10 CFR 26.719/SOC
https://www.gpo.gov/fdsys/pkg/FR-2008-03-31/html/E8-4998.htm
Section 26.719 Reporting Requirements
The NRC has added Sec. 26.719 to the final rule to replace former
Sec. 26.73 and combines it with former Section 2.8(e)(4), (e)(5), and (e)(6) in Appendix A to Part 26. The final rule groups into one section reporting requirements that are interspersed throughout the former rule to meet Goal 6 of this rulemaking to improve clarity in the organization and language of the rule.
The NRC added Sec. 26.719(a) to the final rule to introduce the
section, consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. This provision specifies the categories of significant events that licensees and other entities must report to the NRC (i.e., significant violations of the FFD policy, significant FFD program failures, and errors in drug and alcohol testing). The second sentence of the paragraph retains the requirement in former Sec. 26.73(c) that significant events must be reported under this section, rather than under the provisions of 10 CFR 73.71 [Reporting of safeguards events].
Section 26.719(b) of the final rule reorganizes and amends former
Sec. 26.73(a)(1), (a)(2), and (b), consistent with Goal 6 of this rulemaking to improve clarity in the organization and language of the rule. Paragraph 26.719(b) retains the requirement in former Sec. 26.73(b) that notifications of events must be made to the NRC Operations Center within 24 hours of their discovery. However, the final rule presents this requirement at the beginning of the paragraph to clarify that it applies to all of the events that are listed in the paragraph.
Section 26.719(b)(1) amends former Sec. 26.73(a)(1). The former
provision required licensees to report the sale, use, or possession of illegal drugs within a protected area. The final rule adds a requirement for licensees and other entities also to report the consumption or presence of alcohol in a protected area. This change is consistent with the NRC's increased concern with the adverse effects of alcohol abuse on safe performance, as discussed with respect to Sec. 26.75(e). The agency has made the change for consistency with the performance objective in Sec. 26.23(d), which is to provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs and alcohol, as discussed with respect to that paragraph. This change also meets Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs, as the consumption or presence of alcohol in a protected area constitutes a significant programmatic failure in achieving this performance objective.
Section 26.719(b)(2) amends former Sec. 26.73(a)(2). Former Sec.
26.73(a)(2) required licensees to report any acts by licensed operators and supervisory personnel involving the sale, use, or possession of a controlled substance; resulting in confirmed positive test results for such persons; involving the use of alcohol within the protected area; or resulting in a determination of unfitness for scheduled work because of the consumption of alcohol. The final rule expands the former reporting requirement to include SSNM transporter personnel and FFD program personnel. The NRC has made this
change to ensure that it is informed of events involving these individuals because of the important roles they play in assuring public health and safety and the common defense and security, in the former case, and the integrity of the FFD program, in the latter. The agency's change meets Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.
Section 26.719(b)(2)(i) retains former Sec. 26.73(a)(2)(i). The
provision requires licensees and other entities to report any acts by the subject individuals that involve the use, sale, or possession of a controlled substance.
Section 26.719(b)(2)(ii) combines and amends former Sec.
26.73(a)(2)(ii) and (a)(2)(iv). The former section required licensees and other entities to report any confirmed positive test results for such persons and any acts by the subject individuals that result in a determination of unfitness for scheduled work because of the consumption of alcohol, respectively. The final rule amends the former requirements by mandating that licensees and other entities report any acts by the subject individuals that result in a determination that the individual has violated the licensee's or other entity's FFD policy (including subversion as defined in Sec. 26.5 [Definitions]). This change is consistent with two other changes to the rule: (1) the addition of validity testing requirements to the final rule, as discussed with respect to Sec. 26.31(d)(3)(i), and (2) the addition of new requirements in Subpart D [Management Actions and Sanctions to be Imposed] that impose the same sanctions for confirmed positive alcohol test results as those required for confirmed positive drug test results, as discussed with respect to Sec. 26.75(e). Therefore, the final rule requires licensees and other entities to report confirmed positive drug test results, any other acts to subvert or attempt to subvert the testing process, and confirmed positive alcohol test results for these individuals.
Section 26.719(b)(2)(iii) amends former Sec. 26.73(a)(2)(iii). The
former provision required licensees and other entities to report any events involving the consumption of alcohol within the protected area by the subject individuals. The final rule adds the requirement to report any acts involving the consumption of alcohol while performing the duties that require these individuals to be subject to this part. This change is consistent with the addition of SSNM transporters and FFD program personnel to this paragraph, as discussed with respect to Sec. 26.719(b)(2), because transporter and FFD program personnel typically do not work within a protected area. However, the NRC maintains an interest in the consumption of alcohol by the individuals listed in Sec. 26.719(b)(2) while they are performing the duties specified in Sec. 26.4 at any location.
Section 26.719(b)(3) establishes a new requirement for licensees
and other entities to report any intentional act that casts doubt on the integrity of the FFD program. Because of the wide array of possible acts that could fit this definition and be of concern to the NRC, the final rule does not specify the acts that licensees and other entities must report. However, such intentional acts may include, but are not limited to:
(1) Notifying individuals, outside of the FFD program's normal
notification procedures, that they will be selected for random or followup testing on a particular date or at a specific time so that the individuals have sufficient time available to attempt to mask drug use by, for example, obtaining a substitute urine specimen or an adulterant, drinking large amounts of liquid in order to provide a dilute urine specimen, or leaving the site to avoid testing;
(2) Attempting to divert or tamper with urine specimens that are
being prepared for transfer to a licensee testing facility or HHS- certified laboratory by stealing the specimens, substituting specimens in the package, or altering the specimens' custody-and-control documentation;
(3) Attempting to tamper with testing instruments so that they
provide false negative test results;
(4) Collusion by collection site personnel, an MRO, or MRO staff
with an individual who is subject to testing to alter the individual's test results; and
(5) Attempts by information technology personnel to alter the
software that the FFD program uses to randomly select individuals for testing to ensure that specific individuals are not selected.
The intentional acts that this final rule requires licensees and
other entities to report could involve any aspect of the operations of the FFD program and the testing process.
The final rule adds this reporting requirement because of other
changes to the final rule that permit licensees and other entities to rely on other Part 26 programs to a much greater extent than under the former requirement. The final rule permits licensees and other entities to rely on testing performed by another Part 26 program, FFD training, other programs' suitable inquiries and determinations of fitness, and audits. Therefore, intentional acts that cast doubt on the integrity of one FFD program may also indirectly affect the integrity and effectiveness of other FFD programs. The NRC requires reporting of these acts in order to monitor their impacts and ensure that other FFD programs that may be affected are informed of the problem so that they can take corrective actions, if necessary. The agency has made this change to meet Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.
The NRC has added Sec. 26.719(b)(4) to the final rule to require
licensees and other entities to report any programmatic failure, degradation, or discovered vulnerability of an FFD program that may permit undetected drug or alcohol use or abuse by individuals within a protected area, or by individuals who are assigned to perform the duties that require them to be subject to the FFD program. In Item 10.1 of NUREG-1385, ``Fitness for Duty in the Nuclear Power Industry: Responses to Implementation Questions, the NRC emphasized that it expects licensees to exercise prudent judgment in determining whether to report unusual situations and that the significant events the licensees must report are not limited to the examples contained in the rule. However, the NRC understands that licensees have not reported many significant events that would be useful for formulating public policy or that the NRC should respond to in a timely fashion because licensee management decided not to do so unless the rule specifically required this reporting. Therefore, this final rule adds Sec. 26.719(b)(4) to clarify that significant events and programmatic failures are not limited to those listed in Sec. 26.719(b), but include any programmatic failures or weaknesses that potentially could permit substance abuse to be undetected. The agency has made this change to meet Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.
Section 26.719(c) of the final rule reorganizes and amends former
requirements for reporting errors in drug and alcohol testing, consistent with Goal 6 of the rulemaking to improve clarity in the organizational of the rule. The final rule retains the former requirements for licensees and other entities to investigate and take corrective actions for drug and alcohol testing errors in Sec. Sec. 26.137(f) and 26.167(g) for licensee testing facilities and HHS- certified laboratories, respectively, but moves the reporting requirements to this section.
Section 26.719(c)(1) updates the portion of former Sec. 2.8(e)(4)
in Appendix A to Part 26 that mandated that licensees and other entities must report within 30 days of completing an investigation any testing errors or unsatisfactory performance in performance testing at either a licensee testing facility or an HHS-certified laboratory. This section amends the former requirement by specifying that the report of the incident must describe the corrective actions taken or planned. Although licensees and other entities have consistently described corrective actions in such reports, the agency has added this new requirement to meet Goal 6 of the rulemaking to improve clarity in the language of the rule.
In addition, this section adds cross-references to other sections
of the final rule that define processes that may also result in the identification of errors, including the reviews required under Sec. 26.39 [Review process for fitness-for-duty policy violations] and Sec. 26.185 [Determining a fitness-for-duty policy violation]. In the original rule, the NRC intended that testing or process errors discovered in any part of the program, including these review processes, would be investigated as an unsatisfactory performance of a test. Thorough investigation and reporting of such test results will continue to assist the NRC, the licensees, HHS, and the HHS-certified laboratories in preventing future occurrences. Therefore, this change, consistent with Goal 6 of the rulemaking to improve clarity in the language of the rule, clarifies that the requirement to investigate, correct, and report errors is not limited only to errors identified through blind performance testing in licensee testing facilities and HHS-certified laboratories but also applies to errors identified through any means.
Section 26.719(c)(2) amends the portion of former Section 2.8(e)(5)
in Appendix A to Part 26 that required licensees to promptly notify the NRC if a false positive error occurs on a blind performance test sample. This section replaces the former requirement that the report must be made ``promptly with one to report the false positive error within 24 hours of the discovery. The agency has made this change as a result of the public meetings discussed in Section I.D, during which the stakeholders noted that the term ``promptly is vague. Therefore, the final rule clarifies the former requirement by establishing a 24- hour time limit for the notification, consistent with Goal 6 of this rulemaking to improve clarity in the language of the rule.
The rule establishes a 24-hour time limit because false positive
test results would cause licensees and other entities to impose sanctions on individuals who have not, in fact, abused drugs and/or attempted to subvert the testing process. HHS may decertify a laboratory as a result of false positive test results. The 24-hour time limit ensures that the NRC can quickly notify HHS of the problem so that HHS may initiate the applicable steps required under its guidelines for such circumstances. In addition, the NRC may use the information to inform other licensees and entities who rely on the same HHS-certified laboratory of the problem, so that they may determine whether to require the laboratory or a second laboratory to retest any specimens a licensee or other entity has submitted. The agency has established the 24-hour time limit to meet Goal 7 of the rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.
The NRC has added Sec. 26.719(c)(3) to the final rule to require
licensees and other entities to report any false negative errors identified through quality assurance checks of validity screening tests within 24 hours of the discovery if the licensee or other entity uses these tests for validity screening at a licensee testing facility. This reporting requirement ensures that the NRC is aware of any testing failures, so that other Part 26 programs that rely on the tests may be informed of the error and stop using them until the cause of the error is identified and the problem is resolved. Continued use of unreliable tests may permit attempts to subvert the testing process to go undetected, with the result that individuals who have engaged in a subversion attempt may be granted or allowed to maintain authorization. The agency has added this requirement to meet Goal 3 of the rulemaking to improve the effectiveness and efficiency of FFD programs.
The final rule does not require licensees and other entities to
report false positive errors identified through quality assurance checks of validity screening tests for two reasons. First, other provisions of the rule prohibit licensees and other entities from taking management actions or imposing sanctions on individuals on the basis of validity screening test results, as discussed with respect to Sec. 26.75(h). Second, donors are protected from the adverse consequences of false positive validity screening test results because these specimens are forwarded to an HHS-certified laboratory for initial and confirmatory testing, if required, before a licensee or other entity is permitted to act, as discussed with respect to Sec. 26.137(c). Therefore, reporting of false positive errors is unnecessary to protect the interests of either donors or the public.
The NRC has added Sec. 26.719(d) to the final rule to require
licensees and other entities to document, trend, and correct nonreportable FFD issues that identify programmatic weaknesses under the licensee's or other entity's corrective action program. The final rule includes this requirement because some licensees have not documented, trended, or corrected programmatic weaknesses, while others have created separate systems, with the result that corrective actions for FFD program weaknesses have not been timely or effective. Therefore, the final rule adds these requirements for consistency with Criterion XVI in Appendix B to 10 CFR Part 50 [Domestic licensing of production and utilization facilities] and to meet Goal 3 of this rulemaking to improve the effectiveness and efficiency of FFD programs.
This section also requires licensees and other entities to
document, trend, and correct any programmatic weaknesses in a manner that protects individuals' privacy. For example, this section prohibits licensees and other entities from documenting a single confirmed positive, adulterated, substituted, or invalid drug test result in the corrective action program, because such documentation, along with other cues in the work environment, may permit any individual who has access to the corrective action system easily to identify the donor. However, under the final rule, the NRC expects licensees and other entities to document, trend, analyze, and take corrective actions for an increase in the rate of confirmed positive, adulterated, substituted, or invalid test results in the aggregate if the licensee or other entity determines that the increasing trend indicates programmatic weaknesses rather than improved effectiveness of the FFD program or some other factor. The agency has added the requirement to protect individuals' privacy within the corrective action program to meet Goal 7 of this rulemaking to protect the privacy and other rights (including due process) of individuals who are subject to Part 26.