Collapse to view only § 219.617 - Participation in random alcohol and drug testing.

§ 219.601 - Purpose and scope of random testing programs.

(a) Purpose. The purpose of random alcohol and drug testing is to promote safety by deterring regulated employees from misusing drugs and abusing alcohol.

(b) Regulated employees. Each railroad must ensure that a regulated employee is subject to being selected for random testing as required by this subpart whenever the employee performs regulated service on the railroad's behalf.

(c) Contractor employees and volunteers. A regulated employee who is a volunteer or an employee of a contractor to a railroad may be incorporated into the random testing program of more than one railroad if:

(1) The contractor employee or volunteer is not already part of a random testing program that meets the requirements of this subpart and has been accepted by the railroad for which he or she performs regulated service (as described in § 219.609); or

(2) The railroad for which the contractor employee or volunteer performs regulated service is unable to verify that the individual is part of a random testing program acceptable to the railroad that meets the requirements of this subpart.

(d) Multiple DOT agencies. (1) If a regulated employee performs functions subject to the random testing requirements of more than one DOT agency, a railroad must ensure that the employee is subject to selection for random drug and alcohol testing at or above the current minimum annual testing rate set by the DOT agency that regulates more than 50 percent of the employee's DOT-regulated functions.

(2) A railroad may not include a regulated employee in more than one DOT random testing pool for regulated service performed on its behalf, even if the regulated employee is subject to the random testing requirements of more than one DOT agency.

§ 219.603 - General requirements for random testing programs.

(a) General. To the extent possible, each railroad must ensure that its FRA random testing program is designed and implemented so that each employee performing regulated service on its behalf should reasonably anticipate that he or she may be called for a random test without advance warning at any time while on duty and subject to performing regulated service.

(b) Prohibited selection bias. A random testing program may not have a selection bias or an appearance of selection bias, or appear to provide an opportunity for a regulated employee to avoid complying with this section.

(c) Plans. As required by §§ 219.603 through 219.609, each railroad must submit for FRA approval a random testing plan meeting the requirements of this subpart. The plan must address all regulated employees, as defined in § 219.5.

(d) Pools. Each railroad must construct and maintain random testing pools in accordance with § 219.611.

(e) Selections. Each railroad must conduct random testing selections in accordance with § 219.613.

(f) Collections. Each railroad must perform random testing collections in accordance with § 219.615.

(g) Cooperation. Each railroad and its regulated employees must cooperate with and participate in random testing in accordance with § 219.617.

(h) Responsive action. Each railroad must handle positive random tests and verified refusals to test in accordance with § 219.619.

(i) Service agents. Each railroad may use a service agent to perform its random testing responsibilities in accordance with § 219.621.

(j) Records. Each railroad must maintain records required by this subpart in accordance with § 219.623.

§ 219.605 - Submission and approval of random testing plans.

(a) Plan submission. (1) Each railroad must submit for review and approval a random testing plan meeting the requirements of §§ 219.607 and 219.609 by email to [email protected]. The submission must include the name of the railroad or contractor in the subject line. A railroad commencing start-up operations must submit its plan no later than 30 days before its date of commencing operations. A railroad that must comply with this subpart because it no longer qualifies for the small railroad exception under § 219.3 (due to a change in operations or its number of covered employees) must submit its plan no later than 30 days after it becomes subject to the requirements of this subpart. A railroad may not implement a Federal random testing plan or any substantive amendment to that plan before FRA approval.

(2) A railroad may submit separate random testing plans for each category of regulated employees (as defined in § 219.5), combine all categories into a single plan, or amend its current FRA-approved plan to add additional categories of regulated employees, as defined by this part.

(b) Plan approval notification. FRA will notify a railroad in writing whether its plan is approved. If the plan is not approved because it does not meet the requirements of this subpart, FRA will inform the railroad of its non-approval, with specific explanations of any required revisions. The railroad must resubmit its plan with the required revisions within 30 days of the date of FRA's written notice. Failure to resubmit the plan with the necessary revisions will be a failure to submit a plan under this part.

(c) Plan implementation. Each railroad must implement its random testing plan no later than 30 days from the date of FRA approval.

(d) Plan amendments. (1) Each railroad must submit to FRA a substantive amendment to an approved plan at least 30 days before its intended effective date. A railroad may not implement any substantive amendment before FRA approval.

(2) Each railroad must provide a non-substantive amendment to an approved plan (such as the replacement or addition of service providers) to the FRA Drug and Alcohol Program Manager in writing (by letter or email) before its effective date. However, FRA pre-approval is not required.

(e) Previously approved plans. A railroad is not required to resubmit a random testing plan that FRA had approved before March 4, 2022, unless the railroad must amend the plan to comply with the requirements of this subpart. A railroad must submit new plans, combined plans, or amended plans incorporating new categories of regulated employees (i.e., mechanical employees) for FRA approval at least 60 days after March 4, 2022.

[81 FR 37937, June 10, 2016, as amended at 87 FR 5736, Feb. 2, 2022]

§ 219.607 - Requirements for random testing plans.

(a) General. A random testing plan that a railroad submits under this subpart must address and comply with the requirements of this subpart. The railroad must also comply with these requirements in implementing the plan.

(b) Model random testing plan. A railroad (or a contractor or service agent that submits a part 219-compliant random testing plan to a railroad for submission as a part of the railroad's random testing plan) may complete, modify if necessary, and submit a plan based on the FRA model random testing plan that can be downloaded from FRA's Drug and Alcohol Program Web site.

(c) Specific plan requirements. Each random testing plan must contain the following items of information, each of which must be contained in a separate, clearly identified section:

(1) Total number of covered employees, including covered service contractor employees and volunteers;

(2) Total number of maintenance-of-way employees, including maintenance-of-way contractor employees and volunteers;

(3) Total number of mechanical employees, including mechanical contractor employees and volunteers;

(4) Names of any contractors who perform regulated service for the railroad, with contact information;

(5) Method used to ensure that any regulated service contractor employees and volunteers are subject to the requirements of this subpart, as required by § 219.609;

(6) Name, address, and contact information for the railroad's Designated Employer Representative (DER) and any alternates (if applicable);

(7) Name, address, and contact information for any service providers, including the railroad's Medical Review Officers (MROs), Substance Abuse and Mental Health Services Administration (SAMHSA) certified drug testing laboratory(ies), Drug and Alcohol Counselors (DACs), Substance Abuse Professionals (SAPs), and Consortium/Third Party Administrators (C/TPAs) or collection site management companies. Individual collection sites do not have to be identified;

(8) Number of random testing pools and the proposed general pool entry assignments for each pool. If using a C/TPA, a railroad must identify whether its regulated employees are combined into one pool, contained in separate pools, or combined in a larger pool with other FRA or other DOT agency regulated employees, or both.

(9) Target random testing rates meeting or exceeding the minimum annual random testing rates;

(10) Method used to make random selections, including a detailed description of the computer program or random number table selection process employed;

(11) Selection unit(s) for each random pool (e.g., employee name or ID number, job assignment, train symbol) and whether the individual selection unit(s) will be selected for drugs, alcohol, or both;

(12) If a railroad makes alternate selections, under what limited circumstances these alternate selections will be tested (see § 219.613);

(13) Frequency of random selections (e.g., monthly);

(14) Designated testing window. A designated testing window extends from the beginning to the end of the designated testing period established in the railroad's FRA-approved random plan (see § 219.603), after which time any individual selections for that designated testing window that have not been collected are no longer active; and

(15) Description of how the railroad will notify a regulated employee that he or she has been selected for random testing.

[81 FR 37937, June 10, 2016, as amended at 87 FR 5736, Feb. 2, 2022]

§ 219.609 - Inclusion of contractor employees and volunteers in random testing plans.

(a) Each railroad's random testing plan must demonstrate that all of its regulated service contractor employees and volunteers are subject to random testing that meets the requirements of this subpart. A railroad can demonstrate that its regulated service contractor employees and volunteers are in compliance with this subpart by either:

(1) Directly including regulated service contractor employees and volunteers in its own random testing plan and ensuring that they are tested according to that plan; or

(2) Indicating in its random testing plan that its regulated service contractor employees and volunteers are part of a random testing program which is compliant with the requirements of this subpart, e.g., conducted by a contractor or C/TPA (“non-railroad random testing program”). If a railroad chooses this option, the railroad must append to its own random testing plan one or more addenda describing the method it will use to ensure that the non-railroad random testing program is testing its regulated service contractor employees and volunteers according to the requirements of this subpart. A railroad may comply with this requirement by appending the non-railroad random testing program or a detailed description of the program and how it complies with this subpart.

(b) Each railroad's random testing plan(s) and any addenda must contain sufficient detail to fully document that the railroad is meeting the requirements of this subpart for all personnel performing regulated service on its behalf.

(c) If a railroad chooses to use regulated service contractor employees and volunteers who are part of a non-railroad random testing program, the railroad remains responsible for ensuring that the non-railroad program is testing the regulated service contractor employees and volunteers according to the requirements of this subpart.

(d) FRA does not pre-approve contractor or service agent random testing plans, but may accept them as part of its approval process of a railroad's plan.

§ 219.611 - Random alcohol and drug testing pools.

(a) General. Each railroad must ensure that its random testing pools include all regulated employees who perform regulated service on its behalf, except that a railroad's random testing pools do not have to include regulated employees who are part of a non-railroad random testing program that is compliant with the requirements of this subpart and that has been accepted by the railroad.

(b) Pool entries. Each railroad must clearly indicate who will be tested when a specific pool entry is selected.

(1) Pool entries may be employee names or identification numbers, train symbols, or specific job assignments, although all the entries in a single pool must be of generally consistent sizes and types.

(2) Pool entries must not allow a field manager or field supervisor to have discretion over which employee is to be tested when an entry is selected.

(3) Pool entries must be constructed and maintained so that all regulated employees have an equal chance of being selected for random testing for each selection draw.

(c) Minimum number of pool entries. A railroad (including a service agent used by a railroad to carry out its responsibilities under this subpart) may not maintain a random testing pool with less than four pool entries. Placeholder pool entries (entries that do not represent legitimate selections of regulated employees) are not permitted. A railroad or contractor with less than four regulated employees can comply with this requirement by having its regulated employees incorporated into a railroad or non-railroad random testing pool that contains more than four entries.

(d) Pool construction. (1) An individual who is not subject to the random testing requirements of FRA or another DOT agency may not be placed in the same pool as a regulated employee.

(2) A railroad may not include a regulated employee in more than one random testing pool established under the regulations of a DOT agency.

(3) A regulated employee may be placed in a random testing pool with employees subject to the random testing requirements of another DOT agency, only if all entries in the pool are subject to testing at the highest minimum random testing rate required by the regulations of a DOT agency for any single member in the pool.

(4) A regulated employee does not have to be placed in separate pools for random drug and random alcohol testing selection.

(5) A regulated employee must be incorporated into a random testing pool as soon as possible after his or her hire or first transfer into regulated service.

(e) Frequency of regulated service. (1) A railroad may not place a person in a random testing pool for any selection period in which he or she is not expected to perform regulated service.

(2) A railroad employee who performs regulated service on average less than once a quarter is a de minimis safety concern for random testing purposes, and does not have to be in a random testing program. A railroad that chooses to random test de minimis employees must place them in a separate random testing pool from employees who perform regulated service on a regular basis (e.g., engineers, conductors, dispatchers, and signal maintainers).

(3) A railroad must make a good faith effort to determine the frequency of an employee's performance of regulated service and must evaluate the employee's likelihood of performing regulated service in each upcoming selection period.

(f) Pool maintenance. Pool entries must be updated at least monthly, regardless of how often selections are made, and a railroad must ensure that each of its random testing pools is complete and does not contain outdated or inappropriate entries.

(g) Multiple random testing pools. A railroad may maintain more than one random testing pool if it can demonstrate that its random testing program is not adversely impacted by the number and types of pools or the construction of pool entries, and that selections from each pool will meet the requirements of this subpart.

§ 219.613 - Random testing selections.

(a) General. Each railroad must ensure that each regulated employee has an equal chance of being selected for random testing whenever selections are made. A railroad may not increase or decrease an employee's chance of being selected by weighting an entry or pool.

(b) Method of selection. (1) Each railroad must use a selection method that is acceptable to FRA and meets the requirements of this subpart, such as a computer selection program, proper use of a random number table, or an alternative method which FRA has approved as part of the railroad's random testing plan.

(2) A selection method must be free of bias or apparent bias and employ objective, neutral criteria to ensure that every regulated employee has an equal statistical chance of being selected within a specified time frame. The selection method may not utilize subjective factors that permit a railroad to manipulate or control selections in an effort to either target or protect any employee, job, or operational unit from testing.

(3) The randomness of a selection method must be verifiable, and, as required by § 219.623, any records necessary to document the randomness of a selection must be retained for not less than two years from the date the designated testing window for that selection expired.

(c) Minimum random testing rate. (1) Each railroad must distribute random tests reasonably throughout the calendar year and make sufficient selections to ensure that each random testing pool meets the Administrator's minimum annual random testing rates as established according to § 219.625.

(2) Each railroad must continually monitor changes in its workforce to ensure that the required number of selections and tests are conducted each year.

(d) Selection frequency. Each railroad must select at least one entry from each of its random testing pools every three months.

(e) Discarded selection draws. Each selection draw must identify who will be subject to random testing. A railroad cannot discard a selection draw without an acceptable explanation (e.g., the selection was drawn from an incomplete or inaccurate pool). A railroad must document and retain records for all discarded selection draws, including the specific reason the selection draw was not used, as required by § 219.623.

(f) Increasing random selections. A railroad that is unable to complete a collection for each selection made during a designated testing period may increase the number of selections in a subsequent selection period to ensure that it meets the annual minimum random testing rate for the calendar year.

(g) Selection snapshots. Each railroad must capture and maintain an electronic or hard copy snapshot of each random testing pool at the time it makes a testing selection. A railroad must not re-create pool entries from records after the time of the original selection. The railroad must maintain this snapshot for a period of two years, as required by subpart J of this part.

(h) Multiple DOT agencies. Each railroad must ensure that each regulated employee who performs functions subject to the random testing requirements of more than one DOT agency is subject to random selection at or above the current minimum annual testing rate set by the DOT agency that regulates more than 50 percent of the employee's DOT-regulated functions.

§ 219.615 - Random testing collections.

(a) Minimum random testing rates. Each railroad must complete a sufficient number of random alcohol and drug testing collections from each of its random testing pools to meet the Administrator's minimum annual testing rates established in accordance with § 219.625.

(b) Designated testing window. Each railroad must complete the collection for a selected pool entry within the FRA-approved designated testing window for that selection. Once a designated testing window has closed, any selections not collected during that window are no longer valid and may not be subject to random testing.

(c) Collection timing. (1) A regulated employee may be subject to random testing only while on duty and subject to performing regulated service.

(2) Each railroad's random alcohol and drug testing collections must be unannounced and spread reasonably throughout the calendar year. Collections must also be distributed unpredictably throughout the designated testing window and must reasonably cover all operating days of the week (including operating weekends and holidays), shifts, and locations.

(3) Random alcohol test collections must be performed unpredictably and in sufficient numbers at either end of an operating shift to attain an acceptable level of deterrence throughout the entire shift. At a minimum, a railroad must perform 10% of its random alcohol tests at the beginning of shifts and 10% of its random alcohol tests at the end of shifts.

(4) If a regulated employee has been selected for both random drug and alcohol testing, a railroad may conduct these tests separately, so long as both required collections can be completed by the end of the employee's shift and the railroad does not inform the employee that an additional collection will occur later.

(d) Collection scheduling. While pool entries must be selected randomly, a railroad may schedule each random test collection during a designated testing window according to its approved plan.

(1) A railroad may schedule a collection based on the availability of the selected pool entry, the logistics of performing the collection, and any other requirements of this subpart.

(2) If a selected pool entry does not identify the selection by name (i.e., train crews or job functions), a railroad may not use its scheduling discretion to deliberately target or protect a particular employee or work crew. Unless otherwise approved in a random testing plan, railroad field supervisors or field management personnel may not use discretion to choose or to change collection dates or times if that choice could intentionally alter who is to be tested.

(e) Notification requirements. (1) A railroad may notify a regulated employee that he or she has been selected for random testing only during the duty tour in which the collection is to be conducted, and only so far in advance as is reasonably necessary to ensure the employee's presence at the scheduled collection time and place.

(2) A railroad must make collections as soon as possible. Each collection must begin within two hours after the railroad has notified the employee of his or her selection for random testing, unless the railroad has an acceptable reason for the delay. A railroad should monitor each employee after notification and, whenever possible, arrange for the employee to be immediately escorted by supervisory or management personnel to the collection location.

(3) A railroad must inform each regulated employee that he or she has been selected for random testing at the time the employee is notified. Completion of the Federal Drug Testing Custody and Control Form (CCF) or the DOT Alcohol Testing Form (ATF) indicating the basis of the test satisfies this requirement, so long as the employee has been shown and directed to sign the CCF or ATF as required by §§ 40.73 and 40.241 of this title.

(f) Incomplete collections. A railroad must use due diligence to ensure that a random testing collection is completed for each selected pool entry, unless it has an acceptable explanation for not conducting the collection. All reasons for incomplete collections must be fully documented and are subject to inspection by FRA upon request.

(g) Hours-of-service limitations. (1) Except as provided by paragraph (g)(2) of this section, a railroad must immediately terminate a random collection and may not reschedule it if the collection is not completed within a covered employee's hours-of-service limitations.

(2) If a random collection requires a direct observation collection under § 40.67 of this title, the directly observed collection must immediately proceed until completed. A railroad must submit an excess service report, as required by part 228 of this chapter, if completion of the directly observed collection causes the covered employee to exceed his or her hours-of-service limitations.

[81 FR 37937, June 10, 2016, as amended at 87 FR 5736, Feb. 2, 2022]

§ 219.617 - Participation in random alcohol and drug testing.

(a) Railroad responsibility. (1) A railroad must, under the conditions specified in this subpart and subpart H of this part, require a regulated employee selected for random testing to cooperate in alcohol and/or drug testing.

(2) If an employee is performing regulated service at the time he or she is notified of his or her selection for random testing, the railroad must ensure that the employee immediately ceases to perform regulated service and proceeds to the collection site without adversely affecting safety. A railroad must also ensure that the absence of an employee from his or her assigned duties to report for testing does not adversely affect safety. Once an employee begins the testing process, he or she may not be returned to regulated service until the testing process is complete.

(3) A railroad may excuse a regulated employee who has been notified of his or her selection for random testing only if the employee can substantiate that a medical emergency involving the employee or an immediate family member (e.g., birth, death, or medical emergency) supersedes the requirement to complete the test. A medical emergency is defined in this part as an acute medical condition requiring immediate emergency care. To be eligible for exclusion from random testing, the employee must provide verifiable documentation of the emergency situation from a credible outside professional within a reasonable period of time (e.g., a doctor, dentist, hospital, law enforcement officer, or school authority). A railroad may not test an employee who has been excused from testing under the same random selection.

(b) Employee responsibility. (1) A regulated employee subject to the random testing requirements of this subpart must cooperate with the selection and testing process, and must proceed to the testing site upon notification that he or she has been selected for random testing.

(2) A regulated employee must fully cooperate and comply with the body fluid drug collection and/or breath alcohol testing procedures required by subpart H of this part, and provide the required specimen(s), and must, upon request, complete the required paperwork and certifications.

[81 FR 37937, June 10, 2016, as amended at 87 FR 5736, Feb. 2, 2022; 88 FR 27652, May 2, 2023]

§ 219.619 - Positive alcohol and drug test results and refusals; procedures.

Section 219.104 contains the procedures for administrative handling by the railroad or contractor in the event a body fluid specimen provided under this subpart is reported as a verified positive by the Medical Review Officer, a breath alcohol specimen is reported at 0.04 or greater by the Breath Alcohol Technician, or a refusal to test has occurred. The responsive action required in § 219.104 is not stayed pending the result of the testing of a split body fluid specimen or a challenge to any part of the testing process or procedure.

[81 FR 37937, June 10, 2016, as amended at 88 FR 27652, May 2, 2023]

§ 219.621 - Use of service agents.

(a) A railroad may use a service agent (such as a consortium/third party administrator (C/TPA)) to act as its agent to carry out any role in random testing specifically permitted under subpart Q of part 40 of this title, such as maintaining random pools, conducting random selections, and performing random body fluid drug collections and breath alcohol tests.

(b) A railroad may not use a service agent to notify a regulated employee that he or she has been selected for random testing. A regulated employee who has been selected for random testing must otherwise be notified of the selection by his or her employer. A service agent may also not perform any role that § 40.355 of this title specifically reserves to an employer, which, for purposes of this subpart, is defined as a railroad or a contractor performing railroad-accepted testing.

(c) A railroad is primarily responsible for compliance with the random alcohol and drug testing of this subpart, but FRA reserves the right to bring an enforcement action for noncompliance against the railroad, its service agents, its contractors, and/or its employees.

(d) If a railroad conducts random drug and/or alcohol testing through a C/TPA, the number of employees required to be tested may be calculated for each individual railroad belonging to the C/TPA, or may be based on the total number of regulated employees covered by the C/TPA in a larger combined railroad or DOT agency random pool. Selections from combined railroad random pools must meet or exceed the highest minimum annual percentage rate established under this subpart or any DOT agency drug testing rule that applies to any member of that pool.

[81 FR 37937, June 10, 2016, as amended at 88 FR 27652, May 2, 2023]

§ 219.623 - Records.

(a) As provided by § 219.901, each railroad is required to maintain records related to random testing for a minimum of two years.

(b) Contractors and service agents performing random testing responsibilities under this subpart must provide records required by this subpart whenever requested by the contracting railroad or by FRA. A railroad remains responsible for maintaining records demonstrating that it is in compliance with the requirements of this subpart.

§ 219.625 - FRA Administrator's determination of random alcohol and drug testing rates.

(a) Notice. Each year, the Administrator publishes a Federal Register notice announcing the minimum annual random alcohol and drug testing rates which take effect on January 1 of the following calendar year. These rates are based on the railroad industry's random testing violation rates for the preceding two consecutive calendar years, which are determined using annual railroad alcohol and drug program data required to be submitted to the FRA's Management Information System (MIS) under § 219.800.

(b) Information. Data from MIS reports provide the information used for this determination. In order to ensure reliability of the data, the Administrator may consider the quality and completeness of the reported data, obtain additional information or reports from railroads, or make appropriate modifications in calculating the industry positive rate.

(c) Initial minimum annual random testing rates. The Administrator has established an initial minimum annual random testing rate of 50 percent for drugs and 25 percent for alcohol for any new category of regulated employees added to those already being tested under this part.

(1) These initial testing rates are subject to amendment by the Administrator in accordance with paragraphs (d) and (e) of this section after at least two consecutive calendar years of MIS data have been compiled for the category of regulated employee.

(2) The Administrator will determine separate minimum annual random testing rates for each added category of regulated employees for a minimum of three calendar years after that category is incorporated into random testing under this part.

(3) The Administrator may move to combine categories of regulated employees requiring separate determinations into a single determination once the categories' testing rates are identical for two consecutive years.

(d) Drug testing rate. The Administrator may set the minimum annual random drug testing rate for the railroad industry at either 50 percent or 25 percent.

(1) When the minimum annual percentage rate for random drug testing is 50 percent, the Administrator may lower the rate to 25 percent if the Administrator determines that the MIS data for two consecutive calendar years show that the reported random testing positive rate is less than 1.0 percent.

(2) When the minimum annual percentage rate for random drug testing is 25 percent, and the MIS data for any calendar year show that the reported random testing positive rate is equal to or greater than 1.0 percent, the Administrator will increase the minimum annual percentage rate for random drug testing to 50 percent.

(e) Alcohol testing rate. The Administrator may set the minimum annual random alcohol testing rate for the railroad industry at 50 percent, 25 percent, or 10 percent.

(1) When the minimum annual percentage rate for random alcohol testing is 50 percent or 25 percent, the Administrator may lower this rate to 10 percent if the Administrator determines that the MIS data for two consecutive calendar years show that the random testing violation rate is less than 0.5 percent.

(2) When the minimum annual percentage rate for random alcohol testing is 50 percent, the Administrator may lower the rate to 25 percent if the Administrator determines that the MIS data for two consecutive calendar years show that the random testing violation rate is less than 1.0 percent but equal to or greater than 0.5 percent.

(3) When the minimum annual percentage rate for random alcohol testing is 25 percent, and the MIS data for that calendar year show that the random testing violation rate for drugs is equal to or greater than 0.5 percent but less than 1.0 percent, the Administrator will increase the minimum annual percentage rate for random drug testing to 50 percent.

(4) When the minimum annual percentage rate for random alcohol testing is 10 percent or 25 percent, and the MIS data for any calendar year show that the random testing violation rate is equal to or greater than 1.0 percent, the Administrator will increase the minimum annual percentage rate for random alcohol testing to 50 percent.

[81 FR 37937, June 10, 2016, as amended at 87 FR 5736, Feb. 2, 2022]