ML19155A270

VR-SECY-17-0027: Proposed Rulemaking: Fitness-for-Duty Drug Testing Requirements (Rin 3150-Al67)

ML19155A270
Person / Time
Issue date:	06/03/2019
From:	Jeff Baran, Bavol R, Annie Caputo, Kristine Svinicki, David Wright NRC/Chairman, NRC/OCM/AXC, NRC/OCM/DAW, NRC/OCM/JMB, NRC/SECY
To:
References
SECY-17-0027 VR-SECY-17-0027
Download: ML19155A270 (269)

Text

TO: FROM:

SUBJECT:

RESPONSE SHEET Annette Vietti-Cook , Secretary Commissioner Caputo SECY-17-0027:

PROPOSED RULEMAKING:

FITNESS FOR DUTY DRUG TESTING REQUIREMENTS (RIN 3150 Al67). Approved XX Disapproved_

Abstain_ Not Participating_

Comments:

Below Entered iJ1 STARS Yes v No Attached XX None Commissioner Caputo's Comments on SECY-17-0027, "Proposed Rulemaking:

Fitness-for-Duty Drug Testing Requirements" In SECY-17-0027 , the Staff proposes various changes to the NRC's current Fitness for Duty (FFD) rules. The NRC generally aligns its regulations with guidelines provided by the U.S. Department of Health and Human Services (HHS), and this rule seeks to incorporate the 2008 revisions to the HHS guidelines that went into effect over 10 years ago. Specifically , the Staff proposes to enact changes that will lower the initial and confirmatory drug testing cutoff levels for amphetamines and cocaine metabolites , add initial drug test for a heroin metabolite and three Ecstasy-type drugs, strengthen methods for detecting subversion attempts , and enhance donor protection by requiring consideration of certain circumstances as possible causes for some invalid test results. Staff recognizes that this rulemaking is a backfit because it constitutes a new or amended provision in the Commission

's regulations that would be imposed on current licensees.

The Staff asserts that this rulemaking would result in an estimated 10-to 12-percent increase in the number of individuals identified each year using illegal drugs, misusing legal drugs , or attempting to subvert the drug testing process. Thus, this rulemaking constitutes a substantial increase in the overall protection of public health and safety and the common defense and security.

Staff also asserts that this rulemaking is cost justified. Staff quantified the benefits of three attributes, 1 but considered the remaining seven attributes 2 using qualitative techniques. Staff asserted that the use of qualitative techniques was required because monetizing the full impact each attribute was not possible or practical because it would require the estimation of factors such as the frequency of accidents and other safety-and security-related events cause by drug-induced impairment and the consequences of such events. Staff states that this data does not exist. After reviewing the proposed rule and the Staff's backfit analysis, I agree that this rule constitutes a substantial increase in the overall protection public health and safety and the comm.on defense and security. I also agree that the rule is cost justified. While I am typically skeptical of reliance on the use of qualitative techniques for evaluating benefits , I recognize the limitation of data regarding the majority of the attributes evaluated by Staff. I therefore accept Staff's justification of this rule as cost-justified.

Despite my acceptance of the Staff's proposed rule, I am concerned with the lag in incorporating the information contained in the HHS Guidelines. It is my understanding that in 2017 HHS released updated guidelines which, among other th i ngs, expands the testing panel to include four prescription opiate painkillers (hydromorphone, hydrocodone, oxymorphone, and oxycodone

). While I understand the Staff's process for incorporating these updates relies on gathering sufficient data to support a technical basis for imposing these requirements on licensees, I am concerned that such lag unnecessarily increases the danger of an impaired 1 Industry implementation , industry operation , and NRC implementation 2 Public health (accident), occupat i onal health (accident , offsite property , onsite property , regulatory efficiency , safeguards and security considerations , and other considerations (which include public perception , workplace productivity , workplace safety , and improved protect i on of individual rights) individual gaining access to restricted areas. Absent this lag, the 10-to 12-percent increase anticipated by this rule would have been recognized over the past 10 years. The Staff should therefore analyze this issue and provide the Commission with an options paper examining making our FFD regulations more performance based with the intent to formulate a more performance-based approach that would eliminate this lag in incorporating new drugs and testing procedures into our regulations.

AC Edits NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 [NRC-2009-0225]

RIN 3150-Al67 Fitness for Duty Drug Testing Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule and draft regulatory guide; request for comment. [7590-01-P]

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug testing requirements with the updates made in 2008 to the U.S. Department of Health and Human Services (HHS) " Mandatory Guidelines for Federal Workplace Drug Testing Programs" (HHS Guidelines). The proposed rule would also incorporate lessons learned from implementation of the NRC's current FFD regulations. These changes would enhance the ability of NRC licensees and other entities to identify additional individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. The proposed rule would also provide additional protections to individuals subject to drug testing , and would improve the clarity , organization , and flexibility of the NRC's FFD regulations.

The NRC is also requesting comment on draft regulatory guide (DG) DG-5040.

DATES: Submit comments by [INSERT DATE 75 DAYS FROM DATE OF PUBLICATION).

Comments received after this date will be considered if it is practical to do so , but the Commission is able to assure consideration only for comments received on or before this date. ADDRESSES:

You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

• Federal Rulemaking Web site: Go to http://www.requlations

.gov and search for Docket ID NRC-2009-0225.

Address questions about NRC dockets to Carol Gallagher; telephone:

301-415-3463; e-mail: Carol.Gallaqher@nrc

.gov. For technical questions, contact the individual listed in the FOR FURTHER INFORMATION CONTACT section of this proposed rule.

• E-mail comments to: Rulemaking

.Comments@nrc.gov. If you do not receive an automatic e-mail reply confirming receipt, then contact us at 301-415-1677.

• Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-11

01.

• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

• Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852, between 7:30 a.m. and 4: 15 p.m. (Eastern Time) Federal workdays; telephone: 301-415-1677. For additional direction on obtaining information and submitting comments , see "Obtaining Information and Submitting Comments" in the SUPPLEMENTARY INFORMATION section of this document.

2 FOR FURTHER INFORMATION CONTACT: Stewart Schneider, Office of Nuclear Reactor Regulation, telephone: 301-415-4123

e-mail

Stewart.Schneider@nrc.gov

Brian Zaleski , Office of Nuclear Security and Incident Response , telephone

301-287-0638

email

Brian.Zaleski@nrc

.gov; or Paul Harris, Office of Nuclear Security and Incident Response, telephone:

301-287-9294; e-mail: Paul.Harris@nrc

.gov; U.S. Nuclear Regulatory Commission, Washington DC 20555-0001. SUPPLEMENTARY INFORMATION:

EXECUTIVE

SUMMARY

A. Need for the Regulatory Action The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug test i ng requirements with the updates made in 2008 to the U.S. Department of Health and Human Services (HHS) " Mandatory Guidelines for Federal Workplace Drug Testing Programs" (HHS Guidelines), which were published in the Federal Register on November 25, 2008 (73 FR 71858), and became effective on October 1, 2010. The HHS Guidelines govern Federal employee workplace drug testing programs at more than 100 Federal agencies and comparable Federal agency drug testing programs (e.g., U.S. Department of Transportation (DOT) that test civilians in safety-and sensitive positions similar to personnel tested under Part 26 , " Fitness for Duty Programs ," in Title 10 of the Code of Federal Regulations ( 10 CFR). More closely aligning the drug testing provisions under 10 CFR part 26 with the 2008 HHS Guidelines would enhance the ability of licensees and other entities to identify additional individuals using illegal drugs and misusing 3 legal drugs. The proposed rule would also incorporate lessons learned from implementation of the 10 CFR part 26 final rule published in the Federal Register on March 31 , 2008 (73 FR 16966; hereafter referred to as " 2008 FFD final rule"). These lessons include improved methods to identify attempts to subvert the drug testing process , and improvements in the clarity , consistency , and flexibility of ,--aoo donor protections under 10 CFR part 26. Historically , the NRC has relied upon the HHS Guidelines to establish the technical requirements for urine specimen collection , drug testing , and results evaluation, and has required licensees and other entities to use HHS-certified laboratories to perform drug testing. The last NRC alignment with the HHS Guidelines was completed with the 2008 FFD final rule , which incorporated provisions from the 2004 HHS Guidelines (69 FR 19644; April 13 , 2004). B. Major Provisions Major provisions of the proposed rule include changes tothe following:

• Add initial and confirmatory drug testing for three illegal amphetamine-based controlled substances

-methylenedioxymethamphetamine (MOMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA)-referred to as Ecstasy-type drugs in this proposed rule.

• Add initial drug testing for 6-acetylmorphine (6-AM), a metabolite of the illegal drug heroin , and update the confirmatory drug testing method for 6-AM.

• Lower the drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine.

• Enhance the detection of subversion attempts by strengthening the testing methods used to identify drugs and drug metabolites in urine specimens with dilute validity test results and in specimens collected under direct observation. 4

• Require Medical Review Officers (MROs) to evaluate the elapsed time from specimen collection to testing and exposure to high temperature, as possible causes of some invalid test results due to high solvated hydrogen ion concentration (i.e., pH).

• Improve the clarity , consistency , and organization of 10 CFR part 26 (e.g., add and update definitions), increase flexibility (e.g., personnel who may monitor a donor in a shybladder situation who is hydrating), and enhance both donor protections (e.g., additional instructions for same-gender observers used in observed collections) and due process (e.g., MRO documenting the date and time that an oral request is received from a donor to initiate the retesting of a specimen). C. Costs and Benefits The NRC prepared a draft regulatory analysis to quantify the costs and benefits of the proposed rule, as well as to examine the qualitative factors to be considered in the NRC's rulemaking decision.

The analysis concluded that the proposed rule would result in net costs to the industry. The proposed rule , relative to the regulatory baseline , would result in a net cost for industry of between $2.4 million based on a 7 percent net present value and $3.4 million based on a 3 percent net present value. The estimated average net cost per licensee or other entity site would be a one-time cost of $5,031 and an annual cost of $2,516. Thirteen qualitative factors were evaluated in the draft regulatory analysis:

public health (accident), occupational health (accident), offsite property, onsite property, regulatory efficiency, safeguards and security considerations, and other considerations (public perception, public trust , worker productivity, improved protection of individual rights, work environment free of drugs and the effects of such substances , safety vulnerability , and security vulnerability). The draft regulatory analysis includes a discussion of each qualitative factor. 5 If the results of the regulatory analysis were based solely on the costs and the benefits that could be quantified , then the regulatory analysis would show that rulemaking is not justified because the total estimated quantified benefits of the proposed regulatory action do not equal or exceed the estimated costs of the proposed regulatory action. However, if the qualitative benefits are considered, together with the quantified benefits, then the benefits outweigh the identified quantitative and qualitative impacts. In the draft regulatory analysis, the NRC concluded that the proposed rule should be adopted because it would result in a 10-to 12-percent increase per year in the detection of individuals using drugs or attempting to subvert the drug testing process. In comparison to the test results from calendar years 2013 and 2014, the estimated increase in detection each year is equivalent to identifying approximately 95 additional individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. This improved detection would prevent additional drug-using individuals from gaining or maintaining unescorted access authorization to NRG-licensed facilities (i.e., operating nuclear power reactors, nuclear power reactors under construction, and Category I fuel cycle facilities) and other locations (e.g., Emergency Operations Facilities, Technical Support Centers).

In addition, the enhanced detection would prevent additional drug-using individuals from gaining or maintaining unescorted access authorization to special strategic nuclear material (SSNM) or sensitive information.

An enhanced drug testing program might also deter additional drug-using individuals from seeking employment in 10 CFR part 26-regulated positions and/or incentivize those already in regulated positions to cease drug use or to seek medical assistance to address an addiction or misuse issue. For more information, please see the regulatory analysis (Accession No. ML16123A006 in the NRC's Agencywide Documents Access and Management System (ADAMS)). 6

' TABLE OF CONTENTS:

I. Obtaining Information and Submitting Comments A. Obtaining Information

8. Submitting Comments 11. Background A. The Health and Human Services Gu i delines 8. History of the NRC's Fitness for Duty Program 111. Discussion A. The Need for Rulemaking

1. Alignment with the 2008 Health and Human Services Guidelines

2. Societal Drug Use 8. Public Input Regarding Proposed Revisions to 10 CFR Part 26 to Include Aspects of the 2008 Health and Human Services Guidelines C. Description of Proposed Changes IV. Section-by-Section Analys i s V. Specific Requests for Comments VI. Regulatory Flexibility Certification VII. Regulatory Analysis VII I. Backfitting and Issue Finality IX. Cumulative Effects of Regulation X. Plain Writing XI. Environmental Impact: Categorical Exclusion XII. Paperwork Reduction Act Statement 7

XIII. Compatibility of Agreement State Regulations XIV. Voluntary Consensus Standards XV. Availability of Guidance XVI. Availability of Documents I. Obtaining Information and Submitting Comments A. Obtaining Information Please refer to Docket ID NRC-2009-0225 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0225.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www.nrc.gov/reading-rm/adams.html.

To begin the search, select " ADAMS Public Documents" and then select " Begin Web-based ADAMS Search." For problems with ADAMS , please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr.resource@nrc.gov. For the convenience of the reader , instructions about obtaining materials referenced in this document are provided in the " Availability of Documents" section of this document.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR , Room 01-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. 8 B. Submitting Comments Please include Docket ID NRC-2009-0225 in your comment submission. The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission.

The NRC will post all comment submissions at http://www.regulations.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information. If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS. II. Background A. The Health and Human Services Guidelines Through Executive Order 12564 (51 FR 32889; September 17, 1986), the President of the United States designated the Department of Health and Human Services (HHS) as the Federal agency responsible for establishing and maintaining the requirements and guidance for conducting Federal employee workplace drug testing. In execution of this designation , and under the authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 notes, HHS developed the " Mandatory Guidelines for Federal Workplace Drug Testing Programs" (HHS Guidelines) that established a robust legal framework to conduct drug testing to provide the 9 following: reasonable assurance of donor privacy~. drug testing accuracy and precision~. specimen collection

... aR*1-custody ... and control~. and results review by a Medical Review Officer (MRO). The HHS Guidelines also established the certification requirements that each laboratory must meet to test specimens for Federal employee workplace drug testing programs.

To obtain certification, a laboratory must successfully complete several rounds of performance testing and a National Laboratory Certification Program (NLCP) inspection.

The certification requirements include, but are not limited to , laboratory staffing and qualifications , testing procedures , quality assurance and quality control, and results reporting. Once certified , each laboratory is subject to quarterly performance testing and NLCP inspection every 6 months to verify adherence to the HHS Guidelines.

The HHS laboratory certification process provides assurance to the NRC , licensees, and other entities that the testing of specimens, under 10 CFR part 26, is conducted with the highest standards of accuracy, precision, and quality. HHS periodically updates the HHS Guidelines to.;-enhance testing program effectiveness based on advances in drug testing technologies, processes, methodologies, and instrumentation

include additional substances in the testing panel , as societal drug-use trends change; and incorporate lessons learned from the NLCP. Each revision of the HHS Guidelines is published following a rigorous process that includes , but is not limited to, scientific, policy, legal , and technical review by the independent Drug Testing Advisory Board , which advises the Administrator of the HHS Substance Abuse and Mental Health Services Administration (SAMHSA);

academic peer reviews; public review and comment; and input from Federal agencies that implement the HHS Guidelines. The HHS also conducts extensive outreach with affected stakeholders and researches societal drug-use trends to promulgate effective drug testing methods. 10 The HHS Guidelines govern the drug testing programs of over 100 Federal agencies that test Federal employees, are used by many Federal agencies that test civilians in and security-sensitive positions similar to personnel tested under 10 CFR part 26, such as the U.S. Department of Transportation (DOT), and by many private entities. The NRC has historically relied on HHS to establish the technical requirements for urine specimen collection , specimen testing and test result evaluation, and in general, only deviates from the HHS Guidelines for considerations specific to the nuclear industry.

The NRC relies on the HHS Guidelines as part of its technical basis for the drug testing requirements contained under 10 CFR part 26. Updating 10 CFR part 26 to align with changes in the 2008 HHS Guidelines would help to ensure that the NRC's regulations continue to be scientifically and technically sound. B. History of the NRC's Fitness for Duty Program In the 1970s, the NRC and the commercial nuclear power industry began addressing concerns about the potential public health and safety impacts of fitness for duty (FFD) problems at nuclear power plants. Most nuclear utilities voluntarily implemented FFD programs during the 1980s, and the NRC monitored the comprehensiveness and effectiveness of these programs. On August 4, 1986, the NRC published the Commission Policy Statement on Fitness for Duty of Nuclear Power Plant Personnel (51 FR 27921 ), which outlined the need for nuclear power plant licensees to implement programs to address FFD problems -including illegal drug use, alcohol abuse, misuse of legal drugs, and any other mental or physical problems that could impair job performance. An evaluation of licensee programs following the implementation of the policy statement identified a wide range in the quality and comprehensiveness of licensee FFD testing programs that ultimately resulted in the NRC's decision to pursue rulemaking. 11 The NRC published a final rule, entitled " Fitness-for-Duty Programs ," in the Federal Register on June 7 , 1989 (54 FR 24468), adding 10 CFR part 26. The 1989 FFD final rule was based on the 1988 version of the HHS Guidelines (53 FR 11970; April 11, 1988). A subsequent final rule, published in the Federal Register on June 3, 1993 (58 FR 31467), expanded the scope of 10 CFR part 26 to include licensees authorized to possess , use , or transport formula quantities of strategic special nuclear materials (SSNM). The NRC issued the first substantial revision to 10 CFR part 26 in a final rule on March 31, 2008 (73 FR 16966; hereafter referred to as the " 2008 FFD final rule"). The 2008 FFD final rule updated the NRC's drug testing requirements to align with the then-latest HHS Guidelines, which were issued in 2004 (69 FR 19644; April 13 , 2004 ). The 10 CFR part 26 updates included the following: 1) required validity testing of each specimen to address the potential for subversion of the testing process, 2) advancements in drug and alcohol testing technologies , 3) changes to drug and alcohol testing cutoff levels, and 4) lessons learned from the implementation of 10 CFR part 26 since its addition in 1989. On November 25 , 2008, HHS issued the 2008 HHS Guide.lines (73 FR 71858), which included the following: 1) an expanded drug testing panel , 2) lower drug testing cutoff levels for some substances, 3) advances in testing technologies , and 4) more detailed requirements for specimen collectors and MROs. The 2008 HHS Guidelines became effective on October 1 , 2010. The 2008 Guidelines

' updates to the 2004 Guidelines are currently not reflected in 10 CFR part 26. 12 Ill. Discussion A. The Need for Rulemaking

1. Alignment with the 2008 Health and Human Services Gu i delines In the 2008 HHS Guidelines , HHS enhanced the detection of illegal drug use and the misuse of prescr i ption drugs through the following changesby: 1) lowering the initial and confirmatory testing cutoff levels for amphetamine , cocaine , and methamphetamine;

2) establishing an initial testing requirement and revising the confirmatory testing cutoff level for the heroin metabolite 6-AM; and 3) establishing testing for Ecstasy-type drugs (which are part of the amphetamine class of drugs). The effectiveness of the 2008 HHS Guidelines is demonstrated by the enhanced detection evident in the test results reported by HHS, the DOT , and Quest Diagnostics (Quest), which is an HHS-certified laboratory that conducts testing for both Federal workplace drug testing programs (i.e., Federally-mandated) and private company testing programs (i.e., U.S. general workforce).

Quest annually publishes a Drug Testing IndexŽ report, which presents Quest laboratory testing results for Federally-mandated drug tests. On March 13 , 2012 , Quest reported a 33 percent increase from 2010 to 2011 in cocaine positive test results for 1.6 million Federal workplace tests conducted.

Quest attributed the increase, in large part , to the lower cocaine testing cutoff levels implemented as a result of the 2008 HHS Guidelines (Quest, 2012). In the same report , Quest also noted that amphetamines positives rose by nearly 26 percent , continuing an existing upward trend , but also were " likely boosted by better detection related to the new, lower Federally-mandated cutoffs." In compar i son to the 201 O positive testing rates for Federal workplace drug testing performed by Quest , the results for 2012 indicate a 12.5 percent increase in cocaine positives and a 37 percent increase in amphetamines positives with 2013 continuing the multi-year upward trend (Quest , 2014). 13 As detailed in the most resent NRC report, "Summary of Fitness for Duty Performance Reports for Calendar Year 2013," an adverse trend in the commercial nuclear industry has been observed over the ~prior 5 years associated with the year-over-year increases in amphetamines 1 positive test results (see table in this section).

While accounting for a relatively small percentage of the total positive drug test results in 2013 at 8.9 percent, amphetamines positives have continued to grow in comparison to previous years. For example, the share of amphetamines positives, as a percentage of all positive drug test results in 2013 (8.9 percent), is 2.3 times higher than the percentage in 2009 (3.9 percent).

Viewed another way, the percentage of individuals testing positive for amphetamines has trended upward since 2009. In 2009, 0.023 percent of individuals tested positive for amphetamines; by 2013, the positive rate increased to 0.052 percent. Conversely, cocaine use as a percentage of all positives has declined by 15.9 percent from 1990 (the first year of 10 CFR part 26 drug testing) to 2013. While cocaine use has trended downward, it continues to be the third most detected substance, accounting for 13.2 percent of positive drug test results in 2013. Trends in Amphetamines and Cocaine Use Substance 1990 2009 2010 2011 2012 2013 Change (1990 -2013) Amphetamines 2.8% 3.9% 5.7% 8.3% 6.2% 8.9% 6.1% Cocaine 29.0% 16.2% 13.1% 12.4% 12.9% 13.2% -15.9% Notes: 1. The positive testing percentages are calculated by taking the total number of positives for the particular substance and dividing that figure by the total number of positive drug test results in the year. 2. Data from 1990 , the first year of testing under 1 O CFR part 26, are included as the baseline for comparison. 1 10 CFR part 26 requires initial drug testing for amphetamines and confirmatory drug testing for amphetamine and methamphetamine. 14 I While most of the proposed changes in this rulemaking would be made to better align 10 CFR part 26 with the 2008 HHS Guidelines , some are based on lessons learned during the implementation of the 2008 FFD final rule by licensees and other entities. In particular, the NRC is proposing a number of changes that would enhance the ability of licensees and other entities to identify individuals attempting to subvert the drug testing process. Beginning in 2009 , licensees and other entities had the option to use electronic reporting forms (e-forms) created by the NRC , in collaboration with licensees and other entities, in order to meet the annual FFD drug and alcohol testing program reporting requirements in § 26. 717, " Fitness-for-duty program performance data" and § 26.417(b )(2). These e-forms 2 provide a uniform way of reporting detailed information on each drug and alcohol testing violation, and their use by licensees and other entities has continued to grow (from over 80 percent in 2011 to 93 percent in 2013). Analysis of FFD program performance data from 2011 through 2014 identified a significant new trend: the prevalence of subversion attempts of the drug testing process. In 2011 , over 13.2 percent of the total testing violations were donor subversion attempts ( 143 of 1,080 testing violations), with even more subversion attempts in subsequent years: 15.9 percent in 2012 ( 177 of 1, 114 testing violations), 14. 7 percent in 2013 ( 148 of 1,007 violations), and 16.5 percent in 2014 ( 187 of 1, 133 testing violations). If the number of alcohol positive testing violations is removed from the total testing violations each year , the percentage of drug testing violations determined to be subversion attempts increases to 17 .5 percent in 2011, 20.6 percent in 2012 , 19.2 percent in 2013, and 21.3 percent in 2014. An attempt to subvert the testing process demonstrates a lack of integrity and honesty and a willful act to 2 The NRC FFD e l ectronic forms are available for review at the following NRC website: http://www

.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-programs/submit-ffd-reports.html 15 refuse to comply with an NRG-required drug test (see 10 CFR 26.89(c), 26.825 , " Criminal penalties ," and 50.5 , " Deliberate misconduct

"). Consequently, these drug-using individuals present a safety vulnerability because of the potential for human performance issues due to drug use. These drug-using individuals also present a security vulnerability because of their impairment or w i llful misconduct.

As a result , the NRC is proposing a number of changes in this proposed rule to enhance the ability of FFD testing programs to detect individuals attempting to subvert the drug testing process. As described in Section 111.B of this document , representatives of the commercial nuclear power industry have expressed support for implementing select provisions from the 2008 HHS Guidelines to enhance detection of illegal drug use and misuse of prescription drugs and to enhance the testing methods to identify subversion attempts.

The basis for each proposed change is discussed in Section 111.C of this document.

The regulatory basis for this proposed rule , issued on May 3, 2013 , provides an in dopthfurther discussion on the technical merits of this rulemaking. 2. Societal Drug Use As described in the U.S. President's 2014 National Drug Control Strategy," societal use of legal and illegal drugs and substances continues to evolve and affects every sector of society (e.g., adolescents , adults , and persons in tho U.S. workforce). The prevalence of drug use in society is also documented in the " Behavioral Health Trends in the United States: Results from the 2014 National Survey on Drug Use and Health" (NSDUH), an annual survey sponsored by SAMHSA. This survey is the primary source of information on the use of illegal drugs, alcohol, and tobacco in the civilian , non-institutionalized population in the United States , ages 12 and olde r. The NSDUH survey estimated that i n 20 1 4 , 10.2 percent of the U.S. population aged 12 16 or older (approximately 27.0 million Americans) used an illegal drug in the past month. This estimate was based on the number of individuals surveyed that reported using an illegal drug during the month prior to participating in the NSDUH survey interview.

Among adults aged 26 or older, those potentially in the U.S. workforce, the rate of illegal drug use was 8.3 percent, representing an upward trend since 2002. Although SAMHSA believes thatattributes this increase was driven byto marijuana use, it demonstrates the prevalence of illegal drug use in the workforce. Societal drug use presents a continual challenge to the fitness of the workforce relied on by licensees and other entities to perform safety and security significant duties, with the result that potential impairment and the adverse impact on human performance may affect public health and safety. B. Public Input Regarding Proposed Revisions to 10 CFR part 26 to Include Aspects of the 2008 Health and Human Services ~uidelines After HHS issued the 2008 HHS Guidelines , the NRC performed a comprehensive review of 10 CFR part 26 and the 2008 HHS Guidelines to identify provisions in the NRC.'s regulations that may need to be revised. Two public meetings were held in 2009 , on February 24 and June 24 , with regulated entities, interest groups, and members of the general public to discuss the changes in the 2008 HHS Guidelines.

In 2010 , the NRC analyzed the DOT's final rule changes to 49 CFR part 40 , " Procedures for Transportation Workplace Drug and Alcohol Testing Programs" (75 FR 49850; August 16 , 2010) to understand how another Federal agency that tests civilians implemented the 2008 HHS Guidelines. The NRC also analyzed lessons learned from implementation of the 2008 FFD final rule. Collectively , these efforts resulted in a list of potential changes to 10 CFR part 26 that the NRC presented, for feedback , at a third public meeting held on October 11 , 2011. The NRC summarized public comments received at the October 11 meeting, as well as e-mailed comments received 17 subsequent to the meeting , in a document titled "Comments for the October 11 , 2011, Public Meeting" (included in package available via ADAMS Accession No. ML112930153). A fourth meeting was held on September 11, 2013, to inform the public GR-Of the status of the rulemaking.

Public meetings were attended by representatives of nuclear power plant licensees , the Nuclear Energy Institute , the Institute of Nuclear Power Operations , the International Brotherhood of Electrical Workers, and HHS. Based upon feedback received during the four public meetings , some of the NRG-proposed revisions were removed from consideration because the NRC decided that it . was not appropriate to pursue those particular issues in this rulemaking , while others were revised. The NRG-proposed revisions, along with associated issues raised by the public , are discussed in Section 111.C of this document.

C. Description of Proposed Changes This section includes a description of each proposed change , the rationale for each change, and a discussion of public comments that informed the NRC's development of the changes. Definitions During the October 11 , 2011 , public meeting , an industry participant requested that the NRC review the use of certain terms under 10 CFR part 26 for consistency with the 2008 HHS Guidelines. The NRC performed a review and proposes to add seven new definitions and revise seven existing definitions under§ 26.5 , " Definitions

." The revisions and additions would improve consistency with Section 1.5 of the 2008 HHS Guidelines and would improve the clarity, consistency , and accuracy of the requirements under 10 CFR part 26. Specifically , the following definitions would be added: cancelled test, carryover, Certifying Scientist , Federal 18 custody and control form, lot, rejected for testing, and Responsible Person. The following definitions would be revised: calibrator, control, dilute specimen, HHS-certified laboratory, invalid result, limit of quantitation, and substituted specimen.

Cancelled test. The MRO will cancel the testing of a donor's urine specimen and report that action to the licensee or other entity after the testing laboratory (i.e., licensee testing facility (L TF) or HHS-certified laboratory) reports that the specimen was rejected for testing, or the donor requested additional testing of a specimen at a second HHS-certified laboratory under § 26.165(b) and the specimen was not available for testing due to circumstances outside of the donor's control (e.g., specimen is lost in transit). Sections 26.129(b )(2) and 26.159(b )(2) describe the only circumstances requiring an MRO to " cancel the testing of a donor's urine specimen." However,§§ 26.129(b)(2) and 26.159(b)(2) do not use the term cancelled test , nor is the term defined under § 26.5. Adding the definition for cancelled test and updating §§ 26.129(b )(2) and 26.159(b )(2) to specifically use that term would clarify the actions taken by an MRO and improve consistency between 10 CFR part 26 and the 2008 HHS Guidelines. The NRC is also proposing to add the term cancelled test to§ 26.165(f)(1) and (f)(2) to clarify the actions taken by an MRO when a specimen is rejected for testing by the laboratory and the MRO cancels the testing of the specimen.

For completeness , a cancelled test for alcohol breath testing is also defined. The definit i on presented by the NRC staff at the October 11, 2011, public meeting only described cancelled test results associated with urine testing. For alcohol testing only, cancelled test means a test result that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91. Carryover.

The proposed rule would add a definition for carryover to § 26.5. Carryover is the effect that occurs when a test result for a donor's specimen or quality control sample has been affected by a preceding specimen tested on the same analytical instrument.

For example, 19 if the concentration of a drug in one donor specimen was not completely eliminated from the analytical instrument before the next donor specimen is tested , the residual drug concentration in the instrument may contribute to a false positive test result for the next donor specimen tested. Carryover would also apply to donor specimens containing an adulterant or interfering substance. The term carryover is not currently defined under § 26.5. However , the term carryover is used in§§ 26.137(e)(7) and 26.167(a), which require LTFs and HHS-certified laboratories to ensure that carryover does not contaminate the testing of a donor's specimen or otherwise affect a donor's specimen results. In addition ,§ 26.91(c)(5) describes the requirement to ensure that carryover does not affect alcohol testing results when using evidential breath testing devices. The NRC's proposed definition is similar to the definition in Section 1.5 of the 2008 HHS Guidelines but does not i nclude the phrase " (e.g., drug concentration)

," because carryover applies also to validity testing (e.g., adulterants , interfering substances) and alcohol testing. Certifying Scientist. The proposed rule would add a definition for Certifying Scientist to § 26.5. The position title is used in§ 26.169(a) and (g) but is not currently defined. A Certifying Scientist would be defined as the individual at the HHS-cert i fied laboratory responsible for verifying the chain of custody and scientific reliability of any test result reported by the certified laboratory.

Adding this definition would improve consistency between 10 CFR part 26 and the 2008 HHS Guidelines. A conforming change would be made to§ 26.169(a) to capitalize t he position title in the phrase " the laboratory

's certifying sc i entist." Federal custody and control form (Federal CCF). The proposed rule would add a definition for the term Federal custody and control form (Federal CCF) to§ 26.5. The Federal CCF is defined as any HHS-approved form , which has not expired , that is published in the Fede r al Regis t er and i s used t o document the collection , custody , transport , and testing of a 20 specimen.

Including this definition would align 10 CFR part 26 with Section 1.5 of the 2008 HHS Guidelines and improve the clarity of the rule by defining the term, which is already used in § 26.153(9).

The proposed rule would revise the NRC's initial intended definition of Federal CCF, based on feedback received during the October 11, 2011, public meeting. The definition that the NRC proposed at that meeting listed the specific name of the HHS-approved form used for urine drug testing (i.e., Federal Drug Testing Custody and Control Form) and closely paralleled the definition in Section 1.5 of the 2008 HHS Guidelines.

However, based on comments received during the meeting , the NRC agrees that referencing the specific name on the form was too prescriptive and could require additional revision to 10 CFR part 26 , should HHS revise the form name in the future. Therefore, the NRC is proposing to use the generic title, Federal CCF , to avoid the need for future regulatory changes , should the title of the form change. The definition may also provide flexibility in accommodating for additional forms that SAMHSA may create , at a later date , for use when conducting drug and validity testing of alternative specimens (e.g., oral fluids, hair). To align with the new definition, " Federal and-control form ," which appears in § 26.153(9), would be replaced with the term " Federal CCF." In addition , to improve the consistency of terminology used throughout 10 CFR part 26 , the NRC is also proposing to replace the term " custody and control form" with the term "Federal CCF." The plural versions, " custody and control forms" and " custody and control form(s)," would also be replaced with the terms " Federal CCFs" and " Federal CCF(s)," respectively. Finally , the proposed rule would correct inconsistenciesa few instances were identified under 10 CFR part 26 where " custody-and-control" form or forms were used incorrectly and instead , should have referred to " chain of custody" form or forms. The proposed rule would correct these inconsistencies.

21 The NRC's regulations under 10 CFR part 26 do not preclude the use of electronic versions of the Federal CCF or the use of licensee or other entity-developed forms, consistent with existing requirements in § 26.153(g). The NRC supports the use of technological advancements to improve the quality of information included on the Federal CCF (e.g., legibility , accuracy , and completeness of information)

reduce undue delays and/or the canceling of specimen tests due to paperwork irregularities

facilitate timely transmission of information to and from collectors , laboratories , and responsible licensee represe n tatives (e.g., the MRO); and reduce recordkeeping and reporting costs. Lot. The proposed rule would add a definition for Jot to§ 26.5 , representing units that have the same starting materials , performance characteristics , and expiration date. The term i s used in 10 CFR part 26 but is not currently defined. Adding this definition would improve consistency between 10 CFR part 26 and the definition of lot in Section 1.5 of the 2008 HHS Guidelines.

The proposed rule would use the same definition in the 2008 HHS Guidelines by defining Jot as a number of units of an item manufactured from the same starting materials within a specified period of time for which the manufacturer states that the i tems have essentially the same performance characteristics and the same expiration date. The proposed rule also would include in the definition the parenthetical statement from the 2008 HHS Guidelines definition that provides examples of the term " item." The NRC would change one of the examples in the parenthetical statement by replacing

" quality control material" with " quality control samples." The term " quality control material" has not been used in 10 CFR part 26. Rejected for testing. The proposed rule would add to§ 26.5 a definition for rejected for testing that is similar to the definition in Section 1.5 of the 2008 HHS Guidelines , referring to a report by a licensee testing facility or HHS-certified laboratory that no tests can be performed on a specimen. The term rejected for testing appears in§ 26.169(h)(8) but is not currently defined. 22 Including a definition would clarify what information is being reported by the HHS-certified laboratory to the licensee or other entity in the annual quantitative summary of test results. In addition, defining the term would align with two additional proposed changes to §§ 26.129(b)(1 )(ii) and 26.159(b)(1

)(ii), to clarify the existing step that an L TF or HHS-certified laboratory would take, if a licensee or other entity had reason to question the integrity and identity of a specimen (i.e., reject the specimen for testing).

In§ 26.129(b)(1

)(ii), the phrase "the specimen may not be tested" would be replaced with the phrase "the licensee testing facility shall reject the specimen for testing." In§ 26.159(b)(1

)(ii), the phrase " the specimens may not be tested" would be replaced with the phrase "the laboratory shall reject the specimens for testing." Improving the consistency of terminology used when a specimen cannot be tested improves the regulatory efficiency of 10 CFR part 26. Responsible Person. The proposed rule would add a definition for Responsible Person to§ 26.5. The position title is used in§ 26.31(d)(1)(D) but is not currently defined. A Responsible Person would be defined as the person at the HHS-certified laboratory who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory.

Adding this definition would improve consistency between 1 O CFR part 26 and the 2008 HHS Guidelines.

A conforming change would be made to § 26.167 (f)(3) to capitalize the position title in the phrase " a statement by the laboratory's responsible person." Calibrator.

The proposed rule would revise the definition for calibrator in § 26.5 to more closely align with the definition in Section 1.5 of the 2008 HHS Guidelines and to also improve internal consistency of terminology used in 10 CFR part 26. The definition of calibrator would be revised to include a clarifying statement that a calibrator is a solution of known concentration

" in the appropriate matrix" that aligns with the definition in the 2008 HHS Guidelines.

The 23 phrase " test specimen/sample" would be replaced with the phrase " donor specimen or quality control sample" to improve consistency with the terminology used in 10 CFR part 26. The last sentence of the definition , which states that " calibrators may be used to establish a cutoff concentration and/or a calibration curve over a range of interest ," would be deleted. Although a part of this sentence al i gns with the 2008 HHS Guidelines , the sentence is not a definition , but rather a voluntary provision that a laboratory may use a calibrator to establish a calibration curve. The determination of calibration curves is an internal laboratory process that already must be described in standard operating procedures for LTFs in§ 26.127 , " Procedures

," and is evaluated during NLCP inspection of HHS-certified laboratories.

Control. The proposed rule would revise the definition of control in § 26.5 to conform to the definition of the term in Section 1.5 of the 2008 HHS Guidelines. The term control in § 26.5 would be revised by replacing the phrase " a sample used to monitor the status of an analysis to maintain its performance within predefined limits" with the phrase " a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits." Dilute specimen. The proposed rule would rev i se the definition of dilute specimen in § 26.5 , to conform to the definition of the term in Section 1.5 of the 2008 HHS Guidelines. The phrase " concentrations that are lower than expected for human urine" would be revised to read as " values that are lower than expected but are still within the physiologically producible ranges of human ur i ne." The current definition i ncorrectly references

" concentrations" which does not apply to a specific gravity reading. The current definition also does not clearly state that creatinine and specific gravity measurements in a dilute specimen are still within the range that could be produced by a human being. HHS-certified laboratory.

The current definition of an HHS-certified laboratory in § 26.5 l i sts the Federal Reg i s t e r cita ti ons for each final vers i on of th e HHS Guidel i nes (o r iginally 24 published in 1988 , and amended in 1994 , 1998, and 2004 ). Under this definition , an HHS-certified laboratory must meet the 2004 HHS Guidelines, which were published on April 13 , 2004 (69 FR 19643). No laboratory performing testing for 10 CFR part 26 licensees or other entities currently meets this definition because the definition refers to the out of aatesuperseded 2004 HHS Guidelines

rather , HHS certifies laboratories to the HHS Guidelines that are in effect (i.e., the 2008 HHS Guidelines).

The proposed rule would correct this restriction by defining an HHS-certified laboratory as a laboratory that is certified to meet the standards of the HHS Guidelines at the time that drug and validity testing of a specimen is performed for a licensee or other entity. Other requirements in 10 CFR part 26 already specify the drug testing panel and testing cutoff levels , validity testing requirements , and quality control requirements.

The proposed change to the definition of HHS-certified laboratory would eliminate the need to revise 10 CFR part 26 , should future versions of the HHS Guidelines be published.

Two conforming changes would also be made, based on the revision to the definition of HHS-certified laboratory.

The first change would revise §§ 26.40)(3) and 26.153(a) to reference

" HHS-certified laboratories as defined in§ 26.5." Section 26.153(a) would also be revised to remove the reference to the physical address of the Division of Workplace Programs as the location to obtain information concerning the certification status of laboratories. +Re revised definition includes a reference to the F-ederai Register as the location of the notice that HHS publishes on a monthly basis that lists the current HHS certified laboratories. Invalid result. The proposed rule would revise the definition of invalid result in § 26.5 to be consistent with the definition of the term in Section 1.5 of the 2008 HHS Guidelines and would also improve the clarity and accuracy of the 10 CFR part 26 rule. The phrase " for a specimen that contains an unidentified adulterant , contains an unidentified interfering substance , has an abnormal physical characteristic , contains inconsistent phys i ological 25 constituents , or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test resul t" would be replaced with " in accordance with the criteria established in§ 26.161(f) when a positive , negative , adulterated , or substituted result cannot be established for a specific drug or specimen validity test." The revised definition would also correct an inaccuracy in the current definition of i nvalid result , which does not include " specimen validity test." Limit of Quantitation. The proposed rule would revise the definition for Limit of Quantitation (LOQ) in § 26.5 to more closely align with Sect i on 1.5 of the 2008 HHS Guidelines. To align w i th the terminology used in 10 CFR part 26 , the proposed definition would use " analyte" i nstead of the word " measurand."~ Substituted specimen. The proposed rule would revise the definition for substituted specimen in § 26.5 , to align with the definition of the term in Section 1.5 of the 2008 HHS Guidelines. The ph r ase " specimen with creatin i ne and specific gravity values that are so diminished or so divergent that they are not consistent with normal human physiology" would be replaced with " a specimen that has been submitted in place of the donor's ur i ne , as evidenced by creat i nine and specific gravity values that are outside the physiologically producible ranges of human ur i ne."~ The revision would also improve the clarity of the rule by explaining that a subst i tuted specimen is the result of donor action to subvert the testing process by stating that the specimen " has been submitted in place of the dono r's urine." 3 " Analyte" means the drug or drug metabolite measured by an i nitial or confirmatory drug test. 4 " Creatinine" means a substance that is created in a human being as a result of muscle metabolism and is excreted in urine. The creatinine concentration of each urine specimen is measured by validity testing. 26 Drug Testing Panel Additions The proposed rule would add three amphetamine-based chemical compounds: methylenedioxymethamphetamine (MOMA), methylenedioxyamphetamine (MOA), and methylenedioxyethylamphetamine (MOEA) to the NRG-required drug testing panel , consistent with the drug testing panel in Section 3.4 of the 2008 HHS Guidelines. MOMA (also known as Ecstasy or Molly), MOA, and MOEA are listed in Schedule I of the Controlled Substances AstSchedules of Controlled Substances (21 CFR 1308.11 ). A Schedule I drug or substance has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks an accepted safe ty for use of the drug or substance under medical supervision (21 U.S.C. § 812 (2012)). The proposed rule would revise§§ 26.31 (d)(1) and 26.405(d) to identify MOMA, MOA, and MOEA as substances for which licensees and other entities are required to test; § 26.133 , " Cutoff levels for drugs and drug metabolites

," and § 26.163(a)(1) to require initial testing for MOMA; and§ 26.163(b)(1) to require confirmatory testing for MOMA, MOA, and MOEA. By requiring licensees and other entities to test for additional substances , a greater range of drugs that impair human performance can be detected.

Also, it would assist in the identification of those persons who , because they use illegal drugs, exhibit characteristics of not being trustworthy and reliable. The drugs MOMA, MOEA , and MOA would be added to the NRG-required drug testing panel because of their potential adverse effects on human performance , which were detailed by the HHS in the notice of proposed revisions to the HHS Guidelines, published in the Federal Register on April 13, 2004 (69 FR 19673). The proposed rule would also expand the NRG-required drug testing panel to include initial testing for 6-AM , consistent with Section 3.4 of the 2008 HHS Guidelines.

This change would i mprove the assurance that the testing method used under 10 CFR part 26 would identify 27 an individual using heroin, a Schedule I drug. Currently , 10 CFR part 26 only permits the testing of a specimen for 6-AM when the specimen also tests positive for morphine (i.e., the morphine concentration is greater than the confirmatory testing cutoff level). The HHS implemented initial testing for 6-AM in the 2008 HHS Guidelines, based on the analysis of laboratory testing data that demonstrated that 6-AM was detectable i n the specimens of some individuals , even when the specimens tested negative for morphine.

Revised Initial Drug Testing Cutoff Levels The 2008 HHS Guidelines established the scientific and technical bases for lowering the

• initial drug testing cutoff levels for amphetamines and cocaine metabolites. The proposed rule would update the substances and cutoff levels for initial drug testing , as listed i n the tables in §§ 26.133 and 26.163(a)(1), to conform with Section 3.4 of the 2008 HHS Guidelines. Specifically , the proposed rule would make the folle>wing changes in each table: 1) lowe r the in i tial test cutoff level for amphetamines (abbreviated in the tables as AMP), 2) lower the initia l test cutoff level for cocaine metabolites , 3) clarify the existing testing requ i rement for " opiate metabolites" by replacing the term with " codeine/morphine

," 4) include a new footnote 1 to each table to clarify that the target analyte for " codeine/morphine" testing is morphine , 5) clarify in a new footnote 2 to each table that either a single or multiple initial test kit(s) may be used for amphetamines testing, and 6) include a new footnote 3 in each table to clarify that methamphetamine (abbreviated in the tables as MAMP) is the target analyte for amphetam i nes and methamphetamine testing. The column header " Drug or metabolites" in the tables in §§ 26.133 and 26.163(b)(1) would also be rev i sed to " Drugs or drug metabolites" to align with the table titles. Lowering the cutoff levels for these existing drugs and drug metabolites in the NRG-required testing panel would increase the timeframe (i.e., the w i ndow of detection) in 28 which these drugs can be detected in an individual's urine after use and may also lead to improved deterrence. Increasing the window of detection for these substances would provide a higher degree of assurance that persons who are using illegal drugs or misusing legal drugs would be identified.

The NRC anticipates that the proposed lower testing cutoff levels would increase the num~er of urine specimens identified as containing amphetamine, cocaine metabolite, and methamphetamine.

These anticipated outcomes are based on increases in detection reported by Federal employee workplace drug testing programs and the DOT testing program subsequent to implementing the lower testing cutoff levels in the 2008 HHS Guidelines, as discussed in the regulatory basis and the regulatory analysis for this proposed rule. In addition, the proposed rule would revise§§ 26.133 and 26.163(a)(1) to clarify that the specified testing cutoff levels are used by an LTF or an HHS-certified laboratory to determine whether a specimen is either "negative" or "positive" for each drug or drug metabolite being tested. This change better aligns 10 CFR part 26 with Section 11.19(aQ) and (bg) of the 2008 HHS Guidelines, which require the HHS-certified laboratory to make a determination that each specimen is either "positive" or "negative , or " positive" respectively, for each drug and drug metabolite tested. Revised Confirmatory Drug Testing Cutoff Levels The 2008 HHS Guidelines established the scientific and technical bases to justify lowering the confirmatory drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine, and expanding the testing panel to include confirmatory drug testing for the Ecstasy drugs MOMA, MDEA, and MDA. The NRC proposes to expand the number of substances in the NRG-required testing panel and to lower the cutoff levels for confirmatory drug tests, as listed in the table in § 26.163(b )( 1 ), to align with Section 3.4 of the 2008 HHS Guidelines.

Specifically, the proposed rule would make the following changes: 1) lower the 29 confirmatory test cutoff level for amphetamine from 500 ng/mL 5 to 250 ng/mL, 2) lower the confirmatory test cutoff level for cocaine metabolite from 150 ng/mL to 100 ng/mL, 3) lower the confirmatory test cutoff level for methamphetamine from 500 ng/mL to 250 ng/mL, 4) eliminate table footnote 3, which specified the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine concentration exceeding 2000 ng/mL, 5) redesignate table footnote 4 as footnote 3 and update the text to lower the amphetamine concentration from 200 ng/mL to 100 ng/mL that must also be present in a specimen to be positive for methamphetamine, 6) include confirmatory testing for MOMA , MDA, and MDEA at a cutoff level of 250 ng/mL, and 7) provide the full chemical names for MDA and MDEA in new footnotes 4 and 5 to the table, respectively.

Similar to the changes made to the initial testing cutoff levels, lowering the confirmatory testing cutoff levels for amphetamine , cocaine metabolite, and methamphetamine would increase the timeframe in which these drugs can be detected in an individual

's urine after use and may also add to the deterrent effect of the rule. In addition, the proposed rule would make two clarifying changes to the table in § 26.163(b )( 1) by revising the term " Opiates" to " Opiate metabolites" and adding the abbreviation

" (6-AM)" after 6-acetylmorphine. Finally , the column header "Drug or metabolites" in the table in § 26.163(b)(1) would be revised to " Drugs or drug metabolites

," to align with the table title. These changes would improve consistency with Section 3.4 of the 2008 HHS Guidelines and with the proposed revisions to§§ 26.133 and 26.163(a)(1). The proposed rule would update the information that each HHS-certified laboratory must include in the annual statistical summary report of test results provided to each licensee or other entity under§ 26.169(h)(3) to reflect the expanded drug testing panel in revised §§ 26.31 (d)(1) and 26.405. Specifically, the proposed rule would require each HHS-certified laboratory to 5 The unit ng/ml is nanograms per milliliter or a millionth of a gram per liter. 30

~include , in the annual statistical summary of urinalysis testing provided to each licensee and other entity, the number of specimens reported as positive for MOMA, MOA, and MOEA. Additional conforming changes would improve the clarity and uniformity of the names of the drugs and drug metabolites listed in§ 26.169(h){3), to include adding " (as THCA)"6 after "Marijuana metabolites

," adding " (as benzoylecgonine)" after " Cocaine metabolite

," revising " 6-AM" to "6-acetylemorphine (6-AM)," and revising " Phencyclidine" to " Phencyclidine (PCP)." Validity Testing of Adulterants at HHS-Certified Laboratories The proposed rule would revise the decision point used in the validity tests performed by HHS-certified laboratories, as described in§ 26.161(c)(3) through (c)(6) and§ 26.161(f)(5) and (f){?), by replacing the limit of detection (LOO) with the limit of quantitation (LOO) as the decision point for determining if a specimen contains an adulterant (i.e., adulterated test result) or the possible presence of an adulterant (i.e., invalid test result). The difference between the LOO and the LOO for a testing assay is the ability to reliably quantify the analyte. At the LOO , the validity test must meet all HHS-certified laboratory criteria for result acceptance, except quantitation.

At the LOO, the validity test must reliably confirm the presence of the analyte , reliably quantify the concentration of the analyte, and meet all HHS-certified laboratory criteria for result acceptance. Use of the LOO provides an additional donor protection on the accuracy of validity testing (i.e., in making the conclusion that results are adulterated or invalid).

The proposed changes to§ 26.161(c)(3) through (c)(6) are consistent with Section 3.5 of the 2008 HHS Guidelines, which describe the validity testing criteria for the adulterants chromium (VI), halogens (e.g., bleach , iodine, fluoride), glutaraldehyde, and pyridine (pyridinium chlorochromate).

The proposed changes to§ 26.161 (f)(5) and (f){?) are consistent with the 6 THCA is an abbreviation for delta-9-tetrahydrocannabinol carboxyl i c acid. 31 validity testing criteria in Section 3.8 of the 2008 HHS Guidelines for the same adulterants described in the previous sentence but as applied to invalid results. The NRC is not proposing to change the initial validity testing requirement in § 26.131(b)(5) that applies to L TF testing for the possible presence of halogen. Section 26.131 (b)(5) currently permits an L TF to use a " halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOO))." The NRC is not proposing to change the use of LOO in this instance , because L TFs already must send any specimen identified with the possible presence of an adulterant to an HHS-certified laboratory for initial and confirmatory validity testing, where the LOQ of the test would be utilized.

The proposed rule would also revise§ 26.161(c)(5) and (c)(6) to permit HHS-certified laboratories to conduct confirmatory validity testing for the adulterants glutaraldehyde and pyridinium chlorochromate using " a different confirmatory method (e.g., gas chromatography/mass spectrometry (GC/MS))" instead of what is currently required , which is only " GC/MS for the confirmatory test." The proposed changes would provide additional flexibility in the confirmatory testing methods that may be used by the laboratory and would align with similar testing requirements in § 26.167( e )( 1 ), the change tocurrent version of § 26.153( c ), as described in the Statement of Considerations for the 2008 FFO final rule (73 FR 17091 and 17102), and would align with Section 11.19(d) of the 2008 HHS Guidelines.

Special Analyses Testing of Urine Specimens Special analyses testing is an NRC testing methodology introduced in the 2008 FFO final rule to address the circumstance where a donor consumes a large quantity of fluid just prior to providing a urine specimen for testing in the hope of diluting the concentration of any drugs and drug metabolites in the specimen below the standard testing cutoff levels aRG-to avoid detection (i.e., to produce a negative drug test result). This testing methodology is not included 32 in the HHS Guidelines, but provides licensees and other entities with an added level of assurance that an individual with a dilute specimen is not attempting to hide drug use. Section 26.163(a)(2) currently provides each licensee and other entity with the option to require the HHS-certified laboratory to conduct special analyses of dilute specimens (i.e., conduct confirmatory testing to the LOO for drugs and drug metabolites when the immunoassay response of the initial drug test is equal to or greater than 50 percent of the cutoff calibrator).

For example, if a specimen is dilute and the initial test for marijuana metabolites measured a concentration of 25 ng/ml (the initial cutoff level for marijuana metabolites is 50 ng/ml), special analyses testing would then be performed on the specimen.

Using a lower cutoff level for the testing of dilute specimens enhances the ability of licensees and other entities to identify using individuals attempting to avoid detection through the consumption of large quantities of fluid just prior to providing a specimen for testing. The proposed rule would make four changes to the special analyses testing requirements in§ 26.163(a)(2).

First , the proposed rule would require all licensees and other entities to conduct special analyses testing of dilute specimens. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 demonstrates the effectiveness of special analyses testing because these data show that additional positive results were identified for access, random, and post-event special analyses tests. As of 2014, 92 percent of licensees and other entities have adopted the special analyses testing policy. The proposed rule would eliminate references to the option for licensees and other entities to conduct special analyses testing of specimens with dilute validity test results that appear in§§ 26.31 (d)(1 )(ii); 26.163(a)(1) and (b )(1 ); 26.183( c), ( c)(1 ), and (d)(2)(ii);

and 26.185(9)(2) and (g)(3). These tests would instead be required.

33 Second, the proposed rule would lower the immunoassay percentage response for initial testing in § 26.163(a)(2)(ii) that HHS-certified laboratories must use to determine if special analyses testing is to be conducted.

The proposed rule would lower the immunoassay response from " equal to or greater than 50 percent of the cutoff calibrator" to " equal to or greater than 40 percent of the cutoff calibrator." Use of a lower cutoff level to evaluate the immunoassay response could increase the number of specimens subject to special analyses testing and would improve the ability of licensees and other entities to identify additional drug-using individuals attempting to subvert the drug testing process. This change would not affect the drug testing assays used by HHS-certified laboratories because under the 2008 HHS Guidelines , each laboratory must already validate the accuracy of each assay to 40 percent of the cutoff calibrator.

Laboratories would need to change their administrative procedures to define the initial test result concentration that would trigger special analyses testing. Third , the proposed rule would replace the LOO with the LOO as the confirmatory drug testing cutoff level to be used by HHS-certified laboratories when conducting special analyses testing. Currently,§ 26.163(a)(2)(ii) requires the use of the LOO as the cutoff level for special analyses testing of dilute specimens. The difference between the LOO and the LOO for a drug testing assay is the ability to reliably quantify the analyte. At the LOO, the confirmatory drug test must meet all HHS-certified laboratory criteria for result acceptance except quantitation.

At the LOO , the confirmatory drug test must reliably confirm the presence of the analyte , reliably quantify the concentration of the analyte, and meet all HHS-certified laboratory criteria for result acceptance. The LOO provides an additional donor protection on the accuracy of special analyses test results. To receive and maintain laboratory certification by the NLCP , certified laboratories must already determine both the LOO and LOO for each drug testing 34 assay. Therefore, changing the decision point from the LOO to the LOO for reporting confirmatory drug test results would not require laboratories to change the testing assays used. The NLCP also requires all HHS-certified laboratories to validate the accuracy and precision of each confirmatory drug test at or below 40 percent of the cutoff. To meet this testing specification, the laboratory must establish both the LOO and the LOO below the 40 percent cutoff, which results in variability amongst laboratories on how far below the 40 percent cutoff the LOO and LOO are established (this is dependent, in part, on the instrumentation and testing processes used at the laboratory).

The NRC acknowledges this variability and that some attendees at the public meetings requested a standardized level be used across all laboratories performing special analyses testing. However, this position would be contrary to the 10 CFR part 26 regulatory framework that enables licensees and other entities to use lower cutoff levels in the testing for drugs and drug metabolites, as permitted under§ 26.31(d)(3)(iii). Fourth , the proposed rule would expand the special analyses testing requirement in § 26.163(a)(2)(i) to include the testing of some specimens collected under direct observation.

Section 26.115(a) describes the exclusive grounds for performing a directly observed collection. Under the current rule, a directly observed collection may be performed when sufficient information has been obtained during the collection process or in the testing of a previous specimen to indicate a possible subversion attempt by the donor, or when an individual has a confirmed positive drug test result on a prior occasion.

As such, a directly observed collection after either of these circumstances provides additional assurance that the subsequent specimen obtained for testing came directly from the donor's body and was not altered to avoid detection of drug use. Likewise , special analyses testing would provide additional assurance that drugs and drug metabolites present in the specimen collected under direct observation from a donor 35 would be identified , which would improve the MRO's ability to determine whether a subversion attempt was made on the initial specimen collected from the donor. For example , an initial unobserved specimen provided by a donor is determined by the collector to be out of the acceptable temperature range specified in § 26.111 (a) and tests negative for drugs , and the second specimen collected under direct observation from the donor tests positive for a drug. In this example , the differences in test results from the initial and second specimen collected provides conclusive evidence to the MRO to make a subversion determination on the initial specimen provided. Therefore , the proposed rule would revise§ 26.163(a)(2)(i) to require that special analyses testing be performed on specimens collected under§ 26.115(a)(1) through (a)(3), and (a)(5). Section 26.115(a)(1) describes the situation where a donor has presented a specimen that has been reported by an HHS~certified laboratory as adulterated , substituted, or invalid , and the MRO determines that no adequate medical explanation exists for the result and that another specimen should be collected from the donor. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 i dentified subversion attempts where the HHS-certified laboratory reported an invalid test result for the initial specimen provided by the donor , and either the donor refused to provide a second specimen under direct observation or the second specimen collected under direct observation tested positive for a drug. Use of special analyses testing on the second specimen collected would provide additiona l assurance that drug use would be detected , because a period of days would lapse from the point of collect i on of the initial specimen , testing of that specimen at a laboratory , MRO review of the test results and discussion with the donor, MRO determination that a second specimen should be collected, and finally , the donor appearance at a collection site to provide a second specimen under d i rect observation. 36 Section 26.115(a)(2) describes the situation where a donor provides a specimen that falls out of the acceptable temperature range specified in § 26.111 (a). Section 26.115(a)(3) describes the situation where donor conduct during the collection process indicates an attempt to dilute, substitute, or adulterate the specimen.

An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 demonstrates that the majority of subversion attempts are identified based on information obtained during the specimen collection process by the collector (e.g., specimen temperature) and the collection of a second specimen from the donor under direct observation. Use of special analyses testing in these two instances would provide additional assurance that drug use would be detected in the second specimen collected under direct observation, because the information from the initial collection process indicated a possible subversion attempt. Section 26.11 S(a)(S) addresses the situation where the MRO verifies that a specimen is positive, adulterated, or substituted, and the donor requests that a retest of the specimen be performed at a second HHS-certified laboratory, but the specimen is not available for testing. As a result , the confirmed test result from the initial testing laboratory must be cancelled by the MRO because the donor was not afforded the opportunity to verify the test results through additional testing at a second HHS-certified laboratory.

Use of special analyses testing in this instance would provide additional assurance for the same reason described for specimens collected under§ 26.115(a)(1

). The proposed change to require special analyses testing of specimens collected under direct observation would require licensees and other entities to establish an approach for the licensee or other entity to use when notifying a laboratory that special analyses testing is required for a specimen. 37 Alternative Specimen Collection Sites Sections 26.4( e )(6)(iv) and 26.31 (b )(2) include the statement that " licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40 , 'Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs' (65 FR 41944; Augus t 9 , 2001 )." Section 26.415(c) also i ncludes a statement that licensees and other entities need not audit " the specimen collection and alcohol testing services 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)." The proposed rule would eliminate the Federal Register citation from each part 26 section because the DOT final rule found on page 41944 in the August 9 , 2001 , edition of the Federal Register no longer represents the current version of 49 CFR part 40. The intent of these prov i sions was to provide licensees and other entities with flexibility to utilize collection sites that meet the DOT specimen collection requ i rements in 49 CFR part 40. List i ng the specific Federal Register notice of the applicable DOT final rule is not necessary because the existing requ i rements in§§ 26.4(e)(6)(iv), 26.31(b)(2), 26.405(e), and 26.415(c) already spec i fy that the local hospital or other organization must meet the requirements in 49 CFR part 40. Specimen Collection Procedures The proposed rule would make a number of revis i ons to the specimen collection procedures in 10 CFR part 26. Specifically , the proposed rule would: 1) clarify and enhance the instructions on conducting an observed collection , 2) permit the use of mirrors to assist in performing directly observed collections , 3) allow FFD program personnel to observe a donor who i s in the hydration process following the donor's inab i l i ty to provide a specimen of adequate v olume , a n d 4) cla ri fy uri n e specimen quantity and accep t ab i lity p r ov i sions. The r evis i ons wo u ld 38 be made to improve the clarity , consistency , and flexibility of the collection procedures and ta align more closely with the 2008 HHS Guidelines.

Sections 26.115( e ), (f), and (f)( 1) through (f)(3) would be revised to improve the clarity of instruction on conducting a directly observed specimen collection, which would improve consistency with Sections 4.4(a) and 8.9 of the 2008 HHS Guidelines. The proposed rule would remove the first sentence in § 26.115(f), which states, " If someone other than the collector is to observe the collection , the collector shall instruct the observer to follow the procedures in this paragraph." The NRC proposes to add the following sentence to the end of the existing requirements in § 26.115( e ): " If the observer is not a trained collector , the collector shall , in the presence of the donor , instruct the observer on the collection procedures in paragraph (f)." The proposed change would improve the clarity of the existing requirements and ensure that the donor is informed that an individual other than the collector is to observe the specimen prov i sion and understands the procedures that must be followed to complete the specimen collection.

The proposed change also incorporates feedback received at the October 11 , 2011 , publ i c meeting , at which a participant suggested using the phrase " who has received instruct i on" instead of the phrase " who has received training ," when referring to the information that is prov i ded to a same-gender observer by the collector. " Training" implies a forr,:ial process rather than provid i ng oral or written instructions , which is a more accurate description of the information that the collector would convey to a same-gender observer. The NRC agrees with this comment. The collector would only be required to give the same-gender observer i nstruction , rather than formal training. In§ 26.115(f)(2), the proposed rule would add the parenthetical statement

" (a mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room , stall , or pr i vate a r ea is not suff ici ent to meet this d i rect observation requ ir ement; the 39 use of a video camera to assist in the observation process is not permitted)" to the end of the existing requirement.

This proposed change also incorporates stakeholder feedback at the public meeting on October 11, 2011 , at which the NRC proposed to prohibit the use of mirrors and video cameras to aid an observer in conducting a directly observed specimen collection , to align with Section 8.9(b) of the 2008 HHS Guidelines.

Several industry participants commented that mirrors are currently used at some collection facilities, where the configuration of the stall does not provide adequate space for the collector to directly observe the provision of a specimen from the donor's body into the specimen container.

These participants suggested that if the NRC prohibited the use of a mirror to aid in the direct observation process , physical configuration changes at some collection sites would be needed. Based on subsequent licensee and NRC inspector feedback, the NRC has concluded that the observed collection process in § 26 .115(f)( 1 ) continues to ensure that subversion paraphernalia would be identified prior to the provision of a specimen during the observed collection process and that the use of reflective mirrors (i.e., reflective and not two-way mirrors) would be acceptable. As required by § 26.115(f)( 1 ), prior to conducting the directly observed collection, the donor already must adjust his or her clothing to expose the area between his or her waist and knees. This step ensures that no materials to subvert the testing process (e.g.,§. prosthetic device, a container of synthetic urine, an oampule of an oxidizing chemical.synthetic tlfiRe , or other subversion paraphernalia) are concealed on the donor's body and could be used during the specimen collection.

Subsequent to this step, the observer would then watch urine flow from the donor's body into the collection cup. To accomplish this , the collector (or gender observer) must be in close proximity (in the stall or room where the specimen is provided) to meet this observation requirement.

The use of a reflective mirror only aids in this assurance by preventing the donor's body or the configuration of the stall or room from 40 obstructing the collector's view of urine flowing from the donor's body directly into the specimen collection container. By observing the area where the urine leaves the body , the direct observation process ensures that the specimen provided is from the donor and ensures the integrity of the specimen collection process. As a result, the NRC is proposing to revise § 26.115(f)(2) to permit the use of reflective mirrors. The NRC also proposes to revise § 26.115(f)(2) to prohibit the use of video cameras to assist in visualizing the provision of a specimen under direct observation.

The NRC does not consider a video camera to be an acceptable means of providing direct observation, in part, because the conversion of visible light to an electronic format, through a video camera , is not a direct observation.

The use of a video camera for direct observation would be inconsistent with the intent of the rule because the collector or observer would not be in the room or stall with the donor. Further, a video feed is an incomplete source of information because it may not detail the physiological characteristics associated with a subversion attempt and also cannot guarantee the privacy of the donor beyond the individual conducting the observation. During the public meeting on October 11 , 2011, one participant requested that the NRC consider eliminating the requirement in§ 26.115(f)(1) that the donor adjust his or her clothing during the observed collection process to expose the area of the donor's body from the waist to the knees. The NRC considered this request but is not proposing to eliminate this provision for three reasons. First , the purpose of directly observing the provision of a spec i men is to ensure that the drug testing process is not being subverted.

The NRC's collection procedure requires the donor to remove his or her clothing between the waist and knees so that the collector can identify any paraphernalia on the individual

's body that may be used to subvert the testing process (for example , a prosthetic device , a container of synthetic urine , or ampule of an oxidizing chem i cal). Secondly , materials used t o subvert a d r ug test are easily available for 41 purchase, and licensees and other entities have reported in annual performance reports required by§ 26. 717 that donors have been identified fR-.attempting to subvert the oolleotion prooess during the directly observed collection process (e.g., concealed paraphernalia has been discovered).

Finally, the prevalence of subversion attempts demonstrates that individuals are actively attempting to thwart the drug testing process by specimen adulteration, substitution , and dilution.

In § 26.115(f)(3), the proposed rule would replace the phrase " If the observer is not the collector, the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector," with the phrase " If the observer is not the collector, the observer may not touch or handle the collection container, but shall maintain visual contact with the specimen until the.donor hands the collection container to the collector." The proposed rule changes would improve the clarity of the existing requirement by more closely aligning with Sections 8.9(c) and (d)(2) of the 2008 HHS Guidelines and by using terminology consistent with § 26.113(b )(3 ). The proposed rule would add§ 26.4(9)(6) and would revise§ 26.109(b)(1) to improve the efficiency of FFD programs by providing licensees and other entities with additional flexibility in the personnel who may monitor a donor during the hydration process (i.e., the 3-hour period of time that is initiated after a donor is unable to provide an acceptable quantity of urine during the initial specimen collection attempt , during which fluid is provided to assist the donor in providing a specimen of adequate volume). In addition to the specimen collector that initiated the specimen collection process with the donor, a staff member designated as FFD program personnel in § 26.4(9) would be allowed to monitor the donor during the hydration process in place of the original collector.

All FFD program personnel must meet honesty and integrity requirements in§ 26.31 (b). FFD program personnel also have familiarity with the collection 42 facility , specimen collectors , and 10 CFR part 26 requirements sufficient to monitor the donor during the hydration process. The additional flexibility of monitoring provided by the rule change would enable the collector , who initiated the collection process with a donor , to complete additional specimen collections with other donors while the initial donor hydrates and is monitored by another staff member designated as FFD program personnel.

Another specimen collector , who meets the requirements in § 26.85(a), could also monitor the donor in the hydration process. The proposed change could reduce the regulatory burden on FFD programs by affording licensees and other entities witR-additional staffing options to better manage the collection process, while maintaining appropriate oversight of the collection process by persons of known integrity. If a hydration monitor or another collector is used , the original collector would be required to note the name of the individual on the Federal CCF and the hydration monitor or second collector then would maintain control of the Federal CCF during the observation process (e.g., to document the time and volume of fluid provided to the donor , to note any unusual donor behavior , and to verify that the donor is provided with 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> to provide a specimen). In addition, to i mprove the clarity of§ 26.109 , the NRC is also proposing that the last sentence of§ 26.109(b )(1 ), " The collector shall provide the donor with a separate collection container for each successive specimen/' would become the new first sentence of § 26.109(b)(2).

Section 26.109(b)(1) describes the procedures for providing fluid to a dono r who is in the hydration process , and includes the instruction to the collector to provide a separate collection container for each successive specimen provided by the donor. The instruction to provide a separate collection container for each specimen is more appropriate in § 26.109(b )(2), which describes the provision of subsequent specimens once a donor is in the hydration process. 43 The proposed rule would revise§ 26.89(d) in three ways. First , § 26.89(d) would be revised to clarify that a collector shall conduct only one collection procedure at any given time , except in the instance when another collector who meets the requirements in§ 26.85(a) or a hydration monitor is observing the donor during the hydration process , as permitted by the proposed change to § 26.109(b )( 1 ). Second , § 26.89( d) would be revised to more precisely describe the actions taken by the collector when sealing the collection container with evident tape and completing the Federal CCF to end the collection process. The phrase " the urine specimen container has been sealed and initialed, the chain of custody form has been executed , and the donor has departed the collection site" would be replaced with the phrase " the urine specimen container has been sealed with tamper-evident tape, the seal has been dated and initialed , and the Federal CCF has been completed." Third , the phrase " or if a refusal to test has been determined under§ 26.107(d)" would be added to§ 26.89(d) to more accurately describe when the collection process has been completed if a refusal to test has been determined.

The three changes would improve the clarity of the existing collection requirements , correct an editorial error in the name of the form that is used to document the specimen collection , and include a reference to a refusal to test as another circumstance when the collection process is complete.

The proposed rule would revise§ 26.107 , " Collecting a urine specimen ," in four ways related to how the donor is observed. First , the proposed rule would redesignate paragraph (b) as paragraph (b)(1). Second, the phrase", except as provided in§ 26.109(b)(1)

," would be added in the first sentence after " The collector shall pay careful attention to the donor during the entire collection process." This revision is necessary because of the proposed rule change to permit an individual other than the original specimen collector to monitor a donor in the hydration process; as a result , the original collector may not be present with the donor during 44 the entire collection process. Third 1 § 26.107(b )( 1) would be revised to replace the phrase " to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine is in plain view or an attempt to bring an adulterant or urine substitute into the private area used for urination)" with the phrase "to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain view; attempting to bring an adulterant, urine substitute, temperature measurement device, and/or heating element into the room, stall, or private area used for urination)

." The proposed changes would provide additional examples of subversion attempt actions that have been reported by licensees and other entities in the annual information reports required by § 26. 719 , "Reporting requirements

." More accurate examples of subversion attempts in the regulatory text provide additional clarity on donor actions that may be considered a subversion attempt. Lastly, the phrase "the collector shall document the conduct" in proposed§ 26.107(b)(1) would be revised to " the collector shall document a description of the conduct," which would improve the clarity of the description of the existing regulatory requirement.

Section 26.107(b )(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process , this individual would immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site , donor refuses to follow directions). This rule change would be necessary because this acti*,ity

• .vould not be tho responsibility of tho specimen collector who initiated tho collection process; and the collector must be informed of any unacceptable donor behavior so that appropriate action may be taken. The proposed rule would revise§ 26.89(c) to correct an editorial error in the instructions that a collector must provide to the donor regarding refusing to cooperate with the testing process. Currently ,* the word " adulterated" is used twice in the phrase " adulterated , diluted , or 45 adulterated the specimen," which describes the situation where a donor admits to subverting the testing process. The phrase would be revised to " adulterated , diluted , or substituted the specimen." The proposed rule would revise § 26.117 , " Preparing urine specimens for storage and shipping ," in three ways. First , the proposed r ule would revise§ 26.117(a) to add the phrase "Once the collector is presented with the specimen from the donor at the beginning of the first sentence to clarify when the collector would begin to keep the donor's " urine specimen(s) in view at all times." This r evision would improve the clarity of an existing activity in the collection process. For example , the collector would not be able to keep the donor's urine specimen in view at all times when the donor is in the room , stall , or pr i vate area used for urination , as described in§ 26.107(a). Second, two editorial errors would also be corrected in§ 26.117(f):

the term " chain-of-custody forms" would be replaced with the term " Federal CCFs," and the phrase " or the licensee's testing facility" would be replaced with the phrase "or to the licensee testing facility." Third , the proposed rule would revise§ 26.117(9) to add the phrase " except as provided in § 26.109(b)(1 )(ii}, for the Federal CCF ," to describe an instance when the custody documents would not be under the control of the collector. This change is needed because t he proposed rule change to § 26.109(b )( 1 )(ii) would permit anothe r collector or hydration monitor to observe the donor during the hydration process and to maintain the Federal CCF during that time period. With regard to urine specimen acceptability, the proposed rule would revise the term " altered ," as used in§ 26.111(a) and (c) to clarify that the term means that the collector has determined that a specimen may have been adulterated and/or diluted. This determination by a collector is not equivalent to the determination that a specimen is an adulterated specimen as 46 defined in § 26.5, which is a specimen testing determination made by an HHS-certified laboratory.

The proposed rule would correct an editorial error in § 26.111 (a) associated with the minimum volume requirement for a urine specimen.

Specifically, the phrase "but greater than 15 ml" would be replaced with "but equal to or greater than 15 ml." This change conforms with the existing minimum specimen volume requirements in §§ 26.109(b )( 4) and 26.111 (b) and ( d). Collector Actions Following a Refusal to Test The proposed rule would add § 26.107(d) and revise§§ 26.111 (c) and (e), and 26.115(9), to more explicitly describe the actions that a collector must take when a refusal to test is determined during the specimen collection process, including the retention or disposal of any specimen(s) provided by the dorior. Section 26.107(d) would be added to state that, if the collector determines a refusal to test during the specimen collection process, the collector shall do the following: 1) inform the donor that a refusal to test has been determined;

2) terminate the collection process; 3) document a description of the refusal to test on the Federal CCF; 4) discard any urine specimen(s) provided by the donor, unless provided for a post-event test in§ 26.31(c)(3);

and 5) immediately inform the FFD program manager of the refusal to test. The majority of these proposed changes are consistent with existing collector practice.

However, the proposed change to discard any urine specimens, except if collected for a post-event test, would be a new requirement to improve the uniformity of licensee and other entity actions taken once a refusal to test had been determined.

The NRC is aware of instances in which a licensee or other entity would conduct specimen testing, even though a refusal to test had already been determined at the collection site. This change would address this inconsistency. The proposed revisions to 47

§ 26.107(d) would help ensure that if a donor refuses to cooperate with the collection process , uniform action is taken , which would improve the consistency and effectiveness of 10 CFR part 26 with Section 8.12 of the 2008 HHS Guidelines.

The proposed change to retain and test any specimen collected for a post-event test in § 26.31(c)(3) would help to inform licensee root cause determinations, as required by other parts of the NRC's regulations , such as§§ 20.2203(b), 50.73(b), and 70.SO(c).

Although a refusal to test determination at the collection site subsequent to a specimen being provided for a post-event test is a very rare occurrence , a regulatory framework is needed to enable the testing of an individual

's urine (or other specimen matrix such as oral fluid) to assist in determining whether the individual who committed or contr i buted to the event may have been impaired from the use of alcohol , an illegal drug, or prescription or over-the-counter med i cation. This assessment (which is informed by the requirements in §§ 26.185 , " Determining a fitness-for-duty policy violation" and 26.189 , " Determination of fitness") is very important because post-event testing is co"nducted , in part , in response to the occurrence of a very significant event such as , but not limited to: 1) a death , 2) a s i gn i ficant illness or personal injury ,

• 3) a radiation exposure or release of radioactivity in excess of regulatory limits , or 4) an actual or potential substantial degradation of the level of safety of the plant. Section 26.111(c) would be revised to remove the word " designated" from the phrase " designated FFD program manager." This proposed change conforms with the existing terminology used in§§ 26.105(b), 26.109(b)(3), 26.111(c), 26.1 15(a), (b), and (h), and 26.139(b).

Section 26.111(e) specifies that " as much of the suspect specimen as poss i ble must be preserved." The proposed rule would add the clarifying phrase " except under the conditions descr i bed in § 26.107(d)(4)," i.vhich would describeto reference the condit i ons when a collector 48 is to discard any urine specimen(s) collected.

This change aligns with the proposed changes to § 26: 107(d). Some participants at the public meeting on October 11 , 2011 , requested that the NRC consider eliminating

§ 26.111 (f) because they believe this particular requirement is unnecessary. Section 26.111 (f) defines the criteria for an acceptable urine specimen as free from apparent contaminants, of at least 30 ml in quantity, and within the acceptable temperature range. However , this requirement does not aid in the implementation of 1 O CFR part 26 and is not used in the NRC's drug testing requirements. The participants stated that this provision is unnecessary because other sections in 10 CFR part 26 require specimens that do not meet the criteria in § 26.111 (f) to be sent to an HHS-certified laboratory for testing. The NRC agrees that this requirement is unnecessary because other sections in the rule already provide explicit detail as to the determination of whether a specimen is valid or invalid, as well as the specific steps required if either determination is made. Section 26.109 , " Urine specimen quantity ," contains provisions regarding urine specimen quantity , § 26.111 (a) contains provisions regarding specimen temperature , and§ 26.111 (d) requires that any specimen a collector suspects has been adulterated, diluted, substituted, or that is collected under direct observation, must be sent to an HHS-certified laboratory for initial and , if necessary, confirmatory testing. Therefore, the NRC is proposing to remove § 26.111 (f) to improve the clarity of 10 CFR part 26. Section 26.115(g) states that if-a donor's declin ationes to allow a directly observed collection , then that action is an act to subvert the testing process. The proposed rule would include a new requirement that in this instance , " the collector shall follow the procedures in § 26.107(d)." This proposed requirement describes the actions that the collector must take when a refusal to test has been determined during the specimen collection process. 49 The NRC also received a public comment regarding the retention or disposal of a urine specimen. The commenter recommended that the initially collected specimen be retained, unless the MRO or FFD program manager determined that a directly observed collection was necessary and the donor refused to comply.,., which-+!he NRC has determined that the commenter was referring interpreted as a reference to § 26.111 ( c) of the regulations.

Section 26.111 ( c) requires the collector to contact the FFD program manager if there is reason to believe that a donor may have attempted to adulterate , dilute , or substitute a specimen based on the physical characteristics of a specimen (e.g., temperature , color, odor, presence of a precipitant) or other observations made during the collection.

The FFD program manager may consult with the MRO to determine if the donor has attempted to subvert the testing process, and the FFD program manager or the MRO may require the donor to provide a second specimen, as soon as possible , and under direct observation. This section also requires the collector to inform the donor that he or she may volunteer to submit a second specimen under direct observation. The NRC has determined that there is no regulatory necessity to maintain any specimen provided by a donor, who has subsequently refused to cooperate or otherwise subverted the testing process , unless this specimen was for a post-event test, as required by § 26.31(c)(3).

This approach is justified because upon such a determination, the donor who refuses to test is permanently denied authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of§ 26.4, " FFD program applicability to catego~ies of individuals

," regardless of the outcome of the drug test. Therefore , the NRC is not proposing a rule change based on the public comment. However, even though the individual would be subject to § 26. 75 sanctions, drug and alcohol testing results from persons who caused or contributed to an event can inform a licensee's root or apparent cause determination 50 required by other parts of the NRC's regulations , such as§§ 20.2203(b), 50.73(b), and 70.50(c). The importanoe of this speoimen testing for signifioant events was addressed previously. Blind Performance Test Sample Lot In-Service Requirement The proposed rule would revise§ 26.168(h)(1

), which currently requires blind performance test sample (BPTS) suppliers to place a sample lot in service for no more than 6 months. Feedback received from industry and BPTS suppliers indicates that sample lots can remain viable for much longer than 6 months (e.g., 2 years). Further, Section 10.2 of the 2008 HHS Guidelines does not impose an in-service l i mit on BPTS lots. The NRC is proposing to eliminate the 6 month use limit and to enab l e the BPTS supplier , based on laboratory testing data on lot stability, to establish a specified shelf-life for each BPTS sample lot. Allowing the BPTS supplier to determine the expiration date (instead of the NRC requiring a uniform shelf life) would improve the effectiveness of 10 CFR part 26 , reduce burden on BPTS supp l iers and entities implementing 10 CFR part 26 requirements , and align with the 2008 HHS Guidel i nes. Furthermore , if a BPTS is no longer stable and unexpected test results were reported by the laboratory inconsistent with the formulation , § 26. 719( c) already requires the licensee or other entity to report to the NRC the testing error and the results of the investigation. The§ 26.719(c) reporting requirement ensures that the NRC receives timely information on any BPTS formulation irregularities. HHS-Certified Laboratory Personnel Qualifications and Responsibilities The proposed rule would remove § 26.155 , " Laboratory personnel ," which re-states the qualifications and responsibilities of HHS-certified laboratory personnel (e.g., Responsible Person , Cert i fying Scient i st) included in the HHS Guidelines. The NRC finds that it is unnecessary t o r estate these HHS Gu i delines requ i rements in 10 CFR part 26 because 51 licensees and other entities are required to use HHS-certified laboratories to conduct drug and validity testing in § 26.153(a).

Each laboratory is certified and then inspected every 6 months by the NLCP , which provides assurance that laboratory personnel are appropriately trained , qualified, and meet acceptable academic and technical requirements. The proposed change would reduce the potential for dual regulation of HHS-certified laboratories because each laboratory is also annually inspected by the licensee or other entity as required in § 26.41 (c). Eliminating these redundant requirements would improve the regulatory efficiency of 10 CFR part 26 by reducing unnecessary regulatory oversight.

A conforming change based on the removal of§ 26.155 would be to eliminate the reference to§ 26.155 in§ 26.8 , " Information collection requirements

0MB approval ," which lists the information collection requirements in 10 CFR part 26 that were approved by the Office of Management and Budget (0MB). HHS-Certified Laboratory Procedures The proposed rule would remove § 26.157(b) through ( e ), which re-state the laboratory procedures requirements included in the HHS Guidelines.

Section 26.157 , " Procedures

," describes the written procedures that HHS-certified laboratories must develop , implement, and maintain.

The NRC finds that it is unnecessary to restate these HHS Guidelines requirements in 1 O CFR part 26 because licensees and other entities are required to use HHS-certified laboratories to conduct drug and validity testing in § 26.153(a).

As discussed for the proposed changes to § 26.155, each HHS-cert i fied laboratory is certified and then inspected on a periodic basis by the NLCP , which provides assurance that the procedures requirements in the HHS Guidelines are developed, implemented, and maintained by the laboratory.

The proposed change would reduce the potential for dual regulation of HHS-certified laboratories w i th respect 52 to maintaining a duplicative set of laboratory procedures already required to be maintained by the HHS Guidelines and reviewed and evaluated by the NLCP. The proposed rule would revise the requirement in § 26.157(a) to replace the phrase that each HHS-certified laboratory must "develop , implement , and maintain clear and documented procedures for accession, receipt , shipment , and testing of urine specimens" with "develop , implement , and maintain procedures specific to this part that document the accession , receipt , shipment , and testing of specimens." The proposed changes would do the following: 1) ensure that each laboratory would continue to maintain procedures specific to 10 CFR part 26, such as for special analyses testing in§ 26.163(a) and the use of more stringent testing cutoff levels and/or the testing of additional substances permitted in § 26.31 (d)(3); 2) remove the word " urine" from the phrase " testing of urine specimens ," to provide additional flexibility, should the testing of additional specimen matrices (e.g., hair , oral fluids) be allowed by future changes to the HHS Guidelines and subsequent amendments to 10 CFR part 26 requirements; and 3) replace " clear and well-documented" with " documented" laboratory procedures to better align with the terminology in§ 26.27(c) and the 2008 HHS Guidelines.

The proposed changes to § 26.157(a) would enhance regulatory efficiency and reduce burden by clarifying that each laboratory must maintain procedures specific only to 10 CFR part 26 testing. Quality Control Samples for Validity and Drug Testing Section 26.137( e )(6) lists the specifications for the quality control samples to be included in each analytical run of initial drug testing performed at an LTF, and§ 26.167(d)(3) and (e) list the quality control sample specifications to be included in each analytical run of initial and confirmatory drug tests performed at an HHS-certified laboratory , respectively.

The proposed 53 rule would make a number of conforming changes to these quality control sample requirements to improve the clarity of 10 CFR part 26 and its consistency with Sections 11.12 , 11.14, and 11.15{a)(1) of the 2008 HHS Guidelines.

The proposed rule would replace the word " drugs" in the first sentence of § 26.137( e )(6) and the phrase "drug and metabolite" in the second sentence of§ 26.137(e)(6) with "drugs and drug metabolites" and " drug and drug metabolite," respectively. The phrases " drug(s) or drug metabolite(s)" in § 26.137(e)(6)(ii) and (e)(6)(iii) and " a drug(s) or drug metabolite(s)" in § 26.167(d)(3)(ii), (d)(3)(iii), and (e)(3)(iii) would be replaced with the phrase "the drug or drug metabolite." Similarly , the phrase " no drug" would be expanded to "no drug or drug metabolite" in§ 26.167(e)(3)(i), and the phrase " no drugs or drug metabolites" would be revised to " no drug or drug metabolite" in§§ 26.137(e)(6)(i) and 26.167(d)(3)(i).

The proposed rule would remove the parenthetical phrase " (i.e., negative urine samples)" from §§ 26.137(e )(6)(i) and 26.167(d)(3)(i) and (e )(3)(i). Each of those requirements already specifies that the quality control sample is to contain no drug or drug metabolite, so ttie parenthetical is redundant.

The phrase "targeted at 25 percent below the cutoff' would be replaced in the proposed rule with the phrase " targeted at 75 percent of the cutoff' in §§ 26.137( e )(6)(iii) and 26.167( d)(3)(iii). The term " sample(s)" would be replaced in the proposed rule with the phrase " at least one control" in §§ 26.137( e )(6)(i) and 26.167( d)(3)(i) and ( e )(3)(i). Similarly, the phrase " at least one calibrator or control that is" would be replaced in the proposed rule with the phrase " at least one control" in§ 26.167(e)(3)(iv). The parenthetical statement

" (i.e., calibrators and controls)" would be added after the phrase " quality control samples" in§§ 26.137(e)(6) and 26.167(d)(4), and a conforming change 54 would be made in § 26.167( e )(2) to the phrase " calibrators and controls" by replacing it with the phrase " quality control samples (i.e., calibrators and controls)." The phrase " Positive calibrator(s) and control(s) with a drug(s) or drug metabolite(s)" in § 26.167( e )(3)(ii) would be replaced in the proposed rule with the phrase " A calibrator with its drug concentration at the cutoff." The proposed rule would replace the phrase " A minimum of 10 percent of all specimens in each analytical run" in § 26.137( e )(6) with the phrase " A minimum of 10 percent of the total specimens in each analytical run ," to more clearly describe how to determine the number of quality control samples to include in each analytical run of initial drug testing performed at an L TF. Conforming changes would be made in§ 26.167(e)(2) to the quality control samples that are to be included in each analytical run of confirmatory drug tests performed at an certified laboratory , by replacing the phrase " At least 10 percent of the samples in each analytical run of specimens" with the phrase " A minimum of 10 percent of the total specimens in each analytical run." The proposed change to§ 26.167(e)(2) is consistent with the existing terminology used in the quality control sample requirement for initial drug testing in § 26.167(d)(4).

Section 26.167(f)(3) would be revised to make an editorial correction to the phrase " a statement by the laboratory

's responsible person" by capitalizing the " r" and the " p" in the position title , so that it reads as follows: " Responsible Person." The proposed rule would also correct two of three inaccuracies described in an NRC enforcement guidance memorandum (EGM-09-003 , dated March 31 , 2009) that pertain to the L TF quality control sample requirements for initial validity testing in§ 26.137(d)(5) and for initial drug testing in§ 26.137(e)(6)(v). The third inaccuracy , incorrectly us i ng the term " laboratory analysts" instead of " licensee testing fac i lity technicians

," has already been addressed in a 55 1 O CFR part 26 final rule correcting amendment , which was published in the Federal Register on August 3, 2009 (74 FR 38326). The first inaccuracy pertains to the requirements in§ 26.137(d)(5) and (e)(6)(v), which require that at least one quality control specimen in each analytical run must appear as a "donor specimen" instead of as a " normal specimen" to the LTF technician.

To meet this requirement , _ a different individual would be required to prepare the quality control sample to ensure that the L TF technician that is conducting the specimen testing would be unaware of the origin of the sample. The current rule does not require that different individuals prepare quality control samples and conduct specimen testing. Without EGM-09-003, § 26.137(d)(5) and (e)(6)(v) would place an unnecessary burden on licensees and other entities because additional L TF procedural changes would be necessary , including the use of an additional qualified person , either to prepare quality control samples or to conduct specimen testing. The majority of L TFs use a single L TF technician to prepare quality control samples and to perform specimen testing , which is consistent with the intent of the current rule. To correct this inaccuracy and to address the currently applicable enforcement discretion, the proposed rule would replace the phrase " donor specimen" with the phrase " normal specimen" in§ 26.137(d)(5) and (e)(6)(v). The second inaccuracy pertains to the requirement in § 26.137(e)(6)(v) that " at least one positive control" is to be included in each analytical run of initial drug testing of specimens at an L TF. The intent of this requirement is to verify the custody and control procedures and confirm the accuracy of initial drug testing performed at an L TF, neither of which require the use of only a positive quality control sample. Since§ 26.137(e)(6)(ii) and (e)(6)(iii) already specify the positive quality control samples to be included in each analytical run , the proposed rule would replace the phrase " at least one positive control , certified to be positive by an HHS-certified laboratory" with the phrase " at least one quality control sample" in § 26.137( e )(6)(v). 56 The NRC would rescind EGM-09-003 if the proposed rule changes correcting these inaccuracies is-are finalized. Additional MRO Review for Invalid Specimens with pH of 9. 0 to 9. 5 Section 26.185(f) describes the process that an MRO is to use to review invalid specimen test results. The proposed rule would redesignate paragraph (f)(3) as paragraph (f)(4) and would add a new paragraph (f)(3) to§ 26.185, to align the MRO review process for invalid specimen test results with Section 13.4(f) of the 2008 HHS Guidelines.

Specifically, if a donor did not provide an acceptable medical explanation to the MRO for a pH value in the range of 9.0 to 9.5 , the MRO would then have to consider if elapsed time and/or high temperature might have caused the test result. This change is being proposed because of research that demonstrated that exposing a urine specimen to high temperature and/or an extended delay in specimen testing from the time of collection may result in a pH in the range of 9.0 to 9.5 (Cook, et al., 2007). The 2008 HHS Guidelines addressed this topic in Section 13.4(f). In the proposed rule, ii f the MRO obtains sufficient information from the licensee or other entity, collection site, L TF, or HHS-certified laboratory regarding elapsed time and/or temperature conditions at specimen collection , receipt , transportation , or storage to conclude that an acceptable technical explanation exists for the invalid test result due to pH , then the MRO would direct the licensee or other entity to collect a second urine specimen from the donor , as soon as reasonably practicable.

The second specimen would not be collected under direct observation because sufficient evidence was obtained to conclude that donor action likely was not the cause of the invalid test result. This proposed new step to consider technical explanations for a discrepant pH result would provide an additional protection to the donor and limit the instances in which a second collection under direct observation is necessary (i.e., only for invalid specimen test results where no legitimate medical or technical explanation has been determined by the MRO). 57

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While Section 13.4(f) of the 2008 HHS Guidelines differs in that it does not require a second test in these circumstances, this approach is inapplicable because a valid test is necessary for determining whether to grant or deny authorization.

Based on feedback received during the October 11 , 2011 , public meeting , the NRC has chosen not to propose adding detailed instructions in 10 CFR part 26 on how the MRO is to interpret time and temperature information with respect to specimen pH. Meeting participants commented that the draft instructions presented by the NRC at the public meeting were too prescriptive and unnecessary and that the MRO should be provided with flexibility in making this determination.

The NRC agreed and instead is proposing to include guidance on the methods an MRO could use to review invalid test results reported in § 26.185(f)(3) in draft regulatory guide (DG) 5040, " Urine Specimen Collection and Test Result Review under 10 CFR Part 26, Fitness for Duty Programs." This draft guidance is being issued concurrently for comment with this proposed rule. The NRC also discussed at the October 11, 2011, public meeting the potential to change § 26.131 (b )(2) to assist in the documentation of time and/or temperature information for invalid test results, based on a pH of 9.0 or greater obtained at an L TF. However , participants opposed these documentation requirements because they would be burdensome to implement.

The NRC agreed and instead is proposing to include in DG-5040 the methods that L TF staff may use to document information to support the MRO review of invalid test results in § 26.185(f)(3).

Donor Request for Specimen Retesting or Bottle B Testing Section 26.165(b)(2) instructs the MRO to " inform the donor that he or she may, within 3 business days of notification by the MRO of the confirmed positive , adulterated , or substituted test result, request the retesting of an aliquot of the single specimen or the testing of the 58 Bottle B split specimen." Z The proposed rule would include a new requirement in § 26.165(b )(2) for the MRO to document in his or her records when (i.e., date and time) a request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.

Documenting when a donor initiated the request for testing would ensure that a record was maintained to demonstrate that the donor had made the request within the required 3 business days timeframe.

This rule change would document an existing practice already conducted byof MROs when receiving such a request because, to ensure that notification is received within 3 business days , a method to record the date and time of receipt of the donor's request for testing must already be in place. Section 26.165(b )(3) requires the donor to provide his or her permission for the retesting of an aliquot of the single specimen or the testing of Bottle Band states that " Neither the licensee , MRO , NRC, nor any other entity may order retesting of the single specimen or testing of the specimen in Bottle B without the donor's written permission , except as permitted in § 26.185(1)." The proposed rule would revise § 26.165(b)(3) to state that " No entity , other than the MRO as permitted in § 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's written permission

." The proposed change would address an inconsistency in the current rule because § 26.165(b )(2) already states that the " donor's request may be oral~ or in writing." At present , even though the MRO may have received an oral request from the donor to proceed w i th the retesting of an aliquot of a single specimen or to test the Bottle B split specimen, some licensees are 7 " Aliquot" means a portion of a specimen that is used for testing. It is taken as a sample representing the whole specimen. " Bottle B testing" means the drug or validity testing performed by a second HHScertified laboratory on the split (Bottle B) specimen to verify the test results reported by the first HHScertified laboratory that tested the Bottle A specimen.

59 interpreting the current rule to require that the MRO must receive written permission from the donor before initiating the retesting of a specimen. These proposed changes to§ 26.165(b)(2) and (b)(3) would improve the consistency of 10 CFR part 26 with Section 14.1(b) of the 2008 HHS Guidelines and would enhance due process by ensuring that the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen could proceed as quickly as possible.

Collection of a Second Specimen under Direct Observation when Bottle Boran Aliquot of a Single Specimen Is Not Available for Testing Section 26.11 S(a) lists the exclusive grounds for collecting a urine specimen under direct observation.

However, the list does not include an existing requirement in§ 26.165(f)(2) in which an observed collection is required when a donor requests a retest and either Bottle B or the single specimen is not available, due to circumstances outside of the donor's control. The proposed rule would correct this omission by including a new paragraph (a)(S) to reference the direct observation requirement in § 26.165(f)(2).

The proposed rule would also make an editorial correction to improve the clarity of an existing requirement in the first sentence of § 26.11 S(a), by including a comma after the word "subpart" in the phrase " directed by this subpart or the MRO or FFD program manager." Section 26.165(f)(2) requires MRO action for a positive drug test result or an adulterated or substituted validity test result, when the Bottle B of a split specimen or an aliquot ofa single specimen is not available for testing at the donor's request. In this instance, the MRO is required to cancel the initial test result and inform the licensee or other entity that a second specimen must be collected under direct observation "as soon as reasonably practical." Section 14.1(c) of the 2008 HHS Guidelines, for this same circumstance, states that no 60 advanced notice is to be provided to the donor regarding the second specimen collection until immediately before the collection is to commence.

The proposed rule would revise the requirement in § 26.165(f)(2) to specify that no prior notice shall be given to a donor until i mmediately before the collection. Clarifying the procedure to follow in this circumstance would improve the effectiveness of licensees' or other entities' testing programs to detect illegal drug use and/or the misuse of legal drugs and would align 10 CFR part 26 with the 2008 HHS Guidelines. The proposed rule would also revise § 26.165(f)(2) to state that the MRO is to report a cancelled test result to the licensee or other entity. The process i n § 26.165(f)(2) already states that the licensee or other entity may not impose any sanctions on the donor for a cancelled test result. This revision clarifies the existing action that the MRQ. must take to report the results of the testing of a donor's specimen to the licensee or other entity. Subsequent action by the licensee or other entity cannot be taken until the MRO provides the test result information for a donor's specimen. The revision would also state that the licensee or other entity must continue the administrative withdrawal of an i ndividual's FFD authorization until the test results from the second specimen collection are determined.

Continuing to administratively withdraw an individual's authorization would be consistent with § 26.165(f)(1 ), which requires the licensee or other entity to administratively withdraw an individual

's FFD authorization on the basis of the first confirmed positive , adulterated , or substituted test result until the results of a donor-requested Bottle B split specimen test or single specimen retest are available and have been reviewed by the MRO. A participant at the October 11, 2011, public meeting also requested that the NRC include in § 26.165(f)(2) a reference to §§ 26.129(b )(2) and 26.159(b )(2) to clarify that the action of the licensee or other entity was taken based on the test results of the second specimen 61 collected under direct iefl observation. The NRC agrees with this request and is proposing to revise this section accordingly. FFD Program Performance Data Reporting The NRC has periodically received questions from licensees and other entities on the annual drug and alcohol testing reporting requirements on "populations tested" in § 26. 717(b) and (c). Specifically , the reporting requirements to provide FFD program performance data by populations tested " (i.e., individuals in applicant status, permanent licensee employees , [contractors/vendors]

CNs)" has resulted in two types of questions.

First, licensees already report the pre-access testing results separately for the licensee employee and CN tested populations , so they requested clarification on the term " individuals in applicant status." Applicant status is not a distinct tested population category , rather , it is the status of individuals that are subject to pre-access testing. Currently , licensees and other entities must report the test results by tested population for each condition of testing (i.e., access, random , for-cause , post-event, and follow-up) as required by§ 26.717(b)(5). By reporting the pre-access test results for each of the two tested populations (i.e., licensee employees , CNs), licensees and other entities are already reporting the results for individuals in " applicant status." To improve the clarity of the existing reporting requirement , the proposed rule would remove the phrase " individuals in applicant status" from§ 26.717(b)(3) and (b)(4). Second, the NRC has received questions from entities other than the licensees that report§ 26.717 drug and alcohol test results. Because§ 26.717(b)(3) and (b)(4) does not specify " other entity" in the parenthetical statements defining the tested populations, these entities were unclear on how to classify their tested populations on the § 26. 717 annual summary reports to the NRC. To correct this oversight , the proposed rule would revise the 62 '

tested population

" licensee employees" to " licensee or other entity employees" in § 26.717(b)(3) and (b)(4). IV. Section-by-Section Analysis Nomenclature Changes Throughout 1 O CFR part 26 , the NRC is proposing to revise the term " custody and control form" to read " Federal CCF." Two additional iterations of the term , " custody-and-control forms" and " custody-and-control form(s)," would also be revised to read " Federal CCFs" and " Federal CCF(s)," respectively.

Throughout 10 CFR part 26 , the NRC is proposing to revise the term " chain-of-custody" to read " chain of custody." The nomenclature changes to " custody-and-control form" and " chain-of-custody" would align with the spelling of these terms in the 2008 HHS Guidelines and would also improve consistency in 10 CFR part 26. The proposed rule would also correct a number of instances where " chain-of-custody form" was used instead of " custody and control form ," and vice versa. These corrections pertain to§§ 26.89(d); 26.117(f); and 26.159(c), (d) and (e), as described later in this section. § 26.4 FFD program applicability to categories of individuals Section 26.4(e)(6)(iv) would be revised to eliminate the phrase " (65 FR 41944; August 9 , 2001 )." Section 26.4(g)(6) would be added to describe a new activity that the FFD program personnel could perform: monitoring a dono r dur i ng the hydration process descr i bed in 63

§ 26.109(b). The punctuation at the end of§ 26.4(g)(4) and (5) would be updated to accommodate the addition of§ 26.4(g)(6).

Section 26.4U)(3) would be revised to replace the phrase " laboratory certified by the Department of Health and Human Services (HHS)" with "Department of Health and Human Services (HHS)-certified laboratory as defined in § 26.5." § 26. 5 Definitions As described in Section 111.C of this document , the NRC is proposing to add definitions for cancelled test , carryover, Certifying Scientist, Federal custody and control form, Jot, rejected for testing, and Responsible Person. The definition for calibrator would be revised to include a clarifying statement that a calibrator is a solution of known concentration "in the appropriate matrix." The phrase "test specimen/sample" would be replaced with the phrase " donor specimen or quality control sample." The last sentence of the current definition which states that " calibrators may be used to establish a cutoff concentration and/or a calibration curve over a range of interest" would be deleted. The definition for control would be revised by replacing the phrase " a sample used to monitor the status of an analysis to maintain its performance within predefined limits" with the phrase " a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits." The definition for dilute specimen would be revised by replacing the phrase " concentrations that are lower th~n expected for human urine" with the phrase " values that are lower than expected but are still within the physiologically producible ranges of human urine." 64 The definition for HHS-certified laboratory would be revised to eliminate the Federal Register citations for each final versioh of the HHS Guidelines. Instead, the definition would state that " HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that drug and validity testing of a specimen is performed for a licensee or other entity." The definition for invalid result would be revised to replace the phrase " for a specimen that contains an unidentified adulterant, contains an unidentified interfering substance, has an abnormal physical characteristic, contains inconsistent physiological constituents, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result" with the phrase " in accordance with the criteria established in§ 26.161(f) when a positive , negative , adulterated , or substituted result cannot be established for a specific drug or specimen validity test." The definition for limit of quantitation (LOQ) would be revised to replace the phrase " the lowest concentration of an analyte at which the concentration of the analyte can be accurately determined under defined conditions" with the phrase " for quantitation assays , the lowest concentration at which the identity and concentration of the analyte can be accurately established

." The definition for substituted specimen would be revised to replace the phrase " with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human physiology" with the phrase " a specimen that has been submitted in place of the donor's urine , as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine." 65

§ 26. 8 Information collection requirements:

0MB approval Section 26.8(b) would be revised to remove the reference to § 26.155. § 26. 31 Drug and Alcohol Testing Section 26.31(b)(2) would be revised to eliminate the phrase " (65 FR 41944; August 9 , 2001 )." Section 26.31 (d)(1) would be revised to include MOMA , MDA , and MDEA as substances for which licensees and other entities are required to test for in each specimen. Section 26.31(d)(1)(i)(D) would be revised to eliminate the phrase " as specified in § 26.155(a)." Section 26.31 (d)(1 )(ii) would be revised to replace the phrase " except if the specimen is dilute and the licensee or other entity has required the HHS-certified laboratory to evaluate the specimen in §§ 26.163(a)(2) or 26.168(g)(3) with the phrase "except if special analyses of the specimen is performed under§ 26.163(a)(2) by the HHS-certified laboratory

." § 26. 89 Preparing to Collect Specimens for Testing Section 26.89(c) would be revised to replace the phrase " adulterated , diluted, or adulterated the specimen" with the phrase "adulterated, diluted, or substituted the specimen." Section 26.89(d) would be revised to include this phrase at the end of the first sentence:

", except as described in§ 26.109(b)(1

)." The second sentence in § 26.89(d) would be revised in three ways. First , the phrase " For this purpose, a urine collection" would be replaced with the phrase " The urine collection

." Second , the phrase " sealed and initialed" would be replaced with the phrase " sealed with. tamper-evident tape , the seal has been dated and initialed." Finally , the phrase " the chain of custody form has been executed , and the donor has departed the collection 66 site" would be replaced with the phrase " and the Federal CCF has been completed , or when a refusal to test has been determined under§ 26.107(d)." § 26. 107 Collecting a Urine Specimen Section 26.107(b) would be revised in four ways. First , the proposed rule would redesignate paragraph (b) as paragraph (b)(1). Secondly , the phrase " except as provided in § 26.109(b )( 1 )" would be added in the first sentence after " The collector shall pay careful attention to the donor during the ent i re collection process." Third , § 26.107(b) would be revised to replace the phrase " to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine is in plain view or an attempt to bring an adulterant or urine substitute into the privacy area)" with the phrase " to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain v i ew; attemp ti ng to bring an adulterant , urine substitute , heating element , and/or temperature measurement device into the room, stall , or private area used for urination)

." Lastly , the phrase " the collector shall document the conduct" would be revised to read as follows: " the collector shall document a description of the conduct." Section 26.107(b )(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process , this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site , donor refuses to follow directions). Section 26.107(d) and (d)(1) through (d)(5) would be added to describe requirements regarding the actions a collector must take if a refusal to test is determined at any point during the specimen collection process. Specifically , the collector shall: 1) i nform the donor that a refusal to tes t has been determ i ned , 2) te r m i nate the collection process , 3) document a 67 description of the refusal to test on the Federal CCF , 4) discard any urine specimen(s) provided by the donor unless the specimen was collected for a post-event test required by§ 26.31 (c)(3), and 5) immediately inform the FFD program manager of the refusal to test. § 26. 109 Urine Specimen Quantity Section 26.109(b)(1) would be revised, and new paragraphs (b)(1 )(i) through (b)(1 )(iii) would be added, to provide a licensee or other entity with new flexibility in the personnel that may be used to monitor a donor during the hydration process that is initiated when a donor is unable to provide an acceptable quantity of urine during the initial collection attempt. For clarity, the last sentence of§ 26.109(b )( 1) would become the new first sentence of§ 26.109(b )(2). The proposed rule would permit another staff member designated as FFD program personnel , as described in § 26.4(g)(6), or another specimen collector meeting the requirements in § 26.85(a), instead of the specimen collector who initiated the collection process, to monitor a donor during the hydration process. The collector shall: 1) explain the hydration process and acceptable donor behavior to the hydration monitor, and 2) record the name of the individual observing the donor on the Federal CCF and then provide the Federal CCF to the observer for the duration of the hydration process. The original collector may .then perform other collections while the donor is in the hydration process. § 26. 111 Checking the Acceptability of the Urine Specimen Section 26.111 (a) would be revised to replace the phrase " greater than 15 ml" with the phrase "equal to or greater than 15 ml" and to add the phrase " (e.g., adulterated or diluted)" after the word " altered." 68 Section 26.111 ( c) would be revised to remove the word " designated" from the phrase " designated FFD program manager" in the first sentence.

The parenthetical phrase " (e.g., adulterated or diluted)" would be added after the word " altered" in the second sentence. Section 26.111 ( e) would be revised to include the phrase ", except under the cond i tions described in§ 26.107(d)(4)" at the end of the existing requirement.

Section 26.111 (f) would be removed. § 26. 115 Collecting a Urine Specimen under Direct Observation Section 26.115(a)(3) would be revised to replace the phase " The collector observes conduct clearly and unequivocally indicating an attempt to dilute , substitute , o r adulterate the specimen" with the phrase " The collector , or the hydrat i on monitor if one is used as permitted in § 26.109(b)(1 ), observes conduct by the donor indicating an attempt to subvert the testing process." Also , the proposed rule would remove the word " and" at the end of§ 26.115(a)(3). Paragraph (a)(S) would be added to include an additional instance when an observed collection i s required: " The donor requests a retest and e i ther Bottle B or the single specimen is not available due to circumstances outside of the donor's control , as specified in § 26.165(f)(2)." The period at the end of the sentence-in§ 26.115(a)(4) would be replaced with a"; aR*1-or" to accommodate for the new paragraph (a)(S) in the lis t of exclusive grounds for perform i ng a directly observed collection. In § 26.11 S(f), the proposed rule would revise the first sentence , " If someone other than the collector is to observe the collection , the collector shall instruct the observer to follow the procedures i n this paragraph ," so that it reads " If the observer is not a trained collector , the collector shall , i n the presence of the dono r, instruct the observer on the collection procedures in 69 paragraph (f)." The revised sentence would be added to the end of existing requirements in § 26.115(e). In § 26.115(f)(2), the proposed rule would add the following parenthetical statement to the end of the existing requirement:

" (a mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room , stall , or pr i vate area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted)

." In § 26.115(f)(3), the proposed rule would replace the phrase " If the observer is not the collector , the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector'

' with the phrase " If the observer is not the . collector, the observer may not touch or handle the collection container , but shall maintain visual contact with the specimen until the donor hands the collection container to the collector." Section 26.11 S(g) would be revised to include the phrase ", and the collector shall follow the procedures in§ 26.107(d)" at the end of the existing requirement.

§ 26. 117 Preparing Urine Specimens for Storage and Shipment Section 26.11 ?(a) would be revised to add the phrase " Once the collector is presented with the specimen from the donor" at the beginning of the first sentence to clar i fy when the collector would ee-begin to keep the donor's " urine specimen(s) in view at all times." 70 Section 26.117(f) would be revised to replace the term "chain-of-custody forms" with the term " Federal CCFs." Section 26.117(f) would also be revised to replace the phrase "or the licensee's testing facility," with the phrase "or to the licensee testing facility." Section 26.117(g) would be revised to add the phrase" , except as provided in § 26.1 09(b)(1 )(ii) for the Federal CCF ," to the end of the first sentence.

§ 26. 129 Assuring Specimen Security, Chain of Custody , and Preservation Section 26.129(b )( 1 )(ii) would be revised by replacing the phrase "the specimen may not be tested," with the phrase "the licensee testing facility shall reject the specimen for testing." Section 26.129(b )(2) would be revised by adding the phrase " and report a cancelled test result to the licensee or other entity," after the phrase "requiring the MRO to cancel the testing of a donor's urine specimen." § 26. 133 Cutoff Levels for Drugs and Drug Metabolites The introductory paragraph under § 26.133 would be revised to clarify that the specified cutoff level must be used to determine whether the specimen is negative "or positive" for the indicated drug or drug metabolite being tested. The table in § 26.133 would be revised to: 1) lower the initial test cutoff level for cocaine metabolites from 300 ng/ml to 150 ng/ml, 2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morphine is the target analyte , 3) lower the initial test cutoff level for amphetamines (abbreviated in the table as AMP) from 1000 ng/ml to 500 ng/ml, 4) add initial testing for 6-AM at a cutoff level of 10 ng/ml, 5) include a new table footnote 2 regarding initial test kits, 6) include a new table footnote 3 to clarify that for amphetamines testing, methamphetamine (abbreviated in the table as MAMP) is the target analyte, and 7) add initial testing for MOMA at a cutoff level of 500 ng/ml. The column header "Drug or metabolites" in 71 the table in § 26.133 would also be revised to "Drugs or drug metabolites" to align with the table title. § 26. 137 Quality Assurance and Quality Control Section 26.137( d)(5) would be revised to replace the term " donor specimen" with the term "normal specimen." Section 26.137( e )(6) would replace the phrase " A minimum of 10 percent of all specimens" at the start of the first sentence with the phrase " A minimum of 10 percent of the total specimens." The parenthetical phrase " (i.e., calibrators and controls)" would be added after the phrase " quality control samples" in the first sentence of§ 26.137(e)(6).

The word " drugs" in the first sentence of§ 26.137(e)(6) and the phrase " drug and metabolite" in the second sentence of§ 26.137(e)(6) would be replaced with the phrases " drugs and drug metabolites" and " drug and drug metabolite

," respectively. Section 26.137(e)(6)(i) would replace the phrase " Sample(s) certified by an HHS-certified laboratory to contain no drugs or drug metabolites (i.e., negative urine samples)" with the phrase " At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite." Section 26.137(e)(6)(ii) would be revised to replace the phrase " drug(s) or drug metabolite(s)" with the phrase " the drug or drug metabolite

." Section 26.137(e)(6)(iii) would be revised to replace the phrase "the drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff' with the phrase " the drug or drug metabolite targeted at 75 percent of the cutoff." Section 26.137( e )(6)(v) would be revised to replace the phrase " At least one positive control, certified to be positive by an HHS-certified laboratory , which appears to be a donor 72 specimen" with the phrase " At least one quality control sample that appears to be a normal specimen." § 26. 153 Using Certified Laboratories for Testing Urine Specimens Section 26.153(a) would be revised to replace the phrase " laboratories certified under the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs [published in the Federal Register on April 11 , 1988 (53 FR 11970), and as amended, June 9, 1994 (59 FR 29908), November 13, 1998 (63 FR 63483), and April 13, 2004 (69 FR 19643)]" with the phrase " HHS-certified laboratories as defined in § 26.5." The sentence " Information concerning the current certification status of laboratories is available from the Division of Workplace Programs , Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815, 5600 Fishers Lane , Rockwall 2 Bldg., Rockville , Maryland 20857" would be removed. Section 26.153(g) would be revised to replace the term " Federal custody-and-control form" with " Federal CCF" and the term " non-Federal form" with " non-Federal CCF." § 26. 155 Laboratory Personnel Section 26.155 would be removed and reserved. § 26. 157 Procedures Section 26.157(a) would be revised to replace the phrase " clear and well-documented procedures for" with the phrase " procedures specific to this part that document the." 73 Section 26.157(a) would also be revised to remove " urine" in the phrase " testing of urine specimens." Section 26.157(b) would be removed and reserved , and § 26.157(c) through (e) would be removed. § 26. 159 Assuring Specimen Security , Chain of Custody , and Preservation Section 26.159(b )( 1 )(ii) would be revised to replace the phrase " the specimens may not be tested" with the phrase " the laboratory shall reject the specimens for testing" when the integrity or identity of the specimens is in question. Section 26.159(b )(2) would be revised to add after " The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen ," the phrase " and report a cancelled test to the licensee or other entity." Section 26.159(c) would be revised in the second sentence of the paragraph to replace the term " custody-and-control" with the term " chain of custody." Also , the term "

control form" would be replaced with the term " Federal CCF" in the third sentence of the paragraph.

Section 26.159( d) would be revised to replace the term "custody-and-control" with the term " chain of custody." Section 26.159( e) would be revised to replace the term " custody-and-control" with the term " chain of custody" in the two instances that it occurs in the paragraph. 74

§ 26. 161 Cutoff Levels for Validity Testing Sections 26.161 (c)(3) through (c)(6) would be revised to replace all instances of " LOO" with " LOO." Sections 26.161(c)(5) would be revised to replace the phrase " GC/MS fo r the confirmatory test" with the phrase " a different confirmatory method (e.g., gas chromatography/mass spectrometry (GC/MS))." Sections 26.161 (c)(6) would be revised to replace the phrase " GC/MS for the confirmatory test" with the phrase " a different confirmatory method (e.g., GC/MS)." Sections 26.161 (f)(5) and (f)(7) would be revised to replace all instances of the term " LOO" with the term " LOQ." § 26. 163 Cutoff Levels for Drug and Drug Metabolites Section 26.163(a)(1) would be revised to replace the phrase " negative for the indicated drugs and _drug metabolites" with the phrase "negative or positive for the indicated drugs and drug metabolites

." The phrase " except if validity testing indicates that the specimen is dilute" would also be revised to "except as specified in paragraph (a)(2) of this section." The table in§ 26.163(a)(1) would be revised to: 1) lower the initial test cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL , 2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morph i ne i s the target analyte , 3) lower the initial test cutoff level for amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 ng/mL, 4) add initial testing for 6-AM at a cutoff level of 10 ng/mL , 5) include a new footnote 2 regarding initial test kits , 6) include a new footnote 3 to clarify that for amphetamines testing , methamphetamine (abbreviated in the table as MAMP) is the target analyte , and 7) add initial testing for MOMA at a cutoff level of 500 ng/mL. The column header " Drug or metabolites" in the table in§ 26.163(a)(1) would also be revised to 75

" Drugs or drug metabolites" to align with the table title. Section 26.163(a)(2) would be revised to remove the phrase " At the licensee's or other entity's discretion , as documented in the FFD program policies and procedures , the licensee or other entity may require the" and replace the provision with " HHS-certified laboratories shall conduct special analyses of specimens as follows:." Section 26.163(a)(2)(i) would be revised to replace the phrase " the HHS-certified laboratory shall compare the responses of the dilute specimen to the cutoff calibrator in each of the drug classes" with the phrase " or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5)." Section 26.163(a)(2)(ii) would be revised to state " If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator , the laboratory shall conduct confirmatory drug testing of the specimen to the LOO for those drugs and/or drug metabolites

and." The table in § 26.163(b )( 1) would be revised to

1) lower the confirmatory test cutoff level for cocaine metabolite from 150 ng/ml to 100 ng/ml, 2) revise " Opiates" to read " Opiate metabolites," 3) remove footnote 3 regarding the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine concentration exceeding 2000 ng/ml, 4) lower the confirmatory test cutoff levels for amphetamine and methamphetamine from 500 ng/ml to 250 ng/ml , 5) redesignate footnote 4 as footnote 3 and revise the text to lower the concentration of amphetamine that must be present in the specimen from 200 ng/ml to 100 ng/ml, 6) add confirmatory testing for MOMA , MDA , and MDEA at a cutoff level of 250 ng/ml, and 7) include new footnotes 4 and 5 to the cutoff level table to present the full names for the substances MDA and MDEA , respectively.

The column header " Drug or metabolites" in the table in § 26.163(b)(1) would also be revised to " Drugs or drug metabolites

." 76

§ 26.165 Testing Split Specimens and Retesting Single Specimens A new fifth sentence would be added to § 26.165(b )(2) that states, " The MRO shall document in his or her records when (i.e., date and time) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen." The first sentence in§ 26.165(b)(3) would be deleted. The second sentence in § 26.165(b )(3) would be revised to state " No entity , otper than the MRO as permitted in § 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's written permission

." The last sentence in§ 26.165(f)(1) would be revised by adding the phrase " the MRO shall report a cancelled test result to the licensee or other entity , and" to indicate that the MRO must report the cancelled test. Section 26.165(f)(2) would be revised to clarify the actions that an MRO is to take when a donor requests testing of Bottle B or a retest of a single specimen and the specimen to be tested is unavailable due to circumstances outside of the donor's control. Specifically, the proposed rule would: 1) add instruction for the MRO to report a cancelled test*to the licensee or other entity for the donor's specimen;

2) add instruction for the licensee or other entity to perform a second collection without prior notice to the donor and to continue to administratively withdraw the individual

's authorization until the results of the second collection are received by the MRO; and 3) add a reference to §§ 26.129(b )(2) and 26.159(b )(2), which describes the circumstances that require the MRO to cancel a test result. 77

§ 26. 167 Quality Assurance and Quality Control Section 26.167(d)(3)(i) would be revised to replace the phrase " Sample(s) certified to contain no drugs or drug metabolites (i.e., negative urine samples)" with the phrase " At least one control certified to contain no drug or drug metabolite

." Section 26.167(d)(3)(ii) would be revised to replace the phrase " a drug(s) or drug metabolites" with the phrase " the drug or drug metabolite." Section 26.167(d)(3)(iii) would be revised to replace the phrase " a drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff' with the phrase " the drug or drug metabolite targeted at 75 percent of the cutoff." Section 26.167( d)( 4) would be revised to add the parenthetical statement

" (i.e., calibrators and controls)" after the phrase "quality control samples." Section 26.167( e )(2) would be revised to replace the phrase " At least 10 percent of the samples in each analytical run of specimens must be calibrators and controls" with the phrase " A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls)." Section 26.167(e)(3)(i) would be revised to replace the phrase " Sample(s) certified to contain no drug (i.e., negative urine samples)" with the phrase " At least one control certified to contain no drug or drug metabolite

." Section 26.167(e)(3)(ii) would be revised to replace the phrase " Pos i tive calibrator(s) and control(s) with a drug(s) or drug metabolite(s)" with the phrase " A calibrator with its drug concentration at the cutoff." Section 26.167(e)(3)(iii) would be revised to replace the phrase " a drug(s) or drug metabolites" with the phrase " the drug or drug metabolite

." 78 Section 26.167(e)(3)(iv) would be revised to replace the phrase " At least one calibrator or control that is targeted" with the phrase " At least one control targeted." Section 26.167(f)(3) would be revised to make an editorial correction to the phrase "a statement by the laboratory's responsible person" by capitalizing the position title in that phrase to "Responsible Person." § 26. 168 Blind Performance Testing Section 26.168(h )( 1) would be revised to remove the phrase "and for no more than 6 months" from this requirement.

§ 26. 169 Reporting Results Section 26.169(a) would be revised to correct the capitalization of the " c" and the " s" in the position title in the phrase "the laboratory's certifying scientist" to "Certifying Scientist." The HHS-certified laboratory annual statistical summary reporting requirements in § 26.169(h)(3) would be revised to add MOMA, MDA, and MDEA to the list of amphetamines test results that a laboratory must report as required by§ 26.169(h)(3)(v).

Additional conforming changes would be made to the names of the drugs and drug metabolites listed in§ 26.169(h)(3) to include adding "(as THCA)" after "Marijuana metabolite" in§ 26.169(h)(3)(i), adding " (as benzoylecgonine)" after "Cocaine metabolite" in§ 26.169(h)(3)(ii), revising 6-AM to " 6-acetylmorphine (6-AM)" in§ 26.169(h)(3)(iii)(C), and revising "Phencyclidine" to "Phencyclidine (PCP)" in§ 26.169(h)(3)(iv). 79

§ 26. 183 Medical Review Officer Section 26.183 would be revised to remove the phrase " at the licensee's or other entity's discretion" from§ 26.183(c), (c)(1), and (d)(2)(ii). § 26. 185 Determining a Fitness-for-Duty Policy Violation Section 26.185(f)(3) would be redesignated as (f)(4), and a new paragraph (f)(3) would be added to state that , if there is no legitimate technical or medical explanation for an invalid test result based on a pH result greater than or equal to 9.0 but less than or equal to 9.5 , the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If the MRO obtains objective and sufficient information regarding elapsed time , temperature conditions , or both , to conclude that an acceptable explanation exists for the i nvalid test result due to pH , the MRO would direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. This second specimen may not be collected from the donor under direct observation cond i tions. Section 26.185(g)(2) would be revised to replace the phrase " If the licensee or other entity requires the HHS-certified laboratory to conduct the special analysis of dilute specimens permitted by§ 26.163(a)(2), the results of the special analysis are positive," with the phrase " If the results of the special analysis testing required by§ 26.163(a)(2) are positive." Section 26.185(g)(2)(iii) would be revised to remove the phrase " clearly and unequivocally

." Section 26.185(g)(3) would be removed. 80 Section 26.185(g)(4) and (g)(5) would be redesignated as§ 26.185(g)(3) and (g)(4), respectively, and the cross-reference under§ 26.163(a)(1) would be updated to reflect these changes. § 26. 405 Drug and Alcohol Testing Section 26.405(d) would be revised to add MOMA, MDA, and MDEA as substances for which licensees and other entities are required to test in each specimen.

§ 26.415 Audits Section 26.415( c) would be revised to eliminate the phrase " (65 FR 41944; August 9, 2001 )." § 26. 717 Fitness-for-duty program performance data Section 26.717(b)(3) would be revised to replace the phrase " (i.e., individuals in applicant status, permanent licensee employees , CNs)," with the phrase "(i.e., licensee and other entity employees , CNs)." Section 26.717(b)(4) would be revised to replace the phrase " (i.e., individuals in applicant status, permanent licensee employees, CNs)," with the phrase " (i.e., licensee and other entity employees, CNs)." 81 V. Specific Requests for Comment The NRC is seeking advice and recommendations from stakeholders on this proposed rule. We are particularly interested in comments and supporting rationale from the public on the following: 1. Alignment with the HHS Guidelines Two proposed changes in this rule would eliminate redundant provisions in 1 O CFR part 26 that also appear in the HHS Guidelines (i.e., HHS-certified laboratory personnel qualifications requirements in § 26.155 , " Laboratory personnel ," and HHS-certified laboratory procedures requirements specific to the HHS Guidelines in § 26.157 , " Procedures

"). Because the NLCP inspection process verifies laboratory compliance with the HHS Guidelines, additional review and oversight by NRC licensees and other entities (e.g., of laboratory security requirements) would be duplicative. The NRC is seeking comment on additional provisions in 10 CFR part 26 that are consistent with the HHS Guidelines and could be eliminated from 10 CFR part 26. 2. Special Analyses Testing The proposed rule includes new requirements in§ 26.163(a)(2) for the special analyses testing of urine specimens for drugs and drug metabolites. The first would require special analyses testing of specimens with dilute validity test results when initial drug testing identifies a drug or drug metabolite within 40 percent of the testing cutoff level. Currently , special analyses testing of dilute specimens is optional.

The second new requirement would expand special analyses test i ng to specimens collected under direct observation as required by§ 26.115(a)(1) through (a)(3) and new paragraph (a)(5). The NRC is seeking comment on whether special 82 analyses testing should also apply to the testing of individuals that already have tested positive on a 10 CFR part 26 test (i.e., denied unescorted access authorization by § 26. 75( d) for a first or second drug testing positive result). Requiring special analyses testing in this case would add a level of assurance to follow-up testing required by§ 26.69(b)(6), which i s conducted to confi r m continued abstinence from illegal drug use and/or the misuse of legal drugs. 3. Provide Flexibility to Conduct Additional Specimen Validity Tests Section 26.31(d)(1)(i)(D) permits a licensee or other entity to utilize lower cutoff levels and drug testing assays without forensic toxicologist review , if the HHS Guidelines are revised to authorize use of the assay and testing cutoff levels. However , § 26.161 (h) prohibits licensees and other entities from using more stringent cutoff levels for validity tests. The NRC is seeking comment on whether§ 26.161 (h) should be revised to provide a licensee or other entity with the option to conduct additional specimen valid i ty tests and/or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such testing. 4. Effective Date of the Final Rule If the proposed rule is finalized, the NRC anticipates providing a 60-day implementation period from the date that the final rule is published in the Federal Register. The effective date of the final rule and the compliance date for licensees and other entities would be 60 days after the date that the final rule is published in the Federal Register. The NRC is seeking comment on whether this implementat i on time period is appropr i ate based on the proposed rule changes. 5. Direct Observation of Specimen Collection 83 The proposed rule retains the requirement for direct observation during the collection of a second sample when there are indications of a subversion attempt during the initial collection. The NRC is seeking comment on whether there are any effective alternatives to direct observation that will assist in preventing subversion of the drug testing process. VI. Regulatory Flexibility Certification Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.

This proposed rule affects the licensing and operation of nuclear power plants and Category I fuel cycle facilities.

The companies that own these facilities do not fall within the scope of the definition of "small entities" set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). The NRC estimates that none of the 67 entities affected by the rule would fall within the scope of the definition of "small entities" set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). Therefore, the rule would not impact a substantial number of small entities.

VII. Regulatory Analysis The NRC has prepared a draft regulatory analysis on this proposed regulation.

The analysis examines the costs and benefits of the alternatives considered by the NRC. The NRC requests public comment on the draft regulatory analysis.

The regulatory analysis is available as indicated in the " Availability of Documents" section of this document.

Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES caption of this document.

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VIII. Backfitting and Issue Finality The proposed rule would apply to all current nuclear power plant licensees (including holders of renewed licenses under 10 CFR part 54 , "Requirements for Renewal of Operating Licenses for Nuclear Power Plants ," and combined licenses under 10 CFR part 52 , " Licenses , Certifications, and Approvals for Nuclear Power Plants") and holders of licenses authorizing the possession, use, or transport of formula quantities of SSNM under 1 O CFR part 70 , "Domestic Licensing of Special Nuclear Material." The proposed rule would apply to holders of a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76, " Certification of Gaseous Diffusion Plants ," if the holder engages in activities involving , formula quantities of SSNM. Some or all of the proposed rule would apply to: (i) current and future applicants for combined licenses under 10 CFR part 52 who have been issued a limited work authorization (LWA) under§ 50.1 O(e), if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety-and security-related structures, systems , and components (SSCs) under the LWA; (ii) combined license holders before the Commission has made the finding und~r § 52.103(g); (iii) power reactor construction permit applicants (under 10 CFR part 50, "Domestic Licensing of Production and Utilization Facilities")

who have been issued an LWA, if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety-and security-related SSCs under the LWA; (iv) power reactor construction permit holders; and (v) early site permit holders who have been issued an LWA , if the LWA authorizes the early site permit holder to install the foundations , including the placement of concrete, for safety-and security-related SSCs under the LWA. The rule would constitute backfitting as defined under§ 50.109(a)(1) for current holders of 10 CFR part 50 operating licenses and construction permits for power reactors , and under 85

§ 70.76(a)(1) for applicable current 10 CFR part 70 licensees. The NRC has performed a backfit analysis consistent with NUREG/BR-0058, Revision 4 , " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission." The backfit analysis can be found at appendix E of the regulatory analysis. The NRC has determined the backfitting is justified because: 1) there would be a substantial i ncrease in the overall level of protect i on of the public health and safety or the common defense and security to be derived from the backfitting

and 2) the costs of implementation and the annual costs would be justified in view of this increase. Imposing the requirements of the proposed rule on current holders of combined licenses would represent an inconsistency with the issue finality provision applicable to combined licenses under§ 52.98 , " Finality of combined licenses; information requests." Therefore , the NRC has addressed the criteria in§ 52.98 that would allow imposition of the proposed ru l e on current holders of combined licenses, despite the issue finality accorded to the combined license holders. The NRC be li eves that the proposed rule may be imposed as a cost-justified substantial increase in the protection of the public health and safety or common defense and security.

The bases for this determination are presented in the backfit analys i s found in appendix F of the regulatory analysis. Imposing the requirements of the proposed rule on current and future applicants for powe r reactor construction permits under 10 CFR part 50 , part 70 licenses , or early site permits or combined licenses under 10 CFR part 52 would not constitute backfitting. Neither§ 50.109 , " Backfitting

," nor the issue finality provisions for early site permits or combined licenses under 10 CFR part 52 protect either a current or prospective applicant for a construction permit , part 70 license , early site permit , or combined license from changes in the NRC rules and regulations. The NRC has long adopted the position that§ 50.109 does not protect current or pro s pective appl i cants from changes i n NRC req uir emen t s o r gu i dance , because the pol i cies 86 underlying

§ 50.109 are largely inapplicable in the context of a current or future application. This position also applies to each of the issue finality provisions under 10 CFR part 52. The provisions under 10 CFR part 26 also apply to applicants for construction permits , early site permits , or combined licenses who have been issued an LWA , if the LWA authorizes the applicant to install the foundations , including the placement of concrete, for safety-and security-related SSCs under the LWA. As of [INSERT DATE OF ISSUANCE OF NOTICE], no LWAs have been issued to an applicant for a construction permit, early site permit , or combined license , so no such entity is protected by the backfitt i ng and issue finality provisions from the changes proposed in this rulemaking.

Simi l arly , no entity holds a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76 , so no entity is protected by the backfitting provisions of § 76. 76 , " Backfitting

," from the changes proposed in this rulemaking. Draft Regulatory Guidance The guidance in DG-5040 presents methods acceptable to the NRC for implementing portions of this proposed rule. The draft guide would apply to current holders of nuclear power plant licensees (including holders of renewed licenses under 10 CFR part 54 and combined licenses under 10 CFR part 52) and current holders of licenses authorizing the possession , use, or transport of formula quant i ties of SSNM under 10 CFR part 70. The DG would also apply to holders of a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76, if the holder engages in activities invo l ving formula quantities of SSNM. The DG would also apply to the following current and future entities: 1) applicants for combined licenses under 1 0 CFR part 52 who have been issued an LWA unde r§ 50.1 O(e), if 87 the LWA authorizes the applicant to install the foundations, including the placement of concrete , for safety-and security-related SSCs under the LWA; 2) combined license holders before the Commission has made the finding under§ 52.103(g); 3) power reactor construction permit applicants (under 10 CFR part 50) who have been issued an LWA, if the LWA authorizes the applicant to install the foundations , including the placement of concrete , for safety-and related SSCs under the LWA; 4) power reactor construction permit holders; and 5) early site permit holders who have been issued an LWA , if the LWA authorizes the early site permit holder to install the foundations , including the placement of concrete , for safety-and security-related SSCs under the LWA, if these entities elect to implement an FFD program that meets the requirements of subparts A through H , N , and O of 1 O CFR part 26. Issuance of the DG in final form would not constitu t e backfitting under 10 CFR part 50 , 70, or 76 and would not otherwise be inconsistent with the issue finality provisions under 1 O CFR part 52. As discussed i n the " Implementat i on" se"ction of the DG , the NRC has no current intention to impose the DG, if finalized , on current holders of 10 CFR part 50 operating licenses or construction permits; 10 CFR part 52 combined licenses or early site permits; 10 CFR part 70 licenses , or 10 CFR part 76 certificates of compliance or approved compliance plans. The DG , iffinalized , could be applied to applicants for 1 0 CFR part 50 operating licenses or construction permits for power reactors , 10 CFR part 52 comb i ned licenses or early site permits, licenses issued under 10 CFR part 70, or 10 CFR part 76 certificates of compliance or approved compliance plans. Such action would not constitute backfitting as defined under § 50.109 , § 70. 76 , or§ 76. 76 , or be otherw i se inconsistent with the appl i cable issue finality provisions under 10 CFR part 52 , inasmuch as such applicants are not within the scope of ent iti es protected by§ 50.1 09 , § 70. 76 , § 76. 76 , or the relevan t issue fi nal i ty provisions unde r 88 10 CFR part 52, except in one circumstance. The exception to this principle is a combined license, early site permit , or construction permit applicant that has _been issued an LWA , if the LWA authorizes the applicant to install the foundations, including the placement of concrete, for safety-and security-related SSCs under the LWA. However, that exception would provide backfitting and issue finality protection for the LWA holder only to the extent that it conducts activities under the LWA. IX. Cumulative Effects of Regulation The NRC seeks to minimize any potential negative consequences resulting from the cumulative effects of regulation (CER). The CER describes the challenges that licensees, or other impacted entities such as State partners, face while implementing new regulatory positions, programs , or requirements (e.g., rules, generic letters , backfits, inspections). The CER is an organizational effectiveness challenge that results from a licensee or impacted entity implementing a number of complex regulatory pos i tions, programs, or requirements within limited available resources.

In an effort to better understand the potential CER implications incurred due to this proposed rule, the NRC is requesting comment on the following questions.

Responding to these questions is voluntary, and the NRC will respond to any comments received in the final rule. 1. In light of any current or projected CER challenges , does the proposed rule's effective date provide sufficient time to implement the new proposed requirements, including changes to programs, procedures , and the facility?

2. If current or projected CER challenges exist, what should be done to address this situation?

For example, if more time is required for implementation of the new requirements , what period of time i s sufficient?

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3. Do other regulatory actions (from the NRC or other agencies) influence the implementation of the proposed rule's requ i rements? 4. Are there unintended consequences?

Does the proposed rule create conditions that would be contrary to the proposed rule's purpose and objectives?

If so , what are the unintended consequences , and how should they be addressed?

5. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports the proposed rule. X. Plain Writing The Pla i n Wr i ting Act of 2010 (Pub. L. 111-274) requ i res Federal agencies to write documents in a clear , concise , and well-organized manner. The NRC has written th i s document to be consistent with the Plain Writing Act as well as the Presidential Memorandum , " Plain Language in Government Writing ," published June 10 , 1 998 (63 FR 31883). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used. XI. Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described under § 51.22(c)(1). Therefore , neither an environmental impact statement nor an env i ronmental assessment has been prepared for this proposed rule. XII. Paperwork Reduction Act Statement This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This proposed rule has been 90 submitted to the Office of Management and Budget (0MB) for review and approval of the information collection( s ). Type of submission , new or revision: Revision. The title of the information collection

10 CFR Part 26, Fitness for Duty Drug Testing Requirements.

The form number if applicable:

Not applicable. How often the collection is required:

Once and annually. One-time information collections include the licensee or other entity of each FFD program completing revisions to the FFD program policy and FFD procedures , to distribute information on the FFD program policy updates to individuals subject to 10 CFR part 26 , and for those subject individuals to review the information on the FFD program policy changes. Annual information collections include the licensee or other entity of each FFD program submitting an FFD program performance report to the NRC to provide information on the additional positive drug test results that would result from the proposed rule changes. On occasion, a third party disclosure would be made for each additional positive drug test result from the proposed rule changes. Also , on occasion , the license or other entity would report information to the NRC in the form of a 24-hour event report 91 when some individuals (e.g., licensed reactor operators , supervisors) test positive as a result of the proposed rule changes. Who will be required or asked to report: Licensees of nuclear power reactor sites (operating and under construction), licensees of Category I fuel cycle facilities, contractors/vendors, HHS-certified laboratories, and individuals with a positive drug test result. An estimate of the number of annual responses:

7 , 813 (33 recordkeepers

+ 68 reporting responses+

7,712 third-party disclosures).

The estimated number of annual respondents

149 (27 FFD programs, 12 HHS-certified laboratories , 6 licensee testing facilities, and 104 individuals with a positive drug test result). An estimate of the total number of hours needed annually to complete the requirement or request: 1,382 (559 hours0.00647 days <br />0.155 hours <br />9.242725e-4 weeks <br />2.126995e-4 months <br /> recordkeeping

+ 71 hours8.217593e-4 days <br />0.0197 hours <br />1.173942e-4 weeks <br />2.70155e-5 months <br /> reporting

+ 752 hours0.0087 days <br />0.209 hours <br />0.00124 weeks <br />2.86136e-4 months <br /> third-party disclosure). Abstract:

1 O CFR part 26 contains the NRC's requirements for licensee and other entity FFD programs, which focus on preventing and detecting the impairment of personnel from the misuse of legal drugs and alcohol, use of illegal drugs , fatigue , and any other causes such as mental or psychological distress. The NRC is seeking to update the drug testing panel and to lower the testing cutoff levels for some drugs tested, which would impact the information collections contained in 10 CFR part 26, because additional individuals would likely test positive for drugs. These The expected additional positive test results would i ncrease the recordkeeping 92 and reporting burdens on licensees and other entities. The NRC is proposing to include new information collection requirements in§§ 26.107(d), 26.157(a), 26.165(b)(2) and (b)(3), 26.165(f)(1) and 26.185(f)(3).

This information is needed to: uniformly address subversion attempts identified at the collection site(§ 26.107(d)), clarify that HHS-certified laboratories are to maintain testing procedures specific to 10 CFR part 26 (§ 26.157(a)), permit the MRO to initiate retesting of a donor specimen upon receiving an oral request from the donor and maintaining a record of receiving that request(§ 26.165(b )(2) and (b )(3)), document the existing process that the MRO is to report a cancelled test result to the licensee or other entity if the results of specimen retesting fail to confirm the test results from the initial laboratory(§ 26.165(f)( 1 )), and establish procedures to review invalid specimen test results due to high pH values(§ 26.165(f)(3)).

The NRC is seeking public comment on the potential impact of the information collection(s) contained in this proposed rule and on the following issues: 1. Is the proposed information collection necessary for the proper performance of the functions of the NRC , including whether the information will have practical utility? 2. Is the estimate of burden of the proposed information collection accurate?

3. Is there a way to enhance the quality , utility, and clarity of the information to be collected?

4. How can the burden of the proposed information collection on respondents be minimized , including the use of automated collection techniques or other forms of information technology?

A copy of the 0MB clearance package and proposed rule is avai l able in ADAMS under Accession No. ML16123A003 or may be viewed free of charge at the NRC's PDR , One White 93 Flint North, 11555 Rockville Pike, Room 0-1 F21, Rockville , MD 20852. You may obtain information and comment submissions related to the 0MB clearance package by searching on http://www.regulations.gov under Docket ID NRC-2009-0225.

You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues , by the following methods:

• Federal rulemaking Web Site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0225.

• Mail comments to: FOIA, Privacy , and Information Collections Branch, Office of Information Services , Mail Stop: T-5 F53 , U.S. Nuclear Regulatory Commission , Washington , DC 20555-0001, or to Vlad Dorjets, Desk Officer, Office of Information and Regulatory Affairs (3150-0146), NEOB-10202, Office of Management and Budget, Washington , D.C. 20503; telephone: 202-395-17 41, email: oira submission@omb

.eop.gov. Submit comments by [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date. Public Protection Notification The NRC may not conduct or sponsor , and a person is not required to respond to , a request for information unless the document requesting or requiring the collection displays a currently valid 0MB control number. 94 XIII. Compatibility of Agreement State Regulations Under the "Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30, 1997, and published in the Federal Register (62 FR 46517; September 3, 1997), this rule is classified as compatibility "NRC." Compatibility is not required for Category " NRC" regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the AEA or the provisions of title 10 of the Code of Federal Regulations, and although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State. XIV. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-113, requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies, unless the use of such a standard is inconsistent with applicable law or otherwise impractical.

In this proposed rule , the NRC is proposing to update and enhance the consistency of 10 CFR part 26 with the 2008 HHS Guidelines

improve the effectiveness and efficiency of FFD programs with regard to drug testing; and improve clarity in the organization and language of the rule. This action would not constitute the establishment of a voluntary consensus standard that contains generally applicable requirements. XV. Availability of Guidance The NRC is issuing for comment new draft regulatory guidance , Draft Regulatory Guide DG-5040 , " Urine Specimen Collection and Test Result Review under 10 CFR Part 26, Fitness for Duty Programs ," to support the implementation of the proposed requirements in this 95 rulemaking.

You may access information and comment submissions related to the DG by searching on http://www.regulations

.gov under Docket ID NRC-2009-0225. Comments on the DG may be submitted to the NRC as indicated under the ADDRESSES caption of this document.

The guidance describes methods that the NRC would consider acceptable for complying with some of the proposed changes in this notice. For example , guidance would be provided concerning monitoring of a donor during the 3-hour hydration period , use of mirrors for directly observed collections, use of a same-gender observer other than the collector during a directly observed collection, and MRO review of invalid test results due to high pH. XVI. Availability of Documents The documents identified in the following table are available to interested persons through one or more of the following methods , as indicated.

DOCUMENT ADAMS ACCESSION NO. / WEB LINK/ FEDERAL REGISTER CITATION 1988 HHS Guidelines

-Final Guidelines 53 FR 11970 (April 11 , 1988) 1994 HHS Guidelines

-Revised Mandatory 59 FR 29908 Guidelines (June 9 , 1994) 1998 HHS Guidelines

-Revised Mandatory 63 FR 63483 Guidelines (November 13 , 1998) 2004 HHS Guidelines

-Notice of Proposed Revisions to Mandatory Guidelines 69 FR 19673 (April 13, 2004) 2004 HHS Guidelines

-Revised Mandatory 69 FR 19644 Guidelines (April 13, 2004) 2008 HHS Guidelines

-Revised Mandatory 73 FR 71858 Guidelines (November 25, 2008) 1989 NRC 10 CFR Part 26 final rule 54 FR 24468 (June 7, 1989) 1993 NRC 10 CFR Part 26 final rule 58 FR 31467 (June 7 , 1989) 96

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, DOCUMENT ADAMS ACCESSION NO./ WEB LINK/ FEDERAL REGISTER CITATION 2008 NRC 1 O CFR Part 26 final ru l e 7 3 FR 1 6966 (March 31 , 2008) 2009 NRC 10 CFR Part 26 final rule , correcting 74 FR 38326 amendment (AuQust 3 , 2009) 2014 Nationa l Drug Contro l St r ateg y htt12://www.whitehouse.gov/sites/default/file (Ju l y 9 , 2014) s/ondco/oolicv-and

-research/ndcs 2014. odf Behav i oral Health Trends i n t h e Un i ted S t ates: htt12://www.samhsa

.gov/data/sites/default/fil Results from the 2014 National Survey on Drug es/NSDUH-FRR 1-2014/NSDUH-FRR 1-Use and Health (September 2015), HHS 2014.(2df Publication No. SMA 15-4927 Commission Policy Statemen t on F i tness fo r Duty of Nuclear Power Plant Personnel 51 FR 27921 (August 4 , 1 986) Cook J.D., Strauss K.A., Caplan Y.H., LoDico C.P., and Bush D.M. (200 7), " Urine pH: the htt12://www

.ncbi.nlm.nih.gov/12ubmed/

effects of time and temperature after collec ti on , 17988463 Journal of Analytical Toxicology

," Vol. 31 , 486 -496. Executive Order 12564 (September 17 , 1986) 51 FR 32889 NRC Draft Regulatory Guide DG-5040 , " Urine Spec i men Collection and Test Result Rev i ew ML16120A435 under 10 CFR Part 26 , F i tness for Duty Programs" (Month , day 2017). NRC Enforcement Guidance Memorandum

-Dispositioning Violations of NRC Requ i rements for In i tial Validity and Drug Tests at Licensee ML090760728 Testing Facilities (EGM-09-003) (March 31 , 2009) NRC Public Meeting Summary ML090771060 (February 24 , 2009) NRC Publ i c Meet i ng Summary (June 24 , 2009) ML091910511 NRC Public Meet i ng Summary and Meeting ML112930153 Materials (Octobe r 1 1, 2011) NRC Publ i c Meeting Summary ML13290A236 (September 11 , 2013) NRC Regulatory Analys i s and Backfit Analysis , Fitness For Duty Drug Testing Requ i rements ML16123A006 (Month , day 2017) NRC Regulatory Analysis Guidelines , NUREG/BR-0058 , Revis i on 4 ML042820192 (September 30 , 2004) 97 DOCUMENT ADAMS ACCESSION NO. / WEB LINK / FEDERAL REGISTER CITATION NRC Regulatory Basis: Proposed Rulemaking to Amend 10 CFR Part 26 , "Fitness for Duty ML13066A703 Programs," based on Select Provisions of the 2008 HHS Guidelines (May 3, 2013) NRC report " Summary of Fitness for Duty Program Performance Reports for Calendar ML14246A440 Year 2013" (September 3, 2014) NRC report "Summary of Fitness for Duty Program Performance Reports for Calendar ML13225A131 Year 2012" (August 13, 2013) NRC report "Summary of Fitness for Duty Program Performance Reports for Calendar ML12151A270 Year 2011" (August 1 , 2012) Quest Diagnostics (2011 ). Impacts of Panel httQ://blog.emQloyersolutions.com/imQacts-Changes -The First Three Months of-Qanel-changes-the-first-three-months/ (January 25, 2011) Quest Diagnostics (2012). Cocaine Positives Spike 33% After New Government Rule for httQ://www.guestdiagnostics.com/dms/Docu Safety-Sensitive Workers ments/DTI-ReQorts/2012-03-13 DTI. Qdf (March 13, 2012) Quest Diagnostics.

(2014). Workforce Drug Drug Testing Index press release: Test Positivity Rate Increases for the First Time httQ://newsroom.guestdiagnostics.com/201 in 10 Years, Driven by Marijuana and 4-09-11-Workforce-Drug-T est-Positivity-Amphetamines, Finds Quest Diagnostics Drug Rate-lncreases-for-the-First-Time-in Testing IndexŽ Analysis of Employment Drug Years-Driven-by-Marijuana-and-Tests (September 11 , 2014) Am Qhetam i nes-Finds-Quest-Diag nostics-Drug-Testing-Index-Analysis-of-EmQloyment-Drug-Tests Drug Testing Index, 2014 Report: httQ://www. em Qloyer-sol utions-resources.com/whiteQaQer/2015-drug-testina-index 98 List of Subjects 10 CFR Part 26 Administrative practice and procedure, Alcohol abuse , Alcohol testing, Appeals, Chemical testing , Drug abuse , Drug testing , Employee assistance programs , Fitness for duty, Management actions, Nuclear power plants and reactors, Privacy, Protection of information, Radiation protection , Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954 , as amended; the Energy Reorganization Act of 1974 , as amended; and 5 U.S.C. 552 and 553 the NRC is proposing to adopt the following amendments to 10 CFR part 26: PART 26-FITNESS FOR DUTY PROGRAMS 1. The authority citation for Part 26 continues to read as follows: Authority:

Atomic Energy Act of 1954 , secs. 53, 103 , 104 , 107,161 , 223 , 234 , 1701 (42 U.S.C. 2073 , 2133, 2134, 2137, 2201 , 2273, 2282 , 2297f); Energy Reorganization Act of 1974, secs. 201 , 202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note. 2. In part 26, wherever it may occur , remove the term " custody-and-control form" and add in its place the term " Federal CCF". 99

3. In part 26 , wherever it may occur , remove the term " custody-and-control forms" and add in its place the term " Federal CCFs".

• 4. In part 26 , wherever it may occur , remove the term " custody-and-control form(s)" and add in its place the term " Federal CCF(s)". 5. In part 26 , wherever it may occur , remove the phrase " chain-of-custody" and add in its place the phrase " chain of custody". 6. In§ 26.4: a. Remove the phrase " (65 FR 41944; August 9 , 2001)" in paragraph (e)(6)(iv)

b. Revise paragraph (g)(4) to remove the " and" at the end of the first sentence; c. Revise paragraph (g)(5) to remove the period at the end of the first sentence and add in its place";" and to add the word " and" after the";"; d. Add new paragraph (9)(6); and e. Revise paragraph U)(3) to read as follows

§ 26.4 FFD program applicability to categories of individuals.

• * * * * (g) * * * (6) All persons monitoring a donor during the hydration process described in § 26.109(b ). * * * *

• 100 U) * * * (3) Urine specimens are tested for validity and the presence of drugs and drug metabolites at a Department of Health and Human Services (HHS)-certified laboratory, as defined in § 26.5; * * * *

• 7. In§ 26.5: a. Add the definitions for cancelled test, carryover, Certifying Scientist, Federal custody and control form , lot, rejected for testing, and Responsible Person in alphabetical order; and b. Revise the definitions for calibrator , control, dilute specimen, HHS-certified laboratory , invalid result, limit of quantitation , and substituted specimen.

The additions and revisions read as follows: § 26.5 Definitions.

• * * *

• Calibrator means a solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a donor specimen or quality control sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation.

• * * *

• 101 Cancelled test means the test result reported by the MRO to the licensee or other entity when a specimen has been reported to the MRO by the HHS-certified laboratory as an invalid result (for which the donor has no legitimate explanation), a specimen has been rejected for testing by the licensee testing facility or HHS-certified laboratory, or the retesting of a single specimen or the testing of Bottle B of a split specimen fails to reconfirm the original test result. For alcohol testing only, cancelled test means a test result that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91. * * * *

• Carryover means the effect that occurs when a test result has been affected by a preceding sample or specimen during analysis.

• * * *

• Certifying Scientist means the individual at an HHS-certified laboratory responsible for verifying the chain of custody and scientific rel i ability of any test result reported by an HHS-certified laboratory. * * * *

• Control means a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits. * * * *

• Dilute specimen means a urine specimen with creatinine and specific gravity values that are lower than expected but are still within the physiologically producible ranges of human urine. 102

• * * *

• Federal custody and control form (Federal CCF) means any HHS-approved form, which has not expired, that is published in the Federal Register and is used to document the collection, custody, transport , and testing of a specimen. * * * *

• HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that drug and validity testing of a specimen is performed for a licensee or other entity. * * * *

• Invalid result means the result reported by an HHS-certified laboratory in accordance with the criteria established in § 26.161 (f) when a positive , negative , adulterated , or substituted result cannot be established for a specific drug or specimen validity test. * * * *

• Limit of quantitation (LOQ) means for quantitation assays, the lowest concentration at which the identity and concentration of the analyte can be accurately established.

• * * *

• Lot means a number of units of an item (e.g., drug test kits, reagents, quality control samples) manufactured from the same starting materials within a specified period of time for which the 103

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~---manufacturer states that the items have essentially the same performance characteristics and the same expiration date. * * * *

• Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when no tests can be performed on a specimen.

• * * *

• Responsible Person means the person at the HHS-certified laboratory who assumes professional, organizational, educational, and administrative responsibility for the day-to-day management of the HHS-certified laboratory.

• * * *

• Substituted specimen means a specimen that has been submitted in place of the donor's urine , as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine. * * * *

• 8. In § 26.8, remove the reference

" 26.155" in paragraph (b ). 9. In§ 26.31: a. Remove the phrase "(65 FR 41944; August 9 , 2001)" in paragraph (b)(2); b. Revise paragraph (d)(1 ); 104

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c. Remove the phrase ", as specified in § 26.155(a)" at the end of the second sentence in paragraph (d)(1 )(i)(D); and d. Revise the third sentence in paragraph (d)(1 )(ii). The revisions read as follows: § 26.31 Drug and alcohol testing. * * * * * (d)*** (1) Substances tested. At a minimum , licensees and other entities shall test for marijuana metabolite , cocaine metabolite , opiates (codeine , morphine , 6-acetylmorphine), amphetamines (amphetamine , methamphetamine, methylenedioxymethamphetamine , methylenedioxyamphethamine , and methylenedioxyethylamphetamine

), phencyclidine , adulterants , and alcohol. * * * * * (ii)*** Test results that fall below the established cutoff levels may not be considered when determin i ng appropriate action under subpart D of this part , except if special analyses of the specimen is performed under§ 26.163(a)(2) by the HHS-certified laboratory. * * * *

• 105

10. In § 26.89: a. In paragraph (c) remove the phrase " adulterated , diluted , or adulterated the specimen" and add in its place the phrase " adulterated , diluted , or substituted the specimen"; and b. Revise paragraph (d) to read as follows: § 26.89 Preparing to collect specimens for testing. * * * * * (d) In order to promote the secur i ty of specimens , avoid distraction of the collector , and ensure against any confusion in the identification of specimens, a collector shall conduct only one collection procedure at any given time, except as described in § 26.109(b )( 1 ). The urine collection procedure is complete when the ur i ne specimen container has been sealed with tamper-evident tape , the seal has been dated and i nitialed, and the Federal CCF has been completed , or when a refusal to test has been determined under § 26.107( d). 11. In § 26.107: a. Rev i se and redesignate paragraph (b) introductory text as (b )( 1) and add new paragraph (2); and b. Add new paragraphs (d) introductory text and (d)(1) through (5). The additions and revisions read as follows: 106

§ 26.107 Collecting a urine specimen.

• * * * * (b )( 1) The collector shall pay attention to the donor during the entire collection process, except as provided in § 26.109(b )( 1 ), to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain view; attempting to bring an adulterant, urine substitute, heating element, and/or temperature measurement device into the room, stall, or private area used for urination).

If any such conduct is detected, the collector shall document a description of the conduct on the Federal CCF and contact FFD program management to determine whether a directly observed collection is required, as described in § 26.115. (2) If a hydration monitor is used to observe a donor during the § 26.109(b )( 1) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site, donor refuses to follow instructions).

• * * * (d) If a refusal to test is determined at any point during the specimen collection process, the collector shall do the following: (1) Inform the donor that a refusal to test has been determined; (2) Terminate the collection process; (3) Document a description of the refusal to test on the Federal CCF; 107 (4) Discard any urine specimen(s) provided by the donor , unless the specimen was collected for a post-event test under§ 26.31(c)(3);

and (5) Immediately inform the FFD program manager. 12. In§ 26.109: a. Revise paragraph (b){1) and add new paragraphs (b)(1)(i) through (iii); and b. In paragraph (b)(2) A.§.dd the sentence " The collector shall provide the donor with a separate collection container for each successive spec i men." as the new first sentence.

The additions and revisions read as follows: § 26.109 Urine specimen quantity.

• * * * * (b) * * * (1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally , 8 ounces of water every 30 minutes , but not to exceed a maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) until the donor provides a specimen of at least 30 ml. Alternatively , as specified in the licensee's or other entity's FFD program procedures , the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor who meets the requirements in § 26.4(9)(6).

If another collector or hydration monitor i s used , the collector:

(i) Shall explain t he hydration process and acceptable do n or behavior to the hydrat i on monitor; 108 (ii) Shall record the name of the other collector or hydration monitor on the Federal CCF and then provide the Federal CCF to that individual for the duration of the hydrat i on process; and (iii) May perform other collections while the donor is in the hydration process; (2) The collector shall provide the donor with a separate collection container for each success i ve specimen. * * * * * * *

• 13. In § 26.111: a. Revise paragraph (a), b. In paragraph (c), first sentence, remove the word " designated" and revise the third sentence , c. Revise paragraph (e) and d. Remove paragraph (f). The revisions read as follows: § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the donor provides the urine specimen to the collector , including specimens of less than 30 ml but equal to or greater than 15 ml, the collector shall measure the temperature of the specimen. The temperature measuring device used must accurately reflect the temperature of the specimen and not contaminate the specimen.

The time from urination to temperature measurement may not exceed 4 minutes. If the temperature of a urine 109 specimen is outside the range of 90 °F to 100 °F (32 °C to 38 °C), that is a reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen. * * * * * (c) * *

• In addition, the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen.

• * * * * (e) As much of the suspect specimen as possible must be preserved, except under the conditions described in§ 26.107(d)(4).

14. In § 26.115: a. Revise paragraph (a) introductory text , paragraphs (a)(3) and (4), and add paragraph (a)(5); b. Revise paragraph (e); c. Revise paragraph (f) introductory text , republish paragraph (f)(1 ), and revise paragraphs (f)(2) and (3); and d. Revise paragraph (g). The additions and revisions read as follows: § 26.115 Collecting a urine specimen under direct observation. (a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart, or the MRO or FFD program manager determines that a directly 110 observed collection is warranted. The following circumstances constitute the exclusive grounds for performing a directly observed collection:

• * * * * (3) The collector, or the hydration monitor if one is used as permitted in§ 26.109(b)(1

), observes conduct by the donor indicating an attempt to subvert the testing process; ( 4) A directly observed collection is required under § 26.69; aRGOr (5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control , as described in § 26.165(f)(2).

• * * * * (e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions.

The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector , the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) before proceeding with the directly observed collection. (f) The individual who observes the collection shall follow these procedures

(1) The observer shall 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; (2) The observer shall watch the donor urinate into the collection container. Specifically, the observer shall watch the urine go from the donor's body into the collection container (a mirror 111 may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted)

(3) If the observer is not the collector, the observer may not touch or handle the collection container, but shall maintain visual contact with the specimen until the donor hands the collection container to the collector; and * * * * * (g) If a donor declines to allow a directly observed collection that is required or permitted under this section, the donor's refusal constitutes an act to subvert the testing process, and the collector shall follow the procedures in § 26.107( d). * * * *

• 15. In § 26.117: a. Revise paragraph (a); b. Revise the first sentence in paragraph (f); and c. Add in paragraph (g), the phrase ", except as provided in § 26.109(b )( 1 )(ii) for the Federal CCF" to the end of the first sentence. The addition arid revisions read as follows: § 26.117 Preparing urine specimen for storage and shipping (a) Once the collector is presented with the specimen from the donor, both the donor and the collector shall keep the donor's urine specimen(s) in view at all times before the specimen(s) 112 are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal. * * * * * (f) The specimens and Federal CCFs* must be packaged for transfer to the HHS-certified laboratory or to the licensee testing facility.

• * * *

• 16. In § 26.129, revise paragraphs (b )( 1 )(ii) and (b )(2) to read as follows: § 26.129 Assuring specimen security, chain of custody, and preservation.

• * * * * (b) * * * (1)*** (ii) If there is reason to believe that the integrity or identity of a specimen is in question (as a result of tampering or discrepancies between the information on the specimen bottle and on the accompanying Federal CCFs that cannot be resolved), the licensee testing facility shall reject the specimen for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 ml of 113 urine. In this instance, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.

(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test result to the licensee or other entity: * * * *

• 17. Revise § 26 .133 to read as follows: § 26.133 Cutoff levels for drugs and drug metabolites. Subject to the provisions of§ 26.31 (d)(3)(iii), licensees and other entities may specify more stringent cutoff levels for drugs and drug metabolites than those in the table below and , in such cases , may report initial test results for only the more stringent cutoff levels. Otherwise, the following cutoff levels must be used for initial testing of urine specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites:

114 INITIAL TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Marijuana metabolites

...................................................... . Cocaine metabolites

........................................................ . Opiate metabolites:

Codeine/Morphine 1 ...*..........................*................ 6-acetylmorphine (6-AM) ..........................

........... . Phencyclidine (PCP) ........................................................ . Amphetamines 2: AMP/MAMP 3 .........................

................*............... MDMA 4 *..*....*........**......*.............

........................... 1 Morphine is the target analyte for codeine/morphine testing. Cutoff level 2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff. 50 150 2000 10 25 500 500 3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing. 4 Methylened ioxymetham phetam i ne. 18. In§ 26.137, revise paragraphs (d)(5),(e)(6), (e)(6)(i) through (iii), and (e)(6)(v) to read as follows: § 26.137 Quality assurance and quality control. * * * * * (d) * * * (5) Each analytical run performed to conduct initial validity testing shall include at least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.

• * * * * (e)*** 115

( (6) A minimum of 10 percent of the total specimens in each analytical run of specimens to be initially tested for drugs and drug metabolites by the licensee testing facility must be quality control samples (i.e., calibrators and controls), which the licensee testing facility shall use for internal quality control purposes. (These samples are not forwarded to the HHS-certified laboratory for further testing, other than for performance testing of the samples.) Licensee testing facilities shall ensure that quality control samples that are positive for each drug and drug metabolite for which the FFD program conducts testing are included in at least one analytical run each calendar quarter. The quality control samples for each analytical run must include-(i) At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite; (ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; (iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff; (iv) * * * (v) At least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.

• * * *

• 19. In § 26.153, revise paragraphs (a) and (g) to read as follows: 116

§ 26.153 Using certified laboratories for testing urine specimens. (a) Licensees and other entities who are subject to this part shall use only HHS-certified laboratories as defined in § 26.5. * * * * * (g) If licensees or other entities use a form other than the current Federal CCF, licensees and other entities shall provide a memorandum to the laboratory explaining why a non-Federal CCF was used, but must ensure, at a minimum, that the form used contains all the required information on the Federal CCF. 20. Remove and reserve § 26.155. § 26.155 [Remove and Reserve] 21. In§ 26.157 revise paragraph (a); remove and reserve paragraph (b); and remove paragraphs (c)-(e). The revision to read as follows: § 26.157 Procedures. (a) HHS-certified laboratories shall develop, implement , and maintain procedures specific to this part that document the accession , receipt , shipment , and testing of specimens. (b) [Reserved]

117

22. In § 26.159, revise paragraph (b )( 1 )(ii), (b )(2), the second sentence in paragraph ( c ), and paragraphs (d) and (e) to read as follows: § 26.159 Assuring specimen security, chain of custody, and preservation. * * * * * (b) * * * (1)*** (ii) If the licensee or other entity has reason to question the integrity and identity of the specimens , the laboratory shall reject the specimens for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical , except if a split specimen collection was performed , either the Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 ml of urine. In this instance , if the licensee testing facility has retained the specimen in Bottle B , the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.

(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen , and report a cancelled test to the licensee or other entity: * * * * * (c) ***Laboratory personnel shall use aliquots and laboratory internal chain of custody forms when conducting i nitial and confirmatory tests. 118 (d) The laboratory's internal chain of custody form must allow for identification of the donor , and documentation of the testing process and transfers of custody of the specimen. ( e) Each time a specimen is handled or transferred within the laboratory, laboratory personnel shall document the date and purpose on the chain of custody form and every individual in the chain shall be identified. Authorized technicians are responsible for each urine specimen or aliquot in their possession and shall sign and complete chain of custody forms for those specimens or aliquots as they are received. * * * *

• 23. In§ 26.161: a. In paragraphs (c)(3) and (c)(4), (f)(S), and (f)(7) remove the term " LOO" and add in its place the term "LOQ"; and b. Revise paragraphs (c)(S) and (c)(6) to read as follows: § 26.161 Cutoff levels for validity testing. * * * * * (c)*** (5) The presence of glutaraldehyde i s verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (e.g., gas chromatography/mass spectrometry (GC/MS)) for the confirmatory test with t he glutaraldehyde concentration equal to or greater than the LOQ of the analysis on the second aliquot; 119 (6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/ml nitrite-equivalent cutoff or an equal to or greater than 50 mcg/ml chromium {VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/ml) for the initial test on the first aliquot and a different confirmatory test (e.g., GC/MS) for the confirmatory test with the pyridine concentration equal to or greater than the LOQ of the analysis on the second al i quot; * * * *

• 24. In§ 26.163: a. Republish paragraph (a) introductory text and revise paragraphs (a)(1 ), (a)(2), (a)(2)(i) and (a)(2)(ii)

and b. Republish paragraph (b) introductory text and revise paragraph (b)(1) to read as follows

§ 26.163 Cutoff levels for drugs and drug metabolites. (a) Initial drug testing. (1) HHS-certified labo r atories shall apply the following cutoff levels for initial testing of specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites, except as specified in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels: 120 INITIAL TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Cutoff level Marijuana metabolites

..........................

............................. . Cocaine metabolites

..........

............................................... . Opiate metabolites:

Codeine/Morphine 1 .*..............................*............... 6-acetylmorphine (6-AM) ..............

.....................

... . Phencyclidine (PCP) ......................................

.................. . Amphetamines 2: AMP/MAMP 3 ...................

...................................

.. . MDMA 4 ................................................................. . 1 Morphine is the target analyte for codeine/morphine testing. 2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff. 3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing. 4 Methylenedioxymethamphetamine. (2) HHS-certified laboratories shall conduct special analyses of specimens as follows: (i) If initial validity testing indicates that a specimen is dilute, or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5), the laboratory shall compare the immunoassay responses of the specimen to the cutoff calibrator in each drug class tested; (ii) If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator, the laboratory shall conduct confirmatory drug testing of the specimen to the LOQ for those drugs and/or drug metabolites; and * * * * * /ml 50 150 2000 10 25 500 500 (b} Confirmatory drug testing. (1) A specimen that is identified as positive on an initial drug test must be subject to confirmatory testing for the class(es) of drugs for which the specimen initially 121 tested positive.

The HHS-certified laboratory shall apply the confirmatory cutoff levels specified in this paragraph, except as permitted in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels. CONFIRMATORY TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Cutoff level n /ml Marijuana metabolite 1 ..................................

............................. . Cocaine metabolite 2 ...............

.................*

.................................

Opiate metabolites

Morphine .............................................................

......... . Codeine ................................................

........................ . 6-acetylmorphine (6-AM) ........................

............

........ . Phencyclidine (PCP) ..............

........................

.......................... . Amphetamines:

Amphetamine

....................................................

... . Methamphetamine 3 ..................................................... . MDMA ............................

...................

.......................... . MDA 4 ...........................

.............

................................... . MDEA 5 ..............................

........................................... . 1 As delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 2 As benzoylecgonine.

3 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100 ng/ml. 4 Methylenedioxyamphetamine.

5 Methylenedioxyethylamphetamine. * * * *

• 15 100 2000 2000 10 25 250 250 250 250 250 25. In§ 26.1 65 , revise the fourth sentence in paragraph (b)(2), paragraph (b)(3), the last sentence in paragraph (f)(1 ), and paragraph (f)(2) to read as follows: § 26.165 Testing split specimens and retesting single specimens.

• * * *

• 122 (b) * * * (2) ***The MRO shall document in his or her records when (i.e., date and time) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.

(3) No entity, other than the MRO as permitted in § 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's written permission. * * * * * (f) * * * (1) * *

• If the results of testing Bottle B or retesting the aliquot of a single specimen are negative, the MRO shall report a cancelled test result to the licensee or other entity , and the licensee and other entity-* * * * * (2) If a donor requests that Bottle B be tested or that an aliquot of a single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to , circumstances

• in which there is an insufficient quantity of the single specimen or the specimen in Bottle B to permit retesting , either I Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory , or Bottle B has been lost at the HHS-certified laboratory or licensee testing facility), the MRO shall cancel the test , report a cancelled test result to the licensee or other entity for the donor's 123 specimen , and inform the licensee or other entity that another collection is required under direct observation as soon as reasonably practical.

The donor shall receive no notice of the collection requirement before he or she is instructed to proceed to the collection site. The licensee or other entity shall continue to administratively withdraw the individual's authorization , as required by § 26.165(f)( 1) until the results of the second specimen collection have been received by the MRO. The licensee or other entity shall eliminate from the donor's personnel and other records any matter that could link the donor to the original positive, adulterated , or substituted test result(s) and any temporary administrative action, and may not impose any sanctions on the donor for a cancelled test. If test results from the second specimen collected are positive, adulterated, or substituted and the MRO determines that the donor has violated the FFD policy, the licensee or other entity shall impose the appropriate sanctions specified in subpart D of this part, but may not consider the original confirmed positive , adulterated, or substituted test result that was reported as a cancelled test by the MRO under §§ 26.129(b )(2) or 26.159(b )(2) in determining the appropriate sanctions. 26. In § 26.167: a. Republish paragraph (d)(3), and revise paragraphs (d)(3)(i) through (iii); b. Revise paragraph (d)(4); c. Revise paragraph (e)(2), republish paragraph (e)(3), and revise paragraphs (e)(3)(i) through (iv); and d. Revise paragraph (f)(3) to capitalize the words " responsible person". The revisions read as follows: § 26.167 Quality assurance and quality control. 124

• * * * * (d) * * * (3) Quality control samples for each analytical run of specimens for initial testing must include-(i) At least one control certified to contain no drug or drug metabolite;

• (ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; (iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff; * * * * * (4) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls), as defined by paragraphs (d)(3)(i) through (iv) of this section. (e) * * * (2) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls).

(3) Each analytical run of specimens that are subjected to confirmatory testing must include-(i) At least one control certified to contain no drug or drug metabolite; (ii) A calibrator with its drug concentration at the cutoff; 125 (iii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and (iv) At least one control targeted at or below 40 percent of the cutoff. * * * *

• 27. In§ 26.168, revise paragraph (h)(1) to read as follows: § 26.168 Blind performance testing. * * * * * (h) * * * (1) Ensure that all blind performance test sample lots are placed in service by the supplier only after confirmation by an HHS-certified laboratory

* * * *

• 28. In § 26.169: a. In paragraph (a) wherever it may appear , capitalize the words " certifying scientist". b. Republish paragraph (h)(3), and revise paragraphs (h)(3)(i) and (ii), (h)(3)(iii)(C), and (h)(3)(iv)

c. Republish paragraph (h)(3)(v) and revise paragraph (h)(3)(v)(A);

and d. Add new paragraphs (h)(3)(v)(C) through (E). 126 The additions and revisions read as follows: § 26.169 Reporting results. * * * * * (h) * * * (3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted , including , but not limited to-(i) Marijuana metabolite (as THCA); (ii) Cocaine metabolite (as benzoylecgonine)

(iii)*** (C) 6-acetylmorphine (6-AM); (iv) Phencyclidine (PCP); (v) Amphetamines (total); (A) Amphetamine

(B)*** (C) Methylenedioxymethamphetamine (MOMA); (D) Methylened i oxyamphetamine (MDA); and (E) Methylenedioxyethylamphetamine (MDEA); 127

• * * *

• 29. In § 26.183, revise paragraphs ( c) introductory text , ( c)( 1 ), and ( d)(2)(ii) to read as follows: § 26.183 Medical review officer. * * * * * (c) Responsibilities.

The primary role of the MRO is to review and interpret positive , adulterated, substituted, invalid, and dilute test results obtained through the licensee's or other entity's testing program and to identify any evidence of subversion of the testing process. The MRO is also responsible for identifying any issues associated with collecting and testing specimens , and for advising and assisting FFD program management in planning and overseeing the overall FFD program. (1) In carrying out these responsibilities , the MRO shall examine alternate medical explanations for any positive, adulterated , substituted , invalid , or dilute test result. This action may include , but is not limited to , conducting a medical interview with the donor , reviewing the donor's medical history , or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive , adulterated , substituted , invalid, or dilute test result could have resulted from responsible use of legally prescribed medicat i on, a documented condition or disease state , or the demonstrated physiology of the donor. * * * *

• 128

( d) * * * (2) * * * (ii) The staff reviews of positive, adulterated , substituted , invalid, and dilute test results must be limited to reviewing the Federal CCF to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in Federal CCFs that require corrective action(s), but shall forward the Federal CCFs to the MRO for review and approval of the resolution.

• * * *

• 30. In§ 26.185: a. Redesignate paragraph (f)(3) as (f)(4), and add new paragraph (f)(3); b. In paragraph (g)(1) remove the reference

" paragraph (g)(4)" and add in its place the reference

" paragraph (g)(3)"; and c. Revise paragraphs (g)(2) and (g)(2)(iii), remove paragraph (g)(3); and redesignate paragraphs (g)(4) and (g)(5) as paragraphs (g)(3) and (g)(4), respectively.

The addition and revisions read as follows: § 26.185 Determining a fitness-for-duty policy violation.

• * * * * (f) * *

• 129 (3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result , and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable.

The second specimen collected may not be collected under direct observation.

• * * * * (g) * * * (2) If the results of the special analysis testing required by§ 26.163(a)(2) are positive, the MRO determines that there is no legitimate medical explanation for the presence of the drug(s) or drug metabolite(s) in the specimen, and a clinical examination, if required under paragraph (g)(3) of this section, has been conducted under paragraph U) of this section, the MRO shall determine whether the positive and dilute specimen is a refusal to test. If the MRO does not have sufficient reason to believe that the positive and dilute specimen is a subversion attempt , he or she shall determine that the drug test results are positive and that the donor has violated the FFD policy. When determining whether the donor has diluted the specimen in a subversion attempt , the MRO shall also consider the following circumstances, if applicable

* * * *

• 130 (iii) The collector observed conduct indicating an attempt to dilute the specimen. * * * *

• 31. In § 26.405 , revise paragraph (d) to read as follows: § 26.405 Drug and alcohol testing. * * * * * (d) At a minimum , licensees and other entities shall test specimens for marijuana metabolite , cocaine metabolite , opiates ( codeine , morphine, 6-acetylmorphine

), amphetamines ( amphetamine , metham phetam i ne, methylened ioxymetham pheta mine , methylenedioxyamphetamine , and methylenedioxyethylamphetamine

), phencyclidine , adulterants , and alcohol at the cutoff levels specified in this part , or comparable cutoff levels if specimens other than u r ine are collected for drug test i ng. Urine specimens collected for drug testing must be subject to validity testing. * * * *

• 32. In§ 26.415(c), remove the citation , " (65 FR 41944; August 9 , 2001)". 33. In§ 26.717, revise paragraphs (b)(3) and (4) to read as follows: § 26.717 Fitness-for-duty program performance data. 131

• * * * * (b) * * * (3) Populations tested (i.e., licensee or other entity employees, CNs); (4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees , CNs); * * * *

• Dated at Rockville , Maryland , this_ day of ____ , 2017. For the Nuclear Regulatory Comm i ssion. Annette Vietti-Cook , Secretary of the Commission.

132 i * * * * * (b) * * * (3) Populations tested (i.e., licensee or other entity employees, CNs); (4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees, CNs ); * * * *

• Dated at Rockville, Maryland , this_ day of ____ , 2017. DISTRIBUTION:

Public RidsResOd Resource RidsNroMailCenter Resource RidsNroOd Resource RidsNsirMailCenter Resource RidsNsirOd Resource RidsOeMailCenter Resource RidsAdmMailCenter Resource RidsNmssOd Resource RidsOgcMailCenter Resource RidsOcfoMailCenter Resource RidsACRS_MailCTR Resource HBenowitz , OGC DCullison , OCIO For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission.

LCupidon , CRGR RCorreia , RES SPeters , RES VBarnes , RES DKi, RES MGalloway , NSIR WGott , NSIR PHarris , NSIR BZalesk i, NSIR NHilton , OE DFurst , OE MMayfield , NRO JColaccino , NRO SSahle , NRO MCheok, NRO DDesaulniers , NRO CBladey , ADM LTerry , ADM TBarczy, ADM JShepherd , ADM CErlanger , NMSS RJohnson , NMSS KRamsey , NMSS Llund , NRR MGavrilas , NRR Glappert , NRR SSchneider , NRR ADAMS Accession No(s): (Pkg) ML16123A004

• via email OFFICE NSIR/DSP/FCTSB/PM

• NRR/DPR/PRMB/PM NRR/DPR/PRMB/RS NRR/DPR/PRMB/BC NAME BZaleski SSchneider Glaooert MKhanna DATE 5/25/2016 5/27/2016 5/31/2016 6/20/2016 OFFICE NRR/DPR/D NRO/D* NMSS/D* RES/D* NAME Llund JUhle, MCheok for SMoore , Mlombard for MWeber , RCorreia for DATE 6/28/2016 7/12/2016 7/12/2016 7/8/2016 OFFICE OE/D* OCFO/D* NSIR/D* ADM/DAS/RADB/BC* NAME PHolahan , DFurst for MWvlie , VPortillo for BHolian , CJohnson fo r CBladey, CGallagher for DATE 7/11/2016 7/11/2016 8/15/2016 8/8/2016 OFFICE OCIO/CSD/FPIB/CO OGC (NLO) NRR/D EDO NAME DCullison HBenowitz WDean* VMcCree DATE 10/27/2016 10/07/2016 12/1/2016 2/22/2017 OFFICIAL RECORD COPY 127 TO: FROM:

SUBJECT:

RESPONSE SHEET Annette Vietti-Cook, Secretary Commissioner Wright SECY-17-0027:

PROPOSED RULEMAKING:

FITNESS FOR DUTY DRUG TESTING REQUIREMENTS (RIN 3150 Al67) Approved _x Disapproved_

Abstain Not Participating_

Comments:

Below X Attached X None I appreciate the staff's efforts to update the NRC's Part 26 regulations to align them more closely with the drug testing requ i rements in the 2008 U.S. Department of Health and Human Serv i ces (HHS) "Mandatory Guidelines for Federal Workplace Drug Testing Programs" (2008 HHS Guidelines). The proposed revisions primarily expand the panel of drugs to be tested , lower the drug testing cutoff levels for some substances , and enhance specimen valid i ty testing. I was initially hesitant to approve publishing these proposed revisions , given that revised HHS Guidelines are now in effect for urine testing (the 2017 HHS Guidelines) 1 and new guidel i nes are expected this year on oral fluid testing. However, the staff has concluded that the technical information and analyses underlying the proposed rule are still valid and that sufficient data does not yet exist for the staff to assess the costs and benefits of updating 10 CFR Part 26 to incorporate the 2017 HHS Guidelines. If this conclusion changes , the staff should promptly notify the Commiss i on. After review i ng the staff's analyses , I approve publishing the proposed rule in the Federal Register , subject to the attached edits. I support Commission Saran's proposal to include a question in the Specific Requests for Comment section of the Federal Register notice on effect i ve alternatives to direct observation during the urine collection process. I also support the Chairman's proposal that the paper accompanying the draft final rule inform the Commission regarding the staff's forecast of the necessary timing of the next update of these provisions through rulemaking. Finally, for future rulemakings proposing to align the NRC's regulations with updated HHS Guidelines, the staff should consider whether incorporation by reference (either in whole or in part) provides efficiencies. My initial impress i on is that this process may be a reasonable , transparent , and efficient regulatory decision that would not impact safety or security. Entered 1 in STARS Yes v No --*---. ( ..... --\ , ( DATE ' 1 1 See 82 Fed. Reg. 7920 (Jan. 23 , 2017). The 2017 HHS Guidelines expanded Federal urine workplace drug testing to i nclude four Schedule II drugs (hydrocodone , hydromorphone , oxycodone , and oxymorphone), among other changes.

DAW Edits NUCLEAR REGULATORY COMMISSION 10 CFR Part 26 [NRC-2009-0225]

RIN 3150-Al67 Fitness for Duty Drug Testing Requirements AGENCY: Nuclear Regulatory Commission. ACTION: Proposed rule and draft regulatory guide; request for comment. [7590-01-P]

SUMMARY

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug testing requirements with the updates made in 2008 to the U.S. Department of Health and Human Services (HHS) " Mandatory Guidelines for Federal Workplace Drug Testing Programs" (HHS Guidelines). The proposed rule would also incorporate lessons learned from implementation of the NRC's current FFD regulations.

These changes would enhance the ability of NRC licensees and other entities to identify additional individua l s using illegal drugs , misusing legal drugs , or attempting to subvert the drug testing process. The proposed rule would also prov i de additional protections to individuals subject to drug testing , and would improve the clarity , organization , and flexibility of the NRC's FFD regulations. The NRC is also requesting comment on draft regulatory guide (DG) DG-5040.

DATES: Submit comments by [INSERT DATE 75 DAYS FROM DATE OF PUBLICATION].

Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received on or before this date. ADDRESSES:

You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0225. Address questions about NRC dockets to Carol Gallagher; telephone:

301-415-3463; e-mail: Carol.Gallagher@nrc.gov. For technical questions, contact the individual listed i n the FOR FURTHER INFORMATION CONTACT section of this proposed rule.

• E-mail comments to: Rulemaking.Comments@nrc.gov. If you do not receive an automatic e-mail reply confirming receipt, then contact us at 301-415-1677.

• Fax comments to: Secretary, U.S. Nuclear Regulatory Commission at 301-415-11 01 .

• Mail comments to: Secretary, U.S. Nuclear Regulatory Commission , Washington, DC 20555-0001, ATTN: Rulemakings and Adjudications Staff.

• Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland 20852 , between 7:30 a.m. and 4:15 p.m. (Eastern Time) Federal workdays; telephone:

301-415-1677.

For additional direction on obtaining information and submitting comments, see "Obtaining Information and Submitting Comments" in the SUPPLEMENTARY INFORMATION section of this document.

2 FOR FURTHER INFORMATION CONTACT: Stewart Schneider , Office of Nuclear Reactor Regulation , telephone: 301-415-4123; e-mail: Stewart.Schneider@nrc

.gov; Brian Zaleski , Office of Nuclear Security and Incident Response, telephone:

301-287-0638; email: Brian.Zaleski@nrc

.gov; or Paul Harris , Office of Nuclear Security and Incident Response, telephone: 301-287-9294

e-mail

Paul.Harris@nrc.gov

U.S. Nuclear Regulatory Commission , Washington DC 20555-0001. SUPPLEMENTARY INFORMATION

EXECUTIVE

SUMMARY

A. Need for the Regulatory Action The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations regarding fitness for duty (FFD) programs for certain NRC licensees and other entities to more closely align the NRC's drug testing requirements with the updates made in 2008 to the U.S. Department of Health and Human Services (HHS) " Mandatory Guidelines for Federal Workplace Drug Testing Programs" (HHS Guidelines), which were published in the Federal Register on November 25, 2008 (73 FR 71858), and became effective on October 1 , 2010. The HHS Guidelines govern Federal employee workplace drug testing programs at more than 100 Federal agencies and comparable Federal agency drug testing programs (e.g., U.S. Department of Transportation (DOT)} that test civilians in safety-and secur isensitive positions sim i lar to personnel tested under Part 26 , " Fitness for Duty Programs ," in Title 10 of the Code of Federal Regulations ( 10 CFR). More closely aligning the drug testing provis i ons under 1 O CFR part 26 with the 2008 HHS Gu i delines would enhance the ability of licensees and other entities to identify additional i ndividuals using illegal drugs and misusing 3 legal drugs. The proposed rule would also incorporate lessons learned from implementation of the 10 CFR part 26 final rule published in the Federal Register on March 31, 2008 (73 FR 16966; hereafter referred to as " 2008 FFD final rule"). These lessons include improved methods to identify attempts to subvert the drug testing process, and improvements in the clarity , consistency , and flexibility of ,--aRG donor protections under 10 CFR part 26. Historically , the NRC has relied upon the HHS Guidelines to establish the technical requirements for urine specimen collection, drug testing, and results evaluation, and has required licensees and other entities to use HHS-certified laboratories to perform drug testing. The last NRC alignment with the HHS Guidelines was completed with the 2008 FFD final rule, which incorporated provisions from the 2004 HHS Guidelines (69 FR 19644; April 13, 2004). B. Major Provisions Major provisions of the proposed rule include changes to:

• Add initial and confirmatory drug testing for three illegal amphetamine-based controlled substances

-methylenedioxymethamphetamine (MOMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA) -referred to as Ecstasy-type drugs in this proposed rule.

• Add initial drug testing for 6-acetylmorphine (6-AM), a metabolite of the illegal drug heroin , and update the confirmatory drug testing method for 6-AM.

• Lower the drug testing cutoff levels for amphetam i ne , cocaine metabolite , and methamphetamine.

• Enhance the detection of subversion attempts by strengthening the testing methods used to identify drugs and drug metabolites in urine specimens with dilute validity test results and i n spec i mens collected under d i rect observation. 4

• Require Medical Review Officers (MROs) to evaluate the elapsed time from specimen collection to testing and exposure to high temperature, as possible causes of some invalid test results due to high solvated hydrogen ion concentration (i.e., pH).

• Improve the clarity, consistency , and organization of 10 CFR part 26 QY~ add iog and updat ln9.e definitions

,}, increase flexibility by addressing~

personnel who may monitor a donor in a shy-bladder situation who is hydrating ,}, and enhance both donor protections QY providing~

additional instruct i ons for same-gender observers used in observed collections

,} and due process by requiring~

MRO s to document iHg the date and time that an oral request is received from a donor to initiate the retesting of a specimen ,}. C. Costs and Benefits The NRC prepared a draft regulatory analysis to quantify the costs and benefits of the proposed rule, as well as to examine the qualitative factors to be considered in the NRC's rulemaking decision. The analysis concluded that the proposed rule would result in net costs to the industry. The proposed rule , relative to the regulatory baseline, would result in a net cost for industry of between $2.4 million based on a 7 percent net present value and $3.4 million based on a 3 percent net present value. The estimated average net cost per licensee or other entity site would be a one-time cost of $5,031 and an annual cost of $2 , 516. Thirteen qualitative factors were evaluated in the draft regulatory analysis: public health (accident), occupational health (accident), offsite property , onsite property, regulatory efficiency , safeguards and security considerations, and other considerations (public perception , public trust, worker productivity, improved protection of individual rights , work environment free of drugs and the effects of such substances , safety vulnerability , and security vulnerability). The draft regulatory analysis includes a discussion of each qualitative factor. 5 If the results of the regulatory analysis were based solely on the costs and the benefits that could be quantified, then the regulatory analysis would show that rulemaking is not justified because the total estimated quantified benefits of the proposed regulatory action do not equal or exceed the estimated costs of the proposed regulatory action. However, ff-when the qualitative benefits are considered, together with the quantified benefits, then the benefits outweigh the identified quantitative and qualitative impacts. In the draft regulatory analysis, the NRC concluded that the proposed rule should be adopted because it would result in a 10-to 12-percent increase per year in the detection of individuals using drugs or attempting to subvert the drug testing process. In comparison to the test results from calendar years 2013 and 2014, the estimated increase in detection each year is equivalent to identifying approximately 95 additional individuals using illegal drugs, misusing legal drugs, or attempting to subvert the drug testing process. This improved detection would prevent additional drug-using individuals from gaining or maintaining unescorted access authorization to NRC-licensed facilities (i.e., operating nuclear power reactors, nuclear power reactors under construction, and Category I fuel cycle facilities) and other locations (e.g., Emergency Operations Facilities, Technical Support Centers).

In addition, the enhanced detection would prevent additional drug-using individuals from gaining or maintaining unescorted access authorization to special strategic nuclear material (SSNM) or sensitive information.

An enhanced drug testing program might also deter additional drug-using individuals from seeking employment in 10 CFR part 26-regulated positions and/or incentivize those already in regulated positions to cease drug use or to seek medical assistance to address an addiction or misuse issue. For more information, please see the regulatory analysis (Accession No. ML16123A006 in the NRC's Agencywide Documents Access and Management System (ADAMS)).

6 TABLE OF CONTENTS:

I. Obtaining Information and Submitting Comments A. Obtaining Information B. Submitting Comments II. Background A. The Health and Human Services Guidelines B. History of the NRC's Fitness for Duty Program 111. Discussion A. The Need for Rulemaking

1. Alignment with the 2008 Health and Human Services Guidelines

2. Societal Drug Use B. Public Input Regarding Proposed Revisions to 10 CFR Part 26 to Include Aspects of the 2008 Health and Human Services Guidelines C. Description of Proposed Changes IV. Section-by-Section Analysis V. Specific Requests for Comments VI. Regulatory Flexibility Certification VI I. Regulatory Analysis VI 11. Backfitting and Issue Finality IX. Cumulative Effects of Regulation X. Plain Writing XI. Environmental Impact: Categorical Exclusion XII. Paperwork Reduction Act Statement 7

XIII. Compatibility of Agreement State Regulations XIV. Voluntary Consensus Standards XV. Availability of Guidance XVI. Availability of Documents I. Obtaining Information and Submitting Comments A Obtaining Information Please refer to Docket ID NRC-2009-0225 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:

• Federal Rulemaking Web site: Go to http://www.regulations.gov and search for Docket ID NRC-2009-0225.

• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at http://www

.nrc.gov/reading-rm/adams

.html. To begin the search , select " ADAMS Public Documents" and then select " Begin Web-based ADAMS Search." For problems with ADAMS , please contact the NRC's Public Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737 , or by e-mail to pdr.resource@nrc.gov. For the convenience of the reader , instructions about obtaining materials referenced in this document are provided in the " Availability of Documents" section of this document.

• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR , Room 01-F21, One White Flint North , 11555 Rockville Pike , Rockville , Maryland 20852. 8 B. Submitting Comments Please include Docket ID NRC-2009-0225 in your comment submission.

The NRC cautions you not to include identifying or contact information that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at http://www.regulations

.gov as well as enter the comment submissions into ADAMS. The NRC does not routinely edit comment submissions to remove identifying or contact information. If you are requesting or aggregating comments from other persons for submission to the NRC , then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment into ADAMS. II. Background A. The Health and Human Services Guidelines Through Executive Order 12564 (51 FR 32889; September 17 , 1986), the President of the United States designated the Department of Health and Human Services (HHS) as the Federal agency responsible for establishing and maintaining the requirements and guidance for conducting Federal employee workplace drug testing. In execution of this designation , and under the author i ty of Section 503 of Public Law 100-71 , 5 U.S.C. Section 7301 notes , HHS developed the " Mandatory Guidelines fo r Federal Workplace Drug Testing Programs" (HHS Guidelines) that established a robust legal framework to conduct drug testing to provide: 9 reasonable assurance of donor privacy , drug testing accuracy and precision , specimen collection and custody and control , and results review by a Medical Review Officer (MRO). The HHS Guidelines also established the certification requirements that each laboratory must meet to test specimens for F e deral employee workplace drug testing programs. To obtain certification, a laboratory must successfully complete several rounds of performance testing and a National Laboratory Certification Program (NLCP) inspection.

The certification requirements include, but are not limited to , l aboratory staffing and qualifications , testing procedures, quality assurance and quality control , and results reporting. Once certified , each laboratory is subject to quarterly performance testing and NLCP inspection every 6 months to verify adherence to the HHS Guidelines. The HHS laboratory certification process provides assurance t o the NRC , licensees , and other entities that the testing of specimens , under 10 CFR part 26 , is conducted with the highest standards of accuracy , precision , and quality. HHS periodically updates the HHS Guidelines to: enhance testing program effectiveness based on advances i n drug test i ng technologies , processes , methodologies , and instrumentation

include additional substances in the testing pane l, as societal drug-use trends change; and incorporate lessons learned from the NLCP. Each revis i on of the HHS Guidelines is published following a rigorous process that includes , but is not limited to, scientific , policy , legal , and technical review by the independent Drug Testing Advisory Board , which advises the Administrator of the HHS Subs t ance Abuse and Mental Health Serv i ces Administration (SAMHSA); academic peer rev i ews; public review and comment; and input from Federal agencies that implement the HHS Guidelines. The HHS also conducts extensive outreach with affected stakeholders and researches societal drug-use trends to promulgate effective drug testing methods. 10 The HHS Guidelines govern the drug testing programs of over 100 Federal agencies that test Federal employees, are used by many Federal agencies that test civilians in and security-sensitive positions similar to personnel tested under 10 CFR part 26, such as the U.S. Department of Transportation (DOT), and by many private entities.

The NRC has historically relied on HHS to establish the technical requirements for urine specimen collection , specimen testing and test result evaluation, and in general, only deviates from the HHS Guidelines for considerations specific to the nuclear industry.

The NRC relies on the HHS Guidelines as part of its technical basis for the drug testing requirements contained under 10 CFR part 26. Updating 1 O CFR part 26 to align more closely with changes in the 2008 HHS Guidelines would help to ensure that the NRC's regulations continue to be scientifically and technically sound. B. History of the NRC's Fitness for Duty Program In the 1970s , the NRC and the commercial nuclear power industry began addressing concerns about the potential public health and safety impacts of fitness for duty (FFD) problems at nuclear power plants. Most nuclear utilities voluntarily implemented FFD programs during the 1980s, and the NRC monitored the comprehensiveness and effectiveness of these programs.

On August 4, 1986, the NRC published the Commission Policy Statement on Fitness for Duty of Nuclear Power Plant Personnel (51 FR 27921 ), which outlined the need for nuclear power plant licensees to implement programs to address FFD problems -including illegal drug use , alcohol abuse, misuse of legal drugs , and any other mental or physical problems that could impair job performance.

An evaluation of licensee programs following the implementation of the policy statement identified a wide range in the quality and comprehensiveness of licensee FFD test i ng programs that ultimately resulted in the NRC's decision to pursue rulemaking. 11 The NRC published a final rule , entitled " Fitness-for

-Duty Programs ," in the Federal Register on June 7 , 1989 (54 FR 24468), adding 10 CFR part 26. The 1989 FFD final rule was based on t he 1988 version of the HHS Guidelines (53 FR 11970; April 11 , 1988). A subsequent final rule , published in the Federal Register on June 3 , 1993 (58 FR 31467), expanded the scope of 10 CFR part 26 to include l i censees authorized to possess , use , or transport formula quantities of strategic special nuclear materials (SSNM). The NRC issued the first substantial revision to 10 CFR part 26 in a final ru l e on March 31 , 2008 (73 FR 16966; hereafter referred to as the " 2008 FFD final r ule"). The 2008 FFD final rule updated the NRC's drug testing requirements to align with the then-latest HHS Guidel i nes , which were issued in 2004 (69 FR 19644; April 13, 2004). The 10 CFR part 26 updates included the following: 1) required validity testing of each specimen to address the potential for subversion of the testing process , 2) advancements in drug and alcohol testing technologies , 3) changes to drug and alcohol testing cutoff levels , and 4) lessons learned from the implementation of 10 CFR part 26 since its addition in 1989. On November 25, 2008 , HHS issued the 2008 HHS Guidelines (73 FR 71858), which included:

1) an expanded drug testing pane l, 2) lower drug testing cutoff levels for some substances , 3) advances in testing technologies , and 4) more detailed requirements for spec i men collectors and MROs. The 2008 HHS Guidelines became effective on October 1 , 2010. The 2008 Guidelines

' updates to the 2004 Guidelines are currently not reflected in 10 CFR part 26. 12 Ill. Discussion A. The Need for Rulemaking

1. Alignment with the 2008 Health and Human Services Guidelines In the 2008 HHS Guidelines , HHS enhanced the detection of illegal drug use and the misuse of prescription drugs by: 1) lowering the initial and confirmatory testing cutoff levels for amphetamine , cocaine, and methamphetamine;

2) establishing an initial testing requirement and revising the confirmatory testing cutoff level for the heroin metabolite 6-AM; and 3) establishing testing for Ecstasy-type drugs (which are part of the amphetamine class of drugs). The effect i veness of the 2008 HHS Guidelines is demonstrated by the enhanced detection evident in the test results reported by HHS , the DOT , and Quest Diagnostics (Quest), which is an HHS-certified laboratory that conducts testing for both Federal workplace drug testing programs (i.e., Federally-mandated) and private company testing programs (i.e., U.S. general workforce).

Quest annually publishes a Drug Testing IndexŽ report, which presents Quest laboratory testing results for Federally-mandated drug tests. On March 13 , 2012, Quest reported a 33 percent increase from 2010 to 2011 in cocaine positive test results for 1.6 million Federal workplace tests conducted. Quest attributed the increase , in large part, to the lower cocaine testing cutoff levels implemented as a result of the 2008 HHS Guidelines (Quest , 2012). In the same report , Quest also noted that amphetamines positives rose by nearly 26 percent , continuing an existing upward trend , but also were " likely boosted by better detection related to the new , lower Federally-mandated cutoffs." In comparison to the 2010 positive testing rates for Federal workplace drug testing performed by Quest , the results for 2012 indicate a 12.5 percent increase in cocaine positives and a 37 percent increase in amphetamines positives with 2013 continuing the multi-year upward trend (Quest , 2014). 13 As detailed in the most recent NRC report, " Summary of Fitness for Duty Performance Reports for Calendar Year 2013," an adverse trend in the commercial nuclear industry has been observed over the past 5 years associated with the year-over-year increases in amphetamines 1 positive test results (see table in this section).

While accounting for a relatively small percentage of the total positive drug test results in 2013 at 8.9 percent , amphetamines positives have continued to grow in comparison to previous years. For example, the share of amphetamines positives, as a percentage of all positive drug test results in 2013 (8.9 percent), is 2.3 times higher than the percentage in 2009 (3.9 percent).

Viewed another way, the percentage of individuals testing positive for amphetamines has trended upward since 2009. In 2009, 0.023 percent of individuals tested positive for amphetamines

by 2013, the positive rate increased to 0.052 percent. Conversely, cocaine use as a percentage of all positives has declined by 15.9 percent from 1990 (the first year of 10 CFR part 26 drug testing) to 2013. While cocaine use has trended downward, it continues to be the third most detected substance, accounting for 13.2 percent of positive drug test results in 2013. Substance Amphetamines Cocaine Trends in Amphetamines and Cocaine Use 1990 2009 2010 2011 2012 Change 2013 (1990-2013) 2.8% 3.9% 5.7% 8.3% 6.2% 8.9% 6.1% 29.0% 16.2% 13.1% 12.4% 12.9% 13.2% -15.9% Notes

1. The positive testing percentages are calculated by taking the total number of positives for the particular substance and dividing that figure by the total number of positive drug test results in the year. 2. Data from 1990 , the first year of testing under 10 CFR part 26 , are included as the baseline for comparison.

1 10 CFR part 26 requires initial drug testing for amphetamines and confirmatory drug testing for amphetamine and methamphetamine. 14 While most of the proposed changes in this rulemaking would be made to better align 10 CFR part 26 with the 2008 HHS Guidelines, some are based on lessons learned during the implementation of the 2008 FFD final rule by licensees and other entities.

In particular, the NRC is proposing a number of changes that would enhance the ability of licensees and other entities to identify individuals attempting to subvert the drug testing process. Beginning in 2009, licensees and other entities had the option to use electronic reporting forms (e-forms) created by the NRC, in collaboration with licensees and other entities , in order to meet the annual FFD drug and alcohol testing program reporting requirements in § 26. 717, " Fitness-for-duty program performance data" and § 26.417(b )(2). These e-forms 2 provide a uniform way of reporting detailed information on each drug and alcohol testing violation, and their use by licensees and other entities has continued to grow (from over 80 percent in 2011 to 93 percent in 2013). Analysis of FFD program performance data from 2011 through 2014 identified a significant new trend: the prevalence of subversion attempts of the drug testing process. In 2011, over 13.2 percent of the total testing violations were donor subversion attempts (143 of 1,080 testing violations), with even more subversion attempts in subsequent years: 15. 9 percent in 2012 ( 177 of 1 , 114 testing violations), 14. 7 percent in 2013 ( 148 of 1,007 violations), and 16.5 percent in 2014 ( 187 of 1,133 testing violations).

If the number of alcohol positive testing violations is removed from the total testing violations each year, the percentage of drug testing violations determined to be subversion attempts increases to 17.5 percent in 2011, 20.6 percent in 2012 , 19.2 percent in 2013 , and 21.3 percent in 2014. An attempt to subvert the testing process demonstrates a lack of integrity and honesty and a willful act to 2 The NRC FFD electronic forms are available for review at the following NRC website: http://www.nrc.gov/reactors/operating/ops-experience/fitness-for-duty-proqrams/submit-ffd-reports

.html. 15 refuse to comply with an NRC-required drug test (see 10 CFR 26.89(c), 26.825 , " Criminal penalties ," and 50.5 , " Del i berate misconduct

"). Consequently , these drug-using individuals present a safety vulnerability because of the potential for job-related human performance issues due to drug use. These dD rug-using individuals could also present a security vulnerabil i ty because of their impairment or willful misconduct.

As a result , the NRC is proposing a number of changes in this proposed rule to enhance the ability of FFD testing programs to detect individuals attempting to subvert the drug testing process. Stakeholder outreach on the proposed rule is -As described in Section 111.B of this document , representatives of the commercial nuclear power industry have expressed support for implementing select provisions from the 2008 HHS Guidelines to enhance detection of illegal drug use and misuse of prescription drugs and to enhance the testing methods to identify subversion attempts. The basis for each proposed change is discussed in Section 111.C of this document.

The regulatory basis for this proposed rule , issued on May 3 , 2013 , prov i des ~further discussion on the technical merits of th i s rulemaking. 2. Societal Drug Use As described in the U.S. President's 2014 National Drug Control Strategy ," societal use of legal and illegal drugs and substances continues to evolve and affects every sector of society (e.g., adolescents , adults , and persons in the U.S. workforce). The preva l ence of drug use in society is also documented in the " Behavioral Health Trends in the United S t ates: Results from t he 2014 National Survey on Drug Use and Health" (NSDUH), an annual survey sponsored by SAMHSA. Th i s survey is t he p r imary source of information on the use of illegal drugs , alcoho l, and tobacco i n the civilian , non-institutionalized population in the Un i ted States , ages 12 and o l der. The NSDUH survey estimated t ha t i n 2014 , 1 0.2 percent of the U.S. population aged 1 2 16 or older (approximc1tely 27.0 million Americans) used an illegal drug in the past month. This estimate was based on the number of individuals surveyed that reported using an illegal drug during the month prior to participating in the NSDUH survey interview.

Among adults aged 26 or older, those potentially in the U.S. workforce , the rate of illegal drug use was 8.3 percent , representing an upward trend since 2002. Although SAMHSA belie11es attributes tAat-this increase was driven byto marijuana use, it demonstrates the prevalence of illegal drug use in the workforce. Societal drug use presents a continual challenge to the fitness of the workforce relied on by licensees and other ent i ties to perform safety and security significant duties, with the result that potential impairment and the adverse impact on job-related human performance may affect public health and safety. B. Public Input Regarding Proposed Revisions to 10 CFR part 26 to Include Aspects of the 2008 Health and Human Services Guidelines After HHS issued the 2008 HHS Guidelines , the NRC performed a comprehensive review of 10 CFR part 26 and the 2008 HHS Guidelines to identify provisions in the NRC's regulations that may need to be revised. Two public meetings were held in 2009 , on February 24 and June 24, with regulated entities, interest groups, and members of the general public to discuss the changes in the 2008 HHS Guidelines.

In 2010 , the NRC analyzed the DOT's final rule changes to 49 CFR part 40 , " Procedures for Transportation Workplace Drug and Alcohol Testing Programs" (75 FR 49850; August 16 , 2010) to understand how another Federal agency that tests civilians implemented the 2008 HHS Guidelines. The NRC also analyzed lessons learned from implementation of the 2008 FFD final rule. Collectively, these efforts resulted in a list of potential changes to 10 CFR part 26 that the NRC presented , for feedback , at a third public meeting held on October 11 , 2011. The NRC summarized public comments received at the October 11 meeting , as well as e-mailed comments received 17 subsequent to the meeting , in a document titled " Comments for the October 11, 2011, Public Meeting" (included as Enclosure 3 in package available via ADAMS Accession No. ML112930153).

A fourth meeting was held on September 11 , 2013, to inform the public o ffl the status of the rulemaking.

Public meetings were attended by representatives of nuclear power plant licensees, the Nuclear Energy Institute , the Institute of Nuclear Power Operations , the International Brotherhood of Electrical Workers, and HHS. Based upon feedback received during the four public meetings, some of the NRG-proposed revisions were removed from consideration because the NRC decided that it was not appropriate to pursue those particular issues in this rulemaking, while others were revised. The NRG-proposed revis i ons , along with associated issues raised by the public, are discussed in Section 111.C of this document.

C. Description of Proposed Changes This section includes a description of each proposed change , the rationale for each change, and a discussion of public comments that informed the NRC's development of the changes. Definitions During the October 11 , 2011 , public meeting , an industry participant requested that the NRC review the use of certain terms urider 10 CFR part 26 for consistency with the 2008 HHS Guidelines.

The NRC performed a review and proposes to add seven new definitions and revise seven existing definitions under§ 26.5 , " Definitions

." The revisions and additions would improve consistency with Section 1.5 of the 2008 HHS Guidelines and would improve the clarity , consistency , and accuracy of the requirements under 10 CFR part 26. Specifically , the following definitions would be added: cancelled test , carryover , Certifying Scientist , Federal 18 custody and control form , lot , rejected for testing , and Responsible Person. The following definitions would be revised: calibrator , control , dilute specimen , HHS-certified laboratory, invalid result , limit of quantitation , and substituted specimen.

Cancelled test. The MRO will cancel the testing of a donor's urine specimen and report that action to the licensee or other entity after the testing laboratory (i.e., licensee testing facility (L TF) or HHS-cert i fied laboratory) reports that the specimen was rejected for testing, or the donor requested additional testing of a specimen at a second HHS-certified laboratory under § 26.165(b) and the specimen was not available for testing due to circumstances outside of the donor's control (e.g., specimen is lost in transit).

Sections 26.129(b}(2) and 26.159(b)(2) describe the only circumstances requiring an MRO to " cancel the testing of a donor's urine specimen." However, §§ 26.129(b )(2) and 26.159(b )(2) do not use the term cancelled test , nor is the term defined under§ 26.5. Adding the definition for cancelled test and updating §§ 26.129(b )(2) and 26.159(b )(2) to specifically use that term would clarify the actions taken by an MRO and improve consistency between 10 CFR part 26 and the 2008 HHS Guidelines.

The NRC is also proposing to add the term cancelled test to§ 26.165(f)(1) and (f)(2) to clarify the actions taken by an MRO when a specimen is rejected for testing by the laboratory and the MRO cancels the testing of the specimen. For completeness, a cancelled test for alcohol breath testing is also defined. The definition presented by the NRC staff at the October 11 , 2011, public meeting only described cancelled test results associated with urine testing. For alcohol testing only , cancelled test means a test r esult that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91. Carryover.

The proposed rule would add a definition for carryover to § 26.5. Carryover is the effect that occurs when a test result fo r a donor's specimen or quality control sample has been affected by a preceding specimen te s ted on the same analyt i cal i nstrume nt. For example , 19 if the concentration of a drug in one donor specimen was not completely eliminated from the analytical instrument before the next donor specimen is tested , the residual drug concentration i n the instrument may contribute to a false positive test result for the next donor specimen tested. Carryover would also apply to dono r specimens containing an adulterant or interfering substance.

The term carryover is not currently defined under § 26.5. However , the term carryover is used i n§§ 26.137(e)(7) and 26.167(a), which require L TFs and HHS-certified laboratories to ensure that carryover does not contaminate the testing of a donor's specimen or otherwise affect a donor's specimen results. In addition ,§ 26.91(c)(5) describes the requirement to ensure that carryover does not affect alcohol testing results when using evidential breath testing devices. The NRC's proposed definition is similar to the definition in Section 1.5 of the 2008 HHS Guidelines but does not include the phrase " (e.g., drug concentration)

," because carryover applies also to validity testing (e.g., adulterants , interfering substances) and alcohol testing. Certifying Scientist.

The proposed rule wou l d add a definition for Certifying Scientist to § 26.5. The position title is used in§ 26.169(a) and (g) but is not currently defined. A Certifying Scientist would be defined as the individual at the HHS-certified laboratory responsible for ver i fying the chain of custody and scientific reliability of any test result reported by the HHScertified labo r atory. Adding this definition would improve consistency between 10 CFR part 26 and the 2008 HHS Guidelines. A conforming change would be made to§ 26.169(a) to capitalize the position title in the phrase " the laboratory

's certifying scientist." Federal custody and control form (Federal CCF). The proposed rule would add a definition for the term Federal custody and control form (Federal CCF) to § 26.5. The Federal CCF i s defined as any HHS-approved form , which has not expired , t hat is published in the Fede r al Regis t e r and is used t o document the collection , custody , transport , and testing of a 20 specimen.

Including this definition would align 10 CFR part 26 with Section 1.5 of the 2008 HHS Guidelines and improve the clarity of the rule by defining the term, which is already used in § 26.153(9).

The proposed rule would revise the NRC's initial intended proposed definition of Federal CCF , based on feedback received during the October 11, 2011, public meeting. The definition that the NRG proposed at that meeting listed the specific name of the HHS-approved form used for urine drug testing (i.e., Federal Drug Testing Custody and Control Form) and closely paralleled the definition in Section 1.5 of the 2008 HHS Guidelines. However, based on comments received during the meeting, the NRC agrees that referencing the specific name on the form was too prescriptive and could require additional revision to 10 CFR part 26, should HHS revise the form name in the future. Therefore, the NRC is proposing to use the generic title, Federal CCF , to avoid the need for future regulatory changes , should the title of the form change. The definition may also provide flexibility in accommodating accounting for additional forms that SAMHSA may create , at a later date, for use when conducting drug and validity testing of alternative specimens (e.g., oral fluids, hair). To align with the new definition, " Federal custody-and-control form ," which appears in § 26.153(9), would be replaced with the term " Federal CCF." In addition , to improve the consistency of terminology used throughout 10 CFR part 26 , the NRC is also proposing to replace the term "custody and control form" with the term " Federal CCF." The plural versions , " custody and control forms" and " custody and control form(s)," would also be replaced with the terms " Federal CCFs" and " Federal CCF(s)," respectively. Finally , the proposed rule would correct inconsistenciesa few instances wore identified under 10 CFR part 26 where " custody-and-control" form or forms were used incorrectly and instead , should have referred to " chain of custody" form or forms. Tho proposed rule '.¥Ould correct those inconsistencies.

21 The NRC's regulations under 10 CFR part 26 do not preclude the use of electronic versions of the Federal CCF or the use of licensee or other entity-developed forms, consistent with existing requirements in § 26.153(9). The NRC supports the use of technological advancements to improve the quality of information included on the Federal CCF (e.g., legibility, accuracy, and completeness of information);

reduce undue delays and/or the canceling of specimen tests due to paperwork irregularities; facilitate timely transmission of information to and from collectors, laboratories, and responsible licensee representatives (e.g., the MRO); and reduce recordkeeping and reporting costs. Lot. The proposed rule would add a definition for lot to§ 26.5 , representing units that have the same starting materials, performance characteristics, and expiration date. The term is used in 10 CFR part 26 but is not currently defined. Adding this definition would improve consistency between 10 CFR part 26 and the definition of lot in Section 1.5 of the 2008 HHS Guidelines.

The proposed rule would use the same definition in the 2008 HHS Guidelines by defining lot as a number of units of an item manufactured from the same starting materials within a specified period of time for which the manufacturer states that the items have essentially the same performance characteristics and the same expiration date. The proposed rule also would include in the definition the parenthetical statement from the 2008 HHS Guidelines definition that provides examples of the term " item." The NRC would change one of the examples in the parenthetical statement by replacing

" quality control material" with " quality control samples." The term " quality control material" has not been used in 10 CFR part 26. Rejected for testing. The proposed rule would add to§ 26.5 a definition for rejected for testing that is similar to the definition in Section 1.5 of the 2008 HHS Guidelines, referring to a report by a licensee testing facility or HHS-certified laboratory that no tests can be performed on a specimen. The term rejected for testing appears in§ 26.1 69(h)(8) but is not currently defined. 22 Including a definition would clarify what information is being reported by the HHS-certified laboratory to the licensee or other entity in the annual quantitative summary of test results. In addition , defining the term would align with two additional proposed changes to §§ 26.129{b )( 1 )(ii) and 26.159(b )( 1 )(ii), to clarify the existing step that an L TF or HHS-cert i fied laboratory would take , if a licensee or other entity had reason to quest i on the integrity and identity of a specimen (i.e., reject the specimen for testing).

In§ 26.129(b)(1 )(ii), the phrase " the specimen may not be tested" would be replaced with the phrase " the licensee testing facility shall reject the specimen for testing." In§ 26.159(b)(1

)(ii), the phrase " the specimens may not be tested" would be replaced with the phrase " the laboratory shall reject the specimens for testing." Improving the consistency of terminology used when a specimen cannot be tested improves the regulatory efficiency of 10 CFR part 26. Responsible Person. The proposed rule would add a definition for Responsible Person to§ 26.5. The position title is used in § 26.31 (d)(1 )(0) but is not currently defined. A Responsible Person would be defined as the person at the HHS-certified laboratory who assumes professional , organizational , educational , and administrative responsibility for the day-to-day management of the HHS-certified laboratory. Adding this definition would i mprove consistency between 10 CFR part 26 and the 2008 HHS Guidelines. A conforming change would be made to§ 26.167(f)(3) to capitalize the position title in the phrase " a statement by the laboratory

's responsible person." Calibrator.

The proposed rule would revise the definition for calibrator i n § 26.5 to more closely align with the defin i tion in Section 1.5 of the 2008 HHS Guidelines and to also improve internal consistency of terminology used in 10 CFR part 26. The definition of calibrator would be revised to include a clarify i ng statement that a calibrator is a solut i on of known concentration

" in the appropr i ate matrix" that aligns with the definition i n the 2008 HHS Guidelines. The 23 phrase " test specimen/sample" would be replaced with the phrase " donor specimen or quality control sample" to improve consistency with the terminology used in 10 CFR part 26. The last sentence of the definition, which states that " calibrators may be used to establish a cutoff concentration and/or a calibration curve over a range of interest," would be deleted. Although a part of this sentence aligns with the 2008 HHS Guidelines, the sentence is not a definition, but rather a voluntary provision that a laboratory may use a calibrator to establish a calibration curve. The determination of calibration curves is an internal laboratory process that already must be described in standard operating procedures for L TFs in § 26.127 , "Procedures," and is evaluated during NLCP inspection of HHS-certified laboratories. Control. The proposed rule would revise the definition of control in§ 26.5 to conform to the definition of the term in Section 1.5 of the 2008 HHS Guidelines. The term control in § 26.5 woulp be revised by replacing the phrase " a sample used to monitor the status of an analysis to maintain its performance within predefined limits" with the phrase " a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits." Dilute specimen. The proposed rule would revise the definition of dilute specimen in § 26.5, to conform to the definition of the term in Section 1.5 of the 2008 HHS Guidelines.

The phrase " concentrations that are lower than expected for human urine" would be revised to read as " values that are lower than expected but are still within the physiologically produc i ble ranges of human urine." The current definition incorrectly references

" concentrations" which does not apply to a specific gravity reading. The current definition also does not clearly state that creatinine and specific gravity measurements in a dilute specimen are still within the range that could be produced by a human being. HHS-certified laboratory.

The current definition of an HHS-certified laboratory in § 26.5 l i sts the Federal Register citations for each final version of the HHS Guidelines (originally 24 published in 1988, and amended in 1994, 1998, and 2004 ). Under this definition, an HHS-certified laboratory must meet the 2004 HHS Guidelines, which were published on April 13, 2004 (69 FR 19643). No laboratory performing testing for 10 CFR part 26 licensees or other entities currently meets tliis definition because the definition refers to the out of eatesuperseded 2004 HHS Guidelines; rather, HHS certifies laboratories to the HHS Guidelines that are in effect (i.e., the 2008 l=ll=IS Guidelines). The proposed rule would correct this restriction by defining an HHS-certified laboratory as a laboratory that is certified to meet the standards of the HHS Guidelines at the time that drug and validity testing of a specimen is performed for a licensee or other entity. Other requirements in 10 CFR part 26 already specify the drug testing panel and testing cutoff levels , validity testing requirements , and quality control requirements. The proposed change to the definition of HHS-certified laboratory would eliminate the need to revise 10 CFR part 26, should future versions of the HHS Guidelines be published.

Two conforming changes would also be made, based on the revision to the definition of HHS-certified laboratory.

The first change would revise§§ 26.4U)(3) and 26.153(a) to reference

" HHS-certified laboratories as defined in§ 26.5." Section 26.153(a) would also be revised to remove the reference to the physical address of the Division of Workplace Programs as the location to obtain information concerning the certification status of laboratories. +Re revised definition includes a reference to the Federal Register as the location of the notice that l=ll=IS publishes on a monthly basis that lists the current l=ll=IS certified laboratories.

Invalid result. The proposed rule would revise the definition of invalid result in § 26.5 to be consistent with the definition of the term in Section 1.5 of the 2008 HHS Guidelines and would also improve the clarity and accuracy of the 10 CFR part 26 rule. The phrase " for a specimen that contains an unidentified adulterant , contains an unidentified interfering substance, has an abnormal physical characteristic , contains inconsistent physiological 25 constituents, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result" would be replaced with "in accordance with the criteria established in § 26.161 (f) when a positive , negative, adulterated, or substituted result cannot be established for a specific drug or specimen validity test." The revised definition would also correct an inaccuracy in the current definition of invalid result, which does not include "specimen validitJ test." Limit of Quantitation.

The proposed rule would revise the definition for Limit of Quantitation (LOQ) in§ 26.5 to more closely align with Section 1.5 of the 2008 HHS Guidelines. To align with the terminology used in 10 CFR part 26 , the proposed definition would use " analyte" instead of the word " measurand." Substituted specimen. The proposed rule would revise the definition fef..of substituted specimen in § 26.5 , to align with the definition of the term in Section 1.5 of the 2008 HHS Guidelines. The phrase " specimen with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human physiology" would be replaced with " a specimen that has been submitted in place of the donor's urine , as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine." The revision would also improve the clarity of the rule by explaining that a substituted specimen is the result of donor action to subvert the testing process by stating that the specimen " has been submitted in place of the donor's urine." Drug Testing Panel Additions The proposed rule would add three amphetamine-based chemical compounds:

methylenedioxymethamphetamine (MOMA), methylenedioxyamphetamine (MDA), and methylenedioxyethylamphetamine (MDEA) to the NRG-required drug testing panel , consistent 26 with the drug testing panel in Section 3.4 of the 2008 HHS Guidelines.

MOMA (also known as Ecstasy or Molly), MOA, and MOEA are listed in Schedule I of the Controlled Substances AGtSchedules of Controlled Substances (21 CFR 1308.11 ). A Schedule I drug or substance has a high potential for abuse, has no currently accepted medical use in treatment in the United States, and lacks an accepted safe use of the drug or substance under medical supervision (21 U.S.C. § 812 (2012)). The proposed rule would revise§§ 26.31(d)(1) and 26.405(d) to identify MOMA, MOA, and MOEA as substances for wh i ch licensees and other entities are required to test;§ 26.133, " Cutoff levels for drugs and drug metabolites

," and§ 26.163(a)(1) to require initial testing for MOMA; and§ 26.163(b)(1) to require confirmatory testing for MOMA, MOA, and MOEA. By requiring licensees and other entities to test for additional substances, a greater range of drugs that impair human performance can be detected. Also, it would assist in the identification of those persons who , because they use illegal drugs , exhibit characteristics of not being trustworthy and reliable.

The drugs MOMA, MOEA, and MOA would be added to the NRC-required drug testing panel because of their potential adverse effects on human performance, which were detailed by the HHS in the notice of proposed revisions to the HHS Guidelines, published in the Federal Register on April 13, 2004 (69 FR 19673). The proposed rule would also expand the NRC-required drug testing panel to include initial testing for 6-AM, consistent with Section 3.4 of the 2008 HHS Guidelines.

This change would improve the assurance that the testing method used under 10 CFR part 26 would identify an individual using heroin , a Schedule I drug. Currently, 10 CFR part 26 only permits the testing of a specimen for 6-AM when the specimen also tests positive for morphine (i.e., the morphine concentration is greater than the confirmatory testing cutoff level). The HHS implemented initial testing for 6-AM in the 2008 HHS Guidelines, based on the analysis of laboratory testing data 27 that demonstrated that 6-AM was detectable in the specimens of some individuals , even when the specimens tested negative for morphine. Revised Initial Drug Testing Cutoff Levels The 2008 HHS Guidelines established the scientific and technical bases for lowering the initial drug testing cutoff levels for amphetamines and cocaine metabolites.

The proposed rule would update the substances and cutoff levels for initial drug testing, as listed in the tables in §§ 26.133 and 26.163( a)( 1 ), to conform with Section 3.4 of the 2008 HHS Guidelines.

Specifically, the proposed rule would make the following changes in each table: 1) lower the initial test cutoff level for amphetamines (abbreviated in the tables as AMP), 2) lower the initial test cutoff level for cocaine metabolites , 3) clarify the existing testing requirement for " opiate metabolites" by replacing the term with " codeine/morphine

," 4) include a new footnote 1 to each table to clarify that the target analyte for " codeine/morphine" testing is morphine , 5) clarify in a new footnote 2 to each table that either a single or multiple initial test kit(s) may be used for amphetamines testing , and 6) include a new footnote 3 in each table to clar i fy tha t methamphetamine (abbreviated i n the tables as MAMP) is the target analyte for amphetamines and methamphetamine testing. The column header " Drug or metabolites" in the tables in §§ 26.133 and 26.163(b)(1) would also be revised to " Drugs or drug metabolites" to align with the table titles. Lowering the cutoff levels for these existing drugs and drug metabolites in the NRG-required testing panel would increase the timeframe (i.e., the window of detection) in which these drugs can be detected in an individual

's urine after use and may also lead to improved deterrence.

Increasing the window of detection for these substances would provide a higher degree of assurance that persons who are using illegal d r ugs o r misusing legal drugs would be identified. The NRC ant i cipates that the proposed lower testing cutoff levels would 28 increase the number of urine specimens identified as containing amphetamine, cocaine metabolite, and methamphetamine.

These anticipated outcomes are based on increases in detection reported by Federal employee workplace drug testing programs and the DOT testing program subsequent to implementing the lower testing cutoff levels in the 2008 HHS Guidelines, as discussed in the regulatory basis and the regulatory analysis for this proposed rule. In addition, the proposed rule would revise §§ 26.133 and 26.163(a)( 1) to clarify that the specified testing cutoff levels are used by an L TF or an HHS-certified laboratory to determine whether a specimen is either "negative" or "positive" for each drug or drug metabolite being tested. This change better aligns 10 CFR part 26 with Section 11.19(,!la) and (b_g) of the 2008 HHS Guidelines, which require the HHS-certified laboratory to make a determination that each specimen is either " positivenegative" or " negativepositive

," respectively, for each drug and drug metabolite tested. Revised Confirmatory Drug Testing Cutoff Levels The 2008 HHS Guidelines established the scientific and technical bases to justify lowering the confirmatory drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine, and expanding the testing panel to include confirmatory drug testing for the Ecstasy drugs MOMA, MDEA, and MDA. The NRG proposes to expand the number of substances in the NRC-required testing panel and to lower the cutoff levels for confirmatory drug tests, as listed in the table in§ 26.163(b)(1

), to align with Section 3.4 of the 2008 HHS Guidelines. Specifically, the proposed rule would make the following changes: 1) lower the confirmatory test cutoff level for amphetamine from 500 ng/ml 3 to 250 ng/ml, 2) lower the confirmatory test cutoff level for cocaine metabolite from 150 ng/ml to 100 ng/ml, 3) lower the 3 The unit ng/ml is nanograms per milliliter or a millionth of a gram per liter. 29 confirmatory test cutoff level for methamphetamine from 500 ng/ml to 250 ng/ml, 4) eliminate table footnote 3, which specified the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine concentration exceeding 2000 ng/ml, 5) redesignate table footnote 4 as footnote 3 and update the text to lower the amphetamine concentration from 200 ng/ml to 100 ng/ml that must also be present in a specimen to be positive for methamphetamine, 6) include confirmatory testing for MDMA, MDA, and MDEA at a cutoff level of 250 ng/ml, and 7) provide the full chemical names for MDA and MDEA in new footnotes 4 and 5 to the table , respectively.

Similar to the changes made to the initial testing cutoff levels , lowering the confirmatory testing cutoff levels for amphetamine, cocaine metabolite , and methamphetamine would increase the timeframe in which these drugs can be detected in an individual

's urine after use and may also add to the deterrent effect of the rule. In addition , the proposed rule would make two clarifying changes to the table in § 26.163(b )( 1) by revising the term " Opiates" to " Opiate metabolites" and adding the abbrev i ation " (6-AM)" after 6-acetylmorphine. Finally , the column header " Drug or metabolites" in the table in § 26.163(b)(1) would be revised to "Drugs or drug metabolites

," to align with the table title. These changes would improve consistency with Section 3.4 of the 2008 HHS Guidelines and with§§ 26.133 and 26.163(a)(1).

The proposed rule would update the informat i on that each HHS-certified laboratory must include in the annual statistical summary report of test results provided to each licensee or other entity under§ 26.169(h)(3) the expanded drug testing panel in revised§§ 26.31(d)(1) and 26.405. Specifically , the proposed rule would require each HHS-certified laboratory to report , in the annual statistical summary of urinalysis testing provided to each licensee and other entity , the number of specimens reported as positive for MOMA, MDA, and MDEA. Additional conforming changes would improve the clar i ty and un i formity of the names of the drugs and 30 drug metabolites listed in § 26.169(h)(3), to include adding "(as THCA)"4 after " Marijuana metabolites," adding " (as benzoylecgonine)" after " Cocaine metabolite

," revising " 6-AM" to " 6-acetylemorphine (6-AM)," and revising " Phencyclidine" to " Phencyclidine (PCP)." Validity Testing of Adulterants at HHS-Certified Laboratories The proposed rule would revise the decision point used in the validity tests performed by HHS-certified laboratories, as described in§ 26.161(c)(3) through (c)(6) and§ 26.161(f)(5) and (f)(7), by replacing the limit of detection (LOO) with the limit of quantitation (LOQ) as the decision point for determining if a specimen contains an adulterant (i.e., adulterated test result) or the possible presence of an adulterant (i.e., invalid test result). The difference between the LOO and the LOQ for a testing assay is the ability to reliably quantify the analyte. At the LOO, the validity test must meet all HHS-certified laboratory criteria for result acceptance, except quantitation.

At the LOQ, the validity test must reliably confirm the presence of the analyte , reliably quantify the concentration of the analyte , and meet all HHS-certified laboratory criteria for result acceptance.

Use of the LOQ provides an additional donor protection on the accuracy of validity testing (i.e., in making the conclusion that results are adulterated or invalid).

The proposed changes to§ 26.161(c)(3) through (c)(6) are consistent with Section 3.5 of the 2008 HHS Guidelines, which describe 2 the validity testing criteria for the adulterants chromium (VI), halogens (e.g., bleach, iodine, fluoride), glutaraldehyde , and pyridine (pyridinium chlorochromate).

The proposed changes to§ 26.161(f)(5) and (f)(7) are consistent with the validity testing criteria in Section 3.8 of the 2008 HHS Guidelines for the same adulterants described in the previous sentence but as applied to invalid results. 4 THCA is an abbreviation for delta-9-tetrahydrocannabinol-9-carboxylic acid. 31 The NRC is not proposing to change the initial validity testing requirement in § 26.131 (b )(5) that applies to L TF testing for the possible presence of halogen. Section 26.131 (b)(5) currently permits an L TF to use a " halogen colorimetric test (halogen concentration equal to or greater than the limit of detection (LOO))." The NRC is not proposing to change the use of LOO in this instance, because L TFs already must send any specimen identified with the possible presence of an adulterant to an HHS-certified laboratory for initial and confirmatory validity testing, where the LOQ of the test would be utilized. The proposed rule would also revise§ 26.161(c)(5) and (c)(6) to permit HHS-certified laboratories to conduct confirmatory validity testing for the adulterants glutaraldehyde and pyridinium chlorochromate using " a different confirmatory method (e.g., gas chromatography/mass spectrometry (GC/MS))" instead of what is currently required , which is only "GC/MS for the confirmatory test." The proposed changes would provide additional flexibility in the confirmatory testing methods that may be used by the laboratory and would align with similar testing requirements in § 26.167( e )( 1 ), the change to § 26.153( c ), as described in the Statement of Considerations for the 2008 FFO final rule (73 FR 17091 and 17102), and would align with Section 11.19(d) of the 2008 HH~ Guidelines. Special Analyses Testing of Urine Specimens Special analyses testing is an NRC testing methodology introduced in the 2008 FFO final rule to address the circumstance where a donor consumes a large quantity of fluid just prior to providing a urine specimen for testing in the hope of diluting the concentration of any drugs and drug metabolites in the specimen below the standard testing cutoff levels aAEl-!Q_avoid detection (i.e., to produce a negative drug test result). This testing methodology is not included in the HHS Guidelines , but provides licensees and other entities with an added level of assurance that an individual w i th a dilute specimen is not attempting to hide drug use. 32 Section 26.163(a)(2) currently provides each licensee and other entity with the option to require the HHS-certified laboratory to conduct special analyses of dilute specimens (i.e., conduct confirmatory testing to the LOO for drugs and drug metabolites when the immunoassay response of the initial drug test is equal to or greater than 50 percent of the cutoff calibrator). For example , if a specimen is dilute and the initial test for marijuana metabolites measured a concentration of 25 ng/ml (the initial cutoff level for marijuana metabolites is 50 ng/ml), special analyses testing would then be performed on the specimen. Using a lower cutoff level for the testing of dilute specimens enhances the ability of licensees and other entities to identify using individuals attempting to avoid detection through the consumption of large quantities of fluid just prior to providing a specimen for testing. The proposed rule would make four changes to the special analyses testing requirements in§ 26.163(a)(2). First , the proposed rule would require all licensees and other entities to conduct special analyses testing of dilute specimens.

An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 demonstrates the effectiveness of special analyses testing because these data show that additional positive results were identified for access , random , and post-event special analyses tests. As of 2014 , 92 percent of licensees and other entities have adopted the special analyses testing policy. The proposed rule would eliminate references to the option for licensees and other entities to conduct special analyses testing of specimens with dilute validity test results that appear in §§ 26.31 (d)(1 )(ii); 26.163(a)(1) and (b )(1 ); 26.183( c), ( c)(1 ), and (d)(2)(ii)

and 26.185(9)(2) and (g)(3). These tests would instead be required. Second , the proposed rule would lower the immunoassay percentage response for initial testing in§ 26.163(a)(2)(ii) that HHS-cert i fied laboratories must use to determine if special analyses t esting is to be conducted. The proposed rule would lower the i mmunoassay 33 response from " equal to or greater than 50 percent of the cutoff calibrator" to " equal to or greater than 40 percent of the cutoff calibrator

." Use of a lower cutoff level to evaluate the immunoassay response could increase the number of specimens subject to special analyses testing and would improve the ability of licensees and other entities to identify additional drug-using individuals attempting to subvert the drug testing process. This change would not affect the drug testing assays used by HHS-certified laboratories because under the 2008 HHS Guidelines, each laboratory must already validate the accuracy of each assay to 40 percent of the cutoff calibrator.

Laboratories would need to change their administrative procedures to define the initial test result concentration that would trigger special analyses testing. Third , the proposed rule would replace the LOO with the LOQ as the confirmatory drug testing cutoff level to be used by HHS-certified laboratories when conducting special analyses testing. Currently ,§ 26.163(a)(2)(ii) requires the use of the LOO as the cutoff level for special analyses testing of dilute specimens.

The difference between the LOO and the LOQ for a drug testing assay is the ability to reliably quantify the analyte. At the LOO, the confirmatory drug test must meet all HHS-certified laboratory criteria for result acceptance except quantitation. At the LOQ, the confirmatory drug test must reliably confirm the presence of the analyte, reliably quantify the concentration of the analyte, and meet all HHS-certified laboratory criteria for result acceptance.

The LOQ provides an additional donor protection on the accuracy of special analyses test results. To receive and maintain laboratory certification by the NLCP , certified laboratories must already determine both the LOO and LOQ for each drug testing assay. Therefore , changing the decision point from the LOO to the LOQ for reporting confirmatory drug test results would not require laboratories to change the testing assays used. The NLCP also requires all HHS-certified laboratories to validate the accuracy and precision of each confirmatory drug test at or below 40 percent of the cutoff. To meet this 34 testing specification, the laboratory must establish both the LOD and the LOO below the 40 percent cutoff , which results in variability amongst laboratories on how far below the 40 percent cutoff the LOD and LOO are established

.:. Ji this is dependent , in part , on the instrumentation and testing processes used at the laboratory

1. The NRC acknowledges this variability

.:. and that _§s ome attendees at the public meetings requested a standardized level be used across all laboratories performing special analyses testing. However, this position would be contrary to the 10 CFR part 26 regulatory framework that enables licensees and other entities to use lower cutoff levels in the testing for drugs and drug metabolites , as permitted under§ 26.31(d)(3)(iii). Fourth, the proposed rule would expand the special analyses testing requirement in § 26.163(a)(2)(i) to include the testing of some specimens collected under direct observation.

Section 26.115(a) describes the exclusive grounds for performing a directly observed collection. Under the current rule, a directly observed collection may be performed when sufficient information has been obtained during the collection process or in the testing of a previous specimen to indicate a possible subversion attempt by the donor, or when an individual has a confirmed positive drug test result on a prior occasion.

As such , a directly observed collection after either of these circumstances provides additional assurance that the subsequent specimen obtained for testing came directly from the donor's body and was not altered to avoid detection of drug use. Likewise, special analyses testing would provide additional assurance that drugs and drug metabolites present in the specimen collected under direct observation from a donor would be identified , which would improve the MRO's ability to determine whether a subversion attempt was made on the initial specimen collected from the donor. For example , an initial unobserved specimen provided by a donor is determined by the collector to be out of the acceptable temperature range specified in § 26.111 (a) and tests negative for drugs , and the 35 second specimen collected under direct observation from the donor tests positive for a drug. In this example, the differences in test results from the initial and second specimen collected provides conclusive evidence to the MRO to make a subversion determination on the initial specimen provided.

Therefore, the proposed rule would revise§ 26.163(a)(2)(i) to require that special analyses testing be performed on specimens collected under§ 26.115(a)(1) through (a)(3), and (a)(5). Section 26.115(a)(1) describes the situation where a donor has presented a specimen that has been reported by an HHS-certified laboratory as adulterated, substituted , or invalid, and the MRO determines that no adequate medical explanation exists for the result and that another specimen should be collected from the donor. An analysis of the NRC's FFD program performance reports for calendar years 2011 through 2014 identified subversion attempts where the HHS-certified laboratory reported an invalid test result for the initial specimen provided by the donor , and either the donor refused to provide a second specimen under direct observation or the second specimen collected under direct observation tested positive for a drug. Use of special analyses testing on the second specimen collected would provide additional assurance that drug use would be detected , because a period of days would lapse from the point of collection of the initial specimen , testing of that specimen at a laboratory , MRO review of the test results and discussion with the donor, MRO determination that a second specimen should be collected , and finally , the donor appearance at a collection site to provide a second specimen under direct observation. Section 26.115(a)(2) describes the situation where a donor provides a specimen that falls out of the acceptable temperature range specified in § 26.111 (a). Section 26.115(a)(3) describes the situation where donor conduct during the collection process indicates an attempt to dilute , subst i tute , or adulterate the specimen. An analysis of the NRC's FFD program 36 performance reports for calendar years 2011 through 2014 demonstrates that the majority of subversion attempts are identified based on information obtained during the specimen collection process by the collector (e.g., specimen temperature) and the collection of a second specimen from the donor under direct observation. Use of special analyses testing in these two instances would provide additional assurance that drug use would be detected in the second specimen collected under direct observation, because the information from the initial collection process indicated a possible subversion attempt. Section 26.115(a)(5) addresses the situation where the MRO verifies that a specimen is positive, adulterated , or substituted, and the donor requests that a retest of the specimen be performed at a second HHS-certified laboratory, but the specimen is not available for testing. As a result , the confirmed test result from the initial testing laboratory must be cancelled by the MRO because the donor was not afforded the opportunity to verify the test results through additional testing at a second HHS-certified laboratory.

Use of special analyses testing in this instance would provide additional assurance for the same reason described for specimens collected under§ 26.115(a)(1

). The proposed change to require special analyses testing of specimens collected under direct observation would require licensees and other entities to establish an approach for the licensee or other entity to use when notifying a laboratory that special analyses testing is required for a specimen.

Alternative Specimen Collection Sites Sections 26.4(e)(6)(iv) and 26.31(b)(2) include the statement that " licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR Part 40 , 'Procedures for Department of Transportation Workplace Drug and Alcohol Testing Programs' (65 FR 41944; August 9 , 2001)." Section 26.415(c) also includes a 37 statement that licensees and other entities need not audit "the specimen collection and alcohol testing services 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)." The proposed rule would eliminate the Federal Register citation from each part 26 section because the DOT final rule found on page 41944 in the August 9 , 2001, edition of the Federal Register no longer represents the current version of 49 CFR part 40. The intent of these provisions was to provide licensees and other entities with flexibility to utilize collection sites that meet the DOT specimen collection requirements in 49 CFR part 40. Listing the specific Federal Register notice of the applicable DOT final rule is not necessary because the existing requirements in§§ 26.4(e)(6)(iv), 26.31 (b)(2), 26.405(e), and 26.415(c) already specify that the local hospital or other organization must meet the requirements in 49 CFR part 40. Specimen Collection Procedures The proposed rule would make a number of revisions to the specimen collection procedures in 10 CFR part 26. Specifically, the proposed rule would: 1) clarify and enhance the instructions on conducting an observed collection, 2) permit the use of mirrors to assist in . performing directly observed collections , 3) allow FFD program personnel to observe a donor who is in the hydration process following the donor's inability to provide a specimen of adequate volume, and 4) clarify urine specimen quantity and acceptability provisions.

The revisions would be made to improve the clarity, consistency, and flexibility of the collection procedures and to align more closely with the 2008 HHS Guidelines. Sections 26.115( e ), (f), and (f)( 1) through (f)(3) would be revised to improve the clarity of instruction on conducting a directly observed specimen collection, which would improve consistency with Sections 4.4(a) and 8.9 of the 2008 HHS Guidelines.

38 The proposed rule would remove the first sentence in § 26.115(f), which states, "If someone other than the collector is to observe the collection , the collector shall instruct the observer to follow the procedures in this paragraph." The NRC proposes to add the following sentence to the end of the existing requirements in§ 26.115(e): "If the observer is not a trained collector, the collector shall, in the presence of the donor , instruct the observer on the collection procedures in paragraph (f)." The proposed change would improve the clarity of the existing requirements and ensure that the donor is informed that an individual other than the collector is to observe the specimen provision and understands the procedures that must be followed to complete the specimen collection. The proposed change also incorporates feedback received at the October 11, 2011 , public meeting, at which a participant suggested using the phrase "who has received instruction" instead of the phrase " who has received training," when referring to the i nformation that is provided to a same-gender observer by the collector.

" Training" implies a formal process rather than providing oral or written instructions, which is a more accurate description of the information that the collector would convey to a same-gender observer. The NRC agrees with this comment. The collector would only be required to give the same-gender observer instruction, rather than formal training.

In § 26.115(f)(2), the proposed rule would add the parenthetical statement

"(a mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room, stall, or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted)" to the end of the existing requirement.

This proposed change also incorporates stakeholder feedback at the public meeting on October 11, 2011 , at which the NRC proposed to prohibit the use of mirrors and video cameras to aid an observer in conducting a directly observed specimen collection , to align with Section 8.9(b) of the 2008 HHS Guidelines.

Several industry participants commented 39 that mirrors are currently used at some collection facilities , where the configuration of the stall does not provide adequate space for the collector to directly observe the provision of a specimen from the donor's body into the specimen container.

These participants suggested that if the NRC prohibited the use of a mirror to aid in the direct observation process, physical configuration changes at some collection sites would be needed. Based on subsequent licensee and NRC inspector feedback, the NRC has concluded that the observed collection process in § 26.115(f){1) continues to ensure that subversion paraphernalia would be identified prior to the provision of a specimen during the observed collection process and that the use of reflective mirrors ... (i.e., reflective and not two-way mirrors....) would be acceptable. As required by § 26.115(f)( 1 ), prior to conducting the directly observed collection, the donor already must adjust his or her clothing to expose the area between his or her waist and knees. This step ensures that no materials to subvert the testing process (e.g.,£ prosthetic device, a container of synthetic urine, an ampule of oxidizing chemical, synthetic OOR&. or other subversion paraphernalia) are concealed on the donor's body and could be used during the specimen collection.

Subsequent to this step , the observer would then watch urine flow from the donor's body into the collection cup. To accomplish this, the collector (or gender observer) must be in close proximity (in the stall or room where the specimen is provided) to meet this observation requirement.

The use of a reflective mirror only aids in this assurance by preventing the donor's body or the configuration of the stall or room from obstructing the collector's view of urine flowing from the donor's body directly i nto the specimen collection container.

By observing the area where the urine leaves the body , the direct observation process ensures that the specimen provided is from the donor and ensures the integrity of the specimen collection process. As a result , the NRC is proposing to revise § 26.115(f)(2) to permit the use of reflect i ve mirrors. 40 The NRC also proposes to revise § 26.115(f)(2) to prohibit the use of video cameras to assist in visualizing the provision of a specimen under direct observation.

The NRC does not consider a video camera to be an acceptable means of providing direct observation, in part, because the conversion of visible light to an electronic format, through a video camera, is not a direct observation

.* The use of a video camera for direct observation would be inconsistent with the intent of the rule because the collector or observer would not be in the room or stall with the donor. Further, a video feed is an incomplete source of information because it may not detail the physiological characteristics associated with a subversion attempt and also cannot guarantee the privacy of the donor beyond the individual conducting the observation.

During the public meeting on October 11, 2011, one participa~t requested that the NRC consider eliminating the requirement in § 26.115(f)( 1) that the donor adjust his or her clothing during the observed collection process to expose the area of the donor's body from the waist to the knees. The NRC considered this request but is not proposing to eliminate this provision for three reasons. First, the purpose of directly observing the provision of a specimen is to ensure that the drug testing process is not being subverted. The NRC's collection procedure requires the donor to remove his or her clothing between the waist and knees so that the collector can identify any paraphernalia on the individual's body that may be used to subvert the testing process J... (for examplesuch as , a prosthetic device, a container of synthetic urine, or ampule of an oxidizing chemical~. Secondly , materials used to subvert a drug test are easily available for purchase, and licensees and other entities have reported in annual performance reports required by§ 26. 717 that donors subversion attempts have been identified in attempting to subvert the collection process during the directly observed collection process (e.g., concealed paraphernalia has been discovered). Finally , the prevalence of subversion attempts 41 demonstrates that individuals are actively attempting to thwart the drug testing process by specimen adulteration, substitution, and dilution.

In § 26.115(f)(3), the proposed rule would replace the phrase " If the observer is not the collector, the observer may not take the collection container from the donor, but shall observe the specimen as the donor takes it to the collector," with the phrase "If the observer is not the collector, the observer may not touch or handle the collection container, but shall maintain visual contact with the specimen until the donor hands the collection container to the collector." The proposed rule changes would improve the clarity of the existing requirement by more closely aligning with Sections 8.9(c) and (d)(2) of the 2008 HHS Guidelines and by using terminology consistent with § 26.113(b )(3). The proposed rule would add§ 26.4(9)(6) and would revise§ 26.109(b)(1) to improve the efficiency of FFD programs by providing licensees and other entities with additional flexibility in the personnel who may monitor a donor during the hydration process. which is-fhe,, the 3-hour period of time that is initiated after a donor is unable to provide an acceptable quantity of urine during the initial specimen collection attempt, during which fluid is provided to assist the donor in providing a specimen of adequate volume-). In addition to the specimen collector that initiated the specimen collection process with the donor, a staff member designated as FFD program personnel in § 26.4(g) would be allowed to monitor the donor during the hydration process in place of the original collector. All FFD program personnel must meet honesty and integrity requirements in§ 26.31(b). FFD program personnel also have familiarity with the collection facility, specimen collectors, and 10 CFR part 26 requirements sufficient to monitor the donor during the hydration process. The additional flexibility of monitoring provided by the rule change would enable the collector, who initiated the collection process with a donor, to complete additional specimen collections with other donors while the initial donor hydrates-aRtl 42 is monitored by another staff member designated as FFD program personnel.

Another specimen collector, who meets the requirements in § 26.85(a), could also monitor the donor in the hydration process. The proposed change could reduce the regulatory burden on FFD programs by affording licensees and other entities with-additional staffing options to better manage the collection process , while maintaining appropriate oversight of the collection process by persons of known integrity. If a hydration monitor or another collector is used, the original collector would be required to note the name of the individual on the Federal CCF and the hydration monitor or second collector then would maintain control of the Federal CCF during the observation process (e.g., to document the time and volume of fluid provided to the donor, to note any unusual donor behavior, and to verify that the donor is provided with 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br /> to provide a specimen). In addition, to improve the clarity of§ 26.109 , the NRC is also proposing that the last sentence of§ 26.109(b )(1 }, " The collector shall provide the donor with a separate collection container for each successive specimen ," would become the new first sentence of § 26.109(b )(2). Section 26.109{b )( 1) describes the procedures for providing fluid to a donor who is in the hydration process , and includes the instruction to the collector to provide a separate collection container for each successive specimen provided by the donor. The instruction to provide a separate collection container for each specimen is more appropriate in § 26.109(b )(2), which describes the provision of subsequent specimens once a donor is in the hydration process. The proposed rule would revise§ 26.89(d) in three ways. First,§ 26.89(d) would be revised to clarify that a collector shall conduct only one collection procedure at any given time , except in the instance when another collector who meets the requirements in§ 26.85(a) or a hydration monitor is observing the donor during the hydration process, as permitted by the proposed change to§ 26.109(b)(1

). Second ,§ 26.89(d) would be revised to more precisely 43 describe the actions taken by the collector when sealing the collection container with evident tape and completing the Federal CCF to end the collection process. The phrase the urine specimen container has been sealed and initialed , the chain of custody form has been executed , and the donor has departed the collection site" would be replaced with the phrase " the urine specimen container has been sealed with tamper-evident tape, the seal has been dated and initialed, and the Federal CCF has been completed." Third , the phrase 11 or if a refusal to test has been determined under§ 26.107(d)" would be added to§ 26.89(d) to more accurately describe when the collection process has been completed if a refusal to test has been determined. The three changes would improve the clarity of the existing collection requirements , correct an editorial error in the*name of the form that is used to document the specimen collection, and include a reference to a refusal to test as another circumstance when the collection process is complete.

The proposed rule would revise § 26.107 , " Collecting a urine specimen ," in four ways related to how the donor is observed. First, the proposed rule would redesignate paragraph (b) as paragraph (b)(1). Second , the phrase", except as provided in§ 26.109(b)(1)," would be added in the first sentence after "The collector shall pay careful attention to the donor during the entire collection process." This revision is necessary because of the proposed rule change to permit an individual other than the original specimen collector to monitor a donor in the hydration process; as a result , the original collector may not be present with the donor during the entire collection process. Third,§ 26.107(b)(1) would be revised to replace the phrase " to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine is in plain view or an attempt to bring an adulterant or urine substitute into the private area used for urination)" with the phrase " to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain v i ew; 44 attempting to bring an adulterant , urine substitute, temperature measurement device, and/or heating element into the room, stall , or private area used for urination)." The proposed changes would provide additional examples of subversion attempt actions that have been reported by licensees and other entities in the annual information reports required by§ 26. 719 , " Reporting requirements

." More accurate examples of subversion attempts in the regulatory text provide additional clarity on donor actions that may be considered a subversion attempt. Lastly, the phrase " the collector shall document the conduct" in proposed § 26.107(b )( 1) would be revised to " the collector shall document a description of the conduct," which would improve the clarity of the description of the existing regulatory requirement.

Section 26.107(b )(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process, this individual would immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process , such as ~the donor leav eiogs the collection site_Q[, donor refus ioges-_t o follow directions

1. This rule change would be necessary because this activity would not be the responsibility of the specimen collector who initiated the collection process; and the collector must be informed of any unacceptable donor behavior so that appropriate action may be taken. The proposed rule would revise§ 26.89(c) to correct an editorial error in the instructions that a collector must provide to the donor regarding refusing to cooperate with the testing process. Currently , the word " adulterated" is used twice in the phrase " adulterated , diluted , or adulterated the specimen ," which describes the situation where a donor adm i ts to subverting the testing process. The phrase would be revised to " adulterated, diluted , or substituted the specimen." The proposed rule would revise § 26.117 , " Preparing urine specimens for storage and shipping ," in th r ee ways. First , t he proposed rule would revise§ 26.117(a) to add t he phrase 45 "Once the collector is presented with the specimen from the donor" at the beginning of the first sentence to clarify when the collector would begin to keep the donor's "urine specimen(s) in view at all times." This revision would improve the clarity of an existing activity in the collection process. For example , the collector would not be able to keep the donor's urine specimen in view at all times when the donor is in the room, stall, or private area used for urination, as described in § 26.107(a). Second , two editorial errors would also be corrected in § 26.11 ?(f): the term " chain-of-custody forms" would be replaced with the term " Federal CCFs," and the phrase " or the licensee's testing facility" would be replaced with the phrase " or to the licensee testing facility." Third , the proposed rule would revise § 26.11 ?(g) to add the phrase " except as provided in § 26.109(b)(1

)(ii), for the Federal CCF," to describe an instance when the custody documents would not be under the control of the collector.

This change is needed because the proposed rule change to § 26.109(b )( 1 )(ii) would permit another collector or hydration monitor to observe the donor during the hydration process and to maintain the Federal CCF during that time period. With regard to urine specimen acceptability, the proposed rule would revise the term " altered ," as used in § 26.111 (a) and ( c) to clarify that the term means that the collector has determined that a specimen may have been adulterated and/or diluted. This determination by a collector is not equivalent to the determination that a specimen is an adulterated specimen as defined in § 26.5 , which is a specimen testing determination made by an HHS-certified laboratory.

The proposed rule would correct an editorial error in§ 26.111 (a) associated with the minimum volume requirement for a urine specimen.

Specifically , the phrase " but greater than 15 ml" would be replaced with " but equal to or greater than 15 ml." This change conforms with the existing minimum specimen volume requirements in §§ 26.109(b )( 4) and 26.111 (b) and ( d). 46 Collector Actions Following a Refusal to Test The proposed rule would add § 26.107( d) and revise §§ 26.111 ( c) and ( e ), and 26.115(9), to more explicitly describe the actions that a collector must take when a refusal to test is determined during the specimen collection process, including the retention or disposal of any specimen(s) provided by the donor. Section 26.107( d) would be added to state that , if the collector determines a refusal to test during the specimen collection process, the collector shall: 1) inform the donor that a refusal to test has been determined;

2) terminate the collection process; 3) document a description of the refusal to test on the Federal CCF; 4) discard any urine specimen(s) provided by the donor, unless provided for a post-event test in§ 26.31(c)(3)

and 5) immediately inform the FFD program manager of the refusal to test. The majority of these proposed changes are consistent with existing collector practice. However , the proposed change to discard any urine specimens, except if collected for a post-event test , would be a new requirement to improve the uniformity of licensee and other entity actions taken once a refusal to test had been determined. The NRC is aware of instances in which a licensee or other entity would conduct specimen testing , even though a refusal to test had already been determined at the collection site. This change would address this inconsistency. The proposed revisions to§ 26.107(d) would help ensure that if a donor refuses to cooperate with the collection process , uniform action is taken , which would improve makethe consistency and effectiveness of 10 CFR part 26 consistent with Section 8.12 of the 2008 HHS Guidelines and improve its effectiveness. The proposed change to retain and test any specimen collected for a post-event test in § 26.31(c)(3) would help to inform licensee root cause determinations , as required by other parts of the NRC's regulations , such as§§ 20.2203(b), 50.73(b), and 70.50(c). Although a 47

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refusal to test determination at the collection site subsequent to a specimen being provided for a post-event test is a very rare occurrence, a regulatory framework is needed to enable the testing of an individual

's urine (or other specimen matrix such as oral fluid) to assist in determining whether the individual who committed or contributed to the event may have been impaired from the use of alcohol , an illegal drug , or prescription or over-the-counter medication.

This assessment (which is informed by the requirements in §§ 26.185 , " Determining a fitness-for-duty policy violation" and 26.189 , " Determination of fitness") is very important because post-event testing is conducted, in part, in response to the occurrence of a very significant event such as , but not limited to: 1) a death , 2) a significant illness or personal injury , 3) a radiation exposure or release of radioactivity in excess of regulatory limits, or 4) an actual or potential substantial degradation of the level of safety of the plant. Section 26.111(c) would be revised to remove the word " designated" from the phrase " designated FFD program manager." This proposed change conforms with the existing terminology used in §§ 26.105(b ), 26.109(b )(3), 26.111 ( c), 26.11 S(a), (b ), and (h), and 26.139(b). Section 26.111 ( e) specifies that " as much of the suspect specimen as possible must be preserved." The proposed rule would add the clarifying phrase "except under the conditions described in § 26.107(d)(4)," which would describeto reference the conditions when a collector is to discard any urine specimen(s) collected.

This change aligns with the proposed changes to § 26.107( d). Some participants at the public meeting on October 11 , 2011 , requested that the NRC consider eliminating

§ 26.111 (f) because they believe this particular requirement is unnecessary.

Section 26.111 (f) defines the criteria for an acceptable urine specimen as free from apparent contaminants , of at least 30 ml i n quant i ty , and within the acceptable 48 temperature range. However, this requirement does not aid in the implementation of 10 CFR part 26 and is not used in the NRC's drug testing requirements.

The participants stated that this provision is unnecessary because other sections in 10 CFR part 26 require specimens that do not meet the criteria in § 26.111 (f) to be sent to an HHS-certified laboratory for testing. The NRC agrees that this requirement is unnecessary because other sections in the rule already provide explicit detail as to the determination of whether a specimen is valid or invalid, as well as the specific steps required if either determination is made. Section 26.109 , "Urine specimen quantity," contains provisions regarding urine specimen quantity, § 26.111 (a) contains provisions regarding specimen temperature, and § 26.111 ( d) requires that any specimen a collector suspects has been adulterated, diluted, substituted , or that is collected under direct observation, must be sent to an HHS-certified laboratory for initial and, if necessary, confirmatory testing. Therefore , the NRC is proposing to remove § 26.111 (f) to improve the clarity of 10 CFR part 26. Section 26.115(9) states that if-a donor's declin ationes to allow a directly observed collection , then that action is an act to subvert the testing process. The proposed rule would include a new requirement that in this instance, "the collector shall follow the procedures in § 26.107(d)." This proposed requirement describes the actions that the collector must take when a refusal to test has been determined during the specimen collection process. The NRC also received a public comment regarding the retention or disposal of a urine specimen.

The commenter recommended that the initially collected specimen be retained, unless the MRO or FFD program manager determined that a directly observed collection was necessary and the donor refused to comply._~ which-+ j he NRC has determined that the commenter was ref.erringinterpreted as a reference to§ 26.111 ( c) of the regulations.

Section 26.111 ( c) requires the collector to contact the FFD program manager if there is reason 49 to believe that a donor may have attempted to adulterate , dilute, or substitute a specimen based on the physical characteristics of a specimen (e.g., temperature, color , odor , presence of a precipitant) or other observations made during the collection. The FFD program manager may consult with the MRO to determine if the donor has attempted to subvert the testing process , and the FFD program manager or the MRO may require the donor to provide a second specimen, as soon as possible, and under direct observation.

This section also requires the collector to inform the donor that he or she may volunteer to submit a second specimen under direct observation. The NRC has determined that there is no regulatory necessity to maintain any specimen provided by a donor, who has subsequently refused to cooperate o r otherwise subverted the testing process , un l ess this specimen was for a post-event test , as required by § 26.31(c)(3). This approach is justified because upon such a determination , the donor who refuses to test is permanently denied authorization to have the types of access or perform the activities described in paragraphs (a) through (d) of§ 26.4 , " FFD program applicability to categories of individuals

," regardless of the outcome of the drug test. Therefore , the NRC is not proposing a rule change based on the public comment. However, even though the individual would be subject to § 26.75 sanctions, drug and alcohol testing results from persons who caused or contributed to an event can inform a licensee's root or apparent cause determination required by other parts of the NRC's regulations , such as §§ 20.2203(b), 50.73(b), and 70.50(c). The importance of this specimen testing for significant events 1 Nas addressed previously.

Blind Performance Test Sample Lot In-Service Requirement The proposed rule would revise§ 26.168(h)(1 ), which currently requires blind performance test sample (BPTS) suppliers to place a sample lot in service for no more than 6 months. Feedback received from industry and BPTS suppliers i n dicates that sample lo t s can r ema i n viable for much l onger than 6 months (e.g., 2 years). Further , Sec t ion 10.2 of the 2008 50 HHS Guidelines does not impose an in-service limit on BPTS lots. The NRC is proposing to eliminate the 6 month use limit and to enable the BPTS supplier , based on laboratory testing data on lot stability , to establish a specified shelf-life for each BPTS sample lot. Allow i ng the BPTS supplier to determine the expiration date .. f instead of the NRC requiring a uniform shelf life...-) would improve the effectiveness of 10 CFR part 26 , reduce burden on BPTS suppliers and entities implementing 10 CFR part 26 requirements , and align with the 2008 HHS Guidelines. Furthermore , if a BPTS is no longer stable and unexpected test results were reported by the laboratory inconsistent with the formulation

,§ 26.719(c) already requires the licensee or other entity to report to the NRC the testing error and the results of the investigation. The § 26. 719( c) reporting requirement ensures that the NRC receives timely information on any BPTS formulation irregularities. HHS-Certified Laboratory Personnel Qualifications and Responsibilities The proposed rule would remove§ 26.155 , " Laboratory personnel ," which re-states the qualifications and responsibilities of HHS-certified laboratory personnel (e.g., Responsible Person, Certifying Scientist) included in the HHS Guidelines. The NRC finds that it is unnecessary to restate these HHS Guidelines requirements in 10 CFR part 26 because licensees and other entities are required to use HHS-certified laboratories to conduct drug and validity testing in § 26.153(a).

Each laboratory is certified and then inspected every 6 months by the NLCP , which provides assurance that laboratory personnel are appropriately trained , qualified, and meet acceptable academic and technical requirements.

The proposed change would reduce the potential for dual regulation of HHS-certified laboratories because each laboratory is also annually inspected by the licensee or other entity as required in § 26.41 (c). Eliminating these redundant requirements would improve the regulatory efficiency of 10 CFR part 26 by reducing unnecessary regulatory oversight.

51 A conforming change based on the removal of§ 26.155 would be to eliminate the reference to § 26.155 in § 26.8 , " Information collection requirements

0MB approval," which lists the information collection requirements in 10 CFR part 26 that were approved by the Office of Management and Budget (0MB). HHS-Certified Laboratory Procedures The proposed rule would remove § 26.157(b) through ( e ), which re-state the laboratory procedures requirements included in the HHS Guidelines.

Section 26.157, " Procedures

," describes the written procedures that HHS-certified laboratories must develop, implement, and maintain.

The NRC finds that it is unnecessary to restate these HHS Guidelines requirements in 10 CFR part 26 because licensees and other entities are required to use HHS-certified laboratories to conduct drug and validity testing in § 26.153(a). As discussed for the proposed changes to § 26.155, each HHS-certified laboratory is certified and then inspected on a periodic basis by the NLCP, which provides assurance that the procedures requirements in the HHS Guidelines are developed, implemented, and maintained by the laboratory.

The proposed change would reduce the potential for dual regulation of HHS-certified laboratories with respect to maintaining a duplicative set of laboratory procedures already required to be maintained by the HHS Guidelines and reviewed and evaluated by the NLCP. The proposed rule would revise the requirement in § 26.157(a) to replace the phrase that each HHS-certified laboratory must " develop , implement , and maintain clear and documented procedures for accession , receipt , shipment , and testing of urine specimens" with " develop , implement , and maintain procedures specific to this part that document the accession, receipt , shipment , and testing of specimens." The proposed changes would: 1) ensure that each laboratory would continue to maintain procedures specific to 10 CFR part 26, such as for special analyses testing in§ 26.163(a) and the use of more stringent testing cutoff levels and/or 52 the testing of additional substances permitted in§ 26.31(d)(3)

2) remove the word " urine" from the phrase " testing of urine specimens ," to provide additional flexibility , should the testing of additional specimen matrices (e.g., hair , oral fluids) be allowed by future changes to the HHS Guidelines and subsequent amendments to 10 CFR part 26 requirements; and 3) replace " clear and well-documented" with " documented" laboratory procedures to better align with the terminology in§ 26.27(c) and the 2008 HHS Guidelines. The proposed changes to§ 26.157(a) would enhance regulatory efficiency and reduce burden by clarifying that each laboratory must maintain procedures specific only to 10 CFR part 26 testing. Quality Control Samples for Validity and Drug Testing Section 26.137( e)(6) lists the specifications for the quality control samples to be i ncluded in each analytical run of initial drug testing performed at an LTF, and§ 26.167(d)(3) and (e) list the quality control sample specifications to be included in each analytical run of initial and confirmatory drug tests performed at an HHS-certified laboratory , respectively.

The proposed rule would make a number of conforming changes to these quality control sample requirements to improve the clarity of 10 CFR part 26 and its consistency with Sections 11.12 , 11.14 , and 11.15(a)(1) of the 2008 HHS Guidelines. The proposed rule would replace the word " drugs" i n the first sentence of § 26.137( e )(6) and the phrase " drug and metabolite" in the second sentence of§ 26.137(e)(6) with " drugs and drug metabolites" and " drug and drug metabolite

," respect i vely. The phrases " drug(s) or drug metabolite(s

)" in § 26.137(e)(6)(ii) and (e)(6)(iii) and " a drug(s) or drug metabolite(s)" in § 26.167(d)(3)(ii), (d)(3)(iii), and (e)(3)(iii) would be replaced with the phrase " the drug or drug metabolite

." Similarly , the phrase " no drug" would be expanded to " no drug or drug metabolite" 53 in§ 26.167(e)(3)(i), and the phrase " no drugs or drug metabolites" would be revised to " no drug or drug metabolite" in §§ 26.137(e){6){i) and 26.167(d)(3)(i). The proposed rule would remove the parenthetical phrase " (i.e., negative urine samples)" from §§ 26.137(e)(6)(i) and 26.167(d)(3)(i) and (e )(3)(i). Each of those requirements already specifies that the quality control sample is to contain no drug or drug metabolite, so the parenthetical is redundant.

The phrase " targeted at 25 percent below the cutoff' would be replaced in the proposed rule with the phrase " targeted at 75 percent of the cutoff' in §§ 26.137( e )(6)(iii) and 26.167( d)(3)(iii). The term " sample(s)" would be replaced in the proposed rule with the phrase " at least one control" in§§ 26.137(e)(6)(i) and 26.167(d)(3)(i) and (e)(3)(i). Similarly , the phrase " at least one calibrator or control that is" would be replaced in the proposed rule with the phrase "at least one control" in§ 26.167(e)(3)(iv).

The parenthetical statement

" (i.e., calibrators and controls)" would be added after the phrase " quality control samples" in§§ 26.137(e)(6) and 26.167(d)(4), and a conforming change would be made in§ 26.167(e)(2) to the phrase " calibrators and controls" by replacing it with the phrase " quality control samples (i.e., calibrators and controls)." The phrase "Positive calibrator(s) and control(s) with a drug(s) or drug metabolite(s

)" in § 26.167(e)(3)(ii) would be replaced in the proposed rule with the phrase " A calibrator with its drug concentration at the cutoff." The proposed rule would replace the phrase " A minimum of 10 percent of all specimens in each analytical run" i n § 26.137( e )(6) with the phrase " A minimum of 10 percent of the total specimens in each analytical run ," to more clearly describe how to determine the number of quality control samples to include in each analytical run of initial drug testing perfo r med a t an 54 L TF. Conforming changes would be made in§ 26.167(e)(2) to the quality control samples that are to be included in each analytical run of confirmatory drug tests performed at an certified laboratory , by replacing the phrase " At least 10 percent of the samples in each analytical run of specimens" with the phrase "A minimum of 10 percent of the total specimens in each analytical run." The proposed change to§ 26.167(e)(2) is consistent with the existing terminology used in the quality control sample requirement for initial drug testing in § 26.167(d)(4).

Section 26.167(f)(3) would be revised to make an editorial correction to the phrase " a statement by the laboratory

's responsible person" by capitalizing the " r" and the " p" in the position title, so that it reads.as follows: " Responsible Person." The proposed rule would also correct two of three inaccuracies described in an NRC enforcement guidance memorandum (EGM-09-003, dated March 31, 2009) that pertain to the L TF quality control sample requirements for initial validity testing in § 26.137(d)(5) and for initial drug testing in § 26.137(e)(6)(v). The third inaccuracy , incorrectly using the term " laboratory analysts" instead of " licensee testing facility technicians

," has already been addressed i n a 10 CFR part 26 final rule correcting amendment , which was published in the Federal Register on August 3 , 2009 (74 FR 38326). The first inaccuracy pertains to the requ i rements in§ 26.137(d)(5) and (e)(6)(v), which require that at least one quality control specimen in each analytical run must appear as a " donor specimen" instead of as a " normal specimen" to the LTF techn i cian. To meet this requirement , a different individual would be required to prepare the quality control sample to ensure that the L TF technician that is conducting the specimen testing would be unaware of the origin of the sample. The current rule does not require that different individuals prepare quality control samples and conduct specimen testing. Without EGM-09-003 , § 26.137(d)(5) and (e)(6)(v) 55 would place an unnecessary burden on licensees and other entities because additional L TF procedural changes would be necessary, including the use of an additional qualified person, either to prepare quality control samples or to conduct specimen testing. The majority of L TFs use a single L TF technician to prepare quality control samples and to perform specimen testing, which is consistent with the intent of the current rule. To correct this inaccuracy and to address the currently applicable enforcement discretion, the proposed rule would replace the phrase "donor specimen" with the phrase "normal specimen" in § 26.137(d)(5) and (e)(6)(v). The second inaccuracy pertains to the requirement in§ 26.137(e)(6)(v) that "at least one positive control" is to be included in each analytical run of initial drug testing of specimens at an L TF. The intent of this requirement is to verify the custody and control procedures and confirm the accuracy of initial drug testing performed at an L TF, neither of which require the use of only a positive quality control sample. Since§ 26.137(e)(6)(ii) and (e)(6)(iii) already specify the positive quality control samples to be included in each analytical run, the proposed rule would replace the phrase " at least one positive control, certified to be positive by an HHS-certified laboratory" with the phrase " at least one quality control sample" in § 26.137( e )(6)(v). The NRC would rescind EGM-09-003 if the proposed rule changes correcting these inaccuracies is-are finalized.

Additional MRO Review for Invalid Specimens with pH of 9. 0 to 9. 5 Section 26.185(f) describes the process that an MRO is to use to review invalid specimen test results. The proposed rule would redesignate paragraph (f)(3) as paragraph (f)(4) and would add a new paragraph (f)(3) to§ 26.185, to align the MRO review process for invalid specimen test results with Section 13.4(f) of the 2008 HHS Guidelines. Specifically , if a donor did not provide an acceptable medical explanation to the MRO for a pH value in the range of 9.0 to 9.5, the MRO would then have to consider if elapsed time and/or high temperature 56 might have caused the test result. This change is being proposed because of research that demonstrated that exposing a urine specimen to high temperature and/or an extended delay in specimen testing from the time of collection may result in a pH in the range of 9.0 to 9.5 (Cook, et al., 2007). The 2008 HHS Guidelines addressed this topic in Section 13.4(f). I n the proposed rule, i f the MRO obtains sufficient information from the licensee or other entity, collection site, L TF, or HHS-certified laboratory regarding elapsed time and/or temperature conditions at specimen collection , receipt, transportation, or storage to conclude that an acceptable technical explanation exists for the invalid test result due to pH, then the MRO would direct the licensee or other entity to collect a second urine specimen from the donor, as soon as reasonably practicable.

The second specimen would not be collected under direct observation because sufficient evidence was obtained to conclude that donor action likely was not the cause of the invalid test result. This proposed new step to consider technical explanations for a discrepant pH result would provide an additional protection to the donor and limit the instances in which a second collection under direct observation is necessary (i.e., only for invalid specimen test results where no legitimate medical or technical explanation has been determined by the MRO). Based on feedback received during the October 11, 2011, public meeting, the NRC has chosen not to propose adding detailed instructions in 10 CFR part 26 on how the MRO is to interpret time and temperature information with respect to specimen pH. Meeting participants commented that the draft instructions presented by the NRC at the public meeting were too prescriptive and unnecessary and that the MRO should be provided with flexibility in making this determination.

The NRC agreed and instead is proposing to include guidance on the methods an MRO could use to review invalid test results reported in § 26.185(f)(3) in draft regulatory guide (DG) 5040 , "Urine Specimen Collection and Test Result Review under 10 CFR Part 26 , 57 Fitness for Duty Programs." This draft guidance is being issued concurrently for comment with this proposed rule. The NRC also discussed at the October 11 , 2011, public meeting the potential to change § 26.131 (b )(2) to assist in the documentation of time and/or temperature information for invalid test results , based on a pH of 9.0 or greater obtained at an L TF. However, participants opposed these documentation requirements because they would be burdensome to implement.

The NRC agreed and instead is proposing to include in DG-5040 the methods that L TF staff may use to document information to support the MRO review of invalid test results in § 26.185(f)(3).

Donor Request for Specimen Retesting or Bottle B Testing Section 26.165(b )(2) instructs the MRO to "i nform the donor that he or she may , within 3 business days of notification by the MRO of the confirmed positive, adulterated, or substituted test result, request the retesting of an aliquot of the single specimen or the testing of the Bottle B split specimen." The proposed rule would include a new requirement in§ 26.165(b)(2) for the MRO to document in his or her records when (i.e., the date and time~ a request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.

Documenting when a donor initiated the request for testing would ensure that a record was maintained to demonstrate that the donor had made the request within the required 3 business days timeframe. This rule change would document an existing practice already conducted by of MROs when receiving such a request because , to ensure that notification is received within 3 business days , a method to record the date and time of receipt of the donor's request for testing must already be in place. Section 26.165(b)(3) requires the donor to provide his or her permission for the retesting of an aliquot of the single specimen or the testing of Bottle B and states that " Neither the 58 licensee , MRO, NRC, nor any other entity may order retesting of the single specimen or testing of the specimen in Bottle B without the donor's written permission, except as permitted in § 26.185(1)." The proposed rule would revise§ 26.165(b)(3) to state that " No entity, other than the MRO as permitted in§ 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's written permission

." The proposed change would address an inconsistency in the current rule because § 26.165(b )(2) already states that the " donor's request may be orally or in writing." At present , even though the MRO may have received an oral request from the donor to proceed with the retesting of an aliquot of a single specimen or to test the Bottle B split specimen, some licensees are interpreting the current rule to require that the MRO must receive written permission from the donor before initiating the retesting of a specimen.

These proposed changes to § 26.165(b )(2) and (b )(3) would improve the consistency of 10 CFR part 26 with Section 14.1 (b) of the 2008 HHS Guidelines and would enhance due process by ensuring that the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen could proceed as quickly as possible.

Collection of a Second Specimen under Direct Observation when Bottle B or an Aliquot of a Single Specimen Is Not Available for Testing Section 26.115(a) lists the exclusive grounds for collecting a urine specimen under direct observation.

However , the list does not include an existing requirement in § 26.165(f)(2) in which an observed collection is required when a donor requests a retest and either Bottle B or the single specimen is not available, due to circumstances outside of the donor's control. The proposed rule would correct this omission by including a new paragraph (a)(5) to reference the direct observation requirement i n§ 26.165(f)(2).

The proposed rule would also make an 59 editorial correction to improve the clarity of an existing requirement in the first sentence of § 26.11 S(a), by including a comma after the word " subpart" in the phrase " directed by this subpart or the MRO or FFD program manager." Section 26.165(f)(2) requires MRO action for a positive drug test result or an adulterated or substituted validity test result, when the Bottle B of a split specimen or an aliquot of a single specimen is not available for testing at the donor's request. In this instance, the MRO is required to cancel the initial test result and inform the licensee or other entity that a second specimen must be collected under direct observation

" as soon as reasonably practical." Section 14.1 ( c) of the 2008 HHS Guidelines , for this same circumstance, states that no advanced notice is to be provided to the donor regarding the second specimen collection until immediately before the collection is to commence.

The proposed rule would revise the requirement in § 26.165(f)(2) to specify that no prior notice shall be given to a donor until immediately before the collection.

Clarifying the procedure to follow in this circumstance would improve the effectiveness of licensees' or other entities' testing programs to detect illegal drug use and/or the misuse of legal drugs and would align 10 CFR part 26 with the 2008 HHS Guidelines.

The proposed rule would also revise § 26.165(f)(2) to state that the MRO is to report a cancelled test result to the licensee or other entity. The process in § 26.165(f)(2) already states that the licensee or other entity may not impose any sanctions on the donor for a cancelled test result. This revision clarifies the existing action that the MRO must take to report the results of the testing of a donor's specimen to the licensee or other entity. Subsequent action by the licensee or other entity cannot be taken until the MRO provides the test result information for a donor's specimen. The revision would also state that the licensee or other entity must continue the administrative withdrawal of an individual's FFD authorization until the test results from the 60 second specimen collection are determined.

Continuing to administratively withdraw an individual

's authorization would be consistent with§ 26.165(f)(1

), which requires the licensee or other entity to administratively withdraw an individual

's FFD authorization on the basis of the first confirmed positive, adulterated , or substituted test result until the results of a donor-requested Bottle B split specimen test or single specimen retest a r e available and have been reviewed by the MRO. A participant at the October 11 , 2011 , public meeting also requested that the NRC include in § 26.165(f)(2) a reference to §§ 26.129(b )(2) and 26.159(b )(2) to clarify that the action of the licensee or other entity was taken based on the test results of the second specimen collected under direction observation.

The NRC agrees with this request and is proposing to rev i se this section accordingly. FFD Program Performance Data Reporting The NRC has periodically received questions from licensees and other entities on the annual drug and alcohol testing reporting requirements on " populations tested" in § 26. 71 ?(b) and (c). Specifically , the reporting requirements to provide FFD program performance data by populations tested " (i.e., individuals in applicant status , permanent licensee employees , [contractors/vendors]

CNs)" has resulted in two types of questions.

F i rst , licensees already report the pre-access testing results separately for the licensee employee and CN tested populations, so they requested clarification on the term "individuals in applicant status." Applicant status is not a distinct tested population category , rather , it is the status of individuals that are subject to pre-access testing. Currently , licensees and other entities must report the test results by tested population for each condition of testing (i.e., access , random , for-cause , post-event , and follow-up) as r eq uir ed by§ 26. 71 ?(b )(5). By 61 reporting the pre-access test results for each of the two tested populations (i.e., licensee employees , CNs), licensees and other entities are already reporting the results for individuals in " applicant status." To j mprove the clarity of the existing reporting requirement , the rtroposed rule would remove the phrase "i ndividuals in applicant status" from § 26. 717(b )(3) and (b )( 4 ). Second , the NRC has received questions from entities other than the licensees that report§ 26.717 drug and alcohol test results. Because§ 26.717(b)(3) and (b)(4) does not specify " other entity" in the parenthetical statements defining the tested populations , these entities were unclear on how to classify their tested populations on the § 26. 717 annual summary reports to the NRC. To correct this oversight , the proposed rule would revise the tested populat i on " licensee employees" to " licensee or other entity employees" in § 26.717(b)(3) and (b)(4). IV. Section-by-Section Analysis Nomenclature Changes Throughout 10 CFR part 26 , the NRC is proposing to revise the term " custody and control form" to read " Federal CCF." Two additional iterations of the term , " custody-and-control forms" and " custody-and-control form(s)," would also be revised to read " Federal CCFs" and " Federal CCF(s)," respectively. Throughout 1 O CFR part 26 , the NRC is proposing to revise the term " chain-of-custody" to read " cha i n of custody." The nomenclature changes to " custody-and

-control form" and " chain-of-custody" would align with the spelling of these terms in the 2008 HHS Gu i delines and would also improve consistency i n 10 CFR part 26. 62 The proposed rule would also correct a number of instances where " chain-of-custody form" was used instead of " custody and control form ," and vice versa. These corrections pertain to§§ 26.89(d); 26.11 ?(f); and 26.159(c), (d) and (e), as described later in this section. § 26.4 FFD program applicability to categories of individuals Section 26.4( e )(6)(iv) would be revised to eliminate the phrase " (65 FR 41944; August 9 , 2001 )." Section 26.4(9)(6) would be added to describe a new activity that the FFD program personnel could perform: monitoring a donor during the hydration process described in § 26.109(b). The punctuation at the end of§ 26.4(g)(4) and (5) would be updated to accommodate the addition of§ 26.4(9)(6).

Section 26.4U)(3) would be revised to replace the phrase " laboratory certified by the Department of Health and Human Services (HHS)" with " Department of Health and Human Services (HHS)-certified laboratory as defined in§ 26.5." § 26. 5 Definitions As described in Section 111.C of this document , the NRC is proposing to add definitions for cancelled test , carryover , Certifying Scientist , Federal custody and control form , Jot , rejected for testing , and Responsible Person. The defin i tion for calibrator would be rev i sed to include a clarify i ng statement that a calibrator is a solution of known concentration

" in the appropriate matrix." The phrase " test specimen/sample" would be replaced with the phrase " donor specimen or quality control sample." The last sentence of the current definition which states that " calibrators may be used 63 to establish a cutoff concentration and/or a calibration curve over a range of interest" would be deleted. The definition for control would be revised by replacing the phrase " a sample used to monitor the status of an analysis to maintain its performance within predefined limits" with the phrase "a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits." The definition for dilute specimen would be revised by replacing the phrase " concentrations that are lower than expected for human urine" with the phrase " values that are lower than expected but are still within the physiologically producible ranges of human urine." The definition for HHS-certified laboratory would be revised to eliminate the Federal Register citations for each final version of the HHS Guidelines. Instead, the definition would state that " HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that drug and validity testing of a specimen is performed for a licensee or other entity." The definition for invalid result would be revised to replace the phrase " for a specimen that contains an unidentified adulterant , contains an unidentified interfering substance , has an abnormal physical characteristic, contains inconsistent physiological constituents, or has an endogenous substance at an abnormal concentration that prevents the laboratory from completing testing or obtaining a valid drug test result" with the phrase " in accordance with the criteria established in § 26.161 (f) when a positive, negat i ve , adulterated , or substituted result cannot be established for a specific drug or specimen validity test." The definition for limit of quantitation (LOQ) would be revised to replace the phrase " the lowest concentration of an analyte at which the concentration of the analyte can be accurately 64 determined under defined conditions" with the phrase " for quantitation assays , the lowest concentration at which the identity and concentration of the analyte can be accurately established." The definition for substituted specimen would be revised to replace the phrase " with creatinine and specific gravity values that are so diminished or so divergent that they are not consistent with normal human physiology" with the phrase " a specimen that has been submitted in place of the donor's urine , as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine." § 26.8 Information collection requirements:

0MB approval Section 26.8(b) would be revised to remove the reference to § 26.155. § 26. 31 Drug and Alcohol Testing Section 26.31(b)(2) would be revised to eliminate the phrase " (65 FR 41944; August 9, 2001)." Section 26.31(d)(1) would be revised to include MOMA, MDA, and MDEA as substances for which licensees and other entities are required to test for in each specimen. Section 26.31 (d)(1 )(i)(D) would be revised to eliminate the phrase " as specified in § 26.155(a)." Section 26.31(d)(1 )(ii) would be revised to replace the phrase "except if the specimen is dilute and the licensee or other entity has required the HHS-certified laboratory to evaluate the specimen in §§ 26.163(a){2) or 26.168(g)(3) with the phrase " except i f special analyses of the specimen is performed under§ 26.163(a)(2) by the HHS-certified laboratory

." 65

§ 26. 89 Preparing to Collect Specimens for Testing Section 26.89(c) would be revised to replace the phrase " adulterated, diluted, or adulterated the specimen" with the phrase " adulterated, diluted, or substituted the specimen." Section 26.89(d) would be revised to include this phrase at the end of the first sentence: ", except as described in § 26.109(b )( 1 ). " The second sentence in § 26.89( d) would be revised in three ways. First, the phrase " For this purpose , a urine collection" would be replaced with the phrase "The urine collection

." Second , the phrase "sealed and initialed" would be replaced with the phrase "sealed with tamper-evident tape , the seal has been dated and initialed." Finally , the phrase "the chain of custody form has been executed, and the donor has departed the collection site" would be replaced with the phrase "and the Federal CCF has been completed , or when a refusal to test has been determined under§ 26.107(d)." § 26.107 Collecting a Urine Specimen Section 26.107(b) would be revised in four ways. First, the proposed rule would redesignate paragraph (b) as paragraph (b)(1). Secondly, the phrase " except as provided in § 26.109(b)(1 )" would be added in the first sentence after "The collector shall pay careful attention to the donor during the entire collection process." Third ,§ 26.107(b) would be revised to replace the phrase "to note any conduct that clearly indicates an attempt to tamper with a specimen (e.g., substitute urine is in plain view or an attempt to bring an adulterant or urine substitute into the privacy area)" with the phrase "to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain view; attempting to bring an adulterant , urine substitute, heating element, and/or temperature measurement device into the room, stall , or private area used for urination)

." 66 Lastly, the phrase " the collector shall document the conduct" would be revised to read as follows: "the collector shall document a description of the conduct." Section 26.107(b )(2) would be added to ensure that if a hydration monitor is used to observe a donor during the § 26.109(b) hydration process, this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site, donor refuses to follow directions).

Section 26.107(d) and (d)(1) through (d)(5) would be added to describe requirements regarding the actions a collector must take if a refusal to test is determined at any point during the specimen collection process. Specifically, the collector shall: 1) inform the donor that a refusal to test has been determined, 2) terminate the collection process, 3) document a description of the refusal to test on the Federal CCF , 4) discard any urine specimen(s) provided by the donor unless the specimen was collected for a post-event test required by§ 26.31 (c)(3), and 5) immediately inform the FFD program manager of the refusal to test. § 26. 109 Urine Specimen Quantity Section 26.109(b)(1) would be revised, and new paragraphs (b)(1 )(i) through (b)(1 )(iii) would be added, to provide a licensee or other entity with new flexibility in the personnel that may be used to monitor a donor during the hydration process that is initiated when a donor is unable to provide an acceptable quantity of urine during the initial collection attempt. For clarity , the last sentence of§ 26.109(b )( 1) would become the new first sentence of§ 26.109(b )(2). The proposed rule would permit another staff member designated as FFD program personnel , as described in§ 26.4(9)(6), or another specimen collector meeting the requirements in§ 26.85(a), instead of the specimen collector who initiated the collection process , to monitor a donor during the hydration process. The collector shall: 1) explain the hydration process and acceptable 67 donor behavior to the hydration monitor, and 2) record the name of the individual observing the donor on the Federal CCF and then provide the Federal CCF to the observer for the duration of the hydration process. The original collector may then perform other collections while the donor is in the hydration process. § 26. 111 Checking the Acceptability of the Urine Specimen Section 26.111 (a) would be revised to replace the phrase " greater than 15 ml" with the phrase "equal to or greater than 15 ml" and to add the phrase "(e.g., adulterated or diluted)" after the word "altered." Section 26.111(c) would be revised to remove the word " designated" from the phrase " designated FFD program manager" in the first sentence. The parenthetical phrase " (e.g., adulterated or diluted)" would be added after the word " altered" in the second sentence.

Section 26.111 ( e) would be revised to include the phrase ", except under the conditions described in§ 26.107(d)(4)" at the end of the existing requirement.

Section 26.111 (f) would be removed. § 26. 115 Collecting a Urine Specimen under Direct Observation Section 26.115(a)(3) would be revised to replace the phase "The collector observes conduct clearly and unequivocally indicating an attempt to dilute, substitute, or adulterate the specimen" with the phrase " The collector , or the hydration monitor if one is used as permitted in § 26.109(b )( 1 ), observes conduct by the donor indicating an attempt to subvert the testing process." Also , the proposed rule would remove the word "and" at the end of§ 26.115(a)(3).

Paragraph (a)(5) would be added to include an additional instance when an observed collection is required: " The donor requests a retest and either Bottle B or the single specimen is not 68 available due to circumstances outside of the donor's control , as specified in§ 26.165(f)(2)." The period at the end of the sentence in § 26.115(a)(4) would be replaced with a "; aMC>r to accommodate for the new paragraph (a)(5) in the list of exclus i ve grounds for performing a directly observed collection.

In § 26.115(f), the proposed rule wou l d rev i se the first se n tence , " If someone other than the collector is to observe the collection , the collector shall instruct the observer to follow the procedures in this paragraph ," so that it reads " If the observer is not a trained collector , the collector shall, in the presence of the donor , instruct the observer on the collection procedures in paragraph (f)." The revised sentence would be added to the end of ex i sting requirements in § 26.115(e). In § 26.115(f)(2), the proposed rule would add the following parenthetical statement to the end of the existing requirement:

"{a-A reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room , stall , or private area is not sufficient to meet this direct observation requirement

the use of a video camera to assist in the observation process is not permitted~." In § 26.115(f)(3), the proposed rule would replace the phrase " If the observer is not the collector , the observer may not take the collection container from the donor , but shall observe the specimen as the donor takes it to the collector'

' with the phrase " If the observer is not the collector , the observer may no t t ouch or handle t he collection container , but shall mainta i n visual contact w i th the specimen until the donor hands the collection container to the collector." Section 26.115(9) would be revised to i nc l ude the phrase " , and the collector shall follow the procedures in§ 26.107(d)" at the end of the existing requirement.

§ 2 6. 1 1 7 P r epar i ng Ur i ne Spec i mens fo r Sto r age and Sh i pment 69 Section 26.117(a) would be revised to add the phrase " Once the collector is presented with the specimen from the donor" at the beginning of the first sentence to clarify when the collector would ea-begin to keep the donor's " urine specimen(s) in view at all times." Section 26.117(f) would be revised to replace the term " chain-of-custody forms" with the term " Federa l CCFs." Section 26.117(f) would also be revised to replace the phrase " or the licensee's testing facility ," with the phrase " or to the licensee testing facility." Section 26.117(g) would be revised to add the phrase" , except as provided in § 26.109(b )(1 )(ii) for the Federal CCF ," to the end of the first sentence. § 26. 129 Assuring Specimen Security , Chain of Custody , and Preservation Section 26.129(b )( 1 )(ii) would be revised by replacing the phrase " the specimen may not be tested ," with the phrase "the licensee testing facility shall reject the specimen for testing." Section 26.129(b )(2) would be revised by adding the phrase " and report a cancelled test result to the licensee or other entity ," after the phrase " requiring the MRO to cancel the testing of a donor's urine specimen." § 26. 133 Cutoff Levels for Drugs and Drug Metabolites The introductory paragraph under § 26.133 would be revised to clarify that the specified cutoff level must be used to determine whether the specimen is negative " or positive" for the indicated drug or drug metabolite being tested. The table in § 26.133 would be revised to: 1) lower the initial test cutoff level for cocaine metabolites from 300 ng/ml to 150 ng/ml , 2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morphine is the target analyte , 3) lower the initial test cutoff level for amphe t amines (abbreviated in the table as AMP) from 1000 ng/ml to 500 ng/ml , 4) add initial testing for 6-AM at a cutoff level of 10 ng/ml , 5) include a new table footnote 2 regarding initial 70 test kits, 6) include a new table footnote 3 to clarify that for amphetamines testing, methamphetamine

{abbreviated in the table as MAMP) is the target analyte , and 7) add initial testing for MOMA at a cutoff level of 500 ng/ml. The column header " Drug or metabolites" in the table in § 26.133 would also be revised to " Drugs or drug metabolites" to align with the table title. § 26. 137 Quality Assurance and Quality Control Section 26.137( d)(5) would be revised to replace the term " donor specimen" with the term " normal specimen." Section 26.137( e )(6) would replace the phrase " A m i nimum of 10 percent of all specimens" at tJ,e start of the first sentence with the phrase " A minimum of 10 percent of the total specimens." The parenthetical phrase " (i.e., calibrators and controls)" would be added after the phrase " quality control samples" in the first sentence of§ 26.137(e)(6). The word " drugs" in the first sentence of§ 26.137(e)(6) and the phrase " drug and metabolite" in the second sentence of§ 26.137(e)(6) would be replaced with the phrases " drugs and drug metabolites" and " drug and drug metabolite

," respectively. Section 26.137(e)(6)(i) would replace the phrase " Sample(s) certified by an HHS-certified laboratory to contain no drugs or drug metabolites (i.e., negative urine samples)" with the phrase " At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite

." Section 26.137(e)(6)(ii) would be revised to replace the phrase " drug(s) or drug metabolite(s)" with the phrase " the drug or drug metabolite." 71 Section 26.137(e)(6)(iii) would be revised to replace the phrase "the drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff' with the phrase "the drug or drug metabolite targeted at 75 percent of the cutoff." Section 26.137( e )(6)(v) would be revised to replace the phrase " At least one positive control, certified to be positive by an HHS-certified laboratory, which appears to be a donor specimen" with the phrase "At least one quality control sample that appears to be a normal specimen." § 26.153 Using Certified Laboratories for Testing Urine Specimens Section 26.153(a) would be revised to replace the phrase "laboratories certified under the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs [published in the Federal Register on April 11 , 1988 (53 FR 11970), and as amended, June 9, 1994 (59 FR 29908), November 13, 1998 (63 FR 63483), and April 13, 2004 (69 FR 19643)]" with the phrase "HHS-certified laboratories as defined in§ 26.5." The sentence " Information concerning the current certification status of laboratories is available from the Division of Workplace Programs, Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration, Room 815, 5600 Fishers Lane , Rockwall 2 Bldg., Rockville , Maryland 20857" would be removed. Section 26.153(9) would be revised to replace the term " Federal custody-and-control form" with "Federal CCF" and the term " non-Federal form" with " non-Federal CCF." § 26. 155 Laboratory Personnel Section 26.155 would be removed and reserved.

72

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§ 26. 157 Procedures Section 26.157(a) would be revised to replace the phrase " clear and well-documented procedures for" with the phrase " procedures specific to this part that document the." Section 26. 1'57(a) would also be revised to remove " urine" in the phrase " testing of urine specimens." Section 26.157(b) would be removed and reserved, and§ 26.157(c) through (e) would be removed. § 26. 159 Assuring Specimen Security , Chain of Custody , and Preservation Section 26.159(b )( 1 )(ii) would be revised to replace the phrase " the specimens may not be tested" with the phrase " the laboratory shall reject the specimens for testing" when the integrity or identity of the specimens is in question.

Section 26.159(b )(2) would be revised to add after " The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen ," the phrase " and report a cancelled test to the licensee or other entity." Section 26.159( c) would be revised in the second sentence of the paragraph to replace the term "custody-and-control" with the term "chain of custody." Also , the term control form" would be replaced with the term " Federal CCF" in the third sentence of the paragraph. Section 26.159( d) would be revised to replace the term " custody-and-control" with the term " chain of custody." Section 26.159( e) would be revised to replace the term " custody-and-control" with the term " chain of custody" in the two instances that it occurs in the paragraph. 73

§ 26.161 Cutoff Levels for Validity Testing Sections 26.161 (c)(3) through (c)(6) would be revised to replace all instances of " LOD" with " LOO." Sections 26.161 (c)(5) would be revised to replace the phrase " GC/MS for the confirmatory test" with the phrase " a different confirmatory method (e.g., gas chromatography/mass spectrometry ( GC/MS) ). " Sections 26.161 (c)(6) would be revised to replace the phrase " GC/MS for the confirmatory test" with the phrase " a different confirmatory method (e.g., GC/MS)." Sections 26.161 (f)(5) and (f)(7) would be revised to replace all instances of the term " LOD" with the term " LOO." § 26. 163 Cutoff Levels for Drug and Drug Metabolites Section 26.163(a)(1) would be revised to replace the phrase " negative for the indicated drugs and drug metabolites" with the phrase " negative or positive for the indicated drugs and drug metabolites." The phrase " except if validity testing indicates that the specimen is dilute" would also be revised to " except as specified in paragraph (a)(2) of this section." The table in§ 26.163(a)(1) would be revised to: 1) lower the in i tial test cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL , 2) include a new footnote 1 to clarify that the initial test cutoff level for opiate metabolites is for codeine/morphine and that morphine is the target analyte , 3) lower the initial test cutoff level for amphetamines (abbreviated in the table as AMP) from 1000 ng/mL to 500 ng/mL , 4) add initial testing for 6-AM at a cutoff level of 10 ng/mL , 5) include a new footnote 2 regarding initial test kits , 6) include a new footnote 3 to clarify that for amphetamines test i ng , methamphetamine (abbreviated in the table as MAMP) is t he targe t analyte , and 7) add init i al tes t ing for MOMA at a cutoff level of 500 ng/m l. The column header " Drug or metabolites" in the table i n§ 26.163(a)(1) would also be revised to 74

" Drugs or drug metabolites" to align with the table title. Section 26.163(a)(2) would be revised to remove the phrase " At the licensee's or other entity's discretion, as documented in the FFD program policies and procedures, the licensee or other entity may require the" and replace the provision with " HHS-certified laboratories shall conduct special analyses of specimens as follows:." Section 26.163(a)(2)(i) would be revised to replace the phrase " the HHS-certified laboratory shall compare the responses of the dilute specimen to the cutoff calibrator in each of the drug classes" with the phrase " or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5)." Section 26.163(a)(2)(ii) would be revised to state " If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator , the laboratory shall conduct confirmatory drug testing of the specimen to the LOO for those drugs and/or drug metabolites

and." The table in § 26.163(b )( 1) would be revised to

1) lower the confirmatory test cutoff level for cocaine metabolite from 150 ng/ml to 100 ng/ml , 2) revise " Opiates" to read " Opiate metabolites," 3) remove footnote 3 regarding the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine concentration exceeding 2000 ng/ml, 4) lower the confirmatory test cutoff levels for amphetamine and methamphetamine from 500 ng/ml to 250 ng/ml , 5) redesignate footnote 4 as footnote 3 and revise the text to lower the concentration of amphetamine that must be present in the specimen from 200 ng/ml to 100 ng/ml , 6) add confirmatory testing for MOMA, MDA , and MDEA at a cutoff level of 250 ng/ml, and 7) include new footnotes 4 and 5 to the cutoff level table to present the full names for the substances MDA and MDEA, respectively. The column header " Drug or metabolites" in the table in § 26.163(b )( 1) would also be revised to " Drugs or drug metabolites

." 75

§ 26. 165 Testing Split Specimen_s and Retesting Single Specimens A new fifth sentence would be added to § 26.165(b )(2) that states , The MRO shall document in his or her records when (i.e., date and time) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen." The first sentence in§ 26.165(b)(3) would be deleted. The second sentence in § 26.165(b )(3) would be revised to state " No entity , other than the MRO as permitted in § 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's written permission

." The last sentence in § 26.165(f)( 1) would be revised by adding the phrase " the MRO shall report a cancelled test result to the licensee or other entity , and" to indicate that the MRO must report the cancelled test. Section 26.165(f)(2) would be revised to clarify the actions that an MRO is to take when a donor requests testing of Bottle B or a retest of a single specimen and the specimen to be tested is unavailable due to circumstances outside of the donor's control. Specifically , the proposed rule would: 1) add instruction for the MRO to report a cancelled test to the licensee or other entity for the donor's specimen;

2) add instruction for the licensee or other entity to perform a second collection without prior notice to the donor and to continue to administratively withdraw the individual

's authorization until the results of the second collection are received by the MRO; and 3) add a reference to §§ 26.129(b )(2) and 26.159(b )(2), which describes the circumstances that require the MRO to cancel a test result. 76

§ 26. 167 Quality Assurance and Quality Control Section 26.167(d)(3)(i) would be revised to replace the phrase " Sample(s) certified to contain no drugs or drug metabolites (i.e., negative urine samples)" with the phrase " At least one control certified to contain no drug or drug metabolite

." Section 26.167(d)(3)(i i) would be revised to replace the phrase " a drug(s) or drug metabolites" with the phrase " the drug or drug metabolite." Section 26.167(d)(3)(iii) would be revised to replace the phrase " a drug(s) or drug metabolite(s) targeted at 25 percent below the cutoff' with the phrase " the drug or drug metabolite targeted at 75 percent of the cutoff." Section 26.167(d)(4) would be revised to add the parenthetical statement

" (i.e., calibrators and controls)" after the phrase " quality control samples." Section 26.167( e )(2) would be revised to replace the phrase " At least 10 percent of the samples in each analytica l run of specimens must be calibrators and controls" with the phrase " A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls)." Section 26.167(e)(3)(i) would be revised to replace the phrase " Sample(s) certified to contain no drug (i.e., negative urine samples)" with the phrase " At least one control certified to contain no drug or drug metabolite

." Section 26.167(e)(3)(ii) would be revised to replace the phrase " Positive calibrator(s) and control(s) with a drug(s) or drug metabolite(s)" with the phrase " A calibrator with its drug concentration at the cutoff." Section 26.167(e)(3)(iii) would be revised to replace the phrase " a drug(s) or drug metabolites" w i th the phrase " the drug or drug metabolite

." 77 Sect i on 26.167(e)(3)(iv) would be revised to replace the phrase " At l east one calibrator or control that is targeted" with the phrase " At least one control targeted." Section 26.167(f)(3) would be revised to make an editorial correction to the phrase " a statement by the laboratory

's respons i ble person" by capitalizing the position title in that phrase to " Responsible Person." § 26. 168 Blind Performance Testing Section 26.168(h)(1) would be revised to remove the phrase " and for no more than 6 months" from this requirement.

§ 26. 169 Reporting Results Section 26.169(a) would be revised to correct the capitalization of the " c" and the " s" in the position title in the phrase " the laboratory

's certifying scientist" to "Certifying Scientist." The HHS-certified laboratory annual statistical summary reporting requirements in § 26.169(h)(3) would be revised to add MOMA , MDA, and MDEA to the list of amphetamines test results that a laboratory must report as required by§ 26.169(h)(3)(v). Additional conforming changes would be made to the names of the drugs and drug metabolites listed in§ 26.169(h)(3) to include adding " (as THCA)" after " Marijuana metabolite" in § 26.169(h)(3)(i), adding " (as benzoylecgonine

)" after " Cocaine metabolite" in§ 26.169(h)(3)(ii), revising 6-AM to " 6-acetylmorphine (6-AM)" in§ 26.169(h)(3)(iii)(C), and revising " Phencyclidine" to " Phencyclidine (PCP)" in§ 26.169(h)(3)(iv). 78

§ 26. 183 Medical Review Officer Section 26.183 would be revised to remove the phrase " at the licensee's or other entity's discretion" from§ 26.183(c), (c)(1), and (d)(2)(ii). § 26. 185 Determining a Fitness-for-Duty Policy Violation Section 26.185(f)(3) would be redesignated as (f)( 4 ), and a new paragraph (f)(3) would be added to state that , i f there i s no legitimate technical or medical explanation for an invalid test result based on a pH result greater than or equal to 9.0 but less than or equal to 9.5 , the MRO shall consider whether there i s evidence of elapsed time , exposure of the specimen to high temperature , or both that could account for the pH value. If the MRO obtains objective and suffic i ent information regarding e l apsed time , temperature conditions , or both, to conclude that an acceptable explanation exists for the invalid test result due to pH , the MRO would direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. This second specimen may not be collected from the donor under direct observat i on cond i tions. Section 26.185(g)(2) would be revised to replace the phrase " If the licensee or other entity requires the HHS-certified laboratory to conduct the special analysis of dilute specimens permitted by§ 26.163(a)(2), the results of the special analysis are positive ," with the phrase " If the results of the special analysis testing required by§ 26.163(a)(2) are positive." Section 26.185 (g)(2)(iii) would be revised to remove the phrase " clearly and unequivocally

." Section 26.185(g)(3) would be removed. 79 Section 26.185(9)(4) and (g)(5) would be redesignated as§ 26.185(g)(3) and (g)(4), r espectively , and the cross-reference under§ 26.163(a)(1) would be updated to reflect these changes. § 26.405 Drug and Alcohol Testing Section 26.405(d) would be revised to add MDMA, MDA , and MDEA as substances for which licensees and other entities are required to test i n each specimen. § 26.415 Audits Section 26.415(c) would be revised to eliminate the phrase " (65 FR 41944; August 9 , 2001 )." § 26. 717 Fitness-for-duty program performance data Section 26.717(b)(3) would be revised to replace the phrase " (i.e., individuals in applicant status , permanent l i censee employees , CNs)," w i th the phrase " (i.e., l i censee and other entity employees , CNs)." Section 26.717(b)(4) would be revised to replace the phrase " (i.e., individuals in applicant status , permanent licensee employees , CNs)," with the phrase " (i.e., licensee and other entity employees , CNs)." 80 V. Specific Requests for Comment The NRC is seeking advice and recommendations from stakeholders on this proposed rule. We are particularly interested in comments and supporting rationale from the public on the following:

1. Alignment with the HHS Guidelines Two proposed changes in this rule would eliminate redundant provisions in 10 CFR part 26 that also appear in the HHS Guidelines (i.e., HHS-certified laboratory personnel qualifications requirements in § 26.155 , " Laboratory personnel ," and HHS-certified laboratory procedures requirements specific to the HHS Guidelines in § 26.157 , " Procedures

"). Because the NLCP inspection process verifies laboratory compliance with the HHS Guidelines , additional review and oversight by NRC licensees and other entities (e.g., of laboratory security requirements) would be duplicative.

The NRC is seeking comment on additional provisions in 10 CFR part 26 that are consistent with the HHS Guidelines and could be eliminated from 10 CFR part 26. 2. Special Analyses Testing The proposed rule includes new requirements in§ 26.163(a)(2) for the special analyses testing of urine specimens for drugs and drug metabolites. The first would require special analyses testing of specimens with dilute validity test results when initial drug testing identifies a drug or drug metabolite within 40 percent of the testing cutoff level. Currently , special analyses testing of dilute specimens is optional.

The second new requirement would expand special analyses testing to specimens collected under direct observation as required by§ 26.115(a)(1) through (a)(3) and new paragraph (a)(5). The NRC is seeking comment on whether special 81 analyses testing should also apply to the testing of individuals that already have tested positive on a 10 CFR part 26 test (i.e., denied unescorted access authorization by § 26. 75( d) for a first or second drug testing positive result). Requiring special analyses testing in this case would add a level of assurance to follow-up testing required by§ 26.69(b)(6), which is conducted to confirm continued abstinence from illegal drug use and/or the misuse of legal drugs. 3. Provide Flexibility to Conduct Additional Specimen Validity Tests Section 26.31(d)(1

)(i)(D) permits a licensee or other entity to utilize lower cutoff levels and drug testing assays without forensic toxicologist review, if the HHS Guidelines are revised to authorize use of the assay and testing cutoff levels. However,§ 26.161(h) prohibits licensees and other entities from using more stringent cutoff levels for validity tests. The NRC is seeking comment on whether§ 26.161(h) should be revised to provide a licensee or other entity with the option to conduct additional specimen validity tests and/or to utilize lower cutoff levels if the HHS Guidelines are revised in the future to include such testing. 4. Effective Date of the Final Rule If the proposed rule is finalized, the NRG anticipates providing a 60-day implementation period from the date that the final rule is published in the Federal Register.

The effective date of the final rule and the compliance date for licensees and other entities would be 60 days after the date that the final rule is published in the Federal Register.

The NRC is seeking comment on whether this implementation time period is appropriate based on the proposed rule changes. 5. Direct Observation of Specimen Collection The proposed rule retains the requirement for direct observation during the collection of a second sample when there are indications of a subversion attempt during the initial collection.

82 The NRC is seeking comment on whether there are any effective alternatives to direct observation that will assist in preventing subversion of the drug testing process. VI. Regulatory Flexibility Certification Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule will not , if promulgated, have a significant economic impact on a substantial number of small entities.

This proposed rule affects the licensing and operation of nuclear power plants and Category I fuel cycle facilities.

The companies that ow11 these facilities do not fall within the scope of the definition of " small entities" set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). The NRC estimates that none of the 67 entities affected by the rule would fall within the scope of the definition of " small entities" set forth in the Regulatory Flexibility Act or the size standards established by the NRC (§ 2.810). Therefore , the rule would not impact a substantial number of small entities. VII. Regulatory Analysis The NRC has prepared a draft regulatory analysis on this proposed regulation. The analysis examines the costs and benefits of the alternatives considered by the NRC. The NRC requests public comment on the draft regulatory analysis. The regulatory analysis is available as indicated in the " Availability of Documents" section of this document.

Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES caption of this document.

83 VIII. Backfitting and Issue Finality The proposed rule would apply to all current nuclear power plant licensees (including holders of renewed licenses under 10 CFR part 54,-" Requirements for Renewal of Operating Licenses for Nuclear Power Plan.ts," and combined licenses under 10 CFR part 52 , " Licenses , Certifications , and Approvals for Nuclear Power Plants") and holders of licenses authorizing the possession, use, or transport of formula quantities of SSNM under 10 CFR part 70 , " Domestic Licensing of Special Nuclear Material." The proposed rule would apply to holders of a certificate of compliance or an approved compliance plan under the provisions of 10 CFR part 76 , " Certification of Gaseous Diffusion Plants ," if the holder engages in activities involving formula quantities of SSNM. Some or all of the proposed rule would apply to: (i) current and future applicants for combined licenses under 10 CFR part 52 who have been issued a limited work authorization (LWA) under§ 50.1 O(e), if the LWA authorizes the applicant to install the foundations, including the placement of concrete , for safety-and security-related structures, systems, and components (SSCs) under the LWA; (ii) combined license holders before the Commission has made the finding under§ 52.103(g); (iii) power reactor construction permit applicants (under 10 CFR part 50 , " Domestic Licensing of Production and Utilization Facilities

") who have been issued an LWA , if the LWA authorizes the applicant to install the foundations , including the placement of concrete, for safety-and security-related SSCs under the LWA; (iv) power reactor construction permit holders; and (v) early site permit holders who have been issued an LWA, if the LWA authorizes the early site permit holder to install the foundations, including the placement of concrete , for safety-and security-related SSCs under the LWA. The rule would constitute backfitting as defined under§ 50.109(a)(1) for current holders of 10 CFR part 50 operating licenses and construction permits for power reactors , and under § 70.76(a)(1) for applicable current 10 CFR part 70 l i censees. The NRC has performed a 84 backfit analysis consistent with NUREG/BR-0058, Revision 4 , " Regulatory Analysis Guidelines of the U.S. Nuclear Regulatory Commission." The backfit analysis can be found at appendix E of the regulatory analysis.

The NRC has determined the backfitting is justified because: 1) there would be a substantial increase in the overall level of protection of the public health and safety or the common defense and security to be derived from the backfitting; and 2) the costs of implementation and the annual costs would be justified in view of this increase.

Imposing the requirements of the proposed rule on current holders of combined licenses would represent an inconsistency with the issue finality provision applicable to combined licenses under§ 52.98 , "Finality of combined licenses; information requests." Therefore, the NRC has addressed the criteria in § 52.98 that would allow imposition of the proposed rule on current holders of combined licenses , despite the issue finality accorded to the combined license holders. The NRC believes that the proposed rule may be imposed as a cost-justified substantial increase in the protection of the public health and safety or common defense and security.

The bases for this determination are presented in the backfit analysis found in appendix F of the regulatory analysis.

Imposing the requirements of the proposed rule on current and future applicants for power reactor construction permits under 10 CFR part 50, part 70 licenses, or early site permits or combined licenses under 10 CFR part 52 would not constitute backfitting. Neither§ 50.109 , " Backfitting

," nor the issue finality provisions for early site permits or combined licenses under 10 CFR part 52 protect either a current or prospective applicant for a construction permit , part 70 license , early site permit, or combined license from changes in the NRC rules and regulations.

The NRC has long adopted the position that§ 50.109 does not protect current or prospective applicants from changes in NRC requirements or guidance , because the policies 85 underlying

§ 50.109 are largely inapplicable in the context of a current or future application.

This position also applies to each of the issue finality provisions under 1 O CFR part 52. The provis i ons unde r 10 CFR part 26 also apply to applicants for construction permits , early site permits , or combined licenses who have been issued a!l LWA, if the LWA authorizes the applicant to install the foundations , including the placement of concrete , for safety-and security-related SSCs under the LWA. As of [INSERT DATE OF ISSUANCE OF NOTICE], no LWAs have been issued to an applicant for a construction permit , early site permit , or combined license , so no such entity is protected by the backfitting and issue finality provisions from the changes proposed i n this rulemaking. Similarly , no entity holds a certificate o f compliance or an approved compliance plan under the provisions of 10 CFR part 76 , so no entity is protected by the backfitting provisions of § 76.76 , " Backfitting

," from the changes proposed in this rulemaking. Draft Regulatory Guidance The guidance in DG-5040 (DG) presents methods acceptable to the NRC for implementing portions of this proposed rule. The draft guideDG would apply to current holders of nuclear power plant license e s (including holders of renewed licenses under 10 CFR part 54 and combined l i censes under 10 CFR part 52) and current holders of licenses authorizing the possession , use , or transport of formula quantities of SSNM under 10 CFR part 70. The DG would also apply to holders of a certifica t e of compliance or an approved compliance plan under the provisions of 10 CFR part 76 , if the holder engages in activities involving formula quantities of SSNM. 86 The DG would also apply to cu r rent and future: 1) appl i cants for comb i ned licenses under 10 CFR part 52 who have been issued an LWA under § 50 .10( e ), if the LWA authorizes the applicant to install the foundations , includ i ng the placement of concrete , for safety-and secur i ty-related SSCs under the LWA; 2) combined license holders before the Commission has made the finding under§ 52.103(g); 3) power reactor construction permit applicants (under 10 CFR part 50) who have been issued an LWA, if the LWA authorizes the applicant to install the foundations , including the placement of concrete , for safety-and security-related SSCs under the LWA; 4) power reactor construction permit holders; and 5) early site permit holders who have been issued an LWA, if the LWA authorizes the early site perm i t holder to i nstall the foundations , including the placemen t of concrete , for safety-and security-related SSCs under the LWA , if these entit i es elect to implement an FFD program that meets the requirements of subparts A through H , N , and O of 10 CFR part 26. Issuance of the DG in final form would not constitute backfitting under 10 CFR part 50 , 70 , or 76 and wou l d not otherwise be inconsistent with the issue finality provisions under 10 CFR part 52. As discussed in the " Implementation" section of the DG , the NRC has no current intention to impose the DG , if finalized, on current holders of 10 CFR part 50 operating licenses or construction permits; 10 CFR part 52 combined licenses or early s i te perm i ts; 10 CFR part 70 licenses , or 10 CFR part 76 certificates of compliance or approved comp l iance plans. The DG , if finalized , could be applied to app li cants for 10 CFR part 50 operating licenses or construction permits for power reactors , 10 CFR part 52 combined licenses or early site permits , licenses i ssued under 10 CFR part 70 , or 10 CFR part 76 certificates of compliance or approved compl i ance plans. Such action would not constitute backfitting as defined unde r § 50.109 , § 70. 76 , o r§ 7 6. 76 , or be otherw i se inconsistent with the applicab l e issue finality 87 provisions under 10 CFR part 52, inasmuch as such applicants are not within the scope of entities protected by§ 50.109, § 70. 76, § 76. 76, or the relevant issue finality provisions under 10 CFR part 52, except in one circumstance.

The exception to this principle is a combined license, early site permit, or construction permit applicant that has been issued an LWA, if the LWA authorizes the applicant to install the foundations , including the placement of concrete, for safety-and security-related SSCs under the LWA. However, that exception would provide backfitting and issue finality protection for the LWA holder only to the extent that it conducts activities under the LWA. IX. Cumulative Effects of Regulation The NRC seeks to minimize any potential negative consequences resulting from the cumulative effects of regulation (CER). The CER describes the challenges that licensees , or other impacted entities such as State partners, may face while implementing new regulatory positions, programs , or requirements (e.g., rules , generic letters, backfits , inspections).

The CER is an organizational effectiveness challenge that may result s from a licensee or impacted entity implementing a number of complex regulatory positions, programs , or requirements within limited available resources.

In an effort to better understand the potential CER implications incurred due to this proposed rule , the NRC i s requesting comment on the following questions. Responding to these questions is voluntary , and the NRC will respond to any comments received in the final rule. 1. In light of any current or projected CER challenges , does the proposed rule's effective date provide sufficient time to implement the new proposed requirements , including changes to programs , procedures , and the facility?

88

2. If current or projected CER challenges exist, what should be done to address this situation?

For example, if more time is required for implementation of the new requirements, what period of time is sufficient?

3. Do other regulatory actions (from the NRC or other agencies) influence the implementation of the proposed rule's requirements?

4. Are there unintended consequences?

Does the proposed rule create conditions that would be contrary to the proposed rule's purpose and objectives?

If so , what are the unintended consequences , and how should they be addressed?

5. Please comment on the NRC's cost and benefit estimates in the regulatory analysis that supports the proposed rule. X. Plain Writing The Plain Writing Act of 2010 (Pub. L. 111-274) requires Federal agencies to write documents in a clear , concise , and well-organized manner. The NRC has written this document to be consistent with the Plain Writing Act as well as the Presidential Memorandum , " Plain Language in Government Writing ," published June 10, 1998 (63 FR 31883). The NRC requests comment on this document with respect to the clarity and effectiveness of the language used. XI. Environmental Impact: Categorical Exclusion The NRC has determined that this proposed rule is the type of action described under § 51.22(c)(1

). Therefore , neither an environmental impact statement nor an environmental assessment has been prepared for this proposed rule. XII. Paperwork Reduction Act Statement 89 This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This proposed rule has been submitted to the Office of Management and Budget (0MB) for review and approval of the information collection(s). Type of submission , new or revision: Revision.

The title of the information collection:

10 CFR Part 26, Fitness for Duty Drug Testing Requirements.

The form number if applicable

Not applicable.

How often the collection is required:

Once and annually.

One-time information collections include the licensee or other entity of each FFD program completing revisions to the FFD program policy and FFD procedures, to distribute information on the FFD program policy updates to individuals subject to 10 CFR part 26, and for those subject individuals to review the information on the FFD program policy changes. Annual information collections include the licensee or other entity of each FFD program submitting an FFD program performance report to the NRC to provide information on the additional positive drug test results that would result from the proposed rule changes. On occasion, a third party disclosure would be made for each additional positive drug test result from the proposed rule changes. Also , on occasion , the license or other entity would report information to the NRC in the form of a 24-hour event report 90 when some individuals (e.g., licensed reactor operators , supervisors) test positive as a result of the proposed rule changes. Who will be required or asked to report: Licensees of nuclear power reactor sites (operating and under construction), licensees of Category I fuel cycle facilities , contractors/vendors, HHS-certified laboratories, and individuals with a positive drug test result. An estimate of the number of annual responses:

7,813 (33 recordkeepers

+ 68 reporting responses+

7 , 712 third-party disclosures).

The estimated number of annual respondents

149 (27 FFD programs, 12 HHS-certified laboratories, 6 licensee testing facilities , and 104 individuals with a positive drug test result). An estimate of the total number of hours needed annually to complete the requirement or request: 1,382 (559 hours0.00647 days <br />0.155 hours <br />9.242725e-4 weeks <br />2.126995e-4 months <br /> recordkeeping

+ 71 hours8.217593e-4 days <br />0.0197 hours <br />1.173942e-4 weeks <br />2.70155e-5 months <br /> reporting

+ 752 hours0.0087 days <br />0.209 hours <br />0.00124 weeks <br />2.86136e-4 months <br /> third-party disclosure).

Abstract:

10 CFR part 26 contains the NRC's requirements for licensee and other entity FFD programs , which focus on preventing and detecting the impairment of personnel from the misuse of legal drugs and alcohol , use of illegal drugs, fatigue, and any other causes such as mental or psychological distress. The NRC is seeking to update the drug testing panel and to lower the testing cutoff levels for some drugs tested, which would impact the information collections contained in 10 CFR part 26, because additional individuals would likely test positive for drugs. These The expected additional positive test results would increase the recordkeeping 91 and reporting burdens on licensees and other entities.

The NRC is proposing to .include new information collection requirements in§§ 26.107(d), 26.157(a), 26.165(b)(2) and (b)(3), 26.165(f)(1) and 26.185(f)(3).

This information is needed to: uniformly address subversion attempts identified at the collection site(§ 26.107(d)), clarify that HHS-certified laboratories are to maintain testing procedures specific to 10 CFR part 26 (§ 26.157(a)), permit the MRO to initiate retesting of a donor specimen upon receiving an oral request from the donor and maintaining a record of receiving that request(§ 26.165(b )(2) and (b )(3)), document the existing process that the MRO is to report a cancelled test result to the licensee or other entity if the results of specimen retesting fail to confirm the test results from the initial laboratory(§ 26.165(f)(1 )), and establish procedures to review invalid specimen test results due to high pH values(§ 26.165(f)(3)). The NRC is seeking public comment on the potential impact of the information collection(s) contained in this proposed rule and on the following issues: 1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? 2. Is the estimate of burden of the proposed information collection accurate?

3. Is there a way to enhance the quality , utility , and clarity of the information to be collected?

4. How can the burden of the proposed information collection on respondents be minimized , including the use of automated collection techniques or other forms of information technology?

A copy of the 0MB clearance package and proposed rule is available in ADAMS under Accession No. ML16123A003 or may be viewed free of charge a t the NRC's PDR , One White 92 Flint North, 11555 Rockville Pike, Room 0-1 F21, Rockville , MD 20852. You may obtain information and comment submissions related to the 0MB clearance package by searching on http://www.regulations

.gov under Docket ID NRC-2009-0225.

You may submit comments on any aspect of these proposed information collection(s), including suggestions for reducing the burden and on the above issues, by the following methods:

• Federal rulemaking Web Site: Go to http://www

.regulations

.gov and search for Docket ID NRC-2009-0225.

• Mail comments to: FOIA, Privacy , and Information Collections Branch, Office of Information Services, Mail Stop: T-5 F53, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, or to Vlad Dorjets, Desk Officer, Office of Information and Regulatory Affairs (3150-0146), NEOB-10202, Office of Management and Budget, Washington , D.C. 20503; telephone:

202-395-1741, email: oira submission@omb.eop.gov. Submit comments by [INSERT DATE 30 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER].

Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date. Public Protection Notification The NRC may not conduct or sponsor , and a person is not required to respond to, a request for information unless the document requesting or requiring the collection displays a currently valid 0MB control number. 93 XIII. Compatibility of Agreement State Regulations Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30 , 1997, and published in the Federal Register (62 FR 46517; September 3 , 1997), this rule is classified as compatibility

" NRC." Compatibility is not required for Category " NRC" regulations. The NRC program elements in this category are those that relate directly to areas of regulation reserved to the NRC by the AEA or the provisions of title 10 of the Code of Federal Regulations, and although an Agreement State may not adopt program elements reserved to the NRC, it may wish to inform its licensees of certain requirements via a mechanism that is consistent with the particular State's administrative procedure laws, but does not confer regulatory authority on the State. XIV. Voluntary Consensus Standards The National Technology Transfer and Advancement Act of 1995, Pub. L. 104-113 , requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies , unless the use of such a standard is inconsistent with applicable law or otherwise impractical.

In this proposed rule, the NRC is proposing to update and enhance the consistency of 10 CFR part 26 with the 2008 HHS Guidelines

improve the effectiveness and efficiency of FFD programs with regard to drug testing; and improve clarity in the organization and language of the rule. This action would not constitute the establishment of a voluntary consensus standard that contains generally applicable requirements.

XV. Availability of Guidance The NRC is issuing for comment new draft regulatory guidance , Draft Regulatory Guide DG-5040 , " Urine Specimen Collection and Test Result Review unde r 1 0 CFR Part 26 , Fitness for Duty Programs ," (DG) to support the implementation of the proposed requirements in this 94 rulemaking. You may access information and comment submissions related to the DG by searching on http://www.regulations

.gov under Docket ID NRC-2009-0225. Comments on the DG may be submitted to the NRC as indicated unde r the ADDRESSES caption of this document.

The guidance descr i bes methods that the NRC would consider acceptable for complying with some of the proposed changes in this notice. For example, guidance would be provided concerning monitoring of a donor during the 3-hour hydration period , use of reflective mirrors for directly observed collections , use of a same-gender observer other than the collecto r during a directly observed collection , and MRO review of invalid test results due to h i gh pH. XVI. Availability of Documents The documents identified in the following table are available to interested persons through one or more of the following methods , as ind i cated. DOCUMENT ADAMS ACCESSION NO. / WEB LINK / FEDERAL REGISTER CITATION 1988 HHS Guidelines

-Final Guidelines 53 FR 11970 (April 11 , 1988) 1994 HHS Guidelines

-Revised Mandatory 59 FR 29908 Guidelines (June 9, 1994) 1998 HHS Guidelines

-Revised Mandatory 63 FR 63483 Guidelines (November 13 , 1998) 2004 HHS Guidelines

-Notice of Proposed Revisions to Mandatory Guidelines 69 FR 19673 (April 13 , 2004) 2004 HHS Guidelines

-Revised Mandatory 69 FR 19644 Guidelines (April 13, 2004) 2008 HHS Guidelines

-Revised Mandatory 73 FR 7 1 858 Guidelines (November 25, 2008) 1989 NRC 10 CFR Part 26 final rule 54 FR 24468 (June 7 , 1989) 1993 NRC 10 CFR Pa rt 26 fina l r ule 58 FR 3 1 467 (June 7 , 1989) 95 DOCUMENT ADAMS ACCESSION NO. / WEB LINK / FEDERAL REGISTER CITATION 2008 NRC 10 CFR Part 26 final rule 73 FR 16966 (March 31, 2008) 2009 NRC 10 CFR Part 26 final rule, correcting 74 FR 38326 amendment (August 3, 2009) 2014 National Drug Control Strategy htt12://www.whitehouse.gov/sites/default/file (July 9, 2014) s/ondco/oolicv-and-research/ndcs 2014. odf Behavioral Health Trends in the United States: htt12://www.samhsa.gov/data/sites/default/fil Results from the 2014 National Survey on Drug es/NSDUH-FRR 1-2014/NSDUH-FRR 1-Use and Health (September 2015), HHS 2014.12df Publication No. SMA 15-4927 Commission Policy Statement on Fitness for Duty of Nuclear Power Plant Personnel 51 FR 27921 (August 4, 1986) Cook J.D., Strauss K.A., Caplan Y.H., LoDico C.P., and Bush D.M. (2007), "Urine pH: the htt12://www.ncbi

.nlm.nih.gov/12ubmed/

effects of time and temperature after 17988463 collection,: Journal of Analytical Toxicology

vol. 31, 486 -496. Executive Order 12564 (September 17, 1986) 51 FR 32889 NRC Draft Regulatory Guide DG-5040, " Urine Specimen Collection and Test Result Review ML16120A435 under 10 CFR Part 26, Fitness for Duty Programs" (Month, day 2017). NRC Enforcement Guidance Memorandum

-Dispositioning Violations of NRC Requirements for Initial Validity and Drug Tests at Licensee ML090760728 Testing Facilities (EGM-09-003) (March 31, 2009) NRC Public Meeting Summary ML090771060 (February 24, 2009) NRC Public Meeting Summary (June 24, 2009) ML091910511 NRC Public Meeting Summary and Meeting ML112930153 Materials (October 11, 2011) NRC Public Meeting Summary ML13290A236 (September 11, 2013) NRC Regulatory Analysis and Backfit Analysis, Fitness For Duty Drug Testing Requirements ML16123A006 (Month, day 2017) NRC Regulatory Analysis Guidelines, NUREG/BR-0058, Revision 4 ML042820192 (September 30, 2004) 96 DOCUMENT ADAMS ACCESSION NO. / WEB LINK / FEDERAL REGISTER CITATION NRC Regulatory Basis: Proposed Rulemaking to Amend 10 CFR Part 26, "Fitness for Duty ML13066A703 Programs ," based on Select Provisions of the 2008 HHS Guidelines (May 3, 2013) NRC report "Summary of Fitness for Duty Program Performance Reports for Calendar ML14246A440 Year 2013" (September 3 , 2014) NRC report "Summary of Fitness for Duty Program Performance Reports for Calendar ML13225A131 Year 2012" (August 13, 2013) NRC report "Summary of Fitness for Duty Program Performance Reports for Calendar ML12151A270 Year2011" (August 1, 2012) Quest Diagnostics (2011 ). Impacts of Panel htt12 ://blog .em 12loyersolutions.

com/im 12acts-Changes -The First Three Months of-12anel-changes-the-first-three-months/ (January 25, 2011) Quest Diagnostics (2012). Cocaine Positives Spike 33% After New Government Rule for htt12://www

.g uestd iag nos tics. com/dms/Docu Safety-Sensitive Workers ments/DTI-Re12orts/2012-03-13 DTI .1;2df (March 13, 2012) Quest Diagnostics. (2014). Workforce Drug Drug Testing Index press release: Test Positivity Rate Increases for the First Time htt12://newsroom.guestdiagnostics.com/201 in 10 Years, Driven by Marijuana and 4-09-11-Workforce-Drug-Test-Positivity-Amphetamines, Finds Quest Diagnostics Drug Rate-lncreases-for-the-First-Time-in Testing IndexŽ Analysis of Employment Drug Years-Driven-by-Marijuana-and-Tests (September 11, 2014) Am12hetamines-Finds-Quest-Diagnostics-Drug-Tes ting-Index-Analysis-of-Em12loyment-Drug-Tests Drug Testing Index, 2014 Report: htt12 ://www. em 12loyer-solutions-resources.com/white12a12er/2015-drug-testina-index 97 List of Subjects 10 CFR Part 26 Administrative practice and procedure, Alcohol abuse, Alcohol testing, Appeals, Chemical testing, Drug abuse , Drug testing , Employee assistance programs, Fitness for duty, Management actions, Nuclear power plants and reactors, Privacy, Protection of information, Radiation protection, Reporting and recordkeeping requirements.

For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954 , as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553 the NRC is proposing to adopt the following amendments to 10 CFR part 26: PART 26--FITNESS FOR DUTY PROGRAMS 1. The authority citation for Part 26 continues to read as follows: Authority:

Atomic Energy Act of 1954, secs. 53, 103, 104 , 107, 161, 223, 234, 1701 (42 U.S.C. 2073, 2133, 2134, 2137 , 2201, 2273, 2282, 2297f); Energy Reorganization Act of 1974 , secs. 201,202 (42 U.S.C. 5841, 5842); 44 U.S.C. 3504 note. 2. In part 26, wherever it may occur, remove the term " custody-and-control form" and add in its place the term " Federal CCF". 98

3. In part 26, wherever it may occur, remove the term "custody-and-control forms" and add in its place the term " Federal CCFs". 4. In part 26, wherever it may occur 1 remove the term " custody-and-control form(s)" and add in its place the term " Federal CCF(s)". 5. In part 26, wherever it may occur, remove the phrase " chain-of-custody" and add in its place the phrase " chain of custody". 6. In§ 26.4: a. Remove the phrase "(65 FR 41944; August 9 , 2001 )" in paragraph ( e )(6)(iv);

b. Revise paragraph (g)(4) to remove the "and" at the end of the first sentence;

c. Revise paragraph (g)(5) to remove the period at the end of the first sentence and add in its place ";" and to add the word " and" after the ";"; d. Add new paragraph (9)(6); and e. Revise paragraph 0)(3) to read as follows: § 26.4 FFD program applicability to categories of individuals.

• * * * * (g) * * * (6) All persons monitoring a donor during the hydration process described in § 26.109(b).

• * * *

• 99 U) * * * (3) Urine specimens are tested for validity and the presence of drugs and drug metabolites at a Department of Health and Human Services (HHS)-certified laboratory, as defined in § 26.5; * * * *

• 7. In§ 26.5: a. Add the definitions for cancelled test, carryover, Certifying Scientist, Federal custody and control form, lot, rejected for testing, and Responsible Person in alphabetical order; and b.

• Revise the definitions for calibrator, control, dilute specimen, HHS-certified laboratory, invalid result, limit of quantitation, and substituted specimen.

The additions and revisions read as follows: § 26.5 Definitions.

• * * *

• Calibrator means a solution of known concentration in the appropriate matrix that is used to define expected outcomes of a measurement procedure or to compare the response obtained with the response of a donor specimen or quality control sample. The concentration of the analyte of interest in the calibrator is known within limits ascertained during its preparation.

• * * *

• 100 Cancelled test means the test result reported by the MRO to the licensee or other entity when a specimen has been reported to the MRO by the HHS-certified laboratory as an invalid result (for which the donor has no legitimate explanation), a specimen has been rejected for testing by the licensee testing facility or HHS-certified laboratory, or the retesting of a single specimen or the testing of Bottle B of a split specimen fails to reconfirm the original test result. For alcohol testing only, cancelled test means a test result that was not acceptable because testing did not meet the quality assurance and quality control requirements in § 26.91. * * * *

• Carryover means the effect that occurs when a test result has been affected by a preceding sample or specimen during analysis. * * * *

• Certifying Scientist means the individual at an HHS-certified laboratory responsible for verifying the chain of custody and scientific reliability of any test result reported by an HHS-certified , laboratory. * * * *

• Control means a sample used to evaluate whether an analytical procedure or test is operating within predefined tolerance limits. * * * *

• Dilute specimen means a urine specimen with creatinine and specific gravity values that are lower than expected but are still within the physiologically producible ranges of human urine. 101

• * * *

• Federal custody and control form (Federal CCF) means any HHS-approved form , which has not expired , that is published in the Federal Register and is used to document the collection , custody, transport, and testing of a specimen. * * * *

• HHS-certified laboratory means a laboratory that is certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (the HHS Guidelines) at the time that drug and validity testing of a specimen is performed for a licensee or other entity. * * * *

• Invalid result means the result reported by an HHS-certified laboratory in accordance with the criteria established in§ 26.161(f) when a positive , negative , adulterated , or substituted result cannot be established for a specific drug or specimen validity test. * * * *

• Limit of quantitation (LOQ) means for quantitation assays , the lowest concentration at which the identity and concentration of the analyte can be accurately established. * * * *

• Lot means a number of units of an item (e.g., drug test kits, reagents , quality control samples) manufactured from the same starting materials within a specified period of time for which the 102 manufacturer states that the items have essentially the same performance characteristics and the same expiration date. * * * *

• Rejected for testing means the result reported to the MRO by a licensee testing facility or HHS-certified laboratory when no tests can be performed on a specimen.

• * * *

• Responsible Person means the person at the HHS-certified laboratory who assumes professional , organizational , educationa l, and administrative responsibility for the day-to-day management of the HHS-certified laboratory. * * * *

• Substituted specimen means a specimen that has been submitted in place of the donor's urine , as evidenced by creatinine and specific gravity values that are outside the physiologically producible ranges of human urine. * * * *

• 8. In § 26.8 , remove the reference

" 26.155" in paragraph (b). 9. In§ 26.31: a. Remove the phrase " (65 FR 41944; August 9 , 2001 )" in paragraph (b )(2); b. Revise paragraph (d)(1 ); 103

c. Remove the phrase" , as specified in§ 26.155(a)" at the end of the second sentence in paragraph (d)(1 )(i)(D); and d. Revise the third sentence in paragraph (d)(1 )(ii). The revisions read as follows: § 26.31 Drug and alcohol testing. * * * * * (d) * * * (1) Substances tested. At a minimum, licensees and other entities shall test for marijuana metabolite, cocaine metabolite, opiates ( codeine, morphine, 6-acetylmorphine

), amphetamines (amphetamine, methamphetamine, methylenedioxymethamphetamine, methylenedioxyamphethamine, and methylenedioxyethylamphetamine

), phencyclidine, adulterants, and alcohol. * * * * * (ii)*** Test results that fall below the established cutoff levels may not be considered when determining appropriate action under subpart D of this part, except if special analyses of the specimen is performed under§ 26.163(a)(2) by the HHS-certified laboratory.

• * * *

• 104

10. In § 26.89: a. In paragraph (c) remove the phrase " adulterated , diluted , or adulterated the specimen" and add in its place the phrase " adulterated , diluted , or substituted the specimen"; and b. Revise paragraph (d) to read as follows: § 26.89 Preparing to collect specimens for testing. * * * * * (d) In order to promote the security of specimens , avoid distraction of the collector, and ensure against any confusion in the identification of specimens , a collector shall conduct only one collection procedure at any given time , except as described in § 26.109(b )( 1 ). The urine collection procedure i s complete when the urine specimen container has been sealed with tamper-evident tape , the seal has been dated and initialed , and the Federal CCF has been completed, or when a refusal to test has been determined under§ 26.107(d). 11. In § 26.107: a. Revise and redesignate paragraph (b) i ntroductory text as (b)(1) and add new paragraph (2); and b. Add new paragraphs (d) introductory text and (d)(1) through (5). The addit i ons and revisions read as follows: 105

~-------§ 26.107 Collecting a urine specimen.

• * * * * (b )( 1) The collector shall pay attention to the donor dur i ng the entire collection process , except as provided in § 26.109(b )( 1 ), to observe any conduct that indicates an attempt to subvert the testing process (e.g., tampering with a specimen; having a substitute urine in plain view; attempting to bring an adulterant , urine substitute , heating element , and/or temperature measurement device into the room , stall , or private area used for urination).

If any such conduct is detected, the collector shall document a description of the conduct on the Federal CCF and contact FFD program management to determine whether a directly observed collection is required , as described in § 26.115. (2) If a hydration monitor is used to observe a donor during the § 26.109(b )( 1) hydration process , this individual shall immediately inform the collector of any donor conduct that may indicate an attempt to subvert the testing process (e.g., donor leaves the collection site , donor refuses to follow i nstructions). * * * * * (d) If a refusal to test i s determined at any point during the specimen collection process , the collector shall: (1) Inform the donor that a refusal to test has been determined

(2) Terminate the collection process; (3) Document a description of the r efusal to test on the Federal CCF; 106 (4) Discard any urine specimen(s) provided by the donor, unless the specimen was collected for a post-event test under§ 26.31(c)(3);

and (5) Immediately inform the FFD program manager. 12. In§ 26.109: a. Revise paragraph (b )( 1) and add new paragraphs (b )( 1 )(i) through (iii); and b. In paragraph (b)(2) Ag dd the sentence "The collector shall provide the donor with a separate collection container for each successive specimen." as the new first sentence.

The additions and revisions read as follows: § 26.109 Urine specimen quantity.

• * * * * (b) * * * (1) The collector shall encourage the donor to drink a reasonable amount of liquid (normally, 8 ounces of water every 30 minutes, but not to exceed a maximum of 40 ounces over 3 hours3.472222e-5 days <br />8.333333e-4 hours <br />4.960317e-6 weeks <br />1.1415e-6 months <br />) until the donor provides a specimen of at least 30 ml. Alternatively, as specified in the licensee's or other entity's FFD program procedures, the collector may assign responsibility for monitoring a donor during the hydration process to another collector who meets the requirements in § 26.85(a) or to a hydration monitor who meets the requirements in § 26.4(9)(6).

If another collector or hydration monitor is used, the collector: (i) Shall explain the hydration process and acceptable donor behavior to the hydration monitor; 107 l (ii) Shall record the name of the other collector or hydration monitor on the Federal CCF and then provide the Federal CCF to that individual for the duration of the hydration process; and (iii) May perform other collections while the donor is in the hydration process; (2) The collector shall provide the donor with a separate collection container for each successive specimen.*

• * * * * *

• 13.ln§26.111

a. Revise paragraph (a), b. In paragraph (c), first sentence, remove the word " designated" and revise the third sentence , c. Revise paragraph (e) and d. Remove paragraph (f). The revisions read as follows: § 26.111 Checking the acceptability of the urine specimen. (a) Immediately after the donor provides the urine specimen to the collector , including specimens of less than 30 ml but equal to or greater than 15 ml , the collector shall measure the temperature of the specimen. The temperature measur i ng device used must accurately reflect the temperature of the specimen and not contaminate the specimen. The time from urination to temperature measurement may not exceed 4 minutes. If the temperature of a urine 108 specimen is outside the range of 90 °F to 100 °F (32 °C to 38 °C), that is a reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen.

• * * * * (c) ***In addition , the collector shall inform the donor that he or she may volunteer to submit a second specimen under direct observation to counter the reason to believe the donor may have altered (e.g., adulterated or diluted) or substituted the specimen.

• * * * * (e) As much of the suspect specimen as possible must be preserved , except under the conditions described in§ 26.107(d)(4).

14. In § 26.115: a. Revise paragraph (a) introductory text, paragraphs (a)(3) and (4), and add paragraph (a)(5); b. Revise paragraph (e); c. Revise paragraph (f) introductory text , republish paragraph (f)(1 ), and revise paragraphs (f)(2) and (3); and d. Revise paragraph (g). The additions and revisions read as follows: § 26.115 Collecting a urine specimen under direct observation. (a) Procedures for collecting urine specimens must provide for the donor's privacy unless directed by this subpart, or the MRO or FFD program manager determines that a directly 109 observed collection is warranted.

The following circumstances constitute the exclusive grounds for performing a directly observed collection:

• * * * * (3) The collector , or the hydration monitor if one is used as permitted in § 26.109(b )( 1 ), observes conduct by the donor indicating an attempt to subvert the testing process; (4) A directly observed collection is required under§ 26.69; aRGOr (5) The donor requests a retest and either Bottle B or the single specimen is not available due to circumstances outside of the donor's control , as described in § 26.165(f)(2). * * * * * (e) The collector shall ensure that the observer is the same gender as the donor. A person of the opposite gender may not act as the observer under any conditions.

The observer may be a different person from the collector and need not be a qualified collector. If the observer is not a qualified collector , the collector shall, in the presence of the donor, instruct the observer on the collection procedures in paragraph (f) before proceeding with the directly observed collection. (f) The individual who observes the collection shall follow these procedures:

(1) The observer shall 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; (2) The observer shall watch the donor urinate into the collection container. Specifically , the observer shall watch the urine go from the donor's body into the collection container.:. (a8 110 reflective mirror may be used to assist in observing the provision of the specimen only if the physical configuration of the room , stall , or private area is not sufficient to meet this direct observation requirement; the use of a video camera to assist in the observation process is not permitted~; (3) If the observer is not the collector , the observer may not touch or handle the collection container , but shall maintain visual contact with the specimen until the donor hands the collection container to the collector; and * * * * * (g) If a donor declines to allow a directly observed collection that is required or permitted under this section , the donor's refusal constitutes an act to subvert the test i ng process , and the collector shall follow the procedures in§ 26.107(d). * * * *

• 15. In§ 26.117: a. Revise paragraph (a); b. Revise the first sentence in paragraph (f); and c. Add in paragraph (g), the phrase ", except as provided in § 26.109(b )( 1 )(ii) for the Federal CCF" to the end of the first sentence. The addition and revisions read as follows: § 26.117 Preparing urine specimen for storage and shipping 111 (a) Once the collector is presented with the specimen from the donor, both the donor and the collector shall keep the donor's urine specimen(s) in view at all times before the specimen(s) are sealed and labeled. If any specimen or aliquot is transferred to another container, the collector shall ask the donor to observe the transfer and sealing of the container with a tamper-evident seal. * * * * * (f) The specimens and Federal CCFs must be packaged for transfer to the HHS-certified laboratory or to the licensee testing facility.

• * * *

• 16. In§ 26.129, revise paragraphs (b)(1 )(ii) and (b)(2) to read as follows: § 26.129 Assuring specimen security, chain of custody, and preservation.

• * * * * (b) * * * (1)*** (ii) If there is reason to believe that the integrity or identity of a specimen is in question (as a result of tampering or discrepancies between the information on the specimen bottle and on the accompanying Federal CCFs that cannot be resolved), the licensee testing facility shall reject the specimen for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical, except if a split specimen collection was performed, either the 112 Bottle A or Bottle B seal remains intact, and the intact specimen contains at least 15 ml of urine. In this instance , the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility.

(2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen and report a cancelled test result to the licensee or other entity: * * * *

• 17. Revise § 26.133 to read as follows: § 26.133 Cutoff levels for drugs and drug metabolites.

Subject to the provisions of § 26.31 ( d)(3)(iii), licensees and other entities may specify more stringent cutoff levels for drugs and drug metabolites than those in the table below and, in such cases, may report initial test results for only the more stringent cutoff levels. Otherwise , the following cutoff levels must be used for initial testing of urine specimens to determine whether they are negative or positive for the indicated drugs and drug metabolites:

113 INITIAL TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Cutoff level Marijuana metabolites

...................................................... . Cocaine metabolites

........................................................ . Opiate metabolites:

Codeine/Morphine 1 .....................................

......... . 6-acetylmorphine (6-AM) ..............

....................... . Phencyclidine (PCP) ...................................................

..... . Amphetamines 2: AMP/MAMP 3 ................................

....................... ,. MDMA 4 .................

........................

........................ . 1 Morphine is the target analyte for codeine/morphine testing. 2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff. 50 150 2000 10 25 500 500 3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing. 4 Methylenedioxymethamphetamine.

18. In § 26.137, revise paragraphs ( d)(5),( e )(6), ( e )(6)(i) through (iii), and ( e )(6)(v) to read as follows: § 26.137 Quality assurance and quality control. * * * * * (d) * * * (5) Each analytical run performed to conduct initial validity testing shall include at least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.

• * * * * (e) * *

• 114 (6) A minimum of 10 percent of the total specimens in each analytical run of specimens to be initially tested for drugs and drug metabolites by the licensee testing facility must be quality control samples (i.e., calibrators and controls), which the licensee testing facility shall use for internal quality control purposes. (These samples are not forwarded to the HHS-certified laboratory for further testing, other than for performance testing of the samples.)

Licensee testing facilities shall ensure that quality control samples that are positive for each drug and drug metabolite for which the FFD program conducts testing are included in at least one analytical run each calendar quarter. The quality control samples for each analytical run must include-(i) At least one control certified by an HHS-certified laboratory to contain no drug or drug metabolite

(ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; (iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff; (iv) * * * (v) At least one quality control sample that appears to be a normal specimen to the licensee testing facility technicians.

• * * *

• 19. In§ 26.153 , revise paragraphs (a) and (g) to read as follows: 115

§ 26.153 Using certified laboratories for testing urine specimens. (a) Licensees and other entities who are subject to this part shall use only HHS-certified laboratories as defined in § 26.5. * * * * * (g) If licensees or other entities use a form other than the current Federal CCF, licensees and other entities shall provide a memorandum to the laboratory explaining why a non-Federal CCF was used, but must ensure, at a minimum, that the form used contains all the required information on the Federal CCF. 20. Remove and reserve § 26.155. § 26.155 [Remove and Reserve] 21. In§ 26.157 revise paragraph (a); remove and reserve paragraph (b); and remove paragraphs (c)-(e). The revision to read as follows: § 26.157 Procedures. (a) HHS-certified laboratories shall develop, implement, and maintain procedures specific to this part that document the accession, receipt, shipment, and testing of specimens. (b) [Reserved]

116

22. In§ 26.159, revise paragraph (b)(1)(ii), (b)(2), the second sentence in paragraph (c), and paragraphs (d) and (e) to read as follows: § 26.159 Assuring specimen security, chain of custody, and preservation.

• * * * * (b) * * * . (1)*** (ii) If the licensee or other entity has reason to question the integrity and identity of the specimens , the laboratory shall reject the specimens for testing. The licensee or other entity shall ensure that another collection occurs as soon as reasonably practical , except if a split specimen collection was performed, either the Bottle A or Bottle B seal remains intact , and the intact specimen contains at least 15 ml of urine. In this instance, if the licensee testing facility has retained the specimen in Bottle B, the licensee testing facility shall forward the intact specimen for testing to the HHS-certified laboratory and may not conduct any testing at the licensee testing facility. (2) The following are exclusive grounds requiring the MRO to cancel the testing of a donor's urine specimen, and report a cancelled test to the licensee or other entity: * * * * * (c) ***Laboratory personnel shall use aliquots and laboratory internal chain of custody forms when conducting initial and confirmatory tests. 117 (d) The laboratory's internal chain of custody form must allow for identification of the donor, and documentation of the testing process and transfers of custody of the specimen. (e) Each time a specimen is handled or transferred within the laboratory , laboratory personnel shall document the date and purpose on the chain of custody form and every individual in the chain shall be identified. Authorized technicians are responsible for each urine specimen or aliquot in their possession and shall sign and complete chain of custody forms for those specimens or aliquots as they are received. * * * *

• 23. In§ 26.161: a. In paragraphs (c)(3) and (c)(4), (f)(5), and (f)(7) remove the term " LOO" and add in its place the term " LOQ"; and b. Revise paragraphs (c)(5) and (c)(6) to read as follows: § 26.161 Cutoff levels for validity testing. * * * * * (c)*** (5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (e.g., gas chromatography/mass spectrometry (GC/MS)) for the confirmatory test with the glutaraldehyde concen t ration equal to or greater than the LOQ of the analysis on the second aliquot; 118 (6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/ml nitrite-equivalent cutoff or an equal to or greater than 50 mcg/ml chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test ( chromium (VI) concentration equal to or greater than 50 mcg/ml) for the initial test on the first aliquot and a d i fferent confirmatory test (e.g., GC/MS) for the confirmatory test with the pyridine concentration equal to or greater than the LOQ of the analysis on the second aliquot; * * * *

• 24. In§ 26.163: a. Republish paragraph (a) introductory text and revise paragraphs (a)(1 ), (a)(2), (a)(2)(i) and (a)(2)(ii)

and b. Republish paragraph (b) introductory text and revise paragraph (b )( 1) to read as follows

§ 26.163 Cutoff levels for drugs and drug metabolites. (a) Initial drug testing. (1) HHS-certified laboratories shall apply the following cutoff levels for i nitial testing of spec i mens to determine whether they are negative or positive for the indicated drugs and drug metabolites , except as spec i fied i n paragraph (a)(2) of th i s sect i on or the licensee or other entity has established more stringent cutoff levels: 119 INITIAL TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Cutoff level Marijuana metabolites

............................

........................... . Cocaine metabolites

...............................................

.......... . Opiate metabolites:

Codeine/Morphine 1 *****.**.***.*.*.**....*..**.*...*..**..**.*.... 6-acetylmorphine (6-AM) ......................

................ . Phencyclidine (PCP) ...............

......................

................... . Amphetamines 2: AMP/MAMP 3 .......................................

............

..... . MDMA 4 ..............

...............

..............................

...... . 1 Morphine is the target analyte for codeine/morphine testing. 2 Either a single initial test kit or multiple initial test kits may be used provided the single test kit detects each target analyte independently at the specified cutoff. 3 Methamphetamine (MAMP) is the target analyte for amphetamine (AMP)/MAMP testing. 4 Methylenedioxymethamphetamine.

(2) HHS-certified laboratories shall conduct special analyses of specimens as follows: (i) If initial validity testing indicates that a specimen is dilute, or if a specimen is collected under direct observation for any of the conditions specified in § 26.115(a)(1) through (a)(3) or (a)(5), the laboratory shall compare the immunoassay responses of the specimen to the cutoff calibrator in each drug class tested; (ii) If any immunoassay response is equal to or greater than 40 percent of the cutoff calibrator , the laboratory shall conduct confirmatory drug testing of the specimen to the LOO for those drugs and/or drug metabolites; and * * * * * /ml 50 150 2000 10 25 500 500 (b) Confirmatory drug testing. ( 1) A specimen that is identified as positive on an initial drug test must be subject to confirmatory testing for the class(es) of drugs for which the specimen initially 120

• tested positive. The HHS-certified laboratory shall apply the confirmatory cutoff levels specified in this paragraph, except as permitted in paragraph (a)(2) of this section or the licensee or other entity has established more stringent cutoff levels. CONFIRMATORY TEST CUTOFF LEVELS FOR DRUGS AND DRUG METABOLITES Drugs or drug metabolites Cutoff level n /ml Marijuana metabolite 1 ..*...................................

....................*.....

Cocaine metabolite 2 .....*......*.

• • • ..***......*.*...............

.............*...*.. Opiate metabolites:

Morphine ...................................................

................... . Codeine .............................

.................................

.......... . 6-acetylmorphine (6-AM) ......................................

....... . Phencyclidine (PCP) ....................................

............................ . Amphetamines:

Amphetamine

....................................................... . Metham phetam i ne 3 ***....**...............................*

...*..*...*.. MOMA ..............................................

......................

..... . MDA 4 ......*..........................

• ...................

• ...*................*. MDEA 5 .................................

...............**.*........*....*........ 1 As delta-9-tetrahydrocannabinol-9-carboxylic acid (THCA). 2 As benzoylecgonine.

3 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 100 ng/ml. 4 Methylenedioxyamphetamine.

5 Methylenedioxyethylamphetamine. * * * *

• 15 100 2000 2000 10 25 250 250 250 250 250 25. In § 26.165, revise the fourth sentence in paragraph (b )(2), paragraph (b )(3), the last sentence in paragraph (f)(1 ), and paragraph (f)(2) to read as follows: § 26.165 Testing split specimens and retesting single specimens.

• * * *

• 121 (b) * * * (2) ***The MRO shall document in his or her records when (i.e., date and time) the request was received from the donor to retest an aliquot of the single specimen or to test the Bottle B split specimen.

(3) No entity , other than the MRO as permitted in § 26.185(1), may order the retesting of an aliquot of a single specimen or the testing of the Bottle B split specimen without the donor's 1 Nritten permission. * * * * * (f) * * * (1) * *

• If the results of testing Bottle B or retesting the aliquot of a single specimen are negative , the MRO shall report a cancelled test result to the licensee or other entity , and the licensee and other entity-* * * * * (2) If a donor requests that Bottle B be tested or that an aliquot of a single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to, circumstances in which there is an insufficient quantity of the single specimen or the specimen in Bottle B 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 lost at the HHS-certified laboratory or licensee testing facility), the MRO shall cancel the test , report a cancelled test resul t to the licensee or other entity for the donor's 122 specimen, and inform the licensee or other entity that another collection is required under direct observation as soon as reasonably practical.

The donor shall receive no notice of the collection requirement before he or she is instructed to proceed to the collection site. The licensee or other entity shall continue to administratively withdraw the individual's authorization, as required by § 26.165(f)( 1) until the results of the second specimen collection have been received by the MRO. The licensee or other entity shall eliminate from the donor's personnel and other records any matter that could link the donor to the original positive, adulterated, or substituted test result(s) and any temporary administrative action, and may not impose any sanctions on the donor for a cancelled test. If test results from the second specimen collected are positive, adulterated, or substituted and the MRO determines that the donor has violated the FFD policy, the licensee or other entity shall impose the appropriate sanctions specified in subpart D of this part, but may not consider the original confirmed positive, adulterated, or substituted test result that was reported as a cancelled test by the MRO under§§ 26.129(b )(2) or 26.159(b )(2) in determining the appropriate sanctions.

26. In§ 26.167: a. Republish paragraph (d)(3), and revise paragraphs (d)(3)(i) through (iii); b. Revise paragraph (d)(4); c. Revise paragraph (e)(2), republish paragraph (e)(3), and revise paragraphs (e)(3)(i) through (iv); and d. Revise paragraph (f)(3) to capitalize the words " responsible person". The revisions read as follows: § 26.167 Quality assurance and quality control. 123

• * * * * (d) * * * (3) Quality control samples for each analytical run of specimens for initial testing must include-(i) At least one control certified to contain no drug or drug metabolite; (ii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; (iii) At least one positive control with the drug or drug metabolite targeted at 75 percent of the cutoff; * * * * * ( 4) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls), as defined by paragraphs (d)(3)(i) through (iv) of this section. (e)*** (2) A minimum of 10 percent of the total specimens in each analytical run must be quality control samples (i.e., calibrators and controls).

(3) Each analytical run of specimens that are subjected to confirmatory testing must include-(i) At least one control certified to contain no drug or drug metabolite

(ii) A calibrator with its drug concentration at the cutoff; 124 (iii) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and (i v) At least one control targeted at or below 40 percent of the cutoff. * * * *

• 27. In § 26.168 , revise paragraph (h )( 1) to read as follows: § 26.168 Blind performance testing. * * * * * (h) * * * (1) Ensure that all blind performance test sample lots are placed in service by the supplier only after confirmation by an HHS-certified laboratory;

• * * *

• 28. In § 26.169: a. In paragraph (a) wherever it may appear , capitalize the words " certifying scientist". b. Republish paragraph (h)(3), and revise paragraphs (h)(3)(i) and (ii), (h)(3)(iii)(C), and (h)(3)(iv);

c. Republish paragraph (h)(3)(v) and revise paragraph (h)(3)(v)(A)

and d. Add new paragraphs (h)(3)(v)(C) through (E). 125 The additions and revisions read as follows

§ 26.169 Reporting results. * * * * * (h) * * * (3) Number of specimens reported as positive on confirmatory tests by drug or drug metabolite for which testing is conducted , including , but not limited to-(i) Marijuana metabolite (as THCA); (ii) Cocaine metabolite (as benzoylecgonine)

(iii)*** (C) 6-acetylmorphine (6-AM); (iv) Phencyclidine (PCP); (v) Amphetamines (total); (A) Amphetamine

(B)*** (C) Methylenedioxymethamphetamine (MOMA); (D) Methylenedioxyamphetamine (MDA); and (E) Methylenedioxyethy l amphetamine (MDEA); 126

• * * *

• 29. In§ 26.183, revise paragraphs (c) introductory text, (c)(1), and (d)(2)(ii) to read as follows: § 26.183 Medical review officer. * * * * * ( c) Responsibilities.

The primary role of the MRO is to review and interpret positive , adulterated, substituted, invalid, and dilute test results obtained through the licensee's or other entity's testing program and to identify any evidence of subversion of the testing process. The MRO is also responsible for identifying any issues associated with collecting and testing specimens, and for advising and assisting FFD program management in planning and overseeing the overall FFD program. (1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any positive, adulterated, substituted, invalid, or dilute test result. This action may include , but is not limited to , conducting a medical interview with the donor , reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive, adulterated, substituted, invalid, or dilute test result could have resulted from responsible use of legally prescribed medication , a documented condition or disease state, or the demonstrated physiology of the donor. * * * *

• 127 (d)*** (2) * * * (ii) The staff reviews of positive, adulterated, substituted, invalid , and dilute test results must be limited to reviewing the Federal CCF to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in Federal CCFs that require corrective action(s), but shall forward the Federal CCFs to the MRO for review and approval of the resolution.

• * * *

• 30. In § 26.185: a. Redesignate paragraph (f)(3) as (f)(4), and add new paragraph (f)(3); b. In paragraph (g)(1) remove the reference "paragraph (g)(4)" and add in its place the reference "paragraph (g)(3)"; and c. Revise paragraphs (g)(2) and (g)(2)(iii), remove paragraph (g)(3); and redesignate paragraphs (g)(4) and (g)(5) as paragraphs (g)(3) and (g)(4), respectively. The addition and revisions read as follows: § 26.185 Determining a fitness-for-duty policy violation.

• * * * * (f) * *

• 128 (3) If the MRO and the laboratory agree that further testing would not be useful and there is no legitimate technical or medical explanation, and the invalid result is based on pH in the range of 9.0 to 9.5, the MRO shall consider whether there is evidence of elapsed time, exposure of the specimen to high temperature, or both that could account for the pH value. If an acceptable explanation exists for the invalid test result due to pH, based on objective and sufficient information, that elapsed time, high temperature, or both caused the high pH and donor action did not result in the invalid pH result, the MRO shall report a cancelled test result to the licensee or other entity, cancel the test result, and direct the licensee or other entity to collect a second urine specimen from the donor as soon as reasonably practicable. The second specimen collected may not be collected under direct observation.

• * * * * (g) * * * (2) If the results of the special analysis testing required by§ 26.163(a)(2) are positive, the MRO determines that there is no legitimate medical explanation for the presence of the drug(s) or drug metabolite(s) in the specimen, and a clinical examination , if required under paragraph (g)(3) of this section, has been conducted under paragraph U) of this section, the MRO shall determine whether the positive and dilute specimen is a refusal to test. If the MRO does not have sufficient reason to believe that the positive and dilute specimen is a subversion attempt, he or she shall determine that the drug test results are positive and that the donor has violated the FFD policy. When determining whether the donor has diluted the specimen in a subversion attempt, the MRO shall also consider the following circumstances, if applicable:

• * * *

• 129 (iii) The collector observed conduct indicating an attempt to dilute the specimen.

• * * *

• 31. In§ 26.405, revise paragraph (d) to read as follows: § 26.405 Drug and alcohol testing. * * * * * (d) At a minimum , licensees and other entities shall test specimens for marijuana metabolite , cocaine metabolite , opiates ( codeine, morphine , 6-acetylmorphine

), amphetamines ( amphetamine , metham phetam i ne , methylened ioxymetha mphetam i ne , methylenedioxyamphetamine , and methylenedioxyethylamphetamine

), phencyclidine , adulterants, and alcohol at the cutoff levels specified in this part , or comparable cutoff levels if specimens other than urine are collected for drug testing. Urine specimens collected for drug testing must be subject to validity testing. * * * *

• 32. In§ 26.415(c), remove the citation , " (65 FR 41944; August 9 , 2001)". 33. In§ 26.717 , revise paragraphs (b)(3) and (4) to read as follows: § 26. 717 Fitness-for-duty program performance data. 130

• * * * * (b) * * * (3) Populations tested (i.e., licensee or other entity employees, CNs); (4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees, CNs); * * * *

• Dated at Rockville, Maryland, this_ day of ____ , 2017. For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission.

131

• * * * * (b) * * * (3) Populations tested (i.e., licensee or other entity employees, CNs); (4) Number of tests administered and results of those tests sorted by population tested (i.e., licensee or other entity employees, CNs); * * * *

• Dated at Rockville, Maryland, this_ day of ____ , 2017. DISTRIBUTION:

Public RidsResOd Resource RidsNroMailCenter Resource RidsNroOd Resource RidsNsirMailCenter Resource RidsNsirOd Resource RidsOeMailCenter Resource RidsAdmMailCenter Resource RidsNmssOd Resource RidsOgcMailCenter Resource RidsOcfoMailCenter Resource RidsACRS_MailCTR Resource HBenowitz , OGC DCullison , OCIO For the Nuclear Regulatory Commission. Annette Vietti-Cook, Secretary of the Commission.

LCupidon , CRGR RCorreia, RES SPeters, RES VBames, RES DKi, RES MGalloway, NSIR WGott, NSIR PHarris , NSIR BZaleski, NSIR NHilton , OE DFurst, OE MMayfield, NRO JColaccino, NRO SSahle, NRO MCheok, NRO DDesaulniers , NRO CBladey, ADM l Terry, ADM TBarczy , ADM JShepherd , ADM CErlanger, NMSS RJohnson, NMSS KRamsey, NMSS Llund , NRR MGavrilas, NRR Glappert, NRR SSchneider, NRR ADAMS Accession No(s): (Pkg) ML16123A004

• via email OFFICE NSIR/DSP/FCTSB/PM*

NRR/DPR/PRMB/PM NRR/DPR/PRMB/RS NRR/DPR/PRMB/BC NAME BZaleski SSchneider Glaooert MKhanna DATE 5/25/2016 5/27/2016 5/31/2016 6/20/2016 OFFICE NRR/DPR/D NRO/D* NMSS/D* RES/D* NAME Llund JUhle, MCheok for SMoore, Mlombard for MWeber , RCorreia for DATE 6/28/2016 7/12/2016 7/12/2016 7/8/2016 OFFICE OE/D* OCFO/D* NSIR/D* ADM/DAS/RA DB/BC* NAME PHolahan, DFurst for MWylie, VPortillo for BHolian , CJohnson for CBladev , CGallaaher for DATE 7/11/2016 7/11/2016 8/15/2016 8/8/2016 OFFICE OCIO/CSD/FPIB/CO OGC (NLO) NRR/D EDO NAME DCullison HBenowitz WDean VMcCree DATE 10/27/2016 10/07/2016 12/1/2016 2/22/2017 OFFICIAL RECORD COPY 127