USCG Regulations 49 CFR Part 40 – DOT Procedures Continue to Next Part
46 CFR Part 16 – Coast Guard Regulations (click here for link)
49 CFR Part 40 — Subparts A–D
Administrative Provisions, Employer Responsibilities, Collection Personnel & Sites
Authority: 49 U.S.C. 102, 301, 322, 5331, 20140, 31306, and 54101 et seq.
Source: 65 FR 79526, Dec. 19, 2000, unless otherwise noted.
Table of Contents
Subpart A—Administrative Provisions
§ 40.1 Who does this regulation cover?
(a) This part tells all parties who conduct drug and alcohol tests required by Department of Transportation (DOT) agency regulations how to conduct these tests and what procedures to use.
(b) This part concerns the activities of transportation employers, safety-sensitive transportation employees (including self-employed individuals, contractors and volunteers as covered by DOT agency regulations), and service agents.
(c) Nothing in this part is intended to supersede or conflict with the implementation of the Federal Railroad Administration’s post-accident testing program (see 49 CFR 219.200).
§ 40.3 What do the terms used in this part mean?
In this part, the terms listed in this section have the following meanings:
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.
Affiliate. Persons are affiliates of one another if, directly or indirectly, one controls or has the power to control the other, or a third party controls or has the power to control both. Indicators of control include, but are not limited to: interlocking management or ownership; shared interest among family members; shared facilities or equipment; or common use of employees. Following the issuance of a public interest exclusion, an organization having the same or similar management, ownership, or principal employees as the service agent concerning whom a public interest exclusion is in effect is regarded as an affiliate. This definition is used in connection with the public interest exclusion procedures of Subpart R of this part.
Air blank. In evidential breath testing devices (EBTs) using gas chromatography technology, a reading of the device’s internal standard. In all other EBTs, a reading of ambient air containing no alcohol.
Alcohol. The intoxicating agent in beverage alcohol, ethyl alcohol or other low molecular weight alcohols, including methyl or isopropyl alcohol.
Alcohol concentration. The alcohol in a volume of breath expressed in terms of grams of alcohol per 210 liters of breath as indicated by a breath test under this part.
Alcohol confirmation test. A subsequent test using an EBT, following a screening test with a result of 0.02 or greater, that provides quantitative data about the alcohol concentration.
Alcohol screening device (ASD). A breath or saliva device, other than an EBT, that is approved by the National Highway Traffic Safety Administration (NHTSA) and appears on ODAPC’s Web page for “Approved Screening Devices to Measure Alcohol in Bodily Fluids” because it conforms to the model specifications from NHTSA.
Alcohol screening test. An analytic procedure to determine whether an employee may have a prohibited concentration of alcohol in a breath or saliva specimen.
Alcohol testing site. A place selected by the employer where employees present themselves for the purpose of providing breath or saliva for an alcohol test.
Alcohol use. The drinking or swallowing of any beverage, liquid mixture or preparation (including any medication), containing alcohol.
Aliquot. A fractional part of a specimen used for testing. It is taken as a sample representing the whole specimen.
Alternate specimen. An authorized specimen, other than the type of specimen previously collected or attempted to be collected.
Breath Alcohol Technician (BAT). A person who instructs and assists employees in the alcohol testing process and operates an evidential breath testing device.
Cancelled test. A drug or alcohol test that has a problem identified that cannot be or has not been corrected, or which this part otherwise requires to be cancelled. A cancelled test is neither a positive nor a negative test.
Chain of custody. The procedure used to document the handling of the urine specimen from the time the employee gives the specimen to the collector until the specimen is destroyed. This procedure uses the Federal Drug Testing Custody and Control Form (CCF) as approved by the Office of Management and Budget.
Collection container. A container used to collect a specimen.
Collection site. A place selected by the employer where employees present themselves for the purpose of providing a specimen for a drug test.
Collector. A person who instructs and assists employees at a collection site, who receives and makes an initial inspection of the specimen provided by those employees, and who initiates and completes the CCF. Commercial Driver’s License Drug and Alcohol Clearinghouse (Clearinghouse). A database, administered by the Federal Motor Carrier Safety Administration, containing records of commercial motor vehicle drivers’ violations of controlled substances and alcohol testing program requirements, as set forth in part 382 of this title, as well as their return-to-duty status.
Confirmatory drug test. A second analytical procedure performed on a different aliquot of the original specimen to identify and quantify a specific drug or drug metabolite.
Confirmatory validity test. A second test performed on a different aliquot of the original urine specimen to further support a validity test result.
Confirmed drug test. A confirmation test result received by an MRO from a laboratory.
Consortium/Third-party administrator (C/TPA). A service agent that provides or coordinates the provision of a variety of drug and alcohol testing services to employers. C/TPAs typically perform administrative tasks concerning the operation of the employers’ drug and alcohol testing programs. This term includes, but is not limited to, groups of employers who join together to administer, as a single entity, the DOT drug and alcohol testing programs of its members. C/TPAs are not “employers” for purposes of this part.
Continuing education. Training for substance abuse professionals (SAPs) who have completed qualification training and are performing SAP functions, designed to keep SAPs current on changes and developments in the DOT drug and alcohol testing program.
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 substituted) or the need for further testing.
Designated employer representative (DER). An employee authorized by the employer to take immediate action(s) to remove employees from safety-sensitive duties, or cause employees to be removed from these covered duties, and to make required decisions in the testing and evaluation processes. The DER also receives test results and other communications for the employer, consistent with the requirements of this part. Service agents cannot act as DERs.
Dilute specimen. A urine specimen with creatinine and specific gravity values that are lower than expected for human urine.
DOT, The Department, DOT Agency. These terms encompass all DOT agencies, including, but not limited to, the Federal Aviation Administration (FAA), the Federal Railroad Administration (FRA), the Federal Motor Carrier Safety Administration (FMCSA), the Federal Transit Administration (FTA), the National Highway Traffic Safety Administration (NHTSA), the Pipeline and Hazardous Materials Safety Administration (PHMSA), and the Office of the Secretary (OST). For purposes of this part, the United States Coast Guard (USCG), in the Department of Homeland Security, is considered to be a DOT agency for drug testing purposes only since the USCG regulation does not incorporate Part 40 for its alcohol testing program. These terms include any designee of a DOT agency.
Drugs. The drugs for which tests are required under this part and DOT agency regulations are marijuana, cocaine, amphetamines, phencyclidine (PCP), and opioids.
Employee. Any person who is designated in a DOT agency regulation as subject to drug testing and/or alcohol testing. The term includes individuals currently performing safety-sensitive functions designated in DOT agency regulations and applicants for employment subject to pre-employment testing. For purposes of drug testing under this part, the term employee has the same meaning as the term “donor” as found on CCF and related guidance materials produced by the Department of Health and Human Services.
Employer. A person or entity employing one or more employees (including an individual who is self-employed) subject to DOT agency regulations requiring compliance with this part. The term includes an employer’s officers, representatives, and management personnel. Service agents are not employers for the purposes of this part.
Error Correction Training. Training provided to BATs, collectors, and screening test technicians (STTs) following an error that resulted in the cancellation of a drug or alcohol test. Error correction training must be provided in person or by a means that provides real-time observation and interaction between the instructor and trainee.
Evidential Breath Testing Device (EBT). A device that is approved by the National Highway Traffic Safety Administration (NHTSA) for the evidential testing of breath at the .02 and .04 alcohol concentrations, and appears on ODAPC’s Web page for “Approved Evidential Breath Measurement Devices” because it conforms with the model specifications available from NHTSA.
HHS. The Department of Health and Human Services or any designee of the Secretary, Department of Health and Human Services.
Initial drug test. The first test used to differentiate a negative specimen from one that requires further testing for drugs or drug metabolites.
Initial specimen validity test. The first test used to determine if a specimen is adulterated, diluted, substituted, or invalid.
Invalid result. The result reported by an HHS-certified in accordance with the criteria established by HHS when a positive, negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test.
Laboratory. Any U.S. laboratory certified by HHS under the National Laboratory Certification Program as meeting the minimum standards set by HHS; or, in the case of foreign laboratories, a laboratory approved for participation by DOT under this part.
Limit of Detection (LOD). The lowest concentration at which the analyte (e.g., drug or drug metabolite) can be identified.
Limit of Quantitation (LOQ). For quantitative assays, the lowest concentration at which the identity and concentration of the analyte (e.g., drug or drug metabolite) can be accurately established.
Medical Review Officer (MRO). A person who is a licensed physician and who is responsible for receiving and reviewing laboratory results generated by an employer’s drug testing program and evaluating medical explanations for certain drug test results.
Negative result. The result reported by an HHS-certified laboratory to an MRO when a specimen contains no drug or the concentration of the drug is less than the cutoff concentration for the drug or drug class and the specimen is a valid specimen.
Non-negative specimen. A specimen that is reported as adulterated, substituted, positive (for drug(s) or drug metabolite(s)), or invalid.
Compliance (ODAPC)”
Office of Drug and Alcohol Policy and Compliance (ODAPC). The office in the Office of the Secretary, DOT, that is responsible for coordinating drug and alcohol testing program matters within the Department and providing information concerning the implementation of this part.
Oral fluid specimen. A specimen that is collected from an employee’s oral cavity and is a combination of physiological fluids produced primarily by the salivary glands. An oral fluid specimen is considered to be a direct observation collection for all purposes of this part.
Oxidizing adulterant. A substance that acts alone or in combination with other substances to oxidize drugs or drug metabolites to prevent the detection of the drug or drug metabolites, or affects the reagents in either the initial or confirmatory drug test.
Primary specimen. In drug testing, the specimen bottle that is opened and tested by a first laboratory to determine whether the employee has a drug or drug metabolite in his or her system; and for the purpose of specimen validity testing. The primary specimen is the portion of the donor’s subdivided specimen designated as the primary (“A”) specimen by the collector to distinguish it from the split (“B”) specimen, as defined in this section.
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 cutoff concentrations.
Qualification Training. The training required in order for a collector, BAT, MRO, SAP, or STT to be qualified to perform their functions in the DOT drug and alcohol testing program. Qualification training may be provided by any appropriate means (e.g., classroom instruction, internet application, CD-ROM, video).
Reconfirmed. The result reported for a split (Bottle B) specimen when the second HHS-certified laboratory corroborates the original result reported for the primary (Bottle A) specimen.
Refresher Training. The training required periodically for qualified collectors, BATs, and STTs to review basic requirements and provide instruction concerning changes in technology (e.g., new testing methods that may be authorized) and amendments, interpretations, guidance, and issues concerning this part and DOT agency drug and alcohol testing regulations. Refresher training can be provided by any appropriate means (e.g., classroom instruction, internet application, CD-ROM, video).
Rejected for testing. The result reported by an HHS-certified laboratory when no tests are performed for a specimen because of a fatal flaw or a correctable flaw that is not corrected.
Screening Test Technician (STT). A person who instructs and assists employees in the alcohol testing process and operates an ASD.
Secretary. The Secretary of Transportation or the Secretary’s designee.
Service agent. Any person or entity, other than an employee of the employer, who provides services to employers and/or employees in connection with DOT drug and alcohol testing requirements. This includes, but is not limited to, collectors, BATs and STTs, laboratories, MROs, substance abuse professionals, and C/TPAs. To act as service agents, persons and organizations must meet DOT qualifications, if applicable. Service agents are not employers for purposes of this part.
Shipping container. A container that is used for transporting and protecting specimen bottles and associated documents from the collection site to the laboratory.
Specimen. Fluid, breath, or other material collected from an employee at the collection site for the purpose of a drug or alcohol test.
Specimen bottle. The bottle that, after being sealed and labeled according to the procedures in this part, is used to hold a primary (“A”) or split (“B”) specimen during transportation to the laboratory. In the context of oral fluid testing, it may be referred to as a “vial,” “tube,” or “bottle.”
Split specimen. In drug testing, the specimen that is sent to a first laboratory and stored with its original seal intact, and which is transported to a second laboratory for retesting at the employee’s request following MRO verification of the primary specimen as positive, adulterated or substituted.
Split specimen collection. A collection in which the single specimen collected is divided into two separate specimen bottles, the primary specimen (Bottle A) and the split specimen (Bottle B).
SSN or Employee ID No. This number serves as a unique identifier that must be used on the Federal Drug Testing Custody and Control Form (CCF) or Alcohol Testing Form (ATF) for a donor, on the MRO’s reports, on SAP reports, or on other documents that are required under this part. For all purposes of this part, this term means: only the Commercial Driver’s License (CDL) Number and State of issuance for drivers tested under the authority of the Federal Motor Carrier Safety Administration (FMCSA); and, for all drivers and other safety-sensitive employees tested under the authority of the other DOT agencies, this can be the individual’s actual Social Security Number, a unique identifier issued by the employer, a State-issued identification card number, a State-issued driver’s license number (including a CDL number) or any other State-issued or federally-issued identification number.
Stand-down. The practice of temporarily removing an employee from the performance of safety-sensitive functions based only on a report from a laboratory to the MRO of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test, before the MRO has completed verification of the test result.
Substance Abuse Professional (SAP). A person who evaluates employees who have violated a DOT drug and alcohol regulation and makes recommendations concerning education, treatment, follow-up testing, and aftercare.
Substituted specimen. An employee’s specimen not consistent with a normal human specimen, as determined by HHS (e.g., a urine specimen, with creatinine and specific gravity values that are so diminished, or so divergent that they are not consistent with normal human urine).
Undiluted (neat) oral fluid. An oral fluid specimen to which no other solid or liquid has been added. For example: 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.
Urine specimen. Urine collected from an employee at the collection site for the purpose of a drug test.
Verified test. A drug test result or validity testing result from an HHS-certified laboratory that has undergone review and final determination by the MRO.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 71 FR 49384, Aug. 23, 2006; 71 FR 55347, Sept. 22, 2006; 73 FR 35969, June 25, 2008; 75 FR 49861, Aug. 16, 2010; 76 FR 59577, Sept. 27, 2011; 80 FR 19553, Apr. 13, 2015; 81 FR 52365, Aug. 8, 2016; 82 FR 52243, Nov. 13, 2017; 88 FR 27636, May 2, 2023]
§ 40.5 Who issues authoritative interpretations of this regulation?
ODAPC and the DOT Office of General Counsel (OGC) provide written interpretations of the provisions of this part. These written DOT interpretations are the only official and authoritative interpretations concerning the provisions of this part. DOT agencies may incorporate ODAPC/OGC interpretations in written guidance they issue concerning drug and alcohol testing matters. Only Part 40 interpretations issued after August 1, 2001, are considered valid.
§ 40.7 How can you get an exemption from a requirement in this regulation?
(a) If you want an exemption from any provision of this part, you must request it in writing from the Office of the Secretary of Transportation, under the provisions and standards of 49 CFR part 5. You must send requests for an exemption to the following address: Department of Transportation, Deputy Assistant General Counsel for Regulation and Enforcement, 1200 New Jersey Avenue, SE., Washington, DC 20590.
(b) Under the standards of 49 CFR part 5, we will grant the request only if the request documents special or exceptional circumstances, not likely to be generally applicable and not contemplated in connection with the rulemaking that established this part, that make your compliance with a specific provision of this part impracticable.
(c) If we grant you an exemption, you must agree to take steps we specify to comply with the intent of the provision from which an exemption is granted.
(d) We will issue written responses to all exemption requests.
Subpart B—Employer Responsibilities
§ 40.11 What are the general responsibilities of employers under this regulation?
(a) As an employer, you are responsible for meeting all applicable requirements and procedures of this part.
(b) You are responsible for all actions of your officials, representatives, and agents (including service agents) in carrying out the requirements of the DOT agency regulations.
(c) All agreements and arrangements, written or unwritten, between and among employers and service agents concerning the implementation of DOT drug and alcohol testing requirements are deemed, as a matter of law, to require compliance with all applicable provisions of this part and DOT agency drug and alcohol testing regulations. Compliance with these provisions is a material term of all such agreements and arrangements.
§ 40.13 How do DOT drug and alcohol tests relate to non-DOT tests?
(a) DOT tests must be completely separate from non-DOT tests in all respects.
(b) DOT tests must take priority and must be conducted and completed before a non-DOT test is begun. When conducting a urine DOT drug test, you must discard any excess urine left over from a DOT test and collect a separate urine void for the subsequent non-DOT test.
(c) Except as provided in paragraph (d) of this section, you must not perform any tests on DOT specimens other than those tests specifically authorized by this part or DOT agency regulations. For example, you must not test a DOT specimen for additional drugs. In addition, a laboratory is prohibited from making a DOT specimen available for a DNA test or other types of specimen identity testing.
(d) When a DOT urine drug test collection is conducted as part of a physical examination required by DOT agency regulations, it is permissible to conduct medical tests related to this physical examination (e.g., for glucose) on any specimen remaining in the collection container after the DOT portion has been sealed into the specimen bottles.
(e) A non-DOT drug or alcohol test administered, as part of a physical examination, is not a DOT drug or alcohol test for purposes of this part and/or related DOT agency drug and alcohol testing rules, if that test was performed to determine if an employee is medically qualified for a license or certificate. Consequently, the results of such a test do not have consequences under this part.
(f) No one is permitted to change or disregard the results of DOT tests based on the results of non-DOT tests. For example, as an employer you must not disregard a verified positive DOT drug test result because the employee presents a negative test result from a blood or urine specimen collected by the employee’s physician or a DNA test result purporting to question the identity of the DOT specimen.
(g) As an employer, you must not use the CCF or the ATF in your non-DOT drug and alcohol testing programs. This prohibition includes the use of the DOT forms with references to DOT programs and agencies crossed out. You also must always use the CCF and ATF for all your DOT-mandated drug and alcohol tests.
(h) No one is permitted to conduct a DOT drug or alcohol test on an individual who is not a DOT-regulated employee, as defined by the DOT agency regulations.
[65 FR 79526, Dec. 19, 2000, as amended at 88 FR 27637, May 2, 2023]
§ 40.14 What collection information must employers provide to collectors?
As an employer, or an employer’s service agent—for example a C/TPA, you must ensure the collector has the following information when conducting a specimen collection for you:
(a) Full name of the employee being tested.
(b) SSN or Employee ID No.
(c) Laboratory name and address (can be pre-printed on the CCF).
(d) Employer name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-A).
(e) DER information required at § 40.36.
(f) MRO name, address, phone number, and fax number (can be pre-printed on the CCF at Step 1-B).
(g) The DOT Agency which regulates the employee’s safety-sensitive duties (the checkmark can pre-printed in the appropriate box on the CCF at Step 1-D).
(h) Test reason, as appropriate: Pre-employment; Random; Reasonable Suspicion/Reasonable Cause; PostAccident; Return-to-Duty; and Follow-up. (i)
Whether the test is to be observed or not (see § 40.67 of this part).
(j)
(Optional) C/TPA name, address, phone, and fax number (can be pre-printed on the CCF).
(k) Specimen type to be collected (i.e., oral fluid or urine).
[75 FR 59107, Sept. 27, 2010, as amended at 88 FR 27637, May 2, 2023; 89 FR 51983, June 21, 2024]
§ 40.15 May an employer use a service agent to meet DOT drug and alcohol testing requirements?
(a) As an employer, you may use a service agent to perform the tasks needed to comply with this part and DOT agency drug and alcohol testing regulations, consistent with the requirements of Subpart Q and other applicable provisions of this part.
(b) As an employer, you are responsible for ensuring that the service agents you use meet the qualifications set forth in this part (e.g., § 40.121 for MROs). You may require service agents to show you documentation that they meet the requirements of this part (e.g., documentation of MRO qualifications required by § 40.121(e)).
(c) You remain responsible for compliance with all applicable requirements of this part and other DOT drug and alcohol testing regulations, even when you use a service agent. If you violate this part or other DOT drug and alcohol testing regulations because a service agent has not provided services as our rules require, a DOT agency can subject you to sanctions. Your good faith use of a service agent is not a defense in an enforcement action initiated by a DOT agency in which your alleged noncompliance with this part or a DOT agency drug and alcohol regulation may have resulted from the service agent’s conduct.
(d) As an employer, you must not permit a service agent to act as your DER.
§ 40.17 Is an employer responsible for obtaining information from its service agents?
Yes, as an employer, you are responsible for obtaining information required by this part from your service agents. This is true whether or not you choose to use a C/TPA as an intermediary in transmitting information to you. For example, suppose an applicant for a safety-sensitive job takes a pre-employment drug test, but there is a significant delay in your receipt of the test result from an MRO or C/TPA. You must not assume that “no news is good news” and permit the applicant to perform safety-sensitive duties before receiving the result. This is a violation of the Department’s regulations.
§ 40.19 [Reserved]
§ 40.21 May an employer stand down an employee before the MRO has completed the verification process?
(a) As an employer, you are prohibited from standing employees down, except consistent with a waiver a DOT agency grants under this section.
(b) You may make a request to the concerned DOT agency for a waiver from the prohibition of paragraph (a) of this section. Such a waiver, if granted, permits you to stand an employee down following the MRO’s receipt of a laboratory report of a confirmed positive test for a drug or drug metabolite, an adulterated test, or a substituted test pertaining to the employee.
(1) For this purpose, the concerned DOT agency is the one whose drug and alcohol testing rules apply to the majority of the covered employees in your organization. The concerned DOT agency uses its applicable procedures for considering requests for waivers.
(2) Before taking action on a waiver request, the concerned DOT agency coordinates with other DOT agencies that regulate the employer’s other covered employees.
(3) The concerned DOT agency provides a written response to each employer that petitions for a waiver, setting forth the reasons for the agency’s decision on the waiver request.
(c) Your request for a waiver must include, as a minimum, the following elements:
(1) Information about your organization: (i)
Your determination that standing employees down is necessary for safety in your organization and a statement of your basis for it, including any data on safety problems or incidents that could have been prevented if a stand-down procedure had been in place;
(ii) Data showing the number of confirmed laboratory positive, adulterated, and substituted test results for your employees over the two calendar years preceding your waiver request, and the number and percentage of those test results that were verified positive, adulterated, or substituted by the MRO;
(iii) Information about the work situation of the employees subject to stand-down, including a description of the size and organization of the unit(s) in which the employees work, the process through which employees will be informed of the stand-down, whether there is an in-house MRO, and whether your organization has a medical disqualification or stand-down policy for employees in situations other than drug and alcohol testing; and
(iv) A statement of which DOT agencies regulate your employees.
(2) Your proposed written company policy concerning stand-down, which must include the following elements: (i)
Your assurance that you will distribute copies of your written policy to all employees that it covers;
(ii) Your means of ensuring that no information about the confirmed positive, adulterated, or substituted test result or the reason for the employee’s temporary removal from performance of safety-sensitive functions becomes available, directly or indirectly, to anyone in your organization (or subsequently to another employer) other than the employee, the MRO and the DER;
(iii) Your means of ensuring that all covered employees in a particular job category in your organization are treated the same way with respect to stand-down;
(iv) Your means of ensuring that a covered employee will be subject to stand-down only with respect to the actual performance of safety-sensitive duties;
(v) Your means of ensuring that you will not take any action adversely affecting the employee’s pay and benefits pending the completion of the MRO’s verification process. This includes continuing to pay the employee during the period of the stand-down in the same way you would have paid him or her had he or she not been stood down;
(vi) Your means of ensuring that the verification process will commence no later than the time an employee is temporarily removed from the performance of safety-sensitive functions and that the period of stand-down for any employee will not exceed five days, unless you are informed in writing by the MRO that a longer period is needed to complete the verification process; and
(vii) Your means of ensuring that, in the event that the MRO verifies the test negative or cancels it—
(A) You return the employee immediately to the performance of safety-sensitive duties;
(B) The employee suffers no adverse personnel or financial consequences as a result;
(C) For a verified negative result, the employee will not be required to submit an alternate specimen for the same testing action. For a cancelled result, the employee could be required to submit an alternate specimen on a re-collection; and
(D) You maintain no individually identifiable record that the employee had a confirmed laboratory positive, adulterated, or substituted test result (i.e., you maintain a record of the test only as a negative or cancelled test).
(d) The Administrator of the concerned DOT agency, or his or her designee, may grant a waiver request only if he or she determines that, in the context of your organization, there is a high probability that the procedures you propose will effectively enhance safety and protect the interests of employees in fairness and confidentiality.
(1) The Administrator, or his or her designee, may impose any conditions he or she deems appropriate on the grant of a waiver.
(2) The Administrator, or his or her designee, may immediately suspend or revoke the waiver if he or she determines that you have failed to protect effectively the interests of employees in fairness and confidentiality, that you have failed to comply with the requirements of this section, or that you have failed to comply with any other conditions the DOT agency has attached to the waiver.
(e) You must not stand employees down in the absence of a waiver, or inconsistent with the terms of your waiver. If you do, you are in violation of this part and DOT agency drug testing regulations, and you are subject to enforcement action by the DOT agency just as you are for other violations of this part and DOT agency rules.
[65 FR 79526, Dec. 19, 2000, as amended at 88 FR 27637, May 2, 2023]
§ 40.23 What actions do employers take after receiving verified test results?
(a) As an employer who receives a verified positive drug test result, you must immediately remove the employee involved from performing safety-sensitive functions. You must take this action upon receiving the initial report of the verified positive test result. Do not wait to receive the written report or the result of a split specimen test.
(b) As an employer who receives a verified adulterated or substituted drug test result, you must consider this a refusal to test and immediately remove the employee involved from performing safety-sensitive functions. You must take this action on receiving the initial report of the verified adulterated or substituted test result. Do not wait to receive the written report or the result of a split specimen test.
(c) As an employer who receives an alcohol test result of 0.04 or higher, you must immediately remove the employee involved from performing safety-sensitive functions. If you receive an alcohol test result of 0.02-0.039, you must temporarily remove the employee involved from performing safety-sensitive functions, as provided in applicable DOT agency regulations. Do not wait to receive the written report of the result of the test.
(d) As an employer, when an employee has a verified positive, adulterated, or substituted test result, or has otherwise violated a DOT agency drug and alcohol regulation, you must not return the employee to the performance of safety-sensitive functions until or unless the employee successfully completes the returnto-duty process of Subpart O of this part.
(e) As an employer who receives a drug test result indicating that the employee’s specimen was dilute, take action as provided in § 40.197.
(f) As an employer who receives a drug test result indicating that the employee’s test was cancelled because it was invalid and that a second collection must take place under direct observation—
(1) You must immediately direct the employee to provide a new specimen under direct observation (either an oral fluid specimen or a urine specimen under direct observation).
(2) You must not attach consequences to the finding that the test was invalid other than collecting a new specimen under direct observation.
(3) You must not give any advance notice of this test requirement to the employee.
(4) You must instruct the collector to note on the CCF the same reason (e.g., random test, post-accident test) and DOT Agency (e.g., check DOT and FMCSA) as for the original collection.
(5) You must ensure that the collector conducts the collection under direct observation (either an oral fluid specimen or a urine specimen under direct observation).
(g) As an employer who receives a cancelled test result when a negative result is required (e.g., preemployment, return-to-duty, or follow-up test), you must direct the employee to provide another specimen immediately.
(h) As an employer, you may also be required to take additional actions required by DOT agency regulations (e.g., FAA rules require some positive drug tests to be reported to the Federal Air Surgeon). (i)
As an employer, you must not alter a drug or alcohol test result transmitted to you by an MRO, BAT, or C/ TPA.
[65 FR 79526, Dec. 19, 2000, as amended at 71 FR 49384, Aug. 23, 2006; 73 FR 35970, June 25, 2008; 75 FR 59107, Sept. 27, 2010; 88 FR 27637, May 2, 2023]
§ 40.25 Must an employer check on the drug and alcohol testing record of employees it is intending to use to perform safety-sensitive duties?
(a)
(1) Yes, as an employer, you must, after obtaining an employee’s written consent, request the information about the employee listed in paragraphs (b) through (j) of this section. This requirement applies only to employees seeking to begin performing safety-sensitive duties for you for the first time (i.e., a new hire, an employee transferring into a safety-sensitive position). If the employee refuses to provide this written consent, you must not permit the employee to perform safetysensitive functions.
(2) If you are an employer regulated by FMCSA, you must comply with the requirements of this section by using the FMCSA’s Drug and Alcohol Clearinghouse in accordance with 49 CFR 382.71(a). In addition, you must continue to comply with the requirements of this § 40.25 when checking an employee’s testing history with employers regulated by a DOT operating administration other than FMCSA.
(3) If you are an employer regulated by FMCSA, with a prospective employee subject to drug and alcohol testing with a DOT agency other than FMCSA, you must continue to request the information about the employee listed in paragraphs (b) through (j) of this section. For example, if you are an employer
regulated by both FMCSA and PHMSA, and you are hiring an employee to perform functions regulated by both DOT agencies, then you must query FMCSA’s Clearinghouse to satisfy FMCSA’s requirements and you must request the information listed in paragraphs (b) through (j) of this section to satisfy PHMSA’s requirements.
(b) You must request the information listed in this paragraph (b) from DOT-regulated employers who have employed the employee during any period during the two years before the date of the employee’s application or transfer:
(1) Alcohol tests with a result of 0.04 or higher alcohol concentration;
(2) Verified positive drug tests;
(3) Refusals to be tested (including verified adulterated or substituted drug test results);
(4) Other violations of DOT agency drug and alcohol testing regulations; and
(5) With respect to any employee who violated a DOT drug and alcohol regulation, documentation of the employee’s successful completion of DOT return-to-duty requirements (including follow-up tests). If the previous employer does not have information about the return-do-duty process (e.g., an employer who did not hire an employee who tested positive on a pre-employment test), you must seek to obtain this information from the employee.
(c) The information obtained from a previous employer includes any drug or alcohol test information obtained from previous employers under this section or other applicable DOT agency regulations.
(d) If feasible, you must obtain and review this information before the employee first performs safetysensitive functions. If this is not feasible, you must obtain and review the information as soon as possible. However, you must not permit the employee to perform safety-sensitive functions after 30 days from the date on which the employee first performed safety-sensitive functions, unless you have obtained or made and documented a good faith effort to obtain this information.
(e) If you obtain information that the employee has violated a DOT agency drug and alcohol regulation, you must not use the employee to perform safety-sensitive functions unless you also obtain information that the employee has subsequently complied with the return-to-duty requirements of Subpart O of this part and DOT agency drug and alcohol regulations.
(f) You must provide to each of the employers from whom you request information under paragraph (b) of this section written consent for the release of the information cited in paragraph (a) of this section.
(g) The release of information under this section must be in any written form (e.g., fax, e-mail, letter) that ensures confidentiality. As the previous employer, you must maintain a written record of the information released, including the date, the party to whom it was released, and a summary of the information provided.
(h) If you are an employer from whom information is requested under paragraph (b) of this section, you must, after reviewing the employee’s specific, written consent, immediately release the requested information to the employer making the inquiry. (i)
As the employer requesting the information required under this section, you must maintain a written, confidential record of the information you obtain or of the good faith efforts you made to obtain the information. You must retain this information for three years from the date of the employee’s first performance of safety-sensitive duties for you.
(j)
As the employer, you must also ask the employee whether he or she has tested positive, or refused to test, on any pre-employment drug or alcohol test administered by an employer to which the employee applied for, but did not obtain, safety-sensitive transportation work covered by DOT agency drug and alcohol testing rules during the past two years. If the employee admits that he or she had a positive test or a refusal to test, you must not use the employee to perform safety-sensitive functions for you, until and unless the employee documents successful completion of the return-to-duty process (see paragraphs (b)(5) and (e) of this section).
[65 FR 79526, Dec. 19, 2000, as amended at 88 FR 27637, May 2, 2023]
§ 40.26 What form must an employer use to report Management Information System (MIS) data to a DOT agency?
As an employer, when you are required to report MIS data to a DOT agency, you must use the U.S. Department of Transportation Drug and Alcohol Testing MIS Data Collection Form to report that data. You must use the form and instructions referenced at appendix J to part 40. You must submit the MIS report in accordance with rule requirements (e.g., dates for submission; selection of companies required to submit, and method of reporting) established by the DOT agency regulating your operation.
[84 FR 16773, Apr. 23, 2019, as amended at 88 FR 27638, May 2, 2023]
§ 40.27 May an employer require an employee to sign a consent or release in connection with the DOT drug and alcohol testing program?
No, as an employer, you must not require an employee to sign a consent, release, waiver of liability, or indemnification agreement with respect to any part of the drug or alcohol testing process covered by this part (including, but not limited to, collections, laboratory testing, MRO and SAP services).
[66 FR 41950, Aug. 9, 2001]
Subpart C—Specimen Collection Personnel
§ 40.31 Who may collect specimens for DOT drug testing?
(a) Collectors meeting the requirements of this subpart are the only persons authorized to collect urine specimens for DOT drug testing.
(b) A urine collector must meet training requirements of § 40.33.
(c) An oral fluid collector must meet the training requirements of § 40.35.
(d) To avoid the appearance of a conflict of interest, if you are the immediate supervisor of the employee being tested, you must not act as the collector when that employee is tested, unless no other collector is available and you are permitted to do so under DOT agency drug and alcohol regulations.
(e) You must not act as the collector for the employee being tested if you work for a HHS-certified laboratory (e.g., as a technician or accessioner) and could link the employee with a urine specimen, drug testing result, or laboratory report.
(f) Employees are not permitted to be their own collector.
(1) An employee who is a qualified collector is not permitted to be their own collector; another qualified collector must perform the collection in accordance with this part.
(2) To avoid a potential conflict of interest, a collector must not be related to the employee being tested (e.g., spouse, ex-spouse, relative) or a close personal friend.
[65 FR 79526, Dec. 19, 2000, as amended at 88 FR 27637, May 2, 2023]
§ 40.33 What training requirements must a collector meet for urine collection?
To be permitted to act as a urine collector in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, the current “DOT Urine Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, the DOT Urine Specimen Collection Procedures Guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE., Washington DC, 20590, 202-366-3784, or on the ODAPC Web site (https://www.transportation.gov/ odapc). You must keep current on any changes to these materials. You must subscribe to the ODAPC listserve at: https://www.transportation.gov/odapc/get-odapc-email-updates.
(b) Qualification training. You must receive qualification training meeting the requirements of this paragraph. Qualification training must provide instruction on the following subjects:
(1) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;
(2) “Problem” collections (e.g., situations like “shy bladder” and attempts to tamper with a specimen);
(3) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(4) The collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate;
(c) Initial Proficiency Demonstration. Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections.
(1) The five mock collections must include two uneventful collection scenarios, one insufficient quantity of urine scenario, one temperature out of range scenario, and one scenario in which the employee refuses to sign the CCF and initial the specimen bottle tamper-evident seal.
(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between the instructor and trainee, and attest in writing that the mock collections are “error-free.” This person must be a qualified urine collector who has demonstrated necessary knowledge, skills, and abilities by— (i)
Regularly conducting DOT urine drug test collections for a period of at least one year;
(ii) Conducting urine collector training under this part for at least one year; or
(iii) Successfully completing a urine “train the trainer” course.
(d) You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions.
(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) of this section, you must complete refresher training that meets all the requirements of paragraphs (b) and (c) of this section.
(f) Error correction training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining. Errors that cause cancellation but occur outside the collection process (e.g., when a specimen is crushed or otherwise damaged during the transportation process, or is lost in transit), the cancellation would not be the result of an error by the collector during the collection process and does not require the collector to be retrained.
(1) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) of this section.
(2) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.
(3) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”
(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
[65 FR 79526, Dec. 19, 2000; 66 FR 3885, Jan. 17, 2001, as amended at 66 FR 41950, Aug. 9, 2001; 82 FR 52244, Nov. 13, 2017; 88 FR 27638, May 2, 2023; 89 FR 87798, Nov. 5, 2024]
§ 40.35 What training requirements must a collector meet for oral fluid collection?
To be permitted to act as an oral fluid collector in the DOT drug testing program, you must meet each of the requirements of this section:
(a) Basic information. You must be knowledgeable about this part, the current “DOT Oral Fluid Specimen Collection Procedures Guidelines,” and DOT agency regulations applicable to the employers for whom you perform collections. DOT agency regulations, guidelines, and other materials are available from ODAPC (Department of Transportation, 1200 New Jersey Avenue SE, Washington DC, 20590, 202-366-3784, or on the ODAPC website (https://www.transportation.gov/odapc). You must keep current on any changes to these materials. You must subscribe to the ODAPC list-serve at: https://www.transportation.gov/odapc/ get-odapc-email-updates.
(b) Qualification training. You must receive qualification training meeting the requirements of this paragraph (b). Qualification training must provide instruction on the following subjects:
(1) Training on the testing procedures of this part;
(2) Training to proficiency in the operation of the particular oral fluid collection device(s) you will be using.
(3) All steps necessary to complete a collection correctly and the proper completion and transmission of the CCF;
(4) “Problem” collections (e.g., situations like “dry mouth” and attempts to tamper with a specimen);
(5) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(6) The collector’s responsibility for maintaining the integrity of the collection process, ensuring the privacy of employees being tested, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(c) Initial proficiency demonstration. Following your completion of qualification training under paragraph (b) of this section, you must demonstrate proficiency in collections under this part by completing five consecutive error-free mock collections for each device you will use.
(1) The five mock collections for each device must include one uneventful collection scenario, one insufficient specimen quantity scenario; one scenario in which the employee has something in their mouth that might interfere with the collection; one scenario in which the employee attempts to tamper with the specimen; and one scenario in which the employee refuses to sign the CCF. For each of the five mock collections, the collector must check the expiration date of the device, show it to the employee, and record the date on the CCF used. The collector must ensure, when applying the labels, they do not cover the expiration dates.
(2) Another person must monitor and evaluate your performance, in person or by a means that provides real-time observation and interaction between you and the qualified collector, who must attest in writing that the mock collections are “error-free.” Except as provided in paragraph (c)(3) of this section, this person must be a qualified oral fluid collector who has demonstrated necessary knowledge, skills, and abilities by— (i)
Regularly conducting DOT oral fluid drug test collections for a period of at least one year;
(ii) Conducting oral fluid collector training under this part for at least one year; or
(iii) Successfully completing an oral fluid “train the trainer” course.
(3) As the person monitoring and evaluating the collector’s five mock collections pursuant to paragraphs (c)(1) and (2) of this section, you need not be a qualified oral fluid collector to do so if you meet the necessary knowledge, skills, and abilities in paragraph (c)(2)(ii) or (iii) until otherwise specified (one year after HHS publishes a FEDERAL REGISTER notification of the first certified oral fluid drug testing laboratory (HHS notification)). Furthermore, the one-year requirement in paragraph (c)(2)(ii) is not applicable until otherwise specified (one year after the HHS notification).
(d) Schedule for qualification training and initial proficiency demonstration. You must meet the requirements of paragraphs (b) and (c) of this section before you begin to perform collector functions.
(e) Refresher training. No less frequently than every five years from the date on which you satisfactorily complete the requirements of paragraphs (b) and (c) of this section, you must complete refresher training that meets all the requirements of paragraphs (b) and (c).
(f) Error correction training. If you make a mistake in the collection process that causes a test to be cancelled (i.e., a fatal or uncorrected flaw), you must undergo error correction training. This training must occur within 30 days of the date you are notified of the error that led to the need for retraining.
(1) Error correction training must be provided and your proficiency documented in writing by a person who meets the requirements of paragraph (c)(2) of this section.
(2) Error correction training is required to cover only the subject matter area(s) in which the error that caused the test to be cancelled occurred.
(3) As part of the error correction training, you must demonstrate your proficiency in the collection procedures of this part by completing three consecutive error-free mock collections. The mock collections must include one uneventful scenario and two scenarios related to the area(s) in which your error(s) occurred. The person providing the training must monitor and evaluate your performance and attest in writing that the mock collections were “error-free.”
(g) Documentation. You must maintain documentation showing that you currently meet all requirements of this section. You must provide this documentation on request to DOT agency representatives and to employers and C/TPAs who are using or negotiating to use your services.
[88 FR 27638, May 2, 2023, as amended at 89 FR 87798, Nov. 5, 2024]
§ 40.36 What information about the DER must employers provide to collectors?
As an employer, you must provide to collectors the name and telephone number of the appropriate DER (and C/TPA, where applicable) to contact about any problems or issues that may arise during the testing process.
[65 FR 79526, Dec. 19, 2000. Redesignated at 88 FR 27639, May 2, 2023]
Subpart D—Collection Sites, Forms, Equipment and Supplies Used in DOT Urine and Oral Fluid Collections
§ 40.40 What form is used to document a DOT collection?
(a) The Federal Drug Testing Custody and Control Form (CCF) must be used to document every collection required by the DOT drug testing program. You may view this form on the Department’s website (https://www.transportation.gov/odapc) or the HHS website (https://www.workplace.samhsa.gov).
(b) You must not use a non-Federal form or an expired CCF to conduct a DOT collection. As a laboratory, C/ TPA or other party that provides CCFs to employers, collection sites, or other customers, you must not provide copies of an expired CCF to these participants. You must also affirmatively notify these participants that they must not use an expired CCF.
(c) As a participant in the DOT drug testing program, you are not permitted to modify or revise the CCF except as follows:
(1) You may include, in the area outside the border of the form, other information needed for billing or other purposes necessary to the collection process.
(2) The CCF must include the names, addresses, telephone numbers and any other appropriate contact information (e.g., an email address of the employer and the MRO), including the DER’s name and contact information. All of this information must be preprinted, typed, or handwritten. Fax numbers
may be included but are not required. The MRO information must include the physician’s name and address, as opposed to only a generic clinic, health care organization, company name, or post office box. This information is required, and an employer, collector, service agent or any other party is prohibited from omitting it. In addition, a C/TPA’s name, address, telephone and fax numbers, and any other appropriate contact information should be included, but is not required. The employer may use a C/TPA’s address in place of its own, but must continue to include its name, telephone and fax numbers, and any other appropriate contact information.
(3) As an employer you may preprint the box in Step 1-D of the CCF for the DOT agency under whose authority the test will occur.
(4) As a collector, you may use a CCF with your name, address, telephone number, and fax number preprinted, but under no circumstances may you sign the form before the collection event. If a collection takes place at a clinic, the actual address of the clinic should be used, not a corporate address of the collection company. If the collection takes place onsite at the employer, the employer’s address must be noted as the collection site address. If the collection takes place in a “mobile unit” or at an accident site, the collector must enter the actual location address of the collection or as near an approximation as possible. The collector must ensure that the required collector telephone number is the number that the laboratory, MRO, or employer may use to directly contact the individual collector and/or the collector’s supervisor during the collection site’s business hours. The collector must not provide a number for a call center.
(5) When using an electronic CCF, you must establish adequate confidentiality and security measures to ensure that confidential employee records are not available to unauthorized persons. This includes protecting the physical security of records, access controls, and computer security measures to safeguard confidential data in electronic form.
(d) Under no circumstances may the CCF transmit personal identifying information about an employee (other than a SSN or Employee ID No.) to a laboratory.
(e) As an employer, you may use an equivalent foreign-language version of the CCF approved by ODAPC. You may use such a non-English language form only in a situation where both the employee and collector understand and can use the form in that language.
(f) An employer who uses an electronic CCF must ensure that the collection site, the primary and split laboratories, and MRO have compatible systems, and that the employee and any other program participants in the testing process will receive a legible copy of the CCF.
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001; 75 FR 59107, Sept. 27, 2010; 76 FR 59577, Sept. 27, 2011; 80 FR 19553, Apr. 13, 2015; 82 FR 52244, Nov. 13, 2017. Redesignated and amended at 88 FR 27639, May 2, 2023]
§ 40.41 May employers use the CCF for non-Federal collections or non-Federal forms for DOT collections?
(a) No, as an employer, you are prohibited from using the CCF for non-Federal collections. You are also prohibited from using non-Federal forms for DOT collections. Doing either subjects you to enforcement action under DOT agency regulations. (b)
(1) In the rare case where the collector, either by mistake or as the only means to conduct a test under difficult circumstances (e.g., post-accident or reasonable suspicion test with insufficient time to obtain the CCF), uses a non-Federal form for a DOT collection, the use of a non-Federal form does not present a reason for the laboratory to reject the specimen for testing or for an MRO to cancel the result.
(2) The use of the non-Federal form is a “correctable flaw.” As an MRO, to correct the problem you must follow the procedures of § 40.205(b)(2).
[65 FR 79526, Dec. 19, 2000, as amended at 66 FR 41950, Aug. 9, 2001. Redesignated and amended at 88 FR 27639, June 1, 2023]
§ 40.42 Where does a urine collection for a DOT drug test take place?
(a) A urine collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating a collection site, you must ensure that it meets the security requirements of § 40.43.
(c) If you are operating a collection site, you must have all necessary personnel, materials, equipment, facilities and supervision to provide for the collection, temporary storage, and shipping of urine specimens to a laboratory, and a suitable clean surface for writing.
(d) Your collection site must include a facility for urination described in either paragraph (e) or paragraph (f) of this section.
(e) The first, and preferred, type of facility for urination that a collection site may include is a single-toilet room, having a full-length privacy door, within which urination can occur.
(1) No one but the employee may be present in the room during the collection, except for the observer in the event of a directly observed collection.
(2) You must have a source of water for washing hands, that, if practicable, should be external to the closed room where urination occurs. If an external source is not available, you may meet this requirement by securing all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and providing moist towelettes outside the closed room.
(f) The second type of facility for urination that a collection site may include is a multistall restroom.
(1) Such a site must provide substantial visual privacy (e.g., a toilet stall with a partial-length door) and meet all other applicable requirements of this section.
(2) If you use a multi-stall restroom, you must either— (i)
Secure all sources of water and other substances that could be used for adulteration and substitution (e.g., water faucets, soap dispensers) and place bluing agent in all toilets or secure the toilets to prevent access; or
(ii) Conduct all collections in the facility as monitored collections (see § 40.69 for procedures). This is the only circumstance in which you may conduct a monitored collection.
(3) No one but the employee may be present in the multistall restroom during the collection, except for the monitor in the event of a monitored collection or the observer in the event of a directly observed collection.
(g) A collection site may be in a medical facility, a mobile facility (e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section.
[65 FR 79526, Dec. 19, 2000. Redesignated at 88 FR 27639, May 2, 2023]
§ 40.43 What steps must operators of collection sites and collectors take to protect the security and integrity of urine collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Secure any water sources or otherwise make them unavailable to employees (e.g., turn off water inlet, tape handles to prevent opening faucets);
(2) Ensure that the water in the toilet is blue;
(3) Ensure that no soap, disinfectants, cleaning agents, or other possible adulterants are present;
(4) Inspect the site to ensure that no foreign or unauthorized substances are present;
(5) Tape or otherwise secure shut any movable toilet tank top, or put bluing in the tank;
(6) Ensure that undetected access (e.g., through a door not in your view) is not possible;
(7) Secure areas and items (e.g., ledges, trash receptacles, paper towel holders, under-sink areas) that appear suitable for concealing contaminants; and
(8) Recheck items in paragraphs (b)(1) through (7) of this section following each collection to ensure the site’s continued integrity.
(c) If the collection site uses a facility normally used for other purposes, like a public rest room or hospital examining room, you must, as a collector, also ensure before the collection that:
(1) Access to collection materials and specimens is effectively restricted; and
(2) The facility is secured against access during the procedure to ensure privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(d) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “shy bladder” situation (see § 40.193(b)), you may conduct a collection for another employee.
(2) To the greatest extent you can, keep an employee’s collection container within view of both you and the employee between the time the employee has urinated and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is poured into the bottles and sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(e) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which urine specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer (e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (e).
(2) Except for the observer in a directly observed collection or the monitor in the case of a monitored collection, you must not permit anyone to enter the urination facility in which employees provide specimens.
(3) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site.
(4) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process.
(f) If you are operating a collection site, you must minimize the number of persons handling specimens.
§ 40.44 What materials are used to collect urine specimens?
For each DOT drug test, you must use a collection kit meeting the requirements of Appendix A of this part.
[65 FR 79526, Dec. 19, 2000. Redesignated at 88 FR 27639, May 2, 2023]
§ 40.45 What materials are used to send urine specimens to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from shipment damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.
[65 FR 79526, Dec. 19, 2000. Redesignated at 88 FR 27639, May 2, 2023]
§ 40.47 Where does an oral fluid collection for a DOT drug test take place?
(a) An oral fluid collection for a DOT drug test must take place in a collection site meeting the requirements of this section.
(b) If you are operating an oral fluid collection site:
(1) You must ensure that it meets the security requirements of § 40.48;
(2) The site may be a permanent or temporary facility located either at the work site or at a remote site;
(3) The site may be in a medical facility, a mobile facility (e.g., a van), a dedicated collection facility, or any other location meeting the requirements of this section; and
(4) You must have all necessary personnel, materials, equipment, and facilities that include privacy and supervision to provide for the collection, temporary storage, and shipping of specimens to a laboratory, and a suitable clean surface for writing.
(c) If a 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, if the collection is performed by a collector who has been trained to collect oral fluid specimens in accordance with this part and the manufacturer’s procedures for the collection device.
[88 FR 27640, May 2, 2023]
§ 40.48 What steps must operators of collection sites and collectors take to protect the security and integrity of oral fluid collections?
(a) Collectors and operators of collection sites must take the steps listed in this section to prevent unauthorized access that could compromise the integrity of collections.
(b) As a collector, you must do the following before each collection to deter tampering with specimens:
(1) Ensure that access to collection materials and specimens is effectively restricted;
(2) Ensure that undetected access (e.g., through a door not in your view) is not possible; and
(3) Ensure the security of the facility during the collection process to maintain privacy to the employee and prevent distraction of the collector. Limited-access signs must be posted.
(c) As a collector, you must take the following additional steps to ensure security during the collection process:
(1) To avoid distraction that could compromise security, you are limited to conducting a collection for only one employee at a time. However, during the time one employee is in the period for drinking fluids in a “dry mouth” situation (see § 40.72(b)(1)), you may conduct a collection for another employee as long as the employee with “dry mouth” remains supervised.
(2) To the greatest extent practicable, keep an employee’s collection container within view of both you and the employee between the time the employee has provided the oral fluid specimen and the specimen is sealed.
(3) Ensure you are the only person in addition to the employee who handles the specimen before it is sealed with tamper-evident seals.
(4) In the time between when the employee gives you the specimen and when you seal the specimen, remain within the collection site.
(5) Maintain personal control over each specimen and CCF throughout the collection process.
(d) If you are operating a collection site, you must implement a policy and procedures to prevent unauthorized personnel from entering any part of the site in which oral fluid specimens are collected or stored.
(1) Only employees being tested, collectors and other collection site workers, DERs, employee and employer representatives authorized by the employer (e.g., employer policy, collective bargaining agreement), and DOT agency representatives are authorized persons for purposes of this paragraph (d).
(2) You must ensure that all authorized persons are under the supervision of a collector at all times when permitted into the site.
(3) You or the collector may remove any person who obstructs, interferes with, or causes a delay in the collection process.
(e) If you are operating a collection site, you must minimize the number of persons handling specimens.
[88 FR 27640, May 2, 2023]
§ 40.49 What materials are used to collect oral fluid specimens?
For each DOT drug test, you must use a collection device meeting the requirements of appendix B of this part.
[88 FR 27640, May 2, 2023]
§ 40.51 What materials are used to send oral fluid specimens to the laboratory?
(a) Except as provided in paragraph (b) of this section, you must use a shipping container that adequately protects the specimen bottles from damage in the transport of specimens from the collection site to the laboratory.
(b) You are not required to use a shipping container if a laboratory courier hand-delivers the specimens from the collection site to the laboratory.
[88 FR 27640, May 2, 2023]