Frequently Asked Questions About Program Administration
This section provides the NRC staff's answers to the following questions related to Program Administration, as it relates to fitness-for-duty:
When an employee is requested to perform a random drug and alcohol (D&A) test, does the rule require the formal communication to be made verbally? Does the rule require the communication to be made in person? Should a non-supervisor co-employee contact a fellow employee to report to a random test after a supervisor directs the co-employee to make this notification to the selected employee for a random test?
The 2008 rule does not specify the method(s) a licensee or other entity should or shall use to notify an individual to report to the collection site for random drug and alcohol testing. However, § 26.27(c) does require each licensee and other entity to maintain and implement written procedures that describe the methods to be used in implementing the FFD policy. These procedures should describe the process to be followed to ensure that individuals who are called upon for random testing are tested as soon as reasonably practicable after notification (see § 26.31(d)(iii)). These procedures should also specify the individuals who are authorized to inform a donor that he or she has been selected for random testing and how the individual is to be informed, such as acceptable communication/notification methods.
Furthermore, notifying an employee who is off site to report for random testing is inconsistent with § 26.31(d)(2)(v) which requires "that individuals who are off site when selected for testing… shall be tested at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing and without prior notification to the individual that he or she has been selected for testing" (emphasis added). Notifying an employee that he or she has been selected for random testing when the employee is off site provides a potential opportunity for the individual to subvert the testing process.
Although the question does not specify that the employee's supervisor was the individual authorized by the FFD program to notify the selected employee, if that were the case, then relying on a peer of the selected individual to notify the employee would be a violation of the licensee's notification procedure. In the "Section-by-Section Analysis of Substantive Changes" accompanying the Part 26 final rule, on page 17168 of the March 31, 2008, Federal Register Notice, the NRC provides some context to this issue as it relates to a new reporting requirement in § 26.719(b)(3). Section 26.719(b)(3) requires the reporting of intentional acts that cast doubt on the integrity of the FFD program. While it is not clear that the example described in the question was an intentional act to subvert the testing process, the Section-by-Section discussion describes the underlying concerns: "Because of the wide array of possible acts that could fit this definition and be of concern to the NRC, the final rule does not specify the acts that licensees and other entities must report. However, such intentional acts may include, but are not limited to: (1) Notifying individuals, outside of the FFD program's normal notification procedures, that they will be selected for random or followup testing on a particular date or at a specific time so that the individuals have sufficient time available to attempt to mask drug use by, for example, obtaining a substitute urine specimen or an adulterant, drinking large amounts of liquid in order to provide a dilute urine specimen, or leaving the site to avoid testing…"
If the HHS lab detects the presence of drug metabolites below the cutoff and the sample is not dilute, can and should it be reported to the MRO to determine if an observed recollect is warranted. OR can it automatically be taken to limits of detection? As another alternative, can all specimens be tested to limits of detection?
Section 26.115 specifies the exclusive grounds for collecting a urine specimen under direct observation. A specimen with drug metabolites detected by the HHS-certified laboratory, but at a concentration below the initial cutoff level for the drug is not a condition where a second specimen collection under direct observation is permitted. However, § 26.163(a) and (b) do permit licensees and other entities to establish more stringent cutoff levels for initial and confirmatory testing respectively, if the cutoff levels have been certified in writing to be scientifically sound and legally defensible by an independent, qualified forensic toxicologist as described in § 26.31(d)(i)(D).
Section 26.163(a)(2) applies to dilute samples and does not provide the option to conduct limit of detection testing on any specimen that does not meet the dilute criteria.
What is the difference between the scheduled drug list in Section 812 and Section 1308.13? It seems the regs refer to Section 812 for the identification of schedule 1-V drugs but the footnotes in Section 812 indicate that 1308.13 is the most up to date. Does the NRC utilize the most up to date list of Scheduled substances and if so why doesn't the regulatory language refer to section 1308.13?
The fitness-for-duty rule refers to the schedules of controlled substances listed in 21 U.S.C. Section 812. Footnote 1 to Section 812 states that amendments to the schedule of drugs will be published in 21 CFR Part 1308. Therefore, please refer to 21 CFR Part 1308 for the current schedule of controlled substances. NRC applies the current schedule of controlled substances as listed in 21 CFR Part 1308 to the fitness-for-duty rule. Note, that Section 1308.13 only contains a list of substances classified in Schedule III. References to the schedules of controlled substances in the fitness-for-duty rule include all applicable sections of Part 1308 (i.e., Sections 1308.11 through 1308.15).
10 CFR 26.4 states that Fitness for Duty program personnel includes: "All persons involved in the selecting or notifying individuals of testing," which according to § 26.31 requires these individuals to have an updated FFD background check every five years. Are supervisors or other plant management who coordinate the reporting of the subject to the Fitness for Duty collection station included in the category of Fitness for Duty program personnel? Does this also include persons who schedule and notify these supervisors and who monitor to ensure that the subject reports as scheduled for random collections?
Fitness for Duty program personnel who select and notify individuals of testing are those personnel involved in selecting individuals for testing and providing the initial notification that an individual has been selected for testing. This definition is not intended to broaden the scope of FFD program personnel to individual other personnel (e.g., secretaries or laborers) or supervisors (e.g., team/shift leads) who may receive and pass on the notification from the FFD program group that an individual needs to report for random testing.
If an individual who would fall under the 10 CFR 26.719(b)(2) requirement for licensees to report significant violations within 24 hours to the NRC Operations Center, requests a re-test as allowed in accordance with 26.165(b)(2), when would the licensee be required to report and make the 24 hour call? After the initial MRO-confirmed positive or after the re-test results, if reconfirmed?
While licensees shall administratively withdraw an individual's authorization based on an MRO-confirmed positive, adulterated, or substituted test result(s) from the first HHS-certified laboratory under 10 CFR 26.165(f), the determination of violation would not be made until the retest confirms the positive test result, in accordance with 10 CFR 26.185(n).
As the 10 CFR 26.719 requirement is for notification to the NRC ". . . within 24 hours after the licensee or other entity discovers the violation," the notification would be required within 24 hours after the positive test result is reconfirmed and the individual is determined to have violated the licensee's FFD policy as determined and reported by the MRO.