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Fitness-for-Duty Frequently Asked Questions

The 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:

• Managing Fatigue
• Training
• Drug and Urine Specimen Validity Testing
• Alcohol Testing
• Collection Sites and Collection Procedures
• Audits
• Recordkeeping
• FFD Programs for Construction
• Sanctions

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 Fatigue

Q:  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.

Q:  Regulatory Guide 5.73 states that if a licensee chooses to implement 10 CFR Part 26, Subpart I using a method that is different from one specified in Regulatory Guide 5.73 then the NRC would review this methodology for acceptability.  Does this require that a licensee submit to the NRC for review any methods that are not specified in RG 5.73?
A:  Regulatory Guide (RG) 5.73 provides acceptable methods for licensees and applicants to implement the fatigue management requirements of 10 CFR Part 26, Subpart I.  Licensees need not submit alternate implementation methods, prior to implementation, for NRC review.  Audits or inspections may include a review of a licensee's specific implementation methods.

Page 14 of RG 5.73 in the section titled "Use of Other Methods" includes the following paragraph:

Licensees and other entities subject to Subpart I of 10 CFR Part 26 may use methods other than those described in NEI 06-11, as clarified by the regulatory guide, to meet the requirements of the regulations in 10 CFR Part 26.  The NRC will determine the acceptability of other methods on a case-by-case basis.  Methods and solutions that differ from those set forth in this regulatory guide may be deemed acceptable if they are accompanied by a sufficient basis for the finding required for issuance or continuance of a permit or license by the Commission.

Q:  Concerning the Table on page 12 of Regulatory Guide 5.73, “Minimum Number of Individuals per Shift Working Non-Outage Schedules for Onsite Staffing of Operating Nuclear Power Units during Outages”:

• For a three unit station with one unit in operation, the table specifies that the entire minimum site complement of operators per 10 CFR 50.54(m) is not eligible for outage minimum days off (MDO) treatment. Please provide the rationale for specifying that all the minimum required site operators are to be excluded from the outage MDO?



• For two unit stations, each of the minimum required senior operators per 10 CFR 50.54(m) is not eligible for outage minimum days off (MDO) requirements.  What is the rationale for all the minimum required senior operators to be excluded from the outage MDO?

A:  The referenced table, published in draft final Regulatory Guide (RG) 5.73 contained two typos; the corrected table is included below.  The numbers in parentheses are the 50.54(m) requirements, which are included in the final RG.  The numbers outside the parentheses indicate the number of control room operators responsible for the operating unit(s) that the staff considers not eligible for outage MDO requirements.

The NRC policy basis for excluding operators who are responsible for the operating unit(s) from working outage hours includes:

• 1989 "Policy Statement on the Conduct of Nuclear Power plant Operations"
• 2008 Regulatory Guide 1.114 "Guidance to Operators at the Controls and to Senior Operators in the Control Room of a Nuclear Power Unit.

The Regulatory basis for the exclusion includes:

• 10 CFR 50.54(m)(2)(i), which establishes the minimum control room shift staffing requirements based on number of operating units and the control room configuration.
• 10 CFR 50.54(k), which requires an operator at the controls of any operating unit at all times.
• 10 CFR 50.54(m)(2)(iii), which requires a senior operator in the control room of any operating unit at all times.  Additionally, for any fueled unit, an operator or senior operator shall be present at the controls at all times.

The corrected table below shows that the number of senior reactor operators (SROs) and reactor operators (ROs) who should remain on operating hours depends on the configuration of the control rooms for the units at the site.  In general, the guidance recommends that the required operator at the controls and the senior operator in the control room for each operating unit should be excluded from outage MDO requirements.  One additional RO and SRO who have not been working outage hours also should be available to provide relief for the operator at the controls and the senior operator in the control room.  

Also, many control rooms have control panels that are arranged such that two ROs are required to operate the equipment ad systems affected by plant transients or relied upon to mitigate significant events.  Two ROs per operating unit are necessary to ensure that the reactor operator at the controls required by 10 CFR 50.54(k) is alert and fully capable of responding to any event that may occur.

One SRO would be expected to maintain oversight of control room activities as the senior operator in the control room with relief provided by the second SRO.  During an event, the second SRO would be expected to oversee the response in the plant as well as to coordinate emergency plan implementation as necessary.  Two SROs per operating unit are necessary to ensure that the senior operator in the control room required by 10 CFR 50.54(m)(2)(iii) is alert and fully capable of responding to any event that may occur.

Therefore, for a two-unit site with one unit in an outage, all of the SROs and 2 of the ROs required under 10 CFR 50.54(m)(2)(i) are to remain on operating hours.

Q:  On page 11 of Regulatory Guide 5.73, the phrase, “the minimum shift complement of operators required under 10 CFR 50.54(m) for the operating unit”, is used.  However, 10 CFR 50.54(m) addresses on-site minimum staffing and does not include a column or note that refers to the minimum shift complement for an operating unit.  What is this statement referring to in 50.54(m)?

A: This minimum complement specified by the staff is derived from the minimum site staffing requirements of 10 CFR 50.54(k) and (m) and reflects that portion of the minimum site staffing of operators necessary to ensure the safety of the operating unit.  For example, at a two‑unit site with one unit in outage, the staff position is that two ROs and two SROs would not be eligible for the outage MDO requirement.

Q:  The wording in regulatory guide 5.73 for multi-unit station eligibility for outage MDO appears to require that some minimum portion of the operating staff remain not eligible for outage MDO’s even when all plants on the site are in an outage.  Is this interpretation correct?

A:  The interpretation is incorrect.  When all units on a site are in an outage, all covere workers are eligible for outage work hour controls, including all control room operators.

Q:  Regulatory Guide  5.73 states that a shift cycle could not be less than one week.  If a contractor works less than one week at a station, is he/she to be given days off?

A:  Regulatory Guide RG 5.73 refers to shift cycles being as short as one week because the minimum day off (MDO) provisions are based on a weekly average.  For individuals with unescorted access, who perform covered work, for a period that is less than one week in duration, there is no applicable MDO requirement. 

The licensee is responsible for understanding whether any transitions are occurring, such as beginning or resuming duties subject to work hour controls, or such as performing work at another licensee site.  Transitions may require the individual to receive days off per the MDO provisions.  This guidance is applicable to licensee employees, employees on-site from other licensees and contractors/vendors.

Q:  Need clarification on how to determine significance to the public health and safety for maintenance and ops covered activities. 

• Part 26 rule states use 10 CFR 50.65(a)(4) but lot of items in a(4) are not safety significant during outages.  For example auxiliary feedwater is not risk significant during an outage.  Everything in a(4) is significant to public health and safety per definition so everything is covered.



• Maintenance rule a(1) and a(2) high safety significance is a different set of systems than a(4).

  Which part of the maintenance rule should we be using?

A:  Regarding the definition of maintenance, for the purposes of Part 26 use the 10 CFR 26.05 definition.  In your example the auxiliary feed water system is safety significant when the unit is operating.  If an individual works on the auxiliary feed water system either during outage or operations, the individual would be considered to be subject to the work hour controls in 10 CFR 26.205.

Q:  When a covered worker is performing activities in multiple work categories, for example operating and maintaining, is it acceptable to leave them in the more restrictive work hour restriction categories.

For example: A worker performs fuel handling during an outage and also performs equipment tagouts.  This worker performs activities under both operating and maintaining categories.  It is acceptable that the worker is maintained on the more restrictive operating MDO.

A:  If an individual is performing work under multiple categories, the licensee must manage the fatigue of the individual by having the individual adhere to the more restrictive work hour controls, as the minimum day off (MDO) requirements for the most restrictive category must be met.  If there is a transition, for example, between covered groups or onto a covered group, please refer to Regulatory Guide 5.73 for guidance.

Q:  Does a phone call at home while you are on you 12-hour break in between shifts interrupt your required rest time under the new guidelines.

A:  A phone call at home while you are on any of your 10 CFR 26.205 required breaks is considered to be an incidental duty under 10 CFR 26.205(b)(5).  Incidental duties may be excluded from the calculation of work hours provided the total duration of the unscheduled work does not exceed a nominal 30 minutes.  The 30 minutes is cumulative and could result from, for example, three 10-minute phone calls.  If the cumulative 30-minute limit is exceeded, the total amount of time the individual has spent on incidental duties must be included in the calculation of his/her work hours.  Depending on when the incidental duties are performed, they may be determined to be an additional work day or they could be added to the work hour calculation for the previous or upcoming shift.  Please refer to the implementation guidance in RG 5.73 for additional information.

Q:  When Transitioning out of a Planned Outage Schedule the output breakers close on a Tuesday at 2000.  My shift cycles always start on a Sunday at 0000.  My on line requirements now apply but I have less than a week until my cycle begins.  In order to transition all workers onto their normal cycle on Sunday at 0000 I need to leave them on the same schedule they worked for the outage until Saturday at 1900.  I would manage their hours to be less than the 54 hours required by the on line rules for the 4 day period of time and ensure that a 34 hour break is scheduled to occur in the 9 day period around the transition date.  In addition all MDO requirements would be met for the outage and they would be met going forward from Sunday at 1900.  Would this be an acceptable way to handle the transition?  The Transitions out of an Outage are going to be the hardest to make.  The Transitions will need to be planned very carefully especially when a worker is changing from a day shift to a night shift or night shift to day shift. 

A:  There is no 54 hour requirement, other than reporting, related to 10 CFR 26, Subpart I work hour controls.  Although it is possible that certain schedules could be acceptable when using 54 hours as your criteria, we cannot blanketly accept the use of a 54 hour maximum, because various schedules can be envisioned that would exceed the work hour controls in §26.205. 

It is important to reiterate that a 54 criteria would not ensure that an individual has an acceptable work schedule or hours worked.

When exiting from an outage that does not end exactly when your new shift schedule begins (from your example, Sunday at 0000), there are different ways to handle the few "extra" days.  One way is to just add the extra days onto the beginning of the planned shift cycle.  This will create an odd length schedule, for example, a 6 week and 4 day schedule, which is an acceptable shift cycle length under 10 CFR 26.205(d)(3).  

Another way to handle coming out of the outage is to create a short cycle of, perhaps 11 days.  The short cycle could include the 4 extra days plus the next full week.  This type of schedule allows you to account for the extra days, including MDO and allows you to start a full cycle at the end of the short cycle.

A third way to handle these extra days is to set up your cycle to start the day the outage ends and then roll the schedule (6 weeks perhaps) on a daily basis.  When the rolling schedule meets up with the desired start of the fixed 6 week schedule, end the rolling schedule and begin the fixed.

Q:  According to the minutes from the November public meeting with NEI the licensees will be able to exclude turnover at both ends of the shift.  This is due to security requiring a turnover at both ends and possibly control room turnovers that may require a turnover at each end.  Is this in writing anywhere? 

A:  10 CFR 26.205(b)(1) states that licensees may exclude shift turnover from the calculation of an individual's work hours.  Regulatory Guide 5.73 clarifies that shift turnover may include the time taken by security guards to arm and disarm.

However, for the purposes of calculating the minimum number of days off, 10 CFR 26.205(d)(2) states that one period of shift turnover must be included in the calculation of break times.  This period of shift turnover can be at the beginning or end of the shift, but not both. 

Q:  When we hold someone over for a double shift, we decided that if a person was held for more than 4 hours they would have started another shift and therefore it would count as a day worked in the MDO calculation.  When this is programmed into the software it will not differentiate shifts.  When this is programmed it will tell us a new shift was started anytime an OT shift exceeds 4 hours.  The software will figure this as a normal 8 hour shift and a second shift of 4.5 hours all in the same day and they are adjacent shifts.  So now when the calculation is done to determine the shift average for MDO you will never get more than a 12 hour shift average and when you have these shortened shifts it will lower the shift average.

If you work a worker a 6 hour OT shift because this is the maximum you can work and still get a 10 hour break now you will average a 8 hour shift and a 6 hour shift into the MDO calculation instead of a 14 hour shift.  This helps the shift average calculation to be a lower average and if the OT occurs after 0000 when the shift started the previous day the software categorizes the shift as starting on the next day and it is not counted as a day off.

Here is my problem, now when I make this change the program will do this for all shifts over 4 hours.  It makes sense that if it is more than splitting the shift it should be considered a separate shift but if it is a separate shift it will change the calculation for the MDO requirements.  This situation could be looked upon as playing games with the calculation but it needs to be one way or the other in the computer.  Any help in this matter is appreciated.

A:  Section 26.205(d)(2)(i) requires licensees to ensure that individuals have a minimum 10-hour break between successive work periods, or an 8-hour break between successive work periods when a break of fewer than 10 hours is necessary to accommodate a crew’s scheduled transition between work shifts.  Thus, treating an OT shift that is successive to a regular shift as a new shift would violate this provision.  To address your question regarding the programming software at your facility, for the purposes of Subpart I, the programming software must calculate regular work hours plus any successive OT hours as a single shift.

Q:  Our site has implemented the new FFD portion of the rule changes on 12/19/08.  The Worker Fatigue portion will be implemented in 07/2009. We are currently in the process of revising procedures to meet the deadlines.  Should we include Worker Fatigue and Fatigue Assessments at this time or is it acceptable to wait until implementation of Subpart I?

A:  It is acceptable to wait until Subpart I is implemented at your site, 07/2009, to implement specific Subpart I provisions.

Q:  We have a group of workers who work a straight 12 hour day shift, performing covered job duties.  There is no back shift, the job is only worked 12 hours per day and the job is idle the other 12 hours.  Is the period after the workers arrive for work each day considered to be turnover time, which – by the definition of turnover time, would not be counted as work hours?  The individuals are not turning over with anyone on the previous shift because there was no previous shift.  However, they would be doing things like getting briefed on:

• This is what happened on your last shift
• This is what's changed since your last shift
• This is what we want you to do this shift

The same status information is being communicated and serves the same purpose as a direct turnover between two adjacent shifts.  Should this time should be counted as worked hours and not counted as turnover time?

A:  The situation you describe does not meet the definition of shift turnover.  We agree that the information you describe is important to the individual's job performance, however, a shift turnover as described in 10 CFR Part 26, typically occurs when the on-coming shift worker comes in before the start of the work shift to obtain important information required to perform his/her duties.  A shift turnover is dependent on the off-going shift worker to provide this information.  For the purpose of Subpart I, the time taken to provide the briefing described in your question is more akin to a pre-shift brief and should be counted toward the individual's hours worked.

The staff is currently developing an answer to the following questions and will post the answers shortly:

Q:  During the day a supervisor directs a covered individual to report from site 1 to site 2 which is  one hour away.  The individual travels to site 2 during the typical work day.  At the end of the shift the individual travels to his/her personal residence from site 2.

Q:  During the day a supervisor directs a covered individual to report from site 1 to site 2 that is one hour away from site 1.  The travel time is prior to the start of the work day. 

Q:  During the day a supervisor directs an individual to report from site 1 to site 2.  The travel time is done in the evening and the person stays in a hotel overnight, prior to starting work the next day.  Is the travel time to the hotel included in work hours?  Is the travel time to site 2 from the hotel included in work hours? 

Q:  If the person stays at site 2 for extended work, e.g. four weeks, and chooses to travel to his/her personal residence on the weekends is this weekend travel time included in work hours?

Training

Q:  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 Testing

Q:  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.

Alcohol Testing

Q:  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 Procedures

Q:  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.

Audits

Q:  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.

Recordkeeping

Q:  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 Construction

Q:  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.

Sanctions

Q: 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)].  
 
If an individual whose authorization was denied under the 1989 FFD rule as a result of two confirmed positive drug test results seeks authorization under the March 31, 2008, rule, a licensee may initiate the necessary steps to grant authorization once the 3 years have expired.  Although the March 31, 2008, rule requires a denial of authorization for a minimum of 5 years for the same offense [as stated in § 26.75(e)(2)], this revised sanction is not retroactive. 

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?

A:  The sanction requirement to which you refer to is located in § 26.75(e)(1) of the March 31, 2008, rule, which states that the first violation of an FFD policy involving a confirmed positive test drug or alcohol test result must, at a minimum, result in the immediate unfavorable termination of the individual's authorization for "at least" 14 days.  Also, § 26.75(a) states that a licensee "may impose more stringent sanctions, except as specified in [26.75(h)]."  (The exceptions in § 26.75(h) refer to initial drug and validity test results, rather than confirmed positive test results.)  Therefore, it is permissible for a licensee to implement a more stringent sanction for a confirmed positive drug test result beyond the 14-day minimum while imposing the 14-day requirement for the positive alcohol test result.  However, note that all sanctions must be consistent with the licensee's documented policies and procedures [see § 26.27, including in particular § 26.27(b)(8) and § 26.27(c)(2)].

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.

Resources

• Fitness-for Duty Programs Home Page
• History of the Fitness-for-Duty Program 
• FFD Program Performance Reports

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Wednesday, April 22, 2009