes MRO actions when the donor has no legitimate medical explanation for a positive drug test result. The Department has revised this section to remove the exceptions for codeine and morphine. As described above under MRO verification of codeine and morphine test results, the Department has removed the additional 15,000 ng/mL decision point for codeine and morphine, as well as the requirement for the MRO to report such specimens as positive based on clinical evidence of illicit drug use (in addition to the drug test results). The MRO will follow the same verification procedures for all specimens with positive test results.

Section 13.9 describes how an MRO reports primary (A) drug test results to an agency. The Department proposes to add a new item 13.9(e) stating that the MRO must use the HHS-specified nomenclature published with the drug and biomarker testing panels on reports. See also Section 3.4.

HHS-specified nomenclature published with the drug and biomarker testing panels on reports. See also Section 3.4.

The Department has included a new Section 13.11 describing the proposed requirement for an MRO to send semiannual reports to the Secretary or designated HHS representative for Federal agency specimens that were reported as positive by a laboratory and verified as negative by the MRO. As described under Medical Review Officer (MRO) semiannual reports above, this change will enable Department oversight of MRO practices and will enhance the Department's ability to verify the accuracy of MRO reports and address areas of confusion about Guidelines requirements. In addition, the information in the MRO reports will be matched to information submitted to the NLCP by HHS-certified laboratories for the same specimens, thereby improving statistical analyses and providing a clearer picture of illicit drug use by Federal job applicants and employees. The reports must not include any personally identifiable information for the donor, and must be submitted within 14 working days after the end of the semiannual period ( i.e., in July and January). Section 13.11 lists the information that must be included on the reports. To facilitate report preparation and review, the Department will include a template for these MRO reports in the MRO Guidance Manual and will arrange a secure method for MROs to submit reports electronically.

The Department has included a new Section 13.12 describing the Federal agency's responsibilities for designating an MRO. These responsibilities include verifying and documenting that individuals meet the MRO requirements in these Guidelines before allowing them to serve as an MRO for the agency's drug testing program and on an ongoing basis, and ensuring that each MRO reports drug test results in accordance with the Guidelines

new Section 13.12 describing the Federal agency's responsibilities for designating an MRO. These responsibilities include verifying and documenting that individuals meet the MRO requirements in these Guidelines before allowing them to serve as an MRO for the agency's drug testing program and on an ongoing basis, and ensuring that each MRO reports drug test results in accordance with the Guidelines. Further, the Federal agency must obtain documentation from the MRO to confirm that the MRO and any external service provider ensures the confidentiality integrity and availability of the data and limits the access to any data transmission, storage, and retrieval system.

Subpart N—Split Specimen Tests

Section 14.4 describes how an HHS-certified laboratory reports a split (B) urine specimen when the primary (A) specimen was reported substituted. The Department proposes to revise this section to address primary (A) specimens reported as substituted based on biomarker test results, in addition to those reported as substituted based on creatinine and specific gravity test results. See also Section 1.5.

Section 14.5 states that the HHS-certified laboratory that tested a split (B) specimen must report the results to the MRO. The Department proposes to reword this section to require the laboratory to use the HHS-specified nomenclature published with the drug and biomarker testing panels on reports for split (B) specimens. See also Section 3.4.

Section 14.6 describes the actions an MRO takes after receiving a split (B) urine specimen result from an HHS-certified laboratory. Section 14.6(c) specifies MRO actions when the laboratory failed to reconfirm one or more positive results and reported the split specimen as substituted. The Department proposes to revise this item to address actions when the B specimen was reported as substituted based on biomarker test results, in addition to those reported as substituted based on creatinine and specific gravity test results. See also Section 1.5

cifies MRO actions when the laboratory failed to reconfirm one or more positive results and reported the split specimen as substituted. The Department proposes to revise this item to address actions when the B specimen was reported as substituted based on biomarker test results, in addition to those reported as substituted based on creatinine and specific gravity test results. See also Section 1.5. The Department also proposes to add a new item 14.6(k) to address MRO verification of split (B) specimen results when the B specimen fails to reconfirm adulteration or substitution and is invalid.

Section 14.7 describes how an MRO reports split (B) specimen test results to an agency. The Department proposes to add a new item 14.7(e) stating that the MRO must use the HHS-specified nomenclature published with the drug and biomarker testing panels on reports. See also Section 3.4.

General Revisions

In addition to the proposed changes described by subpart and section above, the Department has edited the UrMG to address proposed changes ( e.g., removing “for urine” when referring to substituted specimens; referencing the proposed annual FRN with drug and biomarker testing panels) and has reworded some items for clarity and/or for consistency with the OFMG.

Impact of These Guidelines on Government Regulated Industries

The proposed revised Guidelines may impact the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) regulated industries depending on these agencies' decisions to incorporate the final UrMG revisions into their programs under their own authority.

Costs and Benefits

Costs

The proposed UrMG revision to publish the drug testing panel in a separate FRN each year ( e.g., Section 3.4) may result in a cost increase for HHS-certified test facilities and MROs ( e.g., costs for test supplies, assay validation, administrative changes) when a new drug is added to the panel or when analytes or cutoffs are changed for current drugs. The added costs will depend on the change. For example, implementation costs would be lower for laboratories that already offer the drug test or use the different analyte or cutoff for their non-regulated clients. MROs may experience increased costs when an agency chooses to test their Federal job applicants and employees for a new authorized drug with a high positivity rate or a Schedule II drug requiring the MRO to review medical explanations. Additional costs for testing and MRO review will be incorporated into the overall cost for the Federal agency submitting the specimen to the laboratory. Added costs to MROs would be expected to shift to Federal agencies over time, as existing contracts expire and new contract terms are negotiated. As noted earlier in this preamble, the Department will consider costs when deciding whether to make a change to the authorized drug tests. At this time, the Department will not

The proposed change to the morphine confirmatory test cutoff from 2,000 ng/mL to 4,000 ng/mL will result in some initial costs for HHS-certified laboratories ( e.g., to revalidate their opiate confirmatory assays, revise opiate calibrators and controls, and revise review and reporting procedures). However, there should also be some cost savings as described below under Benefits.

There will be some administrative costs for MROs associated with the generation and submission of the semiannual reports of verified-negative results (see Section 13.11)

ries ( e.g., to revalidate their opiate confirmatory assays, revise opiate calibrators and controls, and revise review and reporting procedures). However, there should also be some cost savings as described below under Benefits.

There will be some administrative costs for MROs associated with the generation and submission of the semiannual reports of verified-negative results (see Section 13.11). The Department encourages the use of electronic recordkeeping to facilitate information retrieval and report generation, and will enable secure submission of electronic information to reduce MRO costs to provide these reports.

Benefits

The potential benefits of more timely changes to the drug testing panel will result in a healthier and more productive 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 and workplace accidents, decreased risk of low-probability high consequence events, a 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 drug misuse, the benefits to the Federal workplace and the individuals within that workplace justify the more agile method of changing the drug testing panel for the Federal workplace drug testing programs.

The number of commercial substitution and adulteration products aimed at defeating a drug test continues to proliferate for both urine and oral fluid. Manufacturers alter their existing products or develop new products to subvert drug and specimen validity tests in federally regulated workplace programs. (Ref. 15 and 16) When the Department added provisions for biomarker testing in the current UrMG, the intent was to identify non-human urine samples that were submitted for testing in place of the donor's urine

rate for both urine and oral fluid. Manufacturers alter their existing products or develop new products to subvert drug and specimen validity tests in federally regulated workplace programs. (Ref. 15 and 16) When the Department added provisions for biomarker testing in the current UrMG, the intent was to identify non-human urine samples that were submitted for testing in place of the donor's urine. The proposed revision to report a specimen as substituted (not invalid) based on biomarker testing is consistent with this intention. This revision, as well as the Department review and approval of biomarker tests and the added flexibility for making changes to the drug and biomarker testing panels, will strengthen the Federal Government's ability to identify illicit drug use and donor attempts to subvert drug tests.

The proposed requirement for semiannual MRO reports on laboratory-positive/MRO-negative results will enable the Department to ensure accurate reports and MRO compliance with Guidelines requirements. The information in the MRO reports will be matched to information for the same specimens that was submitted to the NLCP by the HHS-certified laboratory, thereby improving statistical analyses and providing a clearer picture of illicit drug use by Federal job applicants and employees.

As noted above under Costs, HHS-certified laboratories will incur some initial costs for changing the morphine confirmatory test cutoff; however, laboratories will also experience some benefits in that the removal of the 15,000 ng/mL decision points for codeine and morphine will simplify codeine and morphine review and reporting procedures. MROs may also experience some savings, as the removal of the decision points and clinical evaluation requirement for some codeine and morphine positive results will simplify the MRO verification process. That is, codeine and morphine positive results will be reviewed and verified using the same procedures as positive results for other drugs

ify codeine and morphine review and reporting procedures. MROs may also experience some savings, as the removal of the decision points and clinical evaluation requirement for some codeine and morphine positive results will simplify the MRO verification process. That is, codeine and morphine positive results will be reviewed and verified using the same procedures as positive results for other drugs.

Information Collection/Record Keeping Requirements

The information collection requirements ( i.e., reporting and recordkeeping) in the current Guidelines, which establish the scientific and technical guidelines for Federal workplace drug testing programs and establish standards for certification of laboratories engaged in urine drug testing for Federal agencies under authority of 5 U.S.C. 7301 and Executive Order 12564, are approved by the Office of Management and Budget (OMB) under control number 0930-0158. The Federal Drug Testing Custody and Control Form (Federal CCF) used to document the collection and chain of custody of urine and oral fluid 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.

In support of the Government Paperwork Reduction Act (PRA), the Department revised the Federal CCF to enable its use as an electronic form (78 FR 42091, July 15, 2013) and developed requirements and oversight procedures to ensure that HHS-certified test facilities and other service providers ( e.g., collection sites, MROs) using an electronic version of the Federal CCF (ECCF) maintain the accuracy, security, and confidentiality of electronic drug test information

artment revised the Federal CCF to enable its use as an electronic form (78 FR 42091, July 15, 2013) and developed requirements and oversight procedures to ensure that HHS-certified test facilities and other service providers ( e.g., collection sites, MROs) using an electronic version of the Federal CCF (ECCF) maintain the accuracy, security, and confidentiality of electronic drug test information. Before a Federal ECCF can be used for Federal agency specimens, HHS-certified test facilities must submit detailed information and proposed standard operating procedures (SOPs) to the NLCP for SAMHSA review and approval, and undergo an NLCP inspection focused on the proposed ECCF.

Since 2013, SAMHSA has encouraged the use of Federal ECCFs and other electronic processes in HHS-certified test facilities, when practicable, for federally regulated testing operations. In accordance with Section 8108(a) of the SUPPORT for Patients and Communities Act, SAMHSA has set a deadline of August 31, 2023, for all HHS-certified laboratories to submit a request for approval of an electronic (paperless) Federal CCF.

The title and description of the information collected and respondent description 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.

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 12564

Title: The Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine.

Description of Respondents: Individuals or households, businesses, or other-for-profit and 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 or are employed in testing designated positions, 100 collectors, 25 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 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 Laboratory submits qualifications of responsible person (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 semiannual 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 semiannual 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 13.11 Specifications for MRO semiannual report to the Secretary or designated representative for Federal agency specimen results that were laboratory-positive and MRO-verified negative 100 2 0.5 100 16.1(b) &

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 13.11 Specifications for MRO semiannual report to the Secretary or designated representative for Federal agency specimen results that were laboratory-positive and MRO-verified negative 100 2 0.5 100 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 259 395 1 Although IITFs are allowed under the UrMG, SAMHSA has not received any IITF application 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 proposed 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(d)); 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

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(d)); 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 25 10 3 750 12.20, 12.21 Information on drug test that IITF 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 226 4956 The following disclosure requirements are also included in the proposed Guidelines, but have not been addressed in the above disclosure burden table: The collector must explain the basic collection procedure to the donor and answer any questions (Section 8.3(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

re also included in the proposed Guidelines, but have not been addressed in the above disclosure burden table: The collector must explain the basic collection procedure to the donor and answer any questions (Section 8.3(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) 2,660 8.8(d) & (f) Donor initials specimen labels/seals and signs statement on the Federal CCF 38,000 1 0.08 (5 min) 3,040 11.8(a) & 11.19 Laboratory completes Federal CCF upon receipt of specimen and before reporting result 25 1,520 0.05 (3 min) 1,900 12.8(a) & 12.15 IITF 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 100 2 0.05 (3 min) 10 Total 38,326 9,511 The proposed Guidelines contain several recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector (Section 4.3(a)(3)) and the documentation must be maintained in the collector's training file (Section 4.3(c)). SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a Federal agency specimen, the collector is required to provide a statement (Section 6.2(b)) explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden

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 is 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 14,862 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,809 hours currently approved by OMB under control number 0930-0158 for urine testing under the current Guidelines.

As required by section 3507(d) of the PRA, the Secretary has submitted a copy of these proposed Guidelines to OMB for its review

y the laboratories and IITFs is estimated to be 14,862 hours (that is, the sum of the total hours from the above tables). This is in addition to the 1,788,809 hours currently approved by OMB under control number 0930-0158 for urine testing under the current Guidelines.

As required by section 3507(d) of the PRA, the Secretary has submitted a copy of these proposed Guidelines to OMB for its review. Comments on the information collection requirements are specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) enhance the quality, utility, and clarity of the information to be collected; and (4) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other

OMB is required to make a decision concerning the collection of information contained in these proposed Guidelines between 30 and 60 days after publication of this document in the Federal Register . Therefore, a comment to OMB is best assured of having its full effect if OMB receives it within 30 days of publication. This does not affect the deadline for the public to comment to HHS on the proposed Guidelines.

Organizations and individuals desiring to submit comments on the information collection requirements should direct them to the Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, comments may also be sent to 202-395-6974 (fax).

References

1. Colby, J.M., Wu, A.H.B., Lynch, K.L, 2015. Analysis of codeine positivity in urine of pain management patients, J. Anal

d direct them to the Office of Information and Regulatory Affairs, OMB, New Executive Office Building, 725 17th Street NW, Washington, DC 20502, Attn: Desk Officer for SAMHSA. Because of delays in receipt of mail, comments may also be sent to 202-395-6974 (fax).

References

1. Colby, J.M., Wu, A.H.B., Lynch, K.L, 2015. Analysis of codeine positivity in urine of pain management patients, J. Anal. Toxicol, 39(5), 407-410, https://doi.org/10.1093/jat/bkv031. 2. Cone, E.J., Welch, P., Mitchell, J.M., Paul, B.D, 1991. Forensic drug testing for opiates: I. detection of 6-acetylmorphine in urine as an indicator of recent heroin exposure; drug and assay considerations and detection times, J. Anal. Toxicol, 15(1), 1-7, https://doi.org/10.1093/jat/15.1.1. 3. Maas, A., Krämer, M., Sydow, K., Chen, P.‐S., Dame, T., Musshoff, F., Diehl, B.W.K., Madea, B., Hess, C, 2017. Urinary excretion study following consumption of various poppy seed products and investigation of the new potential street heroin marker ATM4G. Drug Test. Analysis, 9, 470-478, https://doi.org/ 10.1002/dta.2058. 4. Wang, L., Ni, C., Shen, H., Sheng, Z., Liang, C., Wang, R., Zhang, Y, 2020. Comparison of the detection windows of heroin metabolites in human urine using online SPE and LC-MS/MS: Importance of morphine-3-glucuronide. J. Anal. Toxicol, 44(1), 22-28, https://doi.org/10.1093/jat/bkz040. 5. Özbunar, E., Aydoğdu, M., Döğer, R., Bostanci, H.I., Koruyucu, M., Akgür, S.A., 2019. Morphine concentrations in human urine following poppy seed paste consumption. Forensic Sci. Int, 295, 121-127. 6. Gan, C.Y., Zainuddin, Z., Noh, H.M., Rahmat, R., Akir, F.M., Mahad, N.H, Mohd Fazil, N.F., Nasir, R., Isahak, M., Samad, H.A, 2019. Profiling of morphine and codeine in urine after the ingestion of curry containing poppy seed as an evidence for opiates defence in Malaysia. Forensic Sci. Int, 302, 1-5. 7. Samano, K.L., Clouette, R.E., Rowland, B.J., Sample, R.H.B, 2015

ic Sci. Int, 295, 121-127. 6. Gan, C.Y., Zainuddin, Z., Noh, H.M., Rahmat, R., Akir, F.M., Mahad, N.H, Mohd Fazil, N.F., Nasir, R., Isahak, M., Samad, H.A, 2019. Profiling of morphine and codeine in urine after the ingestion of curry containing poppy seed as an evidence for opiates defence in Malaysia. Forensic Sci. Int, 302, 1-5. 7. Samano, K.L., Clouette, R.E., Rowland, B.J., Sample, R.H.B, 2015. Concentrations of morphine and codeine in paired oral fluid and urine specimens following ingestion of a poppy seed roll and raw poppy seeds. J. Anal. Toxicol, 39(8), 655-661, https://doi.org/10.1093/jat/bkv081. 8. ElSohly, H.N., Stanford, D.F., Jones, A.B., ElSohly, M.A., Snyder, H., Pedersen, C, 1988. Gas chromatographic/mass spectrometric analysis of morphine and codeine in human urine of poppy seed eaters. J. Forensic Sci, 33, 347-356. 9. Selavka, C.M, 1991. Poppy seed ingestion as a contributing factor to opiate-positive urinalysis results: The pacific perspective. J. Forensic Sci, 36, 685-696. 10. Rohrig, T.P., Moore, C, 2003. The determination of morphine in urine and oral fluid following ingestion of poppy seeds. J. Anal. Toxicol, 27, 449-452. 11. Smith, M.L., Nichols, D.C., Underwood, P., Fuller, Z., Moser, M.A., LoDico, C., Gorelick, D.A., Newmeyer, M.N., Concheiro, M., Huestis, M.A, 2014. Morphine and codeine concentrations in human urine following controlled poppy seeds administration of known opiate content. Forensic Sci. Int, 241, 87-90. 12. Drug Enforcement Administration (DEA) Diversion Control Division Drug and Chemical Evaluation Section. Unwashed poppy seed, November 2019. DEA/DC/DO/DOE, DEA PRB 11-15-19-44. 13. U.S. Department of Justice (DOJ), Drug Enforcement Agency (DEA), Diversion Control Division. Controlled Substance Schedules. https://www.deadiversion.usdoj.gov. Accessed June 9, 2021. 14. U.S. Department of Defense (DoD). Instruction 1010.16, Technical procedures for the military drug abuse testing program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf

11-15-19-44. 13. U.S. Department of Justice (DOJ), Drug Enforcement Agency (DEA), Diversion Control Division. Controlled Substance Schedules. https://www.deadiversion.usdoj.gov. Accessed June 9, 2021. 14. U.S. Department of Defense (DoD). Instruction 1010.16, Technical procedures for the military drug abuse testing program. https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/101016p.pdf. Accessed June 9, 2021. 15. Kim, V.J., Okano, C.K., Osborne, C.R., Frank, D.M., Meana, C.T., Castaneto, M.S, 2018. Can synthetic urine replace authentic urine to “beat” workplace drug testing? Drug Test. Anal., 11(2), 331-335. 16. Quest Diagnostics, 2018. Workforce drug positivity at highest rate in a decade, finds analysis of more than 10 million drug test results. https://www.questdiagnostics.com/dms/Documents/Employer-Solutions/DTI-2018/2018-quest-diagnostics-drug-testing-index-2018-report/2018QuestDiagnosticsDrugTestingIndex.pdf . Accessed October 19, 2018. Summary

These proposed revisions are intended to simplify changes to the authorized drug testing panel for Federal workplace drug testing programs, facilitate the identification of substituted specimens using biomarker testing, improve detection of illicit codeine and/or morphine use, and provide the Department with information on Federal agency drug test specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified negative by the Medical Review Officer (MRO). The Department believes that the proposed revisions to the Mandatory Guidelines save costs and improve the effectiveness of Federal workplace drug testing programs.

Dated: March 22, 2022. Miriam E. Delphin-Rittmon, Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration.

Approved: March 22, 2022. Xavier Becerra, Secretary, Department of Health and Human Services

t the proposed revisions to the Mandatory Guidelines save costs and improve the effectiveness of Federal workplace drug testing programs.

Dated: March 22, 2022. Miriam E. Delphin-Rittmon, Assistant Secretary for Mental Health and Substance Use, Substance Abuse and Mental Health Services Administration.

Approved: March 22, 2022. Xavier Becerra, Secretary, Department of Health and Human Services.

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 drugs other than those in the drug testing panel? 3.3 May any of the specimens be used for other purposes? 3.4 What are the drug and biomarker test analytes and cutoffs 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 i

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

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 maintenan

ations 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

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 avai

ch 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, substit

ity 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 reports must an HHS-certified IITF provide? 12.20 What HHS-certified IITF information is available to a federal agency? 12.21 What HHS-certified IITF information is available to a federal employee? 12.22 What types of relationships are prohibited between an HHS-certified IITF and an MRO? 12.23 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? 13.11 What reports must an MRO provide to the Secretary for urine testing? 13.12 What are

st 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? 13.11 What reports must an MRO provide to the Secretary for urine testing? 13.12 What are a federal agency's responsibilities for designating an MRO? 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 urine 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 ther

ficient 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

ive 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.

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

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.

n a waiver, a federal agency must submit a written request to

Section 1.4 How are these Guidelines revised?

(b) Revisions to these Guidelines 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 a normal constituent ( e.g., nitrite in urine).

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.

Biomarker Testing Panel

cian 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.

Biomarker Testing Panel. The panel published in the Federal Register that includes the biomarkers authorized for testing, with analytes and cutoffs for initial and confirmatory biomarker tests, as described under Section 3.4.

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)

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 donor's drug test 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

ocedure 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, drug metabolite, or biomarker concentration) used as the decision point to determine a result ( e.g., negative, positive, adulterated, invalid, or 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.

Drug Testing Panel. The panel published in the Federal Register that includes the drugs authorized for testing, with analytes and cutoffs for initial and confirmatory drug tests, as described under Section 3.4.

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)

trol 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 adulterated, invalid, substituted, or (for urine) dilute.

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 (LOQ). 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

cordkeeping 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 (LOQ). 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 confirmatory test cutoff.

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

ITF 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 confirmatory test cutoff.

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

ollection site for the purpose of a drug test.

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 specimen, as evidenced by the absence of a biomarker or a biomarker concentration inconsistent with that established for a human specimen, as indicated in the biomarker testing panel, or (for urine) creatinine and specific gravity values that are outside the physiologically producible ranges of human urine, in accordance with the criteria to report a specimen as substituted in UrMG Section 3.7.

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.

. 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 https://www.hhs.gov/hipaa/index.html.

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 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;

(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;

(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;

red 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;

(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 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?

iluting 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) A refusal to take a test may result in the initiation of disciplinary or adverse action for a federal employee, up to and including removal from federal employment. An applicant's refusal to take a pre-employment test may result in 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, 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 facsimile [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

e 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;

(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?

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 Specimen 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 in the drug testing panel described under Section 3.4;

(b) Is authorized to test each specimen for other Schedule I or II drugs as provided in the drug testing panel;

(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) Is authorized to test each specimen for one or more biomarkers as provided in the biomarker testing panel; and

ation 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) Is authorized to test each specimen for one or more biomarkers as provided in the biomarker testing panel; and

(e) 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 drugs other than those in the drug testing panel?

(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.

pon 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 the drug testing panel described under Section 3.4. 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 and biomarker test analytes and cutoffs for urine?

The Secretary will publish the drug and biomarker test analytes and cutoffs ( i.e., the “drug testing panel” and “biomarker testing panel”) for initial and confirmatory drug and biomarker tests in the Federal Register each year. The drug and biomarker testing panels will also be available on the internet at http://www.samhsa.gov/workplace/drug-testing

omarker test analytes and cutoffs for urine?

This drug testing panel will remain in effect until the effective date of a new drug testing panel published in the Federal Register :

Initial test analyte Initial test cutoff 1 Confirmatory test analyte Confirmatory test cutoff concentration Marijuana metabolite (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 4,000 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

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). (a) The drug testing panel will include drugs authorized for testing in federal workplace drug testing programs, with the required test analytes and cutoffs;

(b) The biomarker testing panel will include biomarkers authorized for testing in federal workplace drug testing programs, with the required test analytes and cutoffs; and

lenedioxymethamphetamine (MDMA). 5 Methylenedioxyamphetamine (MDA). (a) The drug testing panel will include drugs authorized for testing in federal workplace drug testing programs, with the required test analytes and cutoffs;

(b) The biomarker testing panel will include biomarkers authorized for testing in federal workplace drug testing programs, with the required test analytes and cutoffs; and

(c) HHS-certified IITFs, HHS-certified laboratories, and Medical Review Officers must use the nomenclature ( i.e., analyte names and abbreviations) published in the Federal Register with the drug and biomarker testing panels to report federal workplace drug test results.

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). 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;

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:

(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

(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 LOQ of the confirmatory test on the second aliquot;

(d) The presence of a halogen ( e.g., chlorine from 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;

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

he 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:

(a) 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), or

(b) A biomarker is not detected or is present at a concentration inconsistent with that established for human urine for both the initial (first) test and the confirmatory (second) test on two separate aliquots ( i.e., using the test analytes and cutoffs in the biomarker testing panel).

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.

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

(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;

pecific 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);

(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., chlorine from 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)-

characteristic immunoassay response on one or more drug immunoassay tests 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;

(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) A specimen validity test ( i.e., other than the tests listed above) on two separate aliquots of the specimen indicates that the specimen is not valid for testing.

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.

dicates that the specimen is not valid for testing.

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 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 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 the collection procedure described in these Guidelines;

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

Is knowledgeable about the collection procedure described in 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 process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.

(4) Has demonstrated proficiency in collections by completing five consecutive error-free mock collections.

(i) The five mock collections must include one uneventful collection scenario, one insufficient specimen quantity scenario, one temperature out of range scenario, one scenario in which the donor refuses to sign the Federal CCF, and one scenario in which the donor refuses to initial the specimen bottle tamper-evident seal.

(ii) A qualified trainer for collectors must monitor and evaluate the individual being trained, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are error-free.

(b) A trained collector must complete refresher training at least every five years that includes the requirements in paragraph (a) of this section.

(c) The collector must maintain the documentation of their training and provide that documentation to a federal agency when requested.

en the trainer and the trainee, and the trainer must attest in writing that the mock collections are error-free.

(b) A trained collector must complete refresher training at least every five years that includes the requirements in paragraph (a) of this section.

(c) The collector must maintain the documentation of their training and provide that documentation to a federal agency when requested.

(d) An individual may not collect specimens for a federal agency until the individual's training as a collector has been properly documented.

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

(a) An individual may serve as an observer for a direct observed collection when the individual has satisfied the requirements:

(1) Is knowledgeable about the direct observed collection procedure described in Section 8.9 of these Guidelines;

(2) Is knowledgeable about any guidance provided by the federal agency's Drug-Free Workplace Program or additional information provided by the Secretary relating to the direct observed collection procedure described in these Guidelines;

(3) Has received training on the following subjects:

(i) All steps necessary to perform a direct observed collection; and

(ii) The observer's responsibility for maintaining the integrity of the collection process, ensuring the privacy of individuals being tested, ensuring that the observation is done in a professional manner that minimizes the discomfort to the employee so observed, ensuring the security of the specimen by maintaining visual contact with the collection container until it is delivered to the collector, and avoiding conduct or statements that could be viewed as offensive or inappropriate.

(b) The gender of the observer must be the same as the donor's gender, which is determined by the donor's gender identity. The observer selection process is described in Section 8.10(b).

ecurity of the specimen by maintaining visual contact with the collection container until it is delivered to the collector, and avoiding conduct or statements that could be viewed as offensive or inappropriate.

(b) The gender of the observer must be the same as the donor's gender, which is determined by the donor's gender identity. The observer selection process is described in Section 8.10(b).

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

(a) Individuals are considered qualified trainers for collectors and may train others to collect urine specimens when they have completed the following:

(1) Qualified as a trained collector and regularly conducted urine drug test collections for a period of at least one year; or

(2) Completed a “train the trainer” course given by an organization ( e.g., manufacturer, private entity, contractor, federal agency).

(b) A qualified trainer for collectors must complete refresher training at least every five years in accordance with the collector requirements in Section 4.3(a).

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

A federal agency must ensure the following:

(a) The collector has satisfied the requirements described in Section 4.3;

(b) The collector, who may be self-employed, or an organization ( e.g., third party administrator that provides a collection service, collector training company, federal agency that employs its own collectors) maintains a copy of the training record(s); and

Subpart E—Collection Sites

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

(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.

that employs its own collectors) maintains a copy of the training record(s); and

Subpart E—Collection Sites

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

(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.

(b) In the event that an agency-designated collection site is not accessible and there is an immediate requirement to collect a urine specimen ( e.g., an accident investigation), a public restroom may be used for the collection, using the procedures for a monitored collection described in Section 8.12.

Section 5.2 What are the requirements for a collection site?

The facility used as a collection site must have the following:

(a) Provisions to ensure donor privacy during the collection (as described in Section 8.1);

(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;

(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS-certified laboratory or IITF;

(d) A restricted access area where only authorized personnel may be present during the collection;

(e) A restricted access area for the storage of collection supplies;

(f) The ability to store records securely; and

(g) The ability to restrict the donor access to potential diluents in accordance with Section 8.2.

Section 5.3 Where must collection site records be stored?

Collection site records must be stored at a secure site designated by the collector or the collector's employer.

Section 5.4 How long must collection site records be stored?

Collection site records ( e.g., collector copies of the OMB-approved Federal CCF) must be stored securely for a minimum of 2 years. The collection site may convert hardcopy records to electronic records for storage and discard the hardcopy records after 6 months

t a secure site designated by the collector or the collector's employer.

Section 5.4 How long must collection site records be stored?

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

(a) A collector must do the following to maintain the security and integrity of a specimen:

(1) Not allow unauthorized personnel to enter the collection area during the collection procedure;

(2) Perform only one donor collection at a time;

(3) Restrict access to collection supplies before, during, and after collection;

(4) Ensure that only the collector and the donor are allowed to handle the unsealed specimen;

(5) Ensure the chain of custody process is maintained and documented throughout the entire collection, storage, and transport procedures;

(6) Ensure that the Federal CCF is completed and distributed as required; and

(7) Ensure that specimens transported to an HHS-certified laboratory or IITF are sealed and placed in transport containers designed to minimize the possibility of damage during shipment ( e.g., specimen boxes, padded mailers, or other suitable shipping container), and those containers are securely sealed to eliminate the possibility of undetected tampering;

eted and distributed as required; and

(b) Couriers, express carriers, and postal service personnel are not required to document chain of custody since specimens are sealed in packages that would indicate tampering during transit to the HHS-certified laboratory or IITF.

Section 5.6 What are the privacy requirements when collecting a urine specimen?

Collections must be performed at a site that provides reasonable privacy (as described in Section 8.1).

Subpart F—Federal Drug Testing Custody and Control Form

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

The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.

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

(a) The use of a non-federal CCF or an expired Federal CCF is not, by itself, a reason for the HHS-certified laboratory or IITF to automatically reject the specimen for testing or for the MRO to cancel the test.

(b) If the collector does not use the correct OMB-approved Federal CCF, the collector must document that it is a federal agency specimen collection and provide the reason that the incorrect form was used. Based on the information provided by the collector, the HHS-certified laboratory or IITF must handle and test the specimen as a federal agency specimen.

ting or for the MRO to cancel the test.

(c) If the HHS-certified laboratory, HHS-certified IITF, or MRO discovers that the collector used an incorrect form, the laboratory, IITF, or MRO must obtain a memorandum for the record from the collector describing the reason the incorrect form was used. If a memorandum for the record cannot be obtained, the laboratory or IITF reports a rejected for testing result to the MRO and the MRO cancels the test. The HHS-certified laboratory or IITF must wait at least 5 business days while attempting to obtain the memorandum before reporting a rejected for testing result to the MRO.

Subpart G—Urine Specimen Collection Containers and Bottles

Section 7.1 What is used to collect a urine specimen?

A single-use collection container with a means ( i.e., thermometer) to measure urine temperature and two specimen bottles must be used.

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

(a) The collection container, the thermometer, and the specimen bottles must not substantially affect the composition of drugs and/or metabolites in the urine specimen.

(b) The two specimen bottles must be sealable and non-leaking, and must maintain the integrity of the specimen during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory or IITF for the presence of drugs or their metabolites.

the specimen bottles must not substantially affect the composition of drugs and/or metabolites in the urine specimen.

(c) The two specimen bottles must be sufficiently transparent to enable an objective assessment of specimen appearance and identification of abnormal physical characteristics without opening the bottle.

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

(a) The collection container must be capable

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