Mandatory Guidelines for Federal Workplace Drug Testing Programs

Federal RegisterMay 15, 2015

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration

Mandatory Guidelines for Federal Workplace Drug Testing Programs

AGENCY:

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

ACTION:

Notice of proposed revisions to the mandatory guidelines by the Secretary of Health and Human Services.

SUMMARY:

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

DATES:

Submit comments on or before July 14, 2015.

ADDRESSES:

In commenting, please refer to file code SAMHSA-2015-0002. 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 regulation to

http://www.regulations.gov

. Follow “Submit a comment” instructions.

•

By regular mail.

You may mail written comments to the following address ONLY: SAMHSA, Attention Division of Workplace Programs (DWP), 1 Choke Cherry RD., Rm. #7-1045, Rockville, MD 20857. Please allow sufficient time for mailed comments to be received before the close of the comment period.

•

By express or overnight mail.

You may send written comments to the following address ONLY: SAMHSA, Attention DWP, 1 Choke Cherry RD., Rm. #7-1045, Rockville, MD 20850.

•

By hand or courier.

Alternatively, you may deliver (by hand or courier) your written comments ONLY to the following address prior to the close of the comment period: SAMHSA, Attention DWP, 1 Choke Cherry RD., Rm. #7-1045, Rockville, MD 20850. If you intend to deliver your comments to the Rockville address, call telephone number (240) 276-2600 in advance to schedule your arrival with one of our staff members. Because access to the interior of the SAMHSA Building is not readily available to persons without federal government identification, commenters are encouraged to schedule their delivery or to leave comments with the security guard front desk located in the main lobby of the building. Comments erroneously mailed to the address indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.

FOR FURTHER INFORMATION CONTACT:

Charles LoDico, M.S., DABFT, Division of Workplace Programs, Center for Substance Abuse Prevention (CSAP), SAMHSA mail to: 1 Choke Cherry Road, Room 7-1045, Rockville, MD 20857, telephone (240) 276-2600, fax (240) 276-2610, or email at

charles.lodico@samhsa.hhs.gov

SUPPLEMENTARY INFORMATION:

Executive Summary

This notice of proposed revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) will revise the initial and confirmatory drug test analytes and methods for urine testing, revise the cutoff for reporting a specimen as adulterated based on low pH, revise the requalification requirements for individuals serving as Medical Review Officers (MROs) and, where appropriate, include references to the use of an alternate specimen in federal workplace drug testing programs. References to an alternate specimen are not applicable until final Guidelines are implemented for the use of the alternative specimen matrix. The Department is issuing a separate Notice in the

Federal Register

proposing Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) to allow federal agencies to collect and test oral fluid specimens in their workplace drug testing programs.

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

i.e.,

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

e.g.,

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

Costs and Benefits

Using data obtained from the Federal Workplace Drug Testing Programs and HHS certified laboratories, the Department estimates the number of specimens tested annually for federal agencies to be 150,000. HHS projects that approximately 7% (or 10,500) of the 150,000 specimens tested per year will be oral fluid specimens and 93% (or 139,500) will be urine specimens once the proposed OFMG have been

implemented. The approximate annual numbers of regulated specimens for the Department of Transportation (DOT) and Nuclear Regulatory Commission (NRC) are 6 million and 200,000, respectively. Should DOT and NRC allow oral fluid testing in regulated industries' workplace programs, the estimated annual numbers of specimens for DOT would be 180,000 oral fluid and 5,820,000 urine, and number of specimens for NRC would be 14,000 oral fluid and 186,000 urine.

In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analyte(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.

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

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

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

Once the testing has been implemented, the cost per specimen for initial testing for the added analytes will range from $.06 to $0.20 due to reagent costs. Current costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported as positive due to costs of sample preparation and analysis. Based on information from non-regulated workplace drug testing for these analytes in 2012 and testing performed by the Department on de-identified federally regulated specimens in 2011, approximately 1% of the submitted specimens is expected to be confirmed as positive for the added analytes. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This would indicate that the total cost per specimen submitted for testing will increase by $0.11-$0.30.

The additional costs for testing and MRO review will be incorporated into the overall cost for the federal agency submitting the specimen to the laboratory. The estimation of costs incurred is based upon overall cost to the federal agency because cost is usually based on all specimens submitted from an agency, rather than individual specimen testing costs or MRO review of positive specimens. Agencies may also incur some costs for training of federal employees such as drug program coordinators due to implementation of the revised Guidelines. However, costs are expected to be minimal in the training process to understand the required changes in these Guidelines.

Based on the current figures, the cost for urine testing in the first year is estimated on 139,500 urine specimens for HHS, 5,820,000 urine specimens for DOT, and 186,000 urine specimens for NRC. Estimated costs are $99,045-$230,175 for HHS, $4,132,200-$9,603,000 for DOT, and $132,060-$306,900 for NRC.

Inspection of Public Comments:

All comments received before the close of the comment period are 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 a comment. SAMHSA posts all comments before the close of the comment period on the following Web site as soon as possible after they have been received:

http://www.regulations.gov

. Follow the search instructions on the Web site to view public 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 the Substance Abuse and Mental Health Services Administration, Division of Workplace Programs, 1 Choke Cherry RD., Rockville, MD, 20850, Monday through Friday of each week from 8:30 a.m. to 4:00 p.m. To schedule an appointment to view public comments, call (240) 276-2600.

Background

The Department of Health and Human Services (HHS), by the authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, has established the scientific and technical guidelines for federal workplace drug testing programs and established standards for certification of laboratories engaged in urine drug testing for federal agencies. As required, HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the

Federal Register

[FR] on April 11, 1988 [53 FR 11979]. The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 [59 FR 29908], September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR 63483], April 13, 2004 [69 FR 19644],

and November 25, 2008 [73 FR 71858] with an effective date of May 1, 2010 (correct effective date published on December 10, 2008; [73 FR 75122]). The effective date of the Guidelines was further changed to October 1, 2010 on April 30, 2010 [75 FR 22809].

History and Proposed Changes to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs

At the July 2011 meeting of SAMHSA's Drug Testing Advisory Board (DTAB), Board members voted unanimously for the following:

(1) Based on review of the science, DTAB recommends that SAMHSA include oral fluid as an alternative specimen in the Mandatory Guidelines for Federal Workplace Drug Testing Programs; and (2) DTAB recommends the inclusion of additional Schedule II prescription medications (

e.g.,

oxycodone, oxymorphone, hydrocodone and hydromorphone) in the Mandatory Guidelines for Federal Workplace Drug Testing Programs.

At the January 2012 DTAB meeting, the SAMHSA Administrator received the DTAB recommendations from the July 2011 meeting.

The responses to the April 13, 2004 notice proposing alternative specimen matrices (69 FR 19673) had made it clear that if the Department were to subsequently authorize alternative specimens for the Mandatory Guidelines for Federal Workplace Drug Testing Programs, separate Guidelines would be needed to provide clear and comprehensive information on the scientific and technical requirements for each specimen matrix. Therefore, HHS is proposing Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Urine (UrMG) and Mandatory Guidelines for Federal Workplace Drug Testing Programs Using Oral Fluid (OFMG). The proposed UrMG and OFMG have been organized into analogous sections and use the same language where possible. The only differences are due to requirements that are specific for each specimen matrix.

Since the original Guidelines were published in 1988, a number of recommendations have been made for additional drugs to be included in federal workplace drug testing programs. Further, the Department monitors drug abuse trends and reviews information on new drugs of abuse from sources such as federal regulators, researchers, the drug testing industry, and public and private sector employers. The Department revised the Guidelines to include 6-acetylmorphine in 1998 (63 FR 63483) and three amphetamine analogues [methylenedioxymethamphetamine (MDMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA)] in 2008 (73 FR 71858). The July 21, 2011 DTAB recommendations for the added drugs were based on the Board members' review of scientific information on the methods necessary to detect the analytes of these drugs and on drug abuse trends.

The DTAB recommendations, current drug abuse trends and other relevant information, and the private sector experience have led the Department to conclude that the additional opiates oxycodone, oxymorphone, hydrocodone, and hydromorphone should be added in the federal program.

Provisions for the Administration of the National Laboratory Certification Program (NLCP)

In accordance with the current practice, an HHS contractor will perform certain functions on behalf of the Department. These functions include maintaining laboratory inspection and performance testing (PT) programs that satisfy the requirements described in the Guidelines. These activities include, but are not limited to, reviewing inspection reports submitted by inspectors, reviewing PT results submitted by laboratories, preparing inspection and PT result reports, and making recommendations to the Department regarding certification or suspension/revocation of laboratories' certification. It is important to note that, although a contractor gathers and evaluates information provided by the inspectors or laboratories, all final decisions regarding laboratory certification, suspension, or revocation of certification are made by the Secretary.

The Department contributes funds to this contract for purposes not directly related to laboratory certification activities, such as evaluating technologies and instruments and providing assessments of their potential applicability to workplace drug testing programs.

Organization of Proposed Guidelines

This preamble describes the differences between the current Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) and the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine Specimens (UrMG), and the rationale for the differences. In addition, the Preamble presents two topics of special interest to be addressed for the revised Guidelines. These topics are presented first in summary as they appear in the text of the proposed UrMG and later as topics of special interest for which the Department is seeking public comments.

Subpart A—Applicability

Section 1.5 defines terms used in the UrMG. Where possible, the Department proposes to revise the definitions in the current Guidelines to apply to any specimen matrix allowed in federal workplace drug testing programs, so the terms and their definitions will be identical in both the UrMG and the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid Specimens (OFMG). In addition, the Department proposes to add new definitions or revise the definitions in the current Guidelines as needed for terms that apply only to urine (

e.g.,

collection container). The Department also proposes to revise and update terms and definitions in the current Guidelines for clarity and consistency with current scientific terminology (

e.g.,

changing the term limit of quantitation to limit of quantification; no longer using the term quality control samples for both calibrators and controls).

Sections 1.6, 1.7, and 1.8 contain the same policies as described in the current Guidelines with regard to what an agency is required to do to protect employee records, the conditions that constitute refusal to take a federally regulated drug test, and the consequences of a refusal to take a federally regulated drug test. In the proposed UrMG, Section 1.7 of the current Guidelines was divided into two sections for clarity: Section 1.7 describes what constitutes a refusal to test and Section 1.8 describes the subsequent actions and consequences. Section 1.7 also has been reworded as needed to address other authorized specimen types.

Subpart B—Urine Specimen

The Department proposes to revise Section 2.1 of the current Guidelines to reflect the Department's proposed expansion of the drug-testing program for federal agencies to permit the use of oral fluid specimens. There is no requirement for federal agencies to use oral fluid as part of their program. When the OFMG become effective and HHS has certified laboratories under the OFMG, a federal agency may choose to use urine, oral fluid, or both specimen types in their drug testing program. Any agency choosing to use urine is required to follow the UrMG and any agency choosing to use oral fluid is required to follow the OFMG. For example, an agency program can randomly assign

individuals to either urine or OF testing, for random or pre-employment testing. This would not only help reduce subversion, but would allow comparison of urine and OF testing outcomes for planning purposes.

Section 2.6 was added to clarify that all entities and individuals identified in Section 1.1 of these Guidelines are prohibited from releasing specimens collected under the federal workplace drug testing program to any individual or entity unless expressly authorized by these Guidelines or in accordance with applicable federal law.

While these Guidelines do not authorize the release of specimens, or portions thereof, to federal employees, the Guidelines afford employees a variety of protections that ensure the identity, security and integrity of their specimens from the time of collection through final disposition of the specimen. There are also procedures that allow federal employees to request the retesting of their specimen (for drugs, adulteration, or substitution) at a different certified laboratory. Furthermore, the Guidelines grant federal employees access to a wide variety of information and records related to the testing of their specimens, including a documentation package that includes, among other items, a copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, and any memoranda generated by the laboratory or Instrumented Initial Test Facility (IITF).

Therefore, the Guidelines offer federal employees and federal agencies transparent and definitive evidence of a specimen's identity, security, control and chain of custody. However, the Guidelines do not entitle employees access to the specimen itself or to a portion thereof. The reason for this prohibition is that specimens collected under the Guidelines are uniquely designed for the purpose of drug and validity testing only. They are not designed for other purposes such as deoxyribonucleic acid (DNA) testing. Furthermore, conducting additional testing outside the parameters of the Guidelines would not guarantee incorporation of the safeguards, quality control protocols, and the exacting scientific standards developed under the Guidelines to ensure the security, reliability and accuracy of the drug testing process.

Subpart C—Urine Specimen Tests

Section 3.3(a) includes the same requirement as the current Guidelines for urine specimens collected for federal agency workplace drug testing programs to be tested only for drugs and to determine their validity. While satisfied that the policy as stated in the current Guidelines prohibits other testing (

e.g.,

DNA testing) on a specimen, the Department has removed the phrase “unless otherwise authorized by law” and reworded for clarity. The revised section states that specimens must only be tested for drugs and to determine their validity in accordance with Subpart C of these Guidelines. The reasons for this prohibition are described above, in comments for Section 2.6.

Section 3.4 lists the drug test analytes and cutoff concentrations for urine. The table in Section 3.4 is the same in the current Guidelines with three notable exceptions. First, the proposed UrMG include the added opiates oxycodone, oxymorphone, hydrocodone, and hydromorphone as initial and confirmatory test analytes. Second, the proposed UrMG include methylenedioxyamphetamine (MDA) and methylenedioxyethylamphetamine (MDEA) as initial test and confirmatory test analytes. The current Guidelines include these two drugs as confirmatory test analytes only. Third, the requirement for initial testing using immunoassay-based technology has been changed to allow initial testing by “alternate” technologies (see footnote 2 of the table). This is also the reason for specifying the target analyte for each initial test. Considerable discussion was conducted in DTAB meetings regarding these proposed revisions. The DTAB received input from laboratories, reagent manufacturers, subject matter experts, and the FDA.

For initial tests for opiates and amphetamines using immunoassay, the Department is proposing that the immunoassay be calibrated with one analyte from the group that is identified as the target analyte. Footnote 2 of the table in Section 3.4 includes the proposed criteria for calibrating initial tests for these grouped analytes. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80% or greater. The Department is aware that an FDA-cleared immunoassay meeting these criteria may not exist at the time of the UrMG effective date. If an FDA-cleared immunoassay does not demonstrate at least 80 percent cross-reactivity to each analyte, the laboratory or IITF may use the lowest-reacting analyte to establish a decision point to identify specimens as negative or requiring confirmatory testing. This is accomplished by calibrating the FDA-cleared immunoassay using the manufacturer's target analyte, including a control containing the lowest-reacting analyte at its cutoff concentration in each initial test batch, and comparing the immunoassay responses of specimens in the batch to that of the lowest-reacting analyte control. Alternatively, the laboratory or IITF must use separate immunoassays. The proposed analytes and cutoffs are addressed separately and in detail below. The Department is proposing to permit the use of technologies other than immunoassay techniques for initial drug testing. In recent years, technological advances have been made to techniques (

e.g.,

methods using spectrometry or spectroscopy) that enable their use as efficient and cost-effective alternatives to the immunoassay techniques for initial drug testing while maintaining the required degree of sensitivity, specificity, and accuracy. The proposed Guidelines allow the use of alternate technologies provided that the laboratory or IITF validates the method in accordance with Section 11 for laboratories or Section 12 for IITFs and demonstrates acceptable performance in the PT program.

The proposed analytes and cutoffs follow.

Inclusion of Oxycodone, Oxymorphone, Hydrocodone, Hydromorphone

Misuse and abuse of psychotherapeutic prescription drugs, including opioid pain relievers, are issues of concern for all populations regardless of age, gender, ethnicity, race, or community. Recent data show that opioid-related overdose deaths in the U.S. now outnumber overdose deaths involving all illicit drugs such as heroin and cocaine combined. In addition to overdose deaths, emergency department visits, substance treatment admissions and economic costs associated with opioid abuse have all increased in recent years. The Department is continuing to work with partners at the federal, state, and local levels to implement policies and programs to reduce prescription drug abuse and improve public health.

The Department proposes the inclusion of additional Schedule II prescription medications (

i.e.,

oxycodone, oxymorphone, hydrocodone and hydromorphone) in the list of authorized drug tests and cutoff concentrations. This action was recommended by the DTAB, reviewed by the Department's Prescription Drug Subcommittee of the Behavioral Health Coordinating Committee, and received by the SAMHSA Administrator in January 2012. The inclusion of oxycodone, oxymorphone, hydrocodone and hydromorphone is supported by various data. According to the 2012

National Survey on Drug Use and Health, which provides data on illicit drug use in the United Sates, current (past month) nonmedical users aged 12 years and older of prescription psychotherapeutic drugs increased from 2003 (6.5 million) to 2012 (6.8 million).

Psychotherapeutic drugs are defined as opioid pain relievers, tranquilizers, sedatives, and stimulants. The abuse of psychotherapeutic drugs non-medically is ranked second behind marijuana, where pain relievers represent the majority of the group. The Drug Abuse Warning Network (DAWN), which provides national estimates of drug-related visits to hospital emergency departments (ED), showed that, of the 1.2 million ED visits involving nonmedical use of pharmaceuticals in 2011, 46.0 percent involved nonmedical use of pain relievers, with 29 percent being narcotic pain relievers.

The most frequently involved narcotic pain relievers were oxycodone and hydrocodone. From 2004 to 2011, ED visits involving nonmedical use of narcotic pain relievers increased by 153 percent. ED visits involving opiates/opioids increased by 183 percent during this period, with increases of 438 percent for hydromorphone, 263 percent for oxycodone, and over 100 percent for hydrocodone, as well as fentanyl and morphine. In addition, the National Forensic Laboratory Information System (NFLIS) found that oxycodone and hydrocodone were among the top ten drugs seized in law enforcement operations and sent to federal, state, and municipal forensic laboratories.

Among prescription drugs, oxycodone and hydrocodone ranked first and second. Information on over 5 million drug tests in general workplace drug testing shows that the positivity rate for oxycodone and hydrocodone (0.96%) was second only to marijuana in 2012.

The addition of these Schedule II prescription medications will require MRO review to verify legitimate drug use. Consistent with the current Guidelines, the MRO must contact the donor to determine if there is a legitimate medical explanation for a positive result. If the donor provides a legitimate medical explanation (

e.g.,

a valid prescription) for the positive result, the MRO reports the test result as negative to the agency.

The use of medications, specifically Schedule II drugs, without a prescription is a growing concern for the Department in workplace drug testing, and the proposal for their inclusion offers the opportunity to deter nonmedical use of these drugs among federal workers. The Department does note that in recognition of the prescription drug abuse issue, the Department of Defense issued a memorandum on January 30, 2012, announcing the expansion of their drug testing panel to include hydrocodone and benzodiazepines starting on May 1, 2012. Similarly, the Department proposes that federal agencies include the testing of oxycodone, oxymorphone, hydrocodone, and hydromorphone in urine specimens as described below.

Oxycodone/Oxymorphone

The Department is proposing to test for oxycodone/oxymorphone using a 100 ng/mL cutoff concentration for the initial test and 50 ng/mL for the confirmatory test cutoff concentration. Both oxycodone and oxymorphone are potent analgesics that are available by prescription for pain relief. Oxycodone is partially metabolized by O-demethylation to oxymorphone and both parent drug and metabolite are excreted in urine following oxycodone administration.

6-10

Following oxymorphone administration, oxymorphone is metabolized and excreted in urine primarily as a glucuronide conjugate of the parent drug.

6 10

An immunoassay initial test for oxycodone/oxymorphone should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 100 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.

The 50 ng/mL confirmatory test cutoff concentration applies equally to oxycodone and oxymorphone. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 50 ng/mL.

Hydrocodone/Hydromorphone

The Department is proposing to test for hydrocodone/hydromorphone using a 300 ng/mL cutoff concentration for the initial test and 100 ng/mL for the confirmatory test cutoff concentration. Both hydrocodone and hydromorphone are potent analgesics that are available by prescription for pain relief. Hydrocodone is partially metabolized by O-demethylation to hydromorphone and both parent drug and metabolite are excreted in urine following hydrocodone administration.

6 9 12-14

Following hydromorphone administration, hydromorphone is metabolized and excreted in urine primarily as a glucuronide conjugate of the parent drug.

Hydrocodone has been reported to be a minor metabolite of codeine

and hydromorphone has been reported to be a minor metabolite of morphine.

17 18

An immunoassay initial test for hydrocodone/hydromorphone should be calibrated with one of the two analytes and demonstrate sufficient cross-reactivity with the other analyte. The Department proposes that the minimum cross-reactivity with either analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or both analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the two analytes must be equal to or greater than 300 ng/mL. The quantitative sum of the two analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.

The confirmatory test cutoff concentration applies equally to hydrocodone and hydromorphone. A positive test would be comprised of either or both analytes with a confirmed concentration equal to or greater than 100 ng/mL.

In 2009, the U.S. Drug Enforcement Administration (DEA) asked the U.S. Department of Health and Human Services (HHS) for a recommendation regarding whether to change the schedule for hydrocodone combination drug products, such as Vicodin. The proposed change was from Schedule III to Schedule II, which would increase the controls on these products. Due to the unique history of this issue and the tremendous amount of public interest, in October 2013, the FDA Center for Drug Evaluation and Research announced the agency's intent to recommend to HHS that hydrocodone combination drug products should be reclassified to Schedule II. FDA stated that this determination came after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which FDA received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.

In December 2013, FDA, with the concurrence of the National Institute on Drug Abuse (NIDA), submitted a formal recommendation package to HHS to

reclassify hydrocodone combination drug products into Schedule II. Also in December 2013, the Secretary of HHS submitted the scientific and medical evaluation and scheduling recommendation to the DEA for its consideration. On August 22, 2014, DEA published the Final Rule that moves hydrocodone combination drug products from Schedule III to Schedule II.

Inclusion of Methylenedioxyamphetamine (MDA) and Methylenedioxyethylamphetamine (MDEA) as Initial Test Analytes

The Department proposes adding MDA and MDEA as initial test analytes in the list of authorized drug tests and cutoff concentrations. The current Guidelines include these two drugs as confirmatory test analytes only, in conjunction with an initial test for MDMA. Specifying these compounds as initial test analytes (in addition to MDMA) improves their detection by initial tests using immunoassay, and enables detection by initial tests using an alternate technology, as allowed under these proposed Guidelines. All three analytes are Schedule I drugs. The Department is proposing to test for MDMA/MDA/MDEA using a 500 ng/mL cutoff concentration for the initial test and 250 ng/mL for the confirmatory test cutoff concentration.

An immunoassay initial test for MDMA/MDA/MDEA should be calibrated with one of the three analytes and demonstrate sufficient cross-reactivity with the other analytes. The Department proposes that the minimum cross-reactivity with each analyte be 80 percent or greater. If an alternate technology initial test is performed instead of immunoassay, either one or all analytes in the group should be used to calibrate, depending on the technology. The quantitative sum of the three analytes must be equal to or greater than 500 ng/mL. The quantitative sum of the three analytes must be based on quantitative values for each analyte that are equal to or above the laboratory's validated limit of quantification.

The confirmatory test cutoff concentration applies equally to MDMA, MDA, and MDEA. A positive test would be comprised of one or more analytes with a confirmed concentration equal to or greater than 250 ng/mL.

Section 3.5 authorizes HHS-certified laboratories to perform additional tests to assist the Medical Review Officer (MRO) in making a determination of positive or negative results. The Department believes that additional tests requested by the MRO can provide useful information to determine the veracity of a donor's medical explanation. This is a revision to the current Guidelines, but is consistent with current practices. An example of an additional test currently requested by an MRO is when the laboratory reports a positive methamphetamine result. The MRO may request a d,l-stereoisomer determination for methamphetamine, to determine whether the result could be attributed to use of an over-the-counter nasal inhaler. Another example of current practice is when the laboratory reports a positive THCA result, and the MRO requests testing for cannabivarin, to distinguish marijuana use from dronabinol (

e.g.,

Marinol®).

In Section 3.6, the Department proposes to revise the criteria to report a urine specimen as adulterated based on pH. Specifically, in paragraph 3.6(a), the Department is proposing to raise the low pH cutoff for adulteration from less than 3 to less than 4. This decision is based on the fact that the physiologically minimum achievable urine pH that can be produced by the kidneys is about pH 4.5.

Furthermore, there are no known medical conditions or medications that would cause urine pH to be less than 4.5. Any free hydrogen ions present in the renal tubular fluid are either buffered and secreted into urine in the form of ammonium, phosphate, sulfate, and weak organic acid ions with minimal change to the urine pH or they back leak into the extracellular fluid and are not excreted into the urine, which explains the physiological lower limit of 4.5 for urine pH. A proposed pH cutoff for adulteration of less than 4 creates an invalid pH range of “equal to or greater than 4 and less than 4.5,” which protects the donor from a pH test result less than 4.5 that could be due to analytical imprecision.

Section 3.8 contains the same criteria as the current Guidelines for reporting a urine specimen as dilute in conjunction with positive or negative drug test results. The section has been revised to clarify the criteria for specific gravity results measured to four-decimal places (

i.e.,

as required when creatinine is less than or equal to 5 mg/dL).

Section 3.9 contains the criteria for reporting an invalid result for a urine specimen. This section contains the same criteria for reporting an invalid result for a urine specimen as in the current Guidelines with four revisions. Paragraph 3.9(b) contains the criteria for reporting a specimen as invalid based on pH. The lower pH range has been changed to “equal to or greater than 4 and less than 4.5,” consistent with the proposed change to the low pH cutoff for adulteration [

i.e.,

raising the pH 3 cutoff to 4; Section 3.6(a)]. Paragraph 3.9(i) addresses interference using an alternate initial drug test method (

i.e.,

other than immunoassay) as proposed in the UrMG. This section includes an additional criterion in Paragraph 3.9(m) that allows reporting an invalid result when the specimen is not consistent with human urine as evidenced by additional specimen validity test results. This is consistent with the proposed Section 3.5 that allows the MRO to request additional tests. For example, at least one HHS-certified laboratory currently tests their non-regulated workplace urine specimens for a urine biomarker (

i.e.,

uric acid) to distinguish urine of human origin from synthetic urine. The Department believes that such tests can be useful, especially in light of the proliferation of urine substitution products that have been formulated to meet the criteria for routine specimen validity tests (

i.e.,

creatinine and pH). The tests must be forensically acceptable and scientifically sound.

Subpart D—Collectors

Sections 4.1 through 4.6 contain the same policies as the current Guidelines in regard to who may or may not collect a specimen, the requirements to be a collector, the requirements to be an observer for a direct observed collection, the requirements to be a trainer for collectors, and what a federal agency must do before a collector is permitted to collect a specimen. The only changes from the current Guidelines are some rewording for clarity and a minor change in the type of mock collections required for collector training in Section 4.3(a)(4).

Subpart E—Collection Sites

Sections 5.1 through 5.6 address requirements for collection sites, collection site records, how a collector ensures the security and integrity of a specimen at the collection site, and the privacy requirements when collecting a specimen. Most requirements are the same as in the current Guidelines, but some items have been reworded for clarity. The Department added a new Section 5.3 clarifying that collection site records must be stored at a secure site designated by the collector or the collector's employer. The Department also revised Section 5.4 to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.

Subpart F—Federal Drug Testing Custody and Control Form

Sections 6.1 and 6.2 are the same as in the current Guidelines, requiring an OMB-approved Federal CCF be used to document custody and control of each specimen at the collection site, and specifying what should occur if the correct OMB-approved CCF is not used.

Subpart G—Urine Specimen Collection Containers and Bottles

Sections 7.1 through 7.3 describe requirements for the collection container, temperature strip, and bottles that must be used to for urine specimen collections. The Department has added detailed requirements for these items, to enable proper collection and maintenance of the urine specimen.

Section 7.1 requires a single use container that has a means to measure urine temperature and two specimen bottles for urine collection.

Section 7.2 requires that the urine collection container, including the temperature strip and the bottles, not substantially affect the composition of drug and/or drug metabolites in the specimen. In addition, the two bottles must be sealable and non-leaking and maintain the integrity of the specimen during storage and transport, and must be sufficiently transparent to enable an objective assessment of the A and B specimens' appearance and identification of abnormal physical characteristics upon receipt at the HHS-certified laboratory or IITF.

Section 7.3 details the minimum performance requirements for a collection container and bottles (

i.e.,

required volume capacity and volume markings) and for the thermometer used to measure specimen temperature. The thermometer may be affixed to or built into the collection container and must provide graduated temperature readings. Alternatively, the collector may use another technology to measure specimen temperature (

e.g.,

thermal radiation scanning), providing the thermometer does not come into contact with the specimen.

Subpart H—Urine Specimen Collection Procedure

This subpart addresses the same topics, in the same order, as the OFMG procedures for oral fluid specimen collection. While the procedure is essentially the same as described in the current Guidelines, the Department has reordered and/or reworded steps for clarity and for consistency with the proposed OFMG. Differences exist due to the differences in urine and oral fluid collection procedures. In addition, the Department is proposing to allow federal agencies to authorize collection of oral fluid as an alternate specimen when a donor does not provide an adequate urine specimen. References to agency authorization and collection procedures for oral fluid are applicable only when the OFMG become effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines.

Section 8.5 describes the responsibilities and procedures the collector must follow during and after a urine collection. The Department has revised Section 8.5 to enable a federal agency to authorize collection of oral fluid as an alternate specimen when a donor is unable to provide a sufficient volume of urine within the allowed wait period (

i.e.,

up to three hours). As noted above, this revision will be applicable when the OFMG become effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines. Specifically, Paragraph 8.5(f)(2)(iii) instructs the collector to request authorization for the alternate specimen collection when he/she notifies the federal agency representative of the insufficient urine specimen.

Section 8.6 describes the procedures the collector must follow when a donor is unable to provide a urine specimen. The Department has revised Section 8.5 to enable a federal agency to authorize collection of oral fluid as an alternate specimen when a donor is unable to provide a urine specimen. As noted above, this revision will be applicable when the OFMG become effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines. Specifically, Paragraph 8.6(b)(2) instructs the collector to request authorization for the alternate specimen collection when he/she notifies the federal agency representative of the donor's inability to provide a urine specimen.

Section 8.7 prohibits collection of an alternate specimen when a donor is unable to provide an adequate urine specimen, unless specifically authorized by the Mandatory Guidelines for Federal Workplace Drug Testing Programs and by the federal agency. As noted above, Paragraphs 8.5(f)(2)(iii) and 8.6(b)(2) describe the circumstances in which the federal agency representative can authorize the collector to collect an alternate specimen (

e.g.,

oral fluid).

Section 8.14 describes a federal agency's responsibilities for a collection site. The Department has included an additional example of appropriate action that may be taken in response to a reported collection site deficiency: Self-assessment using the Collection Site Checklist for the Collection of Urine Specimens for Federal Agency Workplace Drug Testing Programs. This document is available on the SAMHSA Web site

http://www.samhsa.gov/workplace

Subpart I—HHS Certification of Laboratories and IITFs

This subpart contains the same requirements for HHS certification of laboratories and instrumented initial test facilities (IITFs) as the current Guidelines.

Section 9.5 includes the same qualitative and quantitative specifications for PT samples as the current Guidelines. Section 9.19 describes where the monthly list of laboratories and IITFs certified by HHS to conduct forensic drug testing for federal agencies is published. The list will indicate the type of specimen (

e.g.,

urine or oral fluid) that each laboratory is certified to test.

Subpart J—Blind Samples Submitted by an Agency

This subpart describes the policies for federal agency blind samples. In Section 10.1, the Department is keeping the annual 3 percent requirement for federal agency blind samples (

i.e.,

as a percentage of the agency's donor specimens) but is proposing to limit the annual number of blind samples to a maximum of 400.

Section 10.2 includes the same requirements for a blind sample as the current Guidelines. The Department has reworded the section for clarity. Also, in Paragraph 10.2(e), the Department added information that blind sample suppliers must provide and specified that the information is to be provided to the collection site/collector sending the sample and, upon request, to the MRO, federal agency, or the Secretary.

In Section 10.4, the Department added that the MRO must contact the laboratory or IITF as the first step after receiving a report for a blind sample with a result that is inconsistent with the expected result.

Subpart K—Laboratory

Section 11.10 addresses initial drug test requirements. These are the same as the current Guidelines requirements, except that the Department is proposing to allow the use of technologies other than immunoassay (

i.e.,

alternate initial test technologies). In recent years, technological advances have been made to techniques (

e.g.,

methods using spectrometry or spectroscopy) that enable their use as efficient and cost-effective alternatives to the

immunoassay techniques for initial drug testing while maintaining the required degree of sensitivity, specificity, and accuracy.

Section 11.11 describes validation requirements for initial drug tests. The Department has included a requirement in Paragraph 11.11(a)(5) for laboratories to assess potential interferences during assay validation. The revision is consistent with current requirements for HHS-certified laboratories. In Paragraphs 11.11(a)(6) and 11.11(c), the Department is proposing additional requirements for alternate technology initial drug tests based on the characteristics of these technologies.

Section 11.13 addresses confirmatory drug test requirements. The Department is proposing to allow analytical procedures using mass spectrometry or other equivalent technologies. Based on ongoing reviews of the scientific and forensic literature, and the assessment of a DTAB working group that has studied newer instruments and technologies, the Department believes that scientifically valid confirmatory methods other than combined chromatographic and mass spectrometric methods can be used to successfully detect and report the drug analytes in Subpart C—Urine Specimen Drug Tests.

Section 11.14 describes validation requirements for confirmatory tests. The Department has included a requirement for laboratories to assess matrix effects when validating a confirmatory drug test using liquid chromatography coupled with mass spectrometry and has added the requirement for laboratories to verify each new lot of reagent prior to placement into service. These revisions are consistent with current requirements for HHS-certified laboratories.

In Section 11.17, the Department added the requirement for laboratories to verify each new lot of reagent for specimen validity testing prior to placement into service, consistent with current requirements for HHS-certified laboratories.

The requirements for conducting each specimen validity test are the same as the current Guidelines, with the exception of pH testing and quality control requirements in Section 11.18(c) which have been revised in accordance with the proposed change to the low pH cutoff for adulteration [

i.e.,

raising the pH 3 cutoff to 4; Section 3.6(a)].

Section 11.19 addresses laboratory requirements for reporting test results. The Department made a change to wording in Section 11.19(a), deleting the requirement for laboratories to report results directly to the MRO, to allow the use of external service providers. Providing test results electronically to MROs can be timely and cost-effective, and is expected to increase following implementation of the Federal Custody and Control Form (CCF) as an electronic document. Section 11.19(n) was revised to require HHS-certified laboratories and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes test results and donor personal identifying information (PII), and to limit access to any data transmission, storage, and retrieval system. Changes have been made to the criteria for reporting a specimen as adulterated or as invalid based on low pH [

i.e.,

Sections 11.19(d) and 11.19(h)(2)] to reflect the proposed change to the low pH cutoff for adulteration [

i.e.,

raising the pH 3 cutoff to 4; Section 3.6(a)]. In Section 11.19(p), the Department has added the requirement for the laboratory to send a legible image or copy of the Federal CCF for rejected specimens to the MRO, as is current practice.

The Department revised Section 11.21(a) to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.

Section 11.22 describes the semiannual statistical summary report that a laboratory must provide to a federal agency for urine testing. The Department is proposing to require the laboratory to submit a copy (paper or electronic) of each statistical summary report to the Secretary or designated HHS representative.

Section 11.23 is a new section addressing the laboratory information to be made available to a federal agency and describes the contents of a standard laboratory documentation package, which are the same as in the current Guidelines. The Department is proposing that a federal agency may obtain laboratory information related to a positive, adulterated, or substituted drug test reported for a federal employee tested in its workplace program, as well as any relevant certification, review, or revocation of certification records for the laboratory.

Section 11.24 was modified to clarify that specimens are not a part of the information package that donors can receive from HHS-certified laboratories.

Subpart L—Instrumented Initial Test Facility (IITF)

This subpart addresses requirements for IITFs. Most requirements remain the same as the current Guidelines. The proposed revisions, detailed below, are consistent with the proposed revisions for laboratories in Section 11.

Section 12.9 addresses initial drug test requirements for IITFs. The Department is proposing to allow IITFs to use technologies other than immunoassay (

i.e.,

alternate initial test technologies). In recent years, technological advances have been made to techniques (

e.g.,

Section 12.10 describes validation requirements for initial drug tests. The Department has included a requirement in Paragraph 12.10(a)(5) for IITFs to assess potential interferences during assay validation. The revision is consistent with current requirements for HHS-certified IITFs. In Paragraphs 12.10(a)(6) and 12.10(c), the Department is proposing additional requirements for alternate technology initial drug tests based on the characteristics of these technologies.

In Section 12.13, the Department added the requirement for IITFs to verify each new lot of reagent for specimen validity testing prior to placement into service, consistent with current requirements for HHS-certified IITFs.

Section 12.15 addresses IITF requirements for reporting test results. The Department made a change to wording in Section 12.15(a), deleting the requirement for IITFs to report results directly to the MRO, to allow the use of external service providers. Providing test results electronically to MROs can be timely and cost-effective, and is expected to increase following implementation of the Federal Custody and Control Form (CCF) as an electronic document. Section 12.15(e) was revised to require HHS-certified IITFs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes test results and donor PII, and to limit access to any data transmission, storage, and retrieval system. In Section 12.15(g), the Department has added the requirement for the IITF to send a legible image or copy of the Federal CCF for rejected specimens to the MRO.

The Department revised Section 12.18(a) to allow hardcopy records to be discarded 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and

is consistent with the Paperwork Reduction Act.

Section 12.19 describes the semiannual statistical summary report that an IITF must provide to a federal agency for urine testing. The Department is proposing to require the IITF to submit a copy of each semiannual statistical summary report (paper or electronic) to the Secretary or designated HHS representative.

Section 12.20 is a new section addressing the IITF information to be made available to a federal agency and describes the contents of a standard IITF documentation package, which are the same as in the current Guidelines. The Department is proposing that a federal agency may obtain IITF information related to a positive, adulterated, or substituted drug test reported by a laboratory for a federal employee tested in its workplace program, as well as any relevant certification, review, or revocation of certification records for the IITF.

Subpart M—Medical Review Officer (MRO)

Section 13.1 describes who may serve as an MRO. With the inclusion of additional Schedule II prescription medications in the Guidelines and the ever-changing field of drug testing, medical review of drug test results is more complex today than before. Therefore, the Department proposes to incorporate MRO requalification training and reexamination on a regular basis (at least every five years). The UrMG and OFMG do not include a requirement for MROs to obtain continuing education units (CEUs). The Department understands that it would be difficult to determine whether CEUs obtained are related to federal agency drug testing. The requalification requirement every five years will assure agency auditors and inspectors and regulated employers that MROs are appropriately qualified. This requirement is not expected to increase costs to MROs. Current practices for MRO requirements have equivalent standards but vary among MRO training entities. These requirements will standardize the length of time each MRO is required to take a requalification examination. Currently, some MRO requalification periods are longer than five years, while others are less than five years. The Department assumes that the costs to those MROs that have requalification periods over five years will be offset by the cost savings to MROs that have periods shorter than five years. Thus, the Department has not estimated any costs associated with this provision, but it welcomes comment on this assumption.

The Department anticipates that MROs will continue to obtain CEUs by virtue of maintaining their medical licensure requirements. In addition, the MRO certification/training entities provide MRO manuals and periodic newsletters with updates on federal drug testing program requirements. However, the Department is seeking comments on requiring MRO requalification CEUs and on the optimum number of credits and the appropriate CEU accreditation bodies should CEUs be required as part of MRO requalification.

MROs play a key role in the federal safety program and maintain the balance between the safety and privacy objectives of the program. The MRO's role in gathering and evaluating the medical evidence and providing due process is imperative. These are duties that must be carried out by the MRO, and cannot be delegated to other personnel who are not certified by an MRO entity.

The MRO is charged with certain important medical and administrative duties. The MRO must have detailed knowledge of the effects of medications and other potential alternative medical explanations for laboratory reported drug test results. He or she is responsible for determining whether legitimate medical explanations are available to explain an employee's drug test result. This medical review process has become far more complex as a result of specimen validity testing and the myriad of donor explanations for adulterated, substituted, and invalid laboratory test results.

In addition, MROs confer with prescribing physicians in making decisions about prescription changes so that alternative medications can be used that will not impact public safety. Similarly, the MRO is required to report to employers the employees' prescription and over-the-counter medication use (or dangerous combinations of use) that the MRO believes will negatively affect duty performance. In addition, the MRO is required to medically assess referral physician examinations and evaluations in certain positive and refusal-to-test situations. These, too, have become more complex over time.

Section 13.2 describes how nationally recognized entities or subspecialty boards that certify MROs are approved. The Department is proposing to extend the due date for resubmission of qualifications for HHS approval from each year to every two years and to publish the list of approved entities at least every two years, rather than annually. The revised time periods appear sufficient to ensure that educational material is updated at least every two years and the Department requiring the nationally recognized entities that approves MROs ensures the qualifications are being met. The Department has also revised this section to require submission of the certification examination delivery method along with other documentation for review.

Section 13.3 describes the training that is required before a physician may serve as an MRO. With the issue of prescription drug abuse and the inclusion of additional opiates to the federal drug-testing panel, MROs have the difficult task of interpreting positive drug test results from prescription drugs. Further guidance on these drug test results will be included in the MRO manual. The Department has added a requirement for MRO training to include information about how to discuss substance misuse and abuse and how to access those services. MROs performing the review of federal employee drug test results should be aware of prevention and treatment opportunities for individuals and can provide information to the donor.

The Department also revised Section 13.4 to allow the MRO to discard hardcopy records 6 months after conversion to electronic records. This change ensures the availability of the records while reducing the recordkeeping burden, and is consistent with the Paperwork Reduction Act.

Section 13.5 describes MRO actions when reviewing a urine specimen's test results. Section 13.5(d) contains the same procedure as the current Guidelines: When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result. If the donor provides a legitimate medical explanation for the positive result, the MRO reports the test result as negative to the agency. The Department added a new Section 13.5(c) to address multiple test results for one specimen and added Section 13.5(h) to address MRO procedures for multiple specimens from the same testing event (

e.g.,

when the collector forwarded to the laboratory a urine specimen with temperature out of range and the subsequently collected specimen—urine or another authorized specimen type). In Paragraphs 13.5(b) and 13.5(g), the Department added instructions for handling recollected negative/dilute or invalid specimens that provide the same results as the first specimen (

i.e.,

when another specimen

was collected from a donor because of a negative/dilute or invalid result, and the recollected specimen provides the same result as the first specimen). The proposed revisions provide a final resolution to report such drug tests, which were not adequately addressed in the current Guidelines. The Department revised Section 13.5(i) to specify the type of specimen (

i.e.,

urine) to be collected from the donor following a cancelled test for a rejected specimen.

Section 13.6 describes what an MRO must do when the collector reports that a donor did not provide a sufficient amount of urine for a drug test. For those instances in which the donor did not provide an adequate urine specimen and the federal agency authorized collection of another specimen type (

e.g.,

oral fluid), the Department is proposing that the MRO review and report those results. If the federal agency did not authorize collection of another specimen type, the current Guidelines procedures remain in effect (

i.e.,

medical evaluation). The Department revised this section to address collection of an alternative specimen for any subsequent tests when the donor has a permanent or long-term medical condition that prevents provision of a sufficient volume of urine for the drug test. As noted previously, a federal agency may authorize collection of oral fluid only when the OFMG are effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines.

Section 13.7 describes what an MRO must do when a donor has a permanent or long-term medical condition that prevents him or her from providing a sufficient amount of urine, a negative test is required (

i.e.,

for a federal agency applicant/pre-employment, follow-up, or return-to-duty test), and the federal agency did not authorize collection of another specimen type (

e.g.,

oral fluid). As noted previously, a federal agency may authorize collection of oral fluid only when the OFMG are effective and HHS has certified laboratories to perform oral fluid testing under the Guidelines.

Section 13.9 describes how an MRO reports a primary (A) specimen result to an agency. The Department revised Section 13.9(a) to address MRO use of external service providers. The revised section requires MROs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes donor PII, and to limit access to any data transmission, storage, and retrieval system. The Department is also proposing to delete the requirement in Paragraph 13.9(c) for the MRO to send a paper copy of the Federal CCF or separate letter/memorandum. The MRO may report results electronically.

Subpart N—Split Specimen Tests

The Department is proposing to revise Section 14.1(c) to clarify that, in a case where a B specimen is not available for testing, the MRO reports only to the federal agency and not to the donor. This is consistent with the requirement in the next sentence that no notice be given to the donor until immediately before the observed recollection.

Section 14.3(a) addresses criteria for reconfirming an adulterated result. The low pH cutoff in Section 14.3(a)(1) has been changed to reflect the proposed change to the low pH cutoff for adulteration [

i.e.,

raising the pH 3 cutoff to 4; Section 3.6(a)].

Section 14.5 describes who receives the split specimen report from the laboratory. The Department reworded this section to address MRO use of external service providers, similar to the change made to Section 11.19(a) for primary specimen reports.

Section 14.7 describes how an MRO reports a split (B) specimen result to an agency. The Department revised Section 14.7(a) to address MRO use of external service providers. The revised section requires MROs and external service providers to maintain the confidentiality, integrity, and availability of the data, which includes donor PII, and to limit access to any data transmission, storage, and retrieval system. The Department revised Section 14.7(c) to clarify that MRO must use the Federal CCF or separate letter/memorandum to report all split specimens (

i.e.,

not just positive, adulterated, or substituted specimens), and deleted the requirement for the MRO to send paper copies of these documents. The MRO may report results electronically.

Subpart O—Criteria for Rejecting a Specimen for Testing

In Section 15.1, the Department is proposing a new Paragraph 15.1(e) requiring specimen rejection if the accessioner has not documented the primary (A) seal condition at the time of accessioning and the split (B) specimen cannot be redesignated as the primary (A) specimen. This is consistent with current practice. The Department maintains that relying on the accessioner's recall of a particular specimen's bottle seal condition is not a forensically acceptable practice.

Subpart P—Laboratory or IITF Suspension/Revocation Procedures

This subpart includes procedures to revoke or suspend the HHS-certification of laboratories and IITFs. These are the same as in the current Guidelines.

Impact of These Guidelines on Government Regulated Industries

The Department is aware that these proposed new 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.

Topics of Special Interest

The Department requests public comment on all aspects of this notice. However, the Department is providing the following list of areas for which specific comments are requested.

Section 3.4 lists the proposed new analytes oxycodone, oxymorphone, hydrocodone, and hydromorphone and their cutoff concentrations. The Department is specifically requesting comments on these revisions.

Section 13.1 describes proposed requirements for MRO requalification training and reexamination on a regular basis (

i.e.,

every five years) but does not require MROs to obtain continuing education units (CEUs). The Department is seeking comments on requiring MRO CEUs and on the optimum number of credits and the appropriate CEU accreditation bodies should CEUs be required.

Regulatory Impact and Notices

The Department welcomes public comment on all figures and assumptions used for the regulatory impact assessment described in this section.

Executive Orders 13563 and 12866

Executive Order 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) states “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with this mandate, Executive Order 13563 requires agencies to tailor “regulations to impose the least burden on society, consistent with obtaining regulatory objectives.” Executive Order 13563 also requires agencies to “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice” while selecting “those approaches that maximize net benefits.” This notice proposes a

regulatory approach that will reduce burdens to providers and to consumers while continuing to provide adequate protections for public health and welfare.

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

According to Executive Order 12866, a regulatory action is “significant” if it meets any one of a number of specified conditions, including having an annual effect on the economy of $100 million; adversely affecting in a material way a sector of the economy, competition, or jobs; or if it raises novel legal or policy issues. The proposed Guidelines do establish additional regulatory requirements and allow an activity that was otherwise prohibited. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for “a matter relating to agency management or personnel” 5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary govern federal workplace drug testing programs, HHS has taken the position that the Guidelines are a “matter relating to agency management or personnel” and, thus, are not subject to the APA's requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs. However, the statute under which the mandatory guidelines were created (Pub. L. 100-71, section 503(a)(3)) required notice and comment apart from the APA. This provision provides the following: Notwithstanding any provision of chapter 5 of title 5, United States Code, the mandatory guidelines to be published pursuant to subsection (a)(l)(A)(ii) shall be published and made effective exclusively according to the provisions of this paragraph. Notice of the mandatory guidelines proposed by the Secretary of Health and Human Services shall be published in the

Federal Register

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

Federal Register

and shall become effective upon publication.

Need for Revisions to the Guidelines

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

1-4

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

Costs

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

In Section 3.4, the Department is proposing criteria for calibrating initial tests for grouped analytes such as opiates and amphetamines, and specifying the cross-reactivity of the immunoassay to the other analytes(s) within the group. These proposed Guidelines allow the use of methods other than immunoassay for initial testing. In addition, these proposed Guidelines include an alternative for laboratories to continue to use existing FDA-cleared immunoassays which do not have the specified cross-reactivity, by establishing a decision point with the lowest-reacting analyte. An immunoassay manufacturer may incur costs if they choose to alter their existing product and resubmit the immunoassay for FDA clearance.

de minimis.

de minimis

costs.

Once the testing has been implemented, the cost per specimen for initial testing for the added analytes will range from $.06 to $0.20 due to reagent costs. Current costs for each confirmatory test range from $5.00 to $10.00 for each specimen reported positive, due to sample preparation and analysis costs. Based on information from non-regulated workplace drug testing for these analytes and testing performed by the Department on de-identified federally regulated specimens in 2011, approximately 1% of the submitted specimens is expected to be confirmed as positive for the added analytes. Therefore, the added cost for confirmatory testing will be $0.05 to $0.10 per submitted specimen. This

would indicate that the cost per specimen submitted for testing will increase by $0.11-$0.30.

The addition of the Schedule II prescription medications will require MRO review to verify legitimate drug use. Based on the positivity rates from non-regulated workplace drug testing for these analytes and the additional review of specimens confirmed positive for prescription medications, MRO costs are estimated to increase by approximately 3%. This 3% cost increase is expected to occur gradually as agencies' existing contracts expire and they renegotiate the terms of new contracts, with an increase to the total cost of a federal drug test over time to between $0.60-$1.35. This cost would indicate a total cost for federal agencies of $83,700 to $188,325 in the urine testing program.

The additional costs for testing and MRO review will be incorporated into the overall cost for the federal agency submitting the specimen to the laboratory. The estimation of costs incurred is based upon overall cost to the federal agency because the review of positive specimens is usually based on all specimens submitted from an agency, rather than individual specimen testing costs or MRO review of positive specimens. Agencies may also incur some costs for training of federal employees such as drug program coordinators due to implementation of the revised Guidelines. Based on current training modules offered to drug program coordinators, and other associated costs including travel for 90% of drug program coordinators, the estimated total training cost for a one-day training session would be between $54,000 and $69,000 (

i.e.,

assuming 8 hours of time multiplied by a GS 12/13 wage).

Recurring Annual Costs Summary Table

Lower bound

Upper bound

Reagent Costs

$368,730.00

$1,229,100.00

Additional Confirmatory tests

307,275.00

614,550.00

MRO Costs

3,687,300.00

8,296,425.00

Total annual costs

4,363,305.00

10,140,075.00

Upfront (One-Time) Costs Summary Table

Lower bound

Upper bound

Performance Testing

$27,900.00

$55,800.00

Training

54,000

69,000

Total

81,900.00

124,800.00

Benefits

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

e.g.,

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

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

Regulatory Flexibility Analysis

For the reasons outlined above, the Secretary has determined that the proposed Guidelines will not have a significant impact upon a substantial number of small entities within the meaning of the Regulatory Flexibility Act [5 U.S.C. 605(b)]. The flexibility added by the UrMG will not require addition expenditures. Therefore, an initial regulatory flexibility analysis is not required for this notice.

The Secretary has determined that the proposed Guidelines are not a major rule for the purpose of congressional review. For the purpose of congressional review, a major rule is one which is likely to cause an annual effect on the economy of $100 million; a major increase in costs or prices; significant effects on competition, employment, productivity, or innovation; or significant effects on the ability of U.S.-based enterprises to compete with foreign-based enterprises in domestic or export markets. This is not a major rule under the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996.

Unfunded Mandates

The Secretary has examined the impact of the proposed Guidelines under the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104-4). This notice does not trigger the requirement for a written statement under section 202(a) of the UMRA because the proposed Guidelines do not impose a mandate that results in an expenditure of $100 million (adjusted annually for inflation) or more by either state, local, and tribal governments in the aggregate or by the private sector in any one year.

Environmental Impact

The Secretary has considered the environmental effects of the UrMG. No information or comments have been received that would affect the agency's determination there would be a significant impact on the human environment and that neither an environmental assessment nor an environmental impact statement is required.

Executive Order 13132: Federalism

The Secretary has analyzed the proposed Guidelines in accordance with Executive Order 13132: Federalism.

Executive Order 13132 requires federal agencies to carefully examine actions to determine if they contain policies that have federalism implications or that preempt state law. As defined in the Order, “policies that have federalism implications” refer to regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

In this notice, the Secretary is proposing to revise the standards for certification of laboratories engaged in urine fluid drug testing for federal agencies and the use of urine testing in federal drug-free workplace programs. The Department of Health and Human Services, by authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301, and Executive Order No. 12564, establishes the scientific and technical guidelines for federal workplace drug testing programs and establishes standards for certification of laboratories engaged in urine drug testing for federal agencies. Because the Mandatory Guidelines govern standards applicable to the management of federal agency personnel, there should be little, if any, direct effect on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Secretary has determined that the Guidelines do not contain policies that have federalism implications.

Paperwork Reduction Act of 1995

The proposed Guidelines contain information collection requirements which are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 [the PRA 44 U.S.C. 3507(d)]. Information collection and recordkeeping requirements which would be imposed on laboratories engaged in drug testing for federal agencies concern quality assurance and quality control documentation, reports, performance testing, and inspections as set out in subparts H, I, K, L, M and N. To facilitate ease of use and uniform reporting, a Federal CCF for each type of specimen collected will be developed as referenced in section 6.1. The Department has submitted the information collection and recordkeeping requirements contained in the proposed Guidelines to OMB for review and approval.

Privacy Act

The Secretary has determined that the Guidelines do not contain information collection requirements constituting a system of records under the Privacy Act. The

Federal Register

notice announcing the proposed Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine is not a system of records as noted in the information collection/recordkeeping requirements below. As required, HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the

Federal Register

on April 11, 1988 [53 FR 11979]. SAMHSA subsequently revised the Guidelines on June 9, 1994 [59 FR 29908], September 30, 1997 [62 FR 51118], November 13, 1998 [63 FR 63483], April 13, 2004 [69 FR 19644], and November 25, 2008 [73 FR 71858] with an effective date of May 1, 2010 (correct effective date published on December 10, 2008 [73 FR 75122]). The effective date of the Guidelines was further changed to October 1, 2010 on April 30, 2010 [75 FR 22809].

Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

Executive Order 13175 (65 FR 67249, November 6, 2000) requires SAMHSA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” as defined in the Executive Order, include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the federal government and the Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes.” The proposed Guidelines do not have tribal implications. The Guidelines will not have substantial direct effects on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175.

Information Collection/Record Keeping Requirements

The information collection requirements (

i.e.

, reporting and recordkeeping) in the current Guidelines, 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 used to document the collection and chain of custody of urine specimens at the collection site, for laboratories to report results, and for Medical Review Officers to make a determination, the National Laboratory Certification Program (NLCP) application, the NLCP Laboratory Information Checklist, and recordkeeping requirements in the current Guidelines, as approved under control number 0930-0158, will remain in effect until final Guidelines including the use of another specimen matrix are issued.

The title, description and respondent description of the information collections are shown in the following paragraphs with an estimate of the annual reporting, disclosure and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.

Title:

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

Description:

The Mandatory Guidelines establish the scientific and technical guidelines for federal drug testing programs and establish standards for certification of laboratories engaged in drug testing for federal agencies under authority of Public Law 100-71, 5 U.S.C. 7301 note, and Executive Order No. 12564. Federal drug testing programs test applicants to sensitive positions, individuals involved in accidents, individuals for cause, and random testing of persons in sensitive positions.

Description of Respondents:

Individuals or households; businesses; or other-for-profit; not-for-profit institutions.

The burden estimates in the tables below are based on the following number of respondents:

38,000 donors who apply for employment in testing designated positions, 100 collectors, 30 urine specimen testing laboratories, 5 IITFs, 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

9.12(a)(3)

Materials to submit to become an HHS inspector

11.3(a)

Laboratory submits qualifications of RP to HHS

11.4(c)

Laboratory submits information to HHS on new RP or alternate RP

11.22

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

0.5

12.3(a)

IITF submits qualifications of RT to HHS

12.4(c)

IITF submits information to HHS on new RT or alternate RT

12.19

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

13.9 and 14.7

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

100

* 0.05

16.1(b) & 16.5(a)

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

16.4

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

0.5

16.6

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

0.5

16.7(a)

Specifies contents of appellant submission for review

16.9(a)

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

16.9(c)

Specifies contents of review file and briefs

Total

156

247

* 3 min.

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(c)]; 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

* 0.05

11.23, 11.24

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

1,500

12.20, 12.21

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

13.8(b)

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

100

1,500

Total

210

3,505

* 3 min.

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.

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

2,534

8.8(d) & (f)

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

38,000

** 0.08

3,167

11.8(a) & 11.19

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

3,800

*** 0.05

1,900

12.8(a) & 12.15

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

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

1,900

14.1(b)

MRO documents donor's request to have split specimen tested

300

*** 0.05

Total

38,510

9,516

* 4 min.

** 5 min.

*** 3 min.

The proposed Guidelines contain a number of recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector [Section 4.3(a)(3)] and the documentation must be maintained in the collector's training file [Section 4.3(c)]. SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a federal agency specimen, the collector is required to provide a statement [Section 6.2(b)] explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H [Sections 8.4(c), 8.5(d)(2), 8.5(e)(1) and (2)] requires collectors to enter any information on the Federal CCF of any unusual findings during the urine specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries are included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subpart K describes a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records [

i.e.

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

Thus the total annual response burden associated with the testing of urine specimens by the laboratories and IITFs is estimated to be 13,268 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 technological collection techniques or other forms of information technology.

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. U.S. Department of Health and Human Services, Behavioral Health Coordinating Committee, Prescription Drug Abuse Subcommittee,

Addressing Prescription Drug Abuse in the United States: Current Activities and Future Opportunities.

Department of Health and Human Services, 2013.

http://www.cdc.gov/HomeandRecreationalSafety/pdf/HHS_Prescription_Drug_Abuse_Report_09.2013.pdf

(accessed 15 September 2014).

2. Substance Abuse and Mental Health Services Administration,

Results from the 2012 National Survey on Drug Use and Health: Summary of National Findings,

NSDUH Series H-46, HHS Publication No. (SMA) 13-4795. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

3. Substance Abuse and Mental Health Services Administration,

Drug Abuse Warning Network, 2011: National Estimates of Drug-Related Emergency Department Visits.

HHS Publication No. (SMA) 13-4760, DAWN Series D-39. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2013.

4. U.S. Drug Enforcement Administration, Office of Diversion Control, 2013.

National Forensic Laboratory Information System: Year 2012 Annual Report.

Springfield, VA: U.S. Drug Enforcement Administration.

5. Quest Diagnostics Incorporated,

Drug Use Among American Workers Declined 74% Over the Past 25 Years, Finds Unprecedented Analysis of More Than 125 Million Workplace Urine Tests

http://blog.employersolutions.com/wp-content/uploads/2013/11/dti25-press-release-11-18-2013.pdf

, 18 November 2013 (accessed 19 August 2014).

6. Smith, M.L., Hughes, R.O., Levine, B., Dickerson, S., Darwin, W.D., and Cone, E.J. (1995), Forensic drug testing for opiates. VI. Urine testing for hydromorphone, hydrocodone, oxymorphone, and oxycodone with commercial opiate immunoassays and gas chromatography-mass spectrometry. J. Anal. Toxicol., 19, 18-26.

7. Cone, E.J., Zichterman, A., Heltsley, R., Black, D.L., Cawthon, B., Robert, T., Moser, F., and Caplan, Y.H. (2010), Urine testing for norcodeine, norhydrocodone, and noroxycodone facilitates interpretation and reduces false negatives. Forensic Sci. Int., 198, 58-61.

8. Lalovic, B., Kharasch, E., Hoffer, C., Risler, L., Liu-Chen, L.Y., and Shen, D.D. (2006), Pharmacokinetics and pharmacodynamics of oral oxycodone in healthy human subjects: role of circulating active metabolites. Clin. Pharmacol. Ther., 79, 461-479.

9. Heltsley, R., Zichterman, A., Black, D.L., Cawthon, B., Robert, T., Moser, F., Caplan, Y.H., and Cone, E.J. (2010), Urine drug testing of chronic pain patients. II. Prevalence patterns of prescription opiates and metabolites. J. Anal. Toxicol., 34, 32-38.

10. Poyhia, R., Seppala, T., Olkkola, K.T., and Kalso, E. (1992), The pharmacokinetics and metabolism of oxycodone after intramuscular and oral administration to healthy subjects. Br. J. Clin. Pharmacol., 33, 617-621.

11. Yee, D.A., Best, B.M., Atayee, R.S., and Pesce, A.J. (2012), Observations on the urine metabolic ratio of oxymorphone to oxycodone in pain patients. J. Anal. Toxicol., 36, 232-238.

12. Cone, E.J., Darwin, W.D., Gorodetzky, C.W., and Tan, T. (1978), Comparative metabolism of hydrocodone in man, rat, guinea pig, rabbit, and dog. Drug Metab. Dispos., 6, 488-493.

13. Cone, E.J. and Darwin, W.D. (1978), Simultaneous determination of hydromorphone, hydrocodone and their 6a-and 6B hydroxy metabolites in urine using selected ion recording with methane chemical ionization. Biochem. Mass Spectrom., 5, 291-295.

14. Valtier, S. and Bebarta, V.S. (2012), Excretion profile of hydrocodone, hydromorphone and norhydrocodone in urine following single dose administration of hydrocodone to healthy volunteers. J. Anal. Toxicol., 36, 507-514.

15. Cone, E.J., Phelps, B.A., and Gorodetzky, C.W. (1977), Urinary excretion of hydromorphone and metabolites in humans, rats, dogs, guinea pigs, and rabbits. J.Pharm.Sci., 66, 1709-1713.

16. Oyler, J.M., Cone, E.J., Joseph, R.E., Jr., and Huestis, M.A. (2000), Identification of hydrocodone in human urine following controlled codeine administration. J. Anal. Toxicol., 24, 530-535.

17. Cone, E.J., Heit, H.A., Caplan, Y.H., and Gourlay, D. (2006), Evidence of morphine metabolism to hydromorphone in pain patients chronically treated with morphine. J. Anal. Toxicol., 30, 1-5.

18. Cone, E.J., Caplan, Y.H., Moser, F., Robert, T., and Black, D. (2008), Evidence that morphine is metabolized to hydromorphone but not to oxymorphone. J. Anal. Toxicol., 32, 319-323.

19. Cook, J.D., Strauss, K.A., Caplan, Y.H., LoDico, C.P., Bush, D.M. (2007), Urine pH: the effects of time and temperature after collection. J. Anal. Toxicol., 31, 486-496.

Dated: May 4, 2015.

Pamela S. Hyde,

Administrator, SAMHSA.

Dated: May 7, 2015.

Sylvia M. Burwell,

Secretary.

For reasons set forth in the preamble, the Department proposes to revise the Mandatory Guidelines for Federal Workplace Drug Testing Programs to include Mandatory Guidelines using Urine Specimens to read as follows:

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

2.2 Under what circumstances may a urine

specimen be collected?

2.3 How is each urine specimen collected?

2.4 What volume of urine is collected?

2.5 How does the collector split the urine specimen?

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

Subpart C—Urine Specimen Tests

3.1 Which tests are conducted on a urine specimen?

3.2 May a specimen be tested for additional drugs?

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

3.4 What are the drug test cutoff concentrations for urine?

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

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

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

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

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

Subpart D—Collectors

4.1 Who may collect a specimen?

4.2 Who may not collect a specimen?

4.3 What are the requirements to be a collector?

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

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

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

Subpart E—Collection Sites

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

5.2 What are the requirements for a collection site?

5.3 Where must collection site records be stored?

5.4 How long must collection site records be stored?

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

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

Subpart F—Federal Drug Testing Custody and Control Form

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

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

Subpart G—Urine Specimen Collection Containers and Bottles

7.1 What is used to collect a urine specimen?

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

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

Subpart H—Urine Specimen Collection Procedure

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

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

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

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

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

8.6 What procedure is used when the donor states that he or she is unable to provide a urine specimen?

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

8.8 How does the collector prepare the urine specimens?

8.9 When is a direct observed collection conducted?

8.10 How is a direct observed collection conducted?

8.11 When is a monitored collection conducted?

8.12 How is a monitored collection conducted?

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

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

Subpart I—HHS Certification of Laboratories and IITFs

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

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

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

9.4 What is the process when a laboratory or IITF does not maintain its HHS certification?

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

9.6 What are the PT requirements for an applicant laboratory?

9.7 What are the PT requirements for an HHS-certified urine laboratory?

9.8 What are the PT requirements for an applicant IITF?

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

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

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

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

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

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

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

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

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

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

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

Subpart J—Blind Samples Submitted by an Agency

10.1 What are the requirements for federal agencies to submit blind samples to HHS-certified laboratories or IITFs?

10.2 What are the requirements for blind samples?

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

10.4 What happens if an inconsistent result is reported for a blind sample?

Subpart K—Laboratory

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

11.2 What are the responsibilities of the responsible person (RP)?

11.3 What scientific qualifications must the RP have?

11.4 What happens when the RP is absent or leaves an HHS-certified laboratory?

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

11.6 What qualifications and training must other personnel of an HHS-certified laboratory have?

11.7 What security measures must an HHS-certified laboratory maintain?

11.8 What are the laboratory chain of custody requirements for specimens and aliquots?

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

11.10 What are the requirements for an initial drug test?

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

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

11.13 What are the requirements for a confirmatory drug test?

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

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

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

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

11.18 What are the requirements for

conducting each specimen validity test?

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

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

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

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

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

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

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

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

Subpart L—Instrumented Initial Test Facility (IITF)

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

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

12.3 What qualifications must the RT have?

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

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

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

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

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

12.9 What are the requirements for an initial drug test?

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

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

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

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

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

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

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

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

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

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

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

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

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

Subpart M—Medical Review Officer (MRO)

13.1 Who may serve as an MRO?

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

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

13.4 What are the responsibilities of an MRO?

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

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

13.7 What happens when an individual is unable to provide a sufficient amount of urine for a federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test because of a permanent or long-term medical condition?

13.8 Who may request a test of a split (B) specimen?

13.9 How does an MRO report a primary (A) specimen test result to an agency?

13.10 What types of relationships are prohibited between an MRO and an HHS-certified laboratory or an HHS-certified IITF?

Subpart N—Split Specimen Tests

14.1 When may a split (B) specimen be tested?

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

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

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

14.5 Who receives the split (B) specimen result?

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

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

14.8 How long must an HHS-certified laboratory retain a split (B) specimen?

Subpart O—Criteria for Rejecting a Specimen for Testing

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

15.2 What discrepancies require an HHS-certified laboratory or an HHS-certified IITF to report a specimen as rejected for testing unless the discrepancy is corrected?

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

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

Subpart P—Laboratory or IITF Suspension/Revocation Procedures

16.1 When may the HHS certification of a laboratory or IITF be suspended?

16.2 What definitions are used for this subpart?

16.3 Are there any limitations on issues subject to review?

16.4 Who represents the parties?

16.5 When must a request for informal review be submitted?

16.6 What is an abeyance agreement?

16.7 What procedures are used to prepare the review file and written argument?

16.8 When is there an opportunity for oral presentation?

16.9 Are there expedited procedures for review of immediate suspension?

16.10 Are any types of communications prohibited?

16.11 How are communications transmitted by the reviewing official?

16.12 What are the authority and responsibilities of the reviewing official?

16.13 What administrative records are maintained?

16.14 What are the requirements for a written decision?

16.15 Is there a review of the final administrative action?

Subpart A—Applicability

Section 1.1 To whom do these Guidelines apply?

(a) These Guidelines apply to:

(1) Executive Agencies as defined in 5 U.S.C. 105;

(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3) (but excluding the Armed Forces as defined in 5 U.S.C. 2101(2));

(3) Any other employing unit or authority of the federal government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and

(4) The Intelligence Community, as defined by Executive Order 12333, is subject to these Guidelines only to the extent agreed to by the head of the affected agency;

(5) Laboratories and instrumented initial test facilities (IITFs) that provide drug testing services to the federal agencies;

(6) Collectors who provide specimen collection services to the federal agencies; and

(7) Medical Review Officers (MROs) who provide drug testing review and interpretation of results services to the federal agencies.

(b) These Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice

system, such as arrestees, detainees, probationers, incarcerated persons, or parolees.

The NRC-related information in this notice pertains to individuals subject to drug testing conducted pursuant to 10 CFR part 26, “Fitness for Duty Programs” (

i.e.,

employees of certain NRC-regulated entities).

Although HHS has no authority to regulate the transportation industry, the Department of Transportation (DOT) does have such authority. DOT is required by law to develop requirements for its regulated industry that “incorporate the Department of Health and Human Services scientific and technical guidelines dated April 11, 1988, and any amendments to those guidelines . . .” See 49 U.S.C. 20140(c)(2). In carrying out its mandate, DOT requires by regulation at 49 CFR part 40 that its federally-regulated employers use only HHS-certified laboratories in the testing of employees, 49 CFR 40.81, and incorporates the scientific and technical aspects of the HHS Mandatory Guidelines.

Section 1.2 Who is responsible for developing and implementing these Guidelines?

(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for federal workplace drug testing programs.

(b) The Secretary has the responsibility to implement these Guidelines.

Section 1.3 How does a federal agency request a change from these Guidelines?

(a) Each federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.

(b) To obtain a waiver, a federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.

Section 1.4 How are these Guidelines revised?

(a) To ensure the full reliability and accuracy of specimen tests, the accurate reporting of test results, and the integrity and efficacy of federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.

(b) The changes will be published in final as a notice in the

Federal Register

Section 1.5 What do the terms used in these Guidelines mean?

The following definitions are adopted:

Accessioner.

The individual who signs the Federal Drug Testing Custody and Control Form at the time of specimen receipt at the HHS-certified laboratory or (for urine) the HHS-certified IITF.

Adulterated Specimen.

A specimen that has been altered, as evidenced by test results showing either a substance that is not a normal constituent for that type of specimen or showing an abnormal concentration of an endogenous substance.

Aliquot.

A portion of a specimen used for testing.

Alternate Responsible Person.

The person who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory when the responsible person is unable to fulfill these obligations.

Alternate Responsible Technician.

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

Alternate Technology Initial Drug Test.

An initial drug test using technology other than immunoassay to differentiate negative specimens from those requiring further testing.

Batch.

A number of specimens or aliquots handled concurrently as a group.

Biomarker.

An endogenous substance used to validate a biological specimen.

Blind Sample.

A sample submitted to an HHS-certified test facility for quality assurance purposes, with a fictitious identifier, so that the test facility cannot distinguish it from a donor specimen.

Calibrator.

A sample of known content and analyte concentration prepared in the appropriate matrix used to define expected outcomes of a testing procedure. The test result of the calibrator is verified to be within established limits prior to use.

Cancelled Test.

The result reported by the MRO to the federal agency when a specimen has been reported to the MRO as an invalid result (and the donor has no legitimate explanation) or rejected for testing, when a split specimen fails to reconfirm, or when the MRO determines that a fatal flaw or unrecovered correctable flaw exists in the forensic records (as described in Sections 15.1 and 15.2).

Carryover.

The effect that occurs when a sample result (

e.g.,

drug concentration) is affected by a preceding sample during the preparation or analysis of a sample.

Certifying Scientist (CS).

The individual responsible for verifying the chain of custody and scientific reliability of a test result reported by an HHS-certified laboratory.

Certifying Technician (CT).

The individual responsible for verifying the chain of custody and scientific reliability of negative, rejected for testing, and (for urine) negative/dilute results reported by an HHS-certified laboratory or (for urine) an HHS-certified IITF.

Chain of Custody (COC) Procedures.

Procedures that document the integrity of each specimen or aliquot from the point of collection to final disposition.

Chain of Custody Documents.

Forms used to document the control and security of the specimen and all aliquots. The document may account for an individual specimen, aliquot, or batch of specimens/aliquots and must include the name and signature of each individual who handled the specimen(s) or aliquot(s) and the date and purpose of the handling.

Collection Container.

A receptacle used to collect a urine specimen.

Collection Site.

The location where specimens are collected.

Collector.

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

Confirmatory Drug Test.

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

Confirmatory Specimen Validity Test.

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

Control.

A sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits.

Cutoff.

The analytical value (

e.g.,

drug or drug metabolite concentration) used as the decision point to determine a result (

e.g.,

negative, positive, adulterated, invalid, or, for urine, substituted) or the need for further testing.

Dilute Specimen.

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

Donor.

The individual from whom a specimen is collected.

Failed to Reconfirm.

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

Federal Drug Testing Custody and Control Form (Federal CCF).

The Office of Management and Budget (OMB) approved form that is used to document the collection and chain of custody of a specimen from the time the specimen is collected until it is received by the test facility (

i.e.,

HHS-certified laboratory or,

for urine, HHS-certified IITF). It may be a paper (hardcopy), electronic, or combination electronic and paper format (hybrid). The form may also be used to report the test result to the Medical Review Officer.

HHS.

The Department of Health and Human Services.

Initial Drug Test.

An analysis used to differentiate negative specimens from those requiring further testing.

Initial Specimen Validity Test.

The first analysis used to determine if a specimen is invalid, adulterated, or (for urine) diluted or substituted.

Instrumented Initial Test Facility (IITF).

A permanent location where (for urine) initial testing, reporting of results, and recordkeeping are performed under the supervision of a responsible technician.

Invalid Result.

The result reported by an HHS-certified laboratory when the laboratory determines that it cannot complete testing or obtain a valid drug test result.

Laboratory.

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

Limit of Detection.

The lowest concentration at which the analyte (

e.g.,

drug or drug metabolite) can be identified.

Limit of Quantification.

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

e.g.,

drug or drug metabolite) can be accurately established.

Lot.

A number of units of an item (

e.g.,

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

Medical Review Officer (MRO).

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

Negative Result.

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

Non-Medical Use of a Drug:

The use of a prescription drug, whether obtained by prescription or otherwise, other than in the manner or for the time period prescribed, or by a person for whom the drug was not prescribed.

Oral Fluid Specimen.

An oral fluid specimen is collected from the donor's oral cavity and is a combination of physiological fluids produced primarily by the salivary glands.

Oxidizing Adulterant.

A substance that acts alone or in combination with other substances to oxidize drug or drug metabolites to prevent the detection of the drugs or drug metabolites, or affects the reagents in either the initial or confirmatory drug test.

Performance Testing (PT) Sample.

A program-generated sample sent to a laboratory or (for urine) to an IITF to evaluate performance.

Positive Result.

The result reported by an HHS-certified laboratory when a specimen contains a drug or drug metabolite equal to or greater than the confirmation cutoff concentration.

Reconfirmed.

The result reported for a split (B) specimen when the second HHS-certified laboratory corroborates the original result reported for the primary (A) specimen.

Rejected for Testing.

The result reported by an HHS-certified laboratory or (for urine) HHS-certified IITF when no tests are performed on a specimen because of a fatal flaw or an unrecovered correctable error (see Sections 15.1 and 15.2).

Responsible Person (RP).

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

Responsible Technician (RT).

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

Sample.

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

Secretary.

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

Specimen.

A sample collected from a donor at the collection site for the purpose of a drug test.

Split Specimen Collection (for Urine).

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

Standard.

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

Substituted Specimen.

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

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

Consistent with 5 U.S.C. 552a and 48 CFR 24.101-24.104, all agency contracts with laboratories, IITFs, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of Section 503 of Public Law 100-71. Each federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.

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

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

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

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

(1) Fail to appear for any test (except a pre-employment test) within a reasonable time, as determined by the federal agency, consistent with applicable agency regulations, after being directed to do so by the federal agency;

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

(3) Fail to provide a specimen (

e.g.,

urine or another authorized specimen type) for any drug test required by these Guidelines and authorized by federal agency regulations (with the exception of a donor who leaves the collection site before the collection process begins for a pre-employment test);

(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 13.5;

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

e.g.,

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

i.e.,

as described in Section 8.6);

(7) Fail to undergo a medical examination or evaluation, as directed by the MRO as part of the verification process (

i.e.,

Section 13.6) or as directed by the federal agency. In the case of a federal agency applicant/pre-employment drug test, the donor is deemed to have refused to test on this basis only if the federal agency applicant/pre-employment test is conducted following a contingent offer of employment. If there was no contingent offer of employment, the MRO will cancel the test;

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

e.g.,

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

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

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

(11) Admit to the collector or MRO that you have adulterated or (for urine) substituted the specimen.

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

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

(b) When a donor has refused to participate in a part of the collection process, the collector must terminate that portion of the collection process and take action as described in Section 8.9; immediately notify the federal agency's designated representative by any means (

e.g.,

telephone or secure fax machine) that ensures that the refusal notification is immediately received, document the refusal on the Federal CCF, sign and date the Federal CCF, and send 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?

Entities and individuals subject to these Guidelines under Section 1.1 may not release specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines to donors or their designees. Specimens also may not be released to any other entity or individual unless expressly authorized by these Guidelines or by applicable federal law. This section does not prohibit a donor's request to have a split (B) specimen tested in accordance with Section 13.8.

Subpart C—Urine Drug and Specimen Validity Tests

Section 3.1 Which tests are conducted on a urine specimen?

A federal agency:

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

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

(1) Determine the creatinine concentration on every specimen;

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

(3) Determine the pH on every specimen; and

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

(d) If a specimen exhibits abnormal characteristics (

e.g.,

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

e.g.,

non-recovery of internal standard, unusual response), or contains an unidentified substance that interferes with the confirmatory analysis, then additional testing may be performed.

Section 3.2 May a specimen be tested for additional drugs?

(a) On a case-by-case basis, a specimen may be tested for additional drugs, if a federal agency is conducting the collection for reasonable suspicion or post accident testing. A specimen collected from a federal agency employee may be tested by the federal agency for any drugs listed in Schedule I or II of the Controlled Substances Act (other than the drugs listed in Section 3.1, or when used pursuant to a valid prescription or when used as otherwise authorized by law). The federal agency must request the HHS-certified laboratory to test for the additional drug, include a justification to test a specific specimen for the drug, and ensure that the HHS-certified laboratory has the capability to test for the drug and has established properly validated initial and confirmatory analytical methods. If an initial test procedure is not available upon request for a suspected Schedule I or Schedule II drug, the federal agency can request an HHS-certified laboratory

to test for the drug by analyzing two separate aliquots of the specimen in two separate testing batches using the confirmatory analytical method. Additionally, the split (B) specimen will be available for testing if the donor requests a retest at another HHS-certified laboratory.

(b) A federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in Section 3.1. Such approval must be limited to the use of the appropriate science and technology and must not otherwise limit agency discretion to test for any drug tested under paragraph (a) of this section.

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

(a) Specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines must only be tested for drugs and to determine their validity in accordance with Subpart C of these Guidelines. Use of specimens by donors, their designees, or any other entity, for other purposes (

e.g.,

deoxyribonucleic acid, DNA, testing) is prohibited unless authorized in accordance with applicable federal law.

(b) These Guidelines are not intended to prohibit federal agencies, specifically authorized by law to test a specimen for additional classes of drugs in its workplace drug testing program.

Section 3.4 What are the drug test cutoff concentrations for urine?

Initial test analyte

Initial test cutoff (ng/mL)

Confirmatory test analyte

Confirmatory test cutoff concentration (ng/mL)

Marijuana (THCA)

THCA

Benzoylecgonine

150

Benzoylecgonine

100

Codeine/Morphine

2000

Codeine

2000

Morphine

2000

Hydrocodone/Hydromorphone

300

Hydrocodone

100

Hydromorphone

100

Oxycodone/Oxymorphone

100

Oxycodone

Oxymorphone

6-Acetylmorphine

Phencyclidine

Amphetamine/Methamphetamine

500

Amphetamine

250

Methamphetamine

250

MDMA

/MDA

/MDEA

500

MDMA

250

MDA

250

MDEA

250

Δ-9-Tetrahydrocannabinol-9-carboxylic acid (THCA)

Immunoassay:

The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the analytes within the group.

Alternate technology:

Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present (i.e., equal to or greater than the laboratory's validated limit of quantification) must be equal to or greater than the initial test cutoff.

Methylenedioxymethamphetamine (MDMA).

Methylenedioxyamphetamine (MDA).

Methylenedioxyethylamphetamine (MDEA).

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 as necessary to provide information that the MRO would use to report a verified drug test result (

e.g.,

d,l-stereoisomers determination for methamphetamine, tetrahydrocannabivarin, and other specimen validity tests using biomarkers). All tests must meet appropriate validation and quality control requirements.

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

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

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

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

e.g.,

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

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

e.g.,

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

(d) The presence of halogen (

e.g.,

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

e.g.,

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

(e) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic

immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (

e.g.,

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

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

e.g.,

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

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

e.g.,

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

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

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

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

i.e.,

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

i.e.,

a refractometer is used to test both aliquots).

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

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

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

(b) In addition, an HHS-certified laboratory reports a primary (A) specimen as dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than or equal to 5 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030.

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

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

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

i.e.,

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

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

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

e.g.,

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

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

(e) The possible presence of a halogen (

e.g.,

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

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

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

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

(i) Interference occurs on the immunoassay or alternate technology initial drug tests on two separate aliquots (

i.e.,

valid immunoassay or alternate technology initial drug test results cannot be obtained);

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

(k) The physical appearance of the specimen (

e.g.,

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

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

e.g.,

color) are clearly different; or

(m) The concentration of a biomarker is not consistent with that established for human urine.

Subpart D—Collectors

Section 4.1 Who may collect a specimen?

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

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

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

The hiring official must be a trained collector.

Section 4.2 Who may not collect a specimen?

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

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

(c) An employee working for an HHS-certified laboratory or IITF must not act as a collector if the employee could link the identity of the donor to the donor's drug test result.

(d) To avoid a potential conflict of interest, a collector must not be related to the employee (

e.g.,

spouse, ex-spouse, relative) or a close personal friend (

e.g.,

fiancée).

Section 4.3 What are the requirements to be a collector?

(a) An individual may serve as a collector if he or she fulfills the following conditions:

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

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

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

(i) All steps necessary to complete a urine collection;

(ii) Completion and distribution of the Federal CCF;

(iii) Problem collections;

(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and

(v) The collector's responsibility for maintaining the integrity of the collection 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, 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 his or her training and provide that documentation to a federal agency when requested.

(d) An individual may not collect specimens for a federal agency until his or her 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 observer must be the same gender as the donor.

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).

(c) A qualified trainer for collectors must maintain the documentation of his or her training and provide that documentation to a federal agency when requested.

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 col

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