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Fitness-for-Duty Frequently Asked QuestionsThe NRC has updated this FAQ webpage in response to questions the staff has received on the amended Part 26 (10 CFR Part 26 Final Rule) was published in the Federal Register on March 31, 2008. The questions and the staff’s responses are organized by topics, as follows:
If you would like to provide comments about our program or contact someone in NRC about the FFD Program, please contact us. Index to All NRC Frequently Asked Questions Pages Note: The information herein is provided as a public service and solely for informational purposes and is not, nor should be deemed as, an official NRC position, opinion or guidance, or "a written interpretation by the General Counsel" under 10 CFR 26.7, on any matter to which the information may relate. The opinions, representations, positions, interpretations, guidance or recommendations which may be expressed by the NRC technical staff responding to your inquiry are solely the NRC technical staff's and do not necessarily represent the same for the NRC. Accordingly, the fact that the information was obtained through the NRC technical staff will not have a precedential effect in any legal or regulatory proceeding. Managing FatigueQ: Does the NRC have a summary of the regulatory changes regarding fatigue and working hours at nuclear plants resulting from the issuance of the Part 26 final rule on March 31, 2008? A: The NRC has not developed a summary of the regulatory changes regarding fatigue and working hours at nuclear plants. However, the March 31, 2008, Federal Register Notice (Vol. 73, No. 62) for the Part 26 final rule describes the fatigue management requirements. Section VI, page 16997 of the Federal Register Notice contains a "Section-by-Section Analysis of Substantive Changes." The discussion of Subpart I, "Managing Fatigue," begins on page 17118. The Subpart I rule language is found starting on page 17224 of the Federal Register Notice and concludes on page 17227. Q. When is Part 26, Subpart I, “Managing Fatigue,” required to be implemented? A. The requirements of Subpart I in Part 26 must be implemented on or before October 1, 2009. Q: When using a shift schedule that rotates every 8 weeks, for the purposes of calculating days off, may a licensee stop every 6 weeks and ensure the number of days off requirement is met? A: The rule does not prescribe the length of shift cycles. However, § 26.205(d)(3) requires that individuals must have the minimum days off required for their shift schedules (i.e., an 8-, 10- or 12-hour shift), averaged over a period not to exceed 6 consecutive weeks. Therefore, yes, reviewing work hours every 6 weeks to ensure that the applicable minimum days off requirements are met is an acceptable means to meet the requirement, if a licensee’s shift cycles are longer than 6 weeks. Q: How will § 26.31(b)(1)(ii), which provides general requirements for who may perform assessment or evaluation procedures, apply to fatigue assessments? A: Section 26.31(b)(1)(ii) does not apply to fatigue assessments. Section 26.31(b)(1)(ii), like all of § 26.31, applies only to drug and alcohol testing. Section 26.211(b) specifies those individuals who may and may not perform fatigue assessments. Section 26.211(b)(1) provides the requirements regarding for-cause fatigue assessments. Section 26.211(b)(2) provides the requirements for who may perform a post-event fatigue assessment. Q: Are contractors considered to be subject to Subpart I of Part 26 if they are doing work within the protected area? A: The applicability of Part 26 requirements to an individual depends on the types of access the licensee or other entity has granted to the individual and the job duties the individual performs rather than by whom the individual is employed. Therefore, there are circumstances in which contractors are subject to the requirements of Subpart I, as specified in § 26.201, “Applicability.” Contractors who have been granted unescorted access to the protected area and are performing the job duties listed in § 26.4(a)(1) through (a)(5) (i.e., “covered job duties”) are subject to all of the requirements in Subpart I. If a contractor has been granted unescorted access to protected areas but is not performing covered job duties, the contractor is subject to the requirements of §§ 26.203 and 26.211. Contractors who are performing any job duties in protected areas under escort are not subject to the requirements of Subpart I. The table below is intended to illustrate the Subpart I requirements that apply to any individuals who have unescorted access to protected areas, regardless of the individuals’ employer.
Q: If, during a shift cycle, a security crew has a training week where they are not performing security duties as an armed security force officer, alarm station operator, response team leader, or watchperson, do those hours spent on-site during the training week count in calculating work hours? [10 CFR 26.205(b)] A: Under § 26.205(b), yes, the hours spent on-site during the training week count in the calculation of work hours during non-outage periods. For any individuals who perform covered work during a shift cycle, such as the security personnel mentioned in the question, § 26.205(b) requires licensees to include in the calculation of the individuals’ work hours all hours during which an individual performs work for the licensee, whether or not the work is covered by Part 26. Q: Section 26.203(a) states that licensees shall establish a policy for the management of fatigue for all individuals who are subject to the licensee’s Fitness-for-Duty (FFD) program and incorporate it into the written policy required in § 26.27(b). Section 26.27(b) is required to be completed by March 31, 2009. Is this implying that a fatigue assessment for all individuals, not just for a work hour waiver or what is required as part of Subpart I, needs to be implemented by March 31, 2009 or September 2009? A: Licensees are not required to implement the fatigue management requirements in Subpart I, including the requirements for conducting fatigue assessments and the processes for granting a waiver, until the end of the 18-month implementation period. The 18-month implementation period for Subpart I ends October 1, 2009. Thus, the requirement in § 26.203(a) to incorporate a fatigue management policy into the written policy required in § 26.27(b) must be completed by October 1, 2009. Q: Below is a proposed schedule that has a 3-week rotating cycle. This schedule runs 8 hours a day from 0800-1600. Would this schedule meet the 34-hour break period requirement?
A: As laid out in the example, the 34-hour criterion in § 26.205(d)(2)(ii) is met. The 34-hour period starts at the end of the work shift and is accommodated by the days off as designated by an "X" in the example. In addition, this shift schedule also exceeds the criterion in § 26.205(d)(3)(i) that requires individuals who are working an 8-hour shift (during non-outage periods) to have a minimum of 1 day off per week, averaged over the shift cycle. In this example, the shift schedule provides for an average of 2 days off per week.
TrainingQ: Section 26.29 of the March 31, 2008, rule requires “the successful completion of training by passing a comprehensive examination that addresses the KAs” for certain individuals. The regulation goes on to read “individuals shall complete refresher training on a nominal 12-month frequency,” however, “individuals who pass a comprehensive annual examination that meets the requirements in paragraph (b) of this section may forgo the refresher training.” Upon successful completion of the comprehensive examination, are individuals required to pass the comprehensive examination on an annual basis or do they receive only the refresher training on an annual basis? Is the comprehensive examination used for initial training only and refresher training done on an annual basis? A: The intent of the training requirements, as they pertain to these questions, is to ensure that all individuals who are subject to the rule attain and retain the knowledge and abilities (KAs) specified in the rule. Individuals are required to demonstrate their initial attainment of the KAs by passing a comprehensive examination (CE) and their retention of the KAs by passing a CE at least annually thereafter. If individuals successfully pass the CE each year, refresher training is not required. However, if individuals do not pass the CE, then the rule requires remediation through refresher training. Q: Section 26.29(c)(3) states that "Initial and refresher training may be delivered using a variety of media including, but not limited to, classroom lectures, required reading, video, or computer-based training systems. The licensee or other entity shall monitor the completion of training and provide a qualified instructor or designated subject matter expert [SME] to answer questions during the course of training." Would it be acceptable to provide to personnel the phone number and name of an available SME during training and testing? A: Yes, it would be acceptable for the qualified instructor or designated subject matter expert to be available by telephone, provided that s/he is available during the period during which an individual is completing the training.
Drug and Urine Specimen Validity TestingQ: With regard to the drug and alcohol testing provisions, does a descriptive summary document for the 2008 FFD rule exist? A: The March 31, 2008, Federal Register Notice for the Part 26 final rule includes a summary and detailed descriptions of the changes to the drug and alcohol testing requirements. The Federal Register notice is available on the NRC’s Fitness-for-Duty website. Section VI, page 16997 of the Federal Register Notice contains a "Section-by-Section Analysis of Substantive Changes" from the former rule provisions. Q: Is a licensee testing facility required to include the quality control samples specified in § 26.137(e)(6)(i)–(v) in at least one analytical run each quarter or for each analytical run? A: Section 26.137(e)(6)(i)-(v) describes the quality control samples that must be included in each analytical run of testing performed at a licensee testing facility. Q: Would the drug Ecstasy be detected by the drug tests that NRC requires licensees to perform under Part 26?
Alcohol TestingQ: The 1989 FFD rule allowed for donors to request a gas chromatography analysis of blood for further confirmation of a positive alcohol test (§ 26.24 Chemical and alcohol testing). The 2008 FFD rule eliminates the analysis of blood for confirmatory testing. May a gas chromatography analysis of blood be used for an appeal of a positive alcohol test? If not, does the donor have a method to appeal a confirmatory alcohol test result? Also, please provide a section number for Appeals in the 2008 rule. A: The final Part 26 rule was published in the Federal Register on March 31, 2008, and does not require licensees and other entities subject to the rule to provide donors with the opportunity to volunteer to submit a blood sample for gas chromatography analysis. The March 31, 2008, rule includes § 26.39, "Review process for fitness-for-duty policy violations," which replaces the requirements in the former rule's § 26.28, "Appeals."
Collection Sites and Collection ProceduresQ: Can a licensee request pre-access observed urine drug screens of employees without cause? According to § 26.115, “collecting urine specimens must provide for donor's privacy” unless certain conditions are met. A: The answer to this question is no. Section 26.115(a) specifies the circumstances in which a urine specimen may or must be collected under direct observation. The rule prohibits collecting urine specimens under direct observation without cause. Q: Does the 1989 FFD rule, which is currently in effect, require collection sites to refrigerate specimens? A: Section 2.7 in Appendix A of the 1989 FFD rule requires specimen refrigeration by licensee testing facilities but not collection sites. However, the final rule that was published in the Federal Register on March 31, 2008, and must be implemented by March 31, 2009, requires refrigeration of urine specimens at collection sites under the conditions specified in § 25.117(j). Q: Do "contractors" come under the same rules as "House" technicians for the new Part 26 (Fatigue Management)? More specifically, Health Physics Technicians, Do both the "House and Contractor Technicians come under the same work hour rules for Outages greater than 60 days? A: Yes, "house” and contractor technicians come under the same work hour rules for outages greater than 60 days. 10 CFR 26.201 addresses the applicability of Subpart I – Managing Fatigue and explains that the work hour rules (which are found in section 26.205(d)) apply to all individuals in section 26.4(a), including the individuals in section 26.4(a)(2). Section 26.4(a)(2) doesn’t differentiate between contractors and "house" technicians; it identifies personnel who are granted unescorted access to nuclear power reactor protected areas and perform health physics or chemistry duties that are required as a member of the onsite emergency response organization minimum shift complement.
AuditsQ: Is it necessary to review the laboratory’s completed HHS inspection records in order to determine which items of the HHS inspection records are acceptable to the utility? If so, what records or reports are provided to the HHS laboratory and how does a licensee obtain these documents? A: Yes, licensees and other entities who are subject to the rule must review HHS inspection reports and records as one portion of the auditing activities required under § 26.41 of the March 31, 2008, rule. These reviews are necessary in order to ensure the continuing effectiveness of the FFD program, including ensuring that corrective actions are taken to resolve any problems identified by the HHS certification inspections. In addition, § 26.41(c)(2) requires, in part, that licensees and other entities “review the HHS certification inspection records and reports to identify any areas in which the licensee or other entity uses services that the HHS certification inspection did not address.” The intent of this provision is to ensure that licensees and other entities audit “any areas” that the HHS inspection did not evaluate where the HHS-certified lab is providing services to licensees and other entities that are outside the scope of the HHS certification inspection. Accordingly, audits performed by licensees and other entities must review the inspection records and audit any areas in which licensees and other entities use services that the HHS certification inspection did not address. The discussion on page 17030 of the March 31, 2008, Federal Register notice, states, “The NRC has added § 26.41(d)(2) to ensure that licensees’ and other entities’ contracts with C/Vs and HHS-certified laboratories permit the licensee or other entity to obtain copies of and take away any documents that auditors may need to assure that the C/V, its subcontractors, or the HHS-certified laboratory are performing their functions properly and that staff and procedures meet applicable requirements.” Therefore, through § 26.41(d)(2), the NRC has ensured that access to these inspection reports will enable licensees and other entities to meet the requirements of § 26.41(c)(2). Q: Is it acceptable to verify that the lab is HHS-certified and audit the laboratory program and procedures for effective implementation for only the differences in cutoff levels and any additional drugs that are not listed in the tables in Subpart G, § 26.163, and the corrective actions from any finding from the HHS inspection? A: Although the discussion of § 26.41(c)(2) on page 17030 of the March 31, 2008, Federal Register Notice states, “If a licensee or other entity chooses to implement more stringent cutoff levels or a broader panel of drugs than required under the final rule, the licensee or other entity is required to ensure that annual audits of the HHS certified services related to those cutoff levels and drug tests are performed,” cutoff levels and a broader panel of drugs were used as examples, not the total definition of “any areas” in § 26.41(c)(2). For example, if a licensee or other entity relies on the HHS-certified laboratory to test dilute urine specimens that were collected for-cause for drugs at the limits of detection (LOD), the audit would evaluate this service. Therefore, it is sufficient for a “licensee to verify that the lab is HHS-certified and audit the laboratory program and procedures for effective implementation for only the differences in cutoff levels and any additional drugs that are not listed in the tables in Subpart G, § 26.163, and the corrective actions from any finding from the HHS inspection,” if those are the only two services not covered by the HHS inspection. In addition, as noted in the response to the previous question, if the HHS inspection identified problems, the licensee’s or other entity’s audit would also be required to verify that appropriate corrective actions have been taken to resolve the problems identified. Q: What if the licensee does not require the HHS-certified lab to conduct special analyses of a dilute specimen (§ 26.163(a)(2) states “at the licensee discretion...”) and the specimen does not confirm at the cut-off level, so in reality it is negative, but still dilute? Section 26.185(g)(5) states that an MRO review is not required for specimens that the HHS-certified laboratory reports as negative and dilute. The licensee or other entity may not take any administrative actions or impose any sanctions on a donor who submits a negative and dilute specimen. Under the 1989 FFD rule, licensees were able to re-collect under observed conditions for a dilute specimen, but this is not allowed in the 2008 FFD rule. In addition, the Statements of Consideration (SOC) for the 2008 FFD rule indicate that testing the specimen at the level of detection (LOD) (special analysis) is how the MRO can determine the results of this type of test. Licensees, at their discretion, can allow this to happen, but by saying that it “may” be done does not mean that it must be done. How does a dilute specimen with no special analysis that is negative get resolved? Or is § 26.185(g)(5) the answer: no MRO review and no further action? A: As stated in the SOC for the final rule that was published in the Federal Register on March 31, 2008, there are many reasons that an individual may produce a dilute urine specimen, the majority of which are the result of normal physiological processes, specific circumstances, or an individual’s personal characteristics (e.g., body type, race, athleticism). Because dilute specimens are relatively common for these reasons, neither the HHS Guidelines nor the U.S. Department of Transportation Procedures for Transportation Workplace Drug and Alcohol Testing Programs permit further processing of negative and dilute specimens. The NRC chose not to require further processing of negative and dilute specimens for consistency with these other federal agencies’ programs. However, Part 26 permits licensees to direct the HHS-certified laboratory to perform drug testing of dilute specimens at the LOD and establishes requirements for that process. A licensee may choose not to subject negative and dilute specimens to drug testing at the LOD or, for example, may limit this type of testing to dilute specimens obtained from for-cause or follow-up tests only. If a licensee does not implement a policy and procedures for testing negative and dilute specimens at the LOD, then a specimen that yields “negative and dilute” test results from the HHS-certified laboratory is considered a negative test result and no MRO review or further action is required.
RecordkeepingQ: With the elimination of the permanent record book from the new 10 CFR Part 26, would a licensee still need to maintain the old ones and, if so, for how long? A: Under the 1989 FFD rule, collection site personnel were required to maintain a permanent record book that identified data on each specimen collected at a collection site in the sequence of collection. The 1989 FFD rule instructed collection site personnel to record any unusual circumstances (e.g., donor’s behavior or appearance, specimen color, evidence of contaminants) in the permanent record book. Although the 2008 revisions to 10 CFR Part 26 eliminated requirements regarding recording collector comments on specimen collections in a “permanent record book,” a licensee should continue to retain any permanent record books (or equivalent records) in accordance with § 26.715(a) of the March 31, 2008, rule. This section of the rule requires collection sites to maintain documentation on all aspects of the testing process for at least 2 years or until the completion of all legal proceedings related to a determination of an FFD violation, whichever is later.
FFD Programs for ConstructionQ: Our company builds power plants. Do the FFD regulations apply to the workers involved in the actual construction of the plant? A: Yes. Section 26.4(e) and (f) specify the individuals involved in nuclear power plant construction who must be subject to a fitness-for-duty program.
SanctionsQ: Under the 2008 FFD rule, must individuals who have already violated the rule for alcohol twice be terminated? Under the 1989 FFD rule, they could have essentially “two strikes” with alcohol and still remain employed. A: The 1989 FFD rule required that if an individual received two confirmed positive drug test results, then his/her authorization would be denied for 3 years [see the 1989 FFD rule’s § 26.27(b)(2)(vii)]. The 1989 FFD rule did not impose the same sanctions for two confirmed positive alcohol test results. Instead, § 26.27(b)(5) stated that “Licensee sanctions for confirmed misuse of alcohol…shall be sufficient to deter abuse.” In contrast, the March 31, 2008, rule imposes the same sanctions both for confirmed positive drug test results and for confirmed positive alcohol test results [see § 26.75(e)]. In the case of an individual who was subject to licensee sanctions for two confirmed positive alcohol test results, the revised requirements in § 26.75(e)(2) also do not apply retroactively. However, for individuals whose second confirmed positive drug or alcohol test result occurred under the 1989 FFD rule, § 26.75(e)(2) of the March 31, 2008, rule specifies that these individuals must be denied authorization for a minimum of 5 years after the next confirmed positive test result. NEI raised a similar question during a public meeting held on September 5, 2007, to discuss implementation guidance for 10 CFR Part 26. The exact question and NRC response is provided in the meeting summary, which is accessible through ADAMS (ML072570657, Attachment 2, question #2). This information is provided for reference only, as the meeting summary does not provide additional detail. Q: The new FFD rule requires the same minimum sanction for a positive alcohol test as for a positive drug test. The minimum sanction for a positive drug test is a 14-day suspension of access. Is it permissible for a licensee to implement a sanction of a 30-day suspension for a positive drug test and a 14-day suspension for a positive alcohol test or must both sanctions be the same?
Note: The information herein is provided as a public service and solely for informational purposes and is not, nor should be deemed as, an official NRC position, opinion or guidance, or "a written interpretation by the General Counsel" under 10 CFR 26.7, on any matter to which the information may relate. The opinions, representations, positions, interpretations, guidance or recommendations which may be expressed by the NRC technical staff responding to your inquiry are solely the NRC technical staff's and do not necessarily represent the same for the NRC. Accordingly, the fact that the information was obtained through the NRC technical staff will not have a precedential effect in any legal or regulatory proceeding. To learn about future meetings on Part 26, see our public meetings schedule page. |
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