ML22133A046

Response to SRM-M220323: Final Rule-Backfitting and Issue Finality Assessment for Fitness for Duty Drug Testing Requirements

ML22133A046
Person / Time
Issue date:	11/10/2022
From:	Office of Nuclear Material Safety and Safeguards, Office of Nuclear Reactor Regulation, Office of Nuclear Security and Incident Response
To:
Schneider, Stewart
Shared Package
ML22133A033	List: ML22133A034 ML22133A046 ML22133A052
References
Final Rule, Fitness for Duty, NRC-2009-0225, RIN 3150-AI67
Download: ML22133A046 (15)

Text

Backfitting and Issue Finality Assessment for the 10CFRPart26 Fitness for Duty Drug Testing Requirements Final Rule

[Docket ID NRC-2009-0225]

U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Office of Nuclear Material Safety and Safeguards Office of Nuclear Reactor Regulation

November 2022

[Page Intentionally Blank]

I. Introduction

The U.S. Nuclear Regulatory Commission (NRC) is amending Part 2 6 of Title 10 of the Code of Federal Regulations (10 CFR), Fitness for Duty Programs, to more closely align t he drug testing requirements with the U.S. Department of Health and Hum an Services (HHS)

Mandatory Guidelines for Federal Workplace Drug Testing Progra ms (HHS Guidelines). The amendments require nuclear power plant licensees, Category I sp ecial nuclear material licensees, and contractors/vendors subject to the requirements of 10 CFR Part 26 to update existing fitness for duty (FFD) program policies and procedures, conduct training, revise contracts with HHS-certified laboratories and blind performance test sample providers, perform mandatory special analyses testing on some specimens, and modif y the drug testing panel.

The final rule constitutes new or amended provisions in the Com missions regulations that result in licensees modifying the procedures required to operate a fac ility. Therefore, it meets the definition of backfitting in 10 CFR 50.109(a)(1) and 10 CFR 7 0.76(a)(1) and affects the issue finality of combined license holders under 10 CFR 52.98, Final ity of combined licenses; information requests. This backfitting and issue finality ass essment examines the aggregation of the subset of the final rules requirements that constitute backfits, which are identified in Section III.B. of this document. 1 The backfit analysis in this assessment concludes that the changes in the final rule will result in a substantial increase in the overall protection of public health and safety or the common defense and security and that t he costs of implementing these changes are justified in view of this increase in protection. Moreover, because the final rule is supported by a backfit analysis under 10 CFR 50.109, Backfitti ng, the final rule meets the issue finality criteria in 10 CFR 52.98(a).

II. Background

The NRC relies on the HHS Guidelines as the technical basis for establishing and updating the FFD program requirements in 10 CFR Part 26. The NRC has deviat ed from the HHS Guidelines only for considerations specific to the nuclear indu stry. Updates to the HHS Guidelines were published in the Federal Register on November 25, 2008 (73 FR 71858) (2008 HHS Guidelines), and on January 23, 2017 (82 FR 7920) (2017 HHS Guidelines). The final rule harmonizes select drug testing requirements in 10 CFR Part 26 w ith the 2008 and 2017 HHS Guidelines and reflects lessons learned from implementing the 2 008 10 CFR Part 26 final rule (Fitness for Duty Programs; Final Rule (73 FR 16966; March 31, 2008)).

By aligning many of the NRC regulations with the HHS Guidelines, the final rule enhances the detection of individuals who are not fit for duty because of il legal drug use, legal drug misuse, or an attempt to subvert the drug testing process. This enables t he NRC to maintain the FFD program performance objectives in 10 CFR 26.23(c), to provide reasonable measures for the early detection of individuals who are not fit to perform the d uties that require them to be subject to the FFD program, and in 10 CFR 26.23(d), to provide reason able assurance that the workplaces subject to this part are free from the presence and effects of illegal drugs. The final rule enhances the ability of licensees to identify individuals seeking employment in or already working in the commercial nuclear workforce who are using illeg al drugs, misusing legal drugs, or attempting to subvert the drug testing process. Furthermore, the changes could deter

1 The majority of the requirements constituting backfits achieve two of the three rule objectives, as presented in Table 5-19, Disaggregation, in the regulatory analysis. As a result, disaggregation of the costs and benefits according to the rulemaking objectives does not have meaningful implications for the cost-benefit results.

1 additional individuals using drugs from seeking employment in w orkplaces covered by 10 CFR Part 26 and could either deter existing employees from b eginning to use drugs or encourage them to cease undetected use or seek medical assistan ce to address an addiction or misuse issue, or both.

By maintaining reasonable assurance of a drug-free workplace by strengthening the ability of licensees to detect individuals who are not fit for duty becaus e of illegal drug use, legal drug misuse, or an attempt to subvert the drug testing process, the final rule enhances licensees FFD authorization and access authorization programs. Granting or maintaining access authorization under 10 CFR Part 73, Physical Protection of Pla nts and Materials, is contingent on an individual meeting the FFD authorization requirements in 10 CFR Part 26, which, in part, mandate that the individual have negative test results for drug s. An individual who uses an illegal drug or misuses a legal drug represents a safety vulner ability because drug-induced impairment may cause or contribute to human performance errors that may result in unplanned occupational exposure; personal safety issues; unplanned radiol ogical releases; or improper operation, maintenance, or surveillance of safety-or security-related structures, systems, and components (SSCs). Additionally, granting or maintaining unesc orted access authorization for these individuals presents a security vulnerability because the use of illegal drugs, misuse of legal drugs, and subversion of the 10 CFR Part 26 drug testing program are indicators that an individual is not trustworthy and reliable. An individual exhi biting one or more of these characteristics cannot be granted unescorted access authorizati on (either physically or electronically) because it would challenge the defense in depth afforded by the access authorization requirements in 10 CFR Part 26 and 10 CFR Part 73.

The final rule also enhances donor protection and due process r equirements for individuals subject to drug testing by (1) adding instructions for same-gen der observers who perform an observed collection when a trained collector of the same gender as the donor is not available, (2) requiring the limit of quantitation for special analyses te sting of drugs and testing for adulterants (an added measure of testing accuracy), (3) adding a review by a medical review officer (MRO) of invalid test results of high pH (9.0 to 9.5), and (4) requiring the MRO to document the date and time an oral request was received from a donor to initiate the retesting of a specimen.

The final rule applies to all current nuclear power plant licen sees (i.e., holders of operating licenses under 10 CFR Part 50, Domestic Licensing of Productio n and Utilization Facilities, renewed licenses under 10 CFR Part 54, Requirements for Renewa l 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 license s authorizing the possession, use, or transport of formula quantities of strategic special nu clear material under 10 CFR Part 70, Domestic Licensing of Special Nuclear Material. The final rule also applies to holders of a certificate of compliance or an approved complianc e plan under 10 CFR Part 76, Certification of Gaseous Diffusion Plants, if the holder enga ges in activities involving formula quantities of strategic special nuclear material. Some or all of the final rule would apply to (1) current and future applicants for combined licenses under 1 0 CFR Part 52 that have been issued a limited work authorization (LWA) under 10 CFR 50.10(e), if the LWA authorizes the applicant to install the foundations, including the placement o f concrete, for safety-and security-related SSCs under the LWA; (2) combined license holde rs before the Commission has made the finding under 10 CFR 52.103(g); (3) construction permi t applicants under 10 CFR Part 50 that have been issued an LWA, if the LWA authori zes the applicant to install the foundations, including the placement of concrete, for safety-a nd security-related SSCs under the LWA; (4) construction permit holders, and (5) early site pe rmit holders that have been

2 issued an LWA, if the LWA authorizes the early site permit hold er to install the foundations, including the placement of concrete, for safety-and security-r elated SSCs under the LWA. The final rule also applies to contractor/vendors who implement FFD programs or program elements, to the extent that the licensees and other entities described i n this paragraph rely on those contractor/vendor FFD programs or program elements to meet the requirements of this 10 CFR Part 26.

III. Backfitting

A. Applicable Entities

The final rule constitutes backfitting as defined under 10 CFR 50.109(a)(1) for holders of 10 CFR Part 50 operating licenses and construction permits and 10 CFR Part 54 renewed licenses, and under 10 CFR 70.76(a)(1) for applicable 10 CFR Pa rt 70 licensees, as of the final rules effective date. The final rule also affects the issue f inality accorded to holders of a combined license under 10 CFR Part 52 as of the final rules ef fective date.

The final rule is not backfitting for applicants for constructi on permits or operating licenses under 10 CFR Part 50 or 10 CFR Part 70 licenses and does not affect i ssue finality of applicants for early site permits or combined licenses under 10 CFR Part 52. These applicants are not, with certain exceptions not applicable here, within the scope of the backfitting or issue finality provisions. The backfitting and issue finality regulations inc lude language delineating when the backfitting and issue finality provisions begin; with some exce ptions, they begin after the issuance of a license, permit, or other approval (e.g., 10 CFR 50.109(a)(1)(iii),

10 CFR 52.98(a)). Furthermore, neither the backfitting provisi ons nor the issue finality provisions, with certain exceptions not applicable here, are in tended to apply to NRC actions that substantially change the expectations of current and futur e applicants. Applicants cannot reasonably expect that future requirements will not change.

The provisions under 10 CFR Part 26 also apply to applicants fo r construction permits, early site permits, or combined licenses that have been issued an LWA if t he LWA authorizes the applicant to install the foundations, including the placement o f concrete, for safety-and security-related SSCs under the LWA. However, as of the final rules effective date, no applicant for a construction permit, early site permit, or comb ined license holds an LWA, so no such entity is within the scope of a backfitting or issue final ity provision. Similarly, no entity holds a certificate of compliance or an approved compliance pla n under the provisions of 10 CFR Part 76, so no entity is within the scope of the backfit ting provisions of 10 CFR 76.76, Backfitting.

B. Description of Backfits

The final rule consists of nine categories of amendments to the NRCs regulations. These amendments will result in modifications to the procedures requi red to operate a facility. Thus, they meet the definition of backfitting under 10 CFR 50.109(a )(1) and 10 CFR 70.76(a)(1) or affect the issue finality of a holder of a combined license und er 10 CFR Part 52.

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1. Lower initial and confirmatory testing cutoff levels for amphetamines and cocaine metabolites.

The final rule updates the cutoff levels for initial testing, l isted in 10 CFR 26.133, Cutoff levels for drugs and drug metabolites, and 10 CFR 26.163(a)(1), and c onfirmatory testing, listed in 10 CFR 26.163(b)(1), to conform with changes to the 2008 HHS Gu idelines. The final rule does the following:

• lowers the initial drug testing cutoff level for amphetamines from 1,000 nanograms (ng) per milliliter (mL) to 500 ng/mL

• lowers the confirmatory drug testing cutoff levels for ampheta mine and methamphetamine from 500 ng/mL to 250 ng/mL

• lowers the initial drug testing cutoff level for cocaine metab olites from 300 ng/mL to 150 ng/mL

• lowers the confirmatory drug testing cutoff level for cocaine metabolite from 150 ng/mL to 100 ng/mL

2. Expand initial drug testing panel to include heroin metabolite 6-acetylmorphine (6-AM) and revise confirmatory testing cutoff level for 6-AM.

The final rule requires each urine specimen to be tested for 6-AM. The NRC revised the drug testing panel in 10 CFR 26.133 and 10 CFR 26.163(a) to include initial testing for 6-AM at a cutoff level of 10 ng/mL. The final rule also removes the requ irement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine co ncentration exceeding 2,000 ng/mL (i.e., if initial testing for 6-AM is positive, con firmatory testing for 6-AM is to proceed independent of the morphine concentration).

3. Expand initial and confirmatory drug testing panels to include Ecstasy-type drugs.

The final rule requires each urine specimen to be tested for Ec stasy-type drugs. The NRC revised the list of substances for which each urine specimen is tested in 10 CFR 26.133 and 10 CFR 26.163(a) to include initial testing for methylenedioxym ethamphetamine (MDMA) and methylenedioxyamphetamine (MDA), identified in the final rule a s Ecstasy-type drugs, at a cutoff level of 500 ng/mL. The final rule also amends 10 CFR 2 6.163(b) to include confirmatory testing for MDMA and MDA at a confirmatory test cutoff level of 250 ng/mL. The NRC made conforming changes to add MDMA and MDA to the annual statistica l summary reporting requirements for HHS-certified laboratories in 10 CFR 26.169(h) (3).

4. Expand initial and confirmatory opioid testing panel to include hydrocodone, hydromorphone, oxycodone, and oxymorphone.

The final rule requires each urine specimen to be tested for fo ur opioids: hydrocodone, hydromorphone, oxycodone, and oxymorphone. The NRC revised the list of substances for

4 which each urine specimen is tested in 10 CFR 26.133 and 10 CFR 26.163(a) to include initial testing for hydrocodone and hydromorphone at a cutoff level of 300 ng/mL and oxycodone and oxymorphone at a cutoff level of 100 ng/mL. The final rule als o amends 10 CFR 26.163(b) to include confirmatory testing for hydrocodone, hydromorphone, ox ycodone, and oxymorphone at a confirmatory test cutoff level of 100 ng/mL. In 10 CFR 26.16 9(h)(3), the NRC made conforming changes to add hydrocodone, hydromorphone, oxycodone, and oxymorphone to the annual statistical summary reporting requirements for HHS-certi fied laboratories.

5. Require special analyses testing of dilute specimens and specimens collected during suspected subversion attempts.

The final rule requires mandatory special analyses testing of s pecimens involving subversion attempts and dilute specimens with an immunoassay response that is equal to or greater than 40 percent of the cutoff calibrator in a drug class. This chan ge to 10 CFR 26.163(a)(2) increases the number of specimens that are subject to confirmat ory testing and thereby improves the ability of licensees to identify instances in whic h individuals may be attempting to subvert the testing process.

6. Require the use of the limit of quantitation (LOQ) instead of the limit of detection (LOD) as the decision point for special analyses testing and adulterant testing of specimens.

The final rule requires the use of the LOQ instead of the LOD a s the level at which special analyses testing and adulterant testing would be performed. Th e difference between the LOD and the LOQ for a testing assay is the ability to reliably quan tify the analyte (e.g., drug, adulterant). At the LOD, the test must meet all HHS-certified laboratory criteria for result acceptance except quantitation. At the LOQ, the test must reli ably confirm the presence of the analyte, reliably quantify the concentration of the analyte, an d meet all HHS-certified laboratory criteria for result acceptance. Use of the LOQ provides additi onal donor protection with regard to the accuracy of special analyses and adulterant test results.

7. Require additional MRO review for specimens with invalid validity test results due to high pH values (9.0 to 9.5) and MRO actions when a donor requests testing a Bottle B specimen or retesting an aliquot of a single specimen.

The final rule requires additional actions by the MRO in three circumstances. First, under 10 CFR 26.185(f)(3), the MRO must consider whether elapsed time or high temperature, or both, could have caused an invalid validity test result due to high pH (9.0 to 9.5). Second, if a donor makes an oral request to the MRO for the testing of the B ottle B specimen or a retest of an aliquot of a single specimen, then, under 10 CFR 26.165(b)(2 ), the MRO must document the date and time that the request was received from the donor. In practice, MROs had been performing this action already, but the former rule did not spe cify the documentation requirement. Third, if a donor requests testing of Bottle B or retesting a single specimen, and the specimen to be tested is unavailable because of circumstanc es outside of the donors control, then, under 10 CFR 26.165(f)(2), the MRO must report a cancelled test to the licensee for the donors specimen and order a second collection without prior notice to the donor.

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8. Require the testing of any specimen(s) collected during post-event testing when a refusal to test has been determined during the collection process.

The final rule requires, in 10 CFR 26.107(d)(5), the testing of any specimen collected during a post-event testing situation, even if a refusal to test has bee n determined during the collection process. Previously, any specimen collected could be discarded. In an effort to improve the root-cause evaluation process associated with accidents, the NR C is requiring testing of any collected urine specimen to ensure that all available informati on is obtained to support the evaluation of human performance associated with the accident.

9. Implement the drug testing program changes.

As a result of the above changes to 10 CFR Part 26, licensees w ill need to make several one-time changes to their FFD program policies and procedures, conduct training, and revise contracts with HHS-certified laboratories and blind performance test sample providers.

IV. Basis for Not Performing a Documented Evaluation

The NRC determined that the final rules amendments to 10 CFR P art 26 are not necessary to ensure that the subject facilities provide adequate protection to the public health and safety and are in accord with the common defense and security, define or r edefine the level of protection to the public health and safety or the common defense and security deemed to be adequate, or bring a facility into compliance with a license or the rules or orders of the Commission or into conformance with written commitments by the licensee. The curr ent requirements in 10 CFR Part 26 do not present a condition of undue risk to publ ic health and safety, and the final rule is not necessary to address a compliance issue. The refore, the final rule does not involve the adequate protection or the compliance exceptions to the requirement in 10 CFR 50.109(a)(2)-(3) to justify the backfits with a backfit analysis.

V. Benefits

As explained in the regulatory analysis supporting the final ru le (Agencywide Documents Access and Management System Accession No. ML22133A044), the NR C identified quantitative and qualitative benefits of the final rule. The f inal rule is estimated to result in a 16-to 29-percent increase in the number of individuals identif ied each year using illegal drugs, misusing legal drugs, or attempting to subvert the testing proc ess and who would be determined not to be fit for duty or not trustworthy and reliable, or both, as compared to the average number of individuals with a positive test result or identified as att empting to subvert a test for calendar year (CY) 2009 through CY 2019. The 16-to 29-percent increase equates to an average of approximately 180 individuals each year.

Between 2009 and 2019, pre-access testing accounted for (on ave rage) 67 percent of positive test results each year. The 16-to 29-percent increase in addi tional positive test results or identified subversion attempts each year means that an average of approximately 120 individuals per year will test positive or be identified as att empting to subvert a test before receiving unescorted access authorization and completion of tra ining, thereby saving licensees and other entities approximately $4.3 million in averted traini ng costs using a 7-percent discount rate (approximately $6.5 million using a 3-percent discount rat e) over a 24-year period, as

6 shown in Table 5-3, Summary of One-Time and Annual Benefits an d Costs to Industry, by Regulatory Initiative, in the regulatory analysis.

The NRC also identified and qualitatively analyzed several fact ors, or attributes, within the public and private sectors that the final rule is expected to a ffect. The NRC conducted a qualitative analysis because of the difficulties associated wit h monetizing these affected attributes and the full benefit to industry operations that res ults from the detection each year of additional individuals using illegal drugs, misusing legal drug s, or subverting the testing process.

The NRC determined that the final rule will result in qualitati ve benefits in the attributes of public health (accident), occupational health (accident), offsite prop erty, onsite property, regulatory efficiency, safeguards and security considerations, and other c onsiderations, which include public perception, public trust, workplace productivity, workpl ace safety, and improved protection of individual rights.

The final rule also benefits public health and safety or the co mmon defense and security in the following ways:

• expanding the drug testing panel and lowering the testing cutoff levels for select drugs

Lowering the testing cutoff levels for amphetamine, cocaine met abolites, and methamphetamine increases the timeframe in which these drugs ca n be detected in an individuals body after use (i.e., the window of detection). I ncreasing the window of detection reduces the likelihood that individuals could subvert the testing process through temporary abstinence from a drug. Adding 6-AM to the i nitial drug testing panel and revising the confirmatory testing cutoff together improves the testing method to identify use of the illegal drug heroin. Expanding the initial and confirmatory testing panels to include hydrocodone, hydromorphone, MDMA, MDA, oxycod one, and oxymorphone also improves the ability of licensees and other en tities to identify additional persons using illegal drugs or misusing legal drugs. These changes improve the trustworthiness and reliability of the workforce through th e identification of additional individuals who will be denied unescorted access authorization.

• requiring and expanding special analyses testing

Requiring special analyses testing on dilute specimens and expa nding special analyses testing to include specimens collected during suspected subvers ion attempts reduce the likelihood that individuals would be able to subvert the testin g process. Additionally, using the LOQ instead of the LOD as the level at which confirma tory drug testing is to be conducted increases the assurance provided by special analyses testing by adding a level of precision to the testing method. These changes furthe r enhance the ability of licensees and other entities to identify additional individuals using illegal drugs and misusing legal drugs when specimens do not present normal physi ological characteristics, as well as enhance donor protections when spec ial analyses testing is conducted. These changes improve the trustworthiness and relia bility of the workforce through the identification of i ndividuals using illicit drugs w ho will be denied unescorted access authorization.

• enhancing FFD program integrity and protection of individual rights

By adding MRO review procedures for invalid validity test resul ts due to high pH values and clarifying the requirements for MRO actions when a donor re quests the testing of a

7 Bottle B specimen or a retest of a single specimen, the final r ule enhances consistency with the 2008 HHS Guidelines, FFD program integrity, and the pr otection of individual rights.

• improving regulatory efficiency between 10 CFR Part 26 and other related Federal rules and guidelines

The final rule improves regulatory efficiency by (1) harmonizin g select 10 CFR Part 26 definitions and drug testing procedures with those described in the HHS Guidelines; (2) clarifying ambiguous or imprecise regulatory language in 10 CFR Part 26, such as the terminology related to quality control samples, to reflect lessons learned during implementation of the 2008 10 CFR Part 26 final rule; and (3) a ddressing dual regulation of HHS-certified laboratories (private entities) and the associ ated regulatory burden on licensees by removing select 10 CFR Part 26 requirements alread y included in the HHS Guidelines and verified through National Laboratory Certificati on Program inspections at each laboratory to receive and maintain HHS certification.

• improving root-cause analysis by testing any specimen(s) collected during a post-event test when a refusal to test has been made at the collection site

Under the former rule, if a refusal to test were determined dur ing the specimen collection process, any specimen(s) obtained from the donor could be disca rded. The final rule requires the retention and testing of any specimens collected d uring post-event tests for which a refusal to test determination was made at the collectio n site. This change improves the ability of the licensee or other entity to determi ne whether substance use could have been a contributing factor to an accident.

Licensees and other entities may also recognize a variety of ot her benefits, such as those associated with the following types of activities:

• permanent denial

If an individual is identified as having subverted the testing process, the individual will be permanently denied access under 10 CFR 26.75(b). As a result, the entire industry benefits from no longer incurring the potential risk of this in dividual working at any sites or any of the associated costs.

• second chance policy and follow-up testing

Although they typically do not do so for contractor/vendor work ers, licensees may provide a second chance to their employees who test positive fo r a drug. As a result, individuals who successfully received treatment and return to t he workforce will be subject to a 10 CFR Part 26 follow-up testing program. If pre-access testing detects drug use by the individual, then the cost of conducting follow-up testing on an individual would be averted.

VI. Costs

The NRC quantified the cost of six sets of backfits in the fina l rule, as shown in Table 1. This information is based on Table 5-3 in the regulatory analysis fo r the final rule. The other backfits

8 are expected to result in no costs or negligible costs, as expl ained below, and are not included in Table 1:

• Requiring the use of the LOQ instead of the LOD entails minor procedural changes with negligible incremental costs.

• Requiring additional MRO review fo r specimens with invalid val idity test results due to high pH values will result in some incremental effort on the pa rt of the MRO (e.g., on the order of an hour per occurrence to review specimen handling con ditions), but the cost will be incurred infrequently because an invalid specimen test result is a rare event.

Therefore, the total cost of the change will be small.

• Requiring the MRO to document the time and date of a donors r equest for testing a Bottle B specimen or retesting an aliquot of a single specimen will have negligible implementation costs.

• Requiring the MRO to report a cancelled test for the donors s pecimen and order a second collection without prior notice to the donor, when a don or requests testing of Bottle B or a retest of a single specimen and the specimen to b e tested is unavailable because of circumstances outside of the donors control, will h ave negligible implementation costs because this situation rarely occurs.

• Requiring the testing of any specimen(s) collected during post -event testing when a refusal to test has been determined during the collection proce ss will have negligible incremental costs because post-event testing situations are rar e, and an event in which a donor provides a specimen and then refuses to cooperate with the collector after providing the specimen is even rarer.

Table1 Quantitative Costs of the Final Rules Backfits

Regulatory Initiative 7% 3%

Net Present Value Net Present Value

Implement one-time drug testing ($136,936) ($136,936) program changes

Lower cutoff levels for amphetamine, ($185,898) ($277,775) cocaine, and methamphetamine

Expand testing panel to include initial testing of 6-AM (and revise confirmatory ($935,375) ($1,397,666) testing cutoff level)

Expand initial and confirmatory testing ($702,980) ($1,050,415) panel to include Ecstasy-type drugs

9 Regulatory Initiative 7% 3%

Net Present Value Net Present Value

Expand initial and confirmatory testing panel to include oxycodone, ($1,829,243) ($2,733,312) oxymorphone, hydrocodone, and hydromorphone

Require special analyses testing of dilute specimens and specimens ($109,322) ($163,353) collected under direct observation

TOTALS ($3,899,754) ($5,759,457)

VII. Cost-Justification Determination

The NRC finds that the final rule provides a cost-justified sub stantial increase in overall protection to the public health and safety or the common defens e and security. The determination that the final rule results in a substantial incr ease in overall protection is based on the following factors:

• The final rule is estimated to result in a 16-to 29-percent i ncrease in the number of individuals identified each year using illegal drugs, misusing legal drugs, or attempting to subvert the testing process and who would be determined not to be fit for duty or not trustworthy and reliable, or both.

• The final rule is expected to result in approximately $4.3 mil lion in averted training costs for licensees using a 7-percent discount rate (approximately $6.5 million using a 3-percent discount rate).

• Expanding the drug testing panel and lowering the testing cuto ff levels for select drugs will reduce the likelihood that individuals will be able to sub vert the testing process through temporary abstinence from a drug and will improve the a bility of licensees and other entities to identify additional persons using illegal dru gs.

• Requiring special analyses testing on dilute specimens and exp anding special analyses testing to include specimens collected during suspected subvers ion attempts will reduce the likelihood that individuals will be able to subvert the tes ting process.

• Using the LOQ instead of the LOD as the level at which confirm atory drug testing is conducted will increase the assurance provided by special analy ses testing by adding a level of precision to the testing method.

• The final rule enhances consistency with the HHS Guidelines, F FD program integrity, and the protection of individual rights.

• Requiring the testing of any specimen(s) collected during a po st-event test when a refusal to test has been made at the collection site improves r oot-cause analysis.

10 With the costs of the backfits to industry expected to approxim ate ($3.9 million) using a 7-percent discount rate and ($5.8 million) using a 3-percent di scount rate, the final rules backfits are estimated to result in an incremental benefit to i ndustry of approximately

$0.4 million total present value over a 24-year period, assumin g a 7-percent discount rate

($0.7 million total present value over a 24-year period, assumi ng a 3-percent discount rate).

Therefore, given the substantial increase in overall protection and cost savings to the industry afforded by the final rule, the NRC concludes that the costs of implementing the final rules backfits are justified given the substantial increase in overal l protection to the public health and safety or the common defense and security attributable to the f inal rule.

VIII. Consideration of Backfitting Factors

When imposing backfits, the Commission requires, under 10 CFR 5 0.109(a)(2) and 10 CFR 70.76(a)(2), consideration of the nine factors in 10 CFR 50.109(c)(1) through (9) and 10 CFR 70.76(b)(1) through (9), respectively.

1. Statement of the specific objectives that the backfits are designed to achieve.

The NRC amended certain provisions in 10 CFR Part 26 to (1) har monize select drug testing requirements in 10 CFR Part 26 with the 2008 and 2017 HHS Guide lines and reflect lessons learned from implementation of the 2008 10 CFR Part 26 final ru le; (2) maintain reasonable assurance of a drug-free workplace through the enhanced detecti on of individuals who are not fit for duty because of illegal drug use, legal drug misuse, or an attempt to subvert the drug testing process; and (3) enhance FFD program donor protection a nd due process requirements for individuals subject to drug testing.

2. General description of the activities required by the licensee to complete the backfits.

The backfits require licensees to update policies and procedure s, conduct training, and revise contracts with laboratories and blind performance test sample s uppliers to reflect the new drug testing criteria described in Sections III.B.1-III.B.4 of this document.

In addition, with regard to special analyses testing, licensees need to conduct mandatory LOQ testing of dilute specimens with an immunoassay response equal to or greater than 40 percent of the cutoff calibrator for each drug and for specimens collec ted during suspected subversion attempts, as described in Sections III.B.5-III.B.6 of this docu ment.

Section III.B.7 of this document describes new requirements inv olving MRO reviews. Licensees need to require an updated MRO review process for invalid valid ity specimen test results.

Specifically, if the donor does not provide an acceptable medic al explanation to explain a pH in the range of 9.0 to 9.5, the MRO must consider whether elapsed time and high temperature might have caused the test result. In addition, if a donor req uests testing of Bottle B or a retest of a single specimen, the MRO must document the donors verbal request. If the specimen to be tested is unavailable because of circumstances outside of th e donors control, licensees need to require MROs to report a cancelled test to the licensee for the donors specimen and order a second collection without prior notice to the donor.

11 The final rule requires the testing of any specimen collected d uring a post-event testing situation even if a refusal to test has been determined during the collec tion process, as described in Section III.B.8 of this document.

3. Potential change in the risk to the public from the accidental offsite release of radioactive material and, for 10 CFR Part 70 licensees, hazardous chemicals produced from licensed materials.

The final rule will not directly affect the likelihood of core damage or spent fuel damage. The final rule could reduce the risk that the public would be affec ted by an accidental offsite release of radioactive material and, for 10 CFR Part 70 licensees, haza rdous chemicals produced from licensed materials, as a result of human performance issues ass ociated with drug-induced impairment.

4. Potential impact on radiological exposure or, for 10 CFR Part 70 licensees, exposure of facility employees to hazardous chemicals produced from licensed material.

The final rule will not directly affect the likelihood of core damage or spent fuel damage. The final rule could reduce the risk that NRC-licensed facility emp loyees could be affected by an occupational accident or a radiological exposure as a result of human performance issues associated with drug-induced impairment.

5. Installation and continuing costs associated with the backfits, including the cost of facility downtime or, for power reactor licensees, the cost of construction delay.

The NRC expects the estimated one-time industry cost associated with the backfits to be

($136,936) and the annually recurring cost to be approximately ($322,889). Combining these initial and annual costs, this analysis estimates that the back fits associated with the final rule will cost industry approximately ($3.8 million) (present value, assu ming a 7-percent discount rate) to

($5.6 million) (present value, assuming a 3-percent discount ra te) over a 24-year period.

6. The potential safety impact of changes in plant or operational complexity, including the relationship to proposed and existing regulatory requirements.

The final rule makes minor changes to drug testing operations t hat enhance safety and security by identifying additional individuals using drugs and then deny ing their unescorted access authorization. This will reduce the risk of accidents and secu rity incidents as a result of human performance issues associated with drug-induced impairment.

7. The estimated resource burden on the NRC associated with the backfits and the availability of such resources.

The NRC is not expected to incur any incremental costs resultin g from the final rule. The NRC costs to complete the final rule (i.e., analyze public comments, hold public meeting(s), and develop the final rule) and to issue regulatory guidance are su nk costs. The NRC expects

12 changes to the agencys FFD inspection program to be minor (e.g., minor revisions to internal NRC training or inspection procedures).

8. The potential impact of differences in facility type, design, or age on the relevancy and practicality of the backfits.

The FFD requirements in 10 CFR Part 26 do not relate to, and ar e independent of, the facilitys type, design, or age. Therefore, the benefits and costs attrib utable to the final rule do not vary based upon the facilitys type, design, or age.

9. Whether the backfits are interim or final and, if interim, the justification for imposing the backfits on an interim basis.

The backfits are final.

IX. Issue Finality Assessment

Under 10 CFR 52.98(a), the NRC may not modify any term or condi tion of a combined license except in accordance with the provisions of 10 CFR 52.103, Ope ration under a combined license, or 10 CFR 50.109, as applicable. Section 52.103 is n ot applicable to this rulemaking, so the NRC must satisfy 10 CFR 50.109 to impose this final rule on holders of combined licenses.

X. Conclusion

In light of the direct benefit of improving the detection of in dividuals using illegal drugs, misusing legal drugs, or attempting to subvert the testing process; the savings to the industry through averted costs; and the efficiencies, flexibilities, and donor p rotections included in the final rule, the NRC finds that the backfits contained in the final rule, wh en considered in the aggregate, constitute a cost-justified, substantial increase in public hea lth and safety or the common defense and security under 10 CFR 50.109 and 10 CFR 70.76, Bac kfitting. Moreover, because the NRC determines that the final rule satisfies 10 CFR 50.109, the final rule meets the issue finality criteria in 10 CFR 52.98(a).

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