Model Plan for a Comprehensive 

Federal Drug-Free Workplace Program

Second Edition 

HHS Publication No. (ADM)90-1635

Department of Health and Human Services

Substance Abuse and Mental Health Services Administration

Center for Substance Abuse Prevention

Division of Workplace Programs 

June 2022 
i

Table of Contents

Acknowledgements...................................................................................................... ii

I. Introduction......................................................................................................1

II. Definitions........................................................................................................4

III. Employee Assistance Programs (EAPs)..................................................................6

IV. Supervisory Training ..........................................................................................7

V. Employee Education...........................................................................................8

VI. Special Duties and Responsibilities .......................................................................9

VII. Notice............................................................................................................ 14

VIII. Finding of Drug Use and Disciplinary Consequences .............................................. 15

IX. Random Testing .............................................................................................. 18

X. Reasonable Suspicion Testing............................................................................ 20

XI. Applicant Testing............................................................................................. 21

XII. Additional Types of Drug Testing........................................................................ 22

XIII. Test Procedures in General ............................................................................... 23

XIV. Records and Reports ........................................................................................ 26

XV. Position Titles Designated for Random Testing ..................................................... 29

Appendix A: Executive Order 12564, Drug-Free Federal Workplace

Appendix B: Public Law 100-71, Section 503

Appendix C: Guidance for Selection of Testing Designated Positions

Appendix D: Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine

[UrMG]

Appendix E: Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral 

Fluid [OFMG]
ii

Acknowledgements

The first edition of this model plan was developed by a federal Interagency Coordinating

Group composed of representatives from the Department of Health and Human Services

(HHS), the Office of Personnel Management (OPM), and the Department of Justice (DOJ) and 

distributed to federal agencies by the former National Drug Policy Board in 1989. It has 

served as the standard for federal agency drug-free workplace plans and programs ever since. 

It has also been widely adapted and adopted in the private and non-federal public sectors and 

incorporated into numerous collectively bargained agreements throughout the American 

economy. 

The model plan has proven to be an exceptionally durable document and continues to be the 

standard for federal agency drug-free workplace plans and programs. The second edition

updates legal citations and terms of art, incorporates the addition of four semi-synthetic 

opioids to the list of drugs routinely tested for, and adds the use of oral fluid in lieu of urine 

drug testing. 

The second edition has been shared with the successor group, the Interagency Coordinating 

Group Executive Committee, which is convened by the Office of National Drug Control Policy

(ONDCP) and has the same representation as the predecessor group. 

This publication is made available online to federal agencies and the public through the 

Substance Abuse and Mental Health Services Administration website. 

All material appearing in this volume is in the public domain and may be reproduced or copied 

without permission from the Department or the authors.

Citation of the source is appreciated. Suggested citation: Model Plan for a Comprehensive 

Federal Drug-Free Workplace Program- Second Edition (2021). Department of Health and 

Human Services (HHS)/Substance Abuse and Mental Health Administration (SAMHSA) 

Publication No. (ADM)90-1635. SAMHSA: Rockville, MD.

HHS Publication No. (ADM)90-1635

Printed 1989; Reprinted 1990

Second Edition April 2022
1

I. Introduction

A. Background

On September 15, 1986, President Reagan signed Executive Order 12564, establishing 

the goal of a Drug-Free Federal Workplace. The Order made it a condition of

employment for all federal employees to refrain from using illegal drugs on or off duty. 

The Executive Order recognized that illegal drug use was seriously impairing a portion

of the national work force, resulting in the loss of billions of dollars each year. As the 

largest employer in the Nation, the Federal Government had a compelling proprietary 

interest in establishing reasonable conditions of employment. Prohibiting employee 

drug use is one such condition.

On July 11, 1987, Congress passed legislation affecting implementation of the

Executive Order under Section 503 of the Supplemental Appropriations Act of 1987, 

Pub. L. 100-71, 101 Stat. 391, 468-471, codified at 5 U.S.C. §7301 note (1987), 

(hereafter, the "Act"), in an attempt to establish uniformity among federal agency drug

testing plans, reliable and accurate drug testing, employee access to drug testing 

records, confidentiality of drug test results, and centralized oversight of the Federal 

Government's drug testing program.

The Executive Order and Public Law assigned significant responsibilities to HHS, DOJ, 

and OPM. Representatives of these three agencies came together to form the 

Interagency Coordinating Group which authored the original Model Plan in 1989. In 

1990, the former General Accounting Office conducted a review of the Federal DrugFree Workplace Program, concluding that, while the three agencies were fulfilling their 

responsibilities, no single agency was designated as the lead. On March 5, 1991, 

President Bush designated the ONDCP as the lead agency for Federal Drug-Free 

Workplace Program implementation. ONDCP subsequently convened the three 

agencies as the Interagency Coordinating Group Executive Committee to become the 

policy-setting body for the program and to offer concurrence on substantive changes in 

agency plans and on addition of positions designated for random testing, a role that it 

continues to play.

The purpose of the [Agency/Department ] Drug-Free Workplace Plan is to set forth 

objectives, policies, procedures, and implementation guidelines, to achieve a drug-free 

federal workplace, consistent with the Executive Order and Section 503 of the Act.

B. Statement of Policy

The [Agency/Department], as a result of its [describe type of] responsibilities, as 

well as the sensitive nature of its work, has a compelling obligation to eliminate illicit

drug and illegal opioid use from its workplace. [Insert a one-page summary that 

describes the two or three most significant aspects of your agency's/

Department’s mission and the risk posed by employee use of illicit drugs and 

illegal opioids.]

The success of a drug-free workplace program depends on how well the 

[Agency/Department] informs its employees of the hazards of drug use, and on how 

much assistance it can provide drug users. Equally important is the assurance to 

employees that personal dignity and privacy will be respected in reaching the 

[Agency's/Department’s] goal of a drug-free workplace. Therefore, this plan includes 

policies and procedures for: (1) employee assistance; (2) supervisory training; (3) 
2

employee education; and (4) identification of illicit drug and illegal opioid use through

drug testing on a carefully controlled and monitored basis.

C. Nature, Frequency, and Type of Drug Testing to be Instituted

Section 503 of the Act requires the [Agency/Department] Plan to specify the nature, 

frequency, and type of drug testing to be instituted. The [Agency/Department] Plan

includes the following types of drug testing: (1) applicant testing; (2) random testing of 

those employees in sensitive positions selected as testing designated positions (TDPs); 

(3) reasonable suspicion testing; (4) accident or unsafe practice testing; (5) voluntary 

testing, and (6) testing as part of or as a follow-up to counseling or rehabilitation.

The frequency of testing for random testing, voluntary testing, and follow-up testing is 

specified in Section XV, Section XII(B), and Section XII(C), respectively. The 

[Agency/Department Head] reserves the right to increase or decrease the frequency

of testing based on the Agency's/Department’s mission, need, availability of resources, 

and experience in the program, consistent with the duty to achieve a drug-free 

workplace under the Executive Order.

D. Drugs for Which Individuals Are Tested

Section 503 of the Act requires the [Agency/Department] to specify the drugs for

which individuals shall be tested. The [Agency/Department] will test for the following 

drugs listed by the Drug Enforcement Administration Schedule I and II of the 

Controlled Substance Act: Marijuana, Cocaine. [Agency/Department may also test 

for additional Schedule I or Schedule II drugs on a case-by-case basis for 

reasonable suspicion or post-accident testing: Amphetamines, including 

Amphetamine, Methamphetamine, Methylenedioxymethamphetamine 

(MDMA), and Methylenedioxyamphetamine (MDA); Opioids, including 6-

Acetylmorphine, Codeine, Morphine, Hydrocodone, Hydromorphone, 

Oxycodone, and Oxymorphone; and Phencyclidine (PCP).]

If the Agency/Department desires to test for any other Schedule I or II drug on a 

routine basis, advance written approval from the Secretary, HHS is required.

E. Scope

Upon certification by HHS in accordance with Section 503 of the Act, this order shall be 

effective immediately for all [list divisions of the agency which will be affected by 

the order].

F. Union Cooperation

The active participation and support of labor organizations can contribute to the 

success of this program. Management will seek ways in which recognized bargaining 

unit representatives might assist in program implementation, such as in acquainting 

employees with rehabilitation facilities and by enhancing employee confidence in the 

program. Management will continue to observe agreements already reached, will 

include union representatives in general orientation programs, and will continue to

meet its obligations under Title VII of the Civil Service Reform Act of 1978.
3

G. References

1. Authorities

a. Executive Order 12564, Drug-Free Federal Workplace.

b. Executive Order 13467, Reforming Processes Related to Suitability for 

Government Employment, Fitness for Contractor Employees, and Eligibility 

for Access to Classified National Security Information, June 30, 2008, as 

amended by Executive Order 13764, Amending the Civil Service Rules, 

Executive Order 13488, and Executive Order 13467 to Modernize the 

Executive Branch-Wide Governance Structure and Processes for Security 

Clearances, Suitability and Fitness for Employment, and Credentialing, and 

Related Matters, January 17, 2017.

c. Executive Order 13526, Classified National Security Information.

d. Section 503 of the Supplemental Appropriations Act of 1987, Pub. L. 100-71, 

101 Stat. 391, 468-471, codified at 5 U.S.C. §7301 note (1987).

e. Mandatory Guidelines for Federal Workplace Drug Testing Programs using 

Urine [UrMG], which includes scientific and technical requirements and 

certification of laboratories engaged in urine drug testing, 82 FR 7920 

(2017) as amended.

f. Mandatory Guidelines for Federal Workplace Drug Testing Programs using 

Oral Fluid [OFMG] which includes scientific and technical requirements and 

certification of laboratories engaged in oral fluid drug testing, 84 FR 57554 

(2019).

g. Civil Service Reform Act of 1978, Pub. L. 95-454.

h. Sections 523 and 527 of the Public Health Service Act and implementing 

regulations at 42 CFR Part 2, Confidentiality of Alcohol and Drug-Abuse

Patient Treatment Records.

i. The Privacy Act of 1974 (5 U.S.C. §552a), prescribing requirements 

governing the maintenance of records by agencies pertaining to individuals

and access to these records by the individual(s) to whom they pertain.

j. Regulations implementing the Privacy Act of 1974 for the [Agency].

k. Federal Employees Substance Abuse Education and Treatment Act of 1986, 

Pub. L. 99-570.

l. [Add any relevant Agency/Department orders, including appropriate 

personnel orders.]

2. Guidance

a. Guidance for Selection of Testing Designated Positions, Substance Abuse 

and Mental Health Services Administration, 2013.

b. [Add any appropriate Agency/Department guidance documents.]
4

II. Definitions

A. Applicant

Any individual tentatively selected—either—

1. For employment with the [Agency/Department] 

or

2. For a Testing Designated Position, and who has not, immediately prior to the 

selection, been subject to random testing.

B. Department of Health and Human Services (HHS)/Substance Abuse and Mental 

Health Services Administration (SAMHSA)/Center for Substance Abuse Prevention

(CSAP)/Division of Workplace Programs

The organization given HHS’ responsibilities under the Federal Drug-Free Workplace 

Program, including certification of Agency/Department plans and maintenance of the 

Mandatory Guidelines for Federal Workplace Drug Testing Programs.

C. Employee Assistance Program (EAP)

The [Agency]-based counseling program that offers assessment, short-term 

counseling, and referral services to employees for a wide range of drug, alcohol, and

mental health problems, and monitors the progress of employees while in treatment.

D. EAP Administrator

The individual responsible for ensuring the development, implementation, and review 

of the agency EAP.

E. EAP Coordinator

The individual designated by the EAP Administrator to be responsible for implementing 

and operating the EAP within the [Agency] component assigned to the coordinator, by 

providing counseling, treatment, and education services to employees and supervisors 

regarding the [component] EAP.

F. Employees in Sensitive Positions

1. Employees in positions designated by the [Agency head] as Special Sensitive, 

Critical Sensitive, or Noncritical-Sensitive or employees in positions designated 

by the [Agency head] as sensitive in accordance with Executive Order No. 

13467, as amended by Executive Order No. 13764.

2. Employees granted access to classified information or who may be granted 

access to classified information pursuant to a determination of trustworthiness 

by the [Agency head] under Executive Order No. 13526.

3. Individuals serving under Presidential appointments.

4. Law enforcement officers as defined in 5 U.S.C. §8331(20) and 8401(17).
5

5. Other positions that the [Agency head] determines involve law enforcement, 

national security, the protection of life and property, or public health or safety.

G. Illicit Drugs

A controlled substance included in Schedule I or II, as defined by section 802(6) of 

Title 21 of the United States Code, the Controlled Substances Act, the possession of 

which is unlawful under chapter 13 of that Title. The term "illicit drugs" does not mean 

the use of a controlled substance pursuant to a valid prescription or other uses 

authorized by federal law.

H. Interagency Coordinating Group Executive Committee (ICGEC)

The group chaired by ONDCP and consisting of representatives of HHS, DOJ, and OPM

that sets policy for the Federal Drug-Free Workplace Program and offers concurrence 

on substantive changes in Agency/Department plans and on addition of positions 

designated for random testing.

I. Medical Review Officer (MRO)

The individual responsible for receiving laboratory results generated from the [Agency] 

Drug-Free Workplace Program who is a licensed physician with knowledge of

pharmacology and toxicology of illicit drugs and the appropriate medical training to 

interpret and evaluate all positive test results together with an individual's medical 

history and any other relevant biomedical information.

J. Random Testing

A system of drug testing imposed without individualized suspicion that a particular 

individual is using illicit drugs or illegal opioids, and may either be:

1. Uniform--unannounced testing of testing designated employees occupying a 

specified area, element or position.

2. A statistically random sampling of such employees based on a neutral criterion, 

such as social security numbers.

K. Supervisor

An employee having authority to hire, direct, assign, promote, reward, transfer,

furlough, layoff, recall, suspend, discipline, or remove other employees, to adjust their 

grievances, or to effectively recommend such action, if the exercise of the authority is 

not merely routine or clerical in nature, but requires the consistent exercise of 

independent judgment [5 U.S.C. §7103 (a)(10)].

L. Testing Designated Positions (TDPs)

Employment positions within the [Agency/Department] that have been designated 

for random testing under Section IX(B) of this plan.
6

M. Verified Positive Test Result

A test result that was positive on an initial FDA-approved immunoassay test, confirmed 

by a Gas Chromatography/Mass Spectrometry assay, (or other confirmatory tests 

approved by HHS), and reviewed and verified by the Medical Review Officer in

accordance with this plan and the Mandatory Guidelines for Federal Workplace Drug

Testing Programs.

III. Employee Assistance Programs (EAPs)

A. Function

The [Agency] Employee Assistance Program (EAP) plays an important role in

preventing and resolving employee drug use by: demonstrating the [Agency's]

commitment to eliminating illicit drug and illegal opioid use; providing employees an 

opportunity, with appropriate assistance, to discontinue their drug use; providing 

educational materials to supervisors and employees on drug use issues; assisting 

supervisors in confronting employees who have performance and/or conduct problems 

and making referrals to appropriate treatment and rehabilitative facilities; and

following-up with individuals during the rehabilitation period to track their progress and 

encourage successful completion of the program.

The EAP, however, shall not be involved in the collection of specimens or the initial 

reporting of test results.

The EAP shall:

1. Provide counseling and assistance to employees who self-refer for treatment or 

whose drug tests have been verified positive and monitor the employees' 

progress through treatment and rehabilitation.

2. Provide needed education and training to all levels of the 

[Agency/Department] on types and effects of drugs, symptoms of drug use 

and its impact on performance and conduct, relationship of the EAP to drug

testing, and related treatment, rehabilitation, and confidentiality issues.

3. Ensure that confidentiality of test results and related medical treatment and 

rehabilitation records is maintained in accordance with Section XIV.

B. Referral and Availability

Any employee found to be using drugs shall be referred to the EAP. The EAP shall be 

administered separately from the testing program and shall be available to all 

employees without regard to a finding of drug use. 

The EAP shall provide counseling or rehabilitation for all referrals, as well as education

and training regarding illicit drug and illegal opioid use. The EAP shall be available not 

only to [Agency/Department] employees, but, when feasible, to the families of 

employees with drug problems, and to employees with family members who have drug 

problems. 
7

In the event the employee is not satisfied with the program of treatment or 

rehabilitation, such employee may seek review of the EAP Counselor's referral by 

notifying the EAP Administrator prior to completion of the program. The decision of the

EAP Administrator shall be final and shall not be subject to further administrative 

review.

Regardless of the treatment program chosen, the employee remains responsible for 

successful completion of the treatment, and assertions that the counselor failed to 

consider one or more of the factors in Section VI(D)(5) in making a referral shall not 

constitute either an excuse for continuing to use illicit drugs or illegal opioids or a

defense to disciplinary action if the employee does not complete treatment.

C. Leave Allowance

Employees shall be allowed up to one hour (or more as necessitated by travel time) of 

excused absence for each counseling session, up to a maximum of [state limit here],

during the assessment/referral phase of rehabilitation. Absences during duty hours for 

rehabilitation or treatment must be charged to the appropriate leave category in 

accordance with law and leave regulations.

D. Records and Confidentiality

All EAP operations shall be confidential in accordance with Section XIV of this plan 

relating to records and confidentiality.

E. Structure

The [appropriate division of the Agency/Department] shall be responsible for 

oversight and implementation of the [Agency] EAP, and will provide, with the support 

of the [Agency head], high level direction and promotion of the EAP.

[Describe more fully the structure of the agency's EAP -- in-house, contracted, 

regional locations, etc.]

IV. Supervisory Training

A. Objectives

As supervisors have a key role in establishing and monitoring a drug-free workplace, 

the [Agency] shall provide training to assist supervisors and managers in recognizing

and addressing illicit drug and illegal opioid use by agency employees. The purpose of

supervisory training is to understand:

1. Agency policies relevant to work performance problems, drug use, and [the

Agency] EAP.

2. The responsibilities of offering EAP services.

3. How employee performance and behavioral changes should be recognized and 

documented.
8

4. The roles of the Medical Review Officer, medical staff, supervisors, personnel,

and EAP personnel.

5. The ways to use [the Agency/Department] EAP.

6. The process of reintegrating employees into the workforce. 

B. Implementation

The [appropriate division of the Agency/Department] shall be responsible for 

implementing supervisory training and shall develop a training package to ensure that 

all employees and supervisors are fully informed of the [Agency/Department] DrugFree Workplace Plan.

C. Training Package

Supervisory training shall be required of all supervisors and may be presented as a 

separate course or be included as part of an ongoing supervisory training program. 

Training shall be provided as soon as possible after a person assumes supervisory 

responsibility. Training courses should include:

1. Overall Agency/Department policy.

2. The prevalence of various employee problems with respect to drugs and alcohol.

3. The EAP approach to handling problems, including the supervisor's role and 

relationship to EAP.

4. How to recognize employees with possible problems.

5. Documentation of employee performance or behavior.

6. Skills in confronting employees with possible problems.

7. Agency procedures for referring employees to EAP.

8. Disciplinary action and removals from sensitive positions as required by Section 

5(c) of the Executive Order.

9. Reintegration of employees into the workforce.

10. Written materials that the supervisor can use at the work site.

V. Employee Education

A. Objectives

The EAP Administrator shall offer drug education to all [Agency] employees. Drug 

education should include education and training to all levels of the [Agency] on:

1. Types and effects of drugs.
9

2. Symptoms of drug use and the effects on performance and conduct.

3. The relationship of the EAP to drug testing.

4. Other relevant treatment, rehabilitation, and confidentiality issues. 

B. Means of Education

Drug education activities may include:

1. Distribution of written materials.

2. Audio-visual media.

3. Lunchtime employee forums.

4. Employee drug awareness events.

VI. Special Duties and Responsibilities

[Smaller agencies may choose to combine several of the duties listed into a 

single position upon advice from the Department of Health and Human 

Services, Division of Workplace Programs. Larger agencies may choose to add 

a higher level Drug Program Administrator to oversee and coordinate the 

work of component level or site Coordinators or Managers. It is 

recommended that duties/roles be clearly described so that differences 

among duties/roles are distinct and do not overlap.]

A. Drug Program Coordinator

Each [operating or other appropriate element] shall have a Drug Program 

Coordinator (DPC) assigned to carry out the purposes of this plan. The DPC shall be 

responsible for implementing, directing, administering, and managing the drug

program within the [operating element]. The DPC shall serve as the principal contact 

with the laboratory and for collection activities in assuring the effective operation of the 

testing portion of the program. In carrying out these responsibilities, the DPC shall, 

among other duties:

1. Arrange for all testing authorized under this order.

2. Ensure that all employees subject to random testing receive individual notice 

[as described in Section VII(B) of this plan] prior to implementation of the 

program, and that such employees return a signed acknowledgment of receipt 

form.

3. Document, through written inspection reports, all results of laboratory and 

collection site inspections conducted.

4. Coordinate with and report to the [Agency/Department head] on DPC 

activities and findings that may affect the reliability or accuracy of laboratory 

results.
10

5. In coordination with the EAP Administrator, publicize and disseminate drug 

program educational materials, and oversee training and education sessions 

regarding drug use and rehabilitation.

6. Coordinate all DPC duties in field offices wherever possible to conserve 

resources and to efficiently and speedily accomplish reliable and accurate

testing objectives.

7. Liaise with the HHS/SAMHSA/CSAP/Division of Workplace Programs to maintain 

currency of drug program policy and practice and provide Annual Summary 

Report data.

B. Employee Assistance Program Administrator

The EAP Administrator shall:

1. Receive verified positive test results from the DPC or other official designated by 

[Agency/Department] to receive test results from the MRO.

2. Assume the lead role in the development, implementation, and evaluation of the

EAP.

3. Supervise and designate the headquarters EAP Coordinator and counselors and 

assist them in establishing field office EAPs.

4. Advise [Agency/Department] components on the submission of annual

statistical reports and prepare consolidated reports on the 

[Agency/Department's] EAP activity.

C. Employee Assistance Program Coordinator

The EAP Coordinator shall:

1. Implement and operate the EAP within the [Agency] component assigned to 

the coordinator.

2. Provide counseling and treatment services to all employees referred to the EAP 

by their supervisors or on self-referral, and otherwise offer employees the 

opportunity for counseling and rehabilitation.

3. Coordinate with the [Agency head], the Medical Review Officer and 

supervisors, as appropriate.

4. Work with the Drug Program Coordinator to provide educational materials and 

training to managers, supervisors, and employees on illicit drugs and illegal 

opioids in the workplace.

5. Assist supervisors with performance and/or personnel problems that may be 

related to illicit drug or illegal opioid use.
11

6. Monitor the progress of referred employees during and after the rehabilitation 

period and provide feedback to supervisors in accordance with 42 CFR Part 2, 

Confidentiality of Alcohol and Drug Abuse Patient Records.

7. Ensure that training is provided to assist supervisors in the recognition and 

documentation of facts and circumstances that support a reasonable suspicion 

that an employee may be using illicit drugs or illegal opioids.

8. Maintain a list of rehabilitation or treatment organizations that provide 

counseling and rehabilitative programs, and include the following information on 

each such organization:

a. Name, address, phone number, email(s), and website.

b. Types of services provided.

c. Hours of operation, including emergency hours. 

d. The contact person's name phone number and email.

e. Fee structure, including insurance coverage.

f. Client specialization.

g. Other pertinent information.

9. Periodically visit rehabilitative or treatment organizations to meet administrative 

and staff members, tour the site, and ascertain the experience, certification and 

educational level of staff, and the organization's policy concerning progress 

reports on clients and post-treatment follow-up.

D. EAP Counselors

EAP Counselors shall:

1. Serve as the initial point of contact for employees who ask or are referred for 

counseling.

2. Be familiar with all applicable law and regulations, including drug treatment and 

rehabilitation insurance coverage available to employees through the Federal 

Employee Health Benefits Program.

3. Meet the qualifications as determined by the EAP Administrator and be trained 

in counseling employees in the occupational setting, and in identifying drug use.

4. Document and sign the treatment plan prescribed for all employees referred for 

treatment, after obtaining the employee's signature on this document.

5. In making referrals, consider the:

a. Nature and severity of the problem.
12

b. Location of the treatment.

c. Cost of the treatment.

d. Intensity of the treatment environment.

e. Availability of inpatient/outpatient care.

f. Other special needs, such as transportation and childcare.

g. The preferences of the employee.

E. Medical Review Officer

Each [Agency or other appropriate element] shall have a Medical Review Officer 

(MRO) assigned to carry out the purposes of this Order. The MRO shall, among other 

duties:

1. Receive all laboratory test results.

2. Assure that an individual who has tested positive has been afforded an 

opportunity to discuss the test result in accordance with Section XIII(D) of this 

plan.

3. Consistent with confidentiality requirements, refer written determinations 

regarding all verified positive test results to the appropriate official, including a

positive drug test result form indicating that the positive result has been

verified, together with all relevant documentation and a summary of findings.

4. Confirm with the appropriate personnel official whether an individual who has 

been tentatively selected for employment with the [Agency/Department] has 

obtained a verified positive test result.

5. Coordinate with and report to the [Agency/Department head] on all activities 

and findings on a regular basis.

6. Coordinate all MRO in field offices wherever possible to conserve resources and

to efficiently and speedily accomplish reliable and accurate testing objectives.

F. Supervisors

Supervisors will be trained to recognize and address illicit drug and illegal opioid use by

employees and will be provided information regarding referral of employees to the EAP,

procedures and requirements for drug testing, and behavioral patterns that give rise to 

a reasonable suspicion that an employee may be using illicit drugs or illegal opioids.

Except as modified by the [Agency/Department head] to suit specific program 

responsibilities, first-line supervisors shall:

1. Attend training sessions on illicit drug and illegal opioid use in the workplace.

2. Initiate a drug test based on reasonable suspicion as described in Section X.
13

3. Refer employees to the EAP for assistance in obtaining counseling and 

rehabilitation, upon a finding of illicit drug or illegal opioid use.

4. Initiate appropriate disciplinary action upon a finding of illicit drug or illegal 

opioid use.

5. In conjunction with personnel specialists, assist higher-level supervisors and the

EAP Administrator in evaluating employee performance and or personnel 

problems that may be related to illicit drug or illegal opioid use.

A higher-level supervisor shall review and concur, in advance, with all tests ordered on 

the basis of a reasonable suspicion in accordance with Section X.

G. Implementation

At the direction of the [appropriate Agency/Department official], each [operating 

unit head] shall implement the Drug-Free Workplace Plan within [the operating unit 

head's division] and ensure that the Plan is efficiently and effectively accomplished in 

accordance with this order and all other applicable regulations.

H. General Program/Structural Provisions

The [appropriate Agency/Department official] shall develop implementation 

procedures to enable [Agency/Department field offices] efficiently and swiftly to

implement all aspects of this order, taking into account the unique geographical,

personnel, budgetary and other relevant factors of the field offices. Such procedures 

will permit field office implementation to proceed independently of headquarters 

implementation. Testing may proceed under this order as soon as any field office or 

operating site is prepared to commence testing, and without regard to whether any 

other field office or operating site or headquarters is prepared to commence with 

testing. Such procedures shall also encourage cooperation and coordination among

components so as to conserve resources and efficiently implement this order.

[Agencies/Departments should give careful consideration to overall

structures and determine whether additional management analysis provisions 

should be added.]

I. Government Contractors

Wherever existing facilities are inadequate to implement this order, the [appropriate 

Agency/Department official] shall:

1. Act as Contracting Officer Representative for the administration of all related 

contracts.

2. Ensure that contract laboratories chosen to perform the drug screening tests are 

duly certified according to the Mandatory Guidelines for Federal Workplace Drug 

Testing Programs and that any other contracts to implement this Order conform 

to the technical specifications of the Mandatory Guidelines.

3. Establish, by contract or with [Agency/Department] employees as deemed 

appropriate, the positions and specific responsibilities of the DPC and the MRO

as required by the Mandatory Guidelines.
14

VII. Notice

A. General Notice

A general notice from the [Agency/Department head] announcing the testing 

program, as required by the Executive Order Section 4(a), will be provided to all 

employees no later than sixty (60) days prior to the implementation date of the Plan.

The notices shall be provided immediately upon completion of the congressional 

certification procedures pursuant to Section 503 of the Act, and shall explain:

1. The purpose of the Drug-Free Workplace Plan.

2. That the Plan will include both voluntary and mandatory testing.

3. That those who hold positions selected for random testing will also receive an 

individual notice, prior to the commencement of testing, indicating that their 

position has been designated a Testing Designated Position.

4. The availability and procedures necessary to obtain counseling and rehabilitation 

through the EAP.

5. The circumstances under which testing may occur.

6. That opportunity will be afforded to submit medical documentation of lawful use 

of an otherwise illicit drug.

7. That the laboratory assessment is a series of tests that are highly accurate and 

reliable, and that, as an added safeguard, laboratory results are reviewed by 

the MRO.

8. That positive test results verified by the MRO may only be disclosed to the 

employee, the appropriate EAP administrator, the appropriate management 

officials necessary to process an adverse action against the employee, or a 

court of law or administrative tribunal in any adverse personnel action.

9. That all medical and rehabilitation records in an EAP will be deemed confidential 

"patient" records and may not be disclosed without the prior written consent of 

the patient, an authorizing court order, or otherwise as permitted by federal law 

implemented at 42 CFR Part 2.

B. Individual Notice

In addition to the information provided in the general notice, an individual notice will be 

distributed to all employees in testing designated positions explaining:

1. That the employee's position has been designated a "testing designated 

position."

2. That the employee will have the opportunity to voluntarily admit to being a user 

of illicit drugs or illegal opioids and to receive counseling or rehabilitation, [If 

there is no safe harbor*, add: "in which case disciplinary action is not
15

required;" If there is a safe harbor, add: "and shall not be subject to 

disciplinary action."]. 

*Refer to Section VIII(F) for safe harbor option to create an absolute bar to 

disciplinary action for certain volunteers.

3. That the employee's position will be subject to random testing no sooner than 

thirty (30) days following the notice.

C. Signed Acknowledgement

Each employee in a Testing Designated Position shall be asked to acknowledge in

writing that the employee has received and read the notice that states that the 

employee's position has been designated for random drug testing, and that refusal to 

submit to testing will result in initiation of disciplinary action, up to and including 

dismissal. If the employee refuses to sign the acknowledgement, the employee's 

supervisor shall note on the acknowledgement form that the employee received the

notice. This acknowledgement, which is advisory only, shall be centrally collected for 

easy retrieval by the [operating unit head]. An employee's failure to sign the notice 

shall not preclude testing that employee, or otherwise affect the implementation of this 

order since the general 60-day notice will previously have notified all agency

employees of the requirement to be drug-free.

D. Administrative Relief

If an employee believes his or her position has been wrongly designated a TDP, that 

employee may file an administrative appeal to [specify the designated official] who 

has authority to remove the employee from the Testing Designated Position list. The 

appeal must be submitted by the employee, in writing, to [the designated official]

within 15 days of notification, setting forth all relevant information. The [designated 

official] shall review the appeal based upon the criteria applied in designating that 

employee's position as a Testing Designated Position. The [official's] decision is final 

and is not subject to further administrative review.

VIII. Finding of Drug Use and Disciplinary Consequences

A. Determination

An employee may be found to use illicit drugs or illegal opioids on the basis of any 

appropriate evidence including, but not limited to:

1. Direct observation.

2. Evidence obtained from an arrest or criminal conviction.

3. A verified positive test result.

4. An employee's voluntary admission. 

B. Mandatory Administrative Actions
16

The [Agency/Department] shall refer an employee found to use illicit drugs or illegal

opioids to the EAP, and, if the employee occupies a sensitive position, immediately 

remove the employee from that position without regard to whether it is a TDP. At the 

discretion of the [Agency/Department head], however, and as part of an EAP, an

employee may return to duty in a sensitive position if the employee's return would not 

endanger public health or safety or national security.

C. Range of Consequences

Disciplinary action taken against an employee found to use illicit drugs or illegal opioids 

may include the full range of disciplinary actions, including removal. The severity of the 

action chosen will depend on the circumstances of each case and will be consistent with

the Executive Order. The [Agency/Department] shall initiate disciplinary action

against any employee found to use illicit drugs or illegal opioids.

[Insert either]

provided that such action is not required for an employee who voluntarily admits to 

illicit or illegal drug use and obtains counseling or rehabilitation and thereafter refrains 

from such use. 

[or if a safe harbor exists, insert:] but shall not discipline an employee who 

voluntarily admits to illicit or illegal drug use in accordance with subsection VIII(F) of

this plan.

[In either case, add:] Such disciplinary action, consistent with the requirements of

any governing collective bargaining agreement and the Civil Service Reform Act and 

other statutes, [Agency/Department] orders, and regulations, may include any of 

the following measures but some disciplinary action must be initiated:

1. Reprimanding the employee in writing.

2. Placing the employee in an enforced leave status.

3. Suspending the employee for 14 days or less.

4. Suspending the employee for 15 days or more.

5. Suspending the employee until the employee successfully completes the EAP or 

until the [Agency/Department] determines that action other than suspension 

is more appropriate.

6. Removing the employee from service.

7. Reducing the employee in pay or grade.

D. Initiation of Mandatory Removal from Service

The [Agency/Department] shall initiate action to remove an employee for:

1. Refusing to obtain counseling or rehabilitation through an EAP as required by 

the Executive Order after having been found to use illicit drugs or illegal opioids.
17

2. Not refraining from illicit or illegal drug use after a first finding of such use.

All letters to propose and decide on a separation action should be worked out in 

consultation with the [appropriate servicing personnel office].

E. Refusal to Take Drug Test When Required

An employee who refuses to be tested when so required will be subject to the full range 

of disciplinary action, including dismissal. A refusal occurs when an employee fails to:

1. Appear or remain at the collection site.

2. Provide a specimen of sufficient quantity for testing without a legitimate medical 

explanation.

3. Participate in an alternative specimen collection.

4. Undergo a medical examination as directed by the MRO.

5. Cooperate with the collection process.

A refusal also occurs if an employee brings materials to the collection site for the 

purpose of adulterating, substituting, or diluting the specimen, or attempts or admits 

to adulterating, substituting, or diluting the specimen.

No applicant who refuses to be tested shall be extended an offer of employment. 

F. Voluntary Referral

Under Executive Order 12564, the [Agency/Department] is required to initiate action 

to discipline any employee found to use illicit drugs or illegal opioids in every 

circumstance except that such discipline is not required for an employee who: (1) 

voluntarily admits his or her drug use; (2) completes counseling or an EAP; and (3) 

thereafter refrains from drug use.

[If you do not wish to create an absolute bar to discipline for individuals who

voluntarily come forward, insert the following language:]

The decision whether to discipline a voluntary referral will be made by the 

[Agency/Department head] on a case-by-case basis depending upon the facts and 

circumstances. Although an absolute bar to discipline cannot be provided for certain 

positions because of their extreme sensitivity, the [Agency/Department], in

determining whether to discipline, shall consider that the employee has come forward 

voluntarily. In coming forward voluntarily, and consistent with Section XII(B), an 

employee may volunteer for a drug test as a means of identification. The results of 

this test, however, shall not constitute a second finding of illicit or illegal drug use 

under subsection (D).

[If you do wish to create an absolute bar to discipline for individuals who 

voluntarily come forward, insert the following language:]
18

1. Because the Order permits an agency to create a "safe harbor" for an employee 

who meets all three of these conditions, the [Agency/Department] has 

decided to create such a "safe harbor" and will not initiate disciplinary action

against employees who satisfy the provisions of this Section.

2. A fundamental purpose of the [Agency's/Department’s] Drug-Free Workplace 

Plan is to assist employees who themselves are seeking treatment for drug use.

For this reason, the [Agency/Department] will not initiate disciplinary action

against any employee who meets all three of these conditions:

a. Voluntarily identifies him/herself as a user of illicit drugs or illegal opioids

prior to being identified through other means.

b. Obtains counseling or rehabilitation through an EAP.

c. Thereafter refrains from such use.

This self-referral option allows any employee to step forward and identify

him/herself as an illegal drug user for the purpose of entering a drug treatment 

program under the EAP. In stepping forward, and consistent with Section 

XII(B), an employee may volunteer for a drug

test as a means of identification. Although this self-identification test may yield 

a verified positive test result, such result shall not subject an employee to

discipline assuming the three safe harbor requirements are met.

3. Since the key to this provision's rehabilitative effectiveness is an employee's 

willingness to admit his or her problem, this provision is not available to an 

employee who requests protection under this provision after:

a. Being asked to provide a urine or oral fluid specimen in accordance with this 

plan.

b. Having been found to have used illicit drugs or illegal opioids pursuant to

Section VIII(A)(1) or VIII(A)(2).

IX. Random Testing

A. Sensitive Positions Designated for Random Testing

The Executive Order requires testing for employees in sensitive positions. As specified 

in Section XV of this plan, the [Agency/Department head] has determined that 

some of these sensitive positions are testing designated positions subject to random 

testing. Position titles designated for random drug testing are listed in Section XV, 

which also provides a brief description of relevant duties, the justification for 

designation, and the number of incumbents. 

B. Determining TDPs

To determine TDPs, the [Agency/Department head] applied the Guidance for 

Selection of Testing Designated Positions issued by the Interagency Coordinating Group 

Executive Committee, which defines: 
19

1. Presumptive Testing Designated Positions 

a. Employees Who Carry Firearms 

b. Motor Vehicle Operators Carrying Passengers

c. Aviation Flight Crew Members and Air Traffic Controllers

d. Railroad Operating Crews 

2. Preferred Testing Designated Positions 

a. Certain Health and Safety Positions 

1). Employees authorized to carry firearms 

2). Railroad Employees Engaged in Safety Sensitive Tasks 

3). Aviation Personnel 

b. Presidential Appointees Requiring Senate Confirmation (PAS) 

c. Front Line Law Enforcement Personnel 

d. Drug Rehabilitation Employees 

e. Personnel Having Access to "Truly Sensitive Information" 

1). Top Secret and Higher Clearances 

2). Secret Clearances 

3. Discretionary Designations. Given the unique Agency/Department missions, 

there are a number of other, non-court tested TDPs that may be appropriate for 

inclusion within Agency/Department plans. 

4. Specifically Disfavored Testing Designated Positions 

a. Positions designated based upon the need to foster public trust or 

generalized requirements for integrity, honesty, or responsibility. 

b. Positions designated based upon access to sensitive information not meeting 

the "truly sensitive" criteria [e.g., personnel files, budget and financial 

information, and grand jury information]. 

The [Agency/Department head] reserves the right to add or delete TDPs pursuant 

to the criteria established in the Guidance for Selection of Testing Designated Positions. 

The concurrence of [Agency/Department] general counsel and of the Interagency 

Coordinating Group Executive Committee will be sought for all new TDPs and the 

deletion of any presumptive TDPs. 

The [Agency/Department head] has determined, pursuant to 42 U.S.C. 290dd, that 

all positions which have been or will be designated as TDPs under this plan are 
20

"sensitive positions" and are therefore exempted from provisions prohibiting 

employment deprivation based on prior substance misuse.

C. Implementing Random Testing

In implementing the program of random testing, the DPC shall:

1. Ensure that the means of random selection remains confidential.

2. Evaluate periodically whether the numbers of employees tested and the 

frequency with which those tests will be administered satisfy the

[Agency's/Department’s] duty to achieve a drug-free work force.

The number of sensitive employees occupying TDPs and the rate of random tests will 

be administered are specified in Section XV.

D. Notification of Selection

An individual selected for random testing, and the individual's first-line supervisor,

shall be notified the same day the test is scheduled, preferably, within two hours of the 

scheduled testing. The supervisor shall explain to the employee that the employee is 

under no suspicion of taking drugs and that the employee's name was selected 

randomly.

E. Deferral of Testing

An employee selected for random drug testing may obtain a deferral of testing if the 

employee's first line and higher-level supervisors concur that a compelling need 

necessitates a deferral on the grounds that the employee is:

1. In a leave status (sick, annual, administrative, or leave without pay).

2. In official travel status away from the test site or is about to embark on official 

travel scheduled prior to testing notification.

3. In an undercover assignment in a law enforcement investigation that would be 

unduly jeopardized by the requirement to appear for testing.

An employee whose random drug test is deferred will be subject to an unannounced 

test within the following 60 days.

X. Reasonable Suspicion Testing

Reasonable suspicion testing may be required of any employee in a position which is 

designated for random testing when there is a reasonable suspicion that the employee 

uses illicit drugs or illegal opioids whether on or off duty. Reasonable suspicion testing 

may also be required of any employee in any position when there is a reasonable 

suspicion of on-duty use or on-duty impairment.

A. Grounds
21

Reasonable suspicion testing may be based upon, among other things:

1. Observable phenomena, such as direct observation of drug use or possession 

and/or the physical symptoms of being under the influence of a drug.

2. A pattern of abnormal conduct or erratic behavior.

3. Arrest or conviction for a drug-related offense, or the identification of an 

employee as the focus of a criminal investigation into illegal drug possession, 

use, or trafficking.

4. Information provided either by reliable and credible sources or independently 

corroborated.

5. Newly discovered evidence that the employee has tampered with a previous 

drug test.

Although reasonable suspicion testing does not require certainty, mere "hunches" are 

not sufficient to meet this standard.

B. Procedures

If an employee is suspected of using illicit drugs or illegal opioids, the appropriate 

supervisor will gather all information, facts, and circumstances leading to and 

supporting this suspicion. [Agencies/Departments should insert a higher-level 

approval requirement that is consistent with their organizational structure. In

some agencies, this may be the next level supervisor or a higher-level 

individual above the supervisor making the finding that a reasonable suspicion

of illicit or illegal drug use exists.]

When higher-level concurrence of a reasonable suspicion determination has been

made, the appropriate supervisor will promptly prepare a written report detailing the 

circumstances which formed the basis to warrant the testing. This report should include 

the appropriate dates and times of reported drug related incidents, reliable/credible 

sources of information, rationale leading to the test, and the action taken.

C. Supervisory Training

In accordance with Section IV, supervisors will be trained to address illicit or illegal

drug use by employees, to recognize facts that give rise to a reasonable suspicion, and

to document facts and circumstances to support a finding of reasonable suspicion.

Failure to receive such training, however, shall not invalidate otherwise proper 

reasonable suspicion testing.

XI. Applicant Testing

A. Objectives

To maintain the high professional standards of the [Agency’s/Department’s] 

workforce, it is imperative that individuals who use illicit drugs or illegal opioids be 

screened out during the initial employment process before they are placed on the 
22

employment rolls of the [Agency/Department]. Drug testing shall be required of all

applicants as defined in Section II.

B. Vacancy Announcements

Every vacancy announcement for positions designated for applicant testing shall state:

"All applicants tentatively selected for this position will be required to submit to

screening for illicit and illegal drug use prior to appointment."

In addition, each applicant will be notified that appointment to the position will be 

contingent upon a negative drug test result. Failure of the vacancy announcement to 

contain this statement notice will not preclude applicant testing if advance written

notice is provided applicants in some other manner.

C. Procedures

The DPC shall direct applicants to an appropriate collection facility. The drug test must

be undertaken as soon after notification as possible, and no later than 48 hours after

notice to the applicant. Where appropriate, applicants may be reimbursed for 

reasonable travel expenses.

Applicants shall be advised of the opportunity to submit medical documentation that

may support a legitimate use for a specific drug and that such information will be 

reviewed only by the Medical Review Officer to determine whether the individual is 

licitly using an otherwise illegal drug.

D. Personnel Officials

Upon notification that an individual has been tentatively selected for employment with 

the [Agency/Department], the [Manager of the Personnel Division] shall assure, 

after consultation with the Medical Review Officer, that a drug test has been conducted 

on that individual and determine whether the test result is a verified positive result.

E. Consequences

The [Agency/Department] will decline to extend a final offer of employment to any

applicant with a verified positive test result, and such applicant may not reapply to the

[Agency/Department] for a period of six months. The Personnel Officer working on

the applicant's certificate shall be directed to object to the applicant on the basis of 

failure to pass the physical, a lack of personal characteristics necessary to relate to 

public employment, or failure to support the goals of the [Agency/Department]. The 

[Agency/Department] shall inform such applicant that a confirmed presence of an 

illicit or illegal drug in the applicant's urine or oral fluid precludes the 

[Agency/Department] from hiring the applicant.

XII. Additional Types of Drug Testing

A. Accident or Unsafe Practice Testing

[Agency/Department] is committed to providing a safe and secure working 

environment. It also has a legitimate interest in determining the cause of serious 
23

accidents so that it can undertake appropriate corrective measures. Post-accident drug

testing can provide invaluable information in furtherance of that interest. Accordingly, 

employees may be subject to testing when, based upon the circumstances of the 

accident, their actions are reasonably suspected of having caused or contributed to an 

accident that meets the following criteria:

1. The accident results in a death or personal injury requiring immediate 

hospitalization.

2. The accident results in damage to government or private property estimated to 

be in excess of $10,000.

If an employee is suspected of having caused or contributed to an accident meeting

the above criteria, the appropriate supervisor will present the facts leading to this 

suspicion to the [Agency/Department Official] for approval. Once approval has been 

obtained and arrangements made for testing, the supervisor will prepare a written 

report detailing the facts and circumstances that warranted the testing.

B. Voluntary Testing

In order to demonstrate their commitment to the [Agency's/Department’s] goal of a

drug-free workplace and to set an example for other federal employees, employees not 

in testing designated positions may volunteer for unannounced random testing by 

notifying the DPC. These employees will then be included in the pool of testing 

designated positions subject to random testing, and be subject to the same conditions 

and procedures, including the provisions of Section VIII(F). Volunteers shall remain in

the testing designated positions pool until they withdraw from participation by notifying 

the DPC of such intent at least 48 hours prior to a scheduled test.

C. Follow-up Testing

All employees referred through administrative channels who undergo a counseling or 

rehabilitation program for illicit or illegal drug use through the EAP will be subject to

unannounced testing as a part of or following completion of such a program for a 

period of one year. Such employees shall be tested at the frequency stipulated in the 

abeyance contract, or, in the alternative, at an increased frequency of [state

frequency: e.g., once a month]. Such testing is distinct from additional testing which 

may be imposed as a component of the EAP.

XIII. Test Procedures in General

A. Mandatory Guidelines for Federal Workplace Drug Testing Programs

Drug testing is used to make significant career decisions for federal civilian employees, 

and HHS has established exacting scientific and technical standards for its conduct. At 

the inception of the program, the Department concluded that only urine drug testing 

met these standards. It published the original Mandatory Guidelines for Federal 

Workplace Drug Testing Programs on April 11, 1988 [53 FR 11979]. These guidelines 

were subsequently revised 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 
24

November 25, 2008 [73 FR 71858], and were ultimately re-named to indicate that they 

apply only to urine drug testing on January 23, 2017 [82 FR 7920]. 

In 2015, HHS concluded that oral fluid drug testing met its standards and could be 

used in federal workplace drug testing programs. The Mandatory Guidelines for 

Federal Workplace Drug Testing Programs using Oral Fluid, which authorized the use of 

this alternative specimen, were published on October 25, 2019 [84 FR 57554].

A federal agency may use urine, oral fluid, or both in their testing programs. HHS 

continues to monitor the evolving forensic science of drug testing and considers the 

use of alternative specimens in consultation with its Drug Testing Advisory Board and 

with the review and comment of the public, the scientific community, the drug testing 

industry, and other federal agencies. The Department may publish additional 

guidelines for alternative specimens and technologies when these meet its standards 

for use with federal civilian employees. 

The [Agency/Department] shall adhere to the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using Urine and the Mandatory Guidelines for 

Federal Workplace Drug Testing Programs using Oral Fluid promulgated by HHS. The

[Agency/Department's] drug testing component shall have professionally trained 

collection personnel, quality assurance requirements for laboratory procedures, and 

strict confidentiality requirements.

B. Privacy Assurance

1. Urine Collection

Any individual subject to urine testing under this plan shall be permitted to provide 

specimens in private and in a restroom stall or similar enclosure so that the 

employee is not observed while providing the specimen. Collection site personnel of

the same gender as the individual tested, however, may observe the individual 

provide the urine specimen when such personnel have reason to believe the 

individual may adulterate, substitute, or dilute the specimen to be provided.

Collection site personnel may have reason to believe that a particular individual 

may adulterate, substitute, or dilute the specimen to be provided when:

a. The individual:

1). Has previously been found by the [Agency] to be an illicit or illegal drug

user.

2). Has previously tampered with a specimen.

b. Facts and circumstances suggest that the individual:

1). Is an illicit or illegal drug user.

2). Is under the influence of drugs at the time of the test.

3). Has equipment or implements capable of tampering with or altering urine 

specimens.

c. The specimen:
25

1). Has a temperature outside the range of 32-38 degrees C / 90-100

degrees F.

2). Shows signs of contaminants. 

2. Oral Fluid Collection

Any individual subject to oral fluid testing under this plan shall provide specimens in

a restricted access area with the collector present and in visual contact throughout 

the collection procedure. The collector is not required to be the same gender as the 

donor. 

The collector shall inspect the individual’s oral cavity to ensure that it is free of any 

items that could impede or interfere with the collection of an oral fluid specimen 

(e.g., candy, gum, food, tobacco) or could be used to adulterate, substitute, or 

dilute the specimen. If an item is present that appears to have been brought to the 

collection site with the intent to adulterate, substitute, or dilute the specimen, this 

is considered a refusal to test. 

C. Failure to Appear for Testing

Failure to appear for testing without a deferral will be considered refusal to participate 

in testing and will subject an employee to the range of disciplinary actions, including 

dismissal, and an applicant to the cancellation of an offer of employment. 

If an individual fails to appear at the collection site at the assigned time, the collector 

shall contact the Drug Program Coordinator to obtain guidance on action to be taken.

D. Opportunity to Justify a Positive Test Result

When a confirmed positive result has been returned by the laboratory, the MRO shall 

perform the duties set forth in the Mandatory Guidelines. For example, the MRO may

choose to conduct employee medical interviews, review employee medical history, or 

review any other, relevant biomedical factors. The MRO must review all medical records 

made available by the tested employee when a confirmed positive test could have 

resulted from legally prescribed medication. Evidence to justify a positive result may 

include, but is not limited to:

1. A valid prescription.

2. A verification from the individual's physician verifying a valid prescription. 

Individuals are not entitled, however, to present evidence to the MRO in a trialtype administrative proceeding, although the MRO has the discretion to accept 

evidence in any manner deemed most efficient or necessary. If the MRO 

determines there is no justification for the positive result, such result will then

be considered a verified positive test result. The MRO shall immediately contact

the appropriate management official upon obtaining a verified positive test 

result.

E. Employee Counseling and Assistance
26

While participating in a counseling or rehabilitation program, and at the request of the 

program, the employee may be exempted from the random testing designated

positions pool for a period not to exceed sixty (60) days, or for a time period specified 

in an abeyance contract or rehabilitation plan approved by the Agency head. Upon 

completion of the program, the employee immediately shall be subject to follow-up 

testing pursuant to Section XII(C).

F. Savings Clause

To the extent that any of the procedures specified in this section are inconsistent with

any of those specified in the Mandatory Guidelines for Federal Workplace Drug Testing

Programs using Urine and the Mandatory Guidelines for Federal Workplace Drug 

Testing Programs using Oral Fluid promulgated by HHS, or any subsequent amendment 

thereto, such Mandatory Guidelines or amendment shall supersede the procedures

specified in this section, but only to the extent of the inconsistency.

XIV. Records and Reports

A. Confidentiality of Test Results

The laboratory may disclose laboratory test results only to the MRO or the staff of the

MRO. Any positive result which the MRO justifies by acceptable and appropriate medical 

or scientific documentation to account for the result as other than the intentional 

ingestion of an illicit drug or the illegal use of a licit drug will be treated as a negative 

test result and may not be released for purposes of identifying illicit or illegal drug use. 

Test results will be protected under the provisions of the Privacy Act, 5 U.S.C. §552a,

et seq. and Section 503(e) of the Act and may not be released in violation of either this 

Act or of the Supplemental Appropriations Act of 1987, Pub. L. 100-71, Section 503.

The MRO may maintain only those records necessary for compliance with this order. 

Any records of the MRO, including drug test results, may be released to any 

management official for purposes of auditing the activities of the MRO, except that the

disclosure of the results of any audit may not include personal identifying information

on any employee.

In order to comply with Section 503(e) of the Act, the results of a drug test of a

[Agency] employee may not be disclosed without the prior written consent of such 

employee, unless the disclosure would be:

1. To the MRO.

2. To the EAP Administrator in which the employee is receiving counseling or 

treatment or is otherwise participating.

3. To any supervisory or management official within the [Agency] having 

authority to take adverse personnel action against such employee.

4. Pursuant to the order of a court of competent jurisdiction or where required by 

the United States Government to defend against any challenge against any 

adverse personnel action.
27

For purposes of this Section, "management official" includes any management,

government, security, or personnel official whose duties necessitate review of the test 

results in order to process adverse personnel action against the employee. 

Test results, with all identifying information removed, shall also be made available to 

[Agency/Department] personnel, including the DPC, for data collection and other 

activities necessary to comply with Section 503(f) of the Act.

B. Employee Access to Records

Any employee who is the subject of a drug test shall, upon written request, have

access to any records relating to:

1. Such employee's drug test.

2. The results of any relevant certification, review, or revocation-of-certification 

proceedings, as referred to in Section 503(a)(1)(A)(ii)(III) of the Act.

Except as authorized by law, an applicant who is the subject of a drug test, however, 

shall not be entitled to this information.

C. Confidentiality of Records in General

All drug testing information specifically relating to individuals is confidential and should 

be treated as such by anyone authorized to review or compile program records. In 

order to efficiently implement this order and to make information readily retrievable, 

the DPC shall maintain all records relating to reasonable suspicion testing, suspicion of 

tampering with evidence, and any other authorized documentation necessary to 

implement this order.

All records and information of the personnel actions taken on employees with verified 

positive test results should be forwarded to the [Servicing Personnel Office.] Such

shall remain confidential, locked in a combination safe or stored electronically in secure, 

password-protected files, with only authorized individuals who have a "need-to-know"

having access to them.

D. Employee Assistance Program Records

The EAP Administrator shall maintain only those records necessary to comply with this

order. After [an operating unit head] refers an employee to an EAP, the EAP will

maintain all records necessary to carry out its duties. All medical and or rehabilitation 

records concerning the employee's drug misuse, including EAP records of the identity,

diagnosis, prognosis, or treatment are confidential and may be disclosed only as 

authorized by 42 CFR Part 2, including the provision of written consent by the 

employee. With written consent, the patient may authorize the disclosure of those 

records to the patient's employer for verification of treatment or for a general 

evaluation of treatment progress. 

E. Maintenance of Records

The [Agency/Department] shall establish or amend a recordkeeping system to

maintain the records of the [Agency/Department's] Drug-Free Workplace Program 

consistent with the [Agency/Department's] Privacy Act System of Records and with
28

all applicable Federal laws, rules and regulations regarding confidentiality of records 

including the Privacy Act (5 U.S.C. §552a). If necessary, records may be maintained as 

required by subsequent administrative or judicial proceedings, or at the discretion of

the [Agency/Department head]. The recordkeeping system should capture sufficient 

documents to meet the operational and statistical needs of this order, and include:

1. Notices of verified positive test results referred by the MRO.

2. Written materials justifying reasonable suspicion testing or evidence that an 

individual may have altered or tampered with a specimen.

3. Anonymous statistical reports.

4. Other documents the DPC, MRO, or EAP Administrator deems necessary for 

efficient compliance with this order.

F. Records Maintained by Government Contractors

Any contractor hired to satisfy any part of this order shall comply with the

confidentiality requirements of this order, and all applicable federal laws, rules,

regulations, and guidelines.

G. Statistical Information

The DPC shall collect and compile anonymous statistical data for reporting the number 

of:

1. Random tests, reasonable suspicion tests, accident or unsafe practice tests, 

follow-up tests, or applicant tests administered.

2. Verified positive test results.

3. Voluntary drug counseling referrals.

4. Involuntary drug counseling referrals.

5. Terminations or denial of employment offers resulting from refusal to submit to 

testing.

6. Terminations or denial of employment offers resulting from alteration of 

specimens.

7. Terminations or denial of employment offers resulting from failure to complete a 

drug misuse counseling program.

8. Employees who successfully complete EAP.

These data, along with other pertinent information, shall be compiled for inclusion in

the [Agency's/Department’s] annual report to Congress required by Section 503(f) 

of the Act. These data shall also be provided to HHS annually to assist in overall 

program evaluation and to determine whether changes to the Mandatory Guidelines 

may be required.
29

XV. Position Titles Designated for Random Testing

[List position titles designated for random drug testing; indicate relevant 

duties; explain the justification for inclusion; and provide the current number 

of incumbents in the position. State the rate at which random tests will be 

administered.]
A-1

APPENDIX A

Federal Register 32889

Presidential Documents

Vol. 51. No. 180

 Wednesday, September 17, 1986

Title 3–The President

Executive Order 12564 of September 15, 1986

Drug-Free Federal Workplace

I, RONALD REAGAN, President of the United States of America, find that:

Drug use is having serious adverse effects upon a significant proportion of the national work 

force and results in billions of dollars of lost productivity each year;

The Federal government, as an employer, is concerned with the well-being of its employees, 

the successful accomplishment of agency missions, and the need to maintain employee 

productivity;

The Federal government, as the largest employer in the Nation, can and should show the way

towards achieving drug-free workplaces through a program designed to offer drug

users a helping hand and, at the same time, demonstrating to drug users and potential drug 

users that drugs will not be tolerated in the Federal workplace;

The profits from illegal drugs provide the single greatest source of income for organized crime, 

fuel violent street crime, and otherwise contribute to the breakdown of our society;

The use of illegal drugs, on or off duty, by Federal employees is inconsistent not only with the 

law-abiding behavior expected of all citizens, but also with the special trust placed in such 

employees as servants of the public;

Federal employees who use illegal drugs, on or off duty, tend to be less productive, less 

reliable, and prone to greater absenteeism than their fellow employees who do not use illegal 

drugs;

The use of illegal drugs, on or off duty, by Federal employees impairs the efficiency of Federal 

departments and agencies, undermines public confidence in them, and makes it more difficult

for other employees who do not use illegal drugs to perform their jobs effectively. The use of 

illegal drugs, on or off duty, by Federal employees also can pose a serious health and safety 

threat to members of the public and to other Federal employees;

The use of illegal drugs, on or off duty, by Federal employees in certain positions evidences 

less than the complete reliability, stability, and good judgment that is consistent with access to 

sensitive information and creates the possibility of coercion, influence, and irresponsible action 

under pressure that may pose a serious risk to national security, the public safety, and the 

effective enforcement of the law; and Federal employees who use illegal drugs must 

themselves be primarily responsible for changing their behavior and, if necessary, begin the 

process of rehabilitating themselves.
A-2

By the authority vested in me as President by the Constitution and laws of the United States 

of America, including section 3301(2) of Title 5 of the United States Code, section 7301 of 

Title 5 of the United States Code, section 290dd-1 of Title 42 of the United States Code, 

deeming such action in the best interests of national security, public health and safety, law 

enforcement and the efficiency of the Federal service, and in order to establish standards and 

procedures to ensure fairness in achieving a drug-free Federal workplace and to protect the 

privacy of Federal employees, it is hereby ordered as follows:

Section 1. Drug-Free Workplace.

(a) Federal employees are required to refrain from the use of illegal drugs.

(b) The use of illegal drugs by Federal employees, whether on duty or off duty, is 

contrary to the efficiency of the service.

(c) Persons who use illegal drugs are not suitable for Federal employment.

Section 2. Agency Responsibilities.

(a) The head of each Executive agency shall develop a plan for achieving the objective 

of a drug-free workplace with due consideration of the rights of the government, 

the employee, and the general public.

(b) Each agency plan shall include:

(1) A statement of policy setting forth the agency's expectations regarding drug use 

and the action to be anticipated in response to identified drug use;

(2) Employee Assistance Programs emphasizing high level direction, education, 

counseling, referral to rehabilitation, and coordination with available community

resources;

(3) Supervisory training to assist in identifying and addressing illegal drug use by 

agency employees;

(4) Provision for self-referrals as well as supervisory referrals to treatment with 

maximum respect for individual confidentiality consistent with safety and 

security issues; and

(5) Provision for identifying illegal drug users, including testing on a controlled and 

carefully monitored basis in accordance with this Order.

Section 3. Drug Testing Programs.

(a) The head of each Executive agency shall establish a program to test for the use of

illegal drugs by employees in sensitive positions. The extent to which such 

employees are tested and the criteria for such testing shall be determined by the 

head of each agency, based upon the nature of the agency's mission and its 

employees' duties, the efficient use of agency resources, and the danger to the 

public health and safety or national security that could result from the failure of an 

employee adequately to discharge his or her position.
A-3

(b) The head of each Executive agency shall establish a program for voluntary 

employee drug testing.

(c) In addition to the testing authorized in subsections (a) and (b) of this section, the 

head of each Executive agency is authorized to test an employee for illegal drug use 

under the following circumstances:

(1) When there is a reasonable suspicion that any employee uses illegal drugs;

(2) In an examination authorized by the agency regarding an accident or unsafe

practice; or

(3) As part of or as a follow-up to counseling or rehabilitation for illegal drug use 

through an Employee Assistance Program.

(d) The head of each Executive agency is authorized to test any applicant for illegal 

drug use.

Section 4. Drug Testing Procedures.

(a) Sixty days prior to the implementation of a drug testing program pursuant to this 

Order, agencies shall notify employees that testing for use of illegal drugs is to be 

conducted and that they may seek counseling and rehabilitation and inform them of 

the procedures for obtaining such assistance through the agency's Employee 

Assistance Program. Agency drug testing programs already ongoing are exempted 

from the 60-day notice requirement. Agencies may take action under section 3(c) 

of this Order without reference to the 60-day notice period.

(b) Before conducting a drug test, the agency shall inform the employee to be tested of 

the opportunity to submit medical documentation that may support a legitimate use 

for a specific drug.

(c) Drug testing programs shall contain procedures for timely submission of requests 

for retention of records and specimens; procedures for retesting; and procedures, 

consistent with applicable law, to protect the confidentiality of test results and 

related medical and rehabilitation records. Procedures for providing urine specimens 

must allow individual privacy, unless the agency has reason to believe that a 

particular individual may alter or substitute the specimen to be provided.

(d) The Secretary of Health and Human Services is authorized to promulgate scientific 

and technical guidelines for drug testing programs, and agencies shall conduct their 

drug testing programs in accordance with these guidelines once promulgated.

Section 5. Personnel Actions.

(a) Agencies shall, in addition to any appropriate personnel actions, refer any employee 

who is found to use illegal drugs to an Employee Assistance Program for 

assessment, counseling, and referral for treatment or rehabilitation as appropriate.
A-4

(b) Agencies shall initiate action to discipline any employee who is found to use illegal 

drugs, provided that such action is not required for an employee who:

(1) Voluntarily identifies himself as a user of illegal drugs or who volunteers for 

drug testing pursuant to section 3(b) of this Order, prior to being identified 

through other means;

(2) Obtains counseling or rehabilitation through an Employee Assistance Program: 

and

(3) Thereafter refrains from using illegal drugs.

(c) Agencies shall not allow any employee to remain on duty in a sensitive position who 

is found to use illegal drugs, prior to successful completion of rehabilitation through 

an Employee Assistance Program. However, as part of a rehabilitation or counseling

program, the head of an Executive agency may, in his or her discretion, allow an

employee to return to duty in a sensitive position if it is determined that this action 

would not pose a danger to public health or safety or the national security.

(d) Agencies shall initiate action to remove from the service any employee who is found

to use illegal drugs and:

(1) Refuses to obtain counseling or rehabilitation through an Employee Assistance

Program; or

(2) Does not thereafter refrain from using illegal drugs.

(e) The results of a drug test and information developed by the agency in the course of 

the drug testing of the employee may be considered in processing any adverse action 

against the employee or for other administrative purposes. Preliminary test results

may not be used in an administrative proceeding unless they are confirmed by a 

second analysis of the same specimen or unless the employee confirms the accuracy

of the initial test by admitting the use of illegal drugs.

(f) The determination of an agency that an employee uses illegal drugs can be made on 

the basis of any appropriate evidence, including direct observation, a criminal 

conviction, administrative inquiry, or the results of an authorized testing program. 

Positive drug test results may be rebutted by other evidence that an employee has 

not used illegal drugs.

(g) Any action to discipline an employee who is using illegal drugs (including removal 

from the service, if appropriate) shall be taken in compliance with otherwise 

applicable procedures, including the Civil Service Reform Act.

(h) Drug testing shall not be conducted pursuant to this Order for the purpose of 

gathering evidence for use in criminal proceedings. Agencies are not required to 

report to the Attorney General for investigation or prosecution any information, 

allegation, or evidence relating to violations of Title 21 of the United States Code 

received as a result of the operation of drug testing programs established pursuant 

to this Order.
A-5

Section 6. Coordination of Agency Programs.

(a) The Director of the Office of Personnel Management shall:

(1) Issue government-wide guidance to agencies on the implementation of the 

terms of this Order;

(2) Ensure that appropriate coverage for drug misuse is maintained for employees 

and their families under the Federal Employees Health Benefits Program;

(3) Develop a model Employee Assistance Program for Federal agencies and assist 

the agencies in putting programs in place;

(4) In consultation with the Secretary of Health and Human Services, develop and 

improve training programs for Federal supervisors and managers on illegal drug 

use: and

(5) In cooperation with the Secretary of Health and Human Services and heads of 

Executive agencies, mount an intensive drug awareness campaign throughout the 

Federal work force.

(b) The Attorney General shall render legal advice regarding the implementation of this 

Order and shall be consulted with regard to all guidelines, regulations, and policies 

proposed to be adopted pursuant to this Order.

(c) Nothing in this Order shall be deemed to limit the authorities of the Director of 

Central Intelligence under the National Security Act of 1947, as amended, or the 

statutory authorities of the National Security Agency or the Defense Intelligence 

Agency. Implementation of this Order within the Intelligence Community, as defined 

in Executive Order No. 12333, shall be subject to the approval of the head of the

affected agency.

Section 7. Definitions.

(a) This Order applies to all agencies of the Executive Branch.

(b) For purposes of this Order, the term "agency" means an Executive agency, as 

defined in 5 U.S.C. 105; the Uniformed Services, as defined in 5 U.S.C. 2101 (3) 

(but excluding the armed forces as defined by 5 U.S.C. 2101(2)); or 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.

(c) For purposes of this Order, the term "illegal drugs" means a controlled substance 

included in Schedule I or II, as defined by Section 802(6) of Title 21 of the United 

States Code, the possession of which is unlawful under Chapter 13 of that Title. The 

term "illegal drugs" does not mean the use of a controlled substance pursuant to a 

valid prescription or other uses authorized by law.

(d) For purposes of this Order, the term "employee in a sensitive position" refers to:
A-6

(1) An employee in a position that an agency head designates Special-Sensitive, 

Critical-Sensitive, or Noncritical-Sensitive under Chapter 731 of the Federal 

Personnel Manual or an employee in a position that an agency head designates 

as sensitive in accordance with Executive Order No. 10450, as amended;

(2) An employee who has been granted access to classified information or may be 

granted access to classified information pursuant to a determination of 

trustworthiness by an agency head under Section 4 of Executive Order No.

12356;

(3) Individuals serving under Presidential appointments;

(4) Law enforcement officers as defined in 5 U.S.C. 8331(20); and

(5) Other positions that the agency head determines involve law enforcement, 

national security, the protection of life and property, public health or safety, or 

other functions requiring a high degree of trust and confidence.

(e) For purposes of this Order, the term "employee" means all persons appointed in the

Civil Service as described in 5 U.S.C. 2105 (but excluding persons appointed in the 

armed services as defined in 5 U.S.C. 2102(2)).

(f) For purposes of this Order, the term "Employee Assistance Program" means agencybased counseling programs that offer assessment, short-term counseling, and 

referral services to employees for a wide range of drug, alcohol, and mental health 

programs that affect employee job performance. Employee Assistance Programs are 

responsible for referring drug-using employees for rehabilitation and for monitoring 

employees' progress while in treatment. 

Section 8. Effective Date. This Order is effective immediately.

Ronald Reagan

THE WHITE HOUSE, September 15, 1986.

[FR Doc. 86-21168

Filed 9-15-86: 3:47 pm] Billing code 3195-O1-M

Editorial note: For the President's remarks of September 15 on signing EO 12564, see the

Weekly Compilation of Presidential Documents (vol. 22, no. 38).
B-1

APPENDIX B

101 STAT. 468

PUBLIC LAW 100-71–July 11, 1987

TITLE 5

GENERAL PROVISIONS

Regulations Applicable Sections

Drugs and 

drug abuse.

Government 

organization

and 

employees. 5

USC 7301

note. 3 CFR,

1986 Comp., p. 

224.

Sec. 501. No part of any appropriation contained in this Act shall remain 

available for obligation beyond the current fiscal year unless expressly so

provided herein.

Sec. 502. Except where specifically increased or decreased elsewhere in 

this Act, the restrictions contained within appropriations, or provisions 

affecting appropriations or other funds, available during fiscal year 1987, 

limiting the amount which may be expended for personal services, or for 

purposes involving personal services, or amounts which may be transferred 

between appropriations or authorizations available for or involving such 

services, are hereby increased to the extent necessary to meet increased 

pay costs authorized by or pursuant to law.

Sec. 503. (a)(1) Except as provided in subsection (b) or (c), none of the 

funds appropriated or made available by this Act, or any other Act, with 

respect to any fiscal year, shall be available to administer or implement 

any drug testing pursuant to Executive Order Numbered 12564 (dated 

September 15, 1986), or any subsequent order, unless and until--

(A) the Secretary of Health and Human Services certifies in writing to the 

Committees on Appropriations of the House of Representatives and the 

Senate, and other appropriate committees of the Congress, that–
B-2

Regulations Applicable Sections

3 CFR, 1986

Comp., 

p.224.

(i) each agency has developed a plan for achieving a drug-free workplace in 

accordance with Executive Order Numbered 12564 and applicable provisions of

law (including applicable provisions of this section);

(ii) the Department of Health and Human Services, in addition to the scientific and 

technical guidelines dated February 13, 1987, and any subsequent amendments

thereto, has, in accordance with paragraph (3), published mandatory guidelines

which–

(I) establish comprehensive standards for all aspects of laboratory drug testing

and laboratory procedures to be applied in carrying out Executive Order Numbered

12564, including standards which require the use of the best available technology 

for enduring the full reliability and accuracy of drug tests and strict procedures

governing the chain of custody of specimens collected for drug testing; (II) specify

the drugs for which Federal employees may be tested; and

(III) establish appropriate standards and procedures for periodic review of 

laboratories and criteria for certification and revocation of certification of

laboratories to perform drug testing in carrying out Executive Order Numbered

12564; and

(iii) all agency drug-testing programs and plans established pursuant to Executive 

Order Numbered 12564 comply with applicable provisions of law, including 

applicable provisions of the Rehabilitation Act of 1973 (29 U.S.C. 701 et seq.), title

5 of the United States Code, and the mandatory guidelines under clause (ii);

(B) the Secretary of Health and Human Services has submitted to the Congress, in 

writing, a detailed, agency-by-agency analysis relating to–

(i) the criteria and procedures to be applied in designating employees or positions

for drug testing, including the justification for such criteria and procedures; (ii) the 

position titles designated for random drug testing; and

(iii) the nature, frequency, and type of drug testing proposed to be instituted; and

(C) the Director of the Office of Management and Budget has submitted in writing 

to the Committees on Appropriations of the House of Representatives and the 

Senate a detailed, agency-by-agency analysis (as of the time of certification under 

subparagraph (A)) of the anticipated annual costs associated with carrying out 

Executive Order Numbered 12564 and all other requirements under this section 

during the 5-year period beginning on the date of the enactment of this Act.

(2) Notwithstanding subsection (g), for purposes of this subsection, the term

"agency" means–

(A) the Executive Office of the President;

(B) an Executive department under section 101 of title 5, United States Code; (C) 

the Environmental Protection Agency;

(D) the General Services Administration;

(E) the National Aeronautics and Space Administration; (F) the Office of Personnel 

Management;

(G) the Small Business Administration;

(H) the United States Information Agency; and

(I) the Veteran's Administration;

except that such term does not include the Department of Transportation or any 

other entity (or component thereof) covered by subsection (b).
B-3

Regulations C

Federal

Register, 

publication.

5 USC 500 

et seq.

(3) Notwithstanding any provision of chapter 5 of title 5, United States Code, the 

mandatory guidelines to be published pursuant to subsection (a)(l)(A)(ii) shall be

published and made effective exclusively according to the provisions of this

paragraph. Notice of the mandatory guidelines proposed by the Secretary of 

Health and Human Services shall be published in the Federal Register, and 

interested persons shall be given not less than 60 days to submit written 

comments on the proposed mandatory guidelines. Following review and 

consideration of written comments, final mandatory guidelines shall be published in

the Federal Register and shall become effective upon publication.

(b)(1) Nothing in subsection (a) shall limit or otherwise affect the availability of 

funds for drug testing by–

(A) the Department of Transportation;

(B) Department of Energy, for employees specifically involved in the handling of 

nuclear weapons or nuclear materials;

(C) any agency with an agency-wide drug-testing program in existence as of

September 15.1986; or

(D) any component of an agency if such component had a drug-testing program in 

existence as of September 15, 1986.

(2) The Departments of Transportation and Energy and any agency or component 

thereof with a drug-testing program in existence as of September 15, 1986–

(A) shall be brought into full compliance with Executive Order Numbered 12564 no

later than the end of the 6-month period beginning on the date of the enactment 

of this Act; and

3 CFR, 1986

Comp., p.

224.

(B) shall take such actions as may be necessary to ensure that their respective 

drug-testing programs or plans are brought into full compliance with the

mandatory guidelines published under subsection (a)(1)(A)(ii) no later than 90 

days after such mandatory guidelines take effect, except that any judicial

challenge that affects such guidelines should not affect drug-testing programs or 

plans subject to this paragraph.

(c) In the case of an agency (or component thereof) other than an agency as

defined by subsection (a)(2) or an agency (or component thereof) covered by 

subsection (b), none of the funds appropriated or made available by this Act, or 

any other Act, with respect to any fiscal year, shall be available to administer or 

implement any drug testing pursuant to Executive Order Numbered 12564, or any 

subsequent order, unless and until–

(1) the Secretary of Health and Human Services provides written certification with 

respect to that agency (or component) in accordance with clauses (i) and (iii) of 

subsection (a)(1)(A);

(2) the Secretary of Health and Human Services has submitted a written, detailed

analysis with respect to that agency (or component) in accordance with subsection

(a)(1)(B); and

(3) the Director of the Office of Management and Budget has submitted a written, 

detailed analysis with respect to that agency (or component) in accordance with 

subsection (a)(1)(C).

(d) Any Federal employee who is the subject of a drug test under any program or 

plan shall, upon written request, have access to–

(1) any records relating to such employee's drug test; and

(2) any records relating to the results of any relevant certification, review, or 

revocation-of-certification proceedings, as referred to in subsection

(a)(1)(A)(ii)(III).
B-4

Regulations Applicable Sections

Classified 

information.

(e) The results of a drug test of a Federal employee may not be disclosed without 

the prior written consent of such employee, unless the disclosure would be–

(1) to the employee's medical review official (as defined in the scientific and

technical guidelines referred to in subsection (a)(l)(A)(ii));

(2) to the administrator of any Employee Assistance Program in which the 

employee is receiving counseling or treatment or is otherwise participating;

(3) to any supervisory or management official within the employee's agency

having authority to take the adverse personnel action against such employee; or 

(4) pursuant to the order of a court of competent jurisdiction where required by 

the United States Government to defend against any challenge against any 

adverse personnel action.

Reports.

3 CFR, 1986

Comp., p.

224.

(f) Each agency covered by Executive Order Numbered 12564 shall submit to the

Committees on Appropriations of the House of Representatives and the Senate, 

and other appropriate committees of the Congress, an annual report relating to 

drug-testing activities conducted by such agency pursuant to such executive order. 

Each such annual report shall be submitted at the time of the President's budget

submission to the Congress under section 1105(a) of title 31, United States Code.

(g) For purposes of this section, the terms "agency" and "Employee Assistance 

Program" each has the meaning given such term under section 7(b) of Executive 

Order Numbered 12564, as in effect on September 15, 1986.

Sec. 504. None of the funds appropriated by this Act may be obligated for the 

centralization, consolidation, or redeployment of the Customs Service Air 

Operations unless the Secretary of the Treasury submits a report to the 

Committees on Appropriations which sets forth specific details for the use of such 

funds thirty days in advance of such implementation.

Vessels. Sec. 505. None of the funds appropriated or made available by this or any other 

Act or otherwise appropriated or made available to the Secretary of Transportation 

or the Maritime Administrator for purposes of administering the Merchant Marine

Act, 1936, as amended (46 U.S.C. 1101 et seq.), shall be used by the United

States Department of Transportation or the United States Maritime Administration 

to propose, promulgate, or implement any rule or regulation, or, with regard to 

vessels which repaid subsidy pursuant to the rule promulgated by the Secretary 

May 3, 1985 and vacated by Order of the U.S. Court of Appeals for the D.C. Circuit 

January 16, 1987, conduct any adjudicatory or other regulatory proceeding, 

execute or perform any contract, or participate in any judicial action with respect

to the repayment of construction differential subsidy for the permanent release of 

vessels from the restrictions in section 506 of the Merchant Marine Act, 1936, as 

amended: Provided,

46 USC

1156.

That such funds may be used to the extent such expenditure relates to a rule 

which conforms to statutory standards hereafter enacted by Congress.

Sec. 506. Notwithstanding any other provision of this Act, appropriations made by 

the title I of this Act for the following account shall be as follows:
APPENDIX C

Guidance for Selection of Testing Designated Positions
DATE: May 6, 2013

TO: Federal Executive Branch Agencies

FROM: Interagency Coordinating Group Executive Committee

SUBJECT: Updated Guidelines for Selection of Testing Designated Positions

2013 Guidance for Selection of Testing Designated Positions (TDPs)

I. Purpose

Effective immediately, this guidance supersedes, but does not fundamentally change, the 

previous Testing Designated Position (TDP) guidance initially issued on August 2, 1999 

and updated on April 5, 2010. This guidance document will serve as the primary agency 

reference for selecting and/or reviewing positions designated for random testing under the 

Federal Drug- Free Workplace Program established pursuant to Executive Order No. 

12564.

A. Selection Categories

Note: Agency requests for categorical inclusions of TDPs will not be considered. 

TDP submissions must provide specific position 

title(s)/classification(s)/justifications which includes a concurrence memo from their 

agency OGC.

The 1999 guidance consolidated the results of court decisions and established specific 

categories of TDPs. In January 2010, the Department of Justice reviewed legal activity 

since the issuance of the 1999 guidance and concluded that there were no decisions 

altering the following TDP categories:

• Presumptive Positions: Must be included in all plans. Agencies desiring to

exclude any of these positions must submit a written justification for doing so. 

Exclusions require the prior written approval of the Interagency Coordination 

Group Executive Committee (ICGEC).

• Preferred Positions: Should, but may not be included in all plans. Agencies 

desiring to exclude any of positions must provide a clear justification for doing 

so.

• Discretionary Positions: Agency specific. Agencies desiring to include such 

positions must present a clear justification for doing so, including a detailed 

description/statement of the immediate risks posed by incumbents using illegal 

drugs.

• Disfavored Positions: May not be included in any plan.
B. Review Process

The 1999 TDP Guidance established the role of the Office of National Drug Control Policy

in assuring appropriate consistency among the Executive Branch agencies implementing

Executive Order 12564 and to convene the Interagency Coordinating Group Executive

Committee (consisting of representatives of the Office of National Drug Control Policy,

Department of Health and Human Services, Department of Justice and Office of

Personnel Management) to provide concurrence reviews on agencies seeking to 

implementing substantive changes in their agency plans or TDP lists. These roles and

processes remain in place.

Agencies are encouraged to seek informal, preliminary consultation on proposed

substantive changes and submit their draft proposals to: The ICG Executive Committee,

c/o Hyden S. Shen, Esq., Policy Oversight Lead, Federal Drug Free Workplace Program,

Department of Health and Human Services, Substance Abuse and Mental Health

Services Administration (SAMHSA), Division of Workplace Programs, 5600 Fishers Lane, 

Rockville, Maryland, 208571

. Telephone: (240) 276-2600. E-Mail:

Hyden.Shen@samhsa.hhs.gov

Agency proposals should consist of the following information:

• A detailed statement describing the change(s) sought in the plan and the

proposed language.

• Job descriptions or a summary of the duties performed by positions proposed

for inclusion in the random testing pool.

• Justification for inclusion of each position (In some cases, group justifications 

may suffice for positions that share common duties and fall under the same

TDP category.)

• Supporting opinion from agency General Counsel

II. The Legal Framework

Based upon the prior agency program litigation, the courts have been able to establish

"limits" on the TDP justifications for the presumptive, preferred, discretionary and

disfavored positions noted below. However, given unique agency missions, a substantial

gray area continues to exist within the TDP categories.

Agencies are advised to seek agency counsel review prior to proposing changes or

additions to their TDP lists. The most significant and instructive cases in this field continues 

to be the early pronouncements within United States Supreme Court in Skinner v. Railway 

Labor Executives' Assn., 489 U.S. 602 (1989), and National Treasury Employees Union v. 

Von Raab, 489 U.S. 656 (1989). Additionally, the Supreme Court has upheld the 

constitutionality of drug testing programs in other contexts, such as interscholastic athletics. 

See Vernonia School District 47J v. Acton, 515 U.S. 646 (1995) and "students in

 

1

SAMHSA Address Updated: January 2017
competitive extra-curricula activities," Board of Education Independent School District No.

92 of Pottawatomie County v. Earls, 536 U.S. 822 (2002).

A. Presumptive Testing Designated Positions

In light of the well established case law and clear public interest in testing certain

categories of positions, the positions set forth below have been approved for inclusion

in agency testing plans without the prior approval of the ICG Executive Committee. In

order to improve consistency, it is essential that individual agencies include all positions

in these categories in their plans, unless a clear and compelling reason can be provided

for not doing so. Indeed, almost all agencies already test these positions.

Since courts have consistently found that testing of these safety-sensitive positions is

justified, agencies need not submit for consultative review, their plan to include these

positions as TDPs. However, an information copy of implemented changes should be

forwarded to the ICG Executive Committee. If an agency head is of the opinion, that

unique agency circumstances warrant the exclusion of all or some of the positions in

these categories, these circumstances should be presented in writing to the ICG 

Executive Committee for consultative review. The positions that must be included in

your agency plan are as follows:

1. Employees Who Carry Firearms

NTEU v. Von Raab, 489 U.S. 656, 109 S. Ct. 1384, 1393-94 (1989). This category was 

narrowed from "employees authorized to carry firearms" in order to distinguish various 

investigators and guards who do not carry a firearm on a daily basis, but are merely 

authorized to carry firearms. Employees in the latter category should be placed in the 

appropriate preferred TDP category. However, employees who actually carry firearms on a 

daily or regular basis are included in this presumptive category and should be included.

2. Motor Vehicle Operators Carrying Passengers

NTEU v. Yeutter, 918 F.2d 968, 972 (D.C. Cir. 1990). AFGE v. Skinner, 885 F.2d 884, 

889 n.8 (D.C. Cir. 1989), cert. denied, 495 U.S. 923 (1990). This category also includes 

operators of motor vehicles weighing more than 26,001 pounds and operators of motor 

vehicles transporting hazardous materials. Intern. Broth. of Teamsters v. Department of 

Transportation, 932 F.2d 1292 (9th Cir. 1991). Note: Department of Transportation 

regulations implementing the Omnibus Transportation Employee Testing Act of 1991 

require random testing for drugs and alcohol of Federal employees who operate vehicles 

that require a commercial driver's license. A commercial license is required for vehicle 

operators who: (1) carry 16 or more passengers, (2) transport hazardous materials, or (3) 

operate vehicles weighing 26,001 pounds or more.

3. Aviation Flight Crew Members and Air Traffic Controllers

Bluestein v. Skinner, 908 F.2d 451 (9th Cir. 1990). AFGE v. Skinner, 885 F.2d at 889 n.8.
4. Railroad Operating Crews

Skinner v. RLEA, 489 U.S. 602, 109 S. Ct. 1402 (1989). RLEA v. Skinner, 934 F.2d

1096 (9th Cir. 1991). AFGE v. Skinner, 885 F.2d at 889 n.8.

B. Preferred Testing Designated Positions

The well established law and clear public interest applicable to drug testing make it

evident that the categories set out under this section represents strong government

interests for drug testing and should almost always need established judicial standards.

However, inclusion of the following positions as TDPs is not presumptive. To ensure

reasonable uniformity, agencies will be required to present for ICGEC consultative

review, agency-specific justifications for testing these positions. Agencies choosing to

exclude one or more positions as a TDP will be required to justify their decision to the ICG 

Executive Committee.

1. Certain Health and Safety Positions

The first major category includes certain health and safety responsibilities that could

cause immediate, substantial physical injury if carried out under the influence of drugs,

usually involving a potentially dangerous instrument or machine. These positions are:

a. Employees authorized to carry firearms

NTEU v. Von Raab, 489 U.S. 656, 109 S. Ct. 1384, 1393-94 (1989). This category was 

changed from "employees having access to firearms". In many cases, there are guards or 

security personnel who do not regularly carry a firearm, but are authorized to carry one in 

some circumstances, e.g. emergencies. The rationale for including these positions as TDPs 

is the same as employees with a security clearance who see classified documents only 

rarely--granting security clearances in advance proved flexibility and ensures employees 

can be given access to classified material as soon as the need arises. See Harmon v. 

Thornburgh, 878 F.2d 484, 492 (D.C. Cir. 1989), cert. denied, 493 U.S. 1056 (1990).

b. Railroad Employees Engaged in Safety Sensitive Tasks

This includes persons engaged in handling train movement orders, safety inspectors

and those engaged in maintenance and repair of signal systems. Skinner v. RLEA, 489

U.S. 602, 109 S. Ct. 1402 (1989). RLEA v. Skinner, 934 F.2d 1096 (9th Cir. 1991).

AFGE v. Skinner, 885 F.2d at 889 n.8.

c. Aviation Personnel

This includes flight attendants, flight instructors, ground instructors, flight testing personnel, 

aircraft dispatchers, maintenance personnel, aviation security and screening personnel, 

and aircraft safety inspectors. Bluestein v. Skinner, 908 F.2d 451 (9th Cir. 1990). AFGE v.

Skinner, 885 F.2d at 889 n.8. In 1992, two federal district courts in California considered

challenges to Air Force and Navy TDPs respectively. In AFGE v. Wilson, 5-89-1274 (E.D. 
Cal. Aug. 17, 1992), the Air Force had included an employee who made tools used by

aircraft mechanics to maintain and repair their aircraft. The court held that the danger of

a defective tool causing a crash was too remote to support random testing. Only Air

Force employees with direct aircraft maintenance responsibilities were approved for

random testing. InAFGE v. Cheney, C-89-4443 (N.D. Cal. Aug. 14, 1992) a different

court considered several categories of employees who performed maintenance on Navy

ships, submarines and planes. Those approved as TDPs were able to show a nexus 

between the work performed and a "compelling government interest in safety," such

that small errors or momentary lapses in judgment could have "catastrophic

consequences for crew members". This care highlights the principle that agencies may

randomly test employees with direct and critical responsibilities for maintenance, but

not those in general support roles.

2. Presidential Appointees Requiring Senate Confirmation (PAS)

The second major preferred category involves presidential appointees requiring Senate

confirmation (PAS). While including PAS positions as TDPs is strongly preferred, an

agency head may determine that it is impractical for part-time presidential appointees

who sit on commissions or boards which meet only three or four times to be included in

the TDP. In this instance, the PAS may potentially qualify for an exclusion.

3. Front Line Law Enforcement Personnel

The third major preferred category is front line law enforcement personnel with close

proximity to criminals, drugs, or drug traffickers. These positions include guards and law

enforcement personnel who have access to firearms (but do not carry weapons or

otherwise meet the standards for a presumptive TDP) and those directly involved in

drug interdiction duties. Von Raab, 109 S. Ct. at 1393-94; Guiney v. Roache, 873 F.2d

1557 (1st Cir.), cert. denied, 110 S. Ct. 404 (1989).

4. Drug Rehabilitation Employees

The fourth major preferred category is drug rehabilitation or equivalent employee

assistance duties that are so inimical to illegal drug use that such employees can expect

inquiries into their fitness. These positions include direct service staff of alcohol and drug

abuse treatment centers. NFFE v. Cheney, 884 F.2d 603, 614 (D.C. Cir. 1989), cert.

denied, 493 U.S. 1056 (1990). Although, some agencies believed that all employees

associated with the drug program should be included in the random testing pool, the

courts have taken a narrower view. InNFFE v. Cheney, the court approved drug 

counselors with direct client contact as TDPs; however, it refused to approve either drug

laboratory testing personnel or to those employees in the biochemical chain of custody.

Regarding the latter two categories, the court found an insufficient nexus between a drugrelated lapse and any irreparable harm. Based on the holdings of this case, only drug

program employees who have direct client contact should be included asTDPs. NOTE:

Unless, supervisors of drug counselors meet this test, they should not be included as
TDPs.Additionally, computer employees who help select personnel for random tests do not

qualify as TDPs. The court was not persuaded that the "credibility" or "integrity" of the drug

testing program justified random testing for every employee associated with drug testing.

5. Personnel Having Access to "Truly Sensitive Information"

The fifth major preferred category is personnel having access to "truly sensitive

information". For example, individuals with access to national security material that a

"reasonable person" would consider damaging to national interests if compromised. Von

Raab, 109 S. Ct. at 1396. Specifically, these positions include:

a. Top Secret and Higher Clearances

Harmon v. Thornburgh, 878 F.2d 484, 492 (D.C. Cir. 1989), cert. denied, 110 S. Ct.

865 (1990). AFGE Local1533 v. Cheney, No. 90-15834 (9th Cir. Sept. 11, 1991)

b. Secret Clearances

Hartness v. Bush, 919 F.2d 170, 173 (D.C. Cir. 1990), cert. denied, 59 USLW 3865 

(U.S. 1991).

C. Discretionary Designations

In addition to the categories of positions identified for presumptive and preferred inclusion in

agency plans, there are other agency specific sensitive positions which may warrant

designation for testing. The presumptive and preferred testing categories are not

exhaustive ofTDPs supported by case law. For example, courts have supported testing for:

confidential security clearances holders, NTEU V.Hallet, No. 86-3522 (E.D. LA. Feb 7,

1991); health care professionals responsible for direct patient care, and firefighters, AFGE

v. Derwinski, 777 F. Supp. 1493 (N.D. Cal. 1991). Other federal district courts also have

upheld random testing for medical doctors (except for doctors performing research or

administrative duties), nurses, nursing assistants, pharmacists, and medical technicians

because they were involved in direct patient care.

Given the unique agency missions, there are a number of other, non-court tested TDPs

that may be appropriate for inclusion within agency plans. To the extent that agencies

have identified potential TDP positions, they will be required to submit Appendix A of its

plan with supporting documentation to the ICG Executive Committee for consultative

review. The agency's plan must contain a statement indicating a clear nexus between

the employee's duties and the feared harm to others for each TDP.

D. Specifically Disfavored Testing Designated Positions

Itis possible to identify positions which uniformly have been found by the courts not to

warrant random testing. If an agency has TDPs based solely on the criteria below,

exceptional justifications will be required to be submitted to the ICG Executive

Committee for consultative review. These positions are:
1. Positions designated based upon the need to foster public trust or 

generalized requirements for integrity, honesty, or responsibility. NTEU v. Yeutter, 918 

F.2d 968, 972 (D.C. Cir. 1990) and Chandler v. Miller, 502 U.S. 305 (1997) in which 

random testing cannot be utilized merely for "symbolic" testing. The Chandler case involved 

candidates for public office.

2. Positions designated based upon access to sensitive information not

meeting the "truly sensitive" criteria, e.g. personnel files, budget and financial

information, and grand jury information also is inadequate. Harmon v. Thornburgh, 878

F.2d 484, 492 (D.C. Cir. 1989), cert. denied, 110 S. Ct. 865 (1990). Many questions

were raised about including inspector general employees because of their access to

sensitive information and budget or financial employees because of their influence on

large sums of money. Under current case law, neither group qualifies as a TDP. The 

rationale for excluding inspector general employees is contained in the Harmon case. In 

Harmon, the court approved employees with top secret clearances as TDPs because of

their access to "truly sensitive" information, but it refused to approve as TDPs federal

prosecutors or employees with access to secret grand jury proceedings. The court

stated that "truly sensitive" does not include all information which is confidential or

closed to public view. The rationale for excluding budget and financial employees is 

found in AFGE v. Carazoes, 721 F. Supp. 1361 (D.D.C. 1989), where the court refused

to approve as TDPs a group of computer employees involved with billions of dollars of

government resources who might be subjected to bribery, fraud, waste or

mismanagement. The court concluded that program information which affects large

sums of money does not necessarily mean the information is "truly sensitive". The

clearest examples of "truly sensitive" remain information requiring a top secret

clearance, where by definition, national security would be seriously damaged by an

unauthorized disclosure.
APPENDIX D

Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine [UrMG]
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7920 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Substance Abuse and Mental Health 

Services Administration 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), HHS. 

ACTION: Revised Mandatory Guidelines 

by the Secretary of Health and Human 

Services. 

SUMMARY: The Department of Health and 

Human Services (‘‘HHS’’ or 

‘‘Department’’) has revised the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Guidelines), 73 FR 71858 (November 

25, 2008) for urine testing. 

DATES: Effective Date: October 1, 2017. 

FOR FURTHER INFORMATION CONTACT: 

Charles LoDico, M.S., F–ABFT, Division 

of Workplace Programs, Center for 

Substance Abuse Prevention (CSAP), 

SAMHSA mail to: 5600 Fishers Lane, 

Room 16N03A, Rockville, MD 20857, 

telephone (240) 276–2600 or email at 

charles.lodico@samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

particular, these revised Mandatory 

Guidelines for Federal Workplace Drug 

Testing Programs using Urine (UrMG) 

allow federal executive branch agencies 

to test for additional Schedule II drugs 

of the Controlled Substances Act (i.e., 

oxycodone, oxymorphone, hydrocodone 

and hydromorphone) in federal drugfree workplace programs, remove 

methylenedioxyethylamphetamine 

(MDEA) from the authorized drugs in 

Section 3.4, add 

methylenedioxyamphetamine (MDA) as 

an initial test analyte, raise the lower pH 

cutoff from 3 to 4 for identifying 

specimens as adulterated, require MRO 

requalification training and reexamination at least every five years 

after initial MRO certification, and 

allow federal agencies to authorize 

collection of an alternate specimen (e.g., 

oral fluid) when a donor in their 

program is unable to provide a sufficient 

amount of urine specimen at the 

collection site. Many of the wording 

changes and reorganization of the UrMG 

were made for clarity, to use current 

scientific terminology or preferred 

grammar, and for consistency with the 

OFMG. 

Background 

The Department of Health and Human 

Services (HHS), by the authority of 

Section 503 of Public Law 100–71, 5 

U.S.C. Section 7301, and Executive 

Order No. 12564, has established the 

scientific and technical guidelines for 

federal workplace drug testing programs 

and established standards for 

certification of laboratories engaged in 

urine drug testing for federal agencies. 

As required, HHS originally published 

the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Guidelines) in the Federal Register 

[FR] on April 11, 1988 [53 FR 11979]. 

The Substance Abuse and Mental 

Health Services Administration 

(SAMHSA) subsequently revised the 

Guidelines on June 9, 1994 [59 FR 

29908], September 30, 1997 [62 FR 

51118], November 13, 1998 [63 FR 

63483], April 13, 2004 [69 FR 19644], 

and November 25, 2008 [73 FR 71858] 

with an effective date of May 1, 2010 

(correct effective date published on 

December 10, 2008; [73 FR 75122]). The 

effective date of the Guidelines was 

further changed to October 1, 2010 on 

April 30, 2010 [75 FR 22809]. 

The proposed Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs using Urine (UrMG) published 

in the Federal Register on May 15, 2015 

(80 FR 28101) include revisions to the 

initial and confirmatory drug test 

analytes and methods for urine testing, 

the cutoff for reporting a urine specimen 

as adulterated based on low pH, and the 

requalification requirements for 

individuals serving as Medical Review 

Officers (MROs) and, where appropriate, 

include references to the use of an 

alternate specimen in federal workplace 

drug testing programs. References to an 

alternate specimen are not applicable 

until final Guidelines are implemented 

for the use of the alternative specimen 

matrix. The Department published a 

separate Notice in the May 15, 2015 

Federal Register (80 FR 28054) 

proposing Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Oral Fluid (OFMG) to 

allow federal agencies to collect and test 

oral fluid specimens in their workplace 

drug testing programs. There was a 60- 

day public comment period for both 

Federal Register Notices, during which 

125 commenters submitted comments 

on the proposed changes to the 

Guidelines. These commenters were 

comprised of individuals, organizations, 

and private sector companies. The 

comments are available for public view 

at http://www.regulations.gov/. All 

comments were reviewed and taken into 

consideration in the preparation of the 

revised Guidelines. The issues and 

concerns raised in the public comments 

for the UrMG are set out below. Similar 

comments are considered together in the 

discussion. 

Summary of Public Comments and 

HHS’s Response 

The following comments were 

directed to the information and 

questions in the preamble. 

Costs and Benefits 

The Department requested comments 

on costs and benefits. One commenter 

disagreed that the cost increase for 

laboratories to add analytes to regulated 

testing will be minimal, stating that 

significant costs would be incurred for 

information technology (IT) 

development, as well as incremental 

costs for additional immunoassays (if 

required); for additional calibrators, 

controls, and internal standards; and for 

increased confirmatory testing costs 

(including data review and result 

certification) based on an expected 

increased positivity rate for opioids. 

One commenter disagreed with the 

Department’s estimated 3% cost 

increase for Medical Review Officers 

(MROs) and estimated that the increase 

will be 10%. The commenters did not 

provide any substantive evidence or 

data to support these comments. The 

Department recognizes that there will be 

start-up costs to laboratories to 

implement testing for the additional 

analytes for regulated specimens 

including administrative costs, and 

agrees that the estimated increased costs 

for some MROs may exceed the 3% 

estimate. The Department’s cost analysis 

was based on information provided by 

multiple HHS-certified laboratories and 

MROs, as well as the estimated number 

of additional positives resulting from 

the inclusion of the new opioid 

analytes. Costs are expected to vary 

among individual laboratories and 

MROs, depending on their processes 

and testing populations. Additional 

information on the estimated costs 

associated with these Guidelines is 

included under Regulatory Impact and 

Notices below. 

Proposed New Analytes: Oxycodone, 

Oxymorphone, Hydrocodone, and 

Hydromorphone 

Seven commenters specifically agreed 

with the addition of these drugs to the 

Guidelines. Two commenters expressed 

concerns over the added drugs, 

indicating that individuals who follow 

their physician’s treatment plan of 

taking legally prescribed medication 

would produce positive tests, leading to 

greater reliance on MROs to determine 

whether tests are truly positive (as a 

result of illegal use) or are positive due 

to prescribed usage of the drugs, and a 

greater number of workers will be 

subject to scrutiny and their medical 
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records examined at length. One of the 

commenters maintained that such 

testing would exceed the legal mandate 

under Executive Order No. 12564 and 

the promulgation of scientific 

Guidelines by HHS pursuant to it. The 

Guidelines include requirements to 

protect individuals’ privacy while 

maintaining public safety, including 

procedures for MRO review to verify 

legitimate drug use and maintain the 

confidentiality of donor drug testing 

records. The Department provides 

additional guidance in the Medical 

Review Officer Manual for Federal 

Workplace Drug Testing Programs. The 

inclusion of these additional drugs in 

the Guidelines is within the scope of the 

Department’s regulatory authority to test 

for illegal drug use under Section 

503(a)(1)(A)(ii)(II) of Public Law 100–71 

and Executive Order No. 12564. 

New Analytes—Cutoff Concentrations 

Eight commenters addressed the 

proposed cutoffs for the added drugs: 

Three commenters agreed with the 

proposed cutoffs; four disagreed with 

the cutoffs for one or more of the added 

drugs. Of these, three commenters stated 

that the cutoffs are too low: Two of 

these commenters believe that these 

cutoffs will unnecessarily identify 

workers using prescription drugs and 

one commenter noted that these cutoffs 

will affect accurate quantitation in 

routine specimens. The Department 

recognizes that the added analytes will 

result in an increased number of 

positive opioid results requiring MRO 

review, and has incorporated 

requirements for MRO requalification 

and retraining at least every five years. 

Additional guidance and information on 

the added drugs will be provided in the 

Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs. The Department 

disagrees that the cutoffs will affect 

accurate quantitation in routine 

specimens. Information from HHScertified laboratories indicates that 

testing at these cutoffs can be 

accomplished with current 

instrumentation. However, the 

Department has raised the confirmatory 

test cutoffs for oxycodone and 

oxymorphone from 50 ng/mL to 100 ng/ 

mL. These higher cutoffs are supported 

by a single dose study which showed 

similar detection rates for oxycodone 

and oxymorphone using either a 50 ng/ 

mL or 100 ng/mL cutoff.1 Use of the 100 

ng/mL confirmatory test cutoffs is 

expected to be less analytically 

challenging for laboratories. 

One commenter suggested changing 

the oxycodone and oxymorphone initial 

test cutoff to 300 ng/mL and changing 

the hydrocodone and hydromorphone 

initial test cutoff to 100 ng/mL, to 

equate the detection times for these 

drugs. One commenter requested that 

the Department provide the justification 

and data used to determine the cutoff 

levels for the added opioids. The 

Department raised the oxycodone and 

oxymorphone confirmatory test cutoffs 

to 100 ng/mL as described above. The 

Department has evaluated the comments 

and has concluded that no further 

change is needed. The selection of 

cutoff concentration is not based solely 

on the factor of detection times and 

must take into consideration a variety of 

factors, both pharmacological and 

chemical. Drug potency, disposition in 

urine, impact and prevalence must be 

considered. For example, oxycodone is 

approximately twice as potent as 

hydrocodone and may be prescribed in 

lower doses, thus a cutoff lower than 

that for hydrocodone is warranted. 

Therefore, in selecting the cutoffs, the 

Department considered the detection 

times of equipotent doses as well as 

dispositional patterns of each drug in 

urine. Data on the disposition of 

hydrocodone and oxycodone in urine 

following administration of a single 

dose can be found in two recently 

published scientific articles.12 

Medical Review Officer (MRO) 

Requalification—Continuing Education 

Units (CEUs) 

The Department requested comments 

on requiring MRO requalification 

continuing education units (CEUs) and 

on the optimum number of credits and 

the appropriate CEU accreditation 

bodies should CEUs be required as part 

of MRO requalification. Three 

commenters agreed with requiring MRO 

recertification, but disagreed with the 

addition of CEU requirements to the 

Guidelines. Two commenters disagreed 

with specifying the number of CEUs 

required. Two commenters indicated 

that certification entities already enforce 

training requirements and 

recommended that acceptance of CEUs 

be handled by MRO certification boards, 

not the Department. Two commenters 

recommended a requirement of annual 

CEUs: One suggested 16 CEUs and the 

other recommended three CEUs. One 

commenter recommended 12 CEUs 

prior to initial certification, eight CEUs 

every five years, and also recommended 

two CEUs related to the new 

requirements/topics within two years of 

implementation of the revised 

Guidelines. The Department has 

evaluated the comments and has 

concluded that requirements for 

continuing education units will remain 

with the MRO certification entities and 

will not be included in the Guidelines. 

The Department has removed references 

to MRO training entities in Sections 

13.2 and 13.3, because training 

documentation is maintained by MRO 

certification entities. The Department 

agrees with the comment that MROs 

should receive training on revisions to 

the Guidelines, and has added item 

Section 13.3(b) to require such training 

prior to the effective date of revised 

Guidelines. 

Discussion of Sections 

The Department has not included a 

discussion in the preamble of any 

sections for which public comments 

were not submitted or where minor 

typographical or grammatical changes 

were made. 

Subpart A—Applicability 

1.5 What do the terms used in these 

Guidelines mean? 

One commenter disagreed with the 

definition for ‘‘dilute specimen’’ 

because it does not include numerical 

values for creatinine and specific 

gravity. The Department has concluded 

that no change is needed; the analytical 

(numerical) criteria for a dilute 

specimen are provided in Section 3.8. 

One commenter requested that 

‘‘external service provider’’ be defined, 

because this is a new term included in 

the proposed Guidelines. The 

Department agrees and has added the 

definition. 

The Department has added the 

definition for ‘‘gender identity’’ to 

Section 1.5. This term is now used in 

Guidelines sections addressing observed 

and monitored collections as described 

in this preamble under Sections 4.4, 8.1, 

8.10, and 8.12. Gender identity means 

an individual’s internal sense of being 

male or female, which may be different 

from an individual’s sex assigned at 

birth. 

Two commenters disagreed with the 

proposed definition for ‘‘invalid result’’ 

which indicated that an invalid result 

was reported only when an HHScertified laboratory could not complete 

testing or obtain a valid drug test result. 

The Department agrees with the 

commenters and has reinstituted the 

definition from the Guidelines effective 

October 1, 2010 (73 FR 71858). 

To address comments described in 

this preamble under Section 13.1, the 

Department deleted the definition for 

‘‘non-medical use of a drug.’’ 

Two commenters found the definition 

of ‘‘specimen’’ confusing, because the 

term ‘‘sample’’ used in the definition 

was also defined as a representative 

portion of a donor’s specimen. The 
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Department agrees, and has reinstituted 

some wording for the definition of 

‘‘specimen’’ from the Guidelines 

effective October 1, 2010 (73 FR 71858) 

for clarity. 

1.6 What is an agency required to do 

to protect employee records? 

One commenter suggested that the 

non-applicability of the Health 

Insurance Portability and 

Accountability Act (HIPAA) and the 

Health Information Technology for 

Economic and Clinical Health Act 

(HITECH) should be clearly stated in the 

Guidelines. The Department has 

evaluated the comment and has 

concluded that the applicability of 

HIPAA and other relevant privacy laws 

is clearly stated in Section 1.6. 

Accordingly, except for minor 

rewording for clarity, no further 

revisions are necessary. 

1.7 What is a refusal to take a federally 

regulated drug test? 

One commenter noted that, per 

Sections 8.4(c) and 8.9(b), when a 

collector finds an adulterant or 

substitution product or observes an 

attempt to substitute a urine specimen, 

this prompts a direct observed 

collection, not a refusal to test. The 

commenter suggested bringing an 

adulterant or a substitution product to 

the collection should be a refusal to test. 

The Department has evaluated the 

comment, and agrees that the collector 

must report a refusal to test when a 

donor brings materials for adulterating, 

substituting, or diluting the specimen to 

the collection site, or when the collector 

observes a donor’s clear attempt to 

tamper with a specimen. The 

Department has revised Sections 1.7, 

8.3(h), 8.4(c), and 8.9(b) accordingly. 

One commenter noted that the 

collector does not report a refusal to test 

when a donor leaves the collection site 

before the collection process begins for 

a pre-employment test. The commenter 

recommended defining the beginning of 

the pre-employment test collection 

process as the point at which the donor 

is asked to present photo identification. 

The Department agrees with the 

suggestion to define the beginning of the 

collection process specifically for this 

situation. However, the Department has 

designated the beginning as the step 

described in Section 8.4(a), when the 

collector provides or the donor selects a 

specimen collection container. The 

Department has revised Sections 

1.7(a)(2) and (3) to include a reference 

to this section. All subsequent items in 

Section 1.7(a) (i.e., items 4–13) apply 

once the donor has arrived for the preemployment test collection. 

1.8 What are the potential 

consequences for refusing to take a 

federally regulated drug test? 

The Department reworded Section 

1.8(b) to clarify that the requirements in 

this section apply to donors who fail to 

appear at the collection site in a 

reasonable time for any test (except a 

pre-employment test), as described in 

Section 1.7(a)(1). 

Subpart B—Urine Specimens 

2.1 What type of specimen may be 

collected? 

Two commenters requested 

clarification on the collection/testing 

scenario where the federal agency 

authorizes collection of an oral fluid 

specimen, but the contracted laboratory 

does not perform oral fluid testing. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. This will be addressed in the 

federal agency plan. 

2.2 Under what circumstances may a 

urine specimen be collected? 

One commenter suggested that the 

cost of mandatory random drug and 

alcohol testing among airline pilots 

outweighs the benefit. The Department 

has evaluated the comment and has 

concluded that no change is needed. 

Airline pilots are subject to drug and 

alcohol testing under DOT regulations. 

Therefore, this public comment is not 

relevant to the Guidelines. In regard to 

drug testing of federal agency employees 

and applicants, each federal agency 

establishes its agency plan based on its 

mission, its employees’ duties, and the 

potential consequences to the public 

health and safety or national security 

that could result from the failure of an 

employee to adequately perform their 

duties and responsibilities. 

Subpart C—Urine Specimen Tests 

3.1 Which tests are conducted on a 

urine specimen? 

One commenter suggested changing 

the term ‘‘opiates’’ to ‘‘opioids’’ in the 

Guidelines. The Department agrees with 

the commenter and has changed the 

term ‘‘opiates’’ to ‘‘opioids’’ where 

appropriate to refer to oxycodone, 

oxymorphone, hydrocodone, and 

hydromorphone in addition to codeine, 

morphine, and 6-acetylmorphine (6- 

AM). 

3.2 May a specimen be tested for 

additional drugs? 

The Department reworded Section 

3.2(a) to clarify the additional drug tests 

that may be performed on federal 

employee specimens. 

3.3 May any of the specimens be used 

for other purposes? 

Section 3.3 states that specimens 

collected pursuant to Executive Order 

12564, Public Law 100–71, and these 

Guidelines may not be used for 

purposes other than drug and validity 

testing in accordance with Subpart C of 

the Guidelines. One commenter 

disagreed with prohibiting employees 

from using their drug test specimens for 

other purposes (e.g., deoxyribonucleic 

acid, DNA, testing). The Department has 

evaluated this comment and has 

concluded that no change is needed. 

While the Guidelines do not authorize 

the release of urine specimens, or 

portions thereof, to federal employees, 

the Guidelines afford employees a 

variety of protections that ensure the 

identity, security and integrity of their 

specimens. For example, see Sections 

8.5(b), 8.8, and 15.1(a). 

In addition, under Public Law 100– 

71, Section 503(a)(1)(A)(ii)(I), HHS is 

mandated to establish ‘‘strict procedures 

governing the chain of custody of 

specimens collected for drug testing 

. . . .’’ Sections 11.7(a) and 11.20(a) 

also provide that an ‘‘HHS-certified 

laboratory must control access to the 

drug testing facility, specimens, 

aliquots, and records,’’ and must retain 

specimens that, among other things, 

have been reported ‘‘drug positive’’ for 

a minimum of one year. Therefore, the 

release of specimens to employees, or to 

an employee’s designee, is inconsistent 

with the mandates of the federal drug 

testing process, and could significantly 

compromise a specimen’s integrity, 

security, and an HHS-certified 

laboratory’s ability to fulfill its 

regulatory duties under the Guidelines. 

One commenter requested further 

clarification of the phrase ‘‘unless 

authorized in accordance with 

[applicable] federal law’’ in Section 3.3. 

The phrase ‘‘unless otherwise 

authorized in accordance with 

applicable law in Section 3.3(a) does not 

represent a significant change from the 

intent of the prior Guidelines language. 

Section 3.3, among others, is intended 

to prohibit the use of specimens for 

purposes other than those specifically 

authorized by the Guidelines. However, 

there may be circumstances in which 

federal law authorizes an HHS-certified 

laboratory to handle a specimen in a 

manner that differs from the Guidelines. 

Therefore, the phrase ‘‘unless 

authorized in accordance with 

applicable federal law’’ in Section 3.3 of 

the Guidelines is intended to avoid 

conflict with other applicable federal 

law. 
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It should be noted that Section 3.3 

specifically prohibits conducting 

deoxyribonucleic acid (DNA) testing on 

urine specimens, unless authorized in 

accordance with applicable federal law. 

3.4 What are the drug test cutoff 

concentrations for urine? 

The Department proposed 

methylenedioxyamphetamine (MDA) 

and methylenedioxyethylamphetamine 

(MDEA) as initial test analytes. Three 

commenters disagreed with the addition 

of MDA and MDEA as target analytes, 

stating this change would require 

modification of current immunoassay 

reagents, laboratory processes, or both. 

The commenters noted that this imposes 

an unnecessary burden for compounds 

with such low incidence in workplace 

testing. The Department has evaluated 

the comments and has removed MDEA 

from the Guidelines (i.e., MDEA is no 

longer included as an authorized drug 

in Section 3.4). The number of positive 

MDEA specimens reported by HHScertified laboratories (i.e., information 

provided to the Department through the 

NLCP) does not support testing all 

specimens for MDEA in federal 

workplace drug testing programs. 

Because MDEA is a Schedule I drug, a 

federal agency may test specimens for 

MDEA in accordance with Section 3.2 

(i.e., on a case-by-case basis for 

reasonable suspicion or post accident 

testing, routinely with a waiver from the 

Secretary). The Department understands 

that MDA and some other analytes also 

have a low incidence, but believes that 

continued testing for these analytes is 

warranted in a deterrent program. In 

particular, inclusion of MDA as an 

initial and confirmatory test analyte is 

warranted because, in addition to being 

a drug of abuse, it is a metabolite of 

MDEA and MDMA. 

An HHS-certified laboratory or 

Instrumented Initial Test Facility (IITF) 

may group analytes for initial testing. 

For clarity, the Department has defined 

the term ‘‘grouped analytes’’ where used 

in footnote 1 of the table in Section 3.4: 

‘‘(i.e., two or more analytes that are in 

the same drug class and have the same 

initial test cutoff).’’ 

The Department proposed criteria for 

immunoassays for grouped analytes 

such as opioids and amphetamines, 

specifying the minimum cross-reactivity 

to the other analyte(s) within the group. 

Two commenters disagreed with the 

added cross-reactivity requirements, 

noting this section should not attempt to 

provide equivalence between 

immunoassay and other initial testing 

technologies. One of these commenters 

suggested the Department develop 

separate requirements for initial test 

methods using an alternate technology 

or, alternatively, require the combined 

cross-reactivity of low-reacting 

compounds (e.g., hydrocodone and 

hydromorphone for an opiate assay; 

MDA and MDEA for an amphetamines 

assay) to be equal to or greater than the 

cutoff. The other commenter 

recommended not allowing methods 

other than immunoassay for urine initial 

testing. One commenter stated that 

cross-reactivity specifications for 

hydromorphone are not necessary, 

based on their non-regulated testing 

results (i.e., confirmatory test 

concentrations detected after using an 

immunoassay with 60% cross-reactivity 

for hydromorphone). The Department 

has evaluated the comments and has 

concluded that no change is needed for 

immunoassay cross-reactivity 

requirements. The requirements in 

Section 3.4 are necessary to ensure 

consistency in testing among 

laboratories using different 

immunoassay kits, as well as those 

using different test methods for initial 

drug testing. Cross-reactivity must be 

demonstrated and documented by the 

manufacturer (e.g., package insert) and 

by the HHS-certified laboratory or IITF 

(i.e., assay validation studies, reagent lot 

verification, and batch quality control 

for any analyte that exhibits less than 

100% cross-reactivity). The Department 

will continue to allow the use of 

methods other than immunoassay for 

initial testing. 

However, the Department has revised 

Section 3.4 regarding the use of 

alternate technology initial tests for 

THCA and benzoylecgonine. Depending 

on the technology, the confirmatory test 

cutoff (i.e., 15 ng/mL for THCA, 100 ng/ 

mL for benzoylecgonine) must be used 

as the cutoff for an initial test using an 

alternate technology to ensure 

consistent treatment of specimens. For 

these analytes, the immunoassay test is 

not specific for the target analyte for the 

confirmatory test. For example, 

immunoassays for cannabinoids react 

with multiple compounds that are 

excreted as a result of marijuana use. 

Therefore, it is necessary to use an 

immunoassay cutoff higher than that of 

the confirmatory test in order to detect 

the target analyte (THCA) at or above 

the confirmatory test cutoff. An initial 

test using an alternate technology with 

specificity comparable to the 

confirmatory test requires use of the 

confirmatory test cutoff. 

Also in Section 3.4, the Department 

did not specify the target analyte to be 

used to calibrate an initial test for 

grouped analytes such as amphetamines 

or opioids. Three commenters noted 

that when an immunoassay is calibrated 

with a low-reacting drug, other analytes 

may exhibit high cross-reactivity, 

leading to false initial test positives. 

Two of these commenters also noted 

that this may result in possibly different 

cross-reactivity profiles for some 

structurally unrelated and 

concomitantly used prescription and/or 

over the counter drugs. One commenter 

noted that the option to ‘‘include a 

control containing the lowest reacting 

analyte at its cutoff concentration in 

each batch’’ was described in the 

preamble to the proposed Guidelines, 

but was not specified in Section 3.4 of 

the Guidelines. It was not the 

Department’s intent for the laboratory or 

IITF to calibrate an immunoassay test 

using an analyte other than that 

specified by the manufacturer. In the 

preamble to the proposed UrMG, the 

Department described using a control 

containing the lowest reacting analyte at 

its cutoff concentration to establish the 

decision point (i.e., when an 

immunoassay for grouped analytes did 

not demonstrate at least 80% crossreactivity to each analyte). The 

Department has determined that this 

approach is not necessary, and will not 

be permitted. There are current 

immunoassays that meet the 

requirements of this section for two or 

more analytes in a group (i.e., analytes 

in the same drug class that have the 

same initial test cutoff). As indicated in 

Section 3.4, the laboratory or IITF may 

use multiple test kits or a single kit to 

meet the requirements. 

3.5 May an HHS-certified laboratory 

perform additional drug and/or 

specimen validity tests on a specimen at 

the request of the Medical Review 

Officer (MRO)? 

One commenter recommended that 

HHS maintain a list of allowable 

additional tests and reporting criteria 

(e.g., threshold for reporting as positive, 

adulterated, substituted, and/or invalid, 

and a limit of detection as appropriate), 

to ensure consistency among 

laboratories and within the testing 

program. The Department has evaluated 

the comment and has concluded that no 

change is needed. The Department does 

not want to limit the analytes that may 

be tested, and will provide guidance to 

laboratories as needed. It is also noted 

that the section requires all tests to meet 

appropriate validation and quality 

control requirements. The procedures 

and specimen records for such tests will 

be reviewed at NLCP inspections. The 

Department will continue to maintain a 

list of HHS-certified laboratories that 

choose to perform additional tests for 

regulated specimens. 
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One commenter asked whether an 

MRO could submit a blanket request to 

perform additional testing (e.g., 

additional opioid metabolites) for all 

confirmatory specimens (i.e., would 

laboratories be permitted to monitor the 

additional compounds in all 

confirmatory test assays?). The 

Department believes that testing all 

specimens for additional analytes may 

not be appropriate for some tests, 

especially hydrocodone, 

hydromorphone, oxycodone and 

oxymorphone. Recent studies show that 

testing for norhydrocodone and or 

noroxycodone is not necessary for the 

interpretation of all results.12 

Norhydrocodone and noroxycodone 

metabolites may be helpful for the MRO 

to interpret test results only when a 

donor’s prescription does not support 

the test results. For example, a 

hydrocodone dose may result in urine 

concentrations of only hydromorphone 

metabolite above the cutoff. The 

presence of norhydrocodone metabolite 

would support the use of hydrocodone 

and validate the donor’s prescription. 

The same could be said for interpreting 

test results following an oxycodone 

dose. The presence of noroxycodone 

metabolite would support the use of 

oxycodone when only oxymorphone 

was reported as positive. The 

Department will provide guidance on 

these and other additional tests that may 

provide useful information for the MRO 

in the Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs. The Department has 

revised Section 3.5 to clarify that HHScertified laboratories are authorized to 

perform additional tests upon MRO 

request on a case-by-case basis, but are 

not authorized to routinely perform 

such tests without prior authorization 

from the Secretary or designated HHS 

representative, with the exception of the 

determination of D,L stereoisomers of 

amphetamine and methamphetamine. 

The Department will continue to allow 

HHS-certified laboratories to test for D,L 

amphetamine and methamphetamine 

routinely or upon MRO request. The 

Department will provide guidance on 

these and other additional tests that may 

provide useful information for the MRO 

(e.g., tetrahydrocannabivarin) in the 

Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs. 

Additional drug and specimen 

validity testing under Section 3.5 does 

not include DNA testing. 

3.6 What criteria are used to report a 

urine specimen as adulterated? 

Two commenters agreed and one 

disagreed with raising the lower pH 

cutoff from 3.0 to 4.0 for identifying 

specimens as adulterated. One 

commenter advised caution in changing 

specimen validity test cutoffs, and 

indicated that the proposed change will 

require updates to computer systems for 

reporting, calibrators, and controls. One 

commenter indicated that previous 

review of data (more than 10 years ago) 

indicated this change would have more 

than doubled the number of low pH/ 

adulterated results reported. The 

commenter that disagreed with 

changing the pH cutoff believes HHS 

does not have enough scientific 

evidence supporting the change. The 

Department has evaluated the comments 

and has concluded that no change is 

needed to the proposed cutoff (i.e., 4.0). 

As stated in the preamble to the 

proposed Guidelines (80 FR 28101), this 

decision is based on the fact that the 

physiologically minimum achievable 

urine pH that can be produced by the 

kidneys is about pH 4.5. Furthermore, 

the Department is not aware of any 

medical conditions or medications that 

would cause urine pH to be less than 

4.5. 

3.8 What criteria are used to report a 

urine specimen as dilute? 

One commenter suggested removing 

the three-decimal place criteria for 

reporting a specimen as dilute. One 

commenter indicated that the criteria for 

reporting a specimen as dilute in 

Section 3.8 and 11.19(f) were not 

consistent, and that Section 3.8 does not 

address the situation when creatinine is 

between 5 and 20 mg/dL and the 

specific gravity is less than 1.0020. This 

section was intended to clarify that only 

HHS-certified laboratories (and not 

HHS-certified IITFs) may report a 

specimen as dilute when the creatinine 

concentration is greater than or equal to 

2.0 mg/dL and less than or equal to 5 

mg/dL, and the laboratory must use a 

four-decimal place refractometer for the 

specific gravity test. The Department 

will retain the three-decimal place 

criteria in Section 3.8(a) because both 

HHS-certified IITFs and laboratories 

may use a three-decimal place 

refractometer for a specific gravity 

screening test when the creatinine 

concentration is greater than 5 mg/dL 

and less than 20 mg/dL. However, the 

Department agrees that this section did 

not address all situations, so has revised 

the wording in Section 3.8(b) to be 

consistent with the wording in 11.19(f). 

3.9 What criteria are used to report an 

invalid result for a urine specimen? 

One commenter suggested increasing 

the acceptable pH range upper end from 

9.0 to 9.5 due to heat during summer 

months. One commenter recommended 

that the Department define requirements 

to be met before a new validity marker 

is implemented. One commenter 

suggested that additional biomarkers 

used to support a result of invalid 

should be standardized across all HHScertified laboratories and one solution to 

donor subversion might be random 

assignment of collection of alternative 

specimens. The Department has 

evaluated the comments and has 

concluded that no change is needed. A 

2006 study on the stability of regulated 

drug analytes in urine slightly below 

and within the high pH invalid range 

supports the pH 9.0 decision point due 

to the loss of drug analytes at a pH 

between 9.0 and 9.5.3 

Subpart D—Collectors 

4.4 What are the requirements to be an 

observer for a direct observed 

collection? 

One commenter disagreed with the 

requirement for an observer to be the 

same gender as the donor, and suggested 

that a physician or health care 

professional (regardless of gender) 

should be allowed to function as an 

observer. The commenter indicated that 

gender determination can be 

challenging (i.e., transgender 

employees). The Department has 

evaluated these comments and agrees 

that all observed collections must be 

conducted in a professional manner that 

minimizes discomfort to the donor. The 

Department has revised Sections 4.4(b), 

8.1(b), and 8.10 to allow the donor to be 

observed by a person whose gender 

matches the donor’s gender, which is 

determined by the donor’s gender 

identity (defined in Section 1.5). The 

donor’s gender identity may be the same 

as or different from the donor’s sex 

assigned at birth. The Department also 

revised Sections 8.1(b) and 8.12 for 

monitored collections, to allow the 

donor to be monitored by a person 

whose gender matches the donor’s 

gender, unless the monitor is a medical 

professional (as described in Section 

8.12). 

The Department disagrees with the 

commenter’s suggestion to allow an 

individual to serve as an observer based 

solely on their credentials as a 

physician or health care professional. 

Such credentials alone would not 

guarantee that these individuals could 

appropriately perform the functions of 

an observer (i.e., as specified in Section 

4.4). 

The same commenter expressed 

concerns over the requirement for an 

observer to have received training, 

indicating that this would require 
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documentation and may make finding 

short notice observers more difficult. 

The Department disagrees with this 

comment. These are the same 

requirements as in the Guidelines 

effective October 1, 2010 (73 FR 71858). 

As stated in the preamble to those 

Guidelines, the training elements are 

included to ensure that the observer 

interacts with the donor in a 

professional manner, respecting the 

donor’s modesty and privacy, and that 

the collector maintains the 

confidentiality and integrity of 

collection information. 

Subpart F—Federal Drug Testing 

Custody and Control Form (CCF) 

6.1 What federal form is used to 

document custody and control? 

Two commenters recommended that 

the Department provide instructions on 

recording results for the added drugs on 

the CCF until the Federal CCF is 

revised. Three commenters 

recommended that the CCF be revised to 

address the addition of the oral fluid 

specimen matrix. One commenter 

encouraged SAMHSA to modify the 

CCF to account for collections where 

multiple specimens are collected during 

a single collection event. The 

Department will publish a Federal 

Register Notice with the revised Federal 

CCF, including changes for the added 

analytes, with the same effective date as 

these Guidelines. Guidance on the use 

of the revised Federal CCF will be 

posted on the SAMHSA Web site http:// 

www.samhsa.gov/workplace. In regard 

to when the collector submits multiple 

urine specimens (i.e., different voids) 

collected during the same testing event, 

the Department has concluded that no 

change is needed; the collector must use 

a separate Federal CCF for each 

specimen. 

6.2 What happens if the correct OMB 

approved Federal CCF is not available 

or is not used? 

One commenter questioned the 

purpose of a Memorandum for the 

Record (MFR) obtained from the 

collector when an incorrect CCF was 

used for the collection. The commenter 

suggested that if certain information is 

required to be in the MFR, these 

requirements should be specified in the 

Guidelines. The commenter suggested 

that if the purpose of the MFR is to 

correct the collector’s behavior (i.e., 

using an incorrect form), then it would 

be more effective to reject the specimen 

upon receipt and indicate that it was 

rejected due to the use of an incorrect 

form. The Department has evaluated the 

comments and has concluded that no 

change is needed. Section 6.2 describes 

the information required in the MFR 

from the collector. However, the 

Department reworded items 6.2(b) and 

(c) for clarity. 

Subpart H—Urine Specimen Collection 

Procedure 

8.1 What privacy must the donor be 

given when providing a urine 

specimen? 

As described in this preamble under 

Section 4.4, the Department has revised 

Section 8.1(b) to require that the gender 

of the observer matches the donor’s 

gender, and that the gender of the 

monitor matches the donor’s gender 

unless the monitor is a medical 

professional as described in Section 

8.12. 

8.3 What are the preliminary steps in 

the urine specimen collection 

procedure? 

One commenter was concerned that 

the Guidelines do not mention alcohol 

testing, which was added to the 

Department of Transportation (DOT) 

program in 1991. Alcohol testing is 

outside of the scope of the Department’s 

regulatory authority granted by 

Executive Order 12564 and Public Law 

100–71. 

In response to comments described 

under Sections 1.7 and 8.4 in this 

preamble, the Department revised 

Section 8.3(h) to require the collector to 

report a refusal to test when a donor 

brings materials for adulterating, 

substituting, or diluting a specimen to 

the collection site. 

8.4 What steps does the collector take 

in the collection procedure before the 

donor provides a urine specimen? 

The proposed section included the 

same requirement as the Guidelines 

effective October 1, 2010 (73 FR 71858) 

for the collector to perform an observed 

collection when the donor exhibits 

conduct that clearly indicates an 

attempt to tamper with a specimen (e.g., 

substitute urine in plain view or an 

attempt to bring into the collection site 

an adulterant or urine substitute). One 

commenter stated that if the collector 

finds an adulterant or substitution 

product or observes the donor attempt 

to substitute a urine specimen, this 

should be a refusal to test. As noted 

under Section 1.7 in this preamble, the 

Department agrees that the collector 

must report a refusal to test when a 

donor brings materials for adulterating, 

substituting, or diluting a specimen to 

the collection site, or when the collector 

observes a donor’s clear attempt to 

tamper with a specimen. The 

Department has revised Section 8.4 

accordingly. 

8.5 What steps does the collector take 

during and after the urine specimen 

collection procedure? 

8.6 What procedure is used when the 

donor states that they are unable to 

provide a urine specimen? 

Comments on these two sections are 

addressed here. Numerous commenters 

expressed concern with the 

Department’s urine collection policy, 

stating that 7 to 10% of Americans have 

a condition (‘‘paruresis’’), described as a 

social anxiety disorder which prevents 

a person from producing urine on 

demand or in the presence of other 

people. These commenters stated that if 

the government wants to seek the largest 

group of qualified applicants, the 

Guidelines should specify that a 

diagnosis of paruresis means non-urine 

(i.e., oral fluid) testing will 

automatically be provided, and that 

donors should not have to attempt to 

provide a urine specimen first. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The Guidelines will allow a 

federal agency to use any authorized 

specimen types (e.g., urine, oral fluid, or 

both) in their drug testing programs. The 

Guidelines will continue to require that 

the donor be allowed reasonable 

attempts to provide a urine specimen as 

described in Sections 8.5 and 8.6, and 

allow collection of an authorized 

alternate specimen (i.e., oral fluid). 

Three commenters disagreed with the 

requirement for the collector to contact 

the agency representative for 

authorization to collect an alternate 

specimen each time a donor is unable to 

provide a sufficient volume. These 

commenters suggested that the 

Guidelines allow this to be addressed in 

established standard protocols for the 

agency. The Department agrees with the 

commenters. Each federal agency may 

decide whether to require notification in 

each case or whether to provide a 

standard protocol for collectors to 

follow. Sections 8.5 and 8.6 have been 

revised accordingly. 

Also in regard to Section 8.6, one 

commenter indicated that some 

employers may wish to retain urine 

testing as the primary test due to a 

longer detection window. This 

commenter raised concern that some 

donors may claim they are unable to 

provide a urine specimen so that an 

alternative specimen (i.e., OF) with a 

shorter detection window will be 

collected. The commenter suggested 

that the Guidelines be changed to 

indicate that an alternative specimen 
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may be collected when a donor is 

physiologically unable to provide a 

urine specimen, and not just when the 

donor states that they are unable to 

provide a urine specimen. The 

Department disagrees; collectors are not 

qualified to conduct a medical 

evaluation to verify or refute the donor’s 

claim. It will be the agency’s decision to 

collect urine or an authorized alternate 

specimen, and Sections 13.6 and 13.7 

include procedures for medical 

evaluation as needed during the MRO 

review process. 

The Department reworded Section 

8.5(d) to clarify that the collector must 

record comments on both CCFs when 

two specimens from the same collection 

event are forwarded to a laboratory. 

8.7 If the donor is unable to provide a 

urine specimen, may another specimen 

type be collected for testing? 

The Department proposed within 

Section 8.7 that when the donor is 

unable to provide a urine specimen, 

another specimen type may be collected 

only if specifically authorized by the 

agency. One commenter disagreed with 

the Guidelines as written and suggested 

that when a donor cannot provide the 

primary specimen type, an alternate 

specimen should be collected 

immediately. The commenter cited the 

additional time and cost (evaluation of 

donor for ‘‘shy bladder’’) as well as the 

fact that the collector may not know the 

agency’s policy on alternate specimen 

types. The Department has concluded 

that no change is needed for Section 8.7 

in response to this comment. The 

Guidelines will continue to require that 

the donor be allowed reasonable 

attempts to provide a urine specimen as 

described in Sections 8.5 and 8.6. The 

Department has revised those sections 

to allow a federal agency to either 

require notification in each case or 

provide a standard protocol for 

collectors to follow when the donor is 

unable to provide a urine specimen. The 

Department has reworded this section to 

state ‘‘Yes, if . . .’’ rather than ‘‘No, 

unless . . . .’’ in response to a federal 

agency’s comment and to enhance 

clarity. The meaning of this section 

remains the same. 

8.8 How does the collector prepare the 

urine specimens? 

In response to a federal agency 

comment, the Department deleted a 

sentence in item 8.8(h) that required the 

collector to send a copy of the Federal 

CCF to the HHS-certified laboratory or 

IITF. The Department agreed with the 

federal agency that this instruction is 

redundant because item 8.8(g) instructs 

the collector to distribute copies of the 

Federal CCF as required. 

8.9 When is a direct observed 

collection conducted? 

The proposed section included 

requirements for the collector to 

perform an observed collection when 

the donor exhibits conduct that clearly 

indicates an attempt to tamper with a 

specimen or the collector observed 

materials brought by the donor to the 

collection site for the purpose of 

adulterating, substituting, or diluting 

the specimen. One commenter stated 

that if the collector finds an adulterant 

or substitution product or observes the 

donor attempt to substitute a urine 

specimen, this should be a refusal to 

test. As noted in this preamble under 

Sections 1.7 and 8.4, the Department 

agrees that the collector must report a 

refusal to test when a donor brings 

materials for adulterating, substituting, 

or diluting the specimen to the 

collection site, or when the collector 

observes a donor’s clear attempt to 

tamper with a specimen. The 

Department has revised Section 8.9 

accordingly. 

8.10 How is a direct observed 

collection conducted? 

To address a comment described in 

this preamble under Section 4.4, the 

Department has revised Section 8.10 to 

allow the donor to be observed by an 

observer whose gender matches the 

donor’s gender. At the beginning of the 

observed collection, the collector 

requests that the donor document the 

donor’s gender on the Federal CCF and 

initial the annotation. An observer of 

the same gender is provided, and the 

collector records the name and gender 

of the observer on the Federal CCF. 

8.12 How is a monitored collection 

conducted? 

To address a comment described in 

this preamble under Section 4.4, the 

Department has revised Section 8.12 to 

allow the donor to be monitored by a 

monitor whose gender matches the 

donor’s gender, unless the monitor is a 

medical professional (e.g., nurse, doctor, 

physician’s assistant, technologist, or 

technician licensed or certified to 

practice in the jurisdiction in which the 

collection takes place). As described in 

Section 8.10, at the beginning of the 

monitored collection, the collector 

follows the same procedure as for 

observer selection in Section 8.10(b). 

That is, the collector requests that the 

donor document the donor’s gender on 

the Federal CCF and initial the 

annotation. A monitor of the same 

gender is provided, and the collector 

records the name and gender of the 

monitor on the Federal CCF. A medical 

professional may serve as the monitor, 

regardless of gender. 

Subpart I—HHS Certification of 

Laboratories and IITFs 

9.5 What are the qualitative and 

quantitative specifications of 

performance testing (PT) samples? 

One commenter noted that, because 

proposed initial test requirements allow 

calibration with a low-reacting analyte, 

PT schemes would likely need to be 

designed based on the specific 

implementation at each laboratory. The 

commenter provided an example: When 

an immunoassay is calibrated with a 

drug/metabolite that exhibits 50% crossreactivity, the intended target analyte 

(‘‘calibrant’’) at the cutoff concentration 

would elicit a response well in excess 

of the cutoff. This could result in 

inaccurate initial test results (i.e., a 

positive initial test result for a specimen 

containing the calibrant at a 

concentration below the cutoff). The 

commenter stated that this result could 

be scored as a ‘‘false positive’’ PT result. 

The Department has evaluated the 

comment and has concluded that no 

change is needed. As noted above 

regarding Section 3.4, it was not the 

Department’s intent for the laboratory or 

IITF to calibrate an immunoassay test 

using an analyte other than that 

specified by the manufacturer. NLCP PT 

schemes are designed based on known 

cross-reactivity profiles of the initial 

tests used by HHS-certified laboratories. 

Also in regard to proposed Section 

9.5, one commenter suggested that the 

Guidelines use the same wording as in 

the Guidelines effective October 1, 2010 

(73 FR 71858) for retest PT sample 

specifications (i.e., ‘‘. . . may be as low 

as . . .’’ rather than the proposed 

wording ‘‘. . . may be less than. . .’’). 

The Department agrees and has 

reinstituted wording from Section 9.3 of 

the Guidelines effective October 1, 2010 

(73 FR 71858) into Section 9.5(a)(1)(ii). 

Subpart J—Blind Samples Submitted by 

an Agency 

10.1 What are the requirements for 

federal agencies to submit blind samples 

to HHS-certified laboratories or IITFs? 

Two commenters disagreed with the 

proposed limit to the number of blind 

samples required (i.e., a maximum of 

400 blind samples per year) in Section 

10.1(b). The commenters indicated that 

for a large agency, there is a very large 

difference between 3% and 400 samples 

and suggested keeping only the 3% 

requirement. Another commenter 

disagreed with the 3% requirement for 
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blind samples and requested that the 

amount to be lowered to 1% to lessen 

the burden on employers. One 

commenter suggested that the wording 

be modified to clarify that employers are 

responsible for ensuring blind samples 

are sent to the laboratories, but that 

collectors are tasked with submitting the 

blind samples. The Department has 

evaluated the comments and has 

concluded that no change is needed. 

The 400 sample limit was added to 

reduce the burden on large agencies 

based on the Department’s review of 

agencies’ blind testing programs. The 

wording in Section 10.1(a) clearly 

describes the responsibilities of the 

federal agency and the role of the 

collector in blind sample submission; 

however, the Department reworded 

Section 10.3(a) for clarity as described 

below. 

10.3 How is a blind sample submitted 

to an HHS-certified laboratory? 

The Department has reworded Section 

10.3(a) to clarify that the collector sends 

a blind sample to a laboratory or IITF as 

a split specimen (i.e., Bottle A and 

Bottle B). 

Subpart K—Laboratory 

11.10 What are the requirements for an 

initial drug test? 

One commenter noted that HHS 

previously required initial and 

confirmatory testing using different 

techniques, and asked whether this 

requirement had been removed with 

allowance of technologies other than 

immunoassay for initial testing. The 

commenter expressed concern that an 

error in the initial drug test could be 

repeated in the confirmatory drug test 

using the same method. The Department 

has evaluated the comments and has 

concluded that no change is needed. 

The Guidelines maintain the 

requirement for initial and confirmatory 

tests on two separate aliquots to report 

a result other than negative. The NLCP 

will review validation and quality 

control records, as well as specimen 

records, to ensure that the initial and 

confirmatory testing methods meet 

Guidelines requirements and provide 

scientifically and forensically 

supportable results. 

Also in regard to the proposed Section 

11.10, one commenter asked whether 

non-FDA cleared immunoassays were 

included in the category of alternate 

initial drug test technology. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. This section clearly 

distinguishes initial tests using 

immunoassay from those using an 

alternate technology. Furthermore, 

Section 1.5 includes the definition for 

‘‘alternate technology initial drug test.’’ 

11.11 What must an HHS-certified 

laboratory do to validate an initial drug 

test? 

One commenter noted that an 

immunoassay initial test calibrated with 

a low-reacting analyte may not be able 

to meet Guidelines requirements for 

performance of the test around the 

cutoff concentration. The Department 

has evaluated the comments and has 

concluded that no change is needed. All 

tests must be validated by the HHScertified laboratory to meet the 

requirements prior to use for regulated 

drug testing. 

One commenter noted that the 

requirement in section 11.11(b) for 

reagent verification prior to use is an 

operational, not a validation, 

requirement. The Departments agrees 

with the commenter but has concluded 

that no change is needed. While this 

section addresses initial drug test 

validation requirements, the verification 

of each new reagent lot is essential to 

verify that lot-to-lot differences have not 

significantly affected assay performance 

as demonstrated and documented 

during validation. Therefore, this is the 

most appropriate section of the 

Guidelines to include the requirement. 

11.12 What are the batch quality 

control requirements when conducting 

an initial drug test? 

One commenter noted that this and 

other sections use inconsistent 

terminology when describing quality 

controls samples relative to the cutoff 

concentration (i.e., ‘‘25 percent above 

the cutoff,’’ ‘‘75 percent of the cutoff’’). 

The commenter suggested that the 

Department use one version 

consistently. The Department has 

considered the comment and has 

concluded that no change is needed. 

These terms have been used in the 

Guidelines, in NLCP documents, and in 

other guidance to HHS-certified 

laboratories without issue. 

One commenter asked whether the 

added analytes affect quality control 

content requirements. The Department 

has evaluated the comment and has 

concluded that no change is needed. 

The initial drug test quality control 

requirements in the Guidelines apply to 

each analyte used to calibrate the test 

(i.e., immunoassay or alternate 

technology initial drug test). When a 

single immunoassay test is used for two 

or more analytes in a drug class, the 

HHS-certified laboratory or IITF must 

include a control in accordance with 

item 11.12(a)(2) for each analyte that has 

less than 100% cross-reactivity with the 

assay, to demonstrate that the 

requirement for at least 80% crossreactivity has been met. 

11.12 What are the batch quality 

control requirements when conducting 

an initial drug test? 

11.15 What are the batch quality 

control requirements when conducting a 

confirmatory drug test? 

Comments on these two sections are 

addressed here. One commenter 

requested clarification for the 

requirement for a drug-free control in 

initial and confirmatory drug test 

batches (i.e., whether the control should 

contain no drug or whether the control 

should not contain the specific analyte 

for that test). The Department has 

evaluated the comment and has 

concluded that no change is needed. 

These Guidelines sections list the 

requirement for ‘‘at least one control 

certified to contain no drug or drug 

metabolite,’’ meaning that the control 

must contain no regulated drug 

analytes. 

11.16 What are the analytical and 

quality control requirements for 

conducting specimen validity tests? 

One commenter found the wording of 

Section 11.16(a) to be confusing, noting 

that a specimen would not be subjected 

to a second specimen validity test when 

the first test was in the acceptable range. 

The Department agrees with the 

comment and has revised Section 

11.16(a) to correctly reflect 

requirements. 

11.18 What are the requirements for 

conducting each specimen validity test? 

One commenter noted that the 

proposed changes in the lower pH cutoff 

for identifying adulterated specimens 

and lower pH decision point for 

identifying invalid specimens may 

cause additional costs for manufacturers 

and laboratories. The Department has 

evaluated the comment and has 

concluded that no change is needed. 

The Department recognizes that the 

revised cutoff will necessitate changes 

by HHS-certified laboratories as well as 

by manufacturers of commercial quality 

control samples; however, the 4.0 pH 

cutoff is supported by scientific studies 

and workplace drug testing data, and is 

expected to reduce the incidence of 

undetected attempts to subvert the drug 

test. 

11.19 What are the requirements for an 

HHS-certified laboratory to report a test 

result? 

One commenter suggested that the 

Department remove the requirement for 
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an executed CCF as the official report 

for ‘‘non-negative’’ specimens and 

permit the use of an electronic report 

with the required information. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. The Federal CCF serves as the 

chain of custody for the specimen from 

the time of collection until receipt by 

the laboratory and also contains the 

certification statement signed by the 

certifying scientist. The Federal CCF 

may be paper or electronic. 

11.21 How long must an HHS-certified 

laboratory retain records? 

In Section 11.21, the Department 

proposed that laboratories be allowed to 

convert hardcopy records to electronic 

records for storage and then discard the 

hardcopy records after six months. One 

commenter stated their assumption that 

this section did not require laboratories 

to convert electronic records to 

hardcopy records and maintain them for 

six months. This assumption is correct; 

the intent is to allow laboratories to 

maintain records in electronic format for 

the required storage period. The 

Department has concluded that no 

change is needed. 

11.22 What statistical summary reports 

must an HHS-certified laboratory 

provide for urine testing? 

One commenter asked why the 

proposed Guidelines include a 

requirement for a copy of the 

semiannual statistical summary report 

to be sent to the Secretary or designated 

HHS representative. The Department 

included the requirement in Section 

11.22 (and in Section 12.19 for IITFs) to 

facilitate compilation of statistical 

information for the federal drug-free 

workplace program. This will not place 

an additional burden on the test 

facilities other than transmission of the 

report. The Department will continue to 

evaluate the effectiveness of this 

requirement. 

Subpart M—Medical Review Officer 

(MRO) 

13.1 Who may serve as an MRO? 

Three commenters disagreed with the 

term ‘‘nonmedical use of a drug’’ used 

in Section 13.1 (and defined in Section 

1.5) and indicated that the term changes 

the role of an MRO from review, verify 

and ‘‘report a non-negative result’’ to 

review, verify and ‘‘interpret before 

reporting a result as negative or 

nonmedical use of a drug.’’ Two 

commenters disagreed with use of 

‘‘interpretation of results’’ to supplant 

‘‘alternative medical explanation.’’ One 

commenter noted that this perceived 

change in the MRO’s role represents an 

unjustified shifting of risk to the MRO. 

One commenter believes the term 

presents a possible legal flaw to the 

Guidelines, stating that this term is 

legally different from ‘‘safety concern’’ 

and places MROs in the position of 

being in conflict with the prescribing 

physician and subject to lawsuits. This 

commenter stated that even a lack of a 

finding of nonmedical use could be an 

issue if the donor subsequently had an 

accident after using the drug. The same 

commenter submitted five 

recommendations related to inclusion of 

prescription drugs in federal workplace 

drug testing programs, to address the 

commenter’s concerns with the 

proposed Guidelines. These five specific 

recommendations pertain to matters that 

are outside the scope of these 

Guidelines, and therefore are not 

addressed in the Department’s response 

below. 

The responsibilities of an MRO to 

interpret results have largely remained 

the same between the Guidelines 

effective October 1, 2010 (73 FR 71858) 

and these Guidelines. As stated in 

Section 13.5(c) of these Guidelines, ‘‘if 

the donor provides a legitimate medical 

explanation (e.g., a valid prescription) 

for the positive result, the MRO reports 

the test result as negative to the 

agency.’’ Accordingly, the intent of the 

Guidelines, in this context, is to confirm 

whether a positive drug test is the result 

of drug use under a valid prescription. 

Furthermore, the term ‘‘alternate 

medical explanation’’ has never been 

used in the Guidelines, but has been 

used in the HHS Medical Review Officer 

Manual for Federal Workplace Drug 

Testing Programs. 

For the reasons above, the Department 

believes that the definition of 

‘‘nonmedical use of a drug’’ and the 

requirement for a physician serving as 

an MRO to have knowledge of this topic 

do not fundamentally change the MRO’s 

responsibilities. However, to address the 

commenters’ concerns, the Department 

has removed this term from the 

Guidelines (i.e., revised Sections 1.5 

and 13.1). 

The Department proposed within 

Section 13.1 who may serve as an MRO. 

One commenter requested clarification 

that it is the federal agency’s burden to 

ensure that the MRO is certified. One 

commenter asked how the laboratory 

will be informed that an MRO has met 

requirements for re-qualification. The 

Department evaluated the comments 

and concluded that no change is 

needed. The MRO is an employee or a 

contractor of the agency. Therefore, it is 

the agency’s responsibility to ensure 

that the MRO meets the Guidelines 

qualification requirements. 

Two commenters disagreed with the 

requirement for MRO recertification 

every five years, and recommended that 

MROs complete training every three 

years. Five commenters stated support 

for five year requalification and 

examination requirements. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The Department will keep the 

five-year recertification requirement as 

proposed. 

13.2 How are nationally recognized 

entities or subspecialty boards that 

certify MROs approved? 

One commenter agreed with MRO 

certification/training entities submitting 

the delivery method and content of the 

MRO examination as applicable along 

with other required documents. One 

commenter agreed with extending time 

from one to two years for approved 

MRO certification/training entities’ 

resubmission of qualifications for HHS 

approval. The commenter noted that 

they would support further extension to 

3 years. One commenter recommended 

that approval of MRO educational 

courses and content be at the discretion 

of the MRO certification entities, not 

HHS. Since the certification entities and 

their examinations are subject to HHS 

oversight and approval, the commenter 

noted that it may be burdensome for 

HHS to review and approve the courses 

and content, and be a disincentive to 

development of new courses. One 

commenter recommended that 

examinations be allowed to be in-person 

or online with appropriate security 

precautions for each delivery method. 

The Department has evaluated the 

comments and agrees that the 

submission of training materials to HHS 

would possibly discourage the 

development of new training courses. 

Therefore, the review of MRO 

educational courses and content will 

not be part of the approval process for 

MRO certification entities. As described 

under Medical Review Officer (MRO) 

requalification—continuing education 

units (CEUs) in this preamble, the 

Department has removed references to 

MRO training entities in Section 13.2, 

because training documentation is 

maintained by MRO certification 

entities. The Department will only 

require the MRO certification entities to 

submit their examination and any other 

necessary supporting examination 

materials (e.g., answers, examination 

statistics or background information on 

questions) that will help in the 

Department’s evaluation of the 

examination. The Department will 
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review and evaluate the examination 

delivery method (e.g., in-person or 

online) when reviewing submitted 

training materials to ensure that the 

delivery method employs appropriate 

security and identification procedures. 

13.3 What training is required before a 

physician may serve as an MRO? 

Five commenters disagreed and one 

commenter agreed with the added 

requirement for MRO training to include 

information about how to discuss 

substance misuse and abuse and how to 

access those services. The Department 

has evaluated the comments and has 

revised Section 13.3 to remove this 

requirement. Federal agencies may 

provide this information to employees 

and applicants to facilitate their access 

to effective treatment and support 

recovery. The Department provides 

information to the public on help and 

treatment for substance misuse and 

abuse, and how to access those services, 

on the SAMHSA Web site http:// 

www.samhsa.gov/. 

One commenter stated that the 

Department should add a requirement 

for MRO training on what constitutes a 

refusal to test. One commenter 

suggested that the Department should 

add a requirement for MRO training on 

when and how to report safety concerns 

to employers when prescription and/or 

over-the-counter medications may affect 

performance. The Department has 

evaluated the comments and has 

concluded that no change is needed. 

Criteria for reporting a refusal to test are 

covered under the topics listed in 

Section 13.3 such as items (a)(4) training 

on the Guidelines and (a)(5) procedures 

for interpretation, review, and reporting 

of results. When a donor provides a 

legitimate medical explanation for a 

positive drug test result (e.g., a valid 

prescription), the Guidelines do not 

require MROs to contact federal agency 

employers for the purpose of reporting 

a safety concern. Accordingly, MRO 

training related to reporting ‘‘safety 

concerns’’ does not relate to a 

mandatory function under the 

Guidelines and, therefore, is not an 

essential component of required MRO 

training. The Department will provide 

additional guidance in the HHS Medical 

Review Officer Guidance Manual for 

Federal Workplace Drug Testing 

Programs. 

In addition, the Department revised 

Section 13.3 as described under Medical 

Review Officer (MRO) requalification— 

continuing education units (CEUs) in 

this preamble. The Department removed 

references to MRO training entities, 

because training documentation is 

maintained by MRO certification 

entities, and added item 13.3(b) to 

require MRO training on revised 

Guidelines prior to their effective date. 

13.4 What are the responsibilities of an 

MRO? 

One commenter suggested creating a 

subset of medical professionals trained 

specifically to determine fitness for duty 

since an MRO cannot determine fitness 

for duty over the telephone. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. Fitness for duty evaluations fall 

outside the purview of the Guidelines. 

13.5 What must an MRO do when 

reviewing a urine specimen’s test 

results? 

The Department has revised Section 

13.5(d)(1) to include an example of 

documentation to support a medical 

explanation for a positive drug test 

result. 

Three commenters disagreed with 

MRO procedures for ‘‘a positive result 

for opiates’’ (i.e., requirement for 

clinical evidence of illegal use in 

addition to positive result) and noted 

that the proposed Guidelines wording 

was not changed to clarify that the 

described procedures do not apply to 

the added opioids. The Department 

agrees with the commenters and has 

revised Section 13.5(d) to clarify that 

the procedures do not apply to the 

added opioid analytes. Wording in 

Section 13.5(d)(2)(i) regarding ‘‘clinical 

evidence of illegal use’’ was also edited 

for clarity and for consistency with the 

wording in the OFMG. 

One commenter disagreed with 

requirements concerning two separate 

specimens collected at a single test 

event and sent to the laboratory for 

testing (e.g., a urine specimen outside 

the acceptable temperature range and 

the subsequently collected specimen). 

The proposed Guidelines require that, 

when one of the two specimens is 

negative and other is not, the MRO 

reports only the verified result other 

than negative. This commenter 

suggested that the MRO cancel the 

negative result. The Department has 

evaluated the comments and has 

concluded no change is needed. 

Cancellation of the test may be 

confusing in the situation referenced by 

the commenter and lead to 

inappropriate specimen recollection. 

Both the MRO and the federal agency 

employer will receive their Federal CCF 

copies with explanatory collector 

remarks in Step 2 including the 

specimen identification number of the 

associated specimen, and the MRO may 

provide additional comment in the 

MRO’s report. 

The Department also revised Section 

13.5(d) to reflect the policy of the 

Department that passive exposure to 

marijuana smoke and ingestion of food 

products containing marijuana are not 

acceptable medical explanations for a 

positive drug test result. Individuals 

who are passively exposed to marijuana 

smoke or who consume food products 

containing marijuana can pose public 

safety and/or security risks.45 Marijuana 

is listed as a Schedule I drug under the 

Controlled Substances Act. 

13.6 What action does the MRO take 

when the collector reports that the 

donor did not provide a sufficient 

amount of urine for a drug test? 

One commenter suggested the 

Guidelines define ‘‘appropriate 

expertise’’ of a physician with a list of 

conditions and an appropriate type of 

physician in an appendix. The same 

commenter requested medical referral 

information on the employer’s actions 

when a donor could not provide a urine 

specimen and then could not provide an 

oral fluid specimen. The Department 

has evaluated the comments and has 

concluded that no change is needed. A 

physician who is a trained MRO will 

have the knowledge necessary to 

identify another physician with 

appropriate expertise for the medical 

evaluation. The Department will 

provide additional guidance in the HHS 

Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs as appropriate when 

alternate specimen types (e.g., oral 

fluid) are allowed in federal workplace 

drug testing programs. 

The Department clarified the 

definition of ‘‘permanent or long-term 

medical conditions’’ in Section 

13.6(b)(1) based on a federal agency 

comment. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

15.1 What discrepancies require an 

HHS-certified laboratory or an HHScertified IITF to report a specimen as 

rejected for testing? 

The Department revised wording in 

items a and b of this section, and 

included three additional fatal flaws as 

items f–h, to reflect fatal flaws for 

regulated donor specimens that have 

been identified by HHS-certified 

laboratories. These fatal flaws were 

addressed in NLCP guidance sent to all 

HHS-certified and applicant laboratories 

and IITFs on August 9, 2016. In 

addition, the Department revised this 

section to include an additional item i 

to allow a laboratory or IITF to reject a 

specimen when they identify a flaw that 
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prevents testing or affects the forensic 

defensibility of the drug test, and cannot 

be corrected. This general item enables 

laboratories and IITFs to reject 

specimens with fatal flaws that may be 

rare, but do occur. It is not possible to 

list all such flaws in the Guidelines. 

15.3 What discrepancies are not 

sufficient to require an HHS-certified 

laboratory or an HHS-certified IITF to 

reject a urine specimen for testing or an 

MRO to cancel a test? 

Two commenters indicated that 

inclusion of some items as insignificant 

discrepancies contradicts guidance 

provided to HHS-certified laboratories 

and IITFs in NLCP Notices, which 

required laboratories to attempt to 

recover missing information. One of 

these commenters suggested that if these 

items are important, they should be 

removed from the ‘‘insignificant’’ list. 

Two commenters disagreed with the 

Guidelines designating the listed 

omissions and discrepancies as 

‘‘insignificant only when they occur no 

more than once per month.’’ The 

Department has evaluated the 

comments. The listed discrepancies 

would not result in rejection or 

cancellation. NLCP Notices requiring 

laboratory action are consistent with 

this section. However, the Department 

has reworded section 15.3 to not classify 

these errors as insignificant. While these 

types of errors do not warrant laboratory 

rejection of a specimen or MRO 

cancellation of a test, as noted in section 

15.3(c), corrective action must be 

initiated when they occur more than 

once a month. 

The commenters indicated that this 

section implies that the MRO must keep 

a log of insignificant errors by laboratory 

and by collection site in order to track 

frequency. The commenters noted that 

this is an unenforceable policy, that this 

should be a duty of inspectors of 

laboratories and collection sites, and 

that requiring MROs to keep these types 

of logs would create significant extra 

costs. One commenter suggested that 

item 15.3(c) be modified for the MRO to 

advise the collector or laboratory to 

retrain staff on relevant procedures to 

ensure that collections are completed 

correctly (rather than directing them to 

immediately take corrective action). The 

Department has evaluated the comments 

and has concluded that no change is 

needed. This section is the same as in 

the Guidelines effective October 1, 2010 

(73 FR 71858). 

One commenter suggested modifying 

15.3(a)(5) to read ‘‘donor identification 

number’’ which would include a social 

security number or an employee 

identification number since many 

employers no longer use social security 

numbers for employee identification. 

The Department agrees and has revised 

Section 15.3(a)(5) to include ‘‘employee 

identification number’’ in addition to 

‘‘Social Security Number.’’. 

15.4 What discrepancies may require 

an MRO to cancel a test? 

One commenter suggested adding the 

scenario where the donor did not sign 

the CCF because the collector forgot to 

ask the donor to sign, rather than the 

donor’s refusal to sign. The Department 

has evaluated the comment and has 

concluded that no change is needed. As 

stated in Section 15.4, the MRO contacts 

the collector ‘‘to obtain a statement to 

verify that the donor refused to sign the 

MRO copy.’’ 

Regulatory Impact and Notices 

Executive Orders 13563 and 12866 

Executive Order 13563 of January 18, 

2011 (Improving Regulation and 

Regulatory Review) states ‘‘Our 

regulatory system must protect public 

health, welfare, safety, and our 

environment while promoting economic 

growth, innovation, competitiveness, 

and job creation.’’ Consistent with this 

mandate, Executive Order 13563 

requires agencies to tailor ‘‘regulations 

to impose the least burden on society, 

consistent with obtaining regulatory 

objectives.’’ Executive Order 13563 also 

requires agencies to ‘‘identify and 

consider regulatory approaches that 

reduce burdens and maintain flexibility 

and freedom of choice’’ while selecting 

‘‘those approaches that maximize net 

benefits.’’ This notice presents a 

regulatory approach that will reduce 

burdens to providers and to consumers 

while continuing to provide adequate 

protections for public health and 

welfare. 

The Secretary has examined the 

impact of the Guidelines under 

Executive Order 12866, which directs 

federal agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). 

According to Executive Order 12866, 

a regulatory action is ‘‘significant’’ if it 

meets any one of a number of specified 

conditions, including having an annual 

effect on the economy of $100 million; 

adversely affecting in a material way a 

sector of the economy, competition, or 

jobs; or if it raises novel legal or policy 

issues. The Guidelines do establish 

additional regulatory requirements and 

allow an activity that was otherwise 

prohibited. The Administrative 

Procedure Act (APA) delineates an 

exception to its rulemaking procedures 

for ‘‘a matter relating to agency 

management or personnel’’ 5 U.S.C. 

553(a)(2). Because the Guidelines issued 

by the Secretary govern federal 

workplace drug testing programs, HHS 

has taken the position that the 

Guidelines are a ‘‘matter relating to 

agency management or personnel’’ and, 

thus, are not subject to the APA’s 

requirements for notice and comment 

rulemaking. This position is consistent 

with Executive Order 12564 regarding 

Drug-Free Workplaces, which directs 

the Secretary to promulgate scientific 

and technical guidelines for executive 

agency drug testing programs. However, 

the statute under which the mandatory 

guidelines were created (Pub. L. 100–71, 

section 503(a)(3)) required notice and 

comment apart from the APA. This 

provision provides the following: 

(3) Notwithstanding any provision of 

chapter 5 of title 5, United States Code, the 

mandatory guidelines to be published 

pursuant to subsection (a)(l)(A)(ii) shall be 

published and made effective exclusively 

according to the provisions of this paragraph. 

Notice of the mandatory guidelines proposed 

by the Secretary of Health and Human 

Services shall be published in the Federal 

Register, and interested persons shall be 

given not less than 60 days to submit written 

comments on the proposed mandatory 

guidelines. Following review and 

consideration of written comments, final 

mandatory guidelines shall be published in 

the Federal Register and shall become 

effective upon publication. 

The Department included a 

Regulatory Impact and Notices section 

with cost and benefits analysis and 

burden estimates in the May 15, 2015 

Federal Register Notice for the 

proposed UrMG (80 FR 28101), and 

requested public comment on all figures 

and assumptions. The Department’s 

projections were developed using 

information from current HHS-certified 

urine testing laboratories, with input 

from DOT and the Nuclear Regulatory 

Commission (NRC), and cost analysis 

was based on information provided by 

multiple HHS-certified laboratories and 

MROs. The Department received no 

substantive data or evidence through 

public comments in favor of changing 

the estimated costs and benefits 

provided in the Department’s May 2015 

Federal Register Notice for the UrMG, 

and therefore, has retained the analysis 

and estimates provided in that notice 

below. Comments that related to the 

costs and benefits of this rule are 

summarized and discussed above in the 

Summary of Public Comments and 
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HHS’s Response under the heading 

Costs and Benefits. 

Need for Revisions to the Guidelines 

The inclusion of oxycodone, 

oxymorphone, hydrocodone and 

hydromorphone in the URMG was 

recommended by the DTAB, reviewed 

by the Department’s Prescription Drug 

Subcommittee of the Behavioral Health 

Coordinating Committee, and approved 

by the SAMHSA Administrator in 

January 2012. This action is supported 

by various data, described in this 

preamble.1–4 In addition, in 2008, 12 

percent of military personnel admitted 

to the illicit use of prescription 

medications. Prevalence testing by the 

Department of Defense (DoD) in 2009 

indicated that prescription drug abuse 

exceeded illegal drug abuse. Because of 

this, hydrocodone and hydromorphone 

testing was added to the regular DoD 

drug testing panel in 2011. 

Costs 

Costs associated with the 

implementation of testing for 

oxycodone, oxymorphone, hydrocodone 

and hydromorphone will be minimal 

because the Department has determined 

that all HHS certified laboratories 

testing specimens from federal agencies 

are currently conducting tests for one or 

more of these analytes on non-regulated 

urine specimens. Likewise, there will be 

minimal costs associated with changing 

initial testing to include MDA since the 

current immunoassays can be adapted 

to test for this analyte. Laboratory 

personnel are currently trained and test 

methods have been implemented. 

However, there will be some 

administrative costs associated with 

adding these analytes. Prior to being 

allowed to test regulated specimens for 

these compounds, HHS certified 

laboratories will be required to 

demonstrate that their performance 

meets Guideline requirements by testing 

three (3) groups of PT samples. The 

Department will provide the PT samples 

through the National Laboratory 

Certification Program (NLCP) at no cost 

to the certified laboratories. Based on 

costs charged for specimen testing, 

laboratory costs to conduct the PT 

testing would range from $900 to $1,800 

for each certified laboratory. 

In Section 3.4, the Department 

included criteria for calibrating initial 

tests for grouped analytes such as 

opiates and amphetamines, and 

specified the cross-reactivity of the 

immunoassay to the other analytes(s) 

within the group. These Guidelines 

allow the use of methods other than 

immunoassay for initial testing. An 

immunoassay manufacturer may incur 

costs if they choose to alter their 

existing product and resubmit the 

immunoassay for FDA clearance. 

For the added opiate analytes, the two 

immunoassays currently used for 

oxycodone and oxymorphone meet the 

requirements, and two of the three 

existing opiate immunoassays used in 

certified laboratories meet the 

requirements for hydrocodone and 

hydromorphone analysis. The opiate 

immunoassay that does not have 

sufficient cross-reactivity would be 

acceptable as an initial test under these 

Guidelines when the lowest-reacting 

analyte, hydromorphone, is used to 

establish a decision point. Therefore, 

the Department assumes that all 

certified laboratories will elect to use 

existing immunoassays. Thus, the costs 

associated with implementing the initial 

tests for these analytes is expected to be 

de minimis. 

For amphetamines, one of the three 

existing 

methylenedioxymethamphetamine 

(MDMA) immunoassays used in 

certified laboratories meets the 

requirements. The remaining two 

exhibit insufficient cross-reactivity for 

MDA. These two immunoassays would 

be acceptable as an initial test under 

these Guidelines when the lowestreacting analyte, MDA, is used to 

establish a decision point. An 

immunoassay manufacturer may incur 

costs if they choose to alter their 

existing product and resubmit the 

immunoassay for FDA clearance. Again, 

the Department assumes that certified 

laboratories will use the existing 

immunoassays and incur de minimis 

costs. 

Once the testing has been 

implemented, the cost per specimen for 

initial testing for the added analytes will 

range from $.06 to $0.20 due to reagent 

costs. Current costs for each 

confirmatory test range from $5.00 to 

$10.00 for each specimen reported 

positive, due to sample preparation and 

analysis costs. Based on information 

from non-regulated workplace drug 

testing for these analytes and testing 

performed by the Department on deidentified federally regulated specimens 

in 2011, approximately 1% of the 

submitted specimens is expected to be 

confirmed as positive for the added 

analytes. Therefore, the added cost for 

confirmatory testing will be $0.05 to 

$0.10 per submitted specimen. This 

would indicate that the cost per 

specimen submitted for testing will 

increase by $0.11–$0.30. Annual 

recurring testing costs in the table below 

are based on an estimated number of 

6,145,500 specimens. 

The addition of the Schedule II 

prescription medications will require 

MRO review to verify legitimate drug 

use. Based on the positivity rates from 

non-regulated workplace drug testing 

for these analytes and the additional 

review of specimens confirmed positive 

for prescription medications, MRO costs 

are estimated to increase by 

approximately 3%. The burden of this 

3% cost increase is expected to shift 

gradually from MROs to agencies as 

agencies’ existing contracts expire and 

they renegotiate the terms of new 

contracts, with an increase to the total 

cost of a federal drug test over time to 

between $0.60–$1.35. This cost would 

indicate a total cost of $3,687,300 to 

$8,296,425 in the urine testing program. 

A federal agency may also incur 

additional costs (e.g., additional 

managerial effort to arrange substitute 

workers) when an employee tests 

positive for a prescription medication 

and is removed from duties during the 

MRO verification process. 

The additional costs for testing and 

MRO review will be incorporated into 

the overall cost for the federal agency 

submitting the specimen to the 

laboratory. The estimation of costs 

incurred is based upon overall cost to 

the federal agency because the review of 

positive specimens is usually based on 

all specimens submitted from an 

agency, rather than individual specimen 

testing costs or MRO review of positive 

specimens. Agencies may also incur 

some costs for training of federal 

employees such as drug program 

coordinators due to implementation of 

the revised Guidelines. Based on current 

training modules offered to drug 

program coordinators, and other 

associated costs including travel for 

90% of drug program coordinators, the 

estimated total training cost for a oneday training session would be between 

$108,000 and $138,000 (i.e., assuming 8 

hours of time multiplied by a GS 12/13 

wage including benefits and overhead 

adjustments). The Department will offer 

the choice of online or in-person 

training. This will eliminate travel costs 

for those federal agencies who choose to 

use online training. 
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7932 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

RECURRING ANNUAL COSTS SUMMARY TABLE 

Lower bound Upper bound 

Reagent Costs ............................................................................................................................................. 

Additional Confirmatory tests ....................................................................................................................... 

MRO Costs .................................................................................................................................................. 

$368,730.00 

307,275.00 

3,687,300.00 

$1,229,100.00 

614,550.00 

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 ................................................................................................................................... 

Training ........................................................................................................................................................ 

$27,900.00 

108,000 

$55,800.00 

138,000 

Total ...................................................................................................................................................... 135,900.00 193,800.00 

Benefits 

The potential benefits of deterring use 

of oxycodone, oxymorphone, 

hydrocodone and hydromorphone are 

the prevention of their side effects (e.g., 

anxiety, dizziness, drowsiness, fatigue, 

and other neurological effects), which 

will result in a healthier and more alert 

workforce as well as avoid the issues 

associated with addiction and 

rehabilitation. Since the personnel 

tested under this program are in 

positions that are safety sensitive, 

potential benefits include decreased risk 

of transportation accidents, decreased 

risk of low-probability high 

consequence events, more responsible 

workforce in positions of public trust, 

and potentially reducing individuals’ 

dependence or addiction and the 

personal benefits associated with those 

conditions. 

Considering the potential health and 

performance costs of narcotic abuse, the 

benefits to the federal workplace and 

the individuals within that workplace 

justify the inclusion of oxycodone, 

oxymorphone, hydrocodone and 

hydromorphone in Federal Workplace 

Drug Testing programs. 

Regulatory Flexibility Analysis 

For the reasons outlined above, the 

Secretary has determined that the 

Guidelines will not have a significant 

impact upon a substantial number of 

small entities within the meaning of the 

Regulatory Flexibility Act [5 U.S.C. 

605(b)]. The flexibility added by the 

UrMG will not require addition 

expenditures. Therefore, a final 

regulatory flexibility analysis is not 

required for this notice. 

The Secretary has determined that the 

Guidelines are not a major rule for the 

purpose of congressional review. For the 

purpose of congressional review, a 

major rule is one which is likely to 

cause an annual effect on the economy 

of $100 million; a major increase in 

costs or prices; significant effects on 

competition, employment, productivity, 

or innovation; or significant effects on 

the ability of U.S.-based enterprises to 

compete with foreign-based enterprises 

in domestic or export markets. This is 

not a major rule under the Small 

Business Regulatory Enforcement 

Fairness Act (SBREFA) of 1996. 

Unfunded Mandates 

The Secretary has examined the 

impact of the Guidelines under the 

Unfunded Mandates Reform Act 

(UMRA) of 1995 (Pub. L. 104–4). This 

notice does not trigger the requirement 

for a written statement under section 

202(a) of the UMRA because the 

Guidelines do not impose a mandate 

that results in an expenditure of $100 

million (adjusted annually for inflation) 

or more by either state, local, and tribal 

governments in the aggregate or by the 

private sector in any one year. 

Environmental Impact 

The Secretary has considered the 

environmental effects of the UrMG. No 

information or comments have been 

received that would affect the agency’s 

determination there would be a 

significant impact on the human 

environment and that neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

Executive Order 13132: Federalism 

The Secretary has analyzed the 

Guidelines in accordance with 

Executive Order 13132: Federalism. 

Executive Order 13132 requires federal 

agencies to carefully examine actions to 

determine if they contain policies that 

have federalism implications or that 

preempt state law. As defined in the 

Order, ‘‘policies that have federalism 

implications’’ refer to regulations, 

legislative comments or proposed 

legislation, and other policy statements 

or actions that have substantial direct 

effects on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government. 

In this notice, the Secretary revised 

the standards for certification of 

laboratories engaged in urine fluid drug 

testing for federal agencies and the use 

of urine testing in federal drug-free 

workplace programs. The Department of 

Health and Human Services, by 

authority of Section 503 of Public Law 

100–71, 5 U.S.C. Section 7301, and 

Executive Order No. 12564, establishes 

the scientific and technical guidelines 

for federal workplace drug testing 

programs and establishes standards for 

certification of laboratories engaged in 

urine drug testing for federal agencies. 

Because the Mandatory Guidelines 

govern standards applicable to the 

management of federal agency 

personnel, there should be little, if any, 

direct effect on the states, on the 

relationship between the national 

government and the states, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Secretary has determined that the 

Guidelines do not contain policies that 

have federalism implications. 

Paperwork Reduction Act of 1995 

The Guidelines contain information 

collection requirements which are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

[the PRA 44 U.S.C. 3507(d)]. 

Information collection and 

recordkeeping requirements which 

would be imposed on laboratories 

engaged in drug testing for federal 

agencies concern quality assurance and 
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7933 

quality control documentation, reports, 

performance testing, and inspections as 

set out in subparts H, I, K, L, M and N. 

Information collection and 

recordkeeping requirements which 

would be imposed on MROs engaged in 

drug testing services for federal agencies 

concern drug testing result review and 

reports as set out in subparts M and N. 

To facilitate ease of use and uniform 

reporting, a Federal CCF for each type 

of specimen collected will be developed 

as referenced in section 6.1. The 

Department will submit the information 

collection and recordkeeping 

requirements contained in the 

Guidelines to OMB for review and 

approval prior to the effective date of 

the final Guidelines. Information 

collections changed by these Guidelines 

are not effective until approved by 

OMB. 

Privacy Act 

The Secretary has determined that the 

Guidelines do not contain information 

collection requirements constituting a 

system of records under the Privacy Act. 

The Federal Register notice announcing 

the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Urine is not a system of records as noted 

in the information collection/ 

recordkeeping requirements below. As 

required, HHS originally published the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Guidelines) in the Federal Register on 

April 11, 1988 [53 FR 11979]. SAMHSA 

subsequently revised the Guidelines on 

June 9, 1994 [59 FR 29908], September 

30, 1997 [62 FR 51118], November 13, 

1998 [63 FR 63483], April 13, 2004 [69 

FR 19644], and November 25, 2008 [73 

FR 71858] with an effective date of May 

1, 2010 (correct effective date published 

on December 10, 2008 [73 FR 75122]). 

The effective date of the Guidelines was 

further changed to October 1, 2010 on 

April 30, 2010 [75 FR 22809]. 

Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175 (65 FR 67249, 

November 6, 2000) requires SAMHSA to 

develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ as defined in the 

Executive Order, include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the federal 

government and Indian tribes.’’ The 

Guidelines do not have tribal 

implications. The Guidelines will not 

have substantial direct effects on tribal 

governments, on the relationship 

between the federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

federal government and Indian tribes, as 

specified in Executive Order 13175. 

Information Collection/Record Keeping 

Requirements 

The information collection 

requirements (i.e., reporting and 

recordkeeping) in the current 

Guidelines (73 FR 71858) are approved 

by the Office of Management and 

Budget (OMB) under control number 

0930–0158. The Federal Drug Testing 

Custody and Control Form used to 

document the collection and chain of 

custody of urine specimens at the 

collection site, for laboratories to report 

results, and for Medical Review Officers 

to make a determination, the National 

Laboratory Certification Program (NLCP) 

application, the NLCP Laboratory 

ESTIMATE OF ANNUAL REPORTING BURDEN 

Information Checklist, and 

recordkeeping requirements in the 

current Guidelines, as approved under 

control number 0930–0158, will remain 

in effect until these final Guidelines are 

effective and OMB approves the revised 

information collection. OMB will assign 

a new control number to account for 

changes associated with the final 

Guidelines. 

The title, description and respondent 

description of the information 

collections are shown in the following 

paragraphs with an estimate of the 

annual reporting, disclosure and 

recordkeeping burden. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, gathering and maintaining the 

data needed, and completing and 

reviewing the collection of information. 

Title: The Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine Specimens 

Description: The Mandatory 

Guidelines establish the scientific and 

technical guidelines for federal drug 

testing programs and establish standards 

for certification of laboratories engaged 

in drug testing for federal agencies 

under authority of Public Law 100–71, 

5 U.S.C. 7301 note, and Executive Order 

No. 12564. Federal drug testing 

programs test applicants to sensitive 

positions, individuals involved in 

accidents, individuals for cause, and 

random testing of persons in sensitive 

positions. 

Description of Respondents: 

Individuals or households; businesses; 

or other-for-profit; not-for-profit 

institutions. 

The burden estimates in the tables 

below are based on the following 

number of respondents: 38,000 donors 

who apply for employment in testing 

designated positions, 100 collectors, 30 

urine specimen testing laboratories, 1 

IITF, and 100 MROs. 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

9.2(a)(1) .......................... Laboratory or IITF 1 required to submit application 

for certification. 

10 1 3 .................. 30 

9.12(a)(3) ........................ Materials to submit to become an HHS inspector 10 1 2 .................. 20 

11.3(a) ............................ Laboratory submits qualifications of RP to HHS .. 10 1 2 .................. 20 

11.4(c) ............................ Laboratory submits information to HHS on new 

RP or alternate RP. 

10 1 2 .................. 20 

11.22 .............................. Specifications for laboratory semi-annual statistical report of test results to each federal agency. 10 5 0.5 ............... 25 

12.3(a) ............................ IITF1 submits qualifications of RT to HHS ............ 1 1 1 .................. 1 

12.4(c) ............................ IITF1 submits information to HHS on new RT or 

alternate RT. 

1 1 1 .................. 1 

12.19 .............................. Specifications for IITF 1 semi-annual statistical report of test results to each federal agency. 1 1 1 .................. 1 
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7934 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

ESTIMATE OF ANNUAL REPORTING BURDEN—Continued 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

13.9 and 14.7 ................. 

16.1(b) & 16.5(a) ............ 

16.4 ................................ 

16.6 ................................ 

16.7(a) ............................ 

16.9(a) ............................ 

16.9(c) ............................ 

Total ........................ 

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

Specifies content of request for informal review of 

suspension/proposed revocation of certification. 

Specifies information appellant provides in first 

written submission when laboratory suspension/revocation is proposed. 

Requires appellant to notify reviewing official of 

resolution status at end of abeyance period. 

Specifies contents of appellant submission for review. 

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

Specifies contents of review file and briefs .......... 

................................................................................ 

100 

1 

1 

1 

1 

1 

1 

14 

1 

1 

1 

1 

1 

1 

0.05 (3 min) 

3 .................. 

0.5 ............... 

0.5 ............... 

50 ................ 

3 .................. 

50 ................ 

70 

3 

0.5 

0.5 

50 

3 

50 

159 ........................ ..................... 295 

1 Although IITFs are allowed under the Guidelines effective October 1, 2010 (73 FR 71858), SAMHSA has not received any IITF applications 

for certification to test federally regulated specimens. IITF numbers are provided in this analysis as placeholders for administrative purposes. 

The following reporting requirements [Section 10.3(a)]; MRO notifies the actions an MRO takes for the medical 

are also in the Guidelines, but have not federal agency and HHS when an error evaluation of a donor who cannot 

been addressed in the above reporting occurs on a blind sample [Section provide a urine specimen. SAMHSA has 

burden table: Collector must report any 10.4(c)]; Section 13.5 describes the not calculated a separate reporting 

unusual donor behavior or refusal to actions an MRO takes to report a burden for these requirements because 

participate in the collection process on primary specimen result; Section 14.6 they are included in the burden hours 

the Federal CCF [Sections 1.8, 8.9]; describes the actions an MRO takes to estimated for collectors to complete 

collector annotates the Federal CCF report a split specimen result; and Federal CCFs and for MROs to report 

when a sample is a blind sample Sections 13.6 and 13.7 describe the 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). 

11.23, 11.24 ................... 

12.20, 12.21 ................... 

13.8(b) ............................ 

Collector must contact federal agency point of 

contact. 

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

donor through MRO. 

Information on drug test that IITF1 must provide 

to federal agency upon request or to donor 

through MRO. 

MRO must inform donor of right to request split 

specimen test when a positive, adulterated, or 

substituted result is reported. 

100 

50 

1 

100 

1 

10 

1 

14 

0.05 (3 min) 

3 .................. 

1 .................. 

3 .................. 

5 

1,500 

1 

4,200 

Total ........................ ................................................................................ 211 ........................ ..................... 5,706 

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

The following disclosure The collector must explain the basic collector explain the collection 

requirements are also included in the collection procedure to the donor and procedure to the donor and answer any 

Guidelines, but have not been addressed answer any questions [Section 8.3(e) questions is a standard business practice 

in the above disclosure burden table: and (g)]. SAMHSA believes having the 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 .................... 

8.8(d) & (f) ...................... 

Collector completes Federal CCF for specimen 

collected. 

Donor initials specimen labels/seals and signs 

statement on the Federal CCF. 

100 

38,000 

380 

1 

0.07 (4 min) 

0.08 (5 min) 

2,534 

3,167 
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7935 

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN—Continued 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

11.8(a) & 11.19 .............. 

12.8(a) & 12.15 .............. 

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

14.1(b) ............................ 

Laboratory completes Federal CCF upon receipt 

of specimen and before reporting result. 

IITF1 completes Federal CCF upon receipt of 

specimen and before reporting result. 

MRO completes Federal CCF before reporting 

the primary or split specimen result. 

MRO documents donor’s request to have split 

specimen tested. 

10 

1 

100 

300 

3,800 

1 

380 

1 

0.05 (3 min) 

1 .................. 

0.05 (3 min) 

0.05 (3 min) 

1,900 

1 

1,900 

15 

Total ............................... ................................................................................ 38,511 ........................ ..................... 9,517 

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

The Guidelines contain a number of 

recordkeeping requirements that 

SAMHSA considers not to be an 

additional recordkeeping burden. In 

subpart D, a trainer is required to 

document the training of an individual 

to be a collector [Section 4.3(a)(3)] and 

the documentation must be maintained 

in the collector’s training file [Section 

4.3(c)]. Because this is required by the 

current Guidelines and is consistent 

with general forensic requirements, 

SAMHSA believes this training 

documentation is common practice and 

is not considered an additional burden. 

In subpart F, if a collector uses an 

incorrect form to collect a federal 

agency specimen, the collector is 

required to provide a statement [Section 

6.2(b)] explaining why an incorrect form 

was used to document collecting the 

specimen. SAMHSA believes this is an 

extremely infrequent occurrence and 

does not create a significant additional 

recordkeeping burden. Subpart H 

[Sections 8.4(c), 8.5(d)(2), 8.5(e)(1) and 

(2)] requires collectors to enter any 

information on the Federal CCF of any 

unusual findings during the urine 

specimen collection procedure. These 

recordkeeping requirements are an 

integral part of the collection procedure 

and are essential to documenting the 

chain of custody for the specimens 

collected. The burden for these entries 

are included in the recordkeeping 

burden estimated to complete the 

Federal CCF and is, therefore, not 

considered an additional recordkeeping 

burden. Subpart K describes a number 

of recordkeeping requirements for 

laboratories associated with their testing 

procedures, maintaining chain of 

custody, and keeping records [i.e., 

Sections 11.1(a) and (d); 11.2(b), (c), and 

(d); 11.6(b); 11.7(c); 11.8; 11.11(a); 

11.14(a); 11.17; 11.21(a), (b), and (c); 

11.22; 11.23(a) and 11.24. These 

recordkeeping requirements are 

necessary for any laboratory to conduct 

forensic drug testing and to ensure the 

scientific supportability of the test 

results. Therefore, they are considered 

to be standard business practice and are 

not considered a burden for this 

analysis. 

Thus the total annual response 

burden associated with the testing of 

urine specimens by the laboratories and 

IITFs is estimated to be 15,518 hours 

(that is, the sum of the total hours from 

the above tables). This is in addition to 

the 1,788,809 hours currently approved 

by OMB under control number 0930– 

0158 for urine testing under the current 

Guidelines. 

As required by section 3507(d) of the 

PRA, the Secretary submitted a copy of 

these proposed Guidelines to OMB for 

its review. Comments on the 

information collection requirements 

were specifically solicited in order to: 

(1) Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of HHS’s 

functions, including whether the 

information will have practical utility; 

(2) evaluate the accuracy of HHS’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) enhance the 

quality, utility, and clarity of the 

information to be collected; and (4) 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

References 

1. Cone, E.J., Heltsley, R., Black, D.L., 

Mitchell, J.M., LoDico, C.P., Flegel, R.R, 

2013. Prescription opioids. I. metabolism 

and excretion patterns of oxycodone in 

urine following controlled single dose 

administration. J. Anal. Toxicol, 37, 255– 

264. 

2. Cone, E.J., Heltsley. R., Black, D.L., 

Mitchell, J.M., LoDico, C.P., Flegel, R.R, 

2013. Prescription opioids. II. 

metabolism and excretion patterns of 

hydrocodone in urine following 

controlled single dose administration. J. 

Anal. Toxicol, 37, 486–494. 

3. Esposito, F.M., Mitchell, J.M., Baylor, 

M.R., Bush, D.M, 2006. Influence of basic 

pH on federal regulated drugs in urine at 

room temperature. Poster presented at 

the Society of Forensic Toxicologists 

(SOFT) Annual Meeting, Austin, TX. 

October 2006. 

4. Cone, E.J., Bigelow, G.E., Herrmann, E.S., 

Mitchell, J.M., LoDico, C., Flegel, R., 

Vandrey, R, 2015. Nonsmoker exposure 

to secondhand cannabis smoke. III. oral 

fluid and blood concentrations and 

corresponding subjective effects. J. Anal. 

Toxicol, 39, 497–509. 

5. Hermann, E.S, Cone, E.J., Mitchell, J.M., 

Bigelow, G.E., LoDico, C., Flegel, R., 

Vandrey, R., 2016. Non-smoker exposure 

to secondhand cannabis smoke II: Effect 

of room ventilation on the physiological, 

subjective, and behavioral/cognitive 

effects. Drug alcohol depend, 151, 194– 

202. 

Dated: January 11, 2017. 

Kana Enomoto, 

Acting Deputy Assistant Secretary for Mental 

Health and Substance Use, SAMHSA. 

Dated: January 11, 2017. 

Sylvia M. Burwell 

Secretary. 

The Mandatory Guidelines using 

Urine Specimens as revised are hereby 

adopted in accordance with section 503 

of Public Law 100–71 and Executive 

Order 12564. 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

Using Urine Specimens 

Subpart A—Applicability 

1.1 To whom do these Guidelines apply? 

1.2 Who is responsible for developing and 

implementing these Guidelines? 

1.3 How does a federal agency request a 

change from these Guidelines? 

1.4 How are these Guidelines revised? 

1.5 What do the terms used in these 

Guidelines mean? 

1.6 What is an agency required to do to 

protect employee records? 
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7936 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

1.7 What is a refusal to take a federally 

regulated drug test? 

1.8 What are the potential consequences for 

refusing to take a federally regulated 

drug test? 

Subpart B—Urine Specimens 

2.1 What type of specimen may be 

collected? 

2.2 Under what circumstances may a urine 

specimen be collected? 

2.3 How is each urine specimen collected? 

2.4 What volume of urine is collected? 

2.5 How does the collector split the urine 

specimen? 

2.6 When may an entity or individual 

release a urine specimen? 

Subpart C—Urine Specimen Tests 

3.1 Which tests are conducted on a urine 

specimen? 

3.2 May a specimen be tested for additional 

drugs? 

3.3 May any of the specimens be used for 

other purposes? 

3.4 What are the drug test cutoff 

concentrations for urine? 

3.5 May an HHS-certified laboratory 

perform additional drug and/or 

specimen validity tests on a specimen at 

the request of the Medical Review 

Officer (MRO)? 

3.6 What criteria are used to report a urine 

specimen as adulterated? 

3.7 What criteria are used to report a urine 

specimen as substituted? 

3.8 What criteria are used to report a urine 

specimen as dilute? 

3.9 What criteria are used to report an 

invalid result for a urine specimen? 

Subpart D—Collectors 

4.1 Who may collect a specimen? 

4.2 Who may not collect a specimen? 

4.3 What are the requirements to be a 

collector? 

4.4 What are the requirements to be an 

observer for a direct observed collection? 

4.5 What are the requirements to be a 

trainer for collectors? 

4.6 What must a federal agency do before a 

collector is permitted to collect a 

specimen? 

Subpart E—Collection Sites 

5.1 Where can a collection for a drug test 

take place? 

5.2 What are the requirements for a 

collection site? 

5.3 Where must collection site records be 

stored? 

5.4 How long must collection site records 

be stored? 

5.5 How does the collector ensure the 

security and integrity of a specimen at 

the collection site? 

5.6 What are the privacy requirements 

when collecting a urine specimen? 

Subpart F—Federal Drug Testing Custody 

and Control Form 

6.1 What federal form is used to document 

custody and control? 

6.2 What happens if the correct OMBapproved Federal CCF is not available or 

is not used? 

Subpart G—Urine Specimen Collection 

Containers and Bottles 

7.1 What is used to collect a urine 

specimen? 

7.2 What are the requirements for a urine 

collection container and specimen 

bottles? 

7.3 What are the minimum performance 

requirements for a urine collection 

container and specimen bottles? 

Subpart H—Urine Specimen Collection 

Procedure 

8.1 What privacy must the donor be given 

when providing a urine specimen? 

8.2 What must the collector ensure at the 

collection site before starting a urine 

specimen collection? 

8.3 What are the preliminary steps in the 

urine specimen collection procedure? 

8.4 What steps does the collector take in the 

collection procedure before the donor 

provides a urine specimen? 

8.5 What steps does the collector take 

during and after the urine specimen 

collection procedure? 

8.6 What procedure is used when the donor 

states that they are unable to provide a 

urine specimen? 

8.7 If the donor is unable to provide a urine 

specimen, may another specimen type be 

collected for testing? 

8.8 How does the collector prepare the 

urine specimens? 

8.9 When is a direct observed collection 

conducted? 

8.10 How is a direct observed collection 

conducted? 

8.11 When is a monitored collection 

conducted? 

8.12 How is a monitored collection 

conducted? 

8.13 How does the collector report a 

donor’s refusal to test? 

8.14 What are a federal agency’s 

responsibilities for a collection site? 

Subpart I—HHS Certification of Laboratories 

and IITFs 

9.1 Who has the authority to certify 

laboratories and IITFs to test urine 

specimens for federal agencies? 

9.2 What is the process for a laboratory or 

IITF to become HHS-certified? 

9.3 What is the process for a laboratory or 

IITF to maintain HHS certification? 

9.4 What is the process when a laboratory 

or IITF does not maintain its HHS 

certification? 

9.5 What are the qualitative and 

quantitative specifications of 

performance testing (PT) samples? 

9.6 What are the PT requirements for an 

applicant laboratory? 

9.7 What are the PT requirements for an 

HHS-certified urine laboratory? 

9.8 What are the PT requirements for an 

applicant IITF? 

9.9 What are the PT requirements for an 

HHS-certified IITF? 

9.10 What are the inspection requirements 

for an applicant laboratory or IITF? 

9.11 What are the maintenance inspection 

requirements for an HHS-certified 

laboratory or IITF? 

9.12 Who can inspect an HHS-certified 

laboratory or IITF and when may the 

inspection be conducted? 

9.13 What happens if an applicant 

laboratory or IITF does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

9.14 What happens if an HHS-certified 

laboratory or IITF does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

9.15 What factors are considered in 

determining whether revocation of a 

laboratory’s or IITF’s HHS certification is 

necessary? 

9.16 What factors are considered in 

determining whether to suspend a 

laboratory’s or an IITF’s HHS 

certification? 

9.17 How does the Secretary notify an HHScertified 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 HHScertified 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 HHScertified 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 
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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 HHScertified 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 HHScertified 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/preemployment 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 HHScertified 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 HHScertified laboratory or an HHS-certified 

IITF to report a specimen as rejected for 

testing? 

15.2 What discrepancies require an HHScertified 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 
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(7) Medical Review Officers (MROs) 

who provide drug testing review and 

interpretation of results services to the 

federal agencies. 

(b) These Guidelines do not apply to 

drug testing under authority other than 

Executive Order 12564, including 

testing of persons in the criminal justice 

system, such as arrestees, detainees, 

probationers, incarcerated persons, or 

parolees.1 

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. 

1 The NRC-related information in this notice 

pertains to individuals subject to drug testing 

conducted pursuant to 10 CFR part 26, ‘‘Fitness for 

Duty Programs’’ (i.e., employees of certain NRCregulated 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 1.5 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 HHScertified 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 HHScertified 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 HHScertified 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 HHScertified IITF. 

Chain of Custody (COC) Procedures. 

Procedures that document the integrity 

of each specimen or aliquot from the 

point of collection to final disposition. 

Chain of Custody Documents. Forms 

used to document the control and 

security of the specimen and all 

aliquots. The document may account for 

an individual specimen, aliquot, or 

batch of specimens/aliquots and must 

include the name and signature of each 

individual who handled the specimen(s) 

or aliquot(s) and the date and purpose 

of the handling. 

Collection Container. A receptacle 

used to collect a urine specimen. 

Collection Site. The location where 

specimens are collected. 

Collector. A person trained to instruct 

and assist a donor in providing a 

specimen. 

Confirmatory Drug Test. A second 

analytical procedure performed on a 

separate aliquot of a specimen to 

identify and quantify a specific drug or 

drug metabolite. 

Confirmatory Specimen Validity Test. 

A second test performed on a separate 

aliquot of a specimen to further support 

a specimen validity test result. 

Control. A sample used to evaluate 

whether an analytical procedure or test 

is operating within predefined tolerance 

limits. 

Cutoff. The analytical value (e.g., drug 

or drug metabolite concentration) used 

as the decision point to determine a 

result (e.g., negative, positive, 

adulterated, invalid, or, for urine, 

substituted) or the need for further 

testing. 

Dilute Specimen. A urine specimen 

with creatinine and specific gravity 

values that are lower than expected but 

are still within the physiologically 

producible ranges of human urine. 

Donor. The individual from whom a 

specimen is collected. 

External Service Provider. An 

independent entity that performs 

services related to federal workplace 

drug testing on behalf of a federal 

agency, a collector/collection site, an 
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HHS-certified laboratory, a Medical 

Review Officer (MRO), or, for urine, an 

HHS-certified Instrumented Initial Test 

Facility (IITF). 

Failed to Reconfirm. The result 

reported for a split (B) specimen when 

a second HHS-certified laboratory is 

unable to corroborate the result reported 

for the primary (A) specimen. 

Federal Drug Testing Custody and 

Control Form (Federal CCF). The Office 

of Management and Budget (OMB) 

approved form that is used to document 

the collection and chain of custody of a 

specimen from the time the specimen is 

collected until it is received by the test 

facility (i.e., HHS-certified laboratory or, 

for urine, HHS-certified IITF). It may be 

a paper (hardcopy), electronic, or 

combination electronic and paper 

format (hybrid). The form may also be 

used to report the test result to the 

Medical Review Officer. 

Gender Identity. Gender identity 

means an individual’s internal sense of 

being male or female, which may be 

different from an individual’s sex 

assigned at birth. 

HHS. The Department of Health and 

Human Services. 

Initial Drug Test. An analysis used to 

differentiate negative specimens from 

those requiring further testing. 

Initial Specimen Validity Test. The 

first analysis used to determine if a 

specimen is invalid, adulterated, or (for 

urine) diluted or substituted. 

Instrumented Initial Test Facility 

(IITF). A permanent location where (for 

urine) initial testing, reporting of 

results, and recordkeeping are 

performed under the supervision of a 

responsible technician. 

Invalid Result. The result reported by 

an HHS-certified laboratory in 

accordance with the criteria established 

in Section 3.9 when a positive, negative, 

adulterated, or substituted result cannot 

be established for a specific drug or 

specimen validity test. 

Laboratory. A permanent location 

where initial and confirmatory drug 

testing, reporting of results, and 

recordkeeping are performed under the 

supervision of a responsible person. 

Limit of Detection. The lowest 

concentration at which the analyte (e.g., 

drug or drug metabolite) can be 

identified. 

Limit of Quantification. For 

quantitative assays, the lowest 

concentration at which the identity and 

concentration of the analyte (e.g., drug 

or drug metabolite) can be accurately 

established. 

Lot. A number of units of an item 

(e.g., reagents, quality control material) 

manufactured from the same starting 

materials within a specified period of 

time for which the manufacturer 

ensures that the items have essentially 

the same performance characteristics 

and expiration date. 

Medical Review Officer (MRO). A 

licensed physician who reviews, 

verifies, and reports a specimen test 

result to the federal agency. 

Negative Result. The result reported 

by an HHS-certified laboratory or (for 

urine) an HHS-certified IITF to an MRO 

when a specimen contains no drug and/ 

or drug metabolite; or the concentration 

of the drug or drug metabolite is less 

than the cutoff for that drug or drug 

class. 

Oral Fluid Specimen. An oral fluid 

specimen is collected from the donor’s 

oral cavity and is a combination of 

physiological fluids produced primarily 

by the salivary glands. 

Oxidizing Adulterant. A substance 

that acts alone or in combination with 

other substances to oxidize drug or drug 

metabolites to prevent the detection of 

the drugs or drug metabolites, or affects 

the reagents in either the initial or 

confirmatory drug test. 

Performance Testing (PT) Sample. A 

program-generated sample sent to a 

laboratory or (for urine) to an IITF to 

evaluate performance. 

Positive Result. The result reported by 

an HHS-certified laboratory when a 

specimen contains a drug or drug 

metabolite equal to or greater than the 

confirmation cutoff concentration. 

Reconfirmed. The result reported for 

a split (B) specimen when the second 

HHS-certified laboratory corroborates 

the original result reported for the 

primary (A) specimen. 

Rejected for Testing. The result 

reported by an HHS-certified laboratory 

or (for urine) HHS-certified IITF when 

no tests are performed on a specimen 

because of a fatal flaw or an 

unrecovered correctable error (see 

Sections 15.1 and 15.2). 

Responsible Person (RP). The person 

who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of an HHScertified laboratory. 

Responsible Technician (RT). The 

person who assumes professional, 

organizational, educational, and 

administrative responsibility for the 

day-to-day management of an HHScertified IITF. 

Sample. A performance testing 

sample, calibrator or control used 

during testing, or a representative 

portion of a donor’s specimen. 

Secretary. The Secretary of the U.S. 

Department of Health and Human 

Services. 

Specimen. Fluid or material collected 

from a donor at the collection site for 

the purpose of a drug test. 

Split Specimen Collection (for Urine). 

A collection in which the specimen 

collected is divided into a primary (A) 

specimen and a split (B) specimen, 

which are independently sealed in the 

presence of the donor. 

Standard. Reference material of 

known purity or a solution containing a 

reference material at a known 

concentration. 

Substituted Specimen. A specimen 

that has been submitted in place of the 

donor’s urine, as evidenced by 

creatinine and specific gravity values 

that are outside the physiologically 

producible ranges of human urine. 

Section 1.6 What is an agency required 

to do to protect employee records? 

Consistent with 5 U.S.C. 552a and 48 

CFR 24.101–24.104, all agency contracts 

with laboratories, IITFs, collectors, and 

MROs must require that they comply 

with the Privacy Act, 5 U.S.C. 552a. In 

addition, the contracts must require 

compliance with employee access and 

confidentiality provisions of Section 

503 of Public Law 100–71. Each federal 

agency must establish a Privacy Act 

System of Records or modify an existing 

system or use any applicable 

Government-wide system of records to 

cover the records of employee drug test 

results. All contracts and the Privacy 

Act System of Records must specifically 

require that employee records be 

maintained and used with the highest 

regard for employee privacy. 

The Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

Privacy Rule (Rule), 45 CFR parts 160 

and 164, Subparts A and E, may be 

applicable to certain health care 

providers with whom a federal agency 

may contract. If a health care provider 

is a HIPAA covered entity, the provider 

must protect the individually 

identifiable health information it 

maintains in accordance with the 

requirements of the Rule, which 

includes not using or disclosing the 

information except as permitted by the 

Rule and ensuring there are reasonable 

safeguards in place to protect the 

privacy of the information. For more 

information regarding the HIPAA 

Privacy Rule, please visit http:// 

www.hhs.gov/ocr/hipaa. 

Section 1.7 What is a refusal to take a 

federally regulated drug test? 

(a) As a donor for a federally regulated 

drug test, you have refused to take a 

federally regulated drug test if you: 

(1) Fail to appear for any test (except 

a pre-employment test) within a 
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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 preemployment test as described in section 

8.4(a); 

(3) Fail to provide a specimen (e.g., 

urine or another authorized specimen 

type) for any drug test required by these 

Guidelines or federal agency regulations 

with the exception of a donor who 

leaves the collection site before the 

collection process begins for a preemployment test as described in section 

8.4(a); 

(4) In the case of a direct observed or 

monitored collection, fail to permit the 

observation or monitoring of your 

provision of a specimen when required 

as described in Sections 8.9 and 8.10; 

(5) Fail to provide a sufficient amount 

of urine when directed, and it has been 

determined, through a required medical 

evaluation, that there was no legitimate 

medical explanation for the failure as 

determined by the process described in 

Section 13.6; 

(6) Fail or decline to participate in an 

alternate specimen collection (e.g., oral 

fluid) as directed by the federal agency 

or collector (i.e., as described in Section 

8.6); 

(7) Fail to undergo a medical 

examination or evaluation, as directed 

by the MRO as part of the verification 

process (i.e., Section 13.6) or as directed 

by the federal agency. In the case of a 

federal agency applicant/preemployment drug test, the donor is 

deemed to have refused to test on this 

basis only if the federal agency 

applicant/pre-employment test is 

conducted following a contingent offer 

of employment. If there was no 

contingent offer of employment, the 

MRO will cancel the test; 

(8) Fail to cooperate with any part of 

the testing process (e.g., refuse to empty 

pockets when directed by the collector, 

disrupt the collection process, fail to 

wash hands after being directed to do so 

by the collector); 

(9) For an observed collection, fail to 

follow the observer’s instructions 

related to the collection process; 

(10) Bring materials to the collection 

site for the purpose of adulterating, 

substituting, or diluting the specimen; 

(11) Attempt to adulterate, substitute, 

or dilute the specimen; 

(12) Possess or wear a prosthetic or 

other device that could be used to 

interfere with the collection process; or 

(13) Admit to the collector or MRO 

that you have adulterated or substituted 

the specimen. 

Section 1.8 What are the potential 

consequences for refusing to take a 

federally regulated drug test? 

(a) As a federal agency employee or 

applicant, a refusal to take a test may 

result in the initiation of disciplinary or 

adverse action, up to and including 

removal from, or non-selection for, 

federal employment. 

(b) When a donor has refused to 

participate in a part of the collection 

process, including failing to appear in a 

reasonable time for any test except a 

pre-employment test as described in 

Section 1.7(a)(1), the collector must 

terminate the collection process and 

take action as described in Section 8.13. 

Required action includes immediately 

notifying the federal agency’s 

designated representative by any means 

(e.g., telephone or secure fax machine) 

that ensures that the refusal notification 

is immediately received and, if a 

Federal CCF has been initiated, 

documenting the refusal on the Federal 

CCF, signing and dating the Federal 

CCF, and sending all copies of the 

Federal CCF to the federal agency’s 

designated representative. 

(c) When documenting a refusal to 

test during the verification process as 

described in Sections 13.4, 13.5, and 

13.6, the MRO must complete the MRO 

copy of the Federal CCF to include: 

(1) Checking the refusal to test box; 

(2) Providing a reason for the refusal 

in the remarks line; and 

(3) Signing and dating the MRO copy 

of the Federal CCF. 

Subpart B—Urine Specimens 

Section 2.1 What type of specimen 

may be collected? 

A federal agency may collect urine 

and/or an alternate specimen type for its 

workplace drug testing program. Only 

specimen types authorized by 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs may 

be collected. An agency using urine 

must follow these Guidelines. 

Section 2.2 Under what circumstances 

may a urine specimen be collected? 

A federal agency may collect a urine 

specimen for the following reasons: 

(a) Federal agency applicant/Preemployment test; 

(b) Random test; 

(c) Reasonable suspicion/cause test; 

(d) Post accident test; 

(e) Return to duty test; or 

(f) Follow-up test. 

Section 2.3 How is each urine 

specimen collected? 

Each urine specimen is collected as a 

split specimen as described in Section 

2.5. 

Section 2.4 What volume of urine is 

collected? 

A donor is expected to provide at 

least 45 mL of urine for a specimen. 

Section 2.5 How does the collector 

split the urine specimen? 

The collector pours at least 30 mL 

into a specimen bottle that is designated 

as A (primary) and then pours at least 

15 mL into a specimen bottle that is 

designated as B (split). 

Section 2.6 When may an entity or 

individual release a urine specimen? 

Entities and individuals subject to 

these Guidelines under Section 1.1 may 

not release specimens collected 

pursuant to Executive Order 12564, 

Public Law 100–71, and these 

Guidelines to donors or their designees. 

Specimens also may not be released to 

any other entity or individual unless 

expressly authorized by these 

Guidelines or by applicable federal law. 

This section does not prohibit a donor’s 

request to have a split (B) specimen 

tested in accordance with Section 13.8. 

Subpart C—Urine Drug and Specimen 

Validity Tests 

Section 3.1 Which tests are conducted 

on a urine specimen? 

A federal agency: 

(a) Must ensure that each specimen is 

tested for marijuana and cocaine 

metabolites as provided under Section 

3.4; 

(b) Is authorized to test each specimen 

for opioids, amphetamines, and 

phencyclidine, as provided under 

Section 3.4; and 

(c) Must ensure that the following 

specimen validity tests are conducted 

on each urine specimen: 

(1) Determine the creatinine 

concentration on every specimen; 

(2) Determine the specific gravity on 

every specimen for which the creatinine 

concentration is less than 20 mg/dL; 

(3) Determine the pH on every 

specimen; and 

(4) Perform one or more specimen 

validity tests for oxidizing adulterants 

on every specimen. 

(d) If a specimen exhibits abnormal 

characteristics (e.g., unusual odor or 

color, semi-solid characteristics), causes 

reactions or responses characteristic of 

an adulterant during initial or 

confirmatory drug tests (e.g., nonrecovery of internal standard, unusual 
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response), or contains an unidentified 

substance that interferes with the 

confirmatory analysis, then additional 

testing may be performed. 

Section 3.2 May a specimen be tested 

for additional drugs? 

(a) On a case-by-case basis, a 

specimen may be tested for additional 

drugs, if a federal agency is conducting 

the collection for reasonable suspicion 

or post accident testing. A specimen 

collected from a federal agency 

employee may be tested by the federal 

agency for any drugs listed in Schedule 

I or II of the Controlled Substances Act. 

The federal agency must request the 

HHS-certified laboratory to test for the 

additional drug, include a justification 

to test a specific specimen for the drug, 

and ensure that the HHS-certified 

laboratory has the capability to test for 

the drug and has established properly 

validated initial and confirmatory 

analytical methods. If an initial test 

procedure is not available upon request 

for a suspected Schedule I or Schedule 

II drug, the federal agency can request 

an HHS-certified laboratory to test for 

the drug by analyzing two separate 

aliquots of the specimen in two separate 

testing batches using the confirmatory 

analytical method. Additionally, the 

split (B) specimen will be available for 

testing if the donor requests a retest at 

another HHS-certified laboratory. 

(b) A federal agency covered by these 

Guidelines must petition the Secretary 

in writing for approval to routinely test 

for any drug class not listed in Section 

3.1. Such approval must be limited to 

the use of the appropriate science and 

technology and must not otherwise limit 

agency discretion to test for any drug 

tested under paragraph (a) of this 

section. 

Section 3.3 May any of the specimens 

be used for other purposes? 

(a) Specimens collected pursuant to 

Executive Order 12564, Public Law 

100–71, and these Guidelines must only 

be tested for drugs and to determine 

their validity in accordance with 

Subpart C of these Guidelines. Use of 

specimens by donors, their designees, or 

any other entity, for other purposes (e.g., 

deoxyribonucleic acid, DNA, testing) is 

prohibited unless authorized in 

accordance with applicable federal law. 

(b) These Guidelines are not intended 

to prohibit federal agencies specifically 

authorized by law to test a specimen for 

additional classes of drugs in its 

workplace drug testing program. 

Section 3.4 What are the drug test 

cutoff concentrations for urine? 

Initial test analyte Initial test cutoff 1 Confirmatory test analyte Confirmatory test 

cutoff concentration 

Marijuana metabolites (THCA) 2 .... 50 ng/mL 3 .................................... THCA ............................................ 15 ng/mL. 

Cocaine metabolite 

(Benzoylecgonine). 

150 ng/mL 3 .................................. Benzoylecgonine .......................... 100 ng/mL. 

Codeine/Morphine .......................... 2,000 ng/mL .................................. Codeine ........................................ 2,000 ng/mL. 

Morphine ....................................... 2,000 ng/mL. 

Hydrocodone/Hydromorphone ....... 300 ng/mL ..................................... Hydrocodone ................................ 100 ng/mL. 

Hydromorphone ............................ 100 ng/mL. 

Oxycodone/Oxymorphone ............. 100 ng/mL ..................................... Oxycodone .................................... 100 ng/mL. 

Oxymorphone ............................... 100 ng/mL. 

6-Acetylmorphine ........................... 10 ng/mL ....................................... 6-Acetylmorphine .......................... 10 ng/mL. 

Phencyclidine ................................. 25 ng/mL ....................................... Phencyclidine ................................ 25 ng/mL. 

Amphetamine/Methamphetamine .. 500 ng/mL ..................................... Amphetamine ................................ 250 ng/mL. 

Methamphetamine ........................ 250 ng/mL. 

MDMA 4/MDA 5 ............................... 500 ng/mL ..................................... MDMA ........................................... 250 ng/mL. 

MDA .............................................. 250 ng/mL. 

1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): 

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross-reactivity of the 

immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the 

analytes within the group. 

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one 

analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present 

(i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff. 2 An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 3 Alternate technology (THCA and benzoylecgonine): The confirmatory test cutoff must be used for an alternate technology initial test that is 

specific for the target analyte (i.e., 15 ng/mL for THCA, 100 ng/mL for benzoylecgonine). 4 Methylenedioxymethamphetamine (MDMA). 

5 Methylenedioxyamphetamine (MDA). 

Section 3.5 May an HHS-certified validity tests at the request of an MRO (a) The pH is less than 4 or equal to 

laboratory perform additional drug and/ without prior authorization from the or greater than 11 using either a pH 

or specimen validity tests on a specimen Secretary or designated HHS meter or a colorimetric pH test for the 

at the request of the Medical Review representative, with the exception of the initial test on the first aliquot and a pH Officer (MRO)? determination of D,L stereoisomers of meter for the confirmatory test on the 

An HHS-certified laboratory is amphetamine and methamphetamine. second aliquot; All tests must meet appropriate authorized to perform additional drug (b) The nitrite concentration is equal validation and quality control and/or specimen validity tests on a case- to or greater than 500 mcg/mL using requirements in accordance with these by-case basis as necessary to provide either a nitrite colorimetric test or a Guidelines. information that the MRO would use to general oxidant colorimetric test for the report a verified drug test result (e.g., Section 3.6 What criteria are used to initial test on the first aliquot and a tetrahydrocannabivarin, specimen report a urine specimen as adulterated? different confirmatory test (e.g., multi- validity tests using biomarkers). An wavelength spectrophotometry, ion HHS-certified laboratory is not An HHS-certified laboratory reports a chromatography, capillary authorized to routinely perform primary (A) specimen as adulterated electrophoresis) on the second aliquot; additional drug and/or specimen when: 
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(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 nitriteequivalent 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., multiwavelength 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 nitriteequivalent cutoff or an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., GC/MS) for the confirmatory test 

with the pyridine concentration equal to 

or greater than the LOQ of the analysis 

on the second aliquot; 

(g) The presence of a surfactant is 

verified by using a surfactant 

colorimetric test with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry) with an equal to or 

greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff on the second aliquot; or 

(h) The presence of any other 

adulterant not specified in paragraphs 

(b) through (g) of this section is verified 

using an initial test on the first aliquot 

and a different confirmatory test on the 

second aliquot. 

Section 3.7 What criteria are used to 

report a urine specimen as substituted? 

An HHS-certified laboratory reports a 

primary (A) specimen as substituted 

when the creatinine concentration is 

less than 2 mg/dL on both the initial 

and confirmatory creatinine tests on two 

separate aliquots (i.e., the same 

colorimetric test may be used to test 

both aliquots) and the specific gravity is 

less than or equal to 1.0010 or equal to 

or greater than 1.0200 on both the initial 

and confirmatory specific gravity tests 

on two separate aliquots (i.e., a 

refractometer is used to test both 

aliquots). 

Section 3.8 What criteria are used to 

report a urine specimen as dilute? 

A dilute result may be reported only 

in conjunction with the positive or 

negative drug test results for a 

specimen. 

(a) An HHS-certified laboratory or an 

HHS-certified IITF reports a primary (A) 

specimen as dilute when the creatinine 

concentration is greater than 5 mg/dL 

but less than 20 mg/dL and the specific 

gravity is equal to or greater than 1.002 

but less than 1.003 on a single aliquot. 

(b) In addition, an HHS-certified 

laboratory reports a primary (A) 

specimen as dilute when the creatinine 

concentration is equal to or greater than 

2 mg/dL but less than 20 mg/dL and the 

specific gravity is greater than 1.0010 

but less than 1.0030. 

Section 3.9 What criteria are used to 

report an invalid result for a urine 

specimen? 

An HHS-certified laboratory reports a 

primary (A) specimen as an invalid 

result when: 

(a) Inconsistent creatinine 

concentration and specific gravity 

results are obtained (i.e., the creatinine 

concentration is less than 2 mg/dL on 

both the initial and confirmatory 

creatinine tests and the specific gravity 

is greater than 1.0010 but less than 

1.0200 on the initial and/or 

confirmatory specific gravity test, the 

specific gravity is less than or equal to 

1.0010 on both the initial and 

confirmatory specific gravity tests and 

the creatinine concentration is equal to 

or greater than 2 mg/dL on either or 

both the initial or confirmatory 

creatinine tests); 

(b) The pH is equal to or greater than 

4 and less than 4.5 or equal to or greater 

than 9 and less than 11 using either a 

colorimetric pH test or pH meter for the 

initial test and a pH meter for the 

confirmatory test on two separate 

aliquots; 

(c) The nitrite concentration is equal 

to or greater than 200 mcg/mL using a 

nitrite colorimetric test or equal to or 

greater than the equivalent of 200 mcg/ 

mL nitrite using a general oxidant 

colorimetric test for both the initial 

(first) test and the second test or using 

either initial test and the nitrite 

concentration is equal to or greater than 

200 mcg/mL but less than 500 mcg/mL 

for a different confirmatory test (e.g., 

multi-wavelength spectrophotometry, 

ion chromatography, capillary 

electrophoresis) on two separate 

aliquots; 

(d) The possible presence of 

chromium (VI) is determined using the 

same chromium (VI) colorimetric test 

with a cutoff equal to or greater than 50 

mcg/mL chromium (VI) for both the 

initial (first) test and the second test on 

two separate aliquots; 

(e) The possible presence of a halogen 

(e.g., bleach, iodine, fluoride) is 

determined using the same halogen 

colorimetric test with a cutoff equal to 

or greater than the LOQ for both the 

initial (first) test and the second test on 

two separate aliquots or relying on the 

odor of the specimen as the initial test; 

(f) The possible presence of 

glutaraldehyde is determined by using 

the same aldehyde test (aldehyde 

present) or characteristic immunoassay 

response on one or more drug 

immunoassay tests for both the initial 

(first) test and the second test on two 

separate aliquots; 

(g) The possible presence of an 

oxidizing adulterant is determined by 

using the same general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent 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 
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the second test on two separate aliquots 

or a foam/shake test for the initial test; 

(i) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid immunoassay or alternate 

technology initial drug test results 

cannot be obtained); 

(j) Interference with the drug 

confirmatory assay occurs on two 

separate aliquots of the specimen and 

the laboratory is unable to identify the 

interfering substance; 

(k) The physical appearance of the 

specimen (e.g., viscosity) is such that 

testing the specimen may damage the 

laboratory’s instruments; or 

(l) The specimen has been tested and 

the appearances of the primary (A) and 

the split (B) specimens (e.g., color) are 

clearly different; or 

(m) The concentration of a biomarker 

is not consistent with that established 

for human urine for both the initial 

(first) test and the second test on two 

separate aliquots. 

Subpart D—Collectors 

Section 4.1 Who may collect a 

specimen? 

(a) A collector who has been trained 

to collect urine specimens in 

accordance with these Guidelines. 

(b) The immediate supervisor of a 

federal employee donor may only 

collect that donor’s specimen when no 

other collector is available. The 

supervisor must be a trained collector. 

(c) The hiring official of a federal 

agency applicant may only collect that 

federal agency applicant’s specimen 

when no other collector is available. 

The hiring official must be a trained 

collector. 

Section 4.2 Who may not collect a 

specimen? 

(a) A federal agency employee who is 

in a testing designated position and 

subject to the federal agency drug 

testing rules must not be a collector for 

co-workers in the same testing pool or 

who work together with that employee 

on a daily basis. 

(b) A federal agency applicant or 

employee must not collect their own 

drug testing specimen. 

(c) An employee working for an HHScertified 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., 

fiance ́e). 

Section 4.3 What are the requirements 

to be a collector? 

(a) An individual may serve as a 

collector if they fulfill the following 

conditions: 

(1) Is knowledgeable about the 

collection procedure described in these 

Guidelines; 

(2) Is knowledgeable about any 

guidance provided by the federal 

agency’s Drug-Free Workplace Program 

and additional information provided by 

the Secretary relating to these 

Guidelines; 

(3) Is trained and qualified to collect 

a urine specimen. Training must 

include the following: 

(i) All steps necessary to complete a 

urine collection; 

(ii) Completion and distribution of the 

Federal CCF; 

(iii) Problem collections; 

(iv) Fatal flaws, correctable flaws, and 

how to correct problems in collections; 

and 

(v) The collector’s responsibility for 

maintaining the integrity of the 

collection process, ensuring the privacy 

of the donor, ensuring the security of 

the specimen, and avoiding conduct or 

statements that could be viewed as 

offensive or inappropriate. 

(4) Has demonstrated proficiency in 

collections by completing five 

consecutive error-free mock collections. 

(i) The five mock collections must 

include one uneventful collection 

scenario, one insufficient specimen 

quantity scenario, one temperature out 

of range scenario, one scenario in which 

the donor refuses to sign the Federal 

CCF, and one scenario in which the 

donor refuses to initial the specimen 

bottle tamper-evident seal. 

(ii) A qualified trainer for collectors 

must monitor and evaluate the 

individual being trained, in person or by 

a means that provides real-time 

observation and interaction between the 

trainer and the trainee, and the trainer 

must attest in writing that the mock 

collections are error-free. 

(b) A trained collector must complete 

refresher training at least every five 

years that includes the requirements in 

paragraph (a) of this section. 

(c) The collector must maintain the 

documentation of their training and 

provide that documentation to a federal 

agency when requested. 

(d) An individual may not collect 

specimens for a federal agency until the 

individual’s training as a collector has 

been properly documented. 

Section 4.4 What are the requirements 

to be an observer for a direct observed 

collection? 

(a) An individual may serve as an 

observer for a direct observed collection 

when the individual has satisfied the 

requirements: 

(1) Is knowledgeable about the direct 

observed collection procedure described 

in Section 8.9 of these Guidelines; 

(2) Is knowledgeable about any 

guidance provided by the federal 

agency’s Drug-Free Workplace Program 

or additional information provided by 

the Secretary relating to the direct 

observed collection procedure described 

in these Guidelines; 

(3) Has received training on the 

following subjects: 

(i) All steps necessary to perform a 

direct observed collection; and 

(ii) The observer’s responsibility for 

maintaining the integrity of the 

collection process, ensuring the privacy 

of individuals being tested, ensuring 

that the observation is done in a 

professional manner that minimizes the 

discomfort to the employee so observed, 

ensuring the security of the specimen by 

maintaining visual contact with the 

collection container until it is delivered 

to the collector, and avoiding conduct or 

statements that could be viewed as 

offensive or inappropriate. 

(b) The gender of the observer must be 

the same as the donor’s gender, which 

is determined by the donor’s gender 

identity. The observer selection process 

is described in Section 8.10(b). 

(c) The observer is not required to be 

a trained collector. 

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 the 

trainer’s training and provide that 

documentation to a federal agency when 

requested. 
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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 selfemployed, 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 

(c) The collector has been provided 

the name and telephone number of the 

federal agency representative. 

Subpart E—Collection Sites 

Section 5.1 Where can a collection for 

a drug test take place? 

(a) A collection site may be a 

permanent or temporary facility located 

either at the work site or at a remote 

site. 

(b) In the event that an agencydesignated collection site is not 

accessible and there is an immediate 

requirement to collect a urine specimen 

(e.g., an accident investigation), a public 

restroom may be used for the collection, 

using the procedures for a monitored 

collection described in Section 8.12. 

Section 5.2 What are the requirements 

for a collection site? 

The facility used as a collection site 

must have the following: 

(a) Provisions to ensure donor privacy 

during the collection (as described in 

Section 8.1); 

(b) A suitable and clean surface area 

that is not accessible to the donor for 

handling the specimens and completing 

the required paperwork; 

(c) A secure temporary storage area to 

maintain specimens until the specimen 

is transferred to an HHS-certified 

laboratory or IITF; 

(d) A restricted access area where 

only authorized personnel may be 

present during the collection; 

(e) A restricted access area for the 

storage of collection supplies; 

(f) The ability to store records 

securely; and 

(g) The ability to restrict the donor 

access to potential diluents in 

accordance with Section 8.2. 

Section 5.3 Where must collection site 

records be stored? 

Collection site records must be stored 

at a secure site designated by the 

collector or the collector’s employer. 

Section 5.4 How long must collection 

site records be stored? 

Collection site records (e.g., collector 

copies of the OMB-approved Federal 

CCF) must be stored securely for a 

minimum of 2 years. The collection site 

may convert hardcopy records to 

electronic records for storage and 

discard the hardcopy records after 6 

months. 

Section 5.5 How does the collector 

ensure the security and integrity of a 

specimen at the collection site? 

(a) A collector must do the following 

to maintain the security and integrity of 

a specimen: 

(1) Not allow unauthorized personnel 

to enter the collection area during the 

collection procedure; 

(2) Perform only one donor collection 

at a time; 

(3) Restrict access to collection 

supplies before, during and after 

collection; 

(4) Ensure that only the collector and 

the donor are allowed to handle the 

unsealed specimen; 

(5) Ensure the chain of custody 

process is maintained and documented 

throughout the entire collection, storage, 

and transport procedures; 

(6) Ensure that the Federal CCF is 

completed and distributed as required; 

and 

(7) Ensure that specimens transported 

to an HHS-certified laboratory or IITF 

are sealed and placed in transport 

containers designed to minimize the 

possibility of damage during shipment 

(e.g., specimen boxes, padded mailers, 

or other suitable shipping container), 

and those containers are securely sealed 

to eliminate the possibility of 

undetected tampering; 

(b) Couriers, express carriers, and 

postal service personnel are not 

required to document chain of custody 

since specimens are sealed in packages 

that would indicate tampering during 

transit to the HHS-certified laboratory or 

IITF. 

Section 5.6 What are the privacy 

requirements when collecting a urine 

specimen? 

Collections must be performed at a 

site that provides reasonable privacy (as 

described in Section 8.1). 

Subpart F—Federal Drug Testing 

Custody and Control Form 

Section 6.1 What federal form is used 

to document custody and control? 

The OMB-approved Federal CCF must 

be used to document custody and 

control of each specimen at the 

collection site. 

Section 6.2 What happens if the 

correct OMB-approved Federal CCF is 

not available or is not used? 

(a) The use of a non-federal CCF or an 

expired Federal CCF is not, by itself, a 

reason for the HHS-certified laboratory 

or IITF to automatically reject the 

specimen for testing or for the MRO to 

cancel the test. 

(b) If the collector does not use the 

correct OMB-approved Federal CCF, the 

collector must document that it is a 

federal agency specimen collection and 

provide the reason that the incorrect 

form was used. Based on the 

information provided by the collector, 

the HHS-certified laboratory or IITF 

must handle and test the specimen as a 

federal agency specimen. 

(c) If the HHS-certified laboratory, 

HHS-certified IITF, or MRO discovers 

that the collector used an incorrect 

form, the laboratory, IITF, or MRO must 

obtain a memorandum for the record 

from the collector describing the reason 

the incorrect form was used. If a 

memorandum for the record cannot be 

obtained, the laboratory or IITF reports 

a rejected for testing result to the MRO 

and the MRO cancels the test. The HHScertified laboratory or IITF must wait at 

least 5 business days while attempting 

to obtain the memorandum before 

reporting a rejected for testing result to 

the MRO. 

Subpart G—Urine Specimen Collection 

Containers and Bottles 

Section 7.1 What is used to collect a 

urine specimen? 

A single-use collection container with 

a means (i.e., thermometer) to measure 

urine temperature and two specimen 

bottles must be used. 

Section 7.2 What are the requirements 

for a urine collection container and 

specimen bottles? 

(a) The collection container, the 

thermometer, and the specimen bottles 

must not substantially affect the 

composition of drugs and/or metabolites 

in the urine specimen. 

(b) The two specimen bottles must be 

sealable and non-leaking, and must 

maintain the integrity of the specimen 

during storage and transport so that the 

specimen contained therein can be 

tested in an HHS-certified laboratory or 

IITF for the presence of drugs or their 

metabolites. 

(c) The two specimen bottles must be 

sufficiently transparent to enable an 

objective assessment of specimen 

appearance and identification of 

abnormal physical characteristics 

without opening the bottle. 
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Section 7.3 What are the minimum 

performance requirements for a urine 

collection container and specimen 

bottles? 

(a) The collection container must be 

capable of holding at least 55 mL and 

have a volume marking clearly noting a 

level of 45 mL. 

(b) One of the two specimen bottles 

must be capable of holding at least 35 

mL and the other at least 20 mL, and 

each must have a volume marking 

clearly noting the appropriate level (30 

mL for the primary specimen and 15 mL 

for the split specimen). 

(c) The thermometer may be affixed to 

or built into the collection container and 

must provide graduated temperature 

readings from 32–38 °C/90–100 °F. 

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 

Section 8.1 What privacy must the 

donor be given when providing a urine 

specimen? 

The following privacy requirements 

apply when a donor is providing a urine 

specimen: 

(a) Only authorized personnel and the 

donor may be present in the restricted 

access area where the collection takes 

place. 

(b) The collector is not required to be 

the same gender as the donor. The 

gender of the observer for purposes of a 

direct observed collection (i.e., as 

described in Section 8.10) must be the 

same as the donor’s gender, which is 

determined by the donor’s gender 

identity. The gender of the monitor for 

a monitored collection (i.e., as described 

in Section 8.12) must be the same as the 

donor’s gender, unless the monitor is a 

medical professional (e.g., nurse, doctor, 

physician’s assistant, technologist, or 

technician licensed or certified to 

practice in the jurisdiction in which the 

collection takes place). 

(c) The collector must give the donor 

visual privacy while providing the 

specimen. The donor is allowed to 

provide a urine specimen in an enclosed 

stall within a multi-stall restroom or in 

a single person restroom during a 

monitored collection. 

Section 8.2 What must the collector 

ensure at the collection site before 

starting a urine specimen collection? 

The collector must deter the dilution 

or substitution of a specimen at the 

collection site by: 

(a) Placing a toilet bluing agent in a 

toilet bowl or toilet tank, so the 

reservoir of water in the toilet bowl 

always remains blue. If no bluing agent 

is available or if the toilet has an 

automatic flushing system, the collector 

shall turn the water supply off to the 

toilet and flush the toilet to remove the 

water in the toilet when possible. 

(b) Secure other sources of water (e.g., 

shower or sink) in the enclosure where 

urination occurs. If the enclosure has a 

source of water that cannot be disabled 

or secured, a monitored collection must 

be conducted in accordance with 

Section 8.11. 

Section 8.3 What are the preliminary 

steps in the urine specimen collection 

procedure? 

The collector must take the following 

steps before beginning a urine specimen 

collection: 

(a) If a donor fails to arrive at the 

collection site at the assigned time, the 

collector must follow the federal agency 

policy or contact the federal agency 

representative to obtain guidance on 

action to be taken. 

(b) When the donor arrives at the 

collection site, the collector should 

begin the collection procedure without 

undue delay. For example, the 

collection should not be delayed 

because the donor states that they are 

unable to urinate or an authorized 

employer or employer representative is 

late in arriving. 

(c) The collector requests the donor to 

present photo identification (e.g., 

driver’s license; employee badge issued 

by the employer; an alternative photo 

identification issued by a federal, state, 

or local government agency). If the 

donor does not have proper photo 

identification, the collector shall contact 

the supervisor of the donor or the 

federal agency representative who can 

positively identify the donor. If the 

donor’s identity cannot be established, 

the collector must not proceed with the 

collection. 

(d) The collector must provide 

identification (e.g., employee badge, 

employee list) if requested by the donor. 

(e) The collector explains the basic 

collection procedure to the donor. 

(f) The collector informs the donor 

that the instructions for completing the 

Federal Custody and Control Form are 

located on the back of the Federal CCF 

or available upon request. 

(g) The collector answers any 

reasonable and appropriate questions 

the donor may have regarding the 

collection procedure. 

(h) The collector asks the donor to 

remove any unnecessary outer garments 

(e.g., coat, jacket) that might conceal 

items or substances that could be used 

to adulterate or substitute the urine 

specimen: 

(1) The collector must ensure that all 

personal belongings (e.g., purse or 

briefcase) remain with the outer 

garments; the donor may retain the 

donor’s wallet. 

(2) The collector asks the donor to 

empty the donor’s pockets and display 

the contents to ensure no items are 

present that could be used to adulterate 

or substitute the specimen. 

(3) If no items are present that can be 

used to adulterate or substitute the 

specimen, the donor can place the items 

back into the donor’s pockets and 

continue the collection procedure. 

(4) If an item is present that appears 

to have been brought to the collection 

site with the intent to adulterate, 

substitute, or dilute the specimen, this 

is considered a refusal to test. The 

collector must stop the collection and 

report the refusal to test as described in 

Section 8.13. If the item appears to be 

inadvertently brought to the collection 

site, the collector must secure the item 

and continue the normal collection 

procedure. 

(5) If the donor refuses to show the 

collector the items in the donor’s 

pockets, this is considered a refusal to 

test. The collector must stop the 

collection and report the refusal to test 

as described in Section 8.13. 

(i) The collector shall instruct the 

donor to wash and dry the donor’s 

hands prior to urination. After washing 

the donor’s hands, the donor must 

remain in the presence of the collector 

and must not have access to any water 

fountain, faucet, soap dispenser, 

cleaning agent, or any other materials 

which could be used to adulterate or 

substitute the specimen. 

(1) If the donor refuses to wash the 

donor’s hands when instructed by the 

collector, this is considered a ‘‘refusal to 

test.’’ The collector must stop the 

collection and report the refusal to test 

as described in Section 8.13. 

Section 8.4 What steps does the 

collector take in the collection 

procedure before the donor provides a 

urine specimen? 

(a) The collector will provide or the 

donor may select a specimen collection 

container that is clean, unused, 

wrapped/sealed in original packaging 

and compliant with Subpart G. The 

specimen collection container will be 

opened in view of the donor. 

(b) The collector instructs the donor 

to provide the specimen in the privacy 

of a stall or otherwise partitioned area 

that allows for individual privacy. The 

collector directs the donor to provide a 
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specimen of at least 45 mL, to not flush 

the toilet, and to return with the 

specimen as soon as the donor has 

completed the void. 

(1) Except in the case of a direct 

observed collection (i.e., as described in 

Section 8.10) or a monitored collection 

(i.e., as described in Section 8.12), 

neither the collector nor anyone else 

may go into the room with the donor. 

(2) The collector may set a reasonable 

time limit for specimen collection. 

(c) The collector notes any unusual 

behavior or appearance of the donor on 

the Federal CCF. If the collector detects 

any conduct that clearly indicates an 

attempt to tamper with a specimen (e.g., 

substitute urine in plain view or an 

attempt to bring into the collection site 

an adulterant or urine substitute), the 

collector must report a refusal to test in 

accordance with Section 8.13. 

Section 8.5 What steps does the 

collector take during and after the urine 

specimen collection procedure? 

Integrity and Identity of the 

Specimen. The collector must take the 

following steps during and after the 

donor provides the urine specimen: 

(a) The collector must inform the 

donor that, once the collection 

procedure has begun, the donor must 

remain at the collection site (i.e., in an 

area designated by the collector) until 

the collection is complete. This includes 

the wait period (i.e., up to 3 hours) if 

needed to provide a sufficient specimen 

as described in step (f)(2) below and in 

Section 8.6. 

(b) After providing the specimen, the 

donor gives the specimen collection 

container to the collector. Both the 

donor and the collector must keep the 

specimen container in view at all times 

until the collector seals the specimen 

bottles as described in Section 8.8. 

(c) After the donor has given the 

specimen to the collector, whenever 

practical, the donor shall be allowed to 

wash the donor’s hands and the donor 

may flush the toilet. 

(d) The collector must measure the 

temperature of the specimen within 4 

minutes of receiving the specimen from 

the donor. The collector records on the 

Federal CCF whether or not the 

temperature is in the acceptable range of 

32 °–38 °C/90 °–100 °F. 

(1) The temperature measuring device 

must accurately reflect the temperature 

of the specimen and not contaminate 

the specimen. 

(2) If the temperature of the specimen 

is outside the range of 32 °–38 °C/90 °– 

100 °F, that is a reason to believe that 

the donor may have adulterated or 

substituted the specimen. Another 

specimen must be collected under direct 

observation in accordance with Section 

8.9. The collector must forward both 

specimens (i.e., from the first and 

second collections) to an HHS-certified 

laboratory for testing and record a 

comment on the Federal CCF for each 

specimen. 

(e) The collector must inspect the 

specimen to determine if there is any 

sign indicating that the specimen may 

not be a valid urine specimen (e.g., 

unusual color, presence of foreign 

objects or material, unusual odor). 

(1) The collector notes any unusual 

finding on the Federal CCF. A specimen 

suspected of not being a valid urine 

specimen must be forwarded to an HHScertified laboratory for testing. 

(2) When there is any reason to 

believe that a donor may have 

adulterated or substituted the specimen, 

another specimen must be obtained as 

soon as possible under direct 

observation in accordance with Section 

8.10. The collector must forward both 

specimens (i.e., from the first and 

second collections) to an HHS-certified 

laboratory for testing and record a 

comment on the Federal CCF for each 

specimen. 

(f) The collector must determine the 

volume of urine in the specimen 

container. The collector must never 

combine urine collected from separate 

voids to create a specimen. 

(1) If the volume is at least 45 mL, the 

collector will proceed with steps 

described in Section 8.8. 

(2) If the volume is less than 45 mL, 

the collector discards the specimen and 

immediately collects a second specimen 

using the same procedures as for the 

first specimen (including steps in 

paragraphs c and d of this section). 

(i) The collector may give the donor 

a reasonable amount of liquid to drink 

for this purpose (e.g., an 8 ounce glass 

of water every 30 minutes, but not to 

exceed a maximum of 40 ounces over a 

period of 3 hours or until the donor has 

provided a sufficient urine specimen). 

However, the donor is not required to 

drink any fluids during this waiting 

time. 

(ii) If the donor provides a sufficient 

urine specimen (i.e., at least 45 mL), the 

collector proceeds with steps described 

in Section 8.8. 

(iii) If the employee has not provided 

a sufficient specimen (i.e., at least 45 

mL) within three hours of the first 

unsuccessful attempt to provide the 

specimen, the collector records the 

reason for not collecting a urine 

specimen on the Federal CCF, notifies 

the federal agency’s designated 

representative for authorization of an 

alternate specimen to be collected, and 

sends the appropriate copies of the 

Federal CCF to the MRO and to the 

federal agency’s designated 

representative. The federal agency may 

choose to provide the collection site 

with a standard protocol to follow in 

lieu of requiring the collector to notify 

the agency’s designated representative 

for authorization in each case. If an 

alternate specimen is authorized, the 

collector may begin the collection 

procedure for the alternate specimen 

(see Section 8.7) in accordance with the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

the alternative specimen. 

(g) If the donor fails to remain present 

through the completion of the 

collection, declines to have a direct 

observed collection as required in steps 

(d)(2) or (e)(2) above, refuses to provide 

a second specimen as required in step 

(f)(2) above, or refuses to provide an 

alternate specimen as authorized in step 

(f)(2)(iii) above, the collector stops the 

collection and reports the refusal to test 

in accordance with Section 8.13. 

Section 8.6 What procedure is used 

when the donor states that they are 

unable to provide a urine specimen? 

(a) If the donor states that they are 

unable to provide a urine specimen 

during the collection process, the 

collector requests that the donor enter 

the restroom (stall) and attempt to 

provide a urine specimen. 

(b) The donor demonstrates their 

inability to provide a specimen when he 

or she comes out of the stall with an 

empty collection container. 

(1) If the donor states that they could 

provide a specimen after drinking some 

fluids, the collector gives the donor a 

reasonable amount of liquid to drink for 

this purpose (e.g., an 8 ounce glass of 

water every 30 minutes, but not to 

exceed a maximum of 40 ounces over a 

period of 3 hours or until the donor has 

provided a sufficient urine specimen). If 

the donor simply needs more time 

before attempting to provide a urine 

specimen, the donor is not required to 

drink any fluids during the 3 hour wait 

time. 

(2) If the donor states that they are 

unable to provide a urine specimen, the 

collector records the reason for not 

collecting a urine specimen on the 

Federal CCF, notifies the federal 

agency’s designated representative for 

authorization of an alternate specimen 

to be collected, and sends the 

appropriate copies of the Federal CCF to 

the MRO and to the federal agency’s 

designated representative. The federal 

agency may choose to provide the 

collection site with a standard protocol 

to follow in lieu of requiring the 

collector to notify the agency’s 
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designated representative for 

authorization in each case. If an 

alternate specimen is authorized, the 

collector may begin the collection 

procedure for the alternate specimen 

(see Section 8.7) in accordance with the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

the alternative specimen. 

Section 8.7 If the donor is unable to 

provide a urine specimen, may another 

specimen type be collected for testing? 

Yes, if the alternate specimen type is 

authorized by Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs and specifically authorized by 

the federal agency. 

Section 8.8 How does the collector 

prepare the urine specimens? 

(a) All federal agency collections are 

to be split specimen collections. 

(b) The collector, in the presence of 

the donor, pours the urine from the 

collection container into two specimen 

bottles to be labeled ‘‘A’’ and ‘‘B’’. The 

collector pours at least 30 mL of urine 

into Bottle A and at least 15 mL into 

Bottle B, and caps each bottle. 

(c) In the presence of the donor, the 

collector places a tamper-evident label/ 

seal from the Federal CCF over each 

specimen bottle cap. The collector 

records the date of the collection on the 

tamper-evident labels/seals. 

(d) The collector instructs the donor 

to initial the tamper-evident labels/seals 

on each specimen bottle. If the donor 

refuses to initial the labels/seals, the 

collector notes the refusal on the 

Federal CCF and continues with the 

collection process. 

(e) The collector must ensure that all 

the information required on the Federal 

CCF is provided. 

(f) The collector asks the donor to 

read and sign a statement on the Federal 

CCF certifying that the specimens 

identified were collected from the 

donor. If the donor refuses to sign the 

certification statement, the collector 

notes the refusal on the Federal CCF and 

continues with the collection process. 

(g) The collector signs and prints their 

name on the Federal CCF, completes the 

Federal CCF, and distributes the copies 

of the Federal CCF as required. 

(h) The collector seals the specimens 

(Bottle A and Bottle B) in a package and, 

within 24 hours or during the next 

business day, sends them to the HHScertified laboratory or IITF that will be 

testing the Bottle A urine specimen. 

(i) If the specimen and Federal CCF 

are not immediately transported to an 

HHS-certified laboratory or IITF, they 

must remain under direct control of the 

collector or be appropriately secured 

under proper specimen storage 

conditions until transported. 

(j) The collector must discard any 

urine left over in the collection 

container after both specimen bottles 

have been appropriately filled and 

sealed. There is one exception to this 

requirement: The collector may use 

excess urine to conduct clinical tests 

(e.g., protein, glucose) if the collection 

was conducted in conjunction with a 

physical examination required by 

federal agency regulation. Neither the 

collector nor anyone else may conduct 

further testing (such as specimen 

validity testing) on the excess urine. 

Section 8.9 When is a direct observed 

collection conducted? 

A direct observed collection 

procedure must be conducted when: 

(a) The agency has authorized a direct 

observed collection because: 

(1) The donor’s previous drug test 

result was reported by an MRO as 

positive, adulterated, or substituted; or 

(2) The HHS-certified laboratory 

reports to the MRO that a specimen is 

invalid, and the MRO reported to the 

agency that there was not a legitimate 

medical explanation for the result; or 

(3) The MRO reported to the agency 

that the primary bottle (A) specimen 

was positive, adulterated, or substituted 

result had to be cancelled because the 

test of the split specimen could not be 

tested and/or the split specimen bottle 

(B) failed to reconfirm; or 

(b) At the collection site, an 

immediate collection of a second urine 

specimen is required because: 

(1) The temperature of the specimen 

collected during a routine collection is 

outside the acceptable temperature 

range; or 

(2) The collector suspects that the 

donor has tampered with the specimen 

during a routine collection (e.g., 

abnormal physical characteristic such as 

unusual color and/or odor, and/or 

excessive foaming when shaken). 

(c) The collector must contact a 

collection site supervisor to review and 

concur in advance with any decision by 

the collector to obtain a specimen under 

direct observation. 

(d) If the donor declines to have a 

direct observed collection, the collector 

reports a refusal to test (i.e., as described 

in Section 8.13). 

Section 8.10 How is a direct observed 

collection conducted? 

(a) A direct observed collection 

procedure is the same as that for a 

routine collection, except an observer 

watches the donor urinate into the 

collection container. The observer’s 

gender must be the same as the donor’s 

gender, which is determined by the 

donor’s gender identity, with no 

exception to this requirement. 

(b) Before an observer is selected, the 

collector informs the donor that the 

gender of the observer will match the 

donor’s gender, which is determined by 

the donor’s gender identity (as defined 

in Section 1.5). The collector then 

selects the observer to conduct the 

observation: 

(i) The collector asks the donor to 

identify the donor’s gender on the 

Federal CCF and initial it. 

(ii) The donor will then be provided 

an observer whose gender matches the 

donor’s gender. 

(iii) The collector documents the 

observer’s name and gender on the 

Federal CCF. 

(c) If there is no collector available of 

the same gender as the donor’s gender, 

the collector or collection site 

supervisor shall select an observer 

trained in direct observed specimen 

collection as described in Section 4.4. 

The observer may be an individual that 

is not a trained collector. 

(d) At the point in a routine collection 

where the donor enters the restroom 

with the collection container, a direct 

observed collection includes the 

following additional steps: 

(1) The observer enters the restroom 

with the donor; 

(2) The observer must directly watch 

the urine go from the donor’s body into 

the collection container (the use of 

mirrors or video cameras is not 

permitted); 

(3) The observer must not touch or 

handle the collection container unless 

the observer is also serving as the 

collector; 

(4) After the donor has completed 

urinating into the collection container: 

(i) If the same person serves as the 

observer and collector, that person may 

receive the collection container from the 

donor while they are both in the 

restroom; 

(ii) If the observer is not serving as the 

collector, the donor and observer leave 

the restroom and the donor hands the 

collection container directly to the 

collector. The observer must maintain 

visual contact of the collection 

container until the donor hands the 

container to the collector. 

(5) The collector checks the box for an 

observed collection on the Federal CCF 

and writes the name of the observer and 

the reason for an observed collection on 

the Federal CCF; and 

(6) The collector then continues with 

the routine collection procedure in 

Section 8.3. 
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Section 8.11 When is a monitored 

collection conducted? 

(a) In the event that an agencydesignated collection site is not 

available and there is an immediate 

requirement to collect a specimen (e.g., 

an accident investigation), a public 

restroom may be used for the collection, 

using the procedures for a monitored 

collection described in Section 8.12. 

(b) If the enclosure used by the donor 

to provide a specimen has a source of 

water that cannot be disabled or 

secured, a monitored collection must be 

conducted. 

(c) If the donor declines to permit a 

collection to be monitored when 

required, the collector reports a refusal 

to test (i.e., as described in Section 

8.13). 

Section 8.12 How is a monitored 

collection conducted? 

A monitored collection is the same as 

that for a routine collection, except that 

a monitor accompanies the donor into 

the restroom to check for signs that the 

donor may be tampering with the 

specimen. The monitor remains in the 

restroom, but outside the stall, while the 

donor is providing the specimen. A 

person of the same gender as the donor 

shall serve as the monitor, unless the 

monitor is a medical professional (e.g., 

nurse, doctor, physician’s assistant, 

technologist, or technician licensed or 

certified to practice in the jurisdiction 

in which the collection takes place). The 

same procedures used for selecting an 

observer of the appropriate gender in 

Section 8.10(b) must be used to select 

the monitor for the purposes of Section 

8.12, unless the monitor is a medical 

professional as described above. The 

monitor may be an individual other 

than the collector and need not be a 

qualified collector. 

(a) The collector secures the restroom 

being used for the monitored collection 

so that no one except the employee and 

the monitor can enter the restroom until 

after the collection has been completed. 

(b) The monitor enters the restroom 

with the donor. 

(c) The monitor must not watch the 

employee urinate into the collection 

container. If the monitor hears sounds 

or makes other observations indicating 

an attempt by the donor to tamper with 

a specimen, there must be an additional 

collection under direct observation in 

accordance with Section 8.9. 

(d) The monitor must not touch or 

handle the collection container unless 

the monitor is also the collector. 

(e) After the donor has completed 

urinating into the collection container: 

(1) If the same person serves as the 

monitor and collector, that person may 

receive the collection container from the 

donor while they are both in the 

restroom; 

(2) If the monitor is not serving as the 

collector, the donor and monitor leave 

the restroom and the donor hands the 

collection container directly to the 

collector. The monitor must ensure that 

the employee takes the collection 

container directly to the collector as 

soon as the employee has exited the 

enclosure. 

(f) If the monitor is not serving as the 

collector, the collector writes the name 

of the monitor on the Federal CCF. 

(g) The collector then continues with 

the routine collection procedure in 

Section 8.3. 

Section 8.13 How does the collector 

report a donor’s refusal to test? 

If there is a refusal to test as defined 

in Section 1.7, the collector stops the 

collection, discards any urine collected 

and reports the refusal to test by: 

(a) Notifying the federal agency by 

means (e.g., telephone, email, or secure 

fax) that ensures that the notification is 

immediately received, 

(b) Documenting the refusal to test on 

the Federal CCF, and 

(c) Sending all copies of the Federal 

CCF to the federal agency’s designated 

representative. 

Section 8.14 What are a federal 

agency’s responsibilities for a collection 

site? 

(a) A federal agency must ensure that 

collectors and collection sites satisfy all 

requirements in subparts D, E, F, G, and 

H. 

(b) A federal agency (or only one 

federal agency when several agencies 

are using the same collection site) must 

inspect 5 percent or up to a maximum 

of 50 collection sites each year, selected 

randomly from those sites used to 

collect agency specimens (e.g., virtual, 

onsite, or self-evaluation). 

(c) A federal agency must investigate 

reported collection site deficiencies 

(e.g., specimens reported ‘‘rejected for 

testing’’ by an HHS-certified laboratory 

or IITF) and take appropriate action 

which may include a collection site selfassessment (i.e., using the Collection 

Site Checklist for the Collection of Urine 

Specimens for Federal Agency 

Workplace Drug Testing Programs) or an 

inspection of the collection site. The 

inspections of these additional 

collection sites may be included in the 

5 percent or maximum of 50 collection 

sites inspected annually. 

Subpart I—HHS Certification of 

Laboratories and IITFs 

Section 9.1 Who has the authority to 

certify laboratories and IITFs to test 

urine specimens for federal agencies? 

(a) The Secretary has broad discretion 

to take appropriate action to ensure the 

full reliability and accuracy of drug 

testing and reporting, to resolve 

problems related to drug testing, and to 

enforce all standards set forth in these 

Guidelines. The Secretary has the 

authority to issue directives to any HHScertified laboratory or IITF including 

suspending the use of certain analytical 

procedures when necessary to protect 

the integrity of the testing process; 

ordering any HHS-certified laboratory or 

IITF to undertake corrective actions to 

respond to material deficiencies 

identified by an inspection or through 

performance testing; ordering any HHScertified laboratory or IITF to send 

specimens or specimen aliquots to 

another HHS-certified laboratory for 

retesting when necessary to ensure the 

accuracy of testing under these 

Guidelines; ordering the review of 

results for specimens tested under the 

Guidelines for private sector clients to 

the extent necessary to ensure the full 

reliability of drug testing for federal 

agencies; and ordering any other action 

necessary to address deficiencies in 

drug testing, analysis, specimen 

collection, chain of custody, reporting of 

results, or any other aspect of the 

certification program. 

(b) A laboratory or IITF is prohibited 

from stating or implying that it is 

certified by HHS under these Guidelines 

to test urine specimens for federal 

agencies unless it holds such 

certification. 

Section 9.2 What is the process for a 

laboratory or IITF to become HHScertified? 

(a) A laboratory or IITF seeking HHS 

certification must: 

(1) Submit a completed OMBapproved application form (i.e., the 

applicant laboratory or IITF provides 

detailed information on both the 

administrative and analytical 

procedures to be used for federally 

regulated specimens); 

(2) Have its application reviewed as 

complete and accepted by HHS; 

(3) Successfully complete the PT 

challenges in 3 consecutive sets of 

initial PT samples; 

(4) Satisfy all the requirements for an 

initial inspection; and 

(5) Receive notification of certification 

from the Secretary before testing 

specimens for federal agencies. 
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Section 9.3 What is the process for a 

laboratory or IITF to maintain HHS 

certification? 

(a) To maintain HHS certification, a 

laboratory or IITF must: 

(1) Successfully participate in both 

the maintenance PT and inspection 

programs (i.e., successfully test the 

required quarterly sets of maintenance 

PT samples, undergo an inspection 3 

months after being certified, and 

undergo maintenance inspections at a 

minimum of every 6 months thereafter); 

(2) Respond in an appropriate, timely, 

and complete manner to required 

corrective action requests if deficiencies 

are identified in the maintenance PT 

performance, during the inspections, 

operations, or reporting; and 

(3) Satisfactorily complete corrective 

remedial actions, and undergo special 

inspection and special PT sets to 

maintain or restore certification when 

material deficiencies occur in either the 

PT program, inspection program, or in 

operations and reporting. 

Section 9.4 What is the process when 

a laboratory or IITF does not maintain 

its HHS certification? 

(a) A laboratory or IITF that does not 

maintain its HHS certification must: 

(1) Stop testing federally regulated 

specimens; 

(2) Ensure the security of federally 

regulated specimens and records 

throughout the required storage period 

described in Sections 11.20, 11.21, 

12.18, and 14.8; 

(3) Ensure access to federally 

regulated specimens and records in 

accordance with Sections 11.23, 11.24, 

12.20, 12.21, and Subpart P; and 

(4) Follow the HHS suspension and 

revocation procedures when imposed by 

the Secretary, follow the HHS 

procedures in Subpart P that will be 

used for all actions associated with the 

suspension and/or revocation of HHScertification. 

Section 9.5 What are the qualitative 

and quantitative specifications of 

performance testing (PT) samples? 

(a) PT samples used to evaluate drug 

tests will be prepared using the 

following specifications: 

(1) PT samples may contain one or 

more of the drugs and drug metabolites 

in the drug classes listed in Section 3.4 

and must satisfy one of the following 

parameters: 

(i) The concentration of a drug or 

metabolite will be at least 20 percent 

above the initial test cutoff 

concentration for the drug or drug 

metabolite; 

(ii) The concentration of a drug or 

metabolite may be as low as 40 percent 

of the confirmatory test cutoff 

concentration when the PT sample is 

designated as a retest sample; or 

(iii) The concentration of drug or 

metabolite may differ from 9.5(a)(1)(i) 

and 9.5(a)(1)(ii) for a special purpose. 

(2) A PT sample may contain an 

interfering substance, an adulterant, or 

satisfy the criteria for a substituted 

specimen, dilute specimen, or invalid 

result. 

(3) A negative PT sample will not 

contain a measurable amount of a target 

analyte. 

(b) PT samples used to evaluate 

specimen validity tests shall satisfy, but 

are not limited to, one of the following 

criteria: 

(1) The nitrite concentration will be at 

least 20 percent above the cutoff; 

(2) The pH will be between 1.5 and 

5.0 or between 8.5 and 12.5; 

(3) The concentration of an oxidant 

will be at a level sufficient to challenge 

a laboratory’s ability to identify and 

confirm the oxidant; 

(4) The creatinine concentration will 

be between 0 and 20 mg/dL; or 

(5) The specific gravity will be less 

than or equal to 1.0050 or between 

1.0170 and 1.0230. 

(c) For each PT cycle, the set of PT 

samples going to each HHS-certified 

laboratory or IITF will vary but, within 

each calendar year, each HHS-certified 

laboratory or IITF will analyze 

essentially the same total set of samples. 

(d) The laboratory or IITF must (to the 

greatest extent possible) handle, test, 

and report a PT sample in a manner 

identical to that used for a donor 

specimen, unless otherwise specified. 

Section 9.6 What are the PT 

requirements for an applicant 

laboratory? 

(a) An applicant laboratory that seeks 

certification under these Guidelines 

must satisfy the following criteria on 

three consecutive sets of PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over the three sets of PT 

samples; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over the three sets of PT 

samples; 

(4) For the confirmatory drug tests, 

correctly determine the concentrations 

[i.e., no more than ±20 percent or ±2 

standard deviations (whichever is 

larger) from the appropriate reference or 

peer group means] for at least 80 percent 

of the total drug challenges over the 

three sets of PT samples; 

(5) For the confirmatory drug tests, 

must not obtain any drug concentration 

that differs by more than ±50 percent 

from the appropriate reference or peer 

group mean; 

(6) For each confirmatory drug test, 

correctly identify and determine the 

concentrations [i.e., no more than ±20 

percent or ±2 standard deviations 

(whichever is larger) from the 

appropriate reference or peer group 

means] for at least 50 percent of the 

drug challenges for an individual drug 

over the three sets of PT samples; 

(7) Correctly identify at least 80 

percent of the total specimen validity 

testing challenges over the three sets of 

PT samples; 

(8) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

the three sets of PT samples; 

(9) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total challenges 

over the three sets of PT samples that 

satisfy the following criteria: 

(i) Nitrite and creatinine 

concentrations are no more than ±20 

percent or ±2 standard deviations from 

the appropriate reference or peer group 

mean; and 

(ii) pH values are no more than ±0.3 

pH units from the appropriate reference 

or peer group mean using a pH meter; 

and 

(iii) Specific gravity values are no 

more than ±0.0003 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is less than 

1.0100 and specific gravity values are no 

more than ±0.0004 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is equal to 

or greater than 1.0100; 

(10) Must not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for nitrite and 

creatinine concentrations, ±0.8 pH units 

using a pH meter, ±0.0006 specific 

gravity units when the mean is less than 

1.0100, or ±0.0007 specific gravity units 

when the mean is equal to or greater 

than 1.0100; and 

(11) Must not report any sample as 

adulterated with a compound that is not 

present in the sample, adulterated based 

on pH when the appropriate reference 

or peer group mean is within the 

acceptable pH range, or substituted 

when the appropriate reference or peer 

group means for both creatinine and 

specific gravity are within the 

acceptable range. 

(b) Failure to satisfy these 

requirements will result in 

disqualification. 
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Section 9.7 What are the PT 

requirements for an HHS-certified urine 

laboratory? 

(a) A laboratory certified under these 

Guidelines must satisfy the following 

criteria on the maintenance PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over two consecutive 

PT cycles; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over two consecutive PT 

cycles; 

(4) For the confirmatory drug tests, 

correctly determine that the 

concentrations for at least 80 percent of 

the total drug challenges are no more 

than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

means over two consecutive PT cycles; 

(5) For the confirmatory drug tests, 

obtain no more than one drug 

concentration on a PT sample that 

differs by more than ±50 percent from 

the appropriate reference or peer group 

mean over two consecutive PT cycles; 

(6) For each confirmatory drug test, 

correctly identify and determine that the 

concentrations for at least 50 percent of 

the drug challenges for an individual 

drug are no more than ±20 percent or ±2 

standard deviations (whichever is 

larger) from the appropriate reference or 

peer group means over two consecutive 

PT cycles; 

(7) Correctly identify at least 80 

percent of the total specimen validity 

testing challenges over two consecutive 

PT cycles; 

(8) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

two consecutive PT cycles; 

(9) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total challenges 

over two consecutive PT cycles that 

satisfy the following criteria: 

(i) Nitrite and creatinine 

concentrations are no more than ±20 

percent or ±2 standard deviations from 

the appropriate reference or peer group 

mean; 

(ii) pH values are no more than ±0.3 

pH units from the appropriate reference 

or peer group mean using a pH meter; 

and 

(iii) Specific gravity values are no 

more than ±0.0003 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is less than 

1.0100 and specific gravity values are no 

more than ±0.0004 specific gravity units 

from the appropriate reference or peer 

group mean when the mean is equal to 

or greater than 1.0100; 

(10) Obtain no more than one 

quantitative value over 2 consecutive PT 

cycles on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for nitrite and 

creatinine concentrations, ±0.8 pH units 

using a pH meter, ±0.0006 specific 

gravity units when the mean is less than 

1.0100, or ±0.0007 specific gravity units 

when the mean is equal to or greater 

than 1.0100; and 

(11) Do not report any PT sample as 

adulterated with a compound that is not 

present in the sample, adulterated based 

on pH when the appropriate reference 

or peer group mean is within the 

acceptable pH range, or substituted 

when the appropriate reference or peer 

group means for both creatinine and 

specific gravity are within the 

acceptable range. 

(b) Failure to participate in all PT 

cycles or to satisfy these requirements 

may result in suspension or revocation 

of an HHS-certified laboratory’s 

certification. 

Section 9.8 What are the PT 

requirements for an applicant IITF? 

(a) An applicant IITF that seeks 

certification under these Guidelines 

must satisfy the following criteria on 

three consecutive sets of PT samples: 

(1) Correctly identify at least 90 

percent of the total drug challenges over 

the three sets of PT samples; 

(2) Correctly identify at least 80 

percent of the drug challenges for each 

individual drug test over the three sets 

of PT samples; 

(3) Correctly identify at least 80 

percent of the total specimen validity 

test challenges over the three sets of PT 

samples; 

(4) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

the three sets of PT samples; 

(5) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total specimen 

validity test challenges over the three 

sets of PT samples that satisfy the 

following criteria: 

(i) Creatinine concentrations are no 

more than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

mean; and 

(ii) Specific gravity values are no 

more than ±0.001 specific gravity units 

from the appropriate reference or peer 

group mean; and 

(6) Must not obtain any quantitative 

value on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for creatinine 

concentration, or ±0.002 specific gravity 

units for specific gravity. 

(b) Failure to satisfy these 

requirements will result in 

disqualification. 

Section 9.9 What are the PT 

requirements for an HHS-certified IITF? 

(a) An IITF certified under these 

Guidelines must satisfy the following 

criteria on the maintenance PT samples 

to maintain its certification: 

(1) Correctly identify at least 90 

percent of the total drug challenges over 

two consecutive PT cycles; 

(2) Correctly identify at least 80 

percent of the drug challenges for each 

individual drug test over two 

consecutive PT cycles; 

(3) Correctly identify at least 80 

percent of the total specimen validity 

test challenges over two consecutive PT 

cycles; 

(4) Correctly identify at least 80 

percent of the challenges for each 

individual specimen validity test over 

two consecutive PT cycles; 

(5) For quantitative specimen validity 

tests, obtain quantitative values for at 

least 80 percent of the total specimen 

validity test challenges over two 

consecutive PT cycles that satisfy the 

following criteria: 

(i) Creatinine concentrations are no 

more than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

mean; and 

(ii) Specific gravity values are no 

more than ±0.001 specific gravity units 

from the appropriate reference or peer 

group mean; and 

(6) Obtain no more than one 

quantitative value over 2 consecutive PT 

cycles on a specimen validity test PT 

sample that differs from the appropriate 

reference or peer group mean by more 

than ±50 percent for creatinine 

concentration, or ±0.002 specific gravity 

units for specific gravity. 

(b) Failure to participate in all PT 

cycles or to satisfy these requirements 

may result in suspension or revocation 

of an HHS-certified IITF’s certification. 

Section 9.10 What are the inspection 

requirements for an applicant 

laboratory or IITF? 

(a) An applicant laboratory or IITF is 

inspected by a team of two inspectors. 

(b) Each inspector conducts an 

independent review and evaluation of 

all aspects of the laboratory’s or IITF’s 

testing procedures and facilities using 

an inspection checklist. 
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Section 9.11 What are the 

maintenance inspection requirements 

for an HHS-certified laboratory or IITF? 

(a) An HHS-certified laboratory or 

IITF must undergo an inspection 3 

months after becoming certified and at 

least every 6 months thereafter. 

(b) An HHS-certified laboratory or 

IITF is inspected by one or more 

inspectors. The number of inspectors is 

determined according to the number of 

specimens reviewed. Additional 

information regarding inspections is 

available from SAMHSA. 

(c) Each inspector conducts an 

independent evaluation and review of 

the HHS-certified laboratory’s or IITF’s 

procedures, records, and facilities using 

guidance provided by the Secretary. 

(d) To remain certified, an HHScertified laboratory or IITF must 

continue to satisfy the minimum 

requirements as stated in these 

Guidelines. 

Section 9.12 Who can inspect an HHScertified laboratory or IITF and when 

may the inspection be conducted? 

(a) An individual may be selected as 

an inspector for the Secretary if they 

satisfy the following criteria: 

(1) Has experience and an educational 

background similar to that required for 

either a responsible person or a 

certifying scientist for an HHS-certified 

laboratory as described in Subpart K or 

as a responsible technician for an HHScertified IITF as described in Subpart L; 

(2) Has read and thoroughly 

understands the policies and 

requirements contained in these 

Guidelines and in other guidance 

consistent with these Guidelines 

provided by the Secretary; 

(3) Submits a resume and 

documentation of qualifications to HHS; 

(4) Attends approved training; and 

(5) Performs acceptably as an 

inspector on an inspection of an HHScertified laboratory or IITF. 

(b) The Secretary or a federal agency 

may conduct an inspection at any time. 

Section 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? 

If an applicant laboratory or IITF fails 

to satisfy the requirements established 

for the initial certification process, the 

laboratory or IITF must start the 

certification process from the beginning. 

Section 9.14 What happens if an HHScertified laboratory or IITF does not 

satisfy the minimum requirements for 

either the PT program or the inspection 

program? 

(a) If an HHS-certified laboratory or 

IITF fails to satisfy the minimum 

requirements for certification, the 

laboratory or IITF is given a period of 

time (e.g., 5 or 30 working days 

depending on the nature of the 

deficiency) to provide any explanation 

for its performance and evidence that all 

deficiencies have been corrected. 

(b) A laboratory’s or IITF’s HHS 

certification may be revoked, 

suspended, or no further action taken 

depending on the seriousness of the 

deficiencies and whether there is 

evidence that the deficiencies have been 

corrected and that current performance 

meets the requirements for certification. 

(c) An HHS-certified laboratory or 

IITF may be required to undergo a 

special inspection or to test additional 

PT samples to address deficiencies. 

(d) If an HHS-certified laboratory’s or 

IITF’s certification is revoked or 

suspended in accordance with the 

process described in Subpart P, the 

laboratory or IITF is not permitted to 

test federally regulated specimens until 

the suspension is lifted or the laboratory 

or IITF has successfully completed the 

certification requirements as a new 

applicant laboratory or IITF. 

Section 9.15 What factors are 

considered in determining whether 

revocation of a laboratory’s or IITF’s 

HHS certification is necessary? 

(a) The Secretary shall revoke 

certification of an HHS-certified 

laboratory or IITF in accordance with 

these Guidelines if the Secretary 

determines that revocation is necessary 

to ensure fully reliable and accurate 

drug and specimen validity test results 

and reports. 

(b) The Secretary shall consider the 

following factors in determining 

whether revocation is necessary: 

(1) Unsatisfactory performance in 

analyzing and reporting the results of 

drug and specimen validity tests (e.g., 

an HHS-certified laboratory reporting a 

false positive result for an employee’s 

drug test); 

(2) Unsatisfactory participation in 

performance testing or inspections; 

(3) A material violation of a 

certification standard, contract term, or 

other condition imposed on the HHScertified laboratory or IITF by a federal 

agency using the laboratory’s or IITF’s 

services; 

(4) Conviction for any criminal 

offense committed as an incident to 

operation of the HHS-certified 

laboratory or IITF; or 

(5) Any other cause that materially 

affects the ability of the HHS-certified 

laboratory or IITF to ensure fully 

reliable and accurate drug test results 

and reports. 

(c) The period and terms of revocation 

shall be determined by the Secretary 

and shall depend upon the facts and 

circumstances of the revocation and the 

need to ensure accurate and reliable 

drug testing. 

Section 9.16 What factors are 

considered in determining whether to 

suspend a laboratory’s or IITF’s HHS 

certification? 

(a) The Secretary may immediately 

suspend (either partially or fully) a 

laboratory’s or IITF’s HHS certification 

to conduct drug testing for federal 

agencies if the Secretary has reason to 

believe that revocation may be required 

and that immediate action is necessary 

to protect the interests of the United 

States and its employees. 

(b) The Secretary shall determine the 

period and terms of suspension based 

upon the facts and circumstances of the 

suspension and the need to ensure 

accurate and reliable drug testing. 

Section 9.17 How does the Secretary 

notify an HHS-certified laboratory or 

IITF that action is being taken against 

the laboratory or IITF? 

(a) When laboratory’s or IITF’s HHS 

certification is suspended or the 

Secretary seeks to revoke HHS 

certification, the Secretary shall 

immediately serve the HHS-certified 

laboratory or IITF with written notice of 

the suspension or proposed revocation 

by facsimile, mail, personal service, or 

registered or certified mail, return 

receipt requested. This notice shall state 

the following: 

(1) The reasons for the suspension or 

proposed revocation; 

(2) The terms of the suspension or 

proposed revocation; and 

(3) The period of suspension or 

proposed revocation. 

(b) The written notice shall state that 

the laboratory or IITF will be afforded 

an opportunity for an informal review of 

the suspension or proposed revocation 

if it so requests in writing within 30 

days of the date the laboratory or IITF 

received the notice, or if expedited 

review is requested, within 3 days of the 

date the laboratory or IITF received the 

notice. Subpart P contains detailed 

procedures to be followed for an 

informal review of the suspension or 

proposed revocation. 

(c) A suspension must be effective 

immediately. A proposed revocation 
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must be effective 30 days after written 

notice is given or, if review is requested, 

upon the reviewing official’s decision to 

uphold the proposed revocation. If the 

reviewing official decides not to uphold 

the suspension or proposed revocation, 

the suspension must terminate 

immediately and any proposed 

revocation shall not take effect. 

(d) The Secretary will publish in the 

Federal Register the name, address, and 

telephone number of any HHS-certified 

laboratory or IITF that has its 

certification revoked or suspended 

under Section 9.13 or Section 9.14, 

respectively, and the name of any HHScertified laboratory or IITF that has its 

suspension lifted. The Secretary shall 

provide to any member of the public 

upon request the written notice 

provided to a laboratory or IITF that has 

its HHS certification suspended or 

revoked, as well as the reviewing 

official’s written decision which 

upholds or denies the suspension or 

proposed revocation under the 

procedures of Subpart P. 

Section 9.18 May a laboratory or IITF 

that had its HHS certification revoked 

be recertified to test federal agency 

specimens? 

Following revocation, a laboratory or 

IITF may apply for recertification. 

Unless otherwise provided by the 

Secretary in the notice of revocation 

under Section 9.17 or the reviewing 

official’s decision under Section 16.9(e) 

or 16.14(a), a laboratory or IITF which 

has had its certification revoked may 

reapply for HHS certification as an 

applicant laboratory or IITF. 

Section 9.19 Where is the list of HHScertified laboratories and IITFs 

published? 

(a) The list of HHS-certified 

laboratories and IITFs is published 

monthly in the Federal Register. This 

notice is also available on the Internet 

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

(b) An applicant laboratory or IITF is 

not included on the list. 

Subpart J—Blind Samples Submitted by 

an Agency 

Section 10.1 What are the requirements 

for federal agencies to submit blind 

samples to HHS-certified laboratories or 

IITFs? 

(a) Each federal agency is required to 

submit blind samples for its workplace 

drug testing program. The collector 

must send the blind samples to the 

HHS-certified laboratory or IITF that the 

collector sends employee specimens. 

(b) Each federal agency must submit 

at least 3 percent blind samples along 

with its donor specimens based on the 

projected total number of donor 

specimens collected per year (up to a 

maximum of 400 blind samples). Every 

effort should be made to ensure that 

blind samples are submitted quarterly. 

(c) Approximately 75 percent of the 

blind samples submitted each year by 

an agency must be negative, 15 percent 

must be positive for one or more drugs, 

and 10 percent must either be 

adulterated or substituted. 

Section 10.2 What are the 

requirements for blind samples? 

(a) Drug positive blind samples must 

be validated by the supplier as to their 

content using appropriate initial and 

confirmatory tests. 

(1) Drug positive blind samples must 

be fortified with one or more of the 

drugs or metabolites listed in Section 

3.4. 

(2) Drug positive blind samples must 

contain concentrations of drugs between 

1.5 and 2 times the initial drug test 

cutoff concentration. 

(b) Drug negative blind samples (i.e., 

certified to contain no drugs) must be 

validated by the supplier as negative 

using appropriate initial and 

confirmatory tests. 

(c) A blind sample that is adulterated 

must be validated using appropriate 

initial and confirmatory specimen 

validity tests, and have the 

characteristics to clearly show that it is 

an adulterated sample at the time of 

validation. 

(d) A blind sample that is substituted 

must be validated using appropriate 

initial and confirmatory specimen 

validity tests, and have the 

characteristics to clearly show that it is 

a substituted sample at the time of 

validation. 

(e) The supplier must provide 

information on the blind samples’ 

content, validation, expected results, 

and stability to the collection site/ 

collector sending the blind samples to 

the laboratory or IITF, and must provide 

the information upon request to the 

MRO, the federal agency for which the 

blind sample was submitted, or the 

Secretary. 

Section 10.3 How is a blind sample 

submitted to an HHS-certified 

laboratory or IITF? 

(a) A blind sample must be submitted 

as a split specimen (specimens A and B) 

with the current Federal CCF that the 

HHS-certified laboratory or IITF uses for 

donor specimens. The collector 

provides the required information to 

ensure that the Federal CCF has been 

properly completed and provides 

fictitious initials on the specimen label/ 

seal. The collector must indicate that 

the specimen is a blind sample on the 

MRO copy where a donor would 

normally provide a signature. 

(b) A collector should attempt to 

distribute the required number of blind 

samples randomly with donor 

specimens rather than submitting the 

full complement of blind samples as a 

single group. 

Section 10.4 What happens if an 

inconsistent result is reported for a 

blind sample? 

If an HHS-certified laboratory or IITF 

reports a result for a blind sample that 

is inconsistent with the expected result 

(e.g., a laboratory or IITF reports a 

negative result for a blind sample that 

was supposed to be positive, a 

laboratory reports a positive result for a 

blind sample that was supposed to be 

negative): 

(a) The MRO must contact the 

laboratory or IITF and attempt to 

determine if the laboratory or IITF made 

an error during the testing or reporting 

of the sample; 

(b) The MRO must contact the blind 

sample supplier and attempt to 

determine if the supplier made an error 

during the preparation or transfer of the 

sample; 

(c) The MRO must contact the 

collector and determine if the collector 

made an error when preparing the blind 

sample for transfer to the HHS-certified 

laboratory or IITF; 

(d) If there is no obvious reason for 

the inconsistent result, the MRO must 

notify both the federal agency for which 

the blind sample was submitted and the 

Secretary; and 

(e) The Secretary shall investigate the 

blind sample error. A report of the 

Secretary’s investigative findings and 

the corrective action taken in response 

to identified deficiencies must be sent to 

the federal agency. The Secretary shall 

ensure notification of the finding as 

appropriate to other federal agencies 

and coordinate any necessary actions to 

prevent the recurrence of the error. 

Subpart K—Laboratory 

Section 11.1 What must be included in 

the HHS-certified laboratory’s standard 

operating procedure manual? 

(a) An HHS-certified laboratory must 

have a standard operating procedure 

(SOP) manual that describes, in detail, 

all HHS-certified laboratory operations. 

When followed, the SOP manual 

ensures that all specimens are tested 

using the same procedures. 

(b) The SOP manual must include at 

a minimum, but is not limited to, a 

detailed description of the following: 
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(1) Chain of custody procedures; 

(2) Accessioning; 

(3) Security; 

(4) Quality control/quality assurance 

programs; 

(5) Analytical methods and 

procedures; 

(6) Equipment and maintenance 

programs; 

(7) Personnel training; 

(8) Reporting procedures; and 

(9) Computers, software, and 

laboratory information management 

systems. 

(c) All procedures in the SOP manual 

must be compliant with these 

Guidelines and all guidance provided 

by the Secretary. 

(d) A copy of all procedures that have 

been replaced or revised and the dates 

on which the procedures were in effect 

must be maintained for at least 2 years. 

Section 11.2 What are the 

responsibilities of the responsible 

person (RP)? 

(a) Manage the day-to-day operations 

of the HHS-certified laboratory even if 

another individual has overall 

responsibility for alternate areas of a 

multi-specialty laboratory. 

(b) Ensure that there are sufficient 

personnel with adequate training and 

experience to supervise and conduct the 

work of the HHS-certified laboratory. 

The RP must ensure the continued 

competency of laboratory staff by 

documenting their in-service training, 

reviewing their work performance, and 

verifying their skills. 

(c) Maintain a complete and current 

SOP manual that is available to all 

personnel of the HHS-certified 

laboratory and ensure that it is followed. 

The SOP manual must be reviewed, 

signed, and dated by the RP(s) when 

procedures are first placed into use and 

when changed or when a new 

individual assumes responsibility for 

the management of the HHS-certified 

laboratory. The SOP must be reviewed 

and documented by the RP annually. 

(d) Maintain a quality assurance 

program that ensures the proper 

performance and reporting of all test 

results; verify and monitor acceptable 

analytical performance for all controls 

and calibrators; monitor quality control 

testing; and document the validity, 

reliability, accuracy, precision, and 

performance characteristics of each test 

and test system. 

(e) Initiate and implement all 

remedial actions necessary to maintain 

satisfactory operation and performance 

of the HHS-certified laboratory in 

response to the following: Quality 

control systems not within performance 

specifications; errors in result reporting 

or in analysis of performance testing 

samples; and inspection deficiencies. 

The RP must ensure that specimen 

results are not reported until all 

corrective actions have been taken and 

that the results provided are accurate 

and reliable. 

Section 11.3 What scientific 

qualifications must the RP have? 

The RP must have documented 

scientific qualifications in analytical 

toxicology. 

Minimum qualifications are: 

(a) Certification or licensure as a 

laboratory director by the state in 

forensic or clinical laboratory 

toxicology, a Ph.D. in one of the natural 

sciences, or training and experience 

comparable to a Ph.D. in one of the 

natural sciences with training and 

laboratory/research experience in 

biology, chemistry, and pharmacology 

or toxicology; 

(b) Experience in forensic toxicology 

with emphasis on the collection and 

analysis of biological specimens for 

drugs of abuse; 

(c) Experience in forensic applications 

of analytical toxicology (e.g., 

publications, court testimony, 

conducting research on the 

pharmacology and toxicology of drugs 

of abuse) or qualify as an expert witness 

in forensic toxicology; 

(d) Fulfillment of the RP 

responsibilities and qualifications, as 

demonstrated by the HHS-certified 

laboratory’s performance and verified 

upon interview by HHS-trained 

inspectors during each on-site 

inspection; and 

(e) Qualify as a certifying scientist. 

Section 11.4 What happens when the 

RP is absent or leaves an HHS-certified 

laboratory? 

(a) HHS-certified laboratories must 

have multiple RPs or one RP and an 

alternate RP. If the RP(s) are 

concurrently absent, an alternate RP 

must be present and qualified to fulfill 

the responsibilities of the RP. 

(1) If an HHS-certified laboratory is 

without the RP and alternate RP for 14 

calendar days or less (e.g., temporary 

absence due to vacation, illness, or 

business trip), the HHS-certified 

laboratory may continue operations and 

testing of federal agency specimens 

under the direction of a certifying 

scientist. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

specimens if the laboratory does not 

have an RP or alternate RP for a period 

of more than 14 calendar days. The 

suspension will be lifted upon the 

Secretary’s approval of a new 

permanent RP or alternate RP. 

(b) If the RP leaves an HHS-certified 

laboratory: 

(1) The HHS-certified laboratory may 

maintain certification and continue 

testing federally regulated specimens 

under the direction of an alternate RP 

for a period of up to 180 days while 

seeking to hire and receive the 

Secretary’s approval of the RP’s 

replacement. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

federally regulated specimens if the 

laboratory does not have a permanent 

RP within 180 days. The suspension 

will be lifted upon the Secretary’s 

approval of the new permanent RP. 

(c) To nominate an individual as an 

RP or alternate RP, the HHS-certified 

laboratory must submit the following 

documents to the Secretary: The 

candidate’s current resume or 

curriculum vitae, copies of diplomas 

and licensures, a training plan (not to 

exceed 90 days) to transition the 

candidate into the position, an itemized 

comparison of the candidate’s 

qualifications to the minimum RP 

qualifications described in the 

Guidelines, and have official academic 

transcript(s) submitted from the 

candidate’s institution(s) of higher 

learning. The candidate must be found 

qualified during an on-site inspection of 

the HHS-certified laboratory. 

(d) The HHS-certified laboratory must 

fulfill additional inspection and PT 

criteria as required prior to conducting 

federally regulated testing under a new 

RP. 

Section 11.5 What qualifications must 

an individual have to certify a result 

reported by an HHS-certified 

laboratory? 

(a) A certifying scientist must have: 

(1) At least a bachelor’s degree in the 

chemical or biological sciences or 

medical technology, or equivalent; 

(2) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 

(3) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

(b) A certifying technician must have: 

(1) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 
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(2) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

Section 11.6 What qualifications and 

training must other personnel of an 

HHS-certified laboratory have? 

(a) All HHS-certified laboratory staff 

(e.g., technicians, administrative staff) 

must have the appropriate training and 

skills for the tasks they perform. 

(b) Each individual working in an 

HHS-certified laboratory must be 

properly trained (i.e., receive training in 

each area of work that the individual 

will be performing, including training in 

forensic procedures related to their job 

duties) before they are permitted to 

work independently with federally 

regulated specimens. All training must 

be documented. 

Section 11.7 What security measures 

must an HHS-certified laboratory 

maintain? 

(a) An HHS-certified laboratory must 

control access to the drug testing 

facility, specimens, aliquots, and 

records. 

(b) Authorized visitors must be 

escorted at all times, except for 

individuals conducting inspections (i.e., 

for the Department, a federal agency, a 

state, or other accrediting agency) or 

emergency personnel (e.g., firefighters 

and medical rescue teams). 

(c) An HHS-certified laboratory must 

maintain records documenting the 

identity of the visitor and escort, date, 

time of entry and exit, and purpose for 

access to the secured area. 

Section 11.8 What are the laboratory 

chain of custody requirements for 

specimens and aliquots? 

(a) HHS-certified laboratories must 

use chain of custody procedures 

(internal and external) to maintain 

control and accountability of specimens 

from the time of receipt at the laboratory 

through completion of testing, reporting 

of results, during storage, and 

continuing until final disposition of the 

specimens. 

(b) HHS-certified laboratories must 

use chain of custody procedures to 

document the handling and transfer of 

aliquots throughout the testing process 

until final disposal. 

(c) The chain of custody must be 

documented using either paper copy or 

electronic procedures. 

(d) Each individual who handles a 

specimen or aliquot must sign and 

complete the appropriate entries on the 

chain of custody form when the 

specimen or aliquot is handled or 

transferred, and every individual in the 

chain must be identified. 

(e) The date and purpose must be 

recorded on an appropriate chain of 

custody form each time a specimen or 

aliquot is handled or transferred. 

Section 11.9 What test(s) does an 

HHS-certified laboratory conduct on a 

urine specimen received from an IITF? 

An HHS-certified laboratory must test 

the specimen in the same manner as a 

specimen that had not been previously 

tested. 

Section 11.10 What are the 

requirements for an initial drug test? 

(a) An initial drug test may be: 

(1) An immunoassay or 

(2) An alternate technology (e.g., 

spectrometry, spectroscopy). 

(b) An HHS-certified laboratory must 

validate an initial drug test before 

testing specimens. 

(c) Initial drug tests must be accurate 

and reliable for the testing of specimens 

when identifying drugs or their 

metabolites. 

(d) An HHS-certified laboratory may 

conduct a second initial drug test using 

a method with different specificity, to 

rule out cross-reacting compounds. This 

second initial drug test must satisfy the 

batch quality control requirements 

specified in Section 11.12. 

Section 11.11 What must an HHScertified laboratory do to validate an 

initial drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each initial drug test: 

(1) The ability to differentiate negative 

specimens from those requiring further 

testing; 

(2) The performance of the test around 

the cutoff concentration, using samples 

at several concentrations between 0 and 

150 percent of the cutoff concentration; 

(3) The effective concentration range 

of the test (linearity); 

(4) The potential for carryover; 

(5) The potential for interfering 

substances; and 

(6) The potential matrix effects if 

using an alternate technology. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) Each initial drug test using an 

alternate technology must be re-verified 

periodically or at least annually. 

Section 11.12 What are the batch 

quality control requirements when 

conducting an initial drug test? 

(a) Each batch of specimens must 

contain the following controls: 

(1) At least one control certified to 

contain no drug or drug metabolite; 

(2) At least one positive control with 

the drug or drug metabolite targeted at 

a concentration 25 percent above the 

cutoff; 

(3) At least one control with the drug 

or drug metabolite targeted at a 

concentration 75 percent of the cutoff; 

and 

(4) At least one control that appears 

as a donor specimen to the analysts. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.13 What are the 

requirements for a confirmatory drug 

test? 

(a) The analytical method must use 

mass spectrometric identification [e.g., 

gas chromatography/mass spectrometry 

(GC/MS), liquid chromatography/mass 

spectrometry (LC/MS), GC/MS/MS, LC/ 

MS/MS] or equivalent. 

(b) A confirmatory drug test must be 

validated before it can be used to test 

federally regulated specimens. 

(c) Confirmatory drug tests must be 

accurate and reliable for the testing of a 

urine specimen when identifying and 

quantifying drugs or their metabolites. 

Section 11.14 What must an HHScertified laboratory do to validate a 

confirmatory drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each confirmatory drug 

test: 

(1) The linear range of the analysis; 

(2) The limit of detection; 

(3) The limit of quantification; 

(4) The accuracy and precision at the 

cutoff concentration; 

(5) The accuracy (bias) and precision 

at 40 percent of the cutoff concentration; 

(6) The potential for interfering 

substances; 

(7) The potential for carryover; and 

(8) The potential matrix effects if 

using liquid chromatography coupled 

with mass spectrometry. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) HHS-certified laboratories must reverify each confirmatory drug test 

method periodically or at least annually. 

Section 11.15 What are the batch 

quality control requirements when 

conducting a confirmatory drug test? 

(a) At a minimum, each batch of 

specimens must contain the following 

calibrators and controls: 

(1) A calibrator at the cutoff 

concentration; 

(2) At least one control certified to 

contain no drug or drug metabolite; 
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(3) At least one positive control with 

the drug or drug metabolite targeted at 

25 percent above the cutoff; and 

(4) At least one control targeted at or 

less than 40 percent of the cutoff. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.16 What are the analytical 

and quality control requirements for 

conducting specimen validity tests? 

(a) Each invalid, adulterated, or 

substituted specimen validity test result 

must be based on an initial specimen 

validity test on one aliquot and a 

confirmatory specimen validity test on a 

second aliquot; 

(b) The HHS-certified laboratory must 

establish acceptance criteria and 

analyze calibrators and controls as 

appropriate to verify and document the 

validity of the test results (required 

specimen validity tests are addressed in 

Section 11.18); and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 11.17 What must an HHScertified laboratory do to validate a 

specimen validity test? 

An HHS-certified laboratory must 

demonstrate and document for each 

specimen validity test the appropriate 

performance characteristics of the test, 

and must re-verify the test periodically, 

or at least annually. Each new lot of 

reagent must be verified prior to being 

placed into service. 

Section 11.18 What are the 

requirements for conducting each 

specimen validity test? 

(a) The requirements for measuring 

creatinine concentration are as follows: 

(1) The creatinine concentration must 

be measured to one decimal place on 

both the initial creatinine test and the 

confirmatory creatinine test; 

(2) The initial creatinine test must 

have the following calibrators and 

controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; 

(iii) A control in the range of 3 mg/ 

dL to 20 mg/dL; and 

(iv) A control in the range of 21 mg/ 

dL to 25 mg/dL. 

(3) The confirmatory creatinine test 

(performed on those specimens with a 

creatinine concentration less than 2 mg/ 

dL on the initial test) must have the 

following calibrators and controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; and 

(iii) A control in the range of 3 mg/ 

dL to 4 mg/dL. 

(b) The requirements for measuring 

specific gravity are as follows: 

(1) For specimens with initial 

creatinine test results greater than 5 mg/ 

dL and less than 20 mg/dL, laboratories 

may perform a screening test using a 

refractometer that measures urine 

specific gravity to at least three decimal 

places to identify specific gravity values 

that are acceptable (equal to or greater 

than 1.003) or dilute (equal to or greater 

than 1.002 and less than 1.003). 

Specimens must be subjected to an 

initial specific gravity test using a four 

decimal place refractometer when the 

initial creatinine test result is less than 

or equal to 5 mg/dL or when the 

screening specific gravity test result 

using a three decimal place 

refractometer is less than 1.002. 

(2) The screening specific gravity test 

must have the following calibrators and 

controls: 

(i) A calibrator or control at 1.000; 

(ii) One control targeted at 1.002; 

(iii) One control in the range of 1.004 

to 1.018. 

(3) For the initial and confirmatory 

specific gravity tests, the refractometer 

must report and display specific gravity 

to four decimal places. The 

refractometer must be interfaced with a 

laboratory information management 

system (LIMS), computer, and/or 

generate a paper copy of the digital 

electronic display to document the 

numerical values of the specific gravity 

test results; 

(4) The initial and confirmatory 

specific gravity tests must have the 

following calibrators and controls: 

(i) A calibrator or control at 1.0000; 

(ii) One control targeted at 1.0020; 

(iii) One control in the range of 1.0040 

to 1.0180; and 

(iv) One control equal to or greater 

than 1.0200 but not greater than 1.0250. 

(c) Requirements for measuring pH 

are as follows: 

(1) Colorimetric pH tests that have the 

dynamic range of 3 to 12 to support the 

4 and 11 pH cutoffs and pH meters must 

be capable of measuring pH to one 

decimal place. Colorimetric pH tests, 

dipsticks, and pH paper (i.e., screening 

tests) that have a narrow dynamic range 

and do not support the cutoffs may be 

used only to determine if an initial pH 

specimen validity test must be 

performed; 

(2) For the initial and confirmatory 

pH tests, the pH meter must report and 

display pH to at least one decimal place. 

The pH meter must be interfaced with 

a LIMS, computer, and/or generate a 

paper copy of the digital electronic 

display to document the numerical 

values of the pH test results; 

(3) pH screening tests must have, at a 

minimum, the following controls: 

(i) One control below the lower 

decision point in use; 

(ii) One control between the decision 

points in use; and 

(iii) One control above the upper 

decision point in use; 

(4) An initial colorimetric pH test 

must have the following calibrators and 

controls: 

(i) One calibrator at 4; 

(ii) One calibrator at 11; 

(iii) One control in the range of 3 to 

3.8; 

(iv) One control in the range 4.2 to 5; 

(v) One control in the range of 5 to 9; 

(vi) One control in the range of 10 to 

10.8; and 

(vii) One control in the range of 11.2 

to 12; 

(5) An initial pH meter test, if a pH 

screening test is not used, must have the 

following calibrators and controls: 

(i) One calibrator at 3; 

(ii) One calibrator at 7; 

(iii) One calibrator at 10; 

(iv) One control in the range of 3 to 

3.8; 

(v) One control in the range 4.2 to 5; 

(vi) One control in the range of 10 to 

10.8; and 

(vii) One control in the range of 11.2 

to 12; 

(6) An initial pH meter test (if a pH 

screening test is used) or confirmatory 

pH meter test must have the following 

calibrators and controls when the result 

of the preceding pH test indicates that 

the pH is below the lower decision 

point in use: 

(i) One calibrator at 4; 

(ii) One calibrator at 7; 

(iii) One control in the range of 3 to 

3.8; and 

(iv) One control in the range 4.2 to 5; 

and 

(7) An initial pH meter test (if a pH 

screening test is used) or confirmatory 

pH meter test must have the following 

calibrators and controls when the result 

of the preceding pH test indicates that 

the pH is above the upper decision 

point in use: 

(i) One calibrator at 7; 

(ii) One calibrator at 10; 

(iii) One control in the range of 10 to 

10.8; and 

(iv) One control in the range of 11.2 

to 12. 

(d) Requirements for performing 

oxidizing adulterant tests are as follows: 

(1) The initial test must include an 

appropriate calibrator at the cutoff 

specified in Sections 11.19(d)(2), (3), or 

(4) for the compound of interest, a 

control without the compound of 

interest (i.e., a certified negative 

control), and at least one control with 
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one of the compounds of interest at a 

measurable concentration; and 

(2) A confirmatory test for a specific 

oxidizing adulterant must use a 

different analytical method than that 

used for the initial test. Each 

confirmatory test batch must include an 

appropriate calibrator, a control without 

the compound of interest (i.e., a 

certified negative control), and a control 

with the compound of interest at a 

measurable concentration. 

(e) The requirements for measuring 

the nitrite concentration are that the 

initial and confirmatory nitrite tests 

must have a calibrator at the cutoff 

concentration, a control without nitrite 

(i.e., certified negative urine), one 

control in the range of 200 mcg/mL to 

250 mcg/mL, and one control in the 

range of 500 mcg/mL to 625 mcg/mL. 

Section 11.19 What are the 

requirements for an HHS-certified 

laboratory to report a test result? 

(a) Laboratories must report a test 

result to the agency’s MRO within an 

average of 5 working days after receipt 

of the specimen. Reports must use the 

Federal CCF and/or an electronic report. 

Before any test result can be reported, it 

must be certified by a certifying scientist 

or a certifying technician (as 

appropriate). 

(b) A primary (A) specimen is 

reported negative when each initial drug 

test is negative or if the specimen is 

negative upon confirmatory drug 

testing, and the specimen does not meet 

invalid criteria as described in items 

(h)(1) through (h)(12) below. 

(c) A primary (A) specimen is 

reported positive for a specific drug or 

drug metabolite when both the initial 

drug test is positive and the 

confirmatory drug test is positive in 

accordance with Section 3.4. 

(d) A primary (A) urine specimen is 

reported adulterated when: 

(1) 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; 

(2) 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., multiwavelength spectrophotometry, ion 

chromatography, capillary 

electrophoresis) on the second aliquot; 

(3) The presence of chromium (VI) is 

verified using either a general oxidant 

colorimetric test (with an equal to or 

greater than 50 mcg/mL chromium (VI)- 

equivalent cutoff) or a chromium (VI) 

colorimetric test (chromium (VI) 

concentration equal to or greater than 50 

mcg/mL) for the initial test on the first 

aliquot and a different confirmatory test 

(e.g., multi-wavelength 

spectrophotometry, ion 

chromatography, atomic absorption 

spectrophotometry, capillary 

electrophoresis, inductively coupled 

plasma-mass spectrometry) with the 

chromium (VI) concentration equal to or 

greater than the LOQ of the 

confirmatory test on the second aliquot; 

(4) The presence of halogen (e.g., 

bleach, iodine, fluoride) is verified 

using either a general oxidant 

colorimetric test (with an equal to or 

greater than 200 mcg/mL nitriteequivalent cutoff or an equal to or 

greater 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., multiwavelength 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; 

(5) 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 method (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; 

(6) 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 nitriteequivalent 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 

method (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; 

(7) 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 

(8) The presence of any other 

adulterant not specified in paragraphs 

d(2) through d(7) of this section is 

verified using an initial test on the first 

aliquot and a different confirmatory test 

on the second aliquot. 

(e) A primary (A) urine specimen is 

reported substituted when the 

creatinine concentration is less than 2 

mg/dL 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 creatinine tests (i.e., 

the same colorimetric test may be used 

to test both aliquots) and on both the 

initial and confirmatory specific gravity 

tests (i.e., a refractometer is used to test 

both aliquots) on two separate aliquots. 

(f) A primary (A) urine specimen is 

reported dilute when the creatinine 

concentration is equal to or greater than 

2 mg/dL but less than 20 mg/dL and the 

specific gravity is greater than 1.0010 

but less than 1.0030 on a single aliquot. 

(g) For a specimen that has an invalid 

result for one of the reasons stated in 

items (h)(4) through (h)(12) below, the 

HHS-certified laboratory shall contact 

the MRO and both will decide if testing 

by another HHS-certified laboratory 

would be useful in being able to report 

a positive or adulterated result. If no 

further testing is necessary, the HHScertified laboratory then reports the 

invalid result to the MRO. 

(h) A primary (A) urine specimen is 

reported as an invalid result when: 

(1) 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); 

(2) 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; 

(3) 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 
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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; 

(4) 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; 

(5) 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; 

(6) 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; 

(7) 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 nitriteequivalent 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; 

(8) The possible presence of a 

surfactant is determined by using the 

same surfactant colorimetric test with 

an equal to or 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; 

(9) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid initial drug test results cannot be 

obtained); 

(10) Interference with the 

confirmatory drug test occurs on at least 

two separate aliquots of the specimen 

and the HHS-certified laboratory is 

unable to identify the interfering 

substance; 

(11) The physical appearance of the 

specimen is such that testing the 

specimen may damage the laboratory’s 

instruments; or 

(12) The physical appearances of the 

A and B specimens are clearly different 

(note: A is tested). 

(i) An HHS-certified laboratory shall 

reject a primary (A) specimen for testing 

when a fatal flaw occurs as described in 

Section 15.1 or when a correctable flaw 

as described in Section 15.2 is not 

recovered. The HHS-certified laboratory 

will indicate on the Federal CCF that 

the specimen was rejected for testing 

and provide the reason for reporting the 

rejected for testing result. 

(j) An HHS-certified laboratory must 

report all positive, adulterated, 

substituted, and invalid test results for 

a urine specimen. For example, a 

specimen can be positive for a specific 

drug and adulterated. 

(k) An HHS-certified laboratory must 

report the confirmatory concentration of 

each drug or drug metabolite reported 

for a positive result. 

(l) An HHS-certified laboratory must 

report numerical values of the specimen 

validity test results that support a 

specimen that is reported adulterated, 

substituted, or invalid (as appropriate). 

(m) When the concentration of a drug 

or drug metabolite exceeds the validated 

linear range of the confirmatory test, 

HHS-certified laboratories may report to 

the MRO that the quantitative value 

exceeds the linear range of the test or 

that the quantitative value is greater 

than ‘‘insert the actual value for the 

upper limit of the linear range,’’ or 

laboratories may report a quantitative 

value above the upper limit of the linear 

range that was obtained by diluting an 

aliquot of the specimen to achieve a 

result within the method’s linear range 

and multiplying the result by the 

appropriate dilution factor. 

(n) HHS-certified laboratories may 

transmit test results to the MRO by 

various electronic means (e.g., 

teleprinter, facsimile, or computer). 

Transmissions of the reports must 

ensure confidentiality and the results 

may not be reported verbally by 

telephone. Laboratories and external 

service providers must ensure the 

confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(o) HHS-certified laboratories must 

facsimile, courier, mail, or electronically 

transmit a legible image or copy of the 

completed Federal CCF and/or forward 

a computer-generated electronic report. 

The computer-generated report must 

contain sufficient information to ensure 

that the test results can accurately 

represent the content of the custody and 

control form that the MRO received 

from the collector. 

(p) For positive, adulterated, 

substituted, invalid, and rejected 

specimens, laboratories must facsimile, 

courier, mail, or electronically transmit 

a legible image or copy of the completed 

Federal CCF. 

Section 11.20 How long must an HHScertified laboratory retain specimens? 

(a) An HHS-certified laboratory must 

retain specimens that were reported as 

positive, adulterated, substituted, or as 

an invalid result for a minimum of 1 

year. 

(b) Retained specimens must be kept 

in secured frozen storage (¥20 °C or 

less) to ensure their availability for 

retesting during an administrative or 

judicial proceeding. 

(c) Federal agencies may request that 

the HHS-certified laboratory retain a 

specimen for an additional specified 

period of time and must make that 

request within the 1-year period. 

Section 11.21 How long must an HHScertified laboratory retain records? 

(a) An HHS-certified laboratory must 

retain all records generated to support 

test results for at least 2 years. The 

laboratory may convert hardcopy 

records to electronic records for storage 

and then discard the hardcopy records 

after 6 months. 

(b) A federal agency may request the 

HHS-certified laboratory to maintain a 

documentation package (as described in 

Section 11.23) that supports the chain of 

custody, testing, and reporting of a 

donor’s specimen that is under legal 

challenge by a donor. The federal 

agency’s request to the laboratory must 

be in writing and must specify the 

period of time to maintain the 

documentation package. 

(c) An HHS-certified laboratory may 

retain records other than those included 

in the documentation package beyond 

the normal 2-year period of time. 

Section 11.22 What statistical 

summary reports must an HHS-certified 

laboratory provide for urine testing? 

(a) HHS-certified laboratories must 

provide to each federal agency for 

which they perform testing a 

semiannual statistical summary report 

that must be submitted by mail, 

facsimile, or email within 14 working 

days after the end of the semiannual 

period. The summary report must not 

include any personal identifying 

information. A copy of the semiannual 

statistical summary report will also be 

sent to the Secretary or designated HHS 

representative. The semiannual 

statistical report contains the following 

information: 

(1) Reporting period (inclusive dates); 

(2) HHS-certified laboratory name and 

address; 

(3) Federal agency name; 
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(4) Number of specimen results 

reported; 

(5) Number of specimens collected by 

reason for test; 

(6) Number of specimens reported 

negative and the number reported 

negative/dilute; 

(7) Number of specimens rejected for 

testing because of a fatal flaw; 

(8) Number of specimens rejected for 

testing because of an uncorrected flaw; 

(9) Number of specimens tested 

positive by each initial drug test; 

(10) Number of specimens reported 

positive; 

(11) Number of specimens reported 

positive for each drug and drug 

metabolite; 

(12) Number of specimens reported 

adulterated; 

(13) Number of specimens reported 

substituted; and 

(14) Number of specimens reported as 

invalid result. 

(b) An HHS-certified laboratory must 

make copies of an agency’s test results 

available when requested to do so by the 

Secretary or by the federal agency for 

which the laboratory is performing 

drug-testing services. 

(c) An HHS-certified laboratory must 

ensure that a qualified individual is 

available to testify in a proceeding 

against a federal employee when the 

proceeding is based on a test result 

reported by the laboratory. 

Section 11.23 What HHS-certified 

laboratory information is available to a 

federal agency? 

(a) Following a federal agency’s 

receipt of a positive, adulterated, or 

substituted drug test report, the federal 

agency may submit a written request for 

copies of the records relating to the drug 

test results or a documentation package 

or any relevant certification, review, or 

revocation of certification records. 

(b) Standard documentation packages 

provided by an HHS-certified laboratory 

must contain the following items: 

(1) A cover sheet providing a brief 

description of the procedures and tests 

performed on the donor’s specimen; 

(2) A table of contents that lists all 

documents and materials in the package 

by page number; 

(3) A copy of the Federal CCF with 

any attachments, internal chain of 

custody records for the specimen, 

memoranda (if any) generated by the 

HHS-certified laboratory, and a copy of 

the electronic report (if any) generated 

by the HHS-certified laboratory; 

(4) A brief description of the HHScertified laboratory’s initial drug and 

specimen validity testing procedures, 

instrumentation, and batch quality 

control requirements; 

(5) Copies of the initial test data for 

the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the initial tests; 

(6) A brief description of the HHScertified laboratory’s confirmatory drug 

(and specimen validity, if applicable) 

testing procedures, instrumentation, and 

batch quality control requirements; 

(7) Copies of the confirmatory test 

data for the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the confirmatory tests; and 

(8) Copies of the re ́sume ́ or 

curriculum vitae for the RP(s) and the 

certifying technician or certifying 

scientist of record. 

Section 11.24 What HHS-certified 

laboratory information is available to a 

federal employee? 

A federal employee who is the subject 

of a workplace drug test may submit a 

written request through the MRO and/ 

or the federal agency requesting copies 

of any records relating to the employee’s 

drug test results or a documentation 

package as described in Section 11.23(b) 

and any relevant certification, review, or 

revocation of certification records. 

Federal employees, or their designees, 

are not permitted access to their 

specimens collected pursuant to 

Executive Order 12564, Public Law 

100–71, and these Guidelines. 

Section 11.25 What types of 

relationships are prohibited between an 

HHS-certified laboratory and an MRO? 

An HHS-certified laboratory must not 

enter into any relationship with a 

federal agency’s MRO that may be 

construed as a potential conflict of 

interest or derive any financial benefit 

by having a federal agency use a specific 

MRO. 

This means an MRO may be an 

employee of the agency or a contractor 

for the agency; however, an MRO shall 

not be an employee or agent of or have 

any financial interest in the HHScertified laboratory for which the MRO 

is reviewing drug testing results. 

Additionally, an MRO shall not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or have any agreement with 

an HHS-certified laboratory that may be 

construed as a potential conflict of 

interest. 

Section 11.26 What type of 

relationship can exist between an HHScertified laboratory and an HHScertified IITF? 

An HHS-certified laboratory can enter 

into any relationship with an HHScertified IITF. 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

Section 12.1 What must be included in 

the HHS-certified IITF’s standard 

operating procedure manual? 

(a) An HHS-certified IITF must have 

a standard operating procedure (SOP) 

manual that describes, in detail, all 

HHS-certified IITF operations. When 

followed, the SOP manual ensures that 

all specimens are tested consistently 

using the same procedures. 

(b) The SOP manual must include at 

a minimum, but is not limited to, a 

detailed description of the following: 

(1) Chain of custody procedures; 

(2) Accessioning; 

(3) Security; 

(4) Quality control/quality assurance 

programs; 

(5) Analytical methods and 

procedures; 

(6) Equipment and maintenance 

programs; 

(7) Personnel training; 

(8) Reporting procedures; and 

(9) Computers, software, and 

laboratory information management 

systems. 

(c) All procedures in the SOP manual 

must be compliant with these 

Guidelines and all guidance provided 

by the Secretary. 

(d) A copy of all procedures that have 

been replaced or revised and the dates 

on which the procedures were in effect 

must be maintained for two years. 

Section 12.2 What are the 

responsibilities of the responsible 

technician (RT)? 

(a) Manage the day-to-day operations 

of the HHS-certified IITF even if another 

individual has overall responsibility for 

alternate areas of a multi-specialty 

facility. 

(b) Ensure that there are sufficient 

personnel with adequate training and 

experience to supervise and conduct the 

work of the HHS-certified IITF. The RT 

must ensure the continued competency 

of IITF personnel by documenting their 

in-service training, reviewing their work 

performance, and verifying their skills. 

(c) Maintain a complete and current 

SOP manual that is available to all 

personnel of the HHS-certified IITF, and 

ensure that it is followed. The SOP 

manual must be reviewed, signed, and 

dated by the RT when procedures are 
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first placed into use or changed or when 

a new individual assumes responsibility 

for the management of the HHS-certified 

IITF. The SOP must be reviewed and 

documented by the RT annually. 

(d) Maintain a quality assurance 

program that ensures the proper 

performance and reporting of all test 

results; verify and monitor acceptable 

analytical performance for all controls 

and calibrators; monitor quality control 

testing; and document the validity, 

reliability, accuracy, precision, and 

performance characteristics of each test 

and test system. 

(e) Initiate and implement all 

remedial actions necessary to maintain 

satisfactory operation and performance 

of the HHS-certified IITF in response to 

the following: Quality control systems 

not within performance specifications, 

errors in result reporting or in analysis 

of performance testing samples, and 

inspection deficiencies. The RT must 

ensure that specimen results are not 

reported until all corrective actions have 

been taken and that the results provided 

are accurate and reliable. 

Section 12.3 What qualifications must 

the RT have? 

An RT must: 

(a) Have at least a bachelor’s degree in 

the chemical or biological sciences or 

medical technology, or equivalent; 

(b) Have training and experience in 

the analytical methods and forensic 

procedures used by the HHS-certified 

IITF; 

(c) Have training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise; 

(d) Be found to fulfill RT 

responsibilities and qualifications, as 

demonstrated by the HHS-certified 

IITF’s performance and verified upon 

interview by HHS-trained inspectors 

during each on-site inspection; and 

(e) Qualify as a certifying technician. 

Section 12.4 What happens when the 

RT is absent or leaves an HHS-certified 

IITF? 

(a) HHS-certified IITFs must have an 

RT and an alternate RT. When an RT is 

absent, an alternate RT must be present 

and qualified to fulfill the 

responsibilities of the RT. 

(1) If an HHS-certified IITF is without 

the RT and alternate RT for 14 calendar 

days or less (e.g., temporary absence due 

to vacation, illness, business trip), the 

HHS-certified IITF may continue 

operations and testing of federal agency 

specimens under the direction of a 

certifying technician. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend an IITF’s 

HHS certification for all specimens if 

the IITF does not have an RT or 

alternate RT for a period of more than 

14 calendar days. The suspension will 

be lifted upon the Secretary’s approval 

of a new permanent RT or alternate RT. 

(b) If the RT leaves an HHS-certified 

IITF: 

(1) The HHS-certified IITF may 

maintain certification and continue 

testing federally regulated specimens 

under the direction of an alternate RT 

for a period of up to 180 days while 

seeking to hire and receive the 

Secretary’s approval of the RT’s 

replacement. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend an IITF’s 

HHS certification for all federally 

regulated specimens if the IITF does not 

have a permanent RT within 180 days. 

The suspension will be lifted upon the 

Secretary’s approval of the new 

permanent RT. 

(c) To nominate an individual as the 

RT or alternate RT, the HHS-certified 

IITF must submit the following 

documents to the Secretary: The 

candidate’s current re ́sume ́ or 

curriculum vitae, copies of diplomas 

and licensures, a training plan (not to 

exceed 90 days) to transition the 

candidate into the position, an itemized 

comparison of the candidate’s 

qualifications to the minimum RT 

qualifications described in the 

Guidelines, and have official academic 

transcript(s) submitted from the 

candidate’s institution(s) of higher 

learning. The candidate must be found 

qualified during an on-site inspection of 

the HHS-certified IITF. 

(d) The HHS-certified IITF must fulfill 

additional inspection and PT criteria as 

required prior to conducting federally 

regulated testing under a new RT. 

Section 12.5 What qualifications must 

an individual have to certify a result 

reported by an HHS-certified IITF? 

A certifying technician must have: 

(a) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

IITF relevant to the results that the 

individual certifies; and 

(b) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

Section 12.6 What qualifications and 

training must other personnel of an 

HHS-certified IITF have? 

(a) All HHS-certified IITF staff (e.g., 

technicians, administrative staff) must 

have the appropriate training and skills 

for the tasks they perform. 

(b) Each individual working in an 

HHS-certified IITF must be properly 

trained (i.e., receive training in each 

area of work that the individual will be 

performing, including training in 

forensic procedures related to their job 

duties) before they are permitted to 

work independently with federally 

regulated specimens. All training must 

be documented. 

Section 12.7 What security measures 

must an HHS-certified IITF maintain? 

(a) An HHS-certified IITF must 

control access to the drug testing 

facility, specimens, aliquots, and 

records. 

(b) Authorized visitors must be 

escorted at all times except for 

individuals conducting inspections (i.e., 

for the Department, a federal agency, a 

state, or other accrediting agency) or 

emergency personnel (e.g., firefighters 

and medical rescue teams). 

(c) An HHS-certified IITF must 

maintain records documenting the 

identity of the visitor and escort, date, 

time of entry and exit, and purpose for 

the access to the secured area. 

Section 12.8 What are the IITF chain 

of custody requirements for specimens 

and aliquots? 

(a) HHS-certified IITFs must use chain 

of custody procedures (internal and 

external) to maintain control and 

accountability of specimens from the 

time of receipt at the IITF through 

completion of testing, reporting of 

results, during storage, and continuing 

until final disposition of the specimens. 

(b) HHS-certified IITFs must use 

chain of custody procedures to 

document the handling and transfer of 

aliquots throughout the testing process 

until final disposal. 

(c) The chain of custody must be 

documented using either paper copy or 

electronic procedures. 

(d) Each individual who handles a 

specimen or aliquot must sign and 

complete the appropriate entries on the 

chain of custody form when the 

specimen or aliquot is handled or 

transferred, and every individual in the 

chain must be identified. 

(e) The date and purpose must be 

recorded on an appropriate chain of 

custody form each time a specimen or 

aliquot is handled or transferred. 
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Section 12.9 What are the 

requirements for an initial drug test? 

(a) An initial drug test may be: 

(1) An immunoassay or 

(2) An alternate technology (e.g., 

spectrometry, spectroscopy). 

(b) An HHS-certified IITF must 

validate an initial drug test before 

testing specimens; 

(c) Initial drug tests must be accurate 

and reliable for the testing of urine 

specimens when identifying drugs or 

their metabolites. 

(d) An HHS-certified IITF may 

conduct a second initial drug test using 

a method with different specificity, to 

rule out cross-reacting compounds. This 

second initial drug test must satisfy the 

batch quality control requirements 

specified in Section 12.11. 

Section 12.10 What must an HHScertified IITF do to validate an initial 

drug test? 

(a) An HHS-certified IITF must 

demonstrate and document the 

following for each initial drug test: 

(1) The ability to differentiate negative 

specimens from those requiring further 

testing; 

(2) The performance of the test around 

the cutoff concentration, using samples 

at several concentrations between 0 and 

150 percent of the cutoff concentration; 

(3) The effective concentration range 

of the test (linearity); 

(4) The potential for carryover; 

(5) The potential for interfering 

substances; and 

(6) The potential matrix effects if 

using an alternate technology. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) Each initial drug test using an 

alternate technology must be re-verified 

periodically or at least annually. 

Section 12.11 What are the batch 

quality control requirements when 

conducting an initial drug test? 

(a) Each batch of specimens must 

contain the following calibrators and 

controls: 

(1) At least one control certified to 

contain no drug or drug metabolite; 

(2) At least one positive control with 

the drug or drug metabolite targeted at 

a concentration 25 percent above the 

cutoff; 

(3) At least one control with the drug 

or drug metabolite targeted at a 

concentration 75 percent of the cutoff; 

and 

(4) At least one control that appears 

as a donor specimen to the analysts. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 12.12 What are the analytical 

and quality control requirements for 

conducting specimen validity tests? 

(a) Each specimen validity test result 

must be based on performing a single 

test on one aliquot; 

(b) The HHS-certified IITF must 

establish acceptance criteria and 

analyze calibrators and controls as 

appropriate to verify and document the 

validity of the test results in accordance 

with Section 12.14; and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 12.13 What must an HHScertified IITF do to validate a specimen 

validity test? 

An HHS-certified IITF must 

demonstrate and document for each 

specimen validity test the appropriate 

performance characteristics of the test, 

and must re-verify the test periodically, 

or at least annually. Each new lot of 

reagent must be verified prior to being 

placed into service. 

Section 12.14 What are the 

requirements for conducting each 

specimen validity test? 

(a) The requirements for measuring 

creatinine concentration are as follows: 

(1) The creatinine concentration must 

be measured to one decimal place on 

the test; 

(2) The creatinine test must have the 

following calibrators and controls: 

(i) A calibrator at 2 mg/dL; 

(ii) A control in the range of 1.0 mg/ 

dL to 1.5 mg/dL; 

(iii) A control in the range of 3 mg/ 

dL to 20 mg/dL; and 

(iv) A control in the range of 21 mg/ 

dL to 25 mg/dL. 

(b) The requirements for measuring 

specific gravity are as follows: 

(1) For specimens with creatinine test 

results greater than 5 mg/dL and less 

than 20 mg/dL, an IITF must perform a 

screening test using a refractometer to 

identify specific gravity values that are 

acceptable (equal to or greater 

than1.003) or dilute (equal to or greater 

than1.002 and less than1.003). 

Specimens must be forwarded to an 

HHS-certified laboratory when the 

creatinine test result is less than or 

equal to 5 mg/dL or when the screening 

specific gravity test result is less than 

1.002. 

(2) The screening specific gravity test 

must have the following calibrators and 

controls: 

(i) A calibrator or control at 1.000; 

(ii) One control targeted at 1.002; and 

(iii) One control in the range of 1.004 

to 1.018. 

(c) The requirements for measuring 

pH are as follows: 

(1) The IITF may perform the pH test 

using a pH meter, colorimetric pH test, 

dipsticks, or pH paper. Specimens must 

be forwarded to an HHS-certified 

laboratory when the pH is less than 4.5 

or equal to or greater than 9.0. 

(2) The pH test must have, at a 

minimum, the following calibrators and 

controls: 

(i) One control below 4.5; 

(ii) One control between 4.5 and 9.0; 

(iii) One control above 9.0; and 

(iv) One or more calibrators as 

appropriate for the test. For a pH meter: 

calibrators at 4, 7, and 10. 

(d) The requirements for measuring 

the nitrite concentration are that the 

nitrite test must have a calibrator at 200 

mcg/mL nitrite, a control without nitrite 

(i.e., certified negative urine), one 

control in the range of 200 mcg/mL to 

250 mcg/mL, and one control in the 

range of 500 mcg/mL to 625 mcg/mL. 

Specimens with a nitrite concentration 

equal to or greater than 200 mcg/mL 

must be forwarded to an HHS-certified 

laboratory; and, 

(e) Requirements for performing 

oxidizing adulterant tests are that the 

test must include an appropriate 

calibrator at the cutoff specified in 

Sections 11.19(d)(3), (4), or (6) for the 

compound of interest, a control without 

the compound of interest (i.e., a 

certified negative control), and at least 

one control with one of the compounds 

of interest at a measurable 

concentration. Specimens with an 

oxidizing adulterant result equal to or 

greater than the cutoff must be 

forwarded to an HHS-certified 

laboratory. 

Section 12.15 What are the 

requirements for an HHS-certified IITF 

to report a test result? 

(a) An HHS-certified IITF must report 

a test result to the agency’s MRO within 

an average of 3 working days after 

receipt of the specimen. Reports must 

use the Federal CCF and/or an 

electronic report. Before any test result 

can be reported, it must be certified by 

a certifying technician. 

(b) A primary (A) specimen is 

reported negative when each drug test is 

negative and each specimen validity test 

result indicates that the specimen is a 

valid urine specimen. 

(c) A primary (A) urine specimen is 

reported 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. 

(d) An HHS-certified IITF shall reject 

a urine specimen for testing when a fatal 

flaw occurs as described in Section 15.1 

or when a correctable flaw as described 
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in Section 15.2 is not recovered. The 

HHS-certified IITF will indicate on the 

Federal CCF that the specimen was 

rejected for testing and provide the 

reason for reporting the rejected for 

testing result. 

(e) HHS-certified IITFs may transmit 

test results to the MRO by various 

electronic means (e.g., teleprinter, 

facsimile, or computer). Transmissions 

of the reports must ensure 

confidentiality and the results may not 

be reported verbally by telephone. IITFs 

and external service providers must 

ensure the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(f) HHS-certified IITFs must facsimile, 

courier, mail, or electronically transmit 

a legible image or copy of the completed 

Federal CCF and/or forward a computergenerated electronic report. The 

computer-generated report must contain 

sufficient information to ensure that the 

test results can accurately represent the 

content of the custody and control form 

that the MRO received from the 

collector. 

(g) For rejected specimens, IITFs must 

facsimile, courier, mail, or electronically 

transmit a legible image or copy of the 

completed Federal CCF. 

Section 12.16 How does an HHScertified IITF handle a specimen that 

tested positive, adulterated, substituted, 

or invalid at the IITF? 

(a) The remaining specimen is 

resealed using a tamper-evident label/ 

seal; 

(b) The individual resealing the 

remaining specimen initials and dates 

the tamper-evident label/seal; and 

(c) The resealed specimen and split 

specimen and the Federal CCF are 

sealed in a leak-proof plastic bag, and 

are sent to an HHS-certified laboratory 

under chain of custody within one day 

after completing the drug and specimen 

validity tests. 

Section 12.17 How long must an HHScertified IITF retain a specimen? 

A specimen that is negative, negative/ 

dilute, or rejected for testing is 

discarded. 

Section 12.18 How long must an HHScertified IITF retain records? 

(a) An HHS-certified IITF must retain 

all records generated to support test 

results for at least 2 years. The IITF may 

convert hardcopy records to electronic 

records for storage and then discard the 

hardcopy records after six months. 

(b) A federal agency may request the 

HHS-certified IITF to maintain a 

documentation package (as described in 

Section 12.20) that supports the chain of 

custody, testing, and reporting of a 

donor’s specimen that is under legal 

challenge by a donor. The federal 

agency’s request to the IITF must be in 

writing and must specify the period of 

time to maintain the documentation 

package. 

(c) An HHS-certified IITF may retain 

records other than those included in the 

documentation package beyond the 

normal two-year period of time. 

Section 12.19 What statistical 

summary reports must an HHS-certified 

IITF provide? 

(a) HHS-certified IITFs must provide 

to each federal agency for which they 

perform testing a semiannual statistical 

summary report that must be submitted 

by mail, facsimile, or email within 14 

working days after the end of the 

semiannual period. The summary report 

must not include any personal 

identifying information. A copy of the 

semiannual statistical summary report 

will also be sent to the Secretary or 

designated HHS representative. The 

semiannual statistical report contains 

the following information: 

(1) Reporting period (inclusive dates); 

(2) HHS-certified IITF name and 

address; 

(3) Federal agency name; 

(4) Total number of specimens tested; 

(5) Number of specimens collected by 

reason for test; 

(6) Number of specimens reported 

negative and the number reported 

negative/dilute; 

(7) Number of specimens rejected for 

testing because of a fatal flaw; 

(8) Number of specimens rejected for 

testing because of an uncorrected flaw; 

(9) Number of specimens tested 

positive by each initial drug test; and 

(10) Number of specimens forwarded 

to an HHS-certified laboratory for 

testing. 

(b) An HHS-certified IITF must make 

copies of an agency’s test results 

available when requested to do so by the 

Secretary or by the federal agency for 

which the IITF is performing drugtesting services. 

(c) An HHS-certified IITF must ensure 

that a qualified individual is available to 

testify in a proceeding against a federal 

employee when the proceeding is based 

on a test result reported by the IITF. 

Section 12.20 What HHS-certified IITF 

information is available to a federal 

agency? 

(a) Following a federal agency’s 

receipt of a positive, adulterated, or 

substituted drug test report from a 

laboratory, the federal agency may 

submit a written request for copies of 

the IITF records relating to the drug test 

results or a documentation package or 

any relevant certification, review, or 

revocation of certification records. 

(b) Standard documentation packages 

provided by an HHS-certified IITF must 

contain the following items: 

(1) A cover sheet providing a brief 

description of the procedures and tests 

performed on the donor’s specimen; 

(2) A table of contents that lists all 

documents and materials in the package 

by page number; 

(3) A copy of the Federal CCF with 

any attachments, internal chain of 

custody records for the specimen, 

memoranda (if any) generated by the 

HHS-certified IITF, and a copy of the 

electronic report (if any) generated by 

the HHS-certified IITF; 

(4) A brief description of the HHScertified IITF’s drug and specimen 

validity testing procedures, 

instrumentation, and batch quality 

control requirements; 

(5) Copies of all test data for the 

donor’s specimen with all calibrators 

and controls and copies of all internal 

chain of custody documents related to 

the tests; and 

(6) Copies of the re ́sume ́ or 

curriculum vitae for the RT and for the 

certifying technician of record. 

Section 12.21 What HHS-certified IITF 

information is available to a federal 

employee? 

A federal employee who is the subject 

of a drug test may provide a written 

request through the MRO and/or the 

federal agency requesting access to any 

records relating to the employee’s drug 

test results or a documentation package 

(as described in Section 12.20) and any 

relevant certification, review, or 

revocation of certification records. 

Section 12.22 What types of 

relationships are prohibited between an 

HHS-certified IITF and an MRO? 

An HHS-certified IITF must not enter 

into any relationship with a federal 

agency’s MRO that may be construed as 

a potential conflict of interest or derive 

any financial benefit by having a federal 

agency use a specific MRO. 

This means an MRO may be an 

employee of the agency or a contractor 

for the agency; however, an MRO shall 

not be an employee or agent of or have 

any financial interest in the HHScertified IITF for which the MRO is 

reviewing drug testing results. 

Additionally, an MRO shall not derive 

any financial benefit by having an 

agency use a specific HHS-certified IITF 

or have any agreement with an HHScertified IITF that may be construed as 

a potential conflict of interest. 
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Section 12.23 What type of 

relationship can exist between an HHScertified IITF and an HHS-certified 

laboratory? 

An HHS-certified IITF can enter into 

any relationship with an HHS-certified 

laboratory. 

Subpart M—Medical Review Officer 

(MRO) 

Section 13.1 Who may serve as an 

MRO? 

(a) A currently licensed physician 

who has: 

(1) A Doctor of Medicine (M.D.) or 

Doctor of Osteopathy (D.O.) degree; 

(2) Knowledge regarding the 

pharmacology and toxicology of illicit 

drugs; 

(3) The training necessary to serve as 

an MRO as set out in Section 13.3; 

(4) Satisfactorily passed an initial 

examination administered by a 

nationally recognized entity or a 

subspecialty board that has been 

approved by the Secretary to certify 

MROs; and 

(5) At least every five years from 

initial certification, completed 

requalification training on the topics in 

Section 13.3 and satisfactorily passed a 

requalification examination 

administered by a nationally recognized 

entity or a subspecialty board that has 

been approved by the Secretary to 

certify MROs. 

Section 13.2 How are nationally 

recognized entities or subspecialty 

boards that certify MROs approved? 

All nationally recognized entities or 

subspecialty boards which seek 

approval by the Secretary to certify 

physicians as MROs for federal 

workplace drug testing programs must 

submit their qualifications, a sample 

examination, and other necessary 

supporting examination materials (e.g., 

answers, previous examination statistics 

or other background examination 

information, if requested). Approval 

will be based on an objective review of 

qualifications that include a copy of the 

MRO applicant application form, 

documentation that the continuing 

education courses are accredited by a 

professional organization, and the 

delivery method and content of the 

examination. Each approved MRO 

certification entity must resubmit their 

qualifications for approval every two 

years. The Secretary shall publish at 

least every two years a notice in the 

Federal Register listing those entities 

and subspecialty boards that have been 

approved. This notice is also available 

on the Internet at http:// 

www.samhsa.gov/workplace/drugtesting. 

Section 13.3 What training is required 

before a physician may serve as an 

MRO? 

(a) A physician must receive training 

that includes a thorough review of the 

following: 

(1) The collection procedures used to 

collect federal agency specimens; 

(2) How to interpret test results 

reported by HHS-certified IITFs and 

laboratories (e.g., negative, negative/ 

dilute, positive, adulterated, substituted, 

rejected for testing, and invalid); 

(3) Chain of custody, reporting, and 

recordkeeping requirements for federal 

agency specimens; 

(4) The HHS Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs for all authorized specimen 

types; and 

(5) Procedures for interpretation, 

review (e.g., donor interview for 

legitimate medical explanations, review 

of documentation provided by the donor 

to support a legitimate medical 

explanation), and reporting of results 

specified by any federal agency for 

which the individual may serve as an 

MRO; 

(b) Certified MROs must complete 

training on any revisions to these 

Guidelines prior to their effective date, 

to continue serving as an MRO for 

federal agency specimens. 

Section 13.4 What are the 

responsibilities of an MRO? 

(a) The MRO must review all positive, 

adulterated, rejected for testing, invalid, 

and (for urine) substituted test results. 

(b) Staff under the direct, personal 

supervision of the MRO may review and 

report negative and (for urine) negative/ 

dilute test results to the agency’s 

designated representative. The MRO 

must review at least 5 percent of all 

negative results reported by the MRO 

staff to ensure that the MRO staff are 

properly performing the review process. 

(c) The MRO must discuss potential 

invalid results with the HHS-certified 

laboratory, as addressed in Section 

11.19(g) to determine whether testing at 

another HHS-certified laboratory may be 

warranted. 

(d) After receiving a report from an 

HHS-certified laboratory or (for urine) 

HHS-certified IITF, the MRO must: 

(1) Review the information on the 

MRO copy of the Federal CCF that was 

received from the collector and the 

report received from the HHS-certified 

laboratory or HHS-certified IITF; 

(2) Interview the donor when 

required; 

(3) Make a determination regarding 

the test result; and 

(4) Report the verified result to the 

federal agency. 

(e) The MRO must maintain records 

for a minimum of two years while 

maintaining the confidentiality of the 

information. The MRO may convert 

hardcopy records to electronic records 

for storage and discard the hardcopy 

records after six months. 

(f) The MRO must conduct a medical 

examination or a review of the 

examining physician’s findings and 

make a determination of refusal to test 

or cancelled test when a collector 

reports that the donor was unable to 

provide a specimen, as addressed in 

Section 8.6. 

Section 13.5 What must an MRO do 

when reviewing a urine specimen’s test 

results? 

(a) When the HHS-certified laboratory 

or HHS-certified IITF reports a negative 

result for the primary (A) specimen, the 

MRO reports a negative result to the 

agency. 

(b) When the HHS-certified laboratory 

or HHS-certified IITF reports a negative/ 

dilute result for the primary (A) urine 

specimen, the MRO reports a negative/ 

dilute result to the agency and directs 

the agency to immediately collect 

another specimen from the donor. 

(1) If the recollected specimen 

provides a negative or negative/dilute 

result, the MRO reports a negative result 

to the agency, with no further action 

required. 

(2) If the recollected specimen 

provides a result other than negative or 

negative/dilute, the MRO follows the 

procedures in 13.5(c) through (f) for the 

recollected specimen. 

(c) When the HHS-certified laboratory 

reports multiple results for the primary 

(A) urine specimen, as the MRO, you 

must follow the verification procedures 

described in 13.5(c) through (f) and: 

(1) Report all verified positive and/or 

refusal to test results to the federal 

agency. 

(2) If an invalid result was reported in 

conjunction with a positive, adulterated, 

or substituted result, do not report the 

verified invalid result to the federal 

agency at this time. The MRO reports 

the verified invalid result(s) for the 

primary (A) urine specimen only if the 

split specimen is tested and reported as 

a failure to reconfirm as described in 

Section 14.6(l). 

(d) 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. 

(1) If the donor provides 

documentation (e.g., a valid 
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prescription) to support a legitimate 

medical explanation for the positive 

result, the MRO reports the test result as 

negative to the agency. If the laboratory 

also reports that the urine specimen is 

dilute, the MRO reports a negative/ 

dilute result to the agency and directs 

the agency to immediately collect 

another specimen from the donor. The 

MRO follows the procedures in 

13.5(b)(1) or (2) for the recollected 

specimen. 

(i) Passive exposure to marijuana 

smoke is not a legitimate medical 

explanation for a positive THCA result. 

(ii) Ingestion of food products 

containing marijuana is not a legitimate 

medical explanation for a positive 

THCA result. 

(2) If the donor is unable to provide 

a legitimate medical explanation, the 

MRO reports a positive result to the 

agency for all drugs except codeine and/ 

or morphine (see below). If the 

laboratory also reports that the urine 

specimen is dilute, the MRO may 

choose not to report the dilute result. 

(i) For codeine and/or morphine less 

than 15,000 ng/mL and no legitimate 

medical explanation: the MRO must 

determine if there is clinical evidence of 

illegal use (in addition to the test result) 

to report a positive result to the agency. 

If there is no clinical evidence of illegal 

use, the MRO reports a negative result 

to the agency. However, this 

requirement does not apply if the 

laboratory confirms the presence of 6- 

acetylmorphine (i.e., the presence of 

this metabolite is proof of heroin use). 

(ii) For codeine and/or morphine 

equal to or greater than 15,000 ng/mL 

and no legitimate medical explanation: 

the MRO reports a positive result to the 

agency. Consumption of food products 

must not be considered a legitimate 

medical explanation for the donor 

having morphine or codeine at or above 

this concentration. 

(e) When the HHS-certified laboratory 

reports an adulterated or substituted 

result for the primary (A) urine 

specimen, the MRO contacts the donor 

to determine if the donor has a 

legitimate medical explanation for the 

adulterated or substituted result. 

(1) If the donor provides a legitimate 

medical explanation, the MRO reports a 

negative result to the federal agency. 

(2) If the donor is unable to provide 

a legitimate explanation, the MRO 

reports a refusal to test to the federal 

agency because the urine specimen was 

adulterated or substituted. 

(f) When the HHS-certified laboratory 

reports an invalid result for the primary 

(A) urine specimen, the MRO must 

contact the donor to determine if there 

is a legitimate explanation for the 

invalid result. In the case of an invalid 

result based on pH of 9.0 to 9.5, when 

an employee has no other medical 

explanation for the pH in this range, the 

MRO must consider whether there is 

evidence of elapsed time and high 

temperature that could account for the 

pH value. The MRO may contact the 

collection site, HHS-certified IITF, and/ 

or HHS-certified laboratory to discuss 

time and temperature issues (e.g., time 

elapsed from collection to receipt at the 

testing facility, likely temperature 

conditions between the time of the 

collection and transportation to the 

testing facility, specimen storage 

conditions). 

(1) If the donor provides a legitimate 

explanation (e.g., a prescription 

medication) or if the MRO determines 

that time and temperature account for 

the pH in the 9.0 to 9.5 range, the MRO 

reports a test cancelled result with the 

reason for the invalid result and informs 

the federal agency that a recollection is 

not required because there is a 

legitimate explanation for the invalid 

result. 

(2) If the donor is unable to provide 

a legitimate explanation or if the MRO 

determines that time and temperature 

fail to account for the pH in the 9.0— 

9.5 range, the MRO reports a test 

cancelled result with the reason for the 

invalid result and directs the federal 

agency to immediately collect another 

urine specimen from the donor using a 

direct observed collection. 

(i) If the specimen collected under 

direct observation provides a valid 

result, the MRO follows the procedures 

in 13.5(a) through (e). 

(ii) If the specimen collected under 

direct observation provides an invalid 

result, the MRO reports this specimen as 

test cancelled and recommends that the 

agency collect another authorized 

specimen type (e.g., oral fluid). 

(g) When two separate specimens 

collected during the same testing event 

were sent to the HHS-certified 

laboratory for testing (e.g., the collector 

sent a urine specimen out of 

temperature range and the subsequently 

collected specimen—urine or another 

authorized specimen type), as the MRO, 

you must follow the verification 

procedures described in Sections 13.4, 

13.5, and 13.6, and: 

(1) If both specimens were verified 

negative, report the result as negative. 

(2) If one specimen was verified 

negative and the other was not (i.e., the 

specimen was verified as negative/ 

dilute or as positive, adulterated, 

substituted, and/or invalid), report only 

the verified result(s) other than negative. 

For example, if you verified one 

specimen as negative and the other as a 

refusal to test because the specimen was 

substituted, report only the refusal to 

the federal agency. 

(3) If both specimens were verified as 

positive, adulterated, and/or 

substituted, report all results. For 

example, if you verified one specimen 

as positive and the other as a refusal to 

test because the specimen was 

adulterated, report the positive and the 

refusal results to the federal agency. 

(4) If one specimen has been verified 

and the HHS-certified laboratory has not 

reported the result(s) of the other 

specimen, 

(i) Report verified result(s) of positive, 

adulterated, or substituted immediately 

and do not wait to receive the result(s) 

of the other specimen. 

(ii) Do not report a verified result of 

negative, negative/dilute, or invalid for 

the first specimen to the federal agency. 

Hold the report until results of both 

specimens have been received and 

verified. 

(5) When the HHS-certified laboratory 

reports an invalid result for one or both 

specimens, follow the procedures in 

paragraph c above. 

(h) When the HHS-certified laboratory 

or HHS-certified IITF reports a rejected 

for testing result for the primary (A) 

specimen, the MRO reports a test 

cancelled result to the agency and 

recommends that the agency collect 

another specimen from the donor. The 

recollected specimen must be the same 

type (i.e., urine). 

Section 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? 

(a) When another specimen type (e.g., 

oral fluid) was collected as authorized 

by the federal agency, the MRO reviews 

and reports the test result in accordance 

with the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using the alternative 

specimen. 

(b) When the federal agency did not 

authorize the collection of an alternative 

specimen, the MRO consults with the 

federal agency. The federal agency 

immediately directs the donor to obtain, 

within five days, an evaluation from a 

licensed physician, acceptable to the 

MRO, who has expertise in the medical 

issues raised by the donor’s failure to 

provide a specimen. The MRO may 

perform this evaluation if the MRO has 

appropriate expertise. 

(1) For purposes of this section, a 

medical condition includes an 

ascertainable physiological condition 

(e.g., a urinary system dysfunction) or a 

medically documented pre-existing 
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psychological disorder, but does not 

include unsupported assertions of 

‘‘situational anxiety’’ or dehydration. 

Permanent or long-term medical 

conditions are those physiological, 

anatomic, or psychological 

abnormalities documented as being 

present prior to the attempted 

collection, and considered not amenable 

to correction or cure for an extended 

period of time. Examples would include 

destruction (any cause) of the 

glomerular filtration system leading to 

renal failure; unrepaired traumatic 

disruption of the urinary tract; or a 

severe psychiatric disorder focused on 

genitourinary matters. Acute or 

temporary medical conditions, such as 

cystitis, urethritis or prostatitis, though 

they might interfere with collection for 

a limited period of time, cannot receive 

the same exceptional consideration as 

the permanent or long-term conditions 

discussed in the previous sentence. 

(2) As the MRO, if another physician 

will perform the evaluation, you must 

provide the other physician with the 

following information and instructions: 

(i) That the donor was required to take 

a federally regulated drug test, but was 

unable to provide a sufficient amount of 

urine to complete the test; 

(ii) The consequences of the 

appropriate federal agency regulation 

for refusing to take the required drug 

test; 

(iii) That, after completing the 

evaluation, the referral physician must 

agree to provide a written statement to 

the MRO with a recommendation for 

one of the determinations described in 

paragraph (b)(3) of this section and the 

basis for the recommendation. The 

statement must not include detailed 

information on the employee’s medical 

condition beyond what is necessary to 

explain the referral physician’s 

conclusion. 

(3) As the MRO, if another physician 

performed the evaluation, you must 

consider and assess the referral 

physician’s recommendations in making 

your determination. You must make one 

of the following determinations and 

report it to the federal agency in writing: 

(i) A medical condition as defined in 

paragraph (b)(1) of this section has, or 

with a high degree of probability could 

have, precluded the employee from 

providing a sufficient amount of urine, 

but is not a permanent or long-term 

disability. As the MRO, you must report 

a test cancelled result to the federal 

agency. 

(ii) A permanent or long-term medical 

condition as defined in paragraph (b)(1) 

of this section has, or with a high degree 

of probability could have, precluded the 

employee from providing a sufficient 

amount of urine and is highly likely to 

prevent the employee from providing a 

sufficient amount of urine for a very 

long or indefinite period of time. As the 

MRO, you must follow the requirements 

of Section 13.7, as appropriate. If 

Section 13.7 is not applicable, you 

report a test cancelled result to the 

federal agency and recommend that the 

agency authorize collection of an 

alternative specimen type (e.g., oral 

fluid) for any subsequent drug tests for 

the donor. 

(iii) There is not an adequate basis for 

determining that a medical condition 

has, or with a high degree of probability 

could have, precluded the employee 

from providing a sufficient amount of 

urine. As the MRO, you must report a 

refusal to test to the federal agency. 

(4) When a federal agency receives a 

report from the MRO indicating that a 

test is cancelled as provided in 

paragraph (b)(3)(i) of this section, the 

agency takes no further action with 

respect to the donor. When a test is 

canceled as provided in paragraph 

(b)(3)(ii) of this section, the agency takes 

no further action with respect to the 

donor other than designating collection 

of an alternate specimen type (i.e., 

authorized by the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs) for any subsequent 

collections, in accordance with the 

federal agency plan. The donor remains 

in the random testing pool. 

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? 

(a) This section concerns a situation 

in which the donor has a medical 

condition that precludes the donor from 

providing a sufficient specimen for a 

federal agency applicant/preemployment test, a follow-up test, or a 

return-to-duty test and the condition 

involves a permanent or long-term 

disability and the federal agency does 

not authorize collection of an alternative 

specimen. As the MRO in this situation, 

you must do the following: 

(1) You must determine if there is 

clinical evidence that the individual is 

an illicit drug user. You must make this 

determination by personally 

conducting, or causing to be conducted, 

a medical evaluation and through 

consultation with the donor’s physician 

and/or the physician who conducted the 

evaluation under Section 13.6. 

(2) If you do not personally conduct 

the medical evaluation, you must ensure 

that one is conducted by a licensed 

physician acceptable to you. 

(b) If the medical evaluation reveals 

no clinical evidence of drug use, as the 

MRO, you must report the result to the 

federal agency as a negative test with 

written notations regarding results of 

both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state the 

basis for the determination that a 

permanent or long-term medical 

condition exists, making provision of a 

sufficient urine specimen impossible, 

and for the determination that no signs 

and symptoms of drug use exist. The 

MRO recommends that the agency 

authorize collection of an alternate 

specimen type (e.g., oral fluid) for any 

subsequent collections. 

(c) If the medical evaluation reveals 

clinical evidence of drug use, as the 

MRO, you must report the result to the 

federal agency as a cancelled test with 

written notations regarding results of 

both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state that 

a permanent or long-term medical 

condition [as defined in Section 

13.6(b)(1)] exists, making provision of a 

sufficient urine specimen impossible, 

and state the reason for the 

determination that signs and symptoms 

of drug use exist. Because this is a 

cancelled test, it does not serve the 

purposes of a negative test (e.g., the 

federal agency is not authorized to allow 

the donor to begin or resume performing 

official functions, because a negative 

test is needed for that purpose). 

Section 13.8 Who may request a test of 

a split (B) specimen? 

(a) For a positive, adulterated, or 

substituted result reported on a primary 

(A) specimen, a donor may request 

through the MRO that the split (B) 

specimen be tested by a second HHScertified laboratory to verify the result 

reported by the first HHS-certified 

laboratory. 

(b) The donor has 72 hours (from the 

time the MRO notified the donor that 

the donor’s specimen was reported 

positive, adulterated, or (for urine) 

substituted to request a test of the split 

(B) specimen. The MRO must inform the 

donor that the donor has the 

opportunity to request a test of the split 

(B) specimen when the MRO informs 

the donor that a positive, adulterated, or 

(for urine) substituted result is being 

reported to the federal agency on the 

primary (A) specimen. 
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Section 13.9 How does an MRO report 

a primary (A) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., teleprinter, facsimile, or 

computer). Transmissions of the reports 

must ensure confidentiality. The MRO 

and external service providers must 

ensure the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all positive, 

adulterated, and (for urine) substituted 

results. 

(d) The MRO must not disclose 

numerical values of drug test results to 

the agency. 

Section 13.10 What types of 

relationships are prohibited between an 

MRO and an HHS-certified laboratory or 

an HHS-certified IITF? 

An MRO must not be an employee, 

agent of, or have any financial interest 

in an HHS-certified laboratory or an 

HHS-certified IITF for which the MRO 

is reviewing drug test results. 

This means an MRO must not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or HHS-certified IITF, or have 

any agreement with the HHS-certified 

laboratory or the HHS-certified IITF that 

may be construed as a potential conflict 

of interest. 

Subpart N—Split Specimen Tests 

Section 14.1 When may a split (B) 

specimen be tested? 

(a) The donor may request, verbally or 

in writing, through the MRO that the 

split (B) specimen be tested at a 

different (i.e., second) HHS-certified 

laboratory when the primary (A) 

specimen was determined by the MRO 

to be positive, adulterated, or (for urine) 

substituted. 

(b) A donor has 72 hours to initiate 

the request after being informed of the 

result by the MRO. The MRO must 

document in the MRO’s records the 

verbal request from the donor to have 

the split (B) specimen tested. 

(c) If a split (B) urine specimen cannot 

be tested by a second HHS-certified 

laboratory (e.g., insufficient specimen, 

lost in transit, split not available, no 

second HHS-certified laboratory 

available to perform the test), the MRO 

reports to the federal agency that the test 

must be cancelled and the reason for the 

cancellation. The MRO directs the 

federal agency to ensure the immediate 

recollection of another urine specimen 

from the donor under direct 

observation, with no notice given to the 

donor of this collection requirement 

until immediately before the collection. 

(d) If a donor chooses not to have the 

split (B) specimen tested by a second 

HHS-certified laboratory, a federal 

agency may have a split (B) specimen 

retested as part of a legal or 

administrative proceeding to defend an 

original positive, adulterated, or (for 

urine) substituted result. 

Section 14.2 How does an HHScertified laboratory test a split (B) 

specimen when the primary (A) 

specimen was reported positive? 

(a) The testing of a split (B) specimen 

for a drug or metabolite is not subject to 

the testing cutoff concentrations 

established. 

(b) The HHS-certified laboratory is 

only required to confirm the presence of 

the drug or metabolite that was reported 

positive in the primary (A) specimen. 

(c) For a split (B) urine specimen, if 

the second HHS-certified laboratory 

fails to reconfirm the presence of the 

drug or drug metabolite that was 

reported by the first HHS-certified 

laboratory, the second laboratory must 

conduct specimen validity tests in an 

attempt to determine the reason for 

being unable to reconfirm the presence 

of the drug or drug metabolite. The 

second laboratory should conduct the 

same specimen validity tests as it would 

conduct on a primary (A) urine 

specimen and reports those results to 

the MRO. 

Section 14.3 How does an HHScertified laboratory test a split (B) urine 

specimen when the primary (A) 

specimen was reported adulterated? 

(a) An HHS-certified laboratory must 

use one of the following criteria to 

reconfirm an adulterated result when 

testing a split (B) urine specimen: 

(1) pH must be measured using the 

laboratory’s confirmatory pH test with 

the appropriate cutoff (i.e., either less 

than 4 or equal to or greater than 11); 

(2) Nitrite must be measured using the 

laboratory’s confirmatory nitrite test 

with a cutoff concentration of equal to 

or greater than 500 mcg/mL; 

(3) Surfactant must be measured using 

the laboratory’s confirmatory surfactant 

test with a cutoff concentration of equal 

to or greater than 100 mcg/mL 

dodecylbenzene sulfonate-equivalent 

cutoff; or 

(4) For adulterants without a specified 

cutoff (e.g., glutaraldehyde, chromium 

(VI), pyridine, halogens (such as, bleach, 

iodine), peroxidase, peroxide, other 

oxidizing agents), the laboratory must 

use its confirmatory specimen validity 

test at an established limit of 

quantification (LOQ) to reconfirm the 

presence of the adulterant. 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory specimen validity test(s) 

needed to reconfirm the adulterated 

result reported by the first HHS-certified 

laboratory. 

Section 14.4 How does an HHScertified laboratory test a split (B) urine 

specimen when the primary (A) 

specimen was reported substituted? 

(a) An HHS-certified laboratory must 

use the following criteria to reconfirm a 

substituted result when testing a split 

(B) urine specimen: 

(1) The creatinine must be measured 

using the laboratory’s confirmatory 

creatinine test with a cutoff 

concentration of less than 2 mg/dL; and 

(2) The specific gravity must be 

measured using the laboratory’s 

confirmatory specific gravity test with 

the specified cutoffs of less than or 

equal to 1.0010 or equal to or greater 

than 1.0200. 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory specimen validity test(s) 

needed to reconfirm the substituted 

result reported by the first HHS-certified 

laboratory. 

Section 14.5 Who receives the split (B) 

specimen result? 

The second HHS-certified laboratory 

must report the result to the MRO. 

Section 14.6 What action(s) does an 

MRO take after receiving the split (B) 

urine specimen result from the second 

HHS-certified laboratory? 

The MRO takes the following actions 

when the second HHS-certified 

laboratory reports the result for the split 

(B) urine specimen as: 

(a) Reconfirmed the drug(s), 

adulteration, and/or substitution result. 

The MRO reports reconfirmed to the 

agency. 

(b) Failed to reconfirm a single or all 

drug positive results and adulterated. If 

the donor provides a legitimate medical 

explanation for the adulteration result, 

the MRO reports a failed to reconfirm 

[specify drug(s)] and cancels both tests. 

If there is no legitimate medical 

explanation, the MRO reports a failed to 

reconfirm [specify drug(s)] and a refusal 
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7966 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

to test to the agency and indicates the 

adulterant that is present in the 

specimen. The MRO gives the donor 72 

hours to request that Laboratory A retest 

the primary (A) specimen for the 

adulterant. If Laboratory A reconfirms 

the adulterant, the MRO reports refusal 

to test and indicates the adulterant 

present. If Laboratory A fails to 

reconfirm the adulterant, the MRO 

cancels both tests and directs the agency 

to immediately collect another 

specimen using a direct observed 

collection procedure. The MRO shall 

notify the appropriate regulatory office 

about the failed to reconfirm and 

cancelled test. 

(c) Failed to reconfirm a single or all 

drug positive results and substituted. If 

the donor provides a legitimate medical 

explanation for the substituted result, 

the MRO reports a failed to reconfirm 

[specify drug(s)] and cancels both tests. 

If there is no legitimate medical 

explanation, the MRO reports a failed to 

reconfirm [specify drug(s)] and a refusal 

to test (substituted) to the agency. The 

MRO gives the donor 72 hours to 

request Laboratory A to review the 

creatinine and specific gravity results 

for the primary (A) specimen. If the 

original creatinine and specific gravity 

results confirm that the specimen was 

substituted, the MRO reports a refusal to 

test (substituted) to the agency. If the 

original creatinine and specific gravity 

results from Laboratory A fail to confirm 

that the specimen was substituted, the 

MRO cancels both tests and directs the 

agency to immediately collect another 

specimen using a direct observed 

collection procedure. The MRO shall 

notify the HHS office responsible for 

coordination of the drug-free workplace 

program about the failed to reconfirm 

and cancelled test. 

(d) Failed to reconfirm a single or all 

drug positive results and not 

adulterated or substituted. The MRO 

reports to the agency a failed to 

reconfirm result [specify drug(s)], 

cancels both tests, and notifies the HHS 

office responsible for coordination of 

the drug-free workplace program. 

(e) Failed to reconfirm a single or all 

drug positive results and invalid result. 

The MRO reports to the agency a failed 

to reconfirm result [specify drug(s) and 

give the reason for the invalid result], 

cancels both tests, directs the agency to 

immediately collect another specimen 

using a direct observed collection 

procedure, and notifies the HHS office 

responsible for coordination of the drugfree workplace program. 

(f) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and adulterated. The MRO reports to 

the agency a reconfirmed result [(specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s)]. The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and found that the specimen 

was adulterated. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(g) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and substituted. The MRO reports to the 

agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[(specify drug(s)]). The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and found that the specimen 

was substituted. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(h) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and not adulterated or substituted. The 

MRO reports a reconfirmed result 

[specify drug(s)] and a failed to 

reconfirm result [specify drug(s)]. The 

MRO tells the agency that it may take 

action based on the reconfirmed drug(s) 

although Laboratory B failed to 

reconfirm one or more drugs. The MRO 

shall notify the HHS office responsible 

for coordination of the drug-free 

workplace program regarding the test 

results for the specimen. 

(i) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and invalid result. The MRO reports to 

the agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s)]. The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and reported an invalid 

result. The MRO shall notify the HHS 

office responsible for coordination of 

the drug-free workplace program 

regarding the test results for the 

specimen. 

(j) Failed to reconfirm substitution or 

adulteration. The MRO reports to the 

agency a failed to reconfirm result 

(specify adulterant or not substituted) 

and cancels both tests. The MRO shall 

notify the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(k) Failed to reconfirm a single or all 

drug positive results and reconfirmed an 

adulterated or substituted result. The 

MRO reports to the agency a 

reconfirmed result (adulterated or 

substituted) and a failed to reconfirm 

result [specify drug(s)]. The MRO tells 

the agency that it may take action based 

on the reconfirmed result (adulterated 

or substituted) although Laboratory B 

failed to reconfirm the drug(s) result. 

(l) Failed to reconfirm a single or all 

drug positive results and failed to 

reconfirm the adulterated or substituted 

result. The MRO reports to the agency 

a failed to reconfirm result [specify 

drug(s) and specify adulterant or 

substituted] and cancels both tests. The 

MRO shall notify the HHS office 

responsible for coordination of the drugfree workplace program regarding the 

test results for the specimen. 

(m) Failed to reconfirm at least one 

drug and reconfirmed the adulterated 

result. The MRO reports to the agency 

a reconfirmed result [(specify drug(s) 

and adulterated] and a failed to 

reconfirm result [specify drug(s)]. The 

MRO tells the agency that it may take 

action based on the reconfirmed drug(s) 

and the adulterated result although 

Laboratory B failed to reconfirm one or 

more drugs. 

(n) Failed to reconfirm at least one 

drug and failed to reconfirm the 

adulterated result. The MRO reports to 

the agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s) and specify adulterant]. 

The MRO tells the agency that it may 

take action based on the reconfirmed 

drug(s) although Laboratory B failed to 

reconfirm one or more drugs and failed 

to reconfirm the adulterated result. 

(o) Failed to reconfirm an adulterated 

result and failed to reconfirm a 

substituted result. The MRO reports to 

the agency a failed to reconfirm result 

[(specify adulterant) and not 

substituted] and cancels both tests. The 

MRO shall notify the HHS office 

responsible for coordination of the drugfree workplace program regarding the 

test results for the specimen. 

(p) Failed to reconfirm an adulterated 

result and reconfirmed a substituted 

result. The MRO reports to the agency 

a reconfirmed result (substituted) and a 

failed to reconfirm result (specify 

adulterant). The MRO tells the agency 

that it may take action based on the 

substituted result although Laboratory B 

failed to reconfirm the adulterated 

result. 

(q) Failed to reconfirm a substituted 

result and reconfirmed an adulterated 

result. The MRO reports to the agency 

a reconfirmed result (adulterated) and a 

failed to reconfirm result (not 

substituted). The MRO tells the agency 

that it may take action based on the 

adulterated result although Laboratory B 

failed to reconfirm the substituted 

result. 
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7967 

Section 14.7 How does an MRO report 

a split (B) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., teleprinter, facsimile, or 

computer). Transmissions of the reports 

must ensure confidentiality. The MRO 

and external service providers must 

ensure the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all split 

specimen results. 

(d) The MRO must not disclose the 

numerical values of the drug test results 

to the agency. 

Section 14.8 How long must an HHScertified laboratory retain a split (B) 

specimen? 

A split (B) specimen is retained for 

the same period of time that a primary 

(A) specimen is retained and under the 

same storage conditions. This applies 

even for those cases when the split (B) 

specimen is tested by a second HHScertified laboratory and the second 

HHS-certified laboratory does not 

confirm the original result reported by 

the first HHS-certified laboratory for the 

primary (A) specimen. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

Section 15.1 What discrepancies 

require an HHS-certified laboratory or 

an HHS-certified IITF to report a 

specimen as rejected for testing? 

The following discrepancies are 

considered to be fatal flaws. The HHScertified laboratory or IITF must stop 

the testing process, reject the specimen 

for testing, and indicate the reason for 

rejecting the specimen on the Federal 

CCF when: 

(a) The specimen ID number on the 

primary (A) or split (B) specimen label/ 

seal does not match the ID number on 

the Federal CCF, or the ID number is 

missing either on the Federal CCF or on 

either specimen label/seal; 

(b) The primary (A) specimen label/ 

seal is missing, misapplied, broken, or 

shows evidence of tampering and the 

split (B) specimen cannot be redesignated as the primary (A) specimen; 

(c) The collector’s printed name and 

signature are omitted on the Federal 

CCF; 

(d) There is an insufficient amount of 

specimen for analysis in the primary (A) 

specimen unless the split (B) specimen 

can be re-designated as the primary (A) 

specimen; 

(e) The accessioner failed to 

document the primary (A) specimen 

seal condition on the Federal CCF at the 

time of accessioning, and the split (B) 

specimen cannot be re-designated as the 

primary (A) specimen; 

(f) The specimen was received at the 

HHS-certified laboratory or IITF without 

a CCF; 

(g) The CCF was received at the HHScertified laboratory or IITF without a 

specimen; 

(h) The collector performed two 

separate collections using one CCF; or 

(i) The HHS-certified laboratory or 

IITF identifies a flaw (other than those 

specified above) that prevents testing or 

affects the forensic defensibility of the 

drug test and cannot be corrected. 

Section 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? 

The following discrepancies are 

considered to be correctable: 

(a) If a collector failed to sign the 

Federal CCF, the HHS-certified 

laboratory or IITF must attempt to 

recover the collector’s signature before 

reporting the test result. If the collector 

can provide a memorandum for record 

recovering the signature, the HHScertified laboratory or IITF may report 

the test result for the specimen. If, after 

holding the specimen for at least 5 

business days, the HHS-certified 

laboratory or IITF cannot recover the 

collector’s signature, the laboratory or 

IITF must report a rejected for testing 

result and indicate the reason for the 

rejected for testing result on the Federal 

CCF. 

(b) If a specimen is submitted using a 

non-federal form or an expired Federal 

CCF, the HHS-certified laboratory or 

IITF must test the specimen and also 

attempt to obtain a memorandum for 

record explaining why a non-federal 

form or an expired Federal CCF was 

used and ensure that the form used 

contains all the required information. If, 

after holding the specimen for at least 5 

business days, the HHS-certified 

laboratory or IITF cannot obtain a 

memorandum for record from the 

collector, the laboratory or IITF must 

report a rejected for testing result and 

indicate the reason for the rejected for 

testing result on the report to the MRO. 

Section 15.3 What discrepancies are 

not sufficient to require an HHScertified laboratory or an HHS-certified 

IITF to reject a urine specimen for 

testing or an MRO to cancel a test? 

(a) The following omissions and 

discrepancies on the Federal CCF that 

are received by the HHS-certified 

laboratory or IITF should not cause an 

HHS-certified laboratory or IITF to reject 

a urine specimen or cause an MRO to 

cancel a test: 

(1) An incorrect laboratory name and 

address appearing at the top of the form; 

(2) Incomplete/incorrect/unreadable 

employer name or address; 

(3) MRO name is missing; 

(4) Incomplete/incorrect MRO 

address; 

(5) A transposition of numbers in the 

donor’s Social Security Number or 

employee identification number; 

(6) A telephone number is missing/ 

incorrect; 

(7) A fax number is missing/incorrect; 

(8) A ‘‘reason for test’’ box is not 

marked; 

(9) A ‘‘drug tests to be performed’’ box 

is not marked; 

(10) A ‘‘specimen collection’’ box is 

not marked; 

(11) The ‘‘observed’’ box is not 

marked (if applicable); 

(12) The collection site address is 

missing; 

(13) The collector’s printed name is 

missing but the collector’s signature is 

properly recorded; 

(14) The time of collection is not 

indicated; 

(15) The date of collection is not 

indicated; 

(16) Incorrect name of delivery 

service; 

(17) The collector has changed or 

corrected information by crossing out 

the original information on either the 

Federal CCF or specimen label/seal 

without dating and initialing the 

change; or 

(18) The donor’s name inadvertently 

appears on the HHS-certified laboratory 

or IITF copy of the Federal CCF or on 

the tamper-evident labels used to seal 

the specimens. 

(19) The collector failed to check the 

specimen temperature box and the 

‘‘Remarks’’ line did not have a comment 

regarding the temperature being out of 

range. If, after at least 5 business days, 

the collector cannot provide a 

memorandum for record to attest to the 

fact that the collector did measure the 

specimen temperature, the HHScertified laboratory or IITF may report 

the test result for the specimen but 

indicates that the collector could not 

provide a memorandum to recover the 

omission. 
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7968 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

(b) The following omissions and 

discrepancies on the Federal CCF that 

are made at the HHS-certified laboratory 

or IITF should not cause an MRO to 

cancel a test: 

(1) The testing laboratory or IITF fails 

to indicate the correct name and address 

in the results section when a different 

laboratory or IITF name and address is 

printed at the top of the Federal CCF; 

(2) The accessioner fails to print their 

name; 

(3) The certifying scientist or 

certifying technician fails to print their 

name; 

(4) The certifying scientist or 

certifying technician accidentally 

initials the Federal CCF rather than 

signing for a specimen reported as 

rejected for testing; 

(c) The above omissions and 

discrepancies should occur no more 

than once a month. The expectation is 

that each trained collector and HHScertified laboratory or IITF will make 

every effort to ensure that the Federal 

CCF is properly completed and that all 

the information is correct. When an 

error occurs more than once a month, 

the MRO must direct the collector, HHScertified laboratory, or HHS-certified 

IITF (whichever is responsible for the 

error) to immediately take corrective 

action to prevent the recurrence of the 

error. 

Section 15.4 What discrepancies may 

require an MRO to cancel a test? 

(a) An MRO must attempt to correct 

the following errors: 

(1) The donor’s signature is missing 

on the MRO copy of the Federal CCF 

and the collector failed to provide a 

comment that the donor refused to sign 

the form; 

(2) The certifying scientist failed to 

sign the Federal CCF for a specimen 

being reported drug positive, 

adulterated, invalid, or (for urine) 

substituted; or 

(3) The electronic report provided by 

the HHS-certified laboratory or HHScertified IITF does not contain all the 

data elements required for the HHS 

standard laboratory or IITF electronic 

report for a specimen being reported 

drug positive, adulterated, invalid 

result, or (for urine) substituted. 

(b) If error (a)(1) occurs, the MRO 

must contact the collector to obtain a 

statement to verify that the donor 

refused to sign the MRO copy. If, after 

at least 5 business days, the collector 

cannot provide such a statement, the 

MRO must cancel the test. 

(c) If error (a)(2) occurs, the MRO 

must obtain a statement from the 

certifying scientist that they 

inadvertently forgot to sign the Federal 

CCF, but did, in fact, properly conduct 

the certification review. If, after at least 

5 business days, the MRO cannot get a 

statement from the certifying scientist, 

the MRO must cancel the test. 

(d) If error (a)(3) occurs, the MRO 

must contact the HHS-certified 

laboratory or HHS-certified IITF. If, after 

at least 5 business days, the laboratory 

or IITF does not retransmit a corrected 

electronic report, the MRO must cancel 

the test. 

Subpart P—Laboratory or IITF 

Suspension/Revocation Procedures 

Section 16.1 When may the HHS 

certification of a laboratory or IITF be 

suspended? 

These procedures apply when: 

(a) The Secretary has notified an HHScertified laboratory or IITF in writing 

that its certification to perform drug 

testing under these Guidelines has been 

suspended or that the Secretary 

proposes to revoke such certification. 

(b) The HHS-certified laboratory or 

IITF has, within 30 days of the date of 

such notification or within 3 days of the 

date of such notification when seeking 

an expedited review of a suspension, 

requested in writing an opportunity for 

an informal review of the suspension or 

proposed revocation. 

Section 16.2 What definitions are used 

for this subpart? 

Appellant. Means the HHS-certified 

laboratory or IITF which has been 

notified of its suspension or proposed 

revocation of its certification to perform 

testing and has requested an informal 

review thereof. 

Respondent. Means the person or 

persons designated by the Secretary in 

implementing these Guidelines. 

Reviewing Official. Means the person 

or persons designated by the Secretary 

who will review the suspension or 

proposed revocation. The reviewing 

official may be assisted by one or more 

of the official’s employees or 

consultants in assessing and weighing 

the scientific and technical evidence 

and other information submitted by the 

appellant and respondent on the reasons 

for the suspension and proposed 

revocation. 

Section 16.3 Are there any limitations 

on issues subject to review? 

The scope of review shall be limited 

to the facts relevant to any suspension 

or proposed revocation, the necessary 

interpretations of those facts, the 

relevant Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs, and other relevant law. The 

legal validity of these Guidelines shall 

not be subject to review under these 

procedures. 

Section 16.4 Who represents the 

parties? 

The appellant’s request for review 

shall specify the name, address, and 

telephone number of the appellant’s 

representative. In its first written 

submission to the reviewing official, the 

respondent shall specify the name, 

address, and telephone number of the 

respondent’s representative. 

Section 16.5 When must a request for 

informal review be submitted? 

(a) Within 30 days of the date of the 

notice of the suspension or proposed 

revocation, the appellant must submit a 

written request to the reviewing official 

seeking review, unless some other time 

period is agreed to by the parties. A 

copy must also be sent to the 

respondent. The request for review must 

include a copy of the notice of 

suspension or proposed revocation, a 

brief statement of why the decision to 

suspend or propose revocation is wrong, 

and the appellant’s request for an oral 

presentation, if desired. 

(b) Within 5 days after receiving the 

request for review, the reviewing official 

will send an acknowledgment and 

advise the appellant of the next steps. 

The reviewing official will also send a 

copy of the acknowledgment to the 

respondent. 

Section 16.6 What is an abeyance 

agreement? 

Upon mutual agreement of the parties 

to hold these procedures in abeyance, 

the reviewing official will stay these 

procedures for a reasonable time while 

the laboratory or IITF attempts to regain 

compliance with the Guidelines or the 

parties otherwise attempt to settle the 

dispute. As part of an abeyance 

agreement, the parties can agree to 

extend the time period for requesting 

review of the suspension or proposed 

revocation. If abeyance begins after a 

request for review has been filed, the 

appellant shall notify the reviewing 

official at the end of the abeyance 

period advising whether the dispute has 

been resolved. If the dispute has been 

resolved, the request for review will be 

dismissed. If the dispute has not been 

resolved, the review procedures will 

begin at the point at which they were 

interrupted by the abeyance agreement 

with such modifications to the 

procedures as the reviewing official 

deems appropriate. 
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Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 7969 

Section 16.7 What procedures are used 

to prepare the review file and written 

argument? 

The appellant and the respondent 

each participate in developing the file 

for the reviewing official and in 

submitting written arguments. The 

procedures for development of the 

review file and submission of written 

argument are: 

(a) Appellant’s Documents and Brief. 

Within 15 days after receiving the 

acknowledgment of the request for 

review, the appellant shall submit to the 

reviewing official the following (with a 

copy to the respondent): 

(1) A review file containing the 

documents supporting appellant’s 

argument, tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining why 

respondent’s decision to suspend or 

propose revocation of appellant’s 

certification is wrong (appellant’s brief). 

(b) Respondent’s Documents and 

Brief. Within 15 days after receiving a 

copy of the acknowledgment of the 

request for review, the respondent shall 

submit to the reviewing official the 

following (with a copy to the appellant): 

(1) A review file containing 

documents supporting respondent’s 

decision to suspend or revoke 

appellant’s certification to perform drug 

testing, which is tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not exceeding 

20 double-spaced pages in length, 

explaining the basis for suspension or 

proposed revocation (respondent’s 

brief). 

(c) Reply Briefs. Within 5 days after 

receiving the opposing party’s 

submission, or 20 days after receiving 

acknowledgment of the request for 

review, whichever is later, each party 

may submit a short reply not to exceed 

10 double-spaced pages. 

(d) Cooperative Efforts. Whenever 

feasible, the parties should attempt to 

develop a joint review file. 

(e) Excessive Documentation. The 

reviewing official may take any 

appropriate step to reduce excessive 

documentation, including the return of 

or refusal to consider documentation 

found to be irrelevant, redundant, or 

unnecessary. 

Section 16.8 When is there an 

opportunity for oral presentation? 

(a) Electing Oral Presentation. If an 

opportunity for an oral presentation is 

desired, the appellant shall request it at 

the time it submits its written request 

for review to the reviewing official. The 

reviewing official will grant the request 

if the official determines that the 

decision-making process will be 

substantially aided by oral presentations 

and arguments. The reviewing official 

may also provide for an oral 

presentation at the official’s own 

initiative or at the request of the 

respondent. 

(b) Presiding Official. The reviewing 

official or designee will be the presiding 

official responsible for conducting the 

oral presentation. 

(c) Preliminary Conference. The 

presiding official may hold a prehearing 

conference (usually a telephone 

conference call) to consider any of the 

following: Simplifying and clarifying 

issues, stipulations and admissions, 

limitations on evidence and witnesses 

that will be presented at the hearing, 

time allotted for each witness and the 

hearing altogether, scheduling the 

hearing, and any other matter that will 

assist in the review process. Normally, 

this conference will be conducted 

informally and off the record; however, 

the presiding official may, at their 

discretion, produce a written document 

summarizing the conference or 

transcribe the conference, either of 

which will be made a part of the record. 

(d) Time and Place of the Oral 

Presentation. The presiding official will 

attempt to schedule the oral 

presentation within 30 days of the date 

the appellant’s request for review is 

received or within 10 days of 

submission of the last reply brief, 

whichever is later. The oral presentation 

will be held at a time and place 

determined by the presiding official 

following consultation with the parties. 

(e) Conduct of the Oral Presentation. 

(1) General. The presiding official is 

responsible for conducting the oral 

presentation. The presiding official may 

be assisted by one or more of the 

official’s employees or consultants in 

conducting the oral presentation and 

reviewing the evidence. While the oral 

presentation will be kept as informal as 

possible, the presiding official may take 

all necessary steps to ensure an orderly 

proceeding. 

(2) Burden of Proof/Standard of Proof. 

In all cases, the respondent bears the 

burden of proving by a preponderance 

of the evidence that its decision to 

suspend or propose revocation is 

appropriate. The appellant, however, 

has a responsibility to respond to the 

respondent’s allegations with evidence 

and argument to show that the 

respondent is wrong. 

(3) Admission of Evidence. The 

Federal Rules of Evidence do not apply 

and the presiding official will generally 

admit all testimonial evidence unless it 

is clearly irrelevant, immaterial, or 

unduly repetitious. Each party may 

make an opening and closing statement, 

may present witnesses as agreed upon 

in the prehearing conference or 

otherwise, and may question the 

opposing party’s witnesses. Since the 

parties have ample opportunity to 

prepare the review file, a party may 

introduce additional documentation 

during the oral presentation only with 

the permission of the presiding official. 

The presiding official may question 

witnesses directly and take such other 

steps necessary to ensure an effective 

and efficient consideration of the 

evidence, including setting time 

limitations on direct and crossexaminations. 

(4) Motions. The presiding official 

may rule on motions including, for 

example, motions to exclude or strike 

redundant or immaterial evidence, 

motions to dismiss the case for 

insufficient evidence, or motions for 

summary judgment. Except for those 

made during the hearing, all motions 

and opposition to motions, including 

argument, must be in writing and be no 

more than 10 double-spaced pages in 

length. The presiding official will set a 

reasonable time for the party opposing 

the motion to reply. 

(5) Transcripts. The presiding official 

shall have the oral presentation 

transcribed and the transcript shall be 

made a part of the record. Either party 

may request a copy of the transcript and 

the requesting party shall be responsible 

for paying for its copy of the transcript. 

(f) Obstruction of Justice or Making of 

False Statements. Obstruction of justice 

or the making of false statements by a 

witness or any other person may be the 

basis for a criminal prosecution under 

18 U.S.C. 1505 or 1001. 

(g) Post-hearing Procedures. At their 

discretion, the presiding official may 

require or permit the parties to submit 

post-hearing briefs or proposed findings 

and conclusions. Each party may submit 

comments on any major prejudicial 

errors in the transcript. 

Section 16.9 Are there expedited 

procedures for review of immediate 

suspension? 

(a) Applicability. When the Secretary 

notifies an HHS-certified laboratory or 

IITF in writing that its certification to 

perform drug testing has been 
mstockstill on DSK3G9T082PROD with NOTICES2


7970 Federal Register / Vol. 82, No. 13 / Monday, January 23, 2017 / Notices 

immediately suspended, the appellant 

may request an expedited review of the 

suspension and any proposed 

revocation. The appellant must submit 

this request in writing to the reviewing 

official within 3 days of the date the 

HHS-certified laboratory or IITF 

received notice of the suspension. The 

request for review must include a copy 

of the suspension and any proposed 

revocation, a brief statement of why the 

decision to suspend and propose 

revocation is wrong, and the appellant’s 

request for an oral presentation, if 

desired. A copy of the request for review 

must also be sent to the respondent. 

(b) Reviewing Official’s Response. As 

soon as practicable after the request for 

review is received, the reviewing official 

will send an acknowledgment with a 

copy to the respondent. 

(c) Review File and Briefs. Within 7 

days of the date the request for review 

is received, but no later than 2 days 

before an oral presentation, each party 

shall submit to the reviewing official the 

following: 

(1) A review file containing essential 

documents relevant to the review, 

which is tabbed, indexed, and organized 

chronologically; and 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining the 

party’s position concerning the 

suspension and any proposed 

revocation. No reply brief is permitted. 

(d) Oral Presentation. If an oral 

presentation is requested by the 

appellant or otherwise granted by the 

reviewing official, the presiding official 

will attempt to schedule the oral 

presentation within 7–10 days of the 

date of appellant’s request for review at 

a time and place determined by the 

presiding official following consultation 

with the parties. The presiding official 

may hold a prehearing conference in 

accordance with Section 16.8(c) and 

will conduct the oral presentation in 

accordance with the procedures of 

Sections 16.8(e), (f), and (g). 

(e) Written Decision. The reviewing 

official shall issue a written decision 

upholding or denying the suspension or 

proposed revocation and will attempt to 

issue the decision within 7–10 days of 

the date of the oral presentation or 

within 3 days of the date on which the 

transcript is received or the date of the 

last submission by either party, 

whichever is later. All other provisions 

set forth in Section 16.14 will apply. 

(f) Transmission of Written 

Communications. Because of the 

importance of timeliness for these 

expedited procedures, all written 

communications between the parties 

and between either party and the 

reviewing official shall be by facsimile, 

secured electronic transmissions, or 

overnight mail. 

Section 16.10 Are any types of 

communications prohibited? 

Except for routine administrative and 

procedural matters, a party shall not 

communicate with the reviewing or 

presiding official without notice to the 

other party. 

Section 16.11 How are 

communications transmitted by the 

reviewing official? 

(a) Because of the importance of a 

timely review, the reviewing official 

should normally transmit written 

communications to either party by 

facsimile, secured electronic 

transmissions, or overnight mail in 

which case the date of transmission or 

day following mailing will be 

considered the date of receipt. In the 

case of communications sent by regular 

mail, the date of receipt will be 

considered 3 days after the date of 

mailing. 

(b) In counting days, include 

Saturdays, Sundays, and federal 

holidays. However, if a due date falls on 

a Saturday, Sunday, or federal holiday, 

then the due date is the next federal 

working day. 

Section 16.12 What are the authority 

and responsibilities of the reviewing 

official? 

In addition to any other authority 

specified in these procedures, the 

reviewing official and the presiding 

official, with respect to those authorities 

involving the oral presentation, shall 

have the authority to issue orders; 

examine witnesses; take all steps 

necessary for the conduct of an orderly 

hearing; rule on requests and motions; 

grant extensions of time for good 

reasons; dismiss for failure to meet 

deadlines or other requirements; order 

the parties to submit relevant 

information or witnesses; remand a case 

for further action by the respondent; 

waive or modify these procedures in a 

specific case, usually with notice to the 

parties; reconsider a decision of the 

reviewing official where a party 

promptly alleges a clear error of fact or 

law; and to take any other action 

necessary to resolve disputes in 

accordance with the objectives of these 

procedures. 

Section 16.13 What administrative 

records are maintained? 

The administrative record of review 

consists of the review file; other 

submissions by the parties; transcripts 

or other records of any meetings, 

conference calls, or oral presentation; 

evidence submitted at the oral 

presentation; and orders and other 

documents issued by the reviewing and 

presiding officials. 

Section 16.14 What are the 

requirements for a written decision? 

(a) Issuance of Decision. The 

reviewing official shall issue a written 

decision upholding or denying the 

suspension or proposed revocation. The 

decision will set forth the reasons for 

the decision and describe the basis 

therefore in the record. Furthermore, the 

reviewing official may remand the 

matter to the respondent for such 

further action as the reviewing official 

deems appropriate. 

(b) Date of Decision. The reviewing 

official will attempt to issue their 

decision within 15 days of the date of 

the oral presentation, the date on which 

the transcript is received, or the date of 

the last submission by either party, 

whichever is later. If there is no oral 

presentation, the decision will normally 

be issued within 15 days of the date of 

receipt of the last reply brief. Once 

issued, the reviewing official will 

immediately communicate the decision 

to each party. 

(c) Public Notice. If the suspension 

and proposed revocation are upheld, the 

revocation will become effective 

immediately and the public will be 

notified by publication of a notice in the 

Federal Register. If the suspension and 

proposed revocation are denied, the 

revocation will not take effect and the 

suspension will be lifted immediately. 

Public notice will be given by 

publication in the Federal Register. 

Section 16.15 Is there a review of the 

final administrative action? 

Before any legal action is filed in 

court challenging the suspension or 

proposed revocation, respondent shall 

exhaust administrative remedies 

provided under this subpart, unless 

otherwise provided by Federal Law. The 

reviewing official’s decision, under 

Section 16.9(e) or 16.14(a) constitutes 

final agency action and is ripe for 

judicial review as of the date of the 

decision. 

[FR Doc. 2017–00979 Filed 1–19–17; 8:45 am] 

BILLING CODE 4162–20–P 
APPENDIX E

Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid [OFMG]

57554 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

42 CFR Chapter I 

[SAMHSA—4162–20–P] 

RIN 0930–AA24 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs— 

Oral/Fluid 

AGENCY: Substance Abuse and Mental 

Health Services Administration 

(SAMHSA), HHS. 

ACTION: Issuance of guidelines. 

SUMMARY: The Department of Health and 

Human Services (‘‘HHS’’ or 

‘‘Department’’) has established scientific 

and technical guidelines for the 

inclusion of oral fluid specimens in the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs 

(Guidelines). 

DATES: Effective January 1, 2020. 

FOR FURTHER INFORMATION CONTACT: 

Charles LoDico, M.S., F–ABFT, Division 

of Workplace Programs, Center for 

Substance Abuse Prevention (CSAP), 

SAMHSA, 5600 Fishers Lane, Room 

16N03A, Rockville, MD 20857, 

telephone (240) 276–2600 or email at 

charles.lodico@samhsa.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid (OFMG) will allow federal 

executive branch agencies to collect and 

test an oral fluid specimen as part of 

their drug testing programs. In addition, 

some agencies, such as the Department 

of Transportation, are required to follow 

the Guidelines in developing drug 

testing programs for their regulated 

industries, whereas others, such as the 

Nuclear Regulatory Commission (NRC), 

use the Guidelines as part of the 

regulatory basis for their drug testing 

programs for their regulated industries. 

The OFMG establish standards and 

technical requirements for oral fluid 

collection devices, initial oral fluid drug 

test analytes and methods, confirmatory 

oral fluid drug test analytes and 

methods, processes for review by a 

Medical Review Officer (MRO), and 

requirements for federal agency actions. 

The OFMG provide flexibility for 

federal agency workplace drug testing 

programs to address testing needs and 

revise the requirement to collect only a 

urine specimen, which has existed since 

the Guidelines were first published in 

1988. Since 1988, several products have 

appeared on the market making it easier 

for individuals to adulterate their urine 

specimens. The scientific basis for the 

use of oral fluid as an alternative 

specimen for drug testing has now been 

broadly established and the advances in 

the use of oral fluid in detecting drugs 

have made it possible for this alternative 

specimen to be used in federal programs 

with the same level of confidence that 

has been applied to the use of urine. For 

example, oral fluid collection devices 

and procedures have been developed 

that protect against biohazards, 

maintain the stability of analytes, and 

provide sufficient oral fluid for testing. 

Additionally, specimen volume is also 

much lower, saving time in collection 

and transport cost. Developments in 

analytical technologies have provided 

efficient and cost-effective methods 

with the analytical sensitivity and 

accuracy required for testing oral fluid 

specimens. 

Federal agencies, MROs, and 

regulated industries using the OFMG 

will continue to adhere to all other 

federal standards established for 

workplace drug testing programs. The 

OFMG provide the same scientific and 

forensic supportability of drug test 

results as the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine (UrMG). 

Background 

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 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]. 

The revised Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine (UrMG) were 

published on January 23, 2017 [82 FR 

7920] with an effective date of October 

1, 2017. 

The Department published the 

proposed Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Oral Fluid (OFMG) in 

the May 15, 2015 Federal Register (80 

FR 28054). There was a 60-day public 

comment period, during which 120 

commenters submitted comments on the 

OFMG. These commenters were 

comprised of individuals, organizations, 

and private sector companies. The 

comments are available for public view 

at http://www.regulations.gov/. All 

comments were reviewed and taken into 

consideration in the preparation of the 

Guidelines. The issues and concerns 

raised in the public comments for the 

OFMG are set forth below. Similar 

comments are considered together in the 

discussion. 

Summary of Public Comments and 

HHS’s Response 

The following comments were 

directed to the information and 

questions in the preamble. 

Requirements for Specimen Validity 

Testing 

The Department requested comments 

on requirements for federal agencies to 

test all oral fluid specimens for either 

albumin or immunoglobulin G (IgG) to 

determine specimen validity. Four 

commenters agreed with the proposed 

requirements. Twelve commenters 

disagreed with the Guidelines as 

written, suggesting that specimen 

validity testing is not needed because all 

oral fluid collections are observed, 

collection procedures require visual 

inspection of the mouth by the collector 

and a 10-minute wait period, collection 

devices contain a volume indicator, and 

there is a limited volume of oral fluid 

collected and this volume is needed to 

complete confirmatory drug tests. One 

commenter expressed concern over the 

consequences of erroneous validity test 

results in relation to inappropriate 

cutoffs being set. One commenter 

questioned the proposed specimen 

validity testing analytes and cutoffs, and 

proposed that volume sufficiency be 

determined upon receipt at the 

laboratory. One commenter disagreed 

with the proposed IgG cutoff. One 

commenter disagreed that specimen 

validity testing should be performed on 

all specimens, and recommended 

performing specimen validity testing on 

a randomly chosen subset. This 

commenter also stated that specimen 

validity testing must be subjected to 

oversight by proficiency testing and 

blind sample testing programs. The 

Department has evaluated the comments 

and has revised the Guidelines to allow, 

but not require, specimen validity 

testing. The Department agrees that the 

OFMG collection procedures greatly 

minimize the risks of donor attempts to 

tamper with the specimen, and the 

volume indicator requirement for oral 

fluid collection devices should prevent 

collection of insufficient volume. To 

avoid prohibiting use of albumin and 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57555 

IgG tests, as well as other scientifically 

supportable oral fluid biomarker or 

adulterant tests that may become 

available, the Department is authorizing 

specimen validity testing upon request 

of the Medical Review Officer as 

described in Sections 3.1 and 3.5. All 

tests must be properly validated and 

include appropriate quality control 

samples in accordance with these 

Guidelines. In response to commenters’ 

concerns about expending the limited 

volume of oral fluid collected, it should 

be noted that HHS-certified laboratories 

currently performing specimen validity 

tests for non-regulated oral fluid testing 

use low volumes (i.e., 25 mcL for 

albumin tests, 15 mcL for IgG tests) that 

would not be expected to have a 

significant impact on a laboratory’s 

ability to complete testing. 

Proposed Cutoff Concentrations 

Nineteen commenters submitted 

comments on the proposed drug test 

cutoffs. Some were general comments, 

while others concerned specific drug 

analytes. Cutoffs for marijuana tests are 

discussed in the following section, 

Testing for Marijuana Use. The 

comments and the Department’s 

responses concerning cutoffs for other 

drug tests are described below. 

Two commenters agreed with all 

proposed analytes and cutoffs. Two 

deferred setting cutoffs to HHS-certified 

laboratories. Three disagreed with all 

proposed cutoffs. Two of these 

commenters recommended retaining the 

cutoffs in the proposed Guidelines of 

April 13, 2004 (69 FR 19673). One of 

these commenters believes that the 

technology to detect analytes at these 

low levels is questionable and that these 

cutoffs will identify employees on 

prescribed medications. One commenter 

requested the basis for changing the 

cutoffs from those proposed in 2004. As 

described in the preamble to the 

proposed OFMG (80 FR 28054), the 

Department based the proposed cutoffs 

for each drug on information in public 

comments from the April 2004 proposed 

Guidelines, public responses to the June 

2011 Request for Information (76 FR 

34086), and the recommendations of a 

technical workgroup consisting of 

subject matter experts and 

representatives from various stakeholder 

groups (e.g., collection device and test 

kit manufacturers, oral fluid drug testing 

laboratories). The Department provided 

the recommended cutoffs with 

supporting scientific information to the 

SAMHSA Drug Testing Advisory Board 

(DTAB) for review and discussion and, 

in the preamble to the proposed OFMG 

of May 15, 2015 (80 FR 28054, pages 

28061–28065), included reasons for the 

proposed cutoffs for each drug, with 

references to supporting scientific 

studies. The Department has raised the 

cutoffs for some drug tests to address 

specific comments as described below. 

The Department concluded that no 

change is needed for other analytes. The 

cutoffs in Section 3.4 are supported by 

scientific studies, and are consistent 

with the goals of the federal workplace 

drug testing programs. The National 

Laboratory Certification Program (NLCP) 

Pilot Performance Testing (PT) Program 

has documented that laboratories are 

able to meet the Guidelines 

requirements using the cutoffs in 

Section 3.4. 

One commenter agreed with the 

proposed initial test cutoff for cocaine, 

and recommended that a slightly lower 

cutoff be used for the confirmatory test. 

The Department did not find scientific 

evidence to warrant a change to the 

proposed confirmatory cutoff, which is 

the same as that proposed in 2004. 

Five commenters disagreed with the 

proposed codeine and morphine cutoffs. 

Two commenters stated that the cutoffs 

are too low: One expressed concern over 

the technology to detect analytes at the 

proposed low levels and both noted that 

the change from currently used cutoffs 

will increase the number of initial test 

positives, thereby increasing costs. Two 

commenters stated that the Department 

has not supported changing from the 

cutoffs proposed in 2004 (i.e., 40 ng/mL 

for both the initial and confirmatory 

tests), which are currently used by the 

industry. One commenter indicated that 

their test data support a cutoff of 30 ng/ 

mL for both the initial and confirmatory 

tests. In the preamble to the proposed 

OFMG of May 15, 2015 (80 FR 28054, 

page 28063), the Department included 

reasons for the selected test cutoffs for 

each drug, with references supporting 

those cutoffs. The Department is 

retaining the proposed cutoffs (i.e., 30 

ng/mL for the initial test and 15 ng/mL 

for the confirmatory test) and is 

providing further explanation below to 

address the comments. 

Reports in the literature provide 

information supporting lowering the 

morphine initial test cutoff from 40 to 

30 ng/mL. In one dosing study with 

doses of 20 and 10 mg of morphine 

sulfate, morphine concentrations in 

saliva peaked at 0.5 hours at 37.8 ng/mL 

and 10.8 ng/mL, respectively, with 

detection times of 24 hours using a limit 

of detection (LOD) of 0.6 ng/mL.1 In 

another report, morphine concentrations 

in oral fluid of treatment patients 

(n=4,575) were reported to range from 2 

to 3,026 ng/mL with a median 

concentration of 49.8 ng/mL.2 It was 

also found that 25% of the specimens 

contained morphine less than 13.5 ng/ 

mL. These reports of short detection 

times and low concentrations of 

morphine in oral fluid also justify 

lowering the confirmatory cutoff for 

morphine to 15 ng/mL. The NLCP Pilot 

PT program has demonstrated oral fluid 

testing laboratories’ abilities to meet 

codeine and morphine confirmatory 

cutoffs of 15 ng/mL using current testing 

technologies. 

One commenter agreed with the 

proposed initial test cutoffs for 

oxycodone, oxymorphone, 

hydrocodone, and hydromorphone, but 

recommended that the same cutoffs be 

used for confirmatory testing. One 

commenter disagreed with all proposed 

cutoffs for these drugs, stating that the 

cutoffs are too low and will identify 

legitimate prescription users. The 

Department will retain the cutoffs as 

proposed. In the preamble to the 

proposed OFMG of May 15, 2015 (80 FR 

28054, pages 28064–28065), the 

Department included reasons for the 

selected test cutoffs for each drug, with 

references supporting those cutoffs. 

Considerable research and discussion 

were conducted regarding the complex 

issues surrounding the specification of 

each cutoff concentration. The 

Department solicited input from 

laboratories, reagent and device 

manufacturers, subject matter experts, 

and the Food and Drug Administration 

(FDA). The cutoff concentrations are the 

outcome of the lengthy discussion 

process and represent the best approach 

currently available. Furthermore, the 

OFMG include the same requirements 

as the UrMG for Medical Review 

Officers to interview donors to 

determine whether there is a legitimate 

medical explanation for a positive test 

result, and to review documentation 

provided by the donor to support a 

legitimate medical explanation. 

One commenter disagreed with the 

proposed 3 ng/mL initial test cutoff for 

6-acetylmorphine (6–AM), stating that 

the proposed cutoff is higher than that 

currently used. As suggested by the 

commenter, and based on current 6–AM 

test methods and laboratory results from 

the NLCP Pilot PT Program, the 

Department has raised the proposed 6– 

AM initial test cutoff in Section 3.4 to 

4 ng/mL (i.e., the same as proposed in 

2004). The same commenter 

recommended a higher confirmatory test 

cutoff (3 ng/mL vs. the proposed 2 ng/ 

mL), and noted that their data show that 

using an opiates cutoff of 30 ng/mL and 

a 6–AM confirmatory cutoff of 3 ng/mL 

identifies more positive 6–AM 

specimens than urine testing. The 

comparison of 6–AM positivity rates in 

urine and oral fluid does not support a 

57556 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

change to the proposed confirmatory 

test cutoff. Studies have shown that 6– 

AM is statistically more likely to be 

detected in oral fluid than urine, 

regardless of the cutoff. 345 The 

Department has retained the 2 ng/mL 6– 

AM confirmatory test cutoff proposed in 

2015, primarily for enhanced 

sensitivity. Studies have shown that 6– 

AM concentrations between 1 and 3 ng/ 

mL are detected in the study 

populations. 2367 

One commenter agreed with the 

proposed test cutoffs for phencyclidine 

(PCP). Three others disagreed, 

recommending that the Department use 

the 2004 proposed cutoffs (i.e., 10 ng/ 

mL for both the initial and confirmatory 

tests). The Department has evaluated the 

comments and agrees with commenters 

that there is an insufficient scientific 

basis to warrant changes from the PCP 

test cutoffs in the April 13, 2004 

proposed Guidelines (69 FR 19673), 

which are currently used by many test 

manufacturers and laboratories. 

Therefore, the Department has raised 

the proposed cutoffs in Section 3.4 as 

follows: PCP cutoffs are 10 ng/mL for 

both the initial and confirmatory tests. 

Six commenters disagreed with the 

proposed test cutoffs for amphetamines. 

Two of these commenters recommended 

that the Department use the 2004 

proposed cutoffs (i.e., 50 ng/ml for both 

the initial and confirmatory tests). One 

recommended that the 2004 cutoff be 

used for the initial test; another 

recommended using the 2004 cutoff for 

the initial test and half of that 

concentration (25 ng/mL) as the 

confirmatory test cutoff. One commenter 

suggested cutoffs of 150 ng/mL or 120 

ng/mL. One suggested setting cutoffs at 

120 ng/mL or above to reduce the 

number of unverified positive initial 

tests. One commenter requested the 

basis for using different initial and 

confirmatory test cutoffs for 

methylenedioxymethamphetamine 

(MDMA). 

The Department has evaluated the 

comments and agrees with commenters 

that, for amphetamines, there is an 

insufficient scientific basis to warrant 

changes from the initial test cutoffs in 

the April 13, 2004 proposed Guidelines 

(69 FR 19673), which are currently used 

by many test manufacturers and 

laboratories. Therefore, the Department 

has raised the proposed initial and 

confirmatory test cutoffs in Section 3.4 

as follows: The initial test cutoff for 

amphetamines (i.e., amphetamine, 

methamphetamine, MDMA, and MDA) 

is 50 ng/mL, and the confirmatory test 

cutoff for each amphetamine analyte is 

25 ng/mL. 

Testing for Marijuana Use 

The Department requested comments 

on several topics related to testing for 

marijuana use. Public comments and the 

Department’s responses are described 

below. After reviewing the comments, 

as well as the results of scientific 

studies published after the development 

of the proposed OFMG, the Department 

has decided to test for one marijuana 

analyte, delta-9-tetrahydrocannabinol 

(THC). THC is the primary psychoactive 

constituent (or cannabinoid) of the 

cannabis plant and is the primary 

intoxicant in marijuana. After careful 

consideration of all available evidence 

for THC in oral fluid, the Department 

has decided to retain the proposed 4 ng/ 

mL initial test cutoff for THC in the final 

OFMG. Details regarding this decision 

are described below. 

The Capability of Laboratories To Test 

Delta-9-Tetrahydrocannabinol-9- 

Carboxylic Acid (THCA) Analyte Using 

a Cutoff of 50 pg/mL 

One commenter agreed and four 

commenters disagreed that laboratories 

were currently capable of testing THCA 

in oral fluid using this cutoff. One 

commenter stated that laboratory 

instrumentation required for the 

analysis of THCA in oral fluid is widely 

available and can be added to routine 

laboratory testing. The commenter listed 

examples: Two-dimensional gas 

chromatography/mass spectrometry 

(GC/MS), GC/MS/MS, and liquid 

chromatography (LC)/MS/MS. Three 

commenters disagreed, stating that it 

would require significant investment in 

more sensitive instrumentation. One 

commenter disagreed, stating they doubt 

the capabilities of the laboratories to 

consistently test for THCA with 

accuracy, sensitivity and validity. One 

commenter disagreed, stating that the 

number of laboratories with the 

experience in testing for THCA is 

limited. The Department has evaluated 

the comments and agrees that there is a 

limited number of laboratories currently 

testing for THCA in oral fluid. Only one 

commercial drug testing laboratory 

participating in the Oral Fluid Pilot PT 

program performed THCA testing. 

Furthermore, due to the concentration 

differences between THC (i.e., 

nanogram/milliliter or ng/mL levels) 

and THCA (i.e., picogram/milliliter or 

pg/mL levels), immunoassays do not 

have sufficient cross-reactivity to enable 

use of a single assay for both analytes. 

Initial testing for both THC and THCA 

would require two separate 

immunoassay kits or use of alternative 

technology. No current immunoassay 

has been identified that is selective for 

THCA only. Laboratories planning to 

become HHS-certified to test federal 

agency oral fluid specimens may 

already have instrumentation for 

confirmatory testing that could be used 

as an alternate technology for initial 

testing, but may incur additional costs 

to develop and validate these new 

initial drug tests. 

The Validity of Whether THCA Can Be 

Established as an Accurate, Sensitive 

and Valid Marker for Oral Fluid Testing 

To Detect Marijuana Use and Whether 

THCA Should Be Used To Extend the 

Window of Detection for Marijuana Use 

Four commenters agreed with THCA 

as a test analyte. These commenters 

believe that analysis of THCA may 

prevent or minimize the risk of positive 

results due to ‘‘passive exposure’’ (i.e., 

a nonsmoker’s exposure to secondhand 

marijuana smoke). One commenter 

stated that if both THC and THCA 

analytes are required to be present to 

constitute a rule or policy violation, this 

would also eliminate protracted 

detection of THCA. The commenter 

suggested that if only one of the 

marijuana analytes is reported, it could 

be addressed as a safety concern. This 

commenter also opposed MROs 

requesting THCA testing as needed and, 

as an alternative, suggested requiring 

disclosure from the donor at the time of 

collection (i.e., the collector would ask 

the donor whether the donor had been 

exposed to marijuana recently and 

testing for THCA would be performed 

based on the donor’s answer). If the 

donor indicated no recent exposure, the 

donor has waived the right to a passive 

inhalation defense. One commenter 

recommended an agency or employer 

should have the option to choose either 

test (THC or THCA), providing 

flexibility for employers’ testing goals. 

One commenter noted that THCA 

testing, if included in the Guidelines, 

would be in conjunction with THC 

testing and expressed concerns 

including how to handle two test results 

(THC and THCA) that do not agree, 

additional costs, longer turnaround 

time, and handling of retests. 

Six commenters disagreed with THCA 

as a test analyte. One commenter 

disagreed, suggesting solely testing for 

the active parent drug is one of the 

defining characteristics of oral fluid 

testing. Two commenters disagreed, 

suggesting THCA is not a reliable 

metabolite to be an appropriate marker 

for marijuana use. One commenter 

disagreed, stating that THCA is only 

present in oral fluid at very low levels. 

One commenter disagreed, suggesting 

that under realistic conditions of casual 

passive exposure and specimen 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57557 

collection where the collection occurs 

outside the exposure area, a donor 

would not test positive for THC at the 

currently used initial test (3 ng/mL) and 

confirmatory test (1.5 ng/mL) cutoffs. 

One commenter disagreed, stating that 

more research is needed before adding 

THCA to the Guidelines. One 

commenter disagreed, indicating that, 

for the majority of the time, no 

significant THC positives are reported 

for samples containing THCA alone. 

The commenter also stated that for 

THCA alone (in the absence of THC) to 

be detected as positive in the 

immunoassay, the level must be at least 

1,000 pg/ml, and that specimen volume 

is limited and should not be wasted for 

unnecessary tests. 

The Department has evaluated the 

comments and decided to use THC as 

the sole initial and confirmatory test 

analyte for marijuana, with a 4 ng/mL 

initial test cutoff and a 2 ng/mL 

confirmatory test cutoff. This decision is 

supported by the reasons detailed 

below. 

First, the Department is not aware of 

any scientific evidence to suggest that 

individuals would test positive for THC 

under the standards in these Guidelines 

as the result of incidental exposure to 

secondhand marijuana smoke. The 

preamble to the proposed OFMG, 

published on May 15, 2015, provided 

information on THC and THCA results 

from studies of subjects who were 

passively exposed to marijuana smoke 

under a variety of exposure 

conditions.8–11 These studies, detailed 

below, were conducted under 

conditions of extreme marijuana smoke 

exposure for several hours in enclosed 

spaces (i.e., heavy smoke in 

unventilated and ventilated conditions). 

The study data indicate that transient 

amounts of THC may be present in 

nonsmokers’ oral fluid for a few hours 

(i.e., one to three), but only under those 

extreme conditions, meaning exposure 

to smoke from multiple cannabis 

cigarettes in an enclosed space for an 

extended time period. 

One 2011 study tested nonsmokers in 

two Dutch coffeehouses where 

marijuana was being smoked.10 While 

some positive tests were obtained from 

the subjects, those samples were taken 

during a time of ongoing exposure to 

marijuana smoke in the coffeehouses, no 

subjects tested positive after returning 

for a final collection 12 to 24 hours after 

exposure. It should be noted that at the 

time of this notice’s publishing, 

recreational and/or medical marijuana 

use is not permitted in places of public 

accommodation under either state or 

federal law. While this study 

demonstrated the types of THC oral 

fluid concentrations that could be 

obtained during exposure to 

secondhand marijuana smoke, the study 

is not directly applicable to Federal 

drug testing because the positive 

specimens collected in this study were 

collected during ongoing exposure to 

secondhand marijuana smoke, which 

does not approximate federal drug 

testing collection conditions. 

A more recent study exposed 

nonsmokers to extreme levels of 

marijuana smoke under controlled 

conditions.12 13 The extreme exposure in 

this 2015 study consisted of three 

different one-hour sessions in which 

nonsmokers were enclosed in a sealed 

room with six smokers who smoked 

cannabis cigarettes almost continually 

through each session. The room was a 

specially constructed sealed Plexiglas 

chamber (10 ft. by 13 ft. with a 7-ft. 

ceiling). Nonsmokers and smokers were 

seated around a table in alternating seats 

and the nonsmokers were continually 

exposed to heavy amounts of marijuana 

smoke. In two sessions, there was no air 

flow (i.e., air conditioning was turned 

off) and in one session, the air 

conditioning was turned on. Heavy 

marijuana smoke was present in each 

session and the smoke caused eye 

irritation in the two non-ventilated 

sessions. Because of the extreme smoke 

conditions, most participants elected to 

wear eye goggles to reduce eye 

irritation. In this study, 3 of the 6 

nonsmokers were negative directly after 

the exposure concluded (0 hours) and 4 

of 6 were negative at 0.5 hours. 

Some of these subjects (nonsmokers) 

also reported drug effects that were 

approximately 25% of the smokers’ 

responses (i.e., self-reported effects on a 

visual analog scale). The nonsmokers 

also exhibited detectable levels of 

performance impairment on some 

behavioral/cognitive assessments. 

Therefore, a reasonable donor in a safety 

sensitive position who is aware that he 

or she is in an enclosed environment 

with heavy levels of secondhand 

marijuana smoke should understand 

that he or she is very likely to 

experience the effects of inhaled 

marijuana smoke if he or she remains in 

this type of environment. Importantly, it 

is worth noting that exposure to the 

extreme levels of marijuana smoke in all 

three study sessions (i.e., non-ventilated 

and ventilated) does not represent a 

real-world situation and, therefore, is an 

unlikely passive exposure situation for 

donors in a federal agency testing 

program. 

The marijuana studies described 

above indicate that transient amounts of 

THC may be present in nonsmokers’ 

oral fluid between one to three hours 

after prolonged, extreme exposure. 

Conversely, however, in two similar 

passive exposure studies from 2001 and 

2005, none of the nonsmoking subjects 

tested positive using cutoffs that were 

lower than the OFMG THC cutoffs (i.e., 

4 ng/mL for initial tests and 2 ng/mL for 

confirmatory tests).89 While the 

exposure in the 2005 study was 

‘‘extreme,’’ both the 2001 and 2005 

studies represent more likely ‘‘real 

world’’ situations than the 2015 study. 

In the 2005 study of nonsmoking 

individuals exposed to marijuana smoke 

in an unventilated passenger van, none 

of the passively exposed individuals 

tested positive using a 3 ng/mL initial 

test cutoff when the oral fluid collection 

device was protected from exposure to 

contaminated surfaces.9 In this two-part 

study, four non-smoking subjects sat 

beside four active cannabis smokers 

who each smoked a single cannabis 

cigarette containing either a low dose of 

THC (Study 1) or high dose of THC 

(Study 2). In Study 1, oral fluid was 

collected inside the THC-contaminated 

van. Maximum oral fluid THC 

concentrations in non-smoking subjects 

were 7.5 ng/mL but declined to negative 

levels within 45 minutes of exposure. In 

Study 2, oral fluid was collected outside 

the van. Even though the dose of THC 

was more than twice the dose in Study 

1, the maximum concentration detected 

in the passively exposed subjects was 

1.2 ng/mL, which is well below the 

initial and confirmatory THC cutoffs in 

these Guidelines. When potential 

contamination during collection was 

eliminated in Study 2, all non-smoking 

subjects were negative at both initial 

and confirmatory cutoff concentrations 

throughout the study. 

In the 2001 study, subjects were 

administered a single dose of marijuana 

by smoked and oral routes, and their 

oral fluid and urine THC test results 

were compared.8 The study used a 1 ng/ 

mL THC initial test cutoff and a 0.5 ng/ 

mL THC confirmatory test cutoff, both 

lower than the THC cutoffs in these 

Guidelines (i.e., 4 ng/mL initial test 

cutoff and 2 ng/mL confirmatory test 

cutoff). Two nonsmoking subjects were 

included to simulate passive exposure 

scenarios (e.g., sitting in an unventilated 

room where marijuana is smoked). 

These subjects were positive by 

immunoassay using the 1 ng/mL initial 

test cutoff at 1- and 4-hours postexposure but negative by the 

confirmatory test using a 0.5 ng/mL 

cutoff. 

These carefully executed studies on 

passive exposure are considered strong 

evidence that exposure to secondhand 

marijuana smoke under normal 

ventilation conditions presents no risk 

57558 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

that an individual will have a passive 

exposure related positive test result 

under the standards used in these 

Guidelines. 

Another reason for the Department’s 

decision to test only for THC is that 

THCA cannot be reliably detected in all 

individuals who use marijuana. Two 

recent studies investigated the presence 

of THC and THCA in oral fluid after 

various routes of administration.15 16 

One study characterized marijuana 

analytes including THC and THCA in 

oral fluid of nine occasional and 11 

frequent marijuana smokers after 

smoked, vaporized, and oral 

administration (i.e., ingestion of a 

brownie containing marijuana).15 THC 

was present in oral fluid specimens in 

all individuals from both groups, after 

all routes of administration, 

immediately after use. THC was 

detected above the OFMG confirmatory 

cutoff (i.e., 2 ng/mL) for 32 hours with 

the occasional users and 72 hours with 

the frequent users. Of the nine 

occasional users, all tested positive for 

THC using the OFMG confirmatory 

cutoff after all administration routes. 

However, only three occasional users 

tested positive for THCA (i.e., at or 

above 15 pg/mL) after all administration 

routes. In a second study, drug-free 

subjects ate brownies containing 

marijuana in three separate dosing 

sessions, with THC concentrations of 10 

mg, 25 mg, and 50 mg.16 The 

appearance of THCA in oral fluid in this 

study was highly variable, and THCA 

was not present in all subjects. Within 

the first eight hours after marijuana 

ingestion, 116 oral fluid specimens were 

positive for either THC or THCA. Of 

those specimens, 23 specimens were 

positive for both THC and THCA, 75 

were positive for THC only, and 18 were 

positive for THCA only. Therefore, THC 

was detected in approximately 84.5% of 

the positive oral fluid tests, while THCA 

was only detected in approximately 

35.3%. These studies support the 

Department’s decision to test for THC by 

showing that THCA cannot be as 

reliably detected as THC in all 

marijuana users. 

The Department’s decision to use 

THC as the initial and confirmatory test 

analyte is also supported by the 

differences between the detection 

patterns of the two analytes in 

occasional smokers versus chronic 

frequent smokers. For example, one 

study showed that, although THCA was 

detected in frequent cannabis smokers 

almost 100% of the time studied, 

occasional smokers did not consistently 

test positive for THCA using the 

previously considered confirmatory test 

cutoff concentration of 0.05 ng/mL.17 

Some individuals tested negative for 

THCA after smoking cannabis. 

Consequently, confirmatory testing for 

THCA without performing an initial test 

for THCA would be biased toward 

detecting chronic frequent cannabis 

smokers and would be ineffective in 

detecting occasional users. Such an 

outcome would diminish the reliability 

of marijuana testing using oral fluid. It 

is also important to note that occasional 

users may exhibit greater acute 

impairment than chronic frequent users 

due to the lack of tolerance to cannabis 

effects.18 This consideration suggests 

that an oral fluid drug testing system 

that relies upon testing for THCA to 

detect marijuana use may fail to identify 

occasional users who could pose a 

safety risk to a federal agency’s 

enterprise. 

The Department believes that an 

immunoassay initial test with the 

appropriate sensitivity for testing for 

both THCA and THC could allow oral 

fluid marijuana tests to take advantage 

of THCA’s extended detection window. 

The preamble to the proposed OFMG, 

published on May 15, 2015, noted the 

lack of scientific data on the time course 

of excretion or the detection window of 

THC, THCA, and conjugated THCA in 

oral fluid following marijuana use, 

especially for occasional users. It was 

noted that studies of daily marijuana 

smokers indicated that THC is 

detectable for up to two days, but THCA 

continued to be excreted in oral fluid 

during abstinence for several weeks in 

daily users.19 Two other studies 

evaluated oral fluid results following 

cannabis smoking (i.e., one cannabis 

cigarette containing 6.8% THC).17 20 In a 

2013 study, oral fluid was collected 

from 10 participants using the 

QuantisalTM (Immunalysis) oral fluid 

collection device over a 22-hour 

period.17 The authors used a 0.5 ng/mL 

cutoff for THC and a 7.5 pg/mL cutoff 

for THCA. The mean time to last 

concentration and the mean last 

concentration was 12.3 hours and 5.1 

ng/mL for THC and 14.6 hours and 42.3 

pg/mL for THCA, thus providing 

evidence of a longer detection window 

for THCA. A 2012 study evaluated 

cannabinoid concentrations in oral fluid 

of chronic and occasional smokers.20 

Oral fluid was collected 19 hours before 

smoking to 30 hours after smoking, 

using the Statsure Saliva SamplerTM 

(Statsure Diagnostic Systems). The 

authors concluded that: (1) All 

specimens were THC positive for up to 

13.5 hours post-smoking without 

significant differences between chronic 

and occasional smokers, (2) THCA 

provided longer detection times than 

THC in the 13.5 to 30 hour postsmoking period in all chronic smokers, 

and (3) THCA windows of detection for 

chronic cannabis smokers extended 

beyond 30 hours. 

However, the Department has not 

identified immunoassay technology that 

is feasible as an initial test for both THC 

and THCA in a high-throughput 

laboratory environment. Such 

technology is necessary for the 

implementation of THCA testing in the 

federal drug testing program because: (1) 

THCA-only testing is not a viable option 

for the federal drug testing program (as 

discussed previously), and (2) even 

though THCA and THC can be tested 

during the confirmation phase of drug 

testing, the theoretical advantages of 

THCA’s longer detection window will 

not be achieved unless THCA can be 

detected in the initial test. In other 

words, in the absence of a viable initial 

test to detect THCA, specimens positive 

for THCA only would not advance to 

confirmation testing. Therefore, until a 

suitable immunoassay initial test that is 

capable of screening for both THC and 

THCA is available, the Department 

believes that its decision to test for THC 

using the cutoffs established in these 

Guidelines provides federal agencies 

with an efficient, cost-effective and 

reliable means to detect marijuana use. 

As such, it is the conclusion of the 

Department that a 4 ng/mL initial test 

cutoff for THC is supported by scientific 

studies and is consistent with the 

Department’s objective of detecting the 

use of illicit drugs while, to the extent 

practicable, eliminating the risk of 

positive test results caused solely by the 

drug use of others and not caused by the 

drug use of the individual being tested, 

as directed by the SUPPORT for Patients 

and Communities Act, Public Law 115– 

271, section 8107(b).14 

Lowering the Initial Test Cutoff 

Concentration for THC to Either 2 or 3 

ng/mL and Lowering the Confirmation 

Test Cutoff Concentration for THC to 1 

ng/mL To Extend the Window of 

Detection for Marijuana Use 

Three commenters recommended 

lowering the THC initial test and 

confirmatory cutoffs to extend the 

window of detection; one commenter 

recommended lowering the initial test 

cutoff for this reason, but keeping the 

proposed confirmatory cutoff. One 

commenter recommended a slightly 

lower confirmatory cutoff (i.e., 1.5 ng/ 

mL). Two commenters agreed with the 

proposed THC cutoffs. 

Two other commenters recommended 

increasing the initial and confirmatory 

THC cutoffs, so claims of positive 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57559 

results due to passive exposure will not 

be justified. 

The Department’s decision on initial 

and confirmatory cutoffs is discussed 

above, but to reiterate, the Department 

concluded after careful review of all 

available scientific evidence that: (1) 

Credible claims of positive THC tests 

resulting from second-hand smoke/ 

passive exposure are extremely 

unlikely, and (2) the only scenario in 

which there is a theoretical possibility 

of testing positive for THC as the result 

of second-hand smoke/passive exposure 

under these Guidelines involves 

sustained exposure to extreme levels of 

marijuana smoke. The Department is 

confident that under these Guidelines, 

only a donor’s marijuana use would be 

identified. 

Performance Requirements for an Oral 

Fluid Collection Device 

One commenter agreed and one 

commenter disagreed with requiring the 

use of only collection devices that have 

been cleared by the Food and Drug 

Administration (FDA). One commenter 

suggested the requirements for 

collection devices should be developed 

by appropriate professionals after 

suitable scientific and stakeholder 

review, while another suggested the 

requirements be determined by 

laboratories and manufacturers. One 

commenter disagreed with the 

Guidelines, and suggested that only 

devices using ‘‘the swab technique’’ be 

required. 

The Department has evaluated these 

comments, and maintained the 

requirement in Section 7.1 for oral fluid 

collection devices to be FDA-cleared. 

Five commenters addressed proposed 

volume specifications. Three 

commenters suggested that the 

Department specify oral fluid collection 

and/or diluent volume as a percentage 

and not a specific volume, due to 

variability in commercially available 

devices. One commenter encouraged 

increasing the allowed specimen and 

diluent volume variance to +/¥ 20%. 

One commenter believes that the 

proposed 0.05 mL diluent variance is 

too small and not realistic. One 

commenter suggested that the 

Guidelines not specify a required 

volume, but emphasize that laboratories 

choose devices that would ensure 

sufficient volume is collected for initial 

and confirmatory testing. One 

commenter disagreed with the proposed 

variance in specimen collected and 

suggested that the device must collect a 

known volume (similar to the 

‘‘European Guidelines for Workplace in 

Oral Fluid’’). This commenter also 

disagreed with the 1 mL collection 

requirement, stating that LC/MS/MS 

methods use approximately 200 mcL of 

oral fluid and that reducing the volume 

will reduce the time required for 

collection. 

The Department has evaluated these 

comments, and revised Section 7.3(b) to 

specify oral fluid collection and diluent 

volumes as percentages (rather than 

specific volumes as proposed). The 

Department agreed with commenters 

that specifying allowable diluent 

variance as a percentage rather than 

volume would allow different 

manufacturers to produce their oral 

fluid collection devices with an 

optimized volume of diluent while 

ensuring reliability across systems. The 

Department also changed the specimen 

volume variance to a percentage for 

consistency. Section 7.3 specifies 

variances of 2.5% for diluent volume 

and 10% for specimen volume, based on 

information obtained from device 

manufacturers. The Department also 

maintained the requirement to collect at 

least 1 mL of oral fluid. This is a 

reasonable collection volume that will 

enable sufficient specimen for testing 

(e.g., when repeat testing or 

confirmatory tests for multiple drugs are 

required). 

Four commenters addressed the 

proposed device requirements for 

recovery of ≥90% (but no more than 

120%) of drug and/or drug metabolite at 

(or near) the initial test cutoff. The 

commenters disagreed with the 

proposed requirement of ≥90%, and 

suggested recovery between 80% and 

120%. One commenter noted that 80% 

to 120% recovery is consistent with 

current FDA-cleared systems. One 

commenter cited adherence of THC to 

surfaces as a problem in achieving 90% 

recovery, and recommended either 

requiring ≥80% for all drugs or 

requiring ≥80% recovery for THC and 

≥90% recovery for other drugs. One 

commenter agreed with specifying 

minimum and maximum recovery, and 

recommended additional emphasis on 

the consistency of recovery performance 

of the device and confirmatory methods. 

The Department has evaluated these 

comments, and revised Section 7.3(b) to 

change the lower limit for drug recovery 

from ≥90% to ≥80%. 

Two commenters addressed stability 

at room temperature. One commenter 

agreed with the requirement for stability 

at room temperature for at least one 

week, and one commenter disagreed. 

This commenter indicated that in-house 

studies found cocaine and 6–AM were 

unstable for that length of time and also 

indicated that specimens are typically 

received at the laboratory one to two 

days after collection. 

The Department has evaluated these 

comments, and changed the stability 

requirement in Section 7.3(b) from one 

week at room temperature to five days 

at room temperature. Because oral fluid 

is collected with either a preservative 

buffer (i.e., collection device with 

diluent) or preservative dry reagents 

(i.e., neat oral fluid collection), normal 

transport conditions are not expected to 

affect stability of the drugs and/or drug 

metabolites. The Department will 

include guidance to collectors 

concerning proper collection and 

transport of oral fluid specimens in the 

Oral Fluid Specimen Collection 

Handbook. 

Medical Review Officer (MRO) Reporting 

Procedures for Positive Morphine/ 

Codeine Results 

In Section 13.5, the Department 

proposed a concentration of 150 ng/mL 

for codeine and morphine to be used by 

the MRO to report a positive result in 

the absence of a legitimate medical 

explanation (i.e., prescription), without 

requiring clinical evidence of illegal 

use, and to rule out the possibility of a 

positive result due to consumption of 

food products. The Department 

requested comments on the 

appropriateness of this concentration. 

One commenter agreed. Six commenters 

disagreed: One commenter 

recommended 100–120 ng/mL, one 

commenter recommended 50–100 ng/ 

mL, one commenter recommended 120 

ng/mL, and one commenter 

recommended 40 ng/mL. One 

commenter suggested that no additional 

decision point is needed because, based 

on scientific studies including in-house 

studies, positive opiate results using a 

40 ng/mL cutoff are not typical and are 

difficult to achieve, thus there is no 

justification for an MRO reversal of a 

codeine or morphine result less than 

150 ng/mL. One commenter expressed 

concern that the 150 ng/mL decision 

point would not rule out positive 

codeine/morphine results due to food 

products and suggested that the 

Department use a much higher decision 

point or require clinical evidence of 

illegal drug use before an MRO verifies 

any opiate results as positive. Based on 

evaluation of these comments and 

examination of the data from scientific 

studies, the Department has concluded 

that no change is needed.21–24 The 150 

ng/mL concentration is higher than the 

highest concentration seen in study 

subjects at one hour and later after 

consumption of raw poppy seeds and 

products containing poppy seeds. 

57560 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

HHS List of FDA-Cleared Oral Fluid 

Collection Devices 

The Department requested comments 

on whether HHS should publish a list 

of FDA-cleared oral fluid collection 

devices. Seven commenters agreed. One 

commenter disagreed, stating that it is 

sufficient to provide regulation on 

requirements and noting that the 

Department does not publish a list of 

FDA-cleared urine specimen containers. 

After further review, the Department has 

decided not to publish a list. The list 

might not reflect all current FDAcleared oral fluid collection devices, 

and could be misconstrued as a list of 

SAMHSA-approved devices. Also, FDA 

clearance does not mean that the 

collection device meets OFMG 

requirements. The federal agency and/or 

the HHS-certified laboratory must 

ensure that the FDA-cleared device 

meets the device requirements in 

Sections 7.2 and 7.3. FDA has a 

searchable database on its website that 

can be used to identify FDA-cleared oral 

fluid collection devices. The 

Department will include a link to this 

database on the SAMHSA website 

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

Medical Review Officer (MRO) 

Requalification—Continuing Education 

Units (CEUs) 

The Department requested comments 

on requiring MRO requalification 

continuing education units (CEUs) and 

on the optimum number of credits and 

the appropriate CEU accreditation 

bodies should CEUs be required as part 

of MRO requalification. Three 

commenters agreed with requiring MRO 

recertification, but disagreed with the 

addition of CEU requirements to the 

Guidelines. Two commenters disagreed 

with specifying the number of CEUs 

required. Two commenters indicated 

that certification entities already enforce 

training requirements and 

recommended that acceptance of CEUs 

be handled by MRO certification boards, 

not the Department. Two commenters 

recommended a requirement of annual 

CEUs: One suggested 16 CEUs and the 

other recommended three CEUs. One 

commenter recommended 12 CEUs 

prior to initial certification, eight CEUs 

every five years, and also recommended 

two CEUs related to the new 

requirements/topics within two years of 

implementation of the revised 

Guidelines. The Department has 

evaluated the comments and has 

concluded that requirements for 

continuing education units will remain 

with the MRO certification entities and 

will not be included in the Guidelines. 

The Department has removed references 

to MRO training entities in Sections 

13.2 and 13.3, because training 

documentation is maintained by MRO 

certification entities. The Department 

agrees with the comment that MROs 

should receive training on revisions to 

the Guidelines and has added item 

Section 13.3(b) to require such training 

prior to the effective date of revised 

Guidelines, to ensure that all MROs are 

trained in program requirements before 

performing MRO duties for federal 

agency specimens. 

Split Specimen Collection Methods 

All federal agency collections are to 

be split specimen collections. The 

donor’s primary (A) specimen is tested 

and the split (B) specimen is available 

for testing if the donor requests a retest 

at another HHS-certified laboratory. For 

urine, one specimen is collected from 

the donor, then the collector pours the 

collected specimen into two bottles that 

are then labelled as A and B specimens. 

Most current oral fluid collection 

devices collect a single specimen that 

cannot be divided into A and B 

specimens. Therefore, the Department 

requested comments on whether serial 

or simultaneous collection using two 

collection devices constitutes a split 

oral fluid collection, and 

recommendations for any other oral 

fluid collection processes that enable 

subdividing the collected specimen. 

Three commenters agreed with the 

proposed guidelines as written. Two 

cited problems with collecting 

expectorated oral fluid (i.e., difficult to 

obtain a sufficient specimen, distasteful 

to donor and collector), and stated that 

collection with a device provides 

analyte stability, a homogenous 

specimen, and facilitates processing in 

the laboratory. The commenters noted 

that the split specimen requirement to 

identify the presence of the drug 

addresses any concentration differences 

between first and second specimens. 

They also noted that split collections 

with two devices are currently used for 

non-regulated testing without issue and 

that scientific studies support these 

methods. Five commenters disagreed. 

Some raised concerns over possible 

insufficient specimen volume and nonhomogenous specimens leading to 

possible discrepant primary and split 

specimen results. One commenter 

disagreed stating that the use of two 

devices for each collection increases 

costs. One commenter believes that 

serial collections using two devices may 

increase the likelihood of collection 

problems (e.g., collector forgets to 

perform the second collection; the 

donor may leave the collection site or be 

out of collector’s line-of-sight between 

collections; the two-minute period may 

be exceeded). The Department has 

evaluated the comments and has 

concluded that no change is needed. 

Either serial or simultaneous collection 

using two collection devices constitutes 

a split oral fluid collection for federal 

workplace drug testing programs. These 

split collection procedures are described 

in Section 8.8. The Department revised 

the split specimen collection definition 

in Section 1.5 and revised Section 8.8(a) 

to clarify that the OFMG do not prohibit 

collection of a single specimen and 

subdividing the collected specimen into 

primary (A) and split (B) specimens. In 

Section 2.5, the Department clarified 

that the split oral fluid specimen may be 

collected using two devices or using one 

device and subdividing the specimen. 

Discussion of Sections 

The Department has not included a 

discussion in the preamble of any 

sections for which public comments 

were not submitted or where minor 

typographical or grammatical changes 

were made. 

Subpart A—Applicability 

1.5 What do the terms used in these 

Guidelines mean? 

One commenter requested that 

‘‘external service provider’’ be defined, 

because this is a new term included in 

the proposed Guidelines. The 

Department agrees and has added the 

definition ‘‘An independent entity that 

performs services related to federal 

workplace drug testing on behalf of a 

federal agency, a collector/collection 

site, an HHS-certified laboratory, a 

Medical Review Officer (MRO), or, for 

urine, an HHS-certified Instrumented 

Initial Test Facility (IITF).’’ 

Two commenters disagreed with the 

proposed definition for ‘‘invalid result’’ 

which indicated that an invalid result 

was reported only when an HHScertified laboratory could not complete 

testing or obtain a valid drug test result. 

The Department agrees and has 

reinstituted wording from the definition 

in the Guidelines effective October 1, 

2010 (73 FR 71858). The definition in 

Section 1.5 is ‘‘The result reported by an 

HHS-certified laboratory in accordance 

with the criteria established in Section 

3.7 when a positive or negative result 

cannot be established for a specific drug 

or specimen validity test.’’ 

To address comments described in 

this preamble under Section 13.1, the 

Department deleted the definition for 

‘‘non-medical use of a drug.’’ 

Two commenters found the definition 

of ‘‘specimen’’ confusing, because the 

term ‘‘sample’’ used in the definition 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57561 

was also defined as a representative 

portion of a donor’s specimen. The 

Department agrees and has reinstituted 

some wording for the definition of 

‘‘specimen’’ from the Guidelines 

effective October 1, 2010 (73 FR 71858) 

for clarity. The definition in Section 1.5 

is ‘‘Fluid or material collected from a 

donor at the collection site for the 

purpose of a drug test.’’ 

The Department revised the definition 

of ‘‘split specimen collection (for oral 

fluid)’’ to clarify that the OFMG allow 

collection of a single specimen and 

subdividing the collected specimen into 

primary (A) and split (B) specimens. 

This is consistent with the change 

described in this preamble under 

Section 8.8(a). 

For clarity, the Department added a 

definition for the term ‘‘undiluted (neat) 

oral fluid’’ which is used throughout the 

OFMG. The definition in Section 1.5 is 

‘‘An oral fluid specimen to which no 

other solid or liquid has been added. 

For example, see Section 2.4: a 

collection device that uses a diluent (or 

other component, process, or method 

that modifies the volume of the testable 

specimen) must collect at least 1 mL of 

undiluted (neat) oral fluid.’’ 

1.6 What is an agency required to do 

to protect employee records? 

One commenter suggested that the 

non-applicability of the Health 

Insurance Portability and 

Accountability Act (HIPAA) and the 

Health Information Technology for 

Economic and Clinical Health Act 

(HITECH) should be clearly stated in the 

Guidelines. The Department has 

evaluated the comment and has 

concluded that the applicability of 

HIPAA and other relevant privacy laws 

is clearly stated in Section 1.6. 

Accordingly, except for minor 

rewording for clarity, no further 

revisions are necessary. 

1.7 What is a refusal to take a federally 

regulated drug test? 

The Department proposed within 

Section 1.7 what is a refusal to take a 

federally regulated drug test. Two 

commenters noted that this section does 

not include the same requirements as 

Section 1.7(a)(10) of the UrMG defining 

a refusal to test when a collector finds 

a device intended for the purpose of 

adulteration or substitution and 

recommended adding similar language 

to the OFMG. The Department has 

evaluated the comments, and agrees that 

the collector must report a refusal to test 

when a donor brings materials for 

adulterating, substituting, or diluting 

the specimen to the collection site, or 

when the collector observes a donor’s 

clear attempt to tamper with a 

specimen. The Department has revised 

Sections 1.7, 8.3(d), and 8.4(c) 

accordingly. Collectors will inspect the 

donor’s oral cavity to ensure it is free of 

items that may impede or interfere with 

the drug test as described in Section 8.3. 

One commenter recommended that 

OFMG Section 1.7 include the same 

requirements as UrMG Section 1.7(a)(5) 

defining a refusal to test when the donor 

failed to provide a sufficient amount of 

specimen when directed, ‘‘and the 

required medical evaluation did not 

identify a legitimate medical 

explanation for the failure.’’ The 

Department agrees with this comment 

and has added a new item 4 to Section 

1.7(a) consistent with the UrMG 

requirement. 

One commenter recommended 

clarification that a donor’s refusal to 

provide a split specimen will also 

qualify as a refusal to test. The 

Department has evaluated the comment 

and has added this as a refusal to test 

in Sections 1.7(a)(7) and Section 8.5(b). 

If the donor refuses to provide a split 

specimen, the collector will report this 

as a refusal to test. 

Also in regard to Section 1.7, one 

commenter suggested expanding the 

section to include specific actions that 

would be classified as a refusal to test. 

The commenter suggested wording 

under the current example ‘‘disrupt the 

collection process’’ describing actions 

specific to OF collections ‘‘(e.g., disrupt 

the collection process including: biting 

on the collection device, sucking the 

fluid back out of the device, failure to 

open mouth when directed for 

inspection, failure to rinse mouth when 

directed, failure to remove foreign object 

from mouth when instructed, failure to 

permit the observation or monitoring of 

the specimen collection, avoiding 

swabbing in-between teeth and the gum 

line when instructed, failure to follow 

the collector’s instructions on swab 

location in the mouth, attempting to 

conceal chemicals or mints in the 

mouth, attempting to use a mouth wash 

immediately prior to or during the 

collection, attempting to chew ice 

during the collection, behave in a 

confrontational way that disrupts the 

collection process, fail to wash hands 

after being directed to do so by the 

collector, possess or wear a prosthetic or 

other device that could be used to 

interfere with the collection process, 

other failures to comply with the 

collector’s instructions or attempt to 

defraud the drug test)’’. 

The Department has evaluated the 

comment and has added the failure to 

rinse the mouth when directed by the 

collector as an example of donor actions 

classified as a refusal to test in Sections 

1.7(a)(7) and in Section 8.3(d)(2). It 

should be noted that Section 1.7(a)(7) 

lists some examples. In practice, the 

trained collector determines whether 

the donor’s action is a refusal to test. 

Many of the commenter’s described 

actions would disrupt the collection 

process and thus constitute a refusal to 

test under Section 1.7(a)(7). The 

Department will consider the 

commenter’s suggestions during 

preparation of guidance which will be 

provided in the HHS Oral Fluid 

Specimen Collection Handbook. 

One commenter noted that the 

collector does not report a refusal to test 

when a donor leaves the collection site 

before the collection process begins for 

a pre-employment test. The commenter 

recommended defining the beginning of 

the pre-employment collection process 

as the point at which the donor is asked 

to present photo identification. The 

Department agrees with the suggestion 

to define the beginning of the collection 

process specifically for this situation. 

However, the Department has 

designated the beginning as the step 

described in Section 8.4(a), when the 

collector provides or the donor selects a 

specimen collection device. The 

Department has revised Sections 

1.7(a)(2) and (3) to include a reference 

to this section. All subsequent items in 

Section 1.7(a) (i.e., items 4—10) apply 

once the donor has arrived for the preemployment test collection. 

1.8 What are the potential 

consequences for refusing to take a 

federally regulated drug test? 

The Department reworded Section 

1.8(b) to clarify that the requirements in 

this section apply to donors who fail to 

appear at the collection site in a 

reasonable time for any test (except a 

pre-employment test), as described in 

Section 1.7(a)(1). 

Subpart B—Oral Fluid Specimens 

2.1 What type of specimen may be 

collected? 

Ten commenters agreed with adding 

oral fluid and three commenters 

disagreed with adding oral fluid and 

alternate matrices. One commenter 

raised questions regarding the accuracy 

of oral fluid testing, MRO interpretation 

of detection of the parent compound of 

a prohibited drug, and the cost of oral 

fluid testing. The Department has 

evaluated the comments, and believes 

the concerns raised by the commenters 

are not sufficient to remove oral fluid 

testing from the Guidelines. The 

Department believes that collecting and 

testing oral fluid specimens according to 

57562 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

the requirements in these Guidelines is 

an efficient means to detect illicit drug 

use and ensures that the oral fluid test 

results are forensically and scientifically 

supportable. 

Numerous commenters expressed 

concern with the Department’s urine 

collection policy, stating that 7 to 10% 

of Americans have a condition 

(‘‘paruresis’’), described as a social 

anxiety disorder which prevents a 

person from producing urine on 

demand or in the presence of other 

people. These commenters stated that if 

the government wants to seek the largest 

group of qualified applicants, the 

Guidelines should specify that a 

diagnosis of paruresis means non-urine 

(i.e., oral fluid) testing will 

automatically be provided, and that 

donors should not have to attempt to 

provide a urine specimen first. These 

comments are not relevant to the OFMG. 

The OFMG establish the standards and 

technical requirements for oral fluid 

testing in federal workplace drug testing 

programs. Each federal agency will 

decide whether to collect urine, oral 

fluid, or both specimen types in their 

workplace testing programs. 

2.2 Under what circumstances may an 

oral fluid specimen be collected? 

One commenter recommended that 

oral fluid be restricted based on the 

reason for the test due to the short 

window of detection compared to urine 

(and hair), the benefits of observed 

collection, and the ability to identify the 

parent or active drug that was used. One 

commenter recognized the benefit of 

oral fluid with respect to fewer 

adulterated, substituted, and/or invalid 

specimens, but raised concern over the 

shorter window of detection in oral 

fluid, especially with respect to preemployment testing. Two commenters 

suggested that oral fluid and hair testing 

be performed for pre-employment and 

random tests. The Department has 

evaluated the comments and has 

concluded that no change is needed. 

Each federal agency will decide which 

of the authorized specimen types it will 

collect and the reasons for collecting 

each type of specimen. 

2.3 How is each oral fluid specimen 

collected? 

One commenter noted that this 

section does not clearly describe a split 

specimen ‘‘collected either 

simultaneously or serially.’’ The 

Department has evaluated the comment 

and has revised this section to include 

a reference to Section 8.8, which 

provides clear descriptions of these split 

specimen collection methods. 

2.4 What volume of oral fluid is 

collected? 

2.5 How is the split oral fluid 

specimen collected? 

Comments on these two sections (i.e., 

Section 2.4 and Section 2.5) are 

addressed here. One commenter noted 

that Sections 2.4 and 2.5 require 

collection of ‘‘a known volume’’ of at 

least 1 mL undiluted oral fluid, and 

stated that an absorbent pad device will 

not meet this requirement. The 

commenter recommended that these 

sections be clarified and address all 

types of oral fluid collection devices. 

The Department has evaluated the 

comment and has revised Sections 2.4 

and 2.5 to ensure consistent 

requirements for collection devices with 

and without a diluent (or other 

component, process, or method that 

modifies the volume of the testable 

specimen). The Department revised 

Section 2.4 to require A and B tubes to 

have a volume marking clearly noting a 

level of 1 mL if the device does not 

include a diluent (or other component, 

process, or method that modifies the 

volume of the testable specimen). This 

is consistent with requirements in 

Section 7.3 for devices that modify the 

volume of the testable specimen to have 

a volume indicator, to ensure that at 

least 1 mL of oral fluid is collected. In 

Section 2.5, in addition to referencing 

Section 8.8, the Department clarified 

that the split oral fluid specimen may be 

collected using two devices or using one 

device and subdividing the specimen. 

Subpart C—Oral Fluid Specimen Tests 

3.1 Which tests are conducted on an 

oral fluid specimen? 

One commenter suggested changing 

the term ‘‘opiates’’ to ‘‘opioids’’ in the 

Guidelines. ‘‘Opiates’’ is the term used 

to describe naturally occurring 

substances known as alkaloids derived 

from the opium poppy plant (e.g., 

codeine; morphine; and heroin, which 

is produced by the acetylation of 

morphine) that bind to specific 

receptors in the central nervous system. 

The broadly used term ‘‘opioids’’ 

includes opiates (e.g., codeine, 

morphine, and heroin); semi-synthetic 

compounds (e.g., hydrocodone, 

hydromorphone, methadone, 

oxycodone, and oxymorphone); and 

synthetic compounds (e.g., fentanyl). 

The Department agrees with the 

commenter and has changed the term 

‘‘opiates’’ to ‘‘opioids’’ where 

appropriate to refer to oxycodone, 

oxymorphone, hydrocodone, and 

hydromorphone in addition to codeine, 

morphine, and 6-acetylmorphine 

(6–AM). 

In addition, as described under 

Requirements for specimen validity 

testing in this preamble, the Department 

revised Section 3.1 to allow, but not 

require, oral fluid specimen validity 

testing. 

3.2 May a specimen be tested for 

additional drugs? 

The Department reworded Section 

3.2(a) to clarify the additional drug tests 

that may be performed on federal 

employee specimens. 

3.3 May any of the specimens be used 

for other purposes? 

It should be noted that, consistent 

with the Urine Mandatory Guidelines, 

Section 3.3 specifically prohibits 

conducting, among other types of 

testing, deoxyribonucleic acid (DNA) 

testing, on oral fluid specimens unless 

authorized in accordance with 

applicable federal law. 

3.4 What are the drug test cutoff 

concentrations for undiluted (neat) oral 

fluid? 

Comments concerning marijuana test 

cutoffs are addressed under the Testing 

for Marijuana Use section above. 

Comments on other drug test cutoffs are 

addressed under Proposed cutoff 

concentrations. To summarize, the 

Department revised Section 3.4 to use 

higher cutoffs for some drugs (i.e., initial 

test cutoffs for 6–AM, PCP, and 

amphetamines; confirmatory test cutoffs 

for PCP and amphetamines) than in the 

proposed OFMG. Other comments 

related to Section 3.4 are addressed 

below. 

Three commenters disagreed with 

testing for cocaine in oral fluid, stating 

that cocaine is not stable in oral fluid, 

especially at the pH of human oral fluid. 

The commenters noted that cocaine has 

a short half-life and hydrolyzes to 

benzoylecgonine, and that 

benzoylecgonine is present longer and 

at higher levels. Two of these 

commenters further noted that the 

current industry standard is to test for 

benzoylecgonine only in oral fluid. One 

stated that their in-house studies found 

that testing cocaine did not increase the 

positivity rate compared to testing only 

benzoylecgonine. The other commenter 

refuted the study cited in the preamble 

to the proposed OFMG that supported 

the inclusion of cocaine as a test 

analyte. The Department based the 

proposed analytes for each drug on the 

recommendations of a technical 

workgroup consisting of subject matter 

experts and representatives from various 

stakeholder groups (e.g., collection 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57563 

device and test kit manufacturers, oral 

fluid drug testing laboratories). In the 

preamble to the proposed OFMG of May 

15, 2015 (80 FR 28054, page 28063), the 

Department included the scientific basis 

for including both analytes. The 

inclusion of both cocaine and 

benzoylecgonine as test analytes will 

increase the number of specimens that 

are identified as containing these 

cocaine analytes and, thereby, will 

increase the deterrent effect of the 

program and improve identification of 

employees using this drug. 

One commenter disagreed with 

testing for hydromorphone and 

oxymorphone in oral fluid due to 

extremely low incidence and 

recommended testing for more prevalent 

metabolites. The Department has 

evaluated the comment and decided 

that no change is needed. Information 

provided by initial test manufacturers 

indicates that the proposed analytes 

(i.e., parent drugs) are present in higher 

concentrations and in the absence of 

their metabolites. 

One commenter recommended 

specifying D-isomers as the initial test 

analytes for amphetamines. The 

Department agrees that an antibody that 

is directed toward D-enantiomers in an 

immunoassay method should be 

preferred over an antibody that is 

non-stereoselective, but concluded that 

no change is needed. The wording in 

this section is consistent with the 

UrMG, and the selection of an 

immunoassay kit or methodology will 

remain the testing laboratory’s choice. 

An HHS-certified laboratory may 

group analytes for initial testing. For 

clarity, the Department has defined the 

term ‘‘grouped analytes’’ where used in 

footnote 1 of the table in Section 3.4: 

‘‘(i.e., two or more analytes that are in 

the same drug class and have the same 

initial test cutoff).’’ 

The Department proposed criteria for 

calibrating initial tests for grouped 

analytes such as opioids and 

amphetamines, specifying the minimum 

cross-reactivity to the other analyte(s) 

within the group. The Department also 

proposed including 

methylenedioxyamphetamine (MDA) 

and methylenedioxyethylamphetamine 

(MDEA) as initial test analytes. Four 

commenters stated that 80% crossreactivity may not be possible with 

current immunoassay technology, so 

may require independent analyses (e.g., 

hydrocodone and hydromorphone for 

an opiate assay; MDEA for an 

amphetamines assay). Two of these 

commenters noted concerns with 

additional oral fluid specimen volume 

needed for the independent assays. 

Another commenter stated that crossreactivity specifications for 

hydromorphone are not necessary, 

based on their non-regulated testing 

results (i.e., confirmatory test 

concentrations detected after using an 

immunoassay with 60% cross-reactivity 

for hydromorphone). 

The Department has evaluated these 

comments and concluded that no 

change is needed for immunoassay 

cross-reactivity requirements. The crossreactivity requirements in Section 3.4 

are necessary to ensure consistency in 

testing among laboratories using 

different immunoassay kits, as well as 

those using different test methods for 

initial drug testing. Cross-reactivity 

must be demonstrated and documented 

by the manufacturer (e.g., package 

insert) and by the HHS-certified 

laboratory (i.e., assay validation studies, 

reagent lot verification, and batch 

quality control for any analyte that 

exhibits less than 100% crossreactivity). 

One commenter stated that the low 

prevalence of MDA and MDEA does not 

warrant the burden placed on 

immunoassay manufacturers and 

laboratories. The Department has 

evaluated the comment and has 

removed MDEA from the Guidelines 

(i.e., MDEA is no longer included as an 

authorized drug in Section 3.4). The 

number of positive MDEA specimens 

reported by HHS-certified urine 

laboratories (i.e., information provided 

to the Department through the NLCP) 

does not support testing all specimens 

for MDEA in federal workplace drug 

testing programs. Because MDEA is a 

Schedule I drug, a federal agency may 

test specimens for MDEA in accordance 

with Section 3.2 (i.e., on a case-by-case 

basis for reasonable suspicion or postaccident testing, routinely with a waiver 

from the Secretary). The Department 

understands that some other analytes 

have a low incidence, but believes that 

continued testing for these analytes is 

warranted in a deterrent program. In 

particular, inclusion of MDA as an 

initial and confirmatory test analyte is 

warranted because, in addition to being 

a drug of abuse, it is a metabolite of 

MDEA and MDMA. 

Also in Section 3.4, the Department 

did not specify the target analyte to be 

used to calibrate an initial test for 

grouped analytes such as amphetamines 

or opioids. Three commenters noted 

that when an immunoassay is calibrated 

with a low-reacting drug, other analytes 

may exhibit high cross-reactivity, 

leading to false initial test positives. 

Two of these commenters also noted 

that this may result in possibly different 

cross-reactivity profiles for some 

structurally unrelated and 

concomitantly used prescription and/or 

over the counter drugs. It was not the 

Department’s intent for the laboratory to 

calibrate an immunoassay test using an 

analyte other than that specified by the 

manufacturer. In the preamble to the 

proposed OFMG, the Department 

described using a control containing the 

lowest reacting analyte at its cutoff 

concentration to establish the decision 

point (i.e., when an immunoassay for 

grouped analytes did not demonstrate at 

least 80% cross-reactivity to each 

analyte). The Department has 

determined that this approach is not 

necessary, and will not be permitted. 

There are current immunoassays that 

meet the requirements of this section for 

two or more analytes in a group (i.e., 

analytes in the same drug class that 

have the same initial test cutoff). As 

indicated in Section 3.4, the laboratory 

may use multiple test kits or a single kit 

to meet the requirements. 

However, the Department has revised 

Section 3.4 regarding the use of 

alternate technology initial tests for THC 

and 6-AM. To ensure consistent 

treatment of specimens, depending on 

the technology, the confirmatory test 

cutoff (i.e., 2 ng/mL) must be used for 

THC and 6-AM. For example, because 

immunoassays cross-react with various 

marijuana constituents and metabolites, 

a specimen that is positive using a 

cutoff of 4 ng/mL for an immunoassay 

may not test positive using an alternate 

technology initial test with a 4 ng/mL 

cutoff for THC. When using an alternate 

technology initial test (e.g., LC/MS/MS) 

that is specific for the target analyte, 

THC, must be tested using the 

confirmatory test cutoff. 

3.5 May an HHS-certified laboratory 

perform additional drug and/or 

specimen validity tests on a specimen at 

the request of the Medical Review 

Officer (MRO)? 

One commenter recommended that 

HHS maintain a list of allowable 

additional tests and reporting criteria 

(e.g., threshold for reporting as positive, 

adulterated, substituted, and/or invalid, 

and a limit of detection as appropriate), 

to ensure consistency among 

laboratories and within the testing 

program. The Department has evaluated 

the comment and has concluded that no 

change is needed. The Department does 

not want to limit the analytes that may 

be tested, and will provide guidance to 

laboratories as necessary. It is also noted 

that the section requires all tests to meet 

appropriate validation and quality 

control requirements. The procedures 

and specimen records for such tests will 

be reviewed at NLCP inspections. The 

Department will continue to maintain a 

57564 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

list of HHS-certified laboratories that 

choose to perform additional tests for 

regulated specimens. The Department 

has reworded Section 3.5 in concert 

with revisions to Section 3.1 removing 

the requirement for albumin or IgG 

testing, as described under 

Requirements for specimen validity 

testing in this preamble. 

One commenter asked whether an 

MRO could submit a blanket request to 

perform additional testing (e.g., 

additional opioid metabolites) for all 

confirmatory specimens (i.e., would 

laboratories be permitted to monitor the 

additional compounds in all 

confirmatory test assays?). The 

Department believes that testing all 

specimens for additional analytes may 

not be appropriate for some tests, 

especially hydrocodone, 

hydromorphone, oxycodone and 

oxymorphone. Recent studies show that 

testing for norhydrocodone and/or 

noroxycodone is not necessary for the 

interpretation of all results.26 27 

Norhydrocodone and noroxycodone 

metabolites may be helpful for the MRO 

to interpret test results only when a 

donor’s prescription does not support 

the test results. The presence of 

norhydrocodone metabolite would 

support the use of hydrocodone and 

validate the donor’s prescription. The 

same could be said for interpreting test 

results following an oxycodone dose. 

The presence of noroxycodone 

metabolite would support the use of 

oxycodone and validate the donor’s 

prescription. The Department will 

provide guidance on these and other 

additional tests that may provide useful 

information for the MRO in the Medical 

Review Officer Guidance Manual for 

Federal Workplace Drug Testing 

Programs. The Department has revised 

Section 3.5 to clarify that HHS-certified 

laboratories are authorized to perform 

additional tests upon MRO request on a 

case-by-case basis, but are not 

authorized to routinely perform such 

tests without prior authorization from 

the Secretary or designated HHS 

representative, with the exception of the 

determination of D,L stereoisomers of 

amphetamine and methamphetamine. 

The Department will continue to allow 

HHS-certified laboratories to test for D,L 

amphetamine and methamphetamine 

routinely or upon MRO request. The 

Department will provide guidance on 

these and other additional tests that may 

provide useful information for the MRO 

(e.g., tetrahydrocannabivarin) in the 

Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs. 

Additional drug and specimen 

validity testing under Section 3.5 does 

not include DNA testing. 

3.7 What criteria are used to report an 

invalid result for an oral fluid 

specimen? 

One commenter disagreed and 

recommended deleting Sections 3.7(a-c) 

and 3.7(g) from the Guidelines due to 

observed collections by trained 

collectors. As described under 

Requirements for specimen validity 

testing in this preamble, the Department 

has revised the Guidelines to allow, but 

not require, specimen validity testing. 

Section 3.7 has been revised 

accordingly. 

Subpart D—Collectors 

4.1 Who may collect a specimen? 

One commenter questioned why the 

Department prohibits supervisors or 

hiring officials from collecting oral fluid 

specimens (unless no other collector is 

available). The commenter cited fewer 

privacy concerns in collecting oral fluid 

versus urine, and indicated that having 

supervisors collect specimens would be 

particularly useful in remote locations 

and/or for post-accident tests. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The Department will continue 

to prohibit routine collections by a 

supervisor, to avoid potential conflicts 

of interest due to the employeesupervisor relationship as much as 

possible. The Guidelines permit 

collections by a supervisor who has 

been trained as a collector when no 

other trained collector is available. 

4.2 Who may not collect a specimen? 

One commenter expressed concern 

that this section as written may 

unintentionally prevent the use of valid 

collection methods (i.e., preventing the 

donor from collecting their own 

specimen may prohibit the donor from 

holding the collection device). The 

Department has evaluated the comments 

and has concluded that no change is 

needed to Section 4.2, which includes 

general language concerning the entire 

collection process. Section 8.4 describes 

steps the collector takes before the 

donor provides the oral fluid specimen, 

including reviewing with the donor the 

manufacturer’s instructions for oral 

fluid collection using the specimen 

collection device. Section 8.5 describes 

the collection procedure, including the 

requirement for the donor to position 

the device for collection, and for the 

collector and donor to complete the 

collection in accordance with the 

manufacturer’s instructions for the 

collection device. However, the 

Department has revised the wording in 

Section 8.5(a)(1) to address all types of 

oral fluid collection devices allowed by 

the OFMG (i.e., including those that are 

not placed in the mouth). 

Subpart E—Collection Sites 

5.2 What are the requirements for a 

collection site? 

One commenter suggested that the 

Department require restricted access 

only to be applicable during a collection 

period, and allow supplies and records 

to be stored in nearby secured areas. 

The Department has evaluated the 

comments and has concluded that no 

change is needed. The section clearly 

describes the requirements and 

addresses the commenter’s concerns. 

Subpart F—Federal Drug Testing 

Custody and Control Form (CCF) 

6.1 What federal form is used to 

document custody and control? 

6.2 What happens if the correct OMBapproved Federal CCF is not available 

or is not used? 

Comments on these two sections 

(Sections 6.1 and 6.2) are addressed 

here. Three commenters recommended 

that the Federal Custody and Control 

Form (CCF) be revised to address oral 

fluid specimens. The Department will 

revise the Federal CCF when Guidelines 

allowing oral fluid become effective. 

The Department reworded items 

6.2(b) and (c) for clarity. 

Subpart G—Oral Fluid Specimen 

Collection Devices 

7.3 What are the minimum 

performance requirements for a 

collection device? 

The Department reworded Section 

7.3(a) in reference to oral fluid 

collection volume, as described under 

Sections 2.4 and 2.5 above, and revised 

Section 7.3(b) in response to public 

comments, as described under 

Performance requirements for an oral 

fluid collection device above. 

Subpart H—Oral Fluid Specimen 

Collection Procedure 

8.2 What must the collector ensure at 

the collection site before starting an oral 

fluid specimen collection? 

One commenter stated that this 

section requires the collector to deter 

adulteration or substitution at the 

collection site, but does not provide any 

information on how this is to be done. 

The commenter recommended that 

Section 8.2 be deleted or, alternatively, 

that additional information be added to 

the section. The Department has 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57565 

evaluated the comments and has 

concluded that no change is needed. 

The section provides the general 

requirement; the Department will 

provide more specific guidance as 

needed in the HHS Oral Fluid Specimen 

Collection Handbook, which will be 

issued after these Guidelines become 

effective. 

8.3 What are the preliminary steps in 

the oral fluid specimen collection 

procedure? 

In response to comments described 

under Sections 1.7 and 8.4 in this 

preamble, the Department revised 

Section 8.3(d) to require the collector to 

report a refusal to test when a donor 

brings materials for adulterating, 

substituting, or diluting a specimen to 

the collection site. 

One commenter requested that the 

Guidelines clarify (possibly using a 

flowchart) the different waiting periods 

in Sections 8.3 and 8.6 (i.e., if multiple 

waiting periods are required, do they 

run concurrently or consecutively?). 

The Department has evaluated the 

comments and has concluded that no 

change is needed. The Department will 

consider the commenter’s suggestion 

during preparation of the HHS Oral 

Fluid Specimen Collection Handbook. 

Several comments concerned Section 

8.3 collection procedures regarding 

rinsing or drinking. One commenter 

disagreed with the requirement to have 

tobacco users rinse their mouth prior to 

an oral fluid collection, noting it is an 

inconvenience for the collector to 

provide a place for the donor to spit out 

the liquid. One commenter requested 

clarification on oral fluid collection 

procedures for tobacco users (e.g., is the 

collector required to ask, is it a refusal 

if a tobacco user doesn’t rinse their 

mouth, is the donor required to rinse 

with water, what if the donor uses more 

than 4 oz. of liquid to rinse?). The 

Department removed the reference to 

tobacco users in 8.3(d)(2) because there 

is no need for all tobacco users to rinse 

their mouths. The proposed procedure 

for tobacco users was due to the dark 

brown color of tobacco juice. The issue 

is that any discoloration may interfere 

with initial testing (i.e., not just tobacco 

juice). The Department reworded this 

section to include abnormally colored 

saliva as a reason for the collector to 

give water to the donor for rinsing their 

mouth. 

One commenter recommended that 

the Guidelines clarify that if the donor 

drinks water, the water must not be 

provided by the donor. For clarity, the 

Department revised Section 8.3(d)(2) to 

require the collector to give the donor 

water (for example, up to 4 oz.) to rinse 

the donor’s mouth when the collector’s 

inspection of the oral cavity identifies 

any items that could impede or interfere 

with the collection of an oral fluid 

specimen. If the donor refuses to rinse, 

this is a refusal to test. Rinsing with 

more than 4 oz. of water does not 

invalidate the collection, so this amount 

was given as an example rather than a 

requirement. 

One commenter indicated that some 

collection devices specifically instruct 

against offering the donor anything to 

rinse with or drink. This commenter 

suggested modifying Section 8.3 to 

make offering of water conditionally 

allowed, depending on the collection 

device manufacturer’s instructions. The 

Department has evaluated these 

comments and concluded that no 

change is needed. The Department 

believes that rinsing the oral cavity with 

water prior to a 10-minute wait period 

is a reasonable part of the oral fluid 

collection protocol. The wait period is 

sufficient to comply with the device 

instructions, and will not dilute the 

collected oral fluid. 

Several comments concerned Section 

8.3 collection procedures regarding 

inspection of the donor’s mouth. One 

commenter requested clarification on 

what items need to be removed from a 

donor’s mouth prior to an oral fluid 

collection (tobacco, food, gum, or mints 

versus retainers and piercings). One 

commenter requested clarification of 

whether ‘‘dental retainer’’ refers to a 

temporary or permanent device (or 

both), should the device be removed 

and, if so, where the device should be 

placed during the oral fluid collection. 

The Department has evaluated the 

comments and concluded that only one 

change is needed: Removal of ‘‘dental 

retainer’’ from the examples of items 

that must be removed based on a 

collector’s inspection of the donor’s 

mouth in Section 8.3(d). A donor is not 

required to remove dental appliances 

such as a retainer. The Department will 

provide additional information in the 

Oral Fluid Specimen Collection 

Handbook to clarify items that may 

impede or interfere with the collection. 

One commenter recommended that 

the Guidelines address the situation 

where a donor may have a medical 

condition that prevents them from 

opening their mouth for the collector to 

inspect. The Department agrees with the 

commenter and has revised Section 

8.3(d) to address this situation. The 

collector will proceed with the same 

steps as when a donor is unable to 

provide an oral fluid specimen, as 

described in Section 8.6(b)(2), and the 

MRO will follow the steps in Section 

13.6(b) requiring a medical evaluation of 

the donor. 

8.4 What steps does the collector take 

in the collection procedure before the 

donor provides an oral fluid specimen? 

Two commenters believe that if the 

collector finds an adulterant or 

substitution product, this should be a 

refusal to test. As noted under Sections 

1.7 and 8.3 in this preamble, the 

Department agrees that the collector 

must report a refusal to test when a 

donor brings materials for adulterating, 

substituting, or diluting a specimen to 

the collection site, or when the collector 

observes a donor’s clear attempt to 

tamper with a specimen. The 

Department has revised Section 8.4(c) 

accordingly. 

The Department deleted Section 

8.4(b)(1) for consistency with Section 

8.6(b). The deleted item stated that the 

collector may set ‘‘a reasonable time for 

a collection based on the device used, 

not to exceed 15 minutes.’’ Section 

8.6(b) states that the donor demonstrates 

their inability to provide a specimen 

when, after 15 minutes of using the 

collection device, there is insufficient 

volume or no oral fluid collected using 

the device. 

8.5 What steps does the collector take 

during and after the oral fluid specimen 

collection procedure? 

One commenter suggested that the 

section should state that the collector be 

present and maintain visual contact 

with the donor and collection device 

during the procedures outlined in this 

section. The Department has evaluated 

the comment and has concluded that no 

change is needed: Sections 8.4(a) and 

8.5(a) clearly require the collector to 

keep the unwrapped collection devices 

and the donor in view at all times 

during the collection. 

One commenter asked if there was a 

limit to the number of times a collection 

could be restarted due to collection 

device failures. The Department has 

evaluated the comment and has 

reworded Section 8.5 for clarity. Section 

8.5(a)(1) was revised to indicate that a 

failure to provide a specimen (which 

may or may not be due to device failure) 

prompts recollection using a new device 

and that the collector documents the 

failed collection attempt on the Federal 

CCF. The Department also reworded 

Section 8.5(b) to clarify that a donor’s 

refusal to begin the collection process 

after a failure to collect the specimen is 

a refusal to test. The Department did not 

set a limit for the number of attempts 

because there may be different reasons 

for failing to collect the specimen from 

the donor. However, the Department 

57566 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

revised the section to require the 

collector to follow the procedure in 

Section 8.6 ‘‘after multiple attempts to 

collect the specimen.’’ 

One commenter stated that HHS 

should clarify that a donor’s refusal to 

provide a split specimen will also 

qualify as a refusal to test. The 

Department agrees with the comment 

and has revised Section 8.5(b) to 

include the refusal to provide a split 

oral fluid specimen as a refusal to test. 

Additionally, as described under 

Section 4.2 above, the Department 

revised Section 8.5(a)(1) to address all 

types of collection devices allowed by 

the OFMG (including those that are not 

placed in the mouth). 

8.6 What procedure is used when the 

donor states that they are unable to 

provide an oral fluid specimen? 

Three commenters disagreed with the 

requirement for the collector to contact 

the agency representative for 

authorization to collect an alternate 

specimen each time a donor is unable to 

provide a sufficient volume. These 

commenters suggested that the 

Guidelines allow this to be addressed in 

established standard protocols for the 

agency. The Department agrees with the 

commenters. Each federal agency may 

decide whether to require notification in 

each case or whether to provide a 

standard protocol for collectors to 

follow. Section 8.6 has been revised 

accordingly. 

Also in regard to Section 8.6, one 

commenter requested additional 

information on donor hydration during 

an oral fluid specimen collection (i.e., 

asking if there is evidence that 

hydration improves the ability to 

provide a specimen and whether 

hydration dilutes the specimen). One 

commenter indicated that the volume of 

oral fluid collected does not appear to 

be directly related to fluid intake and 

suggested that, because some donors 

may not be able to provide a sufficient 

specimen even after the one hour wait 

time, a urine specimen should be 

collected immediately. One commenter 

disagreed with the one hour period 

allowed for an oral fluid collection, and 

indicated that there is no evidence 

provided that dry mouth is eliminated 

by waiting one hour. The commenter 

indicated that this extra time allotted 

costs the employer unnecessary time 

and money, and maintained that a 

waiting period of 10 minutes after 

consumption of 8 oz. of water is 

sufficient. The Department has 

evaluated the comments and concluded 

that no change is needed to Section 8.6. 

The proposed procedure sets a 

reasonable time limit within which 

most donors would be able to provide 

an acceptable specimen volume (i.e., 10 

minutes between attempts to provide 

the oral fluid specimen, up to one hour), 

and the section clearly states that the 

donor is not required to drink any fluids 

during the wait time. The Guidelines 

clearly describe the limited 

circumstances in which the collector 

offers the donor fluids. However, the 

Department has revised Section 8.8(a)(2) 

to expressly prohibit rinsing or drinking 

between the collection of the primary 

and split specimens when serially 

collected. 

8.7 If the donor is unable to provide an 

oral fluid specimen, may another 

specimen type be collected for testing? 

One commenter disagreed with the 

Guidelines as written and suggested that 

when a donor cannot provide the 

primary specimen type, an alternate 

specimen should be collected 

immediately. The commenter cited the 

additional time and cost as well as the 

fact that the collector may not know the 

agency’s policy on alternate specimen 

types. The Department has concluded 

that no change is needed for Section 8.7 

in response to this comment. The 

Guidelines will continue to require that 

the donor be allowed reasonable 

attempts to provide an oral fluid 

specimen as described in Sections 8.5 

and 8.6. The Department has revised 

Section 8.6 to allow a federal agency to 

either require notification in each case 

or provide a standard protocol for 

collectors to follow when the donor is 

unable to provide an oral fluid 

specimen. The Department has 

reworded this section to state ‘‘Yes, 

if. . .’’ rather than ‘‘No, unless. . .’’ in 

response to a federal agency’s comment 

and to enhance clarity. The meaning of 

this section remains the same. 

8.8 How does the collector prepare the 

oral fluid specimens? 

One commenter requested 

clarification of the ‘‘simultaneous’’ oral 

fluid collections. The Department has 

evaluated the comment and has 

concluded that no change is needed. 

Section 8.8(a)(1) describes ‘‘Two 

specimens collected simultaneously 

with two separate collection devices.’’ 

One commenter expressed concern 

that the requirement for a serial 

collection of a split specimen to begin 

within two minutes of the first 

collection may be difficult to monitor 

and may lead to differences between the 

two specimens. This commenter 

requested clarification on how this 

process will be monitored. One 

commenter agreed with the two-minute 

maximum time between serial 

collections of a split specimen. The 

Department has evaluated the comments 

and agrees with the second commenter 

that no change is needed. The proposed 

procedure in Section 8.8 sets a 

reasonable time within which the 

collector can take the first collection 

device from the donor and record the 

time on the Federal CCF, while the 

donor positions the second device for 

the collection. Because the collector 

works with one donor at a time, the 

collector should have no difficulty 

monitoring the time between primary 

and split collections. Furthermore, the 

Department believes this timing would 

not affect results of the primary and 

split oral fluid specimens. 

One commenter disagreed with the 

proposed two-minute maximum time 

between serial collections of a split 

specimen and suggested that the time be 

increased to 10 minutes (so as not to 

rush the collector in completing chain 

of custody forms). This commenter 

suggested that a second specimen 

should only be collected after an initial 

test result is obtained (which the 

commenter indicates can usually be 

done in 10 minutes). The Department 

has evaluated the comments and has 

concluded that no change is needed. 

The collector is not required to 

complete the Federal CCF until both the 

primary and split specimens have been 

collected. Point of collection testing is 

not allowed under these Guidelines. 

That is, all testing must be performed at 

an HHS-certified test facility. 

One commenter asked whether 

hydration would be allowed between 

serial split collections. The Department 

revised Section 8.8(a)(2) to expressly 

prohibit rinsing or drinking between the 

collection of the primary and split 

specimens when serially collected. 

Prohibiting rinsing or drinking will 

better ensure consistency of the primary 

and split specimens. 

The Department added an additional 

item under Section 8.8(a) to clarify that 

the OFMG allow collection of a single 

specimen and subdividing the collected 

specimen into primary (A) and split (B) 

specimens. A similar change was made 

to the definition of ‘‘split specimen 

collection (for oral fluid)’’ in Section 

1.5. 

The Department also removed the 

word ‘‘known’’ in Section 8.8(b) in 

reference to oral fluid collection 

volume, as described under Sections 2.4 

and 2.5 above. 

In response to a federal agency 

comment, the Department deleted a 

sentence in item 8.8(h) that required the 

collector to send a copy of the Federal 

CCF to the HHS-certified laboratory. 

The Department agreed with the federal 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57567 

agency that this instruction is redundant 

because item 8.8(g) instructs the 

collector to distribute copies of the 

Federal CCF as required. 

Subpart I—HHS-Certification of 

Laboratories 

9.5 What are the qualitative and 

quantitative specifications of 

performance testing (PT) samples? 

One commenter noted that, because 

proposed initial test requirements allow 

calibration with a low-reacting analyte, 

PT schemes would likely need to be 

designed based on the specific 

implementation at each laboratory. The 

commenter provided an example: When 

an immunoassay is calibrated with a 

drug/metabolite that exhibits 50% crossreactivity, the intended target analyte 

(‘‘calibrant’’) at the cutoff concentration 

would elicit a response well in excess 

of the cutoff. This could result in 

inaccurate initial test results (i.e., a 

positive initial test result for a specimen 

containing the calibrant at a 

concentration below the cutoff). The 

commenter stated that this result could 

be scored as a ‘‘false positive’’ PT result. 

The Department has evaluated the 

comment and has concluded that no 

change is needed. As noted above 

regarding Section 3.4, it was not the 

Department’s intent for the laboratory to 

calibrate an immunoassay test using an 

analyte other than that specified by the 

manufacturer. NLCP PT schemes are 

designed based on known crossreactivity profiles of the initial tests 

used by HHS-certified laboratories. 

Also in regard to proposed Section 

9.5, one commenter suggested that the 

Guidelines use the same wording as in 

the Guidelines effective October 1, 2010 

(73 FR 71858) for retest PT sample 

specifications (i.e., ‘‘. . . may be as low 

as . . .’’ rather than the proposed 

wording ‘‘. . . may be less than . . .’’). 

The Department agrees and has 

reinstituted wording from Section 9.3 of 

the Guidelines effective October 1, 2010 

(73 FR 71858) into Section 9.5(a)(1)(ii). 

As described under Requirements for 

specimen validity testing in this 

preamble, the Department has revised 

the Guidelines to allow, but not require, 

specimen validity testing. Section 9.5 

has been revised accordingly. 

9.6 What are the PT requirements for 

an applicant laboratory? 

9.7 What are the PT requirements for 

an HHS-certified oral fluid laboratory? 

Comments on these two sections 

(Sections 9.6 and 9.7) are addressed 

here. As described under Requirements 

for specimen validity testing in this 

preamble, the Department has revised 

the Guidelines to allow, but not require, 

specimen validity testing. Sections 9.6 

and 9.7 have been revised accordingly. 

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? 

Two commenters disagreed with the 

proposed limit to the number of blind 

samples required (i.e., a maximum of 

400 blind samples per year) in Section 

10.1(b). The commenters indicated that 

for a large agency, there is a very large 

difference between 3% and 400 samples 

and suggested keeping only the 3% 

requirement. Another commenter 

disagreed with the 3% requirement for 

blind samples and requested that the 

amount to be lowered to 1% to lessen 

the burden on employers. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The 400 sample limit was 

added to reduce the burden on large 

agencies based on the Department’s 

review of agencies’ blind testing 

programs. 

One commenter suggested that the 

wording be modified to clarify that 

employers are responsible for ensuring 

blind samples are sent to the 

laboratories, but that collectors are 

tasked with submitting the blind 

samples. The Department has evaluated 

the comment and has concluded that no 

change is needed. The wording in 

Section 10.1(a) clearly describes the 

responsibilities of the federal agency 

and the role of the collector in blind 

sample submission; however, the 

Department reworded Section 10.3(a) 

for clarity as described below. 

10.3 How is a blind sample submitted 

to an HHS-certified laboratory? 

The Department has reworded Section 

10.3(a) to clarify that the collector sends 

a blind sample to a laboratory as a split 

specimen (i.e., specimens A and B). 

Subpart K—Laboratory 

11.9 What are the requirements for an 

initial drug test? 

One commenter noted that HHS 

previously required initial and 

confirmatory testing using different 

techniques, and asked whether this 

requirement had been removed with 

allowance of technologies other than 

immunoassay for initial testing. The 

commenter expressed concern that an 

error in the initial drug test could be 

repeated in the confirmatory drug test 

using the same method. The Department 

has evaluated the comment and has 

concluded that no change is needed. 

The Guidelines maintain the 

requirement for initial and confirmatory 

tests on two separate aliquots to report 

a result other than negative. The NLCP 

will review validation and quality 

control records, as well as specimen 

records, to ensure that the initial and 

confirmatory testing methods meet 

Guidelines requirements and provide 

scientifically and forensically 

supportable results. 

11.10 What must an HHS-certified 

laboratory do to validate an initial drug 

test? 

One commenter noted that Section 

11.10 provides general information on 

validation requirements, and asked 

where detailed requirements can be 

found. The Department has evaluated 

the comment and has concluded that no 

change is needed. The Department will 

continue to provide details for applicant 

and certified test facilities through the 

NLCP. 

One commenter asked whether the 

requirement in 11.10(c) for periodic 

verification of ‘‘each initial drug test 

using an alternate technology’’ applied 

to immunoassay tests used differently 

than originally cleared by the FDA or 

other laboratory developed tests. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. This section clearly 

distinguishes initial tests using 

immunoassay from those using an 

alternate technology. Furthermore, 

Section 1.5 includes the definition for 

‘‘alternate technology initial drug test.’’ 

11.11 What are the batch quality 

control requirements when conducting 

an initial drug test? 

Seven commenters disagreed with the 

requirement for an initial test control 

targeted at 25% above the cutoff. The 

commenters noted that drug 

concentrations are much lower in oral 

fluid than in urine, and stated that 

assays are unlikely to perform robustly 

with current immunoassay technology. 

One commenter also noted that oral 

fluid is diluted three- to four-fold. One 

commenter suggested requiring a 

control targeted at 50% above the cutoff, 

consistent with current FDA-cleared 

assays. The Department has evaluated 

the comments and has concluded that 

no change is needed. Consistent with 

the urine program requirements, 

laboratories must have the ability to 

apply the program cutoffs to regulated 

specimens, and document that ability by 

analyzing a control targeted at 25% 

above the cutoff in each batch. 

One commenter asked whether the 

inclusion of ‘‘additional compounds as 

target analytes’’ for amphetamine and 

57568 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

opioid assays affect quality control 

content requirements. The Department 

has evaluated the comment and has 

concluded that no change is needed. 

The initial drug test quality control 

requirements in the Guidelines apply to 

each analyte used to calibrate the test 

(i.e., immunoassay or alternate 

technology initial drug test). When a 

single immunoassay test is used for two 

or more analytes in a drug class, the 

HHS-certified laboratory must include a 

control in accordance with item 

11.11(a)(2) for each analyte that has less 

than 100% cross-reactivity with the 

assay, to demonstrate that the 

requirement for at least 80% crossreactivity has been met. 

11.14 What are the batch quality 

control requirements when conducting a 

confirmatory drug test? 

One commenter stated that analyzing 

quality control samples with 

concentrations of a drug or metabolite 

targeted at less than 40% of the 

proposed cutoffs would be an analytical 

challenge for high volume laboratories 

utilizing GC/MS or LC/MS/MS. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The NLCP Pilot PT Program has 

documented the capability of 

laboratories to meet the proposed OFMG 

requirements. 

Also in regard to the proposed quality 

control requirements for an initial drug 

test in Section 11.11 and for a 

confirmatory drug test in Section 11.14, 

one commenter requested clarification 

for the requirement for a drug-free 

control (i.e., whether the control should 

contain no drug or whether the control 

should not contain the specific analyte 

for that test). The Department has 

evaluated the comment and has 

concluded that no change is needed. 

These Guidelines sections list the 

requirement for ‘‘at least one control 

certified to contain no drug or drug 

metabolite,’’ meaning that the control 

must contain no regulated drug 

analytes. 

11.15 What are the analytical and 

quality control requirements for 

conducting specimen validity tests? 

The Department has reworded Section 

11.15(a) for clarity, to correctly reflect 

requirements. 

11.17 What are the requirements for 

an HHS-certified laboratory to report a 

test result? 

One commenter suggested that the 

Department remove the requirement for 

an executed CCF as the official report 

for ‘‘non-negative’’ specimens and 

permit the use of an electronic report 

with the required information. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. The Federal CCF establishes the 

chain of custody for the specimen from 

the time of collection until receipt by 

the laboratory and also contains the 

certification statement signed by the 

certifying scientist. The Federal CCF 

may be paper or electronic. 

As described under Requirements for 

specimen validity testing in this 

preamble, the Department has revised 

the Guidelines to allow, but not require, 

specimen validity testing. Section 11.17 

has been revised accordingly. 

11.21 What HHS-certified laboratory 

information is available to a federal 

agency? 

As described under Requirements for 

specimen validity testing in this 

preamble, the Department has revised 

the Guidelines to allow, but not require, 

specimen validity testing. The list of 

items provided in a standard 

documentation package for an oral fluid 

specimen has been revised accordingly 

[i.e., Section 11.21(b)(4)]. 

11.22 What HHS-certified laboratory 

information is available to a federal 

employee? 

One commenter asked why the 

proposed Guidelines include a 

requirement for a copy of the 

semiannual statistical summary report 

to be sent to the Secretary or designated 

HHS representative. The Department 

included the requirement to facilitate 

compilation of statistical information for 

the federal drug-free workplace 

program. This will not place an 

additional burden on the laboratory 

other than transmission of the report. 

The Department will continue to 

evaluate the effectiveness of this 

requirement. 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

12.1 May an IITF test oral fluid 

specimens for a federal agency’s 

workplace drug testing program? 

One commenter disagreed with 

prohibiting IITFs for oral fluid. This 

commenter considers the current HHScertified urine IITF to be a success in 

Canada and stated that prohibiting oral 

fluid IITFs would result in less 

enthusiasm for regulated procedures 

and impact workplace safety. At this 

time, as stated in the preamble to the 

proposed OFMG, IITFs are not practical 

and will not be allowed due primarily 

to the limited specimen volume of oral 

fluid collected from the donor. The 

Department will continue to monitor 

developments in oral fluid drug testing 

after this new specimen type has been 

implemented in federal workplace 

programs, and may reassess the 

feasibility of allowing IITFs for oral 

fluid in the future. 

Subpart M—Medical Review Officer 

(MRO) 

13.1 Who may serve as an MRO? 

Three commenters disagreed with the 

term ‘‘nonmedical use of a drug’’ used 

in Section 13.1 (and defined in Section 

1.5) and indicated that the term changes 

the role of an MRO from review, verify 

and ‘‘report a non-negative result’’ to 

review, verify and ‘‘interpret before 

reporting a result as negative or 

nonmedical use of a drug.’’ Two 

commenters disagreed with use of 

‘‘interpretation of results’’ to supplant 

‘‘alternative medical explanation.’’ One 

commenter noted that this perceived 

change in the MRO’s role represents an 

unjustified shifting of risk to the MRO. 

One commenter believes the term 

presents a possible legal flaw to 

Guidelines, stating that this term is 

legally different from ‘‘safety concern’’ 

and places MROs in the position of 

being in conflict with the prescribing 

physician and subject to lawsuits. This 

commenter stated that even a lack of a 

finding of nonmedical use could be an 

issue if the donor subsequently had an 

accident after using the drug. The same 

commenter submitted five 

recommendations related to inclusion of 

prescription drugs in federal workplace 

drug testing programs, to address the 

commenter’s concerns with the 

proposed Guidelines. These five specific 

recommendations pertain to matters that 

are outside the scope of these 

Guidelines, and therefore are not 

addressed in the Department’s response 

below. 

The responsibilities of an MRO to 

interpret results have largely remained 

the same between the Guidelines 

effective October 1, 2010 (73 FR 71858) 

and these Guidelines. As stated in 

Section 13.5(c) of these Guidelines, ‘‘if 

the donor provides a legitimate medical 

explanation (e.g., a valid prescription) 

for the positive result, the MRO reports 

the test result as negative to the 

agency.’’ Accordingly, the intent of the 

Guidelines, in this context, is to confirm 

whether a positive drug test is the result 

of drug use under a valid prescription. 

Furthermore, the term ‘‘alternate 

medical explanation’’ has never been 

used in the Guidelines, but has been 

used in the HHS Medical Review Officer 

Manual for Federal Workplace Drug 

Testing Programs. 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57569 

For the reasons above, the Department 

believes that the definition of 

‘‘nonmedical use of a drug’’ and the 

requirement for a physician serving as 

an MRO to have knowledge of this topic 

do not fundamentally change the MRO’s 

responsibilities. However, to address the 

commenters’ concerns, the Department 

has removed this term from the 

Guidelines (i.e., revised Sections 1.5 

and 13.1). 

One commenter requested 

clarification that it is the federal 

agency’s burden to ensure that the MRO 

is certified. One commenter asked how 

the laboratory will be informed that an 

MRO has met requirements for requalification. The Department evaluated 

the comments and concluded that no 

change is needed. The MRO is an 

employee or a contractor of the agency. 

Therefore, it is the agency’s 

responsibility to ensure that the MRO 

meets the Guidelines qualification 

requirements. 

Two commenters disagreed with the 

requirement for MRO recertification 

every five years, and recommended that 

MROs complete training every three 

years. Five commenters stated support 

for five year requalification and 

examination requirements. The 

Department has evaluated the comments 

and has concluded that no change is 

needed. The Department will keep the 

five-year requalification requirement as 

proposed. This is consistent with the 

MRO requalification requirement in the 

UrMG. 

13.2 How are nationally recognized 

entities or subspecialty boards that 

certify MROs approved? 

One commenter agreed with MRO 

certification/training entities submitting 

the delivery method and content of the 

MRO examination as applicable along 

with other required documents. One 

commenter agreed with extending time 

from one to two years for approved 

MRO certification/training entities’ 

resubmission of qualifications for HHS 

approval. The commenter noted that 

they would support further extension to 

3 years. 

One commenter recommended that 

approval of MRO educational courses 

and content be at the discretion of the 

MRO certification entities, not HHS. 

Since the certification entities and their 

examinations are subject to HHS 

oversight and approval, the commenter 

noted that it may be burdensome for 

HHS to review and approve the courses 

and content, and be a disincentive to 

development of new courses. One 

commenter recommended that 

examinations be allowed to be in-person 

or online with appropriate security 

precautions for each delivery method. 

The Department has evaluated the 

comments and agrees that the 

submission of training materials to HHS 

would possibly discourage the 

development of new training courses. 

Therefore, the review of MRO 

educational courses and content will 

not be part of the approval process for 

MRO certification entities. As described 

under Medical Review Officer (MRO) 

requalification—continuing education 

units (CEUs) in this preamble, the 

Department has removed references to 

MRO training entities in Section 13.2, 

because training documentation is 

maintained by MRO certification 

entities. The Department will only 

require the MRO certification entities to 

submit their examination and any other 

necessary supporting examination 

materials (e.g., answers, examination 

statistics or background information on 

questions) that will help in the 

Department’s evaluation of the 

examination. The Department has 

revised Section 13.2 accordingly. 

The Department will review and 

evaluate the examination delivery 

method (e.g., in-person or online) when 

reviewing submitted materials to ensure 

that the delivery method employs 

appropriate security and identification 

procedures. 

13.3 What training is required before a 

physician may serve as an MRO? 

Five commenters disagreed and one 

commenter agreed with the added 

requirement for MRO training to include 

information about how to discuss 

substance misuse and abuse and how to 

access those services. The Department 

has evaluated the comments and has 

revised Section 13.3 to remove this 

requirement. Federal agencies may 

provide this information to employees 

and applicants to facilitate their access 

to effective treatment and support 

recovery. The Department provides 

information to the public on help and 

treatment for substance misuse and 

abuse, and how to access those services, 

on the SAMHSA website http:// 

www.samhsa.gov/. 

One commenter stated that the 

Department should add a requirement 

for MRO training on what constitutes a 

refusal to test. One commenter 

suggested that the Department should 

add a requirement for MRO training on 

when and how to report safety concerns 

to employers when prescription and/or 

over-the-counter medications may affect 

performance. The Department has 

evaluated the comments and has 

concluded that no change is needed. 

Criteria for reporting a refusal to test are 

covered under the topics listed in 

Section 13.3 such as items (a)(4) training 

on the Guidelines and (a)(5) procedures 

for interpretation, review, and reporting 

of results. When a donor provides a 

legitimate medical explanation for a 

positive drug test (e.g., a valid 

prescription), the Guidelines do not 

require MROs to contact federal agency 

employers for the purpose of reporting 

a safety concern. Accordingly, MRO 

training related to reporting ‘‘safety 

concerns’’ does not relate to a 

mandatory function under the 

Guidelines and, therefore, is not an 

essential component of required MRO 

training. The Department will provide 

additional guidance in the HHS Medical 

Review Officer Guidance Manual for 

Federal Workplace Drug Testing 

Programs. 

In addition, the Department revised 

Section 13.3 as described under Medical 

Review Officer (MRO) requalification— 

continuing education units (CEUs) in 

this preamble. The Department removed 

references to MRO training entities 

because training documentation is 

maintained by MRO certification 

entities, and added item 13.3(b) to 

require MRO training on revised 

Guidelines prior to their effective date. 

13.4 What are the responsibilities of an 

MRO? 

One commenter suggested creating a 

subset of medical professionals trained 

specifically to determine fitness for duty 

since an MRO cannot determine fitness 

for duty over the telephone. The 

Department has evaluated the comment 

and has concluded that no change is 

needed. Fitness for duty evaluations fall 

outside the purview of the Guidelines. 

13.5 What must an MRO do when 

reviewing an oral fluid specimen’s test 

results? 

The Department has revised Section 

13.5(c)(1) to include ‘‘a valid 

prescription’’ as an example of 

documentation to support a medical 

explanation for a positive drug test 

result. 

As described under Testing for 

Marijuana Use in this preamble, the 

Department has revised Section 

13.5(c)(1) to reflect the Department’s 

policy that passive exposure to a drug 

(e.g., exposure to secondhand marijuana 

smoke) and ingestion of food products 

containing marijuana are not legitimate 

medical explanations for a positive drug 

test result. 

In Section 13.5(c)(2)(i), the 

Department clarified that the 

requirement for ‘‘clinical evidence of 

illegal use’’ does not apply if the 

laboratory confirms the presence of 6- 

57570 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

acetylmorphine (i.e., the presence of 

this metabolite is proof of heroin use). 

13.6 What action does the MRO take 

when the collector reports that the 

donor did not provide a sufficient 

amount of oral fluid for a drug test? 

One commenter requested definition 

of ‘‘appropriate expertise’’ in medical 

issues raised by a donor’s failure to 

provide a specimen. The same 

commenter requested medical referral 

information on the employer’s actions 

when a donor could not provide a urine 

specimen and then could not provide an 

oral fluid specimen. The Department 

has evaluated the comments and has 

concluded that no change is needed. A 

physician who is a trained MRO will 

have the knowledge necessary to 

identify another physician with 

appropriate expertise for the medical 

evaluation. The Department will 

provide additional guidance in the HHS 

Medical Review Officer Guidance 

Manual for Federal Workplace Drug 

Testing Programs as appropriate when 

oral fluid is allowed in federal 

workplace drug testing programs. 

The Department clarified the 

definition of ‘‘permanent or long-term 

medical conditions’’ in Section 

13.6(b)(1) based on a federal agency 

comment. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

15.1 What discrepancies require an 

HHS-certified laboratory to report a 

specimen as rejected for testing? 

The Department revised wording in 

items a and b of this section, and 

included three additional fatal flaws as 

items f-h, to reflect fatal flaws for 

regulated donor specimens that have 

been identified by HHS-certified 

laboratories. These fatal flaws were 

addressed in NLCP guidance sent to all 

HHS-certified and applicant laboratories 

and IITFs on August 9, 2016. In 

addition, the Department revised this 

section to include an additional item i 

to allow a laboratory to reject a 

specimen when they identify a flaw that 

prevents testing or affects the forensic 

defensibility of the drug test, and cannot 

be corrected. This general item enables 

laboratories to reject specimens with 

fatal flaws that may be rare, but do 

occur. It is not possible to list all such 

flaws in the Guidelines. 

15.3 What discrepancies are not 

sufficient to require an HHS-certified 

laboratory to reject an oral fluid 

specimen for testing or an MRO to 

cancel a test? 

Two commenters indicated that 

inclusion of some items as insignificant 

discrepancies contradicts guidance 

provided to HHS-certified laboratories 

and IITFs in NLCP Notices, which 

required laboratories to attempt to 

recover missing information. One of 

these commenters suggested that if these 

items are important, they should be 

removed from the ‘‘insignificant’’ list. 

Two commenters disagreed with the 

Guidelines designating the listed 

omissions and discrepancies as 

‘‘insignificant only when they occur no 

more than once per month.’’ The 

Department has evaluated the 

comments. The listed discrepancies 

would not result in rejection or 

cancellation. NLCP Notices requiring 

laboratory action are consistent with 

this section. However, the Department 

has reworded section 15.3 to not classify 

these errors as insignificant. While these 

types of errors do not warrant laboratory 

rejection of a specimen or MRO 

cancellation of a test, as noted in section 

15.3(c), corrective action must be 

initiated when they occur more than 

once a month. 

The commenters indicated that this 

section implies that the MRO must keep 

a log of insignificant errors by laboratory 

and by collection site in order to track 

frequency. The commenters noted that 

this is an unenforceable policy, that this 

should be a duty of inspectors of 

laboratories and collection sites, and 

that requiring MROs to keep these types 

of logs would create significant extra 

costs. One commenter suggested that 

item 15.3(c) be modified for the MRO to 

advise the collector or laboratory to 

retrain staff on relevant procedures to 

ensure that collections are completed 

correctly (rather than directing them to 

immediately take corrective action). The 

Department has evaluated the comments 

and has concluded that no change is 

needed. This section is the same as in 

the Guidelines effective October 1, 2010 

(73 FR 71858). 

One commenter suggested modifying 

15.3(a)(5) to read ‘‘donor identification 

number’’ which would include a social 

security number or an employee 

identification number since many 

employers no longer use social security 

numbers for employee identification. 

The Department agrees and has revised 

Section 15.3(a)(5) to include ‘‘employee 

identification number’’ in addition to 

‘‘Social Security Number.’’ 

15.4 What discrepancies may require 

an MRO to cancel a test? 

One commenter suggested adding the 

scenario where the donor did not sign 

the CCF because the collector forgot to 

ask the donor to sign, rather than the 

donor’s refusal to sign. The Department 

has evaluated the comment and has 

concluded that no change is needed. As 

stated in Section 15.4, the MRO contacts 

the collector ‘‘to obtain a statement to 

verify that the donor refused to sign the 

MRO copy.’’ 

Regulatory Impact and Notices 

Executive Order 12866 

The Secretary has examined the 

impact of the Guidelines under 

Executive Order 12866, which directs 

federal agencies to assess all costs and 

benefits of available regulatory 

alternatives and, when regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety, 

and other advantages; distributive 

impacts; and equity). In addition, the 

Department published a Federal 

Register notice in June 2011 to solicit 

comments regarding the science and 

practice of oral fluid testing via a 

Request for Information (RFI) [76 FR 

34086]. 

According to Executive Order 12866, 

a regulatory action is ‘‘significant’’ if it 

meets any one of a number of specified 

conditions, including having an annual 

effect on the economy of $100 million; 

adversely affecting in a material way a 

sector of the economy, competition, or 

jobs; or if it raises novel legal or policy 

issues. The Guidelines do establish 

additional regulatory requirements and 

allow an activity that was otherwise 

prohibited. The Administrative 

Procedure Act (APA) delineates an 

exception to its rulemaking procedures 

for ‘‘a matter relating to agency 

management or personnel’’ 5 U.S.C. 

553(a)(2). Because the Guidelines issued 

by the Secretary govern federal 

workplace drug testing programs, HHS 

has taken the position that the 

Guidelines are a ‘‘matter relating to 

agency management or personnel’’ and, 

thus, are not subject to the APA’s 

requirements for notice and comment 

rulemaking. This position is consistent 

with Executive Order 12564 regarding 

Drug-Free Workplaces, which directs 

the Secretary to promulgate scientific 

and technical guidelines for executive 

agency drug testing programs. 

The Department included a 

Regulatory Impact and Notices section 

with cost and benefits analysis and 

burden estimates in the May 15, 2015 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57571 

Federal Register Notice for the 

proposed OFMG (80 FR 28054), and 

requested public comment on all 

estimates and assumptions. 

One commenter disagreed with the 

Department’s projected numbers of oral 

fluid and urine drug tests by federal 

agencies and industries regulated by the 

Department of Transportation (DOT) 

and the Nuclear Regulatory Commission 

(NRC). This commenter predicted that 

there will be a large shift from urine to 

oral fluid testing when oral fluid is 

allowed in regulated testing, stating that 

the oral fluid collection is a more 

efficient and direct process for the 

collector, oral fluid is much less likely 

to be adulterated than urine, oral 

collections are quicker than most urine 

collections, and oral fluid is looked 

upon favorably from a hygienic 

perspective by donors and collectors. 

The commenter did not provide any 

substantive evidence or data to support 

these comments. One commenter 

disagreed with inclusion of cost 

estimates within the Guidelines due to 

the difficulty in comparing urine and 

oral fluid costs. The Department has 

evaluated the comments and has 

concluded that no change is needed. 

The Department’s projections were 

developed using information from 

current HHS-certified urine testing 

laboratories, with input from DOT and 

NRC, and cost analysis was based on 

information provided by multiple oral 

fluid testing laboratories and MROs. 

Each federal agency will decide whether 

to collect urine, oral fluid, or both 

specimen types in their workplace 

testing programs, and DOT and NRC 

will decide whether to allow oral fluid 

testing in workplace drug testing 

regulations for their regulated 

industries. Costs are expected to vary 

among individual laboratories and 

MROs, depending on their processes 

and testing populations. Additional 

information on the estimated costs 

associated is below. 

Need for Regulation 

Enhances Flexibility 

The Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid (OFMG) revise the 

requirement to collect only a urine 

specimen, which has existed since the 

Guidelines were first published in 1988, 

while continuing to promulgate 

established standards to ensure the full 

reliability and accuracy of drug test 

results. Urine testing is subject to issues 

related to a donor’s inability to produce 

a urine specimen due to a legitimate 

medical condition. In such situations, 

the test may produce an invalid result 

or create delays accruing from the need 

to reschedule the test or medically 

assess the donor’s inability to provide a 

urine sample. When the OFMG are 

implemented by an agency, such agency 

will be authorized to collect an oral 

fluid specimen from an individual who 

is unable to provide a urine specimen. 

This added flexibility will reduce both 

the need to reschedule collections and 

the need for the Medical Review Officer 

(MRO) to arrange a medical evaluation 

of a donor’s inability to provide a 

specimen. Therefore, the OFMG provide 

flexibility to address workplace drug 

testing needs of federal agencies by 

permitting the selection of the specimen 

type best suited for their needs and 

authorizing collection of an alternative 

specimen type when a donor is unable 

to provide a specimen. The added 

flexibility will also benefit donors, who 

should be able to provide one of the 

specimen types, thereby facilitating the 

drug test required for their employment. 

Enhances Versatility 

Urine collection requires use of a 

specialized collection facility, secured 

restrooms, the same gender, and other 

special requirements. Oral fluid may be 

collected in various settings. An 

acceptable oral fluid collection site must 

allow the collector to observe the donor, 

maintain control of the collection 

device(s) during the process, maintain 

record storage, and protect donor 

privacy. 

Decreases Invalid Tests 

All unobserved specimen collections 

are at risk for substitution and 

adulteration. Studies conducted by the 

drug testing industry indicate that 0.05 

to 3% of urine specimens collected for 

drug use detection are determined to be 

substituted or adulterated.5 27 28 Oral 

fluid collections will occur under 

observation, which should substantially 

lessen the risks of specimen substitution 

and adulteration that has been 

associated with urine specimen 

collections, most of which are 

unobserved. Specimen validity testing 

of oral fluid specimens will be allowed 

to identify invalid specimens (e.g., 

testing for a biomarker such as albumin 

or immunoglobulin G, IgG). 

Saves Time 

Oral fluid collection can require less 

time than urine collection, reducing 

employee time away from the workplace 

and, therefore, reducing costs to the 

federal agency employer. Oral fluid 

collection does not require a facility that 

provides visual privacy during the 

collection. Unlike urine specimen 

collections, it is expected that many oral 

fluid collections will occur at or near 

the workplace, and not at a dedicated 

collection site, thereby reducing the 

amount of time away from the 

workplace. The collector is allowed to 

be in the vicinity of the donor, reducing 

the loss of productive time. The option 

to collect a urine specimen in the event 

that the donor cannot provide an oral 

fluid specimen (and vice versa) will 

reduce both the need to reschedule a 

collection and the need for the MRO to 

arrange a medical evaluation of a 

donor’s inability to provide a specimen. 

Administrative data for urine 

collections indicates it takes, on 

average, about 4 hours from the start of 

the notification of the drug test to the 

actual time a donor reports back to the 

worksite. Since oral fluid collection 

does not have the same privacy 

concerns as urine collection, onsite 

collections are likely, thereby reducing 

the time a donor is away from the 

worksite. The Department estimates the 

time savings to be more than 2 hours. 

This estimate takes into account the 

time savings if the oral fluid collection 

was conducted at the employee’s 

workplace, and thus incorporates travel 

time savings. Using OPM’s estimate for 

the average annual salary of Federal 

employees converted to an hourly wage, 

the savings generated for the Federal 

Government would be roughly $400,000 

to $1.2 million a year, or $38 to $114 per 

test. 

Versatility in Detection 

The time course of drugs and 

metabolites differs between oral fluid 

and urine, resulting in some differences 

in analytes and detection times. Oral 

fluid tests generally are positive as soon 

as the drug is absorbed into the body. In 

contrast, urine tests that are based solely 

on detection of a metabolite are 

dependent upon the rate and extent of 

metabolite formation. Thus, oral fluid 

may permit more interpretative insight 

into recent drug use drug-induced 

effects that may be present shortly 

before or at the time the specimen is 

collected. A federal agency may select 

the specimen type for collection based 

on the circumstances of the test. For 

example, in situations where drug use at 

the work-site is suspected, the testing of 

oral fluid may show the presence of an 

active drug, which may indicate recent 

administration of the drug and be 

advantageous when assessing whether 

the drug contributed to an observed 

behavior. 

Current Testing in the Drug Free 

Workplace Program 

Urine was the original specimen of 

choice for forensic workplace drug 

57572 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

testing, and urine testing is expected to 

remain an established and reliable 

component of federal workplace drug 

testing programs. Urine testing provides 

scientifically accurate and legally 

defensible results and has proven to be 

an effective deterrent to drug use in the 

workplace. 

A major challenge to urine drug 

testing has been the proliferation of 

commercial products used to adulterate 

or substitute a donor’s urine specimen. 

Due to individual privacy rights, most 

urine collections are unobserved, 

allowing the opportunity to use such 

products. As the Department has 

established requirements and 

laboratories have developed procedures 

to control for adulterated and 

substituted specimens, manufacturers 

have developed new products to avoid 

detection. The use of these products is 

expected to continue. 

Cost and Benefit 

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. The Department 

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. The subsequent transition to 

oral fluid testing is expected to be 

gradual and steady over the course of 

four years, when it should plateau to 

account for 25 to 30% of federal agency 

drug testing (i.e., 37,500 to 45,000 

specimens). This transition estimate is 

based on the non-regulated sector’s time 

course of the testing of oral fluid and 

urine in the four years preceding the 

final OFMG. 

The approximate annual numbers of 

regulated specimens collected from 

applicants and employees under the 

Department of Transportation (DOT) 

and Nuclear Regulatory Commission 

(NRC) drug testing regulations are 6 

million and 155,000, 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 numbers of 

specimens for NRC would be 10,850 

oral fluid and 144,150 urine. Assuming 

the same four-year transition time for 

DOT- and NRC-regulated industries, the 

numbers of oral fluid specimens are 

expected to be 1,500,000 to 1,800,000 

specimens under DOT regulations and 

38,750 to 46,500 specimens under NRC 

regulations. 

In Section 3.4, the Department 

included criteria for calibrating initial 

tests for grouped analytes such as 

opiates and amphetamines, and 

specified the cross-reactivity of the 

immunoassay to the other analytes(s) 

within the group. These Guidelines 

allow the use of methods other than 

immunoassay for initial testing. An 

immunoassay manufacturer may incur 

costs if they choose to alter their 

existing product and resubmit the 

immunoassay for FDA clearance. 

Costs associated with the addition of 

oral fluid testing and testing for 

oxycodone, oxymorphone, hydrocodone 

and hydromorphone will be minimal 

based on information from some HHScertified laboratories currently testing 

private sector oral fluid specimens. 

SUMMARY OF ONE-TIME COSTS 

Prior to being allowed to test regulated 

oral fluid specimens, laboratories must 

be certified by the Department through 

the NLCP. Estimated laboratory costs to 

complete and submit the application are 

$3,000, and estimated costs for the 

Department to process the application 

are $7,200. These estimates are from 

SAMHSA and are based on the NLCP 

fee schedule and historical costs. The 

initial certification process includes the 

requirement to demonstrate that the 

applicant laboratory’s performance 

meets Guidelines requirements by 

testing three (3) groups of PT samples. 

The Department will provide the three 

groups of PT samples through the NLCP 

at no cost. Based on costs charged for 

urine specimen testing, laboratory costs 

to conduct the PT testing would range 

from $900 to $1,800 for each applicant 

laboratory. 

Agencies choosing to use oral fluid in 

their drug testing programs may also 

incur some costs for training of federal 

employees such as drug program 

coordinators. Based on current training 

modules offered to drug program 

coordinators, and other associated costs 

including travel for 90% of drug 

program coordinators, the estimated 

total training cost for a one-day training 

session would be between $108,000 and 

$138,000 (i.e., assuming 8 hours of time 

multiplied by a GS 12/13 wage 

including benefits and overhead 

adjustments). This training cost is 

included in the costs of the revised 

URMG. The Department will offer the 

choice of online or in-person training. 

This will eliminate travel costs for those 

federal agencies who choose to use 

online training. 

Lower bound Upper bound Primary 

Cost of Application * ..................................................................................................................... 

Application Processing * .............................................................................................................. 

Performance Testing * ................................................................................................................. 

Training * ...................................................................................................................................... 

........................ 

........................ 

$27,900.00 

108,000.00 

........................ 

........................ 

$55,800.00 

138,000.00 

$93,000.00 

217,000.00 

........................ 

........................ 

Total ...................................................................................................................................... 445,900.00 503,800.00 ........................ 

* Estimated using costs presented above multiplied by the number of Laboratories (31). 

Costs and Benefits regulations), the Department is Executive Order 13771: Reducing 

confident that the benefits would Regulation and Controlling Regulatory Thus, the Department estimates one- outweigh the costs. Even if NRC and Costs time, upfront costs of between $446,000 DOT do not implement oral fluid testing and $504,000. While the Department This set of Guidelines is considered for their regulated industries’ drug has only monetized a small portion of an E.O. 13771 deregulatory action. The testing programs, the benefits to Federal the benefits (time savings) to a small net cost savings, annualized over a subset of the workplace drug testing workplace testing programs, estimated perpetual time horizon using a 7% programs that could be affected by the at between $400,000 and $1.2 million, discount rate and expressed in 2016 OFMG (i.e., federal employee testing would recur on an annual basis. 

dollars, is estimated to be $87.34 programs and not drug testing programs million. conducted under NRC and DOT 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57573 

Regulatory Flexibility Analysis 

For the reasons outlined above, the 

Secretary has determined that the 

Guidelines will not have a significant 

impact upon a substantial number of 

small entities within the meaning of the 

Regulatory Flexibility Act [5 U.S.C. 

605(b)]. The flexibility added by the 

OFMG will not require additional 

expenditures. Therefore, a final 

regulatory flexibility analysis is not 

required for this notice. 

As mentioned in the section on 

Executive Order 12866, the Secretary 

anticipates that there will be an overall 

reduction in costs if drug testing is 

expanded under the OFMG. The costs to 

implement this change to regulation are 

negligible. The added flexibility will 

permit federal agencies to select the 

specimen type best suited for their 

needs and to authorize collection of an 

alternative specimen type when an 

employee is unable to provide the 

originally authorized specimen type. 

Insofar as there are costs associated with 

each drug test, this could lead to lower 

overall testing costs for federal agencies. 

The added flexibility will also benefit 

federal employees, who should be able 

to provide one of the specimen types, 

thereby facilitating the drug test 

required for their employment. 

The Secretary has determined that the 

Guidelines are not a major rule for the 

purpose of congressional review. For the 

purpose of congressional review, a 

major rule is one which is likely to 

cause an annual effect on the economy 

of $100 million; a major increase in 

costs or prices; significant effects on 

competition, employment, productivity, 

or innovation; or significant effects on 

the ability of U.S.-based enterprises to 

compete with foreign-based enterprises 

in domestic or export markets. This is 

not a major rule under the Small 

Business Regulatory Enforcement 

Fairness Act (SBREFA) of 1996. 

Unfunded Mandates 

The Secretary has examined the 

impact of the Guidelines under the 

Unfunded Mandates Reform Act 

(UMRA) of 1995 (Pub. L. 104–4). This 

notice does not trigger the requirement 

for a written statement under section 

202(a) of the UMRA because the 

Guidelines do not impose a mandate 

that results in an expenditure of $100 

million (adjusted annually for inflation) 

or more by either state, local, and tribal 

governments in the aggregate or by the 

private sector in any one year. 

Environmental Impact 

The Secretary has considered the 

environmental effects of the OFMG. No 

information or comments have been 

received that would affect the agency’s 

determination there would be a 

significant impact on the human 

environment and that neither an 

environmental assessment nor an 

environmental impact statement is 

required. 

Executive Order 13132: Federalism 

The Secretary has analyzed the 

Guidelines in accordance with 

Executive Order 13132: Federalism. 

Executive Order 13132 requires federal 

agencies to carefully examine actions to 

determine if they contain policies that 

have federalism implications or that 

preempt state law. As defined in the 

Order, ‘‘policies that have federalism 

implications’’ refer to regulations, 

legislative comments or proposed 

legislation, and other policy statements 

or actions that have substantial direct 

effects on the states, on the relationship 

between the national government and 

the states, or on the distribution of 

power and responsibilities among the 

various levels of government. 

In this notice, the Secretary 

establishes standards for certification of 

laboratories engaged in oral fluid drug 

testing for federal agencies and the use 

of oral fluid 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. 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. 

Privacy Act 

The Secretary has determined that the 

Guidelines do not contain information 

collection requirements constituting a 

system of records under the Privacy Act. 

The Federal Register notice announcing 

the Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

Oral Fluid 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]. The 

revised Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using Urine (UrMG) were 

published on January 23, 2017 [82 FR 

7920] with an effective date of October 

1, 2017. 

Executive Order 13175: Consultation 

and Coordination With Indian Tribal 

Governments 

Executive Order 13175 (65 FR 67249, 

November 6, 2000) requires SAMHSA to 

develop an accountable process to 

ensure ‘‘meaningful and timely input by 

tribal officials in the development of 

regulatory policies that have tribal 

implications.’’ ‘‘Policies that have tribal 

implications’’ as defined in the 

Executive Order, include regulations 

that have ‘‘substantial direct effects on 

one or more Indian tribes, on the 

relationship between the federal 

government and the Indian tribes, or on 

the distribution of power and 

responsibilities between the federal 

government and Indian tribes.’’ The 

Guidelines do not have tribal 

implications. The Guidelines will not 

have substantial direct effects on tribal 

governments, on the relationship 

between the federal government and 

Indian tribes, or on the distribution of 

power and responsibilities between the 

federal government and Indian tribes, as 

specified in Executive Order 13175. 

Information Collection/Record Keeping 

Requirements 

The information collection 

requirements (i.e., reporting and 

recordkeeping) in the current 

Guidelines (82 FR 7920), 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 

57574 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

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 for regulated urine drug testing 

under the UrMG. The same documents 

specifically for regulated oral fluid drug 

testing under the OFMG will be 

submitted for OMB approval under a 

new control number. 

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 Oral Fluid Specimens 

Description: The 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. The program has 

depended on urine specimen testing 

since 1988; the reporting, recordkeeping 

ESTIMATE OF ANNUAL REPORTING BURDEN 

and disclosure requirements associated 

with urine specimen testing are 

approved under OMB control number 

0930–0158. These Guidelines establish 

when oral fluid specimens may be 

collected, the procedures that must be 

used in collecting an oral fluid 

specimen, and the certification process 

for approving a laboratory to test oral 

fluid specimen. 

Description of Respondents: 

Individuals or households; businesses; 

or other-for-profit; not-for-profit 

institutions. 

The annual burden estimates in the 

tables below are based on the following 

number of respondents: 10,500 donors 

who apply for employment or are 

employed in testing designated 

positions, 100 collectors, 10 oral fluid 

specimen testing laboratories, and 100 

MROs. 

Section Purpose Number of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

9.2(a)(1) ......................... 

9.10(a)(3) ....................... 

11.3(a) ........................... 

11.4(c) ............................ 

11.20 .............................. 

13.9 & 14.6 .................... 

16.1(b) & 16.5(a) ........... 

16.4 ................................ 

16.6 ................................ 

16.7(a) ........................... 

16.9(a) ........................... 

16.9(c) ............................ 

Total ........................ 

Laboratory required to submit application for 

certification. 

Materials to submit to become an HHS inspector. 

Laboratory submits qualifications of RP to HHS 

Laboratory submits information to HHS on new 

RP or alternate RP. 

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

agency. 

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

federal agency. 

Specifies content of request for informal review 

of suspension/proposed revocation of certification. 

Specifies information appellant provides in first 

written submission when laboratory suspension/revocation is proposed. 

Requires appellant to notify reviewing official of 

resolution status at end of abeyance period. 

Specifies contents of appellant submission for 

review. 

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

Specifies contents of review file and briefs ......... 

.............................................................................. 

10 

10 

10 

10 

10 

100 

1 

1 

1 

1 

1 

1 

1 

1 

1 

1 

5 

14 

1 

1 

1 

1 

1 

1 

3 

2 

2 

2 

0.5 

* 0.05 

3 

0.5 

0.5 

50 

3 

50 

30 

20 

20 

20 

25 

70 

3 

0.5 

0.5 

50 

3 

50 

156 ........................ ........................ 292 

* (3 min). 

The following reporting requirements 

are also in the Guidelines, but have not 

been addressed in the above reporting 

burden table: Collector must report any 

unusual donor behavior or refuse to 

participate in the collection process on 

the Federal CCF (sections 1.8, 8.9); 

collector annotates the Federal CCF 

when a sample is a blind sample 

(section 10.3(a)); MRO notifies the 

federal agency and HHS when an error 

occurs on a blind sample (section 

10.4(c)); section 13.5 describes the 

actions an MRO takes to report a 

primary specimen result; and section 

14.5 describes the actions an MRO takes 

to report a split specimen result. 

SAMHSA has not calculated a separate 

reporting burden for these requirements 

because they will be included in the 

burden hours estimated for collectors to 

complete Federal CCFs and for MROs to 

report results to federal agencies. 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57575 

ESTIMATE OF ANNUAL DISCLOSURE BURDEN 

Section Purpose No. of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

8.3(a) & 8.6(b)(2) ........... 

11.21 & 11.22 ................ 

13.8 (b) .......................... 

Collector must contact federal agency point of 

contact. 

Information on drug test that laboratory must 

provide to federal agency upon request or to 

donor through MRO. 

MRO must inform donor of right to request split 

specimen test when a positive or adulterated 

result is reported. 

100 

50 

100 

1 

10 

14 

* 0.05 

3 

3 

5 

1,500 

4,200 

Total ........................ .............................................................................. 210 ........................ ........................ 5,705 

* (3 min). 

The following disclosure collection procedure to the donor and 8.4(b)). The Department believes having 

requirements are also included in the answer any questions (section 8.3(f) and the collector explain the collection 

Guidelines, but have not been addressed (h), and must review the procedures for procedure to the donor and answer any 

in the above disclosure burden table: the oral fluid specimen collection questions is a standard business practice 

The collector must explain the basic device used with the donor (section and not a disclosure burden. 

ESTIMATE OF ANNUAL RECORDKEEPING BURDEN 

Section Purpose No. of 

respondents 

Responses/ 

respondent 

Hours/ 

response Total hours 

8.3, 8.5, & 8.8 ................ 

8.8(d) & (f) ..................... 

11.8(a) & 11.17 ............. 

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

14.6(c). 

14.1(b) ........................... 

Collector completes Federal CCF for specimen 

collected. 

Donor initials specimen labels/seals and signs 

statement on the Federal CCF. 

Laboratory completes Federal CCF upon receipt 

of specimen and before reporting result. 

MRO completes Federal CCF before reporting 

the result. 

MRO documents donor’s request to have split 

specimen tested. 

100 

10,500 

10 

100 

300 

380 

1 

3,800 

380 

1 

0.07 (4 min) 

0.08 (5 min) 

0.05 (3 min) 

0.05 (3 min) 

0.05 (3 min) 

... 

... 

... 

... 

... 

2,534 

875 

1,900 

1,900 

15 

Total ....................... .............................................................................. 11,010 ........................ ........................ 7,224 

The Guidelines contain a number of 

recordkeeping requirements that 

SAMHSA considers not to be an 

additional recordkeeping burden. In 

subpart D, a trainer is required to 

document the training of an individual 

to be a collector [section 4.3(a)(3)] and 

the documentation must be maintained 

in the collector’s training file [section 

4.3(c)]. Because this is required by the 

current Guidelines using urine 

specimens as well as these Guidelines 

using oral fluid specimens and is 

consistent with general forensic 

requirements, SAMHSA believes this 

training documentation is common 

practice and is not considered an 

additional burden. In subpart F, if a 

collector uses an incorrect form to 

collect a federal agency specimen, the 

collector is required to provide a 

statement [section 6.2(b)] explaining 

why an incorrect form was used to 

document collecting the specimen. 

SAMHSA believes this is an extremely 

infrequent occurrence and does not 

create a significant additional 

recordkeeping burden. Subpart H 

[sections 8.4(d) and 8.5(a)(1)] requires 

collectors to enter any information on 

the Federal CCF of any unusual findings 

during the oral fluid specimen 

collection procedure. These 

recordkeeping requirements are an 

integral part of the collection procedure 

and are essential to documenting the 

chain of custody for the specimens 

collected. The burden for these entries 

is included in the recordkeeping burden 

estimated to complete the Federal CCF 

and is, therefore, not considered an 

additional recordkeeping burden. 

Subparts K describe 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; 11.10(1); 

11.13(a); 11.16; 11.17(a), (b), and (c); 

11.20; 11.21, and 11.22. 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 

oral fluid specimens by the laboratories 

is estimated to be 13,221 hours (that is, 

the sum of the total hours from the 

above tables). Because of the expected 

transition from urine to oral fluid 

testing, this number will replace some 

of the 1,788,809 hours currently 

approved by OMB under control 

number 0930–0158 for urine testing 

under the current Guidelines. 

As required by section 3507(d) of the 

PRA, the Secretary submitted a copy of 

the proposed Guidelines to OMB for its 

review. Comments on the information 

collection requirements were 

specifically solicited in order to: (1) 

Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of HHS’s 

functions, including whether the 

information will have practical utility; 

(2) evaluate the accuracy of HHS’s 

estimate of the burden of the proposed 

57576 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) enhance the 

quality, utility, and clarity of the 

information to be collected; and (4) 

minimize the burden of the collection of 

information on those who are to 

respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

References 

1. Cone, E.J., 1990. Testing human hair for 

drugs of abuse. I. Individual dose and 

time profiles of morphine and codeine in 

plasma, saliva, urine, and beard 

compared to drug-induced effects on 

pupils and behavior. J Anal Toxicol, 14, 

1–7. 

2. Cone, E.J., Clarke, J., Tsanaclis, L., 2007. 

Prevalence and disposition of drugs of 

abuse and opioid treatment drugs in oral 

fluid. J Anal Toxicol, 31, 424–433. 

3. Petrides, A.K., Melanson, SEF., Kantartjis, 

M., Le, R.D., Demetriou, C.A., Flood, J.G., 

2018. Monitoring opioid and 

benzodiazepine use and abuse: Is oral 

fluid or urine the preferred specimen 

type? Clin Chim Acta, 481, 75–82. 

4. Vindenes, V., Yttredal, B., ;iestad, E.L., 

Waal, H., Bernard, J.P., M<rland, J.G., 

Christophersen, A.S., 2011. Oral fluid is 

a viable alternative for monitoring drug 

abuse: Detection of drugs in oral fluid by 

liquid chromatography-tandem mass 

spectrometry and comparison to the 

results from urine samples from patients 

treated with Methadone or 

Buprenorphine. J Anal Toxicol, 35, 32– 

39. 

5. Quest Diagnostics, 2018. Workforce drug 

positivity at highest rate in a decade, 

finds analysis of more than 10 million 

drug test results. https:// 

www.questdiagnostics.com/dms/ 

Documents/Employer-Solutions/DTI– 

2018/2018-quest-diagnostics-drugtesting-index-2018-report/2018Quest 

DiagnosticsDrugTestingIndex.pdf 

Accessed October 19, 2018. 

6. Dams, R., Choo, R.E., Lambert, W.E., Jones, 

H., Huestis, M.A., 2007. Oral fluid as an 

alternative matrix to monitor opiate and 

cocaine use in substance-abuse treatment 

patients. Drug Alcohol Depend, 87, 258– 

267. 

7. Cone, E.J., 2012. Oral fluid results 

compared to self reports of recent 

cocaine and heroin use by methadone 

maintenance patients. Forensic Sci Int, 

215, 88–91. 

8. Niedbala, R.S., Kardos, K.W., Fritch, D.F., 

Kardos, S., Fries, T., Waga, J., Robb, J., 

Cone, E.J., 2001. Detection of marijuana 

use by oral fluid and urine analysis 

following single-dose administration of 

smoked and oral marijuana. J Anal 

Toxicol, 25, 289–303. 

9. Niedbala, R.S., Kardos, K.W., Fritch, D.F., 

Kunsman, K.P., Blum, K.A., Newland, 

G.A., Waga, J., Kurtz, L., Bronsgeest, M., 

Cone, E.J., 2005. Passive cannabis smoke 

exposure and oral fluid testing. II. Two 

studies of extreme cannabis smoke 

exposure in a motor vehicle. J Anal 

Toxicol, 29, 607–615. 

10. Moore, C., Coulter, C., Uges, D., Tuyay, 

J., van der Linde, S., van Leeuwen, A., 

Garnier, M., Orbita, J. Jr., 2011. 

Cannabinoids in oral fluid following 

passive exposure to marijuana smoke. 

Forensic Sci Int, 212, 227–230. 

11. Niedbala, S., Kardos, K., Salamone, S., 

Fritch, D., Bronsgeest, M., Cone, E.J., 

2004. Passive cannabis smoke exposure 

and oral fluid testing. J Anal Toxicol, 28, 

546–552. 

12. Herrmann, E.S., Cone, E.J., Mitchell, J.M., 

Bigelow, G.E., LoDico, C., Flegel, R., 

Vandrey, R., 2015. Non-smoker exposure 

to secondhand cannabis smoke. II. Effect 

of room ventilation on the physiological, 

subjective, and behavioral/cognitive 

effects. Drug Alcohol Depend, 151, 194– 

202. 

13. Cone, E.J., Bigelow, G.E., Herrmann, E.S., 

Mitchell, J.M., LoDico, C., Flegel, R., 

Vandrey, R., 2015. Nonsmoker exposure 

to secondhand cannabis smoke. III. Oral 

fluid and blood drug concentrations and 

corresponding subjective effects. J Anal 

Toxicol, 39, 497–509. 

14. SUPPORT for Patients and Communities 

Act, H.R. 6, 115th Cong. (2018). https:// 

www.congress.gov/bill/115th-congress/ 

house-bill/6. 

15. Swortwood, M.J., Newmeyer, M.N., 

Andersson, M., Abulseoud, O.A., 

Scheidweiler, K.B., Huestis, M.A., 2017. 

Cannabinoid disposition in oral fluid 

after controlled smoked, vaporized, and 

oral cannabis administration. Drug Test 

Anal, 9, 905–915. 

16. Vandrey, R., Herrmann, E.S., Mitchell, 

J.M., Bigelow, G.E., Flegel, R., LoDico, C., 

Cone, E.J., 2017. Pharmacokinetic profile 

of oral cannabis in humans: blood and 

oral fluid disposition and relation to 

pharmacodynamic outcomes. J Anal 

Toxicol, 41, 83–89. 

17. Anizan, S., Milman, G., Desrosiers, N., 

Barnes, A.J., Gorelick, D.A., Huestis, 

M.A., 2013. Oral fluid cannabinoid 

concentrations following controlled 

smoked cannabis in chronic frequent and 

occasional smokers. Anal Bioanal Chem, 

405, 8451–8461. 

18. Desrosiers, N.A., Ramaekers, J.G., 

Chauchard, E., Gorelick, D.A., Huestis, 

M.A., 2015. Smoked cannabis’ 

psychomotor and neurocognitive effects 

in occasional and frequent smokers. J 

Anal Toxicol, 39, 251–261. 

19. Lee, D., Milman, G., Barnes, A.J., 

Goodwin, R.S., Hirvonen, J., Huestis, 

M.A., 2011. Oral fluid cannabinoids in 

chronic, daily cannabis smokers during 

sustained, monitored abstinence. Clin 

Chem, 57, 1127–1136. 

20. Lee, D., Schwope, D.M., Milman, G., 

Barnes, A.J., Gorelick, D.A., Huestis, 

M.A., 2012. Cannabinoid disposition in 

oral fluid after controlled smoked 

cannabis. Clin Chem, 58, 748–756. 

21. Rohrig, T.P., Moore, C., 2003. The 

determination of morphine in urine and 

oral fluid following ingestion of poppy 

seeds. J Anal Toxicol, 27, 449–452. 

22. Samano, K.L., Clouette, R.E., Rowland, 

B.J., Sample, R.H.B., 2015. 

Concentrations of morphine and codeine 

in paired oral fluid and urine specimens 

following ingestion of a poppy seed roll 

and raw poppy seeds. J Anal Toxicol, 39, 

655–661. 

23. Newmeyer, M.N., Concheiro, M., da 

Costa, J.L., LoDico, C., Gorelick, D.A., 

Huestis, M.A., 2015. Simultaneous 

plasma and oral fluid morphine and 

codeine concentrations after controlled 

administration of poppy seeds with 

known opiate content. Forensic Toxicol, 

33, 235–243. 

24. Concheiro, M., Newmeyer, M.N., da 

Costa, J.L., Flegel, R., Gorelick, D.A., 

Huestis, M.A., 2015. Morphine and 

codeine in oral fluid after controlled 

poppy seed administration. Drug Test 

Anal, 7, 586–591. 

25. Cone, E.J., DePriest, A.Z., Heltsley, R., 

Black, D.L., Mitchell, J.M., LoDico, C., 

Flegel, R., 2015. Prescription opioids. III. 

Disposition of oxycodone in oral fluid 

and blood following controlled single 

dose administration. J Anal Toxicol, 39, 

192–202. 

26. Cone, E.J., DePriest, A.Z., Heltsley, R., 

Black, D.L., Mitchell, J.M., LoDico, C., 

Flegel, R., 2015. Prescription opioids. IV. 

Disposition of hydrocodone in oral fluid 

and blood following single dose 

administration. J Anal Toxicol, 39: 510– 

518. 

27. Goggin, M.M., Tann, C., Miller, A., 

Nguyen, A., Janis, G.C., 2017. Catching 

fakes: New markers of urine sample 

validity and invalidity. J Anal Toxicol, 

41, 121–126. 

28. Kluge, J., Rentzsch, L., Remane, D., 

Peters, F.T., Wissenbach, D.K., 2018. 

Systematic investigations of novel 

validity parameters in urine drug testing 

and prevalence of urine adulteration in 

a two-year cohort. Drug Test Anal, 

10,1536–1542. 

Dated: October 7, 2019. 

Elinore F. McCance-Katz, 

Assistant Secretary for Mental Health and 

Substance Use. 

Dated: October 7, 2019. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

The Mandatory Guidelines using Oral 

Fluid Specimens are hereby adopted in 

accordance with section 503 of Public 

Law 100–71 and Executive Order 12564. 

Mandatory Guidelines For Federal 

Workplace Drug Testing Programs 

Using Oral Fluid 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? 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57577 

1.8 What are the potential consequences for 

refusing to take a federally regulated 

drug test? 

Subpart B—Oral Fluid Specimens 

2.1 What type of specimen may be 

collected? 

2.2 Under what circumstances may an oral 

fluid specimen be collected? 

2.3 How is each oral fluid specimen 

collected? 

2.4 What volume of oral fluid is collected? 

2.5 How is the split oral fluid specimen 

collected? 

2.6 When may an entity or individual 

release an oral fluid specimen? 

Subpart C—Oral Fluid Specimen Tests 

3.1 Which tests are conducted on an oral 

fluid 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 undiluted (neat) oral 

fluid? 

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 an oral 

fluid specimen as adulterated? 

3.7 What criteria are used to report an 

invalid result for an oral fluid 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 a 

trainer for collectors? 

4.5 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 an oral fluid 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 OMBapproved Federal CCF is not available or 

is not used? 

Subpart G—Oral Fluid Specimen Collection 

Devices 

7.1 What is used to collect an oral fluid 

specimen? 

7.2 What are the requirements for an oral 

fluid collection device? 

7.3 What are the minimum performance 

requirements for a collection device? 

Subpart H—Oral Fluid Specimen Collection 

Procedure 

8.1 What privacy must the donor be given 

when providing an oral fluid specimen? 

8.2 What must the collector ensure at the 

collection site before starting an oral 

fluid specimen collection? 

8.3 What are the preliminary steps in the 

oral fluid specimen collection 

procedure? 

8.4 What steps does the collector take in the 

collection procedure before the donor 

provides an oral fluid specimen? 

8.5 What steps does the collector take 

during and after the oral fluid specimen 

collection procedure? 

8.6 What procedure is used when the donor 

states that they are unable to provide an 

oral fluid specimen? 

8.7 If the donor is unable to provide an oral 

fluid specimen, may another specimen 

type be collected for testing? 

8.8 How does the collector prepare the oral 

fluid specimens? 

8.9 How does the collector report a donor’s 

refusal to test? 

8.10 What are a federal agency’s 

responsibilities for a collection site? 

Subpart I—HHS Certification of Laboratories 

9.1 Who has the authority to certify 

laboratories to test oral fluid specimens 

for federal agencies? 

9.2 What is the process for a laboratory to 

become HHS-certified? 

9.3 What is the process for a laboratory to 

maintain HHS certification? 

9.4 What is the process when a laboratory 

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 oral fluid laboratory? 

9.8 What are the inspection requirements 

for an applicant laboratory? 

9.9 What are the maintenance inspection 

requirements for an HHS-certified 

laboratory? 

9.10 Who can inspect an HHS-certified 

laboratory and when may the inspection 

be conducted? 

9.11 What happens if an applicant 

laboratory does not satisfy the minimum 

requirements for either the PT program 

or the inspection program? 

9.12 What happens if an HHS-certified 

laboratory does not satisfy the minimum 

requirements for either the PT program 

or the inspection program? 

9.13 What factors are considered in 

determining whether revocation of a 

laboratory’s HHS certification is 

necessary? 

9.14 What factors are considered in 

determining whether to suspend a 

laboratory’s HHS certification? 

9.15 How does the Secretary notify an HHScertified laboratory that action is being 

taken against the laboratory? 

9.16 May a laboratory that had its HHS 

certification revoked be recertified to test 

federal agency specimens? 

9.17 Where is the list of HHS-certified 

laboratories 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? 

10.2 What are the requirements for blind 

samples? 

10.3 How is a blind sample submitted to an 

HHS-certified laboratory? 

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 HHScertified 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 HHScertified laboratory maintain? 

11.8 What are the laboratory chain of 

custody requirements for specimens and 

aliquots? 

11.9 What are the requirements for an 

initial drug test? 

11.10 What must an HHS-certified 

laboratory do to validate an initial drug 

test? 

11.11 What are the batch quality control 

requirements when conducting an initial 

drug test? 

11.12 What are the requirements for a 

confirmatory drug test? 

11.13 What must an HHS-certified 

laboratory do to validate a confirmatory 

drug test? 

11.14 What are the batch quality control 

requirements when conducting a 

confirmatory drug test? 

11.15 What are the analytical and quality 

control requirements for conducting 

specimen validity tests? 

11.16 What must an HHS-certified 

laboratory do to validate a specimen 

validity test? 

11.17 What are the requirements for an 

HHS-certified laboratory to report a test 

result? 

11.18 How long must an HHS-certified 

laboratory retain specimens? 

11.19 How long must an HHS-certified 

laboratory retain records? 

11.20 What statistical summary reports 

must an HHS-certified laboratory 

provide for oral fluid testing? 

11.21 What HHS-certified laboratory 

information is available to a federal 

agency? 

11.22 What HHS-certified laboratory 

information is available to a federal 

employee? 

57578 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

11.23 What types of relationships are 

prohibited between an HHS-certified 

laboratory and an MRO? 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

12.1 May an IITF test oral fluid specimens 

for a federal agency’s workplace drug 

testing program? 

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 an oral fluid 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 oral 

fluid for a drug test? 

13.7 What happens when an individual is 

unable to provide a sufficient amount of 

oral fluid 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? 

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) oral fluid specimen when 

the primary (A) specimen was reported 

adulterated? 

14.4 Who receives the split (B) specimen 

result? 

14.5 What action(s) does an MRO take after 

receiving the split (B) oral fluid 

specimen result from the second HHScertified laboratory? 

14.6 How does an MRO report a split (B) 

specimen test result to an agency? 

14.7 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 HHScertified laboratory to report a specimen 

as rejected for testing? 

15.2 What discrepancies require an HHScertified laboratory 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 to 

reject an oral fluid 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 Suspension/ 

Revocation Procedures 

16.1 When may the HHS certification of a 

laboratory 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 that provide drug 

testing services to the federal agencies; 

(6) Collectors who provide specimen 

collection services to the federal 

agencies; and 

(7) Medical Review Officers (MROs) 

who provide drug testing review and 

interpretation of results services to the 

federal agencies. 

(b) These Guidelines do not apply to 

drug testing under authority other than 

Executive Order 12564, including 

testing of persons in the criminal justice 

system, such as arrestees, detainees, 

probationers, incarcerated persons, or 

parolees.1 

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 HHScertified IITF. 

1 The NRC-related information in this notice 

pertains to individuals subject to drug testing 

conducted pursuant to 10 CFR Part 26, ‘‘Fitness for 

Duty Programs’’ (i.e., employees of certain NRCregulated 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, e.g., 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. 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57579 

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 HHScertified laboratory when the 

responsible person 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 HHScertified 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 Device. A product that is 

used to collect an oral fluid specimen 

and may include a buffer or diluent. 

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. 

Donor. The individual from whom a 

specimen is collected. 

External Service Provider. An 

independent entity that performs 

services related to federal workplace 

drug testing on behalf of a federal 

agency, a collector/collection site, an 

HHS-certified laboratory, a Medical 

Review Officer (MRO), or, for urine, an 

HHS-certified Instrumented Initial Test 

Facility (IITF). 

Failed to Reconfirm. The result 

reported for a split (B) specimen when 

a second HHS-certified laboratory is 

unable to corroborate the result reported 

for the primary (A) specimen. 

Federal Drug Testing Custody and 

Control Form (Federal CCF). The Office 

of Management and Budget (OMB) 

approved form that is used to document 

the collection and chain of custody of a 

specimen from the time the specimen is 

collected until it is received by the test 

facility (i.e., HHS-certified laboratory or, 

for urine, HHS-certified IITF). It may be 

a paper (hardcopy), electronic, or 

combination electronic and paper 

format (hybrid). The form may also be 

used to report the test result to the 

Medical Review Officer. 

HHS. The Department of Health and 

Human Services. 

Initial Drug Test. An analysis used to 

differentiate negative specimens from 

those requiring further testing. 

Initial Specimen Validity Test. The 

first analysis used to determine if a 

specimen is invalid, adulterated, or (for 

urine) diluted or substituted. 

Instrumented Initial Test Facility 

(IITF). A permanent location where (for 

urine) initial testing, reporting of 

results, and recordkeeping are 

performed under the supervision of a 

responsible technician. 

Invalid Result. The result reported by 

an HHS-certified laboratory in 

accordance with the criteria established 

in Section 3.7 when a positive or 

negative result cannot be established for 

a specific drug or specimen validity test. 

Laboratory. A permanent location 

where initial and confirmatory drug 

testing, reporting of results, and 

recordkeeping are performed under the 

supervision of a responsible person. 

Limit of Detection. The lowest 

concentration at which the analyte (e.g., 

drug or drug metabolite) can be 

identified. 

Limit of Quantification. For 

quantitative assays, the lowest 

concentration at which the identity and 

concentration of the analyte (e.g., drug 

or drug metabolite) can be accurately 

established. 

Lot. A number of units of an item 

(e.g., reagents, quality control material, 

oral fluid collection device) 

manufactured from the same starting 

materials within a specified period of 

time for which the manufacturer 

ensures that the items have essentially 

the same performance characteristics 

and expiration date. 

Medical Review Officer (MRO). A 

licensed physician who reviews, 

verifies, and reports a specimen test 

result to the federal agency. 

Negative Result. The result reported 

by an HHS-certified laboratory or (for 

urine) an HHS-certified IITF to an MRO 

when a specimen contains no drug and/ 

or drug metabolite; or the concentration 

of the drug or drug metabolite is less 

than the cutoff for that drug or drug 

class. 

Oral Fluid Specimen. An oral fluid 

specimen is collected from the donor’s 

oral cavity and is a combination of 

physiological fluids produced primarily 

by the salivary glands. 

Oxidizing Adulterant. A substance 

that acts alone or in combination with 

other substances to oxidize drug or drug 

metabolites to prevent the detection of 

57580 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

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) an 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 HHScertified laboratory. 

Sample. A performance testing 

sample, calibrator or control used 

during testing, or a representative 

portion of a donor’s specimen. 

Secretary. The Secretary of the U.S. 

Department of Health and Human 

Services. 

Specimen. Fluid or material collected 

from a donor at the collection site for 

the purpose of a drug test. 

Split Specimen Collection (for Oral 

Fluid). A collection in which two 

specimens [primary (A) and split (B)] 

are collected, concurrently or serially, 

and independently sealed in the 

presence of the donor; or a collection in 

which a single specimen is collected 

using a single collection device and is 

subdivided 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. 

Undiluted (neat) oral fluid. An oral 

fluid specimen to which no other solid 

or liquid has been added. For example, 

see Section 2.4: A collection device that 

uses a diluent (or other component, 

process, or method that modifies the 

volume of the testable specimen) must 

collect at least 1 mL of undiluted (neat) 

oral fluid. 

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, collectors, and MROs 

must require that they comply with the 

Privacy Act, 5 U.S.C. 552a. In addition, 

the contracts must require compliance 

with employee access and 

confidentiality provisions of Section 

503 of Public Law 100–71. Each federal 

agency must establish a Privacy Act 

System of Records or modify an existing 

system or use any applicable 

Government-wide system of records to 

cover the records of employee drug test 

results. All contracts and the Privacy 

Act System of Records must specifically 

require that employee records be 

maintained and used with the highest 

regard for employee privacy. 

The Health Insurance Portability and 

Accountability Act of 1996 (HIPAA) 

Privacy Rule (Rule), 45 CFR parts 160 

and 164, Subparts A and E, may be 

applicable to certain health care 

providers with whom a federal agency 

may contract. If a health care provider 

is a HIPAA covered entity, the provider 

must protect the individually 

identifiable health information it 

maintains in accordance with the 

requirements of the Rule, which 

includes not using or disclosing the 

information except as permitted by the 

Rule and ensuring there are reasonable 

safeguards in place to protect the 

privacy of the information. For more 

information regarding the HIPAA 

Privacy Rule, please visit http:// 

www.hhs.gov/ocr/hipaa. 

Section 1.7 What is a refusal to take a 

federally regulated drug test? 

(a) As a donor for a federally regulated 

drug test, you have refused to take a 

federally regulated drug test if you: 

(1) Fail to appear for any test (except 

a pre-employment test) within a 

reasonable time, as determined by the 

federal agency, consistent with 

applicable agency regulations, after 

being directed to do so by the federal 

agency; 

(2) Fail to remain at the collection site 

until the collection process is complete 

with the exception of a donor who 

leaves the collection site before the 

collection process begins for a preemployment test as described in section 

8.4(a); 

(3) Fail to provide a specimen (e.g., 

oral fluid or another authorized 

specimen type) for any drug test 

required by these Guidelines or federal 

agency regulations with the exception of 

a donor who leaves the collection site 

before the collection process begins for 

a pre-employment test as described in 

section 8.4(a); 

(4) Fail to provide a sufficient amount 

of oral fluid when directed, and it has 

been determined, through a required 

medical evaluation, that there was no 

legitimate medical explanation for the 

failure as determined by the process 

described in Section 13.6; 

(5) Fail or decline to participate in an 

alternate specimen collection (e.g., 

urine) as directed by the federal agency 

or collector (i.e., as described in Section 

8.6); 

(6) 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/preemployment 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; 

(7) Fail to cooperate with any part of 

the testing process (e.g., disrupt the 

collection process; fail to rinse the 

mouth after being directed to do so by 

the collector; refuse to provide a split 

specimen); 

(8) Bring materials to the collection 

site for the purpose of adulterating, 

substituting, or diluting the specimen; 

(9) Attempt to adulterate, substitute, 

or dilute the specimen; or 

(10) Admit to the collector or MRO 

that you have adulterated or substituted 

the specimen. 

Section 1.8 What are the potential 

consequences for refusing to take a 

federally regulated drug test? 

(a) As a federal agency employee or 

applicant, a refusal to take a test may 

result in the initiation of disciplinary or 

adverse action, up to and including 

removal from, or non-selection for, 

federal employment. 

(b) When a donor has refused to 

participate in a part of the collection 

process, including failing to appear in a 

reasonable time for any test except a 

pre-employment test as described in 

Section 1.7(a)(1), the collector must 

terminate the collection process and 

take action as described in Section 8.9. 

Required action includes immediately 

notifying the federal agency’s 

designated representative by any means 

(e.g., telephone or secure fax machine) 

that ensures that the refusal notification 

is immediately received and, if a 

Federal CCF has been initiated, 

documenting the refusal on the Federal 

CCF, signing and dating the Federal 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57581 

CCF, and sending all copies of the 

Federal CCF to the federal agency’s 

designated representative. 

(c) When documenting a refusal to 

test during the verification process as 

described in Sections 13.4, 13.5, and 

13.6, the MRO must complete the MRO 

copy of the Federal CCF to include: 

(1) Checking the refusal to test box; 

(2) Providing a reason for the refusal 

in the remarks line; and 

(3) Signing and dating the MRO copy 

of the Federal CCF. 

Subpart B—Oral Fluid Specimens 

Section 2.1 What type of specimen 

may be collected? 

A federal agency may collect oral 

fluid 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 oral fluid 

must follow these Guidelines. 

Section 2.2 Under what circumstances 

may an oral fluid specimen be 

collected? 

A federal agency may collect an oral 

fluid specimen for the following 

reasons: 

(a) Federal agency applicant/Preemployment test; 

(b) Random test; 

(c) Reasonable suspicion/cause test; 

(d) Post accident test; 

(e) Return to duty test; or 

(f) Follow-up test. 

Section 2.3 How is each oral fluid 

specimen collected? 

Each oral fluid specimen is collected 

as a split specimen (i.e., collected either 

simultaneously or serially) as described 

in Sections 2.5 and 8.8. 

Section 2.4 What volume of oral fluid 

is collected? 

A volume of at least 1 mL of 

undiluted (neat) oral fluid for each oral 

fluid specimen (designated ‘‘Tube A’’ 

and ‘‘Tube B’’) is collected using a 

collection device. If the device does not 

include a diluent (or other component, 

process, or method that modifies the 

volume of the testable specimen), the A 

and B tubes must have a volume 

marking clearly noting a level of 1 mL. 

Section 2.5 How is the split oral fluid 

specimen collected? 

The collector collects at least 1 mL of 

undiluted (neat) oral fluid in a 

collection device designated as ‘‘A’’ 

(primary) and at least 1 mL of undiluted 

(neat) oral fluid in a collection device 

designated as ‘‘B’’ (split) either 

simultaneously or serially (i.e., using 

two devices or using one device and 

subdividing the specimen), as described 

in Section 8.8. 

Section 2.6 When may an entity or 

individual release an oral fluid 

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—Oral Fluid Drug and 

Specimen Validity Tests 

Section 3.1 Which tests are conducted 

on an oral fluid specimen? 

A federal agency: 

(a) Must ensure that each specimen is 

tested for marijuana and cocaine as 

provided under Section 3.4; 

(b) Is authorized to test each specimen 

for opioids, amphetamines, and 

phencyclidine, as provided under 

Section 3.4; and 

(c) Is authorized upon a Medical 

Review Officer’s request to test an oral 

fluid specimen to determine specimen 

validity using, for example, a test for a 

biomarker such as albumin or 

immunoglobulin G (IgG) or a test for a 

specific adulterant. 

(d) If a specimen exhibits abnormal 

characteristics (e.g., unusual odor or 

color), causes reactions or responses 

characteristic of an adulterant during 

initial or confirmatory drug tests (e.g., 

non-recovery of internal standard, 

unusual response), or contains an 

unidentified substance that interferes 

with the confirmatory analysis, then 

additional testing may be performed. 

Section 3.2 May a specimen be tested 

for additional drugs? 

(a) On a case-by-case basis, a 

specimen may be tested for additional 

drugs, if a federal agency is conducting 

the collection for reasonable suspicion 

or post accident testing. A specimen 

collected from a federal agency 

employee may be tested by the federal 

agency for any drugs listed in Schedule 

I or II of the Controlled Substances Act. 

The federal agency must request the 

HHS-certified laboratory to test for the 

additional drug, include a justification 

to test a specific specimen for the drug, 

and ensure that the HHS-certified 

laboratory has the capability to test for 

the drug and has established properly 

validated initial and confirmatory 

analytical methods. If an initial test 

procedure is not available upon request 

for a suspected Schedule I or Schedule 

II drug, the federal agency can request 

an HHS-certified laboratory to test for 

the drug by analyzing two separate 

aliquots of the specimen in two separate 

testing batches using the confirmatory 

analytical method. Additionally, the 

split (B) specimen will be available for 

testing if the donor requests a retest at 

another HHS-certified laboratory. 

(b) A federal agency covered by these 

Guidelines must petition the Secretary 

in writing for approval to routinely test 

for any drug class not listed in Section 

3.1. Such approval must be limited to 

the use of the appropriate science and 

technology and must not otherwise limit 

agency discretion to test for any drug 

tested under paragraph (a) of this 

section. 

Section 3.3 May any of the specimens 

be used for other purposes? 

(a) Specimens collected pursuant to 

Executive Order 12564, Public Law 

100–71, and these Guidelines must only 

be tested for drugs and to determine 

their validity in accordance with 

Subpart C of these Guidelines. Use of 

specimens by donors, their designees or 

any other entity, for other purposes (e.g., 

deoxyribonucleic acid, DNA, testing) is 

prohibited unless authorized in 

accordance with applicable federal law. 

(b) These Guidelines are not intended 

to prohibit federal agencies specifically 

authorized by law to test a specimen for 

additional classes of drugs in its 

workplace drug testing program. 

Section 3.4 What are the drug test 

cutoff concentrations for undiluted 

(neat) oral fluid? 

57582 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

Initial test analyte 

Initial 

test cutoff 1 

(ng/mL) 

Confirmatory test analyte 

Confirmatory 

test cutoff 

concentration 

(ng/mL) 

Marijuana (THC) 2 ......................................................... 3 4 THC .............................................................................. 2 

Cocaine/Benzoylecgonine ............................................ 15 Cocaine ......................................................................... 8 

Benzoylecgonine .......................................................... 8 

Codeine/Morphine ........................................................ 30 Codeine ........................................................................ 15 

Morphine ....................................................................... 15 

Hydrocodone/Hydromorphone ...................................... 30 Hydrocodone ................................................................ 15 

Hydromorphone ............................................................ 15 

Oxycodone/Oxymorphone ............................................ 30 Oxycodone .................................................................... 15 

Oxymorphone ............................................................... 15 

6-Acetylmorphine .......................................................... 3 4 6-Acetylmorphine .......................................................... 2 

Phencyclidine ................................................................ 10 Phencyclidine ................................................................ 10 

Amphetamine/Methamphetamine ................................. 50 Amphetamine ................................................................ 25 

Methamphetamine ........................................................ 25 

MDMA 4/MDA 5 ............................................................. 50 MDMA ........................................................................... 25 

MDA .............................................................................. 25 

1 For grouped analytes (i.e., two or more analytes that are in the same drug class and have the same initial test cutoff): 

Immunoassay: The test must be calibrated with one analyte from the group identified as the target analyte. The cross reactivity of the 

immunoassay to the other analyte(s) within the group must be 80 percent or greater; if not, separate immunoassays must be used for the 

analytes within the group. 

Alternate technology: Either one analyte or all analytes from the group must be used for calibration, depending on the technology. At least one 

analyte within the group must have a concentration equal to or greater than the initial test cutoff or, alternatively, the sum of the analytes present 

(i.e., equal to or greater than the laboratory’s validated limit of quantification) must be equal to or greater than the initial test cutoff. 

2 An immunoassay must be calibrated with the target analyte, D-9-tetrahydrocannabinol (THC). 3 Alternate technology (THC and 6–AM): The confirmatory test cutoff must be used for an alternate technology initial test that is specific for the 

target analyte (i.e., 2 ng/mL for THC, 2 ng/mL for 6–AM). 4 Methylenedioxymethamphetamine (MDMA). 

5 Methylenedioxyamphetamine (MDA). 

Section 3.5 May an HHS-certified 

laboratory perform additional drug and/ 

or specimen validity tests on a specimen 

at the request of the Medical Review 

Officer (MRO)? 

An HHS-certified laboratory is 

authorized to perform additional drug 

and/or specimen validity tests on a caseby-case basis as necessary to provide 

information that the MRO would use to 

report a verified drug test result (e.g., 

specimen validity tests including 

biomarker and/or adulterant tests, 

tetrahydrocannabivarin). An HHScertified laboratory is not authorized to 

routinely perform additional drug and/ 

or specimen validity tests at the request 

of an MRO without prior authorization 

from the Secretary or designated HHS 

representative, with the exception of the 

determination of D,L stereoisomers of 

amphetamine and methamphetamine. 

All tests must meet appropriate 

validation and quality control 

requirements in accordance with these 

Guidelines. 

Section 3.6 What criteria are used to 

report an oral fluid specimen as 

adulterated? 

An HHS-certified laboratory reports 

an oral fluid specimen as adulterated 

when the presence of an adulterant 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 an invalid result for an oral fluid 

specimen? 

An HHS-certified laboratory reports a 

primary (A) oral fluid specimen as an 

invalid result when: 

(a) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid immunoassay or alternate 

technology initial drug test results 

cannot be obtained); 

(b) Interference with the drug 

confirmatory assay occurs on two 

separate aliquots of the specimen and 

the laboratory is unable to identify the 

interfering substance; 

(c) The physical appearance of the 

specimen (e.g., viscosity) is such that 

testing the specimen may damage the 

laboratory’s instruments; 

(d) The specimen has been tested and 

the appearances of the primary (A) and 

the split (B) specimens (e.g., color) are 

clearly different; or 

(e) The concentration of a biomarker 

(e.g., albumin or IgG) is not consistent 

with that established for human oral 

fluid for both the initial (first) test and 

the second test on two separate aliquots. 

Subpart D—Collectors 

Section 4.1 Who may collect a 

specimen? 

(a) A collector who has been trained 

to collect oral fluid specimens in 

accordance with these Guidelines and 

the manufacturer’s procedures for the 

collection device. 

(b) The immediate supervisor of a 

federal employee donor may only 

collect that donor’s specimen when no 

other collector is available. The 

supervisor must be a trained collector. 

(c) The hiring official of a federal 

agency applicant may only collect that 

federal agency applicant’s specimen 

when no other collector is available. 

The hiring official must be a trained 

collector. 

Section 4.2 Who may not collect a 

specimen? 

(a) A federal agency employee who is 

in a testing designated position and 

subject to the federal agency drug 

testing rules must not be a collector for 

co-workers in the same testing pool or 

who work together with that employee 

on a daily basis. 

(b) A federal agency applicant or 

employee must not collect their own 

drug testing specimen. 

(c) An employee working for an HHScertified laboratory 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., 

fiance ́e). 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57583 

Section 4.3 What are the requirements 

to be a collector? 

(a) An individual may serve as a 

collector if they fulfill the following 

conditions: 

(1) Is knowledgeable about the 

collection procedure described in these 

Guidelines; 

(2) Is knowledgeable about any 

guidance provided by the federal 

agency’s Drug-Free Workplace Program 

and additional information provided by 

the Secretary relating to these 

Guidelines; 

(3) Is trained and qualified to use the 

specific oral fluid collection device. 

Training must include the following: 

(i) All steps necessary to complete an 

oral fluid 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 two uneventful collection 

scenarios, one insufficient specimen 

quantity 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 

tube tamper-evident seal. 

(ii) A qualified trainer for collectors 

must monitor and evaluate the 

individual being trained, in person or by 

a means that provides real-time 

observation and interaction between the 

trainer and the trainee, and the trainer 

must attest in writing that the mock 

collections are error-free. 

(b) A trained collector must complete 

refresher training at least every five 

years that includes the requirements in 

paragraph (a) of this section. 

(c) The collector must maintain the 

documentation of their training and 

provide that documentation to a federal 

agency when requested. 

(d) An individual may not collect 

specimens for a federal agency until the 

individual’s training as a collector has 

been properly documented. 

Section 4.4 What are the requirements 

to be a trainer for collectors? 

(a) Individuals are considered 

qualified trainers for collectors for a 

specific oral fluid collection device and 

may train others to collect oral fluid 

specimens using that collection device 

when they have completed the 

following: 

(1) Qualified as a trained collector and 

regularly conducted oral fluid drug test 

collections using that collection device 

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 the 

trainer’s training and provide that 

documentation to a federal agency when 

requested. 

Section 4.5 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 selfemployed, 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 

(c) The collector has been provided 

the name and telephone number of the 

federal agency representative. 

Subpart E—Collection Sites 

Section 5.1 Where can a collection for 

a drug test take place? 

(a) A collection site may be a 

permanent or temporary facility located 

either at the work site or at a remote 

site. 

(b) In the event that an agencydesignated collection site is not 

accessible and there is an immediate 

requirement to collect an oral fluid 

specimen (e.g., an accident 

investigation), another site may be used 

for the collection, providing the 

collection is performed by a collector 

who has been trained to collect oral 

fluid specimens in accordance with 

these Guidelines and the manufacturer’s 

procedures for the collection device. 

Section 5.2 What are the requirements 

for a collection site? 

The facility used as a collection site 

must have the following: 

(a) Provisions to ensure donor privacy 

during the collection (as described in 

Section 8.1); 

(b) A suitable and clean surface area 

that is not accessible to the donor for 

handling the specimens and completing 

the required paperwork; 

(c) A secure temporary storage area to 

maintain specimens until the specimen 

is transferred to an HHS-certified 

laboratory; 

(d) A restricted access area where 

only authorized personnel may be 

present during the collection; 

(e) A restricted access area for the 

storage of collection supplies; and 

(f) The ability to store records 

securely. 

Section 5.3 Where must collection site 

records be stored? 

Collection site records must be stored 

at a secure site designated by the 

collector or the collector’s employer. 

Section 5.4 How long must collection 

site records be stored? 

Collection site records (e.g., collector 

copies of the OMB-approved Federal 

CCF) must be stored securely for a 

minimum of 2 years. The collection site 

may convert hardcopy records to 

electronic records for storage and 

discard the hardcopy records after 6 

months. 

Section 5.5 How does the collector 

ensure the security and integrity of a 

specimen at the collection site? 

(a) A collector must do the following 

to maintain the security and integrity of 

a specimen: 

(1) Not allow unauthorized personnel 

to enter the collection area during the 

collection procedure; 

(2) Perform only one donor collection 

at a time; 

(3) Restrict access to collection 

supplies before, during, and after 

collection; 

(4) Ensure that only the collector and 

the donor are allowed to handle the 

unsealed specimen; 

(5) Ensure the chain of custody 

process is maintained and documented 

throughout the entire collection, storage, 

and transport procedures; 

(6) Ensure that the Federal CCF is 

completed and distributed as required; 

and 

(7) Ensure that specimens transported 

to an HHS-certified laboratory are sealed 

and placed in transport containers 

designed to minimize the possibility of 

damage during shipment (e.g., specimen 

boxes, padded mailers, or other suitable 

shipping container), and those 

containers are securely sealed to 

eliminate the possibility of undetected 

tampering. 

(b) Couriers, express carriers, and 

postal service personnel are not 

57584 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

required to document chain of custody 

since specimens are sealed in packages 

that would indicate tampering during 

transit to the HHS-certified laboratory. 

Section 5.6 What are the privacy 

requirements when collecting an oral 

fluid specimen? 

Collections must be performed at a 

site that provides reasonable privacy (as 

described in Section 8.1). 

Subpart F—Federal Drug Testing 

Custody and Control Form 

Section 6.1 What federal form is used 

to document custody and control? 

The OMB-approved Federal CCF must 

be used to document custody and 

control of each specimen at the 

collection site. 

Section 6.2 What happens if the 

correct OMB-approved Federal CCF is 

not available or is not used? 

(a) The use of a non-federal CCF or an 

expired Federal CCF is not, by itself, a 

reason for the HHS-certified laboratory 

to automatically reject the specimen for 

testing or for the MRO to cancel the test. 

(b) If the collector does not use the 

correct OMB-approved Federal CCF, the 

collector must document that it is a 

federal agency specimen collection and 

provide the reason that the incorrect 

form was used. Based on the 

documentation provided by the 

collector, the HHS-certified laboratory 

must handle and test the specimen as a 

federal agency specimen. 

(c) If the HHS-certified laboratory or 

MRO discovers that the collector used 

an incorrect form, the laboratory or 

MRO must obtain a memorandum for 

the record from the collector describing 

the reason the incorrect form was used. 

If a memorandum for the record cannot 

be obtained, the laboratory reports a 

rejected for testing result to the MRO 

and the MRO cancels the test. The HHScertified laboratory must wait at least 5 

business days while attempting to 

obtain the memorandum before 

reporting a rejected for testing result to 

the MRO. 

Subpart G—Oral Fluid Specimen 

Collection Devices 

Section 7.1 What is used to collect an 

oral fluid specimen? 

An FDA-cleared single-use collection 

device intended to collect an oral fluid 

specimen must be used. This collection 

device must maintain the integrity of 

such specimens during storage and 

transport so that the specimen 

contained therein can be tested in an 

HHS-certified laboratory for the 

presence of drugs or their metabolites. 

Section 7.2 What are the requirements 

for an oral fluid collection device? 

An oral fluid specimen collection 

device must provide: 

(a) An indicator that demonstrates the 

adequacy of the volume of oral fluid 

specimen collected; 

(b) A sealable, non-leaking container 

that maintains the integrity of the 

specimen during storage and transport 

so that the specimen contained therein 

can be tested in an HHS-certified 

laboratory for the presence of drugs or 

their metabolites; 

(c) Components that ensure preanalytical drug and drug metabolite 

stability; and 

(d) Components that do not 

substantially affect the composition of 

drugs and/or drug metabolites in the 

oral fluid specimen. 

Section 7.3 What are the minimum 

performance requirements for a 

collection device? 

An oral fluid collection device must 

meet the following minimum 

performance requirements. 

(a) Reliable collection of a minimum 

of 1 mL of undiluted (neat) oral fluid; 

(b) If the collection device contains a 

diluent (or other component, process, or 

method that modifies the volume of the 

testable specimen): 

(1) The volume of oral fluid collected 

should be at least 1.0 mL ±10 percent, 

and 

(2) The volume of diluent in the 

device should be within ±2.5 percent of 

the diluent target volume; 

(c) Stability (recoverable 

concentrations ≥80 percent of the 

concentration at the time of collection) 

of the drugs and/or drug metabolites for 

five days at room temperature (64–77 °F/ 

18–25 °C) and under the manufacturer’s 

intended shipping and storage 

conditions; and 

(d) Recover ≥80 percent (but no more 

than 120 percent) of drug and/or drug 

metabolite in the undiluted (neat) oral 

fluid at (or near) the initial test cutoff 

(see Section 3.4). 

Subpart H—Oral Fluid Specimen 

Collection Procedure 

Section 8.1 What privacy must the 

donor be given when providing an oral 

fluid specimen? 

The following privacy requirements 

apply when a donor is providing an oral 

fluid specimen: 

(a) Only authorized personnel and the 

donor may be present in the restricted 

access area where the collection takes 

place. 

(b) The collector is not required to be 

the same gender as the donor. 

Section 8.2 What must the collector 

ensure at the collection site before 

starting an oral fluid specimen 

collection? 

The collector must deter the 

adulteration or substitution of an oral 

fluid specimen at the collection site. 

Section 8.3 What are the preliminary 

steps in the oral fluid specimen 

collection procedure? 

The collector must take the following 

steps before beginning an oral fluid 

specimen collection: 

(a) If a donor fails to arrive at the 

collection site at the assigned time, the 

collector must follow the federal agency 

policy or contact the federal agency 

representative to obtain guidance on 

action to be taken. 

(b) When the donor arrives at the 

collection site, the collector should 

begin the collection procedure without 

undue delay. For example, the 

collection should not be delayed 

because an authorized employer or 

employer representative is late in 

arriving. 

(c) The collector requests the donor to 

present photo identification (e.g., 

driver’s license; employee badge issued 

by the employer; an alternative photo 

identification issued by a federal, state, 

or local government agency). If the 

donor does not have proper photo 

identification, the collector shall contact 

the supervisor of the donor or the 

federal agency representative who can 

positively identify the donor. If the 

donor’s identity cannot be established, 

the collector must not proceed with the 

collection. 

(d) The collector requests that the 

donor open the donor’s mouth, and the 

collector inspects the oral cavity to 

ensure that it is free of any items that 

could impede or interfere with the 

collection of an oral fluid specimen 

(e.g., candy, gum, food, tobacco) or 

could be used to adulterate, substitute, 

or dilute the specimen. If an item is 

present that appears to have been 

brought to the collection site with the 

intent to adulterate, substitute, or dilute 

the specimen, this is considered a 

refusal to test. The collector must stop 

the collection and report the refusal to 

test as described in Section 8.9. 

(1) At this time, the collector starts the 

10-minute wait period and proceeds 

with the steps below before beginning 

the specimen collection as described in 

Section 8.5. 

(2) If the collector’s inspection of the 

donor’s oral cavity reveals any items 

that could impede or interfere with the 

collection of an oral fluid specimen 

(including abnormally colored saliva), 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57585 

or the donor claims to have ‘‘dry 

mouth,’’ the collector gives the donor 

water (e.g., up to 4 oz.) to rinse their 

mouth. The donor may drink the water. 

The collector must then wait 10 minutes 

before beginning the specimen 

collection. If the donor refuses to 

remove the item or refuses to rinse, this 

is a refusal to test. 

(3) If the donor claims that they have 

a medical condition that prevents 

opening their mouth for inspection, the 

collector follows the procedure in 

Section 8.6(b)(2). 

(e) The collector must provide 

identification (e.g., employee badge, 

employee list) if requested by the donor. 

(f) The collector explains the basic 

collection procedure to the donor. 

(g) The collector informs the donor 

that the instructions for completing the 

Federal Custody and Control Form are 

located on the back of the Federal CCF 

or available upon request. 

(h) The collector answers any 

reasonable and appropriate questions 

the donor may have regarding the 

collection procedure. 

Section 8.4 What steps does the 

collector take in the collection 

procedure before the donor provides an 

oral fluid specimen? 

(a) The collector will provide or the 

donor may select a specimen collection 

device that is clean, unused, and 

wrapped/sealed in original packaging. 

The specimen collection device will be 

opened in view of the donor. 

(1) Both the donor and the collector 

must keep the unwrapped collection 

devices in view at all times until each 

collection device containing the donor’s 

oral fluid specimen has been sealed and 

labeled. 

(b) The collector reviews with the 

donor the procedures required for a 

successful oral fluid specimen 

collection as stated in the 

manufacturer’s instructions for the 

specimen collection device. 

(c) The collector notes any unusual 

behavior or appearance of the donor on 

the Federal CCF. If the collector detects 

any conduct that clearly indicates an 

attempt to tamper with a specimen (e.g., 

an attempt to bring into the collection 

site an adulterant or oral fluid 

substitute), the collector must report a 

refusal to test in accordance with 

Section 8.9. 

Section 8.5 What steps does the 

collector take during and after the oral 

fluid specimen collection procedure? 

Integrity and Identity of the 

Specimen. The collector must take the 

following steps during and after the 

donor provides the oral fluid specimen: 

(a) The collector shall be present and 

maintain visual contact with the donor 

during the procedures outlined in this 

section. 

(1) Under the observation of the 

collector, the donor is responsible for 

positioning the specimen collection 

device for collection. The collector must 

ensure the collection is performed 

correctly and that the collection device 

is working properly. If there is a failure 

to collect the specimen, the collector 

must begin the process again, beginning 

with Step 8.4(b), using a new specimen 

collection device (for both A and B 

specimens) and notes the failed 

collection attempt on the Federal CCF. 

If the donor states that they are unable 

to provide an oral fluid specimen during 

the collection process or after multiple 

failures to collect the specimen, the 

collector follows the procedure in 

Section 8.6. 

(2) The donor and collector must 

complete the collection in accordance 

with the manufacturer instructions for 

the collection device. 

(b) If the donor fails to remain present 

through the completion of the 

collection, fails to follow the 

instructions for the collection device, 

refuses to begin the collection process 

after a failure to collect the specimen as 

required in step (a)(1) above, refuses to 

provide a split specimen as instructed 

by the collector, or refuses to provide an 

alternate specimen as authorized in 

Section 8.6, the collector stops the 

collection and reports the refusal to test 

in accordance with Section 8.9. 

Section 8.6 What procedure is used 

when the donor states that they are 

unable to provide an oral fluid 

specimen? 

(a) If the donor states that they are 

unable to provide an oral fluid 

specimen during the collection process, 

the collector requests that the donor 

follow the collector instructions and 

attempt to provide an oral fluid 

specimen. 

(b) The donor demonstrates their 

inability to provide a specimen when, 

after 15 minutes of using the collection 

device, there is insufficient volume or 

no oral fluid collected using the device. 

(1) If the donor states that they could 

provide a specimen after drinking some 

fluids, the collector gives the donor a 

drink (up to 8 ounces) and waits an 

additional 10 minutes before beginning 

the specimen collection (a period of 1 

hour must be provided or until the 

donor has provided a sufficient oral 

fluid specimen). If the donor simply 

needs more time before attempting to 

provide an oral fluid specimen, the 

donor is not required to drink any fluids 

during the 1 hour wait time. The 

collector must inform the donor that the 

donor must remain at the collection site 

(i.e., in an area designated by the 

collector) during the wait period. 

(2) If the donor states that they are 

unable to provide an oral fluid 

specimen, the collector records the 

reason for not collecting an oral fluid 

specimen on the Federal CCF, notifies 

the federal agency’s designated 

representative for authorization of an 

alternate specimen to be collected, and 

sends the appropriate copies of the 

Federal CCF to the MRO and to the 

federal agency’s designated 

representative. The federal agency may 

choose to provide the collection site 

with a standard protocol to follow in 

lieu of requiring the collector to notify 

the agency’s designated representative 

for authorization in each case. If an 

alternate specimen is authorized, the 

collector may begin the collection 

procedure for the alternate specimen 

(see Section 8.7) in accordance with the 

Mandatory Guidelines for Federal 

Workplace Drug Testing Programs using 

the alternative specimen. 

Section 8.7 If the donor is unable to 

provide an oral fluid specimen, may 

another specimen type be collected for 

testing? 

Yes, if the alternate specimen type is 

authorized by Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs and specifically authorized by 

the federal agency. 

Section 8.8 How does the collector 

prepare the oral fluid specimens? 

(a) All federal agency collections are 

to be split specimen collections. 

An oral fluid split specimen 

collection may be: 

(1) Two specimens collected 

simultaneously with two separate 

collection devices; 

(2) Two specimens collected serially 

with two separate collection devices. 

The donor is not allowed to drink or 

rinse their mouth between the two 

collections. Collection of the second 

specimen must begin within two 

minutes after the completion of the first 

collection and recorded on the Federal 

CCF; 

(3) Two specimens collected 

simultaneously using a single collection 

device that directs the oral fluid into 

two separate collection tubes; or 

(4) A single specimen collected using 

a single collection device, that is 

subsequently subdivided into two 

specimens. 

(b) A volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

57586 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

A’’ and a volume of at least 1 mL of 

undiluted (neat) oral fluid is collected 

for the specimen designated as ‘‘Tube 

B’’. 

(c) In the presence of the donor, the 

collector places a tamper-evident label/ 

seal from the Federal CCF over the cap 

of each specimen tube. The collector 

records the date of the collection on the 

tamper-evident labels/seals. 

(d) The collector instructs the donor 

to initial the tamper-evident labels/seals 

on each specimen tube. If the donor 

refuses to initial the labels/seals, the 

collector notes the refusal on the 

Federal CCF and continues with the 

collection process. 

(e) The collector must ensure that all 

the information required on the Federal 

CCF is provided. 

(f) The collector asks the donor to 

read and sign a statement on the Federal 

CCF certifying that the specimens 

identified were collected from the 

donor. If the donor refuses to sign the 

certification statement, the collector 

notes the refusal on the Federal CCF and 

continues with the collection process. 

(g) The collector signs and prints their 

name on the Federal CCF, completes the 

Federal CCF, and distributes the copies 

of the Federal CCF as required. 

(h) The collector seals the specimens 

(Tube A and Tube B) in a package and, 

within 24 hours or during the next 

business day, sends them to the HHScertified laboratory that will be testing 

the Tube A oral fluid specimen. 

(i) If the specimen and Federal CCF 

are not immediately transported to an 

HHS-certified laboratory, they must 

remain under direct control of the 

collector or be appropriately secured 

under proper specimen storage 

conditions until transported. 

Section 8.9 How does the collector 

report a donor’s refusal to test? 

If there is a refusal to test as defined 

in Section 1.7, the collector stops the 

collection, discards any oral fluid 

specimen collected and reports the 

refusal to test by: 

(a) Notifying the federal agency by 

means (e.g., telephone, email, or secure 

fax) that ensures that the notification is 

immediately received, 

(b) Documenting the refusal to test on 

the Federal CCF, and 

(c) Sending all copies of the Federal 

CCF to the federal agency’s designated 

representative. 

Section 8.10 What are a federal 

agency’s responsibilities for a collection 

site? 

(a) A federal agency must ensure that 

collectors and collection sites satisfy all 

requirements in subparts D, E, F, G, and 

H. 

(b) A federal agency (or only one 

federal agency when several agencies 

are using the same collection site) must 

inspect 5 percent or up to a maximum 

of 50 collection sites each year, selected 

randomly from those sites used to 

collect agency specimens (e.g., virtual, 

onsite, or self-evaluation). 

(c) A federal agency must investigate 

reported collection site deficiencies 

(e.g., specimens reported ‘‘rejected for 

testing’’ by an HHS-certified laboratory) 

and take appropriate action which may 

include a collection site self-assessment 

(i.e., using the Collection Site Checklist 

for the Collection of Oral Fluid 

Specimens for Federal Agency 

Workplace Drug Testing Programs) or an 

inspection of the collection site. The 

inspections of these additional 

collection sites may be included in the 

5 percent or maximum of 50 collection 

sites inspected annually. 

Subpart I—HHS Certification of 

Laboratories 

Section 9.1 Who has the authority to 

certify laboratories to test oral fluid 

specimens for federal agencies? 

(a) The Secretary has broad discretion 

to take appropriate action to ensure the 

full reliability and accuracy of drug 

testing and reporting, to resolve 

problems related to drug testing, and to 

enforce all standards set forth in these 

Guidelines. The Secretary has the 

authority to issue directives to any HHScertified laboratory, including 

suspending the use of certain analytical 

procedures when necessary to protect 

the integrity of the testing process; 

ordering any HHS-certified laboratory to 

undertake corrective actions to respond 

to material deficiencies identified by an 

inspection or through performance 

testing; ordering any HHS-certified 

laboratory to send specimens or 

specimen aliquots to another HHScertified laboratory for retesting when 

necessary to ensure the accuracy of 

testing under these Guidelines; ordering 

the review of results for specimens 

tested under the Guidelines for private 

sector clients to the extent necessary to 

ensure the full reliability of drug testing 

for federal agencies; and ordering any 

other action necessary to address 

deficiencies in drug testing, analysis, 

specimen collection, chain of custody, 

reporting of results, or any other aspect 

of the certification program. 

(b) A laboratory is prohibited from 

stating or implying that it is certified by 

HHS under these Guidelines to test oral 

fluid specimens for federal agencies 

unless it holds such certification. 

Section 9.2 What is the process for a 

laboratory to become HHS-certified? 

(a) A laboratory seeking HHS 

certification must: 

(1) Submit a completed OMBapproved application form (i.e., the 

applicant laboratory provides detailed 

information on both the administrative 

and analytical procedures to be used for 

federally regulated specimens); 

(2) Have its application reviewed as 

complete and accepted by HHS; 

(3) Successfully complete the PT 

challenges in 3 consecutive sets of 

initial PT samples; 

(4) Satisfy all the requirements for an 

initial inspection; and 

(5) Receive notification of certification 

from the Secretary before testing 

specimens for federal agencies. 

Section 9.3 What is the process for a 

laboratory to maintain HHS 

certification? 

(a) To maintain HHS certification, a 

laboratory must: 

(1) Successfully participate in both 

the maintenance PT and inspection 

programs (i.e., successfully test the 

required quarterly sets of maintenance 

PT samples, undergo an inspection 3 

months after being certified, and 

undergo maintenance inspections at a 

minimum of every 6 months thereafter); 

(2) Respond in an appropriate, timely, 

and complete manner to required 

corrective action requests if deficiencies 

are identified in the maintenance PT 

performance, during the inspections, 

operations, or reporting; and 

(3) Satisfactorily complete corrective 

remedial actions, and undergo special 

inspection and special PT sets to 

maintain or restore certification when 

material deficiencies occur in either the 

PT program, inspection program, or in 

operations and reporting. 

Section 9.4 What is the process when 

a laboratory does not maintain its HHS 

certification? 

(a) A laboratory that does not 

maintain its HHS certification must: 

(1) Stop testing federally regulated 

specimens; 

(2) Ensure the security of federally 

regulated specimens and records 

throughout the required storage period 

described in Sections 11.18, 11.19, and 

14.7; 

(3) Ensure access to federally 

regulated specimens and records in 

accordance with Sections 11.21 and 

11.22 and Subpart P; and 

(4) Follow the HHS suspension and 

revocation procedures when imposed by 

the Secretary, follow the HHS 

procedures in Subpart P that will be 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57587 

used for all actions associated with the 

suspension and/or revocation of HHScertification. 

Section 9.5 What are the qualitative 

and quantitative specifications of 

performance testing (PT) samples? 

(a) PT samples used to evaluate drug 

tests will be prepared using the 

following specifications: 

(1) PT samples may contain one or 

more of the drugs and drug metabolites 

in the drug classes listed in Section 3.4 

and may be sent to the laboratory as 

undiluted (neat) oral fluid. The PT 

samples must satisfy one of the 

following parameters: 

(i) The concentration of a drug or 

metabolite will be at least 20 percent 

above the initial test cutoff 

concentration for the drug or drug 

metabolite; 

(ii) The concentration of a drug or 

metabolite may be as low as 40 percent 

of the confirmatory test cutoff 

concentration when the PT sample is 

designated as a retest sample; or 

(iii) The concentration of drug or 

metabolite may differ from 9.5(a)(1)(i) 

and 9.5(a)(1)(ii) for a special purpose. 

(2) A PT sample may contain an 

interfering substance or other 

substances for special purposes. 

(3) A negative PT sample will not 

contain a measurable amount of a target 

analyte. 

(b) The laboratory must (to the 

greatest extent possible) handle, test, 

and report a PT sample in a manner 

identical to that used for a donor 

specimen, unless otherwise specified. 

Section 9.6 What are the PT 

requirements for an applicant 

laboratory? 

(a) An applicant laboratory that seeks 

certification under these Guidelines 

must satisfy the following criteria on 

three consecutive sets of PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over the three sets of PT 

samples; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over the three sets of PT 

samples; 

(4) For the confirmatory drug tests, 

correctly determine the concentrations 

[i.e., no more than ±20 percent or ±2 

standard deviations (whichever is 

larger) from the appropriate reference or 

peer group means] for at least 80 percent 

of the total drug challenges over the 

three sets of PT samples; 

(5) For the confirmatory drug tests, 

must not obtain any drug concentration 

that differs by more than ±50 percent 

from the appropriate reference or peer 

group mean; 

(6) For each confirmatory drug test, 

correctly identify and determine the 

concentrations [i.e., no more than ±20 

percent or ±2 standard deviations 

(whichever is larger) from the 

appropriate reference or peer group 

means] for at least 50 percent of the 

drug challenges for an individual drug 

over the three sets of PT samples; 

(b) Failure to satisfy these 

requirements will result in 

disqualification. 

Section 9.7 What are the PT 

requirements for an HHS-certified oral 

fluid laboratory? 

(a) A laboratory certified under these 

Guidelines must satisfy the following 

criteria on the maintenance PT samples: 

(1) Have no false positive results; 

(2) Correctly identify, confirm, and 

report at least 90 percent of the total 

drug challenges over two consecutive 

PT cycles; 

(3) Correctly identify at least 80 

percent of the drug challenges for each 

initial drug test over two consecutive PT 

cycles; 

(4) For the confirmatory drug tests, 

correctly determine that the 

concentrations for at least 80 percent of 

the total drug challenges are no more 

than ±20 percent or ±2 standard 

deviations (whichever is larger) from the 

appropriate reference or peer group 

means over two consecutive PT cycles; 

(5) For the confirmatory drug tests, 

obtain no more than one drug 

concentration on a PT sample that 

differs by more than ±50 percent from 

the appropriate reference or peer group 

mean over two consecutive PT cycles; 

(6) For each confirmatory drug test, 

correctly identify and determine that the 

concentrations for at least 50 percent of 

the drug challenges for an individual 

drug are no more than ±20 percent or ±2 

standard deviations (whichever is 

larger) from the appropriate reference or 

peer group means over two consecutive 

PT cycles; 

(b) Failure to participate in all PT 

cycles or to satisfy these requirements 

may result in suspension or revocation 

of an HHS-certified laboratory’s 

certification. 

Section 9.8 What are the inspection 

requirements for an applicant 

laboratory? 

(a) An applicant laboratory is 

inspected by a team of two inspectors. 

(b) Each inspector conducts an 

independent review and evaluation of 

all aspects of the laboratory’s testing 

procedures and facilities using an 

inspection checklist. 

Section 9.9 What are the maintenance 

inspection requirements for an HHScertified laboratory? 

(a) An HHS-certified laboratory must 

undergo an inspection 3 months after 

becoming certified and at least every 6 

months thereafter. 

(b) An HHS-certified laboratory is 

inspected by one or more inspectors. 

The number of inspectors is determined 

according to the number of specimens 

reviewed. Additional information 

regarding inspections is available from 

SAMHSA. 

(c) Each inspector conducts an 

independent evaluation and review of 

the HHS-certified laboratory’s 

procedures, records, and facilities using 

guidance provided by the Secretary. 

(d) To remain certified, an HHScertified laboratory must continue to 

satisfy the minimum requirements as 

stated in these Guidelines. 

Section 9.10 Who can inspect an HHScertified laboratory and when may the 

inspection be conducted? 

(a) An individual may be selected as 

an inspector for the Secretary if they 

satisfy the following criteria: 

(1) Has experience and an educational 

background similar to that required for 

either a responsible person or a 

certifying scientist for an HHS-certified 

laboratory as described in Subpart K; 

(2) Has read and thoroughly 

understands the policies and 

requirements contained in these 

Guidelines and in other guidance 

consistent with these Guidelines 

provided by the Secretary; 

(3) Submits a resume and 

documentation of qualifications to HHS; 

(4) Attends approved training; and 

(5) Performs acceptably as an 

inspector on an inspection of an HHScertified laboratory. 

(b) The Secretary or a federal agency 

may conduct an inspection at any time. 

Section 9.11 What happens if an 

applicant laboratory does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

If an applicant laboratory fails to 

satisfy the requirements established for 

the initial certification process, the 

laboratory must start the certification 

process from the beginning. 

Section 9.12 What happens if an HHScertified laboratory does not satisfy the 

minimum requirements for either the PT 

program or the inspection program? 

(a) If an HHS-certified laboratory fails 

to satisfy the minimum requirements for 

certification, the laboratory is given a 

period of time (e.g., 5 or 30 working 

days depending on the nature of the 

57588 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

deficiency) to provide any explanation 

for its performance and evidence that all 

deficiencies have been corrected. 

(b) A laboratory’s HHS certification 

may be revoked, suspended, or no 

further action taken depending on the 

seriousness of the deficiencies and 

whether there is evidence that the 

deficiencies have been corrected and 

that current performance meets the 

requirements for certification. 

(c) An HHS-certified laboratory may 

be required to undergo a special 

inspection or to test additional PT 

samples to address deficiencies. 

(d) If an HHS-certified laboratory’s 

certification is revoked or suspended in 

accordance with the process described 

in Subpart P, the laboratory is not 

permitted to test federally regulated 

specimens until the suspension is lifted 

or the laboratory has successfully 

completed the certification 

requirements as a new applicant 

laboratory. 

Section 9.13 What factors are 

considered in determining whether 

revocation of a laboratory’s HHS 

certification is necessary? 

(a) The Secretary shall revoke 

certification of an HHS-certified 

laboratory in accordance with these 

Guidelines if the Secretary determines 

that revocation is necessary to ensure 

fully reliable and accurate drug test 

results and reports. 

(b) The Secretary shall consider the 

following factors in determining 

whether revocation is necessary: 

(1) Unsatisfactory performance in 

analyzing and reporting the results of 

drug tests (e.g., an HHS-certified 

laboratory reporting a false positive 

result for an employee’s drug test); 

(2) Unsatisfactory participation in 

performance testing or inspections; 

(3) A material violation of a 

certification standard, contract term, or 

other condition imposed on the HHScertified laboratory by a federal agency 

using the laboratory’s services; 

(4) Conviction for any criminal 

offense committed as an incident to 

operation of the HHS-certified 

laboratory; or 

(5) Any other cause that materially 

affects the ability of the HHS-certified 

laboratory to ensure fully reliable and 

accurate drug test results and reports. 

(c) The period and terms of revocation 

shall be determined by the Secretary 

and shall depend upon the facts and 

circumstances of the revocation and the 

need to ensure accurate and reliable 

drug testing. 

Section 9.14 What factors are 

considered in determining whether to 

suspend a laboratory’s HHS 

certification? 

(a) The Secretary may immediately 

suspend (either partially or fully) a 

laboratory’s HHS certification to 

conduct drug testing for federal agencies 

if the Secretary has reason to believe 

that revocation may be required and that 

immediate action is necessary to protect 

the interests of the United States and its 

employees. 

(b) The Secretary shall determine the 

period and terms of suspension based 

upon the facts and circumstances of the 

suspension and the need to ensure 

accurate and reliable drug testing. 

Section 9.15 How does the Secretary 

notify an HHS-certified laboratory that 

action is being taken against the 

laboratory? 

(a) When a laboratory’s HHS 

certification is suspended or the 

Secretary seeks to revoke HHS 

certification, the Secretary shall 

immediately serve the HHS-certified 

laboratory with written notice of the 

suspension or proposed revocation by 

facsimile, mail, personal service, or 

registered or certified mail, return 

receipt requested. This notice shall state 

the following: 

(1) The reasons for the suspension or 

proposed revocation; 

(2) The terms of the suspension or 

proposed revocation; and 

(3) The period of suspension or 

proposed revocation. 

(b) The written notice shall state that 

the laboratory will be afforded an 

opportunity for an informal review of 

the suspension or proposed revocation 

if it so requests in writing within 30 

days of the date the laboratory received 

the notice, or if expedited review is 

requested, within 3 days of the date the 

laboratory received the notice. Subpart 

P contains detailed procedures to be 

followed for an informal review of the 

suspension or proposed revocation. 

(c) A suspension must be effective 

immediately. A proposed revocation 

must be effective 30 days after written 

notice is given or, if review is requested, 

upon the reviewing official’s decision to 

uphold the proposed revocation. If the 

reviewing official decides not to uphold 

the suspension or proposed revocation, 

the suspension must terminate 

immediately and any proposed 

revocation shall not take effect. 

(d) The Secretary will publish in the 

Federal Register the name, address, and 

telephone number of any HHS-certified 

laboratory that has its certification 

revoked or suspended under Section 

9.13 or Section 9.14, respectively, and 

the name of any HHS-certified 

laboratory that has its suspension lifted. 

The Secretary shall provide to any 

member of the public upon request the 

written notice provided to a laboratory 

that has its HHS certification suspended 

or revoked, as well as the reviewing 

official’s written decision which 

upholds or denies the suspension or 

proposed revocation under the 

procedures of Subpart P. 

Section 9.16 May a laboratory that had 

its HHS certification revoked be 

recertified to test federal agency 

specimens? 

Following revocation, a laboratory 

may apply for recertification. Unless 

otherwise provided by the Secretary in 

the notice of revocation under Section 

9.15 or the reviewing official’s decision 

under Section 16.9(e) or 16.14(a), a 

laboratory which has had its 

certification revoked may reapply for 

HHS certification as an applicant 

laboratory. 

Section 9.17 Where is the list of HHScertified laboratories published? 

(a) The list of HHS-certified 

laboratories is published monthly in the 

Federal Register. This notice is also 

available on the internet at http:// 

www.samhsa.gov/workplace. 

(b) An applicant laboratory is not 

included on the list. 

Subpart J—Blind Samples Submitted by 

an Agency 

Section 10.1 What are the 

requirements for federal agencies to 

submit blind samples to HHS-certified 

laboratories? 

(a) Each federal agency is required to 

submit blind samples for its workplace 

drug testing program. The collector 

must send the blind samples to the 

HHS-certified laboratory that the 

collector sends employee specimens. 

(b) Each federal agency must submit 

at least 3 percent blind samples along 

with its donor specimens based on the 

projected total number of donor 

specimens collected per year (up to a 

maximum of 400 blind samples). Every 

effort should be made to ensure that 

blind samples are submitted quarterly. 

(c) Approximately 75 percent of the 

blind samples submitted each year by 

an agency must be negative and 25 

percent must be positive for one or more 

drugs. 

Section 10.2 What are the 

requirements for blind samples? 

(a) Drug positive blind samples must 

be validated by the supplier in the 

selected manufacturer’s collection 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57589 

device as to their content using 

appropriate initial and confirmatory 

tests. 

(1) Drug positive blind samples must 

be fortified with one or more of the 

drugs or metabolites listed in Section 

3.4. 

(2) Drug positive blind samples must 

contain concentrations of drugs between 

1.5 and 2 times the initial drug test 

cutoff concentration. 

(b) Drug negative blind samples (i.e., 

certified to contain no drugs) must be 

validated by the supplier in the selected 

manufacturer’s collection device as 

negative using appropriate initial and 

confirmatory tests. 

(c) The supplier must provide 

information on the blind samples’ 

content, validation, expected results, 

and stability to the collection site/ 

collector sending the blind samples to 

the laboratory, and must provide the 

information upon request to the MRO, 

the federal agency for which the blind 

sample was submitted, or the Secretary. 

Section 10.3 How is a blind sample 

submitted to an HHS-certified 

laboratory? 

(a) A blind sample must be submitted 

as a split specimen (specimens A and B) 

with the current Federal CCF that the 

HHS-certified laboratory uses for donor 

specimens. The collector provides the 

required information to ensure that the 

Federal CCF has been properly 

completed and provides fictitious 

initials on the specimen label/seal. The 

collector must indicate that the 

specimen is a blind sample on the MRO 

copy where a donor would normally 

provide a signature. 

(b) A collector should attempt to 

distribute the required number of blind 

samples randomly with donor 

specimens rather than submitting the 

full complement of blind samples as a 

single group. 

Section 10.4 What happens if an 

inconsistent result is reported for a 

blind sample? 

If an HHS-certified laboratory reports 

a result for a blind sample that is 

inconsistent with the expected result 

(e.g., a laboratory reports a negative 

result for a blind sample that was 

supposed to be positive, a laboratory 

reports a positive result for a blind 

sample that was supposed to be 

negative): 

(a) The MRO must contact the 

laboratory and attempt to determine if 

the laboratory made an error during the 

testing or reporting of the sample; 

(b) The MRO must contact the blind 

sample supplier and attempt to 

determine if the supplier made an error 

during the preparation or transfer of the 

sample; 

(c) The MRO must contact the 

collector and determine if the collector 

made an error when preparing the blind 

sample for transfer to the HHS-certified 

laboratory; 

(d) If there is no obvious reason for 

the inconsistent result, the MRO must 

notify both the federal agency for which 

the blind sample was submitted and the 

Secretary; and 

(e) The Secretary shall investigate the 

blind sample error. A report of the 

Secretary’s investigative findings and 

the corrective action taken in response 

to identified deficiencies must be sent to 

the federal agency. The Secretary shall 

ensure notification of the finding as 

appropriate to other federal agencies 

and coordinate any necessary actions to 

prevent the recurrence of the error. 

Subpart K—Laboratory 

Section 11.1 What must be included in 

the HHS-certified laboratory’s standard 

operating procedure manual? 

(a) An HHS-certified laboratory must 

have a standard operating procedure 

(SOP) manual that describes, in detail, 

all HHS-certified laboratory operations. 

When followed, the SOP manual 

ensures that all specimens are tested 

using the same procedures. 

(b) The SOP manual must include at 

a minimum, but is not limited to, a 

detailed description of the following: 

(1) Chain of custody procedures; 

(2) Accessioning; 

(3) Security; 

(4) Quality control/quality assurance 

programs; 

(5) Analytical methods and 

procedures; 

(6) Equipment and maintenance 

programs; 

(7) Personnel training; 

(8) Reporting procedures; and 

(9) Computers, software, and 

laboratory information management 

systems. 

(c) All procedures in the SOP manual 

must be compliant with these 

Guidelines and all guidance provided 

by the Secretary. 

(d) A copy of all procedures that have 

been replaced or revised and the dates 

on which the procedures were in effect 

must be maintained for at least 2 years. 

Section 11.2 What are the 

responsibilities of the responsible 

person (RP)? 

(a) Manage the day-to-day operations 

of the HHS-certified laboratory even if 

another individual has overall 

responsibility for alternate areas of a 

multi-specialty laboratory. 

(b) Ensure that there are sufficient 

personnel with adequate training and 

experience to supervise and conduct the 

work of the HHS-certified laboratory. 

The RP must ensure the continued 

competency of laboratory staff by 

documenting their in-service training, 

reviewing their work performance, and 

verifying their skills. 

(c) Maintain a complete and current 

SOP manual that is available to all 

personnel of the HHS-certified 

laboratory and ensure that it is followed. 

The SOP manual must be reviewed, 

signed, and dated by the RP(s) when 

procedures are first placed into use and 

when changed or when a new 

individual assumes responsibility for 

the management of the HHS-certified 

laboratory. The SOP must be reviewed 

and documented by the RP annually. 

(d) Maintain a quality assurance 

program that ensures the proper 

performance and reporting of all test 

results; verify and monitor acceptable 

analytical performance for all controls 

and calibrators; monitor quality control 

testing; and document the validity, 

reliability, accuracy, precision, and 

performance characteristics of each test 

and test system. 

(e) Initiate and implement all 

remedial actions necessary to maintain 

satisfactory operation and performance 

of the HHS-certified laboratory in 

response to the following: Quality 

control systems not within performance 

specifications; errors in result reporting 

or in analysis of performance testing 

samples; and inspection deficiencies. 

The RP must ensure that specimen 

results are not reported until all 

corrective actions have been taken and 

that the results provided are accurate 

and reliable. 

Section 11.3 What scientific 

qualifications must the RP have? 

The RP must have documented 

scientific qualifications in analytical 

toxicology. 

Minimum qualifications are: 

(a) Certification or licensure as a 

laboratory director by the state in 

forensic or clinical laboratory 

toxicology, a Ph.D. in one of the natural 

sciences, or training and experience 

comparable to a Ph.D. in one of the 

natural sciences with training and 

laboratory/research experience in 

biology, chemistry, and pharmacology 

or toxicology; 

(b) Experience in forensic toxicology 

with emphasis on the collection and 

analysis of biological specimens for 

drugs of abuse; 

(c) Experience in forensic applications 

of analytical toxicology (e.g., 

publications, court testimony, 

57590 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

conducting research on the 

pharmacology and toxicology of drugs 

of abuse) or qualify as an expert witness 

in forensic toxicology; 

(d) Fulfillment of the RP 

responsibilities and qualifications, as 

demonstrated by the HHS-certified 

laboratory’s performance and verified 

upon interview by HHS-trained 

inspectors during each on-site 

inspection; and 

(e) Qualify as a certifying scientist. 

Section 11.4 What happens when the 

RP is absent or leaves an HHS-certified 

laboratory? 

(a) HHS-certified laboratories must 

have multiple RPs or one RP and an 

alternate RP. If the RP(s) are 

concurrently absent, an alternate RP 

must be present and qualified to fulfill 

the responsibilities of the RP. 

(1) If an HHS-certified laboratory is 

without the RP and alternate RP for 14 

calendar days or less (e.g., temporary 

absence due to vacation, illness, or 

business trip), the HHS-certified 

laboratory may continue operations and 

testing of federal agency specimens 

under the direction of a certifying 

scientist. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

specimens if the laboratory does not 

have an RP or alternate RP for a period 

of more than 14 calendar days. The 

suspension will be lifted upon the 

Secretary’s approval of a new 

permanent RP or alternate RP. 

(b) If the RP leaves an HHS-certified 

laboratory: 

(1) The HHS-certified laboratory may 

maintain certification and continue 

testing federally regulated specimens 

under the direction of an alternate RP 

for a period of up to 180 days while 

seeking to hire and receive the 

Secretary’s approval of the RP’s 

replacement. 

(2) The Secretary, in accordance with 

these Guidelines, will suspend a 

laboratory’s HHS certification for all 

federally regulated specimens if the 

laboratory does not have a permanent 

RP within 180 days. The suspension 

will be lifted upon the Secretary’s 

approval of the new permanent RP. 

(c) To nominate an individual as an 

RP or alternate RP, the HHS-certified 

laboratory must submit the following 

documents to the Secretary: The 

candidate’s current resume or 

curriculum vitae, copies of diplomas 

and licensures, a training plan (not to 

exceed 90 days) to transition the 

candidate into the position, an itemized 

comparison of the candidate’s 

qualifications to the minimum RP 

qualifications described in the 

Guidelines, and have official academic 

transcript(s) submitted from the 

candidate’s institution(s) of higher 

learning. The candidate must be found 

qualified during an on-site inspection of 

the HHS-certified laboratory. 

(d) The HHS-certified laboratory must 

fulfill additional inspection and PT 

criteria as required prior to conducting 

federally regulated testing under a new 

RP. 

Section 11.5 What qualifications must 

an individual have to certify a result 

reported by an HHS-certified 

laboratory? 

(a) A certifying scientist must have: 

(1) At least a bachelor’s degree in the 

chemical or biological sciences or 

medical technology, or equivalent; 

(2) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 

(3) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

(b) A certifying technician must have: 

(1) Training and experience in the 

analytical methods and forensic 

procedures used by the HHS-certified 

laboratory relevant to the results that the 

individual certifies; and 

(2) Training and experience in 

reviewing and reporting forensic test 

results and maintaining chain of 

custody, and an understanding of 

appropriate remedial actions in 

response to problems that may arise. 

Section 11.6 What qualifications and 

training must other personnel of an 

HHS-certified laboratory have? 

(a) All HHS-certified laboratory staff 

(e.g., technicians, administrative staff) 

must have the appropriate training and 

skills for the tasks they perform. 

(b) Each individual working in an 

HHS-certified laboratory must be 

properly trained (i.e., receive training in 

each area of work that the individual 

will be performing, including training in 

forensic procedures related to their job 

duties) before they are permitted to 

work independently with federally 

regulated specimens. All training must 

be documented. 

Section 11.7 What security measures 

must an HHS-certified laboratory 

maintain? 

(a) An HHS-certified laboratory must 

control access to the drug testing 

facility, specimens, aliquots, and 

records. 

(b) Authorized visitors must be 

escorted at all times, except for 

individuals conducting inspections (i.e., 

for the Department, a federal agency, a 

state, or other accrediting agency) or 

emergency personnel (e.g., firefighters 

and medical rescue teams). 

(c) An HHS-certified laboratory must 

maintain records documenting the 

identity of the visitor and escort, date, 

time of entry and exit, and purpose for 

access to the secured area. 

Section 11.8 What are the laboratory 

chain of custody requirements for 

specimens and aliquots? 

(a) HHS-certified laboratories must 

use chain of custody procedures 

(internal and external) to maintain 

control and accountability of specimens 

from the time of receipt at the laboratory 

through completion of testing, reporting 

of results, during storage, and 

continuing until final disposition of the 

specimens. 

(b) HHS-certified laboratories must 

use chain of custody procedures to 

document the handling and transfer of 

aliquots throughout the testing process 

until final disposal. 

(c) The chain of custody must be 

documented using either paper copy or 

electronic procedures. 

(d) Each individual who handles a 

specimen or aliquot must sign and 

complete the appropriate entries on the 

chain of custody form when the 

specimen or aliquot is handled or 

transferred, and every individual in the 

chain must be identified. 

(e) The date and purpose must be 

recorded on an appropriate chain of 

custody form each time a specimen or 

aliquot is handled or transferred. 

Section 11.9 What are the 

requirements for an initial drug test? 

(a) An initial drug test may be: 

(1) An immunoassay or 

(2) An alternate technology (e.g., 

spectrometry, spectroscopy). 

(b) An HHS-certified laboratory must 

validate an initial drug test before 

testing specimens. 

(c) Initial drug tests must be accurate 

and reliable for the testing of specimens 

when identifying drugs or their 

metabolites. 

(d) An HHS-certified laboratory may 

conduct a second initial drug test using 

a method with different specificity, to 

rule out cross-reacting compounds. This 

second initial drug test must satisfy the 

batch quality control requirements 

specified in Section 11.11. 

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Section 11.10 What must an HHScertified laboratory do to validate an 

initial drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each initial drug test: 

(1) The ability to differentiate negative 

specimens from those requiring further 

testing; 

(2) The performance of the test around 

the cutoff concentration, using samples 

at several concentrations between 0 and 

150 percent of the cutoff concentration; 

(3) The effective concentration range 

of the test (linearity); 

(4) The potential for carryover; 

(5) The potential for interfering 

substances; and 

(6) The potential matrix effects if 

using an alternate technology. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) Each initial drug test using an 

alternate technology must be re-verified 

periodically or at least annually. 

Section 11.11 What are the batch 

quality control requirements when 

conducting an initial drug test? 

(a) Each batch of specimens must 

contain the following controls: 

(1) At least one control certified to 

contain no drug or drug metabolite; 

(2) At least one positive control with 

the drug or drug metabolite targeted at 

a concentration 25 percent above the 

cutoff; 

(3) At least one control with the drug 

or drug metabolite targeted at a 

concentration 75 percent of the cutoff; 

and 

(4) At least one control that appears 

as a donor specimen to the analysts. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.12 What are the 

requirements for a confirmatory drug 

test? 

(a) The analytical method must use 

mass spectrometric identification [e.g., 

gas chromatography/mass spectrometry 

(GC/MS), liquid chromatography/mass 

spectrometry (LC/MS), GC/MS/MS, LC/ 

MS/MS] or equivalent. 

(b) A confirmatory drug test must be 

validated before it can be used to test 

federally regulated specimens. 

(c) Confirmatory drug tests must be 

accurate and reliable for the testing of 

an oral fluid specimen when identifying 

and quantifying drugs or their 

metabolites. 

Section 11.13 What must an HHScertified laboratory do to validate a 

confirmatory drug test? 

(a) An HHS-certified laboratory must 

demonstrate and document the 

following for each confirmatory drug 

test: 

(1) The linear range of the analysis; 

(2) The limit of detection; 

(3) The limit of quantification; 

(4) The accuracy and precision at the 

cutoff concentration; 

(5) The accuracy (bias) and precision 

at 40 percent of the cutoff concentration; 

(6) The potential for interfering 

substances; 

(7) The potential for carryover; and 

(8) The potential matrix effects if 

using liquid chromatography coupled 

with mass spectrometry. 

(b) Each new lot of reagent must be 

verified prior to being placed into 

service. 

(c) HHS-certified laboratories must reverify each confirmatory drug test 

method periodically or at least annually. 

Section 11.14 What are the batch 

quality control requirements when 

conducting a confirmatory drug test? 

(a) At a minimum, each batch of 

specimens must contain the following 

calibrators and controls: 

(1) A calibrator at the cutoff 

concentration; 

(2) At least one control certified to 

contain no drug or drug metabolite; 

(3) At least one positive control with 

the drug or drug metabolite targeted at 

25 percent above the cutoff; and 

(4) At least one control targeted at or 

less than 40 percent of the cutoff. 

(b) Calibrators and controls must total 

at least 10 percent of the aliquots 

analyzed in each batch. 

Section 11.15 What are the analytical 

and quality control requirements for 

conducting specimen validity tests? 

(a) Each invalid or adulterated 

specimen validity test result must be 

based on an initial specimen validity 

test on one aliquot and a confirmatory 

specimen validity test on a second 

aliquot; 

(b) The HHS-certified laboratory must 

establish acceptance criteria and 

analyze calibrators and controls as 

appropriate to verify and document the 

validity of the test results; and 

(c) Controls must be analyzed 

concurrently with specimens. 

Section 11.16 What must an HHScertified laboratory do to validate a 

specimen validity test? 

An HHS-certified laboratory must 

demonstrate and document for each 

specimen validity test the appropriate 

performance characteristics of the test, 

and must re-verify the test periodically, 

or at least annually. Each new lot of 

reagent must be verified prior to being 

placed into service. 

Section 11.17 What are the 

requirements for an HHS-certified 

laboratory to report a test result? 

(a) Laboratories must report a test 

result to the agency’s MRO within an 

average of 5 working days after receipt 

of the specimen. Reports must use the 

Federal CCF and/or an electronic report. 

Before any test result can be reported, it 

must be certified by a certifying scientist 

or a certifying technician (as 

appropriate). 

(b) A primary (A) specimen is 

reported negative when each initial drug 

test is negative or if the specimen is 

negative upon confirmatory drug 

testing, and the specimen does not meet 

invalid criteria as described in items 

(e)(1) through (e)(4) below. 

(c) A primary (A) specimen is 

reported positive for a specific drug or 

drug metabolite when both the initial 

drug test is positive and the 

confirmatory drug test is positive in 

accordance with Section 3.4. 

(d) For a specimen that has an invalid 

result for one of the reasons stated in 

items (e)(1) through (e)(4) below, the 

HHS-certified laboratory shall contact 

the MRO and both will decide if testing 

by another HHS-certified laboratory 

would be useful in being able to report 

a positive or adulterated result. If no 

further testing is necessary, the HHScertified laboratory then reports the 

invalid result to the MRO. 

(e) A primary (A) oral fluid specimen 

is reported as an invalid result when: 

(1) Interference occurs on the initial 

drug tests on two separate aliquots (i.e., 

valid initial drug test results cannot be 

obtained); 

(2) Interference with the confirmatory 

drug test occurs on at least two separate 

aliquots of the specimen and the HHScertified laboratory is unable to identify 

the interfering substance; 

(3) The physical appearance of the 

specimen is such that testing the 

specimen may damage the laboratory’s 

instruments; 

(4) The physical appearances of the A 

and B specimens are clearly different 

(note: A is tested); or 

(5) The concentration of a biomarker 

(e.g., albumin or IgG) is not consistent 

with that established for human oral 

fluid. 

(f) An HHS-certified laboratory shall 

reject a primary (A) specimen for testing 

when a fatal flaw occurs as described in 

Section 15.1 or when a correctable flaw 

as described in Section 15.2 is not 

57592 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

recovered. The HHS-certified laboratory 

will indicate on the Federal CCF that 

the specimen was rejected for testing 

and provide the reason for reporting the 

rejected for testing result. 

(g) An HHS-certified laboratory must 

report all positive, adulterated, and 

invalid test results for an oral fluid 

specimen. For example, a specimen can 

be positive for a specific drug and 

adulterated. 

(h) An HHS-certified laboratory must 

report the confirmatory concentration of 

each drug or drug metabolite reported 

for a positive result. 

(i) An HHS-certified laboratory must 

report numerical values of the specimen 

validity test results that support a 

specimen that is reported adulterated or 

invalid (as appropriate). 

(j) When the concentration of a drug 

or drug metabolite exceeds the validated 

linear range of the confirmatory test, 

HHS-certified laboratories may report to 

the MRO that the quantitative value 

exceeds the linear range of the test or 

that the quantitative value is greater 

than ‘‘insert the actual value for the 

upper limit of the linear range,’’ or 

laboratories may report a quantitative 

value above the upper limit of the linear 

range that was obtained by diluting an 

aliquot of the specimen to achieve a 

result within the method’s linear range 

and multiplying the result by the 

appropriate dilution factor. 

(k) HHS-certified laboratories may 

transmit test results to the MRO by 

various electronic means (e.g., 

teleprinter, facsimile, or computer). 

Transmissions of the reports must 

ensure confidentiality and the results 

may not be reported verbally by 

telephone. Laboratories and external 

service providers must ensure the 

confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(l) HHS-certified laboratories must 

facsimile, courier, mail, or electronically 

transmit a legible image or copy of the 

completed Federal CCF and/or forward 

a computer-generated electronic report. 

The computer-generated report must 

contain sufficient information to ensure 

that the test results can accurately 

represent the content of the custody and 

control form that the MRO received 

from the collector. 

(m) For positive, adulterated, invalid, 

and rejected specimens, laboratories 

must facsimile, courier, mail, or 

electronically transmit a legible image 

or copy of the completed Federal CCF. 

Section 11.18 How long must an HHScertified laboratory retain specimens? 

(a) An HHS-certified laboratory must 

retain specimens that were reported as 

positive, adulterated, or as an invalid 

result for a minimum of 1 year. 

(b) Retained specimens must be kept 

in secured frozen storage (-20 °C or less) 

to ensure their availability for retesting 

during an administrative or judicial 

proceeding. 

(c) Federal agencies may request that 

the HHS-certified laboratory retain a 

specimen for an additional specified 

period of time and must make that 

request within the 1-year period. 

Section 11.19 How long must an HHScertified laboratory retain records? 

(a) An HHS-certified laboratory must 

retain all records generated to support 

test results for at least 2 years. The 

laboratory may convert hardcopy 

records to electronic records for storage 

and then discard the hardcopy records 

after 6 months. 

(b) A federal agency may request the 

HHS-certified laboratory to maintain a 

documentation package (as described in 

Section 11.21) that supports the chain of 

custody, testing, and reporting of a 

donor’s specimen that is under legal 

challenge by a donor. The federal 

agency’s request to the laboratory must 

be in writing and must specify the 

period of time to maintain the 

documentation package. 

(c) An HHS-certified laboratory may 

retain records other than those included 

in the documentation package beyond 

the normal 2-year period of time. 

Section 11.20 statistical summary 

reports must an HHS-certified 

laboratory provide for oral fluid testing? 

(a) HHS-certified laboratories must 

provide to each federal agency for 

which they perform testing a 

semiannual statistical summary report 

that must be submitted by mail, 

facsimile, or email within 14 working 

days after the end of the semiannual 

period. The summary report must not 

include any personal identifying 

information. A copy of the semiannual 

statistical summary report will also be 

sent to the Secretary or designated HHS 

representative. The semiannual 

statistical report contains the following 

information: 

(1) Reporting period (inclusive dates); 

(2) HHS-certified laboratory name and 

address; 

(3) Federal agency name; 

(4) Number of specimen results 

reported; 

(5) Number of specimens collected by 

reason for test; 

(6) Number of specimens reported 

negative; 

(7) Number of specimens rejected for 

testing because of a fatal flaw; 

(8) Number of specimens rejected for 

testing because of an uncorrected flaw; 

(9) Number of specimens tested 

positive by each initial drug test; 

(10) Number of specimens reported 

positive; 

(11) Number of specimens reported 

positive for each drug and drug 

metabolite; 

(12) Number of specimens reported 

adulterated; and 

(13) Number of specimens reported as 

invalid result. 

(b) An HHS-certified laboratory must 

make copies of an agency’s test results 

available when requested to do so by the 

Secretary or by the federal agency for 

which the laboratory is performing 

drug-testing services. 

(c) An HHS-certified laboratory must 

ensure that a qualified individual is 

available to testify in a proceeding 

against a federal employee when the 

proceeding is based on a test result 

reported by the laboratory. 

Section 11.21 What HHS-certified 

laboratory information is available to a 

federal agency? 

(a) Following a federal agency’s 

receipt of a positive or adulterated drug 

test report, the federal agency may 

submit a written request for copies of 

the records relating to the drug test 

results or a documentation package or 

any relevant certification, review, or 

revocation of certification records. 

(b) Standard documentation packages 

provided by an HHS-certified laboratory 

must contain the following items: 

(1) A cover sheet providing a brief 

description of the procedures and tests 

performed on the donor’s specimen; 

(2) A table of contents that lists all 

documents and materials in the package 

by page number; 

(3) A copy of the Federal CCF with 

any attachments, internal chain of 

custody records for the specimen, 

memoranda (if any) generated by the 

HHS-certified laboratory, and a copy of 

the electronic report (if any) generated 

by the HHS-certified laboratory; 

(4) A brief description of the HHScertified laboratory’s initial drug (and 

specimen validity, if applicable) testing 

procedures, instrumentation, and batch 

quality control requirements; 

(5) Copies of the initial test data for 

the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the initial tests; 

(6) A brief description of the HHScertified laboratory’s confirmatory drug 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57593 

(and specimen validity, if applicable) 

testing procedures, instrumentation, and 

batch quality control requirements; 

(7) Copies of the confirmatory test 

data for the donor’s specimen with all 

calibrators and controls and copies of all 

internal chain of custody documents 

related to the confirmatory tests; and 

(8) Copies of the re ́sume ́ or 

curriculum vitae for the RP(s) and the 

certifying technician or certifying 

scientist of record. 

Section 11.22 What HHS-certified 

laboratory information is available to a 

federal employee? 

A federal employee who is the subject 

of a workplace drug test may submit a 

written request through the MRO and/ 

or the federal agency requesting copies 

of any records relating to the employee’s 

drug test results or a documentation 

package as described in Section 11.21(b) 

and any relevant certification, review, or 

revocation of certification records. 

Federal employees, or their designees, 

are not permitted access to their 

specimens collected pursuant to 

Executive Order 12564, Public Law 

100–71, and these Guidelines. 

Section 11.23 What types of 

relationships are prohibited between an 

HHS-certified laboratory and an MRO? 

An HHS-certified laboratory must not 

enter into any relationship with a 

federal agency’s MRO that may be 

construed as a potential conflict of 

interest or derive any financial benefit 

by having a federal agency use a specific 

MRO. 

This means an MRO may be an 

employee of the agency or a contractor 

for the agency; however, an MRO shall 

not be an employee or agent of or have 

any financial interest in the HHScertified laboratory for which the MRO 

is reviewing drug testing results. 

Additionally, an MRO shall not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or have any agreement with 

an HHS-certified laboratory that may be 

construed as a potential conflict of 

interest. 

Subpart L—Instrumented Initial Test 

Facility (IITF) 

Section 12.1 May an IITF test oral 

fluid specimens for a federal agency’s 

workplace drug testing program? 

No, only HHS-certified laboratories 

are authorized to test oral fluid 

specimens for federal agency workplace 

drug testing programs in accordance 

with these Guidelines. 

Subpart M—Medical Review Officer 

(MRO) 

Section 13.1 Who may serve as an 

MRO? 

(a) A currently licensed physician 

who has: 

(1) A Doctor of Medicine (M.D.) or 

Doctor of Osteopathy (D.O.) degree; 

(2) Knowledge regarding the 

pharmacology and toxicology of illicit 

drugs; 

(3) The training necessary to serve as 

an MRO as set out in Section 13.3; 

(4) Satisfactorily passed an initial 

examination administered by a 

nationally recognized entity or 

subspecialty board that has been 

approved by the Secretary to certify 

MROs; and 

(5) At least every five years from 

initial certification, completed 

requalification training on the topics in 

Section 13.3 and satisfactorily passed a 

requalification examination 

administered by a nationally recognized 

entity or a subspecialty board that has 

been approved by the Secretary to 

certify MROs. 

Section 13.2 How are nationally 

recognized entities or subspecialty 

boards that certify MROs approved? 

All nationally recognized entities or 

subspecialty boards which seek 

approval by the Secretary to certify 

physicians as MROs for federal 

workplace drug testing programs must 

submit their qualifications, a sample 

examination, and other necessary 

supporting examination materials (e.g., 

answers, previous examination statistics 

or other background examination 

information, if requested). Approval 

will be based on an objective review of 

qualifications that include a copy of the 

MRO applicant application form, 

documentation that the continuing 

education courses are accredited by a 

professional organization, and the 

delivery method and content of the 

examination. Each approved MRO 

certification entity must resubmit their 

qualifications for approval every two 

years. The Secretary shall publish at 

least every two years a notice in the 

Federal Register listing those entities 

and subspecialty boards that have been 

approved. This notice is also available 

on the internet at http:// 

www.samhsa.gov/workplace/drugtesting. 

Section 13.3 What training is required 

before a physician may serve as an 

MRO? 

(a) A physician must receive training 

that includes a thorough review of the 

following: 

(1) The collection procedures used to 

collect federal agency specimens; 

(2) How to interpret test results 

reported by HHS-certified IITFs and 

laboratories (e.g., negative, negative/ 

dilute, positive, adulterated, substituted, 

rejected for testing, and invalid); 

(3) Chain of custody, reporting, and 

recordkeeping requirements for federal 

agency specimens; 

(4) The HHS Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs for all authorized specimen 

types; and 

(5) Procedures for interpretation, 

review (e.g., donor interview for 

legitimate medical explanations, review 

of documentation provided by the donor 

to support a legitimate medical 

explanation), and reporting of results 

specified by any federal agency for 

which the individual may serve as an 

MRO; 

(b) Certified MROs must complete 

training on any revisions to these 

Guidelines prior to their effective date, 

to continue serving as an MRO for 

federal agency specimens. 

Section 13.4 What are the 

responsibilities of an MRO? 

(a) The MRO must review all positive, 

adulterated, rejected for testing, invalid, 

and (for urine) substituted test results. 

(b) Staff under the direct, personal 

supervision of the MRO may review and 

report negative and (for urine) negative/ 

dilute test results to the agency’s 

designated representative. The MRO 

must review at least 5 percent of all 

negative results reported by the MRO 

staff to ensure that the MRO staff are 

properly performing the review process. 

(c) The MRO must discuss potential 

invalid results with the HHS-certified 

laboratory, as addressed in Section 

11.17(d) to determine whether testing at 

another HHS-certified laboratory may be 

warranted. 

(d) After receiving a report from an 

HHS-certified laboratory or (for urine) 

HHS-certified IITF, the MRO must: 

(1) Review the information on the 

MRO copy of the Federal CCF that was 

received from the collector and the 

report received from the HHS-certified 

laboratory or HHS-certified IITF; 

(2) Interview the donor when 

required; 

(3) Make a determination regarding 

the test result; and 

(4) Report the verified result to the 

federal agency. 

(e) The MRO must maintain records 

for a minimum of 2 years while 

maintaining the confidentiality of the 

information. The MRO may convert 

hardcopy records to electronic records 

57594 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

for storage and discard the hardcopy 

records after 6 months. 

(f) The MRO must conduct a medical 

examination or a review of the 

examining physician’s findings and 

make a determination of refusal to test 

or cancelled test when a collector 

reports that the donor was unable to 

provide a specimen, as addressed in 

Section 8.6. 

Section 13.5 What must an MRO do 

when reviewing an oral fluid specimen’s 

test results? 

(a) When the HHS-certified laboratory 

reports a negative result for the primary 

(A) specimen, the MRO reports a 

negative result to the agency. 

(b) When the HHS-certified laboratory 

reports multiple results for the primary 

(A) specimen, as the MRO, you must 

follow the verification procedures 

described in 13.5(c) through (f) and: 

(1) Report all verified positive and/or 

refusal to test results to the federal 

agency. 

(2) If an invalid result was reported in 

conjunction with a positive or 

adulterated result, do not report the 

verified invalid result to the federal 

agency at this time. The MRO reports 

the verified invalid result(s) for the 

primary (A) specimen only if the split 

specimen is tested and reported as a 

failure to reconfirm as described in 

Section 14.5(c). 

(c) 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. 

(1) If the donor provides 

documentation (e.g., a valid 

prescription) to support a legitimate 

medical explanation for the positive 

result, the MRO reports the test result as 

negative to the agency. 

(i) Passive exposure to a drug (e.g., 

exposure to secondhand marijuana 

smoke) is not a legitimate medical 

explanation for a positive drug test 

result. 

(ii) Ingestion of food products 

containing marijuana is not a legitimate 

medical explanation for a positive drug 

test result. 

(2) If the donor is unable to provide 

a legitimate medical explanation, the 

MRO reports a positive result to the 

agency for all drugs except codeine and/ 

or morphine as follows: 

(i) For codeine and/or morphine less 

than 150 ng/mL and no legitimate 

medical explanation: The MRO must 

determine if there is clinical evidence of 

illegal use (in addition to the drug test 

result) to report a positive result to the 

agency. If there is no clinical evidence 

of illegal use, the MRO reports a 

negative result to the agency. However, 

this requirement does not apply if the 

laboratory confirms the presence of 6- 

acetylmorphine (i.e., the presence of 

this metabolite is proof of heroin use). 

(ii) For codeine and/or morphine 

equal to or greater than 150 ng/mL and 

no legitimate medical explanation: The 

MRO reports a positive result to the 

agency. Consumption of food products 

must not be considered a legitimate 

medical explanation for the donor 

having morphine or codeine at or above 

this concentration. 

(d) When the HHS-certified laboratory 

reports an adulterated result for the 

primary (A) oral fluid specimen, the 

MRO contacts the donor to determine if 

the donor has a legitimate medical 

explanation for the adulterated result. 

(1) If the donor provides a legitimate 

medical explanation, the MRO reports a 

negative result to the federal agency. 

(2) If the donor is unable to provide 

a legitimate medical explanation, the 

MRO reports a refusal to test to the 

federal agency because the oral fluid 

specimen was adulterated. 

(e) When the HHS-certified laboratory 

reports an invalid result for the primary 

(A) oral fluid specimen, the MRO must 

contact the donor to determine if there 

is a legitimate explanation for the 

invalid result. 

(1) If the donor provides a legitimate 

explanation (e.g., a prescription 

medication), the MRO reports a test 

cancelled result with the reason for the 

invalid result and informs the federal 

agency that a recollection is not 

required because there is a legitimate 

explanation for the invalid result. 

(2) If the donor is unable to provide 

a legitimate explanation, the MRO 

reports a test cancelled result with the 

reason for the invalid result and directs 

the agency to collect another specimen 

from the donor. 

(i) If the second specimen collected 

provides a valid result, the MRO follows 

the procedures in 13.5(a) through (d). 

(ii) If the second specimen collected 

provides an invalid result, the MRO 

reports this specimen as test cancelled 

and recommends that the agency collect 

another authorized specimen type (e.g., 

urine). 

(f) When the HHS-certified laboratory 

reports a rejected for testing result for 

the primary (A) specimen, the MRO 

reports a test cancelled result to the 

agency and recommends that the agency 

collect another specimen from the 

donor. 

13.6 What action does the MRO take 

when the collector reports that the 

donor did not provide a sufficient 

amount of oral fluid for a drug test? 

(a) When another specimen type (e.g., 

urine) was collected as authorized by 

the federal agency, the MRO reviews 

and reports the test result in accordance 

with the Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs using the alternative 

specimen. 

(b) When the federal agency did not 

authorize the collection of an alternative 

specimen, the MRO consults with the 

federal agency. The federal agency 

immediately directs the donor to obtain, 

within five days, an evaluation from a 

licensed physician, acceptable to the 

MRO, who has expertise in the medical 

issues raised by the donor’s failure to 

provide a specimen. The MRO may 

perform this evaluation if the MRO has 

appropriate expertise. 

(1) For purposes of this section, a 

medical condition includes an 

ascertainable physiological condition. 

Permanent or long-term medical 

conditions are those physiological, 

anatomic, or psychological 

abnormalities documented as being 

present prior to the attempted 

collection, and considered not amenable 

to correction or cure for an extended 

period of time. 

(2) As the MRO, if another physician 

will perform the evaluation, you must 

provide the other physician with the 

following information and instructions: 

(i) That the donor was required to take 

a federally regulated drug test, but was 

unable to provide a sufficient amount of 

oral fluid to complete the test; 

(ii) The consequences of the 

appropriate federal agency regulation 

for refusing to take the required drug 

test; 

(iii) That, after completing the 

evaluation, the referral physician must 

agree to provide a written statement to 

the MRO with a recommendation for 

one of the determinations described in 

paragraph (b)(3) of this section and the 

basis for the recommendation. The 

statement must not include detailed 

information on the employee’s medical 

condition beyond what is necessary to 

explain the referral physician’s 

conclusion. 

(3) As the MRO, if another physician 

performed the evaluation, you must 

consider and assess the referral 

physician’s recommendations in making 

your determination. You must make one 

of the following determinations and 

report it to the federal agency in writing: 

(i) A medical condition as defined in 

paragraph (b)(1) of this section has, or 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57595 

with a high degree of probability could 

have, precluded the employee from 

providing a sufficient amount of oral 

fluid, but is not a permanent or longterm disability. As the MRO, you must 

report a test cancelled result to the 

federal agency. 

(ii) A permanent or long-term medical 

condition as defined in paragraph (b)(1) 

of this section has, or with a high degree 

of probability could have, precluded the 

employee from providing a sufficient 

amount of oral fluid and is highly likely 

to prevent the employee from providing 

a sufficient amount of oral fluid for a 

very long or indefinite period of time. 

As the MRO, you must follow the 

requirements of Section 13.7, as 

appropriate. If Section 13.7 is not 

applicable, you report a test cancelled 

result to the federal agency and 

recommend that the agency authorize 

collection of an alternative specimen 

type (e.g., urine) for any subsequent 

drug tests for the donor. 

(iii) There is not an adequate basis for 

determining that a medical condition 

has or, with a high degree of probability, 

could have precluded the employee 

from providing a sufficient amount of 

oral fluid. As the MRO, you must report 

a refusal to test to the federal agency. 

(4) When a federal agency receives a 

report from the MRO indicating that a 

test is cancelled as provided in 

paragraph (b)(3)(i) of this section, the 

agency takes no further action with 

respect to the donor. When a test is 

canceled as provided in paragraph 

(b)(3)(ii) of this section, the agency takes 

no further action with respect to the 

donor other than designating collection 

of an alternate specimen type (i.e., 

authorized by the Mandatory Guidelines 

for Federal Workplace Drug Testing 

Programs) for any subsequent 

collections, in accordance with the 

federal agency plan. The donor remains 

in the random testing pool. 

13.7 What happens when an 

individual is unable to provide a 

sufficient amount of oral fluid for a 

federal agency applicant/preemployment test, a follow-up test, or a 

return-to-duty test because of a 

permanent or long-term medical 

condition? 

(a) This section concerns a situation 

in which the donor has a medical 

condition that precludes the donor from 

providing a sufficient specimen for a 

federal agency applicant/preemployment test, a follow-up test, or a 

return-to-duty test and the condition 

involves a permanent or long-term 

disability and the federal agency does 

not authorize collection of an alternative 

specimen. As the MRO in this situation, 

you must do the following: 

(1) You must determine if there is 

clinical evidence that the individual is 

an illicit drug user. You must make this 

determination by personally 

conducting, or causing to be conducted, 

a medical evaluation and through 

consultation with the donor’s physician 

and/or the physician who conducted the 

evaluation under Section 13.6. 

(2) If you do not personally conduct 

the medical evaluation, you must ensure 

that one is conducted by a licensed 

physician acceptable to you. 

(b) If the medical evaluation reveals 

no clinical evidence of drug use, as the 

MRO, you must report the result to the 

federal agency as a negative test with 

written notations regarding results of 

both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state the 

basis for the determination that a 

permanent or long-term medical 

condition exists, making provision of a 

sufficient oral fluid specimen 

impossible, and for the determination 

that no signs and symptoms of drug use 

exist. The MRO recommends that the 

agency authorize collection of an 

alternate specimen type (e.g., urine) for 

any subsequent collections. 

(c) If the medical evaluation reveals 

clinical evidence of drug use, as the 

MRO, you must report the result to the 

federal agency as a cancelled test with 

written notations regarding results of 

both the evaluation conducted under 

Section 13.6 and any further medical 

examination. This report must state that 

a permanent or long-term medical 

condition [as defined in Section 13.6 

(b)(1)] exists, making provision of a 

sufficient oral fluid specimen 

impossible, and state the reason for the 

determination that signs and symptoms 

of drug use exist. Because this is a 

cancelled test, it does not serve the 

purposes of a negative test (e.g., the 

federal agency is not authorized to allow 

the donor to begin or resume performing 

official functions because a negative test 

is needed for that purpose). 

Section 13.8 Who may request a test of 

a split (B) specimen? 

(a) For a positive or adulterated result 

reported on a primary (A) specimen, a 

donor may request through the MRO 

that the split (B) specimen be tested by 

a second HHS-certified laboratory to 

verify the result reported by the first 

HHS-certified laboratory. 

(b) The donor has 72 hours (from the 

time the MRO notified the donor that 

the donor’s specimen was reported 

positive, adulterated, or (for urine) 

substituted to request a test of the split 

(B) specimen. The MRO must inform the 

donor that the donor has the 

opportunity to request a test of the split 

(B) specimen when the MRO informs 

the donor that a positive, adulterated, or 

(for urine) substituted result is being 

reported to the federal agency on the 

primary (A) specimen. 

Section 13.9 How does an MRO report 

a primary (A) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., teleprinter, facsimile, or 

computer). Transmissions of the reports 

must ensure confidentiality. The MRO 

and external service providers must 

ensure the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all positive, 

adulterated, and (for urine) substituted 

results. 

(d) The MRO must not disclose 

numerical values of drug test results to 

the agency. 

Section 13.10 at types of relationships 

are prohibited between an MRO and an 

HHS-certified laboratory? 

An MRO must not be an employee, 

agent of, or have any financial interest 

in an HHS-certified laboratory for which 

the MRO is reviewing drug test results. 

This means an MRO must not derive 

any financial benefit by having an 

agency use a specific HHS-certified 

laboratory or have any agreement with 

the HHS-certified laboratory that may be 

construed as a potential conflict of 

interest. 

Subpart N—Split Specimen Tests 

Section 14.1 When may a split (B) 

specimen be tested? 

(a) The donor may request, verbally or 

in writing, through the MRO that the 

split (B) specimen be tested at a 

different (i.e., second) HHS-certified 

oral fluid laboratory when the primary 

(A) specimen was determined by the 

MRO to be positive, adulterated, or (for 

urine) substituted. 

(b) A donor has 72 hours to initiate 

the request after being informed of the 

result by the MRO. The MRO must 

57596 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

document in the MRO’s records the 

verbal request from the donor to have 

the split (B) specimen tested. 

(c) If a split (B) oral fluid specimen 

cannot be tested by a second HHScertified laboratory (e.g., insufficient 

specimen, lost in transit, split not 

available, no second HHS-certified 

laboratory available to perform the test), 

the MRO reports to the federal agency 

that the test must be cancelled and the 

reason for the cancellation. The MRO 

directs the federal agency to ensure the 

immediate recollection of another oral 

fluid specimen from the donor, with no 

notice given to the donor of this 

collection requirement until 

immediately before the collection. 

(d) If a donor chooses not to have the 

split (B) specimen tested by a second 

HHS-certified oral fluid laboratory, a 

federal agency may have a split (B) 

specimen retested as part of a legal or 

administrative proceeding to defend an 

original positive, adulterated, or (for 

urine) substituted result. 

Section 14.2 How does an HHScertified laboratory test a split (B) 

specimen when the primary (A) 

specimen was reported positive? 

(a) The testing of a split (B) specimen 

for a drug or metabolite is not subject to 

the testing cutoff concentrations 

established. 

(b) The HHS-certified laboratory is 

only required to confirm the presence of 

the drug or metabolite that was reported 

positive in the primary (A) specimen. 

Section 14.3 How does an HHScertified laboratory test a split (B) oral 

fluid specimen when the primary (A) 

specimen was reported adulterated? 

(a) The HHS-certified laboratory must 

use its confirmatory specimen validity 

test at an established limit of 

quantification (LOQ) to reconfirm the 

presence of the adulterant. 

(b) The second HHS-certified 

laboratory may only conduct the 

confirmatory specimen validity test(s) 

needed to reconfirm the adulterated 

result reported by the first HHS-certified 

laboratory. 

Section 14.4 Who receives the split (B) 

specimen result? 

The second HHS-certified laboratory 

must report the result to the MRO. 

Section 14.5 What action(s) does an 

MRO take after receiving the split (B) 

oral fluid specimen result from the 

second HHS-certified laboratory? 

The MRO takes the following actions 

when the second HHS-certified 

laboratory reports the result for the split 

(B) oral fluid specimen as: 

(a) Reconfirmed the drug(s) or 

adulteration result. The MRO reports 

reconfirmed to the agency. 

(b) Failed to reconfirm a single or all 

drug positive results and adulterated. If 

the donor provides a legitimate medical 

explanation for the adulteration result, 

the MRO reports a failed to reconfirm 

[specify drug(s)] and cancels both tests. 

If there is no legitimate medical 

explanation, the MRO reports a failed to 

reconfirm [specify drug(s)] and a refusal 

to test to the agency and indicates the 

adulterant that is present in the 

specimen. The MRO gives the donor 72 

hours to request that Laboratory A retest 

the primary (A) specimen for the 

adulterant. If Laboratory A reconfirms 

the adulterant, the MRO reports refusal 

to test and indicates the adulterant 

present. If Laboratory A fails to 

reconfirm the adulterant, the MRO 

cancels both tests and directs the agency 

to immediately collect another 

specimen. The MRO shall notify the 

appropriate regulatory office about the 

failed to reconfirm and cancelled test. 

(c) Failed to reconfirm a single or all 

drug positive results and not 

adulterated. The MRO reports to the 

agency a failed to reconfirm result 

[specify drug(s)], cancels both tests, and 

notifies the HHS office responsible for 

coordination of the drug-free workplace 

program. 

(d) Failed to reconfirm a single or all 

drug positive results and invalid result. 

The MRO reports to the agency a failed 

to reconfirm result [specify drug(s) and 

give the reason for the invalid result], 

cancels both tests, directs the agency to 

immediately collect another specimen 

and notifies the HHS office responsible 

for coordination of the drug-free 

workplace program. 

(e) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and adulterated. The MRO reports to 

the agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s)]. The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and found that the specimen 

was adulterated. The MRO shall notify 

the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(f) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and not adulterated. The MRO reports 

to the agency a reconfirmed result 

[specify drug(s)] and a failed to 

reconfirm result [specify drug(s)]. The 

MRO tells the agency that it may take 

action based on the reconfirmed drug(s) 

although Laboratory B failed to 

reconfirm one or more drugs. The MRO 

shall notify the HHS office responsible 

for coordination of the drug-free 

workplace program regarding the test 

results for the specimen. 

(g) Failed to reconfirm one or more 

drugs, reconfirmed one or more drugs, 

and invalid result. The MRO reports to 

the agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s)]. The MRO tells the 

agency that it may take action based on 

the reconfirmed drug(s) although 

Laboratory B failed to reconfirm one or 

more drugs and reported an invalid 

result. The MRO shall notify the HHS 

office responsible for coordination of 

the drug-free workplace program 

regarding the test results for the 

specimen. 

(h) Failed to reconfirm adulteration. 

The MRO reports to the agency a failed 

to reconfirm result (specify adulterant) 

and cancels both tests. The MRO shall 

notify the HHS office responsible for 

coordination of the drug-free workplace 

program regarding the test results for the 

specimen. 

(i) Failed to reconfirm a single or all 

drug positive results and reconfirmed an 

adulterant. The MRO reports to the 

agency a reconfirmed result (specify 

adulterant) and a failed to reconfirm 

result [specify drug(s)]. The MRO tells 

the agency that it may take action based 

on the reconfirmed result (adulterated) 

although Laboratory B failed to 

reconfirm the drug(s) result. 

(j) Failed to reconfirm a single or all 

drug positive results and failed to 

reconfirm the adulterant. The MRO 

reports to the agency a failed to 

reconfirm result [specify drug(s) and 

adulterant] and cancels both tests. The 

MRO shall notify the HHS office 

responsible for coordination of the drugfree workplace program regarding the 

test results for the specimen. 

(k) Failed to reconfirm at least one 

drug and reconfirmed the adulterant. 

The MRO reports to the agency a 

reconfirmed result [specify drug(s) and 

adulterant] and a failed to reconfirm 

result [specify drug(s)]. The MRO tells 

the agency that it may take action based 

on the reconfirmed drug(s) and the 

reconfirmed adulterant although 

Laboratory B failed to reconfirm one or 

more drugs. 

(l) Failed to reconfirm at least one 

drug and failed to reconfirm the 

adulterant. The MRO reports to the 

agency a reconfirmed result [specify 

drug(s)] and a failed to reconfirm result 

[specify drug(s) and adulterant]. The 

MRO tells the agency that it may take 

action based on the reconfirmed drug(s) 

although Laboratory B failed to 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57597 

reconfirm one or more drugs and failed 

to reconfirm the adulterant. 

Section 14.6 How does an MRO report 

a split (B) specimen test result to an 

agency? 

(a) The MRO must report all verified 

results to an agency using the completed 

MRO copy of the Federal CCF or a 

separate report using a letter/ 

memorandum format. The MRO may 

use various electronic means for 

reporting (e.g., teleprinter, facsimile, or 

computer). Transmissions of the reports 

must ensure confidentiality. The MRO 

and external service providers must 

ensure the confidentiality, integrity, and 

availability of the data and limit access 

to any data transmission, storage, and 

retrieval system. 

(b) A verified result may not be 

reported to the agency until the MRO 

has completed the review process. 

(c) The MRO must send a copy of 

either the completed MRO copy of the 

Federal CCF or the separate letter/ 

memorandum report for all split 

specimen results. 

(d) The MRO must not disclose the 

numerical values of the drug test results 

to the agency. 

Section 14.7 How long must an HHScertified laboratory retain a split (B) 

specimen? 

A split (B) specimen is retained for 

the same period of time that a primary 

(A) specimen is retained and under the 

same storage conditions. This applies 

even for those cases when the split (B) 

specimen is tested by a second HHScertified laboratory and the second 

HHS-certified laboratory does not 

confirm the original result reported by 

the first HHS-certified laboratory for the 

primary (A) specimen. 

Subpart O—Criteria for Rejecting a 

Specimen for Testing 

Section 15.1 What discrepancies 

require an HHS-certified laboratory to 

report a specimen as rejected for 

testing? 

The following discrepancies are 

considered to be fatal flaws. The HHScertified laboratory must stop the testing 

process, reject the specimen for testing, 

and indicate the reason for rejecting the 

specimen on the Federal CCF when: 

(a) The specimen ID number on the 

primary (A) or split (B) specimen label/ 

seal does not match the ID number on 

the Federal CCF, or the ID number is 

missing either on the Federal CCF or on 

either specimen label/seal; 

(b) The primary (A) specimen label/ 

seal is missing, misapplied, broken or 

shows evidence of tampering and the 

split (B) specimen cannot be redesignated as the primary (A) specimen; 

(c) The collector’s printed name and 

signature are omitted on the Federal 

CCF; 

(d) There is an insufficient amount of 

specimen for analysis in the primary (A) 

specimen unless the split (B) specimen 

can be re-designated as the primary (A) 

specimen; 

(e) The accessioner failed to 

document the primary (A) specimen 

seal condition on the Federal CCF at the 

time of accessioning, and the split (B) 

specimen cannot be re-designated as the 

primary (A) specimen; 

(f) The specimen was received at the 

HHS-certified laboratory without a CCF; 

(g) The CCF was received at the HHScertified laboratory without a specimen; 

(h) The collector performed two 

separate collections using one CCF; or 

(i) The HHS-certified laboratory 

identifies a flaw (other than those 

specified above) that prevents testing or 

affects the forensic defensibility of the 

drug test and cannot be corrected. 

Section 15.2 What discrepancies 

require an HHS-certified laboratory to 

report a specimen as rejected for testing 

unless the discrepancy is corrected? 

The following discrepancies are 

considered to be correctable: 

(a) If a collector failed to sign the 

Federal CCF, the HHS-certified 

laboratory must attempt to recover the 

collector’s signature before reporting the 

test result. If the collector can provide 

a memorandum for record recovering 

the signature, the HHS-certified 

laboratory may report the test result for 

the specimen. If, after holding the 

specimen for at least 5 business days, 

the HHS-certified laboratory cannot 

recover the collector’s signature, the 

laboratory must report a rejected for 

testing result and indicate the reason for 

the rejected for testing result on the 

Federal CCF. 

(b) If a specimen is submitted using a 

non-federal form or an expired Federal 

CCF, the HHS-certified laboratory must 

test the specimen and also attempt to 

obtain a memorandum for record 

explaining why a non-federal form or an 

expired Federal CCF was used and 

ensure that the form used contains all 

the required information. If, after 

holding the specimen for at least 5 

business days, the HHS-certified 

laboratory cannot obtain a 

memorandum for record from the 

collector, the laboratory must report a 

rejected for testing result and indicate 

the reason for the rejected for testing 

result on the report to the MRO. 

Section 15.3 What discrepancies are 

not sufficient to require an HHScertified laboratory to reject an oral 

fluid specimen for testing or an MRO to 

cancel a test? 

(a) The following omissions and 

discrepancies on the Federal CCF that 

are received by the HHS-certified 

laboratory should not cause an HHScertified laboratory to reject an oral fluid 

specimen or cause an MRO to cancel a 

test: 

(1) An incorrect laboratory name and 

address appearing at the top of the form; 

(2) Incomplete/incorrect/unreadable 

employer name or address; 

(3) MRO name is missing; 

(4) Incomplete/incorrect MRO 

address; 

(5) A transposition of numbers in the 

donor’s Social Security Number or 

employee identification number; 

(6) A telephone number is missing/ 

incorrect; 

(7) A fax number is missing/incorrect; 

(8) A ‘‘reason for test’’ box is not 

marked; 

(9) A ‘‘drug tests to be performed’’ box 

is not marked; 

(10) A ‘‘specimen collection’’ box is 

not marked; 

(11) The lot number of the collection 

device used for the collection is 

missing; 

(12) The collection site address is 

missing; 

(13) The collector’s printed name is 

missing but the collector’s signature is 

properly recorded; 

(14) The time of collection is not 

indicated; 

(15) The date of collection is not 

indicated; 

(16) Incorrect name of delivery 

service; 

(17) The collector has changed or 

corrected information by crossing out 

the original information on either the 

Federal CCF or specimen label/seal 

without dating and initialing the 

change; or 

(18) The donor’s name inadvertently 

appears on the HHS-certified laboratory 

copy of the Federal CCF or on the 

tamper-evident labels used to seal the 

specimens. 

(b) The following omissions and 

discrepancies on the Federal CCF that 

are made at the HHS-certified laboratory 

should not cause an MRO to cancel a 

test: 

(1) The testing laboratory fails to 

indicate the correct name and address in 

the results section when a different 

laboratory name and address is printed 

at the top of the Federal CCF; 

(2) The accessioner fails to print their 

name; 

57598 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

(3) The certifying scientist or 

certifying technician fails to print their 

name; 

(4) The certifying scientist or 

certifying technician accidentally 

initials the Federal CCF rather than 

signing for a specimen reported as 

rejected for testing; 

(c) The above omissions and 

discrepancies should occur no more 

than once a month. The expectation is 

that each trained collector and HHScertified laboratory will make every 

effort to ensure that the Federal CCF is 

properly completed and that all the 

information is correct. When an error 

occurs more than once a month, the 

MRO must direct the collector or HHScertified laboratory (whichever is 

responsible for the error) to immediately 

take corrective action to prevent the 

recurrence of the error. 

Section 15.4 What discrepancies may 

require an MRO to cancel a test? 

(a) An MRO must attempt to correct 

the following errors: 

(1) The donor’s signature is missing 

on the MRO copy of the Federal CCF 

and the collector failed to provide a 

comment that the donor refused to sign 

the form; 

(2) The certifying scientist failed to 

sign the Federal CCF for a specimen 

being reported drug positive, 

adulterated, invalid, or (for urine) 

substituted; or 

(3) The electronic report provided by 

the HHS-certified laboratory does not 

contain all the data elements required 

for the HHS standard laboratory 

electronic report for a specimen being 

reported drug positive, adulterated, 

invalid result, or (for urine) substituted. 

(b) If error (a)(1) occurs, the MRO 

must contact the collector to obtain a 

statement to verify that the donor 

refused to sign the MRO copy. If, after 

at least 5 business days, the collector 

cannot provide such a statement, the 

MRO must cancel the test. 

(c) If error (a)(2) occurs, the MRO 

must obtain a statement from the 

certifying scientist that they 

inadvertently forgot to sign the Federal 

CCF, but did, in fact, properly conduct 

the certification review. If, after at least 

5 business days, the MRO cannot get a 

statement from the certifying scientist, 

the MRO must cancel the test. 

(d) If error (a)(3) occurs, the MRO 

must contact the HHS-certified 

laboratory. If, after at least 5 business 

days, the laboratory does not retransmit 

a corrected electronic report, the MRO 

must cancel the test. 

Subpart P—Laboratory Suspension/ 

Revocation Procedures 

Section 16.1 When may the HHS 

certification of a laboratory be 

suspended? 

These procedures apply when: 

(a) The Secretary has notified an HHScertified laboratory in writing that its 

certification to perform drug testing 

under these Guidelines has been 

suspended or that the Secretary 

proposes to revoke such certification. 

(b) The HHS-certified laboratory has, 

within 30 days of the date of such 

notification or within 3 days of the date 

of such notification when seeking an 

expedited review of a suspension, 

requested in writing an opportunity for 

an informal review of the suspension or 

proposed revocation. 

Section 16.2 What definitions are used 

for this subpart? 

Appellant. Means the HHS-certified 

laboratory which has been notified of its 

suspension or proposed revocation of its 

certification to perform testing and has 

requested an informal review thereof. 

Respondent. Means the person or 

persons designated by the Secretary in 

implementing these Guidelines. 

Reviewing Official. Means the person 

or persons designated by the Secretary 

who will review the suspension or 

proposed revocation. The reviewing 

official may be assisted by one or more 

of the official’s employees or 

consultants in assessing and weighing 

the scientific and technical evidence 

and other information submitted by the 

appellant and respondent on the reasons 

for the suspension and proposed 

revocation. 

Section 16.3 Are there any limitations 

on issues subject to review? 

The scope of review shall be limited 

to the facts relevant to any suspension 

or proposed revocation, the necessary 

interpretations of those facts, the 

relevant Mandatory Guidelines for 

Federal Workplace Drug Testing 

Programs, and other relevant law. The 

legal validity of these Guidelines shall 

not be subject to review under these 

procedures. 

Section 16.4 Who represents the 

parties? 

The appellant’s request for review 

shall specify the name, address, and 

telephone number of the appellant’s 

representative. In its first written 

submission to the reviewing official, the 

respondent shall specify the name, 

address, and telephone number of the 

respondent’s representative. 

Section 16.5 When must a request for 

informal review be submitted? 

(a) Within 30 days of the date of the 

notice of the suspension or proposed 

revocation, the appellant must submit a 

written request to the reviewing official 

seeking review, unless some other time 

period is agreed to by the parties. A 

copy must also be sent to the 

respondent. The request for review must 

include a copy of the notice of 

suspension or proposed revocation, a 

brief statement of why the decision to 

suspend or propose revocation is wrong, 

and the appellant’s request for an oral 

presentation, if desired. 

(b) Within 5 days after receiving the 

request for review, the reviewing official 

will send an acknowledgment and 

advise the appellant of the next steps. 

The reviewing official will also send a 

copy of the acknowledgment to the 

respondent. 

Section 16.6 What is an abeyance 

agreement? 

Upon mutual agreement of the parties 

to hold these procedures in abeyance, 

the reviewing official will stay these 

procedures for a reasonable time while 

the laboratory attempts to regain 

compliance with the Guidelines or the 

parties otherwise attempt to settle the 

dispute. As part of an abeyance 

agreement, the parties can agree to 

extend the time period for requesting 

review of the suspension or proposed 

revocation. If abeyance begins after a 

request for review has been filed, the 

appellant shall notify the reviewing 

official at the end of the abeyance 

period, advising whether the dispute 

has been resolved. If the dispute has 

been resolved, the request for review 

will be dismissed. If the dispute has not 

been resolved, the review procedures 

will begin at the point at which they 

were interrupted by the abeyance 

agreement with such modifications to 

the procedures as the reviewing official 

deems appropriate. 

Section 16.7 What procedures are used 

to prepare the review file and written 

argument? 

The appellant and the respondent 

each participate in developing the file 

for the reviewing official and in 

submitting written arguments. The 

procedures for development of the 

review file and submission of written 

argument are: 

(a) Appellant’s Documents and Brief. 

Within 15 days after receiving the 

acknowledgment of the request for 

review, the appellant shall submit to the 

reviewing official the following (with a 

copy to the respondent): 

Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 57599 

(1) A review file containing the 

documents supporting appellant’s 

argument, tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining why 

respondent’s decision to suspend or 

propose revocation of appellant’s 

certification is wrong (appellant’s brief). 

(b) Respondent’s Documents and 

Brief. Within 15 days after receiving a 

copy of the acknowledgment of the 

request for review, the respondent shall 

submit to the reviewing official the 

following (with a copy to the appellant): 

(1) A review file containing 

documents supporting respondent’s 

decision to suspend or revoke 

appellant’s certification to perform drug 

testing, which is tabbed and organized 

chronologically, and accompanied by an 

index identifying each document. Only 

essential documents should be 

submitted to the reviewing official. 

(2) A written statement, not exceeding 

20 double-spaced pages in length, 

explaining the basis for suspension or 

proposed revocation (respondent’s 

brief). 

(c) Reply Briefs. Within 5 days after 

receiving the opposing party’s 

submission, or 20 days after receiving 

acknowledgment of the request for 

review, whichever is later, each party 

may submit a short reply not to exceed 

10 double-spaced pages. 

(d) Cooperative Efforts. Whenever 

feasible, the parties should attempt to 

develop a joint review file. 

(e) Excessive Documentation. The 

reviewing official may take any 

appropriate step to reduce excessive 

documentation, including the return of 

or refusal to consider documentation 

found to be irrelevant, redundant, or 

unnecessary. 

Section 16.8 When is there an 

opportunity for oral presentation? 

(a) Electing Oral Presentation. If an 

opportunity for an oral presentation is 

desired, the appellant shall request it at 

the time it submits its written request 

for review to the reviewing official. The 

reviewing official will grant the request 

if the official determines that the 

decision-making process will be 

substantially aided by oral presentations 

and arguments. The reviewing official 

may also provide for an oral 

presentation at the official’s own 

initiative or at the request of the 

respondent. 

(b) Presiding Official. The reviewing 

official or designee will be the presiding 

official responsible for conducting the 

oral presentation. 

(c) Preliminary Conference. The 

presiding official may hold a prehearing 

conference (usually a telephone 

conference call) to consider any of the 

following: Simplifying and clarifying 

issues, stipulations and admissions, 

limitations on evidence and witnesses 

that will be presented at the hearing, 

time allotted for each witness and the 

hearing altogether, scheduling the 

hearing, and any other matter that will 

assist in the review process. Normally, 

this conference will be conducted 

informally and off the record; however, 

the presiding official may, at their 

discretion, produce a written document 

summarizing the conference or 

transcribe the conference, either of 

which will be made a part of the record. 

(d) Time and Place of the Oral 

Presentation. The presiding official will 

attempt to schedule the oral 

presentation within 30 days of the date 

the appellant’s request for review is 

received or within 10 days of 

submission of the last reply brief, 

whichever is later. The oral presentation 

will be held at a time and place 

determined by the presiding official 

following consultation with the parties. 

(e) Conduct of the Oral Presentation. 

(1) General. The presiding official is 

responsible for conducting the oral 

presentation. The presiding official may 

be assisted by one or more of the 

official’s employees or consultants in 

conducting the oral presentation and 

reviewing the evidence. While the oral 

presentation will be kept as informal as 

possible, the presiding official may take 

all necessary steps to ensure an orderly 

proceeding. 

(2) Burden of Proof/Standard of Proof. 

In all cases, the respondent bears the 

burden of proving by a preponderance 

of the evidence that its decision to 

suspend or propose revocation is 

appropriate. The appellant, however, 

has a responsibility to respond to the 

respondent’s allegations with evidence 

and argument to show that the 

respondent is wrong. 

(3) Admission of Evidence. The 

Federal Rules of Evidence do not apply 

and the presiding official will generally 

admit all testimonial evidence unless it 

is clearly irrelevant, immaterial, or 

unduly repetitious. Each party may 

make an opening and closing statement, 

may present witnesses as agreed upon 

in the prehearing conference or 

otherwise, and may question the 

opposing party’s witnesses. Since the 

parties have ample opportunity to 

prepare the review file, a party may 

introduce additional documentation 

during the oral presentation only with 

the permission of the presiding official. 

The presiding official may question 

witnesses directly and take such other 

steps necessary to ensure an effective 

and efficient consideration of the 

evidence, including setting time 

limitations on direct and crossexaminations. 

(4) Motions. The presiding official 

may rule on motions including, for 

example, motions to exclude or strike 

redundant or immaterial evidence, 

motions to dismiss the case for 

insufficient evidence, or motions for 

summary judgment. Except for those 

made during the hearing, all motions 

and opposition to motions, including 

argument, must be in writing and be no 

more than 10 double-spaced pages in 

length. The presiding official will set a 

reasonable time for the party opposing 

the motion to reply. 

(5) Transcripts. The presiding official 

shall have the oral presentation 

transcribed and the transcript shall be 

made a part of the record. Either party 

may request a copy of the transcript and 

the requesting party shall be responsible 

for paying for its copy of the transcript. 

(f) Obstruction of Justice or Making of 

False Statements. Obstruction of justice 

or the making of false statements by a 

witness or any other person may be the 

basis for a criminal prosecution under 

18 U.S.C. 1505 or 1001. 

(g) Post-hearing Procedures. At their 

discretion, the presiding official may 

require or permit the parties to submit 

post-hearing briefs or proposed findings 

and conclusions. Each party may submit 

comments on any major prejudicial 

errors in the transcript. 

Section 16.9 Are there expedited 

procedures for review of immediate 

suspension? 

(a) Applicability. When the Secretary 

notifies an HHS-certified laboratory in 

writing that its certification to perform 

drug testing has been immediately 

suspended, the appellant may request 

an expedited review of the suspension 

and any proposed revocation. The 

appellant must submit this request in 

writing to the reviewing official within 

3 days of the date the HHS-certified 

laboratory received notice of the 

suspension. The request for review must 

include a copy of the suspension and 

any proposed revocation, a brief 

statement of why the decision to 

suspend and propose revocation is 

wrong, and the appellant’s request for 

an oral presentation, if desired. A copy 

of the request for review must also be 

sent to the respondent. 

(b) Reviewing Official’s Response. As 

soon as practicable after the request for 

review is received, the reviewing official 

57600 Federal Register / Vol. 84, No. 207 / Friday, October 25, 2019 / Rules and Regulations 

will send an acknowledgment with a 

copy to the respondent. 

(c) Review File and Briefs. Within 7 

days of the date the request for review 

is received, but no later than 2 days 

before an oral presentation, each party 

shall submit to the reviewing official the 

following: 

(1) A review file containing essential 

documents relevant to the review, 

which is tabbed, indexed, and organized 

chronologically; and 

(2) A written statement, not to exceed 

20 double-spaced pages, explaining the 

party’s position concerning the 

suspension and any proposed 

revocation. No reply brief is permitted. 

(d) Oral Presentation. If an oral 

presentation is requested by the 

appellant or otherwise granted by the 

reviewing official, the presiding official 

will attempt to schedule the oral 

presentation within 7–10 days of the 

date of appellant’s request for review at 

a time and place determined by the 

presiding official following consultation 

with the parties. The presiding official 

may hold a prehearing conference in 

accordance with Section 16.8(c) and 

will conduct the oral presentation in 

accordance with the procedures of 

Sections 16.8(e), (f), and (g). 

(e) Written Decision. The reviewing 

official shall issue a written decision 

upholding or denying the suspension or 

proposed revocation and will attempt to 

issue the decision within 7–10 days of 

the date of the oral presentation or 

within 3 days of the date on which the 

transcript is received or the date of the 

last submission by either party, 

whichever is later. All other provisions 

set forth in Section 16.14 will apply. 

(f) Transmission of Written 

Communications. Because of the 

importance of timeliness for these 

expedited procedures, all written 

communications between the parties 

and between either party and the 

reviewing official shall be by facsimile, 

secured electronic transmissions, or 

overnight mail. 

Section 16.10 Are any types of 

communications prohibited? 

Except for routine administrative and 

procedural matters, a party shall not 

communicate with the reviewing or 

presiding official without notice to the 

other party. 

Section 16.11 How are 

communications transmitted by the 

reviewing official? 

(a) Because of the importance of a 

timely review, the reviewing official 

should normally transmit written 

communications to either party by 

facsimile, secured electronic 

transmissions, or overnight mail in 

which case the date of transmission or 

day following mailing will be 

considered the date of receipt. In the 

case of communications sent by regular 

mail, the date of receipt will be 

considered 3 days after the date of 

mailing. 

(b) In counting days, include 

Saturdays, Sundays, and federal 

holidays. However, if a due date falls on 

a Saturday, Sunday, or federal holiday, 

then the due date is the next federal 

working day. 

Section 16.12 What are the authority 

and responsibilities of the reviewing 

official? 

In addition to any other authority 

specified in these procedures, the 

reviewing official and the presiding 

official, with respect to those authorities 

involving the oral presentation, shall 

have the authority to issue orders; 

examine witnesses; take all steps 

necessary for the conduct of an orderly 

hearing; rule on requests and motions; 

grant extensions of time for good 

reasons; dismiss for failure to meet 

deadlines or other requirements; order 

the parties to submit relevant 

information or witnesses; remand a case 

for further action by the respondent; 

waive or modify these procedures in a 

specific case, usually with notice to the 

parties; reconsider a decision of the 

reviewing official where a party 

promptly alleges a clear error of fact or 

law; and to take any other action 

necessary to resolve disputes in 

accordance with the objectives of these 

procedures. 

Section 16.13 What administrative 

records are maintained? 

The administrative record of review 

consists of the review file; other 

submissions by the parties; transcripts 

or other records of any meetings, 

conference calls, or oral presentation; 

evidence submitted at the oral 

presentation; and orders and other 

documents issued by the reviewing and 

presiding officials. 

Section 16.14 What are the 

requirements for a written decision? 

(a) Issuance of Decision. The 

reviewing official shall issue a written 

decision upholding or denying the 

suspension or proposed revocation. The 

decision will set forth the reasons for 

the decision and describe the basis 

therefore in the record. Furthermore, the 

reviewing official may remand the 

matter to the respondent for such 

further action as the reviewing official 

deems appropriate. 

(b) Date of Decision. The reviewing 

official will attempt to issue their 

decision within 15 days of the date of 

the oral presentation, the date on which 

the transcript is received, or the date of 

the last submission by either party, 

whichever is later. If there is no oral 

presentation, the decision will normally 

be issued within 15 days of the date of 

receipt of the last reply brief. Once 

issued, the reviewing official will 

immediately communicate the decision 

to each party. 

(c) Public Notice. If the suspension 

and proposed revocation are upheld, the 

revocation will become effective 

immediately and the public will be 

notified by publication of a notice in the 

Federal Register. If the suspension and 

proposed revocation are denied, the 

revocation will not take effect and the 

suspension will be lifted immediately. 

Public notice will be given by 

publication in the Federal Register. 

Section 16.15 Is there a review of the 

final administrative action? 

Before any legal action is filed in 

court challenging the suspension or 

proposed revocation, respondent shall 

exhaust administrative remedies 

provided under this subpart, unless 

otherwise provided by Federal Law. The 

reviewing official’s decision, under 

Section 16.9(e) or 16.14(a) constitutes 

final agency action and is ripe for 

judicial review as of the date of the 

decision. 

[FR Doc. 2019–22684 Filed 10–24–19; 8:45 am] 

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