Fitness for Duty Programs, 50442-50677 [05-15576]

Download as PDF 50442 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules 10 CFR Part 26 RIN 3150–AF12 Fitness for Duty Programs Nuclear Regulatory Commission. ACTION: Proposed rule. AGENCY: SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations for Fitness for Duty (FFD) programs to update the rule and enhance consistency with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines), and other Federal drug and alcohol testing programs that impose similar requirements on NRC licensees. The proposed amendments would require nuclear power plant licensees to strengthen the effectiveness of their FFD programs in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; and ensure consistency with the NRC’s access authorization requirements for nuclear power plants. The proposed rule would ensure that individuals who are subject to these regulations are trustworthy and reliable, as demonstrated by avoiding substance abuse; are not under the influence of drugs or alcohol while performing their duties; and are not mentally or physically impaired from any other cause, that would in any way adversely affect their ability to perform their duties safely and competently. This proposed rule would also grant, in part, a petition for rulemaking (PRM– 26–1) submitted by Virginia Electric and Power Company (now Dominion Virginia Power) on December 30, 1993, by relaxing several required FFD program audit frequencies, and would partially grant a petition for rulemaking (PRM–26–2) submitted by Barry Quigley on December 28, 1999. DATES: Submit comments on the rule by December 27, 2005. Submit comments specific to the information collections aspects of this rule by September 26, 2005. Comments received after the above dates will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after these dates. VerDate Aug<18>2005 14:39 Aug 25, 2005 You may submit comments on the rule by any one of the following methods. Please include the following number (RIN 3150–AF12) in the subject line of your comments. Comments on rulemakings submitted in writing or in electronic form will be made available to the public in their entirety on the NRC rulemaking Web site. Personal information will not be removed from your comments. Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, Attention: Rulemakings and Adjudications Staff. E-mail comments to: SECY@nrc.gov. If you do not receive a reply e-mail confirming that we have received your comments, contact us directly at (301) 415–1966. You may also submit comments via the NRC’s rulemaking Web site at http://ruleforum.llnl.gov. Address questions about our rulemaking Web site to Carol Gallagher (301) 415– 5905; e-mail cag@nrc.gov. Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 A.M. and 4:15 P.M. on Federal workdays. Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at (301) 415–1101. You may submit comments on the information collections by the methods indicated in the Paperwork Reduction Act Statement. Publicly available documents related to this rulemaking may be examined and copied for a fee at the NRC’s Public Document Room (PDR), Public File Area O1–F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. Copyrighted documents may be viewed at the NRC’s PDR, but may not be copied. The draft Regulatory Analysis and other documents related to this rulemaking, including comments can be viewed and downloaded electronically via the NRC rulemaking Web site at http://ruleforum.llnl.gov. Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC’s Electronic Reading Room at http://www.nrc.gov/NRC/ADAMS/ index.html. From this site, the public can gain entry into the NRC’s Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC’s public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1–800–397–4209, 301–415–4737 or by e-mail to pdr@nrc.gov. FOR FURTHER INFORMATION CONTACT: Rebecca L. Karas, Office of Nuclear ADDRESSES: NUCLEAR REGULATORY COMMISSION Jkt 205001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4702 Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555–0001, telephone (301) 415– 3711, Timothy S. McCune, Office of Nuclear Security and Incident Response, telephone (301) 415–6474, or Dr. David R. Desaulniers, Office of Nuclear Reactor Regulation, telephone (301) 415–1043. All of the above contacts may also be reached by e-mail to FITNESSFORDUTY@NRC.GOV. SUPPLEMENTARY INFORMATION: Table of Contents I. Background A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty Program Provisions B. Work Fatigue Provisions C. Combined Part 26 Rulemaking II. Petitions and Request for Exemption A. Petition for Rulemaking PRM–26–1 B. Petition for Rulemaking PRM–26–2 C. Request for Exemption under 10 CFR 26.6 III. Abbreviations IV. Discussion of Proposed Action A. Overview B. Goals of the Rulemaking Activity C. Overview of Proposed Rule D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26 V. Summary of Public Interactions and Comments A. Public Comments Submitted to OMB on 2000 Final Rule and Responses B. Key Stakeholder Comments not Incorporated into Proposed Rule and Responses VI. Section-by-Section Analysis of Substantive Changes VII. Issues for Public Comment VIII. Criminal Penalties IX. Agreement State Compatibility X. Plain Language XI. Voluntary Consensus Standards XII. Finding of No Significant Environmental Impact: Environmental Assessment XIII. Paperwork Reduction Act Statement XIV. Regulatory Analysis A. Aggregate Analysis B. Screening Review for Disaggregation C. Disaggregation of Worker Fatigue Provisions XV. Regulatory Flexibility Act Certification XVI. Backfit Analysis A. Consideration of Fuel Fabrication Facilities and Gaseous Diffusion Plants B. Aggregate Backfit Analysis C. Screening Review for Disaggregation XVII. References I. Background A. Drug and Alcohol Testing Provisions, and General Fitness-for-Duty Program Provisions On June 7, 1989, the Commission announced the adoption of a new rule, 10 CFR Part 26, Fitness for Duty Programs (54 FR 24468), that required each licensee authorized to operate or construct a nuclear power reactor to implement a FFD program for all E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules personnel having unescorted access to the protected area of its plant. A subsequent final rule published in the Federal Register on June 3, 1993, (58 FR 31467) expanded the scope of Part 26 to include licensees authorized to possess, use, or transport formula quantities of Strategic Special Nuclear Materials (SSNM). At the time the FFD rule was published in 1989, the Commission directed the NRC staff to continue to analyze licensee programs, assess the effectiveness of the rule, and recommend appropriate improvements or changes. The NRC staff reviewed information from several sources including inspections, periodic reports by licensees on FFD program performance, reports of significant FFD events, industry sponsored meetings and current literature, as well as initiatives by industry, the Substance Abuse and Mental Health Services Administration (SAMHSA, formerly the National Institute on Drug Abuse [NIDA]) and SAMHSA’s Drug Testing Advisory Board, and recommended improvements and changes. As a result, the NRC published proposed amendments to the FFD rule in the Federal Register on May 9, 1996 (61 FR 21105). The 90-day public comment period for the proposed rulemaking closed on August 7, 1996. The NRC staff reviewed and considered public comments on the proposed rule, and submitted a final rule to the Commission in a Commission paper (SECY–00–0159), dated July 26, 2000. The Commission affirmed the rule in a Staff Requirements Memorandum (SRM–M001204A) dated December 4, 2000. The affirmed rule was sent to the Office of Management and Budget (OMB) to obtain a clearance under the Paperwork Reduction Act. The request for comments on the clearance was published in the Federal Register on February 2, 2001 (66 FR 8812). OMB and NRC received public comments that objected to some aspects of the rule (responses to those comments are included in Section V of this document). In SECY–01–0134, dated July 23, 2001, the NRC staff recommended withdrawing the request for clearance and preparing a new proposed rule. In a Staff Requirements Memorandum (SRM–SECY–01–0134) dated October 3, 2001, the Commission approved the staff’s recommendation to withdraw the request for clearance and prepare a new proposed rule. B. Worker Fatigue Provisions The NRC’s ‘‘Policy on Factors Causing Fatigue of Operating Personnel at Nuclear Reactors’’ (referred to in this VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 document as NRC’s Policy on Worker Fatigue) was first published in the Federal Register on February 18, 1982, (47 FR 7352), and later issued through Generic Letter (GL) 82–12, ‘‘Nuclear Power Plant Staff Working Hours,’’ on June 15, 1982 (referred to in this document as GL 82–12). In GL 82–12, the NRC requested licensees to revise the administrative section of their technical specifications to ensure that plant administrative procedures were consistent with the revised work-hour guidelines. Those guidelines were: (1) An individual should not be permitted to work more than 16 hours straight (excluding shift turnover time); (2) An individual should not be permitted to work more than 16 hours in any 24-hour period, nor more than 24 hours in any 48-hour period, nor more than 72 hours in any seven day period (all excluding shift turnover time); (3) A break of at least 8 hours should be allowed between work periods (including shift turnover time); and (4) Except during extended shutdown periods, the use of overtime should be considered on an individual basis and not for the entire staff on a shift. Further, the guidelines permitted deviations from these limits in very unusual circumstances if authorized by the plant manager, his deputy, or higher levels of management. The NRC’s Policy on Worker Fatigue was incorporated, directly or by reference, and with variations in wording and detail, into the technical specifications of all but three nuclear power plant sites, who implemented the concept using other administrative controls. When 10 CFR part 26 was issued on June 7, 1989 (54 FR 24468), it focused on establishing requirements for preventing and detecting personnel impairment from drugs and alcohol. However, consistent with SRM–SECY– 88–129, dated July 18, 1988, several requirements addressed other causes of impairment, including fatigue. Those requirements included general performance objectives [§ 26.10(a) and (b)] that provided for ‘‘* * * reasonable assurance that nuclear power plant personnel * * * are not under the influence of any substance, legal or illegal, or mentally or physically impaired from any cause * * *’’ and ‘‘* * * early detection of persons who are not fit to perform activities within the scope of this part * * * ’’ A requirement was also included in § 26.20(a) for licensee policies to ‘‘* * * address other factors that could affect fitness for duty such as mental stress, fatigue and illness.’’ In a letter dated February 25, 1999, Congressmen Dingell, Klink, and PO 00000 Frm 00003 Fmt 4701 Sfmt 4702 50443 Markey expressed concerns to former NRC Chairman Shirley Ann Jackson that low staffing levels and excessive overtime may present a serious safety hazard at some commercial nuclear power plants. The Union of Concerned Scientists (UCS) expressed similar concerns on March 18, 1999, in a letter from David Lochbaum to Chairman Jackson, and in the UCS report ‘‘Overtime and Staffing Problems in the Commercial Nuclear Power Industry,’’ dated March 1999. In a letter dated May 18, 1999, to the Congressmen, the Chairman stated that the NRC staff would assess the need to revise the policy. Soon thereafter, the Commission received a petition for rulemaking (PRM–26–2), dated September 28, 1999, from Barry Quigley. (The petition is discussed in greater detail in Section II. B.) The petition requested that the NRC amend 10 CFR Parts 26 and 55 to establish clear and enforceable work hour limits to mitigate the effects of fatigue for nuclear power plant personnel performing safety-related work. The UCS petitioned the NRC on April 24, 2001, pursuant to 10 CFR 2.206, to issue a Demand for Information (DFI) to specified licensees. The petition asserted that Wackenhut Corporation has the contractual right to fire security guards who refuse to report for mandatory overtime, and that this contractual right conflicts with 10 CFR Part 26. The NRC denied the DFI (ADAMS Accession No. ML013230169), but addressed the concerns of the petition through the NRC’s generic communication process. On May 10, 2002, the NRC issued NRC Regulatory Issue Summary (RIS) 2002–07: ‘‘Clarification of NRC Requirements Applicable to Worker Fatigue and SelfDeclarations of Fitness-for-Duty.’’ The RIS addressed the applicability of 10 CFR Part 26 to worker fatigue, the potential for sanctions related to worker FFD concerns to have adverse implications for maintaining a work environment conducive to reporting FFD concerns, and the protections afforded workers by 10 CFR 50.7, ‘‘Employee Protection.’’ On January 10, 2002, in SRM–SECY– 01–0113, the Commission approved a rulemaking plan, Fatigue of Workers at Nuclear Power Plants, dated June 22, 2001 (referred to in this document as SECY–01–0113). In accordance with the approved plan, the NRC initiated a rulemaking to incorporate fatigue management into 10 CFR Part 26 in order to strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue E:\FR\FM\26AUP2.SGM 26AUP2 50444 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management worker fatigue. During the development of proposed fatigue management requirements, the NRC observed an increase in concerns (e.g, allegations, media and public stakeholder reports) related to the workload and fatigue of security personnel following the terrorist attacks of September 11, 2001. Following an NRC review of the control of work hours for security force personnel, and public interactions with stakeholders, the Commission issued Order EA–03–038 on April 29, 2003, requiring compensatory measures related to fitness-for-duty enhancements for security personnel at nuclear power plants, including work hour limits. The compensatory measures imposed by Order EA–03–038 were similar to the guidelines of the NRC’s Policy on Worker Fatigue. The compensatory measures differed from the Policy guidelines in a few areas in which the NRC believed it was necessary to address previously identified deficiencies in the guidelines, including the need to address cumulative fatigue from prolonged use of extended work hours, matters unique to security personnel, and stakeholder input obtained through public meetings concerning the proposed worker fatigue rulemaking and the Order. The requirements in the Order were imposed to provide the Commission with reasonable assurance that the public health and safety and common defense and security continue to be adequately protected. The provisions specified in proposed 10 CFR Part 26, Subpart I, Managing Fatigue, for security force personnel would replace the requirements imposed by Order. Differences between the proposed requirements in Subpart I and the requirements imposed by Order, and the rationale for those differences, are discussed in Section IV. D. C. Combined Part 26 Rulemaking On March 29, 2004, in COMSECY– 04–0014, the NRC staff informed the Commission of the status of both rulemaking activities. The NRC staff also noted that because both rulemaking activities were being completed in parallel, the draft proposed fatigue rule language was based on the draft language in the proposed overall revision to Part 26, rather than on the current language in Part 26. Therefore, meaningful public comment could be confounded by the simultaneous promulgation of two draft rules which VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 are somewhat interdependent, and staff action to address a comment on one proposed rule could easily impact the other proposed rule, creating a high potential for the need to repropose one or both rules. In SRM–COMSECY–04– 0014, dated May 25, 2004, the Commission directed the staff to combine the rulemaking related to nuclear power plant worker fatigue with the ongoing Part 26 rulemaking activity. This combined proposed rule withdraws the proposed rule published on May 9, 1996. II. Petitions and Request for Exemption A. Petition for Rulemaking PRM–26–1 On December 30, 1993, Virginia Electric and Power Company (now Dominion Virginia Power) submitted a Petition for Rulemaking (PRM–26–1) requesting relaxation of the required 1year audit frequency of the FFD program and of licensee FFD programs and the program elements of contractors and vendors (C/Vs) that are relied upon by licensees. The petition requested that the first sentence of 10 CFR 26.80(a) be amended to read: ‘‘Each licensee subject to this Part shall audit the fitness-for-duty program nominally every 24 months * * * In addition, audits must be conducted, nominally every 24 months, of those portions of fitness-for-duty programs implemented by contractors and vendors * * *’’ In a letter dated March 14, 1994, the NRC informed the petitioner that the petition would be addressed in a proposed rulemaking that was under development. The NRC has periodically communicated with the petitioner regarding the status of this rulemaking since that time. Proposed § 26.41(b) would partially grant two aspects of the petition. That is, the required audit frequency for licensees and other entities who are subject to 10 CFR Part 26 would be reduced from the nominal 1-year frequency in the current rule to a nominal 2-year frequency. Further, audits of C/V services that are performed on site and under the direct daily supervision or observation of licensee personnel would be conducted as part of the 2-year audits of the licensee or other entity’s FFD program, under proposed § 26.41(b). Proposed § 26.41(c)(1) would partially deny two aspects of the petition. That is, the nominal annual audit requirement for HHS-certified laboratories would be retained. In addition, the annual audit requirement would be retained for FFD program elements provided by C/Vs whose personnel ‘‘* * * are off site or PO 00000 Frm 00004 Fmt 4701 Sfmt 4702 are not under the direct daily supervision or observation of licensee personnel * * *’’ The bases for these changes to audit requirements in the proposed rule are addressed in the subsequent sections of this supplementary information. B. Petition for Rulemaking PRM–26–2 On September 28, 1999, Barry Quigley submitted a Petition for Rulemaking (PRM–26–2) requesting that the NRC amend 10 CFR Parts 26 and 55 to establish clear and enforceable work hour limits to mitigate the effects of fatigue for nuclear power plant personnel performing safety-related work. The PRM was published for public comment on December 1, 1999, (64 FR 67202). As described in Attachment 3 to SECY–01–0113, the petition requested the NRC to: (1) Add enforceable working hour limits to 10 CFR Part 26; (2) Add a criterion to 10 CFR 55.33(a)(1) to require evaluation of known sleeping disorders; (3) Revise the NRC Enforcement Policy to include examples of working hour violations that warrant various NRC sanctions; and (4) Revise NRC Form 396 to include self-disclosure of sleeping disorders by licensed operators. The NRC received 176 comment letters in response to the petition. The majority of the comments (157) were in favor of a rule. These comments were principally from individuals and public interest groups. Comments received from licensees, the Nuclear Energy Institute (NEI) and Winston and Strawn, a law firm representing several utilities, were opposed to PRM–26–2. A summary of the comments and responses is available in SECY–01–0113 as Attachment 2. This document may be obtained from the NRC’s Web site, http://www.nrc.gov, by selecting the electronic reading room and then collections of documents by type. It is also available in the NRC’s Agencywide Documentation and Management System (ADAMS) under Package Accession Number ML010180224. Although the NRC received many comments concerning the specific requirements proposed in PRM–26–2, in general, letters in support of the rulemaking— (1) Cited the importance of ensuring that personnel who perform safetyrelated functions are not impaired by fatigue; (2) Expressed concern that the NRC does not have a regulation limiting working hours and the perception that the NRC lacks the authority to enforce E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules the guidelines in the NRC’s Policy on Worker Fatigue; (3) Asserted that the guidelines are ambiguous and that licensees interpret the guidelines as not applicable when the plant is in an outage; (4) Asserted that ‘‘the NRC appears to look the other way’’ when licensee work scheduling practices appear inconsistent with the guidelines; and (5) Expressed the concern that utility restructuring and cost competition will cause reductions in staffing levels and increased working hours and fatigue. Further, several commenters noted that the Federal Government has established work hour limits for personnel in other industries and suggested that similar limits should apply to nuclear power plant workers. In general, comments that opposed the petition expressed the opinion that existing regulatory requirements (i.e., technical specifications and 10 CFR Part 26) are adequate to ensure that personnel are not impaired by fatigue, that the proposed requirements would impose an unnecessary and excessive burden that could not be justified through a backfit analysis, and that industry performance data refute the petitioner’s argument that a rule is necessary to prevent fatigued personnel from performing safety-related work. The NRC has evaluated the merits of PRM–26–2, the comments received in response to the PRM, and assessed the Policy on Worker Fatigue. The NRC has concluded that the petitioner proposed a comprehensive set of requirements that could reasonably be expected to effectively address fatigue from individual and programmatic causes. However, the NRC believes that it is possible to achieve these objectives through alternative requirements that are more flexible, more directly focused on risk, and more aligned and integrated with current regulatory requirements. The proposed rule would therefore grant, in part, PRM–26–2. A detailed discussion of the principal findings that led to the decision to grant, in part, PRM–26–2 through rulemaking are included in Section IV. D. of this document. In addition, for item 3 of PRM–26–2, the NRC revised Inspection Procedure (IP) 71130.08, ‘‘Fitness For Duty Programs’’ on February 19, 2004, to reflect the requirements of Order EA– 03–038, dated April 29, 2003, which required compensatory measures related to fitness-for-duty enhancements for security personnel at nuclear power plants, including work hour limits. The NRC plans to similarly revise the same documents during preparation of the final Part 26 rule. The self-disclosure of sleeping disorders by licensed operators VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 (item 4) is being addressed by the NRC as a separate effort from this proposed rule through changes to Regulatory Guide 1.134, ‘‘Medical Evaluation of Licensed Personnel at Nuclear Power Plants.’’ C. Request for Exemption under 10 CFR 26.6 The current rule requires random drug and alcohol testing for personnel with unescorted access to the protected area of a nuclear power plant. By letter dated March 13, 1990, the International Brotherhood of Electrical Workers (IBEW) Local 1245 requested an exemption from random testing for clerical, warehouse, and maintenance workers at the Diablo Canyon Nuclear Power Plant (Diablo Canyon) under the provisions of 10 CFR 26.6. The NRC denied the request and IBEW Local 1245 sought judicial review. In 1992, the Ninth Circuit Court of Appeals affirmed the NRC’s denial of the request (IBEW, Local 1245 v. NRC, No. 90–70647, 9th Cir., June 11, 1992). In its opinion, the court said that random testing may well be impermissible for clerical workers at Diablo Canyon who perform no safetysensitive work and have no access to vital areas. However, in the record before the court at that time, IBEW Local 1245 had not established that such a group existed. On January 26 and December 6, 1993, IBEW Local 1245 renewed its request for exemption, specifically asking that the NRC exempt from 10 CFR Part 26 requirements for random drug testing, clerical employees at Diablo Canyon who are members of Local 1245 of the IBEW and who have unescorted access to the protected area (PA) only, but not to the radiologically controlled areas (RCAs) or vital areas (VAs) and who are not required to staff the plant’s emergency response center (ERC). The PA is the area inside the security fence of a nuclear power plant, which surrounds the entire plant, and the immediately surrounding area, whereas the VAs enclose key safety systems and are located within the PA. The RCAs contain elevated levels of radiation or contamination and are generally located within the PA. The ERC is located offsite and is where the licensee evaluates and coordinates licensee activities related to an emergency, and communicates to Federal, State and local authorities responding to radiological emergencies. The NRC requested public comment on the issue in the Federal Register of May 11, 1994 (59 FR 24373). Comments were received from the nuclear industry, which largely opposed a reduction in the scope of random testing, and from elements of the IBEW, including Local PO 00000 Frm 00005 Fmt 4701 Sfmt 4702 50445 1245, which favored it. In SRM–SECY– 04–0229, dated January 10, 2005 (available on the NRC Web site at http://www.nrc.gov/reading-rm/doccollections/commission/srm/), the Commission denied the IBEW exemption request because it— (1) Would endanger the common defense and security (as a result of increasing the likelihood of an insider threat); and (2) Was not in the public interest (because reducing the scope of random drug testing could increase the risk to public health and safety due to a greater risk of both sabotage (insider threat due to vulnerability to coercion) and of an accident (impaired worker)). Consequently, this proposed rule would maintain the current requirement for random drug and alcohol testing for personnel with unescorted access to the PA at a nuclear power plant. III. Abbreviations The following abbreviations and acronyms are used in this Statement of Considerations. AEA Atomic Energy Act ASDs Alcohol screening devices BAC Blood alcohol concentration CPL Conforming products list C/V Contractor/vendor DOT Department of Transportation EAP Employee assistance program EBT Evidential breath testing device EPRI Electric Power Research Institute FFD Fitness for duty GC/MS Gas chromatography/mass spectrometry HHS Department of Health and Human Services IBEW International Brotherhood of Electrical Workers KAs Knowledge and abilities LOD Limit of detection LOQ Limit of quantitation mg/dL Milligrams per deciliter MRO Medical Review Officer NEI Nuclear Energy Institute ng/dL Nanograms per deciliter NHTSA National Highway Transportation Safety Administration NRC Nuclear Regulatory Commission NSF National Sleep Foundation OMB Office of Management and Budget PDFFDI Potentially disqualifying fitness-for-duty information pH potential of hydrogen POGO Project on Government Oversight PROS Professional Reactor Operator Society QA/QC Quality assurance/quality control SAE Substance Abuse Expert SAMHSA Substance Abuse and Mental Health Services Administration E:\FR\FM\26AUP2.SGM 26AUP2 50446 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules SSNM Strategic special nuclear material THC Tetrahydrocannabinol, delta-9tetrahydrocannabinol-9-carboxylic acid UCS Union of Concerned Scientists 6–AM 6-acetylmorphine IV. Discussion of Proposed Action A. Overview A review of FFD program experience confirms that the regulatory approach of 10 CFR Part 26 is fundamentally sound and continues to provide a means of deterrence and detection of substance abuse at licensee facilities. NRC Information Notice 2003–04, ‘‘Summary of Fitness-for-Duty Program Performance Reports,’’ dated February 6, 2003, provides the latest published summary of program performance. This document may be obtained from the NRC’s Web site, http://www.nrc.gov, by selecting the electronic reading room and then collections of documents by type. It is also available in ADAMS under Accession No. ML030350473. Nonetheless, the NRC believes that revisions are needed to improve the effectiveness and efficiency of FFD programs; enhance consistency with advances in similar rules and guidelines, including the HHS Guidelines and other Federal drug and alcohol testing programs that place similar requirements on the private sector; strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; enhance consistency with the NRC’s access authorization requirements; improve clarity in the organization and language of the rule; and improve Part 26 by eliminating or modifying unnecessary requirements. B. Goals of the Rulemaking Activity The Nuclear Regulatory Commission (NRC) proposes to amend 10 CFR Part 26, Fitness for Duty Programs. The proposed goals are to: (1) Update and enhance the consistency of 10 CFR Part 26 with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs and other Federal drug and alcohol testing programs (e.g., those required by the U.S. Department of Transportation [DOT]) that impose similar requirements on the private sector. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 (2) Strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue; (3) Improve the effectiveness and efficiency of FFD programs. (4) Improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. (5) Improve Part 26 by eliminating or modifying unnecessary requirements. (6) Improve clarity in the organization and language of the rule. (7) Protect the privacy and due process rights of individuals who are subject to Part 26. Each of these goals is expected to result in substantial improvements in FFD programs. Many changes in the proposed rule relate to each goal. The major changes for each subpart, and the reasons for those changes, are described in Section IV. C and D of this document. For each of the many specific changes that are being proposed, detailed discussions are included in Section VI. However, the following discussion provides a description of each goal, a basis for the need to accomplish that goal, and several examples of proposed changes to the rule that would contribute to meeting the goal. Goal 1—Update and enhance the consistency of 10 CFR Part 26 with advances in other relevant Federal rules and guidelines, including the U.S. Department of Health and Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs (referred to in this document as the HHS Guidelines) and other Federal drug and alcohol testing programs (e.g., those required by the U.S. Department of Transportation [DOT]) that impose similar requirements on the private sector. Goal 1 is central to this rulemaking activity. Many changes are included in the proposed rule to maintain consistency with advances in the conduct of FFD programs, including changes in the HHS Guidelines. The 1994, 1998, and 2004 revisions to the HHS Guidelines differ substantially from the 1988 version of the Guidelines, upon which the current rule is based. The President of the United States designated HHS as the agency responsible for the Federal workplace drug testing program, and HHS’ Substance Abuse and Mental Health Services Administration (SAMHSA) is PO 00000 Frm 00006 Fmt 4701 Sfmt 4702 responsible for maintaining the HHS drug testing guidelines based on the most recent research and the accumulation of lessons learned from the Federal drug testing program, as well as others who are regulated. The NRC has historically relied on HHS to establish the technical requirements for urine specimen collection, testing and evaluation, and has only deviated from HHS’ guidelines for considerations that are specific to the nuclear industry. Updating Part 26 to be consistent with HHS’ most recent Guidelines ensures that NRC regulations continue to be scientifically and technically sound. Further, the HHS-certified laboratories that Part 26 requires licensees to use for drug testing are required by HHS to follow the HHS Guidelines in order to retain their certification. Basing Part 26 on older versions of the HHS Guidelines, or deviating from those Guidelines, increases the cost of drug testing for the nuclear industry. Therefore, updating Part 26 to increase consistency with the HHS Guidelines not only ensures that Part 26 is based on the best scientific and technical information available, but also avoids imposing an unnecessary and costly regulatory burden on the nuclear industry. One example of an improvement from enhancing consistency with the HHS Guidelines is that several cutoff levels for detection of various drugs would be updated, including a revised lower cutoff level for the marijuana metabolite, THC. The lower cutoff level will provide greater assurance that individuals who use marijuana are identified. Additionally, a revision to the HHS Guidelines, published in the Federal Register on April 13, 2004 (69 FR 19643) as a final rule, includes requirements for instrumented specimen validity tests to determine whether a urine specimen has been adulterated, diluted, or substituted. This proposed rule would adopt significant portions of the final HHS specimen validity testing provisions. The new validity testing requirements will substantially improve the effectiveness of the measures to guard against subversion of the testing process that are contained in current Part 26. Several other provisions for drug testing are under consideration by HHS and were published as a proposed rule for public comment in the Federal Register on April 13, 2004 (69 FR 19672). One proposed change to 10 CFR Part 26 that was included from the proposed HHS Guidelines is permission for licensees to use non-instrumented validity testing devices to determine E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules whether a urine specimen must be subject to further testing at an HHScertified laboratory because it may have been adulterated, diluted, or substituted, in lieu of the instrumented validity testing required in the April 13, 2004, final version of the HHS Guidelines. Although the HHS Guidelines that would permit Federal drug testing programs to use noninstrumented validity testing devices for initial testing of urine specimens are not yet final, some NRC licensees desired the flexibility to use these testing methods. A technical basis for use of those methods is included in Section VI. However, the NRC is not proposing to include other provisions in the proposed HHS Guidelines at this time. Those provisions include permitting the drug testing of specimens other than urine (e.g., hair, saliva, sweat), requirements for split specimen procedures for all specimens, and HHS certification of instrumented initial test facilities, which would be analogous to licensee testing facilities. Should such provisions be included in final HHS Guidelines in the future, the NRC will consider incorporating them into 10 CFR Part 26 at that time. In addition to the proposed changes to 10 CFR Part 26 that incorporate the recent revisions to the HHS Guidelines, the Department of Transportation (DOT) revised its Procedures for Transportation Workplace Drug and Alcohol Testing Programs [49 CFR 40, 65 FR 41944; August 9, 2001] to include the use of oral fluids (i.e., saliva) as acceptable specimens for initial alcohol screening tests. The proposed rule would also reflect the new oral fluids testing technology to provide FFD programs with increased flexibility in administering initial alcohol tests. Because the HHS Guidelines do not establish requirements for alcohol testing, NRC relies on the DOT regulations, in part, to ensure that the alcohol testing provisions of Part 26 remain scientifically sound and legally defensible. Because the DOT programs test a much larger number of individuals, in comparison to the number of alcohol tests that are conducted under Part 26, basing the NRC’s alcohol testing regulations on portions of the DOT regulations reflects the lessons learned from that larger population. Goal 2—Strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue. This goal VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 is central to this rulemaking activity. Proposed Subpart I, Managing Fatigue, would add clear and enforceable requirements for licensee management of worker fatigue to 10 CFR Part 26. The proposed requirements would reduce the potential for worker fatigue, and therefore strengthen the effectiveness of FFD programs at nuclear power plants and substantially increase the protection of public health and safety and the common defense and security. Section VI discusses the specific reasons for each proposed worker fatigue provision. Section IV. D provides a detailed discussion of the overall basis for establishing fatigue management requirements for FFD programs, and the benefits expected to result. Goal 3—Improve the effectiveness and efficiency of FFD programs. The NRC has gained experience in the actual implementation of FFD programs since Part 26 was originally promulgated. The NRC is proposing many changes throughout Part 26 based on that experience in order to improve the industry’s programs specifically to increase both the effectiveness of the programs in achieving the goals of Part 26, and the efficiency of program operations. Increasing the effectiveness and efficiency of FFD programs will enhance the protection of public health and safety and the common defense and security. One example of a change related to Goal 3 is the proposed reduction in the period within which pre-access testing must be performed from 60 days, in current § 26.24(a)(1), to 30 days or less, in proposed Subpart C [Granting and Maintaining Authorization]. This proposed change would improve the effectiveness of the pre-access test in detecting drug and alcohol use by individuals who are applying for authorization to perform the types of job duties that require them to be subject to Part 26 (see proposed § 26.25 [Individuals subject to the fitness-forduty program]). Reducing the number of breath specimens required for alcohol testing from two each for initial and confirmatory testing, in current Section 2.4(g)(18) in Appendix A to Part 26, to one specimen for the initial test and one for the confirmatory test, if required, in proposed § 26.91(d), would increase the efficiency of FFD programs without compromising the accuracy and validity of alcohol test results. Another example would be establishing a regulatory framework for the management of worker fatigue that appropriately balances the need for flexibility to manage plant exigencies and worker individual differences relative to fatigue with the need for PO 00000 Frm 00007 Fmt 4701 Sfmt 4702 50447 more readily enforceable requirements and efficient NRC oversight of licensee compliance with the requirements and performance objectives of the rule. Goal 4—Improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Current FFD and access authorization requirements each contain provisions that relate to establishing the trustworthiness and reliability of personnel prior to granting unescorted access to the protected areas of nuclear power plants. The NRC has determined that, because both sets of requirements share this same goal, revising Part 26 would clarify the relationship between these requirements, particularly for licensee access authorization decisions regarding personnel who move between sites with some interruption in their status of having unescorted access to a nuclear power plant. In addition, some requirements in Part 26 address the granting of temporary unescorted access. In response to the terrorist attacks of September 11, 2001, on the World Trade Center and the Pentagon, and the current threat environment, the Commission took action to curtail the use of temporary unescorted access at commercial nuclear power plants. Temporary unescorted access was eliminated by orders issued January 7, 2003, which imposed compensatory measures on existing access authorization programs. Therefore, it is necessary to revise the related provisions in Part 26. Goal 5—Improve 10 CFR Part 26 by eliminating or modifying unnecessary requirements. The proposed rule would incorporate a number of changes to eliminate or modify unnecessary requirements. The experience NRC has gained over the years since Part 26 was promulgated have enhanced the agency’s understanding of implementation by the industry, and the NRC now proposes to eliminate or modify some provisions, while at the same time maintaining the protection of public health and safety and the common defense and security. For example, because of inconsistencies in FFD and access authorization requirements for conducting employment inquiries, many licensees contacted an individual’s previous employers twice— once to obtain the information required under Part 26 and once to obtain the information required for access authorization. Proposed revisions to Part 26 would clarify that licensees may obtain information to satisfy FFD E:\FR\FM\26AUP2.SGM 26AUP2 50448 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules suitable inquiry requirements and related access authorization requirements at the same time when conducting an employment inquiry. Goal 6—Improve clarity in the organization and language of the rule. The proposed rule is organized to facilitate implementation, as compared to the current rule which has generated many questions from licensees. Therefore, in the proposed rule, the NRC has substantially reorganized the requirements to eliminate redundancies, to group related requirements, and to present requirements in the order in which they would apply to licensees’ FFD processes. In addition, the NRC has proposed many language changes to improve clarity. The NRC has undertaken this substantial reorganization to improve the protection of public health and safety and the common defense and security by substantially reducing the likelihood of variations in FFD programs across the industry through differing interpretations of the rule. The proposed rule is clearer in both organization and language, and is expected to result in more uniform implementation, and, consequently, more consistency in achieving the Part 26 goals. In contrast to certain NRC regulations, Part 26 includes a considerable number of detailed requirements. In the public meetings held during the development of this proposed rule, industry representatives indicated that they consider this level of detail necessary to help protect individual privacy and ensure consistency in implementing the requirements. Additionally, industry representatives indicated that this high level of detail can help to avoid unnecessary litigation between licensees and individual personnel regarding worker non-compliance with specific drug and alcohol testing performance steps. Such litigation would be more likely if those specific performance steps were not required by NRC rule. The level of detail and the enhanced clarity in the new language and organization included in proposed Part 26 have eliminated the need for a guidance document. In the public meetings described in Section V, industry representatives commented that a guidance document would not have the same weight as a rule, and that both licensees and individuals should be protected fully with rigor and specificity in a rule. Industry therefore desired the rule to be more specific and detailed, in lieu of a guidance document. Goal 7—Protect the privacy and due process rights of individuals who are subject to 10 CFR Part 26. This goal is VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 an implicit objective of the current rule, and the proposed rule would also continue to protect the privacy and due process rights of individuals who are subject to 10 CFR Part 26. The NRC, DOT, and HHS have all gained experience in implementing workplace drug and alcohol testing programs. This experience has led DOT and HHS to modify many of their requirements for such testing to more clearly protect privacy and due process rights of individuals. Many of the proposed changes to Part 26 related to this goal are based on either DOT or HHS requirements. The NRC believes the protection of individual rights to be of the highest importance, and proposes changes to Part 26 to ensure that those rights are protected through rule language developed using the best available information. One example of such a change is that ‘‘Bottle B’’, the second portion of a split urine specimen, would now only be tested with the donor’s written permission. C. Overview of Proposed Rule The proposed rule would be divided into subparts that contain related requirements. This proposed change would be made to improve the ease of implementing the rule by grouping related requirements and presenting them generally in the order in which they would apply to licensees’ and other entities’ FFD processes. Each subpart would be assigned a descriptive title to aid users in locating rule provisions and to simplify cross-referencing within the proposed rule. The major topics addressed in each subpart and the reasons that the major changes are being proposed are described below. A detailed cross-reference table between the current and proposed Part 26 provisions is included at the end of this notice. Subpart A Administrative Provisions The first subpart, proposed Subpart A [Administrative Provisions], would replace the General Provisions portion of the current rule, but continue to address the same subject matter. Thus, Subpart A would address the purpose and scope of the rule, provide definitions of important terms used in the proposed rule, and update current provisions related to requests for specific exemptions, interpretations of the rule, and communications with the NRC. Subpart B Program Elements Subpart B [Program Elements] of the proposed rule would reorganize and amend current §§ 26.10–26.29, which specify the performance objectives that PO 00000 Frm 00008 Fmt 4701 Sfmt 4702 FFD programs would be required to meet and the FFD program elements that licensees and other entities must implement to meet the performance objectives. However, the proposed rule would not include current § 26.27 [Management actions and sanctions to be imposed] in Subpart B for two reasons. First, at the public meetings described in Section V. B, stakeholders requested that the rule be reorganized to be consistent with the order in which licensees and other entities would implement their programs. Because Subpart B would be focused on establishing the framework of FFD programs, it would be premature to present requirements related to implementing the FFD program (i.e., imposing sanctions on an individual for violating the FFD policy) at this point in the proposed rule. Second, the stakeholders suggested, and the NRC staff concurred after consideration, that the subject matter of current § 26.27 is sufficiently important and complex that a separate subpart is warranted. Therefore, the proposed rule would present requirements related to management actions and sanctions in proposed Subpart D [Management Actions and Sanctions to be Imposed]. Subpart C Granting and Maintaining Authorization Subpart C [Granting and Maintaining Authorization] of the proposed rule would substantially amend current FFD requirements related to the process that licensees and other entities must follow in determining whether an individual is trustworthy and reliable, as demonstrated by avoiding substance abuse, and can be expected to perform his or her job duties safely and competently. The proposed rule would introduce the concept of ‘‘authorization’’ to Part 26 to refer to the status of an individual who the licensee or other entity has determined can be trusted to perform the job duties described in proposed § 26.25 [Individuals subject to the fitness-forduty program], as a result of the process described in this subpart. For example, in the case of nuclear power plant personnel, an individual who is ‘‘authorized’’ under Part 26 may be permitted to have unescorted access to protected areas in nuclear power plants if the individual’s job requires such access. The NRC has published other requirements, such as 10 CFR 73.56, that establish additional steps that licensees and other entities must take as part of the process of determining whether to grant authorization to an individual or permit an individual to E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules maintain authorization. These additional requirements focus on aspects of an individual’s character and reputation other than substance abuse, and, among other steps, require the licensee or other entities who are subject to the rule to conduct a psychological assessment of the individual, a credit and criminal history check, and interview individuals who have knowledge of the applicant for authorization. However, as discussed in Section IV. B, historically there have been some inconsistencies and redundancies between the Part 26 requirements related to granting and maintaining authorization and the other, related regulations, particularly the NRC’s access authorization requirements for nuclear power plant personnel. The inconsistencies have led to many implementation questions from licensees, as well as inconsistencies in how licensees have implemented the requirements. The redundancies have, in other cases, imposed an unnecessary burden on licensees. Therefore, a central goal of adding Subpart C to the proposed rule is to eliminate those inconsistencies and redundancies to ensure that licensees and the other entities who are subject to the rule have clear and easily interpretable requirements to follow when determining whether to grant or maintain an individual’s authorization under Part 26 and also under other, related requirements, including, but not limited to, the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003. The requirements in proposed Subpart C are based upon several fundamental changes to the NRC’s approach to the authorization requirements in current Part 26. The primary concern, which Subpart C is designed to address, is the necessity of increasing the rigor of the authorization process to provide reasonable assurance that any individual who is granted and maintains authorization is trustworthy and reliable, as demonstrated by avoiding substance abuse. The necessity for increased rigor in the authorization process is discussed in Section IV. C with respect to proposed § 26.23(a) in terms of the increased insider threat since the terrorist attacks of September 11, 2001. One change to current Part 26 authorization requirements that reflects this concern is the elimination of temporary access authorization requirements in the second sentence of current § 26.27(a)(4). Other changes are discussed in Section IV with respect to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 the specific provisions that would incorporate them. A second, related change to the NRC’s approach to authorization requirements, which has informed proposed Subpart C, is an increased concern with the sharing of information about individuals between licensees and other entities. At the time the current Part 26 was developed, the industry structure was different and personnel transfers between licensees (i.e., leaving the employment of one licensee to work for another licensee) with interruptions in authorization were less common. Most licensees operated plants at a single site and maintained an FFD program that applied only to that site. When an individual left employment at one site and began working for another licensee, the individual was subject to a different FFD program that often had different requirements. Because some licensees were reluctant to share information about previous employees with the new employer, licensees often did not have access to the information the previous licensee had gathered about the individual and so were required to gather the necessary information again. The additional effort to collect information that another licensee held created an unnecessary burden on both licensees. But, because few individuals transferred, the burden was not excessive. However, since 1989, the industry has undergone significant consolidation and developed new business practices to use its workforce more efficiently. Industry efforts to better use expertise and staffing resources have resulted in the development of a large transient workforce within the nuclear industry that travels from site to site as needed, such as roving outage crews. Although the industry has always relied upon C/Vs for special expertise and staff for outages, the number of transient personnel who work solely in the nuclear industry has increased and the length of time they are on site has decreased. Because the current FFD regulations were written on the basis that individual licensees would maintain independent, site-specific FFD programs and would share limited information, and that the majority of nuclear personnel would remain at one site for years, the regulations do not adequately address the transfer of personnel between sites. These changes in the industry have increased the need for information sharing among licensees and C/Vs. The increased insider threat since September 11, 2001, has also heightened the need for information sharing among licensees and C/Vs to ensure that licensees and PO 00000 Frm 00009 Fmt 4701 Sfmt 4702 50449 other entities have information that is as complete as possible about an individual when making an authorization decision. To address this need, the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003, mandated increased sharing of information. In addition, proposed Subpart C would require licensees and other entities to collect and share greater amounts of information than under the current rule, subject to the protections of individuals’ privacy that would be specified in proposed § 26.37 [Protection of information]. As a result, individuals who are subject to the rule would establish a detailed ‘‘track record’’ within the industry that would follow them if they change jobs and move to a new position that requires them to be granted authorization by another licensee or entity who is subject to the rule. This increased information sharing would contribute to providing reasonable assurance that individuals who are granted and maintain authorization are trustworthy and reliable when individuals move between FFD programs. However, a consequence of increased information sharing is that one violation of any licensee’s FFD policy has greater potential to end an individual’s career. Although an individual who has an active substance abuse problem cannot be permitted to hold authorization, the NRC continues to affirm that individuals who pursue treatment, stop abusing drugs or alcohol, and maintain sobriety for an extended period of time should regain the public’s trust. The length of time that an individual must maintain sobriety in order to demonstrate that he or she can again be trusted with the public’s health and safety and the common defense and security has been a matter of debate since Part 26 was originally under development. However, the research literature continues to indicate that individuals who maintain sobriety past the first 3 years following treatment have substantially reduced recidivism rates (i.e., relapsing into substance abuse) than during the first 3 years after treatment and there is a further drop in recidivism rates after 5 years of sobriety. Despite these research findings, some individuals who have had one confirmed positive test result have been prevented from working in operating nuclear power plants. The increased information sharing that would be required under Subpart C has the potential to result in a greater number of such individuals being banned from working in the industry. Therefore, several requirements would be added to E:\FR\FM\26AUP2.SGM 26AUP2 50450 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules proposed Subpart C to minimize such consequences for individuals who are able to demonstrate that they have resolved a substance abuse problem. Additional requirements for protecting information that would be gathered about individuals under proposed Part 26 would be specified in proposed § 26.37 [Protection of information]. The detailed changes to current requirements are discussed in Section VI with respect to the specific provisions that would incorporate them. In general, the authorization requirements in proposed Subpart C would be structured according to whether an individual who has applied for authorization has previously held authorization under Part 26. If an individual has not established a ‘‘track record’’ in the industry, the proposed rule would require licensees and other entities to meet an extensive set of requirements before granting authorization to the individual. If an individual has established a favorable track record in the industry, the amount of original information gathering that the proposed rule would require licensees and other entities to complete before granting authorization to the individual would be reduced. The need for original information gathering in these instances would be reduced because, under the proposed rule, licensees and other entities would have access to all of the information that previous FFD programs had collected about the individual. For individuals who have established a favorable track record in the industry, the steps that licensees and other entities would be required to complete in order to grant authorization to an individual would also depend upon the length of time that has elapsed since the individual’s last period of authorization was terminated and the amount of supervision to which the individual was subject during the interruption. (The term, ‘‘interruption,’’ refers to the interval of time between periods during which an individual holds authorization under Part 26.) In general, the more time that has elapsed since an individual’s last period of authorization ended, the more steps that the proposed rule would require licensees and other entities to complete before granting authorization to the individual. However, if the individual was subject to behavioral observation under a Part 26 program or continued to be subject to random drug and alcohol testing during the interruption, the proposed rule would require licensees and other entities to complete fewer steps in order to grant authorization to the individual. There are several reasons that the proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 rule would require fewer steps in the authorization process for these individuals. First, individuals who have established a favorable work history in the industry have demonstrated their trustworthiness and reliability from previous periods of authorization, so they pose less potential risk to public health and safety and the common defense and security than individuals who are new to the industry. Much is known about these individuals. Not only were they subject to the initial background screening requirements before they were initially granted authorization, but, while they were working under a Part 26 program, they were watched carefully through ongoing behavioral observation, repeatedly attained negative results from random drug and alcohol tests, and demonstrated the ability to consistently comply with the many procedural requirements that are necessary to perform work safely at operating power reactor facilities. Second, individuals who have established a favorable work history in the industry and whose authorization has been interrupted for only a short period would be unlikely to develop an active substance abuse problem during the interruption. The shorter the period of time since the individual’s last period of authorization ended, the less likely it is that the individual would have developed an active substance abuse problem or undergone significant changes in lifestyle or character that would diminish his or her trustworthiness, reliability, and ability to perform work safely and competently. Further, if the individual was also subject to supervision under some elements of a Part 26 program (e.g., behavioral observation, a requirement to report any arrests, random drug and alcohol testing) during the period that his or her authorization was interrupted, the higher the assurance that the individual does not have an active substance problem. And, the less likely it would be that the individual could have undergone significant changes in lifestyle or character that would be undetected. Therefore, the proposed rule would establish categories of requirements for granting authorization to an individual that would vary, based upon whether the individual has previously held authorization under Part 26; whether the individual’s last period of authorization was terminated favorably or unfavorably; how long it has been since the individual last held authorization under Part 26; and whether the individual was subject to PO 00000 Frm 00010 Fmt 4701 Sfmt 4702 any elements of a Part 26 program during the interruption period. Proposed § 26.55 [Initial authorization] would establish authorization requirements for individuals who have not previously held authorization under Part 26 and individuals who have not held authorization within the past 3 years. Proposed § 26.57 [Authorization update] would establish authorization requirements for individuals who previously held authorization under Part 26, whose last period of authorization was terminated favorably more than 1 year ago but less than 3 years ago. Proposed § 26.59 [Authorization reinstatement] would establish authorization requirements for individuals who previously held authorization under Part 26 and whose last period of authorization was terminated favorably within the past year. Proposed § 26.69 [Authorization with potentially disqualifying fitnessfor-duty information] would define the steps that licensees and other entities must take in granting authorization to an individual about whom potentially disqualifying FFD information has been disclosed or discovered. The time periods used to establish these categories of authorization requirements would be consistent with the categories established in the access authorization orders issued by the NRC to nuclear power plant licensees on January 7, 2003. Basing the proposed requirements on elapsed time is consistent with the programs of other Federal agencies who have similar needs to control access to sensitive information and protected areas. In addition, these time periods have been used successfully within nuclear power plant access authorization programs since 1989 and have met the NRC’s goal of ensuring that individuals who are granted unescorted access are trustworthy and reliable. Therefore, the proposed rule would incorporate these time periods within Part 26. In general, the steps that would be required to grant authorization to an individual who has recently held authorization and whose most recent period of authorization was terminated favorably would be less extensive than the steps required for applicants for authorization who are new to the industry or those who have not recently held authorization. In addition, the requirements for a rigorous evaluation process contained in the current § 26.27(e) would be strengthened and licensees and other entities would be required to meet them before granting authorization to an individual about whom potentially disqualifying FFD information has been disclosed or E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules discovered (see proposed § 26.69). The proposed rule would require licensees and other entities to obtain and review a written self-disclosure from the applicant and an employment history, and ensure that a suitable inquiry and pre-access drug and alcohol testing are completed before granting authorization to an individual, with certain exceptions. The proposed exceptions to the self-disclosure and employment history, suitable inquiry, and pre-access testing requirements would be specified in proposed §§ 26.61 [Self-disclosure and employment history], 26.63 [Suitable inquiry], and 26.65 [Pre-access drug and alcohol testing], respectively. The proposed rule would also require licensees and other entities to ensure that applicants are subject to random testing, as specified in proposed § 26.67 [Random drug and alcohol testing of individuals who have applied for authorization]. Subpart D Management Actions and Sanctions Subpart D [Management Actions and Sanctions] of the proposed rule would replace current § 26.27(b) and (c) and divide the current provisions into two separate sections that specify requirements for responding to FFD policy violations in proposed § 26.75 [Sanctions], and indications of impairment in proposed § 26.77 [Management actions regarding possible impairment]. The current rule would be reorganized in response to stakeholder requests that were made during the public meetings discussed in Section V. The stakeholders requested that the proposed rule generally reflect the order in which the requirements apply to licensees’ and other entities’ FFD processes and that related requirements be grouped into separate sections. Therefore, this change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. In general, proposed Subpart D would include three significant changes from the related provisions in the current rule that are each intended to provide a stronger deterrent to engaging in the unwanted actions specified in the proposed subpart. First, the proposed rule would increase the severity of the minimum sanctions that are required if an individual violates a licensee’s or other entity’s FFD policy. The more stringent sanctions would be necessary in order to strengthen the effectiveness of the rule in providing reasonable assurance that individuals who are subject to this part are trustworthy and reliable, as demonstrated by avoiding substance abuse, and by increasing the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 assurance that only individuals who are fit for duty are permitted to perform the job duties listed in proposed § 26.25 [Individuals subject to the fitness-forduty program]. Second, the proposed rule would require licensees and other entities who are subject to the rule to impose the same sanctions for an FFD violation involving the abuse of alcohol as required for the abuse of illegal drugs. Impairment caused by alcohol abuse creates a risk to public health and safety that is fundamentally similar to the risk posed by the use of illegal drugs. Some licensees, however, have imposed lesser sanctions for alcohol violations, an approach that is inconsistent with the NRC’s intent. Therefore, the proposed rule would rectify this situation by explicitly requiring the same minimum sanctions for abuse of alcohol as currently required for the use of illegal drugs. Third, the proposed rule would add the sanction of permanent denial of authorization for any individuals who subvert or attempt to subvert the testing process. The current rule permits licensees and other entities to have flexibility in establishing sanctions for actions such as refusing to submit to testing and attempting to subvert the testing process by submitting an adulterated or substitute specimen. As a result, different FFD programs have imposed different sanctions and some individuals have been granted authorization or permitted to maintain authorization when they have committed such acts. However, acts to defeat the testing process indicate that an individual is not trustworthy and reliable and suggest that the individual may be engaging in substance abuse that could pose a risk to public health and safety and the common defense and security. Therefore, the proposed rule would establish a minimum sanction that all FFD programs must impose to deter attempts to subvert the testing process as well as provide reasonable assurance that individuals who are granted and maintain authorization can be trusted to comply with the rules and regulations to which they are subject. These three changes would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, as discussed in Section IV. B. Other changes to current § 26.27(b) and (c) in proposed Subpart D would be made primarily to eliminate or modify unnecessary requirements and clarify the intent of current provisions. PO 00000 Frm 00011 Fmt 4701 Sfmt 4702 50451 Subpart E Collecting Specimens for Testing Subpart E [Collecting specimens for testing] of the proposed rule would reorganize and amend the requirements related to collecting specimens for drug and alcohol testing that are contained in current § 26.24 [Chemical and alcohol testing] and interspersed throughout current Appendix A to Part 26. The proposed subpart would group the related requirements and present them in the order in which they would be implemented by FFD programs. The proposed rule would also eliminate some redundancies in the provisions of the current rule that are related to specimen collections, as is discussed in Section VI, with respect to the specific provisions. These proposed changes would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. In general, the procedures in this subpart would be more detailed than those in Appendix A to the current rule, and also those NRC regulations that are based upon a risk-informed, performance-based approach, for several reasons. First, the more detailed procedures in proposed Subpart E would increase the consistency of Part 26 drug and alcohol specimen collection procedures with those of other Federal agencies and therefore would take advantage of the scientific and technical advances that have been made in workplace drug and alcohol testing programs since the current Part 26 was promulgated, as discussed in Section IV. B. Second, the proposed rule would permit Part 26 FFD programs to accept and rely upon other Part 26 programs, as well as the programs of other Federal and State agencies, to a much greater extent than is permitted under the current rule. The proposed permission to rely on other programs would improve the effectiveness and efficiency of FFD programs (Goal 3 of the rulemaking) and improve 10 CFR Part 26 by eliminating or modifying unnecessary requirements (Goal 5 of the rulemaking). For example, under proposed § 26.69(b)(6), the proposed rule would permit licensees and other entities to rely upon another Part 26 program’s drug and alcohol followup testing of an individual who has violated an FFD policy and is consequently required to have at least 15 followup tests within the three-year period following the violation, and is transferring from one licensee’s site to another. The proposed rule would require the receiving licensee or other entity to continue the followup testing E:\FR\FM\26AUP2.SGM 26AUP2 50452 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules program. However, the proposed rule would permit the licensee or other entity to accept the followup testing that was completed by the previous FFD program when determining the remaining number of followup tests to which the individual must be subject and the period of time during which the individual must continue to be subject to followup testing. Therefore, because the proposed rule would permit such reliance on other programs, more detailed requirements for conducting the activities upon which other FFD programs may rely, including drug and alcohol testing, are necessary to provide greater assurance that all Part 26 programs meet minimum standards. Third, at the public meetings discussed in Section V, industry stakeholders requested a greater level of detail in the specimen collection procedures of the proposed rule for the reasons discussed in Section IV. B. Other major changes to the current rule’s requirements for collecting specimens for drug and alcohol testing would be made to incorporate specimen validity testing requirements from the HHS Guidelines into Part 26 (Goal 1 of this rulemaking) and modify current alcohol testing requirements to improve the efficiency of FFD programs (Goal 3 of the rulemaking), while continuing to protect or enhance individuals’ rights to privacy and due process under the rule (Goal 7 of the rulemaking). Subpart F Licensee Testing Facilities Subpart F [Licensee Testing Facilities] of the proposed rule would present detailed requirements for conducting initial urine specimen validity and drug tests at licensee testing facilities, as permitted in § 26.24(d)(1) of the current rule and § 26.31(d)(3)(i) of the proposed rule. The proposed subpart would be entitled, ‘‘Licensee Testing Facilities,’’ for brevity, but other entities who are subject to the proposed rule would be permitted to establish and operate such facilities under the proposed rule. This new subpart would be added to group together in a single subpart the proposed requirements that are related to licensee testing facilities, which are intermixed with requirements related to drug testing at HHS-certified laboratories in Appendix A to Part 26 in the current rule. During the public meetings discussed in Section V, stakeholders requested that the proposed rule present the requirements that would be applicable to licensee testing facilities and HHS-certified laboratories in two separate subparts because, the stakeholders noted, it is not always clear which requirements apply to which type of testing facility in the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 current rule. The stakeholders also requested that any requirements that apply to both types of facilities would be included in both subparts so that it would be unnecessary for licensees and other entities who do not operate licensee testing facilities to review or implement any provisions in Subpart F. Although many of the requirements in this subpart would be redundant with similar requirements in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services], the proposed rule would implement these recommendations to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The most important changes in proposed Subpart F to the current requirements for licensee testing facilities would be the addition of new requirements for licensee testing facilities to conduct urine specimen validity testing, based on similar provisions contained in the most recent revision to the HHS Guidelines (69 FR 19643; April 13, 2004). The reasons for requiring urine specimen validity testing are discussed in Section VI with respect to proposed § 26.31(d)(3)(I). As discussed in Section V, stakeholders have objected to the addition of requirements for licensee testing facilities to conduct validity testing. However, the NRC believes that it is necessary for licensee testing facilities to conduct specimen validity testing because Part 26 permits licensees and other entities to make authorization decisions based on initial drug test results from such facilities. Thus, licensees and other entities are permitted to grant authorization to an individual who has negative initial test results from pre-access testing without further analysis of the urine specimen by an HHS-certified laboratory. If the initial test results from the licensee testing facility are inaccurate because the urine specimen was adulterated or substituted, the licensee or other entity could grant authorization to an individual who poses a risk to public health and safety and the common defense and security. Similarly, if an individual who has been selected for random testing submits an adulterated or substituted specimen that is not detected by initial tests at the licensee testing facility, the individual would be permitted to maintain authorization if the results of drug testing are negative. Therefore, in order to increase the likelihood that individuals who may be using drugs and attempting to defeat the testing process are detected, and to ensure that they would not be permitted PO 00000 Frm 00012 Fmt 4701 Sfmt 4702 to be granted or maintain authorization, the NRC has concluded that it is necessary to require licensee testing facilities to conduct urine specimen validity tests. However, in consideration of the increased costs and burden that are associated with instrumented initial validity testing, proposed Subpart F would permit licensee testing facilities to use non-instrumented validity testing devices to conduct ‘‘validity screening tests’’ of urine specimens, which may be a less expensive alternative than the instrumented initial validity tests required in the current HHS Guidelines. As discussed in Section VI with respect to proposed § 26.5 [Definitions], the proposed rule would use the term, ‘‘validity screening test,’’ to refer to testing using these non-instrumented devices. The term, ‘‘initial validity test,’’ would refer to instrumented validity testing. At the same time that the HHS published its final regulations to require specimen validity testing, which would be incorporated in the proposed rule, HHS also published a proposed revision to the Guidelines (69 FR 19673; April 13, 2004) that would permit the use of validity screening devices for the detection of substitution and the presence of adulterants in urine specimens. These devices include noninstrumented devices with visually-read endpoints as well as semi-automated or automated instrumented testing devices with machine-read end points. Specimen validity tests conducted with these devices use colorimetric assays, which is the same scientific principle as the initial tests conducted at HHScertified laboratories. Non-instrumented specimen validity devices for urine testing have been shown to detect adulterants in urine specimens and creatinine concentrations on tests that were conducted on specimens that were spiked with drug analytes. However, the results from the preliminary studies are variable. Therefore, the proposed HHS Guidelines include extensive performance testing requirements for these devices, which proposed Subpart F would also incorporate. Such performance testing is necessary to ensure that validity test results based on using these devices are accurate. Subpart G Laboratories Certified by the Department of Health and Human Services Subpart G [Laboratories Certified by the Department of Health and Human Services] in the proposed rule would present together in a single subpart requirements related to the HHScertified laboratories that are used by E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules licensees and other entities who are subject to Part 26 for validity and drug testing. The requirements in this subpart would group together the current requirements in Appendix A to Part 26, as they relate to HHS-certified laboratories. However, the current requirements would be updated to be consistent with the HHS Guidelines that were published in the Federal Register on April 13, 2004 (69 FR 19643). The most important changes to the current rule’s requirements for HHS-certified laboratories would be the incorporation of extensive requirements for urine specimen validity testing. Subpart H Determining Fitness-forDuty Policy Violations and Determining Fitness Subpart H [Determining Fitness-forDuty Policy Violations and Determining Fitness] in the proposed rule would reorganize, clarify, and enhance current requirements related to the decisions that MROs and other healthcare professionals must make under Part 26 to provide input to licensees’ and other entities’ management decisions with respect to granting and permitting an individual to maintain authorization under proposed Subpart C [Granting and Maintaining Authorization] and also with respect to imposing sanctions and taking actions to prevent an individual from performing the job duties that require an individual to be subject to this part under proposed Subpart D [Management Actions and Sanctions]. The current requirements, which are interspersed throughout the rule, would be grouped together in the proposed subpart to make them easier to locate within the proposed rule, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The proposed subpart would also make several significant changes to current requirements. In general, proposed Subpart H would include more detailed requirements for determining FFD policy violations and conducting determinations of fitness than are included in the current rule. These more detailed requirements would be added in response to implementation questions that the NRC has received from licensees since Part 26 was first promulgated, ‘‘lessons learned’’ from NRC inspections of FFD programs, and the experience of other Federal agencies that similarly require workplace drug and alcohol testing. However, the NRC’s primary concern in establishing more detailed requirements is to enhance the consistency in how FFD policy violations and fitness are VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 determined among Part 26 programs. The proposed rule would permit licensees and other entities to rely on the determinations made by other Part 26 programs to a greater extent than the current rule. For example, proposed § 26.63(b) would permit licensees and other entities to rely upon a previous licensee’s or other entity’s determinations of fitness, as well as their reviews and resolutions of potentially disqualifying FFD information, for previous periods of authorization. The reasons for adding these permissions were discussed previously in this section, with respect to proposed Subpart C [Granting and Maintaining Authorization]. However, in order to ensure that all licensees’ and other entities’ determinations of FFD policy violations and fitness can be relied upon by other FFD programs, it is necessary to enhance the current requirements and establish clear minimum standards for those processes. Therefore, the proposed subpart would include greater detail to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Under the proposed rule, licensees and other entities who are subject to the rule would continue to be prohibited from imposing sanctions on an individual who has a positive confirmatory drug test result from testing at the HHS-certified laboratory until the MRO has had an opportunity to discuss the result with the individual and determines that there is no legitimate medical explanation for the positive result(s). The proposed rule would extend this requirement to the review of non-negative validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed in Section VI with respect to proposed § 26.31(d)(3)(i). An MRO review of non-negative confirmatory validity test results before a licensee or other entity imposes sanctions on an individual is necessary for the same reasons that an MRO review is required of positive drug test results. That is, there may be legitimate medical reasons for the non-negative test result and the test result may not indicate that the donor has violated the FFD policy, which in this case would mean that he or she has not attempted to subvert the testing process. Requiring the MRO to review non-negative validity test results would be added to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. The HHS Guidelines also require the MRO to review non- PO 00000 Frm 00013 Fmt 4701 Sfmt 4702 50453 negative validity test results. Therefore, adding this requirement to the proposed rule would also meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Another significant change that the proposed rule would make to current requirements is establishing a new position within FFD programs—the ‘‘substance abuse expert’’ (SAE). The SAE would be responsible for performing a determination of fitness, which is determining whether there are indications that an individual may be in violation of the licensee’s or other entity’s FFD policy or is otherwise unable to safely and competently perform his or her duties, in those instances in which an individual may not be fit for duty for reasons related to drug or alcohol abuse. The SAE position would be added for several reasons. First, some MROs who provide services under Part 26 have indicated that they do not feel qualified to assess the presence and severity of substance abuse disorders, make treatment recommendations, and determine when an individual who has had a substance abuse disorder may again be able to safely and competently perform duties under this part. The focus of MRO responsibilities under Part 26 and other Federal workplace drug testing programs is on the medical evaluation of non-negative test results, which requires a knowledge of substance abuse. However, some MROs do not have the extensive knowledge of substance abuse disorders that is necessary to make determinations of fitness and treatment recommendations as required under this part. Therefore, the proposed rule would permit MROs to serve as SAEs if they meet the qualifications for this role that would be established in this subpart. But, licensees and other entities would be required to rely on other healthcare professionals who have the necessary qualifications to conduct determinations of fitness if the MRO does not meet the proposed SAE qualification requirements. Second, during the meetings discussed in Section V, stakeholders requested that healthcare professionals, other than a licensed physician, be permitted to make determinations of fitness under the proposed rule. The stakeholders indicated that the costs of using only licensed physicians are prohibitive and noted that a license to practice medicine does not guarantee that a physician is knowledgeable about substance abuse disorders. The NRC concurs that healthcare professionals E:\FR\FM\26AUP2.SGM 26AUP2 50454 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules other than licensed physicians may have the requisite knowledge and skills to serve as SAEs under the proposed rule. Therefore, the proposed rule would define the position of SAE in terms of the knowledge and skills required, and permit healthcare professionals other than licensed physicians to serve in this role. Third, under the proposed rule, FFD programs would be permitted to accept determinations of fitness and treatment plans from other Part 26 programs, if an individual who has had a substance abuse problem will be granted authorization by another licensee or entity. Consequently, detailed requirements for the qualifications and responsibilities of the SAE are necessary to ensure consistency among FFD programs. Detailed requirements for the qualifications and responsibilities of the SAE are necessary because of the key role the SAE would play in assuring the common defense and security and public health and safety when making a determination of fitness upon which licensees and other entities will rely when making authorization decisions. It is critical that SAEs understand the potential impact on the common defense and security and public health and safety when determining that an individual who has had an active substance abuse problem has resolved the problem and is again worthy of the public’s trust. A sophisticated understanding of substance abuse problems and the types of adverse behaviors they may involve, including knowledge of the research literature and clinical experience, is necessary to inform the SAE’s clinical judgements in these circumstances. Many of the provisions in the proposed subpart would be adapted from related DOT requirements regarding the ‘‘substance abuse professional’’ [49 CFR Part 40, Subpart O; 65 FR 41944; August 9, 2001]. The SAE role is not defined in current Part 26. Subpart I Managing Fatigue Subpart I [Managing Fatigue] of the proposed rule would strengthen the effectiveness of FFD programs at nuclear power plants in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security by establishing clear and enforceable requirements for the management of worker fatigue. Because the overall rationale for including Subpart I, Managing Fatigue, in Part 26, is detailed and extensive, this discussion is presented separately in Section IV. D. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Subpart J Recordkeeping and Reporting Requirements Subpart J [Recordkeeping and Reporting Requirements] would be added to the proposed rule to reorganize the current rule’s requirements for maintaining records and submitting reports to the NRC. The new subpart would combine and amend two sections of the current rule: Section 26.71 [Recordkeeping requirements] and § 26.73 [Reporting requirements], and would incorporate the record retention requirements of current §§ 26.21(b), 26.22(c), and 26.80(c). This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, by grouping related requirements together in the proposed subpart. Major changes to the current rule’s requirements for recordkeeping and reporting would reflect (1) the addition of requirements for specimen validity to the proposed rule; (2) the addition of requirements for managing worker fatigue at nuclear power plants; and (3) a relaxation of the required frequency with which Part 26 programs must submit FFD program performance reports to the NRC from bi-annually to annually. Subpart K Penalties Inspections, Violations, and Subpart K [Inspections, Violations, and Penalties] would be added to the proposed rule to combine into one subpart current §§ 26.70 [Inspections], 26.90 [Violations] and 26.91 [Criminal penalties]. These sections would be grouped together in one subpart because they each establish requirements related to the NRC’s oversight of the implementation of FFD programs. Proposed § 26.221 [Inspections] would retain the requirements in current § 26.70. Proposed § 26.223 [Violations] would retain the requirements in current § 26.90 [Violations]. Proposed § 26.225 [Criminal penalties] would retain the requirements in current § 26.91 [Criminal penalties]. D. Inclusion of Worker Fatigue Provisions in 10 CFR Part 26 The NRC has determined that the effectiveness of FFD programs in ensuring against worker fatigue adversely affecting public health and safety and the common defense and security should be strengthened by establishing clear and enforceable requirements for the management of worker fatigue. Subpart I, Managing Fatigue, of the proposed rule would include these requirements and PO 00000 Frm 00014 Fmt 4701 Sfmt 4702 establish an integrated approach to fatigue management, with fatigue prevention, detection, and mitigation as the fundamental components. As discussed further in this section, the proposed requirements in Subpart I would provide a substantial increase in the protection of public health and safety and common defense and security. In determining the provisions of this proposed rule, the NRC has taken into consideration the effects of fatigue; the specific work practices of the nuclear power industry that contribute to and mitigate fatigue; the inadequacy of the current regulatory framework; the excessive hours currently worked by many nuclear power workers; and the practices of other industries and countries for regulating work hour limits. In addition, many public meetings were held with the nuclear industry and the public to discuss draft provisions for the proposed rule. These interactions are discussed in detail in Section V of this document. The NRC has determined that an integrated approach is necessary to effectively manage worker fatigue because individuals experience fatigue for many reasons, including long work hours, inadequate rest, and stressful or strenuous working conditions. Shiftwork, home-life demands, and sleep disorders can all contribute to inadequate sleep and excessive fatigue. Individual differences in worker tolerances to these conditions also influence worker fitness for duty. As a consequence, fatigue is a complex phenomenon that requires an integrated approach to be managed effectively. The requirements in proposed Subpart I were developed based upon the premise that fatigue management requires the collaboration of individual workers and licensees. Each of the proposed requirements in Subpart I are discussed in detail in Section VI. However, because proposed Subpart I presents an integrated fatigue management approach, this section discusses the principal findings that led to the decision to include fatigue management provisions in Part 26, as well as supporting information on the causes and problems with worker fatigue in the nuclear power industry. The Commission approved a rulemaking plan to include worker fatigue provisions for nuclear power plants in 10 CFR Part 26 on January 10, 2002, (SRM–SECY–01–0113), as described in Section I. Since that time, the NRC has continued to analyze the need for work-hour provisions in the proposed rule. The considerations listed in the numbered paragraphs that follow summarize the NRC’s considerations E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules concerning the appropriate regulatory action to address the potential for worker fatigue to affect public health and safety and the common defense and security. These considerations include: (1) The research literature demonstrating the substantive effects of fatigue and decreased alertness on an individual’s ability to safely and competently perform his or her duties; (2) The prevalence of conditions that contribute to worker fatigue in the U.S. nuclear power industry; (3) With the exception of orders limiting the work hours of security personnel, the NRC’s current regulatory framework does not include consistent or readily enforceable requirements to address worker fatigue; (4) Reviews of industry control of work hours have repeatedly identified practices that were inconsistent with the NRC’s Policy on Worker Fatigue, including excessive use of work hours and work-hour limit deviations; (5) The current regulatory framework includes requirements that are inadequate and incomplete for effective fatigue management; (6) Ensuring effective management of worker fatigue through rulemaking would substantially enhance the effectiveness of FFD programs, but additional orders are not presently warranted to ensure adequate protection of public health and safety or the common defense and security; and (7) Addressing the fatigue of workers in safety-critical positions through regulation is consistent with practices in foreign countries and other industries in the U.S. Each of these considerations is discussed in greater detail below. (1) Fatigue and decreased alertness can substantively degrade an individual’s ability to safely and competently perform his or her duties. The NRC previously noted in its ‘‘Policy Statement on the Conduct of Nuclear Power Plant Operations,’’ dated January 24, 1989, (54 FR 3424), that ‘‘nuclear power plant operators on each shift must have knowledge of those aspects of plant status relevant to their responsibilities to maintain their working environment free of distractions, and using all their senses, be alert to prevent or mitigate any operational problems.’’ The degradation in an individual’s cognitive functioning resulting from inadequate rest includes, but is not limited to, a reduced ability to sustain attention; maintain situational awareness; make timely and conservative decisions; communicate; and work effectively as a team member. Such degradations in performance, if exhibited by individuals performing VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 risk-significant functions, can adversely affect the safety and security of a nuclear power plant. The NRC has evaluated the research available on the degradation of worker abilities that are important to safe plant operation. The research supports the fatigue management provisions in Subpart I. Many of the specific research citations are listed in detail in Section VI. The following is a discussion of the fundamental concerns associated with worker fatigue, and some of the overall research that forms the basis for the integrated fatigue management approach in Subpart I. Many studies have shown that fatigue impairs human alertness and performance (e.g., Alluisi and Morgan, 1982; Rosa, 1991; Scott, 1990; Dinges, 1992; Dinges, 1995; Dawson and Reid, 1997; Bobko, et al., 1998; Harrison and Horne, 2000; Williamson and Feyer, 2000). The lack of adequate days off and extended workdays (overtime) can result in a cumulative sleep debt (i.e., the difference between the amount of sleep an individual needs and the amount of sleep that individual actually obtains) and performance impairment (Webb and Agnew, 1974; Baker, et al., 1994; Colquhoun, et al., 1996; Tucker, et al., 1999; Williamson and Feyer, 2000; Department of Transportation (DOT), May 2, 2000, 65 FR 25546). Across a broad range of industries, studies concerning extended work hours suggest that fatigue-induced personnel impairment can increase human error probabilities by a factor of more than 2 to 3 times (Hanecke, et al., 1998; Colquhoun, et al., 1996; Akerstedt, 1995; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000, 65 FR 25544). Studies of the nuclear power industry indicate that normal daily variations in alertness associated with human circadian rhythms (i.e., physiological processes that vary on an approximate 24-hour cycle) may be responsible for daily variations in the incidence of personnel errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996; Maloney, 1992). The findings of these studies are consistent with the results of a survey of more than 100 nuclear power plant shift supervisors—over 90 percent stated that they notice times of day, and days in the schedule, during which control room operators are less alert, less vigilant, or make more mistakes (Baker, et al., 1990 [EPRI NP– 6748]). These studies suggest that, despite safeguards to ensure correct and reliable human performance, factors that influence alertness may increase the incidence of human errors in nuclear power plants. PO 00000 Frm 00015 Fmt 4701 Sfmt 4702 50455 Fatigue has generalized effects on human performance capabilities, and is associated with performance decrements at a base level, across a variety of tasks (Dinges, 1995). Fatigue can impair both physical and cognitive (i.e., mental) functioning. Generally, cognitive task performance is affected more readily by fatigue than physical or psychomotor tracking performance (Krueger, 1989; 1991). General cognitive fatigue decreases an individual’s ability to remain alert, process complex information, and correctly grasp a complex set of circumstances. Fatigue has been shown to cause memory problems, slowed responses, lapses and false responses (Williams, et al., 1959; Morgan, et al., 1974; Dinges, 1992; Dinges, 1995). Many of the cognitive tasks performed by nuclear power plant personnel that are important to the protection of public health and safety and the common defense and security rely on their ability to sustain attention, analyze problems, make clear decisions, and communicate and work as a team. The following effects of fatigue on cognitive abilities are the primary focus of the proposed fatigue management requirements: (a) Sustaining attention—Vigilance and attention to detail are fundamental for plant safety, whether an individual is operating or maintaining equipment important to plant safety, performing surveillance procedures in the plant, monitoring system status in the control room, or monitoring plant security systems or barriers. Tasks requiring sustained attention (e.g., vigilance tasks) are among the most susceptible to fatigue-induced degradation (Monk and Carrier, 2003). The sensitivity to fatigue of vigilance tasks is one of the primary reasons that tests, such as the psychomotor vigilance task (Dinges, et al., 1997; Doran, et al., 2001), are standard measurement tools used in studies of the effects of sleep deprivation and fatigue. Of particular note are research findings showing that, in operational settings, individuals may experience periods of sleep up to a few seconds (called microsleeps), during which they fail to respond to external stimuli, and are completely unaware that these episodes have occurred (Cabon, et al., 2003; Priest, et al., 2001; Summala, et al., 1999). (b) Decision-making—Conservative decision-making is a cornerstone of safe nuclear power plant operations. Fatigue has been associated with more risky strategies and decreases in the effort individuals exert (Schellekens, et al., 2000). Furthermore, Harrison and Horne (2000) reviewed the impact of sleep deprivation on decision-making and E:\FR\FM\26AUP2.SGM 26AUP2 50456 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules reported that, contrary to popular belief, sleep deprivation impairs decisionmaking even if individuals try to compensate for lack of sleep when responding to heightened stimulation. As noted by Cabon, et al. (2003), studies have shown reductions in aircrew alertness, even during the critical descent phase. These findings suggest that the alerting stimuli of off-normal conditions (e.g., landing an airplane, acknowledging control room annunciators) may not fully negate the effects of fatigue on performance. The National Transportation Safety Board (NTSB) reviewed the performance of flight crews involved in 37 major accidents and found that those crew members who had been awake longer than 12 hours before their accidents made more errors overall, and specifically more tactical decision errors, than did crew members who had been awake for less time (NTSB, 1994). (c) Problem solving—Perseveration is a term used to describe poor problem solving performance, characterized by an individual or group of individuals maintaining a faulty diagnosis or mitigation plan despite contrary information. An example of perseveration from the nuclear power industry was the initial response by plant operators to events at Three Mile Island Unit 2 in 1979. The operators’ initial response was based on a faulty diagnosis of the plant condition (the operators failed to recognize they were dealing with a loss of coolant accident), which the operators maintained throughout the first 2 hours of the event in the face of numerous conflicting indications. Many factors contributed to human performance problems during the Three Mile Island accident and the NRC is not suggesting that operator fatigue was a contributing factor. However, fatigue is one factor that has been found to contribute to this type of performance degradation (Harrison and Horne, 2000), which may have serious consequences for public health and safety. Sleep-deprived workers fail to appropriately allocate attention, set task priorities, or sample for sources of potentially faulty information (Hockey, 1970; Krueger, 1989). Mental fatigue also contributes to decreased originality and flexibility in problem solving and sub-optimal planning (Van der Linden, et al., 2003; Lorist, et al., 2000; Horne, 1988). (d) Communication and teamwork— Fatigue affects skills important to written and oral communication and teamwork. Fatigue degrades speech articulation, verbal fluency, grammatical reasoning (the ability to process oral and written instructions), and memory VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 (Harrison and Horne, 1997; 1998). Studies of individuals in simulated combat and command and control conditions have shown that fatigue slows the encoding, decoding, and transcription of information (Banderet, 1981; Angus and Heslegrave, 1985). Fatigued individuals also tend to be less communicative and have greater difficulty performing multiple tasks concurrently, as demonstrated in simulated aircraft cockpit tasks requiring monitoring and communications (Pascoe, et al., 1995; Harrison and Horne, 2000). These effects have been found in the analysis of incidents and accidents. In a study of major aircraft accidents, crews that had been awake longer (an average of 13.8 hours for captains and 13.4 hours for first officers) made significantly more procedural and tactical decision errors than crews that had been awake for a shorter period (an average of 5.3 hours for captains and 5.2 hours for first officers) (NTSB, 1994). Similar to control room personnel in nuclear power plants, aircraft cockpit crews make extensive use of secondary checks to verify that decisions and performance are correct, and to mitigate the consequences of errors. Although the difference was not statistically significant, analysis of the crew errors indicated that crews that had been awake longer made nearly 50 percent more errors in failing to challenge a faulty action or inaction by another crew member. These studies highlight how fatigue cannot only degrade the fitness of an individual, but also the overall performance of a crew. Although fatigue has long been widely recognized as degrading performance, recent research has helped characterize the magnitude of these effects relative to a historical FFD concern: impairment from alcohol intoxication. The current provisions in 10 CFR Part 26 prohibit the use of alcohol on site and within several hours before a tour of duty, and establish alcohol testing requirements for personnel on duty. The NRC established these requirements based on the recognition that alcohol can have significant adverse effects on a worker’s ability to safely and competently perform his or her duties. Recent studies have shown that fatigue can cause performance degradations that are comparable to the levels observed from blood alcohol concentrations (BACs) in excess of those that would result in a positive breath alcohol test under the current provisions of 10 CFR Part 26. In those studies, individuals who were awake for 17–19 hours had cognitive PO 00000 Frm 00016 Fmt 4701 Sfmt 4702 and psychomotor performance comparable to individuals with a BAC of 0.05 percent (Dawson and Reid, 1997; Williamson and Feyer, 2000). Part 26 establishes a breath alcohol cutoff level of 0.04 percent. The NRC considers the insight that fatigue can impair a worker at levels comparable to those prohibited for alcohol to be particularly significant. (2) Conditions that contribute to worker fatigue are prevalent in the U.S. nuclear power industry. Fatigue may result from an individual remaining awake continuously for an excessive period of time, or from the individual obtaining an inadequate amount or quality of sleep, or both. Conditions that contribute to worker fatigue include: (a) Extended work shifts with five or more consecutive work days—Although the effects of shift length on worker performance is influenced by the nature of the task, various studies have shown that task performance declines after 12 hours on a task (Rosa, 1991; Folkard, 1997; Dawson and Reid, 1997). Other studies have shown that the relative risk of having an accident increases dramatically after 9 consecutive hours on the job (Colquhoun, et al., 1996; Hanecke, et al., 1998; U.S. DOT, 49 CFR Parts 350, et al., Proposed Rule, May 2, 2000, 65 FR 25544). The effects of extended working hours on worker performance can be exacerbated when many extended shifts are scheduled in succession. The use of 12-hour shifts has become increasingly common at U.S. nuclear power plants. Schedules that include 5 or more 12-hour shifts in succession during routine operations are sometimes popular with workers because they allow a long sequence of days off. However, scheduling more than 4 consecutive 12-hour shifts is not a recommended means of managing fatigue (Baker, et al., 1990 [EPRI NP– 6748]; NUREG/CR–4248, ‘‘Recommendations for NRC Policy on Shift Scheduling and Overtime at Nuclear Power Plants’’). As noted in the 2000 Sleep in America Poll, ‘‘waking up unrefreshed’’ was more likely to be reported by individuals working more than 60 hours per week (58 percent vs. 42 percent of those working 41–60 hours per week and 39 percent of those working 31–40 hours) (National Sleep Foundation, 2000). During the public meetings described in Section V, industry stakeholders noted that the use of 6 or more consecutive 12-hour shifts is now standard practice during plant outages. In SECY–01–0113, the NRC staff reported that more than 80 percent of the authorizations written by licensees E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules to exceed the technical specification work hour limits during outages were for exceeding 72 hours (e.g., six 12-hour shifts) in a 7-day period. The NRC’s more recent review of deviations authorized at six plants for refueling outages during 2003 and 2004 also indicates that deviations from the limit of 72 hours in 7 days continue to account for more than 80 percent of the deviations authorized. During these meetings, industry stakeholders also reported that, during outages, some licensees have scheduled personnel for three or more weeks of consecutive 12hour shifts without intervening days off. (b) Extensive Overtime—Many research studies report that excessive working hours cause worker fatigue (Akerstedt, 1995b; Rosa, 1995; Buxton, et al., 2002). The U.S. nuclear power industry makes extensive use of overtime, creating a combined effect of long work hours with reduced break periods. As noted in SECY–01–0113, at approximately one-fourth of the sites, more than 20 percent of the personnel covered by working hour limits work more than 600 hours of overtime annually. This amount of overtime is more than two to three times the level permitted for personnel at some foreign nuclear power plants and more than twice the level recommended by an expert panel in 1985 (NUREG/CR– 4248). In SECY–01–0113, the NRC also noted that some licensees authorized hundreds to several thousand deviations from the limits of 16 hours of work in any 24-hour period, 24 hours of work in any 48-hour period, 72 hours of work in a 7 day period, and from the minimum break requirement of 8 hours between work periods. The NRC also noted the continued excessive use of such deviations in its survey of six plants in 2004. (c) Shiftwork—The nuclear power industry is a round-the-clock operation requiring individuals to be awake and working at times when they would normally be asleep. Although individuals can function in these circumstances, human alertness and task performance are cyclically affected by a daily biological clock, which runs on about a 24-hour (circadian) cycle, as it assists in timing numerous physiological and psychological phenomena (such as core body temperature, the daily release of various hormones, mood swings, and wakesleep cycle) (Liskowsky, et al., 1991). The circadian trough, or lowest levels of function reflected in, for example, alertness, performance, subjective mood, and body temperature, occurs around 3 a.m. to 5 a.m., with many human functions showing reduced VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 levels between 12 a.m. and 6 a.m. Sleepiness is most severe between 3 and 5 a.m., with a less marked but significant expression again between 3 and 5 p.m. There is a substantial scientific literature on circadian variations in alertness that clearly demonstrates the significant roles that worker fatigue, sleep loss, and circadian rhythms play in contributing to errors and accidents (Kryger, et al., 1994; Akerstedt, 1995a; Dinges, 1995; Folkard, 1997; Comperatore and Krueger, 1990; Miller and Mitler, 1997). These findings range from reduced response speed on a variety of tasks, to missing warning signals, to minor hospital incidents and accidents (Krueger, 1994). In addition, as previously described in this section, circadian variations have also been noted in studies of the incidence of personnel errors at nuclear power plants (Bobko, et al., 1998; Dorel, 1996; Maloney, 1992) and noted in observations by a large number of nuclear power plant shift supervisors (Baker, et al., 1990 [EPRI NP–6748]). In addition to causing individuals to perform work at periods of depressed alertness, shiftwork also conflicts with circadian variations in alertness by requiring individuals to sleep during naturally occurring periods of increased cognitive arousal. Circadian rhythms, and naturally occurring tendencies for sleep and wakefulness, do not fully adapt to shiftwork schedules. In addition, daylight, noise and the ‘‘regular day’’ schedules of other family members challenge the ability of shiftworkers to obtain adequate rest. As a result, shiftworkers generally obtain less sleep, and report a higher incidence of sleepiness and sleep-related complaints. For example, in a survey of 1,154 U.S. adults, the National Sleep Foundation (NSF) found that shiftworkers, on average, get less sleep (6 hours, 30 minutes) than regular day workers (6 hours, 54 minutes). Almost half of the shiftworkers they surveyed obtained less than 6.5 hours of sleep per ‘‘night’’ during the work-week, 30–90 minutes less than recommended by most sleep experts. In comparison to regular day workers, shiftworkers were more likely to be sleepy at work 2 or more days per week (34 percent vs. 23 percent) (National Sleep Foundation, 2000). Many studies have demonstrated that decreased performance and increased errors and accidents are associated with night work and are affected by varying sleep schedules and durations of sleep periods (e.g., Balkin, et al., 2000). The challenge for shiftworkers to remain alert during the early morning PO 00000 Frm 00017 Fmt 4701 Sfmt 4702 50457 hours of a shift can be exacerbated by extended shift lengths, overtime, and the inability of many shiftworkers to obtain adequate sleep during the day (Hanecke, 1998). The powerful drive for sleep that is associated with circadian factors, and the fact that shiftwork is a daily influence on the alertness of all shiftworkers at nuclear power plants, has been demonstrated by a number of recent events. For example, there have been instances of operators falling asleep in the control rooms at the Pilgrim nuclear power station (2004) and the test and research reactor at the Massachusetts Institute of Technology (2003), as well as a security officer falling asleep at the Braidwood nuclear power plant while driving a patrol vehicle (2004), despite these individuals recognizing the potential safety and disciplinary consequences. (d) Early start times and extended commutes—Although many plant personnel do not work rotating shifts, start times before 7 a.m. can interfere with a worker’s ability to obtain adequate rest if the schedule is not aligned with his or her circadian cycle and naturally occurring tendency for sleep and wakefulness. In addition, long commutes to remote work sites such as nuclear power plants, which are frequently located in rural areas and distanced from major population centers, contribute to the potential for fatigue associated with early start times. (e) Sleep disorders—Sleep disorders, such as sleep apnea, insomnia, and restless leg syndrome (i.e., a condition that is characterized by uncomfortable or unpleasant sensations in the legs, causing an overwhelming urge to move them, often contributing to difficulty in staying or falling asleep), are conditions that can significantly reduce the quantity and quality of sleep that individuals are able to obtain, affect an individual’s ability to remain alert, and ultimately degrade an individual’s ability to safely and competently perform his or her duties (Kryger, et al., 1994; Lewis and Wessely, 1992). These factors are not effectively addressed by limits on working hours in the absence of other fatigue management practices. Although the NRC does not have data for the incidence of sleep disorders that is specific to U.S. nuclear power plant workers, in the general U.S. population, such conditions are not uncommon. For example, the prevalence of sleep apnea is estimated to be 4 percent for adult males and 2 percent for adult females (Strollo and Rogers, 1996). The incidence of sleep apnea may in fact be higher for shiftworkers at power plants, as this condition is more common in middle-age adult males than in the E:\FR\FM\26AUP2.SGM 26AUP2 50458 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules general population. A survey by the NSF of 1,154 adults living in households in the continental U.S. found self-reports of sleep apnea were more common from shiftworkers than regular day workers (15 percent vs. 9 percent) (National Sleep Foundation, 2000). Similarly, the NSF found that shiftworkers reported a higher incidence of insomnia (66 percent vs. 55 percent) than regular day workers. Although worker motivation can mitigate to a limited degree the effects of fatigue, fatigue has a physiological basis, including changes in glucose metabolism in the brain (Wu, et al., 1991; Thomas, et al., 2000), and such changes are beyond the individual’s control. In addition, several studies have suggested caution with regard to the ability of individuals to self-monitor their abilities to safely and competently perform their duties when fatigued (Dinges, et al., 1997; Belenky, et al., 2003; Akerstedt, 2003). These studies note that individuals experience microsleeps without being aware of their lapses in attention and underestimate their propensity for uncontrolled sleep episodes. As a consequence, a worker’s motivation to remain alert does not provide reasonable assurance that an individual will be able to safely and competently perform his or her duties. Considering the above factors, the NRC believes that fatigue can have a significant adverse effect on worker abilities. Further, the likelihood of a nuclear power plant worker being impaired from fatigue is not trivial, and potentially greater than the likelihood of impairment from drugs and alcohol, which the NRC currently requires licensees to address through their FFD programs. Therefore, the NRC believes that regulatory action is warranted to ensure that fatigue is adequately addressed through licensee FFD programs. Further, the NRC believes that rulemaking is the appropriate regulatory action for the following reasons: (3) With the exception of orders limiting the work hours of security personnel, the NRC’s current regulatory framework does not include consistent or readily enforceable requirements to address worker fatigue. The principal components of the current regulatory framework for matters pertaining to working hours and fatigue for non-security personnel are (a) NRC’s Policy on Worker Fatigue, as issued on June 15, 1982, in GL 82–12, and (b) plant technical specifications related to this policy statement, and (c) certain requirements of 10 CFR Part 26. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 As part of the assessment of PRM–26– 2, in which Barry Quigley petitioned for rulemaking to establish enforceable requirements addressing fatigue of workers at nuclear power plants, the NRC reviewed and assessed the implementation and enforceability of the NRC’s current regulatory framework applicable to worker fatigue, including licensee technical specification requirements for the administrative control of work hours. This review was documented in detail in Attachment 1 to SECY–01–0113. The NRC continued this evaluation during development of this proposed rule, and the principal findings include: (a) NRC’s Policy on Worker Fatigue— NRC guidance documents do not prescribe requirements. Guidance documents establish policy or provide advice on meeting a regulatory requirement. As a result, the policy is enforceable only to the extent that the guidelines have been incorporated into a license condition or technical specification requirements. For the three nuclear power plant sites who have not incorporated the guidelines from the NRC’s Policy on Worker Fatigue into a license condition or technical specification requirement, the guidelines are unenforceable. These plant sites have implemented the concept using other administrative controls that the NRC has determined to be adequate. However, had the NRC determined that the controls were inadequate, it would have no basis for taking enforcement action. (b) Technical Specifications—For those licensees who have incorporated the NRC’s Policy on Worker Fatigue into a license condition or technical specifications, consistent enforcement is complicated by the following factors: —The language in plant technical specifications is largely advisory (e.g., an individual should not be permitted to work more than 16 hours straight) and key terms have not been defined. This deficiency results in inconsistent interpretation and implementation of technical specification requirements by licensees, as well as difficulty for the NRC in enforcing the requirements. For example, many technical specifications use the terms ‘‘routine heavy use of overtime,’’ ‘‘unforeseen problems,’’ and ‘‘temporary basis.’’ The NRC has not defined any of these terms and has not consistently pursued enforcement on the basis of the amount or frequency of overtime authorized. —The technical specifications have inconsistent levels of detail from one nuclear power plant licensee to PO 00000 Frm 00018 Fmt 4701 Sfmt 4702 another. Only three-quarters of the licensees’ technical specifications include the quantitative working hour limit guidelines of the NRC’s Policy on Worker Fatigue. —The technical specifications contain varying scopes of requirements. Some plant technical specifications require periodic reviews of overtime approvals to ensure that excessive hours have not been assigned, while other technical specifications contain no equivalent requirements. Although the observed variability in the controls does not by itself present a safety concern, such variability is inconsistent with establishing a uniform level of assurance that personnel are not in a fatigued condition that could significantly reduce their mental alertness and decision-making capability. —Licensees have inconsistently interpreted the scope of personnel who must be subject to the technical specification work hour limits. The NRC’s Policy on Worker Fatigue applies to personnel who are performing safety-related functions. The NRC’s review of work hour data gathered by NEI regarding the work hours of personnel subject to the technical specifications (Nuclear Energy Institute, 2000) identified variation in the numbers and types of personnel covered by these controls. A limited number of sites may not be applying work hour controls to all personnel performing safety-related functions. At least two nuclear plant sites do not apply the work hour controls to any maintenance personnel even though GL 83–14, ‘‘Definition of Key Maintenance Personnel (clarification of GL 82– 12),’’ issued March 7, 1983, defined key maintenance personnel to include individuals who work on safetyrelated equipment. —The basic measure used to determine whether an individual’s work hours are within or above the technical specification limits is not implemented consistently from one nuclear power plant to another. Work hours included within the limits at some nuclear power plants are not included at others, effectively creating substantively different work hour limits among plants. (c) 10 CFR Part 26, ‘‘Fitness for Duty Programs’’—The general performance objectives of § 26.10 require that licensees provide ‘‘reasonable assurance that nuclear power plant personnel * * * are not * * * mentally or physically impaired from any cause, which in any way adversely affects their ability to * * * perform their duties.’’ E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Although 10 CFR Part 26 contains specific requirements pertaining to alcohol and drug usage, it does not include prescriptive requirements regarding fatigue. Rather, § 26.20 uses general, non-mandatory language to state that the FFD policy ‘‘should’’ address other factors that can affect a worker’s ability to safely and competently perform his or her duties, ‘‘such as mental stress, fatigue, and illness.’’ As a result, it is difficult for the NRC to justify a violation of the regulation based on a licensee’s failure to limit overtime hours. In addition, without a numerical limit on overtime hours, or a provision limiting overtime, a range of overtime practices could be viewed as ‘‘reasonable,’’ and therefore in compliance with the regulation. In summary, the broad and nonprescriptive provisions of Part 26, and the technical specifications and license conditions pertaining to fatigue, in the absence of clearly defined terms or measures of fatigue, make it difficult for the NRC to enforce worker fatigue requirements and working hours limits in an effective, efficient, and uniform manner that ensures that all licensees provide reasonable assurance that workers are able to safely and competently perform their duties. The NRC believes that a consistent fatigue management program and its uniform implementation across the industry is essential, and the most effective regulatory mechanism is to incorporate worker fatigue into 10 CFR Part 26. (4) Reviews of industry control of work hours have repeatedly identified practices that were inconsistent with the NRC’s Policy on Worker Fatigue, including excessive use of work hours and work hour limit deviations. The policy states, in part, ‘‘Enough plant operating personnel should be employed to maintain adequate shift coverage without routine heavy use of overtime.’’ Surveys and expert panels have suggested that tolerance for overtime is generally limited to 300–400 hours of overtime per year (ADAMS Accession No. ML05270310; NUREG/ CR–4248). Baker, et al. (1994) reviewed the hours worked by nuclear power plant operations, technical, and maintenance personnel during 1986, four years after the NRC issued its policy. Based on a sample of 63 percent of U.S. nuclear power plants operating at that time, Baker and colleagues found that operations personnel averaged more than 500 hours of overtime annually at 20 percent of the plants, and more than 700 hours of overtime at 9 percent of the plants. Technical personnel averaged more than 500 hours of overtime annually at 30 percent of the plants, and VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 more than 700 hours of overtime at 18 percent of the plants. Maintenance personnel averaged more than 500 hours of overtime annually at 80 percent of the plants and more than 700 hours of overtime at 14 percent of the plants. The NRC’s Policy on Worker Fatigue includes provisions for licensees to authorize deviations from the NRC’s work and rest guidelines for individual workers in ‘‘very unusual circumstances.’’ On June 10, 1991, following several NRC inspections noting concerns related to licensee work hour control, the NRC issued Information Notice (IN) 91–36, Nuclear Power Plant Staff Working Hours, to alert licensees of potential problems resulting from inadequate controls to prevent excessive working hours. The conditions cited in the notice included an event attributed to fatigue, excessive use of deviations and overtime, and overtime deviations authorized after the fact. Subsequent NRC reviews completed in 1999 and 2001 have identified continued problems with industry control of work hours. In 1999 the NRC reviewed licensee event reports and NRC inspection reports from January 1994 through April 1999. The NRC found that only a few events of limited risk significance had been attributed to fatigue. However, the staff found several instances each year in which licensee use of overtime appeared to be inconsistent with the general objectives or specific guidelines of the NRC’s Policy on Worker Fatigue. The Nuclear Energy Institute (NEI) conducted a survey in the summer of 2000 concerning industry control of work hours for personnel subject to the technical specification requirements (letter dated August 29, 2000, from J.W. Davis, NEI, to G.T. Tracy, NRC, ADAMS Accession No. ML003746495). Fortyseven sites responded to the survey, providing data from 1997–1999. The NRC staff’s review of the data is documented in Attachment 1 to SECY– 01–0113. The NRC evaluated the results of the survey concerning overtime and found that 8 of 36 sites providing data had more than 20 percent of the personnel covered by the policy working in excess of 600 hours of overtime per year. Considering all plants that provided data, the percentage of personnel working in excess of 600 hours of overtime increased from 7 percent in 1997 to 11 percent in 1999. The percentage of licensed operators working in excess of 600 hours increased from 13 percent in 1997 to more than 16 percent in 1999. The NRC believes these percentages represent excessive use of overtime in the nuclear industry. PO 00000 Frm 00019 Fmt 4701 Sfmt 4702 50459 The NRC also reviewed the data collected by NEI concerning deviations, which showed that approximately onethird of the respondents were authorizing more than a thousand, to as many as 7,500, deviations in a year to exceed the policy guidelines. The frequency of deviations did not appear to be consistent with either the specific guidelines or the general objective of the policy. As previously described in this section, the policy permits deviations from the guidelines in ‘‘very unusual circumstances.’’ Subsequent to the Commission’s decision to initiate rulemaking for worker fatigue, the NRC staff also obtained data from six sites in 2004. Those data indicated that between 95 and 603 deviations, with an average of 311 deviations, were issued for individuals. The data were provided by the six sites for each plant’s most recent refueling outage and one month of power operation, and therefore do not reflect the total number of deviations issued for individuals during all of 2004, except for one of the six sites that provided its deviation data (101 deviations) for all of 2004. Data on the deviations from 2004 are reported in detail in Appendix 3 of the draft Regulatory Analysis. The analysis is available as discussed above under the ADDRESSES heading. Single copies may be obtained from the contact listed above under the FOR FURTHER INFORMATION CONTACT heading. The NRC believes that licensee use of deviations and overtime at some sites is excessive, and does not represent the intent of the NRC’s Policy on Worker Fatigue. In addition to excessive work hours and work hour guideline deviations, the NRC has recently identified other concerns related to licensee policies and practices applicable to worker fatigue. On May 10, 2002, the NRC issued Regulatory Issue Summary (RIS) 2002– 007, ‘‘Clarification of NRC Requirements Applicable to Worker Fatigue and SelfDeclaration of Fitness-For-Duty.’’ The NRC issued the RIS following several allegations made to the NRC regarding the appropriateness of licensee actions or policies related to individuals declaring they are not fit due to fatigue. These concerns indicate a need to ensure that individuals and licensees clearly understand their responsibilities with respect to self-declarations of worker fatigue. The proposed rule would establish requirements to address this need. (5) The current regulatory framework includes requirements that are inadequate and incomplete for effective fatigue management. E:\FR\FM\26AUP2.SGM 26AUP2 50460 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules a. The NRC’s Policy on Worker Fatigue did not establish clear expectations for the control of work hours. As previously noted in this section, the NRC did not define key terms of the policy, and, as a consequence, implementation has been varied across the industry. b. Certain policy guidelines and technical specification requirements are inadequate for reasonable assurance that individuals remain capable of safely and competently performing their duties. For example, the requirement for an 8 hour break between work periods would be revised to a 10 hour break. The basis for the need to revise this break period is described in detail in Section VI with respect to proposed § 26.199(d)(2)(I). Further, the specific work hour guidelines of the policy, and most technical specification requirements for the administrative control of work hours, are principally focused on acute fatigue, and do not adequately address the longer term control of work hours and the cumulative fatigue that can result from prolonged periods of extended work hours. Acute fatigue results from restricted sleep, sustained wakefulness, continuous task demands, or other issues over the past 24 hours or more. Cumulative fatigue results from inadequate rest over consecutive sleepwake periods when the worker obtains less sleep than he or she requires. An individual incurs a sleep debt for each day or night during which the worker obtains insufficient sleep. If the individual continues to obtain insufficient sleep, this debt accumulates over successive days, resulting in increasing fatigue and impairment (Belenky, et al., 2003). The inadequacy of the current regulatory framework for addressing cumulative fatigue became particularly apparent in the months following the terrorist attacks of September 11, 2001. As described in Section VI with respect to proposed § 26.199(f)(2), the NRC received numerous allegations from nuclear security officers that certain licensees required them to work excessive amounts of overtime over long periods due to the post-September 11, 2001, threat environment. These individuals questioned their readiness and ability to perform their required job duties due to the adverse effects of cumulative fatigue. The NRC reviewed the actual hours worked by security personnel and determined that, in the majority of cases, individual work hours did not exceed the guidelines specified in the NRC’s Policy on Worker Fatigue, but the review confirmed that individuals had been working up to 60 hours per week for extended periods. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 The concerns expressed by individuals regarding their FFD, in light of work schedules that did not exceed the specific guidelines of the policy, as well as relevant technical research supporting the basis for cumulative fatigue, led the NRC to conclude that the work hour guidelines of the policy are inadequate for addressing cumulative fatigue. The NRC obtained additional worker feedback supporting this conclusion through a review of worker fatigue concerns and work hours during a long-term outage at the Davis Besse nuclear plant (NRC Inspection Report 05000346/2004003, dated March 31, 2004, ADAMS Accession No. ML040910335). The comprehensive fatigue management approach in Subpart I, Managing Fatigue, would establish controls to address cumulative fatigue. Limits to mitigate cumulative fatigue for security personnel were implemented by Order EA–03–038. The proposed rule would codify, with limited changes, these requirements. Changes to those limits that would be imposed by this rule are discussed in detail in Section VI, which also includes a detailed discussion of the proposed limits and other controls to mitigate cumulative fatigue for non-security personnel. c. The existing regulatory framework does not effectively ensure that fatigue from causes other than work hours is addressed. Work hour controls are necessary, but not sufficient, to effectively manage worker fatigue. As a consequence, training and fatigue assessments are essential. Worker fatigue, and its effects on worker alertness and performance, can result from many causes in addition to work hours (e.g., stress, sleep disorders, daily living obligations) (Rosa, 1995; Presser, 2000). In addition, there are substantial individual differences in the ability of individuals to work for extended periods without performance degradation from fatigue (Gander, 1998; Van Dongen, et al., 2004a; Van Dongen, et al., 2004b; Jansen, et al., 2003). Proposed Subpart I, Managing Fatigue, would require a comprehensive fatigue management program. One example would be the strengthening of FFD training requirements concerning worker fatigue. This would improve behavioral observation and assessment of worker fatigue, self-declaration as a means for early detection of fatigue, worker self-management of fatigue, the ability of workers to obtain adequate rest on a shiftwork schedule, and licensee use of effective fatigue countermeasures. (6) Ensuring effective management of worker fatigue through rulemaking PO 00000 Frm 00020 Fmt 4701 Sfmt 4702 would substantially enhance the effectiveness of FFD programs, but additional orders are not presently warranted to ensure adequate protection of public health and safety or the common defense and security. Adequate protection of public health and safety and the common defense and security are ensured under the current regulatory framework, including Order EA–03–038 (for security personnel), the NRC’s Policy on Worker Fatigue, and licensee technical specification requirements. Licensee FFD programs currently include behavioral observation programs to identify individuals whose behavior indicates they may not be fit to safely and competently perform their duties, and ensure that those individuals are removed from duty until any question regarding their fitness has been resolved. The current work hour controls, in conjunction with licensee behavioral observation programs, automatic reactor protection systems and other administrative controls on worker activities (e.g., post-maintenance testing, peer checks, independent verifications) ensure adequate protection of public health and safety and the common defense and security. However, there are substantial limitations to the current regulatory framework, as detailed in this section. Therefore, although the current regulatory framework provides adequate protection, including work hour controls in 10 CFR Part 26 would provide a substantial increase in public health and safety and the common defense and security. The NRC is proposing to incorporate worker fatigue provisions into Part 26 in light of the substantial increase in safety and security that is expected to result. (7) Addressing fatigue of workers in safety-critical positions through regulation is consistent with practices in foreign countries and other industries in the U.S. The NRC reviewed the current and proposed Federal limits on work hours for nuclear plant workers in eight other countries, as well as six other industries in the United States and Canada. Although many factors influence specific regulatory limits, and requirements for other industries should be considered in context, the NRC found that the NRC’s current guidelines are the least restrictive among those reviewed. The work hours of nuclear power plant personnel in other countries are largely based on labor laws or union agreements. With the exception of Spain, which has limits consistent with the NRC’s Policy on Worker Fatigue, each of the other eight countries has E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules more stringent requirements. The more stringent requirements have largely preempted the need in those countries for regulation of work hours based on nuclear safety concerns. The Department of Transportation (DOT) has established regulatory limits on the work hours of pilots, air traffic controllers, and maintenance personnel in the commercial aviation industry (14 CFR Parts 121 and 135), in the maritime industry (46 U.S.C. 8104; 46 CFR Parts 15.705, 15.710 and 15.111), in the rail industry (49 U.S.C. 211; 49 CFR Part 228), and for drivers of heavy trucks in the commercial trucking industry (49 CFR Part 395). The DOT recognized that fatigue can substantively degrade the ability of individuals to perform these duties and, therefore, promulgated regulatory requirements for each of these modes of transportation in keeping with the department’s mission to protect public safety. In the late 1980s and early 1990s, the National Transportation Safety Board (NTSB) identified equipment operator fatigue as a significant issue affecting all transportation modes (Beal and Rosekind, 1995). As a result, DOT classified operator fatigue management as a DOT ‘‘Flagship Initiative’’ and several proactive fatigue management activities ensued across the transportation industries (e.g. U.S. DOT, 1995; Rogers, 1996, 1997; Hartley, 1998; Carroll, 1999). In 1999, the NTSB evaluated DOT’s decade of efforts on operator fatigue (NTSB, 1999). Dissatisfied that enough was being done, NTSB subsequently offered DOT three recommendations: (1) Expedite a coordinated research program on the effects of fatigue, sleepiness, sleep disorders, and circadian factors on transportation safety; (2) develop and disseminate educational materials for transportation industry personnel and management regarding shift work, work rest schedules, and proper regimens of health, diet, and rest; and (3) review and upgrade regulations governing hours of service for all transportation modes to assure they are consistent and incorporate the results of the latest research on fatigue and sleep issues (NTSB, 1999). On April 28, 2003, the DOT issued revised hours-of-service regulations to require motor carriers to provide drivers with better opportunities to obtain sleep. Among other provisions, the regulations (1) increase the required offduty time from 8 to 10 consecutive hours; (2) prohibit work after the end of the fourteenth hour after the driver began work; and (3) require long break recovery periods to prevent cumulative VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 fatigue (68 FR 22456–22517; April 28, 2003). Nuclear power plant licensees in the U.S. have sometimes asserted that the characteristics of the work tasks in nuclear power plants differ from other occupations that have work hour controls (e.g. transportation equipment operators); therefore information from other occupations may not be applicable. In addition, licensees have suggested that the level of automation in nuclear power plants provides an important barrier to human errors resulting from fatigue, and that the amount of control room crew interaction and oversight of operators’ actions assures that fatigue-induced errors will be detected and corrected before they have an opportunity to impact plant operations. The NRC concurs that requirements for other industries should be considered in context. Nevertheless, the fact that other federal agencies with a safety mission have established regulations to address fatigue is relevant for several reasons. First, the human need for sleep and the deleterious effects of sleep deprivation have a physiological basis (e.g., changes in brain glucose metabolism) that is independent of the nature of the work being performed (Wu, et al., 1991). Second, circadian variations in alertness and performance, and the underlying changes in physiological processes, have been observed in individuals performing a wide range of tasks across many industries (Kecklund, et al., 1997). For all individuals, time since awakening, the time of day, and the amount of prior sleep that an individual obtains relative to his or her sleep needs are primary determinants of fatigue and the need for sleep. The NRC acknowledges that task characteristics and time on task may exacerbate the effects of fatigue on the ability of individuals to remain alert. For example, a concern for task-specific effects is reflected in the DOT hours-ofservice regulations for commercial truck drivers, which establish a daily limit on driving time of 11 hours per day. This limit is in addition to the requirements prohibiting driving after 14 hours on duty and mandating minimum 10-hour break periods, which reflect the human physiological need for rest that is necessary to maintain performance (68 FR 22456–22517; April 28, 2003). By comparison to driving a truck, the characteristics of some jobs in nuclear power plants (e.g., reactor operator) permit greater freedom of movement and social interaction, which may serve to temporarily mitigate the effects of fatigue on alertness. However, there is PO 00000 Frm 00021 Fmt 4701 Sfmt 4702 50461 no evidence to indicate that worker motivation or the stimulating effects of the job or environment alter the underlying physiological processes. Although crew interactions and other job characteristics may serve to bolster worker alertness temporarily, environmental stimulation only masks individuals’ physiological need for sleep. Removing the stimulation (e.g., transitioning from the activity of shift turnover to monitoring steady state plant operations during a night shift) will increase the potential for lapses in attention and uncontrolled sleep episodes among individuals who may be partially sleep deprived or otherwise fatigued. Another consideration regarding the relevance of other regulations limiting work hours is that adverse fatigue effects are observed across a broad range of cognitive functions in addition to alertness. Whereas crew interactions may help sustain alertness, sleep deprivation and sustained periods of wakefulness continue to degrade other cognitive functions (e.g., memory and decision making) and elements of performance that are important to safe nuclear plant operations, such as communications and following written and oral instructions. For example, as discussed in paragraph D(1)(d) of this section, studies of crew performance in critical phases of commercial aircraft flight (e.g., take-off and landings) and in simulated battle command station operations have shown fatigue-related degradations in performance despite the stimulation of the interactions, the intense level of activity, and the implications of degraded performance for the loss of human life. Regulations limiting work hours in other industries that use operating crews (e.g., aviation) and allow greater freedom of movement than trucking (e.g. maritime) are consistent with this understanding of the broad effects of fatigue on cognitive performance. There is no reason to believe that nuclear power plant workers’ physiological processes and the adverse effects of fatigue on their abilities to perform their job tasks would differ. In addition, the notion that human performance practices in the nuclear industry prevent fatigue-related performance decrements from resulting in human errors is not supported by studies that have shown circadian variations in performance at nuclear power plants (Bobko, et al., 1998; Dorel, 1996; Maloney, 1992). The NRC acknowledges that the nuclear power industry is perhaps unique, relative to many other industries, in its use of automated safety systems to protect against the E:\FR\FM\26AUP2.SGM 26AUP2 50462 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules consequences of equipment failure and human error. Nevertheless, reliable human performance remains an essential element in the protection of public health and safety and the common defense and security. Current NRC requirements, such as the minimum on-site staffing requirements of 10 CFR 50.54(m) and minimum security staffing requirements in site security plans, are predicated on the expectation that all personnel in these positions are fit for duty and are able to safely and competently perform their duties. As a consequence, the NRC does not consider the use of automated safety systems to be an appropriate basis for permitting conditions that could allow fatigue to degrade the important line of defense of reliable human performance. Further, despite automated systems, the contribution of human error to risk in operating events continues to be notable (NUREG/CR–6753, ‘‘Review of Findings for Human Error Contribution to Risk in Operating Events’’). Because the NRC concurs that task characteristics are an appropriate consideration, the proposed rule would differ from other Federal agencies’ requirements with respect to specific work hour requirements and would require licensees to consider task characteristics when authorizing any waiver from the work hour controls. Nevertheless, the NRC believes that it remains relevant that other Federal agencies with public safety missions have chosen to address worker fatigue through regulation. In summary, the NRC believes that the proposed requirements in Subpart I will provide a substantial increase in the protection of public health and safety and common defense and security. In determining the provisions of this proposed rule, the NRC has taken into consideration the effects of fatigue on human performance, the specific work practices of the nuclear power industry that both mitigate and contribute to fatigue, the inadequacy of the current regulatory framework, the excessive hours currently worked by many nuclear power plan personnel, and the relevant research and practices of other industries and countries for regulating work hour limits. In addition, many public meetings were held with the nuclear industry and the public to discuss draft provisions for the proposed rule. These interactions are discussed in detail in Section V. The specific basis for each provision of the fatigue management portions of the proposed rule are discussed in Section VI. The proposed requirements for managing fatigue will provide a VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 substantial increase in the protection of public health and safety and common defense and security by: (1) Establishing specific, integrated, comprehensive, and enforceable requirements for the effective prevention, detection, and mitigation of worker fatigue; (2) Ensuring that personnel who perform functions that are significant to the protection of public health and safety or the common defense and security are subject to appropriate work hour controls, including: individuals performing risk significant operations or maintenance duties; health physics, chemistry, and fire brigade duties important to emergency response; and individuals performing security duties important to maintaining the security of the plant; (3) Establishing work hour controls that provide increased assurance that workers will have adequate opportunity for rest and that deviations from the work hour limits will only be authorized as necessary for plant safety or security and following appropriate assessment of the worker’s ability to safely and competently perform his or her duties; (4) Ensuring that work hour deviations are only permitted when necessary for plant safety or security, and following assessment of the worker’s ability to safely and competently perform his or her duties; (5) Establishing controls to prevent cumulative fatigue that can result from consecutive weeks of extended work hours; (6) Ensuring workers are provided with sufficient break periods to provide for adequate opportunity for sleep to mitigate acute and cumulative fatigue; (7) Ensuring that, in addition to work hours, other factors that can affect worker fatigue and the ability of workers to remain alert are adequately addressed through licensee FFD programs; (8) Encouraging effective fatigue management by permitting licensees to use alternate measures for prevention and mitigation of fatigue; and (9) Strengthening FFD training requirements concerning worker fatigue. This would improve behavioral observation and assessment of worker fatigue; self-declaration as a means for early detection of fatigue; worker selfmanagement of fatigue; the ability of workers to obtain adequate rest on a shiftwork schedule; and licensee use of effective fatigue counter-measures. V. Summary of Public Interactions and Comments In preparing this proposed rule, the NRC has considered comments received PO 00000 Frm 00022 Fmt 4701 Sfmt 4702 by OMB and the NRC on the prior Part 26 final rule affirmed by the Commission in a SRM dated December 4, 2000, and subsequently submitted to the Office of Management and Budget (OMB) for a clearance under the Paperwork Reduction Act. Those comments and responses to them are provided in Section V. A. The NRC has also considered feedback received from industry, as well as other interested parties and members of the public in preparing this proposed rule. The NRC held 11 stakeholder meetings on the drug and alcohol testing portions of the rule during 2001–2004, and held 13 stakeholder meetings on the fatigue portion of the rule during 2002– 2003. Subsequent to the Commission’s decision to combine the two rulemaking efforts, the NRC held 1 stakeholder meeting on the combined rule in July, 2004, and 2 subsequent meetings on the fatigue provisions of the combined rule in August and September, 2004. Throughout the time the meetings were being held, drafts of proposed rule language, regulatory and backfit analysis data, and other pertinent information were made available to the public on the internet ,as announced in the Federal Register (67 FR 7093) on February 15, 2002. Feedback was received from stakeholders both through the public meetings and the NRC’s rulemaking Web site at http://ruleforum.llnl.gov. Summaries of these meetings, and any comments provided through the Web site are available at http://ruleforum. llnl.gov/cgi-bin/rulemake?source= BQ_PETITION&st=plan for meetings and comments on the fatigue portions of the rulemaking prior to 2004, and at http://ruleforum.llnl.gov/cgi-bin/ rulemake?source=Part26_risk&st=risk for meetings and comments on the drug and alcohol testing portions of the rulemaking, and on the fatigue portions of the rulemaking subsequent to the Commission’s decision to combine the rulemakings in 2004. Address questions about our rulemaking Web site to Carol Gallagher (301) 415–5905; e-mail cag@nrc.gov. These interactions with stakeholders were a significant benefit to the NRC in developing the language for the proposed rule in a manner to ensure it was clearly understandable, could be consistently interpreted, and did not result in unintended consequences. Many of the stakeholders’ comments directly resulted in proposed changes. Where a comment was included in a proposed provision, the comment is discussed in Section VI. Many comments were received during the years the meetings were held, and the draft proposed rule language was E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules changed and re-posted to the web numerous times. Each comment received during these meetings, but not included in the proposed rule text, is not discussed and responded to in detail, given that the NRC is issuing a new proposed rule for formal public comment. However, the most significant comments that were not incorporated are discussed in Section V. B of this document. A. Public Comments Submitted to OMB on 2000 Final Rule and Responses The comments below were received by OMB and the NRC on the prior Part 26 final rule affirmed by the Commission in a SRM dated December 4, 2000, and subsequently submitted to OMB for a clearance under the Paperwork Reduction Act. The NRC’s responses follow each comment. Industry Comment 1: Rule should allow combining partial samples to get the required volume for HHS analysis. Otherwise, it [the Regulatory Analysis] should reflect an added expense with a reduced gain. Response: New provisions in § 26.109, ‘‘Urine specimen quantity,’’ prohibit licensees from combining partial samples because this practice may falsely lower the concentration of a drug or adulterant. Further, HHS and DOT do not permit this practice. Additionally, comments on the previous proposed rule objected to combining specimens for the same reason. However, the proposed rule would lower the required specimen quantity from a minimum of 60 milliliters (mL) to 30 mL. NRC discussions with representatives of HHS-certified laboratories have indicated that advances in testing technologies allow accurate and reliable testing of 15 mL specimens. The NRC has proposed 30 mL, which would allow the HHS laboratory sufficient specimen quantity for retesting, if needed. Because the required specimen quantity has been reduced by at least one-half, there should be few instances in which a donor is unable to produce the necessary quantity and, therefore, few instances in which additional costs would be incurred. Industry Comment 2: Medical professionals other than a licensed physician should be allowed to determine if a history of substance abuse ‘‘raises a concern.’’ Response: The proposed rule in § 26.187 would add a position called the ‘‘Substance Abuse Expert’’ (SAE), adapted from the related DOT regulations. The SAE need not be a licensed physician, but would be required to have extensive expertise, such as a licensed or certified social VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 worker, psychologist, or others listed in § 26.187(b), and additional qualifications specifically related to substance abuse disorders. The SAE would be authorized to make a determination of fitness in at least circumstances: (1) when an individual has violated the substance abuse provisions of a licensee’s or C/V’s FFD policy, including, but not limited to a first positive drug test result; (2) when there is a concern that an individual may be impaired by the use of a substance; or (3) for an applicant for authorization when the self-disclosure, the suitable inquiry, or other sources of information identify potentially disqualifying FFD information (PDFFDI) about the applicant. Industry Comment 3: Reevaluate NRC’s regulatory analysis indicating a $27 million savings in light of industry’s estimate of a $8 million cost increase. Response: A detailed reevaluation of the drug and alcohol provisions, based in part on data obtained from NEI, still indicates a savings to industry of $116 million–$183 million (7 percent—3 percent discount rate) present value. The evaluation of the proposed Part 26 provisions as a whole, including the proposed worker fatigue provisions, indicates a cost to industry of $469 million–$730 million (7 percent—3 percent discount rate) present value. A draft regulatory analysis was provided to industry and other stakeholders during the public meetings held in 2004. Comments received have been considered in developing the regulatory analysis for this proposed rule. Industry Comment 4: New rule requires audits of [HHS] certified labs. Response: The proposed rule includes additional language in proposed § 26.41 to clarify the NRC’s intent that audits of certified labs may be shared among licensees and that licensees are not required to audit areas that are covered by the HHS certification process. Additionally, organizations that do not routinely provide FFD services to a licensee or C/V, such as local hospitals or a substance abuse treatment facility, would be exempt from the annual audit requirement. Industry Comment 5: Rule includes FFD personnel in program. Response: The NRC continues to agree with the original intent of the rule, which was that personnel who administer FFD programs must be covered by 10 CFR Part 26. However, during meetings, stakeholders discussed the numerous logistical difficulties associated with covering FFD program personnel. As a result, the proposed rule includes a number of related language adjustments. PO 00000 Frm 00023 Fmt 4701 Sfmt 4702 50463 Specifically, new language in proposed § 26.25(a)(4) would clarify the NRC’s intent that FFD program personnel must be subject to the program. Proposed § 26.25(a)(4)(I) through (v) would be added to identify the FFD program personnel who must be subject to the FFD program, based upon their job responsibilities. Proposed § 26.25(b)(1) would exempt individuals who may provide an FFD service to a licensee or other entity in special circumstances, and who meet all of the following three criteria: (1) They are not employed by the licensee or C/V, (2) they do not routinely provide services to the licensee’s or other entity’s FFD program, and (3) they do not normally work at a licensee or other entity’s facility. Personnel who meet the three criteria specified in proposed § 26.25(b)(1) would be exempt because the limited nature of their involvement with the FFD program makes it unlikely that they would be subject to coercion or influence attempts to subvert the testing process. In addition, new language in § 26.31(b)(2) would permit FFD program personnel who are distant from a licensee site to be tested at a local facility that meets DOT requirements, including audits. Permitting these FFD program personnel to be tested at local collection sites that follow similar procedures would be adequate to meet the goal of ensuring their continuing honesty and integrity, while addressing some logistical concerns posed by stakeholders. Industry Comment 6: The term, ‘‘history of substance abuse,’’ is pejorative and may incorrectly label some workers in the nuclear industry as substance abusers. Response: Based upon further discussions with stakeholders, the NRC developed a greater appreciation for the connotations of the term, ‘‘history of substance abuse,’’ and agreed that the term has too many pejorative implications. Therefore, the proposed rule would entirely eliminate the use of this term. The rule language no longer discusses this issue in terms of an individual’s personal characteristics. Rather, the language focuses on the type of information that would trigger a determination of fitness. This information is referred to as ‘‘potentially disqualifying FFD information’’ (PDFFDI), which is consistent with terminology used in access authorization programs. Industry Comment 7: History of substance abuse creates a new class of workers and no relief. Response: As noted above, the concept, ‘‘history of substance abuse,’’ E:\FR\FM\26AUP2.SGM 26AUP2 50464 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules has been eliminated in the proposed rule. The proposed rule would provide relief to individuals with PDFFDI in three ways. First, individuals would be required to self-disclose PDFFDI that is related to events that occurred only within the past 5 years. This provision provides relief from the current rule, which requires individuals to selfdisclose certain adverse events every time they apply for authorization, no matter how long ago the adverse events occurred. Second, licensees would be permitted to accept a determination of fitness conducted by a previous licensee and a favorable termination of authorization for an individual who had any PDFFDI that was addressed and resolved under a previous Part 26 program. This provision also provides relief from the current rule, which requires the licensee to conduct a determination of fitness for any individual who has ever been denied access or had access terminated unfavorably, no matter how long ago the event occurred or whether there is evidence that the individual has been rehabilitated. Licensees would be permitted to conduct another determination of fitness, but would not be required to do so, if the individual’s last period of authorization was terminated favorably. Third, licensees would be permitted to accept responsibility for continuing any treatment and followup testing plans that a previous licensee implemented for an individual, rather than conducting a new determination of fitness and developing new treatment and testing plans. These provisions protect the rights of individuals who have successfully resolved or are resolving a substance abuse-related problem as well as reduce the regulatory burden on the individuals and licensees. Industry Comment 8: History of substance abuse creates a tracking burden. Response: As noted above, the concept, ‘‘history of substance abuse,’’ would be eliminated in the proposed rule. Further, the current rule requires licensees to maintain records and share information related to denials and unfavorable terminations of authorization in § 26.27(a)(3). Therefore, the proposed rule’s requirements for licensees to maintain records and share information related to PDFFDI would not create a new tracking burden and are consistent with the access authorization Order. Industry Comment 9: Change the opiate cutoff level of 300 ng/mL to the HHS standard of 2000 ng/mL. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Response: The proposed rule now includes the 2000 ng/mL HHS cutoff level for opiates. Discussions with HHS indicate that the HHS staff’s rationale for changing the cutoff level to 2000 ng/ ML provides sufficient protection for public health and safety from individuals who may be abusing opiates. Industry Comment 10: It is impossible to complete all suitable inquiries within 72 hours. Response: Consistent with the access authorization Order, which the Commission issued to nuclear power reactor licensees on January 7, 2003, the proposed rule would eliminate provisions for routine temporary access. Therefore, the proposed rule would eliminate the requirement in the Affirmed Rule for a 72-hour turnaround on a suitable inquiry prior to granting temporary access. Industry Comment 11: Rule requires verification of all employment periods, including less than 30 days. Response: The proposed rule incorporates feedback received through stakeholder meetings. The revised provisions specify employers required to be addressed during the suitable inquiry for several different cases, including applicants for initial authorization, updated authorization, or reinstated authorization. The employers required to be addressed vary for each of these situations, and are specified in proposed §§ 26.63 and 26.69. In developing this proposed section, the NRC took into account documented substance abuse recidivism rates (highest within the first year following treatment, continuing at a somewhat lower rate for 3 years post-treatment, and decreasing again at 5 years) and stakeholder feedback. Stakeholders have indicated that employers are generally reluctant to provide any information other than dates of employment, but that more recent employers are more likely to disclose adverse information than employers from previous years. Therefore, the NRC has determined that requiring every employer from the past 5 years to be contacted for all persons is both unnecessary and an unwarranted regulatory burden. Thus, for initial authorization, the employment check is to be conducted with every employer, regardless of the length of employment, for the past year, and with each employer by whom the individual claims to have been employed the longest in each calendar month for the previous 2 years. For authorization updates, the employment check is to be conducted with every employer, regardless of the length of employment, PO 00000 Frm 00024 Fmt 4701 Sfmt 4702 for the past year, and with each employer by whom the individual claims to have been employed the longest in each calendar month for the remaining time since authorization was terminated. For authorization reinstatements, the employment check is to be conducted with each employer by whom the individual claims to have been employed the longest in each calendar month since authorization was terminated. For individuals who have had a substance abuse problem, however, § 26.69 requires a suitable inquiry for the applicable period specified by § 26.63, as well as obtaining any records that other licensees or other entities may have developed relating to any potentially disqualifying FFD information about the individual. Industry Comment 12: Allow credit for prior licensee’s suitable inquiry. Response: Proposed § 26.63(b) would permit licensees to rely upon suitable inquiry information that was gathered by other licensees and entities. However, for all applicants for authorization, the suitable inquiry would be more thorough than previous industry practices, in order to increase the likelihood that PDFFDI would be identified, if it existed, and to provide reasonable assurance that individuals are trustworthy and reliable as demonstrated by the avoidance of substance abuse. For individuals who have established a recent, favorable work history within the industry, as demonstrated by having held authorization that was terminated favorably within the past 3 three years, the period of time addressed in the suitable inquiry would be reduced from the past 5 five years in every case, to the past 3 three years or less, depending upon how recently the applicant held authorization. If PDFFDI within the past 5 five years is identified regarding an applicant and the information had not been addressed and favorably resolved by a previous licensee or other entity, the suitable inquiry requirements would be more extensive, as described in proposed § 26.69. Industry Comment 13: Allow credit for prior licensee’s medical determination of fitness. Response: The NRC has clarified the qualification requirements for the medical personnel who may conduct a determination of fitness and believe that these clarifications will provide greater consistency in the determinations made across licensees. Therefore, a requirement for each new licensee to perform another determination of fitness for authorization reinstatements (authorization interrupted for 365 days or less) and authorization updates E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules (authorization interrupted for >365 days to <3 years) when no new PDFFDI has been identified would be unnecessary. Industry Comment 14: Requirements for FFD should be consistent with access authorization requirements. Response: The provisions of the proposed rule are consistent with current access authorization requirements, including those in the recent access authorization Order, which the Commission issued to nuclear power reactor licensees on January 7, 2003. Industry Comment 15: Medical determination of fitness for all individuals with a history of substance abuse creates an unnecessary burden. Response: The proposed rule would add § 26.189(b)–(d) to clarify the NRC’s intent with regard to the circumstances in which a determination of fitness is required. Permitting licensees to accept the results of a determination of fitness conducted by a previous licensee, when no new PDFFDI has been identified, reduces the unnecessary burden that stakeholders referenced. However, a determination of fitness would continue to be required before an individual is granted authorization to perform activities within the scope of this part when PDFFDI is identified and has not been previously evaluated by another licensee. Industry Comment 16: Rule does not allow shared audits of HHS-certified laboratories. Response: The NRC believes that a requirement for independent audits by all licensees who rely on a laboratory is a redundant and unnecessary requirement. The proposed rule would specify requirements for sharing audits in proposed § 26.41(g). This paragraph would state that licensees may jointly conduct audits, or accept audits of C/Vs and HHS-certified laboratories that were conducted by other licensees or entities subject to this part, when the services provided to the sharing licensees or entities by the C/Vs and HHS-certified laboratories are the same. Nonetheless, each sharing licensee is responsible for ensuring the correction of any deficiencies identified in audit results. B. Key Stakeholder Comments Not Incorporated Into Proposed Rule and Responses The headings below provide a listing of the significant comments received, but not incorporated, for each subpart in the proposed rule. The comments were received from stakeholders during development of this proposed rule. Following each comment is a response detailing why the comment was not incorporated into the proposed rule. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Subpart A Administrative Provisions There are no significant comments that were not incorporated into the proposed rule text. Subpart B Program Elements Comment 1 (NEI): The Medical Review Officer should not be included in the random testing program. Response: Although current Section 2.3 [Preventing subversion of testing] in Appendix A to Part 26 requires licensees to carefully select and monitor individuals who are responsible for administering the drug and alcohol testing program based upon the highest standards of honesty and integrity, some licensees’ testing programs did not include all of the FFD program personnel (including MROs) who the NRC originally intended to be subject to testing. The proposed change would be made to clarify the NRC’s original intent because the actions of these individuals have an ongoing effect on public health and safety as a result of their responsibility to ensure that the FFD program is effective. In addition, these persons’ actions affect the confidence that the public, management, and individuals who are subject to testing have in the integrity of the program and the accuracy and reliability of test results. Individuals who are involved in the day-to-day operations of an FFD program are in a position to permit substance abusers to remain undetected. For example, MROs could inadvertently commit errors when reviewing test results as a result of being impaired from drug or alcohol abuse or because of motives associated with maintaining an MRO’s substance abuse or empathy with an abuser. Furthermore, several reported incidents have confirmed the need to assure that FFD program personnel meet the highest standards of honesty, integrity, reliability, and trustworthiness. For example, one licensee added specimen collectors to the testing pool after investigating an allegation and determining that two collectors were substance abusers. In another instance, a contracted MRO who was not in the testing pool was reported to be an alcoholic and an abuser of prescription drugs. Some MROs who provided their services to other Federally regulated industries were identified as substance abusers. Therefore, the proposed rule provision would fulfill the NRC’s original objective and require licensees and other entities to extend their programs to include FFD personnel who (1) can link test results with the individual who was tested before an FFD policy violation determination is made, PO 00000 Frm 00025 Fmt 4701 Sfmt 4702 50465 including, but not limited to the MRO; (2) make determinations of fitness; (3) make authorization decisions; (4) are involved in selecting or notifying individuals for testing; or (5) are involved in the collection or on-site testing of specimens. Comment 2 (NEI): The FFD training requirements are too detailed, particularly the requirement for the FFD exam to be a separate exam, and for each knowledge and ability (KA) to be covered on each test. Response: The proposed rule would require that individuals who are subject to the FFD program demonstrate attainment of the specified KAs by passing a comprehensive examination. This new requirement would be added because there have been several instances since Part 26 was first promulgated in which individuals were able to overturn determinations that they had violated a licensee’s FFD policy on the basis that they had not understood the information they received during FFD training and so could not be expected to comply with the requirements of the policy. Therefore, the proposed rule would require individuals to demonstrate their attainment of the knowledge and abilities to ensure that the FFD training has been effective. There would also be a requirement for the examination to include a comprehensive random sampling of all KAs with questions to test each KA, including at least one question for each KA, and establish a minimum passing score of 80 percent. These requirements would be modeled on other required training programs that have been successful in ensuring that examinations are valid and individuals have achieved an adequate understanding of the subject matter. Comment 3 (Quest Diagnostics): Unannounced audits of HHS laboratories by the licensee, other entity, or NRC inspectors at any time is unreasonable given the other inspections, client tours, scheduled department meetings, and off-site requirements for testimony that are required of laboratories and their staff. The audits should also not be more than 48 hours in duration, and original documents or copies should not be allowed to be removed from the laboratory. Response: The proposed rule would permit audits to be unannounced to enhance the effectiveness of the audit process should unannounced audits appear to be necessary. For example, a licensee or other entity may receive allegations that a laboratory is falsifying records or that laboratory employees are using drugs, and the licensee or other E:\FR\FM\26AUP2.SGM 26AUP2 50466 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules entity may determine that an unannounced audit would provide the most effective means to investigate such allegations. The proposed rule would ensure that the licensee’s or other entity’s contract with the lab would permit the unannounced audit as well as access to any information necessary to conduct the audit. The NRC has also not proposed limits on the duration of such audits, as time limits may decrease the effectiveness and integrity of the audit process. Licensees or other entities may determine they require more lengthy audits to effectively cover all intended areas, or to assess deficiencies. The NRC has incorporated a provision to permit an HHS-certified laboratory to reasonably limit the use and dissemination of any documents copied or taken away by the licensee’s or other entity’s auditors in order to ensure the protection of proprietary information and donors’ privacy. However, the NRC does not believe auditors should be restricted from copying or taking away documents that do not meet the above criteria, because doing so would decrease the efficiency and effectiveness of audits. Subpart C Granting and Maintaining Authorization Comment 1 (NEI): The process for granting authorization for individuals whose prior authorization was terminated unfavorably should be an initial. Response: The proposed rule would require licensees to follow the proposed provisions in § 26.69 for individuals whose prior authorization was terminated unfavorably due to an FFD concern. Licensees would not be permitted to use the proposed process for granting initial authorization for those individuals for several reasons. First, if an individual was terminated for a first positive drug or alcohol test result, and if it has been any period less than 3 years since that individual was terminated, then it would be unnecessary to require licensees and other entities to perform a suitable inquiry of the entire past 3 years (which would be required for an initial authorization). In those cases, proposed § 26.69 would require licensees or other entities to perform a suitable inquiry for the period since the individual’s authorization was terminated. Second, if an individual has had his or her authorization denied for 5 years, the suitable inquiry should be performed for the entire past 5 years (as required in proposed § 26.69). The proposed process for granting initial authorization would only require a suitable inquiry VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 for the past 3 years, and the NRC believes that would not be appropriate in these situations. If an individual’s prior authorization was terminated unfavorably for reasons that are unrelated to an FFD concern, the licensee would implement the relevant requirements in the access authorization Orders, which the Commission issued to nuclear power reactor licensees on January 7, 2003. Comment 2 (NEI): There should not be any additional drug and alcohol testing for applicants for reinstatement of authorization whose last period of authorization ended between 6 and 30 days ago. Response: The proposed rule would require licensees and other entities to subject applicants whose authorization has been interrupted for 6–30 days to the possibility of being selected for preaccess testing at a probability of approximately 4 percent. This probability approximates the likelihood that individuals who are subject to random testing at the 50 percent annual testing rate would be selected for testing at some point within a 30-day period. For applicants selected for such testing, the licensee or other entity would complete an alcohol test and collect a specimen for drug testing before reinstating the individual’s authorization. The provision would enhance the deterrent effect of preaccess testing for individuals who have had a very short break in authorization, without imposing the regulatory burden of requiring that every individual be tested. This is one of many changes to Subpart C that are being proposed to emphasize the NRC’s intent that FFD programs provide reasonable assurance that persons who are subject to this part are trustworthy and reliable as demonstrated by the avoidance of substance abuse and the adverse behaviors that accompany it. To reduce the risk of an insider threat, maintain public health and safety, and provide for the common defense and security in the post-September 11, 2001, threat environment; the NRC has placed an increased emphasis on the trustworthiness and reliability of individuals who have access to certain types of sensitive information, certain types of radiological materials, and protected areas in nuclear power plants—the same individuals who would be subject to the proposed rule. Because these individuals have unimpeded access to sensitive information and safety equipment and systems, their trustworthiness and reliability are essential. The NRC concludes that an increased level of PO 00000 Frm 00026 Fmt 4701 Sfmt 4702 requirements are necessary for the new threat environment, such that there remains reasonable assurance that individuals who are subject to the rule are trustworthy and reliable. Pre-access testing is one important aspect of FFD programs designed to deter and detect substance abuse, which presents an unacceptable risk to public health and safety and the common defense and security in several ways. First, substance abuse increases the likelihood that such individuals may pose an insider threat by increasing an individual’s vulnerability to coercion. Under 10 CFR 73.1, a passive insider is defined as an individual who obtains or attempts to obtain safeguards or other relevant information, such as a nuclear power plant’s physical configuration and design, and who does not have a functional or operational need to know such information. Section 73.1 defines an active insider as a knowledgeable individual who, while within the protected area of a nuclear power plant in an unescorted status, takes direct action to facilitate entrance and exit, disable alarms and communications, and/or participates in a violent attack. An individual who uses illegal drugs may be coerced into cooperating, actively or passively, with a terrorist in an attempt to commit radiological sabotage if, for example, the terrorist were to threaten the individual with revealing his or her illegal drug use or was somehow able to withhold drugs from an individual who is addicted. Second, an individual’s judgement and self-control are impaired while an individual is abusing drugs or alcohol. When an individual is intoxicated from abusing any of the substances for which testing is conducted under Part 26, including alcohol, the individual is more likely to inadvertently reveal sensitive information that terrorists could use in a radiological sabotage attempt than when he or she is not intoxicated. Third, the use of illegal drugs establishes that an individual is willing to disobey the law, thus indicating that the individual will disregard other rules and regulations. The use of illegal drugs raises questions about the individual’s trustworthiness and reliability in terms of scrupulously following the regulations, procedures, and other requirements, such as safeguards requirements, that ensure the protection of public health and safety. Many provisions of the current rule provide means to identify and reduce the risks posed by any individuals whose substance abuse casts doubt on their trustworthiness and reliability. In combination with other measures the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules NRC has taken since September 11, 2001, the proposed requirement that individuals who have had a break in authorization of between 6–30 days must be subject to one-time selection for pre-access testing would provide further assurance that those individuals are trustworthy and reliable. The NRC believes that implementation of this provision and other provisions in the proposed rule, in addition to the other, related measures the Agency has taken in the post-September 11, 2001, threat environment, would provide reasonable assurance that individuals who are subject to the rule are trustworthy and reliable. Subpart D Management Actions and Sanctions To Be Imposed There are no significant comments that were not incorporated into the proposed rule text. Subpart E Collecting Specimens for Testing There are no significant comments that were not incorporated into the proposed rule text. Subpart F Licensee Testing Facilities Comment 1 (NEI): Significant QA requirements have been added, which makes licensee testing facilities perform at the same level as an HHS-certified laboratory. This will result in licensees closing many of their licensee testing facilities. Response: New requirements would be added for conducting initial urine specimen validity tests at licensee testing facilities. Specimen validity testing refers to testing conducted to identify attempts to tamper with a specimen. This includes adulteration, which means putting a substance into a specimen that is designed to mask or destroy the drug or drug metabolite that the specimen may contain or to adversely affect the assay reagent; substitution, which includes replacing a valid urine specimen with a drug-free specimen; and dilution, which includes intentionally diluting a urine specimen with another liquid to decrease the concentration of a drug below the cutoff concentration. When HHS published its Notice of Proposed Revisions (66 FR 43876; August 21, 2001) to the HHS Guidelines to establish requirements for specimen validity testing performed by HHS-certified laboratories, the HHS reported that the number of adulterated and substituted urine specimens has been increasing among the specimens tested under the Federal agency workplace drug testing program and the U.S. Department of Transportation (DOT) regulations (49 CFR part 40). VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Program experience gained since Part 26 was first promulgated has also indicated an increasing number of adulterated and substituted urine specimens. Although current Part 26 contains a number of requirements related to specimen validity, the methods available to tamper with specimens have become more sophisticated since the rule was first published and therefore more sophisticated methods of detecting tampering are necessary. The proposed rule would incorporate new requirements for conducting specimen validity tests that are consistent with similar provisions contained in the most recent revision to the HHS Guidelines (69 FR 19643; April 13, 2004). These new requirements for specimen validity testing would be added to strengthen FFD programs by improving the ability to detect specimens that are adulterated, substituted, or diluted. The requirements for specimen validity testing are proposed to identify individuals who are willing to attempt to subvert the testing process, and so may be willing to subvert other rules and regulations that are important for public health and safety and the common defense and security. Detecting specimen tampering is necessary to identify individuals who may attempt to hide drug abuse, because attempts to tamper with a specimen provide clear evidence that the individual is not trustworthy and reliable. The proposed rule would permit licensees to conduct drug and validity screening tests, and to grant authorization to individuals whose specimens yield negative test results. If the NRC were not to include quality assurance and training requirements in conjunction with such tests, but still permit licensees to grant authorization on the basis of the tests, then the NRC would not have reasonable assurance that only individuals who are trustworthy and reliable are granted authorization. Therefore, the NRC has included such provisions in this proposed rule. Comment 2 (NEI): Licensees should be permitted 3 business days to send Bottle B of a split specimen to the HHS lab for testing, following a request from the donor. Response: The proposed rule would extend the time period provided to the licensee to send Bottle B to the HHScertified laboratory. The current rule requires that the specimen must be sent the same day as the donor request. The proposed rule would allow 1 business day to send the specimen. The proposed rule would not allow 3 days, as requested by NEI, because the proposed rule would also require licensees to PO 00000 Frm 00027 Fmt 4701 Sfmt 4702 50467 administratively withdraw the individual’s authorization at the time Bottle A is confirmed non-negative. The NRC believes that permitting up to 3 days would pose an unnecessary burden on the individual, especially because some licensees temporarily remove pay until the Bottle B test is complete. The NRC also believes that 1 business day would provide sufficient time for the licensee to locate Bottle B, prepare it for shipping, and deliver it to the courier. Subpart G Laboratories Certified by the Department of Health and Human Services Comment 1 (Quest Diagnostics): If an individual who is the subject of a drug test requests in writing to have access to the laboratory’s records related to his or her drug test, the records released should be limited to the laboratory test report and data package, and not include the results of any relevant certification, review, or revocation-ofcertification proceedings. Blanket releases by the employee to third parties should be prohibited. Response: The proposed rule would permit an individual to have access to laboratory records, as well as a third party such as an attorney to whom the employee has released the information. The records that an employee may request include laboratory records beyond the individual’s drug test results because other records may be relevant to litigation. For instance, if a laboratory audit subsequent to the individual’s test uncovers improper testing that may be relevant to the individual’s test, that information may be useful in litigation. The NRC sees no justification for withholding such information from an individual or an authorized third party, and believes access to such information to be consistent with protection of the individual’s rights and with due process. The provision is also consistent with HHS guidelines and Section 503 of Public Law 100–71 for Federal workplace drug testing. Comment 2 (Quest Diagnostics): Cutoff levels should be consistent with new HHS proposed Guidelines. Response: The NRC typically considers HHS provisions for inclusion into a Part 26 proposed rule following the issuance of final HHS Guidelines. This is to minimize the possibility that a Part 26 proposed rule must be reproposed due to changes in the HHS Guidelines between their proposed and final forms, and to ensure proper stakeholder interaction in the technical basis development stage, followed by public review and comment of the Part 26 proposed provisions. The NRC will consider the proposed HHS Guidelines E:\FR\FM\26AUP2.SGM 26AUP2 50468 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules for inclusion into the technical basis development for a future Part 26 rulemaking once they have been finalized by HHS. Subpart H Determining Fitness-forDuty Policy Violations and Determining Fitness Comment 1 (NEI): The MRO has too much independent responsibility, given that the licensee is responsible for the program. The MRO is part of the licensee program and should be accountable within the program, not independent of the program. Response: The proposed rule would require that MRO and MRO staff duties must be independent from any other activity or interest of the licensee or other entity. Although the NRC is unaware of any instances in which the MRO function has been compromised in Part 26 programs, the experience of other Federal agencies has indicated that clear limits on independence and who may direct MRO staff activities are advisable. Further, in contrast to other Federal agencies’ regulations, current Part 26 permits employees of licensees and other entities to perform MRO staff activities for MROs who work off site and are not physically present to supervise the staff, which may provide greater opportunities for inadvertent compromise of the independence of the MRO function than situations in which the MRO and his or her staff are physically co-located. Independence of the MRO function from the licensee or other entity is necessary to ensure that MROs are impartial gatekeepers for the accuracy and integrity of the drug testing process and also to ensure the confidentiality of medical information. Comment 2 (NEI): The SAE requirements for qualification are excessive. Response: Detailed requirements regarding the qualifications and responsibilities of the SAE are necessary to ensure consistency among FFD programs. This is because under the proposed rule, FFD programs would be permitted to accept determinations of fitness and treatment plans from other Part 26 programs, if an individual who has had a substance abuse problem will be granted authorization by another licensee or entity. In addition, detailed requirements regarding the qualifications and responsibilities of the SAE are necessary because of the key role the SAE would play in assuring the public health and safety and common defense and security when making a determination of fitness. The SAE role is not defined in the current rule. Therefore, many of the provisions in the proposed subpart would be adapted VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 from related DOT requirements regarding the ‘‘substance abuse professional’’ [49 CFR Part 40, Subpart O; 65 FR 41944; August 9, 2001]. Additionally, the NRC has received feedback on implementation of the current rule that some MROs do not feel qualified to make decisions on substance abuse treatment and rehabilitation. Under the proposed rule, the critical tasks of assessing the presence of a substance abuse disorder, providing input to authorization decisions, and developing treatment plans would be reserved for professionals who have met the specific training, clinical experience, and knowledge requirements for an SAE. Subpart I Managing Fatigue Subpart I would establish clear and enforceable requirements concerning the management of fatigue at nuclear power plants. Many stakeholders took an interest in, and commented on Subpart I through the public meetings, including IBEW, UCS, the Nuclear Energy Institute (NEI), the Professional Reactor Operator Society (PROS), industry representatives, and Barry Quigley, the petitioner, among others. Because of the level of interest and commenting on Subpart I, in comparison to the other subparts, several key comments that were not incorporated, and their responses, are provided below for each of the stakeholders listed above. Comment 1 (IBEW): Individuals allowed to perform fatigue assessments should be trained to a higher level than others. Response: The NRC is proposing to train individuals and supervisors to the same level because fatigue management is a shared responsibility. The proposed level of training would provide the knowledge needed to perform a fatigue assessment, including providing an understanding of the indications and effects of fatigue, and the appropriate use of fatigue countermeasures. This ensures that those individuals who may undergo a fatigue assessment have been trained to understand the process to which they will be subject and what the assessor will be looking for, in addition to being able to recognize the signs of fatigue in their coworkers. Because the training on what to expect from a fatigue assessment is not substantially different from how to conduct one, for simplicity of implementation, all workers would be trained to the same level. In addition, the proposed revisions to drug and alcohol testing provisions would revise that training such that all workers are required to be trained to the same level. PO 00000 Frm 00028 Fmt 4701 Sfmt 4702 The fatigue training would therefore be consistent with those provisions as well. Comment 2 (Patrick Shaffer, Southern California Edison): The 48 hour/week group average limit is not high enough for groups other than security force personnel that would be subject to the proposed work hour controls. A 60 hour/week group average limit would be preferable. Response: Answered in the response to Comment 4, below. Comment 3 (Barry Quigley, petitioner): The group average limit should not be increased above a 48 hour/week limit. Response: Answered in the response to Comment 4, below. Comment 4 (UCS): The proposed rule would permit the entire affected workforce to work 53-hour weeks [including shift turnover time], which erodes fatigue protection from the 40hour weeks recommended in NRC’s Policy on Worker Fatigue. Response: The objectives of the 48hour group limit during normal plant operations are to ensure that the amount of overtime typically worked by individuals does not adversely affect their abilities to safely and competently perform their duties, to define an enforceable upper limit to the nominal 40-hour work-week policy in GL 82–12, and to permit licensees to manage overtime in a manner that reflects the differing desires and capabilities of individuals with respect to work hours. A more detailed discussion of the basis for requiring a 48 hour/week group average limit is provided in Section VI with respect to proposed § 26.199(f), and is also summarized below. A 40-hour work-week during normal operations is a key objective of the NRC’s Policy on Worker Fatigue. The policy is intended to ensure that there are enough operating personnel to ‘‘maintain adequate shift coverage without routine heavy use of overtime.’’ However, the policy, and the 40-hour work-week objective, are not enforceable. Routine overtime can cause cumulative fatigue, which degrades the abilities of workers to safely and competently perform their duties. The proposed collective work hour controls, including the 48-hour per week group limit during normal plant operations, would address cumulative fatigue by establishing more readily enforceable requirements for the long-term control of work hours, including the limited use of overtime for occasional short-term exigent circumstances (e.g., equipment failure, personnel illness or attrition). The 48-hour group limit would reduce the potential for cumulative fatigue by E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules preventing excessive use of the maximum allowable individual limits during normal plant operations. The current regulatory framework does not contain enforceable requirements to prevent such practices. In addition, by limiting work hours during normal conditions, individuals would be better rested and less susceptible to cumulative fatigue from the long work hours that are common during plant and security system outages. Further, it would provide reasonable assurance that individuals will be better rested prior to an emergency or increased threat condition. The proposed requirement would limit groups of individuals to a 48-hour average, permitting 20 percent overtime in excess of the nominal 40-hour work week. Consideration of several types and sources of information led to the decision to establish a group average limit of 48 hours for normal plant conditions. These included past recommendations from experts and expert panels on work scheduling and maintaining worker alertness in the nuclear industry, surveys of nuclear power plant workers on their desire and ability to work overtime, data and industry practices on the amount of overtime worked by security personnel, and requirements and practices in other industries. A detailed description of the sources of information is included in Section VI with respect to proposed § 26.199(f). Comment 5 (NEI): A 56-day outage exclusion from the 48-hour group average work hour limits is insufficient. Response: Answered in the response to Comment 7, below. Comment 6 (UCS): The work hour limits should not be turned off based on an unrelated artificial construct, such as outage duration(s) and national security levels. Instead, the rule should state the work hour limits for short and long terms. Response: Answered in the response to Comment 7, below. Comment 7 (Barry Quigley, petitioner): Outages should not be excluded from the group work hour average limits. Response: The collective work hour controls address the long-term control of work hours, including the limited use of overtime for occasional short-term exigent circumstances (e.g., equipment failure, personnel illness or attrition). However, the NRC recognizes the need to address separately the control of work hours during outages because of the unique staffing and workload demands of this plant state. Accordingly, the proposed rule would permit a limited VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 exclusion period for plant outages from the collective work hour controls. The NRC considered several factors, including current policy, the bases for the policy, and lessons learned from the policy implementation in developing a provision to permit a limited exclusion period for plant outages from the collective work hour controls. The NRC’s Policy on Worker Fatigue provides guidelines for controlling work hours, ‘‘on a temporary basis,’’ during periods requiring substantial overtime. The policy reflects the NRC’s recognition that outages are unique, relatively short-term, plant circumstances involving levels of activity that are substantially higher than most non-outage operating periods. The policy also reflects the NRC’s understanding that although individuals are capable of working with limited rest without degradation of performance for short periods of time, research has shown that the ability to sustain performance without adequate rest is clearly limited. However, the NRC has never defined the term ‘‘temporary basis’’ as used in the policy. As a consequence, licensees have used the guidelines to control working hours for conditions ranging from a few days to more than a year. Industry experience with conditions such as sustained plant shutdowns and the increased work hours of security personnel following the terrorist attacks of September 11, 2001, have indicated the need to establish clear and more readily enforceable requirements that would limit the sustained use of extended work hours. The NRC considered several factors in setting the exclusion period for plant outages at 8 weeks. First, by the end of 8 weeks of work at the limits permitted, individuals will have worked 540 hours, including 200 hours of overtime. This is 50 percent of the hours that surveys of nuclear plant workers have indicated are acceptable on an annual basis. Second, by the end of 8 weeks of work at the limits permitted, individuals will have missed as many as 17 normally scheduled days off, a reduction of 60 percent in the time available to recover and prevent cumulative fatigue. In addition, with each passing week of an outage, individuals have worked an increasing number of normally scheduled days off. The ability to defer daily living obligations becomes increasingly difficult, causing increased pressure to reduce sleep time in order to meet demands of both work and daily life, and increased potential for cumulative fatigue. In addition to considering the potential for cumulative fatigue, the PO 00000 Frm 00029 Fmt 4701 Sfmt 4702 50469 NRC considered current industry data concerning the duration of plant outages. The average refueling outage duration, as indicated by outage data from 2000–2002 in the Information System on Occupational Exposure database (ADAMS Accession No. ML050190016), is approximately 39 days. Eighty-nine percent were less than 8 weeks in duration. In reviewing the frequency of outages, by duration, the NRC found that it would be necessary to increase the exclusion period substantially to include a marginal number of additional outages. The NRC believes that such an increase in the exclusion period would substantively increase the potential for cumulative fatigue and fatigue-related personnel errors. By contrast, decreasing the exclusion period to less than 8 weeks would rapidly increase the number of outages that would, in part, be subject to the collective work hour controls, potentially increasing the duration and cost of those outages. The NRC acknowledges that decreasing the exclusion period by 1 or 2 weeks could decrease the potential for cumulative fatigue, but the magnitude of the decrease would be difficult to quantify and the benefit would not likely justify the costs. The NRC believes that an exclusion of the first 8 weeks of an outage is consistent with the objective of ensuring that licensees provide adequate shift coverage without routine heavy use of overtime. The exclusion period would be limited to plant outages, which occur regularly, but with limited frequency. In addition, the duration of the exclusion period would be limited to 8 weeks, thereby providing reasonable assurance that workers would be able to safely and competently perform their duties, and not be impaired from cumulative fatigue. The NRC further considers that the exclusion of security system outages and increased threat conditions is appropriate. In these conditions, maintaining plant security is of the utmost importance. It is specifically during these conditions that the NRC believes that the benefits to the common defense and security of augmenting onshift security staffing during those conditions outweigh the potential risk from increased fatigue for those time periods. Comment 8 (PROS and UCS): Turnover time is excluded from the work hour limit calculations, but there is no maximum allowed turnover time. This could lead to excessive time allocated to turnovers, and therefore hours worked. E:\FR\FM\26AUP2.SGM 26AUP2 50470 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Response: Although the NRC believes it is necessary and justified to limit the number of hours worked by certain individuals to ensure public health and safety and the common defense and security, the NRC also believes shift turnovers contribute significantly to safety and security. If the proposed rule included shift turnover in the work hour calculations, licensees may have an incentive to limit turnover time, which could have a negative impact on safety and security. The NRC believes the importance of an accurate and thorough turnover should not be undermined through the imposition of work hour restrictions related to turnover. The NRC shares the commenters’ concern that excessive time allocated to turnovers could result in excessive hours worked. Therefore, proposed § 26.199(b)(1)(I) would specify the types of activities that would and would not be considered shift turnover activities under the proposed rule. For example, the proposed paragraph would define shift turnover activities as only those activities that are necessary to safely transfer information and responsibilities between two or more individuals between shifts. By contrast, the early arrival of an individual for meetings, training, or pre-shift briefings for special evolutions would not be considered shift turnover time. The NRC believes that the proposed specifications for shift turnover activities would be sufficient to ensure that excluding shift turnover time from work hours calculations, combination with the other requirements for fatigue management in the proposed rule, would be sufficient to prevent individuals from working excessive hours. Comment 9 (UCS): The formal determination that a waiver of the individual work hour limits and break requirements ‘‘is necessary to mitigate or prevent a condition adverse to safety,’’ or to ‘‘maintain the security of the facility,’’ is hardly a robust barrier when one considers all the safetychallenged things that have been changed at nuclear power plants under the far more restrictive provisions of 10 CFR 50.59. Response: The provisions of 10 CFR 50.59 do permit many minor changes to be made at nuclear reactors because the safety criteria are stated in the negative. In other words, a licensee is permitted to make changes that do not have an adverse impact. In contrast, the proposed waiver criteria would work in the positive. Minor safety issues would not constitute a valid justification for a waiver of the individual limits or break requirements because the criteria are stated in the positive. Only work that VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 ‘‘is necessary to mitigate or prevent a condition adverse to safety,’’ or to ‘‘maintain the security of the facility,’’ would meet the criteria. This is consistent with the NRC’s intent that waivers be approved only in very limited circumstances. The NRC believes granting of waivers in these extreme cases is justified and in the public interest because the gain in safety or security from the work being completed in an unimpeded manner would offset the potential reduction in safety or security from worker fatigue. Comment 10 (NEI): Waivers should be allowed for pressing economic concerns. Response: The criteria for granting waivers from individual short-term work hour limits and break requirements were strengthened from current plant technical specification requirements to permit the granting of waivers only for conditions adverse to safety or security. Industry data have shown significant over-use of waivers, mostly for commercial reasons, as is detailed in the Regulatory and Backfit Analysis prepared for this proposed rule. The NRC believes the individual short-term work hour limits and break requirements should only be waived in unique circumstances, on a very infrequent basis, and only when necessary for safety or security. Permitting waivers for economic reasons would increase the potential risk to public health and safety and the common defense and security from worker fatigue without an off-setting gain to safety or security. As described in this section with respect to the individual limits in proposed § 26.199(d)(2) and (3), the potential for worker fatigue in conditions that would require a waiver is substantial (Baker, et al., 1994; Dawson and Reid, 1997; Stephens, 1995; Strohl, 1999). As a consequence, the NRC does not believe that licensees can reasonably justify the performance of risk significant functions at work hours in excess of the proposed limits on the basis that the action would not constitute an adverse impact on safety or security. During the public meetings described in Section V, industry stakeholders proposed that a senior site manager have the authority to grant waivers if the manager ‘‘determines that the deviation will not have an adverse impact on safety or security.’’ The NRC does not believe that the criterion proposed by industry stakeholders is appropriate for several reasons. The work hour limits of proposed § 26.199(d) would apply only to personnel performing risk significant functions. If an activity is not risk significant, it is not subject to the work PO 00000 Frm 00030 Fmt 4701 Sfmt 4702 hour controls and therefore a waiver is unnecessary. The proposed waiver criteria, therefore, do not impose unnecessary restrictions in such circumstances. Further, the NRC does not believe the proposed work hour limits and minimum break requirements are unnecessarily conservative. The criterion proposed by industry representatives is also highly subjective. In light of concerns regarding industry’s past use of deviations that the NRC documented in SECY–01–0113, the use of a subjective criterion would not be an effective regulatory approach to mitigating the past over-use of waivers by certain licensees. Comment 11 (NEI): There should not be a reporting requirement for the number of waivers granted. Response: As detailed in the Regulatory and Backfit Analysis, the industry has, and continues to, grant excessive numbers of waivers each year. Although the proposed provisions are expected to greatly limit the number of waivers licensees can grant each year, the NRC believes it is necessary and justified to monitor the number of waivers granted, along with other indicators of FFD program performance that are proposed to be monitored, to ensure the rule is implemented as intended and that the fatigue portions of FFD programs are effective. The NRC has weighed the burden introduced in the proposed reporting requirement with the burden that would otherwise be required of NRC staff and inspectors to perform such monitoring and has determined the burden is justified. In that determination, the NRC has also considered that a yearly FFD program performance report is currently required for the drug and alcohol testing program, and the additional reporting for the fatigue programs would merely add to the report, not create a new one. Comment 12 (NEI): The fire brigade should not be subject to Subpart I requirements. Response: The proposed work hour limits would be applicable only to those members of the fire brigade who are responsible for understanding the effects of fire and fire suppressants on safe shutdown capability for the reactor. This knowledge enables them to provide the control room operators and fire brigade leader with information that is critical to implementing a fire mitigation strategy that maintains safe shutdown capability. For application of the collective work hour controls specified in § 26.199(f), these fire brigade members could be averaged with another work group (e.g., operations) for those individuals who perform the duties of both groups. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Attachment 1 to SECY–99–140, Recommendation for Reactor Fire Protection Inspections, dated May 20, 1999, states that ‘‘based on IPEEE results, fire events are important contributors to the reported core damage frequency (CDF) for a majority of plants. The reported CDF contribution from fire events can, in some cases, approach (or even exceed) that from internal events.’’ Fire brigade members must retain the cognitive ability to be able to think and determine the best way to suppress a fire to prevent additional damage to safety-related equipment, evaluate equipment affected by a fire to report to control room operators concerning equipment availability, make decisions concerning smoke ventilation to prevent the fire effects from affecting other plant operations, and coordinate all activities with control room operators. Fatigue can substantially degrade a worker’s decision-making and communication abilities, cause a worker to take more risks, and cause a worker to maintain faulty diagnoses throughout an event, as detailed in Section IV. D. These abilities are key to the duties of the fire brigade members who are responsible for understanding the effects of fire and fire suppressants on safe shutdown capability for the reactor. Degradations of these abilities could have significant consequences on the outcome of an event involving a fire. For instance, a fatigued worker could incorrectly decide to vent smoke or toxic gas to an area required for alternate shutdown, which could prevent or impair access to equipment needed for safe shutdown of the plant. In addition, a fatigued worker could incorrectly apply the wrong fire suppressant, which could affect additional equipment in the plant. Further, impaired decision-making could lead a worker to improperly control flooding, which could impact other needed equipment, or could incorrectly determine whether an area contains critical equipment and improperly apply a suppressant in that area. Impaired communications could also lead to incomplete disclosure of information to licensed operators in the control room, which could adversely impact the decision-making of those operators. If information known to the impaired worker is not properly communicated, operators may not initiate appropriate actions to mitigate the fire effects, or effects of suppressant activities, on critical equipment. As a consequence, ensuring that the ability of fire brigade members to safely and competently assess the effects of a fire and fire suppressants on safe shutdown VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 capability is essential to the overall success of the fire mitigation strategy and the protection of public health and safety. Further, the NRC periodically grants exemptions from requirements in 10 CFR Part 50, Appendix R [Fire Protection Program for Nuclear Power Facilities Operating Prior to January 1, 1979] based on protection of the levels of defense in depth listed in Section II(A) of Appendix R to Part 50, which are ‘‘To prevent fires from starting; To detect rapidly, control, and extinguish promptly those fires that do occur; To provide protection for structures, systems, and components important to safety so that a fire that is not promptly extinguished by the fire suppression activities will not prevent the safe shutdown of the plant.’’ Granting these exemptions is often predicated on effective manual suppression of a fire by the fire brigade. Comment 13 (NEI): There should not be requirements for a 48-hour break every 14 days and a 24-hour break every 7 days. Response: The NRC believes the proposed 24- and 48-hour break requirements are necessary to reduce the effects of acute and cumulative fatigue. A more detailed discussion of the basis for requiring the 24- and 48hour breaks is provided in Section VI with respect to proposed § 26.199(d)(2), and is also summarized below. Acute fatigue results from excessive cognitive work and especially from significant amounts of missed sleep. It is readily relieved by obtaining adequate rest and sleep. Cumulative fatigue results from individuals receiving inadequate sleep for successive days. As fatigue increases, performance is increasingly impaired, shows greater variability, and manifests itself in the form of errors of omission and commission. Research has shown that lack of adequate days off and extended workdays can result in cumulative sleep debt and performance impairment. This research, as well as other considerations, is discussed in detail in Section VI with respect to proposed § 26.199(d)(2). Additionally, the NRC considers the 24- and 48-hour breaks to be a key component of fatigue mitigation for the transient workforce. Contract and other temporary personnel move from one plant outage to another within a region or nationally. During most portions of an outage, these personnel would be subject only to the proposed individual limits and break requirements. The break requirements, in conjunction with the consideration that such temporary workers likely have periodic seasonal PO 00000 Frm 00031 Fmt 4701 Sfmt 4702 50471 breaks between outages, provides reasonable assurance that they will not be impaired from either acute or cumulative fatigue. Comment 14 (PROS): Utilities should not be allowed to work licensed operators up to 16 hours straight, they should be limited to 12 hours. Response: Although proposed Subpart I would not prohibit the use of 16-hour shifts, the proposed rule includes requirements that collectively address this concern. The proposed rule would include controls that would reduce the frequency of 16-hour shifts. These controls include proposed § 26.199(d)(1)(ii), which would limit the maximum hours worked in any 48-hour period to no more than 26 hours. This limit prohibits individuals from working 16-hour shifts on two consecutive days. Proposed § 26.199(d)(2)(I) would require a minimum 10-hour break between work periods and provide workers with the opportunity for 7–8 hours of sleep. This requirement would create a substantial disincentive for using 16-hour shifts. Specifically, individuals who work 16hour shifts would not be eligible to return to work at the beginning of the next normally available shift. The NRC acknowledges that 16-hour shifts can substantially increase the probability for human error. Accordingly, the NRC believes that fatigue management must include limiting the use of 16-hour shifts to the extent practicable and applying effective behavioral observation and fatigue mitigation strategies when such conditions are unavoidable. The training requirements in the proposed rule would provide individuals and supervisors with the knowledge to make effective decisions regarding fatigue, which should result in the scheduling of fewer 16-hour shifts. The proposed rule would also require licensees to establish a process to be followed if an individual declares that he or she is not fit for duty, for any reason, including fatigue. The NRC would expect that individuals who believe that they are incapable of safely and competently completing a 16-hour shift would make an appropriate selfdeclaration. Collectively, the requirements of the proposed rule would be expected to: (1) Substantially limit the frequency of 16hour shifts, (2) provide assurance that, when such work hours are necessary, licensees have the knowledge and abilities to assess the potential for degraded performance and need for fatigue countermeasures, and (3) ensure workers have a process for resolving concerns regarding fatigue from extended work hours. As a E:\FR\FM\26AUP2.SGM 26AUP2 50472 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules consequence, the NRC believes that the proposed requirements are appropriate for maintaining worker fitness for duty and, thereby, protecting public health and safety and the common defense and security. Comment 15 (Barry Quigley, petitioner): The work hour controls in Subpart I should apply to all individuals performing risk-significant work, such as engineers and all fire brigade personnel. Response: The proposed requirements would cover all personnel who perform duties within one of the following job duty groups: (1) Operating or on-site directing of the operation of systems and components that a risk-informed evaluation process has shown to be significant to public health and safety; (2) performing maintenance or on-site directing of the maintenance of structures, systems, and components that a risk-informed evaluation process has shown to be significant to public health and safety; (3) performing Health Physics or Chemistry duties required as a member of the on-site emergency response organization minimum shift complement; (4) performing the duties of a Fire Brigade member who is responsible for understanding the effects of fire and fire suppressants on safe shutdown capability; and (5) performing security duties as an armed security force officer, alarm station operator, response team leader, or watchperson (hereinafter referred to as security personnel). Engineers who direct, on-site, the maintenance or operations of risksignificant structures, systems, and components would be subject to group work hour controls. The NRC believes those engineers who perform such duties should be subject to group work hour controls. A few examples of such direction would be engineers who act as test directors in the control room, engineers who provide direction to maintenance crews (such as during an outage), engineers who provide technical direction and guidance for reactivity manipulations and power changes, as well as many other similar engineering functions. However, the NRC does not believe that engineers, or other individuals, who do not perform those duties should be subject to group work hour controls. Many engineers do not direct maintenance or operations, and many others do not work with risksignificant plant systems, structures, or components. A few examples of engineering activities that the NRC does not consider direction include design modifications, assisting in procedure changes (including writing and modifying procedures for covered work VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 groups such as operations), performing technical analyses, monitoring the performance of systems and recommend maintenance, as well as many other similar engineering functions. The NRC is not proposing to require licensees and other entities to subject all engineers to work hour controls because many engineering tasks, such as modification design, are reviewed by managers, peer reviewers, and others before being implemented. The same is the case for routine performance monitoring. Any maintenance recommended by an engineer as a result of performance monitoring would typically be reviewed by managers or work planners in maintenance. Therefore, the NRC has reasonable assurance that errors committed by an engineer in these circumstances would be found and corrected through the normal plant review processes. In the case of fire brigade personnel, the NRC is proposing that only those fire brigade personnel who are responsible for understanding the effects of fire and fire suppressants on safe shutdown capability would be subject to work hour controls. The NRC does not propose to include other members of the fire brigade because they are principally engaged in manual actions. These types of actions do not require substantial analysis and decision-making capability, and individuals engaged in manual actions would be expected to perform those actions without significant degradation from fatigue. Diagnosis and decisionmaking functions are affected by fatigue to a much greater extent, and are collectively more critical to emergency response. For these reasons, the NRC proposes work hour controls on only the fire brigade members who are responsible for understanding the effects of fire and fire suppressants on safe shutdown capability. Subpart J Recordkeeping and Reporting Requirements There are no significant comments that were not incorporated into the proposed rule text. Subpart K Inspections, Violations, and Penalties There are no significant comments that were not incorporated into the proposed rule text. VI. Section-by-Section Analysis of Substantive Changes The proposed rule would be organized into eleven subparts that are comprised of related requirements, as follows: Subpart A—Administrative Provisions PO 00000 Frm 00032 Fmt 4701 Sfmt 4702 Subpart B—Program Elements Subpart C—Granting and Maintaining Authorization Subpart D—Management Actions and Sanctions to be Imposed Subpart E—Collecting Specimens for Testing Subpart F—Licensee Testing Facilities Subpart G—Laboratories Certified by the Department of Health and Human Services Subpart H—Determining Fitness-for-Duty Policy Violations and Determining Fitness Subpart I—Managing Fatigue Subpart J—Recordkeeping and Reporting Requirements Subpart K—Inspections, Violations, and Penalties A detailed cross-reference table between the current and proposed Part 26 provisions is included at the end of this notice. Appendix A of the current rule would be deleted and the detailed requirements for conducting drug and alcohol testing that are contained in Appendix A to 10 CFR Part 26 would be moved to Subpart E [Collecting Specimens for Testing], Subpart F [Licensee Testing Facilities], and Subpart G [Laboratories Certified by the Department of Health and Human Services] of the proposed rule. Subpart A—Administrative Provisions Section 26.1 Purpose Section 26.1 [Purpose] of the proposed rule would amend the language of the corresponding section of the current rule. The proposed paragraph would delete the term, ‘‘certain aspects,’’ as unnecessary. The proposed paragraph would add the term, ‘‘implementation,’’ to the phrase in the current rule which states, ‘‘for the establishment and maintenance of * * * fitness-for-duty programs,’’ in order to convey more accurately that the proposed rule includes requirements for implementing FFD programs, in addition to requirements for establishing and maintaining such programs. The portion of current § 26.1 that refers to the entities who are subject to the rule would be moved to proposed § 26.3 [Scope] in order to consolidate this information in a more appropriate location. Section 26.3 Scope Proposed § 26.3 [Scope] would renumber, reorganize, and amend current § 26.2 [Scope]. In general, proposed § 26.3 would retain the list of entities who are subject to the current rule and add other entities. However, the provisions in current § 26.2 that specify the individuals whose job duties require them to be subject to the rule and exempt certain other individuals E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules would be moved to a new section, proposed § 26.25 [Individuals subject to the fitness-for-duty program]. The provisions that would be moved to proposed § 26.25 include the second sentence of current § 26.2(a), the first sentence of current § 26.2(b), and the portion of the second sentence of current § 26.2(d) that pertains to personnel. The NRC determined that separating into two different sections the requirements that address the entities who are subject to the rule and the requirements that address the individuals who must be subject to the rule would make the two sets of provisions easier to locate within the rule without compromising the intended meaning of these provisions. Proposed § 26.3(a) would add combined operating license holders to be consistent with the revised 10 CFR Part 52 licensing process for new reactors. Proposed § 26.3(b) would retain the requirement in the first sentence of current § 26.2(a) that licensees who are authorized to possess or use formula quantities of SSNM or to transport formula quantities of SSNM are subject to the regulations in this part. However, these licensees would not be subject to the requirements contained in proposed Subpart I [Managing Fatigue] for the reasons that will be discussed later in this document in relation to proposed § 26.195 [Applicability]. Proposed § 26.3(c) would retain the requirements of current § 26.2(d) and add references to entities other than a corporation because there may be entities who are organized as firms, partnerships, limited liability companies, or associations who may also obtain a certificate or approved compliance plan under Part 76 and elect to engage in activities involving formula quantities of SSNM. The proposed paragraph would also add a crossreference to proposed § 26.25(a)(3), which specifies the individuals who are employed by or under contract to these entities who would be subject to Part 26. The entities in the proposed paragraph would not be subject to the requirements in proposed Subpart I [Managing Fatigue] for the reasons that will be discussed later in this document in relation to proposed § 26.195 [Applicability]. Proposed § 26.3(d) would retain the meaning of the portion of current § 26.23(a)(1) that requires a contractor/ vendor (C/V) FFD program to meet the standards of this part if licensees rely upon the C/V’s FFD program to meet the requirements of this part, but amend some of the terminology used in the current rule. The proposed paragraph VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 would add C/Vs to the list of entities who are subject to Part 26 in proposed § 26.3 in order to more clearly convey that C/Vs may be directly subject to NRC inspection and enforcement actions than the current rule language implies. The current rule text presents the applicability of the rule’s requirements to a C/V’s FFD program in terms of the contractual relationship between a licensee and the C/V. For example, current § 26.23(a)(1) states, ‘‘The contractor or vendor is responsible to the licensee [emphasis added] for adhering to the licensee’s fitness-forduty policy, or maintaining and adhering to an effective fitness-for-duty program; which meets the standards of this part.’’ This paragraph, and others in the current rule, could be interpreted as implying that a C/V is accountable to the licensee but not to the NRC, should significant weaknesses be identified in the C/V’s FFD program upon which a licensee relies. However, this interpretation would be incorrect. Therefore, proposed § 26.3(d) would include C/V FFD programs and program elements upon which licensees and other entities rely within this section to convey more accurately that C/Vs are directly accountable for meeting the applicable requirements of Part 26, rather than accountable only through their contractual relationships with the licensees and other entities who are subject to the rule. This clarification is also necessary to maintain the internal consistency of the proposed rule because some provisions of the proposed rule apply only to C/Vs, including, but not limited to proposed § 26.217(g). The phrases, ‘‘program elements’’ and ‘‘to the extent that licensees and other entities rely upon those C/V FFD programs or program elements to meet the requirements of this part,’’ would be used in proposed § 26.3(d) because C/Vs would need only meet the requirements of Part 26 for those FFD program elements upon which licensees and other entities rely to meet the requirements of the rule. For example, a C/V may choose to implement all of the program elements that are required for a full FFD program under the proposed rule except drug and alcohol testing. In this case, the proposed rule would not require the C/V to address drug and alcohol testing in the C/V’s FFD policy, procedures, and training program; establish contracts with drugtesting laboratories; collect specimens for drug and alcohol testing; or meet any other requirements in the proposed rule that relate to conducting drug and alcohol testing. However, if a C/V PO 00000 Frm 00033 Fmt 4701 Sfmt 4702 50473 chooses to conduct drug and alcohol testing under some or all of the conditions specified in proposed § 26.31(c) [Conditions for testing], such as for-cause testing, and a licensee or other entity who is subject to Part 26 relies upon the results of the C/V’s tests in determining whether to grant authorization to an individual (see proposed Subpart C [Granting and Maintaining Authorization]), then the use of these two phrases in the proposed paragraph would be correctly interpreted as meaning that the C/V’s drug and alcohol testing program element must meet the proposed rule’s requirements related to drug and alcohol testing when conducting the tests on which the licensee or other entity relies. By contrast, if a C/V implements an FFD program element that is addressed in this part, but that program element is not relied upon by a licensee or other entity who is subject to this part, then the proposed paragraph would not require the C/V to meet the applicable Part 26 requirements for that FFD program element. Proposed § 26.3(d) would require C/ Vs to meet the requirements of proposed Subpart I [Managing Fatigue], if any nuclear power plant licensees rely upon a C/V’s fatigue management program element to meet the requirements of Subpart I. The applicability of proposed Subpart I to C/Vs will be discussed with respect to proposed § 26.195 [Applicability]. Other provisions of current § 26.23 [Contractors and vendors] would either be eliminated from the proposed rule or moved to other sections of the proposed rule. The current requirement for licensees to retain written agreements with C/Vs in the second sentence of § 26.23 would be moved to proposed Subpart J [Recordkeeping and Reporting Requirements]. The requirement in current § 26.23(a)(1), which requires that individuals who have violated an FFD program must not be assigned to work within the scope of this part without the knowledge and consent of the licensee, would be addressed in proposed Subpart C [Granting and Maintaining Authorization]. The audit requirement contained in current § 26.23(b) would be addressed in proposed § 26.41(d) [Contracts]. The current requirements would be moved to different sections of the proposed rule to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B, by grouping related requirements together in one section or subpart that addresses similar topics. E:\FR\FM\26AUP2.SGM 26AUP2 50474 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.3(e) would retain and update the requirements of current § 26.2(c) to be consistent with revisions to related sections of the proposed rule as well as related parts of this chapter. Combined operating license holders (under Part 52 of this chapter) before the Commission has made the finding under § 52.103 of this chapter would continue to be subject to the rule, as well as combined license applicants who have received authorization to construct under § 50.10(e)(3), construction permit holders (under Part 50 of this chapter), construction permit applicants who have received authorization to construct under § 50.10(e)(3), and holders of manufacturing licenses (under Part 52 of this chapter). For consistency, the proposed paragraph would also replace the current cross-references to other sections of the rule with updated crossreferences to the related sections in the proposed rule and replace some terms used in the current paragraph with new terms that would be used throughout the proposed rule. For example, the term, ‘‘chemical testing,’’ would be replaced with ‘‘drug and alcohol testing,’’ and ‘‘appeals’’ would be replaced with ‘‘review’’ for reasons that will be discussed below related to proposed § 26.31 [Drug and alcohol testing] and proposed § 26.39 [Review process for fitness-for-duty violations], respectively. Other new terms in the proposed rule that would replace some of the terms used in the current rule are discussed with respect to proposed § 26.5 [Definitions]. Proposed § 26.3(f) would retain the second sentence of current § 26.2(b) because it addresses entities who would not be subject to the proposed rule. The first sentence of current § 26.2(b), which addresses individuals who are not subject to the rule, would be moved to proposed § 26.25 [Individuals subject to the fitness-for-duty program] for organizational clarity in the proposed rule. Section 26.5 Definitions Proposed § 26.5 [Definitions] would amend current § 26.3 [Definitions] to (1) clarify some definitions; (2) make the listed terms and their definitions more consistent with those used by other Federal agencies (including the Substance Abuse and Mental Health Services Administration and the Department of Transportation); (3) define new terms used in other sections of the proposed rule; and (4) move definitions into this section from current Section 1.2 of Appendix A to 10 CFR Part 26, which contains definitions of important terms used in Appendix A to Part 26. The proposed rule would VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 also eliminate six terms in current § 26.3 and Section 1.2 of Appendix A to Part 26 because they would be fully defined in the text of the proposed rule or would no longer be used in the proposed rule. In addition, the proposed rule would eliminate redundant definitions of some terms, which appear in both current § 26.3 and Section 1.2 in Appendix A to Part 26. Finally, some definitions would be revised to make them simpler and easier to understand, consistent with the Agency’s commitment to using plain language. For example, some definitions in the current rule include requirements that are also contained in other sections of the rule. In these instances, the proposed rule would eliminate the requirements that are embedded in the definitions, but retain the definitions in this section. The requirements would be moved to the related sections of the rule for organizational clarity. The majority of the proposed changes to this section would be made as a result of adding new requirements for urine drug testing, including specimen validity testing, to the proposed rule. The proposed rule would incorporate advances in the science and technology of urine drug testing that are based on the most recent revision to the HHS Guidelines, as published in the Federal Register on April 13, 2004 (69 FR 19643). These proposed changes would require adding terms to proposed § 26.5, modifying a number of the terms that are used in the current rule, and revising the definitions of some terms in the current rule that would also be used in the proposed rule, as follows: The proposed rule would add several new terms to refer to urine specimens that have characteristics that are inconsistent with those expected of normal human urine, as identified through validity testing. The proposed terms would include ‘‘adulterated specimen,’’ ‘‘dilute specimen,’’ ‘‘substituted specimen,’’ and ‘‘invalid result.’’ The proposed rule would also add the term, ‘‘oxidizing adulterant,’’ to refer to one class of substances that may be used to adulterate urine specimens. These new terms and proposed definitions would be adapted from the HHS Guidelines. The proposed rule also would add several terms that are associated with new requirements for maintaining quality control of urine specimen validity and drug testing, such as the term, ‘‘quality control sample.’’ The proposed rule would also add definitions of the terms, ‘‘calibrator,’’ ‘‘control,’’ and ‘‘standard,’’ to distinguish among the types of quality control samples that are associated with urine specimen testing in Subparts F PO 00000 Frm 00034 Fmt 4701 Sfmt 4702 [Licensee Testing Facilities] and G [Laboratories Certified by the Department of Health and Human Services] of the proposed rule. The proposed rule would change certain terms that describe drug and alcohol tests to reflect the addition of urine specimen validity testing requirements. The changes would include replacing the term, ‘‘initial or screening test,’’ with more specific terms to distinguish between drug testing and testing for urine specimen validity. The terms, ‘‘validity screening test,’’ ‘‘initial drug test,’’ and ‘‘initial validity test,’’ would be added to refer to the first tests of a urine specimen that would be performed to determine whether a urine specimen is free of drugs and drug metabolites and has the expected characteristics of normal urine, or whether further testing of the specimen is required. The proposed rule would also modify the definition of ‘‘initial drug test’’ in the current rule to eliminate the requirement that the test must be performed using immunoassay techniques because that requirement would be addressed in the text of the proposed rule. The proposed rule would replace the general term, ‘‘confirmatory test,’’ in the current rule with the more specific terms, ‘‘confirmatory drug or alcohol test’’ and ‘‘confirmatory validity test.’’ In addition, the definitions of these terms in the proposed rule would not include requirements for the methods to be used in performing confirmatory tests because these requirements would be addressed in the text of the proposed rule. Therefore, the requirement that confirmatory drug testing be performed using gas chromatography/mass spectrometry (GC/MS) testing would be removed from the definition. The proposed rule would also eliminate the reference to GC/MS testing of blood samples for confirmatory alcohol testing in the definition of ‘‘confirmatory drug or alcohol test’’ because the proposed rule would no longer give donors the option to provide a blood sample for alcohol confirmatory testing, as discussed with respect to proposed § 26.83(a). The proposed rule would modify several terms that are used in the current rule to describe the results of drug and alcohol testing, in order to reduce the number of terms, increase consistency with terms used by other Federal agencies, and address the addition of urine specimen validity testing requirements. Among these changes, the proposed rule would add the term ‘‘non-negative test result.’’ The term, ‘‘non-negative,’’ would be used to refer to any adverse test result from the different types of testing that would be E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules required under the proposed rule. For example, the proposed rule would use ‘‘non-negative’’ to refer to positive results from alcohol testing as well as results of drug and validity tests of urine specimens that indicate the presence of drugs or drug metabolites, and/or that the specimen may be adulterated, dilute, substituted, or invalid. The term, ‘‘presumptive positive test result,’’ would be eliminated from the proposed section because it would no longer be used in the rule text. The updated term, ‘‘non-negative initial test result,’’ would be used in the rule text instead. The proposed rule would also change the term, ‘‘confirmed positive test,’’ to ‘‘confirmed test result’’ to clarify that this term refers to the results of the MRO’s review of drug and validity tests of urine specimens and to positive results of a confirmatory alcohol test, rather than to a type of testing. The proposed rule would also remove the reference to testing of blood specimens for alcohol that is contained in the current definition of ‘‘confirmed positive test’’ from the definition of ‘‘confirmed test result’’ because blood specimens would no longer be collected at the donor’s request for confirmatory alcohol testing, as discussed with respect to proposed § 26.83(a). The proposed rule would also add two terms that refer to testing for very low levels of drugs, drug metabolites, or adulterants in a urine specimen, ‘‘limit of detection’’ (LOD) and ‘‘limit of quantitation’’ (LOQ). The proposed definitions of these terms would be adapted from the HHS Guidelines. In addition, the definitions of two terms in the current rule would be modified to be consistent with the new drug and alcohol testing terminology that would be used throughout the proposed rule. The proposed rule would amend the definition of ‘‘cutoff level’’ to refer to ‘‘non-negative,’’ rather than ‘‘positive,’’ test results to clarify that the term is also applicable to the interpretation of results from specimen validity testing. And, the definition of ‘‘Medical Review Officer’’ (MRO) would be amended to refer to a ‘‘non-negative’’ test result, rather than a ‘‘positive’’ test result, to clarify that the MRO would review validity test results in addition to drug test results. The proposed rule would also add several terms that would be necessary to implement the proposed requirements contained in two new subparts of the regulation, proposed Subpart C [Granting and Maintaining Authorization] and proposed Subpart I [Managing Fatigue]. The proposed rule would add six new terms that are related to the requirements of proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Subpart C. The term, ‘‘potentially disqualifying fitness-for-duty (FFD) information,’’ would be added to refer to the types of information that licensees and other entities who are subject to the rule would consider when deciding whether to grant or maintain an individual’s authorization to have the types of access or perform the job duties that are listed in proposed § 26.26(a). The proposed rule would also add definitions for four terms that are used within the definition of ‘‘potentially disqualifying FFD information,’’ including ‘‘substance abuse;’’ ‘‘legal action;’’ ‘‘employment action;’’ and ‘‘reviewing official.’’ The term, ‘‘best effort,’’ would also be added to refer to the actions that a licensee or other entity who is subject to the rule must take to obtain the information that is necessary to complete a suitable inquiry and employment history check, as discussed with respect to proposed § 26.63(a). The proposed rule would also add several terms that are necessary to implement the requirements of proposed Subpart I [Managing Fatigue]. These terms would include ‘‘fatigue,’’ ‘‘acute fatigue,’’ and ‘‘cumulative fatigue,’’ which refer to the degradation in an individual’s cognitive (mental) and motor (physical) functioning resulting from inadequate rest within the past 24 hours or over successive days and weeks, respectively. The proposed rule would use the term, ‘‘alertness,’’ to refer to an individual’s ability to remain awake and sustain attention, which is adversely affected by fatigue. The term, ‘‘circadian variation in alertness and performance,’’ would be added to define a factor that licensees would consider when conducting a fatigue assessment under proposed § 26.201 [Fatigue assessments]. The proposed rule would also add the term, ‘‘increase in threat condition,’’ to refer to circumstances in which the proposed rule would provide licensees with some flexibility in implementing the work hour controls of proposed § 26.199 [Work hour controls]. The proposed rule would also add eight new terms related to other proposed revisions to the current rule. Specifically, ‘‘analytical run’’ would be added for use in establishing amended performance testing requirements for licensee testing facilities in proposed § 26.137 [Quality assurance and quality control]. The term, ‘‘directing,’’ would be added to clarify new requirements for MRO staff under proposed § 26.183(d) and the scope of individuals who would be subject to work hour controls in proposed § 26.199(a). For consistency with the use of the term in the related regulations of other Federal agencies, PO 00000 Frm 00035 Fmt 4701 Sfmt 4702 50475 the term, ‘‘donor,’’ would replace the current terms that are used to refer to an individual from whom a specimen is collected for drug or alcohol testing. The term, ‘‘nominal,’’ would be added to refer to the leeway in the time periods within which certain requirements must be met, such as the requirement for annual FFD refresher training in proposed § 26.29(c)(2). The term, ‘‘other entity,’’ would be added to refer to organizations who would be subject to Part 26, but who are not licensed by the NRC, including, but not limited to, the organizations who hold the NRC certificates or permits listed in proposed § 26.3 [Scope]. The terms, ‘‘formula quantity’’ and ‘‘strategic special nuclear material’’ (SSNM), would be defined consistently with the definitions of the same terms in 10 CFR 70.4. The term, ‘‘subversion and subvert the testing process,’’ would be added to clarify the language of new provisions related to urine specimen validity testing, as discussed with respect to proposed § 26.31(d)(3)(i), and new sanctions that would be imposed on individuals who are subject to the proposed rule, in proposed § 26.75(b). Proposed § 26.5 would also retain and amend a number of other definitions currently contained in § 26.3 and Section 1.2 in Appendix A to Part 26, as follows. The proposed rule would revise the current definition of ‘‘aliquot’’ to clarify that an aliquot is a representative sample of a urine specimen that may be used for testing. The amended definition would be consistent with the same definition in the HHS Guidelines. The proposed rule would simplify the current definition of ‘‘blood alcohol concentration’’ (BAC) by deleting references to the instruments and devices that licensees and other entities are permitted to use for alcohol testing. The text of proposed § 26.91 [Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use] would specify acceptable devices for alcohol testing under the proposed rule. The proposed rule would revise the definition of ‘‘category IA material’’ to conform with the current definition contained in 10 CFR 74.4. The proposed rule would expand the definition of ‘‘chain of custody’’ to indicate that the terms ‘‘chain of custody’’ and ‘‘custody and control’’ are synonymous. This proposed change would be made in response to stakeholder requests during the public meetings discussed in Section V. The definition of ‘‘collection site’’ would be modified to include a reference to oral fluids as specimens E:\FR\FM\26AUP2.SGM 26AUP2 50476 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules that are acceptable for initial alcohol testing. The basis for permitting the use of oral fluids for initial alcohol testing is discussed with respect to proposed § 26.83(a). The proposed rule would replace the term, ‘‘collection site person,’’ with the term, ‘‘collector,’’ to simplify the terminology used to refer to individuals who collect specimens for testing and for consistency with the terminology used by other Federal agencies. In addition, the definition would no longer include the qualifications required for collectors because they would be specified in proposed § 26.85 [Collector qualifications and responsibilities]. The proposed rule would add the term ‘‘contractor/vendor’’ (C/V) and combine the definitions of ‘‘contractor’’ and ‘‘vendor’’ in the current rule, because the proposed rule would not distinguish between the two types of entities. The proposed rule would update the definition of ‘‘HHS-certified laboratory’’ to reference the most recent version of the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs. In addition, the proposed rule would simplify the definition of ‘‘licensee testing facility’’ by eliminating the reference to collecting specimens for alcohol testing in the current definition, because alcohol testing typically occurs at a collection site, rather than at the licensee testing facility. Finally, the proposed rule would eliminate six terms that are defined in current § 26.3 and Section 1.2 in Appendix A to Part 26. Specifically, the proposed rule would eliminate ‘‘followup testing,’’ ‘‘random test,’’ ‘‘suitable inquiry,’’ ‘‘reason to believe,’’ and ‘‘split specimen’’ because the text of the proposed rule defines them in the section where each term is used. The proposed rule would also eliminate the term, ‘‘permanent record book,’’ in current Section 1.2 in Appendix A to Part 26 because laboratories now use other mechanisms to maintain testing records. Therefore, this term would no longer be used in the proposed rule. Section 26.7 Interpretations Proposed § 26.7 [Interpretations] would retain current § 26.4 [Interpretations] but move the qualifying phrase, ‘‘other than a written interpretation by the General Counsel,’’ to the end of the sentence to improve the clarity of the sentence. This proposed change would be made in keeping with the Commission’s commitment to using plain language in its regulations and to meet Goal 6 of this rulemaking, which is to improve clarity VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 in the organization and language of the rule, as discussed in Section IV. B. Section 26.8 Information Collection Requirements: OMB Approval Proposed § 26.8 [Information collection requirements: OMB approval] would amend current § 26.8 [Information collection requirements: OMB approval] to reflect the modified sections of the proposed rule in which recordkeeping requirements would be incorporated. Section 26.9 Specific Exemptions Proposed § 26.9 [Specific Exemptions] would revise current § 26.6 [Exemptions] to include the citation of 10 CFR 50.12 and 70.17. This proposed change would be made to ensure consistency between Part 26 and these related requirements. Section 26.11 Communications Proposed § 26.11 [Communications] would be added to improve consistency with similar sections in other parts of 10 CFR and ensure that communications with the NRC are addressed and, therefore, processed properly. Subpart B—Program Elements Section 26.21 Fitness-for-Duty Program Proposed § 26.21 [Fitness-for-duty program] would require that licensees and other entities who are subject to the rule must establish, implement, and maintain FFD programs that comply with the applicable requirements of this part. This statement would be added to serve as an introduction to the remaining text of the proposed rule, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The term, ‘‘applicable,’’ would be included in this sentence because not all the requirements in the proposed regulation would apply to all the entities listed in proposed § 26.3(a)–(d). For example, the requirements in proposed Subpart I [Managing Fatigue] would apply only to nuclear power plant licensees and any C/Vs upon whom they rely to meet the requirements of this part, as discussed with respect to proposed § 26.195 [Applicability]. As another example, the proposed rule would retain the current requirement in § 26.2(c), which states that nuclear power plant construction permit holders must establish a drug and alcohol testing program that includes random testing, but would not require these entities to meet the requirements of the proposed regulation related to drug and alcohol testing, including, but not limited to, proposed PO 00000 Frm 00036 Fmt 4701 Sfmt 4702 § 26.31 [Drug and alcohol testing] and proposed Subpart E [Collecting Specimens for Testing]. The second sentence of the proposed paragraph, which is based on current § 26.23(b), would retain permission for licensees and other entities to rely upon a C/V’s FFD program or program elements to meet the requirements of this part, if the C/V’s FFD program or program element meets the applicable requirements of this part. The other requirements contained in current § 26.23 [Contractors and vendors] are discussed with respect to proposed § 26.23 [Performance objectives]. Section 26.23 Performance Objectives Proposed § 26.23 [Performance objectives] would amend current § 26.10 [General performance objectives], as follows: The proposed rule would amend current § 26.10(a). The proposed rule would divide the performance objectives contained in current § 26.10(a) into two paragraphs (proposed § 26.23(a) and (b), respectively) to clarify that the performance objective of assuring that personnel are trustworthy and reliable is separate and distinct from the performance objective of assuring that personnel are fit for duty. Proposed § 26.23(a) would require that FFD programs provide reasonable assurance that persons who are subject to this part are trustworthy and reliable as demonstrated by the avoidance of substance abuse and the adverse behaviors that accompany it. The NRC has placed an increased emphasis on the trustworthiness and reliability of individuals who have access to certain types of sensitive information, certain types of radiological materials, and protected areas in nuclear power plants since September 11, 2001. This level of emphasis is to reduce the risk of an insider threat, maintain public health and safety, and provide for the common defense and security in the postSeptember 11, 2001, threat environment. These are the same individuals who would be subject to the proposed rule. Because these individuals have unimpeded access to sensitive information and safety equipment and systems, their trustworthiness and reliability are essential. Substance abuse by such individuals presents an unacceptable risk to public health and safety and the common defense and security in several ways. First, substance abuse increases the likelihood that such individuals may pose an insider threat by increasing an individual’s vulnerability to coercion. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Under 10 CFR 73.1, a passive insider is defined as an individual who obtains or attempts to obtain safeguards or other relevant information, such as a nuclear power plant’s physical configuration and design, and who does not have a functional or operational need to know such information. Section 73.1 defines an active insider as a knowledgeable individual who, while within the protected area of a nuclear power plant in an unescorted status, takes direct action to facilitate entrance and exit, disable alarms and communications, and/or participates in a violent attack. An individual who uses illegal drugs may be coerced into cooperating, actively or passively, with a terrorist in an attempt to commit radiological sabotage if, for example, the terrorist were to threaten the individual with revealing his or her illegal drug use or was somehow able to withhold drugs from an individual who is addicted. Second, an individual’s judgement and self-control are impaired while an individual is abusing drugs or alcohol. When an individual is intoxicated from abusing any of the substances for which testing is conducted under Part 26, including alcohol, the individual is more likely to inadvertently reveal sensitive information that terrorists could use in a radiological sabotage attempt than when he or she is not intoxicated. Third, the use of illegal drugs establishes that an individual is willing to disobey the law, thus indicating that the individual will disregard other rules and regulations. The use of illegal drugs raises questions about the individual’s trustworthiness and reliability in terms of scrupulously following the regulations, procedures, and other requirements, such as safeguards requirements, that ensure the protection of public health and safety. Many provisions of the current rule provide means to identify and reduce the risks posed by any individuals whose substance abuse casts doubt on their trustworthiness and reliability. In combination with other measures the NRC has taken since September 11, 2001, a number of the proposed changes to the current rule would provide further assurance that individuals who are subject to the rule are trustworthy and reliable. Proposed changes to strengthen the effectiveness of the rule in assuring individuals’ trustworthiness and reliability include, but are not limited to: (1) Adding requirements for specimen validity testing to identify individuals who are willing to attempt to subvert the testing process, and so may be willing to subvert other rules and VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 regulations that are important for public health and safety and the common defense and security; (2) Increasing the rigor of the evaluations that licensees and other entities must perform before granting authorization to an individual who has previously violated Part 26 requirements to ensure that the individual has ceased abusing drugs or alcohol; and (3) Imposing more stringent sanctions on individuals who violate Part 26 requirements, including, but not limited to, permanently denying authorization to have the types of access and perform the job duties listed in proposed § 26.25(a) to any individual who attempts to subvert the drug and alcohol testing process. The NRC believes that implementation of these provisions of the proposed rule, in addition to the other, related measures the Agency has taken in the post-September 11, 2001, threat environment, provides an increased level of requirements appropriate for the new threat environment, such that there remains reasonable assurance that individuals who are subject to the rule are trustworthy and reliable. Proposed § 26.23(b) would retain the performance objective of providing reasonable assurance that personnel are fit for duty, which appears in current § 26.10(a). The use of the term, ‘‘reasonable,’’ to describe the level of assurance required by the rule reflects the NRC’s awareness that an individual’s fitness at any particular moment in time may be affected by many different factors. Some of these factors may be difficult for the licensee or other entity to detect and many (such as a transitory illness) may not warrant management action or the imposition of sanctions because they would not pose a significant risk to public health and safety. As mentioned above, the level of requirements associated with achieving reasonable assurance of trustworthiness and reliability is greater than that associated with reasonable assurance that individuals are not impaired. Another example of this is with regard to the sanctions that the proposed rule would require licensees and other entities to impose on individuals who demonstrate questionable trustworthiness and reliability compared to the management actions licensees would be expected to take with individuals who may be impaired. For example, if an individual demonstrates dishonesty by attempting to bring a substitute urine specimen to the collection site with a clear intent to PO 00000 Frm 00037 Fmt 4701 Sfmt 4702 50477 subvert the testing process or demonstrates a willingness to break the law by possessing illegal drugs on site, the proposed rule (under proposed §§ 26.75(b) and 26.75(c), respectively) would require the licensee or other entity to terminate the individual’s authorization to have the types of access and perform the job duties that are listed in proposed § 26.25 [Individuals subject to the fitness-for-duty program]. Terminating the individual’s authorization would be necessary to provide reasonable assurance that the individual could pose no further risk to public health and safety or the common defense and security. By contrast, the current and proposed rules would not require a licensee or other entity to terminate an individual’s authorization if he or she is mentally or physically impaired while on duty from such transitory causes as illness and emotional stress resulting from a family problem. For example, an individual who arrives at work with a severe migraine headache may suffer impairment on the job that would adversely affect the individual’s ability to perform his or her duties safely and competently while the headache persists. The proposed (and current) rule (under proposed § 26.77(b)(3) and current § 26.27(b)(1), respectively) would require the licensee or other entity to take action to prevent the individual from performing the job duties that require the individual to be subject to this part, if the individual’s fitness is questionable. These actions could include, for example, assigning the individual to other duties until medication brings the headache under control or sending the individual home until the headache resolves. Such actions would meet the performance objective of providing reasonable assurance that the individual is fit when he or she resumes his or her normal duties. However, it would be unreasonable for a licensee’s FFD policy to impose sanctions on the individual, such as terminating his or her authorization. Sanctions could have no deterrent effect on the recurrence of the individual’s headache, which is one purpose of including requirements for minimum sanctions in Part 26. In addition, there would not be any continuing risk to public health and safety from permitting the individual to resume his or her duties once the headache is resolved. Another difference between the performance objectives of providing ‘‘reasonable’’ assurance of trustworthiness and reliability and ‘‘reasonable’’ assurance that the E:\FR\FM\26AUP2.SGM 26AUP2 50478 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules individuals who are subject to the proposed rule are fit for duty lies in the severity of the enforcement actions that the NRC would be likely to take against an FFD program that failed to meet these performance objectives. The NRC’s enforcement actions would be severe in the case of an FFD program that, for example, granted authorization to an individual who had previously had his or her authorization permanently denied under proposed § 26.75(b) but would be unlikely to take enforcement action in the case of an FFD program that failed to remove an individual who was experiencing impairment related to family stress from his or her duties under proposed § 26.77(b)(3). Proposed § 26.23(c) would retain the performance objective in current § 26.10(b), which is to ‘‘provide reasonable measures for the early detection of persons who are not fit to perform activities within the scope of this part,’’ but would replace the phrase, ‘‘perform activities within the scope of this part,’’ with the phrase, ‘‘perform the job duties that require them to be subject to this part.’’ The proposed rule would make this change for clarity in the language of the rule. As discussed further with respect to proposed § 26.25 [Individuals subject to the fitness-forduty program], the proposed rule would require that certain individuals must be subject to an FFD program based on their job duties, which include not only performing activities, such as measuring, guarding, or transporting Category IA material, but also having access to certain locations, material, and sensitive information, such as nuclear power plant protected areas, Category IA material, procedures and records for safeguarding SSNM, and the drug test results of an individual who was tested before the MRO reviews the drug test results. Therefore, the phrase, ‘‘perform the job duties that require them to be subject to this part,’’ would be more accurate. Replacing the current phrase with the more accurate phrase would be consistent with Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. Proposed § 26.23(d) would amend current § 26.10(c) to require that FFD programs must provide reasonable assurance that the workplaces that are subject to this part are free from the presence and effects of illegal drugs and alcohol. The proposed rule would revise the current performance objective to ‘‘have a goal of achieving a drug-free workplace and a workplace free of the effects of such substances’ for several reasons. First, the terms, ‘‘drug-free’’ VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 and ‘‘free from the effects of such substances,’’ do not accurately capture the NRC’s intent with respect to this performance objective. These terms could be misunderstood as requiring FFD programs to have the goal of preventing any drugs and their effects from being present in the workplace, which could include medications that individuals who are subject to the rule may take to treat health problems. Therefore, the proposed rule would replace ‘‘drug-free’’ and ‘‘free of the effects of such substances’’ with the more specific phrase, ‘‘free from the presence and effects of illegal drugs and alcohol’’ to refer to the specific substances that would be proscribed. The proposed revision would clarify that the NRC does not intend for FFD programs to prohibit individuals from taking the medications they need to maintain their health or bringing those medications to the workplace. This proposed change would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule. The proposed performance objective would also replace the phrase, ‘‘have a goal of,’’ in the current rule with the phrase, ‘‘provide reasonable assurance,’’ which more accurately captures the intent of this performance objective. The phrase, ‘‘have a goal of,’’ would be eliminated because proposed § 26.23(d) is a performance objective and, therefore, the phrase is unnecessary. This proposed change would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, without changing the intended meaning of the performance objective. Proposed § 26.23(e) would be added to require licensees and other entities to provide reasonable assurance that the effects of fatigue and degraded alertness on individuals’ abilities to safely and competently perform their duties are managed commensurate with maintaining public health and safety. This proposed performance objective would be added to specify the objective of the requirements concerning worker fatigue that would be added to the proposed rule. Worker fatigue cannot be measured or controlled with precision, and licensees and other entities do not have direct control over all matters that may influence worker fatigue. Therefore, proposed § 26.23(e) would establish a ‘‘reasonable assurance’’ criterion for the proposed performance objective. Worker fatigue can result from many causes (e.g., work hours, sleep disorders, demands outside the workplace). In addition, individuals differ in their responses to conditions PO 00000 Frm 00038 Fmt 4701 Sfmt 4702 that cause fatigue. As a consequence, work hour limits alone do not address all causes of fatigue, nor do they prevent fatigue from work hours for all workers. Contemporary methods for addressing worker fatigue (e.g. Rogers, 1996, 1997; Hartley, 1998; Carroll, 1999) are commonly referred to as ‘‘fatigue management’’ programs and use diverse methods (e.g., training, behavioral observation, fatigue countermeasures) in addition to work hour controls to prevent, detect, and mitigate fatigue. Accordingly, proposed § 26.23(e) would establish a performance objective of reasonable assurance that effects of fatigue and degraded alertness on individuals’ abilities to safely and competently perform their duties are ‘‘managed’’ commensurate with maintaining public health and safety. The proposed performance objective would permit licensees and other entities to apply risk-informed fatigue management controls for individuals consistent with the significance of their work activities to the protection of public health and safety. Section 26.25 Individuals Subject to the Fitness-for-Duty Program Proposed § 26.25 [Individuals subject to the fitness-for-duty program] would be added to group together in one section the provisions of the proposed rule that specify the individuals who must be subject to the FFD program, based on their job duties, and those who would not be subject to the FFD program. This proposed change would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, by grouping related requirements together within the rule. Proposed § 26.25(a)(1)–(a)(3) would amend the portions of current § 26.2(a) and (d) that describe the individuals whose job duties require them to be subject to Part 26 by presenting the requirements in separate paragraphs. This organizational change would be made to make it easier for users to locate these requirements within the rule text and to support cross-referencing to these paragraphs from other portions of the rule, so that it is unnecessary to repeat the relevant list of job duties each time the rule refers to a specific group of individuals, as the organization of the current rule has required [see, for example, current § 26.27(a)(1), (b)(2), and (b)(3)]. This proposed change would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The proposed rule would add § 26.25(a)(4) to clarify the NRC’s original E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules intent that FFD program personnel must be subject to the FFD program. Although current Section 2.3 in Appendix A to Part 26 requires licensees to carefully select and monitor individuals who are responsible for administering the drug and alcohol testing program based upon the highest standards of honesty and integrity, some licensees’ testing programs did not include all of the FFD program personnel who the NRC originally intended to be subject to testing. The proposed change would be made to clarify the NRC’s original intent because the actions of these individuals have an ongoing effect on public health and safety and the common defense and security as a result of their responsibility to ensure that FFD programs are effective. In addition, these individuals’ actions affect the confidence that the public, management, and individuals who are subject to testing have in the integrity of the program and the accuracy and reliability of test results. Individuals who are involved in the day-to-day operations of an FFD program are in a position to permit substance abusers to remain undetected. For example, specimen collectors could inadvertently commit errors when testing others as a result of being impaired from drug or alcohol abuse or intentionally omit testing an individual because of motives associated with maintaining a collector’s substance abuse or empathy with an abuser. Furthermore, several reported incidents have confirmed the need to assure that FFD program personnel meet the highest standards of honesty, integrity, reliability, and trustworthiness. For example, one licensee added specimen collectors to the testing pool after investigating an allegation and determining that two collectors were substance abusers. In another instance, a contracted MRO who was not in the testing pool was reported to be an alcoholic and an abuser of prescription drugs. Some MROs who provide their services to other Federally regulated industries have also been identified as substance abusers. Therefore, the proposed revision to current § 26.2(a) would fulfill the NRC’s original objective and require licensees and other entities to extend their programs to include FFD personnel who (1) can link test results with the individual who was tested before an FFD policy violation determination is made, including, but not limited to the MRO; (2) make determinations of fitness; (3) make authorization decisions; (4) are involved in selecting or notifying individuals for testing; or (5) are involved in the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 collection or on-site testing of specimens. Although job titles and responsibilities may differ among different Part 26 FFD programs, examples of FFD program personnel who would be subject to Part 26 under the proposed rule would include, but would not be limited to, the following: The FFD program manager under proposed § 26.25(a)(4)(i)–(a)(4)(v); the MRO and MRO staff under proposed § 26.25(a)(4)(i); the licensee’s or other entity’s reviewing officials under proposed § 26.25(a)(4)(iii); specimen collectors under proposed § 26.25(a)(4)(v); SAEs who are under contract to or employed by the FFD program under proposed § 26.25(a)(4)(ii); and licensee testing facility personnel under proposed § 26.25(a)(4)(v). In some cases, information technology personnel who design and implement software programs for selecting individuals for random testing may also be subject to the rule under proposed § 26.25(a)(4)(iv) if such personnel have knowledge of who will be selected for random testing or the ability to affect the selection of specific individuals for random testing. Proposed § 26.25(b)(1)–(b)(3) would be added to group together in one paragraph the proposed rule’s provisions that identify individuals who would not be subject to the rule. This proposed change would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule. A new provision, proposed § 26.25(b)(1), would be added to the rule as a result of extensive discussions with industry stakeholders at the public meetings mentioned in Section V. Industry stakeholders expressed strong concern that the related language in the Affirmed Rule (which was also discussed in Section V), which delineated the FFD program personnel who must be subject to the Part 26, was too broad. Stakeholders agreed that FFD program personnel who work on site and are involved in the day-to-day operations of the FFD program should be subject to the rule. However, the stakeholders noted that the language used in the Affirmed Rule was so vague that it could be interpreted as requiring, for example, that off-site human resources staff at a licensee’s or other entity’s corporate offices, who may have access to some FFD information about individuals, must be covered, as well as any medical or treatment personnel, and their managers, at a hospital or substance abuse treatment facility who provide an occasional FFD program service. These interpretations of the PO 00000 Frm 00039 Fmt 4701 Sfmt 4702 50479 intent of the Affirmed Rule provisions would be incorrect. The stakeholders also strongly disagreed with the requirement in the Affirmed Rule that some FFD program personnel who maintain offices at other locations than a licensee’s or other entity’s facilities and are not involved in day-to-day program operations, such as EAP counselors and some contract MROs, should be subject to the rule. The stakeholders indicated that they believe the honesty and integrity of such off-site personnel is maintained through their professions’ oversight and standards, with the result that requiring these individuals to be subject to the rule would create a significant and unnecessary regulatory burden. Stakeholders stated that the regulatory burden would result from (1) the significant logistical difficulties involved in ensuring that these individuals are subject to behavioral observation and drug and alcohol testing, and (2) excessive costs to hire additional MRO(s) to review any nonnegative drug test results from MRO(s) who serve the FFD program. Based on the stakeholders’ input, ‘‘lessons learned’’ from FFD program experience since the rule was first implemented, the experience gained by other Federal agencies and their regulated industries, and the continuing need to ensure that FFD program personnel meet the highest standards of honesty and integrity, the NRC added § 26.25(b)(1) to the proposed rule. The proposed paragraph would exclude from the rule individuals who may be called upon to provide an FFD program service to a licensee or other entity in special circumstances and who meet all of the following criteria: (1) They are not employed by the licensee or other entity; (2) They do not routinely provide services to the licensee’s or other entity’s FFD program; and (3) They do not normally work at a licensee’s or other entity’s facility. Examples of individuals who would not be subject to the rule under the proposed provision may include, but would not be limited to, a nurse at a local hospital who collects a single specimen for a post-event test from an individual who has been injured and a counselor at a residential substance abuse treatment facility who performs behavioral observation of a patient while the individual is in residence. Personnel who meet the three criteria specified in the proposed paragraph would be excluded from the FFD program because the limited nature of their involvement with the FFD program makes it unlikely that they would be E:\FR\FM\26AUP2.SGM 26AUP2 50480 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules subject to coercion or influence attempts to subvert the testing process and the NRC is not aware of any reports indicating that these types of individuals have been involved in any adverse incidents. Therefore, the NRC concurs with the stakeholders that requiring such individuals to be subject to the FFD program would be unnecessary. However, proposed § 26.25(a)(4) would require MROs and SAEs to be subject to Part 26 (see the discussion of proposed § 26.187 [Substance abuse expert] in Section VI of this document for a detailed description of the SAE’s roles and responsibilities under the FFD program), as well as any EAP counselor who serves as the SAE for a licensee’s or other entity’s FFD program. Individuals who serve in these positions play the key roles of determining whether a non-negative drug test result is an FFD policy violation (i.e., the MRO under proposed § 26.185) and whether an individual is fit to safely and competently perform the job duties that require the individual to be subject to this part (i.e., the SAE). Although the NRC recognizes the significant logistical difficulties and costs that may be associated with covering these individuals, the NRC concluded that MROs and SAEs play such critical roles in the effective functioning of an FFD program that ensuring their continuing honesty and integrity by requiring them to be subject to the rule is warranted and invites further comment on these provisions. Proposed § 26.25(b)(2) and (3) would retain the first sentence of current § 26.2(b) but divide it into two paragraphs. This organizational change would be made to make it easier to locate these requirements within the rule text and to support crossreferencing to these paragraphs from other portions of the rule. The second sentence of current § 26.2(b) would be moved to proposed § 26.3(e) rather than retained in this paragraph because it addresses entities who would not be subject to the rule, rather than individuals. The proposed changes would be made to meet Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. Proposed § 26.25(c) would be added to provide that persons who are covered by a program regulated by another Federal or State agency that meets the performance objectives of Part 26 need not also be covered by a licensee’s or other entity’s FFD program. Duplicate testing and training requirements applicable to an appreciable number of individuals working at nuclear facilities VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 have become an increasing problem as the facilities have implemented the Department of Transportation’s (DOT) drug and alcohol testing requirements [49 CFR Part 40—65 FR 41944, August 9; 2001]. This proposed revision would reduce the burden on some individuals who are currently subject to Federal and State programs with requirements that duplicate those of Part 26. Minor differences in specific program requirements for conducting drug and alcohol testing would be unlikely to adversely affect the ability of a licensee’s or other entity’s FFD program to meet the performance objectives of this part. The licensee or other entity would continue to be responsible for implementing any Part 26 program elements that may not be addressed by the alternate Federal or State program. These program elements may include, but would not be limited to, providing behavioral observation and initiating for-cause testing, if necessary, when an individual who is covered by an alternate program is on site at a licensee’s or other entity’s facility and is performing the job duties that require the individual to be subject to the rule, as well as immediate removal from duty of persons whose fitness may be questionable. Proposed § 26.25(c)(1)–(c)(6) would list the necessary characteristics of an alternative Federal or State program that, under the proposed rule, licensees and other entities could rely upon to satisfy the requirements of this part for an individual who is subject both to Part 26 and an alternative program. Proposed § 26.25(c)(1) and (3) would permit licensees and other entities to rely on the alternative program to meet the proposed rule’s drug testing requirements if the alternative program tests for the drugs and drug metabolites that are specified in the proposed rule at or below the cutoff levels established in the proposed rule and an HHScertified laboratory conducts the program’s specimen validity and drug testing. Similarly, proposed § 26.25(c)(2) would permit licensees and other entities to rely on the alternative program to meet the proposed rule’s alcohol testing requirements if the alternative program’s alcohol testing procedures and devices meet the proposed rule’s requirements and the alternative program uses cutoff levels that are at least as stringent as those specified in proposed § 26.103(a). Proposed § 26.25(c)(4) would permit the licensee or other entity to rely on an alternative program’s FFD training if that training addresses the knowledge and abilities listed in proposed PO 00000 Frm 00040 Fmt 4701 Sfmt 4702 § 26.29(a)(1)–(a)(10). Proposed § 26.25(c)(5) would permit licensees and other entities to rely on the alternative program to meet the proposed rule’s requirements for an impartial and objective procedure for the review and reversal of any findings of an FFD violation if the alternative program provides such a procedure. And, finally, if the licensee or other entity relies on the alternative program, proposed § 26.25(c)(6) would require the licensee or other entity to ensure that the alternative program would inform the licensee or other entity of any FFD violations. These proposed provisions would be consistent with the current and proposed rules’ approaches to permitting licensees and other entities to rely on C/V FFD programs and program elements to meet the requirements of this part if the C/V’s program or program element meets the requirements of this part, as discussed with respect to proposed § 26.21 [Fitness-for-duty programs]. In general, permitting licensees and other entities to rely on FFD programs and program elements that are implemented by others, when those programs or program elements meet the requirements of this part, would fulfill the rule’s performance objectives and improve Part 26 by eliminating or modifying unnecessary requirements, which is Goal 5 of this rulemaking, as discussed in Section IV. B. However, an important difference between the proposed rule’s permission for licensees and other entities to rely on the programs of other Federal and State agencies, compared to the proposed rule’s permission for licensees and other entities to rely on C/ V programs, is that the proposed rule would not require licensees and other entities to audit the alternate Federal and State programs under proposed § 26.41 [Audits and corrective action]. Auditing Federal and State programs would be unnecessary because these programs are subject to other, equally effective audit and inspection requirements. Relieving licensees and other entities who are subject to this part from an audit requirement also would be in keeping with Goal 5 of this rulemaking. Proposed § 26.25(d) would be added to clarify that individuals who have applied for authorization to perform job duties that would require them to be subject to Part 26 would also be subject to some provisions of the proposed rule. The current Part 26 requires an applicant for authorization to provide a written statement related to his or her past activities under this part in current § 26.27(a)(1); provide permission to the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules licensee to conduct a suitable inquiry in current § 26.27(a)(2); and submit to preaccess testing in current § 26.24(a)(1). The proposed rule would impose similar requirements on applicants and add others, such as random testing during the short time period that falls between when a licensee or other entity collects specimens for a pre-access test and then grants authorization to the individual. Therefore, proposed § 26.25(d) would ensure the internal consistency of the proposed rule and would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Section 26.27 Written Policy and Procedures Proposed § 26.27 [Written policy and procedures] would reorganize and amend current § 26.20 [Written policy and procedures]. The proposed rule would reorganize the current section to divide into separate paragraphs the requirements related to the FFD policy and those related to FFD program procedures that are intermixed within the current section. The proposed organizational change would be made so that the requirements related to the FFD policy and procedures would be easier to locate within this section, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. Proposed § 26.27(a) [General] would amend the first paragraph of current § 26.20, which requires licensees to establish and implement written policies and procedures designed to meet the performance objectives and specific requirements of this part and to retain superseded copies of the policies and procedures. The proposed rule would replace the term, ‘‘licensee,’’ in the current rule with the phrase, ‘‘licensees and other entities,’’ because entities other than licensees would be subject to this requirement, as discussed with respect to proposed § 26.3 [Scope]. The term, ‘‘maintain,’’ would be added to the current requirement to ‘‘establish and implement’’ written policies and procedures to reflect the fact that licensees and other entities who are subject to Part 26 must occasionally revise FFD program policies and procedures to keep them current when FFD program personnel or other aspects of the FFD program change. The proposed rule would replace ‘‘specific’’ with the term, ‘‘applicable,’’ in the proposed sentence because all the requirements in Part 26 would not apply to all the licensees and other entities who would be subject to the rule, as discussed with respect to proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 § 26.3 [Scope]. The proposed rule would also eliminate ‘‘designed to’’ from this sentence because it is unnecessary. The records retention requirements contained in the second sentence of the current paragraph would be moved to proposed § 26.213(d) in Subpart J [Recordkeeping and Reporting Requirements], which groups together the recordkeeping and reporting requirements that are interspersed throughout the current rule. These proposed changes to the organization and language of current § 26.27 would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. Proposed § 26.27(b) [Policy] would amend current § 26.20(a), which establishes requirements for the written FFD policy. The proposed rule would expand the list of topics that the FFD policy must address. The list of topics to be addressed by the FFD policy would be expanded as a result of discussions with stakeholders during the public meetings described in Section V. Stakeholders noted that the list of topics in the current rule is incomplete because it does not include many topics about which individuals who are subject to the policy should be aware in order to be able to comply with the policy. Therefore, the proposed rule would add topics to the policy content requirements in current § 26.20(a) to ensure that FFD policies will be complete. This proposed change would be made to meet Goal 7 of this rulemaking, as it relates to protecting the due process rights of individuals who are subject to Part 26, as discussed in Section IV. B. Proposed § 26.27(b) would also add requirements for the written FFD policy to be clear, concise, and readily available to all individuals who are subject to the policy because neither the current nor proposed rules require licensees and other entities to provide site-specific FFD training to individuals. However, FFD policies may vary between licensees and other entities with respect to, for example, the sanctions that are applied for confirmed non-negative test results, the cutoff levels used in drug or alcohol testing, or the time periods within which an individual who has been selected for random testing must report to the collection site. Under the proposed rule, the written FFD policy would continue to be the primary means by which a licensee or other entity would communicate local variations in FFD policy. In the past, however, a few individuals challenged determinations that they had violated a licensee’s FFD PO 00000 Frm 00041 Fmt 4701 Sfmt 4702 50481 policy on the basis that they were not aware of the specific provisions of the policy to which they were subject. Therefore, the proposed rule would add requirements that the FFD policy must be clear, concise, and readily available in order to promote individuals’ awareness of the site-specific FFD policy to which they are subject. This proposed change would be made to meet Goal 7 of this rulemaking, as it relates to protecting the due process rights of individuals who are subject to Part 26. The proposed rule would also add examples of acceptable methods to make the written policy ‘‘readily available’’ to individuals who are subject to the FFD policy, including, but not limited to, posting the policy in various work areas throughout the licensee’s or other entity’s facilities, providing individuals with brochures, or allowing individuals to print the policy from a computer. These examples would be added at the request of stakeholders during the public meetings discussed in Section V, and would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(b)(1) would amend the second sentence of current § 26.20(a), which requires that ‘‘the policy must address the use of illegal drugs and abuse of legal drugs (e.g., alcohol, prescription and over-thecounter drugs).’’ Proposed § 26.27(b)(1) would expand this sentence to require the FFD policy to describe the consequences of on-site or off-site use, sale, or possession of illegal drugs in proposed § 26.27(b)(i); the abuse of legal drugs and alcohol in proposed § 26.27(b)(ii); and the misuse of prescription and over-the-counter drugs in proposed § 26.27(b)(iii). The proposed rule would replace the phrase, ‘‘must address,’’ in the current sentence with the phrase, ‘‘must describe the consequences of,’’ because stakeholders noted that ‘‘must address’’ is vague during the public meetings discussed in Section V. The phrase, ‘‘must describe the consequences of,’’ would clarify the information that the policy must convey to ensure that individuals who are subject to the policy are aware of the consequences of these actions, as specified in the licensee’s or other entity’s FFD policy. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The proposed rule would add a new § 26.27(b)(2), which would require the FFD policy to state the time period E:\FR\FM\26AUP2.SGM 26AUP2 50482 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules within which individuals must report to the collection site after being notified that they have been selected for random testing, as specified by the licensee or other entity. The proposed regulation would not establish a time limit because there are a variety of circumstances among the different entities who are subject to this rule that make it impractical to establish a universal time limit. However, adding the requirement for the licensee’s or other entity’s FFD policy to establish and convey a time limit would be necessary because some programs have not done so. As a result, circumstances have arisen in which individuals who were selected for random testing intentionally delayed reporting to the collection site in order to take steps to subvert the testing process, such as obtaining an adulterant to bring to the collection site or drinking large amounts of liquid to be able to provide a dilute specimen. Further, the longer that an individual who has abused illegal drugs or alcohol is able to delay providing specimens for testing, the more likely it is that the concentrations of an illegal drug or alcohol in the individual’s urine, breath, or oral fluids will decrease due to metabolism, with the result that the concentrations may fall below the cutoff levels for those substances by the time the specimens are collected and the individual’s substance abuse would not be detected. Therefore, the proposed rule would require licensees and other entities to establish a time limit within which individuals must report for random testing after they have been notified to improve the effectiveness of FFD programs, consistent with Goal 3 of this rulemaking. The proposed rule would also require the FFD policy to convey this time limit to ensure that individuals are aware of it, given that a failure to appear for testing within the prescribed time limit may lead to the imposition of sanctions under the FFD policy. This proposed change would be made to meet Goal 7 of this rulemaking, as it relates to protecting the due process rights of individuals who are subject to Part 26. Proposed § 26.27(b)(3) would be added to require the FFD policy to inform individuals of the consequences of refusing to be tested and attempting to subvert the testing process. This provision would be added to ensure that persons who are subject to the rule are aware of proposed § 26.75(b), which would require licensees and other entities to impose the sanction of permanent denial of authorization for these actions. Proposed § 26.27(b)(3) would be added to protect the due VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 process rights of individuals who are subject to drug and alcohol testing under this part by ensuring that they are informed, in advance, of the licensee’s or other entity’s policies to which they are subject. Therefore, adding this requirement would meet Goal 7 of this rulemaking with respect to protecting the due process rights of individuals who are subject to Part 26, as discussed in Section IV. B. Proposed § 26.27(b)(4)(i) would amend current § 26.20(a)(1), which requires the FFD policy to prohibit the consumption of alcohol within an abstinence period of at least 5 hours preceding ‘‘any scheduled working tour.’’ The proposed rule would replace the phrase, ‘‘any scheduled working tour,’’ with the phrase, ‘‘the individual’s arrival at the licensee’s or other entity’s facility,’’ as a result of stakeholder comments on the language in the current rule at the public meetings discussed in Section V. The stakeholders commented that the current phrase lacks clarity and could be misinterpreted as meaning, ‘‘any working tour scheduled by the licensee or other entity.’’ If the phrase was so interpreted, individuals who are subject to the rule may believe that, if they work on a weekend or work overtime that is not part of their normally scheduled working tour, the rule would permit them to consume alcohol within the 5hour period before they arrive at work, which would be incorrect. Therefore, the language of the proposed rule would be revised to clarify that the pre-work abstinence period applies to the 5 hours before an individual arrives at the licensee’s or other entity’s facility for any purpose, except if an individual is called in to perform an unscheduled working tour, as discussed with respect to proposed § 26.27(c)(3). This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV.B. Proposed § 26.27(b)(4)(ii) would retain current § 26.20(a)(2). Proposed § 26.27(b)(5) would be added to require the FFD policy to inform individuals that abstinence from alcohol during the 5 hours preceding arrival at a licensee’s or other entity’s site, as required in proposed § 26.27(b)(4), may not be sufficient to ensure that an individual is fit for duty upon reporting to work. Some individuals who have complied with the 5-hour abstinence requirement could have BACs above the cutoff levels specified in proposed § 26.103 when they arrive at the licensee’s or other entity’s facility, depending upon the amount of alcohol and food that the PO 00000 Frm 00042 Fmt 4701 Sfmt 4702 individual consumed before the abstinence period began, body weight, and other factors. This proposed paragraph would be added to meet Goal 7 of this rulemaking with respect to protecting the due process rights of individuals who are subject to alcohol testing under Part 26 by ensuring that they are aware that the required 5-hour abstinence period may be insufficient to assure they have a BAC below the cutoff levels in this part when arriving for work. Proposed § 26.27(b)(6) would amend the last sentence of current § 26.20(a), which requires the FFD policy to address other factors that could affect individuals’ abilities to perform their duties safely and competently, such as mental stress, fatigue, and illness. The proposed provision would add a requirement for the FFD policy also to address the use of prescription and over-the-counter medications that could cause impairment at work. For example, some licensees or other entities may require individuals to self-report to the FFD program their use of any prescription medications that are labeled with a warning indicating that use of the medication may cause impairment. The licensee’s or other entity’s FFD policy may require that an individual who is taking a medication that can cause impairment must be temporarily re-assigned to job duties that the individual can perform without posing a risk to the individual or public health and safety while he or she is taking the medication. Therefore, the proposed rule would require licensees and other entities to include such information in the FFD policy to ensure that individuals are aware of the actions they may be required to take when using these substances, consistent with Goal 7 of this rulemaking with respect to protecting the due process rights of individuals who are subject to the policy. The addition of this requirement would also increase the internal consistency of the rule because other portions of the proposed (and current) rule establish requirements related to using prescription and over-the-counter medications, including, for example, proposed § 26.29(a)(6), which would require FFD training to address this topic, and proposed § 26.183(j)(2), which would require the MRO to determine whether a non-negative confirmatory drug test result that is due to using a prescription or over-thecounter medication represents substance abuse. Therefore, the proposed requirement for the FFD policy to address the use of prescription and over-the-counter medications that E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules could cause impairment at work would also meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(b)(7) would amend current § 26.20(b), which requires the FFD policy to describe programs that are available to individuals desiring assistance in dealing with drug, alcohol, or other problems that may adversely affect their performance of their job duties. Proposed § 26.27(b)(7) would add fatigue as one of the problems for which individuals may be seeking assistance because sleep disorders (e.g., sleep apnea, insomnia, restless leg syndrome) can substantially affect individuals’ abilities to obtain sufficient quality sleep. Poor quality sleep causes fatigue, which may degrade an individual’s ability to safely and competently perform his or her duties. Sleep disorders affect a sizeable portion of the U.S. work force. According to polls conducted by the NSF about twothirds of U.S. adults report experiencing one or more symptoms associated with insomnia, sleep apnea, or restless leg syndrome at least a few nights a week (National Sleep Foundation, 2003) and nearly one out of five (19 percent) report making occasional or frequent errors due to sleepiness (National Sleep Foundation, 2000). Proposed § 26.27(b)(7) would ensure that individuals are aware of the services that are available for diagnosing and treating sleep disorders that can adversely affect their job performance. This proposed change would be made to meet Goal 2 of this rulemaking, which is to strengthen the effectiveness of FFD programs at nuclear power plants by reducing the potential for worker fatigue to adversely affect public health and safety and the common defense and security, through establishing clear and more readily enforceable requirements concerning the management of worker fatigue. In addition, the proposed rule would replace the phrase, ‘‘adversely affect the performance of activities within the scope of this part,’’ in the current provision with the phrase, ‘‘could adversely affect an individual’s ability to safely and competently perform the job duties that require an individual to be subject to this part,’’ for the reasons discussed with respect to proposed § 26.23(c). Proposed § 26.27(b)(8) would retain the requirement in current § 26.20(d) that the FFD policy must specify the consequences of violating the policy. The current requirements in this paragraph that are related to the procedures that the licensee or other entity would implement if an individual violates the FFD policy would be moved VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 to proposed § 26.27(c) [Procedures], which addresses FFD program procedures for organizational clarity. Proposed § 26.27(b)(9) would add a requirement for licensees’ and other entities’ FFD policies to describe the individual’s responsibility to report legal actions, as defined in proposed § 26.5 [Definitions]. The new requirement to report legal actions is discussed with respect to proposed § 26.61 [Self-disclosure and employment history]. However, the proposed rule would require the FFD policy to address the reporting of legal actions to ensure that individuals are aware of it and are not at risk of being subject to sanctions for failing to report any legal actions. This proposed change would be made to meet Goal 7 of this rulemaking with respect to protecting the due process rights of individuals who are subject to the policy, as discussed in Section IV.B. Proposed § 26.27(b)(10) would add a requirement for the FFD policy to describe the responsibilities of managers, supervisors, and escorts to report FFD concerns. The current rule implies that managers and supervisors have the responsibility to report FFD concerns in § 26.22(a)(5), which requires managers and supervisors to be trained in procedures ‘‘for initiating appropriate corrective action.’’ Similarly, the last phrase of § 26.22(b) requires that escorts be trained in procedures ‘‘for reporting problems to supervisory or security personnel,’’ and, therefore, also implies that escorts have a reporting responsibility. However, the current rule does not explicitly state that the FFD policy must convey this requirement. Therefore, the proposed rule would add § 26.27(b)(10) to enhance the internal consistency of the rule. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(b)(11) would add a requirement for the FFD policy to state that individuals who are subject to the rule must report FFD concerns. The proposed provision would be added for consistency with proposed § 26.33 [Behavioral observation], which would require individuals who are subject to the rule to perform behavioral observation and to report an FFD concern if they detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to the health and safety of the public. Proposed § 26.29 [Training] would establish a PO 00000 Frm 00043 Fmt 4701 Sfmt 4702 50483 requirement for all individuals who are subject to the rule to be trained in behavioral observation. As a group, these proposed requirements would be added to enhance the effectiveness of Part 26 in assuring the early detection of individuals who are not fit to perform the job duties that require them to be subject to this part, which is one of the performance objectives that FFD programs must meet, as discussed with respect to current § 26.10(b) and proposed § 26.23(c). The proposed provision would also be added to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003, as discussed in Section IV.B. The specific requirement for licensees’ and other entities’ FFD policies to state that individuals must report FFD concerns in proposed § 26.27(b)(11) would be necessary to ensure that individuals are aware of their responsibility to report concerns (and that sanctions may be imposed if they do not) to meet Goal 7 of this rulemaking with respect to protecting the due process rights of individuals who are subject to the policy, as discussed in Section IV.B. Proposed § 26.27(c) [Procedures] would combine the requirements related to procedures contained in current § 26.20(c)–(e), and would add other requirements, as follows: Proposed § 26.27(c)(1) would retain the requirements in current § 26.20(c). The phrase, ‘‘privacy and due process rights of an individual,’’ would be added to clarify the requirement for ‘‘protecting the employee,’’ contained in current § 26.20(c). For example, individuals’ privacy rights under the proposed rule include, but are not limited to, requirements for the protection of personal information that is collected about the individual and individual privacy during specimen collections. Examples of individuals’ rights to due process under the proposed rule include, but are not limited to, the right to an objective and impartial review of a determination that the individual has violated the FFD policy, the right to advance knowledge of rule provisions and FFD policy requirements that affect the individual, and the right to request testing of a split specimen or retesting an aliquot of a single specimen, if the individual questions a confirmed non-negative test result. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. E:\FR\FM\26AUP2.SGM 26AUP2 50484 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.27(c)(2)(i) and (c)(2)(ii) would divide current § 26.20(d) into separate paragraphs that address different topics. Proposed § 26.27(c)(2)(i) would retain the requirement for licensees and other entities to have procedures that specify the immediate and followup actions that must be taken if an individual is determined to have been involved in the use, sale, or possession of illegal drugs. Proposed § 26.27(c)(2)(ii) would continue to require licensees’ and other entities’ procedures to specify the immediate and followup actions to be taken if an individual is determined to have consumed alcohol to excess before the mandatory pre-work abstinence period, during the mandatory pre-work abstinence period, or while on duty, as determined by a test that measures BAC. The proposed rule would divide the current paragraph into two paragraphs to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(c)(2)(iii) and (c)(2)(iv) would require that licensees and other entities who are subject to the rule must prepare written procedures for implementing the FFD program that address followup actions for attempted subversion of the testing process. Proposed § 26.27(c)(2)(iii) would require procedures to specify immediate and followup actions if an individual has attempted to subvert the testing process by adulterating, substituting, or diluting specimens (in vivo or in vitro), or by any other means. Proposed § 26.27(c)(2)(iv) would require procedures to address the actions to be taken if an individual has refused to provide a specimen for testing. The proposed rule would add these provisions for consistency with proposed § 26.75(b), which would require licensees and other entities to terminate an individual’s authorization and, thereafter, permanently deny authorization to any individual who has committed any act or attempted act to subvert the testing process, including refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen, for any test required under this part. Adding the proposed requirements for procedures to address these circumstances would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(c)(2)(v) would require that the written procedures must address immediate and followup actions for individuals who have had drug- or alcohol-related legal actions taken against them, as defined in proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 § 26.5 [Definitions]. The proposed paragraph would support related provisions in proposed § 26.69(d) [Maintaining authorization with other potentially disqualifying FFD information], which, in general, require licensees and other entities to take certain steps if an individual has had drug- or alcohol-related legal actions taken against them while they are maintaining authorization to perform the job duties that require them to be subject to this part. Adding the proposed requirement for procedures to address these circumstances would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, and ensure the internal consistency of the proposed rule. Proposed § 26.27(c)(3) would amend current § 26.20(e). The proposed paragraph would continue to require licensees and other entities to have procedures to describe the process that the licensee or other entity will use to ensure that individuals who are called in to perform an unscheduled working tour are fit for duty. The proposed paragraph would also retain the requirement in the last sentence of current § 26.20(e)(3) that consumption of alcohol within the 5-hour pre-duty abstinence period may not by itself preclude a licensee or other entity from using individuals who are needed to respond to an emergency. However, this sentence would be moved from the end of the last sentence in the current paragraph to the introductory paragraph of proposed § 26.27(c)(3) because it applies generally to the topic of this proposed paragraph, rather than only to the topic addressed in current § 26.20(e)(3). This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, as discussed in Section IV. B. The proposed rule also would retain the other requirements of current § 26.20(e), as follows: Proposed § 26.27(c)(3)(i) would retain current § 26.20(e)(1), which requires the individual who is called in to state whether the individual considers himself or herself fit for duty and whether he or she has consumed alcohol within the pre-duty abstinence period stated in the FFD policy. Proposed § 26.27(c)(3)(ii)(A) and (c)(3)(ii)(B) would retain current § 26.20(e)(2) and the first sentence of current § 26.20(e)(3), which require that an individual who reports that he or she has used alcohol and is called in must be subject to alcohol testing, and that the licensee or other entity must establish controls and conditions under PO 00000 Frm 00044 Fmt 4701 Sfmt 4702 which an individual who has consumed alcohol may perform work safely. The proposed rule would also add a requirement to proposed § 26.27(c)(3)(i) and (c)(3)(iii). The proposed rule would require an individual who is called in to state whether he or she considers himself or herself to be fit for duty, in addition to stating whether he or she has consumed alcohol. The proposed rule would add this requirement to recognize that there are conditions other than the consumption of alcohol that may cause an individual to be unable to safely and competently perform duties, including, but not limited to, fatigue (as discussed with respect to Subpart I [Managing Fatigue]). Therefore, requiring individuals to report other conditions that may cause them to be impaired when called in to perform an unscheduled working tour, under proposed § 26.27(c)(3)(i), would strengthen the effectiveness of FFD programs by providing the licensee or other entity with more complete information about the individual’s condition to determine whether there is a need to establish controls and conditions under which the individual may safely perform work, as required under proposed § 26.27(c)(3)(iii). These proposed changes would be made to meet Goal 3 of this rulemaking, which is improve the effectiveness and efficiency of FFD programs. Proposed § 26.27(c)(3)(ii)(C) would be added to clarify that licensees and other entities may not impose sanctions if an individual is called in for an unscheduled working tour and has consumed alcohol during the pre-duty abstinence period specified in the FFD policy. During the public meetings discussed in Section V, the stakeholders requested this clarification to ensure that, if an individual who is called in unexpectedly has a confirmed positive test result for alcohol, he or she would not be subject to the sanctions that are otherwise required under this part for a confirmed positive alcohol test result. The NRC concurs with this recommendation because sanctions for the consumption of alcohol in these circumstances would be inappropriate, given that the individual would have been unaware that he or she would be called in to work. The proposed revision also would be consistent with the original intent of the rule. Therefore, the proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.27(c)(4) would be added to require that FFD procedures must describe the process to be followed when another individual’s behavior E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules raises an FFD concern and for reporting the concern. As discussed with respect to proposed § 26.27(b)(11), this proposed paragraph would be added for consistency with proposed § 26.33 [Behavioral observation], which would establish a new requirement that all individuals who are subject to the rule must perform behavioral observation and report any FFD concerns, and proposed § 26.29 [Training], which requires that individuals who are subject to this part must be trained to perform behavioral observation. The proposed requirement would be added to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs, and Goal 4, which is to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Proposed § 26.27(d) would retain the requirements of current § 26.20(f). Section 26.29 Training Proposed § 26.29 [Training] would combine and amend current § 26.21 [Policy communications and awareness training] and § 26.22 [Training of supervisors and escorts]. The proposed section would require that all individuals who are subject to the rule must receive the same training, to include, for example, behavioral observation, whereas current § 26.22 requires that only supervisors and escorts must receive behavioral observation training. Increasing the number of individuals who are trained in behavioral observation would enhance the effectiveness of FFD programs by increasing the likelihood of detecting potential impairment, consistent with Goal 3 of this rulemaking, as discussed in Section IV.B. Proposed § 26.29(a) [Training content] would combine the training topics listed in current §§ 26.21(a)(1)–(a)(5), 26.22(a)(1)–(a)(5), and 26.22(b). The required training topics would be rewritten in terms of knowledge and abilities (KAs) to be consistent with terminology used by licensees and other entities in other required training programs to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.29(a)(1) would combine current § 26.21(a)(1) with the latter portion of current § 26.21(a)(5). Consistent with the current training requirements, the proposed paragraph would require licensees and other entities to ensure that individuals who VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 are subject to the FFD policy have knowledge of the FFD policy and procedures that apply to them, the methods used to implement the policy and procedures, and the consequences of violating the policy and procedures. Proposed § 26.29(a)(2) would retain the requirement in current § 26.22(a)(1) that licensees and other entities who are subject to the rule must ensure that individuals understand their roles and responsibilities under the FFD program, such as avoiding substance abuse and reporting for testing within the time limit specified in FFD program procedures. Proposed § 26.29(a)(3) would amend the terminology used in current § 26.22(a)(2), which requires FFD training to address the roles and responsibilities of others, such as the personnel, medical, and employee assistance program (EAP) staffs. The proposed paragraph would replace the references to the ‘‘personnel’’ function and ‘‘medical’’ staff in current § 26.22(a)(2) with ‘‘human resources’’ and ‘‘FFD’’ staff, respectively. The proposed rule would also move the reference to the MRO into this paragraph from current § 26.21(a)(3). These proposed changes would be made to update the terminology in this paragraph to be consistent with other terms used throughout the regulation to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.29(a)(4) and (a)(5) would amend current § 26.21(a)(4) and (a)(2), respectively, by changing some of the language used in the current provisions. Current § 26.29(a)(4) requires FFD training to inform individuals who are subject to the rule of any EAPs that are available to them. The proposed rule would eliminate the reference to EAPs ‘‘provided by the licensee’’ in the current provision and amend it as ‘‘EAP services available to the individual’’ because there are other entities who would be subject to this requirement under the proposed rule. Proposed § 26.29(a)(5) would amend current § 26.21(a)(2) by replacing the phrase, ‘‘abuse of drugs and misuse of alcohol,’’ with ‘‘abuse of illegal and legal drugs and alcohol’’ for greater accuracy in describing the required knowledge. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.29(a)(6) would retain the portion of current § 26.21(a)(3) which requires licensees to ensure that individuals understand the effects of prescription and over-the-counter drugs and dietary factors on job performance. PO 00000 Frm 00045 Fmt 4701 Sfmt 4702 50485 The proposed rule would add a requirement for FFD training to address the effects of illness, mental stress, and fatigue on job performance, in order to ensure that individuals understand the bases for the licensee’s or other entity’s FFD policy regarding these conditions. The requirement in the last sentence of current § 26.20(a) for the FFD policy to address these factors would be moved to proposed § 26.27(b)(6) because proposed § 26.27(b) would address FFD policy requirements. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.29(a)(7) would retain the portion of current § 26.21(a)(3) that requires licensees and other entities to ensure that individuals who are subject to the rule understand the effects of prescription and over-the-counter drugs and dietary factors on drug and alcohol test results. Examples of medications, supplements, and dietary factors that can affect drug and alcohol test results may include, but are not limited to, ingesting foods containing poppy seeds, drinking coca tea, using some liquid or inhalant cold and cough preparations containing alcohol or codeine, and taking supplements containing hemp oil. Proposed § 26.29(a)(8) and (a)(9) would retain the requirements in current § 26.22(a)(3) and (a)(4), respectively. Proposed § 26.29(a)(10) would amend current § 26.22(a)(5). The proposed provision would retain the current requirement for FFD training to address the licensee’s or other entity’s process for initiating appropriate corrective action if an individual has an FFD concern about another person, to include referral to the EAP. The proposed rule would add a requirement for FFD training to ensure that individuals understand their responsibility to report FFD concerns to the person(s) who are designated in FFD program procedures to receive such reports. This proposed change would be made for consistency with proposed § 26.33 [Behavioral observation], which would require individuals to perform behavioral observation and report any FFD concerns, as discussed with respect to proposed § 26.27(b)(11), and proposed § 26.27(c)(4), which would require procedures for implementing the requirement. This group of inter-related proposed requirements would be added to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs, and Goal 4 of this rulemaking, which is to improve consistency between FFD E:\FR\FM\26AUP2.SGM 26AUP2 50486 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. A new § 26.29(b) [Comprehensive examination] would require that individuals who are subject to the FFD program must demonstrate attainment of the KAs specified in proposed § 26.29(a) by passing a comprehensive examination. This new requirement would be added because there have been several instances since Part 26 was first promulgated in which individuals were able to overturn determinations that they had violated a licensee’s FFD policy on the basis that they had not understood the information they received during FFD training and so could not be expected to comply with the requirements of the policy. Therefore, the proposed rule would require individuals to demonstrate their attainment of the KAs listed in proposed § 26.29(a) to ensure that the FFD training has been effective. The proposed rule would also require remedial training for those who fail to achieve a passing score on the examination. Proposed § 26.29(b) would require the examination to include at least one question for each KA, and establish a minimum passing score of 80 percent. These proposed requirements would be modeled on other required training programs that have been successful in ensuring that examinations are valid and individuals have achieved an adequate understanding of the subject matter. The proposed paragraph would be added to meet the portion of Goal 3 of this rulemaking that relates to improving the effectiveness of FFD programs by establishing a method to ensure that individuals understand the requirements with which they must comply. The proposed paragraph also would permit the use of various media for administering the comprehensive examination, in order to achieve the efficiencies associated with computerbased training and testing, for example, and other new training delivery technologies that may become available. Permitting the use of various media to administer the examination would meet the portion of Goal 3 of this rulemaking that relates to improving the efficiency of FFD programs. The proposed permission would also meet Goal 5, which is to improve Part 26 by eliminating or modifying unnecessary requirements, by providing flexibility in the methods that licensees and other entities may use to administer the required examination. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.29(c) [Training administration] would combine and amend the portions of current § 26.21(b) and § 26.22(c) that require FFD training for individuals, supervisors, and escorts before they are permitted to perform duties that require them to be subject to this part. Proposed § 26.29(c)(1) would require that all personnel who are subject to this part must complete FFD training before the licensee or other entity grants initial authorization to the individual, as defined in proposed § 26.55 [Initial authorization]. The proposed rule would also require that an individual’s training must be current before the licensee or other entity grants an authorization update or reinstatement to the individual, as defined in proposed § 26.57 [Authorization update] and § 26.59 [Authorization reinstatement], respectively. The proposed paragraph also would eliminate the requirement to upgrade training for newly assigned supervisors within 3 months of a supervisory assignment in current § 26.22(c), because all personnel would receive the same training and be required to complete the training before a licensee or other entity grants authorization to any individual. The proposed changes would be made for consistency with the new requirements related to granting and maintaining authorization that would be established in proposed Subpart C [Granting and Maintaining Authorization], as discussed with respect to that subpart. Proposed § 26.29(c)(2) would retain but combine the requirements for annual refresher training in current § 26.21(b), which addresses individuals who are subject to this part, and § 26.22(c), which addresses supervisors and escorts. The current requirements would be combined because all personnel would receive the same training under the proposed rule. The proposed paragraph would also permit individuals who pass a comprehensive ‘‘challenge’’ examination that demonstrates their continued understanding of the FFD program requirements to be excused from the refresher training that would otherwise be required under the proposed paragraph. The challenge examination would be required to meet the examination requirements specified in proposed § 26.29(b) [Comprehensive examination] and individuals who did not pass would undergo remedial training. Permitting individuals to pass a comprehension examination rather than take refresher training each year would ensure that they are retaining their FFD knowledge and abilities while reducing some costs associated with PO 00000 Frm 00046 Fmt 4701 Sfmt 4702 meeting the annual refresher training requirement. Therefore, this proposed change would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.29(c)(3) would permit licensees and other entities to use various media, in addition to traditional classroom instruction, for presenting initial and refresher training for the same reasons discussed with respect to the portion of proposed § 26.29(b) [Comprehensive examination] that would permit licensees and other entities to use various media to administer the comprehensive examination. The proposed requirements for a licensee or other entity to monitor the completion of training and provide access to an instructor or subject matter expert should ensure that individuals who are trained using different media would achieve the same understanding as persons who are trained in a classroom setting with an instructor present. This proposed flexibility may reduce the costs associated with presenting initial and refresher training only in a classroom setting. Therefore, this proposed change would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. To meet the annual refresher training requirement for individuals, proposed § 26.29(d) [Acceptance of training] would permit licensees and other entities to accept FFD training that was provided by other licensees and entities who are subject to the rule. Licensees and other entities would also be permitted to accept a passing result from a comprehensive examination that was administered by another Part 26 FFD program in lieu of refresher training, if the examination meets the requirements of proposed § 26.29(b) [Comprehensive examination]. Proposed § 26.29(c)(4) would incorporate item 3.3 of NUREG–1385, ‘‘Fitness for Duty in the Nuclear Power Industry: Responses to Implementation Questions,’’ which recommends acceptance of prior training. The proposed provision would also meet Goal 4 of this rulemaking, which is to improve consistency between FFD requirements and access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. These access authorization requirements also permit licensees and other entities to rely on training and examinations administered by other Part 26 programs. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Section 26.31 Testing Drug and Alcohol Proposed § 26.31 [Drug and alcohol testing] would rename current § 26.24 [Chemical and alcohol testing]. The proposed rule, in general, would replace the phrase, ‘‘chemical testing,’’ with the term, ‘‘drug testing,’’ because the testing for chemicals that is required in the rule is performed only in the context of urine drug testing. Therefore, the term, ‘‘drug testing,’’ more accurately conveys the nature of the testing that is performed. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(a) [General] would retain but update the language in current § 26.24(a) to be consistent with the new terminology used throughout the rule, as discussed in proposed § 26.5 [Definitions]. For example, the proposed rule would replace ‘‘licensee’’ with ‘‘licensees and other entities’’ to refer to the entities who are subject to the rule. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.31(b) [Assuring the honesty and integrity of FFD program personnel] would amend current Section 2.3 in Appendix A to Part 26, as explained below. Proposed § 26.31(b)(1) would amend the first paragraph of current Section 2.3 in Appendix A to Part 26, which requires licensees to carefully select and monitor persons responsible for administering the testing program to assure they meet the highest standards of honesty and integrity. The proposed rule would replace the current list of individuals who would be subject to this requirement with a cross-reference to § 26.25(a)(4) of the proposed rule, which specifies, in detail, the FFD program personnel who must be subject to the FFD program. This crossreference would be added to avoid repeating the list of personnel in this paragraph. The proposed paragraph would also add a reference to factors, other than a personal relationship with an individual who is subject to testing, that have the potential to cause an individual to be subject to influence attempts or may adversely affect the honesty and integrity of FFD program personnel. In addition to a personal relationship with an individual who is subject to testing, factors that could cause an individual to be compromised may include, but would not be limited to, a substance abuse problem [as discussed with respect to proposed § 26.25(a)(4)] or VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 financial problems. Therefore, the proposed rule would add a reference to these additional factors to more accurately characterize the scope of potential concerns that licensees and other entities must consider when selecting and monitoring the honesty and integrity of FFD program personnel. The proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.31(b)(1)(i) would amend current Section 2.3(2) in Appendix A to Part 26 in response to implementation questions regarding the current requirements that the NRC staff has received since Part 26 was first promulgated as well as discussions with stakeholders during the public meetings discussed in Section V. In response to numerous questions from licensees, the proposed paragraph would clarify that the background investigations, credit and criminal history checks, and psychological evaluations that are required for persons who are granted unescorted access to protected areas in nuclear power plants are acceptable when determining the honesty and integrity of FFD program personnel. The proposed rule would retain the term, ‘‘appropriate,’’ in the current rule for two reasons. First, it would be used to indicate that, for FFD program personnel who are employed by entities who are subject to the rule but are not nuclear power plants, the requirements may be met through investigations, checks, and evaluations that provide the information needed to determine the honesty and integrity of FFD program personnel but may differ from those required under nuclear power plant access authorization programs. In addition, the proposed rule would retain the term, ‘‘appropriate,’’ because it has particular relevance to the requirement for licensees and other entities to conduct criminal history checks for FFD program personnel. In some cases, licensees and other entities cannot legally obtain the same type of criminal history information about FFD program personnel as they are able to obtain for other individuals who are subject to Part 26. Therefore, the term, ‘‘appropriate,’’ would be used to indicate that local criminal history checks for FFD program personnel who do not have unescorted access to nuclear power plant protected areas are acceptable. These proposed changes would be made to meet the portion of Goal 6 of this rulemaking that pertains to improving clarity in the language of the rule. The requirement in current Section 2.3(2) in Appendix A to Part 26 for PO 00000 Frm 00047 Fmt 4701 Sfmt 4702 50487 ‘‘appropriate background checks and psychological evaluations’’ to be ‘‘conducted at least once every three years’’ would be relaxed to require that credit and criminal history checks and updated psychological assessments be conducted nominally every 5 years. The proposed rule would relax the current requirement for several reasons. First, the NRC is not aware of any instances in which licensees and other entities have identified new information about FFD program personnel from updating the background checks and psychological assessments that had not already been identified through other avenues, including self-reports by FFD program personnel, drug and alcohol testing, and behavioral observation. However, the NRC continues to believe that the required updates provide an independent method to verify the ongoing honesty and integrity of FFD program personnel that is necessary because of the critical importance of FFD program personnel in assuring program effectiveness. Therefore, the proposed rule would retain the current requirement for updated background checks and psychological assessments but would reduce the required frequency of these updates from every 3 years to every 5 years. This proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. In addition, the proposed frequency for these updates would increase the consistency of Part 26 with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003, which is Goal 4 of this rulemaking. Proposed § 26.31(b)(1)(ii) would amend current Section 2.3(1) in Appendix A to Part 26 for clarification in response to the many implementation questions that have arisen since the regulation was published. In the current rule, individuals who have a personal relationship with the individual being tested (i.e., a donor), such as the donor’s ‘‘supervisors, coworkers, and relatives,’’ are prohibited from performing any ‘‘collection, assessment, or evaluation procedures’’ involving the individual being tested. The restriction on ‘‘supervisors, coworkers, and relatives’’ was included in the current rule to provide examples of the ‘‘personal relationships’’ referenced in the introductory paragraph of current Section 2.3 in Appendix A to Part 26. The restriction on coworkers in the current rule has been misinterpreted by some licensees as meaning that no one E:\FR\FM\26AUP2.SGM 26AUP2 50488 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules who is an employee of the same corporation may be involved in collection, assessment, or evaluation procedures. However, in a large corporation, there will be many individuals who are employed by the same corporation who do not have personal relationships with FFD program personnel, specifically, or with other individuals who are subject to testing, in general. Therefore, in proposed § 26.31(b)(1)(ii), the phrase, ‘‘in the same work group,’’ would be added to clarify that the example regarding coworkers pertains to individuals who report to the same manager. For example, FFD program personnel report to the FFD program manager and so would be considered ‘‘coworkers in the same work group’’ to whom the proposed restriction would apply. In addition, the proposed paragraph would add a reference to determinations of fitness (discussed with respect to proposed § 26.189 [Determination of fitness]) to provide a clarifying example of the assessment and evaluation procedures that FFD program personnel would be prohibited from performing if the FFD program staff member has a personal relationship with the subject individual. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(b)(1)(iii) would relax the prohibition on individuals who have ‘‘personal relationships’’ with the donor from performing specimen collection procedures in current Section 2.3(1) in Appendix A to Part 26 in response to stakeholder requests during the public meetings discussed in Section V. With respect to specimen collections, stakeholders were convincing that the current restriction imposes an unnecessary burden when the objective of ensuring the integrity of specimen collections in these circumstances could be achieved by other means. Therefore, in proposed § 26.31(b)(1)(iii), individuals who have a personal relationship with a donor would be permitted to collect specimens, if the collection and preparation of the specimens for shipping is monitored by another individual who does not have a personal relationship with the donor and is not a supervisor, a coworker in the same work group, or a relative of the donor. The proposed rule would require that the independent individual who is designated to monitor the collection must be trained to monitor specimen collections. The proposed paragraph would also provide examples of the types of individuals who may monitor VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 the integrity of specimen collection procedures in these circumstances, including but not limited to, security force or quality assurance personnel. This proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements, by permitting monitored collections in these circumstances while continuing to assure the integrity of specimen collections from FFD program personnel. The proposed rule would retain the prohibition on individuals who have personal relationships with the donor from performing assessment and evaluation procedures because monitoring of these activities by qualified, independent personnel would not be feasible. Proposed § 26.31(b)(1)(iv) would be added to prohibit a collector who has a personal relationship with the donor from acting as a urine collector under monitoring, if a directly observed collection is required. This proposed prohibition would be necessary to minimize embarrassment to the donor (and the collector) during a directly observed collection. The proposed paragraph would be added to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.31(b)(1)(v) would amend current Section 2.3(3) in Appendix A to Part 26 to require that MROs who are on site at a licensee’s or other entity’s facility must be subject to behavioral observation. For the purposes of the proposed paragraph, a ‘‘facility’’ would include, but is not limited to, a licensee’s or other entity’s corporate offices and any medical facilities that are operated by the licensee or other entity. The proposed requirement would be added because MROs are ‘‘persons responsible for administering the testing program,’’ but some FFD programs have not included MROs in the behavioral observation element of their programs. However, the proposed rule would limit the behavioral observation of MROs to those times when they are on site at a licensee’s or other entity’s facility, in order to permit licensees and other entities to continue relying on the services of MROs who normally work independently, often alone, in offices at a geographical distance from the licensee’s or other entity’s facilities so that behavioral observation is impractical. Limiting the proposed requirement for behavioral observation of MROs to those instances in which the MRO is working at a licensee’s or other entity’s facility would be adequate to assure the continuing honesty and PO 00000 Frm 00048 Fmt 4701 Sfmt 4702 integrity of these MROs because MROs who work off site would not be interacting on a daily basis with other individuals who are subject to the FFD program. Therefore, off-site MROs would be less likely to be subject to potential influence attempts than MROs who normally work on site because they are generally inaccessible. Further, the proposed rule would continue to require all MROs to be subject to the other FFD program elements that are required in this proposed Subpart, including drug and alcohol testing and regular psychological assessments and background investigations, which would permit licensees and other entities to monitor off-site MROs’ honesty and integrity. This proposed relaxation would be added to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.31(b)(2) would provide another relaxation related to collecting specimens from FFD program personnel. The proposed paragraph would permit FFD program personnel to submit specimens for testing at collection sites that meet the requirements of 49 CFR Part 40, ‘‘Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs’’ (65 FR 41944; August 9, 2001). As discussed with respect to proposed § 26.31(b)(1), some FFD program personnel, such as contract MROs and EAP staff members, normally work at locations that are so distant from a licensee’s collection site(s) as to make it impractical for them to be randomly tested at a licensee’s or other entity’s collection site. Permitting these FFD program personnel to be tested at local collection sites that follow similar procedures would be adequate to meet the goal of ensuring their continuing honesty and integrity. Therefore, the proposed paragraph would be added to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.31(c) [Conditions for testing] would replace current § 26.24(a)(1)-(a)(4). The proposed paragraph would list the situations in which testing is required in separate paragraphs, such as ‘‘pre-access,’’ ‘‘for cause,’’ and ‘‘post-event’’ testing, to clarify that each situation for which testing is required stands on its own. The current provision in § 26.24(a)(3), in particular, has led to confusion and misinterpretation of the regulations, to be corrected as noted below. Specific requirements for conducting the testing would be addressed in proposed Subparts E [Collecting Specimens for E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Testing], F [Licensee Testing Facilities], and G [Laboratories Certified by the Department of Health and Human Services]. The proposed rule would reorganize and amend current § 26.24(a)(1)-(a)(4) to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(c)(1) [Pre-access] would amend current § 26.24(a)(1), which requires pre-access testing within 60 days before the initial granting of unescorted access to protected areas or assignment to job duties within the scope of this part. The proposed paragraph would introduce the concepts of ‘‘initial authorization,’’ ‘‘authorization update,’’ and ‘‘authorization reinstatement,’’ which refer to categories of requirements that licensees and other entities must meet in order to assign an individual to job duties which require the individual to be subject to Part 26. Section 26.65 [Preaccess drug and alcohol testing] in Subpart C [Granting and Maintaining Authorization] of the proposed rule would specify detailed requirements for conducting pre-access testing. Proposed § 26.31(c)(2) [For cause] and § 26.31(c)(3) [Post event] would clarify and amend current § 26.24(a)(3), as follows: Proposed § 26.31(c)(2) [For cause] would continue to require for-cause testing in response to any observed behavior or physical condition indicating possible substance abuse. The proposed rule would also retain the current requirement for testing if the licensee or other entity receives credible information that an individual is engaging in substance abuse. The term, ‘‘substance abuse,’’ would be defined in proposed § 26.3 [Definitions]. Proposed § 26.31(c)(3) [Post event] would amend the portion of current § 26.24(a)(3) that requires drug and alcohol testing when an event involving a failure in individual performance leads to significant consequences. The proposed rule would amend the current provision because it has been subject to misinterpretation and numerous questions from licensees. The phrase, ‘‘if there is reasonable suspicion that the worker’s behavior contributed to the event,’’ in current § 26.24(a)(3) has been subject to misinterpretation. The location of this phrase at the end of the list of conditions under which post-event testing must be performed has led some licensees to conclude that this phrase applies only to events involving actual or potential substantial degradations of the level of safety of the plant. Other licensees have misinterpreted the term, VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 ‘‘reasonable suspicion’’ as meaning, ‘‘reasonable suspicion of substance abuse,’’ or some other ‘‘illegal’’ or ‘‘disreputable’’ activity. Neither of these interpretations is consistent the intent of this paragraph. Therefore, to clarify the intent of the provision, the proposed rule would eliminate the phrase, ‘‘if there is reasonable suspicion that the worker’s behavior contributed to the event,’’ from the end of the list of significant events that require postevent testing and, instead, require postevent testing as soon as practical after significant events [as listed in proposed § 26.31(c)(3)(i)-(c)(3)(iii)] involving a human error that may have caused or contributed to the event. The proposed rule would use the term, ‘‘human error,’’ rather than the current term, ‘‘worker’s behavior,’’ to emphasize that post-event testing would be required for acts that unintentionally deviated from what was planned or expected in a given task environment (NUREG/CR–6751, ‘‘The Human Performance Evaluation Process: A Resource for Reviewing the Identification and Resolution of Human Performance Problems’’) as well as failures to act (i.e., errors of omission). Therefore, testing would be required regardless of whether there was ‘‘reasonable suspicion’’ that the individual was abusing drugs or alcohol for the consequences listed in the proposed paragraph. In addition, the second sentence of proposed § 26.31(c)(3) would be added in response to stakeholder comments at the public meetings discussed in Section V. The stakeholders noted that the current provision does not clearly delineate the scope of individuals who must be subject to post-event testing. Some licensees have misinterpreted the current provision as requiring that all individuals who are involved in a significant event must be tested, including individuals whose behavior played no causal or contributing role in the event. For example, these licensees’ FFD programs would require that an individual who was exposed to radiation in excess of regulatory limits must be tested, even if other individuals’ actions (or failures to act) were responsible for the event and the individual who suffered the exposure was a bystander. Therefore, the second sentence of the proposed provision would clarify the original intent of this paragraph by stating that only the individual(s) who committed the error(s) would be subject to post-event testing. Proposed § 26.31(c)(3)(i) would provide a threshold for the types of workplace personal injuries and illnesses for which post-event testing PO 00000 Frm 00049 Fmt 4701 Sfmt 4702 50489 would be required in response to implementation questions related to current § 26.24(a)(3). Some licensees have misinterpreted the current provision as requiring post-event testing for any personal injury, no matter how minor. The proposed paragraph would clarify the type of personal injuries and illnesses for which post-event testing would be required by establishing a threshold that is based on the general criteria contained in 29 CFR 1904.7 of the regulations of the Occupational Safety and Health Administration (OSHA) for recording occupational injuries and illnesses. As defined in the OSHA standard and the proposed rule, these would include any injuries and illnesses which result in death, days away from work, restricted work, transfer to another job, medical treatment beyond first aid, loss of consciousness, or other significant injury or illness as diagnosed by a physician or other licensed health care professional, even if it does not result in death, days away from work, restricted work or job transfer, medical treatment beyond first aid, or loss of consciousness. The proposed rule would add this clarification to reduce the number of unnecessary post-event tests performed for minor injuries and illnesses and meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. In response to stakeholder comments at the public meetings discussed in Section V, proposed § 26.31(c)(3)(i) would also include the qualifying phrase, ‘‘within 4 hours after the event,’’ with reference to the recordable personal injuries and illnesses that would trigger post-event testing. The stakeholders noted that, in some cases, it is difficult to detect illnesses and injuries that meet the proposed threshold for post-event testing at the time they occur. For example, if an individual has been injured on site but does not report the injury to the licensee or other entity and waits for several days to seek treatment from his or her private physician, the licensee or other entity may not learn of the injury. The extent of an injury may be unclear at the time it occurs and so it may appear to fall below the threshold for post-event testing until several days have passed. In these examples, if the licensee or other entity learns after several days that the injury would have met the threshold for post-event testing, it would be too late for post-event testing to be of any value in determining whether the individual’s use of drugs or alcohol may have contributed to the event. If alcohol E:\FR\FM\26AUP2.SGM 26AUP2 50490 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules or drug use had contributed to the event, testing several days later would be unlikely to detect it because of the effects of metabolism. Further, it would be difficult to prove that any nonnegative test results reflected the individual’s condition at the time the event occurred rather than subsequent drug or alcohol use. Therefore, the proposed rule would limit post-event testing to situations in which the licensee or other entity can determine that an injury or illness meets the proposed threshold within 4 hours after the event has occurred, and can conduct the testing within a time frame that will provide useful information about the individual’s condition at the time of the event. However, the proposed paragraph should not be misinterpreted as requiring post-event testing to be completed within 4 hours after the event. The time period after the event within which testing must be completed would be defined in proposed § 26.31(c)(3) as ‘‘as soon as practical.’’ This proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Proposed § 26.31(c)(3)(ii) would carry over the relevant language in the corresponding portion of current § 26.24(a)(3), without change. Proposed § 26.31(c)(3)(iii) would carry over the relevant language in the corresponding portion of current § 26.24(a)(3), but, as discussed with respect to proposed § 26.31(c)(3), would eliminate the current qualifying phrase, ‘‘if there is reasonable suspicion that the worker’s behavior contributed to the event.’’ Proposed § 26.31(c)(4) [Followup] would retain the intent of current § 26.24(a)(4) but amend its language. The proposed rule would eliminate the phrase, ‘‘to verify continued abstention from the use of substances covered under this part,’’ because it could be misinterpreted as limiting the substances for which followup testing would be permitted to only those listed in proposed § 26.31(d)(1) [Substances tested]. The proposed rule would revise this phrase as, ‘‘to verify continued abstinence from substance abuse,’’ to clarify that FFD programs would be permitted to conduct followup testing for any substances an individual may have abused, subject to certain additional requirements discussed with respect to proposed § 26.31(d)(1)(i). Detailed requirements for conducting followup testing would be established in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information], where they would apply to licensees’ and other entities’ VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 processes for granting and maintaining authorization. The proposed rule would make these changes to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(c)(5) [Random] would simplify current § 26.24(a)(2) to define random testing as one of the conditions under which testing is required. The detailed requirements for implementing random testing that are contained in current § 26.24(a)(2) would be moved to proposed § 26.31(d) [General requirements for drug and alcohol testing]. The proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(d) [General requirements for drug and alcohol testing] would be added to better organize requirements related to the general administration of drug and alcohol testing. The proposed rule would present more detailed requirements for conducting drug and alcohol testing in proposed Subparts E [Collecting Specimens for Testing], F [Licensee Testing Facilities], and G [Laboratories Certified by the Department of Health and Human Services]. The proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(d)(1) [Substances tested] would retain the list of drugs for which testing must be conducted in current Section 2.1(a) in Appendix A to Part 26, but would clarify that, for some drugs, the testing is conducted to detect drug metabolites. The circumstances in which testing for these substances must be performed (i.e., pre-access, postevent, random) would be moved to proposed § 26.31(c) for organizational clarity. In addition, the proposed paragraph would add adulterants to the list of substances for which testing must be conducted, consistent with the addition of specimen validity testing requirements to the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.31(d)(1)(i) would retain the permission in the second sentence of current § 26.24(c) for licensees and other entities to consult with local law enforcement agencies or other sources of information to identify drugs that may be abused by individuals in the geographical locale of the FFD program. Proposed § 26.31(d)(1)(i)(A) would retain the permission in current § 26.24(c) for licensees and other entities to add to the panel of drugs for PO 00000 Frm 00050 Fmt 4701 Sfmt 4702 which testing is required in proposed § 26.31(d)(1). Additional drugs may include, but are not limited to, ‘‘designer drugs,’’ such as ecstasy or ketamine, and illegal drugs that are popular in some geographical areas, such as lysergic acid diethylamide-25 (LSD). The proposed paragraph would also require that any additional drugs must be listed on Schedules I–V of section 202 of the Controlled Substances Act [21 U.S.C. 812], which would be consistent with the definition of ‘‘illegal drugs’’ in current § 26.3 [Definitions]. Proposed § 26.31(d)(1)(i)(B) would retain the last sentence in current § 26.24(c), which requires licensees and other entities who are subject to the rule to establish appropriate cutoff levels for any additional substances for which testing will be conducted. Proposed § 26.31(d)(1)(i)(C) would retain the requirement in current Section 2.1(c) in Appendix A to Part 26, which requires licensees and other entities to establish rigorous testing procedures for any additional drugs. Proposed § 26.31(d)(1)(i)(D) would be added to further clarify the requirement in proposed § 26.31(d)(1)(i)(C) for ‘‘rigorous testing procedures’’ and would replace the portion of current Section 1.1(2) in Appendix A to Part 26 that requires licensees to obtain written approval from the NRC to test for additional drugs. The purpose of the current requirement is to provide an opportunity for the NRC to verify that the assays and cutoff levels licensees use in testing for additional drugs are scientifically sound and legally defensible. However, the current requirement also imposes a reporting burden. The proposed provision would eliminate this reporting requirement and replace it with requirements for an independent forensic toxicologist to conduct the review that the NRC currently performs. The proposed rule would require the independent forensic toxicologist to certify, in advance and in writing, that the assay to be used in testing for any additional drugs or drug metabolites, and the cutoff levels to be applied, are scientifically sound and legally defensible. The proposed paragraph would also specify the required qualifications for the forensic toxicologist. Certification of the assay and cutoff levels would not be required in two circumstances: (1) If the HHS Guidelines are revised to permit use of the assay and the cutoff levels in Federal workplace drug testing programs, and (2) if the licensee or other entity has received written approval from the NRC to test for the additional drugs or metabolites and to apply the cutoff levels to be used in testing for the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules additional drugs or metabolites, as required in current Section 1.1(2) in Appendix A to Part 26. Certification would be unnecessary in these two circumstances because it would be redundant. This proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements, while continuing to ensure that any drug testing conducted under Part 26 is scientifically sound and legally defensible. Proposed § 26.31(d)(1)(ii) would amend current Section 2.1(b) in Appendix A to Part 26 and would permit licensees and other entities, when conducting for-cause, post-event, and followup testing, to test for any drugs listed on Schedules I-V of the CSA that the licensee or other entity suspects the individual may have abused, as follows: The proposed paragraph would add a reference to post-event testing for consistency with the intent of current Section 2.1(b) in Appendix A to Part 26, which permits testing for any illegal drugs during a for-cause test. The current rule includes post-event testing within the definition of for-cause testing whereas the proposed rule would use a distinct term, ‘‘post-event’’ testing, to refer to the testing that is required following certain events, as discussed with respect to proposed § 26.31(d)(3). Therefore, it would be necessary to add a reference to post-event testing to this paragraph to retain the full intent of the current provision. The proposed paragraph would also add a reference to followup testing, which would permit the licensee or other entity to test for an additional drug if an individual who is subject to followup testing is suspected of having abused it. For example, if an SAE, in the course of performing a determination of fitness under proposed § 26.189 [Determination of fitness], found that an individual was abusing barbiturates, this provision would permit followup testing to verify that the individual is abstaining from such abuse. This proposed change would be made to strengthen the followup testing element of FFD programs by ensuring that followup testing would detect continued drug abuse and would therefore, meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. The proposed paragraph would retain the limitation in current Section 2.1(b) in Appendix A to Part 26, which permits testing only for illegal drugs that the individual is suspected of VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 having abused, and extend that limitation to followup testing. The proposed rule would extend this limitation to followup testing to protect donors’ rights to privacy, which is the same reason that the limitation was established in the current rule with respect to for-cause testing. That is, licensees and other entities would be prohibited from conducting a wide spectrum of tests for any drugs without suspicion that the individual had abused them, because such tests could reveal personal medical information about the individual that is irrelevant to the performance objectives of this part, as discussed with respect to § 26.23 [Performance objectives]. Thus, extending the current limitation on forcause testing to followup testing would meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. The proposed paragraph would replace the term, ‘‘illegal drugs,’’ in current Section 2.1(b) in Appendix A to Part 26 with a specific reference to the drugs that are listed on Schedules I–V of the CSA. These schedules list drugs with abuse potential and include many drugs with legitimate medical uses that are not ‘‘illegal’’ when used in accordance with a valid prescription for medical purposes. Therefore, replacing the term, ‘‘illegal drugs,’’ with the reference to Schedules I–V of the CSA would more accurately characterize the specific drugs for which testing is permitted. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.31(d)(1)(ii) would also apply the new requirements in proposed § 26.31(d)(1)(i)(D) related to testing for drugs that are not included in the FFD program’s panel of drugs to for-cause, post-event, and followup testing. The proposed paragraph would require the assays and cutoff levels to be used in testing for the additional drugs to be certified by a forensic toxicologist in accordance with proposed § 26.31(d)(1)(i)(D). The proposed provision would provide consistency with proposed § 26.31(d)(1)(i)(D) and ensure that the testing would be scientifically sound and legally defensible. The proposed change would be made to protect donors’ rights to due process, as it relates to minimizing the possibility of false positive test results, and strengthen the effectiveness of FFD programs by ensuring that tests for additional drugs that are conducted for cause, post-event, or as part of a followup program will accurately detect drugs that an individual may have PO 00000 Frm 00051 Fmt 4701 Sfmt 4702 50491 abused. Therefore, this proposed change would be made to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26, and Goal 3, which is to improve the effectiveness and efficiency of FFD programs. The last sentence of proposed § 26.31(d)(1)(ii) would be added to prohibit inappropriate practices that some FFD programs have implemented. The NRC is aware that some FFD programs have directed their HHScertified laboratories to test specimens that are collected for for-cause, postevent, or followup testing at the assay’s LOD without first subjecting the specimens to initial testing. In addition, if a drug or drug metabolite is detected at the LOD, the MROs in these programs have confirmed the test result as an FFD policy violation, despite the quantitative test result falling below the FFD program’s established confirmatory cutoff level. Although these practices may increase the likelihood of detecting drug abuse, they are inconsistent with one of the bases for establishing cutoff levels for drug testing in the rule, which is to minimize the likelihood of false positives that could result in the imposition of sanctions on an individual who has not abused drugs. It also subjects individuals who are undergoing for-cause, post-event, or followup testing to unequal treatment when compared to individuals who are subject to random and pre-access testing, in which the established cutoff levels must be applied. Therefore, the proposed rule would specifically prohibit these practices to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26, by requiring that individuals who are subject to for-cause, post-event, and followup testing must be subject to the same testing procedures and cutoff levels as others who are tested under this part. Proposed § 26.31(d)(2) [Random testing] would reorganize and amend the requirements for conducting random testing, which currently appear in § 26.24(a)(2), as follows: Proposed § 26.31(d)(2)(i) would add a new requirement for licensees and other entities to administer random testing in a manner that provides reasonable assurance that individuals are unable to predict the time periods during which specimens will be collected. This proposed provision would be added because the NRC is aware of instances in which individuals who believed they would have a non-negative result, if tested, have been able to determine the E:\FR\FM\26AUP2.SGM 26AUP2 50492 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules days on which collections were being conducted, which then gave them the opportunity to leave work under the guise of illness in order to avoid the possibility of being tested. The ability to detect that specimens are or will be collected for random testing also provides an opportunity for individuals to be prepared to subvert the testing by procuring an adulterant or urine substitute and keeping it available on their persons during the periods that specimens are collected. However, the NRC also recognizes that it is impossible to ensure that individuals are unable to detect the periods during which specimens are being collected. At a minimum, coworkers will be suspicious that collections are occurring if they observe an individual leaving the work site and returning within a short time, even if the supervisor and individual do not discuss the reason for the individual’s short absence. Therefore, the proposed paragraph would require licensees and other entities to conduct random testing in a manner that would provide ‘‘reasonable assurance’’ that individuals are unable to predict when specimens will be collected, rather than requiring them to ‘‘ensure’’ that the period of time during which specimens will be collected cannot be detected. However, licensees and other entities would be required to minimize the likelihood that individuals who are subject to testing know that they are more likely to be called for testing at certain times than others. Within this context, proposed § 26.31(d)(2)(i)(A) would be added to require licensees and other entities to take reasonable steps to either conceal from the workforce that collections will be performed during a scheduled collection period, or create the appearance that specimens are being collected during a portion of each day on at least four days in each calendar week at each site. This proposed provision would require licensees and other entities to take reasonable steps to minimize the cues that persons may use to detect that specimens will be collected at a certain time. These cues may include, but are not limited to, the presence of a mobile collection facility on site and the presence of collectors at the site only on days that collections occur, or having the lights on in a designated collection site and occupying it only when the collection site is in use. A reasonable step to minimize cues associated with activities inside a collection site could be covering any outside windows so that a passerby cannot detect whether the collection site is occupied. Other steps VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 to meet the proposed requirement could include, but would not be limited to, stationing a mobile collection facility on site for some part of the day on four days each week or assigning individuals to staff the designated collection site during periods that specimens are not being collected during some portion of each day on at least four days in each calendar week. Maintaining the appearance that the collection site is active on more than half of the days in each week would make it more difficult for individuals to plan to subvert the testing process by leaving work when they believe specimens are being collected. The requirements in proposed § 26.31(d)(2)(i) and (A) would be added to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by reducing the opportunities for individuals to subvert the testing process by having advanced warning that specimens are being collected. Proposed § 26.31(d)(2)(i)(B) would amend the third sentence of current § 26.24(a)(2), which requires that specimens must be collected ‘‘at various times during the day.’’ The proposed rule would expand the current requirement to require licensees and other entities to ‘‘collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays, and at various times during a shift.’’ The purpose of the current and proposed provisions is to ensure that individuals cannot predict the times at which they will be tested, as well as prevent them from perceiving that there are ‘‘safe’’ periods during which they will not be tested that may lead them to believe they could engage in substance abuse without fear of detection. Varying the time periods during which specimens are collected on an unpredictable schedule would also increase the rule’s effectiveness in deterring substance abuse. Adding this proposed provision would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. Proposed § 26.31(d)(2)(ii) would retain the third sentence of current § 26.24(a)(2), which states that random testing must be administered on a nominal weekly frequency. The current requirement to collect specimens for random testing at ‘‘various times during the day’’ would be retained in proposed § 26.31(d)(2)(i)(B). Proposed § 26.31(d)(2)(iii) would require individuals who are selected for random testing to report to the collection site as soon as reasonably practicable after they have been notified that they have been selected for testing, within the time period established in PO 00000 Frm 00052 Fmt 4701 Sfmt 4702 the FFD policy. The necessity for the FFD policy to establish a time limit within which individuals must report for testing is discussed with respect to proposed § 26.27(b)(2). Proposed § 26.31(d)(2)(iii) would be added to further clarify this requirement by emphasizing the individual’s responsibility to report as soon as reasonably practicable after notification. For example, in order to cover all of the possible situations in which it may not be possible for an individual to immediately report for testing after notification (which could include the time required to travel to a collection site or to change clothes and be monitored for contamination after working under a radiation work permit), the FFD policy may permit individuals up to 2 hours to report for testing after notification. However, if there are no legitimate work, travel, or other demands that prevent an individual from immediately reporting for testing, the proposed provision would require the individual to report as soon as he or she is notified. This provision would strengthen FFD programs by further reducing opportunities for individuals to subvert the testing process, as discussed with respect to proposed § 26.27(b)(2), and, therefore, would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. Proposed § 26.31(d)(2)(iv) would amend the first sentence of current § 26.24(a)(2) to clarify that individuals who are off site and unavailable for testing when selected for a random test, must be tested at the earliest reasonable and practical opportunity. This proposed requirement would be added to prohibit licensees and other entities from returning these individuals’ names to the random testing pool without conducting a test, as has been some licensees’ practice. Returning the individuals’ names to the random testing pool without conducting a test ensures that they are immediately eligible for another unannounced test, as required in proposed § 26.31(d)(2)(v), but does not ensure that all individuals who are subject to this part have an equal probability of being tested. This proposed revision, therefore, would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. The proposed paragraph would include the phrase, ‘‘at the earliest reasonable and practical opportunity when both the donor and collectors are available to collect specimens for testing,’’ to clarify that licensees and other entities would not be required to call an individual back to the site if he E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules or she is off site when selected for testing. In addition, the proposed provision would not require licensees and other entities to make special arrangements to ensure that a collector is available to collect the specimens as soon as the individual returns to the site. The NRC is aware that some licensees have called in individuals and collectors in the past under these circumstances. However, these practices may permit individuals to predict that they will be subject to testing when they return to the site, which would provide them with an opportunity to take actions to subvert the testing process, as discussed with respect to proposed § 26.31(d)(2)(i). Therefore, the proposed paragraph would require licensees and other entities to collect specimens from an individual who is off site when selected for testing, in a manner that also ensures the individual does not have advance notification that he or she has been selected for testing. This proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Proposed § 26.31(d)(2)(v) would retain the second sentence of § 26.24(a)(2), which requires that an individual who has completed a test is immediately eligible for another random test. Proposed § 26.31(d)(2)(vi) would amend the last sentence of current § 26.24(a)(2) in response to licensee implementation questions with respect to the meaning of the term, ‘‘workforce,’’ in the current rule. These questions have related to whether ‘‘workforce’’ means all individuals who are employed by the licensee, including individuals who are not subject to Part 26, all individuals at a site, or all individuals who are subject to the licensee’s FFD program. The proposed paragraph would clarify that the number of random tests that must be performed in a year must be equal to 50 percent of the population of individuals who are subject to random testing under the FFD program. If several sites are covered by a common FFD program, the ‘‘population’’ would include all individuals who are subject to the common FFD program. The population would also include individuals who have applied for authorization and who are subject to random testing under proposed § 26.67 [Random drug and alcohol testing of individuals who have applied for authorization]. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(d)(3) [Drug testing] would be added to group requirements VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 in one paragraph that are related to the general administration of drug testing. This proposed change would be made because requirements that address this topic are dispersed throughout the current rule whereas grouping them together in a paragraph would make them easier to locate within the proposed rule. The proposed reorganization would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.31(d)(3)(i) would combine some of the requirements in current Section 1.1(3) in Appendix A to Part 26, § 26.24(f), the first sentence of current Section 2.8(e)(1) in Appendix A, and current Section 4.1(a) and (b) in Appendix A to Part 26, which require licensees and other entities to use only HHS-certified laboratories to perform drug testing, except if initial tests are performed at a licensee testing facility. Other detailed requirements in these sections would be retained, but presented in the appropriate sections in proposed Subparts E [Collecting specimens for testing], F [Licensee Testing Facilities], and G [Laboratories Certified by the Department of Health and Human Services]. The proposed rule would use the term, ‘‘nonnegative,’’ to replace the term, ‘‘presumptive positive,’’ in this paragraph and throughout the remainder of the rule to refer collectively to adverse validity and drug test results, as discussed with respect to the definition of ‘‘non-negative’’ in proposed § 26.5 [Definitions]. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve the organizational clarity of the rule. The proposed paragraph would also require that specimens sent to the HHScertified laboratory by the licensee or other entity must be subject to initial validity and drug testing by the laboratory, and any specimens that yield non-negative initial validity or drug test results must be subject to confirmatory testing by the laboratory, except for invalid specimens that cannot be tested. Specimen validity testing refers to testing conducted by a laboratory to identify attempts to tamper with a specimen. Attempts to tamper with a specimen may include (1) adulteration, which means putting a substance into a specimen that is designed to mask or destroy the drug or drug metabolite that the specimen may contain or to adversely affect the assay reagent; (2) dilution, which means adding a liquid, which, by contrast to an adulterant, would not be detected by validity testing, to the urine specimen to PO 00000 Frm 00053 Fmt 4701 Sfmt 4702 50493 decrease the concentration of a drug or metabolite below the cutoff concentration; and (3) substitution, which means replacing a valid urine specimen with a drug-free specimen. When HHS published its Notice of Proposed Revisions (66 FR 43876; August 21, 2001) to the HHS Guidelines to establish requirements for specimen validity testing performed by HHScertified laboratories, the HHS reported that the number of adulterated and substituted urine specimens has been increasing among the specimens tested under the Federal agency workplace drug testing program and the U.S. Department of Transportation (DOT) regulations (49 CFR part 40). Program experience gained since Part 26 was first promulgated has also indicated an increasing number of adulterated and substituted urine specimens submitted to HHS-certified laboratories from Part 26 testing programs. Although current Part 26 contains a number of requirements related to specimen validity (e.g., the fifth sentence of current Section 2.1(e), Section 2.4(f)(2), 2.4(g)(14)-(g)(16), and 2.7(d) in Appendix A to Part 26), the methods available to tamper with specimens have become more sophisticated since the rule was first published and more sophisticated methods of detecting tampering are necessary. Therefore, the proposed rule would incorporate new requirements for HHS-certified laboratories to conduct specimen validity tests that are consistent with similar provisions contained in the most recent revision to the HHS Guidelines (69FR 19643; April 13, 2004). These new requirements for specimen validity testing would be added to strengthen FFD programs by improving current laboratory procedures to detect specimens that are dilute, adulterated, or substituted, consistent with Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Detecting specimen tampering is necessary to identify individuals who may attempt to hide drug abuse, because attempts to tamper with a specimen provide clear evidence that the individual is not trustworthy and reliable, and because these individuals’ drug use may pose a risk to public health and safety and the common defense and security, as discussed with respect to proposed § 26.23 [Performance objectives]. Proposed § 26.31(d)(3)(ii) would amend the first sentence of current § 26.24(d)(1), which permits licensees and other entities to conduct initial testing of urine specimens at a licensee E:\FR\FM\26AUP2.SGM 26AUP2 50494 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules testing facility, provided that the licensee testing facility staff possesses the necessary training and skills for the tasks assigned, the staff’s qualifications are documented, and adequate quality controls for the testing are implemented. The proposed rule would add permission for licensees and other entities to perform initial validity testing at a licensee testing facility, for the reasons discussed with respect to proposed § 26.31(d)(3)(i). Detailed requirements related to specimen validity testing at licensee testing facilities would be established in proposed Subpart F [Licensee Testing Facilities]. Proposed § 26.31(d)(3)(iii) would be based upon the portions of current Sections 2.7(e)(1) and 2.7(f)(2) in Appendix A to Part 26 that establish the cutoff levels for initial and confirmatory drug testing, respectively, which licensees must apply under the current rule. However, the proposed paragraph would require FFD programs to apply the updated cutoff levels specified in proposed § 26.163(a)(1) for initial drug testing and proposed § 26.163(b)(1) for confirmatory drug testing. Consistent with the first sentence of current § 26.24(b), the proposed paragraph would also permit FFD programs to implement more stringent cutoff levels than specified in the rule, but would establish additional requirements related to lower cutoff levels, as will be discussed further below. The permission in the first sentence of current § 26.24(b) to implement a broader panel of drugs would be relocated to proposed § 26.31(d)(1), as discussed with respect to that paragraph. Proposed § 26.31(d)(3)(iii)(A) would retain the third and fourth sentences of current § 26.24(b) regarding management actions and sanctions for confirmed positive drug test results based on any lower cutoff levels established by the FFD program. The proposed rule would add a requirement that the lower cutoff levels must be documented in the FFD program’s written policy and procedures to ensure that individuals who are subject to testing are aware of the cutoff levels that would be applied to their drug test results in order to protect their rights to due process. The proposed change would be made to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. Proposed § 26.31(d)(3)(iii)(B) would require that the FFD program’s cutoff levels for drugs and drug metabolites, including any more stringent cutoff levels, must be uniformly applied in all VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 tests conducted under this part and equally to all individuals who are subject to testing, except as permitted under proposed § 26.163(a)(2) for dilute specimens and proposed § 26.165(c)(2) for retesting specimens. As discussed with respect to proposed § 26.31(d)(1)(ii), some FFD programs have adopted the practice of testing specimens at the assay’s LOD for forcause, post-event, and followup tests, which results in some individuals receiving unequal treatment under the rule. Therefore, the proposed paragraph would be added to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.31(d)(3)(iii)(C) would be added to specify requirements for establishing more stringent cutoff levels. Before implementing the more stringent cutoff levels, licensees and other entities who are subject to the rule would be required to obtain certification from an independent forensic toxicologist that the more stringent cutoff levels are technically sound and legally defensible, with two exceptions. Certification by a forensic toxicologist would not be required if: (1) The U.S. Department of Health and Human Services lowers the cutoff levels in the HHS Guidelines for the same drugs or drug metabolites and the FFD program adopts the lower HHS cutoffs or (2) the licensee or other entity previously received written approval from the NRC to apply lower cutoff levels, in accordance with current Section 1.1(2) in Appendix A to Part 26. These proposed requirements would be consistent with those contained in proposed § 26.31(d)(1)(i)(D) related to adding drugs to the panel of drugs for which testing is required under the rule and would be added here for the same reasons discussed with respect to that paragraph. Licensees and other entities would no longer be required to inform the NRC, in writing, that they have implemented new, lower cutoff levels because the purpose of the reporting would be met by the forensic toxicologist’s review. Therefore, these changes would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements, while continuing to protect donors’ right to accurate and reliable drug testing. Proposed § 26.31(d)(4) [Alcohol testing] would update current § 26.24(g), which contains general requirements for conducting alcohol testing, to reflect other changes that would be made in the proposed rule. The current crossreference to Section 2.7(o)(3) in Appendix A to Part 26 would be PO 00000 Frm 00054 Fmt 4701 Sfmt 4702 amended to refer to § 26.91(a) in Subpart E [Collecting Specimens for Testing], which would contain detailed requirements for conducting alcohol testing. Reference to oral fluids as acceptable specimens for initial alcohol testing would be added to this paragraph. The basis for adding oral fluids as acceptable specimens for initial alcohol testing is discussed with respect to proposed § 26.83 [Specimens to be collected]. The BAC at which a confirmatory test is required would be changed to 0.02 percent (from 0.04 percent) in the proposed paragraph for consistency with the revised alcohol cutoff levels in proposed § 26.99 [Determining the need for a confirmatory test for alcohol] and proposed § 26.103 [Determining a confirmed positive test result for alcohol]. The basis for the revised alcohol cutoff levels is discussed with respect to those sections. Reference to blood testing for alcohol would be deleted because donors would no longer be permitted to request blood testing for alcohol in the proposed rule, as discussed with respect to proposed § 26.83(a). Proposed § 26.31(d)(5) [Medical conditions] would be added to address circumstances in which it may be impossible or inadvisable to test an individual using the procedures specified in this part. Circumstances have arisen under Part 26, as well as the programs of other Federal agencies, in which an individual’s medical condition has made it inadvisable to implement testing procedures in accordance with the relevant requirements. Therefore, proposed § 26.31(d)(5)(i) would permit alternative specimen collection and evaluation procedures for rare instances in which it would be difficult or hazardous to the donor to collect breath, oral fluids, or urine specimens, including, but not limited to, required post-event testing when an individual has been seriously injured. Only the MRO would be permitted to authorize an alternative evaluation procedure, which may include, but is not limited to blood testing for alcohol. Proposed § 26.31(d)(5)(ii) would be added to clarify that necessary medical treatment may not be delayed in order to conduct drug and alcohol testing. These proposed paragraphs would be consistent with the requirements of other Federal agencies and meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.31(d)(6) [Limitations of testing] would retain and amend current E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Section 2.1(d) in Appendix A to Part 26, which states that specimens collected under Part 26 may only be designated or approved for testing as described in this part and may not be used for any other analysis or test without the permission of the tested individual. The proposed paragraph would add examples of the types of analyses and tests that would be prohibited without the donor’s written permission. Although the NRC is not aware of any instances in which such unauthorized testing has occurred in FFD programs under this part, the technology for performing these analyses and tests has become increasingly available since the regulation was first promulgated. These examples would be added to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Section 26.33 Behavioral Observation Proposed § 26.33 [Behavioral observation] would be added to emphasize that behavioral observation is a required element of FFD programs. The first sentence of proposed § 26.33 would require behavioral observation of individuals who are subject to this part. The second sentence would retain current § 26.22(a)(3), (a)(4), and (b), which state that the individuals who perform behavioral observation must be trained to do so, and extend the training requirement to all individuals who are subject to Part 26. The third sentence of the proposed paragraph would require that individuals must report FFD concerns arising from behavioral observation to the appropriate personnel designated in the FFD program procedures. These proposed changes would be made to strengthen the behavioral observation element of FFD programs by increasing the likelihood that impairment and other adverse behaviors are detected and appropriately addressed by the licensees and other entities who are subject to the rule. Section 26.35 Employee Assistance Programs Proposed § 26.35 [Employee assistance programs] would amend current § 26.25 [Employee assistance programs (EAP)] for the reasons discussed with respect to each paragraph that would be added to the proposed rule. Proposed § 26.35(a) would retain the current provision. In response to implementation questions, proposed § 26.35(b) would be added to clarify that licensees and other entities are not required to provide EAP services to C/V employees who are working at a licensee’s or other entity’s VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 facility and are subject to this part. This proposed provision would be consistent with the interpretation of the current rule in item 13.1.4 of NUREG–1354. However, the proposed rule would continue to require that C/V employees who are subject to Part 26 must have access to an EAP, and licensees and other entities who rely upon the C/V’s FFD program would continue to be required to ensure that the C/V’s EAP meets the requirements of this part. The proposed paragraph would be added to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The proposed paragraph would also state that licensees and other entities need not provide EAP services to individuals who have applied for authorization to perform job duties that would require them to be subject to this part. Licensees and other entities would not be required to provide an EAP to applicants for authorization because these individuals would not yet be performing job duties that could affect public health and safety or the common defense and security. This proposed clarification would be added because applicants would be subject to other requirements under the proposed rule, as discussed with respect to proposed § 26.25(d). Proposed § 26.35(c) would amend the last sentence of current § 26.25 to emphasize that the identity and privacy of an individual who seeks EAP services must be protected and clarify the conditions under which an individual’s confidentiality may or must be violated by EAP personnel. The proposed rule would permit EAP personnel to communicate information about an individual by name to the licensee or other entity under only two conditions: (1) If the individual waives the right to privacy, or (2) EAP personnel determine that the individual’s condition or actions pose or have posed an immediate threat to himself or herself or others. The proposed provision would clarify the NRC’s intent with respect to EAP confidentiality because the current provision has been misinterpreted. The last sentence of current § 26.25 requires confidentiality for individuals who seek EAP services, except if EAP professionals determine that the individual’s condition ‘‘constitutes a hazard to himself or herself or others.’’ Some licensees have over-interpreted this phrase and routinely require EAP staff to report individuals who self-refer for any reason, which is not the intent of this provision. The NRC is also aware that this phrase has been misinterpreted by some individuals who are subject to the rule as meaning that no self-referral PO 00000 Frm 00055 Fmt 4701 Sfmt 4702 50495 to the EAP would remain confidential and that EAP staff always report selfreferrals to licensee management. This perception appears to be widely shared, including by individuals who are subject to FFD programs that have not misinterpreted the current rule and who correctly permit EAP staff to make the determination whether an individual’s condition should be reported to licensee management. A key purpose of requiring EAPs under Part 26 is to encourage individuals and their family members to self-refer for any type of problem that could potentially impair job performance, so that early intervention may be offered to prevent the problem from adversely affecting the individuals’ job performance. Upon assessment, it is not uncommon for EAP staff to find that a developing substance abuse problem is contributing to a financial or family problem for which an individual has sought assistance. As a result, the EAP provides an important means to detect and achieve early resolution of developing substance abuse and other problems, which, if left untreated, could have the potential to adversely affect an individual’s ability to safely and competently perform his or her job duties. The knowledge or perception among individuals who are subject to the rule that self-referrals to the EAP will be reported to management and will routinely result in the loss of authorization represents a significant barrier to the effectiveness of the EAP element of FFD programs. Therefore, the proposed paragraph would amend the last sentence of current § 26.25 to clarify that an individual’s use of the licensee’s or other entity’s EAP must remain confidential, except in very limited circumstances. Proposed § 26.35(c)(1) would be added to prohibit licensees and other entities from requiring the EAP to routinely report the names of individuals who self-refer to the EAP and the nature of the problems that led to the self-referral. The proposed provision would be necessary to: (1) Eliminate some licensees’ practices of requiring these reports, (2) protect individuals’ privacy, and (3) strengthen the EAP element of FFD programs by eliminating a current barrier to selfreferrals in some FFD programs. The term, ‘‘routinely,’’ would be used to indicate that the proposed rule would permit EAP personnel to report individuals’ names and the nature of their problems if the individuals have waived the right to privacy in writing or EAP personnel determine that an individual’s condition or actions pose or have posed an immediate risk to public E:\FR\FM\26AUP2.SGM 26AUP2 50496 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules health and safety or the common defense and security. The proposed provision would not prohibit EAPs from reporting program utilization statistics or aggregated data that characterize the types of problems for which the program has provided services, because this type of information would not compromise individuals’ privacy. Proposed § 26.35(c)(2) would be added to provide further clarity in the language of the rule with respect to the conditions under which EAP personnel would be excepted from the confidentiality requirement in proposed § 26.35(c) and required to report a concern about an individual to the licensee or other entity. The NRC is confident that EAP personnel have the qualifications and training necessary to continue to make the professional judgments required under the current and proposed rules in these circumstances. However, the proposed rule would include more detail with respect to the conditions and actions that an EAP professional would be required to report to ensure that licensees, other entities, and individuals who are subject to the rule better understand the intent of the current and proposed provisions. The proposed rule would require EAP personnel to report a concern about a specific individual to licensee or other entity management only when they have substantive reasons to believe that an individual’s condition or actions pose or have posed an immediate hazard to himself or herself or others. The phrase, ‘‘substantive reasons to believe,’’ would be used to clarify that casual and/or contextually appropriate comments made by an individual during a counseling session would not be a sufficient basis for reporting to the licensee or other entity. For example, an individual’s statement that he or she is concerned about becoming an alcoholic would not constitute a substantive reason to believe that the individual’s condition poses an immediate hazard. By contrast, this stated concern, in addition to evidence that the individual’s personal relationships, financial condition, and/or health are suffering from his or her alcohol consumption, and any indications that the individual has been impaired while in a work status, would together constitute substantive reasons to believe that the individual’s condition poses an immediate hazard and must be reported. Proposed § 26.35(c)(2)(i)–(c)(2)(iii) would be added to provide several examples of conditions and actions that would require EAP personnel to provide a report about an individual who has self-referred to licensee or other entity VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 management. Proposed § 26.35(c)(2)(i) would require reporting if the EAP staff has substantive reasons to believe that an individual may harm himself or herself or others, including, but not limited to, plans threatening suicide, radiological sabotage, or physical violence against others. Proposed § 26.35(c)(2)(ii) would require reporting if the EAP staff has substantive reasons to believe that an individual has been impaired from drugs or alcohol while in a work status and is likely to be impaired in the future, as discussed with respect to proposed § 26.35(c)(2). Proposed § 26.35(c)(2)(iii) would require reporting if the EAP staff has substantive reasons to believe that an individual has committed any of the acts that would require a report to the NRC under proposed § 26.219(b)(1)– (b)(3), including, but not limited to, the use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area or while performing job duties that require the individual to be subject to this part. The examples included in these proposed paragraphs are illustrative, but do not represent an exhaustive list of the conditions and actions that EAP staff may encounter that would be reported to licensee or other entity management under the proposed rule. For additional clarity, proposed § 26.35(c)(3) would be added to crossreference the provisions in the proposed rule that would specify the actions that licensees and other entities would take after receiving a report from EAP personnel that an individual’s condition or actions pose or have posed an immediate hazard to himself or herself or others. As discussed with respect to those paragraphs, proposed §§ 26.69(d) and 26.77(b) would require the licensee or other entity to take immediate action to: (1) Prevent the individual from performing any job duties that require the individual to be subject to this part; (2) ensure that a determination of fitness is performed by a professional who has specific qualifications and training to address the nature of the individual’s problem; and (3) either terminate the individual’s authorization or ensure that the condition is resolved before permitting him or her to return to performing duties under this part. These proposed changes to current § 26.25 would be consistent with Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26, as well as Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. PO 00000 Frm 00056 Fmt 4701 Sfmt 4702 Section 26.37 Protection of Information Proposed § 26.37 [Protection of information] would amend current § 26.29, which contains requirements for protecting the personal information that must be collected under Part 26. In general, the proposed section would group requirements related to the protection of personal information that are dispersed throughout the current rule to aid in locating these requirements in the proposed rule. The records retention requirement in current § 26.29(a) would be moved to proposed Subpart J [Recordkeeping and Reporting Requirements]. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.37(a) would combine and retain the first sentence of current § 26.29(a) and the second sentence of current Section 3.1 in Appendix A to Part 26. The proposed paragraph would require licensees and other entities to establish and maintain a system of files and procedures to protect the personal information that is collected under this part and maintain and use such records with the highest regard for individual privacy. Proposed § 26.37(b) would amend current § 26.29(b) and would divide it into several paragraphs for clarity. The first sentence of the proposed paragraph would amend the first sentence of current § 26.29(b), which prohibits licensees and other entities from disclosing personal information collected under this part to any individuals other than those listed in the sentence. The proposed paragraph would continue to permit disclosure of the personal information to the listed individuals and would add permission for the licensee or entity to disclose the personal information to others if the licensee or other entity has obtained a signed release for such a disclosure from the subject individual. The proposed permission to release the personal information to individuals who are not listed in the paragraph with the written consent of the subject individual would be added because some licensees have misinterpreted the current requirement as prohibiting them from releasing the personal information under any circumstances, except to the parties listed in this paragraph. In some instances, such failures to release information have inappropriately inhibited an individual’s ability to obtain information that was necessary for a review or appeal of the licensee’s determination that the individual had violated the FFD policy. Therefore, the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules explicit permission for licensees and other entities to release personal information when an individual consents to the release, in writing, would be added to meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.37(b)(1)–(b)(8) would list in separate paragraphs the individuals to whom licensees and other entities would be permitted to release personal information about an individual. Proposed § 26.37(b)(3), (b)(4), and (b)(8) would retain unchanged the current permission for the release of information to NRC representatives, appropriate law enforcement officials under court order, and other persons as required by court order. Proposed § 26.37(b)(1), (b)(2), (b)(5), and (b)(6) would amend the related requirements contained in current § 26.29(b) to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The specific changes to current § 26.29(b) would include the following: Proposed § 26.37(b)(1) would retain the current permission for the release of information to the subject individual and his or her designated representative. The proposed paragraph would add requirements for the individual to designate his or her representative in writing and specify the FFD matters to be disclosed. The proposed changes would be made in response to implementation questions from licensees. Licensees have sought guidance from the NRC related to the manner in which an individual must ‘‘designate’’ a representative. Proposed § 26.37(b)(2) would retain the current permission for the release of information to the licensee’s or other entity’s MROs. The proposed rule would also permit the release of information to MRO staff members for consistency with proposed § 26.183(d), which would permit MRO staff to serve some MRO functions under the direction of the MRO. MRO staff would require access to the personal information in order to perform their job duties. The role of MRO staff in FFD programs is further discussed with respect to proposed § 26.183(d). Proposed § 26.37(b)(5) would amend the current reference to licensee representatives who have a need to have access to the information in performing assigned duties. The current rule refers only to individuals who are performing audits of FFD programs. As a result, the current rule has been misinterpreted by some licensees as limiting the release of personal information only to such individuals. This was not the intent of VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 the provision. Rather, the intent of the current rule was that licensees and other entities would be permitted to release information to their representatives who must have access to the personal information in order to perform assigned job duties. Therefore, the proposed rule would clarify that licensee representatives who perform determinations of fitness, such as the SAE (see the discussion of proposed § 26.187) and human resources functions, as well as auditors and other representatives of the licensee or other entity, may be permitted access to personal information but only to the extent that such access is required to perform their assigned functions. Proposed § 26.37(b)(6) and (b)(7) would amend the portion of current § 26.29(b) that refers to ‘‘persons deciding matters on review or appeal.’’ The proposed changes would be made in response to implementation questions from licensees, including whether the rule covers persons deciding matters in judicial proceedings or only the internal appeals process specified in current § 26.28 [Appeals] as well as whether information could be released in a judicial proceeding that was not initiated by the subject individual. The proposed rule would clarify that the permission includes individuals who are presiding in a judicial or administrative proceeding, but only if the proceeding is initiated by the subject individual in proposed § 26.37(b)(6). Proposed § 26.37(b)(7) would be added to cover ‘‘persons deciding matters under review in § 26.39’’ [Review process for fitness-forduty policy violations], as discussed with respect to that section. Proposed § 26.37(c) would be added to require the disclosure of relevant information to licensees and other entities, including C/Vs, and their authorized representatives who have a legitimate need for the information and a signed release from an individual who is seeking authorization under this part. This proposed provision would be added to further clarify current § 26.29(b), because some licensees have misinterpreted the current provision as prohibiting the release of information to C/Vs who have licensee-approved FFD programs and conduct suitable inquiries on behalf of licensees and other entities. The proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.37(d)–(f) would retain several requirements related to the protection of information in the current rule but move them into this proposed section for organizational clarity. PO 00000 Frm 00057 Fmt 4701 Sfmt 4702 50497 Proposed § 26.37(d) would combine requirements in current § 26.29(b) and Section 3.2 in Appendix A to Part 26, as they relate to an individual’s access to records that are necessary for a review of an FFD policy violation. The proposed paragraph would retain the current requirements for licensees, other entities, HHS-certified laboratories, and MROs to provide the information that an individual requests related to a determination that the individual has violated the FFD policy on the basis of drug test results. Proposed § 26.37(e) and (f) would retain current Section 3.1 in Appendix A to Part 26 and the last sentence of current § 26.29(b), respectively. Section 26.39 Review Process for Fitness-for-Duty Policy Violations Proposed § 26.39 [Review process for fitness-for-duty policy violations] would amend current § 26.28 [Appeals] and separate it into several paragraphs. The current section title would be revised to eliminate the implication that the internal management review is a legal proceeding. Several requirements would be added to clarify and strengthen individuals’ due process rights during the review, as follows: Current § 26.28 requires that individuals who are subject to the rule have an opportunity for a management review of a determination that the individual has violated the licensee’s or other entity’s FFD policy. Proposed § 26.39(a) would retain the requirement that the review must be impartial and add a requirement that the review must be objective. The requirement for an objective review would be added because some licensees have permitted the same individuals who were involved in the initial determination that an individual violated the FFD policy to provide the review that is required under current § 26.28. The impartiality of individuals who are reviewing their own decisions is questionable, and calls into question the effectiveness of the review process. Therefore, the proposed requirement for the review to be both impartial and objective would emphasize the NRC’s intent that the review process must be effective. In keeping with revisions to several other sections that would be intended to counter subversion of the testing process, proposed § 26.39(a) would extend this opportunity to request a review to all FFD violations, including, but not limited to, violations based upon non-negative validity test results. The proposed paragraph would also clarify that applicants for authorization must be given the opportunity for a E:\FR\FM\26AUP2.SGM 26AUP2 50498 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules review. Experience with implementing this section of Part 26 has indicated that some licensees did not provide a review process to individuals who tested positive on pre-access tests. However, the factors that could produce false nonnegative test results among licensee and C/V employees (e.g., administrative or testing errors) are equally likely to occur during pre-access testing of applicants for authorization. If applicants are not provided with a review process, it is possible that some of them would be effectively barred from the industry based on test results erroneously determined to be a violation of the licensee’s or other entity’s FFD policy. Providing applicants with the opportunity to request a review would also enhance program credibility. Proposed § 26.39(b) would specify that FFD procedures must describe the contents and purpose of the notice that licensees and other entities would be required to provide to an individual who has violated an FFD policy and state that the individual may submit additional relevant information as part of the review process. This proposed clarification is necessary because experience with implementing current § 26.28 has indicated that, in some cases, individuals do not understand the purpose of the review process and their associated rights. Proposed § 26.39(c) would require that more than one representative of the licensee’s or other entity’s management must conduct the review and that the reviewers may not be anyone who was involved in the original determination that the individual violated the FFD policy. These proposed clarifications are necessary because experience with implementing current § 26.28 has indicated that, in some instances, the persons who were responsible for the initial determinations have been conducting reviews. The proposed requirements that the reviewers may not have been involved in the initial determination and that more than one management representative must conduct the review would strengthen the impartiality and objectivity of the review process in order to further enhance individuals’ due process rights. Proposed § 26.39(d) would add a requirement that any records associated with the FFD policy violation must be deleted or corrected, as appropriate, if the policy violation decision is overturned. This requirement would be necessary because the proposed rule permits licensees and other entities to share and rely on information gathered by other Part 26 programs to a greater extent than currently. Therefore, incorrect records related to an FFD VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 policy violation could effectively bar an individual from further employment under a Part 26 program if such information is transmitted to other licensees and entities who are considering whether to grant authorization to an individual. The proposed requirement to delete or correct any records associated with an FFD policy violation that has been overturned would protect individuals from such potential adverse consequences. Proposed § 26.39(e) would amend the last sentence of current § 26.28, which states that licensees and other entities are not required to provide a review procedure to a C/V’s employees and applicants when the C/V is administering its own drug and alcohol testing. The proposed rule would amend the current paragraph in response to implementation questions from licensees who have asked whether the current provision excuses them from providing a review process for C/V employees at any time, including situations in which the FFD policy violation was determined as a result of testing conducted by the licensee. The proposed rule would revise this sentence to clarify that the licensee or other entity need not provide a review process if the FFD violation to be reviewed was identified through the C/ V’s drug and alcohol testing program. If the FFD violation was determined through the licensee’s drug and alcohol testing, the licensee would continue to be required to provide the impartial and objective review. Section 26.41 Audits and Corrective Action Proposed § 26.41 [Audits and corrective action] would rename and amend current § 26.80 [Audits]. The phrase, ‘‘and corrective action,’’ would be added to the section title to emphasize the NRC’s intent that licensees and other entities must ensure that corrective actions are taken in response to any adverse findings resulting from an audit. In addition, the proposed rule would reorganize audit requirements in current § 26.80, and move several audit and inspection requirements that are currently addressed in Appendix A to Part 26 into this section. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.41(a) [General] would amend the last sentence in current § 26.80(a), which states that licensees retain responsibility for the effectiveness of C/V programs and the PO 00000 Frm 00058 Fmt 4701 Sfmt 4702 implementation of appropriate corrective action. The proposed paragraph would revise this requirement to include HHS-certified laboratories as well as any C/V FFD program elements and FFD programs upon which the licensee or other entity relies, which is consistent with the original intent of the current requirement. The proposed change would be to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.41(b) [FFD program] would amend the required audit frequency in current § 26.80(a). (The other requirements contained in current § 26.80(a) are addressed in other paragraphs of proposed § 26.41, as discussed with respect to the paragraphs of the proposed rule that address those topics.) The proposed rule would decrease the current 12-month FFD program audit frequency to a nominal 24-month frequency, which would grant a petition for rulemaking (PRM–26–1) submitted by Virginia Power on December 30, 1993. Experience with implementing Part 26 has shown that annual audits of the entire FFD program are unnecessary to ensure continued program effectiveness and, therefore, place an unnecessary burden on those entities who are subject to the rule. The proposed audit frequency would be decreased to 24 months to relieve this burden and to be consistent with the NRC’s schedule for inspecting FFD programs. The proposed change would be consistent with Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Although the proposed rule would decrease the required audit frequency, licensees and other entities would be required to monitor program performance indicators and operating experience, consistent with a performance-based approach, and audit FFD program elements more frequently than every 24 months, as needed. In determining the need for more frequent audits, the proposed rule would require licensees and other entities to consider the frequency, nature, and severity of discovered problems, testing errors, personnel or procedural changes, previous audit findings, and ‘‘lessons learned.’’ The proposed change is intended to promote performance-based rather than compliance-based audit activities and clarify that programs must be audited following a significant change in personnel, procedures, or equipment as soon as reasonably practicable. The NRC recognizes that FFD programs evolve and new issues and problems continue to arise. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Turnover of FFD program personnel and contracted services personnel, such as specimen collectors, exacerbates this concern. Licensee audits have identified problems that were associated in some way with personnel changes, such as new personnel not understanding their duties or procedures, the implications of actions that they took, did not take, or changes in processes. The purpose of these focused audits would be to ensure that changes in personnel, procedures, or equipment do not adversely affect the operation of the particular program element or function in question. Accordingly, the proposed audit requirement would ensure that any programmatic problems that may result from significant changes in personnel, procedures, or equipment are detected and corrected on a timely basis. This proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs, by requiring more frequent audits of FFD program elements that may require closer monitoring than a nominal 24-month frequency would provide. Proposed § 26.41(c) [C/Vs and HHScertified laboratories] would amend the audit and inspection requirements for these entities that are contained in the second sentence of current § 26.80(a) and the third sentence of Section 2.7(m) in Appendix A to Part 26, as follows: Proposed § 26.41(c)(1) would further amend the requirement in current § 26.80(a) for annual audits of C/V FFD programs and program elements and HHS-certified laboratories. The current annual audit frequency would be retained only for those portions of C/V FFD programs whose personnel work off site and are not under the daily supervision of FFD program personnel. The activities of C/V personnel who work on site and are under the daily supervision of FFD program personnel would be audited under proposed § 26.41(b). Retention of the annual audit requirement for C/Vs whose personnel work off site is necessary to ensure that the services provided continue to be effective, given that other means of monitoring their effectiveness, such as daily oversight, are unavailable. The proposed paragraph would also retain the annual audit requirement for HHScertified laboratories. This audit frequency would be retained because of the key role the laboratories play in the overall effectiveness of Part 26 programs. Retention of these annual audit requirements in the proposed paragraph would deny the petition for rulemaking (PRM–26–1) submitted by Virginia Power on December 30, 1993. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.41(c)(2) would be added to relax some requirements related to annual audits and inspections of the HHS-certified laboratories upon which licensees and other entities rely for drug testing services. The proposed rule would permit licensees and other entities who are subject to the rule to rely upon the inspections of HHS laboratories that are performed for HHScertification reviews and would no longer require licensees and other entities to audit the effectiveness of services that are reviewed by HHS inspectors. The current rule contains a number of requirements that are inconsistent with the requirements for drug testing of other Federally mandated programs. For example, the current rule permits donors to request confirmatory alcohol testing of a blood specimen at an HHS-certified laboratory, which is not permitted by other Federal agencies, and some of the cutoff levels established in the current rule are higher, in the case of testing for marijuana metabolite, or lower, in the case of testing for opiates, than other Federal agencies’. These programmatic discrepancies have made licensee audits of HHS-certified laboratories necessary to ensure the effectiveness of the unique drug and alcohol testing services required for Part 26 programs because these services are not addressed in the HHS inspections. However, as discussed in Section IV.B, the proposed rule would eliminate the majority of such discrepancies. Therefore, the annual audits of HHS-certified laboratories by licensees that have been necessary under the current rule would be redundant under the proposed rule, except in certain conditions described below. The proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.41(c)(2) would continue to require licensees and other entities to conduct annual audits of any services provided to the licensee or other entity that were not addressed in the annual HHS-certification review. This annual audit requirement would be retained because proposed § 26.31(d) would retain the permission in the current rule for licensees and other entities to establish lower cutoff levels and test for drugs in addition to those for which testing is required under this part. If a licensee or other entity chooses to implement more stringent cutoff levels or a broader panel of drugs than required in the proposed rule, the licensee or other entity would be required to ensure that annual audits of PO 00000 Frm 00059 Fmt 4701 Sfmt 4702 50499 the HHS-certified services related to those cutoff levels and drug tests are performed. The last sentence of proposed § 26.41(c)(2) would be added in response to stakeholder comments that were made during the public meetings discussed in Section V, related to the scope of the current audit requirements. The stakeholders noted that the scope of the current audit requirements is illdefined in the current rule, which they believe has resulted in unnecessary variability between FFD programs and also an unnecessary burden. For example, the stakeholders noted that some FFD programs have interpreted the current rule as requiring annual audits of any substance abuse treatment program from which individuals who are subject to their FFD program may seek services as well as the entire national EAP company with whom the licensee or other entity contracts to obtain the services of one individual in the local geographical area. The stakeholders suggested that such audits are costly and have little relationship to continuing FFD program effectiveness. The scope of audit requirements was not specified in the current rule because there is a wide variety of contractual relationships between licensees, other entities, and C/Vs for FFD program services that make it impractical to establish limits that would be universally applicable. However, the examples provided by the stakeholders at the public meeting were convincing that some limitations on the scope of the audit requirements would be appropriate in the proposed rule. Therefore, the proposed rule would not require licensees and other entities to audit organizations that do not routinely provide FFD services to the licensee or other entity, such as local hospitals or a substance abuse treatment facility. It would be unnecessary to audit these organizations because the FFD program would use their services infrequently, there would be a reasonable expectation of quality, and weaknesses in these services could be identified through other means. For example, under proposed § 26.187 [Substance abuse professional], the SAE would be required to monitor the substance abuse treatment of individuals who require it and so would have the qualifications and information necessary to assess the quality of the treatment services an individual receives. The SAE would have the authority to seek other services on behalf of the FFD program if he or she identifies weaknesses in a treatment program. Therefore, this change would be made to meet Goal 5 of this E:\FR\FM\26AUP2.SGM 26AUP2 50500 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.41(d) [Contracts] would incorporate and amend the requirements of current Section 2.7(m) in Appendix A to Part 26 and others, which address contractual relationships to permit licensees and other entities access to the HHS-certified laboratories for the purposes of conducting the audits and inspections required under the rule. The portions of current Section 2.7(m) in Appendix A to Part 26 that relate to NRC inspections of HHScertified laboratories would be moved to § 26.221 [Inspections] in Subpart K of the proposed rule, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.41(d)(1) would amend the second sentence of current Section 2.7(m) in Appendix A to Part 26, which requires licensee contracts with HHScertified laboratories for drug testing and alcohol confirmatory testing, as well as contracts for collection site services, to permit the licensee to conduct unannounced inspections. The proposed rule would retain the current requirement with respect to HHScertified laboratories, and expand it to require that contracts with any C/V (which would include collection services providers) must permit the licensee or other entity to conduct audits at any time, including unannounced times, and to review all information and documentation that is reasonably relevant to the audits. The proposed paragraph would extend the current requirement to any C/V with whom the licensee or other entity contracts for FFD program services to enhance the effectiveness of the licensees’ and other entities’ audits should unannounced audits appear to be necessary. For example, a licensee or other entity may receive allegations that an off-site C/V is falsifying records or that a contract MRO or SAE is using drugs, and the licensee or other entity may determine that an unannounced audit would provide the most effective means to investigate such allegations. The proposed paragraph would ensure that the licensee’s or other entity’s contract with the C/V would permit the unannounced audit as well as access to any information necessary to conduct the audit. Therefore, this proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Proposed § 26.41(d)(2) would be added to ensure that licensees’ and other entities’ contracts with C/Vs and VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 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 HHScertified laboratory are performing their functions properly and that staff and procedures meet applicable requirements. This proposed provision would respond to several incidents in which parties under contract to licensees did not permit Part 26 auditors to remove documents from a C/V’s premises that were necessary to document audit findings, develop corrective actions, and ensure that the corrective actions were effective. Therefore, the proposed requirement would meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. The proposed paragraph would permit HHS-certified laboratories to reasonably limit the use and dissemination of the documentation that auditors copy and take away from the laboratories, in order to protect proprietary information and donors’ confidentiality. This proposed permission would be added in response to stakeholder requests at the public meetings discussed in Section V. Because the current and proposed rules permit sharing of audit reports among licensees and C/Vs who rely on a laboratory, and it may be otherwise difficult to maintain appropriate control of proprietary information or donors’ personal information, the NRC concurred with the stakeholders’ request. This proposed change would meet Goal 7 of this rulemaking, as it relates to the privacy of individuals who are subject to Part 26, and would protect the trade secrets of HHS-certified laboratories who would continue to be subject to auditing under the proposed rule. Proposed § 26.41(d)(3) would amend the third sentence of current Section 2.7(m) in Appendix A to Part 26, which requires licensees and other entities to carry out inspections and evaluation of the procedural aspects of an HHScertified laboratory’s drug testing operations before awarding a contract to the laboratory, by adding a crossreference to proposed § 26.41(g). Proposed § 26.41(g) would permit licensees and other entities to forgo the otherwise required pre-award evaluation under certain specific circumstances, as discussed with respect to that paragraph. Proposed § 26.41(e) [Conduct of audits] would retain the requirements in current § 26.80(b). Proposed § 26.41(f) [Audit results] would retain the portion of current PO 00000 Frm 00060 Fmt 4701 Sfmt 4702 § 26.80(c) that requires licensees and other entities to document audit findings and recommendations, report them to senior management, and document corrective actions taken in response to any identified adverse conditions. The proposed paragraph would also add two requirements. The second sentence of proposed § 26.41(f) would specify the required content of audit reports to include identification of any conditions that are adverse to the proper performance of the FFD program, the cause of the condition(s), and, when appropriate, recommended corrective actions. The third sentence of the proposed paragraph would require licensees and other entities to review the audit findings and take corrective actions, including re-auditing of the deficient areas where indicated, to preclude, within reason, repetition of the condition. The proposed rule would add these two sentences for consistency with Criterion XVI in Appendix B to 10 CFR Part 50 to indicate that FFD audit reports are to be included in licensees’ and other entities’ corrective action programs. Some licensees have handled FFD audit reports outside of their normal corrective action programs, which address other conditions adverse to quality. As a result, some corrective actions for FFD program weaknesses have not been timely or effective. Therefore, the proposed rule would add these requirements to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. The last sentence of current § 26.80(c), which refers to the requirements for auditing HHS-certified laboratories in Appendix A to Part 26, would be deleted as redundant with proposed § 26.41(c). This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.41(g) [Sharing of audits] would respond to licensees’ implementation questions related to the third and fourth sentences in current § 26.80(a), which permit licensees and other entities to accept audits of C/Vs that are conducted by other FFD programs. The proposed paragraph would clarify the current permission to accept and rely on others’ audits in response to implementation questions that the NRC has received from licensees with respect to the sharing of audits, as documented in Section 17 of NUREG–1354, and items 11.4 and 11.5 of NUREG–1385. Proposed § 26.41(g) would amend the current provision to incorporate specific permission for licensees and other entities to jointly conduct audits as well E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules as rely on one another’s audits. Reference to HHS-certified laboratories would also be added to indicate the applicability of these permissions to licensees’ and other entities’ audits of HHS-certified laboratories. These proposed changes would be consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices. Therefore, the proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.41(g)(1) and (g)(2) would be added to require licensees and other entities to identify any areas that were not covered by a shared or accepted audit and ensure that any unique services used by the licensee or other entity that were not covered by the shared audit are audited. For example, an FFD program may use lower cutoff levels for drug testing than the FFD program(s) that conducted a shared audit with the result that the shared audit did not address the HHS-certified laboratories’ procedures for testing at the first FFD program’s lower cutoff levels. In this case, the first FFD program would not be permitted to rely on the shared audit with respect to the lower cutoff levels and would be required to ensure that the HHScertified laboratories’ procedures for testing at the lower cutoff levels are audited separately (or in conjunction with other FFD programs who use the same cutoff levels). These proposed provisions would be consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices. Therefore, the proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.41(g)(3) would retain the portion of the third sentence of current § 26.80(a) that states that licensees and other entities need not reaudit the same C/V for the same period of time, and extend this permission to audits of HHS-certified laboratories. Extending the current provision to cover audits of HHS-certified laboratories would be consistent with the guidance issued by the NRC in the documents referenced above and current licensee practices. Therefore, this proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.41(g)(4) would retain the fourth sentence of current § 26.80(a), which requires licensees and other entities to retain copies of the shared audit reports. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.41(g)(5) would be added to permit licensees and other entities to immediately obtain drug testing services from another HHScertified laboratory, subject to certain conditions, in the event that the laboratory used by the licensee or other entity should lose its certification. Within 3 months of obtaining services from the replacement laboratory, the proposed paragraph would require the licensee or other entity to ensure that an audit is conducted of any aspects of the laboratory’s services that are used by the licensee or other entity that have not been audited within the past 12 months by another licensee or entity who is subject to this part. This proposed provision would enhance the effectiveness of FFD programs by ensuring that drug testing would not be interrupted or delayed if an HHScertified laboratory loses its certification, as some licensees have experienced. The reliability of drug testing services provided by the replacement laboratory would be assured by the auditing and inspection activities of other licensees and entities who have been using the services of the replacement laboratory, as well as the audit conducted by the licensee or other entity of any services that have not been audited by other licensees or entities who are subject to this part. The proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Subpart C—Granting and Maintaining Authorization Section 26.51 Purpose A new § 26.51 [Purpose] would be added to describe the purpose of the proposed subpart. Proposed § 26.51 would emphasize that Subpart C contains ‘‘FFD requirements’’ for granting and maintaining authorization because the NRC has also published other requirements that establish additional steps that licensees and other entities must take as part of the process of determining whether to grant authorization to an individual. These additional requirements, found in particular in 10 CFR 73.56 and access authorization orders issued by the NRC to nuclear power plant licensees, require the licensee or other entity to conduct a psychological assessment and a credit and criminal history check of the individual, and to interview persons who have knowledge of the applicant for authorization. A central goal of adding Subpart C to the proposed rule is to eliminate redundancies and ensure consistency between the FFD PO 00000 Frm 00061 Fmt 4701 Sfmt 4702 50501 requirements and these other requirements. Section 26.53 General Provisions A new § 26.53 [General provisions] would provide a generic summary of the requirements and process for determining whether individuals may be granted and maintain authorization. Proposed § 26.53(a) would introduce four new terms to Part 26: (1) ‘‘initial authorization,’’ (2) ‘‘authorization update,’’ (3) ‘‘authorization reinstatement,’’ and (4) ‘‘authorization with potentially disqualifying FFD information.’’ These terms would be used to describe categories of proposed requirements for granting authorization. The proposed categories, which are based upon whether an individual who has applied for authorization has previously held authorization under Part 26 and the length of time that has elapsed since the individual’s last period of authorization ended, are defined in proposed § 26.55 [Initial authorization], proposed § 26.57 [Authorization update], proposed § 26.59 [Authorization reinstatement], and proposed § 26.69 [Authorization with potentially disqualifying fitnessfor-duty information]. Proposed § 26.53(a) would direct licensees or other entities to use the criteria for granting authorization to individuals found in proposed §§ 26.55, 26.57, 26.59, or 26.69, depending on which of the proposed sections would apply to the individual seeking authorization. The current rule in § 26.27 discusses actions that the licensee must take before the initial granting of access or assignment of specified duties to an individual, but does not use the concepts of ‘‘initial authorization,’’ ‘‘authorization update,’’ ‘‘authorization reinstatement,’’ or ‘‘authorization with potentially disqualifying FFD information.’’ These concepts would be used in the proposed rule to focus the requirements for authorization more precisely on whether the individual has established a ‘‘track record’’ in the industry, and to specify the amount of original information gathering that licensees or other entities would be required to perform according to whether previous FFD programs have collected information about the individual. In addition, the same concepts are used in access authorization requirements, so incorporating them into Part 26 would increase the consistency between the related regulations. Proposed § 26.53(b) would define the meaning of the term, ‘‘interruption,’’ which would be used in proposed § 26.57 [Authorization update] and E:\FR\FM\26AUP2.SGM 26AUP2 50502 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules proposed § 26.59 [Authorization reinstatement] to refer to the interval of time between periods during which an individual holds authorization under Part 26. Licensees and other entities would calculate an interruption in authorization as the total number of days falling between the day upon which the individual’s last period of authorization ended and the day upon which the licensee or other entity grants authorization to the individual. Proposed § 26.53(b) would also specify that if potentially disqualifying FFD information is disclosed or discovered about an individual, licensees and other entities must implement the applicable requirements in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information] in order to grant or maintain an individual’s authorization, rather than relying on the requirements in proposed §§ 26.55, 26.57, or 26.59, as discussed further with respect to proposed § 26.69. Proposed § 26.53(c) would reiterate the FFD training requirements in proposed § 26.29 [Training] and the fatigue training requirements in proposed § 26.197(c) [Training and examinations] to clarify that all individuals must meet the applicable requirements for initial or refresher FFD training, as appropriate, before the licensee or other entity may grant authorization to the individuals. The proposed paragraph would repeat the training requirements for organizational clarity, because they apply to the authorization process. As discussed in Section V, stakeholders requested that the proposed rule present requirements in the order in which they would apply to licensees’ and other entities’ FFD processes. Therefore, the proposed paragraph would be added to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.53(d) would permit licensees and other entities to rely upon other licensees’ or entities’ Part 26 programs and program elements, as well as licensee-approved Part 26 programs and program elements of C/Vs, to meet the requirements of this subpart for granting and maintaining authorization. Proposed § 26.53(d) would expand upon two sections of the current rule that similarly permit licensees and other entities to accept and rely upon other Part 26 programs and program elements. Specifically, current § 26.24(a)(1) permits licensees to accept results from drug and alcohol tests that were administered under another Part 26 program within the past 60 days, and current § 26.23 [Contractors and VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 vendors] permits licensees to rely upon C/Vs’ Part 26 programs that have been formally reviewed and approved by the licensee. Consistent with the principle of permitting licensees to accept and rely upon other Part 26 programs in their authorization decisions, guidance contained in NUREG–1385 also indicates that licensees may ‘‘accept’’ an authorization granted by a previous licensee for individuals who transfer between licensees with only a ‘‘short break’’ in authorization. The proposed rule would substantially increase the specificity of the requirements that must be met by licensees or other entities for granting authorization and establish detailed minimum standards that all programs must meet. These proposed detailed minimum standards are designed to address recent changes in industry practices that have resulted in a more transient workforce, as noted in the discussion of Subpart C in Section IV. B. Because the FFD programs of licensees and other entities would be substantially more consistent than in the past under these proposed detailed standards, permitting licensees and other entities to rely on other Part 26 programs to meet the proposed rule’s requirements is reasonable and appropriate. In addition, the proposed provision would eliminate unnecessary redundancies in the steps required to grant authorization to an individual who is transferring from one Part 26 program to another. Section 26.55 Initial Authorization A new § 26.55 [Initial authorization] would define the category of ‘‘initial authorization’’ requirements to apply both to individuals who have not previously held authorization under Part 26 and those whose authorization has been interrupted for a period of 3 years or more and whose last period of authorization ended favorably. Two considerations support the proposed requirement for individuals whose last period of authorization ended 3 or more years previously to satisfy the same requirements as individuals who have never previously held authorization. In general, the longer the period of time since the individual’s last period of authorization ended, the greater the possibility that the individual has developed an active substance abuse problem or undergone significant changes in lifestyle or character that would diminish his or her trustworthiness, reliability, and ability to perform work safely and competently. Therefore, it is reasonable to require a full and extensive screening identical to that given an individual who has not held authorization, and has not been PO 00000 Frm 00062 Fmt 4701 Sfmt 4702 subject to drug and alcohol testing and behavioral observation, for 3 years or more. For similar reasons, access authorization requirements also require that individuals who have not held authorization for 3 years or more must be subject to the same screening as individuals who have not previously held authorization. Therefore, requiring individuals whose last period of authorization ended 3 or more years previously to satisfy the same requirements as individuals who have never held authorization would increase the consistency of Part 26 with the related access authorization requirements. Proposed § 26.55(a)(1) would require the licensee or other entity, before granting initial authorization to an individual, to obtain and review a selfdisclosure in accordance with the applicable requirements of proposed § 26.61 [Self-disclosure and employment history]. As discussed with respect to proposed § 26.61, the selfdisclosure and employment history would require the individual to report violations, if any, involving drugs or alcohol and the individual’s current and past employment history. The proposed requirement is similar to the requirement in § 26.27(a)(1) of the current rule that a written statement must be obtained from the individual addressing the topics that are specified in current § 26.27(a)(1). The discussion of proposed § 26.61 compares the topics required to be addressed in the written statement under the current rule with the topics that would be addressed in the self-disclosure under the proposed rule. As discussed with respect to proposed § 26.61(a)(3), the period of time to be addressed in the selfdisclosure by an applicant for initial authorization would be the shorter period of either the past 5 years or the interval of time since the individual’s eighteenth birthday. Proposed § 26.55(a)(2) would require the licensee or other entity, before granting initial authorization to an individual, to complete a suitable inquiry in accordance with the applicable requirements of proposed § 26.63 [Suitable inquiry]. The proposed requirement is similar to the requirement in § 26.27(a)(2) of the current rule that a suitable inquiry must be completed addressing the topics that are specified in § 26.27(a)(2). The discussion of proposed § 26.63 compares the topics that must be addressed in the suitable inquiry under the current rule with the topics that would be addressed in the suitable inquiry under the proposed rule. Proposed § 26.63(f)(1) specifies that the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules period of time that the suitable inquiry would address for an initial authorization must be the shorter period of either the past 3 years or the interval of time since the individual’s eighteenth birthday. Proposed § 26.55(a)(3) would require the licensee or other entity, before granting initial authorization to an individual, to ensure that the individual is subject to pre-access drug and alcohol testing in accordance with the applicable requirements of proposed § 26.65 [Pre-access drug and alcohol testing]. Current § 26.24(a)(1) requires testing within 60 days prior to the initial granting of unescorted access to protected areas or assignment to activities within the scope of Part 26. The discussion of proposed § 26.65 compares the proposed pre-access drug and alcohol testing requirements for initial authorization to the requirements in the current rule. Proposed § 26.65 would require the licensee or other entity to ensure that the individual had negative drug and alcohol test results from testing that had been completed within the past 30 days before granting authorization to the individual, for the reasons discussed with respect to that section. Proposed § 26.55(a)(4) would require the licensee or other entity also to ensure that the individual is subject to random drug and alcohol testing in accordance with the applicable requirements of proposed § 26.67 [Random drug and alcohol testing of individuals who have applied for authorization]. Current § 26.64(a)(2) requires unannounced drug and alcohol tests imposed in a statistically random and unpredictable manner. The discussion of proposed § 26.67 compares the proposed random drug and alcohol testing requirements for initial authorization to the requirements in the current rule. Proposed § 26.55(b) would be added to require that the licensee or other entity must meet the requirements in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information] to grant authorization to the individual, if potentially disqualifying FFD information is disclosed or discovered about the individual who is applying for authorization that has not previously been evaluated by another licensee or other entity. Section 26.57 Authorization Update Proposed new § 26.57 [Authorization update] would define the category of ‘‘authorization update’’ requirements for granting authorization to individuals whose authorization has been VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 interrupted for more than 365 days but less than 3 years and whose last period of authorization was terminated favorably. As noted in the discussion of Subpart C in Section IV. C, the proposed requirements for granting an authorization update would be less stringent than the proposed requirements for granting initial authorization. The proposed requirements would be less stringent for two reasons: (1) The individual who is applying for an authorization update would have a more recent ‘‘track record’’ of successful performance within the industry, and (2) the licensee or other entity would have access to information about the individual from the licensee or other entity who last granted authorization to him or her because of the increased informationsharing requirements of the proposed rule. However, the licensee or other entity would not have information about the individual’s activities during the period of the interruption, so the proposed rule’s requirements for an authorization update would focus on gathering and evaluating information from the interruption period. For example, in the case of an individual whose last period of authorization ended 2 years ago, the licensee or other entity would focus on gathering information about the individual’s activities within the 2-year interruption period. If an individual’s last period of authorization ended 13 months ago, the licensee or other entity would focus on gathering information about the individual’s activities within those 13 months. Proposed § 26.57(a), like proposed § 26.55(a), would require the licensee or other entity, before granting authorization, to: (1) Obtain and review a self-disclosure in accordance with the applicable requirements of proposed § 26.61; (2) complete a suitable inquiry in accordance with the applicable requirements of proposed § 26.63; (3) ensure that the individual is subject to pre-access drug and alcohol testing in accordance with the applicable requirements of proposed § 26.65; and (4) ensure that the individual is subject to random drug and alcohol testing in accordance with the applicable requirements of proposed § 26.67. However, proposed § 26.61(c)(3)(iii) would limit the period of time to be addressed in the self-disclosure and employment history to the interruption period. That is, if an individual’s last period of authorization ended 2 years ago, the self-disclosure and employment history would cover only the past 2 years. Similarly, proposed § 26.63(f)(2) PO 00000 Frm 00063 Fmt 4701 Sfmt 4702 50503 would provide that the suitable inquiry for an authorization update must cover the interruption period. The proposed rule would require only that the interruption period must be addressed in the self-disclosure, employment history, and suitable inquiry because the licensee or other entity would obtain information from earlier periods in the individual’s history from the licensee or other entity who had last granted authorization to the individual. Proposed § 26.57(b) would be added to specify that if potentially disqualifying FFD information is disclosed or discovered about the individual who is applying for authorization, the licensee or other entity may not grant authorization to the individual, except in accordance with proposed § 26.69. Section 26.59 Authorization reinstatement A new § 26.59 [Authorization reinstatement] would establish two categories of authorization reinstatement requirements for individuals whose authorization has been interrupted for a short period and whose last period of authorization was terminated favorably, for the reasons discussed in Section IV. C. One category of authorization reinstatement requirements would apply to individuals whose authorization has been interrupted for more than 30 days but no more than 365 days in proposed § 26.59(a), and the other to individuals whose authorization has been interrupted for 30 or fewer days in proposed § 26.59(c). The proposed steps for reinstating an individual’s authorization after an interruption of 365 or fewer days would be less stringent than those required for initial authorization or an authorization update because these individuals have a recent, positive track record within the industry and so would pose little risk to public health and safety or the common defense and security. The proposed requirements that are related to an individual whose authorization has been interrupted for more than 30 days but no more than 365 days would be more extensive than the requirements for granting authorization to an individual whose authorization has been interrupted for 30 or fewer days. The proposed requirements for the 31–365 day category would be consistent with those contained in the access authorization orders issued by the NRC to nuclear power plant licensees dated January 7, 2003. However, the proposed requirements for individuals whose authorization has been interrupted for 30 or fewer days E:\FR\FM\26AUP2.SGM 26AUP2 50504 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules would be more stringent than those contained in the access authorization orders issued by the NRC to nuclear power plant licensees dated January 7, 2003. Under the access authorization orders, licensees are required to obtain and review a self-disclosure and employment history from the applicant before reinstating the individual’s authorization. Under the proposed rule, licensees and other entities would also be required to subject the individual to the possibility of being selected for preaccess testing in accordance with proposed § 26.65(e) [Authorization reinstatement after an interruption of 30 days or less]. The NRC has determined that this additional proposed requirement is necessary to meet the proposed rule’s performance objective of providing reasonable assurance that individuals are trustworthy and reliable, as discussed with respect to proposed § 26.23(a), by extending the deterrent effect of pre-access testing to individuals who have had an interruption in authorization of 30 or fewer days in length. For individuals whose authorization has been interrupted for 31–365 days, proposed § 26.59(a)(1) would require the licensee or other entity to obtain and review a self-disclosure and employment history in order to reinstate authorization. Consistent with the requirements for authorization updates in proposed § 26.57, the proposed rule in § 26.61(c)(3)(iii) would limit the period of time to be addressed in the self-disclosure and employment history to the period of the interruption in authorization. A self-disclosure and employment history for earlier periods of time would be unnecessary because the granting licensee or other entity would have access to information about the individual from the licensee or other entity who had recently terminated the individual’s authorization. By contrast to the proposed requirements for an initial authorization and an authorization update, proposed § 26.59(a)(2) would permit the licensee or other entity to reinstate an individual’s authorization without first completing the suitable inquiry. The proposed rule would permit the licensee or other entity to reinstate the individual’s authorization before completing the suitable inquiry because these individuals have a recent, positive track record within the industry and would pose little risk to public health and safety or the common defense and security. As would be required for an authorization update, the proposed rule would limit the period of time to be addressed by the suitable inquiry to the interruption period in proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 § 26.63(f)(3). However, the proposed paragraph would require licensees and other entities to ensure that the suitable inquiry is completed within 5 days after reinstating the individual’s authorization. If the suitable inquiry is not completed within the 5-day period permitted, the proposed rule would permit the licensee or other entity to maintain the individual’s authorization for up to 10 days following the day upon which authorization was reinstated, but only if the licensee or other entity is unaware of any potentially disqualifying information about the individual. If the suitable inquiry is not completed within the 10 days permitted, the proposed rule would require the licensee or other entity to administratively withdraw the individual’s authorization until the suitable inquiry is completed. Proposed § 26.59(a)(3) and (a)(4) would require the licensee or other entity to ensure that the individual whose authorization has been interrupted for 31–365 days is subject to pre-access drug and alcohol testing and random testing, respectively. Proposed § 26.65(d) [Authorization reinstatement after an interruption of more than 30 days] would establish pre-access drug and alcohol testing requirements for authorization reinstatements. Proposed § 26.67 [Random drug and alcohol testing of individuals who have applied for authorization] would specify the requirements for random testing of individuals who are applying for an authorization reinstatement. Proposed § 26.59(b) would be added to ensure that any administrative withdrawal of authorization that would be required under proposed § 26.59(a)(2) would not be reported or recorded as an unfavorable termination of authorization, unless and until the suitable inquiry is completed and it indicates that authorization should not be granted. This proposed provision would ensure that an individual’s temporary administrative withdrawal of authorization, caused by a delay in completing the suitable inquiry, would not be treated as an unfavorable termination caused by an FFD violation. This proposed provision would be necessary to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26, by ensuring that they are not subject to any adverse consequences for the licensee’s or other entity’s delay in completing the suitable inquiry. Proposed § 26.59(c) would establish authorization requirements for individuals whose authorization has been interrupted for 30 or fewer days. PO 00000 Frm 00064 Fmt 4701 Sfmt 4702 Proposed § 26.59(c)(1) would require the licensee or other entity to obtain and review a self-disclosure from the applicant for authorization with certain exceptions that would be specified in proposed § 26.61 [Self-disclosure and employment history]. The licensee or other entity would be permitted to forego conducting a suitable inquiry for individuals whose authorization has been interrupted for such a short period. Proposed § 26.59(c)(2) would permit licensees and other entities also to forego pre-access drug and alcohol testing of individuals whose authorization has been interrupted for 5 or fewer days, but pre-access testing may be required under proposed § 26.65(e) for individuals whose authorization has been interrupted for 6–30 days. Exceptions to the selfdisclosure and pre-access testing requirements in this proposed paragraph would be specified in proposed §§ 26.61 and 26.65, respectively. Section 26.61 Self-Disclosure and Employment History A new § 26.61 [Self-disclosure and employment history] would replace current § 26.27(a)(1) for the reasons discussed in Section IV.C. The proposed rule would replace the term, ‘‘written statement,’’ in the current rule with the phrase,’’ self-disclosure and employment history,’’ to more accurately characterize the requirement. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.61(a) would be added to require licensees and other entities to obtain a written self-disclosure and employment history from every applicant before granting authorization to the individual, except in two circumstances, as follows: Proposed § 26.61(a)(1) would permit the licensee or other entity to forego obtaining a self-disclosure and employment history, if all three of the following conditions are met: (1) The individual previously held authorization under Part 26; (2) the individual’s last period of authorization was terminated favorably; and (3) the individual was subject to a behavioral observation and arrest-reporting program that meets the requirements of this part throughout the time interval during which the individual’s authorization was interrupted. The information to be obtained from the selfdisclosure and employment history would be unnecessary in these circumstances, because it would already be available to the granting licensee or E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules other entity from the Part 26 program that had been implementing the behavioral observation and arrestreporting program during the interruption in the individual’s authorization. A requirement for licensees and other entities to conduct another suitable inquiry would be redundant and impose an unnecessary burden. Proposed § 26.61(a)(2) would permit licensees and other entities to forego obtaining an employment history from applicants for an authorization reinstatement whose authorization has been interrupted for 30 or fewer days. The employment history information would be unnecessary in this case, because the proposed rule would not require licensees or other entities to conduct a suitable inquiry for individuals who have had such a short break in authorization. Proposed § 26.61(b) would be added to specify the required content of the self-disclosure. Affirmative responses to any of the questions in proposed § 26.61(b)(1) would be considered potentially disqualifying FFD information, as defined in proposed § 26.5 [Definitions]. The proposed rule would expand the scope of the questions to be asked from those required in current § 26.27(a)(1) in order to provide greater assurance that individuals would disclose information with regard to indicators of an active substance abuse problem or an increased risk of recidivism into an active substance abuse problem after treatment. Current § 26.27(a)(2) requires information about whether the applicant ‘‘tested positive for drugs or use of alcohol that resulted in on-duty impairment.’’ Proposed § 26.61(b)(1) would require information about whether the applicant used, sold, or possessed illegal drugs, subverted or attempted to subvert a drug or alcohol testing program, or refused to take a drug or alcohol test. Both current § 26.27(a)(2) and proposed § 26.61(b)(1) require information on whether the applicant has been subject to a plan for substance abuse treatment (except for a self-referral). Both require information about previous denials or terminations of authorization. Proposed § 26.61(b)(2) would be added to require the applicant to disclose the circumstances surrounding any potentially disqualifying FFD information and the resolution of the matter. For example, proposed § 26.61(b)(1) would require an applicant to report an arrest on drug-related charges, while proposed § 26.61(b)(2) would require the applicant to report the outcome of the arrest (e.g., charges, VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 a conviction, a finding of not guilty, the dropping of the charges). Proposed § 26.61(b)(3) would define the time period to be addressed in the self-disclosure. The proposed rule would establish a time limit on the number of years in the past that an individual would be required to report and account for potentially disqualifying FFD information. One purpose of the self-disclosure is to identify indicators of an active substance abuse problem or an increased risk of recidivism into an active substance abuse problem after treatment. The relevant research literature indicates that there is a decrease in post-treatment recidivism (i.e., relapse) rates after 3 years of no further substance abuse, and a larger decrease in the recidivism rate after 5 years. If no indicators of a substance abuse problem within the past 5 years are disclosed (or since the applicant’s eighteenth birthday in the case of an applicant who is less than 23 years of age), an applicant for initial authorization (see proposed § 26.55) would not be required to disclose earlier substance-abuse-related events. For applicants who held authorization within the past 3 years, the selfdisclosure would address only the time interval since the individual’s last period of authorization ended. However, the licensee or other entity would obtain further information about the applicant over the past 5 years from reviewing the information made available by licensees or other entities who had granted authorization to the applicant in the past. This information would include information developed as part of previous suitable inquiries (see proposed § 26.63) as well as information from the period(s) during which the individual was subject to other Part 26 programs. Proposed § 26.61(c) would be added to require applicants to provide information about current and past employers, which the licensee or other entity would then use for the suitable inquiry, if a suitable inquiry is required under proposed § 26.63 [Suitable inquiry]. Proposed § 26.61(d) would replace and expand upon current § 26.27(a)(4). The proposed rule would add falsification of the self-disclosure or employment history as sufficient reasons to deny authorization to an individual in order to deter falsification attempts. Reference to temporary access authorization would be deleted from the proposed paragraph because temporary access authorization would no longer be permitted under Part 26, for the reasons discussed in Section IV.C. PO 00000 Frm 00065 Fmt 4701 Sfmt 4702 Section 26.63 50505 Suitable Inquiry A new § 26.63 [Suitable inquiry] would amend current § 26.27(a)(2) and the requirements related to conducting a suitable inquiry that are contained within the definition of the term, ‘‘suitable inquiry,’’ in current § 26.3 [Definitions]. The current rule defines a suitable inquiry as a ‘‘best-effort verification of employment history for the past 5 years, but in no case less than 3 years, obtained through contacts with previous employers to determine if a person was, in the past, tested positive for illegal drugs, subject to a plan for treating substance abuse, removed from, or made ineligible for activities within the scope of 10 CFR Part 26, or denied unescorted access at any other nuclear power plant or other employment in accordance with a fitness-for-duty policy.’’ In general, the proposed changes to the current requirements are intended to: (1) Better focus the suitable inquiry on indicators of an active substance problem and/or an increased risk of recidivism into an active substance abuse problem following treatment, as discussed in Section IV.C; (2) increase the consistency in implementing suitable inquiries among FFD programs by providing more detailed requirements, also as discussed in Section IV.C; and (3) improve Part 26 by eliminating or modifying unnecessary requirements, which is Goal 5 of this rulemaking, as discussed in Section IV.B. For all authorization categories, the suitable inquiry would be more thorough than previous industry practices, in order to increase the likelihood that potentially disqualifying FFD information would be identified, if it existed, and to provide reasonable assurance that individuals are trustworthy and reliable, as demonstrated by avoiding substance abuse. For individuals who have established a recent, favorable work history under Part 26, as demonstrated by having held authorization that was terminated favorably within the past 3 years, the period of time addressed in the suitable inquiry would be reduced from the past 5 years in every case, to the past 3 years or less, depending upon how recently the applicant held authorization. If potentially disqualifying FFD information within the past 5 years is identified regarding an applicant and the information has not been addressed and favorably resolved by a previous licensee or other entity, the suitable inquiry requirements would be more extensive, as described in proposed § 26.69 [Authorization with E:\FR\FM\26AUP2.SGM 26AUP2 50506 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules potentially disqualifying fitness-for-duty information]. Proposed § 26.63(a) would be added to require licensees and other entities to conduct a suitable inquiry for two purposes. One purpose would be to verify the information provided by the applicant in the self-disclosure and employment history obtained under proposed § 26.61. The second purpose would be to determine whether additional potentially disqualifying FFD information is available regarding the applicant. The proposed paragraph would also establish the circumstances in which a licensee or other entity would be permitted to forego the suitable inquiry in order to grant authorization to individuals. A licensee or other entity would be permitted to forego the suitable inquiry if all three of the following conditions are met: (1) The individual previously held authorization under Part 26; (2) the individual’s last period of authorization was terminated favorably; and (3) the individual was subject to a behavioral observation and arrest-reporting program that meets the requirements of this part throughout the period during which the individual’s authorization was interrupted. The information to be obtained from a suitable inquiry would be unnecessary in these circumstances, because it would already be available to the granting licensee or other entity from the Part 26 program that implemented the behavioral observation and arrest-reporting program during the interruption in authorization. Proposed § 26.63(b) would be added to permit licensees and other entities to rely upon suitable inquiry information that was gathered by previous licensees and other entities who are subject to this part. This proposed provision would reduce the number of redundant suitable inquiries that licensees and other entities must conduct, when the suitable inquiries would address the same employers and same time periods. The proposed paragraph would also permit licensees and other entities to accept the results of any determinations of fitness that were performed under a previous Part 26 program, rather than requiring each new licensee and other entity to reevaluate the same information that was reviewed and resolved in accordance with the same requirements under another Part 26 program. This proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.63(c) would be added to specify requirements for the manner in which licensees and other entities VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 must conduct the suitable inquiry. Licensees and other entities would be required to demonstrate a ‘‘best effort’’ to complete the suitable inquiry. The ‘‘best effort’’ criterion recognizes licensees’ and other entities’ status as commercial entities with no legal authority to require the release of the information from other private employers and educational institutions. Because of privacy and potential litigation concerns, some private employers and educational institutions may be unable or unwilling to release qualitative information about a former employee or student. For example, a former employer may verify the dates that an individual was employed by the company, but may be unwilling to reveal that the individual had been in treatment for drug or alcohol abuse while employed with the company. Therefore, the ‘‘best effort’’ criterion would require licensees and other entities to seek suitable inquiry information from the primary source (e.g., a company, private employer, or educational institution that the applicant has listed on his or her employment history), but recognizes that it may not be forthcoming. The ‘‘best effort’’ criterion in the proposed paragraph would be consistent with the ‘‘best-efforts basis’’ in current § 26.27(a)(2), but the proposed rule would provide more detailed requirements in response to questions that the NRC has received from licensees about implementing a suitable inquiry on a ‘‘best effort’’ basis since Part 26 was first promulgated. Proposed § 26.63(c)(1) would be added to specify the type of information that the licensee or other entity must seek from employers regarding the applicant for authorization. The proposed paragraph would require the licensee or other entity to ascertain the reason that the individual’s employment was terminated, his or her eligibility for rehire, and other information that could reflect on the individual’s fitness to be granted authorization. The proposed requirement to obtain this information would be consistent with long-standing industry practices related to granting access authorization and related requirements in the access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Proposed § 26.63(c)(2) would specify the type of information that licensees and other entities must seek when an applicant’s claimed periods of employment include military service. The proposed requirement would be added for consistency with related PO 00000 Frm 00066 Fmt 4701 Sfmt 4702 requirements in the access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Proposed § 26.63(c)(3) also would be added to provide consistency with related requirements in the access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. The proposed paragraph would address circumstances in which a primary source of information refuses to provide the necessary suitable inquiry information or indicates an inability or unwillingness to provide it within 3 days of the request. Licensees and other entities would be required to document that the request for information was directed to the primary source and the nature of the response (i.e., a refusal, inability, or unwillingness). If a licensee or other entity encounters the circumstances addressed in proposed § 26.63(c)(3), the proposed paragraph would require the licensee or other entity to seek suitable inquiry information from an alternate source, to the extent of the alternate source’s ability to provide the information. An alternate source may include, but would not be limited to, a co-worker or supervisor at the same company who had personal knowledge of the applicant, if such an individual could be located. However, the proposed rule would prohibit the licensee or other entity from using the alternate source of suitable inquiry information to meet any other access authorization requirements for a character reference. The proposed rule would permit licensees and other entities to grant authorization, if warranted, when a response has been obtained from an alternate source, without waiting more than 3 days after the request for information was directed to a primary source. These proposed alternative methods of meeting the suitable inquiry requirement are necessary because, as discussed with respect to proposed § 26.63(c), some employers are unwilling or unable to provide suitable inquiry information. Proposed § 26.63(d) would be added to require licensees and other entities who are subject to this part to share suitable inquiry information that they have collected when contacted by another licensee or entity who has a release that would permit the sharing of that information signed by the applicant for authorization. This proposed provision would restate the permission to release suitable inquiry information in current § 26.29(b) as a requirement that licensees and other entities must E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules share the information necessary to conduct the suitable inquiry. The proposed provision would also clarify that the information must also be released to C/Vs who have licenseeapproved FFD programs when the C/V presents the required signed release from the applicant. This proposed clarification is necessary because some licensees have misinterpreted current § 26.29(b) as prohibiting the release of suitable inquiry information to C/Vs who have licensee-approved FFD programs. The proposed paragraph would also permit a licensee or other entity to deny authorization to an individual if the individual will not sign the release necessary to permit the licensee or other entity to conduct the suitable inquiry. The proposed provisions would be consistent with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. Proposed § 26.63(e) would be added to permit licensees and other entities to use electronic means of obtaining the suitable inquiry information. This proposed permission would be consistent with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003. The proposed paragraph would also add crossreferences to the applicable records retention requirements in proposed § 26.211 [General provisions] and proposed § 26.213 [Recordkeeping requirements for licensees and other entities] in proposed Subpart J [Recordkeeping and Reporting Requirements] to ensure that licensees and other entities are aware of the applicability of these requirements to the suitable inquiry information obtained electronically. The proposed change would be consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.63(f) would be added specify the period(s) of time that the suitable inquiry must address for applicants for initial authorization, authorization update, and authorization reinstatement. The proposed paragraph would also specify additional requirements for conducting the suitable inquiry for these authorization categories, as follows: Proposed § 26.63(f)(1) [Initial authorization] would require licensees and other entities to conduct a suitable inquiry to address the 3-year period preceding the date upon which the individual applies for authorization. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 The period of time to be addressed in the suitable inquiry for applicants for initial authorization who do not disclose any potentially disqualifying FFD information would be reduced from 5 years in the current regulation to 3 years for two reasons: First, one purpose of the suitable inquiry is to identify indicators of an active substance abuse problem or an increased risk of recidivism following treatment. Therefore, if no potentially disqualifying FFD information is disclosed by an applicant for initial authorization from the past 5 years and none is identified through the suitable inquiry or other means, it is unlikely that the applicant has an active substance abuse problem. Therefore, seeking a full 5 years of information about the individual would unlikely provide useful information and imposes an unnecessary burden. Second, industry experience has shown that employers are often reluctant to disclose adverse information to other private employers about former employees, and that the longer it has been since an individual was employed, the less likely it is that a former employer will disclose useful information. Therefore, rather than retaining the requirement for a 5year suitable inquiry in all cases, the proposed rule would increase the thoroughness of the suitable inquiry into the past 3 years. Proposed § 26.63(f)(1) would be added to require the licensee or other entity to conduct the suitable inquiry with every employer by whom the applicant claims to have been employed within the past year. This proposed requirement to conduct the suitable inquiry with every claimed employer would be a more rigorous suitable inquiry than was common industry practice prior to issuance of the January 7, 2003, access authorization orders, which imposed additional compensatory measures related to access authorization. The purpose of contacting every employer would be to ensure that the licensee or other entity sought information related to any active substance abuse problem. For the earlier 2 years of the suitable inquiry period, the proposed paragraph would require the licensee or other entity to conduct the suitable inquiry with every employer by whom the applicant claims to have been employed the longest within each calendar month. Contacting these employers would increase the likelihood that the employers would have knowledge of the applicant and so may provide more useful information than contacting employers by whom the applicant was employed only briefly. PO 00000 Frm 00067 Fmt 4701 Sfmt 4702 50507 Proposed § 26.63(f)(2) [Authorization update] would be added to specify the period of time that the suitable inquiry must address for applicants for an authorization update (i.e., those who held authorization within the past 3 years and whose last period of authorization was terminated favorably, but who have not held authorization within the past year). The proposed paragraph would require the licensee or other entity to conduct the suitable inquiry in the same manner as described in proposed § 26.63(f)(1). However, for an authorization update, the suitable inquiry would address only the period that the individual’s authorization was interrupted, rather than the full 3 years that would be required for initial authorization. A 3-year period for the suitable inquiry would be unnecessary for these individuals, because the licensee or other entity would have access to the information about the individual that was gathered by the licensee or other entity under whose program the individual had been granted and successfully maintained authorization within the past 3 years. Proposed § 26.63(f)(3) [Authorization reinstatement after an interruption of more than 30 days] would specify the period of time that the suitable inquiry must address for applicants who held authorization within the past year and whose last period of authorization was terminated favorably, but who have not held authorization within the past 30 days. The proposed rule would require licensees and other entities to contact employers by whom the applicant claims to have been employed the longest in each calendar month of the interruption. The proposed rule would not require licensees and other entities to contact every employer by whom the individual claimed to have been employed during the interruption for the reasons discussed with respect to proposed § 26.59(a)(2). Because these individuals have had only a short break in authorization, a sampling of employers from the interruption period would be sufficient to determine whether any indications exist that the individual had developed a previously undetected substance abuse or other problem that would adversely affect his or her fitness to have authorization reinstated. The time periods and approach to conducting the suitable inquiry established in proposed § 26.63(f)(1)– (f)(3) would be consistent with those established in the access authorization orders issued to nuclear power plant licensees dated January 7, 2003. E:\FR\FM\26AUP2.SGM 26AUP2 50508 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Section 26.65 Pre-Access Drug and Alcohol Testing Proposed § 26.65 [Pre-access drug and alcohol testing] would amend current § 26.24(a)(1), which requires drug and alcohol ‘‘testing within 60 days prior to the initial granting of unescorted access to protected areas or assignment to activities within the scope of this part.’’ The proposed section would amend the current pre-access drug and alcohol testing requirement for individuals who are seeking authorization under Part 26 to strengthen the effectiveness of FFD programs, as discussed in Section IV. C. Proposed § 26.65(a) [Purpose] would be added to describe the purpose of the section and identify the individuals to whom the requirements in the proposed section would apply. The pre-access testing requirements in this section would cover applicants for authorization (1) who have never held authorization under Part 26 or have held authorization under Part 26 and whose most recent period of authorization was terminated favorably, and (2) about whom no potentially disqualifying FFD information has been discovered or disclosed that was not reviewed and favorably resolved by another licensee or entity. Requirements for granting authorization to individuals whose previous periods of authorization were terminated unfavorably or denied, or about whom new potentially disqualifying FFD information has been discovered or disclosed, would be contained in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. Proposed § 26.65(b) [Accepting tests conducted within the past 30 days] would be added to permit licensees and other entities to forego pre-access testing of an individual who has negative test results from drug and alcohol tests that were performed in accordance with the requirements of Part 26 within the 30day period before the licensee or other entity grants authorization to the individual, including tests that were conducted before the individual applied for authorization from the licensee or other entity. For example, if an individual was subject to random testing under another Part 26 program and was selected for testing under the other program before applying for authorization from the granting licensee or other entity: the proposed rule would permit the granting licensee or other entity to accept negative test results from the random test in lieu of performing a pre-access test, if the random test was conducted within 30 days before the day upon which VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 authorization is granted to the individual. A requirement for the licensee or other entity to conduct preaccess testing in these circumstances would be redundant and unnecessary. Proposed 26.65(c) [Initial authorization and authorization update] would be added to establish pre-access testing requirements for individuals who are applying for initial authorization and an authorization update. The proposed rule would require negative results from pre-access testing before the licensee or other entity could grant authorization to the individual, except in the two circumstances described in proposed § 26.65(c)(1) and (c)(2). In proposed § 26.65(c)(1), licensees and other entities would be permitted to forego pre-access testing if the applicant had been subject to drug and alcohol testing (including random testing), behavioral observation, and arrest-reporting requirements under a Part 26 FFD program throughout the period during which the individual’s authorization was interrupted. In proposed § 26.65(c)(2), licensees and other entities would be permitted to forego pre-access testing of an applicant who had negative test results from Part 26 drug and alcohol tests that were performed within the past 30 days and was subject to behavioral observation and arrest-reporting requirements during the time interval between the day upon which the specimens were collected and the day the licensee or other entity grants authorization to the individual. Pre-access testing in these two circumstances would be unnecessary because there would be sufficient opportunity to detect substance abuse without it. Proposed paragraphs § 26.65(d) [Authorization reinstatement after an interruption of more than 30 days] and (e) [Authorization reinstatement after an interruption of 30 days or fewer] would be added to establish requirements for pre-access testing of individuals who are applying for an authorization reinstatement. The proposed requirements for pre-access testing of these individuals would be less stringent than the requirements for initial authorization and an authorization update. The proposed provision would also relax the preaccess testing requirements in current § 26.24(a)(1), which require all applicants for authorization to be subject to pre-access testing within 60 days before granting authorization. Less stringent pre-access testing requirements would be appropriate because these individuals have (1) met the rigorous criteria for initial authorization; (2) established a recent PO 00000 Frm 00068 Fmt 4701 Sfmt 4702 record of successfully maintaining authorization under Part 26; and (3) had only a short break in authorization. Proposed § 26.65(d) would specify pre-access testing requirements for individuals whose authorization has been interrupted for more than 31 days but no more than one year. Proposed § 26.65(d)(1)(i) would require the licensee or other entity to administer an alcohol test and collect a urine specimen for drug testing. The licensee or other entity would be permitted to reinstate the individual’s authorization if the alcohol test results are negative, before the drug test results are available. Proposed § 26.65(d)(1)(ii) would permit the licensee or other entity to maintain the individual’s authorization for 5 days after reinstatement without receiving the drug test results. But, if the licensee or other entity does not receive negative drug test results within 5 days of reinstating the individual’s authorization, the proposed rule would require the licensee or other entity to administratively withdraw the individual’s authorization until negative drug test results are received. These proposed requirements would ensure that individuals whose authorization has been interrupted for more than 30 days are subject to pre-access drug and alcohol testing to deter substance abuse and to detect any current substance abuse problem. However, the proposed provisions would not unduly delay authorization reinstatement, given that these individuals’ recent successful histories of maintaining authorization under Part 26 indicates that they are at low risk of engaging in substance abuse. Proposed § 26.65(d)(2) would permit licensees and other entities to forego pre-access testing of these applicants for reinstatement in the circumstances discussed with respect to proposed § 26.65(c)(1) and (c)(2). Proposed § 26.65(e)(1) would be added to permit licensees and other entities to forego pre-access testing of applicants whose authorization has been interrupted for 5 or fewer days. This proposed provision would be consistent with current licensee practices and recommendations regarding ‘‘short breaks’’ in authorization in NUREG–1385 and other access authorization requirements. However, proposed § 26.65(e)(2) would require licensees and other entities to subject applicants whose authorization has been interrupted for 6–30 days to the possibility of being selected for pre-access testing in order to deter any potential for substance abuse. Proposed § 26.65(e)(2)(i) would require the licensee or other entity to subject the applicant to a one-time E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules chance of being selected for testing at a probability of approximately 4 percent. This proposed probability approximates the likelihood that individuals who are subject to random testing at the 50 percent annual testing rate in proposed § 26.31(d)(2)(vi) would be selected for testing at some point within a 30-day period. Proposed § 26.65(e)(2)(ii) would clarify that, if an applicant is not selected for pre-access testing under the preceding paragraph, the licensee or other entity would not be required to perform a pre-access test. Proposed § 26.65(e)(2)(iii)(A) and (B) would specify requirements for conducting the pre-access testing, should an individual be selected for testing under proposed § 26.65(e)(2)(i). The licensee or other entity would complete an alcohol test and collect a specimen for drug testing before reinstating the individual’s authorization. In order to maintain the individual’s reinstated authorization, the proposed rule would require that the licensee or other entity must receive negative drug test results within 5 days after reinstatement or administratively withdraw the individual’s authorization until negative drug test results are received. However, proposed § 26.65(e)(3) would permit licensees and other entities to forego subjecting an individual to the possibility of being selected for pre-access testing, if the applicant had been subject to the drug and alcohol testing (including random testing), behavioral observation, and arrest-reporting elements of a Part 26 FFD program throughout the interruption in the individual’s authorization; because being subject to these program elements during the interruption period would be sufficient to deter substance abuse and provide assurance that substance abuse would be detected. Proposed § 26.65 would enhance the deterrent effect of preaccess testing for individuals who have had a very short break in authorization, without imposing the burden of requiring that every individual must be tested. Proposed § 26.65(f) [Time period for testing] would be added to require that specimens that are collected for any preaccess testing required in this proposed section must be collected within the 30day period preceding the day upon which the licensee grants authorization to an individual. Under current § 26.24(a)(1), licensees and other entities are permitted to complete pre-access testing within the 60-day period before authorization is granted. The shorter time period within which pre-access testing must be conducted, if required, in the proposed rule would increase the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 likelihood of detecting an active substance abuse problem among applicants for unescorted access to nuclear power plants and others who are subject to Part 26 by increasing the number of pre-access tests that would be performed. In addition, the decreased time period for pre-access testing would increase the likelihood that recent drug use, particularly marijuana, would be detected before the concentration of metabolites in an individual’s body could decrease below the cutoff levels prescribed in the proposed rule. The decreased time period within which pre-access testing must be performed in the proposed rule would provide higher assurance that individuals subject to this part are trustworthy and reliable, as demonstrated by the avoidance of substance abuse, as discussed with respect to proposed § 26.23(a). Proposed § 26.65(g) [Administrative withdrawal of authorization] would be added to ensure that the licensee or other entity does not record or report as an unfavorable termination any administrative withdrawal of authorization that may be required under proposed paragraphs (d)(1)(ii) or (e)(2)(iii)(B) of this proposed section. The point in time at which a licensee or other entity receives drug test results would not be under the control of the applicant and would not reflect upon the applicant’s fitness, trustworthiness, or reliability, if the licensee or other entity is unable to obtain drug test results within the 5 days permitted and must administratively withdraw the individual’s authorization. Therefore, subjecting the individual to the severe consequences associated with a record of an unfavorable termination would be inappropriate. Should the drug test results be non-negative and the licensee or other entity terminates the individual’s authorization for cause, however, the termination would then be recorded as unfavorable. Proposed § 26.65(h) [Sanctions for a confirmed non-negative pre-access test result] would be added to specify the minimum sanctions to be imposed on an individual whose pre-access test results are confirmed by the MRO as an FFD policy violation. Proposed § 26.65(h)(1) and (h)(2) would crossreference the relevant sanctions specified in proposed Subpart D [Management Actions and Sanctions] to clarify that those sanctions would apply to applicants for authorization. For example, if the MRO determines that an individual has submitted an adulterated urine specimen for a pre-access drug test, the licensee or other entity would be required to impose the sanction for an attempt to subvert the testing process PO 00000 Frm 00069 Fmt 4701 Sfmt 4702 50509 (i.e., permanent denial of authorization) in proposed § 26.75(b). Proposed § 26.65(h)(3) would be added to permit licensees and other entities to grant authorization to an individual whose confirmed nonnegative test result is a first drug- or alcohol-related violation under a Part 26 program, consistent with current § 26.27(b)(2). However, the proposed rule would permit authorization to be granted only in accordance with the stringent requirements contained in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. Section 26.67 Random Drug and Alcohol Testing of Individuals Who Have Applied for Authorization A new § 26.67 [Random drug and alcohol testing of individuals who have applied for authorization] would be added to extend current random testing requirements to individuals who have applied for authorization under Part 26 but to whom authorization has not yet been granted. The requirements contained the proposed section would be added to the access authorization requirements that were established by orders to nuclear power plant licensees dated January 7, 2003, for two reasons: (1) To enhance the effectiveness of FFD programs by increasing the likelihood that substance abuse would be detected before authorization is granted, and (2) to deter the potential for substance abuse among applicants. A new § 26.67(a) would require licensees and other entities to conduct random testing of applicants in accordance with the requirements of proposed § 26.31(d)(2). That is, the licensee or other entity would add applicants to the FFD program’s normal population of individuals who are subject to random testing, select individuals for testing at the 50 percent annual rate, and otherwise subject applicants to the same random testing requirements as individuals who currently hold authorization under Part 26. An applicant would be subject to random testing beginning when the licensee or other entity collects the specimens for any required pre-access test, and continuing thereafter, if the licensee or other entity grants authorization to the individual. Licensees and other entities would be permitted to forego random testing of applicants in the two circumstances described in proposed § 26.67(a)(1) and (a)(2). Proposed § 26.67(a)(1) would permit a licensee or other entity to discontinue random testing of any applicant to whom the licensee or other entity does not grant authorization for E:\FR\FM\26AUP2.SGM 26AUP2 50510 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules any reason, including a termination or denial of authorization or a withdrawal of the application for authorization by the individual or the individual’s employer, in the case of a C/V. Proposed § 26.67(a)(2) would address the circumstance described in proposed § 26.65(b), in which the licensee or other entity is permitted to meet preaccess testing requirements by relying upon negative test results from specimens collected under another Part 26 program within 30 days before granting authorization to the individual. Under proposed § 26.67(a)(2), the licensee or other entity would begin subjecting the applicant to random testing when the licensee or other entity takes the first formal action to process the individual’s application for authorization. The actions may include, but are not limited to, the point in time at which the licensee or other entity receives the individual’s signed consent form and begins creating a record of the individual’s application that would be accessible to other licensees and entities; conducts a psychological evaluation; begins a suitable inquiry; or takes other actions that are required under NRC regulations to grant authorization. The first formal action that the licensee or other entity takes to process an individual’s application for authorization will vary, depending upon the licensee’s FFD and access authorization program procedures, whether the applicant’s FFD training is up-to-date, and other factors, which, together, make it impractical to establish in the proposed rule a single point in the authorization process at which random testing must begin. Therefore, the proposed paragraph would require the licensee or other entity to begin subjecting the individual to random testing when the licensee or other entity takes the first formal action, but would not define a specific formal action that would initiate random testing of applicants in all cases. Proposed § 26.67(b) would be added to permit licensees and other entities to grant authorization to an individual before random testing is completed, if the individual has met all of the requirements for authorization but has been selected for one or more random tests while in applicant status. That is, if the applicant has met all other applicable requirements for authorization, licensees and other entities need not delay granting authorization to the individual in order to conduct and obtain the results from a random test, if the applicant was selected for random testing while in applicant status. The proposed rule VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 would not require the testing to be completed before the licensee or other entity grants authorization to the individual because the primary purpose of random testing of applicants would be to deter substance abuse rather than to provide information for the authorization decision. Pre-access testing provides the necessary information for authorization decisionmaking. Proposed § 26.67(c) would crossreference the minimum sanctions to be imposed on an individual whose drug or alcohol test results from random testing are confirmed as non-negative. Proposed § 26.67(c)(1) and (c)(2) would refer to the relevant sanctions specified in proposed Subpart D. Proposed § 26.67(c)(3) would continue to permit licensees and other entities to grant authorization to an individual whose confirmed non-negative test result is a first drug- or alcohol-related violation under a Part 26 program, consistent with current § 26.27(b)(2), but the proposed rule would permit authorization to be granted only in accordance with the stringent requirements contained in proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. Section 26.69 Authorization With Potentially Disqualifying Fitness-forDuty Information A new § 26.69 [Authorization with potentially disqualifying fitness-for-duty information] would replace and clarify the existing requirements contained in § 26.27(b)(4), which establishes requirements for granting authorization to an individual who has violated an FFD policy and had his or her authorization terminated unfavorably or denied for a period of 3 or 5 years under the current rule. Consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, the proposed section would be added to address problems that have arisen in implementing the current rule and clarify the NRC’s intent with respect to several situations that are not addressed in the current rule. Proposed § 26.69(a) [Purpose] would be added to describe the purpose of the section and the applicants to whom the requirements in the proposed section would apply. The proposed rule would require licensees and other entities to meet the applicable requirements in this section before granting authorization to an individual or permitting an individual to maintain his or her authorization when potentially disqualifying FFD information is obtained about an individual through PO 00000 Frm 00070 Fmt 4701 Sfmt 4702 any means and the information has not been assessed and favorably resolved by a previous licensee or other entity. Proposed § 26.63(b) would permit licensees and other entities to rely upon the results of determinations of fitness that were conducted by previous licensees or other entities, rather than requiring each new licensee or other entity to reevaluate the same information that was reviewed and resolved under another Part 26 program. However, if the potentially disqualifying FFD information was not previously reviewed and favorably resolved under another Part 26 program, licensees and other entities would implement the requirements contained in this proposed section. The proposed paragraph would also revise the language contained in current § 26.27(b)(2) to recognize that licensees and other entities may decide not to grant authorization to the subject individual and so, in that case, would not be required to implement these requirements. At the public meetings discussed in Section V, stakeholders noted that some individuals have misinterpreted the current rule as requiring licensees to provide individuals who have violated an FFD policy with the opportunity to seek treatment for a substance abuse problem and to have authorization reinstated. However, although the NRC continues to affirm that individuals who pursue treatment and maintain sobriety may be considered for authorization, both the current and proposed rules assign the responsibility for making authorization decisions to the licensee or other entity. Therefore, the proposed paragraph would clarify that granting or maintaining the authorization of an individual about whom potentially disqualifying FFD information has been disclosed or discovered is ‘‘at the licensee’s or other entity’s discretion.’’ Proposed § 26.69(b) [Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization] would be added to define requirements for granting authorization, at the licensee’s or other entity’s discretion, to an individual who had confirmed positive drug or alcohol test results and whose authorization, as a result, was previously terminated unfavorably or denied for 5 years. The requirements in the proposed paragraph would apply to: (1) An applicant who had a first confirmed positive test result on a pre-access test and was consequently denied authorization by a licensee; (2) an individual who is returning to duty following the 14-day assessment period required in current § 26.26(b)(2), which would be moved to E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules proposed § 26.75(e)(1); (3) an individual whose authorization was terminated unfavorably under another Part 26 program and who had an interruption in authorization that was longer than 14 days; and (4) an individual whose authorization was denied for 5 years under the requirements of proposed § 26.75(c), (d), (e)(2), or (f). The proposed paragraph would replace and strengthen the requirements contained in current § 26.27(b)(2) and expand them to address confirmed positive alcohol test results, which are excluded from this process in current § 26.27(b)(5). The proposed paragraph would include confirmed positive alcohol test results for the reasons discussed with respect to proposed § 26.75(e). Proposed § 26.69(b)(1) would require the licensee or other entity to obtain and review a self-disclosure from the applicant to verify that it does not contain any previously undisclosed potentially disqualifying FFD information. Because the individual’s last period of authorization was terminated unfavorably or denied, licensees and other entities would not be permitted to forego obtaining a selfdisclosure and employment history under any circumstances, because it would be important to review the individual’s activities during the interruption period. The period of time to be addressed in the self-disclosure would be the shorter of either the past 5 years or the intervening period since the individual last held authorization. Proposed § 26.69(b)(2) would increase the scope of the suitable inquiry that the licensee or other entity must conduct by requiring the licensee or other entity to conduct the suitable inquiry with every employer by whom the applicant claims to have been employed during the period of time addressed in the individual’s self-disclosure. This extensive suitable inquiry would be necessary to determine whether any indications exist that the individual has continued to engage in substance abuse. The proposed rule would also required licensees and other entities to obtain and review any records that other licensees or entities may have developed related to any potentially disqualifying FFD information about the individual from the past 5 years. These records may include, but would not be limited to, the results of past suitable inquiries or other investigations, records of arrests or convictions, drug and alcohol test results, treatment records, and the results of determinations of fitness. This information would be used by the SAE to assess the individual’s fitness and the licensee’s or other VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 entity’s reviewing official to determine whether authorization is warranted. Proposed § 26.69(b)(3) would apply only to individuals whose authorization was denied for 5 years under the current rule or in accordance with § 26.75(c), (d), (e)(2), or (f) of the proposed rule. The proposed paragraph would require the licensee or other entity to verify, before granting authorization, that the individual had not abused alcohol or drugs during the 5-year interruption, at a minimum. The proposed requirement would be consistent with the portion of current § 26.27(b)(4) that requires licensees to obtain ‘‘satisfactory medical assurance that the person has abstained from drugs for at least three years.’’ However, the proposed rule would extend the requirement to 5 years to ensure that such an individual would be at the lowest risk of recidivism into an active substance abuse problem before the licensee or other entity could grant authorization to the individual. Proposed § 26.69(b)(4) would amend the requirement in current § 26.27(b)(2), which mandates that an individual who has a first confirmed positive test result must be referred to the EAP for assessment and counseling before the licensee or other entity may grant authorization to the individual. The proposed paragraph would make several changes to the current provision. First, the proposed rule would replace the term, ‘‘management and medical assurance of fitness,’’ which is used in current § 26.27(b)(2) and (b)(4), with the term, ‘‘determination of fitness,’’ to improve the accuracy of the language in the proposed rule. The proposed rule would not use ‘‘management’’ because the licensee’s or other entity’s reviewing official (see the discussion of proposed § 26.69(c)(3) and the definition of ‘‘reviewing official’’ in proposed § 26.5 [Definitions]) is the individual who licensees and other entities currently designate to make authorization decisions and the reviewing official may not be a manager. In addition, the proposed rule would permit professionals other than a licensed physician to conduct a determination of fitness, for the reasons discussed with respect to proposed § 26.189 [Determination of fitness]. Therefore, this proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Consistent with the intent of the current requirement, the proposed paragraph would require the licensee or other entity to ensure that a ‘‘determination of fitness’’ is conducted, as defined in proposed § 26.189 [Determination of fitness], as part of the PO 00000 Frm 00071 Fmt 4701 Sfmt 4702 50511 authorization decision. Proposed § 26.187 [Substance abuse expert] would require that determinations of fitness that are conducted for authorization decisions must be performed by an SAE, whose role, responsibilities, and required qualifications would also be defined in proposed § 26.187. Therefore, proposed § 26.69(b)(4) would require that the individual must be referred to an SAE for a determination of fitness, but the proposed rule would not require the SAE to be an EAP employee. Permitting licensees and other entities to rely upon a professional who meets the required qualifications for an SAE, rather than only on EAP personnel, would more appropriately focus this requirement on assuring that the professional who performs the assessment and treatment planning is qualified, rather than on the professional’s organizational affiliation. Proposed § 26.69(b)(4)(i)–(b)(4)(iii) would replace and strengthen the requirement in current § 26.27(b)(2), which states that ‘‘any rehabilitation program deemed appropriate must be initiated during such suspension period.’’ The proposed paragraph would require that the individual must be in compliance with or have successfully completed treatment plans, rather than simply started treatment, in order for the licensee or other entity to grant authorization to the individual and maintain the individual’s authorization after it has been granted. Proposed § 26.69(b)(5) would be added to impose more stringent preaccess testing requirements on an individual who is being considered for authorization following an unfavorable termination or denial of authorization than those required for individuals whose last period of authorization was terminated favorably. The proposed paragraph would require negative results from an alcohol test performed within 10 business days before authorization is granted. Similarly, the proposed paragraph would require negative results from a urine specimen that was collected for drug testing within 10 business days before authorization is granted, as well as collection of the urine specimen under direct observation. The proposed paragraph would prohibit the licensee or other entity from granting authorization to the individual before the drug test results are reported to the licensee’s or other entity’s MRO so that the MRO may determine whether the drug test results indicated that the individual has not engaged in any further drug abuse [see the discussion of proposed § 26.69(f)]. Completing drug and alcohol testing within 10 days E:\FR\FM\26AUP2.SGM 26AUP2 50512 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules before granting authorization, rather than the 30 days that is permitted in proposed § 26.65(f) [Time period for testing] for the other authorization categories, would provide evidence that the individual has abstained from abusing proscribed substances during the interruption period and that the individual would be able to safely and competently perform duties under this part when authorization is reinstated, if the individual’s authorization has been interrupted for the 14-day assessment period required under current § 26.27(b)(2) and retained in proposed § 26.75(e)(1). Requiring direct observation of the urine specimen collection would be necessary to provide added assurance that the specimen is valid and yields accurate drug test results. Proposed § 26.69(b)(6) would apply only to individuals whose authorization has been unfavorably terminated or denied for at least 14 days for a first confirmed positive drug or alcohol test result. The proposed paragraph would replace the third sentence of current § 26.27(b)(4), which establishes requirements and a schedule for followup drug and alcohol testing for an individual whose authorization was denied for 3 years under the current rule, and apply the requirement for followup testing to individuals who have had a first confirmed positive test result for drugs or alcohol. The proposed requirement would provide greater deterrence of further drug and alcohol use than current § 26.27(b)(4), which requires this followup testing only for the more serious FFD violations that result in a denial of authorization for 3 years or longer. The more stringent requirement would provide higher assurance that individuals who are subject to this part are trustworthy, reliable, and fit for duty. Proposed § 26.69(b)(6) would amend the current fixed schedule for followup testing by requiring licensees and other entities to subject the individual to the possibility of being selected for followup testing, during any period in which he or she holds authorization under Part 26, for a period of 3 calendar years after the individual’s authorization is restored following termination or denial for the first confirmed positive drug or alcohol test result. The proposed rule would require licensees and other entities to ensure that the individual is subject to unannounced testing at least 15 times within the 3-year period and verify that the individual’s test results are negative. Either random or followup tests, which are both unannounced, may be used to meet this proposed requirement. The VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 proposed rule would require licensees and other entities to distribute the unannounced tests over the 3-year period, with at least one unannounced test conducted each quarter. Proposed § 26.69(b)(6)(i)–(b)(6)(iii) would be added to address circumstances in which an individual is not continuously subject to a Part 26 program during the 3 years following restoration of authorization. Proposed § 26.69(b)(6)(i) would require that an individual who intermittently holds authorization over the 3-year period must be subject to unannounced testing at least once in each quarter during which the individual is authorized. Proposed § 26.69(b)(6)(ii) would permit the licensee or other entity to extend the followup testing period to 5 years, if the requirement for 15 tests over the 3-year period has not been met because the individual has not been authorized a sufficient number of times or for sufficient periods of time during the first 3 years to meet the proposed 15-test requirement. Proposed § 26.69(b)(6)(iii) would permit the licensee or other entity to have an SAE conduct a determination of fitness to determine whether further followup testing is required, if an individual is unable to meet the 15-test requirement after 5 years due to brief and infrequent periods of authorization. These proposed changes to the current followup testing requirements respond to information provided by stakeholders in the public meetings discussed in Section V. Stakeholders reported that some individuals who are subject to followup testing have been unable to satisfy the requirements of current § 26.27(b)(4) because they are not continuously employed in the nuclear industry in job positions that require authorization, and, therefore, are not continuously subject to a Part 26 FFD program. As a result, these individuals have been unable to demonstrate negative test results on tests that are performed ‘‘once every month for four months and at least once every three months for the next two years and eight months after unescorted access is reinstated.’’ Stakeholders reported that some individuals have been unable to satisfy the current requirement after 10 years, despite obtaining negative test results on every pre-access, random, and followup test administered during that period, because the individuals were not continuously subject to a Part 26 followup testing program for the required 3-year period. This was not the intent of the current provision. Therefore, the proposed revision to this requirement would increase the PO 00000 Frm 00072 Fmt 4701 Sfmt 4702 flexibility with which licensees and other entities may implement followup testing requirements, but retain the current effectiveness of followup testing in detecting and deterring substance abuse. Proposed § 26.69(b)(7) would be added to require the licensee or other entity to verify that the results of all drug and alcohol tests that are administered to the individual under a Part 26 program following restoration of the individual’s authorization indicate no further drug or alcohol abuse. The proposed paragraph would not specify that the drug test results must be negative, because the metabolites of some drugs, such as marijuana, may be present in an individual’s urine for several weeks after the individual has stopped using the drug. If an individual is tested again soon after the original test that resulted in an FFD violation was conducted, the specimen may yield positive results which would not, in fact, reflect new drug use. Therefore, if subsequent drug test results show the presence of the same drug or drug metabolites in the individual’s urine as detected in the original confirmed positive test result, the MRO, under proposed § 26.185(o), would be required to determine whether the results indicate new drug use or are consistent with results that would be expected from the drug use that resulted in the previous confirmed positive test result. The proposed rule would add this requirement in response to inconsistencies in the manner in which some MROs have implemented current requirements related to return-to-duty drug testing. Some MROs have been inappropriately reluctant to declare a second drug test result as negative if any concentration of the drug or drug metabolites that resulted in a first confirmed positive drug test result are detected in the specimen. The proposed change would permit an individual who has not engaged in further drug use after a first confirmed positive drug test result to regain authorization, at the licensee’s discretion, rather than be incorrectly denied authorization for 5 years on the basis of a subsequent FFD policy violation, under proposed § 26.75(e)(2). Proposed § 26.69(c) [Granting authorization with other potentially disqualifying FFD information] would be added to establish requirements for granting authorization to an individual about whom potentially disqualifying FFD information is discovered or disclosed that was not a confirmed nonnegative drug or alcohol test result or 5year denial of authorization. For example, this type of potentially E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules disqualifying FFD information may include, but would not be limited to: (1) A report of an arrest for an alcoholrelated traffic violation; (2) information from the suitable inquiry that an individual’s employment was terminated by a previous private-sector employer because of drug- or alcoholrelated job performance problems; or (3) information obtained from the suitable inquiry or other sources of information indicating that the individual is known to abuse illegal drugs or alcohol or is experiencing significant mental or emotional stress. The proposed paragraph would be necessary because the current rule does not address the authorization process in such circumstances and the NRC is aware that licensees and other entities have handled these circumstances inconsistently. Therefore, the proposed rule would add these requirements to establish the NRC’s intent with respect to these circumstances and increase consistency between Part 26 programs. Proposed § 26.69(c)(1) would be added to require the licensee or other entity to verify that the individual’s selfdisclosure addresses the applicable period specified in proposed § 26.61(b)(3). The proposed rule would not require the licensee or other entity to ‘‘obtain’’ a self-disclosure in all circumstances, because the individual may have already provided a selfdisclosure under proposed §§ 26.55, 26.57, or 26.59 and an additional selfdisclosure and employment history would be unnecessary. Proposed § 26.69(c)(2) would require the licensee or other entity to conduct a suitable inquiry with every employer for the period that would be addressed in the self-disclosure and employment history. If the potentially disqualifying FFD information was identified during the course of conducting a suitable inquiry in accordance with proposed § 26.63(f) so that the suitable inquiry was partially completed, proposed § 26.69(c)(3) would require the licensee or other entity to conduct a more complete suitable inquiry by contacting every employer that the individual listed during the interruption period. The proposed paragraph would also require the licensee or entity to obtain and review any records that other licensees or entities who are subject to this part may have developed with regard to potentially disqualifying FFD information about the individual from the past 5 years. This more complete suitable inquiry would be necessary to ensure that the licensee or other entity has more information about the individual than is required for individuals whose last period of VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 authorization was terminated favorably in order to make an appropriate authorization decision. Proposed § 26.69(c)(3) would be added and would use the term, ‘‘reviewing official,’’ to refer to the employee who is designated by the licensee or other entity to make authorization decisions, as discussed with respect to proposed § 26.5 [Definitions]. The proposed paragraph would permit the reviewing official to grant or deny authorization, based upon his or her review of the circumstances associated with the potentially disqualifying FFD information. Because of the variety of circumstances that may arise, the proposed paragraph also would grant discretion to the reviewing official in deciding whether a determination of fitness is required, rather than requiring a determination of fitness in every case. However, if the reviewing official requests a determination of fitness and the professional who performs it recommends any form of treatment or drug and alcohol testing, including the collection of urine specimens under direct observation, proposed § 26.69(c)(4) would require the licensee or other entity to implement the treatment and testing recommendations. Proposed § 26.69(c)(5) would be added to require pre-access and random testing of the applicant for authorization. The proposed paragraph would require the licensee or other entity to verify that the results of preaccess drug and alcohol tests are negative before granting authorization to the individual. The proposed rule would require the licensee or other entity to verify that test results are negative before granting authorization to the individual to provide evidence that the individual is avoiding substance abuse. Proposed § 26.69(d) [Maintaining authorization with other potentially disqualifying FFD information] would be added to establish requirements for maintaining an individual’s authorization when new potentially disqualifying FFD information is disclosed or discovered that was not a confirmed non-negative drug or alcohol test result or 5-year denial of authorization, if the reviewing official determines that maintaining authorization is warranted. A selfdisclosure, suitable inquiry, and preaccess testing would not be required because the individual would not be applying for authorization. However, the proposed paragraph would require the reviewing official to review the circumstances related to the information, and, at his or her PO 00000 Frm 00073 Fmt 4701 Sfmt 4702 50513 discretion, ensure that a professional with the appropriate qualifications makes a determination of fitness. The proposed paragraph would require the licensee or other entity to implement any treatment or testing requirements resulting from the determination of fitness. The proposed paragraph would be added because the current rule does not address maintaining an individual’s authorization in such circumstances and the NRC is aware that licensees and other entities have handled these circumstances inconsistently. Therefore, the proposed rule would add these requirements to establish the NRC’s intent with respect to these circumstances and increase consistency between Part 26 programs. A new § 26.69(e) [Accepting followup testing and treatment from another Part 26 program] would establish continuity of care requirements for individuals who were subject to a followup testing and substance abuse treatment plan under one Part 26 program and transfer to another FFD program or leave and then return to the same FFD program. The proposed paragraph would require the receiving licensee other entity to continue the testing and treatment plan to which the individual was subject under the previous FFD program. The proposed rule would also permit the receiving licensee or other entity to accept and rely upon any followup testing that was completed while the individual was subject to the previous Part 26 program in determining how long followup testing must continue. For example, if an individual met all of the requirements for authorization by a new licensee, but had completed only 2 of the 3 years of followup testing required under a previous Part 26 program, then the granting licensee would administer the final year of the followup testing, but would not be required to ‘‘re-start the clock’’ and conduct another 3 full years of followup testing after the individual was authorized. If the transferring individual successfully completed any followup testing and treatment program required under the first FFD program, a previous determination of fitness indicated that the individual is fit for duty, and the individual’s authorization by the first licensee or other entity was terminated favorably, then the proposed paragraph would permit the receiving licensee or other entity to accept the previous determination of fitness and would not require the granting licensee to develop and implement an additional testing and treatment plan. Proposed § 26.69(f) [Sanctions for confirmed non-negative drug and alcohol test results] would be added to E:\FR\FM\26AUP2.SGM 26AUP2 50514 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules clarify the minimum sanctions to be imposed on an individual who has confirmed non-negative drug and alcohol test results on any tests that may be required under this proposed section. Proposed § 26.69(f)(1) and (f)(2) would cross-reference the relevant sanctions specified in proposed Subpart D [Management actions and sanctions] to establish that those sanctions would apply to individuals about whom potentially disqualifying FFD information has been discovered or disclosed. Section 26.71 Maintaining Authorization Proposed § 26.71 [Maintaining authorization] would be added to state the requirements for maintaining authorization under this part. The proposed section would respond to stakeholder requests for this clarification at the public meetings discussed in Section V. Proposed § 26.71(a) would provide that individuals may maintain authorization under the conditions listed in proposed § 26.71(a)(1)–(a)(4), as follows: Proposed § 26.71(a)(1) would establish that an individual must comply with the licensee’s or other entity’s FFD policies to which the individual is subject. This proposed requirement thus relates, although it does not refer, to proposed § 26.27 [Written policy and procedures], which would require the licensee or other entity to prepare a clear and concise statement of its FFD policy and make that policy readily available to all individuals who are subject to it. The proposed rule would require that all individuals who are subject to the FFD policy must have information on what is expected of them and what consequences may result from a lack of adherence to the policy. Proposed § 26.71 would also require that, in order to maintain authorization, an individual must report any legal actions, as defined in proposed § 26.5 [Definitions]. Finally, although not explicitly specified in proposed § 26.71(a)(1), proposed § 26.33 [Behavioral observation] would require individuals to report any FFD concern to the personnel designated in the FFD policy. Proposed § 26.71(a)(2) would establish that an individual may maintain authorization if the individual remains subject to a drug and alcohol testing program that complies with the requirements of Part 26, including random testing. Licensees and other entities who are subject to Part 26 are responsible for implementing drug and alcohol testing programs that comply VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 with the requirements in proposed § 26.31 [Drug and alcohol testing], and the failure of a licensee or other entity to maintain a program would terminate the authorizations of individuals who have been granted authorization by the licensee or other entity. [See the discussion of § 26.71(b).] In addition, proposed § 26.31 also would place certain responsibilities on individuals who are subject to the testing program. In particular, under proposed § 26.31(d)(2)(iii), individuals who are selected for random testing would be required to report to the collection site as soon as reasonably practicable after notification, and within the time period specified in FFD program procedures, as well as to cooperate in the testing process. In appropriate circumstances, an individual’s failure to report or cooperate could be the basis for terminating the individual’s authorization. Proposed § 26.71(a)(3) would establish that an individual may maintain authorization if the individual remains subject to a behavioral observation program that complies with the requirements of Part 26. Behavioral observation, as required by proposed § 26.33 [Behavioral observation], would be performed by individuals, including coworkers, who have been trained to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, might constitute a threat to the health and safety of the public or the common defense and security. Proposed § 26.71(a)(4) would establish that a condition for maintaining authorization is successful completion by the individual of required FFD training, according to the schedule in proposed § 26.29(c). As specified in proposed § 26.29(c)(1), the proposed rule would require the individual to complete training before the licensee or other entity grants initial authorization. Thereafter, as specified in proposed § 26.29(c)(2), the proposed rule would require individuals to complete refresher training or pass a comprehensive examination on a nominal 12-month frequency. Proposed § 26.29(d) would provide that licensees and other entities may accept training of individuals who have been subject to another Part 26 program and have, within the past 12 months, either had initial or refresher training or successfully passed a comprehensive examination that meets the requirements of proposed § 26.29. PO 00000 Frm 00074 Fmt 4701 Sfmt 4702 Proposed § 26.29(d) would require a licensee or other entity to terminate an individual’s authorization if the individual, for more than 30 [consecutive] days, is not subject to an FFD program that meets the requirements of Part 26. The requirements of the proposed paragraph would permit an individual to be away from all elements of a Part 26 program for this period of time in order to accommodate vacations and significant illnesses when the individual would not be reasonably available for behavioral observation or to collect specimens for random drug and alcohol testing. The proposed paragraph would be added in response to stakeholder requests and would be consistent with related requirements in the access authorization orders issued to nuclear power plant licensees on January 7, 2003. Subpart D—Management Actions and Sanctions Section 26.75 Sanctions The first sentence of proposed § 26.75(a) would introduce the purpose of the section, which would be to define the minimum sanctions that licensees and other entities must impose when an individual has violated the drug and alcohol provisions of an FFD policy. The second sentence of the proposed paragraph would restate the second sentence of current § 26.27(b), which permits licensees and other entities to impose more stringent sanctions than those specified in the rule. The proposed rule would add a reference to paragraph (h) of the proposed section, which would establish limits on the sanctions that licensees and other entities may impose for non-negative validity and drug test results, to clarify that there is one exception to the blanket permission to impose more stringent sanctions granted in this paragraph, as discussed with respect to proposed paragraph (h) of this section. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.75(b) would be added to require licensees and other entities to permanently deny authorization to individuals who refuse to be tested or who in any way subvert or attempt to subvert the testing process. The proposed sanction is necessary because acts to subvert the testing process reflect a sufficiently egregious lack of trustworthiness and reliability to warrant permanent denial of authorization. An individual’s willingness to subvert or attempt to subvert the testing process provides E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules strong evidence that the individual will also be willing to disregard other rules and regulations, such as safeguards requirements, which ensure the protection of public health and safety and the common defense and security. In addition, if an individual succeeds in subverting the testing process in order to hide substance abuse, the individual may pose an undetected and unacceptable risk to public health and safety or the common defense and security by performing the duties that require him or her to be subject to this part while impaired. Therefore, the proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by deterring acts to defeat the testing process as well as preventing any individuals who engage in them from posing any further risk to public health and safety and the common defense and security. The proposed rule would specify three examples of actions that would be considered subversion or an attempt to subvert the testing process. These include refusing to provide a specimen and providing or attempting to provide a substituted or adulterated specimen. However, these examples are not intended to be exhaustive. For example, if a licensee or other entity determines that several individuals had colluded to notify potential donors that they would be selected for random testing on a particular day, so that the potential donors could plan to avoid work on that day or take other actions to ensure that their illegal drug use would not be detected, the NRC would expect the licensee or other entity to permanently deny authorization to all of the individuals who were involved in the collusion. The proposed rule would not include submitting a dilute specimen as an example of a subversion attempt without additional evidence that the donor had diluted the specimen in order to mask the presence of drugs or drug metabolites in the specimen, for the reasons discussed with respect to proposed § 26.185(g). Submitting a dilute specimen, in itself, would not necessarily indicate an attempt to subvert the testing process because there are many legitimate causes for a dilute specimen, including drinking liquids in order to provide a specimen of sufficient quantity, as permitted in Section 2.4(g)(11) in Appendix A of the current rule and in proposed § 26.109(b)(1). Therefore, the proposed rule would not require licensees and other entities to apply the sanction of permanent denial of authorization for submitting a dilute specimen, unless there is other evidence VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 that the donor had diluted the specimen in an attempt to subvert the testing process. The phrase, ‘‘for any test required under this part,’’ would be added to proposed § 26.75(b) to indicate that applicants for authorization who subvert or attempt to subvert a preaccess or random test would also be subject to permanent denial of authorization. Although these individuals would not yet be performing any job duties that could affect public health and safety or the common defense and security, an attempt to subvert the testing process while in an applicant status provides strong evidence that the individual cannot be trusted to perform those job duties. Therefore, it is necessary to ensure that any applicant who subverts or attempts to subvert the testing process would be denied authorization. Proposed § 26.75(c) would amend current § 26.27(b)(3), which establishes sanctions for the sale, use, or possession of illegal drugs within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter’s facility or vehicle. The proposed paragraph would retain the current sanction of a 5-year denial of authorization in these instances and add two other instances in which a 5-year denial of authorization would be required. First, the proposed rule would require licensees and other entities to impose a 5-year denial of authorization on any individual who is determined to have consumed alcohol within a protected area of any nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter’s facility or vehicle. This proposed change is necessary because consuming alcohol causes impairment, which poses the same risks to public health and safety as impairment from illegal drugs. Extending the scope of the current sanction to alcohol consumption also would be consistent with the revised FFD program performance objective in proposed § 26.23(d), which is to provide reasonable assurance that the workplaces subject to this part are free from the presence and effects of alcohol as well as illegal drugs. Therefore, the proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by reducing the risk to public health and safety and the common defense and security that on-site use of alcohol poses. Second, the proposed rule would add the phrase, ‘‘or while performing the job PO 00000 Frm 00075 Fmt 4701 Sfmt 4702 50515 duties that require the individual to be subject to this part,’’ to address circumstances in which an individual may be performing job duties that require him or her to be subject to this part but is not performing those duties within the protected area of a nuclear power plant, within a facility that is licensed to possess or use formula quantities of SSNM, or within a transporter’s facility or vehicle. As one example, many nuclear power plant licensees’ designated collection sites are located outside of the plant’s protected area. The intent of the current rule is to prohibit the presence, sale, and use of alcohol or illegal drugs by FFD program personnel at a collection site that is located outside of the protected area, but the current rule does not specifically address such circumstances. The majority of licensees have appropriately interpreted the intent of the current rule, but the proposed rule would add this phrase to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. In addition, the list of activities in the current paragraph that an individual would be prohibited from performing would be deleted in the proposed paragraph and replaced with the summary term, ‘‘authorization,’’ for consistency with the use of this term throughout the proposed rule. As discussed with respect to proposed § 26.25 [Individuals subject to the fitness-for-duty program], the list of job duties that require individuals to maintain authorization and to be subject to this part would be presented once in proposed § 26.25, rather than repeatedly throughout the rule, for consistency with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.75(d) would amend the portion of current § 26.27(c) that requires licensees to record as a removal ‘‘for cause’’ an individual’s resignation that occurs before the licensee ‘‘removes’’ the individual for violating the FFD policy. This portion of the current provision has raised implementation questions from licensees regarding the appropriate action to take in these circumstances. Licensees have questioned whether the intent of the current requirement is to deny authorization to an individual for some period of time, as required under current § 26.27(b)(2)–(b)(4), permanently deny authorization to the individual, or merely to record the resignation. Therefore, the proposed rule would clarify the intent of the current provision, as follows: E:\FR\FM\26AUP2.SGM 26AUP2 50516 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules The proposed rule would establish the sanction of a 5-year denial of authorization for an individual who resigns before a licensee or other entity terminates the individual’s authorization or denies authorization to an applicant for a first violation of the FFD policy involving a confirmed positive drug or alcohol test result. The proposed paragraph would establish a 5year denial of authorization because the confirmed positive drug or alcohol test result, in combination with such a resignation, would be a strong indication that the individual has an active substance abuse problem. However, because the individual resigned or withdrew his or her application for authorization, the individual would not be available for the SAE to evaluate the seriousness of his or her substance abuse problem and devise an appropriate treatment plan, as required under proposed § 26.189 [Determination of fitness]. Therefore, prohibiting the individual from being granted authorization for a 5-year period would give the individual an opportunity to seek treatment and establish a 5-year history of sobriety, which would be required to regain authorization under proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information], while also ensuring that such an individual is not granted authorization without having demonstrated that he or she has overcome the substance abuse problem. In addition, for any type of FFD policy violation, the proposed paragraph would require the licensee or other entity to record the fact that the individual had resigned or withdrawn his or her application for authorization, the nature of the FFD policy violation, and the sanction that would have been imposed if the individual had not resigned or withdrawn. Recording this information would be necessary to ensure that any licensees or other entities who may consider granting authorization to the individual in the future would be aware of the individual’s behavior and the nature of the FFD policy violation. Subsequent licensees and other entities would then be able to ensure that the minimum requirements of this section are met. For example, if the FFD policy violation was a third confirmed positive drug or alcohol test result, proposed § 26.75(g) would prohibit a subsequent licensee or other entity from granting authorization to the individual under any circumstances. The portion of current § 26.27(c) that refers to a refusal to provide a specimen for testing would be moved to proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 § 26.75(b) for organizational clarity, as discussed with respect to that paragraph. Proposed § 26.75(e) would amend current § 26.27(b)(2) and expand its scope to include alcohol. Abuse of alcohol would no longer be excluded from the sanctions specified in this proposed section for several reasons. First, although the possession and use of alcohol are legal for adults and do not adversely reflect on an individual’s trustworthiness and reliability, a perceived need to conceal an untreated, active alcohol abuse problem could cause an individual to be vulnerable to influence to act in ways that are adverse to the common defense and security. Second, alcohol-related impairment in the nuclear workplace poses an undue potential risk to public health and safety that is comparable to the risk imposed by impairment from the use of drugs. Third, some licensees have not imposed appropriately stringent sanctions on individuals who have abused alcohol in a manner that could cause the individual to be impaired while performing the job duties that require individuals to be subject to this part. Therefore, in order to deter individuals from abusing alcohol and ensure that individuals who may be impaired from alcohol are not permitted to perform job duties under this part, the proposed rule would impose the same sanctions for abusing alcohol as those required for abusing drugs in the proposed paragraph. The proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. Proposed § 26.75(e)(1) would retain the intent of the second sentence of current § 26.27(b)(2), which states that licensees and other entities must remove an individual from performing activities under this part for at least 14 days following a first confirmed positive test result. However, the proposed paragraph would require licensees and other entities to terminate the individual’s authorization for at least 14 days, rather than ‘‘remove’’ the individual. At the public meetings discussed in Section V, the stakeholders indicated that the term, ‘‘remove,’’ is confusing because it could be interpreted as requiring licensees and other entities to terminate the individual’s employment, which is not the intent of this paragraph. The stakeholders suggested using the phrase, ‘‘terminate the individual’s authorization,’’ to more accurately characterize the required action, with which the NRC concurred. The stakeholders also requested that the requirements in the current PO 00000 Frm 00076 Fmt 4701 Sfmt 4702 paragraph related to referring the individual to the EAP for assessment and counseling be eliminated from proposed § 26.75(e)(1). The stakeholders noted that many licensees terminate an individual’s employment at the same time that they terminate the individual’s authorization after a first confirmed positive test result. They suggested that, if the licensee or other entity terminates the individual’s employment and does not intend to provide the individual with an opportunity to regain authorization, it is inappropriate to require the licensee or other entity to provide assessment and counseling services to the individual. However, some licensees have interpreted the current provision as requiring them to provide EAP services to individuals who are no longer in their employ. The NRC concurs that the intent of the current rule is for licensees and other entities to provide assessment and counseling services only in those instances in which the licensee or other entity desires to reinstate the individual’s authorization. Therefore, the proposed change would be made to clarify the intent of the provision. The proposed rule would also move the requirements in the current paragraph that are related to permitting the individual to regain authorization from this section to proposed Subpart C [Granting and Maintaining Authorization], because this section would address sanctions for FFD policy violations, rather than FFD requirements for granting authorization. Requirements for granting authorization to an individual after his or her authorization has been terminated unfavorably for a first confirmed positive drug or alcohol test result would be addressed in proposed § 26.69(b) [Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization] of proposed Subpart C. This proposed change would be made for organizational clarity in the rule. Proposed § 26.75(e)(2) would increase the length of the period for which licensees and other entities must deny an individual’s authorization for a second confirmed positive test result from 3 years in current § 26.27(b)(vii) to 5 years. This proposed change would be made to provide higher assurance that individuals who have had a second confirmed positive test result are able to abstain from substance abuse for at least 5 years before a licensee or other entity may again consider granting authorization to them. The 5-year period is based upon the research literature indicating that individuals who abstain from substance abuse for 5 years after E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules treatment are less likely to relapse than individuals who have been able to abstain for 3 years. In addition, the proposed more stringent sanction for a second confirmed positive test result would provide greater deterrence to recidivism than the current 3-year period. Proposed § 26.75(f) would amend current § 26.27(b)(5), which states that the sanctions for confirmed positive drug test results in current § 26.27 do not apply to the misuse of alcohol, valid prescriptions, and over-the-counter drugs, but requires licensees’ FFD policies to establish sanctions that are sufficient to deter misuse of those substances. The proposed rule would require the same minimum sanctions for alcohol abuse as those required for drug abuse. Impairment caused by alcohol abuse creates a risk to public health and safety that is fundamentally similar to the risk posed by the use of illegal drugs. Some licensees, however, have imposed lesser sanctions for alcohol violations, an approach that is inconsistent with the NRC’s intent. Therefore, the proposed rule would rectify this situation by explicitly requiring the same minimum sanctions for abuse of alcohol as currently required for the use of illegal drugs. In addition, proposed § 26.75(f) would require licensees and other entities to impose the same sanctions as required for abuse of illegal drugs if the MRO determines that misuse of prescription drugs or over-the-counter medications that results in a positive drug or alcohol test result represents substance abuse. The MRO would make this determination in accordance with proposed § 26.185(j). Misuse of prescription and over-the-counter medications may include, for example, the use of a spouse’s or other family member’s prescription medications that may cause impairment, such as some pain relievers, or the excessive use of some cold and cough preparations available over-the-counter containing alcohol or other active ingredients that may cause impairment. However, the same substances may be used by an individual who has a substance abuse problem. For example, an individual who has become addicted to opiates may use a spouse’s or other family member’s codeine tablets or other opiates that were prescribed for pain relief to assist the addicted individual in avoiding withdrawal symptoms. Under the proposed paragraph, if the MRO determines that an individual’s use of a prescription or over-the-counter medication represents substance abuse, the licensee or other entity would be required to impose the minimum VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 sanctions specified in this proposed section for a confirmed positive drug or alcohol test result, as appropriate. If the MRO determines that the misuse of a prescription or over-the-counter medication does not represent substance abuse, the proposed rule would require the licensee or other entity to impose the sanctions for substance misuse that the licensee or entity would specify in the FFD policy. The proposed rule would also revise but retain the requirement in the last sentence of current § 26.27(b)(5), which states that sanctions for the misuse of prescription and over-the-counter drugs must be sufficient to ‘‘deter abuse of legally obtainable substances.’’ These sanctions must be sufficient to deter the misuse of prescription and over-thecounter medications because such misuse may lead to impairment on the job. However, the proposed rule would eliminate the phrase, ‘‘as a substitute for abuse of proscribed drugs,’’ in the last sentence of current § 26.27(b)(5) because it unnecessarily limits the circumstances in which sanctions for the misuse of prescription and over-thecounter drugs would be imposed. Proposed § 26.75(g) would amend current § 26.27(b)(4). The portions of the current paragraph that establish requirements for granting authorization to an individual who has violated the licensee’s or other entity’s FFD policy would be moved to proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information] in Subpart C [Granting and Maintaining Authorization] for organizational clarity because proposed § 26.75(g) would only address sanctions for FFD policy violations. The proposed paragraph would retain the portion of the current paragraph that requires licensees and other entities to permanently deny authorization to an individual who has repeatedly violated a licensee’s or other entity’s FFD policy. The proposed rule would require an individual’s authorization to be denied permanently if he or she has another confirmed positive drug or alcohol test result after he or she has had authorization denied for 5 years in accordance with other paragraphs in this proposed section. This proposed more stringent sanction would strengthen the effectiveness of the rule in providing reasonable assurance that individuals who are subject to this part are trustworthy and reliable, as demonstrated by avoiding substance abuse, and by increasing the assurance that only individuals who are fit for duty are permitted to perform the job duties listed in proposed § 26.25 PO 00000 Frm 00077 Fmt 4701 Sfmt 4702 50517 [Individuals subject to the fitness-forduty program]. Proposed § 26.75(h) and (i) would amend current § 26.24(d)(2), which permits licensees to temporarily suspend an individual’s authorization or take other administrative action if an individual has a positive drug test result for marijuana or cocaine metabolites that is identified through initial testing at the licensee testing facility. For organizational clarity, the proposed rule would divide the current paragraph into two paragraphs to separate the requirements related to the conditions under which licensees and other entities may and may not take action on the basis of initial test results. Proposed § 26.75(h) would continue to prohibit licensees and other entities from taking administrative actions or imposing sanctions on an individual based on an positive initial drug test result reported by an HHS-certified laboratory. The proposed paragraph would also continue to permit licensees and other entities to take administrative actions on the basis of positive initial drug test results for marijuana and cocaine from a licensee testing facility. However, in order for the licensee or other entity to take action, the proposed rule would require that the urine specimen that yields a non-negative drug test result(s) must also appear to be a valid specimen, based upon the results of validity screening or initial validity test results at the licensee testing facility. In addition, the proposed paragraph would prohibit licensees and other entities from imposing sanctions or taking other actions in response to non-negative validity screening or initial validity test results from a specimen in which no drug metabolites were detected. This proposed prohibition would be added because the procedures, instruments, and devices used in conducting validity screening and initial validity tests have not yet been proven to be sufficiently accurate and reliable to support management actions or sanctions without confirmatory testing. Permitting licensees and other entities to take actions on the basis of validity screening or initial validity test results would risk imposing substantial burdens on individuals from false non-negative test results. Therefore, this prohibition would be added to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. Proposed § 26.75(i)(1)–(4) would retain the requirements in current § 26.24(d)(2)(i)–(iv) that establish the conditions under which licensees and other entities may take administrative E:\FR\FM\26AUP2.SGM 26AUP2 50518 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules actions on the basis of a positive initial drug test result for marijuana or cocaine metabolites from a licensee testing facility. The proposed rule would add a requirement for specimen validity testing (see the discussion of proposed § 26.31(d)(3)(i) with respect to the addition of validity testing requirements in the proposed rule) and require that the specimen for which action will be taken must appear to be valid, based on validity screening or initial validity test results from the licensee testing facility. The proposed rule would also revise the terminology used in the current paragraph to be consistent with the terminology used throughout the proposed rule (see the discussion of proposed § 26.5 [Definitions] with respect to the new terminology adopted in the proposed rule) and update the cross-references to other sections of the rule to be consistent with the organization of the proposed rule. Section 26.77 Management Actions Regarding Possible Impairment A new § 26.77 [Management actions regarding possible impairment] would amend the requirements of current § 26.27(b)(1). The current paragraph requires licensees and other entities to remove impaired workers, or those whose fitness may be questionable, from performing activities within the scope of this part, and permits them to return the individuals to duty only after the individuals are determined to be fit to safely and competently perform their duties. The proposed section would retain the intent of the current provision, but the terminology used in the proposed section would be revised to be consistent with the terminology used throughout the proposed rule. Cross-references to other sections of the rule would be updated to be consistent with the organization of the proposed rule. In addition, several new requirements would be added. Proposed § 26.77(a) would be added to describe the purpose of the proposed section, which is to prescribe the management actions that licensees and other entities must take when an individual shows indications that he or she is not fit to safely and competently perform the duties that require the individual to be subject to this part. The proposed paragraph would be added to introduce the section and to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.77(b) would retain the portion of current § 26.27(b)(1) that requires the licensee or other entity to take immediate action to prevent an individual from performing the job VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 duties that require the individual to be subject to this part if an individual appears to be impaired, or his or her fitness is questionable. The proposed paragraph would add cross-references to proposed § 26.27(c)(3), and § 26.199(h) and (i), because the proposed provisions would provide exceptions to the requirement for immediate action. Proposed § 26.27(c)(3) would permit licensees and other entities to use individuals who have consumed alcohol if they are needed to respond to an emergency and the licensee or other entity establishes controls and conditions under which the individual may perform work safely. Proposed § 26.199(h) and (i) would also permit licensees who are subject to proposed Subpart I [Managing Fatigue] to use fatigued individuals to perform work if the licensee determines that they are needed to protect the common defense and security or respond to an emergency and establishes controls and conditions under which the individual may perform work safely. The crossreferences would be added to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The proposed rule would also revise some terminology used in the current paragraph in response to stakeholder requests during the public meetings discussed in Section V. The stakeholders indicated that, because the current rule requires them to ‘‘remove’’ individuals whose fitness may be questionable, some FFD programs have interpreted the current paragraph as requiring them to terminate the individual’s authorization. This was not the intent of the current provision. In this instance, the intent of the rule was for licensees and other entities to prevent the individual from performing the job duties that would require the individual to be subject to this part in order to ensure that any potential impairment could not result in errors or lapses in judgment that may pose a risk to public health and safety or the common defense and security until the cause of the problem could be identified and resolved. Therefore, the proposed rule would replace the phrase, ‘‘removed from activities within the scope of this part,’’ with the phrase, ‘‘prevent the individual from performing the job duties,’’ and make other minor changes to the wording of the current requirement to clarify the intent of the provision. The proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.77(b)(1) would retain the intent of current § 26.24(a)(3), which PO 00000 Frm 00078 Fmt 4701 Sfmt 4702 requires licensees and other entities to conduct drug and alcohol testing for cause. The proposed rule would require for-cause testing based upon a ‘‘reasonable suspicion’’ that the individual may be impaired from possible substance abuse. Reasonable suspicion of substance abuse could be based upon an observed behavior, such as unusual lack of coordination or slurred speech, or a physical condition, such as the smell of alcohol. If the only basis for a reasonable suspicion is the smell of alcohol, then alcohol testing would be required, but the proposed rule would not require the licensee or other entity to perform a drug test unless other indicators of possible impairment are present. The proposed rule would not require drug testing without other indicators of impairment in response to stakeholder comments made during the public meetings discussed in Section V. The stakeholders reported that many of the for-cause tests they perform are initiated as a result of a security officer or other person reporting that an individual smells of alcohol without behavioral indications of impairment. They also noted that the very large majority of the for-cause drug tests that they conduct in these circumstances yield negative results, including those instances in which the alcohol test results are positive. The stakeholders suggested that the current requirement to conduct drug tests in these circumstances imposes a significant burden because the drugs tests impose costs, not only for collecting and testing the urine specimens, but also because they cannot permit the individual to resume performing his or her job duties until the drug test results are available, which may take several days. The stakeholders argued that the burden is unnecessary because the drug tests yield positive results so infrequently and, therefore, do not serve their intended purpose of detecting drug abuse. Based on the stakeholders arguments and the FFD program performance data that support them, the NRC concurs that drug testing is unnecessary when the smell of alcohol is the only indication that forcause testing is required, and so would eliminate it from the proposed rule. The proposed rule would continue to require drug testing if there are behavioral or physical indications of impairment in addition to the smell of alcohol. Proposed § 26.77(b)(2) would be added but would apply only to nuclear power plant licensees who would be subject to proposed Subpart I [Managing Fatigue]. The proposed paragraph would permit these licensees to forego drug and alcohol testing and a E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules determination of fitness, if the licensee is certain that the individual’s observed behavior or physical condition is solely due to fatigue. In this case, the proposed rule would require the licensee to conduct a fatigue assessment, as defined in proposed § 26.201 [Fatigue assessments], before permitting the individual to return to performing his or her job duties. Proposed § 26.77(b)(3) would be added to specify the actions that licensees and other entities must take when there are indications that an individual may be impaired, other than behavior or a physical condition that creates a reasonable suspicion of substance abuse (or fatigue, in the case of licensees who are subject to proposed Subpart I). Consistent with current § 26.27(b)(1), the proposed rule would permit the licensee or other entity to return the individual to duty only after identifying and resolving the cause of the impairing condition, and making a determination of fitness indicating that the individual is fit to safely and competently perform his or her duties (see the discussion of proposed § 26.189 [Determination of fitness] for a more detailed discussion of the determination of fitness process). The proposed paragraph would not require licensees and other entities to unfavorably terminate an individual’s authorization for illness, fatigue, temporary mental and emotional stress, or other conditions that may affect an individual’s fitness, but would prohibit the licensee or other entity from assigning the impaired individual to perform job duties that require the individual to be subject to this part until a determination is made that the individual is fit to return to duty. Proposed § 26.77(c) would update current § 26.27(d) to be consistent with current NRC notification procedures. Subpart E—Collecting Specimens for Testing Section 26.81 Purpose Proposed § 26.81 [Purpose] would be added to describe the purpose of proposed Subpart E, which would be to establish requirements for collecting specimens for drug and alcohol testing. Adding the proposed section at the beginning of the proposed subpart would assist in locating provisions within the rule and so would be consistent with Goal 6 of the rulemaking, which is to improve clarity in the organization and language of the rule. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Section 26.83 Specimens To Be Collected A new § 26.83 [Specimens to be collected] would specify the types of specimens that licensees and other entities must collect for initial and confirmatory drug and alcohol testing. Proposed § 26.83(a) would require licensees and other entities to collect either breath or oral fluids (i.e., saliva) for initial tests for alcohol. The proposed rule would continue to require collecting only breath specimens for confirmatory alcohol testing. The proposed rule would add permission to use oral fluids (i.e., saliva) for initial alcohol tests because devices for testing oral fluids for alcohol have matured sufficiently to provide valid and reliable initial test results. Further, there may be circumstances, such as collecting a specimen of oral fluids from a donor who has impaired lung functioning, in which the use of such devices is more efficient for both donors and the FFD program than collecting breath specimens. Therefore, the proposed permission to collect oral fluids for initial alcohol testing would meet Goal 3 of this rulemaking, which is to improve the efficiency of FFD programs. Additionally, other Federally mandated alcohol testing programs permit the use of these devices for initial alcohol testing. Therefore, adding permission to collect oral fluids for initial alcohol testing to the proposed rule would also be consistent with Goal 1 of the rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The proposed rule would eliminate the use of blood as a specimen for alcohol testing at the donor’s discretion, which is permitted in current § 26.24(g) and Section 2.2(d)(4) in Appendix A to Part 26. The proposed rule would eliminate the current provisions related to blood alcohol testing for several reasons. Since the current rule was first promulgated, licensees have repeatedly raised questions related to the proper interpretation of a confirmatory alcohol test result using an evidential breath testing device (EBT) and an alcohol test result derived from a blood specimen when the results from the two types of testing differ. Specifically, if a confirmatory alcohol test result using an EBT is positive, but the result from testing a blood specimen is negative, licensees have asked which test result they should rely on in determining whether the donor has violated the FFD policy. Although the NRC’s original intent was that the result from the blood test was to be definitive, delays in PO 00000 Frm 00079 Fmt 4701 Sfmt 4702 50519 obtaining a blood specimen have sometimes resulted in blood test results that fell below the alcohol cutoff level of 0.04 percent BAC due to alcohol metabolism during the period of the delay. Some licensees have been reluctant to apply sanctions for a positive alcohol test result in these instances even though alcohol metabolism over time would explain the lower test result from the blood sample. Further, experience has shown that few donors request testing of a blood sample. Data gathered from a sampling of representative FFD programs show that individuals requested an average of fewer than one blood test per program within the period reviewed (January– May 2002). Additionally, the use of EBTs for confirmatory alcohol tests has consistently withstood legal challenge. The added protection of donors’ rights that was envisioned when the provisions for voluntary testing of blood specimens were incorporated into the current rule has not been realized in practice. The current requirement has also been costly for licensees, who are required to ensure that an individual who is trained to draw blood is available to do so, should a donor request blood testing. Based upon information provided by stakeholders at the public meetings discussed in Section V, the NRC determined that the costs associated with retaining this provision are not justified because of the very few instances in which donors have requested blood alcohol testing. Therefore, references to collecting and testing blood specimens for alcohol would be deleted from the proposed rule. Proposed § 26.83(b) would retain but make explicit the implied requirement in the first sentence of current § 26.24(b) (and other provisions that are interspersed throughout the current rule) for licensees and other entities to collect only urine specimens for drug testing. At the time the current rule was promulgated, it was unnecessary to establish an explicit requirement to collect and test only urine specimens for drugs in Part 26 programs because methods for testing other specimens were not available and the HHS Guidelines only addressed testing urine specimens. Since that time, methods for testing alternate specimens, such as oral fluids, sweat, and hair, have become commercially available and the HHS has published proposed revisions to its Guidelines (69 FR 19673; April 13, 2004) that would permit the use of such alternate specimens for drug testing in Federal workplace drug testing programs. The NRC is considering E:\FR\FM\26AUP2.SGM 26AUP2 50520 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules permitting the use of alternate specimens for drug testing when the HHS has published final revisions to its Guidelines related to these types of specimens. The revised HHS Guidelines will identify acceptable collection procedures and testing methods. However, HHS has not yet published final Guidelines for collecting and testing these alternate specimens. Therefore, it is necessary to add § 26.83(b) to the proposed rule to clarify that the NRC intends to continue prohibiting the collection and drug testing of specimens other than urine in this rulemaking, except as permitted under proposed § 26.31(d)(5) [Medical conditions] for the reasons discussed with respect to that paragraph. Section 26.85 Collector Qualifications and Responsibilities A new § 26.85 [Collector qualifications and responsibilities] would replace the collector qualifications and training requirements that are specified in the definition of ‘‘collection site person’’ in current Sections 1.2, 2.2(d), and 2.4(b) in Appendix A to Part 26. The intent of the current provisions would be retained in the proposed section, but the proposed rule would group the requirements together within this section for organizational clarity in the rule. In addition, as will be described below, the proposed rule would amend the current collector qualifications and training requirements to increase the consistency of Part 26 with the requirements of other Federal agencies and incorporate the lessons learned from those programs, as discussed in Section IV. B with respect to Goal 1 of this rulemaking. Proposed § 26.85(a) [Urine collector qualifications] would be added to provide more detailed requirements for urine collector qualifications and training than are contained in the current definition of ‘‘collection site person’’ and current Section 2.2(d) in Appendix A to Part 26. The proposed paragraph would require urine collectors to be knowledgeable of the requirements of this part, the FFD policy and procedures of the licensees or other entities for whom collections are performed, and keep current on any changes to urine collection procedures. The proposed changes would increase the consistency of urine collector qualification requirements with those of other Federal workplace drug testing programs as well as consistency between Part 26 urine collection procedures. These more detailed requirements would be added for the reasons discussed in Section IV.C. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.85(a) would retain the requirements in current Section 2.2(d) that urine collectors must receive training to perform their duties and demonstrate proficiency in applying the requirements of the proposed paragraph before serving as a collector. Proposed § 26.85(a)(1)–(a)(3) would list the topics that the proposed rule would require collector training to address. Proposed § 26.85(a)(1) would require collectors to be trained in the steps that are necessary to complete a collection correctly and the proper completion and transmission of the custody-and-control form to the licensee testing facility or HHS-certified laboratory, as appropriate. Proposed § 26.85(a)(2) would require training in methods to address ‘‘problem’’ collections, which may include, but would not be limited to, collections involving ‘‘shy bladder’’ (see the discussion of proposed § 26.119 [Determining ‘‘shy’’ bladder] for an explanation of this term and the procedures involved) and attempts by a donor to tamper with a specimen. Proposed § 26.85(a)(3) would require the training to instruct collectors on how to correct problems in collections, which may include, but would not be limited to, a donor refusing to cooperate with the collection process or an incident in which a urine specimen is spilled. These proposed requirements would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.85(a)(4) would retain the portion of current Section 2.2(d)(1) in Appendix A to Part 26 that requires collector training to emphasize the collector’s responsibility for maintaining the integrity of the specimen collection and transfer process, to carefully ensure the modesty and privacy of the donor, and avoid any conduct or remarks that might be construed as accusatorial or otherwise offensive or inappropriate. Proposed § 26.85(b) [Alcohol collector qualifications] would be added to specify requirements related to alcohol collector qualifications and training. Portions of this paragraph would be the same as the requirements for urine collectors in proposed § 26.85(a), including the first three sentences of proposed § 26.85(b) and proposed § 26.85(b)(4) and (b)(5), and would be added here for the same reasons discussed above with respect to the first three sentences of proposed § 26.85(a), and proposed § 26.85(a)(3) and (a)(4), respectively. The proposed rule would repeat the requirements that are applicable to both urine and alcohol PO 00000 Frm 00080 Fmt 4701 Sfmt 4702 collectors in each of these paragraphs because some FFD programs may not train collectors to perform both types of collections. Repeating the requirements would make it easier to locate the requirements that apply to urine or alcohol collectors, respectively, to meet Goal 6 of the rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.85(b)(1) and (b)(3) would require alcohol collectors to receive training that addresses the alcohol testing requirements of this part and methods to address ‘‘problem’’ collections, including, but not limited to, collections involving ‘‘shy lung’’ problems or attempts by a donor to tamper with a specimen. By contrast to proposed § 26.85(a)(2), which addresses ‘‘shy bladder’’ problems in urine collections, the proposed rule would not incorporate the related DOT procedures for determining ‘‘shy lung’’ problems in alcohol collections. During the public meetings discussed in Section V, stakeholders requested that the proposed rule incorporate DOT’s ‘‘shy bladder’’ procedures, but did not believe that adding DOT’s ‘‘shy lung’’ procedures to the proposed rule is necessary. The stakeholders reported that ‘‘shy lung’’ has not been a problem for donors, based on their experience implementing the breath testing requirements of Part 26 since the rule was first promulgated. Therefore, proposed paragraph § 26.85(b)(3) would require alcohol collectors to be able to implement the ‘‘shy lung’’ procedures established by any FFD program for whom the collectors are providing collection services, but would not establish requirements for responding to ‘‘shy lung’’ problems in the rule. The NRC invites comment on this omission. Proposed § 26.85(b)(2) would be added to require alcohol collectors to be trained in the operation of the particular alcohol testing device(s) [i.e., the alcohol screening devices (ASDs) and evidential breath testing devices (EBTs)] to be used in conducting alcohol tests, consistent with the most recent version of the manufacturers’ instructions. The proposed rule would add a requirement for alcohol collectors to be trained to follow the most recent version of the testing device manufacturers’ instructions because the NRC is aware that some FFD programs did not implement device manufacturers’ recommended changes to instructions for using the testing devices. Although the NRC staff is not aware of any testing errors or instances in which donors have challenged the results of alcohol tests that were not performed in accordance with the most recent version E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules of the device manufacturer’s instructions, the proposed rule would add this requirement to ensure that alcohol test results continue to be accurate and cannot be challenged on this basis. The proposed changes would also be consistent with the alcohol collector training requirements of other Federal agencies. Proposed § 26.85(c) [Alternative collectors] would amend the last sentence of current Section 2.2(d)(2) in Appendix A to Part 26, which permits medical personnel to perform specimen collections without receiving the training that is required for non-medical collectors. The proposed rule would permit medical personnel to conduct specimen collections for the purposes of this part only under the conditions that would be specified in proposed § 26.85(c)(1)–(c)(5), which may include, but would not be limited to the collection of specimens for post-event testing by a nurse or medical technician at a hospital. The proposed rule would limit the circumstances in which an untrained medical professional, technologist, or technician may perform collections for a licensee or other entity because the experience of other Federal agencies has shown that medical personnel who are untrained in specific collection procedures have committed errors in collections that resulted in unnecessary legal challenges to test results. At the same time, the NRC is also aware that licensees and other entities may occasionally have to rely upon such individuals to collect specimens for drug and alcohol testing, as discussed with respect to proposed § 26.25(b)(1). Therefore, the proposed rule would permit untrained medical personnel to collect specimens to facilitate the collection of specimens for testing in rare circumstances in which a qualified collector could not reasonably be expected to be available, but would otherwise require medical personnel who do not meet the criteria specified in proposed § 26.85(c)(1)–(c)(5) to receive the same training as nonmedical collectors. The proposed change would be made to meet Goal 3 of the rulemaking, which is to improve the effectiveness and efficiency of FFD programs, by reducing the likelihood of errors and legal challenges to test results. The proposed rule would eliminate current Section 2.2(d)(4) in Appendix A to Part 26, which requires that donors must be informed of the option to request blood testing. The current requirement would be eliminated because blood specimens would no longer be used for alcohol testing, as VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 discussed with respect to current § 26.83(a). Proposed § 26.85(d) would amend current Section 2.7(o)(5) [Personnel available to testify at proceedings] in Appendix A to Part 26, which requires that the licensee testing facility and HHS-certified laboratory must make available qualified individuals to testify in administrative or disciplinary proceedings related to drug and alcohol test results. The proposed rule would add an explicit requirement for collection site personnel to be available to testify at proceedings because this requirement is implied but not explicitly stated in the current provision. At the time the rule was first published, licensee testing facilities and collection sites were typically colocated at a site. However, this is no longer the case. In some current FFD programs, alcohol testing and urine specimen collections occur at the collection site, but initial testing of urine specimens is performed at a licensee testing facility, which may not be co-located with the collection site. Therefore, the proposed rule would add this paragraph to retain the NRC’s original intent that licensees and other entities must make available collection site personnel to testify, as needed, in administrative and/or legal proceedings related to an alcohol or drug test result. For organizational clarity, the requirements in the current paragraph that address the availability of personnel to testify in proceedings related to drug test results from the licensee testing facility would be moved to § 26.139(c) of proposed Subpart F [Licensee Testing Facilities] and those related to HHS-certified laboratories would be moved to § 26.153(f)(2) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services]. Section 26.87 Collection Sites A new § 26.87 [Collection sites] would be added to reorganize current requirements related to specimen collection sites. In general, the proposed rule would group together in this section the requirements that are related to collection sites, which are currently distributed among several different sections in Appendix A to Part 26. The proposed change would be made to meet Goal 6 of this rulemaking, which is to improve organizational clarity in the rule. Proposed § 26.87(a) would amend current Section 2.4(a) in Appendix A to Part 26, which requires FFD programs to designate collection sites and ensure that they are fully equipped to collect specimens for testing. The proposed PO 00000 Frm 00081 Fmt 4701 Sfmt 4702 50521 paragraph would delete reference to blood specimens because the proposed rule would no longer provide donors with the option to request blood testing for alcohol for the reasons discussed with respect to proposed § 26.83(a). The proposed paragraph would add a requirement for collection sites to be capable of alcohol testing, which was implied in the current paragraph but not explicitly stated. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. The proposed paragraph would retain the current permission for licensees and other entities to use properly equipped mobile collection facilities. Proposed § 26.87(b) would revise the first sentence of current Section 2.4(f) in Appendix A to Part 26 to require visual privacy for donors while the donor and collector are viewing the results of an alcohol test and retain the current requirement for individual privacy during urine specimen collections, except if the urine specimen collection must be conducted under direct observation. The new requirement for visual privacy while viewing alcohol test results would increase the consistency of Part 26 with the alcohol testing procedures of other Federal agencies and assure greater privacy for donors who are subject to FFD programs who do not provide visual privacy under the current rule. This proposed change would be made to meet Goal 7 of this rulemaking, which is to protect the privacy of individuals who are subject to Part 26. For organizational clarity, the proposed rule would move the current requirements in Section 2.4(f) in Appendix A to Part 26 that are related to collecting a specimen under direction observation to proposed § 26.115 [Collecting a urine specimen under direct observation]. Proposed § 26.87(c) would retain only the portion of current Section 2.7(m) in Appendix A to Part 26 that requires licensees’ and other entities’ contracts for collection site services to permit unfettered NRC, licensee, and other entity access to collection sites for unannounced inspections. For organizational clarity, the requirements in the current paragraph related to licensee testing facilities would be relocated to proposed Subpart K [Inspections, Violations, and Penalties] and subsumed under proposed § 26.221(a). The portions of the current paragraph that apply to HHS-certified laboratories would be moved to § 26.153(f) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services], also for organizational clarity. E:\FR\FM\26AUP2.SGM 26AUP2 50522 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules In addition, proposed § 26.87(c) would add a requirement that licensees’ and other entities’ contracts for collection site services must permit unfettered NRC, licensee, and other entity access to all information and documentation that is reasonably relevant to inspections and audits. This proposed requirement for access to documentation would be added for consistency with the HHS Guidelines, which also require collection sites to provide information and documentation as part of inspections and audits. Therefore, this proposed change would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The term, ‘‘audit,’’ would be added to the proposed paragraph because, although the NRC conducts inspections, licensees and other entities would be required to conduct audits under proposed § 26.41 [Audits and corrective action]. Adding this term to the proposed paragraph would increase the clarity of its language, consistent with Goal 6 of the rulemaking. Proposed § 26.87(d) would revise current Section 2.4(c) in Appendix A to Part 26 to clarify current requirements for assuring collection site security and the integrity of specimen collection procedures. The proposed rule would group requirements related to assuring the security of a licensee’s or other entity’s designated collection site in this proposed paragraph for organizational clarity. The requirements contained in current Section 2.4(c) in Appendix A to Part 26 that address assuring collection security when a designated collection site is inaccessible and there is an immediate requirement to collect a urine specimen would be moved to proposed § 26.87(f), also for organizational clarity. The proposed paragraph would include other clarifying changes to current Section 2.4(c) in Appendix A to Part 26, in response to stakeholder requests for such clarifications at the public meetings discussed in Section V, as follows: Proposed § 26.87(d)(1) would retain the first sentence of current Section 2.4(e) in Appendix A to Part 26, which requires that only authorized personnel may have access to any part of a collection site in which specimens are collected and stored. This requirement would be moved to the proposed paragraph because it addresses the topic of collection site security. Therefore, this change would be made for organizational clarity. Proposed § 26.87(d)(2) would amend the second sentence of current Section VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 2.4(c) in Appendix A to Part 26, which requires collection sites to be secure, by providing examples of acceptable methods to assure collection site security. The proposed rule would add these examples in response to stakeholder requests during the public meetings discussed in Section V. The stakeholders noted that the requirement that collection sites ‘‘must be secure’’ has raised many implementation questions. Therefore, the proposed rule would add examples of acceptable means to ensure collection site security, including, but not limited to, physical measures to control access, such as locked doors, alarms, or visual monitoring of the collection site when it is not occupied. The proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.87(d)(3) would amend the third sentence in current Section 2.4(c) in Appendix A to Part 26, which requires that the portion of any facility that is not dedicated solely to drug and alcohol testing must be secured during testing, and combine it with the third sentence of current Section 2.4(c)(1) in Appendix A to Part 26, which requires posting the facility against unauthorized access during the collection. The proposed rule would replace the phrase, ‘‘in the case of a public restroom,’’ in the last sentence of current Section 2.4(c)(1) in Appendix A to Part 26, with the phrase, ‘‘if a collection site cannot be dedicated solely to collecting specimens,’’ to clarify that a specimen may be collected at locations other than public restrooms. The proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.87(e) would be added to specify the steps that licensees and other entities must take to deter dilution and adulteration of specimens during urine collections. The proposed paragraph would retain and amend portions of current Section 2.4(g) in Appendix A to Part 26, as explained below: Proposed § 26.87(e)(1) would relax the requirement for use of a bluing agent in any source of standing water, such as a toilet bowl or tank, in current Section 2.4(g)(1) of Appendix A to Part 26. The proposed rule would permit licensees and other entities to use colors other than blue. A yellow coloring agent would not be permitted because it would preclude the collector’s ability to determine whether a donor had diluted the specimen with water from a source of standing water in the stall or room in which the donor provides a specimen. PO 00000 Frm 00082 Fmt 4701 Sfmt 4702 The proposed relaxation would not affect the accuracy of drug tests, but would give FFD programs increased flexibility in the choice of coloring agents. The proposed rule would make this change in response to stakeholder requests during the public meetings discussed in Section V and to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.87(e)(1) would also add a requirement that the coloring agents that are added to any source of standing water in the stall or room in which the donor is to provide a specimen cannot interfere with drug or validity tests. The proposed requirement would be necessary to ensure that, if a donor attempted to subvert the testing process through diluting his or her specimen, the coloring agent would not interfere with testing assays and, therefore, would permit the detection of prohibited drug use. The proposed requirement would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by deterring dilution attempts using sources of standing water and increasing the likelihood that dilution attempts of this type would be detected. Proposed § 26.87(e)(2) would retain the second sentence of current Section 2.4(g)(1) in Appendix A to Part 26, which requires sources of standing water to be secured, but shorten it without changing the intended meaning of the requirement. The proposed change would be made to improve clarity in the language of the rule. Proposed § 26.87(e)(3) would be added to require that chemicals or products that could be used to adulterate a urine specimen must be secured or removed from the collection site. The collector would also be required to inspect the enclosure to ensure that no potential adulterants are available before the donor would enter the stall or enclosure. These requirements would be added to prevent possible donor attempts to subvert the testing process by adulterating a urine specimen with materials that are available at the collection site. The proposed rule would add this provision to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. The proposed provision would also be consistent with the related requirements of other Federal agencies. Proposed § 26.87(f) would reorganize current Section 2.4(c)(1), portions of Section 2.4(c)(2), and Section 2.4(g)(10) in Appendix A to Part 26 to prescribe acceptable procedures for collecting specimens at locations other than a E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules designated collection site in unusual circumstances, such as a specimen collection for post-event testing at a hospital. The proposed rule would group these requirements together in a single paragraph and separate them from those related to collecting specimens at a designated collection site in proposed § 26.87(d) and (e) to make it easier to locate these requirements within the rule. The proposed change would be made to improve organizational clarity in the rule. Proposed § 26.87(f)(1) would amend current Section 2.4(c)(1) in Appendix A to Part 26, which establishes requirements for securing a location that is not a designated collection site but will be used for a specimen collection(s). The proposed rule would require either an individual to guard access to a public rest room while the collection is occurring, or the posting of a sign to ensure that no unauthorized personnel enter the area during the collection. The current rule requires only the posting of a sign, but stationing an individual to guard access would be at least as effective. The proposed rule would permit an individual to guard access to the collection area in response to stakeholder requests for this flexibility during the public meetings discussed in Section V. The proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.87(f)(2) would retain the third sentence of current Section 2.4(g)(10) in Appendix A to Part 26 that requires a water-coloring agent to be used, if possible, to deter a possible dilution or adulteration attempt when a collection must occur at a location other than the licensee’s or other entity’s designated collection site. Proposed § 26.87(f)(3) would amend the second sentence of current Section 2.4(g)(10), which requires that the collector must be the same gender as the donor. If a collector of the same gender is unavailable, the proposed paragraph would permit another person of the same gender who is instructed in the requirements of proposed Subpart E [Collecting specimens for testing] to assist in the collection. The proposed paragraph would require either the collector or the observer to remain outside the area in which the donor will provide the urine specimen to protect the donor’s privacy and the integrity of the collection process. The proposed rule would require the observer’s identity to be documented on the custody-and-control form so that the observer may be located should any subsequent questions arise with respect VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 to the collection in a review under proposed § 26.39 [Review process for fitness-for-duty policy violations] or legal proceedings. The flexibility to rely on a person of the same gender as an observer, if a collector of the same gender is unavailable, would be consistent with the procedures of other Federal agencies and reduce potential embarrassment to the donor. Therefore, this proposed change would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, and Goal 7, which is to protect the privacy of individuals who are subject to Part 26. Proposed § 26.87(f)(4) would require the collector, once he or she is in possession of the donor’s specimen, to inspect the area in which the specimen donation occurred for any evidence of a subversion attempt by the donor. The proposed paragraph would amend the fifth and sixth sentences of current Section 2.4(g)(10) in Appendix A to Part 26 that describe the required sequence of actions during a specimen collection and specify that a donor is permitted to flush the toilet after a specimen donation. The proposed rule would eliminate the option for the donor to flush the toilet and would direct the collector to instruct the donor not to flush the toilet. The proposed change would reduce the possibility that a donor could dispose of evidence of a subversion attempt by flushing it down the toilet. Proposed § 26.87(f)(4) would direct the collector to inspect the toilet bowl and area once he or she receives the specimen from the donor. The proposed rule would add these provisions to reduce the opportunities for a donor to subvert the testing process and to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. The proposed requirement would also meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.87(f)(5) would amend the portions of current Section 2.4(c)(2) in Appendix A to Part 26 that define requirements for maintaining control of specimens that are not collected at a designated collection site. An ‘‘authorized individual,’’ including, for example, a security officer or hospital medical technician, would be permitted to maintain physical custody and control of specimens in the proposed paragraph, rather than only the collector, as is required in the current rule. The ‘‘authorized individual’’ would be designated by the licensee or other entity and instructed in his or her PO 00000 Frm 00083 Fmt 4701 Sfmt 4702 50523 responsibilities for maintaining custody and control of the specimen. The authorized individual’s custody of the specimen would be documented on the custody-and-control form to ensure that the individual may be located should any subsequent questions arise with respect to the collection in a review under proposed § 26.39 [Review process for fitness-for-duty policy violations] or legal proceedings. The proposed change would continue to ensure specimen integrity and security, but would respond to industry experience, as described by stakeholders at the public meetings discussed in Section V. The stakeholders reported that it is sometimes difficult in unusual circumstances, such as the hospital setting, for the collector to maintain physical custody of the specimen until it is prepared for transfer, storage, or shipping. Therefore, the proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements, while continuing to protect the privacy and due process rights of individuals who are subject to Part 26. Section 26.89 Preparing to Collect Specimens for Testing A new § 26.89 [Preparing to collect specimens for testing] would describe the preliminary steps to be taken by the collector and donor before specimens are collected for drug and alcohol testing. The proposed section would reorganize and amend portions of the current Appendix A to Part 26, and add several new requirements, as explained below. The proposed rule would present these requirements in a new section to facilitate locating them within the proposed rule to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.89(a) would provide more detailed requirements than those contained in current Section 2.4(g)(3) in Appendix A to Part 26 for actions to be taken if an individual does not appear for testing. The current rule requires the collector to contact an ‘‘appropriate authority’’ to determine the actions to take if a donor does not appear for testing. At the public meetings discussed in Section V, some stakeholders indicated that the lack of specificity in the current rule with respect to the actions that the ‘‘appropriate authority’’ must take in these circumstances has led some FFD programs to interpret this provision as requiring the imposition of the sanctions for a ‘‘refusal to test’’ on an individual who fails to appear, including situations in which there is E:\FR\FM\26AUP2.SGM 26AUP2 50524 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules clear evidence that the individual had not been informed that he or she was required to appear for testing or was otherwise not at fault for the failure. This is not the intent of the current provision. Therefore, under the proposed paragraph, when informed that an individual who was selected for testing has not appeared at the required time, FFD program management would be required to ensure that the circumstances are investigated and determine whether the individual’s absence or tardiness represents an attempt to avoid testing and, therefore, subvert the testing process. The proposed rule would require the licensee or other entity to impose the sanctions specified in proposed § 26.75(b) for a refusal to test only if the investigation identifies evidence that the individual’s failure to appear for testing was a subversion attempt. If evidence of a subversion attempt is not identified, the proposed rule would prohibit the licensee or other entity from imposing sanctions and require the individual to be tested at the earliest reasonable and practical opportunity after the individual is located. These more detailed requirements would be added to strengthen the rule’s effectiveness in preventing subversion by ensuring that a failure to appear for testing is investigated, which would increase the likelihood of detecting a willful attempt to avoid testing. In addition, the proposed requirements would prevent an individual from being subject to a permanent denial of authorization, as would be required under proposed § 26.75(b), if the individual’s failure to appear is determined to be outside of the individual’s control or otherwise not a result of a willful attempt to avoid testing. These proposed changes would be made to meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, and Goal 7, which is to protect the due process rights of individuals who are subject to Part 26. Proposed § 26.89(b) would reorganize and expand current Section 2.4(g)(2) in Appendix A to Part 26, which requires the collector to ensure that an individual who arrives at the collection site for testing is positively identified. The proposed rule would add more detailed requirements for the reasons discussed with respect to each requirement in the proposed paragraph. Proposed § 26.89(b)(1) would specify the types of photo identification that the licensee or other entity may accept to identify the donor. Identification of the donor by the employer’s representative would no longer be permitted. The NRC VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 is not aware of any incidents in which an employer’s representative has inaccurately identified an individual who appeared for testing without acceptable identification. However, permitting collectors to rely on identification by an employer’s representative provides an opportunity for individuals to conspire to subvert the testing process by substituting the designated donor, who may have engaged in substance abuse, with another individual who has not abused illegal drugs or alcohol. Such a conspiracy could prevent an individual’s substance abuse from being detected through testing. Therefore, this proposed revision would be made to provide greater assurance that the individual who appears for testing is the designated donor and, thereby, strengthen the effectiveness of FFD programs in detecting substance abuse. The proposed change would also increase the consistency of Part 26 with access authorization requirements established in 10 CFR 73.56, as supplemented by orders to nuclear power plant licensees dated January 7, 2003, which is Goal 4 of this rulemaking. Proposed § 26.89(b)(2) would amend the portion of current Section 2.4(g)(2) in Appendix A to Part 26 that directs the collector to stop the collection if the individual cannot be positively identified. By contrast, the proposed paragraph would direct the collector to proceed with the collection and inform FFD program management that the donor did not present acceptable photo identification. The proposed paragraph would require FFD management to take the necessary steps to determine whether the lack of identification is an attempt to subvert the testing process. However, the proposed paragraph would retain the current requirement for the collector to delay the collection until the individual can be identified if it a pre-access test. The proposed changes would be made for several reasons: First, lessons learned from implementing the current rule have indicated that the large majority of failures to present acceptable identification are the result of miscommunication or other errors that are easily resolved. However, stopping or delaying the specimen collection may alter test results (e.g., if an individual has consumed alcohol, the individual’s alcohol test result would show a lower BAC after a delay or may not be detected if testing is not conducted). Therefore, collecting the specimens first and then resolving the individual’s identity would assure that test results PO 00000 Frm 00084 Fmt 4701 Sfmt 4702 would be available and accurate from donors who are currently authorized and whose identity has previously been confirmed by the licensee or other entity. Therefore, this proposed change would meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Second, the current requirement to stop the collection without investigating the reasons that the individual is unable to present acceptable identification does not ensure that an attempt by an individual to subvert the testing process is detected. For example, an individual who has engaged in substance abuse could delay specimen collection by claiming to have ‘‘forgotten’’ his or her photo identification in his or her car or locker. Permitting the individual to leave the collection site to obtain his or her identification would provide an opportunity for the individual to obtain an adulterant or substitute urine that he or she could then use to subvert the testing process. Steps that FFD program management could take to investigate the reasons that the individual did not present acceptable identification in this instance could include assigning a security officer to accompany the individual to his or her car or locker to verify the individual’s claim, as well as to ensure that the individual does not have the opportunity to bring an adulterant or substitute urine back to the collection site. Therefore, the proposed requirement would strengthen the effectiveness of FFD programs in detecting attempts to subvert the testing process. The requirement to delay the collection until the individual presents acceptable identification if it is a preaccess test would be retained from the current rule at the request of stakeholders during the public meetings discussed in Section V. The stakeholders noted that the current requirement to delay pre-access testing until the individual presents acceptable photo identification does not present a risk to public health and safety or the common defense and security from a possible subversion attempt because the individual would not yet have access to sensitive information, radiological materials, or safety systems and equipment. Further, stakeholders noted that retaining the current provision would save them the expense associated with collecting and testing a specimen that may be collected from the wrong individual. The NRC concurs that it is reasonable to retain the current requirement as it relates to pre-access tests for the reasons given by the stakeholders. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.89(b)(3) would update current Sections 2.4(g)(4) and 2.4(g)(23)(ii) in Appendix A to Part 26, in which, before any specimens are collected, donors are required to list the prescription and over-the-counter medications they have used within the 30 days before testing. To be consistent with the privacy requirements of the Americans with Disabilities Act [Pub. L. 101–336, July 26, 1990], the proposed rule would eliminate the requirement to list medications prior to specimen collection and testing. The proposed rule would require donors to provide medication information to the MRO only in the event of non-negative confirmatory validity or drug test results in order to enhance their rights to privacy under the rule. This revised requirement would also be consistent with the procedures of other Federal agencies and would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.89(b)(3) would also add a requirement for the collector to explain the testing procedure to the donor. Current Section 2.2(d)(3) in Appendix A to Part 26 requires that individuals who are subject to testing must be provided with standard written instructions setting forth their responsibilities. However, the NRC is aware that these instructions are typically provided to individuals as part of the training that is required under current § 26.21 [Policy communications and awareness training] rather than at the collection site before starting the specimen collection process, which was not the intent of Section 2.2(d)(3) in Appendix A to Part 26. Rather than retaining and clarifying the current provision for standard written instructions, which some individuals have may difficulty comprehending, the proposed rule would adopt the related practices of other Federal agencies, which require the collector to explain the testing procedure to the donor. This proposed change would ensure that individuals are informed of the testing process in which they must participate and their responsibilities within it to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. In addition, the proposed revision would enhance the consistency of Part 26 with the requirements of other Federal agencies. Proposed § 26.89(c) would be added to ensure that the donor is aware of his or her responsibilities to cooperate with the specimen collection process. The proposed paragraph would respond to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 reports from stakeholders at the public meetings discussed in Section V that some donors have attempted to obstruct or delay the collection process on the basis that the donor’s responsibility to cooperate with the collection process is implied, but not clearly specified, in the current rule. Therefore, the proposed paragraph would eliminate that basis for obstructing or delaying collections, which would improve the effectiveness and efficiency of FFD programs, consistent with Goal 3 of this rulemaking. The proposed paragraph would also require the collector to inform the donor that a failure to cooperate in the specimen collection process would be considered a refusal to test and may result in the permanent denial of authorization under proposed § 26.75(b). Informing donors of the potential consequences of failing to cooperate in the collection process, in advance, would be consistent with Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. The requirements of this proposed paragraph would also be consistent with the practices of other Federal agencies. Proposed § 26.89(d) would retain the last two sentences of current Section 2.4(e) in Appendix A to Part 26. These sentences require the collector to conduct only one urine specimen collection at a time and define the point at which the collection process ends, which is when the donor has left the collection site. The proposed paragraph would be retained in this section because it relates to the topic of the proposed section, which is preparing for specimen collections, to ensure that collectors are aware of this requirement before they begin collecting any specimens. The proposed change would improve the organizational clarity of the rule. Section 26.91 Acceptable Devices for Conducting Initial and Confirmatory Tests for Alcohol and Methods of Use A new § 26.91 [Acceptable devices for conducting initial and confirmatory tests for alcohol and methods of use] would amend current requirements for alcohol testing devices and methods of use. The requirements in the current rule that are related to this topic appear in current § 26.24(g) and Sections 2.4(g)(18) and 2.7(o)(3)(ii) in Appendix A to Part 26. The proposed section would combine these requirements into one section, amend the current requirements, and add others, as explained below. The proposed rule would group these requirements in one section to meet Goal 6 of this PO 00000 Frm 00085 Fmt 4701 Sfmt 4702 50525 rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.91(a) [Acceptable alcohol screening devices] would be added to permit the use of alcohol screening devices (ASDs) for initial testing and establish requirements for the ASDs that may be used. Acceptable ASDs would include alcohol saliva analysis devices and breath testing devices that are listed on the most recent version of NHTSA’s Conforming Products List (CPL) for ASDs (May 4, 2001, 66 FR 22639, and subsequent amendments thereto). Current Section 2.7(o)(3)(ii) in Appendix A to Part 26 limits FFD programs to using only evidential-grade breath testing devices. However, permitting FFD programs to use ASDs listed on NHTSA’s CPL for initial alcohol testing would be consistent with other Federal agencies’ procedures for workplace alcohol testing. Therefore, the proposed change would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Further, permitting the use of some ASDs for initial alcohol testing would provide increased flexibility in conducting initial alcohol tests. Licensees and other entities may find that, over time, it is less expensive to use a particular ASD than to continue using EBTs for all initial alcohol tests. The option to use alcohol saliva analysis devices also may reduce the burden of alcohol testing for some donors, such as individuals who have impaired lung functioning. The proposed rule’s permission to use ASDs that are listed on NHTSA’s CPL for ASDs for initial alcohol testing would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements, by increasing FFD programs’ flexibility in administering initial alcohol tests. A new § 26.91(b) [Acceptable evidential breath testing devices] would amend current Section 2.7(o)(3)(ii) in Appendix A to Part 26 and establish new requirements for the EBTs that licensees and other entities must use for confirmatory alcohol breath testing. The proposed paragraph would require licensees and other entities to use EBTs that are listed on the most recent version of NHTSA’s CPL for evidential breath testing devices (October 3, 2002, 67 FR 62091, and subsequent amendments thereto) when conducting confirmatory alcohol tests, and permit licensees and other entities to use these EBTs for conducting initial alcohol tests. These EBTs incorporate many improvements in EBT technology and E:\FR\FM\26AUP2.SGM 26AUP2 50526 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules have been shown to accurately detect BACs at the 0.02 percent level. Therefore, they are the appropriate instruments to use for testing at the revised alcohol cutoff levels specified in proposed § 26.103 [Determining a confirmed positive test result for alcohol]. Further, because these EBTs have been shown to provide valid, reliable, and legally defensible results in other Federal programs that also require workplace alcohol testing, the proposed requirement to use these EBTs would permit two additional proposed changes to the alcohol testing procedures contained in current Section 2.4(g)(18) in Appendix A to Part 26: (1) Collecting only one breath specimen for the initial alcohol test and one for the confirmatory test in proposed §§ 26.95(c) and 26.101(c), rather than the two specimens that are currently required for each test; and (2) conducting both the initial and confirmatory tests (if a confirmatory test is required) using the same EBT in proposed § 26.101(d). As discussed further with respect to proposed §§ 26.95(c) and 26.101(c) and (d), these proposed changes to the current alcohol testing requirements would improve the efficiency of alcohol testing while continuing to provide valid, reliable, and legally defensible results that are necessary to protect donor’s rights under workplace alcohol testing programs. The use of these improved EBTs is similarly required for confirmatory alcohol testing and permitted for initial testing under 49 CFR Part 40, ‘‘Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs’ (65 FR 41944; August 9, 2001). Therefore, this proposed change would also meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines; Goal 3, which is to improve the efficiency of FFD programs; and Goal 5, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.91(c) [EBT capabilities] would be added to specify the required capabilities of the EBTs that licensees and other entities may use for initial alcohol testing and must use for confirmatory alcohol tests. The EBT capabilities listed in proposed § 26.91(c)(1)–(c)(3) are necessary to ensure that a test result can be uniquely associated with the instrument used, the time of testing, and the donor. These capabilities are necessary in order to establish an unimpeachable chain of custody for alcohol test results as well VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 as permit the accurate identification of any test results that may have been affected by instrument malfunctions that are discovered later through additional quality assurance checks. The EBT capabilities listed in proposed § 26.91(c)(4)–(c)(6) would ensure that test results will be accurate by permitting collectors to verify that the instrument is functioning properly before each test and there will be no carryover effects from previous testing. These capabilities would improve the effectiveness and efficiency of confirmatory alcohol testing by limiting the need to cancel test results due to instrument errors, as required under proposed § 26.91(e)(3). Using EBTs that have the required capabilities for confirmatory alcohol tests would protect donors’ rights to accurate test results, provide greater assurance that test results will withstand any legal challenges, and improve an FFD programs’ ability to identify tests that may have been affected by instrument errors. Therefore, the proposed requirements would meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs. Proposed § 26.91(d) [Quality assurance and quality control of ASDs] would be added to establish quality assurance and quality control requirements for ASDs. These proposed requirements are necessary to ensure that initial tests that are conducted using an ASD do not yield false negative test results. If an ASD provides a false negative test result, a donor who has a BAC that exceeds the cutoff levels established in this part would not be detected by the test and may be permitted to perform the job duties that require him or her to be subject to this part, thereby creating an unacceptable risk to public health and safety or the common defense and security. The proposed (and current) rule would require confirmatory testing if initial alcohol test results are positive, so false positive test results from an ASD would lead to confirmatory testing, which would provide accurate test results. False positive test results reduce the efficiency of FFD programs and inconvenience donors by causing them to be subject to unnecessary confirmatory testing, but do not pose any risks to public health and safety or the common defense and security. However, confirmatory testing is not required if the result of an initial alcohol test result is negative. Therefore, the quality assurance and quality control requirements contained in this proposed paragraph would be necessary PO 00000 Frm 00086 Fmt 4701 Sfmt 4702 to maintain the effectiveness of FFD programs, which is Goal 3 of this rulemaking. Proposed § 26.91(d)(1) would be added to require FFD programs to implement the most recent version of the quality assurance plan that a manufacturer has submitted to NHTSA for any ASD that the licensee or other entity uses for initial alcohol testing. In order to obtain NHTSA approval for an ASD, the manufacturer of the device must submit a quality assurance plan that (1) specifies the methods that must be used for quality control checks, (2) the temperatures at which the ASD must be stored and used, (3) the shelf life of the device, (4) environmental conditions (e.g., temperature, altitude, humidity) that may affect the ASD’s performance, (5) instructions for its use and care, (6) the time period after specimen collection within which the device must be read, where applicable, and (7) the manner in which the reading is made. The proposed paragraph would require licensees and other entities who intend to use an ASD to obtain and implement the most recent version of the manufacturer’s quality assurance plan to ensure that the ASD will not provide false negative test results from improper storage or use. As discussed with respect to proposed § 26.91(d), the proposed provision would be necessary to maintain the effectiveness of FFD programs that rely on ASDs for initial alcohol testing. Proposed § 26.91(d)(2) would be added to prohibit licensees and other entities from using an ASD that fails the quality control checks that would be specified in the most recent version of the manufacturer’s quality assurance plan or that has passed its expiration date. This proposed prohibition would be necessary to ensure that test results from using the ASD are accurate both to protect public health and safety and donors’ rights to accurate test results under the rule. Proposed § 26.91(d)(3) would be added to require licensees and other entities to follow the device use and care requirements that would be specified in proposed paragraph (e) of this section for an ASD that tests breath specimens. The proposed requirement would be added because some ASDs test specimens of oral fluids while others test breath specimens, and some ASDs that test breath specimens also appear on NHTSA’s CPL for evidential breath testing devices (October 3, 2002, 67 FR 62091, and subsequent amendments thereto). Those ASDs that do test breath specimens and would be used for confirmatory testing have more detailed quality assurance and quality control E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules provisions because their results must be legally defensible. Proposed § 26.91(e) [Quality assurance and quality control of EBTs] would establish new quality assurance and quality control requirements for EBTs. The proposed requirements would be consistent with those of other Federal agencies that require workplace alcohol testing and, therefore, would update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, as follows: Proposed § 26.91(e)(1) would add a requirement that licensees and other entities must implement the most recent version of the manufacturer’s instructions for the use and care of the EBT consistent with the quality assurance plan submitted to NHTSA for the EBT, including the frequency of external calibration checks. An EBT manufacturer is required to submit to NHTSA a quality assurance plan that addresses methods used to perform external calibration checks on the EBT, the tolerances within which the EBT is regarded as being in proper calibration, and the intervals at which these checks must be performed. The proposed rule would require licensees and other entities to perform external calibration checks at the manufacturer’s recommended intervals, at a minimum. These calibration intervals take into account factors such as frequency of use, environmental conditions (e.g., temperature, humidity, altitude), and type of operation (e.g., stationary or mobile). Therefore, this proposed provision would ensure that the EBT will not provide false test results from improper storage or use. Proposed § 26.91(e)(2) would add a requirement for licensees and other entities to use only calibration devices appearing on NHTSA’s CPL for ‘‘Calibrating Units for Breath Alcohol Tests’’ when conducting external calibration checks. This proposed requirement is necessary to ensure that the calibrating units used by licensees and other entities meet minimum standards and provide accurate results. Proposed § 26.91(e)(3) would be added to address circumstances in which an EBT fails an external calibration check. The proposed paragraph would require the licensee or other entity to cancel any positive test results from tests that were conducted during the period since the EBT last passed an external calibration check. This proposed requirement would protect donors’ right to due process under the rule because positive test results from an EBT that has failed an external calibration check are questionable and donors should not be VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 subject to sanctions on the basis of these test results. Because most EBT manufacturers’ recommended intervals are one month, licensees and other entities may choose to conduct the calibration checks more frequently in order to avoid the proposed test cancellations, should an EBT fail an external calibration check. The proposed paragraph would also require the licensee or other entity to take the EBT out of service. An EBT that has failed an external calibration check must be taken out of service to avoid inaccurate reporting of breath alcohol test results that could result either in the imposition of sanctions on a donor who has not abused alcohol or the failure to identify a donor who has. Proposed § 26.91(e)(4) would be added to require that inspection, maintenance, and calibration of the EBT must be performed by its manufacturer or a maintenance representative who is certified by the manufacturer, a State health agency, or other appropriate State agency. This proposed provision would ensure that inspection, maintenance, and calibration of EBTs are performed by qualified personnel for two reasons: (1) To ensure that EBTs used in Part 26 programs continue to provide accurate test results, and (2) because the experience of other Federal agencies that require workplace alcohol testing has demonstrated that such stringent EBT inspection, maintenance, and calibration requirements are necessary to withstand legal challenges to alcohol test results. Section 26.93 Preparing for Alcohol Testing A new § 26.93 [Preparing for alcohol testing] would expand on current Section 2.4(g)(18) in Appendix A to Part 26, which specifies procedures for alcohol testing. The proposed rule would provide more detailed procedures than the current paragraph to increase the consistency of these procedures with those of other Federal workplace alcohol testing programs as well as consistency among the alcohol testing procedures of Part 26 programs. These more detailed requirements would be added for the reasons discussed in Section IV. B. Proposed § 26.93(a) would contain more detailed procedures for implementing the current requirement in the first sentence of current Section 2.4(g)(18) in Appendix A, which instructs collectors to delay alcohol breath testing for 15 minutes if the donor has engaged in any of the activities listed (e.g., smoking, regurgitation of stomach contents from vomiting). Proposed § 26.93(a)(1)–(a)(6) PO 00000 Frm 00087 Fmt 4701 Sfmt 4702 50527 would require the collector to provide the donor with more detailed information about mouth alcohol and the testing process than is currently required and document that the information is provided. Providing more detailed requirements for the 15-minute waiting period would improve the effectiveness and efficiency of the alcohol testing process by reducing false positive test results that are due to residual mouth alcohol or other substances that could potentially trigger a false positive result. Proposed § 26.93(a)(1) would retain the current requirement for the collector to ask the donor about behaviors such as eating and drinking that have may have occurred within the 15 minutes before an alcohol test and add a requirement for the collector to advise the donor to avoid these activities during the collection process. Proposed § 26.93(a)(2) would permit alcohol testing to proceed if the donor states that none of the activities listed in § 26.93(a)(1) had occurred, while proposed § 26.93(a)(3) would retain the current requirement for a 15-minute waiting period before a donor could be tested if he or she had engaged in the activities listed in proposed § 26.93(a)(1). Proposed § 26.93(a)(4) would add a requirement for the collector to explain that it is to the donor’s benefit to avoid the activities listed in § 26.93(a)(1) during the collection process. Proposed § 26.93(a)(5) would add a requirement for the collector to explain to the donor that initial and confirmatory alcohol tests will be conducted at the end of the waiting period regardless of whether the donor has engaged in any of the activities listed in § 26.93(a)(1). Proposed § 26.93(a)(6) would add a requirement for the collector to document that the instructions were communicated to the donor. The proposed additional requirements for the collector to communicate with the donor about the potential effects on test results of the activities listed in proposed § 26.93(a)(1) would ensure that donors clearly understand the reasons for avoiding those activities and the potential consequences of engaging in them in order to protect their rights to due process under the rule. The proposed requirement for the collector to document that the instructions were communicated to the donor would be necessary to ensure that the collector does not inadvertently omit the instructions and improve the legal defensibility of the collection procedure, should a donor challenge it. E:\FR\FM\26AUP2.SGM 26AUP2 50528 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.93(b) would be added to require collectors to minimize delays in administering for-cause drug and alcohol tests and complete alcohol testing before collecting a specimen for drug testing. These proposed requirements would decrease the likelihood that a donor’s test results would fall below the program’s cutoff levels as a result of metabolic processes over time, which could prevent the detection of proscribed alcohol consumption or drug use. Delays between the time at which a donor reports for testing and the time at which testing occurs would continue to be permitted for tests conducted under conditions other than for cause, because, in contrast to for-cause testing, there would be no reason to believe that an individual may have used drugs or alcohol in violation of the FFD policy. Therefore, there would be no basis for a concern that metabolic processes may cause inaccurate test results. The proposed provision would be consistent with the related regulations of other Federal agencies. Section 26.95 Conducting an Initial Test for Alcohol Using a Breath Specimen Proposed § 26.95 [Conducting an initial test for alcohol using a breath specimen] would replace the portions of current Section 2.4(g)(18) in Appendix A to Part 26 that specify procedures for conducting an initial test for alcohol. Collectors would follow the procedures in this section when using ASDs that test breath specimens and EBTs. The proposed section would increase the consistency of Part 26 with the procedures of other Federal agencies for workplace alcohol testing. Consistent with other agencies’ procedures, the proposed rule would eliminate the requirement in current Section 2.4(g)(18) in Appendix A to Part 26 for collecting a second breath specimen for the initial alcohol test. The experience of other Federal agencies indicates that the current Part 26 requirement for two breath specimens is unnecessary to obtain a valid, reliable, and legally defensible test result, if the procedures specified in the proposed section are followed. Therefore, the proposed rule would amend the current procedures to reduce the burden on FFD programs and donors that is associated with collecting two breath specimens for the initial alcohol test, while continuing to ensure that breath alcohol testing provides accurate results. Proposed § 26.95(a) would be added to require the collector to start breath testing as soon as reasonably practical after the donor indicates that he or she VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 has not engaged in any activities that may result in the presence of mouth alcohol or after the 15-minute waiting period, if required. The phrase, ‘‘as soon as reasonably practical,’’ would be added to the proposed paragraph in response to stakeholder comments at the public meetings discussed in Section V. The intent of the provision is for the collector to conduct the initial alcohol test as soon as the individual has received the instructions specified in proposed § 26.93 [Preparing for alcohol testing] in order to ensure the accuracy of the test result, because delays in conducting the test increase the possibility that the donor may inadvertently engage in a behavior that could result in the presence of mouth alcohol as well as permit the donor’s metabolism to lower the alcohol concentration in the specimen, if the donor has consumed alcohol. However, the stakeholders noted that when preparing for outages, in which it is sometimes necessary to test large numbers of individuals, collectors often provide the instructions in proposed § 26.93 to groups of donors at the same time and it is not feasible to test each one immediately after providing the instructions. Therefore, the proposed rule would add the phrase, ‘‘as soon as reasonably practical,’’ to permit reasonable delays in testing associated with outage planning. Proposed § 26.95(b)(1) would permit the donor to select the mouthpiece to be used for testing, at the collector’s discretion. Permitting the donor to select the mouthpiece would not be required, but may increase the donor’s confidence in the integrity of the testing process by assuring the donor that the selection of the mouthpiece is random, if he or she is concerned that a collector would attempt to subvert the testing process by, for example, selecting a mouthpiece that had been contaminated with alcohol or other means of tampering with the testing device. The NRC is not aware of any instances in Part 26 programs in which a donor has accused a collector of altering an alcohol testing device. However, the experience of other Federal agencies who similarly require workplace alcohol testing indicates that taking steps to reduce potential donor concerns about the integrity of the testing process increases donors’ willingness to participate in the testing procedures and reduces the potential for legal challenges. Proposed § 26.95(b)(2) would instruct the collector to open the mouthpiece packaging and insert it into the device in view of the donor. The proposed requirement to insert the mouthpiece PO 00000 Frm 00088 Fmt 4701 Sfmt 4702 into the device in the view of the donor would be added for the same reason described with respect to proposed § 26.95(b)(1). Proposed § 26.95(b)(3) would require the donor to blow into the mouthpiece for at least 6 seconds in order to obtain an adequate breath sample. The requirement to obtain the specimen from the end of the breath exhalation in current Section 2.4(g)(18) in Appendix A to Part 26 would be deleted as unnecessary based upon improvements to breath-testing technology. Proposed § 26.95(b)(4) would require the collector to show the test result to the donor. This proposed requirement is consistent with current industry practices and is intended to increase donor confidence in the integrity of the testing process by ensuring that both the donor and the collector have access to the same information about the donor’s test result. The proposed requirement is consistent with Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26, by ensuring that donors are aware of the information used by the collector to determine whether an alcohol test result is positive or negative. Proposed § 26.95(b)(5) would require the collector to ensure that the test result record can be associated with the donor and is maintained secure, consistent with the many provisions throughout the current and proposed rules that the chain-of-custody must be maintained for specimens and the associated documentation of test results. Proposed §§ 26.129 and 26.159 [Assuring specimen security, chain of custody, and preservation] would establish similar requirements for urine specimens at licensee testing facilities and HHS-certified laboratories, respectively. Proposed § 26.95(c) would be added to require the collection of only one breath specimen for the initial test, unless problems in the collection require that the collection must be repeated. Problems in the collection may include, but would not be limited to, device malfunctions or a donor’s inability to provide an adequate breath specimen on the first try. If a repeat collection is required, the collector would rely on the result from the first successful collection in determining the need for confirmatory alcohol testing. If the procedures specified in this proposed section are followed, relying on one breath specimen for the initial test, rather than the two required in the current rule, would increase the consistency of Part 26 collection procedures with those of other Federal E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules agencies, consistent with Goal 1 of this rulemaking. The proposed provision would also reduce the time required for breath specimen collections without compromising the accuracy, validity, or reliability of the test results. Therefore, the proposed provision would also meet Goal 3 of this rulemaking, which is to improve the efficiency of FFD programs. Section 26.97 Conducting an Initial Test for Alcohol Using a Specimen of Oral Fluids A new § 26.97 [Conducting an initial test for alcohol using a specimen of oral fluids] would establish requirements for conducting initial alcohol tests using an ASD for testing oral fluids specimens. The proposed rule would permit licensees and other entities to rely on ASDs that test oral fluids for the reasons discussed with respect to proposed § 26.83(a). The proposed procedures for conducting alcohol testing with an ASD for testing oral fluids would incorporate the related requirements from 49 CFR Part 40, ‘‘Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs’’ (65 FR 41944; August 9, 2001) and would be added to the proposed rule to ensure that initial alcohol tests of oral fluids provide accurate and legally defensible test results. Proposed § 26.97(a) would be added to specify the procedures that the collector would follow in using an ASD for testing oral fluids, as follows: Proposed § 26.97(a)(1) would require the collector to check the expiration date on the device and show it to the donor. Some devices degrade during storage. Therefore, this step would be necessary to assure both the donor and the collector that the device can be expected to function properly. Proposed § 26.97(a)(2) would require the collector to open an individually wrapped or sealed package containing the device in the presence of the donor. The proposed rule would add the requirement for the collector to open the package in the presence of the donor for the reasons discussed with respect to proposed § 26.95(b)(1). Proposed § 26.97(a)(3) would require the collector to offer the donor a choice of using the device or having the collector use it. If the donor chooses to use the device, the collector would be required to provide instructions for its proper use. The proposed rule would require the collector to offer the donor the choice of using the device to increase the donor’s confidence in the integrity of the testing process, as discussed with respect to proposed § 26.95(b)(1). VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.97(a)(4) would require the collector to gather oral fluids in the proper manner if the donor chooses not to use the device, or in cases in which a second test is necessary because the device failed to activate. In addition, the collector would be required to wear single-use examination or similar gloves while doing so and change them following each test. Proposed § 26.97(a)(5) would require the collector to follow the manufacturer’s instructions to ensure that the device has activated. The proposed requirements in these paragraphs to follow the device manufacturer’s instructions for collecting the specimen and verify that the device has activated would be added to ensure that the collection is properly conducted. The proposed requirement to use single-use examination gloves would ensure that the collector and donor are protected from possible infection from exposure to body fluids. Proposed § 26.97(b) would be added to specify the procedures that the collector would follow if the first attempt to conduct the test using the ASD fails for any reason, including, but not limited to, the ASD failing to activate or the device is dropped on the floor. Proposed § 26.97(b)(1) would require the collector to discard the device and conduct another test using a new device that has been under the collector’s control if the first attempt fails. The proposed rule would require the second device used to have been under the collector’s control to ensure that there have been no opportunities for the donor or another individual to substitute the new device with another that has been altered to provide a false negative test result. This proposed requirement would be necessary to protect the integrity of the collection process. Proposed § 26.97(b)(2) would require the collector to record the reason for the new test. The proposed rule would require documentation of the reason for the new test to ensure that the information is available, should any questions arise with respect to the collection procedure in a review conducted under proposed § 26.39 [Review process for fitness-for-duty policy violations] or legal proceedings. Proposed § 26.97(b)(3) would require the collector to offer the donor the choice of using the device or having the collector use it, unless the collector concludes that the donor was responsible for the new test needing to be conducted. The proposed rule would require the collector to offer the donor the choice of using the device for the PO 00000 Frm 00089 Fmt 4701 Sfmt 4702 50529 reasons discussed with respect to proposed § 26.95(b)(1). The requirement for the collector to use the device if he or she concludes that the donor was responsible for the second test needing to be conducted would enhance the efficiency of the collection procedure by ensuring that the second collection is conducted properly. Proposed § 26.97(b)(4) would require the collector to repeat the collection procedures outlined in proposed § 26.97(a) for the second collection. If the second collection attempt fails, proposed § 26.97(c) would be added to direct the collector to use an EBT to perform the initial alcohol test instead. The proposed rule would require the collector to use an EBT to perform the initial test after two failed attempts at testing oral fluids specimens to ensure that a valid test result is obtained to enhance the efficiency of the collection procedure by changing the method used to conduct the test. If the specimen collection using the ASD for testing oral fluids is successful, proposed § 26.97(d) would instruct the collector to follow the device manufacturer’s instructions for reading the result and show the result to the donor. The proposed rule would prohibit the collector from reading the result sooner than instructed by the device manufacturer because some devices require several minutes after specimen collection to provide an accurate result, but no more than 15 minutes in all cases. The proposed requirement for the collector to show the test result to the donor is intended to increase donor confidence in the integrity of the testing process by ensuring that both the donor and the collector have access to the same information about the donor’s test result. The proposed paragraph would also require the collector to record the test result and that an ASD was used to document the collection and test and ensure that the information is available, should any questions arise with respect to the collection procedure in a review conducted under proposed § 26.39 [Review process for fitness-for-duty policy violations], or legal proceedings. In order to protect collectors and donors from any possible biohazards, proposed § 26.97(e) would be added to prohibit the reuse of any devices, swabs, gloves; and other materials used in collecting oral fluids. Section 26.99 Determining the Need for a Confirmatory Test for Alcohol A new § 26.99 [Determining the need for a confirmatory test for alcohol] would amend the existing requirements in current § 26.24(g) and the portion of E:\FR\FM\26AUP2.SGM 26AUP2 50530 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Section 2.7(e)(1) in Appendix A to Part 26 that addresses cutoff levels for alcohol testing. The proposed rule would amend the current requirements for consistency with a new approach to determining positive alcohol test results in proposed § 26.103 [Determining a confirmed positive test result for alcohol]. The proposed approach would be adopted because some licensees have not taken appropriate action when a donor has obtained alcohol test results just below the current 0.04 percent BAC cutoff level after the donor has been at work for several hours. A BAC below 0.04 percent after the donor has been at work for several hours allows very little doubt that the donor has had an unacceptably high BAC, and has probably been impaired, at some time during the work period. Therefore, new cutoff levels for alcohol testing would be established in proposed §§ 26.99 and 26.103 that would take into account the average rate at which individuals metabolize alcohol over time. In proposed § 26.99(a), the cutoff level for the initial alcohol test result would be decreased from 0.04 to 0.02 percent BAC and a confirmatory alcohol test would be required if a donor’s initial test result is 0.02 percent BAC or higher. In addition, in proposed § 26.99(b), the collector would be required to record the time at which the initial alcohol test result is obtained, so that the length of time during which the donor has been in a work status could be calculated to determine whether a confirmatory test result is positive, in accordance with proposed § 26.103. The proposed changes in the initial alcohol test cutoff level and testing procedure are necessary to support the provisions of proposed § 26.103, which would require the collector to declare an alcohol test as positive if the donor’s confirmatory test result is 0.03 percent or higher after the donor has been on duty for one hour, or 0.02 percent or higher after the donor has been on duty for 2 hours. The revised lower cutoff level for the initial test of 0.02 percent BAC would permit licensees and other entities to identify donors who have had a BAC of 0.04 percent or higher while in a work status, and to initiate confirmatory testing for those individuals. Section 26.101 Conducting a Confirmatory Test for Alcohol A new § 26.101 [Conducting a confirmatory test for alcohol] would be added to provide detailed procedures for conducting confirmatory breath alcohol tests. These proposed procedures would incorporate the related requirements from 49 CFR Part 40, ‘‘Procedures for Department of VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Transportation Workplace Drug and Alcohol Testing Programs’’ (65 FR 41944; August 9, 2001), which would be added to the proposed rule to ensure that confirmatory breath alcohol tests provide accurate and legally defensible test results when using the EBTs that would be required in proposed § 26.91(b) [Acceptable evidential breath testing devices] and relying upon one breath specimen for confirmatory testing, as would be required in proposed paragraph (c) of this section. Proposed § 26.101(a) would require licensees and other entities to conduct the confirmatory test as soon as possible following the initial alcohol test, and in all cases, no later than 30 minutes after the initial test. The proposed rule would add this requirement to reduce the possibility that alcohol metabolism will cause a confirmatory test to provide a result falling below the applicable cutoff level. Current Section 2.4(g)(18) in Appendix A to Part 26 does not require that confirmatory testing must be conducted as soon as possible after a positive initial alcohol test result is obtained, although licensees follow this practice. However, the 30-minute limit would be added because some FFD program personnel may be tested under DOT procedures, as permitted in proposed § 26.31(b)(2), and an EBT that is suitable for confirmatory testing may not be immediately available at the collection site, such that transport to another collection site is required. The 30-minute interim period would be unnecessary at licensees’ and other entities’ collection sites because licensees’ and other entities’ collection sites would have the capability to conduct confirmatory tests with an EBT, as required under proposed § 26.87(a). Therefore, except in these unusual circumstances, licensees and other entities would be expected to continue their current practice of conducting the confirmatory test immediately after a donor’s initial test result is determined to be positive. Proposed § 26.101(b) would be added to specify procedures for conducting a confirmatory alcohol test. Proposed § 26.101(b)(1) and (b)(2) would require the collector to conduct an air blank before beginning the confirmatory test and verify that the air blank reading is 0.00. These proposed steps are necessary to ensure that the EBT is functioning properly before the test begins. Proposed § 26.101(b)(3) would require the collector to take the EBT out of service if a second air blank test reading is above 0.00. This proposed step is necessary because a reading above 0.00 on an air blank test indicates that the PO 00000 Frm 00090 Fmt 4701 Sfmt 4702 EBT is not functioning properly and may provide inaccurate test results. Proposed § 26.101(b)(4)–(b)(7) would be added to specify requirements for handling the EBT’s mouthpiece; reading the test number displayed on the EBT; blowing into the EBT; and showing, recording, and documenting the result displayed on the EBT, respectively. The necessity for these steps would be the same as for those discussed with respect to the related steps in proposed § 26.95 [Conducting an initial test for alcohol using a breath specimen]. However, the proposed rule would not permit the donor to insert the mouthpiece into the EBT for the confirmatory test, because it is necessary to ensure that the confirmatory test is conducted strictly in accordance with the proper procedures to produce a result that meets evidential standards. Meeting evidential standards would be necessary if any questions arise with respect to the collection procedure in a review conducted under proposed § 26.39 [Review process for fitness-for-duty policy violations], or legal proceedings. Proposed § 26.101(c) would be added to require that only one breath specimen must be collected for the confirmatory alcohol test, unless problems in the collection require that the collection be repeated. If a repeat collection is required, the collector would rely upon the result from the first successful collection in determining the confirmatory test result. As discussed with respect to proposed § 26.95(c), if the procedures specified this proposed section are followed, relying on one breath specimen for the initial test, rather than the two required in the current rule, would increase the consistency of Part 26 collection procedures with those of other Federal agencies, and reduce the time required for breath specimen collections without compromising the accuracy, validity, or reliability of the test results. The proposed paragraph would also prohibit licensees and other entities from combining or averaging results from more than one test in order to arrive at the confirmatory test result. These calculations, which are required in current Section 2.4(g)(18) in Appendix A to Part 26, would no longer be necessary with use of the EBTs specified in proposed § 26.91(b). The proposed change would meet Goal 3 of this rulemaking, which is to improve the efficiency of FFD programs. Proposed § 26.101(d) would amend the portion of current Section 2.4(g)(18) in Appendix A of Part 26 that requires using a different EBT for conducting the confirmatory alcohol test than the EBT that the collector used for initial alcohol E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules testing. The proposed rule would permit the use of the same EBT for both initial and confirmatory alcohol testing, rather than require the use of two different EBTs. The licensee or other entity would obtain one breath specimen for initial alcohol testing and one for confirmatory testing, if necessary, but would be permitted to conduct both tests using the same EBT. This proposed change would be made because improvements in EBT technology assure that valid and reliable test results may be obtained from a single EBT, if the proposed specimen collection and quality assurance procedures in this part are followed. Reducing the number of breath specimens required for alcohol testing would not only reduce the costs associated with alcohol testing, but would also reduce the burden on donors that is imposed by the collection process. Use of the same EBT for initial and confirmatory testing is consistent with the procedures of other Federal agencies for workplace alcohol testing. Section 26.103 Determining a Confirmed Positive Test Result for Alcohol A new § 26.103 [Determining a confirmed positive test result for alcohol] would amend the current cutoff level for determining whether a confirmatory alcohol test result is positive, as specified in current § 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26. The proposed rule would establish new cutoff levels that take into account the length of time the donor has been in a work status for the reasons discussed with respect to proposed § 26.99 [Determining the need for a confirmatory test for alcohol]. Proposed § 26.103(a)(1) would retain the 0.04 percent BAC in current § 26.24(g) and Section 2.7(f)(2) in Appendix A to Part 26 as the cutoff level for a confirmed positive alcohol test result at any time, regardless of the length of time the donor has been in a work status. Proposed § 26.103(a)(2) and (a)(3) would establish new cutoff levels for positive alcohol test results that are above the 0.02 percent BAC cutoff level on the initial test and do not meet or exceed the 0.04 percent BAC cutoff level upon confirmatory testing, but indicate that the donor had a BAC of 0.04 percent or greater while in a work status or had consumed alcohol while on duty. The cutoff levels and time periods in proposed § 26.103(a)(2) and (a)(3) are based upon the average rate at which normal metabolic processes reduce an individual’s BAC over time, which is about 0.01 percent BAC per hour. Therefore, a donor whose BAC is measured as 0.03 percent after the donor VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 has been in a work status for one hour would have had a BAC of approximately 0.04 percent when he or she reported for work an hour ago. Through the same metabolic processes, a donor whose BAC is measured as 0.02 percent after he or she has been in a work status for 2 hours would also have had a BAC of approximately 0.04 percent when he or she reported for work 2 hours ago. These proposed changes would improve the effectiveness of FFD programs by ensuring that confirmatory alcohol testing identifies donors who have been impaired from alcohol use while on duty and, therefore, may have posed a risk to public health and safety. Proposed § 26.103(b) would be added to strengthen FFD programs by requiring licensees and other entities to address circumstances in which a donor’s confirmatory alcohol test result is greater than 0.01 percent BAC when the individual has been in a work status for 3 hours or more, but his or her BAC falls below the cutoff levels in proposed § 26.103(a). The proposed rule would require the collector to declare the test as negative because some of the EBTs that licensees and other entities would be permitted to use for confirmatory alcohol testing under the proposed rule have not been thoroughly evaluated by NHTSA for accurately estimating BAC levels below 0.02 percent. However, if an individual has an alcohol test result above 0.01 percent BAC, and has been in a work status for 3 hours or more, the test result would provide a reason to believe that the individual has been impaired while on duty. Therefore, the proposed provision would require the licensee or other entity to ensure that the donor’s alcohol use is evaluated, a determination of fitness is performed, and that the results of the determination of fitness indicate that the donor is fit to safely and competently perform his or her duties before the individual is permitted to perform the duties that require him or her to be subject to this part after testing. This proposed change would strengthen the effectiveness of FFD programs by ensuring that the alcohol use of individuals who may have been impaired when reporting for duty is assessed to determine whether such individuals’ alcohol use is problematic and may pose a future risk to public health and safety and the common defense and security. Current Section 2.4(g)(19) in Appendix A to Part 26, which establishes requirements for collecting a blood specimen for alcohol testing, would be deleted in its entirety because blood testing for alcohol, at the donor’s discretion, would no longer be permitted in the proposed rule. The PO 00000 Frm 00091 Fmt 4701 Sfmt 4702 50531 reasons for eliminating blood testing for alcohol from the proposed rule discussed with respect to proposed § 26.83(a). Section 26.105 Preparing for Urine Collection A new § 26.105 [Preparing for urine collection] would be added to describe the preliminary steps for collecting a urine specimen for drug testing. This proposed section would reorganize the requirements in current Section 2.4(g)(5)–(g)(7) in Appendix A to Part 26 by separating alcohol and urine specimen collection procedures into separate sections of the proposed rule for organizational clarity. The proposed section would also establish several new requirements that would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.105(a) would revise current Section 2.4(g)(5) in Appendix A to Part 26, which requires the donor to remove any unnecessary outer garments and belongings that might conceal items or substances that could be used to tamper with a urine, breath, or blood specimen. The proposed paragraph would eliminate the references to blood and breath specimens in the current paragraph. Reference to blood specimens would be eliminated because blood testing for alcohol, at the donor’s discretion, would no longer be permitted in the proposed rule, as discussed with respect to proposed § 26.83(a). Reference to breath specimens would be eliminated in the proposed paragraph because the proposed rule would present requirements related to preparing for alcohol testing in a separate section, proposed § 26.93 [Preparing for alcohol testing], for organizational clarity. Proposed § 26.105(b) would be added to require the donor to empty his or her pockets and display the items contained in them. The proposed requirement for the collector to examine the contents of the donor’s pockets would increase the likelihood of detecting items (e.g., a vial of powdered urine, bleach, a portable heating unit, a false penis or any other tube or device that may be used to replicate the function of urinary excretion) that could be used to adulterate or substitute the specimen in a subversion attempt. The collector would be required to use his or her judgment in determining whether an item found in the donor’s pockets indicates a clear intent to attempt to subvert the testing process. For example, whereas a container of urine E:\FR\FM\26AUP2.SGM 26AUP2 50532 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules found in a donor’s pocket would be clear evidence of an intent to subvert the testing process, a container of eye drops, which could be used to adulterate the specimen, would, in most cases, be unlikely to indicate an intent to subvert the testing process. Should the collector identify an item that indicates a possible intent to subvert the testing process, the proposed paragraph would require him or her to contact the FFD program manager or MRO in order to obtain direction regarding the need for a directly observed collection. If the collector identifies an item that could be used to tamper with the specimen, but does not indicate an intent to subvert testing, then the collector would secure the item and continue with the collection. These proposed requirements would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, as well as Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by improving the ability of the collector to identify attempts to subvert the drug testing process. The proposed requirement for the donor to permit the collector to make this examination would be added in response to stakeholder requests at the public meetings discussed in Section V to ensure that donors understand that they must cooperate with the examination. Proposed § 26.105(c) would retain current Section 2.4(g)(6) in Appendix A to Part 26, which requires the individual to be instructed to wash his or her hands prior to urination. The proposed rule would make two minor editorial changes to the current provision for clarity in the language of the proposed rule. The proposed rule would clarify that the collector is to instruct the donor to wash and dry his or her hands and would replace the term, ‘‘individual,’’ with the term, ‘‘donor.’’ Proposed § 26.105(d) would retain current Section 2.4(g)(7) in Appendix A to Part 26, which requires the donor to remain in the presence of the collection site person and not to have access to any source of water or other materials that could be used to tamper with the specimen. The proposed rule would make two minor editorial changes to the current provision for clarity in the language of the rule. The proposed rule would replace the term, ‘‘collection site person,’’ with the simpler term, ‘‘collector,’’ and the term, ‘‘individual,’’ with the term, ‘‘donor.’’ Proposed § 26.105(e) would be added to permit the donor, at the collector’s discretion, to select the specimen VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 collection container that he or she will use. Permitting the donor to select the collection kit would not be required, but may increase the donor’s confidence in the integrity of the testing process by assuring the donor that the selection of the collection kit is random, if he or she is concerned that a collector would attempt to subvert the testing process by, for example, selecting a kit that had been contaminated with a substance that would produce a positive or adulterated test result in order to entrap the donor. The importance of providing assurance to the donor regarding the integrity of the collection process is discussed with respect to proposed § 26.95(b)(1). The proposed paragraph would also prohibit the donor from taking collection kit materials (such as the specimen label) other than the collection container into the private area used for urination in order to ensure that a donor could not tamper with the other collection kit materials and thereby disrupt the chain of custody for the urine specimen. The proposed paragraph would be consistent with the related requirements of other Federal agencies and so would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Section 26.107 Collecting a Urine Specimen Proposed § 26.107 [Collecting a urine specimen] would amend current Section 2.4(g)(8), (g)(9), and (g)(12) in Appendix A to Part 26 to update Part 26 urine specimen collection procedures and incorporate advances in other relevant Federal rules and guidelines, consistent with Goal 1 of this rulemaking. Proposed § 26.107(a)(1) would be added to specify the instructions that the collector would be required to provide to the donor. The proposed paragraph would require the collector to instruct the donor to go into the room or stall used for urination, provide a specimen of the quantity that has been predetermined by the licensee or other entity, not flush the toilet, and return with the specimen as soon as the donor has completed the void. The proposed rule would require the collector to provide these instructions to the donor so that the donor would understand his or her responsibilities with respect to the urine collection procedure. In addition, the instructions would be necessary to implement other provisions of the proposed rule, as follows: The quantity of urine that the collector would instruct the donor to provide would be based upon the requirements of the licensee’s or other entity’s drug PO 00000 Frm 00092 Fmt 4701 Sfmt 4702 testing program, as discussed with respect to proposed § 26.109 [Urine specimen quantity]. The collector would instruct the donor not to flush the toilet so that the collector may inspect the private area in which the donor voided after receiving the specimen, as discussed with respect to proposed paragraph (c) of this section. The collector would instruct the donor to return with the specimen as soon as the donor has completed the void in order to minimize the possibility that the urine specimen would cool and its temperature would fall below the acceptable specimen temperature range specified in proposed § 26.111(b). Proposed § 26.107(a)(1) would further amend current Section 2.4(g)(8) in Appendix A to Part 26, which states that the individual may provide his/her urine specimen in the privacy of a stall or otherwise partitioned area that protects individual privacy. For clarity, the proposed paragraph would replace ‘‘may’’ in the current rule with ‘‘shall’’ to indicate that the area in which the donor will urinate must provide for individual privacy. The proposed rule would also add an exception to the current requirement for privacy in the case of a directly observed collection. This proposed change would be made for greater accuracy in the language of the rule, because the requirement for individual privacy would not apply in the case of a directly observed collection, as discussed with respect to proposed § 26.115 [Collecting a urine specimen under direct observation]. Proposed § 26.107(a)(2) would be added to further emphasize the requirement in current Section 2.4(g)(8) in Appendix A to Part 26 that donors must be provided with individual privacy when providing a urine specimen. The proposed paragraph would require that, unless the specimen is to be collected under direct observation, no one other than the donor may go into the private area in which the donor will urinate. Although the NRC is not aware of any instances in Part 26 programs in which the current requirement for individual privacy has been compromised, the experience of other Federal agencies has indicated that such emphasis is necessary. Proposed § 26.107(a)(3) would permit the collector to set a reasonable time limit for the donor to urinate. Rather than establishing a specific time limit, the proposed rule would permit the collector to rely on his or her professional judgment in order to ensure that individuals who may experience difficulty in voiding have sufficient time to provide a specimen, while also E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules permitting collectors to prevent donors from disrupting the testing process by taking an unduly long time to provide a specimen. Proposed training and qualification requirements to ensure that collectors are able to exercise professional judgment appropriately would be specified in proposed § 26.85 (a). At the public meetings discussed in Section V, stakeholders reported incidents in which donors appeared to be attempting to disrupt the testing process by spending an unduly long time providing a specimen and challenged the collector’s authority to set a time limit. The proposed paragraph would clarify that collectors have the authority to set a reasonable time limit for voiding. In addition, the proposed paragraph would increase the consistency of Part 26 with the procedures implemented by other Federal agencies, consistent with Goal 1 of this rulemaking. Proposed § 26.107(b) would amend current Section 2.4(g)(9) in Appendix A to Part 26, which requires the collector to note any unusual behavior or appearance in the permanent record book and on the custody-and-control form. The proposed paragraph would clarify the intent of the current requirement, which has raised implementation questions from licensees, by specifying that the collector must pay careful attention to the donor during the collection process for the purpose of noting any conduct that may indicate an attempt to tamper with the specimen. The proposed paragraph would also provide examples of the types of behavior that may indicate a subversion attempt and require the collector to contact FFD program management if such behavior is observed. The proposed rule would require FFD program management to determine whether a directly observed collection is necessary under proposed § 26.115 [Collecting a urine specimen under direct observation]. Proposed § 26.107(c) would be added to specify the actions to be taken by the collector and donor to complete the specimen collection procedure. The first sentence of proposed § 26.107(c) would retain the existing instruction in current Section 2.4(g)(12) in Appendix A to Part 26, which prohibits the donor from washing his or her hands until the specimen has been delivered to the collector. The proposed paragraph would also add a requirement for the collector to inspect the private area for any evidence of a subversion attempt prior to flushing the toilet. This proposed additional requirement would be consistent with existing industry practices and the procedures of other VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Federal agencies. In addition, it may increase the likelihood of detecting subversion attempts from which physical evidence may remain in the toilet bowl or private area where the donor voided, which could include, but would not be limited to, an empty vial that contains an adulterant, powdered urine spilled on the floor, or the remains of an adulterant in the toilet bowel. Section 26.109 Urine Specimen Quantity A new § 26.109 [Urine specimen quantity] would amend current Section 2.4(g)(11) in Appendix A to Part 26, which establishes 60 milliliters (mL) as the minimum quantity of urine that an FFD program must collect from donors and the procedures to be followed if a donor is unable to provide the specified quantity. Proposed § 26.109(a) would introduce a new term, ‘‘the predetermined quantity.’’ The predetermined quantity of urine that a donor would be requested to provide would be established by the licensee or other entity, depending upon the characteristics of the licensee’s or other entity’s testing program. The proposed rule would require the predetermined quantity to include at least 30 milliliters (mL) of urine, but licensees and other entities could request a larger quantity of urine, if the specimen will be initially tested at a licensee testing facility, if testing will be conducted for additional drugs beyond those required in proposed § 26.31(d)(1), if split specimen procedures will be followed, and if the licensee’s or other entity’s program includes some combination of these characteristics. The proposed paragraph would establish 30 mL as the basic quantity of urine that donors must provide for a testing program that does not include initial tests at a licensee testing facility, does not test for additional drugs, and does not follow split specimen procedures. The 60 mL quantity that is required in current Section 2.4(g)(11) in Appendix A to Part 26 would be reduced to 30 mL to decrease the burden on donors, while ensuring that a sufficient quantity of urine is available to complete initial validity and drug tests, confirmatory validity and drug tests (if required), and any retests that may be requested by the donor and authorized by the MRO under proposed § 26.165(b). NRC staff discussions with representatives of HHS-certified laboratories indicated that advances in testing technologies allow for these minimum testing and retesting procedures to be completed on a 30 mL specimen. Therefore, a 60 mL specimen PO 00000 Frm 00093 Fmt 4701 Sfmt 4702 50533 would no longer be necessary to achieve the NRC’s minimum objectives of conducting validity and drug tests on each specimen for the five classes of drugs specified in proposed § 26.31(d)(1), as well as retesting of the specimen, if required. Proposed § 26.109(a) would also specify the additional quantity of urine, above the basic 30 mL, to be collected when the testing program follows split specimen procedures. Licensees and other entities would be required to collect an additional 15 mL for transfer into Bottle B of a split specimen for storage and possible testing. (As discussed with respect to proposed § 26.113(b), the proposed rule would replace the terms, ‘‘primary specimen’’ and ‘‘split specimen,’’ in the current rule with the terms, ‘‘Bottle A’’ and ‘‘Bottle B,’’ for clarity in the language of the rule and consistency with the terminology used by other Federal agencies.) This additional 15 mL would be sufficient to permit the HHS-certified laboratory to conduct validity and drug tests of the specimen in Bottle B, at the donor’s request, and is consistent with the quantity required in the related provisions of other Federal agencies. Therefore, if a licensee’s or other entity’s testing program follows split specimen procedures, but does not include initial tests at the licensee testing facility or testing for additional drugs beyond those specified in proposed § 26.31(d)(1), then the predetermined quantity for this testing program would be 45 mL (30 mL for basic testing + 15 mL for the split specimen). The predetermined quantity would be larger than 45 mL if the testing program also includes initial tests at a licensee testing facility and testing for additional drugs. Proposed § 26.109(a) would also permit licensees and other entities to include in the predetermined quantity the additional amount of urine that would be necessary to support testing for additional drugs beyond those specified in proposed § 26.31(d)(1). Licensees and other entities would consult with the HHS-certified laboratories they use to identify the quantity of urine required to test for the additional drugs. For example, if the licensee’s or other entity’s testing program does not include initial tests at a licensee testing facility and does not follow split specimen procedures, then the predetermined quantity for that testing program would consist of the 30 mL basic quantity plus the additional amount of urine needed to test for additional drugs. As another example, if a licensee’s or other entity’s testing program includes initial tests at a E:\FR\FM\26AUP2.SGM 26AUP2 50534 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules licensee testing facility, follows split specimen procedures, and tests for additional drugs, then the predetermined quantity would consist of the 30 mL basic quantity plus 15 mL for the split specimen plus the additional amount required to test for additional drugs. Proposed § 26.109(a) would also permit licensees and other entities to include in the predetermined quantity the additional amount of urine that is necessary to perform initial validity and drug tests at the licensee testing facility, if initial tests are performed at the licensee testing facility. For example, one licensee testing program currently requires an additional 10 mL of urine for initial testing at the licensee testing facility, but does not test for additional drugs or follow split specimen procedures. In this program, the predetermined quantity that collectors would request the donor to provide is 40 mL. As another example, if a licensee’s or other entity’s testing program includes initial tests at the licensee testing facility, does not test for additional drugs, and follows split specimen procedures, the predetermined quantity could be 55 mL (30 mL for basic testing + 15 mL for the split specimen + 10 mL for initial testing at the licensee testing facility). If this program also tests for additional drugs, the predetermined quantity could be larger than 55 mL. Proposed § 26.109(b) would be added to establish the actions that the collector must take if a donor provides a specimen that is less than the 30 mL basic quantity. NRC staff discussions with representatives of HHS-certified laboratories indicated that 30 mL is sufficient to meet the NRC’s primary objectives of detecting drug use and subversion attempts through initial validity and drug testing, and for confirmatory validity and drug tests, if required, at an HHS-certified laboratory for the panel of drugs for which testing is required in proposed § 26.31(d)(1). The 30 mL quantity would also ensure that sufficient urine is available for retesting the specimen for validity and for drugs and drug metabolites, should the donor request such retesting, as permitted in proposed § 26.165(b). However, the 30 mL basic quantity would be insufficient to permit testing for additional drugs, initial testing at licensee testing facilities, or splitting the specimen, which are not required under this part. Proposed § 26.109(b)(1) would amend the portions of current Section 2.4(g)(11) in Appendix A to Part 26 that relate to collector actions if a donor provides an insufficient specimen. The proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 paragraph would require the collector to ‘‘encourage’’ the donor to drink a reasonable amount of liquid in order to provide a specimen of at least 30 mL, rather than ‘‘allow’’ the donor to drink additional liquid as currently required. This proposed change would be made to enhance the efficiency of FFD programs, consistent with Goal 3 of this rulemaking, by potentially reducing the time required to obtain a specimen of the required quantity from the donor and, thereby, to complete the collection, should the donor choose to comply. However, the proposed paragraph would establish a limit on the amount of liquid that the individual would be permitted to consume to avoid the potential for ‘‘water intoxication,’’ which is a physical response to consuming too many liquids that may cause harm to the donor. The proposed limit of 24 ounces of water over a 3-hour period would be the same limit imposed in the HHS Guidelines, and would be conservative, in order to ensure that individuals who may have a medical condition that makes them more subject to water intoxication, such as some forms of renal disease or taking some medications, would not be placed atrisk. The proposed rule would retain the current requirement in Section 2.4(g)(11) in Appendix A to Part 26 to collect successive specimens in separate containers. Proposed § 26.109(b)(2) would be added to require the collector to end the specimen collection process as soon as the donor provides a specimen of at least 30 mL in a subsequent attempt. This proposed requirement would reduce the burden on donors who may have some difficulty providing a urine specimen, while meeting the NRC’s objectives of obtaining a specimen of sufficient size to support initial and confirmatory validity and drug testing, as well as retesting of the specimen. Proposed § 26.109(b)(2) would also specify that the licensee or other entity may not impose any sanctions if a donor provides a subsequent specimen that is less than the licensee’s or other entity’s predetermined quantity, as long as the specimen quantity is at least 30 mL. Sanctions for failing to provide sufficient urine to support initial testing at the licensee’s testing facility, split specimen procedures, or testing for additional drugs would be inappropriate, because a specimen of at least 30 mL is sufficient to meet the NRC’s objectives and, therefore, could not be considered a refusal to test. Proposed § 26.109(b)(2) would also require the collector to forward a subsequent specimen that is greater than 30 mL, but less than the licensee’s or PO 00000 Frm 00094 Fmt 4701 Sfmt 4702 other entity’s predetermined quantity, to the HHS-certified laboratory for testing, rather than permit the specimen to be tested at the licensee testing facility. This proposed provision is necessary to ensure that a sufficient quantity of urine is available for validity and drug testing and retesting at the HHS-certified laboratory, if required, consistent with the NRC’s objectives. If the subsequent specimen is equal to or greater than the licensee’s or other entity’s predetermined quantity, however, the licensee or other entity would be permitted to follow the FFD program’s normal testing procedures. Following normal testing procedures in this instance would be permissible because there would be sufficient urine to implement the FFD program’s testing procedures (e.g., split specimen procedures, testing for additional drugs, initial testing at a licensee testing facility), while continuing to ensure that sufficient urine is available for testing and retesting at the HHS-certified laboratory, if required. Proposed § 26.109(b)(3) would be added to require the implementation of ‘‘shy bladder’’ procedures if a donor is unable to provide a 30 mL specimen within 3 hours of the initial attempt to provide a specimen, for the reasons discussed with respect to proposed § 26.119 [Determining shy bladder]. Requirements for implementing ‘‘shy bladder’’ procedures would be contained in that proposed section. Proposed § 26.109(b)(4) would be added to establish additional requirements for specimen collections when a donor provides a specimen of less than 30 mL, as follows: The proposed paragraph would eliminate the requirement in current Section 2.4(g)(11) in Appendix A to Part 26 to combine successive specimens from a donor in order to obtain a specimen of 60 mL. The proposed rule would prohibit the practice of combining specimens to ensure that successive specimens neither contaminate nor dilute a specimen that will be tested. In addition, the proposed prohibition would increase the consistency of Part 26 with the related requirements of other Federal agencies, which is Goal 1 of this rulemaking. Proposed § 26.109(b)(4) would also require the collector to discard any specimens of less than 30 mL unless there is reason to believe that a specimen may have been altered. Examples of reasons to believe that a donor may have attempted to alter the specimen could include, but would not be limited to: (1) Observation of powder (that could be an adulterant or powdered urine) spilled in the private E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules area in which the donor urinated or on the donor’s clothing; (2) unexpected sounds from the private area while the donor should be urinating, such as the sound of something being unwrapped or dropping to the floor; (3) observation that the donor’s pocket appears to contain an item that was not visible before the donor entered the private area (that the donor may have previously had taped to his body); and (4) an unusual color or lack of clarity in the urine specimen. The proposed rule would require the collector to discard specimens of less than 30 mL when there is no reason to believe that the specimens had been subject to tampering because they would not be used for testing and there would be no reason to retain them. If the collector suspects that a specimen has been altered and the suspect specimen is greater than 15 mL, the proposed rule would require the collector to forward the suspect specimen to the HHS-certified laboratory for testing, consistent with current Section 2.4(g)(16) in Appendix A to Part 26. NRC staff discussions with representatives of HHS-certified laboratories indicate that 15 mL is the minimum quantity necessary for HHScertified laboratories to perform the initial and confirmatory (if necessary) validity and drug testing required in this part, although it would be insufficient to support retesting of the specimen at the donor’s request. In these circumstances, in which the collector has observed donor conduct or specimen characteristics that indicate there is a reason to believe that the donor may have altered the specimen, the NRC’s interest in assuring that the testing process is not subverted would take precedence over the individual’s ability to request retesting of the specimen. Any results of validity testing that confirm that the specimen was adulterated or substituted, in combination with the collector’s observations, would provide clear evidence that a donor had tampered with the specimen and had thereby attempted to subvert the testing process. The proposed paragraph would also amend current Section 2.4(g)(17) in Appendix A to Part 26, which requires a directly observed collection whenever there is a reason to believe that a donor has or may attempt to alter a specimen. The proposed paragraph would require the collector to contact FFD program management to determine whether a directly observed collection is required, but would not require a directly observed collection. At the public meetings discussed in Section V, the stakeholders requested flexibility in the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 decision to collect another specimen under direct observation. They noted that there have been numerous instances in which a collector identified incontrovertible evidence that the donor intended to or had tampered with a specimen and that, in such cases, drug testing would not provide additional information that justifies the costs associated with conducting a directly observed collection and testing the additional specimen. The NRC believes that the presence of drugs and drug metabolites in a specimen that is collected under direct observation would establish a clear motive for an alleged attempt to tamper with a specimen and would add further evidence supporting the imposition of sanctions on the donor for attempting to subvert the testing process. However, the NRC agrees with the stakeholders that such additional evidence is unnecessary when there is incontrovertible evidence that the donor intends to or has attempted to tamper with a specimen. Therefore, the proposed rule would permit FFD program management to determine whether an additional specimen collection under direct observation would be conducted. This proposed change would be made to meet Goal 3 of this rulemaking, which is to improve the efficiency of FFD programs, by reducing the number of directly observed collections required under the rule. Section 26.111 Checking the Validity of the Urine Specimen A new § 26.111 [Checking the validity of the urine specimen] would amend current requirements for assessing specimen validity at the collection site, which appear in Section 2.4(g)(13)– (g)(17) in Appendix A to Part 26. In general, the changes contained in the proposed section would be made to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.111(a) would amend current Section 2.4(g)(13) in Appendix A to Part 26, which requires the collector to measure the temperature of the specimen immediately after the urine specimen is collected. The proposed paragraph would require the collector to measure the temperature of any specimen that is 15 mL or more. The proposed rule would not require measuring the temperature of smaller specimens because the collector would be required to discard them, as discussed with respect to proposed § 109(b)(4). The proposed paragraph PO 00000 Frm 00095 Fmt 4701 Sfmt 4702 50535 would also amend the third sentence of current Section 2.4(g)(13) to indicate that, if the ambient temperature is low or the specimen is small, it may be necessary to measure the specimen temperature sooner than 4 minutes after the collector receives the specimen from the donor. A low ambient temperature could cool the specimen more rapidly than normal room temperatures, resulting in an inaccurate temperature reading. Specimens of less than 30 mL will cool more rapidly than specimens of 30 mL or more, so that smaller specimens may also produce inaccurate temperature readings. Therefore, the proposed rule would add an admonition for the collector to expedite the temperature measurement process if the collection is occurring in an environment below normal room temperatures or the specimen is small. Proposed § 26.111(b) would replace current Section 2.4(g)(14) in Appendix A to Part 26, which establishes the acceptable specimen temperature range and requires conducting a second specimen collection under direct observation if a specimen’s temperature falls outside the acceptable range. The proposed rule would increase the range of acceptable specimen temperatures from 90.5°F–99.8°F in the current provision to 90°F–100°F for consistency with the temperature range specified in the HHS Guidelines. The proposed wider acceptable temperature range would provide increased protection against false low or false high temperature readings and, therefore, would protect donors from the imposition of sanctions based upon inaccurate specimen temperature readings. The proposed paragraph would retain the requirement in the current rule for the collector to offer the donor the opportunity to provide a measurement of body temperature, but a measure of oral temperature would no longer be specified. New technologies for obtaining body temperature, such as digital measurement in the ear canal, would also be permitted, because the new technologies provide results more quickly that are at least as accurate as oral thermometers. The portion of current Section 2.4(g)(14) that specifies collector actions if there is a reason to believe that the individual may have tampered with the specimen would be moved to proposed § 26.111(d) for organizational clarity. Proposed § 26.111(c) would amend current Section 2.4(g)(15) in Appendix A to Part 26, which requires the collector to inspect the specimen’s color, determine whether there are any signs of contaminants, and record any unusual findings in the permanent E:\FR\FM\26AUP2.SGM 26AUP2 50536 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules record book. The proposed rule would amend this requirement by deleting reference to the permanent record book and requiring the collector to use the custody-and-control form for recording this information. This change would be made because the proposed rule would no longer require collection sites to maintain a permanent record book, consistent with the elimination of the requirement to maintain a permanent record book in the HHS Guidelines. The proposed rule would also make minor editorial revisions to the current provision by incorporating the related language from the HHS Guidelines. These proposed changes would be made to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with the regulations of other Federal agencies. Proposed § 26.111(d) would replace and revise the first sentence of current Section 2.4(g)(14) in Appendix A to Part 26, which requires a second specimen to be collected under direct observation if the temperature of the first specimen submitted by a donor falls outside of the acceptable specimen temperature range. The proposed paragraph would eliminate the requirement for a second specimen collection under direct observation if the specimen temperature falls outside of the required range, although licensees and other entities could, at their discretion, continue this practice. Instead, the proposed provision would require the collector to contact the FFD program manager, if the collector has a reason to believe the donor has attempted to subvert the testing process based upon observed donor behavior, the specimen temperature, unusual specimen characteristics, or other observations. The FFD program manager, at his or her discretion, would consult with the MRO to determine whether the collector’s observations provide sufficient evidence that a subversion attempt has occurred to warrant the imposition of sanctions. If the MRO and/or FFD program manager determine that a subversion attempt has occurred on the basis of the collector’s observations, the licensee or other entity would be permitted to impose the sanctions for a subversion attempt in proposed § 26.75(b) without conducting a directly observed collection. However, at the FFD program manager’s or the MRO’s discretion, a second specimen may be collected under direct observation. The proposed rule would permit the second specimen to be collected under direct observation to provide further information to assist the MRO in determining whether or not a subversion attempt has occurred. For VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 example, positive drug test results from a second specimen that was collected under direct observation would provide additional evidence that the donor had attempted to tamper with his or her first specimen to hide drug use. This proposed change would be made in response to stakeholder requests, for the reasons discussed with respect to proposed § 26.109(b)(4). Proposed § 26.111(e) would revise current Section 2.4(g)(16) in Appendix A to Part 26, which requires that all urine specimens that are suspected of being adulterated or diluted must be forwarded to the HHS-certified laboratory for testing. The proposed paragraph would add suspicion that a specimen has been substituted as a third reason for forwarding the specimen to the HHS-certified laboratory. As discussed with respect to proposed § 26.31(d)(3)(i), substitution entails replacing a valid urine specimen with a drug-free specimen. This proposed addition would be made for consistency with the addition of substitution to the proposed rule as another method of attempting to subvert the testing process for which licensees and other entities would be required to impose sanctions, as discussed with respect to proposed § 26.75(b). The proposed paragraph would also specifically prohibit testing the suspect specimen at a licensee testing facility for three reasons, which are to: (1) Limit the potential for specimen degradation during the time period required to conduct testing at the licensee testing facility; (2) decrease the time required to obtain confirmatory validity test results if the specimen, in fact, has been altered; and (3) ensure that a sufficient quantity of urine is available for conducting validity tests at more than one HHS-certified laboratory if, for example, the specimen contains a new adulterant or an adulterant that the licensee’s or other entity’s primary laboratory is not capable of identifying [see proposed § 26.161(g)]. Only suspect specimens of 15 mL or more would be sent for testing, rather than all specimens. This proposed lower limit on specimen quantity would be added in order to ensure that there would be sufficient urine available for the HHScertified laboratory to conduct all of the validity and drug tests on the specimen that would required under this part. Proposed § 26.111(f) would require collectors and the HHS-certified laboratory to preserve as much of the specimen as possible. This proposed requirement would be added to provide increased assurance that a sufficient quantity of urine would be available to support further testing, in the event that PO 00000 Frm 00096 Fmt 4701 Sfmt 4702 further testing of the specimen is necessary, and to enhance the consistency of Part 26 with the related provisions of other Federal agencies. Proposed § 26.111(g) would be added to inform donors and collectors of the characteristics of a specimen that is acceptable for testing at an HHScertified laboratory. The proposed paragraph would incorporate the related provision from the HHS Guidelines. Section 26.113 Splitting the Urine Specimen Proposed § 26.113 [Splitting the urine specimen] would update the requirements in current Sections 2.4(g)(20) and 2.7(j) in Appendix A to Part 26, which address collection site procedures for split specimens, and group them together in one section within the proposed rule for organizational clarity. Proposed § 26.113(a) would retain the first sentence of current Section 2.7(j) in Appendix A to Part 26, which permits licensees to follow split specimen procedures. The proposed rule would revise the current sentence in the active voice for increased clarity in the language of the rule. Proposed § 26.113(b) would be added to group together in one paragraph, for organizational clarity, the steps that the collector and donor must follow for the split-specimen collection procedure, which are embedded in current Section 2.4(g)(20) and portions of Section 2.7(j) in Appendix A to Part 26. The proposed rule would also replace the terminology used in the current rule that refers to the split specimen as an ‘‘aliquot,’’ and use the terms, ‘‘Bottle A’’ and ‘‘Bottle B,’’ to refer to the primary and split specimen, respectively. This proposed change would be made for increased clarity in the language of the rule and consistency with the terminology used in other relevant Federal rules and guidelines. Proposed § 26.113(b)(1) would require the collector to instruct the donor to urinate into either a specimen bottle or a specimen container. This step would be added to clarify that the donor is not required to divide a specimen into Bottle A and Bottle B while urinating. The proposed paragraph would incorporate the related provision in the HHS Guidelines. Proposed § 26.113(b)(2) would amend the portions of current Section 2.7(j) in Appendix A to Part 26 that specify the amount of urine to be contained in the split specimen bottles. The proposed rule would replace the implied requirements in the second and third sentences of Section 2.4(j), which refer to the split specimens as ‘‘halves’’ of the specimen that was collected, with E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules updated requirements that would be consistent with those established in proposed § 26.109 [Urine specimen quantity] and the related provisions in the HHS Guidelines. The proposed paragraph would require the collector to ensure that Bottle A contains 30 mL of urine and that Bottle B contains 15 mL. As discussed with respect to proposed § 26.109, advances in urine testing technologies since Part 26 was first promulgated permit a reduction in the quantities of urine that must be collected from donors in order to conduct the testing that would be required under this part. Therefore, 30 mL of urine is now a sufficient quantity for conducting all of the testing that may be required under this part, while 15 mL is sufficient for any retesting that a donor may request. The proposed paragraph would also specify that the specimen in Bottle A would be used for drug and validity testing and that, even if there is less than 15 mL of urine available for Bottle B after the collector ensures that Bottle A contains 30 mL, the specimen in Bottle A must be subject to testing anyway. These clarifications would be added to the proposed rule because, in the experience of other Federal agencies, some collection sites have discarded any specimen of less than 45 mL and conducted another collection to obtain a sufficient amount of urine to fill both Bottles A and B. Should any Part 26 programs follow this practice, the efficiency of FFD programs would be reduced and the burden on donors from being subject to testing would be unnecessarily increased. The 30 mL quantity is sufficient to permit retesting of the specimen in Bottle A, at the donor’s discretion, and, therefore, having 15 mL of urine available for Bottle B is unnecessary to ensure donors’ rights to retesting. The proposed rule would incorporate these clarifications from the HHS Guidelines to ensure that Part 26 programs do not adopt this inefficient and burdensome practice. Proposed § 26.113(b)(3) would retain the portion of current Section 2.4(g)(20) in Appendix A to Part 26 that requires the donor to observe the process of splitting the specimens and maintain visual contact with the specimen bottles until they are sealed and prepared for storage or shipping. Proposed § 26.113(c) would be added to establish priorities for using the specimen that has been collected. The proposed paragraph would permit the licensee testing facility to test aliquots of the specimen at a licensee testing facility or to test for additional drugs beyond those required under proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 § 26.31(d)(1), but only if the donor has provided a specimen of at least the predetermined quantity, as discussed with respect to proposed § 26.109 [Urine specimen quantity]. As discussed with respect to proposed § 26.113(b)(2), the proposed rule would require the collector first to ensure that 30 mL of urine is available for Bottle A and 15 mL for Bottle B. If the donor has provided more than 45 mL of urine and the additional amount is sufficient to support testing at the licensee testing facility, testing for additional drugs, or both, the proposed rule would permit the remaining amount of urine, above the 45 mL required for Bottles A and B, to be subject to such testing. However, if the donor has provided only 45 mL of urine, the proposed rule would require that the 15 mL of urine that remains after 30 mL has been retained for Bottle A must be used for Bottle B rather than to conduct testing at the licensee testing facility or testing for additional drugs. The proposed rule would establish the priority of using the 15 mL of urine for Bottle B, rather than for testing at a licensee testing facility or additional drugs, because the FFD program has established the expectation among donors in this instance that the FFD program will follow split specimen procedures and that Bottle B will be available for retesting at the donor’s request. Reserving the 15 mL of urine for Bottle B would also be consistent with the principle that would be established in the last sentences of proposed §§ 26.135(b) and 26.165(a)(4) that control over testing of the specimen contained in Bottle B would reside with the donor. Section 26.115 Collecting a Urine Specimen Under Direct Observation Proposed § 26.115 [Collecting a urine specimen under direct observation] would group together in one section the requirements of the proposed rule that apply to collecting a urine specimen under direct observation. This organizational change would be made because requirements that address this topic are dispersed throughout the current rule. The proposed section would also incorporate more detailed procedures for collecting specimens under direct observation, based upon related requirements from other relevant Federal rules and guidelines. More detailed procedures are necessary because devices and techniques to subvert the testing process have been developed since Part 26 was first published that are difficult to detect in many collection circumstances, including under direct observation, such as a false penis or other realistic PO 00000 Frm 00097 Fmt 4701 Sfmt 4702 50537 urine delivery device containing a substitute urine specimen and heating element that may be used to replicate urination. Therefore, the proposed changes would be made to increase the likelihood of detecting such attempts to subvert the testing process and, thereby, increase the effectiveness of directly observed collections in assuring that a valid specimen is obtained from the donor. Proposed § 26.115(a) would amend and combine current Section 2.4(f), 2.4(g)(17), and (g)(25) in Appendix A to Part 26, which establish requirements for collecting a urine specimen under direct observation. The proposed paragraph would assign responsibility for approving a directly observed collection to the MRO or FFD program manager, rather than a ‘‘higher level supervisor’’ of the collector in current Section 2.4(b)(25) in Appendix A to Part 26. This proposed change would ensure that the decision to conduct a directly observed collection is made by an individual who is thoroughly knowledgeable of the requirements of this part and the emphasis that the NRC places on maintaining the individual privacy of donors. The proposed change would also be consistent with revised requirements in the HHS Guidelines related to who may authorize a directly observed collection. The proposed rule would also list the circumstances that constitute a reason to believe that a donor may dilute, substitute, adulterate, or otherwise alter a specimen, and that would, therefore, warrant the invasion of individual privacy associated with a directly observed collection, as follows: Proposed § 26.115(a)(1) would amend current Section 2.4(f)(2) in Appendix A to Part 26, which specifies that a directly observed collection may be performed if the last urine specimen provided by donor yielded specific gravity and creatinine concentration results that are inconsistent with normal human urine. The proposed paragraph would amend the current provision in several ways. First, the proposed rule would eliminate the limitation in the current paragraph that a specimen may be collected under direct observation if ‘‘the last urine specimen’’ provided by the individual yielded specific gravity and creatinine concentration results that are inconsistent with normal human urine. The proposed rule would permit a directly observed collection if the donor had presented a specimen with characteristics that are inconsistent with normal human urine ‘‘at this or a previous collection.’’ The proposed change would be necessary for E:\FR\FM\26AUP2.SGM 26AUP2 50538 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules consistency with proposed § 26.75(b), which would require that an individual who has subverted or attempted to subvert any test conducted under Part 26 must be subject to a permanent denial of authorization. Because proposed § 26.75(b) would require permanent denial of authorization to a donor who has engaged in a subversion attempt, individuals whose last specimen had characteristics that are inconsistent with normal human urine would not be subject to further testing under the rule. However, there may be instances in which a licensee or other entity is aware that an individual has engaged in a subversion attempt under a drug testing program that is not regulated by the NRC. If the licensee or other entity is considering granting authorization under Part 26 to the individual, then a directly observed collection would be warranted to ensure that the donor did not have an opportunity to tamper with the specimen and, therefore, that drug test results would be accurate. The amended language of the proposed provision would permit collecting a specimen under direct observation in such circumstances. Second, the proposed rule would update the current provision by replacing the specific gravity and creatinine concentration values that are included in the current paragraph with references to a urine specimen that ‘‘the HHS-certified laboratory reported as being substituted, adulterated, or invalid to the MRO and the MRO reported to the licensee or other entity that there is no adequate medical explanation for the result.’’ This proposed change would be made for consistency with the addition of more detailed requirements for validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The cutoff concentrations and specimen characteristics that would lead the HHSlaboratory to report a specimen as substituted, adulterated, or invalid would be specified in proposed § 26.161 [Cutoff levels for validity testing]. Requirements for the MRO’s review of the test results would be specified in proposed § 26.185 [Determining a fitness-for-duty policy violation]. Proposed § 26.115(a)(2) would combine and update current Sections 2.4(f)(1) and 2.4(g)(14) in Appendix A to Part 26, which establish that the presentation of a specimen that falls outside of the required temperature range is sufficient grounds to conduct a directly observed collection. The proposed paragraph would retain the requirement in current Section 2.4 (f)(1) VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 in Appendix A to Part 26, which specifies that a directly observed collection may be conducted at any time the specimen’s temperature falls outside of the required temperature range. However, the proposed paragraph would amend the current requirement for the collector to take an oral measure of temperature with a sterile thermometer to permit other means of measuring the donor’s body temperature, for the reasons discussed with respect to proposed § 26.111(a). The proposed rule would also retain the current requirement that a directly observed collection may be conducted if the specimen’s temperature falls outside of the required range and the donor declines to provide a measurement of body temperature, in proposed § 26.115(a)(2)(i). However, proposed § 26.115(a)(2)(ii) would eliminate the current permission to conduct a directly observed collection in those instances in which the donor’s body temperature does not equal or exceed that of the specimen. The proposed rule would establish a range of acceptable variability between the donor’s measured temperature and the specimen’s temperature of 1EC/1.8EF. If the donor’s temperature differs from the specified temperature by more than the specified amount, a directly observed collection would be permitted. This proposed change would be made for consistency with the related provision in the HHS Guidelines and to recognize that a specimen temperature that is either much higher or lower than the donor’s body temperature may indicate that the donor has attempted to subvert the testing process. Proposed § 26.115(a)(3) would update current Section 2.4(f)(3) in Appendix A to Part 26, which permits a directly observed collection if a collector observes donor conduct that clearly and unequivocally demonstrates an attempt by the donor to substitute the specimen. The proposed rule would add references to attempts to dilute and adulterate a specimen, in addition to substitution, as behaviors that demonstrate a subversion attempt, consistent with the NRC’s heightened concern for ensuring specimen validity in the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). As discussed with respect to proposed § 26.107(b), donor conduct that clearly and unequivocally demonstrates an attempt to alter a specimen may include, but is not limited to, possession of a urine specimen before the collection has occurred; possession of a vial, or vials, filled with chemicals that are subsequently determined to be urine or PO 00000 Frm 00098 Fmt 4701 Sfmt 4702 an adulterant; possession of a heating element; or evidence that the coloring agent used by the licensee or other entity in a source of standing water at the collection site [see proposed § 26.87(e)(1)] discolors the specimen. Proposed § 26.115(a)(4) would update current Section 2.4(f)(4) in Appendix A to Part 26, which permits directly observed collections if a donor has previously been determined to have engaged in substance abuse and the specimen is being collected as part of a rehabilitation program and/or pre-access testing following a confirmed positive test result. The proposed paragraph would update the current requirement by adding a cross-reference to proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information], which would establish requirements for granting or maintaining the authorization of an individual about whom potentially disqualifying FFD information has been discovered or disclosed. Several provisions in proposed § 26.69 would permit or require directly observed collections, including proposed § 26.69(b)(5), which would require specimens to be collected under direct observation for pre-access drug testing of individuals who have been subject to sanctions under the rule. For organizational clarity, the proposed paragraph would replace the current requirement with a cross-reference to proposed § 26.69, rather than repeat the applicable requirements in this section. Proposed § 26.115(b) would amend the requirement in current Section 2.4(g)(25) in Appendix A to Part 26 that the collector must obtain permission from a ‘‘higher level supervisor’’ before conducting a directly observed collection, as discussed with respect to proposed § 26.115(a). The second sentence of the proposed paragraph would be added to require that, once the decision has been made to conduct a directly observed collection based on a reason to believe that the donor may alter a specimen, the collection must occur as soon as reasonably practical. Although the NRC is not aware of any occasions in Part 26 programs in which a directly observed collection has been unreasonably delayed, the proposed requirement would ensure that test results from the directly observed collection provide information about the presence or absence of drugs and drug metabolites in the donor’s urine. If a collection is delayed for a day or more, metabolism may cause the concentration of drugs and drug metabolites in the donor’s urine, if any are present, to fall below the cutoff levels established in this part or by the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules FFD program and, therefore, not be detected by testing. Non-negative test results from testing a specimen collected under direct observation would provide evidence to support a conclusion that the individual had attempted to subvert the testing process in order to mask drug abuse, whereas negative test results may counter the reason to believe that the individual had attempted to subvert the testing process. Therefore, conducting the directly observed collection as soon as reasonably practical would ensure that test results from the specimen provide relevant and useful information. The proposed requirement would also be consistent with the requirements of other relevant Federal rules and guidelines. Proposed § 26.115(c) would be added to require the collector to inform the donor of the reason(s) for the directly observed collection so that the donor is aware of the nature of the concern that has initiated a directly observed collection. This proposed requirement would be added to the proposed rule for two reasons: (1) Knowing the reason for a directly observed collection may increase a donor’s willingness to cooperate in the procedure in order to counter the reason to believe that the donor has or may attempt to alter the specimen, and (2) informing the donor of the reason for a directly observed collection would meet Goal 7 of this rulemaking, which is to protect donors’ right to due process, by ensuring that the donor is aware of the concern that has initiated the collection. The proposed paragraph would also be consistent with the requirements of other relevant Federal rules and guidelines. Proposed § 26.115(d) would be added to establish recordkeeping requirements related to the directly observed collection. The proposed paragraph would require the collector to record on the specimen’s custody-and-control form that the specimen was collected under direct observation and the reason for the directly observed collection. The proposed requirement is necessary to ensure that the HHS-certified laboratory and the MRO have this information available when the specimen is tested and the MRO conducts his or her review of the test results, as would be required under proposed § 26.185 [Determining a fitness-for-duty policy violation]. This information would be important, for example, in an MRO’s decision to request the laboratory to test a specimen at the LOD that appeared to have been diluted, as permitted under proposed § 26.185(g)(2), in order to compare the results from testing the dilute specimen VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 with those obtained from testing the specimen that was collected under direct observation. Non-negative test results from the dilute specimen and the presence of the same drugs or drug metabolites in the specimen collected under direct observation would provide clear evidence that the donor had diluted the first specimen in an attempt to mask drug use. The proposed paragraph would also be consistent with the requirements of other relevant Federal rules and guidelines. Proposed § 26.115(e) would retain and combine the existing requirements in Sections 1.2, 2.4(b), 2.4(g)(14), (g)(17), and (g)(25) in Appendix A to Part 26, which require that the individual who observes the specimen collection must be of the same gender as the donor. Consistent with the current requirements, the proposed rule would permit another individual of the same gender to serve as the observer if a qualified urine collector of the same gender is not available, as long as the observer receives the instructions specified in proposed § 26.115(f). The proposed rule would combine the current requirements in the proposed paragraph for organizational clarity. Proposed § 26.115(f) would be added to specify the procedures that must be followed in conducting a directly observed collection. The procedures in the proposed paragraph would be followed by either a qualified collector or an individual of the same gender who may serve as the observer. These more detailed procedures are necessary because devices and techniques to subvert the testing process have been developed since Part 26 was first published that can be used under direct observation without detection. Therefore, the proposed changes would be made to increase the likelihood of detecting such attempts to subvert the testing process and, thereby, increase the effectiveness of directly observed collections in assuring that a valid specimen is obtained from the donor. Proposed § 26.115(f)(1) would be added to specify that the observer must instruct the donor to adjust his or her clothing to ensure that the area of the donor’s body between the waist and knees is exposed. This proposed requirement would be added to ensure that the observer could detect the use of an anatomically correct urine delivery device. Proposed § 26.115(f)(2) would be added to specify the action to be observed during the collection. This proposed requirement would be consistent with the requirements of other Federal agencies and is intended PO 00000 Frm 00099 Fmt 4701 Sfmt 4702 50539 to ensure that the urine specimen is obtained from the donor’s body. Proposed § 26.115(f)(3) would be added to prohibit an observer who is not the collector from touching the specimen container. The proposed provision would be consistent with the related requirements of other Federal agencies and is intended to protect the observer from any potential claims by a donor that the observer had altered the specimen. Proposed § 26.115(f)(4) would be added to require the collector to record the observer’s name on the custody-andcontrol form, if the observer is not the collector. The proposed requirement would be consistent with the related requirements of other Federal agencies and is intended to ensure that the observer’s identity is documented, should future questions arise regarding the collection. Proposed § 26.115(g) would be added to clarify that a donor’s refusal to participate in the directly observed collection would constitute a refusal to test and, therefore, would be considered to be an act to subvert the testing process, under proposed § 26.75(b). Current Section 2.4(j) in Appendix A to Part 26 requires the collector to inform the MRO, and the MRO to inform licensee management, if a donor fails to cooperate with the specimen collection process, including, but not limited, to a refusal to provide a complete specimen, complete paperwork, or initial the specimen bottles. The current requirement does not specifically mention that a refusal to participate in a directly observed collection is also an instance of a failure to cooperate. In addition, the current rule does not require the licensee or other entity to impose sanctions on a donor for refusing to be tested. Therefore, the proposed paragraph would both clarify the NRC’s original intent by stating that a refusal to participate in a directly observed collection constitutes a refusal to test and update the current requirement by adding a cross-reference to the proposed sanction of permanent denial of authorization that would be required in such circumstances under proposed § 26.75(b). Proposed § 26.115(h) would be added to specify the actions that a collector must take, if a directly observed collection was required, but was not performed. The collector would inform the FFD program manager or designee of the omission, who would ensure that a directly observed collection is immediately performed. Although the concentrations of any drugs, drug metabolites, or blood alcohol in the donor’s specimens may fall below the E:\FR\FM\26AUP2.SGM 26AUP2 50540 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules cutoff levels that would be specified in this part or in the licensee’s or other entity’s FFD policy if several days have elapsed since the directly observed collection should have occurred, testing a specimen collected several days later would increase the likelihood of detecting any subsequent drug or alcohol use. In addition, the metabolites from using some drugs, such as marijuana, linger in an individual’s body. Therefore, conducting a directly observed collection may result in detecting these metabolites. However, because elapsed time may reduce the concentrations of drugs, drug metabolites, or blood alcohol in the donor’s specimens, the proposed rule would require a directly observed collection to be performed immediately. The proposed provision would use the term, ‘‘immediately,’’ to indicate that the licensee or other entity may be required to call in the donor and a collector to perform the directly observed collection, if the donor and collectors are not on site when the oversight is identified. This proposed requirement would increase consistency with the related requirements of other Federal agencies and is intended to provide instructions for correcting an oversight, which are not addressed in the current rule. Section 26.117 Preparing Urine Specimens for Storage and Shipping A new § 26.117 [Preparing urine specimens for storage and shipping] would reorganize and present together in one section current requirements for safeguarding specimens and preparing them for transfer from the collection site to the licensee’s testing facility or the HHS-certified laboratory for testing. This organizational change would be made because requirements that address these topics are dispersed throughout the current rule whereas grouping them together in a single section would make them easier to locate within the proposed rule. Proposed § 26.117(a) would amend current Section 2.4(g)(20) in Appendix A to Part 26, which requires the donor and collector to maintain visual contact with specimens until they are sealed and labeled. The proposed paragraph would eliminate reference to blood specimens because donors would no longer be permitted to volunteer to provide a blood specimen for alcohol testing under the proposed rule, as discussed with respect to proposed § 26.83(a). The proposed paragraph would also amend the requirements in the second sentence of the current provision. Procedural requirements for observing the splitting of a specimen VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 and sealing the split specimen bottles would be moved to proposed § 26.113 [Splitting the urine specimen] for organizational clarity. However, the proposed paragraph would broaden the current requirement, which addresses only split specimens, to require the donor to observe the transfer of any specimen or aliquot that the collector transfers to a second container and the sealing of the container(s). This proposed requirement would be necessary because some FFD programs who operate licensee testing facilities may transfer an aliquot of the urine specimen to a second container for initial testing at the licensee testing facility, while preserving the primary specimen in the first or another container. The proposed rule would require the donor to observe these actions in order to ensure that the specimen or aliquot(s) that are transferred belong to the donor and that the identity and integrity of the specimen are maintained. Proposed § 26.117(b) would retain current Section 2.4(g)(21) in Appendix A to Part 26, which requires the donor and collector to remain present while the procedures for sealing and preparing the specimen (and aliquots, if applicable) for transfer are performed. Proposed § 26.117(c) would retain the meaning of current Section 2.4(g)(22) in Appendix A to Part 26, which establishes requirements for labeling and sealing the specimen(s), but split the current requirement into several sentences for increased clarity in the language of the provision. For organizational clarity, proposed § 26.117(d) would combine current Section 2.4(g)(23) and 2.4(g)(23)(i) in Appendix A to Part 26, which require the donor to certify that the specimen was collected from him or her. However, the proposed rule would delete current Section 2.4(g)(23)(ii), which requires the donor to have an opportunity to list on the custody-andcontrol form any medications he or she has taken within the past 30 days, for the reasons discussed with respect to proposed § 26.89(b)(3). The proposed rule would delete current Section 2.4(g)(24) in Appendix A to Part 26, which requires the collector to enter into the permanent record book all information identifying the specimen. This requirement would be eliminated because the proposed rule would no longer require collection sites to maintain a permanent record book, consistent with the elimination of the requirement to maintain a permanent record book in the HHS Guidelines. Collection sites would be permitted to use other means of tracking specimen PO 00000 Frm 00100 Fmt 4701 Sfmt 4702 identity, including, but not limited to bar coding. Proposed § 26.117(e) would amend current Section 2.4(g)(26) in Appendix A to Part 26, which requires the collector to complete the chain-ofcustody forms for both the aliquot and the split sample and certify proper completion of the collection. The proposed rule would eliminate reference to the aliquot and split sample in the current paragraph to clarify the intent of this requirement, which is that the collector must complete the appropriate chain-of-custody forms for all of the sealed specimen and aliquot containers, not simply those resulting from a split specimen procedure. For example, if an FFD program follows split specimen procedures and conducts initial testing at a licensee testing facility, the donor’s urine specimen may be divided into Bottle A, Bottle B, and another container that would be used for tests at the licensee testing facility. The proposed paragraph would retain the current requirement for the collector to certify proper completion of the collection. Proposed § 26.117(f) would amend current Section 2.4(g)(27) in Appendix A to Part 26, which states that the specimens and chain-of-custody forms are now ready for transfer and must be appropriately safeguarded if they are not immediately prepared for shipment. The proposed rule would replace the first sentence of the current provision, which states that the specimens and forms are ready for transfer, with a requirement for the collector to package the specimens and forms for transfer to the HHS-certified laboratory or licensee testing facility. This proposed change would improve the clarity in the rule’s language, because it is necessary for the collector to package the specimens and chain-of-custody forms for transfer before they are ready to be transferred. The proposed paragraph would retain the second sentence of the current provision. Proposed § 26.117(g) would retain current Section 2.4(g)(28) in Appendix A to Part 26, which requires the collector to maintain control of the specimens and custody documents and ensure they are secure, if he or she must leave the workstation or collection site for any reason. The proposed paragraph would make minor editorial changes to some of the terminology used in the current paragraph for consistency with the terminology used throughout the proposed rule, as discussed with respect to proposed § 26.5 [Definitions], but retain the intended meaning of the current requirements. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.117(h) would retain the requirements in current Section 2.4(c)(2) in Appendix A to Part 26 related to maintaining specimen security until the specimens are sent to the licensee testing facility or the HHS-certified laboratory for testing from the collection site. The current paragraph would be moved to this section of the proposed rule for organizational clarity because this is the point in the specimen collection procedures at which requirements for maintaining specimen security would apply. The portion of the current paragraph that applies to situations in which it is impractical to maintain continuous physical security of a collection site would be moved to proposed § 26.87(f)(5) for organizational clarity because proposed § 26.87(f) addresses those circumstances. Proposed § 26.117(i) would update the specimen packaging requirements in current Section 2.4(i) in Appendix A to Part 26 by replacing the current paragraph with the related provision from the HHS Guidelines. The first sentence of the current paragraph, which directs collection site personnel to arrange to transfer the specimens to the licensee testing facility or HHScertified laboratory, would be moved to proposed § 26.117(j) for organizational clarity. Proposed § 26.117(j) would address transfer and storage requirements, while proposed § 26.117(i) would address packaging requirements. The proposed paragraph would also eliminate the initial phrases in the second sentence of the current paragraph, which list the conditions under which specimens will be transferred offsite (e.g., shipping specimens that test as ‘‘presumptive positive’’ on initial testing at the licensee testing facility, special processing of suspect specimens), because they would be redundant with other portions of the proposed rule. Proposed requirements related to transferring specimens from a licensee testing facility to an HHS-certified laboratory for further testing would be moved to proposed § 26.129(g) in Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed rule would also eliminate the third sentence of the current paragraph, which requires the collector to sign and date the tape used to seal the container. This requirement would be eliminated because licensees and other entities now rely upon courier services to transfer specimens who offer other means of tracking the date that a container of specimens is shipped and the sender that program experience has shown are equally effective. The proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 paragraph would retain the intended meaning of the current requirements for the collector to place the specimens in a second container that minimizes the possibility of damage during shipment and seal them so that tampering will be detected. At the request of stakeholders during the public meetings discussed in Section V, the proposed rule would add shipping bags to the current set of examples of acceptable shipping containers that protect the specimens from damage. Also at the request of stakeholders, the proposed rule would delete the last sentence of the current paragraph, which requires the collector to ensure that chain-of-custody documents are attached to the container that is used to ship the specimens to the licensee testing facility or laboratory. The stakeholders requested this change because their practice is to seal the specimens’ custody-and-control documentation inside the shipping container to ensure that it cannot be altered. The NRC endorses this practice as providing greater protection for donors and, therefore, proposes this change. Proposed § 26.117(j) would amend and combine the first sentence of current Section 2.4(i) in Appendix A to Part 26 with the requirements applicable to short-term storage of specimens at collection sites in current Section 2.7(c) in Appendix A to Part 26. The first sentence of current Section 2.4(i) in Appendix A to Part 26 would be moved to the proposed paragraph for the reasons discussed with respect to proposed § 26.117(i). Under the proposed paragraph, short-term refrigerated storage of specimens within 6 hours of collection would no longer be required for all specimens, as a result of advances in testing technologies. However, the proposed rule would continue to require licensees and other entities to protect specimens from any conditions that could cause specimen degradation. Collection site personnel would be required to refrigerate specimens that are not transferred or shipped to the licensee testing facility or the HHS-certified laboratory within 24 hours of collection. The proposed rule would also require that any specimens that may have been substituted or adulterated must be refrigerated as soon as they are collected, because some adulterants may interfere with drug testing results unless the specimen is refrigerated. The proposed rule would establish a time-limit of 2 business days for receipt of specimens at the licensee testing facility or HHS-certified laboratory, after shipment from the PO 00000 Frm 00101 Fmt 4701 Sfmt 4702 50541 collection site, to further protect against potential specimen degradation. Proposed § 26.117(k) would amend the portions of current Section 2.4(h) in Appendix A to Part 26 that require every individual in the chain of custody to be identified on a specimen’s custody-and-control form. The proposed rule would not require couriers to meet the requirements in current Section 2.4(h), which state that each time a specimen is handled or transferred, the date and purpose of the transfer must be documented on the chain-of-custody form and every individual in the chain of custody must be identified. Couriers would not be required to meet these requirements because custody-andcontrol forms for individual specimens would be packaged inside the shipping container where they are inaccessible to couriers so that it is impractical to expect them to sign them when handling the specimen shipping containers. The proposed paragraph would codify licensees’ and other entities’ current practices of relying upon courier services’ normal package tracking systems to maintain accountability for specimen shipping containers, which is consistent with the HHS Guidelines and standard forensic practices. The proposed rule would also eliminate the current requirement, contained in the last sentence of Section 2.4(h) in Appendix A to Part 26, to minimize the number of persons handling specimens because this requirement cannot be enforced. Section 26.119 Determining ‘‘Shy’’ Bladder A new § 26.119 [Determining ‘‘shy’’ bladder] would be adapted from the DOT Procedures at 49 CFR 40.193 to specify procedures for determining whether a donor who does not provide a urine specimen of 30 mL within the 3 hours that would be permitted for a specimen collection is refusing to test or has a medical reason for being unable to provide the required 30 mL specimen. The proposed section would be respond to stakeholder requests during the public meetings discussed in Section V. The stakeholders reported that some donors have had difficulty providing the 60 mL of urine that was required in current Section 2.4(g)(11) for medical reasons, but the current rule does not establish procedures for handling such circumstances. As a result, some FFD programs have adopted the DOT ‘‘shy bladder’’ procedures, but the stakeholders preferred that the proposed rule incorporate the requirements to (1) clarify that the NRC accepts the procedures; (2) inform donors of the procedures that they are required to E:\FR\FM\26AUP2.SGM 26AUP2 50542 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules follow if they have medical reasons for being unable to provide a sufficient quantity of urine for testing; (3) enhance consistency among Part 26 programs; and (4) enhance the consistency of Part 26 procedures with the procedures that collectors must follow when conducting tests under DOT requirements. The NRC expects that fewer donors will be subject to ‘‘shy bladder’’ problems under the proposed rule because proposed § 26.109 [Urine specimen quantity] would reduce the minimum quantity of urine required from 60 mL in the current rule to 30 mL. However, because some donors’ medical problems may also interfere with their ability to provide 30 mL of urine, the proposed rule would incorporate the DOT procedures. In general, the purpose of these proposed procedures is to protect the due process rights of individuals who are subject to Part 26. That is, the proposed section would establish procedures for ensuring that there is a legitimate medical reason that a donor was or is unable to provide a urine specimen of the required quantity so that the licensee or other entity has a medical basis for not imposing sanctions on the individual. In addition, the MRO would be authorized to devise alternative methods of drug testing, if it appears that the donor’s medical problem would prevent him or her from being able to provide sufficient urine for drug testing in future tests. Proposed § 26.119(a) would be added to require that a licensed physician, who has appropriate expertise in the medical issues raised by the donor’s failure to provide a sufficient specimen, must evaluate a donor who was unable to provide a urine specimen of at least 30 mL. The MRO would be permitted to perform the evaluation, if the MRO possesses the appropriate expertise. If not, the MRO would be required to review the qualifications of the physician and agree to the selection of that physician. These proposed requirements for the physician who performs the evaluation to be qualified in the relevant medical issues are necessary to ensure that the results of the evaluation would be valid. The proposed paragraph would also require that the evaluation must be completed within 5 days of the unsuccessful collection. The 5-day time limit would be established on the basis of a trade-off between the necessity to provide the donor with sufficient time to locate a qualified physician, obtain an appointment, and for the physician to complete the evaluation (i.e., the donor’s right to due process) and the public’s interest in a rapid determination of whether the donor had VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 attempted to subvert the testing process by refusing to provide a sufficient specimen. The DOT’s experience has indicated that 5 days is sufficient to complete the evaluation. Proposed § 26.119(b) would be added to specify the information that the MRO must provide to the physician who is selected to perform the evaluation if the MRO does not perform it. Proposed § 26.119(b)(1) and (b)(2) would require the MRO to inform the physician that the donor was required to take a drug test under Part 26 but was unable to provide a sufficient quantity of urine for testing, and explain the potential consequences to the donor for a refusal to test. These proposed requirements would ensure that the evaluating physician understands the context in which he or she is being asked to perform the evaluation. Proposed § 26.119(b)(3) would also require the MRO to inform the physician that he or she must agree to follow the procedures specified in proposed § 26.119(c)–(f) if he or she performs the evaluation. This proposed requirement would ensure that the physician understands and consents to follow the proposed procedures specified in this section. Proposed § 26.119(c) would be added to describe the conclusions that the physician must provide to the MRO following the evaluation. Under proposed § 26.119(c)(1), the physician may determine that a medical condition has, or with a high degree of probability could have, precluded the donor from providing the required quantity of urine. Or, under proposed § 26.119(c)(2), the physician may determine that there is an inadequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the donor from providing a sufficient quantity of urine. The proposed rule would limit the physician’s conclusions to one of these two alternatives in order to ensure that the results of the evaluation are relevant to and useful for determining whether sanctions must be imposed on the donor for a refusal to test. Proposed § 26.119(d) would be added to define the physical and psychological conditions that would constitute a medical condition that could have precluded the donor from providing a 30 mL specimen and provide examples of conditions that would not constitute a legitimate medical condition. Legitimate medical conditions would include an ascertainable physiological condition (e.g., a urinary system dysfunction) or a medically documented pre-existing psychological disorder that precluded the donor from providing a 30 mL specimen. Unsupported PO 00000 Frm 00102 Fmt 4701 Sfmt 4702 assertions of ‘‘situational anxiety’’ or dehydration would be examples of conditions that could not be considered legitimate medical conditions. The proposed rule would add this paragraph to provide necessary guidance to the evaluating physician. Proposed § 26.119(e) would be added to require the evaluating physician to provide a written statement of his or her findings and conclusion from the evaluation. By implication, if the MRO performs the evaluation, the MRO would provide this written statement. The written statement would be necessary to communicate the results of the evaluation and create a record of it, should any question arise later with respect to the determination. The proposed paragraph would also require that the physician must provide only the information that is necessary to support the physician’s conclusion. This proposed requirement would be added to protect the donor’s privacy by ensuring that the only medical information documented is information that is necessary to support the determination. Proposed § 26.119(f) would be added to require the physician to inform the MRO, in the written statement, whether any medical condition that may be identified would also preclude the donor from providing specimens of 30 mL or more in future collections. This information would be necessary for the MRO to determine whether alternative methods of drug testing must be implemented for the donor, as required under proposed § 26.119(g)(3). Proposed § 26.119(g) would be added to prescribe the actions to be taken by the MRO based on the results of the evaluation, as follows: Proposed § 26.119(g)(1) would require the MRO to determine that the donor did not violate the FFD policy, if the physician concluded that a medical condition could account for the insufficient specimen and the MRO concurred with that conclusion. In this instance, the licensee or other entity would not impose sanctions on the donor because the donor had not violated the FFD policy by refusing to test. Proposed § 26.119(g)(2) would require the MRO to determine that the donor had refused to be tested by failing to provide a sufficient specimen, if the physician concluded that a medical condition could not account for the insufficient specimen. In this instance, the licensee or other entity would impose the sanction of a permanent denial of authorization for an attempt to subvert the testing process, as required under proposed § 26.75(b). E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.119(g)(3) would require the MRO to devise an alternative method of collecting specimens for drug testing, if the donor’s medical condition would, over the long-term, consistently prevent the donor from providing urine specimens of 30 mL or more. For example, the proposed provision would permit the MRO to direct the collection and testing of alternate specimens, including, but not limited to, hair, or other bodily fluids, if, in the MRO’s professional judgment, the collection and analysis of these alternate specimens would be scientifically defensible and forensically sound. The proposed paragraph would grant flexibility to the MRO in exercising his or her professional judgment in determining an alternative method of conducting drug testing, rather than establish detailed requirements which may not appropriately address the range of possible medical conditions that could arise. Subpart F—Licensee Testing Facilities Section 26.121 Purpose A new § 26.121 [Purpose] would be added to provide an overview of the contents of the proposed subpart, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Section 26.123 Testing Facility Capabilities Proposed § 26.123 [Testing facility capabilities] would amend the second sentence of current Section 2.7(l)(2) in Appendix A to Part 26 as it relates to the capabilities of licensee testing facilities. The proposed paragraph would retain the current requirement for licensee testing facilities to be capable of performing initial tests for each drug and drug metabolite for which testing is conducted by the FFD program and would add a requirement for licensee testing facilities to have the capability to perform either validity screening tests, initial validity tests, or both. The first sentence of current Section 2.7(l)(2), which establishes requirements for the capabilities of HHS-certified laboratories would be moved to proposed Subpart G [Laboratories Certified by the Department of Health and Human Services]. The last sentence of the current paragraph, which permits the testing of breath specimens for alcohol at the collection site, would be deleted here because the proposed rule would address alcohol testing in Subpart E [Collecting Specimens for Testing]. These proposed organizational changes to the current paragraph would VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 be made to meet Goal 6 of this rulemaking, which is to improve organizational clarity in the rule. Section 26.125 Licensee Testing Facility Personnel Proposed § 26.125 [Licensee testing facility personnel] would amend current Section 2.6 in Appendix A to Part 26, as follows: Proposed § 26.125(a) would retain current Section 2.6(a) in Appendix A to Part 26, which requires each licensee testing facility to have one or more individuals who are responsible for the day-to-day operations of the facility and establishes requirements for those individuals’ qualifications. The proposed paragraph would make minor changes in the language of this paragraph, which would be consistent with amended language in the related portion of the HHS Guidelines. Proposed § 26.125(b) would amend current Section 2.6(b) in Appendix A to Part 26, which requires laboratory technicians and nontechnical staff to have the necessary training and skills for the tasks assigned to them. The proposed rule would retain the first sentence of the current provision, but would add another. The proposed rule would require laboratory technicians who perform urine specimen testing to demonstrate proficiency in operating the testing instruments and devices used at the licensee testing facility. This proficiency requirement would be added to ensure that technicians are capable of correctly using the instruments and devices that the licensee testing facility has selected for validity and drug testing. This proposed change is necessary for several reasons. First, the proposed rule would add new requirements for licensee testing facilities to conduct validity testing, and the instruments and devices that the technicians would be using are likely to differ from those previously used at licensee testing facilities. Therefore, additional training and proficiency testing would be required to ensure that validity testing would be conducted properly. Second, proposed rule permits licensees and other entities to rely on drug test results from testing that was performed by another Part 26 program to a greater extent than the current rule. Therefore, it is necessary to ensure that all drug testing performed under Part 26, including tests performed at licensee testing facilities, meets minimum standards. The proposed requirement for technicians to demonstrate proficiency, then, would contribute to meeting this goal. Third, the experience of other Federal agencies has shown that requirements for technicians to PO 00000 Frm 00103 Fmt 4701 Sfmt 4702 50543 demonstrate proficiency assist in any litigation that may occur with respect to urine test results. Proposed § 26.125(c) would amend current Section 2.6(c) in Appendix A to Part 26, which establishes recordkeeping requirements for the personnel files of licensee testing facility personnel. The current requirement for records of tests for color blindness would be eliminated here, consistent with a similar change to the HHS Guidelines. Tests for color blindness would no longer be necessary because current testing technologies provide means other than color for reading test results. Section 26.127 Procedures Proposed § 26.127 [Procedures] would combine, reorganize, and amend requirements for procedures that are interspersed throughout Appendix A to Part 26, including requirements in current Sections 2.2 and 2.7. These organizational changes would be made to improve clarity in the organization of the rule by grouping procedural requirements for licensee testing facilities in one section. Proposed § 26.127(a) would make minor editorial changes to the first sentence of current Section 2.2 in Appendix A to Part 26, which requires licensee testing facilities and HHScertified laboratories to have detailed procedures for conducting testing. The proposed rule would delete the current reference to blood samples because donors would no longer have the option to request blood testing for alcohol, as discussed with respect to proposed § 26.83(a). Reference to HHS-certified laboratories would be moved to proposed § 26.157(a) in Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve the organizational clarity of the rule. The proposed rule would also delete the current reference to procedures for specimen collections, because procedural requirements for specimen collections would be relocated to proposed Subpart E [Collecting Specimens for Testing]. Proposed § 26.127(b) would combine and amend portions of the requirements in the first sentence of current Sections 2.4(d) and 2.7(a)(2) in Appendix A to Part 26 related to the content and implementation of specimen chain-ofcustody procedures. The proposed paragraph would retain the portions of the current paragraphs that require licensee testing facilities to develop, implement, and maintain written chainof-custody procedures to maintain control and accountability of specimens from receipt through completion of E:\FR\FM\26AUP2.SGM 26AUP2 50544 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules testing and reporting of results, during storage and shipping to the HHScertified laboratory, and continuing until final disposition of the specimens. The current requirements related to HHS-certified laboratories would be moved to proposed § 26.157(b) in Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve organizational clarity. The proposed rule would also remove references to custody-andcontrol procedures for blood specimens because donors would no longer have the option to request blood testing for alcohol, as discussed with respect to proposed § 26.83(a). Proposed § 26.127(c) would retain the portions of current Section 2.7(o)(1) in Appendix A to Part 26 that address the required content of procedures for licensee testing facilities and amend the current requirements. The proposed paragraph would retain the portions of the current provision that require licensee testing facilities to develop and maintain procedures to specify all of the elements of the testing process, including, but not limited to, the principles of each test and the preparation of reagents, standards, and controls. The proposed paragraph would present the required topics of the procedures in a list format in proposed § 26.127(c)(1)–(c)(12) to clarify that each topic stands on its own, and to improve clarity in the organization of the rule. Proposed § 26.127(c) would also amend current Section 2.7(o)(1) in Appendix A to Part 26 in several ways. First, the proposed paragraph would eliminate the current requirement for the procedures to be maintained in a laboratory manual as unnecessarily restrictive. Licensee testing facilities would be permitted to use other means to maintain their procedures. Second, the proposed paragraph would add a requirement for the development, implementation, and maintenance of written standard operating procedures for validity testing instruments and devices, consistent with the addition of requirements to conduct validity testing throughout the proposed rule. Third, two portions of the current provision would be moved to other subparts of the proposed rule that address related topics to improve clarity in the organization and language of the rule, as follows: The last two sentences of current Section 2.7(o)(1) in Appendix A to Part 26, which address requirements for retaining copies of superceded procedures, would be relocated to § 26.215(a) of Subpart J [Recordkeeping and Reporting Requirements] of the proposed rule. Procedural requirements for HHS-certified laboratories would be VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 moved to § 26.157(b) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services]. Proposed § 26.127(d) would amend current Section 2.7(o)(3)(iii) in Appendix A to Part 26, which requires procedures for the setup and normal operation of testing instruments, a schedule for checking critical operating characteristics for all instruments, tolerance limits for acceptable function checks, and instructions for major troubleshooting and repair. The proposed paragraph would extend the current requirements to noninstrumented devices (such as some validity screening devices), if the licensee testing facility uses such devices, consistent with the addition of requirements to conduct validity testing throughout the proposed rule. The proposed rule would also make three organizational changes to the current provision. The proposed paragraph would present the required topics of the procedures in a list format in proposed § 26.127(d)(1)–(d)(3) to clarify that each topic stands on its own. The current requirement to maintain records of preventative maintenance would be relocated to § 26.215(b)(10) in Subpart J [Recordkeeping and Reporting Requirements] of the proposed rule. And, the current requirements that apply to HHS-certified laboratories would be moved to § 26.157(d) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services]. These proposed changes would made to improve clarity in the organization of the rule. Proposed § 26.127(e) would reorganize and amend current Section 2.7(o)(4) in Appendix A to Part 26, which requires documented corrective actions if systems are out of acceptable limits or errors are detected. The proposed paragraph would extend the current requirement to noninstrumented validity screening devices, if the licensee testing facility uses such devices, consistent with the addition of requirements to conduct validity testing throughout the proposed rule. The requirements in the current paragraph that apply to HHS-certified laboratories would be moved to § 26.157(e) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Section 26.129 Assuring Specimen Security, Chain of Custody, and Preservation Proposed § 26.129 [Assuring specimen security, chain of custody, and preservation] would be added to PO 00000 Frm 00104 Fmt 4701 Sfmt 4702 group together in one section the requirements of the proposed rule that apply to licensee testing facilities with respect to the safeguarding of specimen identity, integrity, and security. This proposed organizational change would be made because requirements that address these topics are dispersed throughout the current rule whereas grouping them together in a single section would make them easier to locate within the proposed rule. Proposed § 26.129(a) would retain the first four sentences of current Section 2.7(a)(1) in Appendix A to Part 26, which require licensee testing facilities to be secure and accessible only to authorized personnel. These requirements as they apply to HHScertified laboratories would be moved to proposed § 26.159(a). The last sentence of the current paragraph, which establishes recordkeeping requirements, would be moved to § 26.215(b)(13) in proposed Subpart J [Recordkeeping and Reporting Requirements]. The proposed changes would be made for organizational clarity. Proposed § 26.129(b) would amend current Section 2.7(b)(1) in Appendix A to Part 26, which establishes requirements for receiving specimens at the licensee testing facility and assuring their integrity and identity. The proposed rule would move the current requirements related to HHS-certified laboratories to § 26.159(b) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Several requirements would also be added to the proposed paragraph, as follows: The proposed paragraph would add requirements for licensee or other entity management personnel to investigate any indications of specimen tampering and take corrective actions if tampering is confirmed. The proposed rule would add these requirements because some licensees have not investigated or taken corrective actions in response to indications of tampering with specimens under the current rule. The appropriate corrective actions that management personnel would take would depend upon the nature of the tampering identified as a result of the investigation. For example, if the investigation indicated that the tampering was an attempt to subvert the testing process and the persons involved were identified, management personnel would impose the sanctions in proposed § 26.75(b) for a subversion attempt. Management personnel would also be required to correct any systematic weaknesses in specimen custody-andcontrol procedures that may be E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules identified in the investigation, such as inadequate safeguarding of specimen shipping containers. The proposed paragraph would also add a requirement for licensee testing facility personnel to attempt to resolve any discrepancies in the information on specimen bottles or on the accompanying custody-and-control forms to ensure the identity and integrity of specimens and prevent specimens from being unnecessarily rejected for testing by the HHS-certified laboratory (if the specimen must be subject to additional testing) when flaws can be corrected. For example, if the collector’s signature is missing on the custody-and-control form, licensee testing facility personnel would work with collection site personnel to attempt to identify the collector and obtain the collector’s signature on the form if possible. This proposed requirement would reduce the potential burden on donors who may otherwise be required to submit additional specimens to replace those for which the chain-ofcustody could not be confirmed. The proposed requirements would also improve the efficiency of FFD programs by avoiding the need to conduct additional specimen collections when discrepancies can be corrected. The proposed provision would also meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The proposed paragraph would also add a prohibition on testing of any specimens if the licensee or other entity has reason to believe that the specimens that were subject to tampering had been altered in such a manner as to affect specimen identity and integrity. In these circumstances, the MRO would cancel testing of the specimens or any test results from those specimens, and require the licensee or other entity to retest the donors who had submitted them. Although the NRC is not aware of any instances in which these circumstances have arisen in Part 26 programs, the experience of other Federal agencies indicates such tampering is possible. Therefore, this requirement would be necessary to ensure that individuals are not subject to sanctions for a non-negative test result from a specimen that may not have been theirs. The proposed change would be made to meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. The additional provision would also be consistent with the requirements of other Federal agencies. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.129(c) would amend current Section 2.7(b)(2) in Appendix A to Part 26, which establishes requirements for chain-of-custody procedures for specimens and aliquots at licensee testing facilities. The proposed rule would move the requirements in the current paragraph that are related to HHS-certified laboratories to proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve organizational clarity. In addition, the proposed paragraph would add a reference to specimen validity testing for consistency with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed paragraph would incorporate two additional changes to the current provision at the request of stakeholders at the public meetings discussed in Section V. The stakeholders requested that the proposed rule permit licensee testing facilities to use methods other than a custody-and-control form to maintain the chain of custody for aliquots of a specimen that are tested at the licensee testing facility. The proposed change would be incorporated because methods other than a custody-and-control form, such as the use of bar coding, have been shown to be equally effective at tracking the chain of custody for an aliquot at licensee testing facilities. Continuing to permit such flexibility would be consistent with Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. The stakeholders also requested that the proposed paragraph specify the conditions under which specimens and aliquots may be discarded because the current rule does not address discarding of negative specimens. Therefore, the proposed rule would permit licensee testing facilities to discard specimens and aliquots as soon as practical after validity screening or initial validity tests have demonstrated that the specimen appears to be valid and initial test results for drugs and drug metabolites are negative. The proposed clarification would codify current licensee practices. This permission would have no impact on donors’ rights under the rule, because donors are not at risk of management actions or sanctions as a result of negative test results and, therefore, would not need the licensee testing facility to retain the specimen for additional testing for review or litigation purposes. The proposed change would be made to meet Goal 6 of this PO 00000 Frm 00105 Fmt 4701 Sfmt 4702 50545 rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.129(d) would update current Section 2.7(a)(2) in Appendix A to Part 26, which requires licensee testing facility personnel to maintain and document the chain of custody for specimens and aliquots. The proposed paragraph would incorporate the simpler language of the related provision from the HHS Guidelines while retaining the intent of the current paragraph. The proposed rule would relocate the requirements in the current paragraph that are related to HHScertified laboratories to § 26.159(d) and (e) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve organizational clarity. Proposed § 26.129(e) would amend the first sentence of current Section 2.7(d) in Appendix A to Part 26, which requires specimens that test as ‘‘presumptive positive’’ at the licensee testing facility to be shipped to the HHS-certified laboratory for further testing. The proposed rule would replace the term, ‘‘presumptive positive,’’ with the term, ‘‘nonnegative,’’ in order to address validity testing results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). For organizational clarity, the requirements in current Section 2.7(d) in Appendix A to Part 26 that relate to quality control procedures for testing at licensee testing facilities and HHS-certified laboratories would be moved to proposed §§ 26.137 [Quality assurance and quality control] and 26.167 [Quality assurance and quality control], respectively. Proposed § 26.129(f) would clarify and revise current Section 2.7(c) in Appendix A to Part 26, as it relates to refrigerating urine specimens to protect them from degradation. For organizational clarity, the proposed rule would move the current requirements that apply to HHS-certified laboratories to proposed § 26.159(h) in Subpart G [Laboratories Certified by the Department of Health and Human Services]. The proposed paragraph would restate portions of the current provision and add a performance standard regarding ‘‘appropriate and prudent actions’’ to minimize specimen degradation. For the reasons discussed with respect to proposed § 26.117(j), the proposed rule would no longer require all specimens to be refrigerated within 6 hours after collection, but would add a requirement that any specimen that has not been tested within 24 hours of receipt at the licensee testing facility E:\FR\FM\26AUP2.SGM 26AUP2 50546 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules must be refrigerated. The proposed paragraph would continue to require the licensee or other entity to refrigerate any specimen (and the associated Bottle B for that specimen, if the FFD program follows split specimen procedures) that yields non-negative results from initial drug testing at the licensee testing facility. The proposed rule would also add a requirement for refrigerating any specimen (and the associated Bottle B) that yields non-negative results from validity screening or initial validity testing at the licensee testing facility. Refrigerating these specimens would be necessary because some adulterants have been shown to interfere with drug test results more rapidly if the specimen remains at room temperature. The proposed rule would eliminate as unnecessary the last sentence of the current paragraph, which requires licensee testing facilities to ensure that emergency power equipment is available to maintain the specimens cooled in the event of a power failure. With improvements in the courier services available to licensee testing facilities since Part 26 was first published, licensee testing facilities are typically able to ship specimens to the HHS-certified laboratory on the same day that specimens are tested. Further, program experience since the rule was implemented indicates that the periods of time that licensee testing facilities are without off-site power are typically limited to a few hours at most, which would not be long enough for specimen degradation to occur. Therefore, the proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. The proposed rule would also update the terminology used in the current paragraph to be consistent with the new terminology adopted throughout the proposed rule for referring to split specimens. Therefore, in the proposed paragraph, the licensee testing facility would continue to be responsible for protecting from degradation the primary specimen (Bottle A) and the specimen in Bottle B of a split specimen, if the FFD program follows split specimen procedures. The licensee testing facility would also be required to refrigerate any specimen that yields non-negative test results, Bottle B of any specimen in Bottle A that tests as non-negative, and any specimen that is not tested within 24 hours of receipt at the licensee testing facility. These changes in the terminology of the proposed paragraph would be made to improve clarity in the language of the proposed rule. Proposed § 26.129(g) and (h) would separate current Section 2.4(i) in VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Appendix A to Part 26 into two paragraphs for organizational clarity and amend the current provision for the reasons previously discussed with respect to proposed § 26.117(i) and (k). Proposed § 26.129(g) and (h), which repeat the requirements for packaging and shipping specimens contained in proposed § 26.117(i) and (k) of Subpart E [Collecting specimens for testing], would apply these requirements to packaging and shipping specimens from licensee testing facilities to HHScertified laboratories. The bases for these requirements are discussed with respect to proposed §§ 26.117(i) and (k). Section 26.131 Cutoff Levels for Validity Screening and Initial Validity Tests A new § 26.131 [Cutoff levels for validity screening and initial validity tests] would be added to establish cutoff levels for validity screening and initial validity tests at licensee testing facilities for creatinine, pH, and oxidizing adulterants. The procedures, substances, and cutoff levels for initial validity testing in the proposed section would incorporate the related requirements from the HHS Guidelines (69 FR 19643; April 13, 2004). The proposed validity screening test requirements would be adapted from the HHS proposed revision to the Guidelines that was also published in the Federal Register on April 13, 2004 (69 FR 19673). By contrast to the requirements for initial validity testing in the HHS Guidelines, the proposed rule would not require licensee testing facilities to evaluate the specific gravity of a specimen that has a creatinine concentration of less than 20 milligrams (mg) per deciliter (dL). Specimens with a low creatinine concentration may be dilute or substituted. Instead, if the specimen’s creatinine concentration is less than 20 mg/dL, the proposed rule would require the licensee testing facility to forward the specimen to the HHS-certified laboratory to complete the testing, where the specimen’s specific gravity would be measured. The proposed rule would differ from the HHS Guidelines in this provision because the costs of the instruments (i.e., refractometers) that are required in the Guidelines for measuring specific gravity are high. Some licensee testing facilities are currently measuring the specific gravity of specimens. However, the cutoff levels established in the Guidelines require more sensitive measurement and licensee testing facilities would be required to purchase new equipment in order to test at the new HHS specific gravity cutoff levels. Therefore, the proposed rule would PO 00000 Frm 00106 Fmt 4701 Sfmt 4702 require licensee testing facilities to ship specimens with low creatinine concentrations to the HHS-laboratory to complete the initial testing process and would not include cutoff levels for specific gravity or quality control requirements for measuring specific gravity in this proposed subpart. The NRC invites comment on this issue. Proposed § 26.131(a) would be added to require licensee testing facilities to perform either validity screening tests, initial validity tests, or both. Consistent with related requirements for further testing of specimens that yield drugpositive results from initial testing at a licensee testing facility, the proposed rule would also require licensee testing facilities to forward specimens that yield non-negative validity testing results to an HHS-certified laboratory for further testing. Further testing at an HHS-certified laboratory is necessary because licensee testing facilities do not have the sophisticated testing instruments for conducting confirmatory testing that are required under the HHS Guidelines. In addition, further testing at an HHS-certified laboratory provides an independent check on test results from licensee testing facilities that is necessary to protect donors’ rights to due process under Part 26, consistent with Goal 7 of this rulemaking. As discussed in Section IV. C, the primary distinction between validity screening tests and initial validity tests is that validity screening tests may be performed using non-instrumented devices, such as dipsticks, whereas initial validity tests generally rely upon more complex testing technologies. The proposed rule would permit licensee testing facilities to perform validity screening tests before performing initial validity tests, but would not require them to do so, because validity screening tests would be unnecessary if the licensee testing facility will perform initial validity testing. Proposed § 26.131(b) would be added to require licensee testing facilities to test each urine specimen for its creatinine concentration, pH, and the presence of one or more oxidizing adulterants, such as nitrite or bleach. Abnormal creatinine concentrations and pH values, and the presence of oxidizing adulterants are indicators that a specimen has been adulterated or substituted. The proposed rule would permit the FFD program to choose the oxidizing adulterant(s) for which testing would be conducted. The requirements in this proposed paragraph would be consistent with the related requirements in the current HHS Guidelines. E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.131(b) would also establish the criteria for determining whether a specimen must be forwarded to the HHS-certified laboratory for further validity testing. The proposed criteria would be incorporated from the current HHS Guidelines. Because validity testing is complex and the methods for testing are relatively new, the proposed rule would not permit an FFD program to establish more stringent cutoff levels for validity screening and initial validity testing. This proposed prohibition is necessary to decrease the risk of obtaining false non-negative test results and would ensure that donors are not subject to sanctions on the basis of inaccurate test results. Section 26.133 Cutoff Levels for Drugs and Drug Metabolites A new § 26.133 [Cutoff levels for drugs and drug metabolites] would amend current Section 2.7(e)(1) in Appendix A to Part 26, which establishes cutoff levels for initial testing for drugs and drug metabolites. Proposed § 26.133 would replace and amend some cutoff levels for initial tests for drugs and drug metabolites in current Section 2.7(e)(1) in Appendix A to Part 26 to be consistent with the HHS cutoff levels for the same substances. The initial test cutoff level for marijuana metabolites would be decreased from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL. Current immunoassay techniques can now reliably detect the presence of marijuana metabolites at this cutoff level. As discussed in Section IV. B, this proposed change would strengthen the effectiveness of FFD programs by increasing the likelihood of detecting marijuana use. The proposed rule would increase the initial test cutoff level for opiate metabolites from 300 ng/mL in the current rule to 2,000 ng/mL. The proposed change in the cutoff level for opiate metabolites would substantially reduce the number of positive opiate test results that are reported to MROs by HHS-certified laboratories that MROs ultimately verify as negative. The proposed rule would continue to permit licensees and other entities to establish more stringent cutoff levels for initial drug tests, subject to the requirements specified in proposed § 26.31(d)(3)(iii), for the reasons discussed with respect to that paragraph. The current requirement for licensees and other entities to report drug test results for both the cutoff levels in the rule and more stringent cutoff levels would be eliminated in the proposed rule. The reason that the current rule VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 requires FFD programs to report test results for the cutoff levels specified in this part, when the licensee is using more stringent cutoff levels, is that it provides means for the NRC to monitor licensees’ implementation of the permission to use more stringent cutoff levels. The proposed rule would eliminate this requirement, because proposed § 26.31(d)(3)(iii)(C) would require a qualified forensic toxicologist to certify the scientific and technical validity of the licensee’s or other entity’s testing process at any lower cutoff levels. Therefore, the reporting requirement would no longer be needed to assure licensee testing facility performance in this area. Eliminating this requirement would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Section 26.135 Split Specimens A new § 26.135 [Split specimens] would reorganize and amend the requirements contained in current Section 2.7(j) in Appendix A to Part 26 that relate to licensee testing facility handling of split specimens. The proposed requirements would apply only if the FFD program follows split specimen procedures. The current paragraph would be divided into separate paragraphs in the proposed section to indicate that each requirement stands on its own. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.135(a) would amend the second, third, and fourth sentences of current Section 2.7(j) in Appendix A to Part 26. The proposed rule would revise the terminology used in these sentences (e.g., ‘‘Bottle A’’ rather than ‘‘primary specimen,’’ ‘‘Bottle B’’ rather than ‘‘split specimen,’’ ‘‘non-negative’’ rather than ‘‘presumptive positive’’) to be consistent with terminology used in other parts of the proposed regulation without amending the meaning of the sentences. The requirement in the third sentence of current Section 2.7(j) to seal the split specimen prior to placing it in secure storage would be deleted in the proposed rule, because Bottles A and B would have already been sealed at the collection site, as required in proposed § 26.113(b)(3). The proposed paragraph would add a requirement to forward Bottle A of the split specimen to the HHS-certified laboratory, in the case of any non-negative validity test results at the licensee testing facility. This proposed requirement would be consistent with the addition of requirements to conduct validity testing PO 00000 Frm 00107 Fmt 4701 Sfmt 4702 50547 throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.135(b) would amend the requirements in current Section 2.7(j) in Appendix A to Part 26 related to donor requests for testing of the specimen in Bottle B. The proposed paragraph would add non-negative validity test results as a basis for a donor request for testing the specimen in Bottle B consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed paragraph would also add a requirement that the donor must request testing of the Bottle B specimen within 3 business days of being notified by the MRO that the specimen in Bottle A has yielded confirmed non-negative test results. Since 1994, the HHS Guidelines have allowed up to 72 hours for a donor to make this request, so the proposed change would increase the consistency of Part 26 with the HHS Guidelines to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The proposed paragraph would also eliminate the requirement in the fourth sentence of current Section 2.7(j) in Appendix A to Part 26, which requires that the split specimen must be forwarded to another HHS-certified laboratory for testing on the same day of the donor request. Licensees and other entities would be permitted up to one business day to forward Bottle B to a second HHS-certified laboratory following the donor request. This proposed change would respond to stakeholder feedback provided during the public meetings discussed in Section V. The stakeholders reported that implementing the same-day requirement has often been difficult for a number of reasons, including, for example, communication delays among donors, MROs, and FFD program personnel, particularly on weekends and holidays, and the time required to identify a second laboratory with the appropriate capability to test the split specimen, depending upon the nature of the non-negative test result. The proposed rule would alleviate some of these types of logistical difficulties (e.g., logistical problems associated with weekends and holidays) while continuing to provide the donor with timely test results. Therefore, this proposed change would be made to meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. E:\FR\FM\26AUP2.SGM 26AUP2 50548 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules The proposed paragraph would also require the donor to provide written permission to the licensee or other entity for testing of the specimen contained in Bottle B and clarify that only the donor may authorize testing of Bottle B. Stakeholders have indicated that the requirement for a written request from donors would impose a substantial logistical burden for donors who may not be working on site when contacted by the MRO. However, the NRC believes that the proposed requirement is necessary to ensure that the donor’s right to privacy and control of the specimen would be protected, consistent with Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.135(c) would update the terminology used in the portions of current Section 2.7(h) in Appendix A to Part 26 that apply to storing specimens at licensee testing facilities. For example, the proposed provision would replace the term, ‘‘split specimen,’’ with the term, ‘‘Bottle B.’’ The proposed paragraph would continue to require licensee testing facilities who retain Bottle B of a confirmed non-negative split specimen to store it in long-term frozen storage for at least one year before discarding it, or longer if the specimen is under legal challenge, or at the request of the NRC. The proposed rule would extend the current requirement to apply to Bottle B of any specimen that has yielded non-negative validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The portions of current Section 2.7(h) in Appendix A to Part 26 that apply to HHS-certified laboratories would be moved to § 26.159(i) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve the organizational clarity of the rule. Section 26.137 Quality Assurance and Quality Control A new § 26.137 [Quality assurance and quality control] would amend current Section 2.8 in Appendix A to Part 26. The proposed section would add quality control requirements for performing validity screening tests, initial validity tests, and initial tests for drugs and drug metabolites at the licensee testing facility, for the reasons to be discussed with respect to each proposed paragraph. The portions of current Section 2.8 in Appendix A to Part 26 that establish requirements for HHS-certified laboratories would be VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 moved to § 26.167 in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Proposed § 26.137(a) [Quality assurance program] would amend current Section 2.8(a) in Appendix A to Part 26, which requires licensee testing facilities and HHS-certified laboratories to have a quality assurance program for all aspects of the testing process. The requirements for HHS-certified laboratories would be moved to § 26.167(a) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve organizational clarity. The proposed paragraph would extend the current requirements for licensee testing facilities to have a quality assurance program and procedures to validity testing at the licensee testing facility, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.137(b) [Performance testing and quality control requirements for validity screening tests] would be added to establish requirements for conducting validity screening tests for the reasons discussed with respect to proposed § 26.31(d)(3)(i). The proposed requirements in this paragraph are based upon requirements that have been proposed by HHS in a Notice of Proposed Revisions to the Mandatory Guidelines dated April 13, 2004 (69 FR 19673). Proposed § 26.137(b)(1) would permit licensee testing facilities to use noninstrumented devices, such as dipsticks, to determine whether a specimen appears to be valid or must be subject to further validity testing. However, in proposed § 26.137(b)(1)(i) and (ii), licensee testing facilities would be permitted to use only non-instrumented devices that either have been cleared by the U.S. Food and Drug Administration and placed on the SAMHSA list of point-of-collection testing devices that are certified for use in the Federal Workplace Drug Testing Program, as published in the Federal Register, or that meet the performance testing criteria set forth in proposed § 26.137(b)(1)(ii). SAMHSA has yet to publish a list of certified devices, but, in order to be added to SAMHSA’s list, SAMHSA will require that a device must meet the performance testing requirements that are contained in proposed § 26.137(b)(1)(ii). Therefore, adding these requirements to the proposed rule would permit licensee testing facilities to conduct the required performance testing and begin using any PO 00000 Frm 00108 Fmt 4701 Sfmt 4702 devices that meet the criteria before SAMHSA’s list is published. The NRC is aware that the performance testing requirements in proposed § 26.137(b)(1)(ii) are stringent and that few, if any, validity screening devices are yet available that meet them. However, because individuals may be subject to a temporary administrative withdrawal of authorization on the basis of a non-negative initial drug test result for marijuana or cocaine from a specimen that appears to be valid [see proposed § 26.75(i)], it is critical that any validity screening devices used in Part 26 programs provide accurate results. The proposed performance testing requirements would be necessary to protect donors from inaccurate results, as well as ensure that specimens of questionable validity would be detected. Proposed § 26.137(b)(1)(iii) and (b)(1)(iv) would require licensee testing facilities to ensure that any validity screening devices placed into service continue to be effective in determining the validity of urine specimens. Proposed § 26.137(b)(1)(iii) would require licensee testing facilities to ensure that the device(s) either remains on the SAMHSA list of certified devices (when it becomes available) or continues to meet the performance testing criteria in proposed § 26.137(b)(1)(ii)(A)–(b)(1)(ii)(C) by conducting further performance testing on a nominal yearly schedule. The proposed requirement would be consistent with the related requirement in HHS’s proposed revisions to the Guidelines. Proposed § 26.137(b)(1)(iv) would require licensee testing facilities to ensure that the manufacturer of any validity screening device used informs the licensee or other entity of modifications to the device, so that the licensee or other entity may determine whether additional performance testing is required to demonstrate that the modified device continues to be effective. These proposed provisions would be necessary to protect donors from inaccurate results, as well as provide assurance that specimens of questionable validity are detected. Proposed § 26.137(b)(2) would require licensee testing facility personnel to use the validity screening device to test quality control samples at the beginning of any 8-hour period during which validity screening tests will be performed. The proposed rule would require the quality control samples to consist of one sample that is certified as negative and one that is non-negative for the specific validity test for which the device is designed. For example, if the device tests for nitrite, licensee testing E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules facility personnel would use a certified quality control sample containing nitrite. If the device fails to perform correctly when testing the quality control samples, the proposed rule would require the licensee testing facility to stop using it immediately and initiate the investigation required in proposed § 26.137(f). If the test result is a false negative, the last sentence of the proposed paragraph would require the licensee or other entity to notify the NRC. The proposed rule would not require notifying the NRC of a false positive result because any specimen that yields a non-negative validity screening test result would be forwarded to the HHS-certified laboratory for further testing, and licensees and other entities would be prohibited from taking any management actions until the HHS-certified laboratory completes testing of the specimen and the MRO has reviewed the results. Therefore, false positive test results from the device would not impose a burden on donors. These proposed procedures are necessary to protect donors from inaccurate test results, as well as to provide assurance that specimens of questionable validity are detected. Proposed § 26.137(b)(3) would require licensee testing facility personnel to submit 1 out of every 10 donor specimens that yield negative results using the device to the HHS-certified laboratory. If the HHS-certified laboratory’s results indicate that the device had provided a false negative result, the proposed rule would require the licensee testing facility to stop using the device immediately, initiate the investigation required in proposed § 26.137(f), and notify the NRC. The NRC notifications that would be required in proposed § 26.137(a) and (b) would be necessary because false negative results from a validity screening device could mean that some attempts to subvert the testing process may not be detected. For example, if an individual had adulterated his or her specimen and it was not detected because of a faulty device, the licensee or other entity would have no reason to terminate the individual’s authorization. As a result, the individual, who has demonstrated that he or she is not trustworthy and reliable, would be permitted to perform job duties under this part and pose a risk to public health and safety and the common defense and security. The NRC would use the information to ensure that HHS is notified of the device failure as well as inform other licensees and entities who may also be using the device of the false negative results to prevent additional VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 testing errors. Therefore, the proposed notifications would be necessary to protect donors from inaccurate test results, to ensure that specimens of questionable validity are detected, and to ensure that any problems with a device are detected and corrected as soon as possible. Proposed § 26.137(b)(4) would require that any non-instrumented validity screening device used by a licensee testing facility must be capable of measuring creatinine to 1 decimal place. This proposed requirement would be necessary to ensure that the device can support the creatinine cutoff levels established in the HHS Guidelines, as incorporated into the proposed rule. Proposed § 26.137(b)(5) and (b)(6) would establish quality control requirements for performing validity screening tests for pH and oxidizing adulterants, respectively. These proposed requirements would incorporate the related requirements in the proposed HHS Guidelines. Proposed § 26.137(c) [Non-negative validity screening test results] would be added to specify the actions that the licensee testing facility must take if the results of validity screening tests are non-negative. If validity screening test results are non-negative, the proposed rule would require instrumented initial validity testing either at the licensee testing facility or the HHS-certified laboratory. This proposed provision would be consistent with current requirements for handling specimens that test as drug-positive on initial tests at a licensee testing facility. The proposed requirement would be necessary to protect donors from inaccurate test results, as well as provide assurance that specimens of questionable validity are detected using the more sophisticated technologies required for instrumented initial validity testing in the HHS Guidelines and the proposed rule. Proposed § 26.137(d) [Quality control requirements for performing initial validity tests] would be added to specify the required methods for performing initial validity tests at a licensee testing facility to ensure that initial validity testing at the licensee testing facility would provide accurate results. The proposed requirements in this paragraph would incorporate the related requirements in the HHS Guidelines as revised on April 13, 2004 (69 FR 19644). The proposed paragraph would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. PO 00000 Frm 00109 Fmt 4701 Sfmt 4702 50549 Proposed § 26.137(d)(1) would require licensee testing facilities to measure creatinine concentration to 1 decimal place and would establish requirements for the controls to be used in initial tests for creatinine concentration. Proposed § 26.137(d)(2) would establish quality control requirements for performing initial pH tests. Proposed § 26.137(b)(2)(i)–(b)(2)(v) would specify the required calibrators and controls for initial pH testing, based upon the type of testing instrument used and whether a pH validity screening test has been performed. Proposed § 26.137(d)(3) would establish quality control requirements for performing initial tests for oxidizing adulterants, including nitrite, and proposed § 26.137(d)(4) would establish quality control requirements for performing initial tests for ‘‘other’’ adulterants at the licensee testing facility. Proposed § 26.137(e) [Quality control requirements for initial drug tests] would amend and combine portions of current Sections 2.7(d), 2.7(e)(1), and 2.8(b) in Appendix A to Part 26, which establish quality control requirements for performing initial tests for drugs and drug metabolites at licensee testing facilities. The proposed paragraph would group together in one paragraph the current requirements that are dispersed throughout the rule to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.137(e)(1) would amend the first sentence of current Section 2.7(e)(1) in Appendix A to Part 26 but retain the intent of the current provision as it applies to licensee testing facilities. The current and proposed paragraphs require licensee testing facilities to use only immunoassay tests that meet the requirements of the Food and Drug Administration for commercial distribution. The requirements in the current paragraph related to initial drug testing at HHS-certified laboratories would be moved to § 26.167(d)(1) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] to improve organizational clarity in the rule. In addition, the proposed paragraph would prohibit licensee testing facilities from relying on drug test results from any devices they may use to perform validity screening tests. This proposed prohibition would be added because several non-instrumented devices are available that combine tests for the presence of drugs and drug metabolites in a urine specimen with tests for other attributes of a urine specimen, such as creatinine concentration. The proposed E:\FR\FM\26AUP2.SGM 26AUP2 50550 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules rule would permit licensee testing facilities to use such combination devices for validity screening tests, if the devices meet the requirements of proposed § 26.137(b)(1). However, the drug testing capabilities of these devices are not yet sufficiently accurate and sensitive to be used in Part 26 programs, in which licensees and other entities would be permitted to administratively withdraw an individual’s authorization on the basis of positive initial drug test results for marijuana and cocaine metabolites. The NRC may consider accepting the use of initial drug test results from non-instrumented devices in a future rulemaking, when HHS publishes a final revision to the Mandatory Guidelines that establishes requirements for their use in Federal workplace drug testing programs. At this time, however, the proposed rule would retain the current prohibition on using such devices for drug testing at licensee testing facilities. Proposed § 26.137(e)(2) would be added to require licensee testing facilities to either discard specimens that yield negative results from initial tests at the licensee testing facility or pool them and use these specimens as quality control specimens, if the specimens are certified as drug negative and valid by an HHS-certified laboratory. The proposed paragraph would incorporate the related provision from the HHS Guidelines and would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.137(e)(3) would permit licensee testing facilities to conduct multiple tests of a single specimen for the same drug or drug class. The requirements in the proposed paragraph would also be consistent with a similar provision in the HHS Guidelines and would be added for the same reasons discussed with respect to § 26.137(e)(2). Proposed § 26.137(e)(4) would amend the first sentence of current Section 2.8(b) in Appendix A to Part 26, which states that licensee testing facilities are not required to assess their false positive rates in drug testing. The proposed paragraph would retain the intent of the current requirement, but the terminology used in the paragraph would be revised to use the new terms that are used throughout the proposed rule, e.g., ‘‘initial’’ rather than ‘‘screening,’’ as discussed with respect to proposed § 26.5 [Definitions]. Proposed § 26.137(e)(5) would amend the second sentence of current Section 2.8(b) in Appendix A to Part 26, which requires licensee testing facilities to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 submit specimens that yield negative results from initial testing to the HHScertified laboratory as a quality control check on the licensee testing facility’s drug testing process. The proposed paragraph would retain the intent of the current provision but make several changes to the specific requirements. The proposed paragraph would use the term, ‘‘analytical run,’’ rather than the current term, ‘‘test run,’’ to reflect changes in testing technologies that some licensee testing facilities have adopted since the current rule was published. Requirements for blind performance and other quality control testing in the current rule were based on the assumption that specimens would be tested in batches. However, many licensee testing facilities now conduct continuous testing, and no longer test specimens in batches. Therefore, the proposed rule would use the term, ‘‘analytical run,’’ to refer to both batch and continuous processing, as defined in proposed § 26.5 [Definitions]. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. The current rule does not establish a number or percentage of negative specimens that licensee testing facilities are required to submit to the HHScertified laboratory for performance testing, which has raised implementation questions from licensees who have wanted to know how many specimens must be submitted. Therefore, to clarify the current requirement to ‘‘submit a sampling of specimens,’’ the proposed rule would require licensee testing facilities to forward at least one specimen that yields negative drug test results from each analytical run to the HHS-certified laboratory for performance testing. The proposed paragraph would also establish 5 percent of the specimens tested in each analytical run as the percentage of negative specimens that the licensee testing facility must submit to the HHScertified laboratory for testing, except if 5 percent of an analytical run would be a number less than one specimen. In the latter case, the licensee testing facility would submit at least one negative specimen from the analytical run. The proposed requirement would ensure the ongoing evaluation of the accuracy of the licensee testing facility’s initial drug testing without imposing a large performance testing burden. The proposed rule would move the requirement for testing blind performance test samples in current Section 2.8(b) in Appendix A to Part 26 to proposed § 26.137(d)(7). The last PO 00000 Frm 00110 Fmt 4701 Sfmt 4702 sentence of the current paragraph, which addresses performance testing of breath analysis equipment for alcohol testing, would be moved to proposed § 26.91(e) in Subpart E [Collecting Specimens for Testing]. The proposed rule would reorganize the current requirements and group them with related requirements to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule. Proposed § 26.137(e)(6) would amend the requirements of current Section 2.8(c) in Appendix A to Part 26 and apply them to licensee testing facilities. The proposed rule would apply requirements for quality controls to licensee testing facilities to provide greater assurance that initial drug tests performed by these facilities provide accurate results. The increased performance testing would be necessary because the proposed rule permits licensees and other entities to rely on test results from other Part 26 programs to a greater extent than the current rule. Therefore, it is necessary to ensure that any tests performed at licensee testing facilities meet minimum standards. This proposed change would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs. Proposed § 26.137(e)(6)(i)–(e)(6)(iii) would be added to describe the required characteristics of the quality control samples that the licensee testing facility must include in each analytical run of specimens. The proposed paragraphs would require each analytical run to include at least one negative quality control sample as well as quality control samples targeted at 25 percent above the cutoff and at 75 percent of the cutoff level for each drug and drug metabolite for which testing is conducted. The proposed requirements would be consistent with the requirements for processing quality control samples during initial drug testing in the HHS Guidelines. Proposed § 26.137(e)(7) would establish requirements for the number of quality control samples to be included in each analytical run at the licensee testing facility. The proposed rule would require that a minimum of 10 percent of the specimens in each analytical run must be quality control samples. The quality control samples included in the run could be any combination of the types of quality control samples specified in proposed § 26.137(d)(6)(i)–(d)(6)(iii). However, the proposed paragraph would require that one percent or at least one of the quality control samples included in each run must be a blind performance test sample. For example, if an analytical run tested 50 donor specimens, the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules licensee testing facility would include 5 quality control samples in the run. At least one of the 5 would be required to be a blind test sample, and it could be either a blank or a sample fortified with a drug or metabolite at either 25 percent above the FFD program’s cutoff level or at 75 percent of the cutoff level. The remaining 4 samples could include any combination of blanks and fortified samples. Licensee testing facilities would be expected to vary the drugs and drug metabolites used to fortify the quality control samples. The licensee testing facility would not send the quality control samples to the HHScertified laboratory for testing, but use them for internal quality control purposes only. The proposed requirements in this paragraph would incorporate the related requirements in the HHS Guidelines and would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.137(e)(8) would extend to licensee testing facilities the existing requirement in the third sentence of the last paragraph of current Section 2.8(c) in Appendix A to Part 26, which requires HHS-certified laboratories to implement procedures to ensure that carryover does not contaminate the testing of a donor’s specimen and to document the procedures. The proposed rule would extend this requirement to licensee testing facilities because it is a standard forensic practice that is necessary to ensure the integrity of the testing process. Proposed § 26.137(f) [Errors in testing] would be added to require licensees and other entities who maintain testing facilities to investigate any errors or unsatisfactory performance of the testing process, identify the cause(s) of the adverse conditions, and correct them. The proposed rule would require the licensee or other entity to document the investigation and any corrective actions taken. The proposed revision would clarify that licensees must investigate any testing errors or unsatisfactory performance identified throughout the testing process or during the review process that would be required under proposed § 26.91 [Review process for fitness-for-duty policy violations]. The NRC intended, in the original rule, that testing or process errors discovered in any part of the program, including through the review process, 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 VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 future occurrences. The proposed paragraph would also require the cause of the condition be determined and corrective action be taken and documented for consistency with Criterion XVI in Appendix B of 10 CFR Part 50. Proposed § 26.137(g) [Accuracy] would retain current Section 2.7(o)(3)(i) in Appendix A to Part 26, which requires checking the instruments used in testing for accuracy, as it applies to licensee testing facilities. The proposed rule would move the current requirement as it relates to HHScertified laboratories to § 26.167(h) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Proposed § 26.137(h) [Calibrators and controls] would update current Section 2.7(o)(2) in Appendix A to Part 26, which establishes requirements for the standards and quality control samples used for performance testing. At the time the original paragraph was written, most laboratories prepared their own standards and controls. In the ensuing years, the number and variety of sources for materials used in performance testing have increased. The proposed paragraph would update the existing requirements to refer to several of the alternatives, including, but not limited to, pure drug reference materials, stock standard solutions from other laboratories, and standard solutions obtained from commercial manufacturers. The proposed requirements in this paragraph would incorporate the related requirements in the HHS Guidelines and would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Section 26.139 Reporting Initial Validity and Drug Test Results A new § 26.139 [Reporting initial validity and drug test results] would combine existing requirements related to the reporting and management of test results from the licensee testing facility that are interspersed throughout current Appendix A to Part 26. This proposed change would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization of the rule, by grouping related requirements together in a single section. Proposed § 26.139(a) would amend current Section 2.7(g)(2) in Appendix A to Part 26, which establishes requirements for the manner in which HHS-certified laboratories and licensee testing facilities must report test results to licensee management. The PO 00000 Frm 00111 Fmt 4701 Sfmt 4702 50551 requirements in the current paragraph that are related to reporting test results from HHS-certified laboratories would be moved to § 26.169(b) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. The proposed paragraph would delete the current reference to ‘‘special processing’’ and replace it with reference to validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.139(b) would amend the last sentence of current § 26.24(d)(1), which specifies the individuals to whom results of initial tests from the licensee testing facility may be released. The proposed paragraph would add the MRO’s staff to the list of individuals who would be permitted to have access to the results of initial tests performed at the licensee testing facility consistent with the addition of this job role to the proposed rule. Individuals who are serving as MRO staff members would require access to initial test results from a licensee’s testing facility in the course of performing their administrative duties for the MRO. Proposed § 26.139(c) would amend current Section 2.7(o)(5) in Appendix A to Part 26. The requirements in the current paragraph that address the availability of personnel to testify in proceedings related to drug test results from an HHS-certified laboratory would be moved to § 26.153(f)(2) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. The proposed rule would move the current requirement for licensee testing facility personnel to be available to testify at any proceedings with respect to breath analysis test results to proposed § 26.85(d) because licensee testing facilities are typically not responsible for quality control of alcohol testing, which is conducted at the collection site. Proposed § 26.139(d) would amend the portions of current Section 2.7(g)(6) in Appendix A to Part 26 that apply to the summary report that licensee testing facilities must provide to FFD program management. The current requirement for the licensee testing facility to prepare a monthly report of test results would be replaced with a proposed requirement for the licensee testing facility to summarize the data annually in the FFD program performance report required in proposed § 26.217(b). Experience implementing the current requirement for a monthly statistical E:\FR\FM\26AUP2.SGM 26AUP2 50552 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules summary has indicated that the monthly summary has not been as useful to licensees for ongoing monitoring of testing program effectiveness as other mechanisms that licensees have developed. Therefore, the requirement in proposed § 26.139(f) for FFD program management to monitor the ongoing effectiveness of the licensee testing facility testing program would replace the monthly reporting requirement in Section 2.7(g)(6). This proposed change would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. The requirements in the current paragraph that address summary reports from HHS-certified laboratories would be moved to § 26.169(k) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Proposed § 26.139(e) would amend current Section 2.7(g)(7) in Appendix A to Part 26, which requires licensee testing facilities and HHS-certified laboratories to report test results for both the cutoff levels specified in this part and any more stringent cutoff levels used by the FFD program. The current requirement related to HHS-certified laboratories would be relocated to § 26.169(c) of proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. The proposed rule would require licensees and other entities who operate testing facilities and have adopted more stringent cutoff levels for initial tests for drugs and drug metabolites than those specified in proposed § 26.133 [Cutoff levels for drugs and drug metabolites], to conduct tests and report test results based only on their more stringent cutoff levels. The basis for the current requirement to conduct tests and report test results for the cutoff levels specified in this part, when the licensee is using more stringent cutoff levels, was a method by which the NRC monitored licensee implementation of the permission to use more stringent cutoff levels. The proposed rule would eliminate this requirement, because proposed § 26.31(d)(3)(iii)(C) would require a qualified forensic toxicologist to certify the scientific and technical validity of the licensee’s or other entity’s testing process at any lower cutoff levels. Therefore, the testing and reporting requirement would no longer be needed to monitor licensee testing facility performance in this area. The proposed rule would continue to require licensee testing facilities to report test results (and the cutoff levels used) from VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 testing for additional drugs and drug metabolites, beyond those specified in proposed § 26.31(b)(1). Proposed § 26.139(f) would be added to require FFD program management to monitor the ongoing effectiveness of the licensee testing facility testing program. The proposed rule would provide examples of the types of information and possible program performance indicators that licensees and other entities may use for program monitoring. The proposed rule would also require FFD program management to make adjustments to the testing program in response to information gained from the ongoing monitoring. The proposed requirements would replace the current monthly summary reporting requirement in current Section 2.7(g)(7) in Appendix A to Part 26 to strengthen FFD programs by ensuring that licensees monitor licensee testing facility performance on an ongoing basis and correct any weaknesses as they are identified. The proposed paragraph also would be consistent with the NRC’s performance-based approach to regulation. This proposed change would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, as discussed in Section IV. B. Subpart G—Laboratories Certified by the Department of Health and Human Services Section 26.151 Purpose Proposed § 26.151 [Purpose] would be added to introduce the purpose of the proposed subpart, which is to establish requirements for the HHS-certified laboratories that licensees and other entities must use for testing urine specimens for validity and the presence of drugs and drug metabolites. This proposed section would be added to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The majority of the requirements in this proposed subpart would be based upon the current requirements in Appendix A to Part 26, as they relate to HHS-certified laboratories. However, the current requirements would be updated to be consistent with the Department of Health and Human Services’ revisions to the Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines), as published in the Federal Register on April 13, 2004 (69 FR 19643). Section 26.153 Using Certified Laboratories for Testing Urine Specimens A new § 26.153 [Using certified laboratories for testing urine specimens] PO 00000 Frm 00112 Fmt 4701 Sfmt 4702 would be added to present together requirements related to the use of HHScertified laboratories by licensees and other entities who would be subject to the rule. Proposed § 26.153(a) would combine and update current requirements for licensees and other entities to use HHScertified laboratories for initial and confirmatory drug testing of urine specimens. The proposed paragraph would relocate and combine current § 26.24(f), the second sentence of Section 1.1(3), and Section 4.1(a) in Appendix A to Part 26, which require licensees and other entities to use HHScertified laboratories for drug testing. The proposed change would be made to eliminate redundancies in the current rule and improve organizational clarity. The proposed paragraph would update the current citations for the HHS Guidelines because the Guidelines have been amended several times since the current rule was published. In addition, the proposed rule would provide current contact information for obtaining information about the certification status of HHS-certified laboratories because the contact information also has changed since the current rule was published. The proposed paragraph would also add a requirement for licensees and other entities to use HHS-certified laboratories for initial and confirmatory validity testing, consistent with the addition of urine specimen validity testing requirements to the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The cross-reference to current § 26.24(d), which permits licensee testing facilities to conduct initial drug tests, would be updated to reference the related provision in the proposed rule, proposed § 26.31(d)(3)(ii). Proposed § 26.153(b) would amend the first sentence of current Section 2.7(l)(2) in Appendix A to Part 26, which requires HHS-certified laboratories to have the capability, at the same laboratory premises, of performing initial and confirmatory tests for any drug and drug metabolite for which service is offered and confirmatory testing of blood for alcohol concentrations. The current requirement for HHS-certified laboratories to be capable of conducting confirmatory alcohol testing of blood would be deleted for the reasons discussed with respect to proposed § 26.83(a). The proposed paragraph would add a requirement for HHS-certified laboratories to have the capability to perform both initial validity and confirmatory validity tests at the same premises for consistency with the E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules addition of requirements to perform validity testing to the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The second sentence of current Section 2.7(l)(2), which establishes requirements for the capabilities of licensee testing facilities, would be moved to proposed § 26.123 [Licensee testing facility capabilities] of Subpart F [Licensee Testing Facilities] for organizational clarity. The last sentence of the current paragraph, which permits the testing of breath specimens for alcohol at the collection site, would be deleted because the proposed rule would address alcohol testing in Subpart E [Collecting Specimens for Testing]. These organizational changes to the current paragraph would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.153(c) would amend the first sentence of current Section 2.7(k) in Appendix A to Part 26, which restricts HHS-certified laboratories from subcontracting unless authorized by the licensee. The proposed rule would extend this restriction to subcontracting for specimen validity testing for consistency with the addition of requirements to perform validity testing to the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The second sentence of current Section 2.7(k) would be deleted from the proposed paragraph for several reasons: First, the requirement to have the capability to test for marijuana, cocaine, opiates, phencyclidine, and amphetamines would be deleted because it is redundant with proposed § 26.31(d)(1). The requirement to be capable of testing whole blood would be deleted because the proposed rule would no longer permit donors to request confirmatory alcohol testing of blood for the reasons discussed with respect to proposed § 26.83(a). Finally, the requirement for laboratories to be capable of conducting GC/MS testing would be eliminated because HHScertified laboratories would be permitted to use other methods of confirmatory testing, consistent with related revisions to the HHS Guidelines. Proposed § 26.153(d) would amend current Section 4.1(b) in Appendix A to Part 26, which requires licensees and C/Vs to use only HHS-certified laboratories who agree to follow the same rigorous testing, quality control, and chain-of-custody procedures when testing for more stringent cutoff levels, additional drugs to those for which testing is required under Part 26, and blood. The proposed paragraph would eliminate reference to testing for blood VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 because the proposed rule would no longer permit donors to request confirmatory alcohol testing of blood for the reasons discussed with respect to proposed § 26.83(a). Proposed § 26.153(e) would amend the third sentence of current Section 2.7(m) in Appendix A to Part 26, which requires licensees to conduct an inspection and evaluation of a laboratory’s drug testing operations before using the laboratory’s services. Some licensees have incorrectly interpreted the current regulation as requiring licensee employees to perform the pre-award inspection and evaluation. In many cases, however, appropriately qualified licensee employees may not be available to perform the inspection and evaluation, and the use of contracted experts may be necessary to achieve the NRC’s intent. The proposed paragraph would revise the current requirement to indicate that licensees and other entities would be responsible ‘‘to ensure’’ that the inspection and evaluation is performed, in order to clearly indicate that the use of expert contractors is acceptable. In addition, the proposed rule would clarify that the pre-award inspection and evaluation must be performed by qualified individuals. Proposed § 26.153(e) also would permit a licensee or other entity to begin using the services of another HHScertified laboratory immediately, without a pre-award evaluation and inspection, in the event that the licensee’s or other entity’s primary laboratory loses its certification. To be considered acceptable, the proposed rule would require that the replacement laboratory must be in use by another Part 26 program. The proposed rule would add this provision to ensure that testing can continue, in the event that the HHS-certified laboratory upon which a licensee or other entity relies loses its certification, as some licensees have experienced. Related requirements for auditing the replacement laboratory would be specified in proposed § 26.41(g)(5). Proposed § 26.153(f) would be added to require that licensees’ and other entities’ contracts with HHS-certified laboratories must require the laboratories to implement the applicable requirements of this part. Because the NRC does not regulate HHS-certified laboratories, this revision would ensure that the Agency has a legal basis for requiring HHS-certified laboratories to comply with this part when conducting testing for licensees and other entities. Proposed § 26.153(f)(1) would retain the requirement in current Section 2.7(l)(1) in Appendix A to Part 26, PO 00000 Frm 00113 Fmt 4701 Sfmt 4702 50553 which states that HHS-certified laboratories must comply with applicable State licensor requirements. The proposed paragraph would replace the term, ‘‘HHS-certified laboratories,’’ with the term, ‘‘laboratory facilities,’’ to clarify that State requirements apply to laboratory facilities rather than to the HHS-certified laboratory as a corporate entity. The proposed clarification would be necessary because some HHScertified laboratories are operated by large national corporations with facilities in several different States, and only the facilities in a specific State would be required to meet the requirements of that State. The proposed change would be made for clarity in the language of the proposed rule as well as consistency with the HHS Guidelines. Proposed § 26.153(f)(2) would amend current Section 2.7(o)(5) in Appendix A to Part 26, which requires that HHScertified laboratories must make available qualified personnel to testify in proceedings based on urinalysis results reported by the laboratory. Reference to licensee testing facilities would be moved to § 26.139(c) in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. The requirement for qualified personnel to be available to testify in proceedings related to breath analysis results would be moved to proposed § 26.85(d) in proposed Subpart E [Collecting Specimens for Testing] for organizational clarity and because responsibility for testifying with respect to breath analysis results would reside with the licensee’s or other entity’s collection site personnel. Proposed § 26.153(f)(3) would update current Section 3.1 in Appendix A to Part 26, which requires HHS-certified laboratories to protect donors’ records. The current requirement for licensee testing facilities to protect donors’ records would be subsumed within the second sentence of proposed § 26.37(a) for organizational clarity. The crossreference to current § 26.29 would be updated to reference proposed § 26.39 [Protection of information]. Proposed § 26.153(f)(4) would update current Section 3.2 in Appendix A to Part 26. Specifically, the proposed rule would add a reference to Section 503 of Public Law 100–71 to document the basis for this requirement, which would be adapted from the HHS Guidelines. The proposed paragraph would add a requirement for a donor to have access to records relating to his or her validity test results for consistency with the addition of validity testing requirements to the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The E:\FR\FM\26AUP2.SGM 26AUP2 50554 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules proposed paragraph would delete the current reference to records related to alcohol test results because HHScertified laboratories would no longer be testing blood specimens for alcohol, as discussed with respect to proposed § 26.83(a). Proposed § 26.153(f)(5) would be added to clarify that HHS-certified laboratories must avoid relationships with a licensee’s or other entity’s MRO(s) that may be construed as a potential conflict of interest. The proposed paragraph would respond to the experiences of other Federal agencies regarding apparent conflicts of interest involving laboratories and MROs. Although the NRC is not aware of any situations of this type in Part 26 programs, the integrity of the MRO function is sufficiently important that incorporating this requirement would be warranted to prevent potential conflict of interest concerns. The proposed paragraph would be consistent with the related provision in the HHS Guidelines. Proposed § 26.153(f)(6) would amend the requirements in the first two sentences of current Section 2.7(m) in Appendix A to Part 26, which require HHS-certified laboratories to permit the NRC, licensees, and other entities to conduct inspections at any time, including unannounced inspections. The proposed rule would delete, for organizational clarity, the existing references to collection site services and licensee testing facilities, which would be covered under proposed § 26.221 [Inspections]. The proposed paragraph would also delete reference to confirmatory testing of blood specimens for alcohol because HHS-certified laboratories would no longer be testing blood specimens for alcohol, as discussed with respect to proposed § 26.83(a). Proposed § 26.153(g) would require licensees and other entities to provide a memorandum for the record to the HHScertified laboratories that they use to document why the licensee or other entity is using a non-Federal custodyand-control form. Under the HHS Guidelines, laboratories may reject any specimen that is submitted for testing with a non-Federal custody-and-control form unless the licensee or other entity provides a memorandum for the record. The proposed paragraph would be necessary to prevent licensee’s and other entity’s specimens from being rejected. Section 26.155 Laboratory Personnel Proposed § 26.155 [Laboratory personnel] would update current Section 2.5 in Appendix A to Part 26 to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 be consistent with revisions to the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines) published in the Federal Register on April 13, 2004 (69 FR 19643). Proposed § 26.155(a) [Day-to-day management of the HHS-certified laboratory] would amend current Section 2.5(a)(1) in Appendix A to Part 26, which requires the HHS-certified laboratory to have a qualified individual to assume responsibility for day-to-day management of the HHS-certified laboratory. Specifically, the proposed paragraph would replace the term, ‘‘qualified individual,’’ with the term, ‘‘responsible person,’’ for consistency with terminology that other Federal agencies use to refer to this job role. Proposed § 26.155(a) would retain the majority of Section 2.5(a)(2), which establishes qualification requirements for the responsible person. Proposed § 26.155(a)(1)(i)–(a)(1)(iv) would retain current Section 2.5(a)(2)(i)–(a)(2)(iv) in Appendix A to Part 26, with minor grammatical changes that would be consistent with similar changes to the related provisions in the HHS Guidelines. Proposed § 26.155(a)(2) and (a)(3), which establish minimum day-to-day management responsibilities of the responsible person, would retain current Section 2.5(a)(4) and (a)(5) in Appendix A to Part 26. Proposed § 26.155(a)(4) would amend current Section 2.5(a)(5) in Appendix A to Part 26, which relates to the responsible person’s responsibility to maintain the laboratory’s procedures manual. The proposed paragraph would eliminate the current requirement for the procedures to be maintained in a laboratory manual as unnecessarily restrictive. Laboratories would be permitted to use other means to maintain their procedures. The proposed paragraph would retain the current requirements in the second and third sentences of Section 2.5(a)(5) in Appendix A to Part 26, which require the responsible person to review, sign, and date the procedures when they are first placed in use, changed, or a new individual assumes responsibility for management of the laboratory, and maintain copies of them. The current cross-reference to Section 2.7(o) in Appendix A to Part 26 would be updated to reference proposed § 26.157 [Procedures], consistent with the organizational changes made to the rule. Proposed § 26.155(a)(5) and (a)(6) would retain current Section 2.5(a)(6) and (a)(7) in Appendix A to Part 26, which define the responsible person’s responsibilities with respect to PO 00000 Frm 00114 Fmt 4701 Sfmt 4702 maintaining a quality assurance program and taking remedial actions to maintain satisfactory laboratory operations. Proposed § 26.155(b) [Certifying scientist] would amend current Section 2.5(b) in Appendix A to Part 26 to be consistent with changes made to the related requirement in the HHS Guidelines. Consistent with the HHS Guidelines, the proposed rule would provide more detailed requirements with respect to the individual who validates test results at the HHScertified laboratory before they are transmitted to the licensee’s or other entity’s MRO. In proposed § 26.155(b)(1), a new job title, ‘‘certifying scientist,’’ would replace the term, ‘‘qualified individual(s),’’ in the first sentence of current Section 2.5(b) in Appendix A to Part 26 for consistency with a related change in the HHS Guidelines. Proposed § 26.155(b)(2) would specify the required qualifications of individuals who serve as certifying scientists. Proposed § 26.155(b)(3) would permit laboratories to use more than one certifying scientist with differing responsibilities. Proposed § 26.155(c) [Day-to-day operations and supervision of analysts] would retain current Section 2.5(c) in Appendix A to Part 26. The proposed rule would make minor wording changes to the current paragraph to increase the consistency of the wording in this provision with that of the related provision in the HHS Guidelines. Proposed § 26.155(d) [Other personnel] and (e) [Training] would retain current Section 2.5(d) and (e) in Appendix A to Part 26, respectively. Proposed § 26.155(f) [Files] would amend current Section 2.5(f) in Appendix A to Part 26. The proposed revisions would be consistent with related requirements in the HHS Guidelines. The current requirement for records of tests for color blindness would be eliminated, consistent with a similar change to the HHS Guidelines. Tests for color blindness would no longer be necessary because current testing technologies provide means, other than color, for reading test results. Section 26.157 Procedures A new § 26.157 [Procedures] would reorganize and amend requirements for procedures, which are interspersed throughout current Appendix A to Part 26, including requirements contained in current Sections 2.2 and 2.7 in Appendix A to Part 26. The proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve organizational clarity by grouping E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules procedural requirements for HHScertified laboratories in one section. Proposed § 26.157(a) would make minor editorial changes to the first sentence of current Section 2.2 in Appendix A to Part 26, which requires licensee testing facilities and HHScertified laboratories to have detailed procedures for conducting testing. The proposed rule would delete the current reference to blood samples because donors would no longer have the option to request blood testing for alcohol, as discussed with respect to proposed § 26.83(a). Reference to licensee testing facilities would be moved to proposed § 26.127(a) in Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed rule would also delete reference to procedures for specimen collections, because procedural requirements for specimen collections would be relocated to proposed Subpart E [Collecting Specimens for Testing]. Proposed § 26.157(b) would combine and amend portions of the requirements in the first sentence of current Sections 2.4(d) and 2.7(a)(2) in Appendix A to Part 26 related to the content and implementation of specimen chain-ofcustody procedures. The proposed paragraph would retain the portions of the current paragraphs that require HHS-certified laboratories to develop, implement, and maintain written chainof-custody procedures to maintain control and accountability of specimens from receipt through completion of testing and reporting of results, during storage and shipping to another HHScertified laboratory, and continuing until final disposition of the specimens. The current requirements related to licensee testing facilities would be moved to proposed § 26.127(b) in Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed rule would also remove references to custody-and-control procedures for blood specimens because donors would no longer have the option to request blood testing for alcohol, as discussed with respect to proposed § 26.83(a). Proposed § 26.157(c) would amend the portions of current Section 2.7(o)(1) in Appendix A to Part 26 that address the required content of procedures for HHS-certified laboratories. The proposed paragraph would retain the portions of the current provision that require laboratories to develop and maintain procedures to specify all of the elements of the testing process, including, but not limited to, the principles of each test and the preparation of reagents, standards, and controls. The proposed paragraph would present the required topics of the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 procedures in a list format in proposed § 26.157(c)(1)–(c)(12) to clarify that each topic stands on its own. The proposed paragraph would eliminate the current requirement for the procedures to be maintained in a laboratory manual, which is unnecessarily restrictive. HHScertified laboratories would be permitted to use other means to maintain their procedures. For organizational clarity, two portions of the current provision would be moved to other subparts of the proposed rule that address related topics. Requirements for licensee testing facility procedures would be moved to § 26.127(c) in proposed Subpart F [Licensee Testing Facilities]. In addition, the proposed rule would move the last two sentences of current Section 2.7(o)(1), which specify records retention requirements, to § 26.215(b)(4) of proposed Subpart J [Recordkeeping and Reporting Requirements]. Proposed § 26.157(d) would amend current Section 2.7(o)(3)(iii) in Appendix A to Part 26, which requires procedures for the setup and normal operation of testing instruments; a schedule for checking critical operating characteristics for all instruments; tolerance limits for acceptable function checks; and instructions for major troubleshooting and repair. The proposed rule would make three changes to the current provision for organizational clarity. The proposed paragraph would present the required topics of the procedures in a list format in proposed § 26.157(d)(1)–(d)(3) to clarify that each topic stands on its own. The current requirement to maintain records of preventative maintenance would be relocated to proposed § 26.215(b)(10) in Subpart J [Recordkeeping and Reporting Requirements]. And, the current requirements that apply to licensee testing facilities would be moved to § 26.127(d) in proposed Subpart F [Licensee Testing Facilities]. Proposed § 26.157(e) would amend current Section 2.7(o)(4) in Appendix A to Part 26, which requires documented corrective actions if systems are out of acceptable limits or errors are detected. The requirements in the current paragraph that apply to licensee testing facilities would be moved to § 26.127(e) in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. Section 26.159 Assuring Specimen Security, Chain of Custody, and Preservation Proposed § 26.159 [Assuring specimen security, chain of custody, and preservation] would be added to present in one section the requirements PO 00000 Frm 00115 Fmt 4701 Sfmt 4702 50555 of the proposed rule that apply to HHScertified laboratories with respect to the safeguarding of specimen identity, integrity, and security. The proposed organizational change would be made because requirements that address these topics are dispersed throughout the current rule and grouping them together in a single section would make them easier to locate. Proposed § 26.159(a) would amend current Section 2.7(a)(1) in Appendix A to Part 26. Proposed § 26.159(a) would retain the first three sentences of current Section 2.7(a)(1) in Appendix A to Part 26, which require HHS-certified laboratories to be secure and accessible only to authorized personnel. For organizational clarity, the requirements that apply to licensee testing facilities would be moved to proposed § 26.129(a) in Subpart F [Licensee Testing Facilities], and the last sentence of the current paragraph, which establishes recordkeeping requirements, would be moved to § 26.215(b)(13) in proposed Subpart J [Recordkeeping and Reporting Requirements]. In addition, the last sentence of the proposed paragraph would be revised for increased clarity in the requirement and would expand the list of persons who would be authorized to have access to the laboratory to include representatives of the Secretary of the Department of Health and Human Services and emergency responders. This proposed change would be made for consistency with the related provision in the HHS Guidelines. Proposed § 26.159(b) would amend current Section 2.7(b)(1) in Appendix A to Part 26, which establishes requirements for receiving specimens at the HHS-certified laboratory and assuring their integrity and identity. The proposed rule would retain the existing requirement for the HHS-certified laboratory to report evidence of tampering to licensees’ or other entities’ management within 24 hours of discovery, as well as the requirement for the laboratory to document any evidence of tampering on the specimen’s custody-and-control form. The proposed rule would move the current requirements related to licensee testing facilities to § 26.129(b) in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. Several requirements would also be added to the proposed paragraph. The proposed paragraph would require licensee or other entity management personnel to ensure that an investigation is initiated if any indications of specimen tampering are identified, and take corrective actions if tampering is confirmed. The appropriate corrective actions would depend upon E:\FR\FM\26AUP2.SGM 26AUP2 50556 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules the nature of the tampering identified as a result of the investigation. For example, if the investigation indicated that the tampering was an attempt to subvert the testing process and the persons involved were identified, licensee and other entity management personnel would impose the sanctions in proposed § 26.75(b) for a subversion attempt. The proposed paragraph would also require the licensee, other entity, or HHS-certified laboratory to correct any systematic weaknesses in specimen custody-and-control procedures that may be identified in the investigation, such as inadequate safeguarding of specimen shipping containers. The proposed rule would add this provision because some licensees have not investigated or taken corrective actions in response to indications of tampering with specimens under the current rule. The proposed paragraph would also prohibit testing specimens if there is a reason to believe that the specimens have been altered in such a manner as to affect specimen identity and integrity. In these circumstances, the proposed rule would require the licensee or other entity to collect another specimen from the donors. Although the NRC is not aware of any instances in which such circumstances have arisen in Part 26 programs, the experience of other Federal agencies indicates such tampering is possible. Therefore, the proposed requirement would ensure that individuals would not be subject to sanctions for a non-negative test result from a specimen that may not have been theirs. The proposed change would meet Goal 7 of this rulemaking, which is to protect the due process rights of individuals who are subject to Part 26. The additional provision would also be consistent with the requirements of other Federal agencies. Proposed § 26.159(c) would update and combine current Section 2.7(b)(2) with portions of current Sections 2.9(n) and 3.1 in Appendix A to Part 26, which establish requirements for chain-ofcustody procedures for specimens and aliquots at licensee testing facilities and HHS-certified laboratories. The proposed rule would move the requirements in the current paragraphs that are related to licensee testing facilities to § 26.129(c) in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. Proposed § 26.159(c) would also include the requirements in current Sections 2.9(n) and 3.1 in Appendix A to Part 26, which require the laboratory to maintain the original specimen and custody-andcontrol form in secure storage at the HHS-certified laboratory. The proposed changes would be made to reduce VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 redundancies and improve the organization clarity of the rule. Proposed § 26.159(d) and (e) would update the portions of current Section 2.7(a)(2) in Appendix A to Part 26 that establish requirements for HHS-certified laboratory personnel to maintain and document the chain of custody for specimens and aliquots, by replacing the current paragraph with two related provisions from the HHS Guidelines. Proposed paragraph (d) in this section would require the laboratory’s internal custody-and-control form to allow for identification of the donor, and documentation of the testing process and transfers of custody of the specimen. The phrase, ‘‘within the laboratory,’’ would be added to proposed paragraph (e) to clarify that the requirement to document each instance of the handling and transfer of specimens applies to internal laboratory activities and does not apply to transfers involving couriers. The proposed rule would relocate the requirements in the current paragraph that are related to licensee testing facilities to § 26.129(d) and (e) in proposed Subpart G [Laboratories Certified by the Department of Health and Human Services] for organizational clarity. Proposed § 26.159(f) and (g) would separate current Section 2.4(i) in Appendix A to Part 26 into two paragraphs, for the reasons discussed with respect to the similar provisions of proposed § 26.117(i) and (k) and § 26.129(g) and (h). The proposed paragraphs would repeat the requirements for packaging and shipping non-negative specimens that would be presented in proposed § 26.117(i) and (k) of Subpart E [Collecting specimens for testing] and § 26.129(g) and (h) in Subpart F [Licensee Testing Facilities], but apply them to packaging and shipping specimens from one HHS-certified laboratory to another. The bases for these requirements are discussed with respect to proposed § 26.117(i) and (k). Proposed § 26.159(h) [Short-term refrigerated storage] would replace current Section 2.7(c) in Appendix A to Part 26, which establishes requirements for refrigerating urine specimens at the HHS-certified laboratory and licensee testing facility to protect them from degradation. The proposed rule would replace the current paragraph with the simplified language of the related provision in the HHS Guidelines. Requirements related to short-term refrigerated storage at licensee testing facilities would be moved to § 26.129(f) in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. PO 00000 Frm 00116 Fmt 4701 Sfmt 4702 Proposed § 26.159(i) [Long-term storage] would amend current Section 2.7(h) in Appendix A to Part 26, which establishes requirements for long-term frozen storage of positive urine specimens at HHS-certified laboratories and licensee testing facilities. Requirements related to long-term storage of specimens by licensee testing facilities would be moved to proposed § 26.135(c) in Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed paragraph would add requirements for storing specimens that yield non-negative validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The reference to ‘‘administrative or disciplinary proceedings’’ in the first sentence of the current paragraph would be eliminated because there are other circumstances in which it may be necessary to have a specimen available for retesting, including, but not limited to, retesting an aliquot of an invalid specimen at a second HHS-certified laboratory under proposed § 26.161(g) [Additional testing by a second laboratory]. The proposed rule would also update the terminology used in the current paragraph by adding a reference to ‘‘Bottle B’’ of a split specimen and replacing the term, ‘‘positive,’’ with the term, ‘‘nonnegative,’’ to be consistent with the new terminology adopted throughout the proposed rule. As discussed with respect to proposed § 26.5 [Definitions], these proposed changes in terminology would be made to improve clarity in the language of the proposed rule. Proposed § 26.159(j) would be added to incorporate related changes to the HHS Guidelines. The proposed paragraph would permit the HHScertified laboratory to discard negative specimens. The proposed paragraph also would permit laboratories to pool specimens that are certified to be negative for drugs and drug metabolites and valid, as well as use them as quality control samples, as permitted under the HHS Guidelines. Section 26.161 Cutoff Levels for Validity Testing A new § 26.161 [Cutoff levels for validity testing] would be added to establish maximum cutoff levels and methods for conducting specimen validity testing at HHS-certified laboratories, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed rule would incorporate these E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules requirements from the HHS Guidelines as revised on April 13, 2004 (69 FR 19644) to meet, in part, Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.161(a) [Validity test results] would be added to specify that laboratories must conduct initial and confirmatory validity testing using two different aliquots of a urine specimen. Proposed § 26.161(b) [Initial validity testing] would be added to establish requirements and cutoff levels for initial validity tests to be performed at HHScertified laboratories. Proposed § 26.161(b)(1)–(b)(6) would establish requirements for validity tests that HHS-certified laboratories must conduct on a primary specimen, which would be either a single specimen submitted by an FFD program that does not follow split specimen procedures, or the specimen contained in Bottle A of a split specimen. For initial validity tests of each specimen, HHS-certified laboratories would determine the creatinine concentration of each specimen in proposed § 26.161(b)(1)(i). If the creatinine concentration is less than 20 mg/dL, the laboratory would determine the specimen’s specific gravity in proposed § 26.161(b)(1)(ii). Proposed § 26.161(b)(1)(iii) would require the laboratory to determine each specimen’s pH. Proposed § 26.161(b)(1)(iv) would require the laboratory to test the specimen for the presence of oxidizing adulterants, and proposed § 26.161(b)(1)(v) would require additional validity testing, depending upon the characteristics of the specimen. Proposed § 26.161(b)(2)(i)–(b)(2)(ix) would establish the criteria for determining whether a specimen must be subject to confirmatory validity testing. Proposed § 26.161(c) [Results indicating an adulterated specimen] would be added to establish criteria for HHS-certified laboratories to apply in determining whether to report to a licensee’s or other entity’s MRO that a specimen is adulterated. Proposed § 26.161(c)(1)–(c)(7) would specify results from initial and confirmatory validity testing that would indicate that a specimen is adulterated. The proposed paragraphs would also specify the appropriate testing devices and instruments to be used for initial and confirmatory validity tests. In general, the proposed paragraphs would require the HHS-certified laboratory to report to the MRO that a urine specimen is adulterated if it meets any one of the following criteria: (1) It is confirmed to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 contain a substance that should not be present at all in normal human urine; (2) it is confirmed to contain a substance which, although it could be present in normal human urine, is found to be at a concentration that appears to be completely inconsistent with human physiology; or (3) it presents an acid/ base balance (pH) that appears to be inconsistent with human life. The proposed paragraphs would address several substances that some donors have used to try to defeat drug tests through ‘‘in vitro’’ contamination (i.e., adding the substance to a urine specimen). These adulterants include substances that create a urine pH inconsistent with human life, oxidizing adulterants, chromium (VI), halogens, glutaraldehyde, pyridine, and surfactants. These substances, when either placed into an already voided urine or used in place of a urine specimen, generally either attempt to defeat the chemistry of the test or destroy a drug that is present. The NRC recognizes that this list will be updated and/or modified as new substances and formulas are introduced, and as the HHS-certified laboratories develop methods to detect them. Proposed § 26.131(c)(8) would recognize that new adulterants will be found and, therefore, would require HHS-certified laboratories to use appropriate testing methods when conducting initial and confirmatory testing for new adulterants for which cutoff levels and criteria have not yet been established. Proposed § 26.161(d) [Results indicating a substituted specimen] and (e) [Results indicating a dilute specimen] would establish cutoff levels and criteria for a determination by the laboratory that a specimen has been substituted or is dilute, respectively. In proposed § 26.161(d), the HHS-certified laboratory would report to the MRO that a specimen is substituted if it contains less than 2 mg/dL of creatinine and the specific gravity is less than or equal to 1.001 or equal to or greater than 1.020. These low creatinine concentrations combined with the highly skewed specific gravity values indicate that the specimen is not human urine. In proposed § 26.161(e), the HHS-certified laboratory would be required to report to the MRO that a specimen is dilute if it contains 2–20 mg/dL of creatinine and has a specific gravity of less than or equal to 1.001 or equal to or greater than 1.020. Proposed § 26.161(f)(1)–(f)(10) [Results indicating an invalid specimen] would be added to establish the criteria that HHS-certified laboratories would apply when determining that a specimen is invalid. In 1998, HHS PO 00000 Frm 00117 Fmt 4701 Sfmt 4702 50557 established criteria for what were termed ‘‘unsuitable’’ specimens (Program Document 35, September 28, 1998). An unsuitable specimen was defined as one that contained an interfering substance but the laboratory could not determine the nature of the substance with scientific certainty. In these circumstances, the laboratory could not achieve a ‘‘valid’’ test result. The HHS recognized that in some cases, an interfering substance could be a legitimately ingested medication (some non-steroidal anti-inflammatories have been known to interfere with the chemistry of some of the initial tests). However, it was also recognized that many of these problem specimens actually contained an adulterant which the laboratory could not specifically identify with scientific certainty (the requirement for reporting a specimen as adulterated). Therefore, the HHS adopted the term, ‘‘invalid specimen,’’ to mean that the laboratory has determined that valid test results cannot be obtained from a specimen or an unknown substance interfered with the confirmatory test. The proposed rule would adopt the term, ‘‘invalid specimen,’’ with the same meaning. Proposed § 26.161(g) [Additional testing by a second laboratory] would be added to address circumstances in which an HHS-certified laboratory suspects that a specimen is adulterated but cannot identify the adulterant. The proposed paragraph would permit the laboratory to transfer the specimen to a second HHS-certified laboratory for additional testing, if the first HHScertified laboratory cannot identify a possible adulterant in the specimen using their standard testing technologies and the licensee’s or other entity’s MRO concurs with the additional testing. Personnel at the first HHS-certified laboratory would consult with the licensee’s or other entity’s MRO to determine whether to transfer the specimen to a second laboratory for additional testing. Proposed § 26.161(h) [More stringent validity test cutoff levels are prohibited] would be added to prohibit licensees and other entities from requiring an HHS-certified laboratory to apply validity testing cutoff levels and criteria that are more stringent than those specified in this proposed section. Because validity testing is complex and the methods for testing are relatively new, the proposed rule would not permit an FFD program to establish more stringent cutoff levels for validity testing. The proposed prohibition would be necessary to decrease the risk of obtaining false non-negative test results and ensure that donors are not subject E:\FR\FM\26AUP2.SGM 26AUP2 50558 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules to sanctions on the basis of inaccurate test results. Section 26.163 Cutoff Levels for Drugs and Drug Metabolites Proposed § 26.163 [Cutoff levels for drugs and drug metabolites] would group together in one section, for organizational clarity, the proposed requirements for conducting initial and confirmatory tests for drugs and drug metabolites at HHS-certified laboratories. The proposed section would also update requirements related to cutoff levels for drugs and drug metabolites in the current rule to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.163(a) [Initial drug testing] would amend current Section 2.7(e) in Appendix A to Part 26. When determining whether to report to the MRO that a specimen is positive for drug(s) or drug metabolite(s), proposed § 26.163(a)(1) would require HHScertified laboratories to apply the same cutoff levels that licensee testing facilities would be required to use in proposed § 26.133 [Cutoff levels for drugs and drug metabolites], except if the FFD program specifies more stringent cutoff levels or the specimen is dilute, as discussed further with respect to proposed § 26.163(a)(2). The proposed paragraph would reiterate the current permission for licensees and other entities to establish lower cutoff levels. In addition, proposed § 26.163(a)(1) would decrease the initial test cutoff level for marijuana metabolites from 100 nanograms (ng) per milliliter (mL) to 50 ng/mL and increase the initial test cutoff level for opiate metabolites from 300 ng/mL to 2,000 ng/mL for the reasons discussed with respect to proposed § 26.133. The proposed changes would be consistent with the HHS cutoff levels for the same substances. Proposed § 26.163(a)(2) would be added to establish requirements and criteria for the initial drug testing of any specimen that confirmatory validity testing indicates is dilute. Although there are many legitimate reasons that a donor may provide a urine specimen that is dilute, dilution is also a method used to subvert the testing process. Dilution of a specimen decreases the concentration of any drugs or drug metabolites in the specimen. Dilution may decrease the concentration sufficiently that applying the cutoff levels specified in this part, or a licensee’s or other entity’s more stringent cutoff levels, would provide false negative drug test results. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Therefore, the proposed rule would add special testing procedures and criteria for determining which dilute specimens must be subject to confirmatory drug testing. The proposed paragraph would require HHS-certified laboratories to conduct initial drug testing of dilute specimens using FDA-approved analytical kits that have the lowest concentration levels available for the initial testing technologies used. If responses from the dilute specimen on the initial drug test are within 50 percent of the established cutoff level for the drug or drug metabolite, the proposed rule would require the HHScertified laboratory to report this result to the licensee’s or other entity’s MRO. If the FFD program’s policy specifies this requirement, the proposed rule would permit the MRO to direct the HHS-certified laboratory to test the specimen at the confirmatory assay’s LOD for that drug or drug class and report the results to the MRO. This special processing of dilute specimens would increase the likelihood that any drugs and drug metabolites in the specimen would be detected. Therefore, this proposed requirement would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by increasing the likelihood that testing of dilute specimens would reveal drug use, if the donor had engaged in substance abuse. As discussed with respect to proposed § 26.133 [Cutoff levels for drugs and drug metabolites], the proposed rule would eliminate the requirement in the last sentence of current Section 2.7(e)(1) for HHS-certified laboratories to report drug test results for both the cutoff levels in the rule and any more stringent cutoff levels that the licensee or other entity may establish. The basis for the current requirement to report test results for the cutoff levels specified in this part, when the licensee is using more stringent cutoff levels, was a means by which the NRC monitored implementation of the permission to use more stringent cutoff levels. The proposed rule would eliminate this requirement, because proposed § 26.31(d)(3)(iii)(C) would require a qualified forensic toxicologist to certify the scientific and technical validity of any testing at lower cutoff levels. Therefore, the current reporting requirement is no longer needed to assure laboratory performance in this area. Eliminating this requirement would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. PO 00000 Frm 00118 Fmt 4701 Sfmt 4702 The proposed rule would also eliminate current Section 2.7(e)(2), which states that the list of substances and cutoff levels contained in Appendix A to Part 26 are subject to change by the NRC. At the time the current rule was published, the NRC expected to be able to amend the list of substances and cutoff levels in Appendix A to Part 26 without additional rulemaking. However, the NRC has determined that rulemaking is required to make such changes. Therefore, the proposed rule would delete this paragraph because it is unnecessary. The proposed rule would replace current Section 2.7(f) in Appendix A to Part 26, which establishes cutoff levels and requirements related to confirmatory testing for drugs and drug metabolites at the HHS-certified laboratory, with proposed § 26.163(b) [Confirmatory drug testing]. The proposed rule would also make a number of changes to the current paragraph. The proposed rule would move current Section 2.7(f)(1) in Appendix A to Part 26 to proposed § 26.169(b). Current Section 2.7(f)(1) requires the HHS-certified laboratory to report to the MRO that test results are negative for any specimens that yield negative test results when they are subjected to confirmatory testing. This requirement would be moved to proposed § 26.169(b) for organizational clarity because proposed § 26.169 [Reporting results] addresses the topic of reporting test results by the HHS-certified laboratory to the MRO. The proposed rule would also eliminate the requirement in current Section 2.7(f)(1) in Appendix A to Part 26 that the laboratory must conduct confirmatory testing using both the maximum cutoff values established in Part 26 as well as any more stringent cutoff levels adopted by the licensee’s or other entity’s FFD program. The current requirement to conduct testing for the cutoff levels specified in this part, when the licensee is using more stringent cutoff levels, was a means by which the NRC monitored implementation of the permission to use more stringent cutoff levels. The proposed rule would eliminate this requirement, because proposed § 26.31(d)(3)(iii)(C) would require a qualified forensic toxicologist to certify the scientific and technical validity of any testing at lower cutoff levels. Therefore, the requirement to test at both cutoff levels would no longer be needed to assure laboratory performance in this area. For organizational clarity, the requirement in the first sentence of current Section 2.7(f)(2) in Appendix A E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules to Part 26 that the laboratory must use GC/MS techniques for confirmatory testing would be moved to proposed § 26.167(e)(1) [Quality control requirements for performing confirmatory drug tests], which would establish quality control requirements for conducting confirmatory drug tests. The proposed rule would eliminate current Section 2.7(f)(3) in Appendix A to Part 26, which requires HHS-certified laboratories to use GC analysis of blood specimens in testing for alcohol, and the confirmatory alcohol cutoff level in current Section 2.7(f)(1) in Appendix A to Part 26. These provisions would be eliminated because the proposed rule would no longer permit donors to request confirmatory testing of a blood specimen for alcohol, as discussed with respect to proposed § 26.83(a). In addition, the proposed rule would eliminate current Section 2.7(f)(4) in Appendix A to Part 26 for the same reasons discussed with respect to current Section 2.7(e)(2) in Appendix A to Part 26. Proposed § 26.163(b)(1) would amend several of the cutoff levels in current Section 2.7(f)(1) in Appendix A to Part 26 that the HHS-certified laboratory uses to determine that a confirmatory drug test result is positive. The proposed rule would increase the confirmatory test cutoff levels for morphine and codeine to 2,000 ng/mL. This proposed change in the cutoff levels for opiate metabolites would substantially reduce the number of positive opiate test results that are reported to MROs by HHS-certified laboratories that MROs ultimately verify as negative and would be consistent with the opiate cutoff levels contained in the HHS Guidelines. Proposed § 26.163(b)(1) would also amend two of the testing procedures in current Section 2.7(f) in Appendix A to Part 26. The proposed rule would amend Section 2.7(f)(5) in Appendix A to Part 26, which requires the laboratory to test for 6-acetylmorphine (6–AM) if a specimen tests positive for opiates on the initial drug test. The proposed rule would require the HHS-certified laboratory to test for 6–AM, if test results for morphine are at or above the 2,000 ng/mL opiate cutoff levels, and establish a cutoff level of 10 ng/mL for determining that a specimen is positive for 6–AM. In addition, proposed § 26.163(b)(1) would add a requirement that a specimen must contain amphetamine at a concentration equal to or greater than 200 ng/mL in order for the HHS-certified laboratory to report to the MRO that the specimen has yielded a positive test result for methamphetamine. These proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 changes would be made for consistency with the related provisions in the HHS Guidelines. Proposed § 26.163(b)(1) would update the terminology used in current Section 2.7(f)(1) in Appendix A to Part 26. As discussed with respect to proposed § 26.5 [Definitions], the proposed paragraph would replace the term, ‘‘presumptive positive,’’ with the phrase, ‘‘positive on an initial drug test,’’ to increase clarity in the language of the rule. Proposed § 26.163(b)(2) would amend the second sentence of current Section 2.7(f) in Appendix A to Part 26, which requires the HHS-certified laboratory to document drug and drug metabolite concentrations that exceed the linear region of the standard curve in the laboratory record. The proposed rule would replace the current sentence with a new paragraph that incorporates the related provision from the HHS Guidelines. The HHS Guidelines permit the laboratory to dilute an aliquot of the specimen to obtain an accurate quantitative result when the concentration is above the upper limit of the linear range. This proposed change would be made to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Section 26.165 Testing Split Specimens and Retesting Single Specimens A new § 26.165 [Split specimens] would reorganize and amend the requirements currently found in § 26.24(f), and Section 2.7(i) and (j) in Appendix A to Part 26 that are related to testing split specimens and retesting specimens at HHS-certified laboratories. These requirements would be presented together in a single section to make them easier to locate in the proposed rule for organizational clarity. The proposed section would also add several new requirements. Proposed § 26.165(a) [Split specimens] would combine and amend current § 26.24(f) and Section 2.7(j) in Appendix A to Part 26, which establish requirements for HHS-certified laboratories when testing split specimens. The proposed paragraph would use the terms, ‘‘Bottle A’’ and ‘‘Bottle B,’’ to refer to the primary and split specimens, respectively, for consistency with the updated terminology used throughout the proposed rule. The proposed paragraph would also require specimen validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as PO 00000 Frm 00119 Fmt 4701 Sfmt 4702 50559 discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.165(a)(1) would retain the portions of current Section 2.7(j) in Appendix A to Part 26 that require the HHS-certified laboratory to analyze the primary specimen of a split specimen. The current requirements that relate to licensee testing facilities would be moved to § 26.135 [Split specimens] in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed paragraph would retain the requirement that the primary specimen (Bottle A) must be subject to initial testing by the HHS-certified laboratory, and confirmatory testing, if the specimen yields non-negative results from initial testing. The proposed paragraph would specify that the HHScertified laboratory must conduct validity tests on the specimen contained in Bottle A, as well as drug tests, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.165(a)(2) would retain the portion of the second sentence of current § 26.24(f) that requires the HHScertified laboratory to perform initial and confirmatory tests, if required, on the specimen in Bottle A if any initial test results from a licensee testing facility are non-negative. This requirement would be moved to the proposed section for organizational clarity. In addition, the term, ‘‘positive,’’ in the current sentence would be replaced with the term, ‘‘non-negative,’’ to indicate that the HHS-certified laboratory must conduct confirmatory testing of any specimens that yield nonnegative initial validity or drug test results at the licensee testing facility, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.165(a)(3) would retain the permission in the second sentence of current Section 2.7(j) in Appendix A to Part 26 for licensees and other entities to retain custody of the split specimen in Bottle B or forward it with Bottle A to the HHS-certified laboratory for storage until testing of Bottle A is completed. The proposed paragraph would also retain the current permission for the specimen in Bottle B to be discarded if test results from the HHS-certified laboratory are negative. Proposed § 26.165(a)(4) would amend the requirements in current Section 2.7(j) in Appendix A to Part 26, as they relate to donor requests to test the specimen in Bottle B. The proposed E:\FR\FM\26AUP2.SGM 26AUP2 50560 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules paragraph would add non-negative validity test results as a basis for a donor request for testing the specimen in Bottle B, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed paragraph would also add a requirement that the donor must request testing of the Bottle B specimen within 3 business days after notification by the MRO that the specimen in Bottle A has yielded nonnegative test results. Since 1994, the HHS Guidelines have allowed up to 72 hours for a donor to make this request, so the proposed change would increase the consistency of Part 26 with the HHS Guidelines. The proposed paragraph would also require the donor to provide written permission to the licensee or other entity for testing of the specimen contained in Bottle B and clarify that only the donor may authorize testing of Bottle B. At the public meetings discussed in Section V, stakeholders indicated that the proposed requirement for a written request from donors would impose a substantial logistical burden on donors who may not be working on site when contacted by the MRO. However, the NRC believes that the proposed requirement is necessary to ensure that the donor’s right to privacy and control of the specimen is protected, consistent with Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.165(a)(5) would require the HHS-certified laboratory to forward Bottle B to a second HHS-certified laboratory for testing within one business day of the donor’s request for testing. The proposed paragraph would eliminate the requirement in the fourth sentence of current Section 2.7(j) in Appendix A to Part 26, which requires that the split specimen must be forwarded to another HHS-certified laboratory for testing on the same day of the donor request. The proposed change would respond to stakeholder feedback during the public meetings discussed in Section V. The stakeholders reported that implementing the same-day requirement has often been difficult for a number of reasons, including, for example, communication delays among donors, MROs, the HHS-certified laboratories, and FFD program personnel, particularly on weekends and holidays, and the time required to identify a second laboratory with the appropriate capability to test the split specimen, depending upon the nature of the non-negative test result. The proposed change would alleviate some VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 of these types of logistical difficulties (e.g., logistical problems associated with weekends and holidays) while continuing to provide the donor with timely test results. Therefore, this proposed change would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. Proposed § 26.165(a)(6) would retain the last sentence of current Section 2.7(j) in Appendix A to Part 26, which requires the second HHS-certified laboratory to provide quantitative test results from Bottle B to the MRO, who would provide them to the donor. The proposed paragraph would adopt the simpler language from the related provision in the HHS Guidelines, consistent with Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. Proposed § 26.165(b) [Donor request to MRO for a retest of a single specimen] would be added to permit donors to request retesting of an aliquot from a single specimen, if the FFD program does not follow split specimen procedures. The proposed paragraph would assure that donors who are subject to a program that does not follow split specimen procedures have the right to request additional testing. The proposed change would be consistent with related provisions in the HHS Guidelines. However, in order to have sufficient urine to support retesting, the proposed paragraph would apply only if the donor had submitted a specimen of 30 mL or more. Specimens that the HHS-certified laboratory determines to be invalid would not be eligible for retesting because of the risk of damage to laboratory equipment that some invalid specimens may pose and because retesting the specimen would not provide useful information. The proposed procedures for requesting and conducting the retest of a single specimen would be consistent with those for requesting and conducting tests on the specimen in Bottle B of a split specimen. Proposed § 26.165(c) [Retesting a specimen for drugs] would amend current Section 2.7(i) in Appendix A to Part 26, which specifies that retesting of a specimen is not subject to cutoff requirements. The proposed paragraph would update and expand current requirements for retesting a single specimen or Bottle B of a split specimen for drugs and drug metabolites to be consistent with the related provisions in the HHS Guidelines, as follows: Proposed § 26.165(c)(1) would be added to require the second HHScertified laboratory to use the PO 00000 Frm 00120 Fmt 4701 Sfmt 4702 laboratory’s standard confirmatory test for the drug or drug metabolite for which the specimen tested positive at the first laboratory. Initial tests, and tests for other drugs or drug metabolites, would not be performed, consistent with the related requirements in the HHS Guidelines. Proposed § 26.165(c)(2) would amend current Section 2.7(i) in Appendix A to Part 26, which specifies that retesting of a specimen is not subject to cutoff requirements. The proposed paragraph would retain the requirement for the second HHS-certified laboratory to provide data sufficient to confirm the presence of the drug(s) or drug metabolite(s) and add permission to test the specimen down to the assay’s LOD. Adding permission to test down to the assay’s LOD would be consistent with the related requirement in the HHS Guidelines and would ensure that the second laboratory’s testing is as sensitive to the presence of the drug(s) or drug metabolite(s) as scientifically and legally defensible. Proposed § 26.165(c)(3) would be added to require the second laboratory to attempt to determine the reason if retesting fails to confirm the presence of the drug(s) or drug metabolite(s) that was identified by the first HHS-certified laboratory. The proposed paragraph would require the second laboratory to conduct specimen validity testing if the second laboratory fails to reconfirm the first laboratory’s findings, consistent with the related requirements in the HHS Guidelines. Proposed § 26.165(c)(4) would retain the requirement in the last sentence of current Section 2.7(j) in Appendix A to Part 26 that requires the second laboratory to report the test results to the MRO. The proposed rule would extend this requirement to retesting of a single specimen, consistent with the explicit permission added in proposed § 26.165(b) for a donor to request retesting of a single specimen, if the FFD program does not follow split specimen procedures. The proposed requirement would be consistent with the related requirements in the HHS Guidelines. Proposed § 26.165(d) [Retesting a specimen for adulterants] and (e) [Retesting a specimen for substitution] would be added to incorporate related requirements in the HHS Guidelines for performing retests for adulterants and substituted specimens at a second HHScertified laboratory. Retesting for adulterants would be limited to conducting confirmatory testing only for the adulterant(s) identified by the first laboratory. Retesting for specimen substitution would be limited to E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules conducting confirmatory testing only for creatinine and specific gravity. These proposed limitations would be consistent with limitations on retesting specimens for drugs and drug metabolites. Proposed § 26.165(f) [Management actions and sanctions] would be added to specify the actions that licensees and other entities must take when a donor requests a retest of a single specimen or testing of Bottle B of a split specimen. The proposed paragraph would respond to stakeholder comments at the public meetings discussed in Section V. The stakeholders noted that the current rule does not address required management actions when an individual has had a confirmed non-negative test result and requests a retest of a single specimen or Bottle B of a split specimen. Therefore, the proposed paragraph would be added to establish such requirements. Proposed § 26.165(f)(1) would be added to address circumstances in which the MRO has confirmed a nonnegative test result from the HHScertified laboratory as a violation of the licensee’s or other entity’s FFD policy and the donor requests a retest of a single specimen or testing of the specimen in Bottle B. The proposed paragraph would require the licensee or other entity to take the same actions in response to the confirmed non-negative test result(s) from the first HHS-certified laboratory as the actions that licensees and other entities would be permitted to take under proposed § 26.75(i) in response to a positive drug test result for marijuana or cocaine from initial testing at a licensee testing facility. That is, proposed § 26.165(f) would require the licensee or other entity to administratively withdraw the donor’s authorization until the test results from the second HHS-certified laboratory have been reported to and reviewed by the MRO. If the test results from the second laboratory confirm any nonnegative test results from the first HHScertified laboratory, the proposed paragraph would require the licensee or other entity to impose the appropriate sanctions that are specified in proposed Subpart D [Management actions and sanctions] for the non-negative test results that were confirmed by the second laboratory. If the test results from the second laboratory do not confirm any non-negative test results, the proposed rule would (1) prohibit the licensee or other entity from imposing any sanctions on the individual; (2) require the licensee or other entity to eliminate any records of the first confirmed non-negative test results; and (3) require the licensee or other entity to inform the donor, in writing, that the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 records have been expunged and that he or she need not disclose the temporary administrative action to any other licensee or entity. These proposed requirements would protect public health and safety and the common defense and security by ensuring that an individual whose fitness for duty is questionable does not perform any duties or have the types of access that require the individual to be subject to this part, while protecting the donor’s right to due process. Proposed § 26.165(f)(2) would be added to address the unlikely circumstances in which a donor requests retesting of a single specimen or testing Bottle B of a split specimen, but the testing cannot be performed because the single specimen or Bottle B is no longer available due to causes that are outside of the donor’s control. These causes could include, for example, an insufficient quantity of urine in the single specimen to permit retesting, either Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory, or Bottle B has been misplaced. The proposed paragraph would require the MRO to cancel the original test result, prohibit the licensee or other entity from imposing any sanctions on the donor, and require the licensee or other entity to ensure that any records are expunged that could link the donor to the original non-negative test result and the administrative action required under proposed § 26.165(f)(1). The proposed paragraph would require the licensee or other entity to document that the test was performed and cancelled, if the original specimen was collected for random, for-cause, or post-event testing. However, the MRO would direct the licensee or other entity to collect another specimen from the donor as soon as reasonably practical, if the original specimen was collected for preaccess or followup testing. The proposed paragraph would not require a second collection for a random test because a second collection could not satisfy the requirements for random testing [i.e., the donor would not have the same probability of being selected for testing as all other donors who are subject to the FFD program, as required under proposed § 26.31(c)(iv)]. The proposed rule also would not require a second collection when the original test was conducted for cause or post event because test results from a second collection could not accurately measure the presence of drugs or drug metabolites under the conditions that required the original collection due to the passage of time. The proposed paragraph would require a second PO 00000 Frm 00121 Fmt 4701 Sfmt 4702 50561 collection as soon as reasonably practical for pre-access and followup testing because other provisions of the proposed regulation (see proposed Subpart C [Granting and Maintaining Authorization]) require negative test results in order for the licensee or other entity to grant or maintain the donor’s authorization. The last sentence of proposed § 26.165(f)(2) would require the licensee or other entity to impose the appropriate sanctions, as specified in proposed Subpart D [Management actions and sanctions], if the results of testing the specimen from a second collection are non-negative and confirmed by the MRO to be an FFD policy violation. However, the proposed rule would prohibit the licensee or other entity from considering the results of testing the original specimen when imposing sanctions because the donor was (inadvertently) denied his or her right to due process in this case. The new requirements in proposed § 26.165(f) would be generally consistent with related requirements in the HHS Guidelines. The differences from the HHS Guidelines’ requirements in the proposed rule would be variations in the terminology used to adapt the language for the NRC’s purposes and the addition of crossreferences to other portions of the proposed rule. Section 26.167 Quality Assurance and Quality Control Proposed § 26.167 [Quality assurance and quality control] would update current Section 2.8 in Appendix A to Part 26, which establishes quality assurance and quality control requirements for drug testing at HHScertified laboratories. The proposed section would provide more detailed requirements for the quality assurance and quality control programs of HHScertified laboratories for consistency with related provisions in the HHS Guidelines, and add new requirements for validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.167(a) [Quality assurance program] would amend and combine current Section 2.8(a) and the last two sentences of Section 2.8(d) in Appendix A to Part 26, which require HHS-certified laboratories and licensee testing facilities to have quality assurance programs. For increased clarity in the language of the rule, the proposed rule would replace the term, ‘‘specimen acquisition,’’ with the term, ‘‘specimen accessioning,’’ in the first E:\FR\FM\26AUP2.SGM 26AUP2 50562 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules sentence of current Section 2.8(a), which is the more accurate term. The proposed rule would also add a requirement for the quality assurance program to encompass the certification of calibrators and controls to ensure that calibrators and controls are accurate, which would be consistent with the related provision in the HHS Guidelines. In addition, the proposed rule would move to proposed § 26.167(a) and amend the requirements in the last two sentences of current Section 2.8(d) in Appendix A to Part 26, which require that the linearity and precision of testing methods used must be periodically documented as well as the procedures to ensure that carryover does not contaminate a donor’s specimen. The proposed rule would update these requirements for consistency with the HHS Guidelines and require that (1) the performance characteristics (e.g., accuracy, precision, LOD, limit of quantitation (LOQ), specificity) for each test must be validated and documented; (2) validation of procedures must document that carryover does not affect the donor’s specimen results, and (3) the laboratory must periodically re-verify the analytical procedures. These requirements would be moved to proposed § 26.167(a) for organizational clarity because they are aspects of the laboratory’s quality assurance program. The requirements in current Section 2.8(a) in Appendix A to Part 26 that apply to licensee testing facilities would be moved to § 26.137(a) [Quality assurance program] in proposed Subpart F [Licensee Testing Facilities] for organizational clarity. The second sentence of current 2.8(a) would be retained in proposed § 26.167(a). The quality control requirements for initial tests at licensee testing facilities in current Section 2.8(b) in Appendix A to Part 26 would be relocated to § 26.137 [Quality assurance and quality control] in proposed Subpart F [Licensee Testing Facilities]. The proposed change would be made for organizational clarity. Proposed § 26.167(b) [Calibrators and controls required] would retain the portions of current Section 2.8(c) and (d) in Appendix A to Part 26 that require HHS-certified laboratories to use appropriate calibrators and controls for initial and confirmatory drug testing. The proposed rule would add a requirement to include appropriate calibrators and controls for initial and confirmatory validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The more detailed requirements for calibrators VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 and controls in current Section 2.8(c) and (d) would be amended and presented in this section of the proposed rule in separate paragraphs that address each type of test to be performed by the HHS-certified laboratory. The proposed changes would be made for increased consistency with the HHS Guidelines and to improve the organizational clarity of the proposed rule. Proposed § 26.167(c) [Quality control requirements for performing initial and confirmatory validity tests] would be added to establish quality control requirements for performing initial and confirmatory validity tests at an HHScertified laboratory. The quality control requirements for validity tests in this proposed paragraph would incorporate the related provisions of the HHS Guidelines. Proposed § 26.167(c)(1) [Requirements for performing creatinine tests] would be added to require HHS-certified laboratories to measure creatinine concentration to 1 decimal place on initial and confirmatory creatinine tests and establish requirements for the quality control samples to be used in initial and confirmatory tests for creatinine concentration. Proposed § 26.167(c)(2) [Requirements for performing specific gravity tests] would be added to establish the required characteristics of the refractometers used by HHS-certified laboratories to measure specific gravity and the characteristics of the quality control samples to be used for initial and confirmatory tests for a specimen’s specific gravity. Proposed § 26.167(c)(3) [Requirements for performing pH tests] would be added to establish quality control requirements for performing initial and confirmatory pH tests. Proposed § 26.167(c)(3)(i)– (c)(3)(v) would specify the required calibrators and controls for pH testing, based upon the type of testing instrument used and whether a pH validity screening test has been performed. The proposed rule would add three additional paragraphs related to quality control of initial and confirmatory validity testing: proposed § 26.167(c)(4) [Requirements for performing oxidizing adulterant tests], proposed § 26.167(c)(5) [Requirements for performing nitrite tests], and proposed § 26.167(c)(6) [Requirements for performing ‘‘other’’ adulterant tests]. The proposed paragraphs would establish quality control requirements for performing initial and confirmatory tests for oxidizing adulterants, among which nitrites are one example, and for ‘‘other’’ adulterants. PO 00000 Frm 00122 Fmt 4701 Sfmt 4702 Proposed § 26.167(d) [Quality control requirements for initial drug tests] would amend and combine portions of current Sections 2.7(d) and (e)(1), and 2.8(c) in Appendix A to Part 26, which establish quality control requirements for performing initial tests for drugs and drug metabolites at HHS-certified laboratories. The proposed paragraph would group together the current requirements that are dispersed throughout the rule to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. In addition, the proposed rule would amend a number of the current requirements, as follows: Proposed § 26.167(d)(1) would amend the first sentence of current Section 2.7(e)(1) in Appendix A to Part 26 but retain the intent of the current provision as it applies to HHS-certified laboratories. The current and proposed paragraphs require laboratories to use only immunoassay tests that meet the requirements of the Food and Drug Administration for commercial distribution. The requirements in the current paragraph related to initial drug testing at licensee testing facilities would be moved to § 26.137(e)(1) of proposed Subpart F [Licensee Testing Facilities] to improve organizational clarity in the rule. Proposed § 26.167(d)(2) would permit HHS-certified laboratories to conduct multiple tests of a single specimen for the same drug or drug class. The requirements in this paragraph would be consistent with a similar provision in the HHS Guidelines and would be added to meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.167(d)(3)(i)–(d)(3)(vi) would update current Section 2.8(c) in Appendix A to Part 26, which requires HHS-certified laboratories to include quality control samples in each analytical run of specimens for initial drug testing. Proposed § 26.167(d)(3)(i)– (d)(3)(vi) would specify the number and characteristics of the quality control samples to be included in each analytical run of specimens. These proposed requirements would be the same as those contained in proposed § 26.137(e)(6) and (e)(7) for initial drug tests at licensee testing facilities and would be added for consistency with the related provisions in the HHS Guidelines. Proposed § 26.167(e) [Quality control requirements for performing confirmatory drug tests] would update and combine portions of current Sections 2.7(f)(2) and 2.8(d) in E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Appendix A to Part 26, which address quality control requirements for performing confirmatory drug tests. In general, the proposed changes to the current requirements would be made for organizational clarity in the proposed rule and to incorporate the related provisions in the HHS Guidelines. Proposed § 26.167(e)(1) would amend current Section 2.7(f)(2) in Appendix A to Part 26, which requires that confirmatory drug tests must be performed using gas chromatography/ mass spectrometry (GC/MS). The proposed paragraph would permit HHScertified laboratories to use other techniques for confirmatory drug testing that the HHS Guidelines approve for use in Federal workplace drug testing programs. Proposed § 26.167(e)(2)(i)–(e)(2)(iv) would amend the requirements for quality control samples in current Section 2.8(d) in Appendix A to Part 26. Proposed § 26.167(e)(2)(i) and (e)(2)(ii) would retain the current requirements for laboratories to include blank samples and samples that contain known standards in each analytical run. The proposed requirements would adopt the simpler language from the related provisions in the HHS Guidelines to improve clarity in the language of the rule. For consistency with the related requirements in the HHS Guidelines, the proposed paragraph would provide more detailed requirements for ‘‘positive controls with the drug or metabolite at or near the threshold’’ in current Section 2.8(d)(1) in Appendix A to Part 26. The proposed rule would require, in proposed § 26.167(e)(2)(iii), at least one control fortified with a drug or drug metabolite targeted at 25 percent above the cutoff and, in proposed § 26.167(e)(2)(iv), at least one calibrator or control that is targeted at or below 40 percent of the cutoff. Proposed § 26.167(f) [Blind performance testing] would amend current Section 2.8(e) in Appendix A to Part 26, which establishes requirements for licensees and other entities to conduct blind performance testing of HHS-certified laboratories, as follows: Proposed § 26.167(f)(1) would amend the portion of current Section 2.8(e)(2) in Appendix A to Part 26 that establishes the percentages and numbers of blind performance test samples that licensees and other entities must submit to the HHS-certified laboratory during the first 90 days of any initial contract with the HHS-certified laboratory. The proposed paragraph would decrease the percentage of blind performance test samples that licensees and other entities would submit to the HHS-certified VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 laboratory during the initial 90-day period of any contract (not including rewritten or renewed contracts). Specifically, the proposed rule would reduce the percentage from 50 percent to 20 percent of the total number of specimens submitted in the 90-day period, up to a maximum of 100 blind samples, rather than a maximum of 500 samples as specified in the current rule. This proposed decrease in the blind performance testing rate would increase the consistency of Part 26 requirements with the related provisions in the HHS Guidelines. In addition, since the NRC published the current rule, the number and size of Federal agencies who conduct drug testing has substantially increased, and these agencies are also required to submit blind performance test samples under the HHS Guidelines. As a result, the burden on Part 26 programs to conduct performance tests of the HHS-certified laboratories may be reduced without affecting the likelihood that errors in testing will be detected. The proposed rule would also add a requirement for licensees and other entities to submit a minimum of 30 blind performance test specimens in the 90-day period. This proposed minimum would be established to address Part 26 programs who submit only a small number of specimens to HHS-certified laboratories for testing each quarter. For example, for a very small program, 20 percent of the number of specimens submitted in the 90-day period could be less than one blind performance test sample. Establishing a minimum number of samples would provide assurance that the HHS-certified laboratories used by these Part 26 programs are providing accurate test results. Proposed § 26.167(f)(2) would amend the portion of current Section 2.8(e)(2) in Appendix A to Part 26 that addresses ongoing blind performance testing after the first 90 days of an initial contract with an HHS-certified laboratory. The proposed rule would decrease the rate at which licensees and other entities must submit blind performance test samples to an HHS-certified laboratory in each quarter after the initial 90-day period from 10 percent in the current rule to 1 percent, or a total of 10 samples, whichever is greater. The proposed rule would also decrease the maximum number of samples to be submitted per quarter from 250 to 100 samples. The rationale for these proposed changes would be the same as discussed with respect to proposed § 26.167(f)(1). Proposed § 26.167(f)(3) would decrease the proportion of spiked blind samples that licensees and other entities would submit each quarter from 20 PO 00000 Frm 00123 Fmt 4701 Sfmt 4702 50563 percent in Section 2.8(e)(3) in Appendix A to Part 26 to 15 percent. The proposed rule would retain the current requirement that samples must be spiked with only the drugs that are included in the licensee’s or other entity’s panel of drugs. The proposed rule would add a requirement that the spiked samples must be spiked to between 60–80 percent of the initial cutoff levels used by the licensee or other entity to be consistent with related requirements in the HHS Guidelines. In addition, the proposed rule would add a requirement for licensees and other entities to submit samples that meet the criteria for adulteration, dilution, and substitution, in order to challenge the laboratory’s validity testing. Licensees and other entities would be required to submit blind samples each quarter that are appropriately adulterated, diluted, or substituted, in the amount of 5 percent of the specimens submitted that quarter or at least 3 samples per quarter (one each that is adulterated, diluted, or substituted), whichever is greater. This proposed change would be made for consistency with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i), and would be necessary to challenge the accuracy of the HHScertified laboratory’s specimen validity testing. Proposed § 26.167(f)(4) would retain current Section 2.8(e)(3) in Appendix A to Part 26, which requires that 80 percent of the blind samples submitted by the licensee or other entity each quarter to the HHS-certified laboratory must be ‘‘blank’’ (i.e., certified to contain no drugs or drug metabolites). Proposed § 26.167(f)(5) would be added to establish detailed requirements for the blind performance test samples that licensees and other entities must submit to the HHS-certified laboratories. The proposed rule would require the supplier of the blind samples to certify and provide an expiration date for each sample. Proposed § 26.167(f)(i) and (f)(ii) would specify the characteristics of the samples that licensees and other entities would be required to use to challenge the HHS-certified laboratory’s drug and validity testing, respectively. The proposed quality control requirements would be necessary to ensure the effectiveness of the blind performance testing process and would incorporate the related requirements in the HHS Guidelines. Proposed § 26.167(g) [Errors in testing] would amend current Section 2.8(e)(4)–(e)(6) in Appendix A to Part 26, which establishes requirements for licensees, other entities, and HHS- E:\FR\FM\26AUP2.SGM 26AUP2 50564 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules certified laboratories related to unsatisfactory performance, including false positive and false negative test results, by the HHS-certified laboratory. The proposed paragraph would require the licensee or other entity to ensure that the HHS-certified laboratory investigates any conditions that may adversely reflect on the testing process. Notably, the proposed rule would no longer require the licensee to perform the investigation, but rather to ‘‘ensure’’ that the laboratory completes an investigation. This change is proposed because licensees and other entities do not typically retain personnel with the expertise required to investigate the complex technologies and processes involved in testing at the HHS-certified laboratories. The requirement for documentation of the investigation, which currently appears in Section 2.8(e)(4) in Appendix A to Part 26, would be moved to § 26.215(b)(8) in proposed Subpart J [Recordkeeping and Reporting Requirements] for organizational clarity. Proposed § 26.167(g)(1) would explicitly state the requirements that are implied in current Section 2.8(e)(4) in Appendix A to Part 26, that the investigation must identify the root cause(s) of any unsatisfactory performance and the HHS-certified laboratory must take corrective actions. The proposed rule would expand these requirements to include the licensee or other entity, as well as the HHS-certified laboratory, depending upon the causes identified and the extent to which the causes are within each entity’s control. The proposed requirement would be added to recognize that some testing errors are not attributable to the HHScertified laboratory. Proposed § 26.167(g)(2) would amend current Section 2.8(e)(5) in Appendix A to Part 26, which requires the licensee to notify the NRC if a false positive error occurs on a blind performance test sample and the error is determined to be administrative. The proposed paragraph would require the licensee or other entity, and the HHS-certified laboratory, to take corrective actions for any false positive errors in blind performance testing, in response to the findings of the investigation that would be required in proposed § 26.167(i). The proposed rule would continue to authorize licensees and other entities to require the laboratory to review and re-analyze previously tested specimens, if the investigation indicates that the error could have been systematic. The proposed rule would also delete reference to administrative errors, which appears in current Section 2.8(e)(5), so that any type of errors VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 would fall under the requirements of the proposed paragraph. The reporting requirement in current Section 2.8(e)(5) would be moved to § 26.219(c)(2) in proposed Subpart J [Recordkeeping and Reporting Requirements] for organizational clarity. Proposed § 26.167(g)(3) would amend current Section 2.8(e)(6) in Appendix A to Part 26, which addresses false positive errors resulting from methodological errors by the laboratory. The proposed rule would incorporate reference to validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as previously discussed with respect to § 26.31(d)(3)(i). The proposed rule would also replace the reference to the individual who is responsible for day-to-day management of the laboratory with a requirement for the laboratory’s certifying scientist to document the retesting of specimens that may be required under this paragraph. This proposed change would be made for consistency with the related provision of the HHS Guidelines. The proposed paragraph would delete the last sentence of the current paragraph because it addresses the responsibilities of the HHS and is not relevant to the NRC or the licensees and other entities who are subject to Part 26. The proposed paragraph would retain the other provisions of current Section 2.8(e)(6), but adopt the simpler language of the related provision in the HHS Guidelines for increased clarity in the language of the proposed rule. Proposed § 26.167(h) [Accuracy] would retain current Section 2.7(o)(3)(i) in Appendix A to Part 26 with minor editorial revisions. The current paragraph would be relocated to proposed § 26.167 because it is related to quality control of the HHS-certified laboratory’s drug testing processes. These proposed changes would be made to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.167(i) [Calibrators and controls] would update current Section 2.7(o)(2) in Appendix A to Part 26. At the time the original paragraph was written, most laboratories prepared their own standards and controls. In the ensuing years, the number and variety of sources for materials used in performance testing has increased. The proposed paragraph would update current requirements to refer to several of the alternatives, including, but not limited to pure drug reference materials, stock standard solutions from other laboratories, and standard solutions obtained from commercial manufacturers. The proposed PO 00000 Frm 00124 Fmt 4701 Sfmt 4702 requirements in this paragraph incorporate the related requirements in the HHS Guidelines and would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. The labeling requirements in the second sentence of current Section 2.7(o)(2) would be retained. Section 26.169 Reporting Results Proposed § 26.169 [Reporting results] would amend current Section 2.7(g) in Appendix A to Part 26, which contains requirements for HHS-certified laboratories’ reporting of test results to the licensee’s or other entity’s MRO. The proposed rule would update the current requirements for consistency with the HHS Guidelines. In addition, the proposed rule would add requirements for reporting the results of validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.169(a) would amend current Section 2.7(g)(1) in Appendix A to Part 26, which establishes a timelimit on the HHS-certified laboratory’s reporting of test results to the MRO and requirements for the processing and content of the report. The proposed rule would retain the requirement for the laboratory to report results to the MRO within 5 business days of receiving the specimen at the laboratory. Under the proposed rule, the HHS-certified laboratory’s ‘‘certifying scientist,’’ rather than the laboratory’s ‘‘responsible individual,’’ would certify the test results. This proposed change would be made for consistency with the updated term used to refer to this individual, as discussed with respect to proposed § 26.155(b). The proposed rule would add a reference to validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed rule would delete the current prohibition on reporting test results for any specimen in a group of specimens sent to the laboratory by the licensee or other entity until the laboratory completes testing of all of the specimens in the group. The prohibition in the current rule was based upon a concern for maintaining control of specimen identity. However, new technologies for identifying specimens and aliquots (such as bar codes on specimen labels matched to bar codes on aliquots and the associated custody-and-control forms) have reduced the likelihood that specimen E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules identity may be lost, and, therefore, have substantially reduced the need for the requirement in the current rule. Proposed § 26.169(b) would amend current Section 2.7(g)(2) in Appendix A to Part 26, which establishes requirements for the manner in which HHS-certified laboratories and licensee testing facilities must report test results to licensee management. The requirements in the current paragraph that are related to reporting test results from the licensee testing facility would be moved to § 26.139(a) of proposed Subpart F [Licensee Testing Facilities] for organizational clarity. The proposed paragraph would delete the current reference to ‘‘special processing’’ and replace it with reference to validity test results, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). In addition, the proposed rule would make minor changes in terminology, such as referring to a ‘‘drug or drug metabolite,’’ rather than a ‘‘substance,’’ for clarity in the rule language. Proposed § 26.169(c) would amend portions of current Section 2.7(f)(2) in Appendix A to Part 26 by deleting the requirement for the HHS-certified laboratory to conduct tests for drugs and drug metabolites using both the cutoff levels specified in this part and any more stringent cutoff levels specified by the FFD program. Under the proposed rule, if the FFD program specifies cutoff levels that are more stringent than those specified in this part, the laboratory need only conduct testing using those more stringent cutoff levels, and need only report results from those tests to the MRO. This proposed change would be made for the reasons discussed with respect to proposed § 26.31(d)(1)(i)(D). Proposed § 26.169(d) would be added to establish requirements for the laboratory’s reporting of the results of validity testing. Under the proposed rule, HHS-certified laboratories would be required to report to the MRO quantitative results for any specimen that is found to be dilute, adulterated, or substituted. The MRO would be prohibited from reporting the quantitative validity test results to the licensee or other entity, except as permitted with a signed consent from the donor under proposed § 26.37(b). The proposed paragraph also would require the HHS-certified laboratory to contact the licensee’s or other entity’s MRO when the laboratory concludes that a specimen is invalid, and consult with the MRO to determine whether additional testing by a second HHScertified laboratory would be useful in VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 being able to report an adulterated or substituted test result. The proposed rule would permit the laboratory’s contact with the MRO to occur using electronic means, such as telephone, fax, and e-mail. These proposed reporting requirements would be added for consistency with the related provisions in the HHS Guidelines. Proposed § 26.169(e) would be added to require the HHS-certified laboratory to report more than one test result for a single specimen, if the laboratory obtains more than one non-negative test result from testing of the specimen. This proposed provision would require the laboratory to report any drug-positive test results, as well as any non-negative validity test results from the same specimen. This proposed change is necessary because sanctions for the different test results would differ under proposed § 26.75 [Sanctions]. Reporting multiple test results for a single specimen would be consistent with related requirements in the HHS Guidelines. Proposed § 26.169(f) would update current Section 2.7(g)(3) in Appendix A to Part 26, which permits the MRO routinely to obtain quantitative test results from the HHS-certified laboratory. Specifically, the proposed rule would revise the first sentence of current Section 2.7(g)(3) by stating that the HHS-certified laboratory shall provide quantitative test results to the MRO upon request. The proposed paragraph would clarify the current requirement by stating that the MRO’s request may be either a general request covering all such results or a specific case-by-case request. The proposed clarification would be necessary because the current sentence has raised questions from HHS-certified laboratories to the HHS. In addition, the proposed rule would add the third sentence of proposed § 26.169(f) to clarify requirements for reporting drug test results when the concentration of a drug, metabolite, or adulterant exceeds the linear range of the standard curve. The proposed rule would also delete the existing reference to test results from blood specimens for the reasons discussed with respect to proposed § 26.83(a). Disclosure of quantitative test results to licensees and other entities would continue to be subject to the requirements in proposed § 26.37(b). The proposed changes to this paragraph would be consistent with the related provisions in the HHS Guidelines. Proposed § 26.169(g) would require HHS-certified laboratories to report to the MRO quantitative values for confirmatory opiate test results for morphine or codeine that are equal to or PO 00000 Frm 00125 Fmt 4701 Sfmt 4702 50565 greater than 15,000 ng/mL. The proposed rule would add this requirement for consistency with the related provision in the HHS Guidelines and because the MRO would not be required to perform an assessment for clinical signs of opiate abuse in this instance, as discussed with respect to proposed § 26.185(f)(1). Proposed § 26.169(h) would amend current Section 2.7(g)(4) in Appendix A to Part 26, which establishes requirements for the electronic transmission of test results from the HHS-certified laboratory to the MRO. Specifically, the proposed rule would clarify that the licensee or other entity is responsible for assuring the security of data transmissions from the laboratory to the MRO, rather than only the HHS-certified laboratory, as specified in the current requirement. The proposed change would respond to stakeholder comments at the public meetings discussed in Section V. The stakeholders accurately noted that licensees and other entities are responsible to the NRC for ensuring the security of their HHS-certified laboratories’ data storage and transmission systems through their contracts with and audits of the laboratories. The proposed revision would more accurately characterize these relationships without changing the intent of the current provision. Proposed § 26.169(i) would update current Section 2.7(g)(5) in Appendix A to Part 26, which establishes requirements for transmitting chain-ofcustody documentation with test results to the MRO. The proposed rule would permit HHS-laboratories to use various means to transmit test results to the MRO, including transmittal of a computer-generated electronic report for negative test results. However, for nonnegative test results, the proposed rule would require the laboratory to transmit a legible image or copy of the completed custody-and-control form to the MRO. The proposed change would be made for consistency with the related provision in the HHS Guidelines. Proposed § 26.169(j) would further amend current Section 2.7(g)(5) in Appendix A to Part 26. The proposed paragraph would continue to require that the HHS-certified laboratory must retain the original custody-and-control form for any non-negative specimens. However, the proposed paragraph would assign responsibility for certifying the test results to the laboratory’s certifying scientist, rather than to ‘‘the individual responsible for day-to-day management of the laboratory or the individual responsible for attesting to the validity of the test E:\FR\FM\26AUP2.SGM 26AUP2 50566 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules reports.’’ The proposed change would be made for consistency with the updated terminology used to refer to this individual in the HHS Guidelines, as discussed with respect to proposed § 26.155(b). Proposed § 26.169(k) would combine and amend current Section 2.7(g)(6) and (g)(7) in Appendix A to Part 26, which require the laboratory to submit a monthly statistical summary of drug test results to the licensee or other entity. The proposed rule would reduce the required frequency of the statistical summary report from monthly to annually in order to reduce the burden on licensees, other entities, and their laboratories. The proposed requirement for annual reporting would make the reporting time consistent with the NRC’s need for the information as it relates to the NRC’s inspection schedule and the annual FFD program performance report that would be required under proposed § 26.217 [Fitness-for-duty program performance data], for the reasons discussed with respect to that section. The proposed rule would also delete the existing reference to blood specimens because the option for donors to request blood testing for alcohol would be eliminated from the proposed rule, as discussed with respect to proposed § 26.83(a). The proposed rule would also delete the requirement to report drug test results at the cutoff levels specified in this part, if the FFD program uses more stringent cutoff levels, for the reasons discussed with respect to proposed § 26.169(c). The proposed rule would add a requirement to report initial and confirmatory test results for additional drugs (if the FFD program tests for additional drugs), as well as a requirement to report the number of specimens with confirmed positive 6acetylmorphine (6-AM) test results. (The proposed rule would include testing for 6-AM, because the presence of 6-AM in a specimen uniquely identifies heroin use.) In addition, the proposed rule would add requirements to report the results of validity testing. These proposed changes would be made to conform the laboratory’s annual summary report to other changes in the proposed rule, as discussed with respect to proposed §§ 26.217(b)(2), § 26.185(f)(1), and 26.31(d)(3)(i). Subpart H—Determining Fitness-forDuty Policy Violations and Determining Fitness Section 26.181 Purpose Proposed § 26.181 [Purpose] would describe the purpose of Subpart H, which is to establish requirements for VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 MRO reviews of non-negative confirmatory drug test results and for making determinations of fitness. This proposed section would provide an overview of the contents of the proposed subpart, consistent with Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Section 26.183 Medical review officer Proposed § 26.183 [Medical review officer] would be added to present requirements related to the qualifications, relationships, staff, and responsibilities of the MRO to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, by grouping these requirements together in a single section. Proposed § 26.183(a) [Qualifications] would combine and amend the requirements in current § 26.3 [Definitions] and Section 1.2 of Appendix A to Part 26, as well as portions of current Section 2.9(b) in Appendix A to Part 26. The proposed rule would reorganize the current requirements to eliminate redundancies and group together in one paragraph the related provisions in the current rule to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. The proposed paragraph would amend portions of the current requirements related to MRO qualifications. The proposed paragraph would continue to provide that the MRO must be a licensed physician, but would clarify that the MRO may hold either a Doctor of Medicine or Doctor of Osteopathy degree for consistency with the related regulations of other Federal agencies. The proposed rule would add a requirement that the MRO must be knowledgeable of Part 26 and the FFD policies and procedures of the licensees and other entities for whom the MRO provides services. The proposed requirements of this part, and the policies and procedures of various Part 26 FFD programs, may differ from those of other workplace drug and alcohol testing programs for which an MRO provides services. This proposed provision would ensure that an MRO is able to perform his or her function appropriately under this part. In addition, the proposed rule would add a requirement that, within 2 years following the date on which this rule is published in the Federal Register, the MRO must pass an MRO certification examination. The proposed requirement would increase consistency in the performance of the MRO function among FFD programs, given that PO 00000 Frm 00126 Fmt 4701 Sfmt 4702 licensees and other entities would be permitted to accept test results and the results of determinations of fitness conducted by other licensees and entities who are subject to the rule. The 2-year implementation date would provide MROs who are not currently certified with an opportunity to pass the required examination. With the exception of the first sentence of this proposed paragraph, which specifically relates to the MRO function under Part 26, these MRO qualification requirements would be consistent with those of other Federal agencies. Proposed § 26.183(b) [Relationships] would establish requirements related to the relationships that would be permitted or prohibited between the MRO, the licensee or other entity, and HHS-certified laboratories. The first sentence of the proposed paragraph would retain the portion of the first sentence of current Section 2.9(b) in Appendix A to Part 26 that permits the MRO to be an employee of a licensee or other entity, or a contractor. The remaining sentences of the proposed paragraph would be added to prohibit the MRO from being an employee or agent of, or have any financial interest in, a laboratory or a contracted operator of a licensee testing facility for whom the MRO reviews drug testing results for the licensee or other entity. The proposed prohibition would be added based upon the experiences of other Federal agencies and would be consistent with the related provision in the HHS Guidelines. Proposed § 26.183(c) [Responsibilities] would reorganize and update the requirements in current § 26.3 [Definitions] as well as Sections 1.2, 2.4(j), 2.7(d), and 2.9(a) and (b) in Appendix A to Part 26 as they relate to the responsibilities of the MRO in Part 26 programs. The proposed rule would reorganize the current provisions and combine them in one paragraph. In addition, the terminology used in the proposed paragraph would be revised to be consistent with that used throughout the proposed rule (e.g., ‘‘non-negative’’). The proposed changes would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.183(c) would retain the requirement in current Section 2.9(a) in Appendix A to Part 26 for the MRO to review positive confirmatory drug test results and add a requirement for the MRO to review non-negative results from validity testing, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules paragraph would also require the MRO to (1) identify evidence of subversion of the testing process; (2) identify issues or problems associated with the collection and testing of specimens; and (3) work with FFD program management to assure the overall effectiveness of the FFD program. The proposed rule would add these responsibilities to clarify that the MRO carries programmatic responsibilities within a licensee’s or other entity’s FFD program, in addition to responsibility for reviewing drug and specimen validity test results. These proposed additional responsibilities would strengthen the effectiveness of FFD programs by ensuring that the MRO’s expertise is brought to bear in the management of FFD programs. The proposed paragraph would also increase the consistency of the MROs’ responsibilities under Part 26 with the responsibilities of MROs in the drug and alcohol testing programs of other Federal agencies. Therefore, the proposed changes would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, and Goal 3, which is to improve the effectiveness and efficiency of FFD programs. Proposed § 26.183(c)(1) would retain and update the requirements contained in the current definitions of the term, ‘‘Medical Review Officer,’’ in § 26.3 and Sections 1.2 and 2.9(b) in Appendix A to Part 26. The proposed rule would continue to require the MRO to examine alternate medical explanations for any non-negative test result, which would include non-negative results of confirmatory validity testing as well as positive confirmatory drug test results. The proposed paragraph would also retain the current requirement for the MRO to interview the donor and review the donor’s medical history and any other relevant biomedical factors as well as all medical records that the donor may make available to the MRO. In addition to the responsible use of legally prescribed medication, the proposed rule would require the MRO to consider a documented condition or disease state and the demonstrated physiology of the donor in determining whether a nonnegative test result is an FFD policy violation. The proposed rule would require the MRO to consider the latter factors because they may cause some non-negative validity test results. The proposed changes would be necessary for consistency with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i), as well as to increase the VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 consistency of Part 26 with advances in other relevant Federal rules and guidelines, which is Goal 1 of this rulemaking. Proposed § 26.183(c)(2) would retain the meaning of the last sentence of current Section 2.9(b) in Appendix A to Part 26 with minor editorial revisions for consistency with the terminology used throughout the proposed rule. For example, the proposed rule would replace the term,’’ split samples,’’ in the current sentence with the term, ‘‘split specimens.’’ The proposed changes would be made for increased clarity in the language of the rule. Proposed § 26.183(d) [MRO staff] would be added to establish requirements related to individuals who provide routine administrative support functions to MROs, whether the individuals are employees of the licensee or other entity, employees of the MRO, or employees of an organization with whom the licensee or other entity contracts for MRO services. The proposed rule would add requirements related to MRO staff because these individuals (1) have access to drug test results that are forwarded to an MRO from the HHScertified laboratory; (2) perform some administrative functions for MROs that permit them to view donors’ private medical information; and (3) often have contact with donors. The NRC is not aware of any instances in which individuals who serve as MRO staff have compromised the confidentiality of donors’ test results, medical information, or otherwise acted improperly in Part 26 programs. However, the proposed rule would adopt requirements related to the MRO staff function from the regulations of other Federal agencies who similarly permit MRO staff to provide administrative support to MROs to ensure that donors’ medical information is handled with the highest concern for individual privacy. The proposed requirement would also ensure that information related to non-negative test results is not released to licensee or other entity management personnel until the MRO has determined that a donor has violated the FFD policy. These proposed changes would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines, and Goal 7, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.183(d)(1) [Direction of MRO staff activities] would be added to require an MRO to be directly responsible for the administrative, PO 00000 Frm 00127 Fmt 4701 Sfmt 4702 50567 technical, and professional activities of individuals who perform MRO staff duties. The NRC does not intend, through use of this language, to mandate that MROs must share the same physical space with all their staff members at all times. Direction of staff activities need not occur face-to-face on an all-day, every-day basis. Direction may also take place through using a variety of electronic communications. However, the proposed rule would require that the MRO’s direction of staff must be meaningful. Meaningful direction would involve (1) personal oversight of staff members’ work; (2) personal involvement in their performance evaluation, hiring, and firing; (3) line authority over the staff for decisions, direction and control; and (4) regular contact and oversight concerning drug testing program matters. The proposed rule would also require that the MRO’s direction and control of the staff members cannot be superseded by or delegated to anyone else with respect to the review of negative tests and other functions that staff members perform for the MRO. In addition, the proposed rule would require that MROs must personally review a confirmed positive drug test result that is received from the HHS-certified laboratory, as well an adulterated or substituted result, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.183(d)(1)(i) would require that MRO staff duties must be independent from any other activity or interest of the licensee or other entity. The proposed rule would add this requirement because, by contrast to other Federal agencies’ regulations, Part 26 permits employees of licensees and other entities to perform MRO staff activities for MROs who work off site and are not physically present to supervise the staff. These circumstances may provide greater opportunities for inadvertent compromise of the independence of the MRO function than situations in which the MRO and his or her staff are physically co-located, such as the inadvertent release of nonnegative test results before the MRO has reviewed the results with the donor. Therefore, the NRC believes that the proposed requirement is necessary to protect the integrity of the MRO function and donors’ privacy. Proposed § 26.183(d)(ii) would be added to further specify the MRO’s responsibilities for directing MRO staff. These responsibilities would include, but would not be limited to, ensuring that the procedures that must be E:\FR\FM\26AUP2.SGM 26AUP2 50568 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules followed by MRO staff meet the regulations of this part and HHS’ and professional standards of practice, and that personal information about the donor is maintained confidential with the highest regard for individual privacy. The proposed requirements would meet Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.183(d)(1)(iii) would also be added to prohibit the MRO from delegating his or her responsibilities for directing MRO staff activities to any individual or entity, other than another MRO. Although the NRC is unaware of any instances in which the MRO function has been compromised by MRO staff in Part 26 programs, the experience of other Federal agencies has indicated that clear limits on who may direct MRO staff activities are advisable to maintain the independence and integrity of the MRO function. Therefore, proposed § 26.183(d)(1)(iii) would establish these clear limits. Proposed § 26.183(d)(2) [MRO staff responsibilities] would be added to specify the job duties that MRO staff may and may not perform. The proposed provisions would also be based on the experience of other Federal agencies, which has indicated that clear limits on MRO staff job duties are necessary to protect donor confidentiality and the integrity of the MRO process. Proposed § 26.183(d)(2)(i) would permit MRO staff to receive from the HHS-certified laboratory, review, and report negative test results to the licensee’s or other entity’s designated reviewing official, under the MRO’s direction. Proposed § 26.183(c)(2)(ii) would permit MRO staff to review the custody-and-control forms for specimens that the laboratory reports as non-negative and correct errors, but would require the MRO to review and approve the corrections. Proposed § 26.183(d)(2)(iii) would prohibit staff from conducting interviews with donors to discuss non-negative test results and requesting or reviewing medical information from donors related to any non-negative test results. Proposed § 26.183(c)(2)(iv) would prohibit MRO staff from reporting or discussing nonnegative test results received from the HHS-certified laboratory with any individuals other than the MRO and other MRO staff. The proposed provisions would be necessary to protect donor confidentiality and the integrity of the MRO review process while permitting licensees and other entities to realize the cost efficiencies associated with the MRO delegating some tasks to staff. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Section 26.185 Determining a Fitnessfor-Duty Policy Violation Proposed § 26.185 [Determining a fitness-for-duty policy violation] would amend requirements related to the MRO’s determination that a nonnegative test result constitutes an FFD policy violation, as follows: Proposed § 26.185(a) [MRO review required] would amend portions of current Section 2.9(a) in Appendix A to Part 26, which establishes requirements for the MRO’s review of test results from the HHS-certified laboratory. The term, ‘‘non-negative test result,’’ would be used in the proposed paragraph to indicate that the MRO’s review would encompass validity test results, as well as drug test results, consistent with the addition of validity testing requirements in the proposed rule. The proposed paragraph would also expand the MRO’s responsibilities to include assisting the licensee or other entity in determining whether a donor has attempted to subvert the testing process. These responsibilities may include, but would not be limited to, reviewing nonnegative validity test results and authorizing the testing at an HHScertified laboratory of any suspicious substance discovered in a donor’s pockets that could be used to adulterate or substitute a urine specimen. The proposed change would be consistent with the NRC’s increased concern with potential subversion of the testing process, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed rule would also delete the current reference to ‘‘nuclear power plant worker’’ and replace it with ‘‘individual,’’ because persons other than nuclear power plant workers would be subject to the proposed requirement. In addition, the proposed rule would eliminate the current requirement for the MRO to review blood test results from the HHS-certified laboratory because the proposed rule would no longer permit donors to request testing of a blood specimen for alcohol, as discussed with respect to proposed § 26.83(a). However, the proposed paragraph would retain the current requirement that the MRO must complete the review of any non-negative test results before transmitting results to a licensee’s or other entity’s designated representative. Proposed § 26.185(b) [Reporting of initial test results prohibited] would retain the intent of the requirement in the last sentence of current Section 2.9(a) in Appendix A to Part 26. Specifically, the proposed rule would continue to prohibit the MRO from communicating to licensees and other PO 00000 Frm 00128 Fmt 4701 Sfmt 4702 entities any non-negative initial test results reported by the HHS-certified laboratory before confirmatory testing has been completed and the MRO has conducted his or her review. However, the proposed rule would extend this prohibition to MRO staff, consistent with the addition of requirements related to MRO staff in proposed § 26.183(d), as discussed with respect to that paragraph. Proposed § 26.185(c) [Discussion with the donor] would amend current Section 2.9(c) in Appendix A to Part 26. The proposed rule would continue to require the MRO to discuss a positive confirmatory drug test result with the donor before determining that the FFD policy had been violated. The proposed rule would add a requirement for the MRO to discuss non-negative confirmatory validity test results with the donor as part of the review process, consistent with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). The proposed rule would add a reference to ‘‘other occurrence’’ to address circumstances in which the donor may have engaged in a subversion attempt that would be detected through other means, including, but not limited to, the specimen collection process in proposed Subpart E [Collecting Specimens for Testing]. The proposed rule would eliminate the current requirement for the MRO to contact the EAP. Under the proposed rule, referral to the EAP would be at the licensee’s or other entity’s discretion, as documented in FFD procedures. The current requirement would be eliminated because most licensees terminate the employment of individuals who have a confirmed non-negative drug test result, and it would be inappropriate to require licensees and other entities to provide EAP services to persons they will no longer employ. If a licensee or other entity plans to consider granting authorization to the individual after his or her authorization has been terminated unfavorably for the FFD policy violation, the proposed rule would require the licensee or other entity to meet the applicable requirements of proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. The changes in the proposed paragraph would be made for consistency with other proposed changes to the regulation. Proposed § 26.185(d) [Donor unavailability] would be added to clarify the circumstances in which the MRO may confirm a non-negative test E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules result or other occurrence as an FFD policy violation without having first discussed the test result or occurrence with the donor. These circumstances would include (1) the donor expressly declining the opportunity to discuss the possible FFD policy violation with the MRO in proposed § 26.185(d)(1); (2) the donor failing to contact the MRO within one business day after being contacted by the licensee or other entity or an MRO staff member in proposed § 26.185(d)(2); and (3) the MRO being unable to contact the donor after making a reasonable effort to do so in proposed § 26.185(d)(2). The proposed paragraphs would provide more detailed guidance than the first sentence of current Section 2.9(c) in Appendix A to Part 26, in response to the many questions that have arisen regarding implementation of the requirement for MROs to discuss test results with the donor. The proposed revisions would also respond to stakeholders requests during the public meetings discussed in Section V. In questions to the NRC staff and during the public meetings, licensees have pointed out that the current rule makes no provision for these circumstances, which do occasionally arise. Therefore, the proposed paragraphs would address these circumstances. For the same reasons, proposed § 26.185(e) [Additional opportunity for discussion] would specify procedures for addressing a circumstance in which the donor was unable to contact the MRO to discuss a non-negative test result or other occurrence. The proposed paragraph would permit the donor to present information to the MRO documenting the circumstances that unavoidably prevented the donor from being contacted by or from contacting the MRO, and would permit the MRO to reopen the procedure for determining whether the donor had violated the FFD policy. The proposed paragraph would also permit the MRO to modify the initial determination based on the information that the donor provides. The requirements in proposed § 26.185(d) and (e) would incorporate the related requirements in 49 CFR Part 40, ‘‘Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs’’ (65 FR 41944; August 9, 2001). Therefore, in addition to responding to implementation questions from licensees and stakeholder requests, the proposed provisions would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.185(f)–(i) would be added to establish requirements for the MRO’s review of validity test results. These proposed paragraphs would be added for consistency with the addition of requirements to conduct validity testing throughout the proposed rule, as discussed with respect to proposed § 26.31(d)(3)(i). Proposed § 26.185(f) [Review of invalid specimens] would clarify the MRO’s responsibilities in the event that the HHS-certified laboratory reports that a specimen is invalid. The proposed paragraph would be consistent with related provisions in the HHS Guidelines, and would be necessary because MRO actions in response to an invalid specimen are not specified in the current rule. Proposed § 26.185(f) would provide the MRO with several alternative courses of action if a specimen is declared to be invalid by the laboratory, as follows: Proposed § 26.185(f)(1) would require the MRO to consult with the HHScertified laboratory to determine whether additional testing by another HHS-certified laboratory may be useful for completing testing of the specimen. Another laboratory may use different testing methods that could provide more definitive test results regarding the invalid specimen, such as the ability to identify a new adulterant or obtain valid drug test results despite the presence of an interfering substance in the specimen. If the MRO and laboratory agree that additional testing would be useful, the MRO would direct the laboratory to forward an aliquot of the specimen to a second HHS-certified laboratory for further testing. Proposed § 26.185(f)(2) would require the MRO to contact the donor to determine whether there is an acceptable medical explanation for the invalid result, if the MRO and HHScertified laboratory agree that testing at a second laboratory would not be useful. If the MRO determines that there is an acceptable medical explanation for the invalid result, the MRO would report to the licensee or other entity that no FFD policy violation had occurred, but that a negative test result had not been obtained. Because the specimen did not yield negative test results, the licensee or other entity could not use the invalid test result in the decision to grant or deny authorization. However, the proposed paragraph would also require the MRO to assess whether the medical condition would similarly affect a second specimen collection. If the MRO determines that the medical condition is temporary and would not affect a second specimen, he or she would direct the licensee or other entity to PO 00000 Frm 00129 Fmt 4701 Sfmt 4702 50569 collect another specimen from the donor and the licensee or other entity would then rely upon the results of the second test to make an authorization decision. The proposed rule would not require the second specimen to be collected under direct observation in this situation, because there would be no reason to believe that the individual may have attempted to subvert the testing process. If the MRO determines that the medical condition would likely affect the validity of further urine specimens, the proposed paragraph would permit the MRO to authorize an alternative method for drug testing. At this time, the NRC declines to specify the alternative methods that the MRO may authorize, which may include, but would not be limited to, testing of alternate specimens, such as hair, oral fluids, or sweat. The NRC would leave the selection of an alternative method to the professional judgement of the MRO. The proposed rule also would prohibit licensees and other entities from taking management actions or imposing sanctions on the basis of an invalid test result from a medical condition, because no FFD violation would have occurred. Proposed § 26.185(f)(3) would require the MRO to direct the licensee or other entity to collect another specimen under direct observation, if testing by another laboratory would not be useful in obtaining a valid result and the donor did not provide an acceptable medical explanation for the invalid specimen. The invasion of privacy associated with a directly observed collection would be warranted in this situation because the invalid specimen may be the result of a subversion attempt. The proposed rule would require the licensee or other entity to rely upon the test results from the directly observed collection in authorization decision-making because the result from the invalid specimen would be neither negative or nonnegative, and so could not meet the requirements for granting authorization to an individual in proposed Subpart C [Granting and Maintaining Authorization] or serve as the basis for imposing the sanctions specified in proposed Subpart D [Management Actions and Sanctions]. Proposed § 26.185(g) [Review of dilute specimens] would be added to establish requirements for the MRO’s review of positive confirmatory drug test results from dilute specimens. The proposed paragraph would be added because reviewing test results from a dilute specimen is complex and MRO actions in response to a dilute specimen are not addressed in the current rule. Proposed § 26.185(g)(1) would require the MRO to confirm a drug-positive FFD E:\FR\FM\26AUP2.SGM 26AUP2 50570 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules violation for a dilute specimen in which drugs or drug metabolites are detected, if the MRO determines that there is no legitimate medical explanation for the presence of the drugs or metabolites in the specimen. There are many legitimate reasons for submitting a dilute specimen, which is the basis for omitting the submission of a dilute specimen as one type of subversion attempt for which a permanent denial of authorization would be required in proposed § 26.75(b). Although neither the submission of a dilute specimen nor the presence of drugs or drug metabolites in a dilute specimen establishes that the donor has attempted to subvert the testing process without additional evidence of subversion, the presence of drugs or metabolites in a dilute specimen without a legitimate medical explanation is a sufficient basis for the MRO to confirm that the donor has violated the FFD policy. Proposed § 26.185(g)(2) would permit the MRO to require the HHS-certified laboratory to test a dilute specimen for drugs and drug metabolites at the LOD of the confirmatory assay used, if the MRO has reason to believe that the donor may have attempted to subvert the testing process. The proposed rule would authorize the MRO to request testing at the LOD for any drugs or drug metabolites for which testing would be permitted in this part. The MRO would be permitted to request testing at the LOD in these circumstances because the immunoassay tests used for initial drug testing may not be sufficiently sensitive to detect very low concentrations of drugs or metabolites in a dilute specimen. However, confirmatory testing at the LOD may detect very low concentrations of drugs or metabolites in a dilute specimen and, therefore, would ensure that an attempt to hide drug abuse through specimen dilution is unsuccessful. Proposed § 26.185(g)(2)(i)–(g)(2)(iii) would define the circumstances that constitute a reason to believe that a donor may have attempted to subvert the testing process and provide a sufficient basis for the MRO to require the additional testing permitted in proposed § 26.185(g)(2). These circumstances would be the same as those specified in proposed § 26.115(a)(1)-(a)(3), as discussed with respect to those provisions. Proposed § 26.185(g)(3) would clarify that the MRO may also require the additional testing of a dilute specimen that would be permitted in proposed § 26.185(g)(2), if the specimen was collected under direct observation, or if such testing is required by the SAE as a result of a determination of fitness VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 conducted under proposed § 26.69 [Authorization with potentially disqualifying fitness-for-duty information]. The proposed paragraph would add these permissions for consistency with the related provisions in the proposed rule. Proposed § 26.185(g)(4) would require the MRO to determine whether there is clinical evidence of the illegal use of opiates, if opiates other than 6–AM at any concentration are detected in a dilute specimen, before the MRO verifies that the donor has violated the FFD policy. The proposed rule would not require an evaluation for clinical evidence of illegal use of opiates for 6– AM, because it’s presence in a specimen is proof of heroin use. However, the proposed paragraph would not establish cutoff levels below and above which an evaluation for clinical evidence of illegal opiate use is not required (in contrast to those contained in proposed paragraph (j) of this section), because the concentration of opiates in a dilute specimen would not bear any known relationship to the concentration of opiates in vivo (i.e., in the donor’s body). For similar reasons, the proposed rule would also require an evaluation for clinical evidence of abuse before the MRO determines that the donor has violated the FFD policy when drugs or drug metabolites are detected in a dilute specimen, indicating that the donor has used prescription or over-the-counter medications. Proposed § 26.185(h) [Review of substituted specimens] would be added to establish requirements for the MRO review of substituted test results. The proposed provisions would be added because MRO actions in determining an FFD policy violation for a substituted specimen are not addressed in the current rule. The proposed provisions would be consistent with the related provisions in the HHS Guidelines. Proposed § 26.185(h)(1) would require the MRO to contact the donor to determine whether there is a legitimate medical reason for the substituted result. The proposed paragraph would require the MRO to give the donor the opportunity to provide legitimate medical evidence, within 5 business days of being contacted by the MRO, that the individual’s normal physiology produced the substituted result and would establish requirements for the medical evidence that would be necessary. The proposed rule would also provide examples of donor claims that the MRO may not consider to be legitimate medical explanations, including, but not limited to, race, gender, body weight, and dietary factors. PO 00000 Frm 00130 Fmt 4701 Sfmt 4702 Proposed § 26.185(h)(2) would direct the MRO to report to the licensee or other entity that the specimen was substituted, if the MRO determines that there is no acceptable medical explanation for the substituted test result. Proposed § 26.185(h)(3) would direct the MRO to report to the licensee or other entity that no FFD policy violation has occurred, if the MRO determines that the donor has provided an acceptable medical explanation for the substituted test result. Proposed § 26.185(i) [Review of adulterated specimens] would establish requirements for the MRO’s review of adulterated test results. The proposed provisions would be added because MRO actions in determining an FFD policy violation for an adulterated specimen are not addressed in the current rule. Proposed § 26.185(i)(1) would require the MRO to contact the donor and offer him or her the opportunity to provide an acceptable medical explanation for the adulterated result. The proposed rule would also specify the procedures that the donor must follow in providing the medical explanation. If the donor does not provide an acceptable medical explanation for the adulterated result, proposed § 26.185(i)(2) would require the MRO to report to the licensee or other entity that the specimen is adulterated. If the donor provides an acceptable medical explanation, proposed § 26.185(j)(3) would require the MRO to report that no FFD policy violation had occurred. These proposed requirements would be consistent with the related provisions in the HHS Guidelines. Proposed § 26.185(j) [Review for opiates, prescription and over-thecounter medications] would amend current Section 2.9(d) in Appendix A to Part 26 to address circumstances that have arisen since Part 26 was first published and about which licensees have sought guidance from the NRC. The proposed paragraph would amend the current requirements in Section 2.9(d) in Appendix A to Part 26 and add others, as follows: Proposed § 26.185(j)(1) would incorporate updated requirements from the HHS Guidelines related to the MRO’s review of a positive drug test result for opiates. The proposed rule would revise, but retain the meaning of the requirement for the MRO to determine that there is clinical evidence of illegal use of opiates, which appears in current Section 2.9(d) in Appendix A to Part 26. Because some licensees and other entities rely on MROs who work off site and are not available to conduct E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules the required assessment, the proposed rule would permit the MRO to designate another licensed physician who has knowledge of the clinical signs of drug abuse to conduct the evaluation. The proposed change would continue to ensure that the clinical assessment is performed by a qualified physician while reducing unnecessary burden by permitting FFD programs to continue to rely on off-site MROs. Therefore, the proposed change would meet Goal 5 of this rulemaking, which is to improve Part 26 by eliminating or modifying unnecessary requirements. The proposed rule would make other changes to current Section 2.9(d) in Appendix A to Part 26. The proposed paragraph would eliminate the examples of clinical signs of opiate abuse in current Section 2.9(d), because these signs are addressed as part of the training that MROs would obtain in order to pass the comprehensive certification examination required in proposed § 26.183(a) [Qualifications]. The proposed rule would retain the provision in current Section 2.9(d) that permits the MRO to omit the evaluation for clinical evidence of abuse if the laboratory identifies 6-AM in the specimen. However, the proposed rule would add permission for the MRO to omit the evaluation if the morphine or codeine concentration in the specimen is equal to or greater than 15,000 ng/mL without a legitimate medical explanation for the presence of opiates at or above this concentration. The proposed change would be made because, in the experience of other Federal programs, such concentrations without a legitimate medical explanation can only indicate substance abuse. In addition, the proposed rule would prohibit the MRO from considering consumption of food products as a legitimate medical explanation for the specimen having morphine or codeine concentrations at or above 15,000 ng/mL, given that food consumption could not result in a concentration at this level. Proposed § 26.185(j)(2) would retain the last sentence of current Section 2.9(d) in Appendix A to Part 26, which requires the MRO to determine whether there is clinical evidence, in addition to the positive drug test result, of abuse of these substances or their derivatives. Proposed § 26.185(j)(3) would be added to provide greater consistency in MRO determinations related to a donor’s use of another person’s prescription medication. The NRC is aware that MROs in different FFD programs have varied in the determination they make as to whether the use of another person’s prescription VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 medication is an FFD policy violation. The proposed paragraph would clarify the NRC’s intent with respect to these circumstances. In the proposed rule, if a donor claims, and the MRO confirms, that a non-negative drug test result is due to the unauthorized use of another person’s prescription medication, the proposed rule would require the MRO to evaluate or ensure that the donor is evaluated for clinical evidence of abuse. If no clinical evidence of abuse is identified, the MRO would report to the licensee or other entity that a violation of the FFD policy regarding misuse of a prescription medication had occurred. If clinical evidence of abuse is identified, the MRO would confirm that the test results are positive for the drug or metabolites detected. Proposed § 26.185(j)(4) would be added to assure greater consistency in MRO determinations related to a donor’s use of a prescription or overthe-counter medication that the donor obtained legally in a foreign country. Again, the NRC is aware that MROs in different FFD programs have varied in the determination they make as to whether the use of medications legally obtained in a foreign county is an FFD policy violation. The proposed paragraph would clarify the NRC’s intent with respect to these circumstances. At the licensee’s or other entity’s discretion and in accordance with the FFD policy and procedures, the proposed rule would permit the MRO to confirm a test result as negative if there is a legitimate medical use for the medication that the donor obtained legally in a foreign country and the donor has used it properly for its intended medical purpose. The proposed rule would prohibit the MRO from confirming a test result as negative if the drug used has no legitimate medical purpose, including, but not limited to phencyclidine and heroin. Proposed § 26.185(j)(5) would be added to prohibit the MRO from considering the consumption of food products, supplements, and other preparations that are available over-thecounter as a legitimate medical explanation for the specimen having drugs or drug metabolites above the cutoff levels specified in proposed § 26.163, including, but not limited to hemp products and coca leaf tea. In so doing, the proposed rule would provide guidance concerning a potential subversion technique that has become an issue for several licensees (i.e., claims of ingestion of hemp food products as the basis for a positive marijuana test). Ingestion of food products containing hemp seeds or extracts has produced marijuana PO 00000 Frm 00131 Fmt 4701 Sfmt 4702 50571 positive test results, even though the seller claimed that the seeds or extracts were sterilized to remove the THC metabolite. The NRC endorses the Federal policy in this matter that was published by the Department of Transportation, with the concurrence of the Departments of Justice and Health and Human Services and the Office of National Drug Control Policy. MROs must never accept an assertion of consumption of a hemp food product as a basis for confirming that a marijuana test is negative. Consuming a hemp food product is not a legitimate medical explanation for a prohibited substance or metabolite in an individual’s specimen. When a specimen is positive for THC, the only legitimate medical explanation for its presence is a prescription for marinol. Under proposed § 26.29(a)(6) and (a)(7), individuals who are subject to Part 26 would receive training in order to be able to avoid ingesting substances that could result in positive drug test results, such as over-the-counter medications, food products, supplements, and other preparations. Proposed § 26.185(j)(6) would be added to prohibit the MRO from accepting the use of any drugs that are listed in Schedule I of section 202 of the Controlled Substances Act [21 U.S.C. 812] as a legitimate medical explanation for a positive confirmatory drug test result, even if the drug may be legally prescribed and used under State law. Drugs that are listed in Schedule I of section 202 of the Controlled Substances Act have the following characteristics: (1) The drug or other substance has a high potential for abuse; (2) the drug or other substance has no currently accepted medical use in treatment in the United States; and (3) there is a lack of accepted safety for use of the drug or other substance under medical supervision. The proposed prohibition would primarily be intended to address the medical use of marijuana, which some States permit, as well as the use of certain hallucinogenic drugs. Although some have argued that the use of such drugs under State laws may not adversely reflect on an individual’s trustworthiness and reliability, the proposed requirement would be necessary to ensure that individuals who are subject to this part can be trusted and relied upon to comply with Part 26 requirements and are not impaired from using these drugs when performing duties that require them to be subject to this part. Proposed § 26.185(k) [Results consistent with legitimate drug use] would amend current Section 2.9(f) in Appendix A to Part 26. The current E:\FR\FM\26AUP2.SGM 26AUP2 50572 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules paragraph instructs the MRO to report to the licensee that a drug test result is negative if, after review, the MRO determines that there is a legitimate medical explanation for the positive test result and that use of the substance identified through testing in the manner and at the dosage prescribed does not reflect a lack of reliability and is unlikely to create on-the-job impairment. However, the current provision does not provide instructions for MRO action in the case of an individual whose drug use is legitimate but may cause impairment on duty. Therefore, if the MRO determines that a risk exists, the proposed rule would require that a determination of fitness must be performed. Because the MRO determined that the drug test result was negative, the licensee or other entity would not impose sanctions on the individual. However, the results of the determination of fitness may indicate a need to establish controls and conditions on the individual’s performance of certain job duties, in order to ensure that any impairment from the drug use does not result in adverse impacts on public health and safety or the common defense and security. The proposed provision would meet Goal 3 of this rulemaking, which is to improve the effectiveness of FFD programs, by providing greater assurance that individuals who are subject to the rule are fit to safely and competently perform their duties. Proposed § 26.185(l) [Retesting authorized] would amend current Section 2.9(e) in Appendix A to Part 26, which permits the MRO to authorize retesting of an aliquot of a specimen if there is any question about the accuracy or validity of a drug test result. The proposed rule would retain the provisions in current Section 2.9(e) that permit a donor to request a retest of an aliquot of a single specimen or a split specimen, if the FFD program follows split specimen procedures. However, the proposed rule would update the current requirement for consistency with the terminology used throughout the proposed rule (e.g., ‘‘Bottle B’’ to refer to a split specimen), as discussed with respect to proposed § 26.5 [Definitions]. The proposed rule would also add a requirement that the retesting must be conducted at a second HHScertified laboratory that did not conduct the original tests. The proposed requirement that retesting must be performed at a second HHS-certified laboratory would ensure the independence of the second testing and provide additional protection of donors’ due process rights under the proposed VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 rule. In addition, the proposed requirement would increase the consistency of Part 26 with related provisions in the HHS Guidelines. The proposed rule would also require the donor to request the retest in writing, in order to ensure donors’ control over the specimen and rights to privacy, as discussed with respect to § 26.135(b). Proposed paragraph § 26.185(m) [Results scientifically insufficient] would amend current Section 2.9(g) in Appendix A to Part 26, which permits the MRO to determine that a positive drug test result is scientifically insufficient and declare it negative. The proposed paragraph would change some of the terminology used in the current paragraph (e.g., ‘‘samples’’ would be changed to ‘‘specimens’’) for consistency with the terminology used throughout the proposed rule, as discussed with respect to proposed § 26.5 [Definitions]. The proposed rule would also make other changes to this paragraph, as follows: The proposed paragraph would amend the first sentence of the current requirement, which permits the MRO to report to the licensee or other entity that a test result is negative if he or she determines that it is scientifically insufficient for further action. The proposed rule would instruct the MRO to report that the test result is ‘‘not an FFD policy violation’’ in these circumstances, rather than a negative test result. The proposed change would be made for consistency with other changes in the proposed rule related to invalid test results, as discussed with respect to proposed § 26.185(f). That is, a test result that the MRO determines to be scientifically insufficient for further action (as well as an invalid test result) could not be a basis for a licensee or other entity to grant or deny authorization or impose sanctions because it would be neither a negative nor non-negative test result. Therefore, the proposed change would meet Goal 6 of this rulemaking, which is to improve clarity in the language of the rule. The proposed rule would also add a statement to the current paragraph to indicate that the MRO is neither expected nor required to request retesting of the specimen unless, in the sole opinion of the MRO, such retesting is warranted. The proposed rule would add this statement because, in the experience of other Federal agencies, some MROs have been pressured by the organization to whom they provide services to request retesting of specimens that the MRO has confirmed to be non-negative. Although the NRC is not aware of any such instances in Part PO 00000 Frm 00132 Fmt 4701 Sfmt 4702 26 programs, the proposed rule would clarify that the MRO, alone, is authorized to request retesting to further protect the independence of the MRO function. In addition, the last sentence of current Section 2.9(g), which contains records retention requirements, would be moved to § 26.215(b)(11) of proposed Subpart J [Recordkeeping and Reporting Requirements] and grouped with other records retention requirements in the proposed rule for organizational clarity. Proposed § 26.185(n) [Evaluating results from a second laboratory] would establish new requirements for the MRO’s determination of an FFD policy violation based on a retest of a single specimen or a test of the specimen in Bottle B of a split specimen. The proposed paragraph would specify that the test result(s) from the second HHScertified laboratory would supersede the confirmatory test results provided by the HHS-certified laboratory that performed the original testing of the specimen. The proposed rule would incorporate these requirements from the HHS Guidelines because the current rule does not address MRO actions in response to test results from a second laboratory. Therefore, the proposed paragraph would be consistent with the related provisions in the HHS Guidelines and would meet Goal 1 of this rulemaking, which is to update and enhance the consistency of Part 26 with advances in other relevant Federal rules and guidelines. Proposed § 26.185(o) [Reauthorization after a first violation] would be added to address the MRO’s review of drug test results following a first violation of the FFD policy based on a confirmed positive drug test result. The current rule does not require the MRO to evaluate whether drug test results in these instances indicate subsequent drug use after a first confirmed positive drug test result, and MROs from different FFD programs have implemented different policies. Specifically, the proposed paragraph would require the MRO to determine whether subsequent drug test results indicate further drug use since the first positive drug test result was obtained. For example, because marijuana metabolites are fat-soluble and may be released slowly over an extended period of time, a second positive test result for marijuana from a test that is performed within several weeks after a first confirmed positive test result for marijuana may not, in fact, indicate further marijuana use. Therefore, in this case, the proposed provision would prohibit the MRO from determining that a second FFD policy violation for E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules marijuana had occurred, if the quantitative results from confirmatory testing of the second specimen are positive for marijuana metabolites, but at a concentration that would be inconsistent with additional marijuana use since the first non-negative test result was obtained. If the MRO concludes that the concentration of marijuana metabolites identified by confirmatory testing is inconsistent with further marijuana use since the first positive test result, the MRO would declare the test result as negative, even if the quantitative test result exceeds the 15 ng/mL confirmatory cutoff level specified in this part or a licensee’s or other entity’s more stringent cutoff level. The proposed provision would prevent individuals from being subject to a 5-year denial of authorization for a second confirmed positive drug test result under proposed § 26.57(e), when the donor has not engaged in further drug use, consistent with Goal 7 of this rulemaking, which is to protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.185(p) [Time to complete MRO review] would amend current § 26.24(e), which requires the MRO to complete his or her review of test results and notify management of the results of his or her review within 10 days after an initial presumptive positive screening test result. The proposed rule would replace the current phrase, ‘‘initial presumptive positive screening test result,’’ with the phrase, ‘‘initial non-negative test result,’’ for consistency with the terminology used throughout the proposed rule, as discussed with respect to proposed § 26.5 [Definitions]. The proposed paragraph would also require the MRO to report his or her determination that a non-negative test result is an FFD policy violation in writing to the licensee or other entity and in a manner that ensures the confidentiality of the information. The proposed changes would be made for consistency with the related provisions in the HHS Guidelines. Section 26.187 Substance Abuse Expert A new § 26.187 [Substance abuse expert] would be added to establish minimum requirements for a new position within FFD programs, the ‘‘substance abuse expert’’ (SAE), for the reasons discussed in Section IV. C. Proposed § 26.187(a) [Implementation] would be added to require SAEs to meet the requirements of this proposed section within 2 years of the date on which the final rule is published in the Federal Register. The VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 2-year period would be proposed in order to ensure that professionals who may currently be performing determinations of fitness, but who do not meet these proposed requirements, have the time necessary to obtain the required credentials, knowledge, and qualification training. Proposed § 26.187(b) [Credentials] would be added to establish the credentials required for an individual to serve as an SAE under this part. The proposed rule would require that the SAE must possess the extensive education, training, and supervised clinical experience that are prerequisites for obtaining the professional credentials listed in proposed § 26.187(b)(1)–(b)(5). However, proposed § 26.187(c)–(e) would require an SAE to possess additional knowledge and experience directly related to substance abuse disorders and the requirements of this part. Proposed § 26.187(c) [Basic knowledge] and (d) [Qualification training] would be added to establish the specific areas of expertise and training that would be required for an individual to serve as an SAE under this part. The proposed knowledge and training requirements in these two paragraphs would be necessary to ensure that SAEs possess the knowledge and clinical experience required to perform the SAE function effectively in a Part 26 program. Proposed § 26.187(c) would require SAEs to possess the following types of knowledge: (1) Knowledge of and clinical experience in the diagnosis and treatment of alcohol and controlledsubstance abuse disorders, in proposed § 26.187(c)(1); (2) knowledge of the SAE function as it relates to individuals who perform the job duties that require an individual to be subject to this part, in proposed § 26.187(c)(2); and (3) knowledge of this part and any changes to its requirements, in proposed § 26.187(c)(3). Proposed § 26.187(d) would establish the topical areas in which an SAE must be trained. The proposed qualification training requirements would include training in the following areas: (1) The background, rationale, and scope of this part, in proposed § 26.187(d)(1); (2) key drug and alcohol testing requirements of this part, in proposed § 26.187(d)(2) and (d)(3), respectively; (3) SAE qualifications and prohibitions, in proposed § 26.187(d)(4); (4) the role of the SAE in making determinations of fitness, and developing treatment recommendations and followup testing plans, in proposed § 26.187(d)(5); (5) procedures for consulting and communicating with licensee or other PO 00000 Frm 00133 Fmt 4701 Sfmt 4702 50573 entity officials and the MRO, in proposed § 26.187(d)(6); (6) reporting and recordkeeping requirements of this part as they related to the SAE function, in proposed § 26.187(d)(7); and (7) appropriate methods for addressing issues that SAEs confront in carrying out their duties under this part, in proposed § 26.187(d)(8). Proposed § 26.187(e) [Continuing education] would be added to ensure that SAEs maintain the knowledge and skills required to perform the SAE function under this part. The proposed paragraph would require SAEs to complete at least 12 continuing professional education hours relevant to performing the SAE function during each 3-year period following completion of initial qualification training. Proposed § 26.187(e)(1) would describe the topics that must be covered in the continuing education training, to include, but not limited to, new drug and alcohol testing technologies, and any rule interpretations or new guidance, rule changes, or other developments in SAE practice under this part, since the SAE completed the qualification training requirements in proposed § 26.187(d). Proposed § 26.187(e)(2) would require documented assessment of the SAE’s understanding of the material presented in the continuing education activities in order to ensure that the SAE learned the material. These proposed continuing educations requirements would necessary to ensure that SAEs maintain updated knowledge and skills to continue performing the SAE function effectively under this part. Proposed § 26.187(f) [Documentation] would be added to specify the records that the SAE must maintain in order to demonstrate that he or she meets the proposed requirements of this section. The SAE would be required to provide the documentation, as requested, to NRC representatives, and to licensees or other entities who would rely on the SAE’s services. Licensees and other entities who intend to rely upon a determination of fitness that is made by an SAE under another FFD program would also be required to have access to this documentation. These proposed requirements would be necessary to ensure that licensees and other entities, and the NRC, have access to the documentation required to verify that the SAE’s knowledge, training, and practice meet the requirements of this part. Proposed § 26.187(g) [Responsibilities and prohibitions] would be added to specify the responsibilities of SAEs within a licensee’s or other entity’s FFD program and their limitations. E:\FR\FM\26AUP2.SGM 26AUP2 50574 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules Proposed § 26.187(g)(1) would specify at least three circumstances in which the SAE would be responsible for making a determination of fitness under the proposed rule. In proposed § 26.187(g)(1)(i), an SAE may be called upon to make a determination of fitness regarding an applicant for authorization when the self-disclosure, the suitable inquiry, or other sources of information identify potentially disqualifying FFD information about the applicant. In proposed § 26.187(g)(1)(ii), an SAE may be called upon to make a determination of fitness when an individual has violated the substance abuse provisions of a licensee’s or other entity’s FFD policy, including, but not limited to a first confirmed positive drug test result. Related provisions in proposed § 26.69 [Authorization with potentially disqualifying FFD information] would require the licensee or other entity to rely upon the results of the SAE’s determination of fitness when making a decision to grant or maintain an individual’s authorization and implement any recommendations from the SAE for treatment and followup testing. In proposed § 26.187(g)(1)(iii), an SAE may be called upon to make a determination of fitness when there is a concern that an individual may be impaired as a result of the use of prescription or over-the-counter medications, or alcohol. Related provisions in proposed § 26.77 [Management actions regarding possible impairment] would require the licensee or other entity to rely upon the results of the SAE’s determination of fitness when determining whether an individual may perform job duties that require the individual to be subject to this part. Therefore, the proposed paragraph would be added for consistency with other, related provisions in the proposed rule. Proposed § 26.187(g)(2) would be added to require the SAE to act as a referral source to assist an individual’s entry into an appropriate treatment or education program and prohibit the SAE from engaging in any activities that could create the appearance of a conflict of interest. Proposed § 26.187(g)(2)(i) would prohibit the SAE from referring an individual to any organization with whom the SAE has a financial relationship, including the SAE’s private practice, to avoid creating the appearance of a conflict of interest. However, proposed § 26.187(g)(2)(ii)(A)–(g)(2)(ii)(D) would specify circumstances in which the prohibition in proposed § 26.187(g)(2)(i) would not apply. In general, the proposed rule would permit the SAE to VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 refer an individual to an entity with whom the SAE has a financial relationship in situations where treatment and educational resources may be limited by cost considerations or geographical availability. These proposed provisions would be necessary to ensure that the SAE’s determinations are not influenced by financial gain and that individuals who are subject to the rule and the public can have confidence in the integrity and independence of the SAE function in Part 26 programs. Section 26.189 Determination of Fitness Proposed § 26.189 [Determination of fitness] would be added to present together in one section and amend current requirements related to the determination that an individual is fit to safely and competently perform the job duties that require individuals to be subject to this part. The terms, ‘‘medical assurance’’ and ‘‘medical determination of fitness,’’ used in various sections of the current rule [e.g., § 26.27(a)(3), (b)(2) and (b)(4)] would be replaced with the term, ‘‘determination of fitness,’’ as defined in this proposed section. This proposed change in terminology would be made because the rule would permit healthcare professionals other than licensed physicians to conduct determinations of fitness, as discussed with respect to proposed § 26.187 [Substance abuse expert]. Therefore, the proposed change would meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule. Proposed § 26.189(a) would be added. The first sentence of the proposed paragraph would define the term, ‘‘determination of fitness.’’ This term would refer to the process followed to determine whether there are indications that an individual may be in violation of the licensee’s or other entity’s FFD policy or is otherwise unable to safely and competently perform his or her duties. In general, the proposed rule would require that professionals who perform determinations of fitness must be qualified and possess the requisite clinical experience, as verified by the licensee or other entity, to assess the specific fitness issues presented by an individual whose fitness may be questionable. The proposed approach to designating the healthcare professionals who may conduct a determination of fitness focuses on the appropriateness of the professional’s expertise for addressing the subject individual’s fitness issue, rather than on the professional’s organizational affiliation [see the discussion of proposed PO 00000 Frm 00134 Fmt 4701 Sfmt 4702 § 26.69(b)(4)] or whether the individual is a licensed physician. Therefore, proposed § 26.189(a)(1)–(a)(5) would provide examples of the healthcare professionals who would be qualified to address various fitness issues that may arise in a FFD program. When a decision must be made to determine whether an individual may be granted or maintain authorization and a substance abuse disorder is involved, only professionals who meet the requirements to serve as an SAE would be permitted to make determinations of fitness under proposed § 26.189(a)(1). The proposed rule would permit other healthcare professionals to perform determinations of fitness that involve assessing and diagnosing impairment from causes other than substance abuse, such as clinical psychologists in proposed § 26.189(a)(2), psychiatrists in proposed § 26.189(a)(3), physicians in proposed § 26.189(a)(4), or an MRO in proposed § 26.189(a)(5), consistent with their professional qualifications. The proposed rule would also permit other licensed and certified professionals who are not listed in the proposed paragraph, such as registered nurses or physicians’ assistants who have the appropriate training and qualifications, to perform a determination of fitness regarding specific fitness issues that are within their areas of expertise. However, the critical tasks of assessing the presence of a substance abuse disorder, providing input to authorization decisions, and developing treatment plans would be reserved for healthcare professionals who have met the specific training, clinical experience, and knowledge requirements for an SAE under proposed § 26.187 [Substance abuse expert] for the reasons discussed with respect to that proposed section. The proposed rule would also prohibit healthcare professionals who may conduct a determination of fitness for a Part 26 program from addressing fitness issues that are outside of their specific areas of expertise, consistent with the ethical standards of healthcare professionals’ disciplines as well as State laws. The proposed rule would add this prohibition to clarify that the ethical standards and State laws also apply to making determinations of fitness under Part 26 because a determination of fitness conducted by a professional who is not qualified to address the specific fitness issue would be of questionable validity. Therefore, the proposed prohibition would be necessary to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs, as well as Goal 7, which is to E:\FR\FM\26AUP2.SGM 26AUP2 Federal Register / Vol. 70, No. 165 / Friday, August 26, 2005 / Proposed Rules protect the privacy and due process rights of individuals who are subject to Part 26. Proposed § 26.189(b)(1)–(b)(4) would list and present together the circumstances in which a determination of fitness must be performed, as required in other sections of the proposed rule. Although this proposed paragraph would be redundant with other sections of the proposed rule, these circumstances would be listed in the proposed paragraph to meet Goal 6 of this rulemaking, which is to improve clarity in the organization and language of the rule, by grouping related requirements together in the order in which they would apply to licensees’ and other entities’ FFD processes. Proposed § 26.189(b)(1) would reiterate the requirement in current Section 2.9(f) in Appendix A to Part 26 and proposed § 26.185(k) that a determination of fitness must be performed when there is a medical explanation for a non-negative test result, but a potential for impairment exists. For example, legitimate use of some psychotropic medications or medications for pain relief may cause impairment in some individuals and it may be necessary to limit the types of tasks the individual performs until the medication is no longer necessary, or the person adjusts to its effects. Proposed § 26.189(b)(2) would reiterate requirements in current § 26.27(b)(1) and (b)(4) and proposed § 26.69(b) [Authorization after a first confirmed positive drug or alcohol test result or a 5-year denial of authorization] that a determination of fitness must be performed before an individual is granted authorization following an unfavorable termination or denial of authorization for a violation of a licensee’s or other entity’s FFD policy. Proposed § 26.189(b)(3) would reiterate the requirement in proposed § 26.69(c) [Granting authorization with other potentially disqualifying FFD information] that a determination of fitness must be performed before an individual is granted authorization when potentially disqualifying FFD information is identified that has not been previously addressed and resolved under a Part 26 FFD program. Proposed 26.189(b)(4) would address other circumstances in which a determination of fitness may be required. For example, a determination of fitness may be necessary if an FFD concern has been raised regarding another individual, as required in proposed § 26.27(c)(4), and if a licensee’s or other entity’s reviewing official requires one, in accordance with proposed § 26.69(c)(3) and (d)(2). VerDate Aug<18>2005 14:39 Aug 25, 2005 Jkt 205001 Proposed § 26.189(c) would be added to establish requirements for a determination of fitness that is conducted ‘‘for cause.’’ Specifically, proposed § 26.189(c) would require that a determination of fitness that is conducted for cause must be conducted through face-to-face interaction to ensure that the professional who is performing the determination has available all of the sensory information that may be required for the assessment, such as the smell of alcohol or the individual’s physical appearance. The immediacy of the decision would limit the amount of information that could be gathered and made available to the professional by others. Conversely, the proposed paragraph would not require that determinations of fitness for other purposes be conducted face-to-face. These other purposes may include, but would not limited to, the determination of fitness that would be required when an applicant for authorization has selfdisclosed potentially disqualifying FFD information. Determinations of fitness in these other circumstances would focus primarily on historical, rather than immediate, information. The professional would have access to information that could be gathered by others about the individual, and no time urgency would be involved in the evaluation. Therefore, the proposed paragraph would be added to meet Goal 3 of this rulemaking, which is to improve the effectiveness and efficiency of FFD programs, by requiring a face-toface assessment in some circumstances where electronic means of communication could not provide the requisite information for the evaluation, and permitting other means of conducting the assessment when those means provide increased flexibility to licensees and other entities while continuing to achiev