ML20206B510
| ML20206B510 | |
| Person / Time | |
|---|---|
| Issue date: | 04/07/1999 |
| From: | NRC |
| To: | |
| References | |
| OMB-3150-0146, OMB-3150-146, NUDOCS 9904290267 | |
| Download: ML20206B510 (15) | |
Text
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DRAFT SUPPORTING STATEMENT FOR 10 CFR PART 26 FITNESS-FOR-DUTY PROGRAM (OMB Clearance No. 3150-0146)
Revision to Clearance Extension DESCRIPTION OF THE INFORMATION COLLECTION The 10 CFR Part 26 information collection requirements apply to all licensees authorized to construct or operate a nuclear power reactor and all licensees authorized to use, possess, or transport irradiated Category i nuclear material. These licensees shall establish, implement, and retain on file for 5 years the records described below. Where there is a retention requirement different from 5 years, so stated in the applicabic section.
These information collections are necessary to properly manage fitness-for-duty programs and provide information to be used in the development of public policy. The collection of information pertaining to significant fitness-for-duty events is necessary to permit timely evaluation of events that might become problems and that may require a timely response by the NRC staff to ensure that the health and safety of the public is not endangered.
Section 26.20 requires that each licensee subject to Part 26 establish and implement written policies and procedures designed to meet the general performance objectives and specific requirements of Part 26.
The requirement is necessary to inform affected individuals with sufficient detail on licensee rules, what is expected of them, and what consequences may result from lack of adherence to the policy. It also provides a description of programs which are available to personnel desiring assistance in dealing with drug problems that could adversely affect their performance and outlines procedures to be utilized in testing for drugs. The requirement also partia:!y meets the legal necessity of providing " prior notice" and having it documented for evidence in legal proceedings.
These records will be maintained until the license is terminated. Superseded records will be retained for 3 years.
Section 26.21(b) requires that appropriate records of policy communications and awareness training be documented and retained for a period of at least 3 years.
l This ensures that persons assigned to activities within the scope of Part 26 are provided with .
appropriate training so that they understand the methods that will be used to implement the l policy, the personal and public health and safety hazards associated with abuse of drugs, the !
effects of prescription and over-the-counter drugs and dietary conditions on drug test results, !
and the role of the Medical Review Officer (MRO). The requirement also partially meets the legal necessity of providing " prior notice" and having it documented for evidence in legal j proceedings. 1 9904290267 990407 PDR ORG EUSOrtB l PDR I I
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Section 26.22(c) provides for records of training for supervisors and other personnel to document the conduct of such training. This ensures that such persons have been trained and '
understand their role in the implementation of the fitness-for-duty program, that they are sufficiently skilled to detect conditions that arise from abuse or presence of drugs, and that the proper action is initiated. These records must be retained for a period of at least 3 years.
Sections 26.23 and 26.70(b). These sections permit licensees to accept a fitness-for-duty program administered by their contractors and vendors. Written agreements between licensees and their contractors or vendors will clearly show that the licensee is responsible to the Commission for maintaining an effective fitness-for-duty program. These sections also permit the NRC to inspect, copy, take copics of any licensee's, contractor's, or vendor's documents related to implementation of the licensee's, cc.itractor's, or vendor's fitness-for-duty program under the scope of the contracted activities. The records applicable to these sections must be maintained for the life of the contract.
Section 26.24(a) requires chemical testing to provide the licensee a means to deter and detect substance abuse. In this regard the licensee shallimplement chemical testing programs that require:
(1) Testing within 60 days prior to grariting of unescorted access to protected areas; (2) Unannounced tests imposed in a random manner at a rate of 50% for licensee, contractor and vendor employees; (3) Testing for-cause, i.e., as soon as possible following any observed behavior indicating possible substance abuse.
(4) Follow-up testing on an unannounced basis to verify continued abstention from the use of substances covered under Pad 26.
Although no records are required by this section, these requirements influence the records that are made to meet the testing validity standards set forth in Appendix A.
Section 26.24(d)(2)(iv) requires the one-time development of a notification letter for the purpose of providing a written statement to a tested individual, whose preliminary onsite test is positive, but not confirmed by the MRO, that the records have not been retained and that the temporary removal or suspension or other administrative action will not be disclosed. This ensures that the reputations and careers of those individuals are not jeopardized. No report is made to NRC of this notification.
Section 26.27(a) requires a licensee, prior to the initial granting of unescorted access to a protected area or the assignment to activities within the scope of Part 26 to any person, to obtain a written statement from the individual as to whether activities within the scope of Part 26 were ever denied the individual. This is accomplished by checking a few boxes on a form and signing the individual'c name. A suitable inquiry is then conducted to verify the information. This will assist the licensee to determine if persons should be granted or denied unescorted access in accordance with a fitness-for-duty policy. No report is made to ine NRC.
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Section 26.27(d) requires a licensee to notify the NRC when an NRC employee may be under the influence of any substance, or is otherwise unfit for duty. This ensures that the NRC can take appropriate actions as necessary.
Section 26.291a) requires that each licensee subject to Part 26, who collects personal information on an employee for the purpose of complying with Part 26, shall establish and maintain a system of files and procedures for the protection of the personalinformation.
In order to ensure the protection of e rmation, the licensee shall not disclose the personal information collected and maintained to persons other than assigned MRO's, other licensees legitimately seeking the information as required by Part 26 for employment decisions and who have obtained a release from current or prospective employees or contractor personnel, NRC representatives, appropriate law enforcement officials, the subject or his or her representative, or to those licensee personnel who have a need to have access to the information in performing assigned duties. These records are maintained until the license is terminated. I Section 26.71 requires each licensee and each centractor or vendor implementing a licensee approved program to:
(a) retain records of inquiries that result in the granting of unescorted access (i.e.,
background checks). These records must be maintained for 5 years to facilitate suitable inquiries under Section 26.27(a) and because individuals can be denied unescorted access to the protected area or removed from activities within the scope of Part 26 for a
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period of up to 5 years. j l
(b) retain records of confirmed positive test results and the subsequent personnel actions. j These records support the suitable inquiries required by Section 26.27(a). This permits i the evaluation of program performance and the correction of any program weaknesses f so identified. These records also must be retained for 5 years for the same reasons j provided above with Section 26.71(a).
(c) retain records of persons made ineligible for assignment to activities within the scope of Part 26 who have been involved in the saie, use, or possession of illegal drugs while within a protected area. This requires licensees to retain records of persons made ineligible for 3 years or longer until the Commission terminates each license under which the racords were created. These records are needed to facilitate inquiries from other licensees required by Section 26.2T(a) to determine if a person had been made ineligible for assignment to activities within the scope of 10 CFR 26.
(d) collect and compile fitness-for-duty program performance data. This data includes statistics pertaining to drug testing, management actions, management actions on appeals and their resolutions, and for those licensees who choose to exercise the option of temporarily removing an individual as permitted by 10 CFR 26.24(d)(2), data on reporting of test results by process stage. This data will enable proper analysis and assist NRC staff in determining actions needed to correct program weaknesses and revise public policy. This data must be retained for 3 years.
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4 Section 26.73 requires each licensee to inform the NRC Operations Center by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of discovery of significant fitness-for-duty events. This will enable the NRC staff to ,
evaluate the event and determine whether immediate actions by the staff are warranted. 1 Section 26.73(d) requires each licensee to certify to NRC that their fitness-for-duty programs are )
implemented. This one-time reporting requirement provided to NRC the necessary background information that all programs were in place and implemented on schedule. This reqLirement would also apply to any new licensees subject to Part 26. l I
Section 26.80 requires each licensee subject to Part 26 to conduct an audit of their fitness-for- {
duty program nominally every 12 months. Results and recommendations of the audit must be I documented and reported to senior corporate and site management. Resolution of audit i findings and corrective actions must be documented. These documents must be retained for 3 years. This audit documentation will help ensure identification and resolution of program weaknesses and help NRC determine what corrective actions are necessary.
Accendix A sets forth the minimum standards for alcohol and drug testing; it emphasizes the -
procedures and records (chain-of-custody, quality controls, etc.) for ensuring the integrity of the .
test results, and the process for reporting and evaluating test results. The Appendix is an adaptation of the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (53 FR 11970). The documentation and reporting are consistent with Federal standards and are needed to ensure that test results are valid and defendable in any legal proceeding.
A. JUSTIFICATION
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- 1. Need for and Practical Utility of the Collection of Information The regulations in 10 CFR Part 26 establish requirements for licensees authorized to operate nuclear power reactors and licensees authorized to use, possess, or transport j irradiated Category 1 nuclear material to implement a fitness-for-duty program. The l general objective of the program is to provide a reasonable assurance that licensee personnel will perform their ta'sks in a reliable and trustworthy manner and are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause, which in any way adversely affects their ability to safely and .
competently perform their duties. Included in this general objective is the goal of I achieving a drug-free workplace and a workplace free of the effects of such substances.
The NRC has adapted pertinent parts of the Health and Human Services (HHS)
Guidelines concerning drug testing programs for application to the nuclear industry.
This supporting statement is designed to provide a comprehensive overview of the information collection requirements contained in 10 CFR Part 26. The information collection requirements fall into three categories:
- a. Written policies and procedures and associated records to facilitate proper management of the fitness-for-duty program. Included are records of training,
5 program audits, contract provisions and certain protected information used to ensure that those persons who tested positive, were removed for cause, or whose fitness for duty has been questioned, are not returned to duty until they have corrected their problem,
- b. Telephonic reports of significant fitness-for-duty events made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of the event.
- c. Collection and analysis of fitness-for-duty program performance data.
- 2. Acency Use of information The NRC will use the required records and reports for one or more of the following purposes:
- a. To determine if there are problems requiring timely action by the NRC staff.
NRC responses vary depending upon the circumstances but could include immediate telephone contact with the licensee to discuss the event or site inspection.
- b. To monitor compliance with 10 CFR Part 26.
- c. To perform empirical evaluations of this evolving discipline in support of any future considerations. This would include analysis of trends and lessons learned.
- 3. Reduction of Burden Throuch Information Technoloov At the current time, no licensees submit the information electronically. Most licensees collect and store fitness-for-duty data electronically.
The NRC has no objection to NEl or another industry group creating an electronic mail system acceptable to the NRC for submitting information in an acceptable data collection format. The NRC will continue to capitalize on information technology for improving information access, information distribution, and public interaction.
However, the NRC will not eliminate paper in favor of electronic communication without full consideration of the pubic's ability to access information electronically.
- 4. Effort to identify Duolication and Use Similar information The collection of information required by 10 CFR Part 26 does not duplicate any other requirements for collection of information.
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- 5. Effort to Reduce Small Business Burden This information collection does not affect small businesses.
- 6. Consecuences to the Federal Procram or Policy Activities if the Collection is Not Conducted or is Conducted Less Frequently The reporting of significant events is limited to telephone reports on an "as-needed" basis. A frequency of approximately 6 months is established for collection, analysis and reporting of program performance data. Without these records the licensee and
- he NRC would be unable to analyze and take appropriate actions necessary to correct program weaknesses and to take other corrective actions.
- 7. Circumstances Which Justifv Variation from OMB Guidelines Telephonic reports of significant events are to be made within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> and are, 1 therefore, a variation from OMB guidelines. This requirement is intended to provide further assurance that an event within the purview of the fitness-for-duty rule will not adversely affect the public health and safety.
Retention of certain records in excess of 3 years has also been deemed necessary to i ensure that the health and safety of the public will not be adversely affected. These records are specified above under the description of the information collection.
- 8. Consultations Outside the NRC The requirements of 10 CFR Part 26 are discussed on a continuing basis with the Nuclear Energy Institute (NEI), Substance Abuse and Mental Health Services Administration (SAMHSA) and licensees individually and at industry-wide meetings.
l Opportunity for public comment has been published in the Federal Reoister.
- 9. Pavment or Gift to Resoondents Not applicable.
- 10. Confidentiality of Information Section 26.71 requires each licensee to collect personal information for the purpose of complying with 10 CFR 26. However, the licensee is required by Section 26.29 to maintain a system of files and procedures for the protection of the personal information. Personal and sensitive information will not be reported to the NRC by the licensee. Under Section 26.25, Employee Assistance Program staff will provide confidential assistance except where safety considerations must prevail and when the Employee Assistance Program counselor believes that a worker's condition poses a hazard to himself or herself or others. Otherwise, voluntary self-referrals to the Employee Assistance Programs are treated confidentially and are not reported to 1
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7 management. Furthermore, that information would not be available for disclosure in response to an inquiry of previous employers.
To assure the protection of an individual temporarily suspended under the provisions where subsequent testing does not confirm the basis for such removal,10 CFR 26.24(d)(2)(iv) requires the licensee to eliminate from its records any matter that could link the individual to a temporary removal or suspension or other administrative action, prohibits the ncensee from disclosing the matter, and requires the licensee to provide the individual with a written statement of these measures and other related matters.
NOTE The licensee is prohibited from retaining a copy of the document provided to the individual.
- 11. Justification for Sensitive Questions Section 26.27(a) requires each licensee to obtain a written statement concerning substance abuse history and to conduct an inquiry to determine the validity of that information. This information is needed to determine if there are any past actions that may be indicative of an individual's future reliability and trustworthiness that could adversely affect their ability to safely and competently perform their duties. Individua!
names are not required in reports submitted to the NRC in accordance with 10 CFR 26 73(a) and (b), and 26.71(d).
- 12. Estimate of Industrv Burden and Burden Hour Cost Industry costs associated with the information collection requirements contained in 10 CFR Part 26 are provided in Table 1, Attachment 1.
Licensees currently have fitness-for-duty programs in place that adhere to industry guidance. These programs include written policies and procedures and contract provisions which establish fitness-for-duty agreements between the licensee and contractor or vendor; the minor changes to contracts that may be needed in a few instances are deemed insufficient to quantify as a burden.
Burden estimates are based, in part, on discussions with nuclear utility employees and on estimates of NRC personnel familiar with the records and reports required by 10 CFR Part 26.
- 13. Estimate of Other Additional Cosis No other additional costs are anticipated.
- 14. Estimated Annual Cost to the Federal Government The total estimated annual cost to the Federal Government is expected to be $60,264 as shown in Table 2, Attachment 2. This cost is fully recovered through license fees assessed to NRC licensees pursuant to 10 CFR Parts 170 and/or 171.
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- 15. Egasons for Chance in Burden or Cost The estimated burden tot 10 CFR Part 26 is being adjusted to reflect a more accurate assessment of the information collection burden imposed on licensees and a reduction in the number of sites.
- 16. Publication for Statistical Use The NRC has published an annual report (NUREG-5758, Volumes 1 through 6) that summarizes the results of the drug and alcohol testing programs submitted semi-annually by each licensee. The data for CYs 1996 and 1997 were published in Information Notice 98-39.
- 17. Reason for Not Disolavina the Exoiration Date The information collection requirements are contained in the Code of Federal Regulations. Amending the Code to display th-e current expiration date could be unduly burdensome and too difficult to keep current.
- 18. Exceotions to the Certification Statement None.
B. COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS Statistical methods are not used in this information collection. .
Attachments-
- 1. Table 1, Estimate of Burden Required of Industry
- 2. Table 2, Estimate of Cost to the Federal Government 3.10 CFR Part 26 t
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4 Comments and questions about the information collection requirements may be directed to the
$6 NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-6 F37, Washington, DC,20555-0001, by telephone at 301-415-7233, or by Internet electronic mail at BJS1@NRC. GOV.
i Dated at Rockville, Maryland, this day of 1999.
i For the Nuclear Regulatory Commission. l I
Brenda Jo. Shelton, NRC Clearance Officer Office of the Chief Information Officer crh om 1
- See privious concurrence l
- DOCUMENT NAME: A:\60fr26: i To receive a copy of thne document, indicate in the boa: "C" = Copy without attachment / enclosure *E' = copy with attachment / enclosure '
'N' = No copy OFFICE NRR/DRPM l NRR/DRPM NRR/ DISP l OClO , 2 l j NAME LBush TQuay Ringram BSt,.:"JG !
DATE 12/* /98 12/ */98 01/* /99 Op7 /99 OFFICIAL RECORD COPY
[ - l4 3y0 g3004 K g/j_f
I 4
1 I
Comments and questions about the information collection requirements be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulato ommission, T-6 F33,
/
Washington, DC,20555-0001, r by telephone at 301-415-7233, or by Internet electronic mail at BJSi@NRC. GOV. >
j Dated at Rockville, Maryland, this day of 1999.
For the Nuclear Regulatory Commission.
Brenda Jo. SheIton, NRC Clearance Officer Office of the Chief Information Officer See previous concurrence DOCUMENT NAME: A:\60fr26:
To receive a copy of this document, indicate in the boa: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
- W = No copy OFFICE NRR/DRPM l NRR/DRPM l NRR/ DISP L OClO l NAME LBush TQuay Ringram BShelton DATE 12/* /98 12/ */98 1/ * /99 1/ /99 OFFICIAL RECORD COPY i
s
O 4
Comments and questions about the information collection requirements,may be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory' Commission, T-6 F33, Washington, DC,20555-0001, or by telephone at 301-415-7233, or by Internet electronic mail at BJS1@NRC. GOV.
Dated at Rockville, Mayland, this day of 1998.
1 i
{
l For the Nuclear Regulatory Commission.
Brenda Jo. Shelton, NRC Clearance Officer Office of the Chief Information Officer i
l DOCUMENT NAME: A:\60fr26:
i To receive e copy of this document, indicate in the box: "C" = Copy without attachment / enclosure "E" = Copy with attachment / enclosure
! "N" = No copy OFFICE NRR/DRPM 6 NRR/DRPM l aC NRR/ DISP. OClO NAME LBush & TQuay-1Wt Ringram'" BShelton DATE 12r///98 ' 12/)e98 12) 'i/98 12/ /98 OFFICIAL RECORD COPY l
l ;