Frequently Asked Questions About Determining Fitness-for-Duty

This section provides the NRC staff's answers to the following questions related to determining fitness-for-duty.

10 CFR Part 26 requires the Substance Abuse Expert (SAE) to ensure that clinically appropriate treatment plans have been developed for individuals requiring the administrating of a treatment plan. As such, do the NRC regulations place limitations on what the SAE can include as required elements in a treatment plan? Specifically, do NRC regulations preclude an SAE from requiring EtG (ethyl glucuronide) testing (or any other biomarker, such as phosphatidic ethanol, PEth, in the treatment of alcohol disorders) in a treatment plan as a means to monitor an abstinence requirement? Further, 10 CFR Part 26.69(d)(3) identifies that the individual comply and successfully complete the recommendations for treatment and follow up drug and alcohol testing established as part of the determination of fitness. Thus, if the assessed individual refuses to comply with elements of the treatment plan (e.g., taking an EtG test), does the refusal constitute a failure to be "in compliance with a treatment plan"? Can EtG or PEth testing be used in follow-up testing or other NRC-required test?

The NRC regulations do not place limitations on what an SAE can include as SAE-required elements in a treatment plan. The regulations establish required credentials, basic knowledge, and continuing education requirements for SAEs to provide assurance that they can execute their duties and responsibilities competently, independently, and in accordance with State law and consistent with any guidance or standards established by nationally accredited societies or institutes. As a result, the 10 CFR Part 26 regulations empower SAEs to make decisions (e.g., determinations of fitness) and develop treatment programs for individuals based solely (See Section 26.189(d)) on their medical, clinical, and/or professional training.

The regulations in 10 CFR Part 26 enable an SAE to evaluate an individual and make recommendations concerning education, treatment, return to duty, follow-up drug and alcohol testing, and after care (10 CFR 26.187(g)). Therefore, the SAE-developed treatment plan and its associated treatment elements is developed for an individual after the SAE reviews the circumstances necessitating a treatment plan, characteristics of the individual, and any discussion or face-to-face interaction with the individual. This helps ensure that the plan is appropriately tailored to the individual. The plan is then provided as the best recommendation for assisting the individual (26.187(g)) where upon the SAE shall serve as a referral source to assist the individual's entry into an education and/or treatment program. The SAE should discuss all elements with the individual (for example, why the elements are necessary) in order to provide assurance that the individual understands and accepts the plan. Although, specific elements within an SAE-developed treatment plan are not negotiable in the traditional sense, the plan needs to address the specific fitness issues presented by the individual (10 CFR 26.189(a)); as a result, a treatment plan can range from minimum treatment to comprehensive treatment. This process is consistent with "Principles of Drug Addiction Treatment – A Research Guide," 3rd Edition, published by the National Institute on Drug Abuse, National Institutes of Health, U.S. Department of Health and Human Services. After presentation to the individual, the individual has two options: the individual accepts the treatment plan or the individual does not.

If an individual elects to opt out or not implement an element or elements of the treatment plan, this information is potentially disqualifying fitness-for-duty information (PDFFDI) (10 CFR Part 26.5). Opting out: Means that the individual failed to complete the treatment plan, and thus providing conclusive evidence that the individual is not fit for duty. Not Implementing an Element(s): If the individual accepts the treatment plan and then elects not to implement a particular element or elements of the plan, this information will be considered PDFFDI and the SAE will still need to make a fitness determination (10 CFR 26.189). For example, if the SAE determines that abstinence is necessary for that particular individual and abstinence will be determined through EtG testing (or some other biomarker at an established cutoff that provides reasonable assurance that incidental alcohol consumption is not mistaken as a violation of the treatment plan prohibition against alcohol consumption/ingestion verses alcohol exposure), and the individual elects not to be subject to EtG testing, the individual would not be able to demonstrate abstinence in accordance with the SAE-developed treatment plan. In this case, the SAE would not be able to find the individual fit for duty – this is the sole responsibility of the SAE (10 CFR 26.189(d)). The SAE will then inform the licensee of his/her determination and the licensee's reviewing official (10 CFR 26.69(d)) will use the SAE fitness determination and other information as part of his/her finding that the individual cannot safely and competently perform assigned duties and therefore cannot be granted or maintain authorization (10 CFR Part 26.69, et al.). On the other hand, if the individual fails to implement an element of the plan not absolutely necessary to demonstrate fitness, and all principal elements were successfully met, then the SAE could determine the individual fit for duty; however, this is not preordained as it would still be an SAE determination based on the specific circumstances.

As described in the preceding paragraph, an SAE-developed treatment plan for an individual may include EtG testing to verify alcohol use (or abstinence) within the course of the treatment plan; 10 CFR Part 26 does not preclude an SAE from administering EtG testing (or any other clinical, medical, or counseling type element) within a treatment plan. The use of EtG or other biomarker of alcohol use is well established (for example, see U.S. Department of Health and Human Services' (HHS) Publication No. (SMA) 12-4686, "The Role of Biomarkers in the Treatment of Alcohol Use Disorders, 2012 Revision," Spring 2012, Volume 11, Issue 2); however, considerations are provided in this publication as guidance to individuals implementing a biomarker monitoring program.

Regarding the term abstinence, abstinence within 10 CFR Part 26 is used in the description of follow-up testing (Section 26.31(c)(4), 26.69(b)(6)) and the 5-hour alcohol abstention period (Section 26.27(b)(4)). For follow-up testing and the administration of sanctions (Section 27.75), abstinence is based on the initial and confirmatory drug and alcohol cutoff levels described in 10 CFR Part 26. For the 5-hour alcohol abstention period, since an NRC-required test is not conducted during the 5-hour abstinence period, abstinence in this case would have the threshold of no alcohol consumption as communicated to individuals through licensee training (Section 26.29(a)(1)); however, the administration of any resulting sanction would still be based on the NRC alcohol initial and confirmatory cutoffs and the conduct of an NRC-required tests (Section 26.31(c). For example, if Individual A reports Individual B as not abstaining during the 5-hour abstinence period, this credible information (i.e., PDFFDI) would subject Individual B to a for-cause test at the alcohol cutoffs established in 10 CFR Part 26 to determine whether the individual abstained during the 5-hours prior to any scheduled tour of duty (i.e., being subject to the 10 CFR Part 26 requirements). As a last example, if an SAE describes in a treatment plan for a particular individual that he/she must or shall abstain from a substance, the treatment plan should define or describe what abstention means (e.g., no use or cutoffs).

Follow-up testing is a required 10 CFR Part 26.31(c), Condition for testing. Since follow-up testing is a 10 CFR Part 26 test, a follow-up test (like other 10 CFR Part 26 tests) must be conducted in accordance with 10 CFR Part 26 requirements. As a result, for all licensees and affected entities described in 10 CFR 26.3, except those specifically identified in 10 CFR Part 26.401, either breadth or oral fluids shall be collected for initial tests and breadth shall be collected for confirmatory tests for alcohol and the cutoffs established for alcohol testing are provided in 10 CFR 26.99 and 26.103. If a licensee or other entity described in 10 CFR 26.401 elects to use another test other than breadth or urine, a comparable cutoff shall be established (10 CFR 26.405(d)).

Lastly, for a tests conducted under the Conditions for testing, 10 CFR 26.31(c), phosphatidic ethanol, PEth, (or other biomarker) would not be an allowable test method. The only exception would be for the testing of individuals presenting a medical condition, 10 CFR 26.31(d)(5), where it is conceivable that PEth testing (or another biomarker) could be used.

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