Regulatory Analysis for Fitness for Duty Drug Testing Requirements Proposed Rule

Draft Regulatory Analysis
and Backfitting and Issue Finality
10 CFR Part 26
Fitness for Duty Drug Testing Requirements
[Docket ID NRC-2009-0225]

U.S. Nuclear Regulatory Commission
Office of Nuclear Reactor Regulation
Office of Nuclear Security and Incident Response
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Contents
Abbreviations and Acronyms ........................................................................................................................iv
Abstract ......................................................................................................................................................... v
Executive Summary ..................................................................................................................................... vii
1.
Introduction ...................................................................................................................................... 1
1.1
Background................................................................................................................................ 1
1.2
Statement of the Problem and U.S. Nuclear Regulatory Commission Objectives for the
Rulemaking ................................................................................................................................ 3
2.
Identification and Preliminary Analysis of Alternative Approaches .................................................. 5
2.1
Alternative 1: Take No Action ................................................................................................... 5
2.2
Alternative 2: Amend 10 CFR Part 26 ...................................................................................... 6
2.3
Alternative 3: Address Issues through Means Other than Rulemaking ................................... 7
3.
Safety Goal Evaluation..................................................................................................................... 9
4.
Evaluation of Benefits and Costs ................................................................................................... 12
4.1
Identification of Affected Attributes .......................................................................................... 12
4.2
Analytical Methodology............................................................................................................ 17
4.2.1 Baseline for Analysis ............................................................................................................... 18
4.2.2 Affected Entities (Sites and Fitness-for-Duty Programs) ......................................................... 18
4.2.3 Cost and Benefit Calculations ................................................................................................. 19
4.2.4 Incremental Requirements in the Proposed Rule.................................................................... 23
4.2.5 Data Sources ........................................................................................................................... 27
4.2.6 Assumptions ............................................................................................................................ 30
5.
Results ........................................................................................................................................... 32
5.1
Benefits and Costs of the Proposed Rule ............................................................................... 32
5.1.1 One-Time Policy, Procedure, and Training Costs ................................................................... 35
5.1.2 Lowered Initial and Confirmatory Drug Testing Cutoff Levels for Amphetamines and
Cocaine Metabolites ................................................................................................................ 37
5.1.3 Expanded Initial Drug Testing Panel to Include 6-AM and Revised Confirmatory Testing
Cutoff Level for 6-AM............................................................................................................... 38
5.1.4 Expanded Initial and Confirmatory Drug Testing Panels to Include Ecstasy .......................... 38
5.1.5 Required Special Analyses Testing of Dilute Specimens and Specimens Collected
during Suspected Subversion Attempts .................................................................................. 39
5.1.6 Averted Costs .......................................................................................................................... 40
5.1.7 Workplace Free of Drugs and the Effects of Such Substances .............................................. 40
5.1.8 Safety Vulnerability .................................................................................................................. 41
5.1.9 Security Vulnerability ............................................................................................................... 42
5.1.10 Improve Subversion Detection ................................................................................................ 43
5.2
Uncertainty Analysis ................................................................................................................ 44
5.2.1 Uncertainty Analysis Results ................................................................................................... 46
5.2.2 Summary of Uncertainty Analysis............................................................................................ 53
5.3
Disaggregation ........................................................................................................................ 53
5.4
Backfitting and Issue Finality ................................................................................................... 54
5.5
Results for the Committee to Review Generic Requirements ................................................. 54
6.
Decision Rationale ......................................................................................................................... 56
6.1
Regulatory Analysis ................................................................................................................. 56
6.2
Backfitting and Issue Finality ................................................................................................... 58
7.
Implementation............................................................................................................................... 60
8.
References ..................................................................................................................................... 61
Appendix A:
Appendix B:
Appendix C:
Appendix D:
Appendix E:
Appendix F:

Site-Specific Fitness for Duty Program Performance Data (Calendar Years 2009–2014)
General Inputs
Assumptions and Results by Regulatory Initiative
Costs of Subsequent Actions
Averted Costs
Backfitting and Issue Finality

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List of Tables
Table ES-1 Cost-Benefit Comparison of Alternative 2 (Proposed Rule) .......................................................
Table 4-1 Range of Testing Data by Facility Type (CY 2009–2014) ......................................................... 21
Table 4-2. Suspect Specimens Collected Under Direct Observation ........................................................ 30
Table 5-1. Summary of Overall Benefits and Costs (Quantitative and Qualitative), Alternative 2
(Proposed Rule) ...................................................................................................................... 34
Table 5-2. Summary of Total Benefits and Costs to Industry (One-Time and Annual) ............................. 35
Table 5-3. Summary of One-Time and Annual Benefits and Costs to Industry, by Regulatory Initiative . 35
Table 5-4. One-Time Implementation Costs .............................................................................................. 37
Table 5-5. Additional Amphetamines and Cocaine Positives from Lower Testing Cutoff Levels .............. 38
Table 5-6. Additional 6-AM Positive Results from Expanded Drug Testing Panel .................................... 38
Table 5-7. Additional Ecstasy Positive Results from Expanded Drug Testing Panel ................................ 39
Table 5-8. Additional Positive Results from Special Analyses Testing of Dilute and Subversion
Specimens ............................................................................................................................... 40
Table 5-9. Variables Used in the Uncertainty Analysis .............................................................................. 45
Table 5-10. Uncertainty Results Descriptive Statistics .............................................................................. 50
Table 5-11. Estimated Number of Additional Confirmed Positives per Year ............................................. 52
Table F-1. Cost-Benefit Comparison of Alternative 2 (Proposed Rule) ..................................................F-10
Table F-2. Summary of FFD Program Performance Trends and Rulemaking Options Addressing
Each Trend ...........................................................................................................................F-11

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List of Figures
Figure 5-1. Industry implementation costs……………... .. …………………………......……………………...47
Figure 5-2. NRC implementation costs……………………………………… ..................... ……………….....47
Figure 5-3. Industry operations costs (7-percent discount rate) ..……………………......…………………..48
Figure 5-4. Industry operations costs (3-percent discount rate) .………………………......………………...48
Figure 5-5. Total (7-percent discount rate)………… …………………………......………………………...…49
Figure 5-6. Total (3-percent discount rate)…………………………… .............. …………………………......49
Figure 5-7. Key variables whose uncertainty drives the largest impact on costs (7-percent net present
value)...................................... ......... …………………………...................................................51
Figure 5-8. Key variables whose uncertainty drives the largest impact on costs (3-percent net present
value).......................................................................................................................................51
Figure 5-9. Relative frequency of the net benefits of the proposed rule…………………………….............52

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Abbreviations and Acronyms
6-AM
ADAMS
AMP
BPTS
CFR
CPI-U
CRGR
CSAP
C/V
CY
D&A
dL
DOT
DSP
FAA
FFD
FR
FRA
FTA
FTE
HHS
INPO
LOD
LOQ
LTF
MAMP
MDA
MDMA
mg
mL
MRO
NEI
ng
NLCP
NPV
NRC
NSIR
OMB
OSHA
PERT
pH
Ref.
SAMHSA
SSC
SSNM
TVA

6-acetylmorphine
Agencywide Documents Access and Management System
Amphetamine
blind performance test sample
Code of Federal Regulations
Consumer Price Index for all urban consumers
Committee to Review Generic Requirements
Center for Substance Abuse and Prevention
contractor/vendor
calendar year
drug and alcohol
deciliter(s)
U.S. Department of Transportation
Division of Security Policy
Federal Aviation Administration
fitness for duty
Federal Register
Federal Railroad Administration
Federal Transit Administration
full-time equivalent
U.S. Department of Health and Human Services
Institute of Nuclear Power Operations
limit of detection
limit of quantitation
licensee testing facility
Methamphetamine
Methylenedioxyamphetamine
Methylenedioxymethamphetamine
milligram(s)
milliliter(s)
Medical Review Officer
Nuclear Energy Institute
nanogram(s)
National Laboratory Certification Program
net present value
U.S. Nuclear Regulatory Commission
Office of Nuclear Security and Incident Response
Office of Management and Budget
U.S. Occupational Safety and Health Administration
program evaluation and review technique
a measure of the acidity or basicity of an aqueous solution
Reference
Substance Abuse and Mental Health Services
Administration
structure, system, and component
special strategic nuclear material
Tennessee Valley Authority

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Abstract
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations in
Title 10 of the Code of Federal Regulations (10 CFR) Part 26, “Fitness for Duty Programs,” to
more closely align the NRC’s drug testing requirements with updates made 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 enhance the
ability of licensees and other entities to identify additional individuals using drugs and would
incorporate lessons learned from implementation of the 10 CFR Part 26 rule (published in 2008)
to include enhanced methods in identifying attempts to subvert the drug testing process.
The requirements of the 10 CFR Part 26 fitness-for-duty (FFD) program focus, in part, on
preventing and detecting impairment among personnel subject to an FFD program by providing
reasonable assurance that the workplace is free of drugs and the effects of such substances.
These requirements contribute to reasonable assurance that persons who have been granted
unescorted access to the protected areas of NRC-licensed facilities (i.e., operating nuclear
power reactors, nuclear power reactors under construction, and Category I fuel cycle facilities),
who are required by a licensee to physically report to other locations (e.g., Emergency
Operations Facilities, Technical Support Centers), or who have access to strategic special
nuclear material or sensitive information are trustworthy and reliable and can safely and
competently perform their assigned duties. These regulations also establish due process to
protect individual rights.
The effectiveness of a drug testing program may weaken over time if individuals in the
workplace (1) use impairing substances not included in the testing panel or (2) use products and
techniques to successfully subvert the drug testing process. Program effectiveness may also
weaken if the program does not incorporate technological advancements that enhance the
sensitivity of drug testing. HHS is designated as the Federal agency responsible for developing
the scientific and technical guidelines for Federal employee workplace drug testing programs.
HHS is responsible for maintaining its guidelines based on the most recent research and
lessons learned from Federal employee workplace and Federal agency drug testing programs.
The 2008 HHS Guidelines are a national drug testing standard used by all Federal employee
workplace drug testing programs (more than 100 Federal agencies) and all comparable Federal
agency drug testing programs that test civilians in safety- and security-sensitive positions. The
drug testing provisions in 10 CFR Part 26 should align with the national drug testing standard
(i.e., the HHS Guidelines) to maintain reasonable assurance of a drug-free workplace.
The proposed rule would maintain the performance objective in 10 CFR 26.23(d) that requires
FFD programs to “provide reasonable assurance that the workplaces subject to this part are
free from the presence and effects of illegal drugs.” The NRC staff estimates that the lower
testing cutoff levels, expanded drug testing panel, and enhanced subversion detection methods
in the proposed rule would result in the detection of additional individuals (potential employees
and employees of licensees) using illegal drugs, misusing legal drugs, or attempting to subvert
the drug testing process. The proposed changes also could deter additional individuals using
drugs from seeking employment in workplaces covered by 10 CFR Part 26 and could either
deter existing employees from beginning to use drugs or encourage them to cease undetected
use or seek medical assistance to address an addiction or misuse issue, or both.

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This proposed rule would contribute to a drug-free workplace by doing the following:
•

enhancing the capabilities to detect drugs already in the testing panel
(i.e., amphetamine, cocaine, the heroin metabolite (6-acetylmorphine), and
methamphetamine) and expanding the testing panel to include two amphetamine-based
Ecstasy drugs

•

maintaining alignment with the Federal employee workplace drug testing program and
those programs implemented by comparable Federal agencies that test civilians in
safety- and security-sensitive positions (e.g., U.S. Department of Transportation)
(i.e., entities using the HHS Guidelines)

•

addressing trends in societal drug use that demonstrate an increasing use of
amphetamines, methamphetamines, and heroin

•

addressing the prevalence of subversion attempts reported by the 10 CFR Part 26 drug
testing programs since 2011 (approximately 13.2 to 16.5 percent of violations per year;
143 to 187 individuals per year)

Enhancing drug testing capabilities of the FFD program would maintain the effectiveness of
10 CFR Part 26 by identifying an additional 10 to 12 percent of individuals using drugs each
year. The enhancements can be accomplished at low cost (i.e., an average one-time cost per
site of $5,031 and an average annual cost per site of $2,516). As a result, the NRC staff
concludes that the benefit of the proposed improvements would maintain the performance
objective in 10 CFR 26.23(d), and outweigh the low cost of implementation.
This document is the draft regulatory analysis for the proposed rule and the associated Draft
Regulatory Guide 5040, “Urine Specimen Collection and Test Result Review under
10 CFR Part 26, ‘Fitness for Duty Programs.’”

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Executive Summary
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend Title 10 of the Code of
Federal Regulations (10 CFR) Part 26, “Fitness for Duty Programs” (Ref. 1), to accomplish three
objectives:
(1)

enhance detection 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

(2)

harmonize select drug testing requirements under 10 CFR Part 26 with the U.S.
Department of Health and Human Services (HHS) “Mandatory Guidelines for Federal
Workplace Drug Testing Programs” (HHS Guidelines)

(3)

enhance fitness for duty (FFD) program donor protection and due process requirements
for individuals subject to drug testing

Updates to the HHS Guidelines were published on November 25, 2008, in Volume 73,
page 71,858, of the Federal Register (73 FR 71858; Ref. 2) (hereafter referred to as the “2008
HHS Guidelines”). The NRC has relied on the HHS Guidelines as the technical basis to
establish and update the requirements in 10 CFR Part 26 for urine specimen collection,
laboratory testing, and results review. In general, the NRC has only deviated from the HHS
Guidelines for considerations specific to the nuclear industry. At the time the 2008 HHS
Guidelines were published, the NRC had recently issued the 10 CFR Part 26 final rule
(March 31, 2008; 73 FR 16966; Ref. 3). Therefore, the NRC determined that postponing a
rulemaking to adopt the 2008 HHS Guidelines would promote regulatory stability and provide
the NRC staff time to collect data on the rule’s effectiveness and to assess lessons learned from
implementing the 2008 FFD final rule and the 2008 HHS Guidelines (which became effective in
October 2010). These results have now been obtained, such that it is appropriate to propose a
revision to 10 CFR Part 26.
The major provisions of the proposed rule include changes to do the following:
•

Lower the initial and confirmatory drug testing cutoff levels for amphetamines
(i.e., amphetamine and methamphetamine) and cocaine metabolites to increase the
“window of detection”1 for these substances.

•

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.

•

Add initial and confirmatory drug testing for two illegal amphetamine-based Ecstasy-type
drugs.2

1

The “window of detection” refers to the time period after use during which the established detection
technologies, methodologies, and cutoff levels can identify and quantify a target drug metabolite.

2

Ecstasy-type drugs included within the scope of this rule are the Schedule I illegal drugs
methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA). A Schedule I drug,
as defined by the Controlled Substances Act (Ref. 4), has a high potential for abuse, has no currently
accepted medical use in treatment in the United States, and lacks accepted safety for use under medical
supervision.

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•

Strengthen methods for detecting subversion attempts by enhancing the testing for
drugs and drug metabolites in urine specimens with dilute validity test results and in
specimens collected under direct observation.

•

Enhance donor protection by requiring Medical Review Officer evaluation of elapsed
time from specimen collection to testing and exposure to high temperature as possible
causes for some invalid test results due to a high solvated hydrogen ion concentration
(i.e., pH).

The proposed rule also focuses on improving the clarity, consistency, and organization of the
10 CFR Part 26 rule text (e.g., resolving inconsistencies in quality control sample terminology,
adding and revising definitions) and increasing regulatory flexibility (e.g., in the assignment of
personnel who may monitor a hydrating donor in a shy-bladder situation).
Workplace Free of Drugs and the Effects of Such Substances
The general performance objective of an FFD program, as described in the original
10 CFR Part 26 final rule (54 FR 24468; June 7, 1989; Ref. 5), “is to provide reasonable
assurance that nuclear power plant personnel are reliable, trustworthy, and not under the
influence of any substance, legal or illegal, or mentally or physically impaired from any cause,
which in any way adversely affects their ability to safely and competently perform their duties.”
This 1989 final rule also stated that an FFD program “developed under the requirements of this
rule is intended to create an environment which is free of drugs and the effects of such
substances” (54 FR 24468). The regulations in 10 CFR 26.23, “Performance objectives,”
establish these drug-free workplace requirements. Specifically, 10 CFR 26.23(d) states that an
FFD program must “provide reasonable assurance that the workplaces subject to this part are
free from the presence and effects of illegal[3] drugs.” Preventing and detecting impairment
among personnel subject to an FFD program by conducting drug testing provides reasonable
assurance that the workplace is free of drugs and the effects of such substances. An FFD
program contributes to the reasonable assurance that persons who have been granted
unescorted access to the protected areas of NRC-licensed facilities (i.e., operating nuclear
power reactors, nuclear power reactors under construction, and Category I fuel cycle facilities),
who are required by a licensee to physically report to other locations (e.g., Emergency
Operations Facilities, Technical Support Centers), or who have access to strategic special
nuclear material (SSNM) or sensitive information are trustworthy and reliable and can safely and
competently perform their assigned duties.
HHS is designated as the Federal agency responsible for developing the scientific and technical
guidelines for Federal employee workplace drug testing programs. HHS is responsible for
3

The regulations in 10 CFR 26.5, “Definitions,” define the use of any Schedule I to V drug when not used
pursuant to a valid prescription as an “illegal drug.”
A Schedule I drug, as defined by the Controlled Substances Act, is a substance that 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). Schedule II through V
substances have accepted safe uses under medical subversion, pursuant to a valid prescription.
To improve the clarity of the discussion of the proposed rule changes, use of a Schedule I drug is referred to
as “use of an illegal drug,” while use of a Schedule II through V drug without a valid prescription is referred
to as “misuse of a legal drug.”

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maintaining its guidelines based on the most recent research and lessons learned from Federal
employee workplace and Federal agency drug testing programs. The 2008 HHS Guidelines are
a national drug testing standard used by all Federal employee workplace drug testing programs
(more than 100 Federal agencies4) and comparable Federal agency drug testing programs that
test civilians in safety- and security sensitive positions, such as those programs implemented by
the U.S. Department of Transportation (DOT), U.S. Department of Energy, U.S. Department of
Defense, and U.S. Department of Homeland Security. These tested populations transport
people and hazardous materials; operate and maintain our Nation’s electrical, pipeline, and
hydrodynamic infrastructure; protect property and national resources; serve in the armed forces;
and make decisions and execute emergency response plans that contribute to public health and
safety or protection of the environment following a natural disaster or security activity.
The effectiveness of a drug testing program may weaken over time if individuals in the
workplace (1) use impairing substances not included in the testing panel or (2) use products and
techniques to successfully subvert the drug testing process. Program effectiveness may also
weaken if the program does not incorporate technological advancements that enhance the
sensitivity of drug testing. The drug testing provisions in 10 CFR Part 26 should use the
national drug testing standard established by the HHS Guidelines and existing defense-in-depth
methods (e.g., behavioral observation, background checks, collection site security, and
specimen collections) to maintain reasonable assurance of a drug-free workplace.
Based on the analysis of recent annual performance data for FFD programs submitted by
licensees and other entities under 10 CFR 26.717, “Fitness-for-duty program performance
data,” workplaces subject to 10 CFR Part 26 are not free from the presence and effects of
drugs.
Historically, the NRC has incorporated the appropriate provisions of the HHS Guidelines into
10 CFR Part 26 to effectively use advancements in drug testing technology and detection
methods to address societal changes in drug use and in the methods and techniques used to
subvert the drug testing process. The NRC amended 10 CFR Part 26 in 2008 to align with the
2004 HHS Guidelines, the testing standard used at that time to test Federal employees and the
majority of civilians tested by Federal agencies. However, the current drug testing panel and
cutoff levels specified in 10 CFR Part 26 do not align with the 2008 HHS Guidelines. Therefore,
the improvements contained in the proposed rule would enable licensees to maintain
reasonable assurance of a drug-free workplace.
Safety Vulnerability
The proposed rule 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
testing process to conceal drug use and who, as a result, would be determined as not fit for duty
or not trustworthy and reliable, or both. Such a determination would result in a denial of
unescorted access to the protected areas of NRC-licensed facilities and other locations, access
to SSNM, or access to sensitive information. The identification of these individuals enhances
the existing regulatory framework to prevent drug-induced impairment (i.e., acute intoxication
and the consequences of recent drug use, such as withdrawal effects) from causing or
contributing to human performance errors that may result in unplanned occupational exposure;
4

The number of Federal agencies using the 2008 HHS Guidelines appears in the Office of Management and
Budget (OMB) information collection’s supporting statement (OMB No. 0930-0158) filed by the Substance
Abuse and Mental Health Services Administration for the “Mandatory Guidelines for Federal Workplace Drug
Testing Programs,” on May 28, 2014. The supporting statement is available at the OMB Web site
http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201406-0930-001.

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personal safety issues (e.g., injuries); unplanned radiological releases; or improper operation,
maintenance, or surveillance of safety-related structures, systems, or components (SSCs).
This safety outcome is consistent with the original 10 CFR Part 26 rule (Ref. 4), which stated
that “[t]he NRC cannot be confident of the individual’s ability to limit the use of addictive
substances to situations that do not adversely affect plant safety” (54 FR 24470; June 7, 1989),
and that “there is an underlying assumption that workers will abide by the licensee’s policies and
procedures, [therefore] any involvement with illegal drugs shows that the worker cannot be
relied upon to obey laws of a health and safety nature, indicating that the individual may not
scrupulously follow rigorous procedural requirements with the integrity required in the nuclear
power industry to assure public health and safety” (54 FR 24468; June 7, 1989).
Security Vulnerability
The proposed rule would enhance the ability of NRC licensees and other entities to identify
additional individuals determined not to be fit for duty or not to be trustworthy and reliable, or
both, because of their use of illegal drugs, misuse of legal drugs, or attempts to subvert the drug
testing process. A potential security vulnerability exists because persons of questionable
honesty, integrity, and motive may have unescorted access authorization to enable (either
physically or remotely through electronic means) a loss of SSCs and facility control, cause
radiological sabotage at a commercial power reactor, or steal or divert formula quantities of
SSNM from a Category I fuel cycle facility.
A security vulnerability also exists if security personnel use illegal drugs or misuse legal drugs.
Failure to maintain a robust and up-to-date FFD program could significantly challenge the
effectiveness of the site insider mitigation program (10 CFR 73.55(b)(9)), security plan
(10 CFR 73.55(c)), security search program (10 CFR 73.55(h)), and detection and assessment
systems that include requirements to conduct surveillance, observation, and monitoring to
identify tampering and to detect and deter intruders (10 CFR 73.55(i)). These requirements
cannot be effectively implemented if site security personnel are not fit for duty, because many
security duties and responsibilities are conducted by security officers who operate alone
(i.e., individually) and, therefore, do not benefit from a team environment, second checks, or
backup. As a result, a security officer who is mentally, physically, or psychologically impaired or
who does not possess the characteristics of honesty, integrity, trustworthiness, and reliability
cannot be relied upon to competently execute site security requirements. Furthermore, such a
security officer cannot be relied upon to maintain positive control of his or her weapons, access
controls, communication devices, and security-related knowledge and to safely and competently
make decisions about contingency response and the use of deadly force. This argument also
applies to individuals who perform the duties and responsibilities listed in
10 CFR 73.56(i)(1)(v)(B) and those who perform nonsafety or nonsecurity-related job functions.
Identifying Subversion Attempts
The proposed rule would enhance the ability of NRC licensees and other entities to identify
additional individuals attempting to hide their drug use by subverting the drug testing process
(e.g., consuming large quantities of fluid just before submitting a specimen for testing to reduce
the level of a drug in his or her urine below detectable limits or submitting the urine of a
nondrug-using individual in place of his or her own specimen). The proposed rule would require
all specimens with a dilute validity test result (dilute specimens) and specimens collected under
the direct observation requirements in 10 CFR 26.115(a)(1) through (a)(3) or (a)(5)
(i.e., instances where a subversion attempt is suspected) to be tested to the limit of

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quantification, which is the lowest concentration at which the identity and concentration of a
drug can be accurately established by testing. The identification of persons attempting to
subvert the drug testing process is significant because this action is undeniable evidence of a
lack of integrity and honesty and a willful act to refuse to comply with an NRC-required drug
test. Consequently, these individuals present a potential vulnerability to the safe and secure
conduct of NRC-licensed activities.
Safety Goal Evaluation
The NRC staff estimates that if the proposed rule is adopted in its current form, it would result in
a 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, as compared to the
10 CFR Part 26 test results for calendar year (CY) 2013 and CY 2014.5 The NRC staff used
this projected increase in the ability to detect additional individuals using drugs as the basis for
meeting the substantial increase criterion for achieving reasonable assurance that the
workplaces subject to the NRC’s FFD program are free from the presence and effects of drugs.
The NRC staff acknowledges that a small percentage of individuals subject to drug testing test
positive; however, the number of individuals that would be identified as a result of the changes
in the proposed rule meets the substantial increase criterion based on the effects on facility
safety and security that impairment of these individuals could have.
Based on the FFD program performance information reported to the NRC and a comparison of
this information to that from the previous years, as well as other indicators, the commercial
nuclear industry continues to effectively implement the 10 CFR Part 26 drug testing provisions,
and the FFD program has directly contributed to public health and safety and the common
defense and security. Testing data do indicate that persons potentially impaired from the use of
amphetamine, cocaine, methamphetamine, and heroin (as evident from positive for-cause and
post-event test results from CY 2010 through CY 2014) continue to be identified and removed
from the protected area of NRC-licensed facilities. Enhancing the ability to detect additional
amphetamine, cocaine, heroin, and methamphetamine drug users would strengthen the drug
testing program in areas in which the annual FFD program performance data have indicated
impacts related to human performance.
Benefits and Costs
The NRC staff finds that, considered together, the detection of additional drug users and the
qualitative benefits of doing so continue to maintain reasonable assurance of a drug-free
workplace and outweigh the low costs of the proposed rule. The analysis quantified benefits
and costs associated with three affected attributes—industry implementation, industry operation,
and NRC implementation. However, the NRC staff had difficulties in monetizing the benefits
associated with seven affected attributes—public health (accident), occupational health
(accident), offsite property, onsite property, regulatory efficiency, safeguards and security
considerations, and other considerations. The “other considerations” attribute includes public
perception, workplace productivity, workplace safety, and improved protection of individual
5

For example, in the “Summary of Fitness for Duty Program Performance Reports for Calendar Year 2013,”
dated September 3, 2014 (Ref.6), the total number of drug positive test results and subversion attempts in
CY 2013 was 769 (i.e., 1,007 individuals had a drug and/or alcohol testing violation in CY 2013, and 238 of
those individuals tested positive for alcohol; the difference equals the total number of drug positive test
results and subversion attempts). For CY 2014, the total number of drug positive test results and subversion
attempts was 885 (i.e., 1,133 individuals had a drug or alcohol testing violation, or both, with 248 of those
individuals testing positive for alcohol).

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rights. The NRC staff performed a qualitative assessment of these attributes, which is
consistent with the Commission’s direction in the staff requirements memorandum on
SECY-14-0087, “Qualitative Consideration of Factors in the Development of Regulatory
Analyses and Backfit Analyses,” dated March 4, 2015 (Ref. 7). Because the staff could not
rigorously quantify and monetize the benefits, it could not perform a quantified comparison of
costs and benefits. However, for example, preventing the shutdown of a single reactor unit for
1 day as a result of the actions of an impaired individual would far exceed the annual cost to
industry of the proposed rule changes.
The regulatory analysis resulted in the following key findings:
•

Benefits. The direct benefit of this proposed rule would be to enhance the effectiveness
of NRC-required FFD drug testing programs by identifying additional individuals using
drugs. The NRC staff estimates that the proposed rule would result in a 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. The proposed
rule also would improve regulatory efficiency by aligning 10 CFR Part 26 with the 2008
HHS Guidelines and by applying lessons learned from implementation of the NRC’s
2008 FFD final rule by licensees and other entities. A more robust drug testing program
also may deter additional individuals using drugs from seeking employment for positions
subject to 10 CFR Part 26 and incentivize those in regulated positions to cease drug use
or seek medical assistance to address an addiction or misuse issue, or both. While this
analysis quantifies the benefit of identifying additional individuals using drugs, it cannot
monetize the safety and security benefits of identifying these additional individuals,
beyond training costs that would be averted because the individuals would not be given
access. The staff recognizes that there would be additional costs to the organization
from replacing an employee that is identified as using illegal drugs, misusing legal drugs,
or attempting to subvert the drug testing process; while these are not quantified in this
analysis, they represent an additional benefit of identifying these individuals before they
gain access to the facility. Additionally, regulatory efficiency would be gained by
clarifying ambiguous rule language and providing additional regulatory flexibility.

•

Total Cost to Industry. The proposed rule is estimated to result in a total one-time cost
of approximately ($337,100), followed by total annual costs of approximately ($168,600).
The net present value of these costs is approximately ($2.4 million) using a 7-percent
discount rate and approximately ($3.4 million) using a 3-percent discount rate over the
average remaining reactor license period of 25 years. These costs include averted
industry training costs as a result of pre-access testing (industry operations saving) of
approximately $87,800 annually, which reduces the cost of the proposed rule by
between $1.1 million (using a 7-percent discount rate) and $1.6 million (using a
3-percent discount rate).

•

Average Cost per Site. The industry would incur a one-time average cost per site of
($5,031), followed by an average annual cost of ($2,516). The net present value of
these costs per site is approximately ($36,400) using a 7-percent discount rate and
approximately ($50,200) using a 3-percent discount rate over the average remaining
reactor license period of 25 years.

•

Total Cost to the NRC. The proposed rule is estimated to result in a total one-time cost
of ($273,000) to the NRC to complete the final rulemaking (i.e., analyze public

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comments, hold public meeting(s), develop the final rule) and issue final regulatory
guidance.
•

Uncertainty Analysis. The simulation analysis shows that the estimated mean cost for
this proposed rule is ($2.51 million), with a 90-percent confidence interval that the total
cost is between ($1.64 million) and ($3.37 million) assuming a 7-percent discount rate.
The costs of performing initial drug testing for 6-AM and the testing of Ecstasy drive the
largest variation in costs.

Decision Rationale
The proposed rule would maintain the performance objective in 10 CFR 26.23(d) to “provide
reasonable assurance that the workplaces subject to this part are free from the presence and
effects of illegal drugs” by (1) enhancing detection 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;
(2) harmonizing select drug testing requirements under 10 CFR Part 26 with the 2008 HHS
Guidelines; and (3) enhancing FFD program donor protection and due process requirements for
individuals subject to drug testing.
While the full benefit of identifying additional drug-using individuals cannot be monetized, the
detection of these individuals supports the safety and security goals discussed above as well as
ensures the achievement of the goal of the drug testing program (i.e., provide reasonable
assurance that the workplaces subject to this part are free from the presence and effects of
drugs). Table ES-1 (Table F-1 in Appendix F) shows, from a quantitative standpoint, that the
proposed rule alternative is a cost-effective way of achieving incremental improvements in the
detection of illegal drug use, legal drug misuse, and attempts to subvert the drug testing
process. Note that Table ES-1 presents the net present value results for the 25-year time
period of the analysis, while it presents the estimated benefit in the detection of additional drug
users by regulatory initiative on an annual basis.

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Table ES-1 Cost-Benefit Comparison of Alternative 2 (Proposed Rule)

Regulatory Initiative
Enhance detection of
existing paneled drugs by
lowering cutoff levels
(amphetamine, cocaine,
methamphetamine)

7% Net Present Value
(25-year time period of the analysis)
5%
Mean
95%

Estimated Benefit
(Annual Basis)
43 additional positive
results
(i.e., 22 amphetamines
positives and 21 cocaine
positives)

($247,653)

($176,723)

($110,715)

Expand testing panel to
include initial testing of 6AM (and revise confirmatory
testing cutoff level)

($2,105,447)

($1,685,517)

($1,269,515)

27 additional positive
results

Expand testing panel to
include testing for Ecstasy
drugs

($1,550,350)

($931,248)

($316,821)

7 additional positive
results

($71,013)

18 additional positive
results (8 positives from
dilute specimens and
10 positives from suspect
specimens)

($324,339)

Required activities to
implement drug testing
changes at laboratories.
Also informs all subject
employees of drug testing
program changes.

Enhance detection of
subversion attempts by
requiring special analyses
testing of dilute specimens
and specimens collected
under direct observation
To incorporate all drug
testing program changes,
sites would incur one-time
costs to change policies,
procedures, and conduct
training

($175,444)

($353,436)

($123,307)

($338,330)

Historically, 68 percent of
positive test results each
year are identified at preaccess testing.
Averted training costs
(pre-access testing)

6

$647,688

$1,034,618

$1,492,936

Total Industry Results

($3,088,766)

($2,220,507)

($1,358,859)

Average Cost Per Site6

($46,100)

($33,142)

($20,281)

Individuals testing positive
before completion of
training would result in
savings to licensees and
other entities.
95 additional positive
results per year and
additional nonquantified benefits

Section 4.2.2 provides a discussion on affected sites.
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Backfitting and Issue Finality
The provisions of this proposed rule would not impose modifications or additions to existing
structures, components, designs, or organizations. The proposed rule would require licensees
to update existing 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 make modifications to the drug testing panel.
Therefore, it would constitute a “new or amended provision in the Commission’s regulations”
and meet the definition of “backfitting” in 10 CFR 50.109(a).
The changes in the proposed rule fall under the backfitting requirements in 10 CFR 50.109(a)(3)
(Ref. 8), 10 CFR 50.109(c), and 10 CFR 70.76, “Backfitting” (Ref. 9), and the issue finality
requirement in 10 CFR 52.98, “Finality of combined licenses; information requests.” This
requires the NRC staff to make a finding that (1) there is a substantial increase in the overall
protection of public health and safety or the common defense and security, and (2) the costs are
justified in view of this increase in protection.
First, the NRC staff concludes that the proposed rule 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. This is a substantial
increase in the overall protection of public health and safety and the common defense and
security. This conclusion is based on the following:
•

A comparison of the CY 2014 FFD program performance data received by the NRC with
that from previous years, as well as other indicators, indicates year-over-year increases
in amphetamines positive results, a significant number of subversion attempts that have
been identified since CY 2011, and other adverse trends, as summarized in Table F-2.

•

The proposed changes to the drug testing panel are broad based (i.e., the cutoff levels
for multiple substances are being lowered and additional substances are being added)
and address trends in FFD program performance data.

•

Aligning 10 CFR Part 26 with the 2008 HHS Guidelines ensures that the NRC FFD drug
testing program is consistent with this national drug testing standard implemented by all
comparable safety- and security-sensitive workforces tested in the United States
(e.g., Federal employee workplace drug testing programs such as that at DOT).

•

The detection of drugs in the workplace subject to 10 CFR Part 26 testing is a proactive,
risk-informed FFD strategy. Since testing began in 1990, approximately 68 percent of
individuals who test positive for drugs or alcohol each year are identified before they
receive unescorted access authorization (i.e., at pre-access testing).

Second, the analysis of net benefits (i.e., benefits minus costs) shows that five of the six
regulatory initiatives that comprise the proposed rule are not cost beneficial because the
benefits could not be quantified (see Table ES-1). If the proposed rule is adopted as a final rule,
the safety and security value that the Commission assigns to detecting 10 to 12 percent more
individuals using drugs must be greater than $2.2 million (mean value) using a 7-percent
discount rate for the total quantified net benefit result to be positive.

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The NRC staff concludes that the low cost of the proposed rule is justified in view of the
substantial increase in the detection of additional individuals using drugs, as shown in
Table ES-1.

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1.

Introduction

This document presents the draft regulatory analysis of the U.S. Nuclear Regulatory
Commission’s (NRC’s) proposed amendments to the fitness-for-duty (FFD) requirements in
Title 10 of the Code of Federal Regulations (10 CFR) Part 26, “Fitness for Duty Programs”
(Ref. 1), and the associated Draft Regulatory Guide 5040, “Urine Specimen Collection and Test
Result Review under 10 CFR Part 26, ‘Fitness for Duty Programs.’”
The objectives of the rulemaking are to (1) maintain reasonable assurance of a drug-free
workplace through the enhanced detection of individuals who are not fit for duty because of
illegal drug use, legal drug misuse, or attempt to subvert the drug testing process; (2) harmonize
select drug testing requirements under 10 CFR Part 26 with those established by the 2008
U.S. Department of Health and Human Services (HHS) “Mandatory Guidelines for Federal
Workplace Drug Testing Programs,” published on November 25, 2008, in Volume 73,
page 71858, of the Federal Register (73 FR 71858; Ref. 2) (hereafter referred to as the “2008
HHS Guidelines”) and implemented by other Federal agencies; and (3) enhance FFD program
integrity and the protection of individual rights (i.e., donor protection and due process). In
support of these three objectives, the proposed rule would also improve the clarity, organization,
and flexibility of 10 CFR Part 26 rule language.
This introduction contains two sections. Section 1.1 provides background information, and
Section 1.2 states the problem and the objectives for the proposed rulemaking.

1.1

Background

The regulations at 10 CFR Part 26 contain the NRC’s requirements for the FFD programs of
licensees and other entities (also referred to in this document as “licensees” or “affected
entities”7). The regulations focus, in part, on preventing and detecting impairment among
personnel subject to an FFD program by providing reasonable assurance that the workplace is
free of drugs and the effects of such substances.
The general performance objective of an FFD program, as described in the original
10 CFR Part 26 final rule (54 FR 24468; June 7, 1989; Ref. 5), “is to provide reasonable
assurance that nuclear power plant personnel are reliable, trustworthy, and not under the
influence of any substance, legal or illegal, or mentally or physically impaired from any cause,
which in any way adversely affects their ability to safely and competently perform their duties.”
This 1989 final rule also states that an FFD program “developed under the requirements of this
rule is intended to create an environment which is free of drugs and the effects of such
substances” (54 FR 24468). The regulations at 10 CFR 26.23, “Performance objectives,”
establish these drug-free workplace requirements.

7

The entities subject to 10 CFR Part 26 requirements include (1) licensees authorized to possess, use, or
transport formula quantities of strategic special nuclear material (SSNM) (e.g., Category I fuel cycle
facilities), (2) holders of, and certain applicants for, a combined license for a nuclear power plant under the
provisions of 10 CFR Part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants” (Ref. 10),
(3) holders of, and certain applicants for, nuclear power plant construction permits and operating licenses
under the provisions of 10 CFR Part 50, “Domestic Licensing of Production and Utilization Facilities”
(Ref. 8), and (4) contractor/vendors (C/Vs) that implement FFD programs or program elements to the extent
that the licensees rely on C/V FFD programs or program elements.

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The drug-free workplace performance objectives contribute to the ability to provide reasonable
assurance that persons who have been granted unescorted access to the protected areas of
NRC-licensed facilities (i.e., operating nuclear power reactors, nuclear power reactors under
construction, and Category I fuel cycle facilities), who are required by a licensee to physically
report to other locations (e.g., Emergency Operations Facilities, Technical Support Centers), or
who have access to SSNM or sensitive information are trustworthy and reliable and can safely
and competently perform their assigned duties.
The NRC issued a significant revision to the original 1989 FFD rule (Ref. 5) in a final rule
published on March 31, 2008 (Ref. 3). The 2008 revision to the FFD requirements had several
objectives. The revision enhanced the effectiveness of FFD programs by applying
advancements in drug and alcohol testing technologies and lessons learned from licensees’
implementation of the 1989 FFD rule. It also improved the efficiency of FFD regulations by
eliminating unnecessary requirements and by harmonizing the NRC’s original FFD rule with
other Federal drug testing rules and guidelines. Furthermore, it improved the consistency
between FFD requirements and the access authorization requirements established in
10 CFR 73.56, “Access authorization,” as supplemented by NRC orders to nuclear power plant
licensees dated January 7, 2003, thereby strengthening regulatory assurance that persons of
questionable integrity, honesty, trustworthiness, and reliability are not granted unescorted
access authorization to the protected areas of commercial nuclear power plants and Category I
fuel cycle facilities or to SSNM or sensitive information. In addition, the 2008 FFD final rule
helped to protect the privacy and other rights (including due process) of individuals subject to
the NRC FFD requirements, and it established clear and enforceable requirements for the
management of worker fatigue.
NRC FFD Program and the HHS Guidelines
HHS is designated as the Federal agency responsible for developing the scientific and technical
guidelines for Federal employee workplace drug testing programs. HHS is responsible for
maintaining its guidelines based on the most recent research and lessons learned from Federal
employee workplace and Federal agency drug testing programs. The 2008 HHS Guidelines
establish a legal framework to conduct drug testing that provides reasonable assurance of
privacy, drug test accuracy and precision, and custody and control of specimens collected and
tested. It also provides for due process to individuals subject to drug testing. The 2008 HHS
Guidelines can be viewed as the national standard for drug testing based on use by all Federal
employee workplace drug testing programs, prevalence of use by Federal agency drug testing
programs of civilians in safety- and security-sensitive positions, and use by the private sector.
Furthermore, HHS has presented the 2008 HHS Guidelines to segments of the international
community to share testing and policy considerations (Ref. 11).
The NRC has relied on HHS to establish the technical requirements for urine specimen
collection, testing, and evaluation and has only deviated from the 2008 HHS Guidelines for
considerations that are specific to the nuclear industry. One goal of the 2008 FFD final rule
(Ref. 3) was to “update and enhance the consistency of 10 CFR Part 26 with advances in other
relevant Federal rules and guidelines, including the HHS Guidelines and other Federal drug and
alcohol testing programs (e.g., those required by the U.S. Department of Transportation [DOT])
that impose similar requirements on the private sector” (73 FR 16970; March 31, 2008). On
November 25, 2008, nearly 8 months after publication of the NRC’s 2008 FFD final rule, HHS
issued the 2008 HHS Guidelines (Ref. 2), which incorporated advancements in drug testing
technologies to improve the detection of drugs. The 2008 HHS Guidelines became effective on
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October 1, 2010. The NRC’s 10 CFR Part 26 regulation predates and does not fully reflect this
subsequent revision of the HHS Guidelines.
Following publication of the 2008 HHS Guidelines, the NRC held four public meetings, on
February 24, 2009 (Ref. 12), June 24, 2009 (Ref. 13), October 11, 2011 (Ref. 14), and
September 11, 2013 (Ref. 15), to review the changes in the 2008 HHS Guidelines and to
discuss the potential impacts on the NRC FFD drug testing requirements. Based on external
stakeholder feedback and an NRC staff assessment, the NRC staff elected to forego another
10 CFR Part 26 rulemaking so soon after publishing the 2008 FFD final rule. This decision
helped promote regulatory stability and allowed time for the NRC staff to evaluate the
effectiveness of Federal agency programs implementing the revised 2008 HHS Guidelines since
October 2010. Additionally, it allowed time for the NRC and licensees and other entities to learn
lessons from implementing the 2008 FFD final rule.
During the public meetings, representatives from the commercial nuclear power industry
expressed support for revising 10 CFR Part 26 to (1) incorporate select provisions from the
2008 HHS Guidelines, (2) enhance the detection of illegal drug use and misuse of prescription
drugs, and (3) enhance the methods to identify attempts to subvert the drug testing process.

1.2

Statement of the Problem and U.S. Nuclear Regulatory
Commission Objectives for the Rulemaking

The 2008 HHS Guidelines (Ref. 2) incorporated advancements in drug testing technologies to
enhance the detection of drug use within the Federal employee workplace. These revisions
were not incorporated into the 2008 FFD final rule (Ref. 3), which was published earlier.
Therefore, the drug detection and deterrence provisions in 10 CFR Part 26 are not equivalent to
those in the 2008 HHS Guidelines.
Consequently, the 10 CFR Part 26 drug testing program does not conform with (1) the
workplace drug testing programs implemented by more than 100 Federal agencies8 that test
Federal employees, (2) other Federal agency programs that drug test civilians such as those
implemented by the U.S. Department of Transportation (DOT) U.S. Department of Energy,
U.S. Department of Defense, and U.S. Department of Homeland Security, and (3) programs run
by private entities that use the 2008 HHS Guidelines as a technical basis for their drug testing
programs. These tested populations transport people and hazardous materials (e.g., motor
carriers, aviation, railroad, public transit, and maritime workers); operate and maintain our
Nation’s electrical, oil and gas pipeline, and hydrodynamic infrastructure; protect property and
national resources; serve in the armed forces, and make decisions and execute emergency
response plans that contribute to public health and safety or protection of the environment
following a natural disaster or security activity.
Because some individuals seeking employment in or already working in the commercial nuclear
workforce may use illegal drugs or misuse legal drugs, or both, this proposed rule focuses on
enhancing the identification of those individuals using illegal drugs whose potential impairment
could result in unsafe or unsecure conditions at NRC-licensed facilities. Granting or maintaining
8

The number of Federal agencies using the 2008 HHS Guidelines appears in the Office of Management and
Budget (OMB) information collection’s supporting statement (OMB No. 0930-0158) filed by the Substance
Abuse and Mental Health Services Administration for the “Mandatory Guidelines for Federal Workplace Drug
Testing Programs,” on May 28, 2014. The supporting statement is available at the OMB Web site
http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201406-0930-001.

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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

access authorization to these individuals represents a safety vulnerability because drug-induced
impairment may cause or contribute to human performance errors that may result in unplanned
occupational exposure; personal safety issues; unplanned radiological releases; or improper
operation, maintenance, or surveillance of safety- or security-related structures, systems, or
components (SSCs). Additionally, granting or maintaining unescorted access authorization to
these individuals also 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 exhibiting these characteristics cannot be
granted unescorted access authorization9 (either physically or electronically) because it would
challenge the defense in depth afforded by the FFD authorization requirements in
10 CFR Part 26 and access authorization requirements in 10 CFR Part 73, “Physical Protection
of Plants and Materials” (Ref. 16).
The first objective of this rulemaking is to maintain reasonable assurance of a drug-free
workplace at licensee facilities through the enhanced detection of individuals who are not fit for
duty because of illegal drug use, legal drug misuse, or attempt to subvert the drug testing
process. Enhancing the detection of additional individuals using drugs also includes
strengthening the methods used to identify individuals attempting to subvert the drug testing
process, which is a lesson learned from implementing the current 10 CFR Part 26 rule.
The second objective of this rulemaking is to harmonize select drug testing requirements under
10 CFR Part 26 with the 2008 HHS Guidelines. Updating 10 CFR Part 26 with the testing
improvements in the 2008 HHS Guidelines would align the NRC’s FFD program with this
national drug testing standard, and therefore, enhance licensees’ ability to maintain reasonable
assurance that the workplace is free of drugs and the effects of such substances.
The third objective is to enhance donor protection and due process requirements for individuals
subject to drug testing by: (1) adding instructions for same-gender 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 testing of drugs and testing for
adulterants (an added measure of testing accuracy), (3) adding a medical review officer (MRO)
review 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.
In support of these three objectives, the proposed rule would also improve the clarity,
organization, and flexibility of 10 CFR Part 26 rule language.

9

Under 10 CFR 26.69(b), a licensee or other entity may (but is not required to) restore FFD authorization to
an individual who tests positive on a drug or alcohol test, or both, after completion of the sanction under
10 CFR 26.75, “Sanctions,” satisfactory completion of any assigned treatment program (10 CFR 26.189,
“Determination of Fitness”), and inclusion of the individual in a followup testing program
(10 CFR 26.31(c)(5)).

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2.

Identification and Preliminary Analysis of Alternative
Approaches

The NRC staff considered the following three alternatives to address the regulatory problem
identified in Section 1.2:
•

Alternative 1: Take No Action

•

Alternative 2: Amend 10 CFR Part 26

•

Alternative 3: Address issues through means other than amending 10 CFR Part 26
(e.g., regulatory guides, generic communications, and stakeholder meetings)

2.1

Alternative 1: Take No Action

The first alternative is the status quo alternative. This alternative is the regulatory baseline from
which the other alternatives are measured. Under this alternative, the NRC would not amend
the current FFD regulations; and licensees and other entities would continue to comply with the
existing requirements in 10 CFR Part 26 (Ref. 1). As a result, the 10 CFR Part 26 drug testing
provisions would not include the drug testing advancements and donor protections in the 2008
HHS Guidelines or conform with the other Federal agency testing programs that follow them.
Taking no action would not incorporate the improvements in drug testing detection in the 2008
HHS Guidelines. Because the NRC requires all licensees to use HHS-certified laboratories for
confirmatory specimen testing, specimens submitted by licensees and other entities must be
treated differently than the specimens submitted by more than 100 Federal agency employee
workplace drug testing programs. Laboratories would continue to segregate the
10 CFR Part 26 specimens from all other Federal agency specimens because of the different
testing parameters (e.g., drug testing panel and cutoff levels, initial testing protocol for heroin,
calibrators and controls used for assays) and would have to maintain amended procedures and
training.
Under the no-action alternative, the NRC would not require licensees to test for additional
substances or use lower cutoff levels to test for existing drugs and drug metabolites in the
testing panel. Currently, 10 CFR 26.31(d) provides licensees and other entities with the
flexibility to test for additional drugs or use lower testing cutoff levels than specified by rule for
the NRC-required drug testing panel, or both. However, no licensee or other entity testing
program has incorporated the use of the lower testing cutoff levels or tests for the additional
substances included in the 2008 HHS Guidelines. Subsequent to the second public meeting
held on this proposed rulemaking in 2009, the Nuclear Energy Institute submitted a letter on
May 31, 2009 (Ref. 17), detailing the results of a survey it had conducted of its members and
stating the following:
While many of the respondents are in favor of expanding the panel, all
companies responding to the survey responded that they would change their
panel only if the NRC mandated the expansion of the panel to the 7 drugs
specified in the HHS Guidelines. The reason is that many of the companies have
had to negotiate with bargaining units on the drug testing process and expansion

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of the panel by the company without a mandate within the rule would subject the
panel to the negotiation process and not guarantee its adoption.
Regardless of whether this rulemaking is promulgated, the NRC will continue to inform the
public about 10 CFR Part 26 FFD program performance to maintain the public’s trust. The NRC
publishes data on the NRC Web site of domestic operating events, including significant FFD
policy violations or programmatic failures, drug and alcohol testing errors, and indicators of
programmatic weaknesses (i.e., 24-hour and 30-day reportable events under 10 CFR 26.719,
“Reporting requirements”). The agency also provides analysis, trending, and summary of
annual FFD program performance data submitted under 10 CFR 26.717, “Fitness-for-duty
program performance data,” through the publication of the NRC’s Summary of Fitness for Duty
Program Performance Reports (Ref. 5). This information also is used to inform NRC oversight
programs.
In 2009, the NRC developed (with input from industry) and implemented a voluntary electronic
reporting (e-reporting) system to submit 10 CFR 26.717 information. This enhanced data
collection method has led to the NRC’s receipt of much more precise, detailed, and uniform
information on site-specific performance. The staff has also used these data throughout this
analysis. The NRC also regularly consults with regulatory partners (e.g., HHS, DOT, and the
Office of National Drug Control Policy) to assess the effectiveness of the 2008 HHS Guidelines,
societal changes in drug use, and the prevalence of products in the marketplace to enable test
subversion and sample adulteration. The agency periodically provides this information to the
NRC inspectors assigned to commercial power reactors and Category I fuel cycle facilities
during training sessions. Collectively, these efforts have enhanced oversight of existing
licensee and other entity FFD programs. However, FFD programs and NRC oversight
programs cannot benefit under the current regulations from the enhancement in the
effectiveness of the laboratory testing methods or the choice of drugs included in the testing
panel (i.e., the aspects of Alternative 2 that are estimated to result in the majority of the
quantified benefit).
Lastly, not pursuing rulemaking at this time would not incorporate lessons learned from
implementation of the 2008 FFD final rule that would improve the efficiency of the regulatory
framework and enhance the detection of subversion attempts.
By definition, this alternative has no incremental benefits or costs, as it does not change the
status quo.

2.2

Alternative 2: Amend 10 CFR Part 26

This alternative would resolve the problems described in Section 1 about the current
10 CFR Part 26 rule and its implementation. The requirements for licensee FFD programs
focus on preventing and detecting impairment among personnel subject to an FFD program by
providing reasonable assurance that the workplace is free of drugs and the effects of such
substances. This alternative would enhance the detection 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. Specifically, rulemaking would align 10 CFR Part 26 drug testing requirements with
the 2008 HHS Guidelines (Ref. 2) that are used by more than 100 Federal employee workplace
drug testing programs and all comparable Federal agency drug testing programs that test
civilians in safety- and security-sensitive positions. Rulemaking would also incorporate lessons
learned from implementation of the 2008 FFD final rule (Ref. 3).
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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

The NRC staff performed a comprehensive review and comparison of 10 CFR Part 26 and the
2008 HHS Guidelines to identify the specific 10 CFR Part 26 provisions that should be revised.
The NRC staff also analyzed the DOT testing policies in 49 CFR Part 40, “Procedures for
Transportation Workplace Drug and Alcohol Testing Programs” (Ref. 19), and the technical and
policy issues identified during implementation of the 2008 FFD final rule. These efforts resulted
in a list of potential changes to 10 CFR Part 26 (Ref. 18), which the NRC staff presented to
stakeholders in a series of public meetings to elicit feedback to further inform the
decisionmaking process on potential regulatory changes.
Based on the evaluations presented in Section 5 of this document, the NRC staff expects that
the proposed revisions to 10 CFR Part 26 would substantially enhance safety and security at
NRC-licensed facilities by identifying approximately 10 to 12 percent more individuals (potential
employees and employees of licensees and other entities) each year using illegal drugs,
misusing legal drugs, or attempting to subvert the drug testing process. The changes to the
drug testing program (e.g., lower testing cutoff levels, expanded drug testing panel, subversion
detection methods) also could deter additional individuals using drugs from seeking employment
in 10 CFR Part 26-regulated workplaces and could either deter existing employees from
beginning to use drugs or encourage them to cease undetected use or seek medical assistance
to address an addiction or misuse issue, or both.
The proposed rule also would improve regulatory efficiency (e.g., by adding and updating
definitions, incorporating lessons learned from implementation of the 2008 FFD final rule,
increasing flexibility) and enhance donor protection and due process requirements (e.g., by
adding instructions for same-gender observers who perform an observed collection when a
trained collector of the same gender as the donor is not available, requiring the limit of
quantitation (LOQ) for special analyses testing of drugs and testing for adulterants, adding a
provision for MRO review of invalid test results due to high pH values (9.0 to 9.5)).

2.3

Alternative 3: Address Issues through Means Other than
Rulemaking

Under this alternative, the NRC staff would not amend 10 CFR Part 26. This alternative differs
from the Take No Action alternative (Alternative 1) because it would attempt to address FFD
concerns through other means, such as a new regulatory guide, generic communications,
stakeholder meetings, NRC inspections, or other agency initiatives, or a combination of
approaches.
This alternative is not desirable for the following reasons:
•

It would not address all identified issues (see Section 1.2 of this document), because
resolving many issues, such as inconsistencies with the 2008 HHS Guidelines, require
changes to 10 CFR Part 26.

•

It would not incorporate comments from affected entities received by the NRC staff at
public meetings that advocate promulgating rule changes to update the drug testing
panel, testing methodologies, and evaluation criteria to help assure integrity, accuracy,
sensitivity, and due process (Refs. 12–15, and 17).

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•

It would not address an NRC enforcement guidance memorandum dated
March 31, 2009 (Ref. 20), which describes inconsistencies in terminology associated
with quality control samples used at licensee testing facilities.

•

It likely would result in inconsistencies in FFD program implementation. Under this
alternative, affected entities could choose to commit to all, none, or a portion of the
proposed guidance document, which could lead to inconsistent implementation across
the industry and challenge regulatory effectiveness. However, as stated in the
discussion of Alternative 1, 10 CFR 26.31(d) currently provides licensees with the
flexibility to test for additional drugs or to use lower testing cutoff levels than required by
10 CFR Part 26, or both, but no FFD program has incorporated the changes in the 2008
HHS Guidelines. In addition, variability in drug testing programs could lead to additional
burden on the NRC staff to assess and address compliance issues, answer questions
from licensees, and answer questions from personnel subject to FFD program testing
(especially for individuals, such as outage workers, who work for a variety of licensee
programs).

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3.

Safety Goal Evaluation

A safety goal evaluation determines whether a regulatory requirement should not be imposed
generically on nuclear power plants because the residual risk is already acceptably low. The
1989 FFD rule (Ref. 5) addressed the significance of drug and alcohol testing on public health
and safety by stating the following on page 24468 of the final rule Federal Register notice:
The Commission is taking this action to significantly increase assurance of public
health and safety. The scientific evidence is conclusive that significant
detriments in cognitive and physical task performance result from intoxication
due to illicit drug abuse, as well as the use and misuse of legal substances.
Given the addictive and impairing nature of certain drugs, while recognizing that
the presence of drug metabolites does not necessarily relate directly to a current
impaired state, the presence of drugs does strongly suggest the likelihood of
past, present, or future impairment affecting job activities. In addition, the NRC
believes that the reliability, integrity, and trustworthiness of persons working
within nuclear power plants is important to assure public health and safety.
The calendar year (CY) 2013 performance report (Ref. 6), summarizes the performance of the
FFD drug testing program and states the following:
Based on the fitness-for-duty (FFD) performance information reported to the
NRC and a comparison of this information to previous years and other indicators,
the commercial nuclear industry continues to effectively implement the Part 26
drug and alcohol (D&A) provisions and FFD program results have directly
contributed to public health and safety and the common defense and security.
The data indicates no adverse trends;10 persons under the influence of illicit
drugs and/or alcohol are being identified and removed from the protected area
(PA) of NRC-licensed facilities; and, persons of questionable trustworthiness and
reliability are being identified through aggressive testing methods
(e.g., limit-of-detection testing, lower cutoffs, and effective monitoring during
specimen collections). Industry identification and communication of program
weaknesses, lessons learned, and corrective actions demonstrate commitment
to improved performance and a drug-free work environment.
The CY 2013 performance report also discussed the year-over-year increases in results that
were positive for amphetamines and the significant number of subversion attempts that were
identified since CY 2011. In terms of potential impairment from substance use and abuse, the
CY 2013 report included data on for-cause and post-event testing positives. These tests are
conducted in response to possible impairment or an adverse safety or security outcome, or
both, as a result of substance use. For-cause testing, as described in 10 CFR 26.31(c)(2)
(Ref. 1), is required when observed behavior, physical condition, or credible information, or a
combination, indicate the potential for substance use. Post-event testing is required after
certain workplace safety events, as described in 10 CFR 26.31(c)(3), which include but are not
limited to events that cause death, days away from work, restricted work, medical treatment

10

“An adverse trend is one in which the NRC would evaluate the necessity to undertake a scalable response
based on the severity or significance of the trend. The NRC response could include, but not be limited to:
inspection, issuance of guidance, licensing, or rulemaking.”
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beyond first aid, loss of consciousness, radiation exposure or release in excess of regulatory
limits, or actual or potential substantial degradations of the plant safety level.
Table 3-1 presents data on FFD program performance from CY 2011 through CY 2014 for the
number of for-cause and post-event testing violations (i.e., drug positive results, subversion
attempts). This analysis does not include alcohol positive results because testing for this
substance would not change in the proposed rule. The table presents the number of individuals
who tested positive for any of the drugs that would be modified through lower testing cutoff
levels, improved testing methods, and improved detection of subversion attempts.
Table 3-1 FFD Program Performance Data on Possible Impairment from Substance Use
Test
Type

Performance
Data

2011

2012

2013

2014

Total results
(drug & alcohol
positives &
subversions)

66

65

80

83

Total results
(drug positives
& subversions)

27

19

30

36

12 of 27 (44%)

12 of 19 (64%)

15 of 30 (50%)

16 of 36 (44%)

• 1 AMP
• 3 AMP & MAMP
• 1 cocaine &
marijuana
• 7 subversions

• 1 AMP & MAMP
• 1 AMP, MAMP,
& marijuana
• 3 cocaine
• 2 cocaine &
alcohol
• 1 MAMP
• 7 subversions

For-Cause
Test results
associated with
proposed rule
changes
(panel of drugs,
subversions)

Post-Event

•
•
•
•

1 AMP & cocaine
1 AMP & codeine
1 AMP & MAMP
1 AMP, MAMP, &
hydrocodone
• 3 cocaine
• 1 MAMP
• 8 subversions

Total results
(drug & alcohol
positives &
subversions)

7

7

5

13

Total results
(drug positive &
subversions)

6

7

4

11

3 of 6 (50%)

3 of 7 (43%)

3 of 4 (75%)

6 of 11 (55%)

Test results
associated with
proposed rule
changes (panel
of drugs &
subversion)

Notes:

• 1 AMP & MAMP
• 3 cocaine
• 1 cocaine &
marijuana
• 1 MAMP
• 6 subversions

• 6-AM
• 1 cocaine
• 6-AM & morphine • 2 subversions
• AMP

• 1 AMP
• 2 cocaine

• 1 cocaine
• 2 MAMP
• 3 subversions

1. 6-AM = 6-acetylmorphone; AMP = amphetamine; MAMP = methamphetamine.
2. This table only presents testing event data that were reported through the e-reporting
system. Sufficient data were not provided using other reporting means to evaluate testing
positives on an event-specific basis.

The data on for-cause testing show that between 44 and 64 percent of positive drug test results
and subversion attempts from CY 2011 through CY 2014 were associated with the panel of
drugs that would be updated in the proposed rule. For post-event testing, 43 to 75 percent of
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the positive drug test results and subversion attempts from CY 2011 through CY 2014 were
associated with the panel of drugs that would be updated by the proposed rule.
The NRC staff estimates that if the proposed rule is adopted, an additional 95 individuals using
drugs would be detected per year. This represents an estimated 10- to 12-percent increase in
detection over the number of individuals with a positive drug test result or identified as
attempting to subvert a test in CY 2013 and CY 2014. These estimated benefits in detection
apply to the seven qualitatively analyzed attributes described in Section 4.1. Specifically, the
seven attributes are: public health (accident), occupational health (accident), offsite property,
onsite property, regulatory efficiency, safeguards and security considerations, and other
considerations (public perception, workplace productivity, workplace safety, and improved
protection of individual rights). The proposed rule would accomplish this by lowering the testing
cutoff levels and improving the methods of detection for amphetamine, cocaine,
methamphetamine, and heroin. Enhanced testing capabilities may result in the identification of
additional individuals before testing as a result of events based on possible impairment
(i.e., identifying individuals during pre-access, random, and followup testing). The dominant
safety effect of the proposed rule would be to maintain reasonable assurance of a workplace
free of impairing drugs and the effects of such substances (both illegal drugs and the misuse of
legal drugs).

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4.

Evaluation of Benefits and Costs

This section examines the benefits and costs estimated to result from this rulemaking when
compared to Alternative 1 (Take No Action). Section 4.1 identifies attributes that are expected
to be affected by the rulemaking. Section 4.2 describes how the staff analyzed benefits and
costs.

4.1

Identification of Affected Attributes

This section identifies the factors within the public and private sectors that the regulatory
alternatives discussed in Section 2 are expected to affect. These factors are classified as
“attributes” using the list of potential attributes provided in Chapter 5 of NUREG/BR-0184,
“Regulatory Analysis Technical Evaluation Handbook,” issued January 1997 (Ref. 21). Each of
the following 10 attributes is quantified when possible and an uncertainty analysis is performed
to report benefit and cost estimate confidence levels and to identify those variables that most
affect the variation in the results distribution:
(1)

Public Health (Accident): The proposed rule would reduce the risk to public health by
helping to prevent events that may initiate or contribute to accidents or transients that
could result in radiological releases to the environment. The proposed changes would
reduce this public health risk by identifying additional individuals that may be impaired by
their use of illegal drugs or misuse of legal drugs, thereby enabling licensees to deny or
remove unescorted access authorization from these persons. This licensee action not
only prevents individuals using drugs from being granted or maintaining unescorted
access to the protected areas of NRC-licensed facilities, SSNM, or sensitive information,
it prevents these individuals from conducting the safety- and security-sensitive duties
and responsibilities described in 10 CFR 26.4, “FFD program applicability to categories
of individuals.” If individuals are impaired during the conduct of these activities, they
would have a higher potential to initiate accidents and transients as a result of human
performance errors.
The NRC established a strong link between the FFD-related authorization provisions in
10 CFR Part 26 and the physical protection access authorization requirements described
in 10 CFR Part 73 (Ref. 16). This relationship between FFD and access authorization
strengthens the defense in depth associated with the enhanced ability to identify
individuals using drugs who are not fit for duty or are not trustworthy and reliable, or
both. As described in the original 10 CFR Part 26 rule (54 FR 24470; Ref. 5):
The NRC believes that the reliability, integrity, and trustworthiness of
persons working within nuclear power plants are important to assure
public health and safety. The granting of a license is based on the
assumption that workers will abide by the licensees’ policies and
procedures in all areas. Indications of lack or reliability, integrity, or
trustworthiness, therefore, even so far as they pertain to off-site
behaviors, are relevant to the NRC’s need to assure that nuclear power
plants are operated safely.

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The NRC further discussed these positions in the 2008 FFD final rule (73 FR 16971;
Ref. 3):
Part 26 and the access authorization requirements [of Part 73] each
contain provisions that require establishing the trustworthiness and
reliability of personnel before granting unescorted access authorization to
the protected area of nuclear power plants.
Consequently, unless the NRC FFD program is robust in the identification of these
individuals, security and safety vulnerabilities could exist because individuals of
questionable motives may have unescorted access authorization.
The identification of additional individuals with confirmed positive test results would
result not only in the denial of their unescorted access to that licensee’s facility in
accordance with the site FFD program (see 10 CFR 26.75, “Sanctions”), but it also
would address these security and safety vulnerabilities at other commercial power
reactor facilities. This occurs, in part, because denial of authorization information is
shared with other NRC licensees and these licensees must meet the authorization
requirements described in both 10 CFR Part 26 and 10 CFR Part 73 before granting
unescorted access authorization to any individual who was previously found to be in
violation of a licensee’s FFD policy. Therefore, this program provision assures that
individuals of questionable honesty and integrity would not represent a safety or security
concern at a different facility without adjudication by the licensee reviewing official.
(2)

Occupational Health (Accident): The proposed rule could reduce the risk that
occupational health would be adversely affected by radiological releases and workplace
mishaps, events, or occurrences. Risk reduction would be accomplished by identifying
additional individuals using drugs who are subject to the 10 CFR Part 26 drug testing
requirements.
The identification of additional individuals who are not fit for duty facilitates licensee
action to prevent drug-induced impairment from causing or contributing to human
performance errors that may result in unplanned occupational radiation exposure;
personal safety issues; or improper operation, maintenance, or surveillance of safetyand security-related SSCs. This outcome also assures that timely and effective actions
will be initiated in response to accidents, transients, environmental conditions, and
security threats and that human performance during these exigent situations will not
degrade with time because of substance-induced impairment or withdrawal symptoms.
Although non-radiological occupational health is not within the scope of the NRC’s
regulatory authority (Refs. 22 and 23), a beneficial consequence of the 10 CFR Part 26
drug testing program is that it provides assurance that individuals are fit for duty. As
described in 10 CFR 26.23(d) and (b), the FFD program must, in part, “[p]rovide
reasonable assurance that the workplaces subject to this part are free from the presence
and effects of illegal drugs” and “that individuals are not under the influence of any
substance, legal or illegal, or mentally or physically impaired from any cause, which in
any way adversely affects their ability to safely and competently perform their duties,”
respectively.
Consequently, the identification of additional persons not fit for duty through the conduct
of drug testing and the subsequent denial of unescorted access authorization to these
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individuals would reduce the risk of occupational health (radiological and nonradiological) accidents.
(3)

Offsite Property: The proposed rule could reduce the risk that offsite property would be
affected by radiological releases by identifying additional individuals impaired from using
illegal drugs or misusing legal drugs among persons applying for unescorted access and
those already granted unescorted access to an NRC-licensed facility. Identifying
additional individuals using drugs would reduce the risk of accidents and security
incidents resulting from impairment that could adversely affect offsite property.

(4)

Onsite Property: The proposed rule could reduce the risk of damage to onsite property
by identifying additional individuals impaired by using illegal drugs or misusing legal
drugs among individuals applying for unescorted access and those already granted
unescorted access to an NRC-licensed facility. Identifying additional individuals using
drugs would reduce the risk of accidents and security incidents resulting from
impairment that could adversely affect onsite property.

(5)

Industry Implementation: The proposed rule would require licensees to revise their
policies, procedures, training, and contracts with HHS-certified laboratories and blind
performance test sample (BPTS) suppliers. Licensees that use a licensee testing facility
(LTF) also would train laboratory technicians on the drug testing panel changes and
perform a validation of the updated drug testing assays. Though licensees would incur
the implementation costs of HHS-certified laboratories by their inclusion in the costs
charged to the licensee when the laboratories test specimens (see “Industry Operation”
below), the increased detection of impaired individuals would reduce the risk of
accidents and security incidents resulting from that impairment. Section 5.1.1 and
Appendix C provide the quantitative analysis of this attribute.

(6)

Industry Operation: The proposed rule would result in an increase in the cost to test
each specimen because the testing panel would include more drugs. The changes to
the drug testing panel also would result in an increase in the number of individuals
identified as using illegal drugs or misusing legal drugs and the number of
10 CFR Part 26 actions that each licensee must take subsequent to a positive drug test
result or a confirmed subversion attempt. However, the increased detection of impaired
individuals would reduce the risk of accidents and security incidents resulting from that
impairment. The proposed rule would result in savings during pre-access testing from
averted training costs associated with additional individuals testing positive as a result of
the proposed rule changes.11 Sections 5.1.2 through 5.1.6 and Appendix C provide the
quantitative analysis of this attribute.

(7)

NRC Implementation: NRC implementation actions would consist of completing the
rulemaking (i.e., analyzing public comments on the proposed rule, holding public
meeting(s) on the rulemaking, and developing the final rule) and developing regulatory
guidance. The staff anticipates that changes to the agency’s FFD inspection program
would be minor (e.g., revisions to internal NRC training or inspection procedures are
expected to be an insignificant incremental burden). Section 5.1.1 and Appendix C
provide the quantitative analysis of this attribute.

11

The NRC staff does not anticipate false positive results (i.e., errors in the laboratory testing process) as a
result of the proposed testing changes. Historical FFD program performance data demonstrate the rigor of
the laboratory testing process and the rarity of such a testing error.

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(8)

Regulatory Efficiency: The proposed rule would result in improved regulatory efficiency
by achieving better consistency and less redundancy with select drug testing procedures
in the 2008 HHS Guidelines, as well as better internal consistency within
10 CFR Part 26. The proposed rule also would harmonize some of the NRC’s
definitions with those in the 2008 HHS Guidelines, prevent dual regulation of
HHS-certified laboratories in the areas of laboratory personnel and procedures, and
clarify ambiguous or imprecise regulatory language in 10 CFR Part 26 (such as the
proposed changes to the 10 CFR Part 26 definitions). Lastly, the proposed changes
would improve the protections afforded to individuals by requiring certain drug tests to be
evaluated to the limit of quantification (LOQ) instead of the limit of detection (LOD) and
requiring the MRO perform an additional review of an invalid test results due to high
urine pH. These donor protection changes could improve regulatory efficiency by
reducing the potential for appeals associated with FFD policy violations and any
subsequent followup NRC inspections.

(9)

Safeguards and Security Considerations: The proposed rule would increase the ability
of affected entities to identify additional individuals who are not trustworthy and reliable
by enhancing the detection of illegal drug use, legal drug misuse, and attempts to
subvert the drug testing process. The proposed changes also may enhance deterrence
through the training of subject personnel on the rule changes. This could occur because
the requirements in 10 CFR 26.29, “Training,” necessitate the communication of the
panel of drugs to be tested, the drug testing cutoffs, required sanctions, and licensee
actions that would be taken if an individual violates the licensee’s FFD policy.
The benefit of the proposed rule related to safeguards and security considerations is
reflected qualitatively under the “Other Considerations” attribute listed below.

(10)

Other Considerations
–

Public Perception: The proposed changes would provide the public with
additional assurance that the NRC is addressing potential safety concerns that
could result from worker use of impairing drugs and security concerns by
identifying individuals who display or demonstrate characteristics of not being fit
for duty, or not being trustworthy and reliable, or both. Furthermore, the
proposed rule changes would more closely align 10 CFR Part 26 with existing
Federal agency drug testing programs for individuals in positions analogous to
those covered by the NRC testing program. These Federal agency drug testing
programs include, but are not limited to, those implemented by over 100 Federal
agencies that test Federal employees, and all comparable Federal agencies
testing civilians in safety- and security-sensitive positions. An example of such a
comparable Federal agency is DOT, with testing for airline pilots, armed security
guards, bus drivers, rail and transit engineers, and commercial truck drivers
hauling hazards materials. Parity with all comparable Federal agency drug
testing programs improves public perception of the effectiveness of
10 CFR Part 26.

–

Public Trust: The proposed changes would strengthen the defense-in-depth
regulatory framework associated with the identification of individuals using illegal
drugs, misusing legal drugs, or attempting to subvert the testing process and who
are determined not to be fit for duty, or not to be trustworthy and reliable, or both.
Therefore, the proposed changes would reinforce the link between the
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FFD-related authorization provisions in 10 CFR Part 26 and the physical
protection access authorization requirements in 10 CFR Part 73. This
rulemaking would address these safety and security vulnerabilities and should
boost public trust, because once unescorted access authorization is denied, an
individual cannot act as an insider threat to challenge the safe and secure
operation of the facility and the transportation of SSNM, the safety and security of
licensee employees and C/Vs, or the safeguarding of sensitive information.
–

Worker Productivity: Affected licensees may accrue benefits from using the
proposed expanded drug testing panel and the increased testing sensitivities,
which could result in deterring additional individuals from using the drugs
included in the NRC testing panel. A beneficial outcome is that this could result
in improved workforce productivity, reduced employee turnover, and reduced
absenteeism related to the health effects associated with drug use and possible
addiction (Ref. 24). The effects of productivity loss caused by undetected
amphetamine, cocaine, heroin, Ecstasy drugs, or methamphetamine drug use
could have direct and indirect effects on operating costs. Furthermore, the
impact of employee drug use is a problem that extends beyond the drug-using
employee. Coworkers may have to work harder, redo work, or cover a shift for a
coworker as a result of a fellow employee’s absence (Ref. 24). In addition,
enhancing the detection of illegal drug use, legal drug misuse, and subversion
attempts may deter individuals using drugs from seeking employment and
existing employees from starting to use drugs. It may also encourage existing
employees to seek medical assistance to address an addiction or misuse issue,
which could result in a lower turnover rate for individuals possessing requisite
skills, knowledge, and experience that contribute to the safe and secure
operation of the NRC-licensed facility. With a lower turnover rate, licensees may
accrue benefits from not having to expend resources in recruiting, hiring, and
training replacement employees (Refs. 25 and 26).

–

Improved Protection of Individual Rights: Individuals subject to 10 CFR Part 26
may accrue benefits from the revised MRO review procedures for invalid test
results due to high pH values and from clearer requirements describing MRO
actions when a donor requests testing of Bottle B or a retest of a single specimen
and the specimen is unavailable. Additionally, workers may accrue benefits from
the proposed change to use the LOQ instead of the LOD in various test
scenarios. The LOQ reliably detects and quantifies an analyte (the substance
tested), whereas the LOD reliably detects an analyte but does not precisely
quantify it. This change provides an additional measure of accuracy in the
testing process. The proposed changes improve consistency with the 2008 HHS
Guidelines, provide additional protection of individual rights, and may reduce the
number of potential appeals of drug testing results (10 CFR 26.39, “Review
process for FFD policy violations”).

The staff does not expect this rulemaking to affect the attributes of public health (routine),
occupational health (routine), NRC operation, other government, general public, improvements
in knowledge, antitrust considerations, and environmental considerations.

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4.2

Analytical Methodology

This section describes the process used to evaluate benefits and costs associated with the
proposed alternatives. The benefits include any desirable changes in affected attributes
(e.g., monetary savings, improved safety, improved security) while the costs include any
undesirable changes in affected attributes (e.g., monetary costs, increased exposures).
Of the 10 affected attributes discussed in Section 4.1, the analysis evaluates three on a
quantitative basis—industry implementation, industry operation, and NRC implementation.
Quantitative analysis requires a baseline characterization of the affected universe (see
Table 5-9 and Appendices B and C of this document), including the characterization of factors
such as the number of affected entities, the nature of the activities being conducted, and the
types of systems and procedures that licensees would implement or would no longer implement
(if the proposed rule alternative was chosen). Affected entities differ from each other in a variety
of ways, such as FFD program management (e.g., specific to a site, or centrally managed at a
corporate office by a licensee that owns multiple sites) and testing laboratories used (e.g., LTF,
HHS-certified laboratory). As a result, affected entities may respond to the proposed rule in
different ways. Sections 4.2.1 through 4.2.6 present the analytical data and assumptions used
in the quantitative analysis of these attributes, which the staff then used in performing the
uncertainty analysis contained in Section 5.2.
The analysis relies on non-quantitative techniques for the remaining seven affected attributes
(public health (accident), occupational 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 protection of
individual rights)). Non-quantitative techniques are used because monetizing the full impact of
each attribute is not possible or practical. Monetizing the impact of these attributes would
require the estimation of factors such as the frequency of accidents and other safety- and
security-related events caused by drug-induced impairment and the consequences of such
events. These data do not exist. However, improving the detection of individuals who use
impairing drugs supports the general performance objective of 10 CFR Part 26, to “provide
reasonable assurance that the workplaces subject to this part are free from the presence and
effects of illegal drugs.” Sections 4.2.1 through 4.2.6 describe the analytical method and
assumptions used in the quantitative and non-quantitative analysis of these attributes.
Appendices B through D present the analysis calculations, unit costs, data sources, and
assumptions used.
To estimate the costs associated with the evaluated alternative, the NRC staff used a work
breakdown approach to deconstruct the activities for each requirement. For each required
activity, the NRC staff further subdivided the work across labor categories (e.g., FFD manager,
facility worker). The NRC staff estimated the necessary level of effort for each required activity
and labor rates for personnel performing these activities to develop cost estimates.
The NRC staff gathered data from a number of sources to develop levels of effort and unit cost
estimates. The NRC staff applied several cost estimation methods in this analysis. The NRC
staff used professional knowledge and judgment to estimate some of the costs and benefits.
Additionally, the staff used an engineering buildup method, solicitation of licensee input, and
extrapolation techniques to estimate costs and benefits. The engineering buildup method used
a step-by-step, bottom-up description of task requirements and estimated resources for labor,
materials, and other direct costs to estimate a total cost. The NRC staff also consulted subject
matter experts within and outside of the agency to develop inputs used in the analysis. For
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example, the NRC staff collected industry wage data, cost for specimen testing and other inputs
for this analysis.
The NRC staff extrapolated to estimate some cost activities, which rely on past or current costs
to estimate the future cost of similar activities. For example, to estimate the cost to conduct
testing for Ecstasy-type drugs at an HHS-certified laboratory, the NRC staff used the testing
cost published by DOT in its final rule aligning 49 CFR Part 40 with the 2008 HHS Guidelines
(75 FR 49850; Ref. 27) and increased that cost based on operational data for current drug
testing costs and the projected number of future positive test results. However, for steps in the
current and proposed alternative with no data, the NRC staff estimated the level of effort based
on similar steps in the process for which data are available.
To evaluate the effect of uncertainty in the model, the NRC staff employed a Monte Carlo
simulation, which is an approach to uncertainty analysis in which input variables are expressed
as distributions. The simulation was run 5,000 times, and values were chosen at random from
the distributions of the input variables provided in Section 5.2 of this document. The result is a
distribution of values for the output variable of interest. A Monte Carlo simulation also makes it
possible to determine the input variables that have the greatest effect on the value of the output
variable. Section 5.2 gives a detailed description of the Monte Carlo simulation methods and
the results.

4.2.1

Baseline for Analysis

This draft regulatory analysis measures the incremental impacts of the proposed alternative
relative to a baseline that reflects the anticipated behavior if the NRC undertakes no other
regulatory action (Alternative 1, Take No Action). As part of the regulatory baseline used in this
analysis, the NRC staff assumes licensee compliance with existing NRC regulations.
Section 5.1 presents the estimated incremental costs and benefits of the proposed rule relative
to this baseline.

4.2.2

Affected Entities (Sites and Fitness-for-Duty Programs)

For use in this analysis, the NRC staff created the following groupings based on how the
alternative affects NRC licensees:
•

Sites12: The analysis modeled 67 sites covered by the 10 CFR Part 26 FFD program
requirements, including 59 power reactor sites (includes 57 operating sites and 2
construction sites),13,14 5 corporate offices, 2 Category I fuel cycle facilities, and 1 C/V

12

The term “site” corresponds to the term “facility,” which is used to describe licensees and other entities that
are subject to the reporting requirements in 10 CFR 26.717 and that submit drug and alcohol testing data to
the NRC in annual FFD program performance summary reports. The number of sites used in this analysis is
based on information in the “Summary of Fitness for Duty Program Performance Reports for Calendar Year
2013” (Ref. 6).

13

The two power reactor construction sites are the Vogtle Electric Generating Plant (Vogtle), Units 3 and 4,
and the Virgil C. Summer Nuclear Station (Summer), Units 2 and 3. Vogtle Units 3 and 4 are assumed to
begin commercial operation in CY 2019 and CY 2020, respectively. Summer Units 2 and 3 are assumed to
begin commercial operation in CY 2019 and CY 2020, respectively.

14

This analysis does not include the Bellefonte Nuclear Power Station (Bellefonte) because the site does not
have any operating units and new construction is indefinitely delayed. Bellefonte Units 1 and 2 are covered

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that maintains its own FFD program. Appendix A to this document contains site-specific
FFD program performance data supporting this quantification. These site counts include
Watts Bar Nuclear Power Plant Unit 2, which received its operating license in
October 2015 and is scheduled to begin commercial operation in CY 2016. These site
counts exclude the FitzPatrick, Oyster Creek, and Pilgrim reactors because their
licensees have decided to permanently cease power operations before or during
CY 2019.15 The net result is that beginning in CY 2020, the analysis models 67 sites
with FFD programs, which by that time includes 59 operating power reactor sites and no
power reactor construction sites.
•

FFD Programs: The analysis models 27 FFD programs for the 67 sites covered by
10 CFR Part 26. FFD programs are based on corporate ownership. If a corporate entity
operates multiple sites, the entity will maintain one FFD program for all of its sites (Ref. 6
and Appendix A to this document).

•

Drug Testing Laboratories: Each licensee and other entity may choose to conduct initial
urine specimen testing at an LTF; then, it must conduct confirmatory testing at an
HHS-certified laboratory. Alternatively, the licensee or entity may conduct all urine
testing at an HHS-certified laboratory. The analysis models that 61 sites will conduct all
urine testing at HHS-certified laboratories and that 6 sites will use an LTF for initial
testing and an HHS-certified laboratory for confirmatory testing.

4.2.3

Cost and Benefit Calculations

This section describes the method used to estimate the quantifiable costs and benefits
associated with the proposed alternative.
•

All licensees are assumed to be in compliance with the existing regulatory requirements.
Therefore, this analysis only presents the incremental costs associated with the
proposed rule changes.

•

The Total Industry Cost or Benefit associated with each proposed rule requirement is
calculated using the following five-step approach:

under the Commission Policy Statement on Deferred Plants (52 FR 38077; October 14, 1987). The analysis
also excludes Fermi Unit 3 because, although as of May 1, 2015, the NRC issued a combined license to
DTE Electric Company, DTE Electric Company has no immediate plans to begin construction. South Texas
Project Units 3 and 4 are excluded because, although as of February 12, 2016, the NRC issued a combined
license to Nuclear Innovation North America, LLC, the company has no immediate plans to begin
construction. If the construction plans for these units change during the final rule phase, the staff will update
the regulatory analysis accordingly to reflect the costs and benefits of the rule considering these additional
units.
15

On November 18, 2015, Entergy Nuclear Operations, Inc. certified to the NRC that it had decided to
permanently cease power operations at James A. FitzPatrick (one reactor) on January 27, 2017 (Ref. 28).
During CY 2019, the licensees for the Oyster Creek (one reactor) and Pilgrim (one reactor) operating reactor
sites plan to permanently cease power operations. The licensees for FitzPatrick, Oyster Creek, and Pilgrim
had announced intentions to begin decommissioning before the end 2019. This set of sites reflects the
NRC’s understanding of licensees’ plans to decommission at the time this regulatory analysis was prepared.
Subsequent to completing the analysis, the licensee for FitzPatrick reported that it now plans to continue to
operate and the licensee for Fort Calhoun permanently shut down in October 2016. Adjustments to the
number of operating power reactors will be made in the analysis for the final rule. However, the costs and
benefits of the rule would be further affected if the number of facilities that decommission change over time.

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–

Step 1: Estimate the average incremental cost or benefit per affected entity
(i.e., a site or FFD program) to comply with the new requirement (e.g., the cost to
conduct initial urine drug testing for Ecstasy). The use of average incremental
cost or benefit per entity is a simplification, with some affected entities incurring
higher or lower costs.

–

Step 2: Estimate the number of times an affected entity would incur the
incremental cost or benefit associated with the new requirement in a year
(e.g., how many individuals will be drug tested for Ecstasy at each site).

–

Step 3: Estimate the number of affected entities that would incur the incremental
cost or receive the benefit associated with the new requirement in a year.

–

Step 4: Estimate the number of years the incremental cost or benefit would be
incurred.

–

Step 5: Multiply the outcomes of Steps 1 through 4.

Not all proposed rule requirements apply to all 67 sites or all 27 FFD programs. For
example, some proposed rule changes would only impact the six sites that conduct initial
drug and validity testing at LTFs and not the 61 sites that only use HHS-certified
laboratories to conduct all drug and validity testing. The cost calculations for the
proposed rule requirements in Appendix C reflect these differences.
•

The Average Cost per Site to comply with each proposed rule requirement is calculated
by dividing the Total Industry Cost or Benefit per requirement by the total number of
affected sites. While the Average Cost or Benefit per Site does not present the potential
variability for an estimated value based on facility type (e.g., corporate office, fuel cycle
facility, operating power reactor), the NRC staff believes that this is a reasonable
measure to present the potential impact to the nuclear industry of each proposed rule
change for the following reasons:
(1)

The majority of sites included in the analysis are operating power reactors (59 of
67 sites).

(2)

The proposed rule changes (beyond the implementation activities in the initial
year of the rule associated with policy updates, contract revisions, and training)
only pertain to conducting drug tests and the associated positives that result from
those tests. Therefore, the impact of the rule is directly dependent on the
number of individuals tested at each site and the resulting positive tests.
Typically, a multiunit nuclear power reactor site will use a larger workforce than a
single-unit site. However, the workforce at any site is affected by plant outages
because of the additional workers brought on site. Appendix A gives site-specific
testing data from CY 2009 through CY 2014.

(3)

The number of positive test results may vary from year to year at a site. Possible
reasons for changes in the positive testing rate at a site might include changes in
the characteristics of the workforce (e.g., age of workers, job duties, and
employment types), number of new hires, or changes in the availability of illegal
drugs in the local area. For example, the analysis of FFD program performance
data has consistently identified that C/Vs, on average, have a higher rate of
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positive test results (i.e., approximately 3.7 times more) than licensee employees
(Ref. 6). In outage years at a site, it is typical to see an increase in the number of
positive results because of the surge in the number of short-term contractors
used to support the outage.
(4)

•

The size of the workforce at the two Category I fuel cycle facilities, five corporate
offices, and one C/V (Institute of Nuclear Power Operations (INPO)) is much
smaller and more stable than at operating power reactor sites and power reactor
construction sites because these sites do not experience periodic workforce
surges for refueling outages or new construction. Drug use is also very low, as
presented in Appendix A. As a result, the NRC staff anticipates a lower than the
average cost per site for these types of facilities.

Testing Data by Facility Type: To evaluate variability among facility types, the NRC staff
analyzed testing data for CY 2009 through CY 2014 and calculated the average number
of tests performed and the average number of positive results for each of the 67 sites.
Table 4-1 summarizes the results of the site-specific testing data analysis. Appendix A
includes the site-specific testing data summarized in this table.
Table 4-1 Range of Testing Data by Facility Type (CY 2009–2014)
Positives/Year
Tests/Year
Number
of
Minimum Maximum
Minimum Maximum
Average
Average
Units
(10%)
(90%)
(10%)
(90%)
All
1,218
3,973
2,566
5.0
27.0
14.9
1
927
2,776
1,774
3.0
19.5
10.5
Power Reactor Operating
2
1,949
4,013
2,894
8.0
29.0
17.0
3
3,310
4,825
4,102
14.3
27.7
20.6
Power Reactor - Construction
232
6,181
3,961
3.6
131.1
76.7
Corporate Office
289
716
500
0
2.0
0.8
Fuel Cycle
747
865
811
0
3.0
1.6
C/V (INPO)
203
374
310
0
1.0
0.5
Facility
Type

–

Operating power reactors have the largest variability in the number of tests
conducted by facility type. This variability primarily depends on the number of
reactors at the site (e.g., one to three units), although an analysis of the data in
Appendix A shows that a single-unit site may perform more tests annually than a
two-unit site, and a two-unit site may conduct more tests annually than a
three-unit site.

–

Variability in the size of the workforce at a reactor construction site depends on
the stage of construction. The NRC FFD program performance data for CY 2009
through CY 2014 reflect construction on Vogtle Units 3 and 4, which began in
CY 2009, and Summer Units 2 and 3, which began in CY 2011.

–

Reactor construction sites have the largest number of positive tests of any facility
type. Reactor construction sites primarily rely on C/V personnel, and the positive
testing rates for these workers have been higher than comparable C/V
workforces used at operating power reactor sites (including during outages) (see
Appendix A).
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•

Analysis Horizon: Licensees would incur costs and savings over a 25-year period, which
is the average remaining license term of the 67 sites16 included in the analysis. The time
period that each site will be in operation is dependent on the term of the operating
license and whether the licensee chooses to operate the site for the duration of the
licensed period. The average life term is based on the following assumptions:
–

The licensee for each operating nuclear power reactor is known or assumed to
apply for and receive a 20-year license extension beyond the original 40-year
licensed term.

–

Each nuclear power reactor currently under construction is assumed to operate
for the 40-year period of the original operating license and to receive a 20-year
license extension. As part of the uncertainty analysis, the staff assumed that
each reactor currently under construction will apply for and receive a 20-year
license extension beyond the original 40-year licensed term.

–

Each licensee for a Category I fuel cycle facility is assumed to request and
receive operating license extensions to support the possession, use, and
manufacturing of nuclear material. As these facilities provide nuclear material for
noncommercial nuclear power reactors, the NRC staff assumed that their
operations would continue (assumed at 63 years) independent of activities
associated with civilian nuclear power reactors.

•

Base Year: The base year of this analysis is CY 2017. Monetized benefits and costs in
this analysis are expressed in 2017 dollars. The NRC staff assumes that the final rule is
effective in CY 2017. One-time implementation costs are assumed to be incurred in
CY 2017. Ongoing and annual costs of operation related to the alternatives are
assumed to begin in CY 2017, unless otherwise stated. Calculated benefits and costs
are then discounted into 2017 dollars.

•

Discounting of Costs and Savings: The costs or savings incurred in each year of the
analysis are discounted back at a 7-percent and 3-percent discount rate to the base
year. These discount rates are in accordance with NUREG/BR-0058, “Regulatory
Analysis Guidelines of the U.S. Nuclear Regulatory Commission,” Revision 4, issued
September 2004 (Ref. 29). Section 5.1 gives these results.

•

Cost/Benefit Inflators: To evaluate the costs and benefits consistently, the analysis
inputs are put into base year dollars. The most common inflator is the Consumer Price
Index for all urban consumers (CPI-U), developed by the U.S. Department of Labor,
Bureau of Labor Statistics. The formula to determine the amount in base year dollars is
as follows:
CPI
CPI

16

∗ Value

= Value

The NRC analyzed data on power reactors (operating, under construction) and Category I fuel cycle facilities
from NUREG-1350, Volume 27, “2015–2016 Information Digest,” issued August 2015 (Ref. 30), which is
adjusted for early plant retirement announcements.

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•

Sign conventions: The sign convention used in this analysis is that all favorable
consequences for the alternative are positive and all adverse consequences for the
alternative are negative. Negative values are shown using parentheses (e.g., negative
$500 is displayed as ($500)).

•

Labor rates: In estimating the incremental costs of the alternatives, the analysis uses
hourly labor rates that include salary, fringe benefits (e.g., paid leave and health
benefits), and overhead (e.g., payroll costs). Table 5-9 provides the labor rates used for
the uncertainty analysis, and Appendix B gives the labor rates for the base case. The
labor rates are in 2017 dollars.

4.2.4

Incremental Requirements in the Proposed Rule

The NRC quantitatively evaluated the impacts of the following four proposed rule changes
relative to the baseline described in Section 4.2.1:
(1)

Lowered initial and confirmatory drug testing cutoff levels for amphetamines and cocaine
metabolites.
The proposed rule would update the cutoff levels for initial drug testing, listed in
10 CFR 26.133, “Cutoff levels for drugs and drug metabolites,” and
10 CFR 26.163(a)(1), and for confirmatory drug testing, listed in 10 CFR 26.163(b)(1), to
conform with the changes to Section 3.4 of the 2008 HHS Guidelines as follows:
•

lower the initial drug testing cutoff level for cocaine metabolites by 50 percent
(from 300 nanograms (ng) per milliliter (mL) to 150 ng/mL)

•

lower the initial drug testing cutoff level for amphetamines by 50 percent (from
1,000 ng/mL to 500 ng/mL)

•

lower the confirmatory drug testing cutoff level for cocaine metabolites by
33 percent (from 150 ng/mL to 100 ng/mL)

•

lower the confirmatory drug testing cutoff levels for amphetamine and
methamphetamine by 50 percent (from 500 ng/mL to 250 ng/mL)

Significantly lowering the drug testing cutoff levels for amphetamines and cocaine
metabolites would increase the timeframe in which these drugs would be identified after
use (i.e., the window of detection). Increasing the window of detection would increase
the number of individuals identified with urine specimens containing amphetamines or
cocaine metabolites, or both. Increased detection of amphetamines and cocaine use
would provide a higher degree of assurance that persons subject to 10 CFR Part 26
testing are not using these drugs and would contribute to a licensee determination of
whether each individual is fit for duty and trustworthy and reliable.17

17

Sections 3.8 and 3.9 of the Regulatory Basis for this proposed rulemaking (Ref. 31) provide additional
information on the technical basis for lowering the initial and confirmatory drug testing cutoff levels for
amphetamines and cocaine metabolites.

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(2)

Expanded initial drug testing panel to include 6-acetylmorphine (6-AM) and revised
confirmatory drug testing cutoff level for 6-AM.
The proposed rule would add testing for 6-AM to the initial drug testing panel in
10 CFR 26.31(d)(1) and 10 CFR 26.405(d); make conforming changes to the
substances for initial testing listed in 10 CFR 26.133 and 10 CFR 26.163(a)(1) and for
confirmatory drug testing listed in 10 CFR 26.163(b)(1); and make conforming changes
to the annual statistical summary reporting requirements for HHS-certified laboratories to
include the revised drug testing panel in 10 CFR 26.169(h)(3). These changes would
ensure that 10 CFR Part 26 is consistent with Section 3.4 of the 2008 HHS Guidelines.
The proposed rule would revise the list of substances to be tested as follows:
•

Include initial drug testing for 6-AM with a 10-ng/mL testing cutoff level.

•

Eliminate the requirement to conduct confirmatory drug testing of 6-AM only
when the confirmatory drug test result for morphine exceeded 2,000 ng/mL.
(If initial testing for 6-AM is positive, confirmatory testing for 6-AM is to proceed
independent of the morphine concentration.)

The enhanced testing capability would enable the identification of additional instances of
heroin use (6-AM is a metabolite of heroin). Enhancing the detection of 6-AM is
important given the increasing prevalence of heroin use among individuals performing
safety-sensitive duties in other sectors of the economy and the adverse effect of these
illegal drugs on persons in the workplace.18 In addition, improved testing for 6-AM could
deter additional individuals from seeking employment in 10 CFR Part 26 regulated
workplaces.
(3)

Expanded initial and confirmatory drug testing panels to include Ecstasy.
The proposed rule would add testing for Ecstasy-type drugs
methylenedioxymethamphetamine (MDMA), and methylenedioxyamphetamine (MDA),
to the drug testing panel in 10 CFR 26.31(d)(1) and 10 CFR 26.405(d). MDMA and
MDA would be added to the substances for initial drug testing listed in 10 CFR 26.133
and 10 CFR 26.163(a)(1), and MDMA and MDA would be added to the substances for
confirmatory drug testing listed in 10 CFR 26.163(b)(1). Conforming changes would be
made to the annual statistical summary reporting requirements for HHS-certified
laboratories to include the revised drug testing panel in 10 CFR 26.169(h)(3). These
changes would ensure that 10 CFR Part 26 is consistent with Section 3.4 of the 2008
HHS Guidelines, with the exception of not listing methylenedioxyethylamphetamine
(MDEA), which HHS subsequently removed from the list of authorized test analytes in
the 2017 HHS mandatory guidelines (Ref. 35).

18

Sections 3.3, 3.7 and 3.8 of the Regulatory Basis for this proposed rulemaking (Ref. 31) provide additional
information on the technical basis for expanding the initial drug testing panel to include 6-AM and revising
the confirmatory drug testing cutoff level for 6-AM.

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The proposed rule would revise the list of substances to be tested as follows:
•

Include initial drug testing for MDMA and MDA with a 500-ng/mL testing cutoff
level.

•

Include confirmatory drug testing for MDMA and MDA with 250-ng/mL testing
cutoff levels.

Testing for this additional substance would enable the identification of a greater range of
illegal drugs that could impair human performance. Ecstasy would be added to the drug
testing panels because of its increasing prevalence and adverse effects on persons in
the workplace.19 Testing for Ecstasy also may deter additional individuals from seeking
employment in 10 CFR Part 26 regulated workplaces.
(4)

Required special analyses testing of dilute specimens and specimens collected during
suspected subversion attempts.
Existing regulations in 10 CFR 26.163(a)(2) provide licensees with the option to conduct
special analyses testing on any urine specimen with a dilute validity test result (i.e., a
creatinine concentration greater than or equal to 2 milligrams per deciliter (mg/dL) but
less than 20 mg/dL). Special analyses testing consists of conducting confirmatory drug
testing to the LOD for any drug with an initial test result (i.e., immunoassay response)
equal to or greater than 50 percent of the testing cutoff level.
The NRC is proposing three changes:
(1)

Require special analyses testing for any drug in a dilute specimen with an initial
drug test result that is equal to or greater than 40 percent of the testing cutoff
level.

(2)

Expand special analyses testing to circumstances in which a subversion attempt
is suspected during the specimen collection process (e.g., if the initial specimen
is out of the expected temperature range, the second specimen collected under
direct observation would be subject to the special analyses provisions).

(3)

Use the LOQ instead of the LOD as the level at which confirmatory drug testing
is to be conducted.

These three changes would enhance the detection of individuals using illegal drugs or
misusing legal drugs, or both, in circumstances in which the urine specimens provided
do not present normal physiological characteristics. The 2008 HHS Guidelines do not
address special analyses testing, but the proposed changes are based on industry
experience (i.e., high industry adoption of the voluntary 10 CFR 26.163(a)(2) special
analyses testing of dilute specimens and the additional dilute positive test results

19

Sections 3.4 through 3.7 of the Regulatory Basis for this proposed rulemaking (Ref. 31) provides additional
information on the technical basis for expanding initial and confirmatory drug testing panels to include
Ecstasy.

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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

identified each year) and feedback received from HHS-certified laboratories in
implementing the 2008 FFD final rule.20
The NRC staff developed equations to estimate costs and savings using available data and
described any assumptions used, when necessary. Appendices B, C, and D document this
analysis, including the specific per-site or per-FFD-program cost assumptions used to quantify
costs and savings.
The proposed rule also would include the following changes, which would result in either no or
negligible incremental costs to licensees but would lead to some benefits as discussed below:
•

The proposed rule would add and revise definitions in 10 CFR Part 26 to improve
consistency with the definitions in the 2008 HHS Guidelines and also improve internal
consistency in 10 CFR Part 26. These changes would be administrative, are estimated
to result in negligible incremental costs, and could result in savings. The changes would
lead to improved regulatory efficiency, in part, by promoting clear and unambiguous
communications.

•

The proposed rule would replace the LOD with the LOQ as the decision point for
determining whether a specimen contains an adulterant or is invalid (i.e., a valid test
result cannot be determined) based on the possible presence of a halogen or an
oxidizing adulterant. This would entail minor procedural changes with negligible
incremental costs (see Section 4.2.4). The change to LOQ enhances the protection
afforded to individuals subject to validity testing because the test result reliably identifies
and quantifies the substance tested.

•

The proposed rule would clarify the procedures for observed urine specimen collections,
as well as specimen quantity, altered specimens, and refusals to test. These changes
would take the form of clarifications to existing procedures, and the staff therefore
expects incremental costs to be negligible. The changes would enhance consistency
with the 2008 HHS Guidelines and allow for increased flexibility in licensee
implementation of the proposed rule.

•

The proposed rule would permit additional trained licensee or other entity staff at the
collection site (i.e., FFD program personnel) to observe a donor in the hydration process.
An individual enters the hydration process when he or she is unable to provide a urine
specimen of adequate volume for testing (i.e., a shy bladder). Currently, the specimen
collector must remain with the donor for the duration of the hydration period (a maximum
of 3 hours) and not conduct an additional collection until the first collection (of the
hydrating individual) has been completed. The proposed changes add flexibility to the
collection process by permitting a specimen collector to conduct additional collections
while the donor is hydrating. The NRC staff finds that the savings associated with this
proposed change would be minimal because the incidence of shy-bladder events is
infrequent.

20

Sections 3.11 through 3.13 of the Regulatory Basis for this proposed rulemaking (Ref. 7) provide additional
information on the technical basis for requiring special analyses testing of dilute specimens and specimens
collected during suspected subversion attempts.

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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

•

The proposed rule would eliminate the 6-month in-service limit for BPTSs and allow
BPTS suppliers to specify the shelf life of sample lots. The option to specify shelf life
adds flexibility to the rule and would not impose any incremental costs because current
practice would still be acceptable. The change also would result in enhanced
consistency with the 2008 HHS Guidelines, which do not require similar in-service limits
on BPTS lots.

•

The proposed rule would remove 10 CFR 26.155, “Laboratory personnel,” and
paragraphs (b) through (e) of 10 CFR 26.157, “Procedures,” which repeat requirements
contained in the HHS Guidelines that the National Laboratory Certification Program
(NLCP) verifies in order for a laboratory to achieve and maintain HHS certification. This
would eliminate dual regulation of an HHS-certified laboratory (a private entity) and
reduce the regulatory burden on licensees.

•

The proposed rule would clarify terminology associated with quality control samples.
This change would be administrative and would correct inconsistencies in
10 CFR Part 26 that are described in the enforcement guidance memorandum dated
March 31, 2009 (Ref. 20).

•

The proposed rule would clarify MRO actions with regard to invalid validity test results
due to high pH values (between 9.0 and 9.5). This would result in some incremental
effort on the part of the MRO (e.g., on the order of an hour per occurrence to review
such results), but the cost would be incurred infrequently (i.e., for a subset of invalid
specimens) so the total cost of the change would be small. This change would enhance
FFD program integrity and the protection of individual rights.

•

The proposed rule would require the MRO to document a verbal request from a donor to
test Bottle B of a split specimen or retest a single specimen. This change would ensure
that a record of the donor’s request is documented and would confirm that the request
was made in a timely manner (required by 10 CFR 26.165(b)(2) to be within 3 business
days of the donor being informed of the MRO-verified drug positive, adulterated, or
substituted validity test result). This change would enhance consistency with the 2008
HHS Guidelines, transparency of the testing process, and due process afforded to the
donor.

•

The proposed rule would require the testing of any specimen collected during a postevent testing situation in which a testing refusal was determined during the collection
process. Previously, any specimen collected would be discarded. In an effort to
improve the root-cause evaluation process associated with accidents, testing of any
urine specimen collected would be required in order to ensure that all available
information is obtained to support the evaluation of human performance associated with
the event. Because post-event testing situations are rare, 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, the incremental cost associated with this rule change would be
negligible (i.e., the cost of testing a specimen for an infrequent event).

4.2.5

Data Sources

The analysis used the following data sources:

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•

Affected entities: The determination of 67 affected entities, also called sites in the
analysis, is based on the CY 2014 FFD program performance information reported to the
NRC under 10 CFR 26.717. The analysis does not include data for any site that already
has entered decommissioning (i.e., Crystal River Unit 3, Kewaunee, San Onofre Units 2
and 3, and Vermont Yankee), or announced early plant closure (i.e., FitzPatrick, Oyster
Creek, and Pilgrim) and would cease operations before or during calendar year 2019
and no longer be subject to 10 CFR Part 26.21

•

Site-specific drug and alcohol testing data: Appendix A to this document presents the
NRC FFD program performance data on the total number of drug tests conducted as
well as the total number of positive, adulterated, substituted, and refusal to tests results
by site for CY 2009 through CY 2014. The NRC staff used the average of 6 years of
testing data, which accounts for several outage cycles for an operating power reactor.

•

Workforce to receive training on policy changes: Each site reports its workforce subject
to 10 CFR Part 26 random testing in its annual FFD program performance report
submission to the NRC as required by 10 CFR 26.717. This information is the best
source available to the NRC of the workforce size that would require training on the rule
changes. The NRC’s analysis of CY 2009 through CY 2014 submissions determined
that the average overall workforce size subject to 10 CFR Part 26 testing in a year is
107,620.

•

NRC drug testing information: The “Summary of Fitness for Duty Program Performance
Reports for Calendar Year 2013” (Ref. 6) and FFD program performance data received
for CY 2014 (the agency has not yet published the summary report) are the sources of
NRC licensee and other entity drug testing data used in the analysis. In the base case
estimate, the NRC staff used the 6-year average of data from CY 2009 through CY 2014
for the following:
–
–
–

number of drug tests conducted annually = 157,632
positive rate for amphetamines (0.047 percent)
positive rate for cocaine (0.072 percent).

•

Reactors under construction (test results): The NRC staff has modeled the drug tests to
be performed and the positive results to be expected for the units currently under
construction at Summer (Units 2 and 3) and Vogtle (Units 3 and 4) based on the FFD
program performance data of the co-located operating sites. Because these units under
construction are anticipated to be completed in CY 2019 and CY 2020, the workforces
subject to testing and the drug use profile of those individuals are expected to be more
analogous to the workforce at the co-located operating sites than the current
construction workforce. For example, for Vogtle Units 3 and 4, the analysis used the test
results at Vogtle Units 1 and 2 as the anticipated testing performance of these units once
operational. The effect of this assumption is a slightly lower baseline of positive drug
tests.

•

Percent change in positive rates (amphetamines and cocaine): These rates are based
on an NRC staff analysis of MRO-verified drug test results from CY 2010 and CY 2011

21

As stated in Note 15, this set of sites reflects the NRC’s understanding of licensees’ plans to decommission
at the time this regulatory analysis was prepared. The costs and benefits of the rule would change if the
number of facilities that decommission changes over the timeframe considered in this analysis.

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for three DOT modal administrations (i.e., Federal Aviation Administration (FAA),
Federal Transit Administration (FTA), and Federal Railroad Administration (FRA)). Use
of MRO-verified results is important for Schedule II drugs because these drugs can be
legally prescribed to treat a medical condition (e.g., amphetamines may be prescribed to
treat attention deficit disorder) and so the results could be downgraded to a negative
result upon medical doctor review. Use of MRO-verified results ensures that the
detection improvements modeled are based on illegal drug use and not legitimate
prescription use. In addition, to limit the potential differences between drug use among
the NRC- and DOT-covered workforces, the change in positive testing rate from
CY 2010 through CY 2011 is used to estimate detection improvements from lower
testing cutoff levels. The use of positive test result data for modeling over longer periods
of time (e.g., CY 2010 through CY 2014) would more likely include other factors, such as
workforce use trends.

•

–

The NRC staff assumes that positive laboratory test results for amphetamines
will be confirmed as illegal drug use or legal drug misuse by an MRO 75 percent
of the time.

–

The NRC staff assumes that all cocaine positive laboratory test results will be
confirmed as illegal drug use or legal drug misuse by an MRO. It is unlikely that
an individual subject to 10 CFR Part 26 would have recently been subject to a
medical procedure for which cocaine might have been used (e.g., nasal or throat
surgery, an intubation procedure) and then returned to work before the medical
condition had resolved and the individual was able to physically return to work.

Expected positive rates for the new drugs included in the testing panel (6-AM and
Ecstasy drugs): The NRC staff based these rates on its analysis of HHS-certified
laboratory drug test results from DOT testing after DOT implemented the 2008 HHS
Guidelines changes starting October 1, 2010. While an MRO did not verify these
laboratory data, these substances are Schedule I (illegal drugs with no medical use
permitted in the United States). Also, MRO-verified data for the DOT modal
administrations were not available for these substances, unlike for the amphetamines
and cocaine positive results. The positive rate used in the analysis for each drug is
based on the average positive rate for CY 2010 through CY 2014:
–
–

6-AM = 0.017 percent
Ecstasy drugs = 0.004 percent.

•

Specimen testing costs: The analysis used input from stakeholders received during and
after public meetings held on the proposed rule and the professional judgment of the
NRC staff, when necessary. Appendix B lists the data sources for these inputs.

•

Special analyses testing of specimens collected under direct observation (suspect
specimens): E-reported FFD program performance data provide detailed information on
each subversion attempt. Table 4-2 presents information on the total number of
subversion attempts confirmed in CY 2011 through CY 2014, the number of subversion
attempts confirmed through the testing of specimens collected under direct observation,
the percentage of subversion attempts determined through the testing of specimens
collected under direct observation, and the percentage of all specimens collected each
year that are suspect specimens collected under direct observation and that test
positive.
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Table 4-2. Suspect Specimens Collected Under Direct Observation

•

Year

Total
Number of
Subversion
Attempts

Number of
Subversion Attempts
Confirmed by Testing
of Specimens
Collected under
Direct Observation

2011
2012
2013
2014

123
158
145
187

42
55
44
63

Percentage of
Subversion Attempts
Confirmed Through
the Testing of
Specimens Collected
under Direct
Observation
34.1%
34.8%
30.3%
33.7%

Percentage of Total
Specimens Collected
Each Year that are
Suspect Specimens
Collected under
Direct Observation
and Test Positive
0.030%
0.035%
0.029%
0.038%

Special analyses testing of dilute specimens: Beginning in CY 2013, changes to the
e-reporting forms permitted the uniform collection of data on the number of dilute
specimens subject to specimen analyses testing (i.e., 652 specimens in CY 2013 and
834 specimens in CY 2014). By comparison, the number of dilute specimens that tested
positive during special analyses testing has been collected uniformly in the e-reporting
system since CY 2011. Based on CY 2014 FFD program performance report data,
92 percent of licensees and other entities (69 of 75 sites) have voluntarily adopted the
optional special analyses testing of dilute specimens in 10 CFR 26.163(a)(2).

Appendices B, C, and D give the assumptions and data sources used in the analysis.

4.2.6

Assumptions

The NRC staff made the following assumptions to quantify the costs and benefits of the
proposed rule alternative:
•

The NRC staff estimates on the expected positive testing rates for 6-AM and Ecstasy
drugs are based on the HHS-certified laboratory test results for DOT drug tests
performed from CY 2010 through CY 2014. These testing data represent a
comprehensive set of annual drug testing results (approximately 5 to 6 million tests per
year) for a federally regulated industry (the transportation industry) with safety- and
security-sensitive positions comparable to those in the commercial nuclear industry.
Comparison of DOT and NRC drug testing data documented in the Regulatory Basis
(Ref. 31) for this proposed rule reveals that, in general, DOT positive testing rates
historically have been higher than in the workforce subject to testing under
10 CFR Part 26. In CY 2011, for example, DOT positive testing rates were about
4.5 times greater than the NRC rates for cocaine and about 9 times greater for
amphetamines. This difference can be explained in part by the fact that DOT data are
laboratory results that have not been MRO verified (i.e., positive rates can be higher for
Schedule II drugs, which can be medically downgraded by the MRO if an acceptable
medical explanation for use exists), whereas the NRC results are MRO verified. In the
case of 6-AM and Ecstasy drugs, each is a Schedule I drug and therefore must be
verified by an MRO as positive (no medical use is authorized in the United States for
these substances). In the case of the expected increase in positive results for
amphetamines and cocaine, the NRC staff believes that it is reasonable to use the
incremental change in DOT positive testing rates after the Department implemented the
2008 HHS Guidelines as a basis for forecasting the increased number of expected
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positive test results that would result from the proposed rule changes. Using a limited
timeframe to measure the detection improvement changes (from CY 2010 through
CY 2011) minimizes differences in drug use that may be occurring between these
populations. For heroin and Ecstasy drugs, the analysis modeled the detection of these
drugs by taking the average annual DOT positive rate from October 2010 (when the
Department began implementing the 2008 HHS Guidelines) through CY 2014.
•

The NRC staff evaluated 6 years of site-specific FFD program performance testing data
(CY 2009 through CY 2014) to establish the baseline estimates used for tested
populations and positive testing rates for substances evaluated in the regulatory
analysis. The staff also used this time series of data to determine how certain inputs
could be expected to vary in order to establish realistic ranges for use in the uncertainty
analysis.

•

The NRC staff used FFD program performance testing data (Ref. 6) as the basis to
forecast the future positive testing rates for amphetamines, cocaine, dilute specimens,
and suspect specimens (subversion attempts). The FFD program performance data
include results from construction sites, which have had higher positive testing rates than
all other types of sites. However, as is evident in Appendix A, the number of tests
conducted and the number of positive results each year were most influential on results
in CY 2012 through CY 2014 (the analysis models testing data from a longer period of
time, CY 2009 through CY 2014, when construction site testing was low or comparable
to that of operating sites). Also, only 2 of the 59 power reactor sites included in the
analysis have power reactors under construction. Therefore, while including the
construction site test results with the other site results yields higher values for the
number of positive test results than the values that would be expected when the current
nuclear plant construction programs complete construction in CY 2020, the impact on
the results is limited because of the time period of the data used in the analysis and the
variability in testing conducted at each of the sites during the various phases of
construction. It is also important to note that the test results reflected in Appendix A
include alcohol positive results. For example, an analysis of FFD program performance
data for construction sites from CY 2010 through CY 2014 indicates that approximately
14.3 to 16.7 percent of the positive results each year were from alcohol positive tests.

•

Because of the prevalence of attempts to subvert the drug testing process, the positive
test rates used as the current FFD program testing rates for amphetamines,
methamphetamines, and cocaine could be higher than reported. The model forecasts
detection improvements using the average positive rate for these substances from
CY 2010 through CY 2014. Because two-thirds of those identified as subverting a test
do not submit a specimen for testing (approximately 80 to 100 individuals per year), the
drug(s) in a donor’s body will not be detected and captured in the total results for the
year.

Appendices B, C, and D document the assumptions used in the analysis. Section 5.2
documents the inputs and results of the uncertainty analysis.

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5.

Results

This section organizes the analytical results into five sections. Section 5.1 presents results on
the benefits and costs of the proposed rule. Section 5.2 evaluates the uncertainties in the
benefit and cost estimate and identifies those uncertain variables that most affect the variation
in the results. Section 5.3 addresses the disaggregation results for each of the regulatory
initiatives that comprise the proposed rule. Section 5.4 contains the evaluation of changes in
the proposed rule in accordance with 10 CFR 50.109, “Backfitting” (Ref. 8), 10 CFR 52.98,
“Finality of combined licenses; information requests” (Ref. 10), and 10 CFR 70.76, “Backfitting”
(Ref. 9). Section 5.5 describes the information required for review by the Committee to Review
Generic Requirements (CRGR).

5.1

Benefits and Costs of the Proposed Rule

This section discusses the benefits and costs estimated for the proposed rule (as summarized
in Tables 5-1 and 5-2) and for each quantifiable regulatory initiative contained in the proposed
rule (as summarized in Table 5-3). Sections 5.1.7 through 5.1.10 describe the qualitatively
evaluated attributes in the analysis.
The proposed rule (Alternative 2) would result in an estimated net cost of between ($2.7 million)
and ($3.6 million), at a 7-percent and 3-percent discount rate, respectively. These costs are
associated with three affected attributes—industry implementation, industry operation, and NRC
implementation. These numbers include averted training costs (i.e., quantified benefits) to
industry operation associated with additional individuals testing positive during pre-access drug
testing.
Appendix C provides details on the industry’s and the NRC’s incremental activities that would be
required under the proposed rule and estimates the one-time and annual costs associated with
these activities. This analysis considers the potential costs associated with required sanctions
resulting from additional positive test results. The regulations in 10 CFR 26.75(e) require that a
first positive drug or alcohol test result must lead to termination of the individual’s unescorted
access authorization for at least 14 days. For a second positive drug or alcohol test result,
10 CFR 26.75(e) requires a 5-year denial of access (Ref. 1).22

22

In practice, some affected entities may take additional actions in response to positive drug test results, which
may involve staffing actions such as compensating other staff for overtime to cover the assignments of the
individual who committed the FFD violation or hiring and training a replacement. The NRC staff assumes
that the costs associated with staffing actions in response to any additional positive drug test results each
year from the proposed rule would be negligible for the following reasons. First, data collected by the NRC
on existing FFD programs indicate that approximately 68 percent of positive test results occur during preaccess testing (Ref. 6). The NRC staff assumes that this historical trend will continue, such that 68 percent
of the additional positive drug test results would not result in costs associated with staffing actions because
these individuals are detected during pre-access testing. Second, existing FFD program performance data
indicate that C/V staff account for 70 percent of the remaining (non-preaccess) positive drug test results, and
the NRC staff assumes that this historical trend will continue. Licensees typically impose a “zero tolerance”
policy on C/Vs, which are primarily fungible employees, so individuals with positive test results are
immediately replaced with another C/V employee. Removing the estimated positive test results associated
with pre-access testing and C/V staff leaves 10 percent of the estimated additional positive test results
attributable to licensee employees under random, for-cause, post-event, and followup testing conditions.
For this analysis, the NRC staff assumes that these additional positive test results are evenly distributed
across the industry, resulting in an average of approximately 0.1 positive test result per site per year.

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The NRC staff assumes that Alternative 2 would result in qualitative benefits in the attributes of
public health (accident), occupational health (accident), offsite property, onsite property,
regulatory efficiency, safeguards and security considerations, and other considerations, which
include public perception, public trust, workplace productivity, workplace safety, and improved
protection of individual rights.
As benefits, the proposed rule is estimated to result in a 10- to 12- percent increase in the
number of individuals identified each year using illegal drugs, misusing illegal 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 proposed rule would maintain the existing
performance objective in 10 CFR 26.23(d) that requires FFD programs to “provide reasonable
assurance that the workplaces subject to this part are free from the presence and effects of
illegal drugs.” Based on the analysis of annual FFD program performance data submitted to the
NRC by licensees and other entities, the workplaces subject to 10 CFR Part 26 testing are not
free from the presence and effects of illegal drugs.
Licensees and other entities also may recognize a variety of other 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 individual
working at any sites or any of the associated costs.

•

Second chance policy and followup testing: Unlike C/V workers, licensees may provide
a second chance to their employees who test positive for a drug. As a result, each of
these individuals who successfully received treatment and returns to the workforce will
be subject to a 10 CFR Part 26 followup testing program. If pre-access testing detects
drug use by the individual, then the cost of conducting followup testing on an individual
would be averted.

The proposed rule changes also would improve regulatory efficiency through regulatory and
compliance improvements, including by harmonizing definitions and procedures with those
described in the 2008 HHS Guidelines, eliminating dual regulation of HHS-certified laboratories,
and clarifying ambiguous or imprecise regulatory language in 10 CFR Part 26.

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Table 5-1. Summary of Overall Benefits and Costs (Quantitative and Qualitative),
Alternative 2 (Proposed Rule)
Benefits

(Costs)

Estimated 10- to 12-percent increase in detection of
individuals using drugs or attempting to subvert the drug
testing process. This equates to approximately
95 individuals per year or 2,375 individuals over the 25-year
time period of the analysis.

Industry Implementation, Industry Operation
(25-year time period of the analysis)
($2.4 million) using a 7% discount rate
($3.4 million) using a 3% discount rate
NRC Implementation ($273,000)

Public Health (Accident): Identification of additional
individuals using drugs and denying them unescorted access
authorization would reduce the risk that public health would be
affected by an accident resulting from human performance
issues associated with drug-induced impairment.

Total Net Costs
($2.7 million) using a 7% discount rate
($3.6 million) using a 3% discount rate

Occupational Health (Accident): Identification of additional
individuals using drugs and denying them unescorted access
authorization would reduce the risk that occupational health
would be affected by an accident resulting from human
performance issues associated with drug-induced impairment.
Offsite Property: Identification of additional individuals using
drugs and denying them unescorted access authorization
would reduce the risk that offsite property would be affected by
an accident resulting from human performance issues
associated with drug-induced impairment.
Onsite Property: Identification of additional individuals using
drugs and denying them unescorted access authorization
would reduce the risk that onsite property would be affected by
radiological releases resulting from human performance issues
associated with drug-induced impairment.
Regulatory Efficiency: Harmonizing definitions and
procedures with those in the 2008 HHS Guidelines, addressing
dual regulation of HHS-certified laboratories, clarifying
ambiguous rule language, providing additional regulatory
flexibility in 10 CFR Part 26, and enhancing donor due process
provisions would improve regulatory efficiency.
Safeguards and Security Considerations: Increased
assurance that individuals are trustworthy and reliable by
enhancing the detection and deterrence of illegal drug use,
legal drug misuse, and attempts to subvert the drug testing
process would improve safeguards and security.
Other Considerations: The deterrent of a drug testing
program would provide benefits to industry in that it would
eliminate additional individuals prone to illegal drug use and
legal drug misuse from seeking employment in 10 CFR Part 26
regulated positions. Industry benefits from fewer drug users in
the workforce may include increased worker productivity, fewer
sick days, less turnover in positions, reduced number of
job-related accidents, reduced number of disability claims, and
reduced likelihood of equipment damage as a result of
impairment from the use of drugs (6-AM, amphetamine,
cocaine, Ecstasy, and methamphetamine).

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Table 5-2. Summary of Total Benefits and Costs to Industry (One-Time and Annual)
One-Time
Benefit
(Cost)
($337,090)
1
2
3

Total Benefits and (Costs)
Annual
Net Present
Benefit
Value
(Cost)
(7 percent)
($168,594)
($2,439,343)

Net Present
Value
(3 percent)
($3,360,912)

Average per Site1
One-Time
Annual
Benefit
Benefit
(Cost)
(Cost)
($5,031)
($2,516)

Average cost per site calculated by dividing the total industrywide cost by the number of sites (67).
In addition to these industry costs, the NRC implementation costs as a result of the final rule are estimated to be
($273,000).
Results stated in 2017 dollars.

Table 5-3. Summary of One-Time and Annual Benefits and Costs to Industry, by
Regulatory Initiative
Total Benefits and (Costs)

Average per Site1

Annual
Net Present Value
Net Present Value
Annual
Benefit (Cost)
(7 percent)
(3 percent)
Benefit (Cost)
Costs to implement drug testing program changes
(One-time policy, procedure, and training costs)
($337,090)
($337,090)
1. Lowered initial and confirmatory testing cutoff levels for amphetamines and cocaine
metabolites
($13,733)
($171,241)
($246,309)
($205)
2. Expanded initial drug testing panel to include 6-AM and revised confirmatory testing cutoff
level for 6-AM
($136,555)
($1,702,750)
($2,449,188)
($2,038)
3. Expanded initial and confirmatory drug testing panels to include Ecstasy
($94,871)
($1,182,978)
($1,701,563)
($1,416)
4. Required special analyses testing of dilute specimens and specimens collected during
suspected subversion attempts
($11,256)
($140,355)
($201,882)
($168)
5. Averted training costs as a result of pre-access testing
$87,821
$1,095,071
$1,575,120
$1,311
TOTAL
($168,594)
($2,439,343)
($3,360,912)
($2,516)
1
2

Average cost per site is calculated by dividing the total industrywide cost by the number of sites (67).
Results stated in 2017 dollars.

Sections 5.1.1 through 5.1.6 discuss the quantified one-time costs and annual costs associated
with each of the five regulatory initiatives. Sections 5.1.7 through 5.1.10 present further
discussion on qualitatively evaluated elements in the analysis. Appendices B, C, and D provide
the specific inputs and calculations that resulted in the summary results presented in the tables
in this section.

5.1.1

One-Time Policy, Procedure, and Training Costs

The five regulatory initiatives would impact FFD program policies, procedures, and training.
Specifically, licensees would need to update FFD program policies and procedures to account
for the new drug testing protocols and inform individuals who are covered by the FFD program
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of the changes in policies and procedures. In addition, the proposed rule changes would
require each FFD program to update three contracts—two with its HHS-certified laboratories
(the primary and secondary labs) and one with its BPTS supplier to reflect the new drug testing
criteria. Additionally, sites using LTFs for initial drug testing would need to train laboratory
technicians on the new protocols and validate the immunoassays that would change because of
lower cutoff levels and the inclusion of additional substances in the testing panel.
The NRC staff assumes that licensees would pursue the least-cost approach to implementing
the proposed rule. With respect to informing individuals already subject to an FFD program on
the changes in the FFD program policies and procedures, the analysis estimates that
80 percent of sites would incorporate this information into the annual refresher training required
by 10 CFR 26.29(c). This approach would not result in an incremental change in costs of
training individuals on the FFD policy changes because the refresher training already includes
time to update individuals on changes in the FFD program from the previous training. However,
the NRC staff does estimate that the remaining 20 percent of sites would distribute information
on FFD program changes outside the annual refresher training process and would provide each
individual a summary of the FFD policies and procedures to read and sign an acknowledgment
of receipt of the information.23
In addition to one-time industry costs, the NRC would incur implementation costs. The staff
expects the proposed rule to result in a total one-time cost of ($273,000) to the NRC to
complete the rulemaking (i.e., analyze public comments, hold public meeting(s), and develop
the final rule) and issue regulatory guidance.
In summary, the one-time costs include the following:
•
•
•

one-time cost to industry:
one-time average cost per site:
one-time cost to the NRC:

($337,090)24
($5,031)
($273,000).

Table 5-4 summarizes the one-time costs by implementation activity for industry and the NRC.

23

The NRC staff estimates that approximately 20 percent of sites (i.e., 14 of 67 sites) would conduct an
independent training on the rule changes (in accordance with labor agreements) instead of including the
information update as part of annual FFD refresher training.

24

This cost could be as high as ($1.4 million) if all sites choose to hold trainings and distribute information on
FFD program changes outside of annual refresher training required by 10 CFR 26.29(c) (i.e., if sites do not
pursue the least-cost approach).

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Table 5-4. One-Time Implementation Costs
Affected
Entity

Base Estimate Cost
(Undiscounted,
2017 dollars)

Implementation Activity
Update policies and procedures

Industry

($6,102)

Inform employees of policy change

($289,720)

Revise contract with the primary HHS-certified laboratory

($12,177)

Revise contract with the backup HHS-certified laboratory

($12,177)

Revise contract with BPTS supplier

($6,102)

Train LTF technicians

($3,438)

Validate drug testing assays at LTF

($7,374)
Total for all sites
Average cost per site

NRC

5.1.2

Final rule and regulatory guide development

($337,090)
($5,031)
($273,000)

Lowered Initial and Confirmatory Drug Testing Cutoff Levels for
Amphetamines and Cocaine Metabolites

Lowering the testing cutoff levels for amphetamines and cocaine metabolites would increase the
timeframe (i.e., the window of detection) in which these drugs can be detected in an individual’s
urine specimen after use. As a result, the NRC staff anticipates that the use of lower testing
cutoffs will increase the number of individuals who test positive for amphetamines and cocaine
metabolites. Licensees will incur the costs associated with confirmatory testing and subsequent
actions taken when an individual tests positive (i.e., on the part of the FFD program staff, the
MRO, and the donor). These incremental costs are estimated as follows:
•
•

total annual cost to industry:
average annual cost per site:

($13,733)
($205)

In making these changes to maintain reasonable assurance of a drug-free workplace, the NRC
staff estimates that this regulatory initiative would result in 43 additional confirmed positive test
results, as presented in Table 5-5. Therefore, lowering the testing cutoff levels for
amphetamines and cocaine metabolites would provide additional assurance that persons who
are using illegal drugs or misusing legal drugs would be identified and denied unescorted
access authorization than under the current 10 CFR Part 26 framework. Appendices B and C
provide additional information on the estimated increase in positive test results.

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Table 5-5. Additional Amphetamines and Cocaine Positives
from Lower Testing Cutoff Levels
(Estimated Total for All Sites)

5.1.3

Substance

Number of Additional Confirmed Positive
Test Results Projected per Year

Amphetamines

22

Cocaine

21

Expanded Initial Drug Testing Panel to Include 6-AM and Revised
Confirmatory Testing Cutoff Level for 6-AM

Licensees would incur costs to conduct initial testing of each urine specimen for 6-AM (the
metabolite of the illegal drug heroin), which would increase the number of urine specimens
identified as containing 6-AM. Licensees also would incur costs associated with any specimens
that test positive on confirmatory testing and the subsequent actions taken when an individual
tests positive (i.e., on the part of the FFD program staff, the MRO, and the donor). These
incremental costs are estimated as follows:
•
•

total annual cost to industry:
average annual cost per site:

($136,555)
($2,038)

In making these changes to maintain reasonable assurance of a drug-free workplace, the NRC
staff estimates that this regulatory initiative would result in an additional 27 confirmed positive
test results per year, as presented in Table 5-6. Therefore, expanding the initial drug testing
panel to include 6-AM and revising the confirmatory testing cutoff level for 6-AM would provide
additional assurance that persons who are using the illegal drug heroin would be identified and
denied unescorted access authorization than under the current 10 CFR Part 26 framework.
Appendices B and C provide additional information on the estimated increase in positive test
results.
Table 5-6. Additional 6-AM Positive Results from Expanded
Drug Testing Panel (Estimated Total for All Sites)

5.1.4

Substance

Number of Additional Confirmed
Positive Test Results Projected per Year

6-AM

27

Expanded Initial and Confirmatory Drug Testing Panels to Include
Ecstasy

Licensees would incur costs to conduct initial testing of each urine specimen for MDMA.
Licensees also would incur costs associated with any specimens that test positive on
confirmatory testing and the subsequent actions taken when an individual tests positive (i.e., on
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the part of the FFD program staff, the MRO, and the donor). These incremental costs are
estimated as follows:
•
•

total annual cost to industry:
average annual cost per site:

($94,871)
($1,416)

In making these changes to maintain reasonable assurance of a drug-free workplace, the NRC
staff estimates that this regulatory initiative would result in an additional seven confirmed
positive test results per year, as presented in Table 5-7. As a result, this proposed change
would provide additional assurance that persons who are using illegal drugs would be identified
and denied unescorted access authorization than under the current 10 CFR Part 26 framework.
Appendices B and C provide additional information on the estimated increase in positive test
results.
Table 5-7. Additional Ecstasy Positive Results from Expanded
Drug Testing Panel (Estimated Total for All Sites)

5.1.5

Substance

Number of Additional Confirmed Positive
Test Results Projected per Year

Ecstasy

7

Required Special Analyses Testing of Dilute Specimens and
Specimens Collected during Suspected Subversion Attempts

Licensees would incur costs to conduct mandatory special analyses testing of dilute specimens
(presently 10 CFR 26.163(a)(2) provides licensees with the option to conduct this testing, and
92 percent of licensees instituted this testing policy as of CY 2014). Licensees also would incur
incremental costs to conduct special analyses testing of specimens collected under direct
observation (i.e., specimens collected during suspected subversion attempts). These special
analyses requirements would result in incremental improvement with additional costs associated
with the newly required confirmatory testing and subsequent actions associated with additional
positive test results (i.e., on the part of the FFD program staff, the MRO, and the donor). These
incremental costs are estimated as follows:
•
•

total annual cost to industry:
average cost per site:

($11,256)
($168)

In making these changes to maintain reasonable assurance of a drug-free workplace, the NRC
staff estimates that this regulatory initiative would result in an additional 18 confirmed positive
test results, as presented in Table 5-8.25 Therefore, this proposed change would provide
additional assurance that persons who are using illegal drugs, misusing legal drugs, or
attempting to subvert the drug testing process would be identified and denied unescorted
access authorization than under the current 10 CFR Part 26 framework. Appendices B and C
provide additional information on the estimated increase in positive test results.

25

Based on trends in subversion attempts (Ref. 6), the majority of the 18 additional confirmed positive test
results would be expected to occur during pre-access testing.

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Table 5-8. Additional Positive Results from Special Analyses
Testing of Dilute and Subversion Specimens
(Estimated Total for All Sites)

5.1.6

Specimen Type

Number of Additional Confirmed
Positive Test Results Projected per Year

Dilute Specimens

8

Suspect Specimens

10

Averted Costs

The NRC estimates that the proposed rule would result in savings to licensees and other
entities (i.e., averted costs) associated with training during the in-processing of licensee
employees and C/Vs. Approximately 68 percent of positive test results each year are identified
during pre-access testing. As a result, if an individual tests positive for a drug during pre-access
testing, any remaining training not completed by that individual at the time of receipt of the
confirmed positive test result would result in savings to the licensee or other entity because the
individual would immediately be denied unescorted access authorization for failing the required
FFD drug test. Appendix E provides additional information.
These incremental savings (averted costs) are estimated to be as follows:
•
•

total annual savings to industry: $87,821
average savings per site: $1,311

The projected savings associated with the proposed rule are based on the estimated increase in
the number of individuals testing positive each year and would be distributed based on the
projected number of additional confirmed positives detected.

5.1.7

Workplace Free of Drugs and the Effects of Such Substances

The proposed rule would maintain the performance objective in 10 CFR 26.23(d) that requires
FFD programs to “provide reasonable assurance that the workplaces subject to this part are
free from the presence and effects of illegal drugs.” Based on the analysis of annual FFD
program performance data submitted to the NRC by licensees and other entities, the
workplaces subject to 10 CFR Part 26 testing are not free from the presence and effects of
illegal drugs.
The effectiveness of a drug testing program may erode over time if the workforce uses impairing
substances not in the testing panel, if individuals use products and techniques to successfully
subvert the drug testing process, and if testing programs do not use technological
advancements that enhance drug testing sensitivity. Therefore, the drug testing provisions in
10 CFR Part 26 should remain at least as effective as the national drug testing standard of the
2008 HHS Guidelines and should apply defense-in-depth requirements (e.g., behavioral
observation, background checks, collection site security, and specimen collections) to maintain
reasonable assurance of a drug-free workplace.

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The 2008 HHS Guidelines are a national drug testing standard used by all Federal employee
workplace drug testing programs (over 100 Federal agencies26) and comparable Federal
agency drug testing programs that test civilians, such as those programs implemented by the
U.S. Department of Defense, U.S. Department of Energy, U.S. Department of Homeland
Security, and DOT. HHS is responsible by law27 to maintain its guidelines based on the most
recent research and lessons learned from Federal employee workplace drug testing programs
and from implementation of the HHS Guidelines by HHS-certified laboratories and private
entities. HHS also revises its guidelines to address findings and observations from the NLCP
and in response to expert and public review.
The NRC historically has incorporated appropriate provisions of the HHS Guidelines into
10 CFR Part 26 apply advancements in drug testing technology and detection methods to
address societal changes in drug use, as well as to align the methods and techniques used to
subvert the drug testing process with a standard used for testing Federal employees and the
majority of civilians tested by Federal agencies. The drug testing panel and cutoff levels
specified in 10 CFR Part 26 are currently not in alignment with the 2008 HHS Guidelines.

5.1.8

Safety Vulnerability

The proposed rule would enhance the identification of additional individuals subject to
10 CFR Part 26 who are using illegal drugs, misusing legal drugs, or attempting to subvert the
testing process and who are determined not to be fit for duty or not to be trustworthy and
reliable, or both. Such a determination would result in a denial of unescorted access to the
protected areas of NRC-licensed facilities and other locations and a denial to have access to
SSNM or sensitive information. Of the approximately 95 additional individuals determined to be
using drugs, 65 would be identified during pre-access testing, preventing each from entering an
NRC-licensed facility or accessing information and potentially challenging safety.28 The
remaining 30 individuals would be identified after being granted authorization (i.e., identified
during random, for-cause, followup, or post-event testing), during the performance of safetyand security-sensitive duties as described in 10 CFR 26.4.
The identification of these 30 individuals performing safety- and security-sensitive duties
enhances the existing regulatory framework to prevent drug-induced impairment (both acute
intoxication, as well as the consequences of recent drug use such as withdrawal effects) from
causing or contributing to human performance errors that may result in consequences to the
safe operation of a licensed facility. For example, an impaired individual could introduce or fail
to identify latent failures during maintenance, surveillance, modification, or operation of safety26

The number of Federal agencies using the HHS Guidelines appears in the Office of Management and
Budget (OMB) information collection’s supporting statement (OMB No. 0930-0158) filed by the Substance
Abuse and Mental Health Services Administration for the “Mandatory Guidelines for Federal Workplace Drug
Testing Programs,” on May 28, 2014. The supporting statement is available at the OMB Web site
http://www.reginfo.gov/public/do/PRAViewDocument?ref_nbr=201406-0930-001.

27

Section 503 of Public Law 100–71, 5 U.S.C. Section 7301 note.

28

Most licensees impose a sanction for a pre-access positive drug test result that is more stringent than that
required by 10 CFR 26.75 (i.e., the minimum NRC sanction for a first positive drug test result is a 14 day
denial of unescorted access). The NRC analysis of historical FFD program performance data indicates that
approximately 68 percent of positive test results occur during pre-access testing (Ref. 6); therefore, the NRC
staff estimates that 65 of the 95 additional positive drug test results and subversion attempts each year
would be identified at pre-access testing.

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and security-related SSCs, and these failures could contribute to an unplanned occupational
exposure, personal safety issues, unplanned radiological releases, an accident, or a transient.
Similarly, the labor categories of individuals identified as testing positive for drugs includes
licensed operators, supervisors, and managers whose job performance includes facility
operations; responding to accidents, transients, and fires; directing the workforce; and staffing
the Emergency Operations Facility and Technical Support Center upon execution of the site
emergency plan. An evaluation of FFD program performance data from CY 2012 through
CY 2014 (i.e., 24-hour events reported to the NRC under 10 CFR 26.719) demonstrates that
more than 30 individuals each year test positive for drugs (including amphetamine and cocaine,
the cutoff levels for which would be lowered by the proposed rule) or alcohol. Consequently,
any programmatic assurance that helps ensure that the workforce is fit for duty reduces the
safety vulnerability.
This safety outcome is consistent with the original 10 CFR Part 26 rule (Ref. 5), which stated
“[t]he NRC cannot be confident of the individual’s ability to limit the use of addictive substances
to situations that do not adversely affect plant safety” (54 FR 24470; June 7, 1989) and that
“there is an underlying assumption that workers will abide by the licensee’s policies and
procedures, [therefore] any involvement with illegal drugs shows that the worker cannot be
relied upon to obey laws of a health and safety nature, indicating that the individual may not
scrupulously follow rigorous procedural requirements with the integrity required in the nuclear
power industry to assure public health and safety” (54 FR 24468; June 7, 1989).

5.1.9

Security Vulnerability

The proposed rule would lead to the identification of additional individuals determined not to be
fit for duty or not to be trustworthy and reliable, or both, because of their use of illegal drugs,
misuse of legal drugs, or attempts to subvert the drug testing process. This would strengthen
the defense-in-depth regulatory framework provided by the authorization requirements in
10 CFR Part 26, Subpart C, “Granting and Maintaining Authorization,” and 10 CFR Part 73
(Ref. 16) for both commercial power reactors and Category I fuel cycle facilities.
This security vulnerability would also be reduced, in part, because once unescorted access
authorization is denied, the individual cannot act as an insider threat—an important security
determination linked to the conduct of drug testing. To help identify an insider threat, as
required by 10 CFR 73.55(b)(1), commercial power reactor licensees “shall establish and
maintain a physical protection program...which will have its objective to provide high assurance
that activities involving special nuclear material are not inimical to the common defense and
security and do not constitute an unreasonable risk to the public health and safety.” One
requirement that helps achieve this general performance objective is the provision in
10 CFR 73.55(b)(9) that licensees shall establish, maintain, and implement an insider mitigation
program (Ref. 32). This program, as described in 10 CFR 73.55(b)(9)(i), “must monitor the
initial and continuing trustworthiness and reliability of individuals granted or retaining unescorted
access authorization to a protected or vital area, and implement defense-in-depth
methodologies to minimize the potential for an insider to adversely affect, either directly or
indirectly, the licensee’s capability to prevent significant core damage and spent fuel sabotage.”
The insider mitigation program shall also include, in part, elements from the FFD program
described in 10 CFR Part 26. Consequently, the regulatory framework establishes a strong link
between the FFD-related authorization provisions in 10 CFR Part 26 and the physical protection
access authorization requirements described in 10 CFR Part 73.
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An insider threat is an individual who cannot be trusted or relied upon to follow licensee policies
and procedures or Federal regulations designed, implemented, and maintained to protect public
health and safety, promote the common defense and security, and protect the environment. An
insider threat could physically or remotely (through electronic means) cause inoperable safetyor security-related SSCs, a loss of facility control, radiological sabotage at a commercial power
reactor, or the theft or diversion of formula quantities of SSNM from a Category I fuel cycle
facility. Additionally, individuals who use illegal drugs may be co-opted or subverted by
adversaries.
The original 10 CFR Part 26 rule (54 FR 24470; Ref. 5) states the following:
The NRC believes that the reliability, integrity, and trustworthiness of persons
working within nuclear power plants is important to assure public health and
safety. The granting of a license is based on the assumption that workers will
abide by the licensees’ policies and procedures in all areas. Indications of lack
or reliability, integrity or trustworthiness, therefore, even so far as they pertain to
off-site behaviors, are relevant to the NRC’s need to assure that nuclear power
plants are operated safely.
The NRC further discussed these positions in the 2008 FFD final rule (73 FR 16971; Ref. 3):
Part 26 and the access authorization requirements [of 10 CFR Part 73] each
contain provisions that require establishing the trustworthiness and reliability of
personnel before granting unescorted access authorization to the protected area
of nuclear power plants.
Consequently, the FFD program objective to identify individuals using illegal drugs reduces a
potential security vulnerability. The failure to identify security personnel who use illegal drugs or
misuse legal drugs could significantly challenge the effectiveness of the site insider mitigation
program (10 CFR 73.55(b)(9)); security plan (10 CFR 73.55(c)); security search program
(10 CFR 73.55(h)); and the detection and assessment systems that include requirements to
conduct surveillance, observation, and monitoring to identify tampering and to detect and deter
intruders (10 CFR 73.55(i)). These requirements cannot be effectively implemented if site
security personnel are not fit for duty. This is important because many security duties and
responsibilities are conducted by security officers who operate alone (i.e., individually) and
therefore do not benefit from a team environment, second checks, or backup. As a result, a
security officer who is mentally, physically, or psychologically impaired or who does not possess
the characteristics of honesty, integrity, trustworthiness, and reliability cannot be relied upon to
competently execute site security requirements.

5.1.10

Improve Subversion Detection

The proposed rule would strengthen the methods used to identify persons attempting to subvert
the drug testing process. The proposed rule would require all suspect urine specimens to be
tested to the LOQ, which is the lowest concentration at which the identity and concentration of a
drug can be accurately established. This proposed change increases the licensees’ ability to
identify individuals who attempt to hide their drug use through subversive techniques or
temporary abstention from drug use. The NRC staff estimates that approximately 18 of the
additional 95 individuals each year will be identified as attempting to subvert the drug testing
process (10 additional individuals with dilute specimens and 8 additional individuals with
suspect specimens). An attempt to subvert the drug testing process is a willful act by an
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individual to refuse to comply with an NRC-required drug test (see 10 CFR 50.5, “Deliberate
Misconduct” (Ref. 8), 10 CFR 26.89(c), and 10 CFR 26.825, “Criminal penalties”).
Consequently, these individuals present a potential security vulnerability to the safe and secure
conduct of NRC-licensed activities. LOQ testing is consistent with the reasonable assurance
performance objectives in 10 CFR 26.23 as the proposal would proactively resolve a known
hazard, leverage a testing method used in HHS-certified laboratories, and achieve these
improvements at low incremental cost.

5.2

Uncertainty Analysis

To determine the robustness of the costs and net benefits (i.e., benefits minus costs) of the
proposed rule, the NRC staff examined how the industry and the NRC costs change as a result
of uncertainties associated with the NRC staff’s analytical assumptions, input data, and worker
drug use behavior. As mentioned in Section 4.2, the NRC staff used Monte Carlo simulation to
examine the impact of uncertainty on the estimated net benefits of the proposed rule. These
Monte Carlo simulations were performed using the @RISK® software program.29
Monte Carlo simulations involve introducing uncertainty into the analysis by replacing the point
estimates of the variables used to estimate base case costs and benefits with probability
distributions. By defining input variables as probability distributions instead of as point
estimates, the researcher can effectively model the effect of uncertainty on the results of the
analysis (i.e., the net benefits).
The probability distributions chosen to represent the different variables in the analysis were
bounded by the range-referenced input, DOT and FFD historical data, and the NRC staff’s
professional judgment. When defining the probability distributions for use in the Monte Carlo
simulation, summary statistics are needed to characterize the distributions. These summary
statistics include the minimum, most likely, and maximum values of a program evaluation and
review technique (PERT) distribution30, the minimum and maximum values of a uniform
distribution, and the specified integer values of a discrete population.
For the majority of uncertain variables, the staff used the PERT distribution to reflect the relative
spread and skewness of the distribution defined by the three estimates. In cases for which the
likelihood of the result was judged to be equally likely within a range, the data were modeled
using a uniform distribution defined by the low and high values. In a few cases, the staff used a
discrete distribution to model possible outcomes and their likelihood, such as the number of
sites using an LTF.
Table 5-9 identifies the data elements, the distribution and summary statistic, and the mean
value of the distribution that the staff used in the uncertainty analysis.
29

Information about this software is available online at www.palisade.com.

30

A PERT distribution is a special form of the beta distribution with a minimum and maximum value specified.
The shape parameter is calculated from the defined most likely value. The PERT distribution is similar to a
triangular distribution in that it has the same set of three parameters. Technically, it is a special case of a
scaled beta (or beta general) distribution. It can generally be considered to be superior to the triangular
distribution when the parameters result in a skewed distribution, as the smooth shape of the curve places
less emphasis in the direction of skew. Similar to the triangular distribution, the PERT distribution is
bounded on both sides and therefore may not be adequate for some modeling purposes, such as those
intended to capture tail or extreme events.

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Table 5-9. Variables Used in the Uncertainty Analysis
Distribution

Low
Estimate

Base
Case

High
Estimate

Discrete

3

6

6

NRC FFD Program Data
Number of workers subject to a 10 CFR Part 26 FFD
program
Number of drug tests conducted per year under
10 CFR Part 26

PERT

101,642

107,620

113,949

PERT

150,211

157,632

168,879

Average percentage of total positive, adulterated,
substituted, and refusal to test results occurring at
pre-access testing

PERT

64.8%

67.8%

69.0%

Data Element
Regulated Universe
Number of sites using an LTF

Hourly Wage Rates (dollars per hour)
Clerical
Facility Worker
(weighted average of licensee employees and C/V
workers)
FFD Manager

PERT

$20.66

$21.69

$22.73

PERT

$61.85

$63.86

$68.45

PERT

$34.43

$44.21

$49.66

FFD Staff

PERT

$33.19

$36.87

$44.25

LTF Laboratory Technician

PERT

$32.90

$36.55

$43.86

LTF Laboratory Supervisor

PERT

$55.31

$61.45

$73.74

Legal

PERT

$110.62

$122.91

$147.49

MRO

PERT

$103.30

$137.73

$172.17

PERT

$400

$500

$800

Initial testing for one additional drug at an LTF

PERT

$1.25

$1.50

$1.75

Initial and confirmatory drug testing, HHS-certified
laboratory (sites using an LTF for initial testing)

PERT

$23.00

$29.00

$36.00

Testing for 6-AM
(sites only using an HHS-certified laboratory)

Uniform

$0.50

$0.75

$1.00

Testing for Ecstasy drugs
(sites only using an HHS-certified laboratory)

Uniform

$0.00

$0.50

$0.75

PERT

$0.00

$7.75

$15.00

PERT

0.010%

0.017%

0.022%

FFD current confirmed positive test rate

PERT

0.032%

0.047%

0.067%

Projected percent increase in confirmed positive test rate

PERT

0.00%

39.38%

62.35%

Projected percentage of additional positive results that
will confirm positive after MRO interview with donor

PERT

50%

75%

75%

Industry Implementation—Training
Cost of LTF training materials (per LTF)
Industry Operations—FFD Drug Testing Costs

Special analyses testing at an HHS-certified laboratory
Industry Operations—FFD Drug Testing Rates
6-AM
Projected confirmed positive test rate
Amphetamines

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Distribution

Low
Estimate

Base
Case

High
Estimate

FFD current confirmed positive test rate

PERT

0.064%

0.072%

0.077%

Projected increase in positive test rate

PERT

11.60%

18.38%

32.85%

PERT

0.002%

0.004%

0.005%

Data Element
Cocaine

Ecstasy Drugs
Projected confirmed positive test rate

Dilute Specimens and Specimens Collected during Suspected Subversion Attempts
Average annual percentage of specimens tested that are
dilute and special analyses testing is performed

PERT

0.431%

0.466%

0.501%

Average annual percentage of specimens tested that are
dilute and test positive on special analyses testing

PERT

0.001%

0.005%

0.007%

Average annual percentage of specimens tested that are
determined to be a subversion attempt and that test
positive (suspect specimens that test positive on special
analyses testing)

PERT

0.029%

0.033%

0.038%

Projected percent increase in confirmed positive test rate
for specimens collected under direct observation

Uniform

0%

20%

25%

PERT

0.25

0.75

1.00

PERT

1.4

1.5

2.0

Labor Following a Laboratory Positive Test Result or Subversion Event
MRO subsequent action labor hours
NRC Implementation
Staff hours, reflected in full-time equivalent (FTE), to
complete the final rulemaking (i.e., analyze public
comments, hold public meeting(s), develop the final rule)
and issue final regulatory guidance. One FTE is equal to
one staff person working full time for 1 year.

5.2.1 Uncertainty Analysis Results
The staff performed the Monte Carlo simulation by repeatedly recalculating the results, up to
5,000 times. For each analysis iteration, the values identified in Table 5-9 were chosen
randomly from the probability distributions that define the input variables. The value of the
output variables was recorded for each iteration, and these resulting output variable values were
used to define the resultant probability distribution.
For each figure below, 5,000 Monte Carlo simulations were run in which the key variables were
changed to assess the resulting effect on costs. The cost distributions illustrated in Figures 5-1
through 5-6 represent the incremental costs from the regulatory baseline of Alternative 1 (Take
No Action). As can be seen from Figures 5-1 through 5-6, none of the curves are net beneficial
because of the inability to monetize the benefits of this proposed rule.

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Figure 5-1. Industry implementation costs

Figure 5-2. NRC implementation costs

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Figure 5-3. Industry operations costs (7-percent discount rate)

Figure 5-4. Industry operations costs (3-percent discount rate)

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Figure 5-5. Total (7-percent discount rate)

Figure 5-6. Total (3-percent discount rate)

Table 5-10 presents descriptive statistics on the uncertainty analysis. Note that the 5.0 percent
and the 95 percent values that appear as vertical lines with a numerical value at the top in
Figures 5-1 through 5-6 are reflected in Table 5-10 as the 0.05 and 0.95 values, respectively.
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Table 5-10. Uncertainty Results Descriptive Statistics
Uncertainty Result

Min

Uncertainty Results (2017 million dollars)
Mean
Mode
Median
Max
0.05

0.95

Industry Implementation

($0.37)

($0.34)

($0.34)

($0.34)

($0.31)

($0.35)

($0.32)

NRC Implementation

($0.35)

($0.29)

($0.29)

($0.28)

($0.25)

($0.32)

($0.26)

Industry Operation
(7% Discount Rate)

($3.55)

($1.88)

($2.01)

($1.89)

$0.14

($2.75)

($1.02)

Industry Operation
(3% Discount Rate)

($5.11)

($2.71)

($2.89)

($2.72)

$0.21

($3.95)

($1.47)

Total (7% Discount Rate)

($4.16)

($2.51)

($2.52)

($2.52)

($0.45)

($3.37)

($1.64)

Total (3% Discount Rate)

($5.72)

($3.33)

($3.60)

($3.34)

($0.39)

($4.58)

($2.09)

By examining the range of the resulting output distribution in Table 5-10, it is possible to more
confidently discuss the potential costs and benefits of the proposed rule. This table displays the
key statistical results, including the 90 percent confidence interval in which the net benefits
would fall between the 0.05 and 0.95 percentile values.
Figures 5-7 and 5-8 identify the key variables whose uncertainty drives the largest impact on
total costs (and averted costs) for this proposed rulemaking. These figures rank the variables
based on their contribution to cost uncertainty. Two variables—the costs that HHS-certified
laboratories charge sites to conduct testing for Ecstasy and 6-AM—drive the most uncertainty in
the costs; the rest of the key variables have less variation.
In addition to estimating the probability distributions for the net benefits of the proposed rule, the
staff used the Monte Carlo simulation to determine the variables with the greatest impact on the
resulting net benefits. Variables shown to have a large effect on the resulting net benefits may
deserve more attention and scrutiny than variables shown to have a small or minimal effect.
To estimate the effect of each variable on the net benefits, the staff performed a regression, with
the net benefits modeled as the dependent variable and the inputs as the independent
variables. The result of this regression is called a tornado diagram, and it represents in vertical
order the variables with the greatest influence on the net benefits. The tornado diagram also
displays the resulting impact on the calculated mean value for each of the input variables.
Figure 5-7 presents the tornado diagram for the total cost of the proposed rule using a 7-percent
discount factor. Similarly, Figure 5-8 presents the tornado diagram for the total cost of the
proposed rule using a 3-percent discount factor.
Examining the tornado diagrams provides insight into which inputs have the largest impacts on
the results of this quantitative analysis. Figure 5-7 shows that the parameters having the
greatest impact on the net benefits of the proposed rule when using a 7-percent discount factor
are the uncertainties associated with the potential costs an HHS-certified laboratory may charge
a site to perform testing for Ecstasy and 6-AM. The influence of a variable on the output is not
only a function of the value of that variable but also of the spread of its distribution. In
Figure 5-8, using a 3-percent discount factor, the same parameters appear in the same ranked
order as in Figure 5-7.

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Figure 5-7. Key variables whose uncertainty drives the largest impact on costs
(7-percent net present value)
HHS Ecstasy cost per test

-$3,100,036.55

HHS 6-AM cost per test

-$1,890,443.93

-$2,905,892.72

Projected cocaine positive increase

-$2,689,659.77

Projected amphetamines confirmed positive increase

-$2,711,553.49

-$2,083,605.37
-$2,285,837.92
-$2,353,843.60

Projected 6-AM confirmed positive rate

-$2,604,552.78

-$2,370,753.34

Projected positive subversion rate increase

-$2,606,978.51

-$2,381,333.60

Current NRC amphetamines positive test rate

-$2,600,422.02

NRC annual percentage of positive dilute tests

-$2,609,203.93

-$2,408,684.80
-$2,449,039.14

Baseline = -$2,505,640.18

-4.00

-3.60

-3.20

-2.80
-2.40
-2.00
Values in Millions ($)

-1.60

-1.2

Inputs ranked by effect on output mean

Figure 5-8. Key variables whose uncertainty drives the largest impact on costs
(3-percent net present value)
HHS Ecstasy cost per test

-$4,185,410.72

HHS 6-AM cost per test

-$2,445,766.59

-$3,905,865.66

Projected cocaine positive increase

-$3,595,511.41

Projected amphetamines confirmed positive increase

-$3,626,748.10

-$2,724,750.03
-$3,013,480.21
-$3,112,463.24

Projected 6-AM confirmed positive rate

-$3,473,208.59

-$3,136,624.99

Projected positive subversion rate increase

-$3,477,054.15

-$3,151,869.18

Current NRC amphetamines positive test rate

-$3,466,053.67

-$3,191,053.96

NRC annual percentage of positive dilute tests

-$3,479,494.18

-$3,249,607.58

Baseline = -$3,330,734.16

-5.20

-4.25

-3.30
-2.35
Values
in
Millions
($)
Inputs ranked by effect on output mean

-1.4

Table 5-11 presents the range of additional positive results that are estimated to be detected if
the proposed rule is implemented. These estimates of additional positive results are based on
the uncertainty estimate inputs and distributions in Table 5-9 and reflect the uncertainties
associated with using historical DOT test results data to forecast future FFD test results.

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Table 5-11. Estimated Number of Additional Confirmed Positives per Year
Substance
6-AM
Amphetamines
Cocaine
Ecstasy drugs
Dilute
Subversion specimens
Total

Minimum
16.8
1.5
12.0
3.2
2.6
0
54.4

Mean
26.7
19.7
25.2
6.3
7.3
6.5
91.7

Maximum
34.9
41.8
40.6
9.0
10.7
14.9
133.2

Figure 5-9 presents three plots that summarize the distribution of the undiscounted net benefits,
the net benefits discounted at 3 percent, and net benefits discounted at 7 percent. As illustrated
by this figure, regardless of discount rate, the proposed rule has a negative monetized net
benefit (i.e., 100 percent of the distributions informed by these data are less than zero).
Figure 5-9. Relative frequency of the net benefits of the proposed rule

7 Percent NPV

3 Percent NPV

Undiscounted

Figure 5-9 also displays the sensitivity of the uncertainty analysis to the discount rates used for
the net benefits (i.e., benefits minus costs) of the proposed rule based on 5,000 simulations. By
allowing uncertain assumptions and inputs to vary across a distribution, the results are no
longer static and instead are spread across a range with varying degrees of certainty. For this
simulation, the analysis indicates that for the attributes that could be quantified, the proposed
rule is estimated to result in a net cost of between ($0.30 million) and ($7.73 million).

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5.2.2 Summary of Uncertainty Analysis
The simulation analysis shows that the estimated mean cost for this proposed rule is
($2.51 million), with 90-percent confidence that the cost is between ($1.64 million) and
($3.37 million) using a 7-percent discount rate.
The NRC staff assessed which variables have the largest impact on total costs (and averted
costs) for the proposed rulemaking. As shown in Figures 5-7 and 5-8, the two largest
uncertainties in cost are associated with the potential costs that an HHS-certified laboratory may
charge a site to perform testing for Ecstasy and 6-AM. The next three largest variations in costs
are associated with the projected increase in confirmed positive tests for 6-AM, amphetamine,
cocaine, and methamphetamine, based on detection improvements seen after DOT
implemented the 2008 HHS Guidelines. The next three variables have lesser and comparable
impacts on the total cost of implementing the proposed rule.
As illustrated in Figure 5-9, variation in the key variables results in cost distributions that range
from ($0.30 million) and ($7.73 million) from the regulatory baseline of Alternative 1 (Take No
Action) when accounting for different discount factors.

5.3

Disaggregation

In order to implement the guidance in Section 4.3.2, “Criteria for the Treatment of Individual
Requirements,” in NUREG/BR-0058, Revision 4 (Ref. 29), the NRC staff performed a screening
review to determine whether any of the individual requirements (or set of integrated
requirements) of the rule would be unnecessary to achieve the objectives of the rulemaking.
The NRC staff concludes that each of the proposed rule changes would be necessary to
achieve one or more of the objectives of the rulemaking, as described in Section 1.2 and
summarized in Table 5-12. The objectives of the rulemaking are achieved by maintaining
reasonable assurance of a drug-free workplace through the improved detection of persons who
are not fit for duty because of illegal drug use or legal drug misuse; harmonizing select drug
testing requirements under 10 CFR Part 26 with those implemented by the 2008 HHS
Guidelines and other Federal agencies; and improving the clarity, organization, and flexibility of
the 10 CFR Part 26 rule language.
Table 5-12. Disaggregation
Improve
Detection

Align
Requirements

Lower drug testing cutoff levels for amphetamine, cocaine,
and methamphetamine

X

X

Expand initial drug testing panel to include 6-AM and revise
confirmatory testing cutoff level for 6-AM

X

X

Expand testing panel to include Ecstasy-type drugs

X

X

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

X

Revised Requirement

Add and revise definitions to improve consistency with
definitions in the 2008 HHS Guidelines

X

X

53

Individual Rights
and Lessons
Learned

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Align
Requirements

Individual Rights
and Lessons
Learned

Replace the LOD with the LOQ as the decision point in special
analyses testing and adulterant testing of specimens

X

X

Clarify procedures for observed collections of urine
specimens, specimen quantity, altered specimens, and refusal
to test situations

X

X

Improve
Detection

Revised Requirement

Permit use of additional qualified staff beyond the specimen
collector to observe a donor in the hydration process
subsequent to an inability to provide a urine specimen of
adequate volume for testing (i.e., a shy bladder)

X

Eliminate 6-month in service requirement for blind
performance test samples and permit the suppliers to specify
the shelf life

X

X

Eliminate dual regulation of HHS-certified laboratory by
removing documentation requirements for laboratory
personnel and procedures that are already contained in the
2008 HHS Guidelines and verified in the HHS laboratory
certification process

X

Clarify the terminology for laboratory quality control samples to
address inconsistencies raised in an enforcement guidance
memorandum (Ref. 20)

X

Enhance donor protection by requiring MRO review of
specimens with invalid validity test results due to high pH
values (between 9.0 and 9.5)

X

X

Enhance donor protection and the transparency of the
retesting process by requiring the MRO to document an oral
request made by a donor for a second laboratory to test
Bottle B of a split specimen or to retest an aliquot of a single
specimen

X

X

Require retention of any specimen collected during a postevent testing (even if the donor refuses to complete the test
after providing a specimen) to enhance the root-cause
evaluation process associated with accidents

5.4

X

Backfitting and Issue Finality

Appendix F presents the NRC staff’s evaluation of changes in the proposed rule in accordance
with the backfitting and issue finality requirements in 10 CFR 50.109, “Backfitting” (Ref. 8),
10 CFR 52.98, “Finality of combined licenses; information requests” (Ref. 10), and
10 CFR 70.76, “Backfitting” (Ref. 9).

5.5

Results for the Committee to Review Generic Requirements

This section addresses the regulatory analysis information requirements for rulemaking actions
or NRC staff positions subject to CRGR review. All information called for by the CRGR charter
(Ref. 33) is presented in this regulatory analysis or in the Federal Register notice for the
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proposed rule. As a reference aid, Table 5-13 provides a cross-reference between the relevant
information and its location in this document or the Federal Register notice.
Table 5-13. Specific CRGR Regulatory Analysis Information Requirements
CRGR
Charter Citation
(Ref. 33)

Information Item to be Included in a Regulatory
Analysis Prepared for CRGR Review

Where Item Is
Discussed

Appendix C, (i)

Proposed generic requirement or staff position as it is
proposed to be sent out to licensees.

Proposed rule text in
Federal Register notice.

Appendix C, (ii)

Draft papers or other documents supporting the
requirements or staff positions.

Federal Register notice
for the proposed rule.

Appendix C, (iii)

The sponsoring office's position on each proposed
requirement or staff position as to whether the
proposal would modify requirements or staff positions,
implement existing requirements or staff positions, or
relax or reduce existing requirements or staff
positions.

Regulatory Analysis,
Section 5.1 and Backfit
Analysis, Appendix F.

Appendix C, (iv)

The proposed method of implementation.

Regulatory Analysis,
Section 7.

Appendix C, (vi)

Identification of the category of power reactors, new
reactors, or nuclear materials facilities or activities to
which the proposed generic requirement or staff
position is applicable.

Regulatory Analysis,
Section 4.2.2.

Appendix C,
(vii)–(viii)

If the proposed action involves a power reactor backfit
and the exceptions at 10 CFR 50.109(a)(4) are not
applicable, the items required at 10 CFR 50.109(c)
and the required rationale at 10 CFR 50.109(a)(3) are
to be included.

Backfit Analysis,
Appendix F.

III.

Federal Register notice
for the proposed rule.

For proposed generic relaxations or decreases in
current requirements or staff positions, provide a
determination along with the rationale that (a) the
public health and safety and the common defense and
security would be adequately protected if the proposed
relaxations were implemented and (b) the cost savings
attributed to each action would be significant enough
to justify the action.
Appendix C, (xi)

Preparation of an assessment of how the proposed
action relates to the Commission’s Safety Goal Policy
Statement (Ref. 34).

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Section 3.

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6.

Decision Rationale

6.1

Regulatory Analysis

This analysis is based on the qualitative consideration of the benefits resulting from seven
affected attributes (i.e., public health (accident), occupational 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 protection of individual rights). The staff performed a qualitative analysis because of
the difficulties associated with monetizing these seven affected attributes as well as the full
benefit to industry operations that would result from the detection each year of additional
individuals using illegal drugs, misusing legal drugs, or subverting the testing process. For
example, monetizing the impact of these attributes would require estimation of factors such as
the frequency and consequences of accidents and other safety- or security-related events
(e.g., an insider threat) caused by drug-induced impairment, and the benefits of deterring
additional individuals using drugs from seeking employment in positions that require testing
under 10 CFR Part 26 (Ref. 1).
The staff was able to quantify the costs resulting from three other affected attributes (industry
implementation, industry operation, and NRC implementation). Relative to Alternative 1 (Take
No Action), the proposed rule is estimated to result in an incremental cost to industry of
approximately ($2.4 million) total present value over a 25-year period, assuming a 7-percent
discount rate, or approximately ($3.4 million), assuming a 3-percent discount rate. The cost
includes a one-time industry implementation cost of ($337,090) (averaging $5,031 per site) and
annual industry operations cost of ($2,516) per site.31 In addition, the NRC is estimated to incur
a total one-time cost of ($273,000) to complete the final rulemaking (i.e., analyze public
comments, hold public meeting(s), and develop the final rule) and issue regulatory guidance.
The estimated total cost for this proposed rule ranges from ($2.7 million) assuming a 7-percent
discount rate to ($3.6 million) assuming a 3-percent discount rate.
Because the staff cannot monetize the benefit of an additional 10- to 12-percent increase each
year in the number of individuals (approximately 95) identified as using illegal drugs, misusing
31

The NRC staff assumes that the licensee or other entity for each site would incur an average cost per
requirement. This assumption is a simplification; some licensees and other entities would incur a higher or
lower operations cost depending on the size of the population drug tested at the site (e.g., an operating
power reactor site conducts more drug tests than a corporate office). The licensees and other entities
subject to 10 CFR Part 26 includes 57 operating power reactor sites, 2 power reactor construction sites,
5 corporate offices, 2 Category I fuel cycle facilities, and 1 C/V (see Appendix A). Corporate offices,
Category I fuel cycle facilities, and C/Vs use much smaller workforces than operating power reactor sites
and power reactor construction sites (see Table 4-1 and Appendix A). They also do not incur periodic
workforce surges as a result of changing site conditions, unlike power reactor sites (e.g., refueling outages,
various states of site construction). An analysis of CY 2013 and CY 2014 FFD program performance data
indicated that between 23 and 25 percent of drug positive test results for operating power reactor sites and
between 33 and 40 percent of drug positive test results for power reactor construction sites were associated
with substances in the current testing panel that will be affected by the proposed rule (i.e., amphetamine,
cocaine metabolites, methamphetamine, 6-AM). The proposed rule changes would have limited impact on
additional detection at other facility types given the very low number of positive results (see Table 4-1). As a
result, the NRC staff anticipates improvement in detection at operating power reactor and power reactor
construction sites. By using an average cost per site, the analysis overestimates the operations costs for
smaller workforce sites and underestimates the costs for larger workforce sites, but on balance it provides a
reasonable estimate of the incremental testing costs associated with the proposed rule given that the
majority of the sites and tested workforces (57 of 67) are at operating power reactors.

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legal drugs, or attempting to subvert the drug testing process, a net cost-beneficial
determination is not meaningful. However, the NRC staff concludes that the proposed rule has
merit relative to the non-monetized benefit of identifying additional individuals using illegal
drugs, misusing legal drugs, or attempting to subvert the drug testing process each year. The
proposed rule would benefit public health and safety and the common defense and security at a
low average cost per site32 for the following reasons:
•

The proposed rule would enhance FFD program effectiveness (i.e., detection) by
identifying additional individuals each year determined not to be fit for duty or not to be
trustworthy and reliable, or both, because of illegal drug use, legal drug misuse, or
attempts to subvert the drug testing process, which would benefit public health and
safety and the common defense and security by reducing safety and security
vulnerabilities.

•

The proposed rule would improve regulatory effectiveness and efficiency through
regulatory and compliance improvements. Updating 10 CFR Part 26 to be consistent
with the 2008 HHS Guidelines (Ref. 2) would improve the effectiveness of the
10 CFR Part 26 drug testing provisions by aligning it with a national drug testing
standard used by all Federal employee workplace drug testing programs (more than
100 Federal agencies) and by comparable Federal agency drug testing programs that
test civilians in safety- and security-sensitive positions. Alignment with the 2008 HHS
Guidelines would ensure that drug testing provisions in 10 CFR Part 26 continue to be
scientifically and technically sound, reduce administrative burden on licensees and HHScertified laboratories, and help maintain the public trust.

•

A more robust drug testing program may deter individuals from seeking employment in
10 CFR Part 26 regulated positions by doing the following:

32

–

Expanding the drug testing panel and lowering the testing cutoff levels for select
drugs. Lowering the testing cutoff levels for amphetamines, cocaine metabolites,
and 6-AM would increase the timeframe (i.e., the window of detection) in which
these drugs can be detected in an individual’s body after use. This would reduce
the likelihood that individuals would be able to subvert the testing process
through temporary abstinence from a drug. Expanding the initial drug testing
panel to include 6-AM, MDMA, and MDA and the confirmatory drug testing panel
to include MDMA and MDA would improve the trustworthiness and reliability of
the workforce through the identification of individuals using illegal drugs or
misusing legal drugs who would be denied unescorted access authorization.

–

Requiring and expanding special analyses testing. Requiring special analyses
testing on dilute specimens and expanding special analyses testing to specimens
collected under direct observation would reduce the likelihood that individuals
would be able to subvert the testing process. Additionally, using the LOQ instead
of the LOD as the level at which confirmatory drug testing is to be conducted
would increase the assurance provided by special analyses testing by adding a
level of precision to the testing method. These changes would further enhance
the detection of drugs in specimens that do not present normal physiological
characteristics. The identification of additional persons using illegal drugs,
misusing legal drugs, or attempting to subvert the drug testing process would

Each site would incur an average one-time cost of ($5,031) and an average annual cost of ($2,516).

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improve the trustworthiness and reliability of the workforce by denying
unescorted access authorization to these individuals.
–

Enhancing FFD program integrity and protection of individual rights. By adding
MRO review procedures for invalid validity test results due to high pH values and
clarifying the requirements for MRO actions when a donor requests the testing of
a Bottle B specimen or a retest of a single specimen, the proposed rule would
enhance consistency with the 2008 HHS Guidelines, FFD program integrity, and
the protection of individual rights. Requiring the use of the LOQ instead of the
LOD as the decision point for validity testing protocols for dilute and adulterated
specimens also enhances the protection of individual rights because the LOQ
adds a level of precision to the testing method.

–

Improving regulatory efficiency between 10 CFR Part 26 and other related
Federal rules and guidelines. The proposed rule would improve regulatory
efficiency by (1) harmonizing select 10 CFR Part 26 definitions and drug testing
procedures with those described in the 2008 HHS Guidelines; (2) clarifying
ambiguous or imprecise regulatory language in 10 CFR Part 26, such as the
terminology related to quality control samples, applying lessons learned during
implementation of the 2008 FFD final rule; and (3) eliminating dual regulation of
HHS-certified laboratories (private entities) and reducing the regulatory burden
on licensees by removing select 10 CFR Part 26 requirements also included in
the 2008 HHS Guidelines that the NLCP verifies in order for a laboratory to
achieve and maintain HHS-certification.

–

Enhancing root-cause analysis in post-event testing situations associated with a
refusal to test determination at the collection site. Under the current rule, if a
refusal to test is determined during the specimen collection process, any
specimen(s) obtained from the donor are discarded. The proposed rule would
require the retention and testing of any specimen collected during post-event
situations in which a refusal to test determination was made at the collection site.
This change would enhance the ability of the licensee or other entity to determine
whether substance use could have been a contributing factor to an accident.

The NRC staff concludes that the benefit of the proposed improvements to the measures
designed to meet the general performance objective of the 10 CFR Part 26 drug testing
program, to “provide reasonable assurance that the workplaces subject to this part are free from
the presence and effects of illegal drugs,” outweighs the low cost of implementation.

6.2

Backfitting and Issue Finality

The NRC staff conducted an analysis of the proposed rule pursuant to the backfitting and issue
finality requirements in 10 CFR 50.109 (Ref. 8), 10 CFR 52.98 (Ref. 10), and 10 CFR 70.76
(Ref. 9) (see Appendix F). The proposed rule constitutes a backfit because it would impose
new requirements on licensees. These new measures include lowering the initial and
confirmatory drug testing cutoff levels for amphetamines and cocaine metabolites; expanding
the initial drug testing panel to include 6-AM and revising the confirmatory testing cutoff levels
for 6-AM; expanding the initial and confirmatory drug testing panels to include Ecstasy; requiring
special analyses testing of dilute specimens and specimens collected during suspected
subversion attempts; and requiring additional MRO review of invalid validity test results
stemming from high pH values (9.0 to 9.5) and MRO actions when a donor requests testing of
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Bottle B or a retest of a single specimen and the specimen is unavailable. These measures fall
under the definition of “backfitting” in 10 CFR 50.109(a)(1) because such efforts are new or
amended provisions in the Commission’s regulations.
In light of the substantial benefits of the proposed rule as summarized in Section 5.1, the NRC
staff finds that the backfits contained in the proposed rule, when considered in the aggregate,
would substantially enhance safety and security by maintaining reasonable assurance of a
workplace free from drugs and the effects of such substances by resulting in an estimated 10- to
12-percent increase each year in the number of individuals identified as using illegal drugs,
misusing legal drugs, or attempting to subvert the drug testing process. As a consequence,
each of these individuals would be denied unescorted access authorization.

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7.

Implementation

The proposed NRC regulatory instrument for implementing the proposed action is to amend
select provisions of 10 CFR Part 26 (Ref. 1) through rulemaking and to develop a regulatory
guide to describe a method that is acceptable to the NRC for 10 CFR Part 26 implementation.
The regulatory analysis for the proposed rule was based on completion of this regulatory activity
in 2017. Adjustments to the implementation dates will be made in the analysis accompanying
the final rule.
The dates used in this analysis for the proposed rule are as follows:
•

publication of the final rule: CY 2017

•

effective date of the final rule: CY 2017 (60 days after publication date of the final rule)

•

compliance date of the final rule: CY 2017 (60 days after publication date of the final
rule)

This schedule would give licensees and other entities time to revise site policies and
procedures, conduct training, and revise contracts with HHS-certified laboratories and BPTS
suppliers.
The staff does not expect the proposed implementation schedule to result in a cumulative
impact on affected entities because (1) no other pending 10 CFR Part 26 regulatory actions
exist that would impact the site professionals responsible for implementing the proposed
requirements and (2) the changes to FFD policy, procedures, contracts, and training are
minimal. This implementation schedule also enables the NRC staff to finalize updates to NRC
inspector guidance.

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8.

References

1.

U.S. Code of Federal Regulations, “Fitness for Duty Programs,” Part 26, Chapter I,
Title 10, “Energy.”

2.

U.S. Department of Health and Human Services, Substance Abuse and Mental Health
Services Administration, “Mandatory Guidelines for Federal Workplace Drug Testing
Programs,” Federal Register, Vol. 73, No. 228, November 25, 2008, pp. 71858–71907.

3.

U.S. Nuclear Regulatory Commission, “Fitness for Duty Programs,” Federal Register,
Vol. 73, No. 62, March 31, 2008, pp. 16966–17235.

4.

Controlled Substances Act, § 202, 21 U.S. Code § 812.

5.

U.S. Nuclear Regulatory Commission, “Fitness for Duty Programs,” Federal Register,
Vol. 54, No. 108, June 7, 1989, pp. 24468–24508.

6.

U.S. Nuclear Regulatory Commission, “Summary of Fitness for Duty Program
Performance Reports for Calendar Year 2013” (most recent report available),
September 3, 2014, Agencywide Documents Access and Management System
(ADAMS) Accession No. ML14246A440. The 2013 report and the reports for previous
years are available at http://www.nrc.gov/reactors/operating/ops-experience/fitness-forduty-programs/performance-reports.html.

7.

U.S. Nuclear Regulatory Commission, “Qualitative Consideration of Factors in the
Development of Regulatory Analyses and Backfit Analyses,” Staff Requirements
Memorandum SRM-SECY-14-0087, March 4, 2015, ADAMS Accession
No. ML15063A568.

8.

U.S. Code of Federal Regulations, “Domestic Licensing of Production and Utilization
Facilities,” Part 50, Chapter I, Title 10, “Energy.”

9.

U.S. Code of Federal Regulations, “Domestic Licensing of Special Nuclear Material,”
Part 70, Chapter I, Title 10, “Energy.”

10.

U.S. Code of Federal Regulations, “Licenses, Certifications, and Approvals for Nuclear
Power Plants,” Part 52, Chapter I, Title 10, “Energy.”

11.

Hersh, Giselle (, Center for Substance Abuse and Prevention), email to Harris, Paul W
(NRC, Office of Nuclear Security and Incident Response, Division of Security Policy),
“FW: Giving HHS and DOT Credit—International Consensus Building off the HHS
Guidelines,” July 2, 2015, ADAMS Accession No. ML15187A080.

12.

U.S. Nuclear Regulatory Commission, “Meeting Summary of a Public Meeting to Discuss
the Impact of New Department of Health and Human Services Guidelines on Title 10
Code of Federal Regulations Part 26,” summary of public meeting held
February 24, 2009, summary dated March 17, 2009, ADAMS Accession
No. ML090771060.

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13.

U.S. Nuclear Regulatory Commission, “Summary of Public Meeting to Discuss the
Potential Impact of the Revised U.S. Department of Health and Human Services Drug
Testing Guidelines on U.S. Nuclear Regulatory Commission Fitness for Duty
Requirements,” summary of public meeting held June 24, 2009, summary dated
July 14, 2009, ADAMS Accession No. ML091910511.

14.

U.S. Nuclear Regulatory Commission, “Summary of the October 11, 2011, Public
Meeting to Discuss Staff Proposed Changes to Title 10 of the Code of Federal
Regulations, Part 26, Based on the U.S. Department of Health and Human Services
Guidelines for Drug Testing,” summary of public meeting held October 11, 2011,
summary dated November 14, 2011, ADAMS Accession No. ML112980110.

15.

U.S. Nuclear Regulatory Commission, “Summary of the September 11, 2013,
Category 2 Public Meeting to Discuss NRC Staff-Proposed Changes to Title 10 of the
Code of Federal Regulations, Part 26, Based on the U.S. Department of Health and
Human Services’ Guidelines for Drug Testing,” summary of public meeting held
September 11, 2013, summary dated October 29, 2013, ADAMS Accession
No. ML13290A236.

16.

U.S. Code of Federal Regulations, “Physical Protection of Plants and Materials,” Part 73,
Chapter I, Title 10, “Energy.”

17.

U.S. Nuclear Regulatory Commission, “Summary of Public Meeting to Discuss the
Potential Impact of the Revised U.S. Department of Health and Human Services Drug
Testing Guidelines on U.S. Nuclear Regulatory Commission Fitness for Duty
Requirements,” Enclosure C, “NEI Memo Containing Results of Industry Survey,”
enclosure dated May 31, 2009, summary dated July 14, 2009, ADAMS Accession
No. ML091910480.

18.

U.S. Nuclear Regulatory Commission, “NRC Staff-Proposed Changes for Direct Final
Rulemaking 10 CFR Part 26,” October 10, 2011, ADAMS Accession No. ML112980140.

19.

U.S. Code of Federal Regulations, “Procedures for Transportation Workplace Drug and
Alcohol Testing Programs,” Part 40, Subtitle A, Title 49, “Transportation.”

20.

U.S. Nuclear Regulatory Commission, “Enforcement Guidance
Memorandum—Dispositioning Violations of NRC Requirements for Initial Validity and
Drug Tests at Licensee Testing Facilities,” EGM-09-003, March 31, 2009, ADAMS
Accession No. ML090760728.

21.

U.S. Nuclear Regulatory Commission, “Regulatory Analysis Technical Evaluation
Handbook, Final Report,” NUREG/BR-0184, January 1997, ADAMS Accession
No. ML050190193.

22.

Atomic Energy Act, Pub. L. No. 83-703, 68 Stat. 919, 42 U.S.C., August 30, 1954.

23.

Energy Reorganization Act, Pub. L. No. 93-438, 88 Stat. 1233, 42 U.S.C.,
October 11, 1974.

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24.

Office of National Drug Control Policy, Executive Office of the President, “How Illicit Drug
Use Affects Business and the Economy,” May 24, 2011,
https://obamawhitehouse.archives.gov/sites/default/files/ondcp/Fact_Sheets/effects_of_
drugs_on_economy_jw_5-24-11_0.pdf

25.

Boushey, H., and Glynn, S.J., Center for American Progress, “There are Significant
Business Costs to Replacing Employees,” Washington DC, November 16, 2012,
https://cdn.americanprogress.org/wpcontent/uploads/2012/11/16084443/CostofTurnover0815.pdf.

26.

Tracey, J.B., and Hinkin, T.R., Cornell University School of Hotel Administration, The
Scholarly Commons, “Contextual Factors and Cost Profiles Associated with Employee
Turnover,” Ithaca, NY, February 2008, Available for purchase,
http://scholarship.sha.cornell.edu/cgi/viewcontent.cgi?article=1216&context=articles.

27.

U.S. Department of Transportation, “Procedures for Transportation Workplace Drug and
Alcohol Testing Programs,” Federal Register, Vol. 75, No. 157, pp. 49850-49864,
August 16, 2010.

28.

Entergy Nuclear Operations, Inc., “Certification of Permanent Cessation of Power
Operations,” letter JAFP-16-0045, March 16, 2016, ADAMS Accession
No. ML16076A391.

29.

U.S. Nuclear Regulatory Commission, “Regulatory Analysis Guidelines of the
U.S. Nuclear Regulatory Commission,” NUREG/BR-0058, Revision 4, September 2004,
ADAMS Accession No. ML042820192.

30.

U.S. Nuclear Regulatory Commission, “2015–2016 Information Digest,” NUREG-1350,
Vol. 27, August 2015, ADAMS Accession No. ML ML15254A321.

31.

U.S. Nuclear Regulatory Commission, “Proposed Rulemaking to Amend
10 CFR Part 26, ‘Fitness for Duty Programs,’ based on Select Provisions of the 2008
HHS Guidelines,” Regulatory Basis, May 3, 2013, ADAMS Accession
No. ML13066A703.

32.

U.S. Nuclear Regulatory Commission, “Insider Mitigation Program,” Regulatory
Guide 5.77, Official Use Only—Security-Related Information, not publicly available.

33.

U.S. Nuclear Regulatory Commission, “Charter: Committee to Review Generic
Requirements,” Revision 8, March 2011, ADAMS Accession No. ML110620618.

34.

U.S. Nuclear Regulatory Commission, “Policy Statement on Safety Goals for the
Operation of Nuclear Power Plants,” August 4, 1986. Corrected and reprinted at Federal
Register, Vol. 51, No. 162, pp. 30028–30035, August 21, 1986,
http://www.nrc.gov/reading-rm/doc-collections/commission/policy/51fr30028.pdf.

35.

U.S. Department of Health and Human Services, Substance Abuse and Mental Health
Services Administration, “Mandatory Guidelines for Federal Workplace Drug Tersting
Programs,” Federal Register, Vol. 82, No. 13, January 23, 2017, pp. 7920–7970.

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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

SUBJECT: Draft Regulatory Analysis and Backfitting and Issue Finality, 10 CFR Part 26,
Fitness for Duty Drug Testing Requirments [Docket ID NRC-2009-0025], dated
August 9, 2019

ADAMS Accession Numbers: Package: ML19169A110; Regulatory Analysis: ML19169A115.
OFFICE
NSIR/DSP/FCTSB/PM*
NRR/DPR/PRMB/CA*
NRR/DPR/PRMB/TL*
NAME
BZaleski
CHowells
FSchofer
DATE
5/25/2016
5/26/2016
5/31/2016
OFFICE
NRR/DPR/PRMB/RS
NRR/DPR/PRMB/BC
NRR/DPR/D
NAME
GLappert
MKhanna
LLund
DATE
5/31/2016
6/21/2016
6/28/2016
OFFICE
NMSS/D*
RES/D*
OE/D*
NAME
SMoore, MLombard for
MWeber, RCorreia for
PHolahan, DFurst for
DATE
7/12/2016
7/8/2016
7/11/2016
OFFICE
ADM/DAS/RADB/BC*
OCFO/D*
OCIO/CSD/FPIB/CO*
NAME
CBladey, CGallagher for
MWylie, VPortillo for
DCullison
DATE
8/8/2016
7/11/2016
10/27/2016
OFFICE
OGC (NLO)*
NRR/D
EDO
NAME
HBenowitz
WDean
VMcCree
DATE
10/7/2016
12/1/2016
2/22/2017

*via email
NRR/DPR/PRMB/PM
SSchneider
5/27/2016
NRO/D*
JUhle, MCheok for
7/12/2016
NSIR/D*
BHolian, CJohnson for
8/15/2016
QTE*
Hsu
9/22/2016

OFFICIAL RECORD COPY

64

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

[Page Intentionally Blank]

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Appendices

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Appendix A: Site-Specific Fitness-for-Duty Program Performance Data (Calendar Years 2009–2014)
(Table sorted by Facility Type, then FFD Program, and then Units)
2009 Total

2011 Total

2012 Total

2013 Total

Average
2009–2014

2014 Total

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Duke Energy

Duke Energy

1

337

0

373

1

402

0

443

1

475

0

612

2

440

0.7

Exelon

Exelon

2

444

0

431

2

459

0

525

0

580

0

537

0

496

0.3

Southern Nuclear
Tennessee Valley Authority
(TVA)

Southern Nuclear

1

656

1

716

1

781

2

717

1

691

2

649

1

702

1.3

TVA

1

649

1

787

1

557

0

250

3

585

2

590

0

570

1.2

Xcel Energy

Xcel Energy

1

160

0

225

2

293

1

311

0

370

0

399

1

293

0.7

Institute of Nuclear Power
Operations (INPO)
BWX Technologies, Inc.

INPO

1

81

0

348

1

367

0

362

0

380

1

324

1

310

0.5

Lynchburg, VA

1

710

2

765

0

747

1

852

1

847

0

830

0

792

0.7

Nuclear Fuel Services

Erwin, TN

1

849

1

866

2

874

4

858

3

790

3

747

2

831

2.5

Ameren UE

Callaway

1

1,005

3

1,766

6

1,924

7

924

3

1,840

8

2,044

18

1,584

7.5

Arizona Public Service

Palo Verde

3

6,961

18

4,873

19

4,422

11

4,377

16

4,171

18

4,194

21

4,833

17.2

Detroit Edison

Fermi Unit 2

1

2,550

1

2,922

19

1,625

9

2,855

15

1,842

10

3,030

15

2,471

11.5

Millstone

2

2,206

9

2,206

16

2,917

25

2,403

7

2,384

19

3,526

22

2,607

16.3

North Anna

2

1,828

12

3,085

14

2,031

6

2,121

14

2,305

12

2,269

5

2,273

10.5

Surry

2

2,069

17

2,147

18

2,744

48

2,306

19

1,520

15

1,869

8

2,109

20.8

H.B. Robinson

1

734

3

1,596

10

1,368

7

2,458

16

2,771

15

1,266

3

1,699

9.0

Dominion Generation

Reactor

Tested

Fuel Cycle

Positive

C/V

Facility

Tested

Corporate
Office

FFD Program

Units

Facility Type

2010 Total

Duke Energy

Energy Northwest

Entergy Nuclear

Shearon Harris

1

1,114

3

2,460

12

1,128

0

1,943

6

1,870

6

1,481

4

1,666

5.2

Brunswick

2

2,311

16

2,603

10

2,697

15

2,779

17

3,789

18

3,546

13

2,954

14.8

Catawba

2

2,976

14

2,670

16

2,453

16

3,054

20

3,007

17

2,091

11

2,709

15.7

McGuire

2

2,703

17

2,536

16

4,370

18

3,568

6

2,965

10

4,198

19

3,390

14.3

Oconee

3

3,742

22

3,309

21

2,643

16

3,443

14

3,106

15

3,792

28

3,339

19.3

Columbia

1

3,209

29

1,494

6

3,835

32

1,171

2

2,083

23

1,354

7

2,191

16.5

Grand Gulf

1

1,202

2

2,080

18

2,427

19

5,314

22

1,230

11

2,380

15

2,439

14.5

Palisades

1

2,019

7

2,060

24

893

8

1,855

22

1,083

7

1,894

7

1,634

12.5

River Bend

1

2,083

16

1,632

13

1,421

5

1,054

8

2,184

11

1,078

10

1,575

10.5

Waterford

1

1,623

15

1,475

7

1,451

11

2,918

30

930

8

1,511

21

1,651

15.3

Arkansas Nuclear One

2

2,309

14

2,628

14

2,820

25

2,407

16

3,182

32

2,331

23

2,613

20.7

Indian Point

2

2,211

14

2,485

16

2,090

17

2,032

9

2,071

18

2,088

10

2,163

14.0

A-1

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines
2009 Total

2011 Total

2012 Total

2013 Total

Average
2009–2014

2014 Total

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Tested

Positive

Tested

Reactor
(continued)

Positive

Exelon

Facility

Tested

FFD Program

Units

Facility Type

2010 Total

Clinton

1

1,265

11

1,958

8

1,743

13

755

3

2,018

11

952

3

1,449

8.2

R.E. Ginna

1

1,890

30

933

11

1,306

2

1,217

15

778

1

1,035

10

1,193

11.5

Three Mile Island

1

2,699

32

1,002

5

1,618

12

837

3

1,556

7

911

5

1,437

10.7

Braidwood

2

3,511

33

2,510

17

2,053

9

3,013

15

2,491

5

1,804

8

2,564

14.5

Byron

2

2,290

18

1,841

7

3,974

30

2,694

9

1,894

12

3,010

21

2,617

16.2

Calvert Cliffs

2

2,343

10

2,305

14

2,225

13

2,504

13

2,463

15

2,231

8

2,345

12.2

Dresden

2

1,631

11

2,046

5

2,294

8

1,876

9

1,894

12

1,807

13

1,925

9.7

LaSalle

2

2,440

9

2,698

18

3,270

11

2,829

9

2,360

11

2,583

5

2,697

10.5

Limerick

2

2,526

16

2,599

16

3,049

23

3,622

23

2,751

24

2,551

9

2,850

18.5

Nine Mile Point

2

2,520

20

3,132

31

2,552

13

3,141

24

2,678

16

2,256

16

2,713

20.0

Peach Bottom

2

3,075

21

2,912

14

3,802

19

3,643

18

4,123

19

3,836

14

3,565

17.5

Quad Cities

2

2,247

19

2,476

17

2,014

10

2,111

11

2,242

19

1,854

10

2,157

14.3

Davis-Besse

1

863

3

2,662

9

2,903

15

1,545

3

1,867

10

3,017

14

2,143

9.0

FirstEnergy Nuclear

Perry

1

2,512

12

1,126

2

2,066

16

1,192

5

2,561

19

1,265

3

1,787

9.5

Beaver Valley

2

2,924

21

2,149

11

2,129

9

3,391

19

2,736

12

2,683

9

2,669

13.5

Indiana Michigan Power

DC Cook

2

4,337

52

4,017

30

3,565

22

3,012

17

4,482

29

3,493

15

3,818

27.5

Luminant Generation

Comanche Peak

2

2,248

15

2,274

6

3,119

16

2,351

10

2,490

7

3,837

17

2,720

11.8

Nebraska Public Power
District

Cooper

1

2,478

12

1,070

2

1,681

10

2,173

13

793

4

1,734

4

1,655

7.5

Duane Arnold

1

1,418

6

1,339

2

745

1

1,730

14

537

2

1,704

21

1,246

7.7

NextEra Energy

Seabrook

1

2,628

19

1,050

6

2,021

18

2,293

19

848

3

1,597

10

1,740

12.5

Point Beach

2

2,340

4

2,214

5

4,831

12

1,290

3

1,260

0

1,771

8

2,284

5.3

St. Lucie
Turkey Point
Units 3 & 4

2

2,525

17

4,534

26

5,204

22

4,887

14

2,809

13

2,504

15

3,744

17.8

2

3,813

19

3,827

20

4,718

21

8,216

40

2,247

10

2,904

10

4,288

20.0

Omaha Public Power District

Fort Calhoun

1

1,839

7

1,186

5

2,643

20

1,758

10

1,705

9

1,063

6

1,699

9.5

Pacific Gas & Electric

Diablo Canyon

2

4,731

28

3,105

14

2,973

17

2,826

14

2,937

10

3,486

25

3,343

18.0

PSEG Nuclear

Salem/Hope Creek

3

3,768

24

4,291

28

4,199

23

4,288

34

4,252

24

4,195

27

4,166

26.7

1

1,667

13

1,112

4

1,792

11

2,016

11

1,867

16

2,781

28

1,873

13.8

South Carolina Electric & Gas V.C. Summer Unit 1

A-2

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines
2009 Total

2012 Total

2013 Total

Average
2009–2014

2014 Total

Tested

Positive

Positive

3,187

31

3,592

47

3,114

18

3,205

17

3,078

23

3,167

23.8

29

3,968

43

3,724

39

2,681

42

2,797

11

1,935

16

2,936

30.0

Tested

Positive

7

2,513

Tested

Positive

2,823

2

Tested

Positive

2

Joseph M. Farley

Tested

Positive

Reactor—
Construction

2011 Total

E.I. Hatch

Tested

Reactor
(continued)

Positive

Southern Nuclear

Facility

Tested

FFD Program

Units

Facility Type

2010 Total

Vogtle Units 1 & 2

2

2,774

30

2,837

26

3,856

21

3,284

57

2,605

27

3,749

34

3,184

32.5

STP Nuclear

South Texas Project

2

2,672

17

2,757

8

3,082

15

2,302

17

2,629

17

2,428

13

2,645

14.5

Talen Energy

Susquehanna

2

3,167

14

3,324

13

3,327

8

2,914

9

2,985

11

3,435

15

3,192

11.7

TVA

Sequoyah

2

2,916

18

2,974

22

2,849

20

5,048

28

2,660

14

1,942

14

3,065

19.3

Watts Bar

2

4,799

19

6,506

40

5,918

26

5,628

38

4,477

27

5,244

34

5,429

30.7

Browns Ferry

3

3,313

16

4,958

17

3,607

9

4,713

25

3,922

27

3,897

22

4,068

19.3

Wolf Creek

Wolf Creek

1

2,117

5

1,246

1

2,667

17

1,756

7

3,286

8

2,017

9

2,182

8

Xcel Energy

Monticello

1

2,452

11

1,234

8

3,329

17

1,019

5

2,794

18

835

4

1,944

10.5

Prairie Island
V.C. Summer
South Carolina Electric & Gas
Units 2 & 3

2

1,663

9

1,625

5

1,260

6

2,057

9

2,822

11

1,824

4

1,875

7.3

252

4

2,724

52

3,532

80

5,484

127

2,998

65.8

Southern Nuclear

2

3,933

80

5,440

101

5,862

98

9,055

168

4,602

84.0

889 165,624 1,008 167,190 1,057 153,266

967

158,417 1,084 158,303

1,005

2

Vogtle Units 3 & 4
Totals

110

47
148,525

0

3,277

894 150,799

57

Notes on Appendix A:
1. Site construction at Vogtle Units 3 and 4 began in calendar year (CY) 2009.
2. Site construction at V.C. Summer Units 2 and 3 began in CY 2011.
3. Watts Bar Unit 2 construction restarted in CY 2008 and completed in CY 2015; the licensee did not report separately for the construction site.

A-3

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Appendix B: General Inputs
Model Inputs
Final Rule—Effective Date and Scope
Year rule finalized
Year rule effective
Total number of fitness-for-duty (FFD)
programs

Total number of sites

Number of sites using a licensee testing
facility (LTF)
Number of sites only using a
U.S. Health and Human Services
(HHS)-certified laboratory

Number of workers subject to a
10 CFR Part 26 FFD program

Average number of workers subject to a
10 CFR Part 26 FFD program per site

Value
2017
2017

Data Source
U.S. Nuclear Regulatory Commission (NRC) staff assumption
NRC staff assumption

27

NRC FFD Program Performance Results Calendar Year (CY) 2014

67

NRC FFD program Performance Data CY 2014 (see Appendix A).
Total sites = 57 operating power reactor sites, 2 power reactor
construction sites, 2 Category I fuel cycle facilities, 5 corporate offices,
and 1 contractor/vendor (C/V). (This analysis excludes sites that are in
decommissioning or sites with announced dates when their unit will
permanently cease commercial operation, as described in Section
4.2.2.)

6

NRC FFD Program Performance Results CY 2014

61

NRC FFD Program Performance Results CY 2014

107,620

1,606
individuals
per site

Number of drug tests conducted per
year

157,632 tests

Number of drug tests conducted per
site per year

2,353 tests
per site

NRC FFD Program Performance Results CY 2009–2014. In the
annual 10 CFR 26.717 FFD program performance report submitted to
the NRC, each licensee or other entity reports the average number of
licensee employees and C/Vs subject to random testing in the
reporting year. The average of the yearly total for all 67 sites in
CY 2009–2014 is the best approximation of the total number of
individuals in the workforce who would require training on policy
changes resulting from the proposed rule. Adjusted for construction
sites going operational in CY 2019 and CY 2020.
Calculated from the NRC FFD Program Performance Results
CY 2009–CY 2014 [(total number of individuals subject to random
testing per year) / (total number of sites)]
NRC FFD Program Performance Results (average of total number of
tests conducted for CY 2009–CY 2014), adjusted for construction sites
going operational (used operating site data at the co-located reactors
to model test results)
Calculated from the NRC FFD Program Performance Results
CY 2009–CY 014. [(total number of drug tests conducted per year) /
(total number of sites)]

Industry Implementation (One-Time)—Hourly Wage Rates
Clerical
$21.69
Facility Worker (weighted average of
$63.86
Model facility data: “Inputs—Wages” (from January to May 2002)
licensee and C/V workers)
provided to the NRC by the Nuclear Energy Institute on FFD drug and
FFD Manager
$44.21
alcohol testing programs.
FFD Staff
$36.87
These data were used in the regulatory impact analysis for the
LTF Laboratory Technician
$36.55
10 CFR Part 26 FFD final rule (March 2008), converting wage data
LTF Laboratory Supervisor
$61.45
from 2002 to 2017 dollars.
Legal
$122.91
Medical Review Officer (MRO)
$137.73
Industry Implementation (One-Time)—Training
Number of sites that distribute a
summary of FFD program rule
changes to employees outside of
routine training

14

NRC staff assumption. Based on the implementation timeframe, most
licensees and other entities will incorporate training on the new FFD
program requirements into existing annual training/refresher training
opportunities, as well as post information at the collection sites and on
bulletin boards, etc. Estimate that 20% of sites will conduct training
specifically on rule changes and outside routine training.
(0.2 x 67 sites = 14 sites)

Number of FFD programs with a blind
performance test sample (BPTS)
supplier contract

27

NRC staff assumption
(all sites have a contract with a BPTS supplier)

B-1

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Model Inputs
Cost of LTF training materials

Value
$500.00
per LTF

Number of Laboratory Technicians per
2
LTF
NRC Implementation (One-Time)—Wage Rate
Annual Full-Time Equivalent (FTE)
Rate for NRC Regulatory Analysis
Industry Operations (Annual)—Costs
Initial testing for one additional drug at
an LTF
Initial and confirmatory drug testing,
HHS-certified laboratory
(sites using an LTF for initial testing)

$182,000
per FTE
$1.50
per test
$29.00
per specimen

Testing for 6-AM (sites only using an
HHS-certified laboratory)

$0.75
per test

Testing for Ecstasy (sites only using an
HHS-certified laboratory)

$0.50
per test

Special analyses testing at an
HHS-certified laboratory
Cost of subsequent actions
(per positive result)

$7.75
per specimen
$283.24
per test

Data Source
NRC staff assumption based on the 2008 10 CFR Part 26 FFD final
rule regulatory impact analysis (March 2008)
NRC staff assumption based on communications in CY 2016 with
licensees using LTFs
For fiscal year 2016 regulatory analyses (as of October 2015)
[1 FTE = 1,420 annual productive hours x $128 hour NRC staff rate]
NRC staff assumption based on industry feedback received in
CY 2015 and CY 2016 from licensees using LTFs
NRC staff assumption, based on industry feedback received in
CY 2015 and CY 2016 (weighted average of LTF testing costs for
positive results from CY 2009–CY 2014)
NRC staff assumption, partially informed by the August 16, 2010,
49 CFR Part 40 Final Rule (Ref. 27) that aligned the
U.S. Department of Transportation (DOT) drug testing panel with the
2008 HHS Guidelines (it reported an average cost per 6-AM test as
$0.26)
NRC staff assumption, partially informed by the August 16, 2010,
49 CFR Part 40 Final Rule (Ref. 27) that aligned the DOT drug
testing panel with the 2008 HHS Guidelines (it reported an average
cost per Ecstasy test as $0.09)
NRC staff assumption based on industry feedback received in
CY 2015 and CY 2016
Hours estimates based on information in the 10 CFR Part 26 Office of
Management and Budget Clearance Supporting Statement
(No. 3150-0146) approved on November 13, 2014, as well as the NRC
staff assumption on MRO review time

Industry Operations (Annual)—Drug Testing Rates
6-Acetylmorphine (6-AM)
Projected confirmed positive test rate

0.017%

DOT laboratory test results
Average positive rate for 6-AM (CY 2010–2014)
[2010 = 0.010%; 2011 = 0.014%; 2012 = 0.016%; 2013 = 0.019%;
2014 = 0.022%]

0.047%

NRC FFD Program Performance Results
Average positive rate for amphetamines (CY 2010–CY 2014)
[CY 2010 = 0.032%; CY 2011 = 0.048%; CY 2012 = 0.036%;
CY 2013 = 0.052%; CY 2014 = 0.067%]

Amphetamines
FFD current confirmed positive test
rate

Projected percent increase in
confirmed positive test rate

39.38%

MRO-verified test results for CY 2010 and CY 2011 for DOT (Federal
Aviation Administration (FAA), Federal Railroad Administration (FRA),
and Federal Transit Administration (FTA)). Did not use DOT
laboratory test results (not verified by MRO) because amphetamines
results may be downgraded to negative results following MRO review
because of legitimate prescription use.
[Average positive rate for amphetamines by year:
CY 2010 = 0.057%; CY 2011 = 0.080%]

Projected percentage of additional
positive results that will confirm
positive after MRO interview with
donor

75%

NRC staff assumption based on FFD program performance data on
amphetamine and methamphetamine positive results

0.072%

NRC FFD Program Performance Results
Average positive rate for cocaine (CY 2010–CY 2014)
[CY 2010 = 0.075%; CY 2011 = 0.071%; CY 2012 = 0.075%; CY 2013
= 0.076%; CY 2014 = 0.064%]

18.38%

MRO-verified test results for CY 2010 and CY 2011 for DOT (FAA,
FRA, and FTA). Change in average cocaine positive rate for CY 2011,
using CY 2010 as the baseline year for comparison [Average positive
rate for cocaine by year: CY 2010 = 0.175%; CY 2011 = 0.207%]

Cocaine
FFD current confirmed positive test
rate

Projected percent increase in
confirmed positive test rate

B-2

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Model Inputs
Ecstasy Drugs
Projected confirmed positive test rate

Value

0.004%

Data Source
DOT laboratory test results
Average positive rate for Ecstasy drugs (MDMA, MDA, MDEA)
(CY 2010–CY 2014) [CY 2010 = 0.003%; CY 2011 = 0.005%;
CY 2012 = 0.004%; CY 2013 = 0.005%; CY 2014 = 0.005%]

Dilute Specimens (Special Analyses Testing)

Average annual percentage of
specimens tested that are dilute and
special analyses testing performed

0.466%

NRC FFD Program Performance Data on dilute specimens subject to
special analyses testing (an e-form change was made to collect this
data starting in CY 2013):
•
CY 2013: special analyses testing performed on 652 specimens
of the 137,642 specimens collected by 65 sites with a special
analyses testing policy
•

Average annual percentage of
specimens tested that are dilute and
test positive on special analyses
testing

0.005%

CY 2014: special analyses testing performed on 834 specimens
of the 153,629 specimens collected by 69 sites with a special
analyses testing

NRC FFD Program Performance Data for CY 2011–CY 2014 (began
collecting e-reported data on special analyses testing of dilute positive
test results in CY 2011):
• CY 2011: 2 positive specimens of 151,581 tested
• CY 2012: 8 positive specimens of 148,067 tested
• CY 2013: 9 positive specimens of 137,642 tested
• CY 2014: 10 positive specimens of 153,269 tested

Subversion Attempts (Special Analyses Testing of Suspect Specimens)

Average annual percentage of
specimens tested that are determined
to be a subversion attempt and that
test positive (suspect specimens that
test positive on special analyses
testing)

Project percent increase in confirmed
positive test rate for specimens
collected under direct observation
Averted Training Costs—Pre-Access Testing
Percentage of total positive,
adulterated, substituted, and refusal
to test results occurring at pre-access
testing (6-year average)

The proposed rule would require special analyses testing in two
circumstances:
(1) On the second specimen collected under direct observation when
the initial specimen collected exhibits unusual characteristics
(e.g., temperature out of range, unusual color or odor)
(2) On the second specimen collected under direct observation when
the initial specimen is reported as an invalid test result.
0.037%
NRC FFD Program Performance e-reported data (only includes those
sites that e-reported provided sufficient information to analyze
subversion attempts in this manner) for CY:
• 2011: 42 suspect specimens/141,234 tests (at 62 sites) = 0.030%
• 2012: 55 suspect specimens/157,528 tests (at 67 sites) = 0.035%
• 2013: 44 suspect specimens/151,323 tests (at 71 sites) = 0.029%
• 2014: 63 suspect specimens/166,590 tests (at 75 sites) = 0.038%
20%

NRC staff assumption

67.8%

NRC FFD Program Performance Data (CY 2009–CY 2014)
[CY 2009= 68.2%; CY 2010 = 69.0%; CY 2011 = 68.6%; CY 2012 =
68.8%; CY 2013 = 64.8%; CY 2014 = 67.3%]

25 years

Calculated based on license expiration date (assumes all operating
power reactor licenses are extended for 20 years), the fuel cycle
facilities continue to operate as long as any reactor is operating, and
the new power reactors under construction operate for the original
40-year operating license and a 20-year license extension.

Entity-Specific Information

Average remaining life per site

Inflation Rates
Ratio of 2017 Annual Average CPI-U
to 2006 Annual Average CPI-U

1.23

Ratio of 2017 Annual Average CPI-U
to 2002 Annual Average CPI-U

1.38

U.S. Bureau of Labor Statistics (Table 24. Historical Consumer
Price Index for All Urban Consumers (CPI-U): U.S. city average, all
items)
[CPI-U: CY 2002 = 179.9; CY 2006 = 201.6; CY 2017 = 247.783]

B-3

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Appendix C: Assumptions and Results by Regulatory Initiative
C.1 Policy, Procedure, and Training Costs
The U.S. Nuclear Regulatory Commission’s (NRC’s) proposed rule would impose one-time costs on industry as a result of the
following activities:
(1) updating fitness-for-duty (FFD) program policies and procedures
(2) training employees on the revised drug testing policies
(3) revising contracts with primary and backup U.S. Department of Health and Human Services (HHS)-certified laboratories, and
blind performance test sample (BPTS) suppliers
(4) training licensee testing facility (LTF) technicians on new drug testing protocols
(5) validating newly implemented drug testing assays at the LTFs
Wage Rate or
Benefits
Entities Total Benefits
Activity
Labor Category
Quantity
Unit Cost
(Cost)
Affected
(Costs)
INDUSTRY IMPLEMENTATION (ONE-TIME)

(1) Update policies
and procedures

(2) Inform employees
of policy change

(3) Revise contract
with primary HHScertified laboratory
(3) Revise contract
with HHS-certified
laboratory
(3) Revise contract
with BPTS supplier
(4) Train LTF
Technicians
(5) Validate drug test
assays at the LTF

FFD Manager
FFD Staff
Clerical
Legal
FFD Manager
Clerical
Legal

$44.21/hour
$36.87/hour
$21.69/hour
$122.91/hour
$44.21/hour
$21.69/hour
$122.91/hour

Facility Worker

$63.86/hour

FFD Manager
FFD Staff
Clerical
Legal
FFD Manager
FFD Staff
Clerical
Legal
FFD Manager
FFD Staff
Clerical
Legal

$44.21/hour
$36.87/hour
$21.69/hour
$122.91/hour
$44.21/hour
$36.87/hour
$21.69/hour
$122.91/hour
$44.21/hour
$36.87/hour
$21.69/hour
$122.91/hour

LTF Technician

$36.55/hour

Training Materials

$500.00/LTF

LTF Supervisor

$61.45/hour

1 hour/program
($44)
27
1 hour/program
($37)
27
1 hour/program
($22)
27
1 hour/program
($123)
27
0.5 hours/program
($22)
27
0.5 hours/program
($11)
27
0.5 hours/program
($61)
27
0.2 hours/worker and
($20,513)
14
1,606 workers per site
2 hours/program
($88)
27
2 hours/program
($74)
27
2 hours/program
($43)
27
2 hours/program
($246)
27
2 hours/program
($88)
27
2 hours/program
($74)
27
2 hours/program
($43)
27
2 hours/program
($246)
27
1 hour/program
($44)
27
1 hour/program
($37)
27
1 hour/program
($22)
27
1 hour/program
($123)
27
1 hour/technician
($73)
6
(2 technicians/LTF)
1 per LTF
($500)
6
5 hours per drug assay
($1,174)
6
(4 drug assays per LTF)
Total Industry Implementation Cost
Average Implementation Cost Per Site

($1,188)
($999)
($594)
($3,321)
($594)
($297)
($1,647)
($287,182)
($2,376)
($1,998)
($1,161)
($6,642)
($2,376)
($1,998)
($1,161)
($6,642)
($1,188)
($999)
($594)
($3,321)
($438)
($3,000)
($7,374)
($337,090)
($5,031)

NRC IMPLEMENTATION (ONE-TIME)
Rule Development
and Regulatory
Guide

NRC Staff

$182,000
per full-time
equivalent
(FTE)

1.5 FTE

-

($273,000)

-

Total NRC Implementation Cost
Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Entity = Unit Cost x Unit(s) [rounded]
•
Total Benefits (Cost) = Benefits (Cost) Per Entity x Entities Affected
•
Total Industry Implementation Cost = Sum (Total Industry Benefits (Cost))
•
Average Implementation Cost Per Site = Total Industry Implementation Cost / Total Number of Sites
•
Total NRC Implementation Cost = Sum (Total NRC Benefits (Cost))

($273,000)

Assumptions:
•
One-time policy, procedure, and training costs accrue to different entities—programs, sites, and LTFs. Most of these costs
accrue at the corporate level (i.e., FFD program), with the exception of the costs for facility workers to review policy change
information (which accrue to sites) and the costs for LTFs to train technicians on new requirements and validate drug assays
(which accrue to sites with LTFs).
•

NRC implementation costs would include analyzing public comments received on the proposed rule, holding public
meeting(s), developing the final rule, and issuing final regulatory guidance.

•

Hour estimates are based on the best professional judgment of NRC staff.

•

Appendices B and D give additional information on inputs used in these estimates.

C-1

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

C.2 Lower Initial and Confirmatory Testing Cutoff Levels for Amphetamines and Cocaine
The proposed rule would revise the cutoff levels for initial testing (10 CFR 26.133, “Cutoff Levels for Drugs and Drug
Metabolites,” and 10 CFR 26.163(a)(1)) and confirmatory testing (10 CFR 26.163(b)(1)) to align with Section 3.4 of the 2008
HHS Guidelines as follows:
(1)
(2)
(3)
(4)

Lower the initial drug testing cutoff level for amphetamines from 1,000 nanograms (ng) per milliliter (mL) to 500 ng/mL.
Lower the confirmatory drug testing cutoff levels for amphetamine and methamphetamine from 500 ng/mL to 250 ng/mL.
Lower the initial drug testing cutoff level for cocaine metabolites from 300 ng/mL to 150 ng/mL.
Lower the confirmatory drug testing cutoff level for cocaine metabolite from 150 ng/mL to 100 ng/mL.

Lower cutoff levels for amphetamines and cocaine metabolites would increase the window of detection in which these drugs might
be identified in the urine specimens provided by individuals. The changes also would provide additional assurance that persons
will be unable to subvert the drug testing process through temporarily abstaining from using these drugs. As a result, the lower
cutoffs are estimated to result in an increase in the number of urine specimens identified as containing amphetamines or cocaine
metabolites, or both. The rule changes would improve the detection of drug users and may increase the deterrent effect of the
testing program under 10 CFR Part 26, “Fitness for Duty.”
Activity

Parameter

Value

INDUSTRY OPERATIONS (ANNUAL)
Amphetamines
Number of drug tests conducted per site per year
Additional testing at
under 10 CFR Part 26
HHS-certified laboratory
FFD current positive test rate
for amphetamines
Projected percent increase in positive testing rate
positive results
Initial and confirmatory drug testing, HHS-certified
(sites using LTFs)
laboratory
Number of drug tests conducted per site per year
under 10 CFR Part 26
FFD current positive test rate
Medical Review Officer
Projected percent increase in positive test rate
(MRO) review of result,
Expected percent of additional positive results that
donor interview, and
will be negative after MRO interview with donor
medical downgrade for
MRO activities (1 hour per positive):
valid prescription use of
review laboratory result, interview donor, and
amphetamines
evaluate medical information from donor
Facility Worker activities (1 hour per positive):
participate in interview with MRO, obtain medical
information on valid use, and provide to MRO)
Number of drug tests conducted per site per year
under 10 CFR Part 26
Subsequent actions by
FFD current positive test rate
FFD program personnel
Projected percent increase in confirmed positive
for additional
test rate
amphetamines
Projected percent of additional positive results
confirmed positive test
that will confirm positive after MRO interview with
results (all sites)
donor

Sites
Affected

Total
Benefits
(Costs)

($13)

6

($78)

($22)

67

($1,474)

($92)

67

($6,164)

($9)

6

($54)

($89)

67

($5,963)

0.072%
18.38%
$283.24
Total Industry Operations Cost
Average Operations Cost Per Site

($13,733)
($205)

Cost of subsequent actions (per positive result)

2,353

Benefits
(Cost)

0.047%
39.38%
$29.00
2,353
0.047%
39.38%
25%
$137.73
per hour
$63.86
per hour
2,353
0.047%
39.38%
75%
$283.24

Cocaine
Additional testing at
HHS-certified laboratory
for cocaine positive
results (sites using
LTFs)
Subsequent actions by
FFD program personnel
for additional cocaine
positive test results
(all sites)

Number of drug tests conducted per site per year
under 10 CFR Part 26
FFD current positive test rate
Projected percent increase in positive test rate
Initial and confirmatory drug testing, HHS-certified
laboratory
Number of drug tests conducted per site per year
under 10 CFR Part 26
FFD current positive testing rate
Projected percent increase in positive test rate
Cost of subsequent actions (per positive result)

C-2

2,353
0.072%
18.38%
$29.00
2,353

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Site = Product (Data Inputs)
•

Total Benefits (Cost) = Benefits (Cost) Per Site x Sites Affected

•

Total Industry Operations Cost = Sum (Total Benefits (Cost))

•

Average Operations Cost Per Site = Total Industry Operations Cost / Total Number of Sites

Assumptions:
•
Licensees that only use HHS-certified laboratories for all drug testing pay a per-specimen cost, which includes initial drug
testing of all specimens and confirmatory drug testing when applicable. Licensees that use LTFs for initial drug testing and
HHS-certified laboratories for confirmatory testing would incur an incremental cost to conduct confirmatory testing at an
HHS-certified laboratory for any additional specimens that screen positive at the LTF as a result of the rule changes.
•

Lowering the testing cutoff levels would not change the LTF assay costs, nor would it require equipment upgrades. LTFs
would purchase different standards and controls to comply with the new testing cutoff levels; however, purchasing standards,
controls, and assays is a normal cost of operations and occurs on a regular basis.

•

For amphetamines, 75 percent of HHS-certified laboratory positive tests results would be confirmed positive by the MRO
(i.e., 25 percent of laboratory positives would be medically downgraded by the MRO based on a valid medical condition and
prescription).

•

For cocaine, all HHS-certified laboratory positive results would be confirmed positive by the MRO.

•

Appendices B and D give additional information on parameters used in these calculations.

C-3

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

C.3 Expand Initial Drug Testing Panel to Include 6-AM and Revise Confirmatory Testing Cutoff
Level for 6-AM
The proposed rule would add testing for 6-acetylmorphine (6-AM) to the initial testing panel (10 CFR 26.31(d)(1) and
10 CFR 26.405(d)); make conforming changes to the substances for initial testing (10 CFR 26.133 and 10 CFR 26.163(a)(1))
and confirmatory testing (10 CFR 26.163(b)(1)); and make conforming changes to the annual statistical summary reporting
requirements for HHS-certified laboratories to include the revised testing panel (10 CFR 26.169(h)(3)). These changes would
align 10 CFR Part 26 with Section 3.4 of the 2008 HHS Guidelines as follows:
(1)

Include initial testing for 6-AM (10 ng/mL cutoff level).

(2)

Remove the requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a morphine
concentration exceeding 2,000 ng/mL (such that, under the proposed rule, if initial testing for 6-AM is positive,
confirmatory testing for 6-AM proceeds independent of the morphine concentration).

Conducting initial testing for an additional substance, 6-AM, would enable the improved detection of the illegal drug heroin,
which has been increasing in use in society. The performance of initial testing for 6-AM is estimated to result in an increase the
number of urine specimens identified as containing 6-AM. The rule change also may increase the deterrent effect of the
10 CFR Part 26 testing program.
Activity

Benefits
(Cost)

Sites
Affected

Total Benefits
(Costs)

($3,530)

6

($21,180)

($1,765)

61

($107,665)

($12)

6

($72)

($114)

61

($7,638)

$283.24
Total Industry Operations Cost
Average Operations Cost Per Site

($136,555)
($2,038)

Parameter

Value

INDUSTRY OPERATIONS (ANNUAL)
6-AM
Number of drug tests conducted per site per year
6-AM initial testing
under 10 CFR Part 26
(sites using LTFs)
Initial testing for one additional drug at an LTF
Number of drug tests conducted per site per year
6-AM testing
under 10 CFR Part 26
(sites only using HHSTesting for 6-AM
certified laboratories)
(sites only using an HHS-certified laboratory)
Number of drug tests conducted per site per year
Additional testing at HHS- under 10 CFR Part 26
certified laboratory for
Projected confirmed positive test rate
6-AM positive results
Initial and confirmatory drug testing, HHS-certified
(sites using LTFs)
laboratory (sites using an LTF for initial testing)
Subsequent actions by
Number of drug tests conducted per site per year
FFD program personnel
under 10 CFR Part 26
for additional 6-AM
Projected confirmed positive test rate
positive test results
Cost of subsequent actions (per positive result)
(all sites)

2,353
$1.50
2,353
$0.75
2,353
0.017%
$29.00
2,353
0.017%

Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Site = Product (Data Inputs)
•

Total Benefits (Cost) = Benefits (Cost) Per Site x Sites Affected

•

Total Industry Operations Cost = Sum (Total Benefits (Cost))

•

Average Operations Cost Per Site = Total Industry Operations Cost / Total Number of Sites

Assumptions:
•
Initial drug testing of each urine specimen for 6-AM would result in an incremental cost per test performed at LTFs and
HHS-certified laboratories.
•

Licensees that only use HHS-certified laboratories for all drug testing pay a per-specimen cost, which includes initial drug
testing of all specimens and confirmatory drug testing when applicable. Licensees that use LTFs for initial drug testing and
HHS-certified laboratories for confirmatory drug testing would incur an incremental cost to conduct confirmatory testing at an
HHS-certified laboratory for any additional specimens that screen positive at the LTF as a result of the rule changes.

•

All HHS-certified laboratory positive results for 6-AM would be confirmed positive by the MRO (i.e., no medical downgrades
possible for heroin, a Schedule I drug—that is, an illegal drug).

•

Appendices B and D give additional information on parameters used in these calculations.

C-4

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

C.4 Expand the Initial and Confirmatory Drug Testing Panels to Include Ecstasy
The proposed rule would add testing for two Ecstasy-type drugs (MDMA/MDA) to the testing panel (10 CFR 26.31(d)(1) and
10 CFR 26.405(d)); make conforming changes to the substances for initial testing (10 CFR 26.133 and 10 CFR 26.163(a)(1))
and confirmatory testing (10 CFR 26.163(b)(1)); and make conforming changes to the annual statistical summary reporting
requirements for HHS-certified laboratories to include the revised testing panel (10 CFR 26.169(h)(3)). These changes would
ensure that 10 CFR Part 26 is consistent with Section 3.4 of the 2008 HHS Guidelines.
The rule would revise the list of substances to be tested as follows:
•
•

Include initial testing for MDMA and MDA (500 ng/mL testing cutoff level).
Include confirmatory testing for MDMA and MDA (250 ng/mL cutoff levels).

Testing for Ecstasy would enable the detection of additional illegal drugs that could impair employee performance and that have
been increasing in use in society. The performance of testing for Ecstasy drugs is estimated to result in an increase in the
number of urine specimens identified as containing MDMA or MDA, or a combination. The rule change also may increase the
deterrent effect of the 10 CFR Part 26 testing program by including these additional substances in the testing panel.
Activity

Parameter

Value

INDUSTRY OPERATIONS (ANNUAL)
Ecstasy
Number of drug tests conducted per site per
Ecstasy initial testing
year under 10 CFR Part 26
(sites using LTFs)
Initial testing for one additional drug at an LTF
Ecstasy testing
(sites only using HHScertified laboratories)
Additional testing at HHScertified laboratory for
Ecstasy positive results
(sites using LTFs)
Subsequent actions by FFD
program personnel for
additional Ecstasy positive
test results (all sites)

Number of drug tests conducted per site per
year under 10 CFR Part 26
Testing for Ecstasy
(sites only using an HHS-certified laboratory)
Number of drug tests conducted per site per
year under 10 CFR Part 26
Projected confirmed positive test rate
Initial and confirmatory drug testing,
HHS-certified laboratory (sites using an LTF for
initial testing)
Number of drug tests conducted per site per
year under 10 CFR Part 26
Projected confirmed positive test rate
Cost of subsequent actions (per positive result)

2,353

Benefits
(Cost)

Total
Benefits
(Costs)

Sites
Affected

($3,530)

6

($21,180)

($1,177)

61

($71,797)

($3)

6

($18)

($28)

67

($1,876)

0.004%
$283.24
Total Industry Operations Cost
Average Operations Cost Per Site

($94,871)
($1,416)

$1.50
2,353
$0.50
2,353
0.004%
$29.00
2,353

Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Site = Product (Data Inputs)
•

Total Benefits (Cost) = Benefits (Cost) Per Site x Sites Affected

•

Total Industry Operations Cost = Sum (Total Benefits (Cost))

•

Average Operations Cost Per Site = Total Industry Operations Cost / Total Number of Sites

Assumptions:
•
Initial drug testing of each urine specimen for MDMA would result in an incremental cost per test performed at LTFs and
HHS-certified laboratories.
•

Licensees that only use HHS-certified laboratories for all drug testing pay a per-specimen cost, which includes initial drug
testing of all specimens and confirmatory drug testing when applicable. Licensees that use LTFs for initial drug testing and
HHS-certified laboratories for confirmatory drug testing also would incur an incremental cost to conduct confirmatory testing
at an HHS-certified laboratory for any additional specimens that screen positive at the LTF as a result of the rule change.

•

All HHS-certified laboratory positive results for Ecstasy would be confirmed positive by the MRO (i.e., no medical
downgrades possible for MDMA/MDA, each is a Schedule I drug—that is, an illegal drug).

•

Appendices B and D give additional information on parameters used in these calculations.

C-5

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

C.5 Special Analyses Testing of Dilute Specimens and Specimens Collected during Suspected
Subversion Attempts
The regulations in 10 CFR 26.163(a)(2) provide licensees and other entities with the option to conduct special analyses testing
on a donor specimen with a dilute validity test result (i.e., specimens with a creatinine concentration greater than or equal to
2 milligrams per deciliter (mg/dL) but less than 20 mg/dL). The special analyses testing consists of conducting confirmatory
testing to the limit of detection (LOD) if the immunoassay response during initial drug testing is equal to or greater than
50 percent of the cutoff calibrator in a drug class.
The proposed rule would do the following:
(1)

Require special analyses testing of dilute specimens if the immunoassay response for a drug is equal to or greater
than 40 percent of the cutoff calibrator for initial drug testing.

(2)

Expand the use of special analyses testing to circumstances where a subversion attempt is suspected during the
specimen collection process (e.g., if the initial specimen provided is out of temperature range, the second specimen
collected under direct observation would be subject to the special analyses testing provisions).

(3)

Increase the assurance of special analyses testing by using the limit of quantitation (LOQ) instead of the LOD as the
level at which confirmatory testing is to be conducted. Each HHS-certified laboratory must establish both the LOD
and the LOQ for each assay and both measures are scientifically valid. However, the LOQ requires that the analyte
be reliably detected and reliably quantified. The LOD only requires that a drug analyte be reliably identified but not
quantified.

These changes would further enhance the detection of drugs when specimens do not present normal physiological
characteristics. The 2008 HHS Guidelines do not address special analyses testing, but the proposed changes are based on
industry experience and feedback received from HHS-certified laboratories in implementing the 2008 FFD final rule.
Activity

Sites
Affected

($85)

67

($5,695)

($33)

67

($2,211)

67

($402)

67

($2,948)

$283.24
Total Industry Operations Cost
Average Operations Cost Per Site

($11,256)
($168)

Value

INDUSTRY OPERATIONS (ANNUAL)
Special Analyses Testing of Dilute Specimens
Number of drug tests conducted per site per year
under 10 CFR Part 26
LOQ special analyses
Average annual percentage of specimens tested
testing at an HHS-certified that are dilute and special analyses testing
laboratory (all sites)
performed
Special analyses testing at an HHS-certified
laboratory
Number of drug tests conducted per site per year
under 10 CFR Part 26
Subsequent actions by
FFD program personnel for Average annual percentage of specimens tested
that are dilute and test positive on special
additional dilute positive
analyses testing
test results (all sites)

2,353
0.466%
$7.75
2,353
0.005%

Cost of subsequent actions (per positive result)
$283.24
Special Analyses Testing of Specimens Collected during Suspected Subversion Attempts
Number of drug tests conducted per site per year
2,353
($6)
under 10 CFR Part 26
LOQ special analyses
testing at an HHS-certified
laboratory (all sites)

Average annual percentage of specimens tested
that are determined to be a subversion attempt
and that test positive (suspect specimens that test
positive on special analyses testing)
Special analyses testing at an HHS-certified
laboratory
Number of drug tests conducted per site per year
under 10 CFR Part 26

Average annual percentage of specimens tested
Subsequent actions by
that are determined to be a subversion attempt
FFD program personnel
and that test positive (suspect specimens that test
for additional positive drug positive on special analyses testing)
test results (all sites)
Projected percent increase in confirmed positive
test rate
Cost of subsequent actions (per positive result)

C-6

Total
Benefits
(Costs)

Benefits
(Cost)

Parameter

0.033%

$7.75
2,353

($44)

0.033%

20%

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Site = Product (Data Inputs)
•

Total Benefits (Cost) = Benefits (Cost) Per Site x Sites Affected

•

Total Industry Operations Cost = Sum (Total Benefits (Cost))

•

Average Operations Cost Per Site = Total Industry Operations Cost / Total Number of Sites

Assumptions:
•
Appendices B and D give additional information on parameters used in these calculations.

C-7

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Appendix D: Costs of Subsequent Actions
Subsequent Action Labor Hours and Costs per
Positive, Adulterated, Substituted, or Refusal to Test Result
"Subsequent actions” refers to the activities completed by staff of the licensee or other entity and the Medical Review Officer
(MRO) following a drug or alcohol positive result, an adulterated or substituted validity test result, or refusal to test (as required
by 10 CFR Part 26, “Fitness for Duty Programs”).
Subsequent actions consist of activities performed by the licensee or other entity staff and the MRO regarding the review and
confirmation of a test result, communications with the donor throughout the verification and sanctioning process, and
recordkeeping and reporting. For example, subsequent actions include MRO communications with the donor about the result,
the communications between the MRO and the licensee about a confirmed test result (recording and reporting the result),
licensee or other entity administrative actions implemented by the 10 CFR 26.75, “Sanctions,” and any request by the donor to
request the retesting of an aliquot of a single specimen or the testing of Bottle B of the split specimen, or appeal of the result.
Wage Rate

Labor Per Result

Total Benefits (Cost)
Per Result

MRO

$137.73/hour

0.75 hours

$103.30

FFD Manager

$44.21/hour

2.00 hours

$88.42

FFD Staff

$36.87/hour

0.75 hours

$27.65

Facility Worker

$63.86/hour

1.00 hours

$63.86

4.50 hours

$283.24

Labor Category

Total
Calculations:
•
Benefits (Cost) Per Entity = Unit Cost x Unit(s)

Assumptions:
•
Hour estimates based on best professional judgment of the U.S. Nuclear Regulatory Commission staff.

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Appendix E: Averted Costs
Averted Training Costs—Pre-Access Testing
The proposed rule is estimated to result in savings to licensees and other entities (i.e., averted costs) associated with training during
the in-processing of licensee employees and contractor/vendors (C/Vs). Approximately 68 percent of positive test results each year
are identified during pre-access testing. As a result, if an individual tests positive for a drug during pre-access testing, any remaining
training not completed by that individual at the time of the confirmed positive test result is received would result in savings because
access authorization immediately would be denied to the individual for failing the required fitness-for-duty (FFD) drug test.
The staff estimated averted training costs by calculating the "Total Additional Positive Test Results Expected from the Proposed Rule
Changes" and multiplying that value by the cost of labor that would be averted for each positive result.
Activity

Parameter

Value

INDUSTRY OPERATIONS (ANNUAL)
Total Additional Positive Test Results Projected from Proposed Rule Changes
Number of drug tests conducted per site per year under
Additional
6-AM positive 10 CFR Part 26, “Fitness for Duty Programs”
results
Projected confirmed positive test rate

2,353

Positives
Per Site

Sites
Total
Affected Positives

0.40

67

27

0.33

67

22

0.31

67

21

0.10

67

7

0.12

67

8

0.15

67

10

Total Additional Positive Test Results Projected from Proposed Rule Changes
Averted Training Costs—Pre-Access Testing
Change in number of positive results per site based on proposed rule
changes (division of "Total Additional Positive Test Results Projected
1.42/site
$923
67
from Proposed Rule Changes" by the number of sites)

95

0.017%

Number of drug tests conducted per site per year under 10 CFR Part 26

Additional
FFD current confirmed positive test rate
Amphetamine
Projected percent increase in positive test rate
Positive
Results
Projected percentage of additional positive results that will confirm
positive after Medical Review Officer (MRO) interview with donor
Additional
Number of drug tests conducted per site per year under 10 CFR Part 26
Cocaine
FFD current confirmed positive test rate
Positive
Projected percent increase in positive test rate
Results
Additional
Number of drug tests conducted per site per year under 10 CFR Part 26
Ecstasy
Positive
Projected confirmed positive test rate
Results
Additional
Number of drug tests conducted per site per year under 10 CFR Part 26
Dilute
Average annual percentage of specimens tested that are dilute and test
Specimen
positive on special analyses testing
Positives
Number of drug tests conducted per site per year under 10 CFR Part 26
Additional
Average annual percentage of specimens that are determined to be a
Suspect
subversion attempt and that test positive (suspect specimens that test
Specimen
positive on special analyses testing)
Positives
Projected percent increase in confirmed positive test rate

Averted
training costs
for new
licensee
employees
and C/Vs
with positive
pre-access
drug test
results

Percentage of total positive test results occurring at pre-access testing

2,353
0.047%
39.38%
75.0%
2,353
0.072%
18.38%
2,353
0.004%
2,353
0.005%
2,353
0.033%
20%

67.8%

Weighted average of total in-processing training time for a new licensee
employee or C/V

43 hours

Average number of training hours until receipt of MRO-verified positive
drug test result after collection

28 hours

Training time (in hours) averted for an individual with a positive drug
test during in-processing. (Difference between "Weighted average of
total in-processing training time for a new licensee employee or C/V"
and the "Average number of training hours until receipt of MRO-verified
positive drug test result after collection)

15 hours

Facility Worker hourly wage rate

$63.86
Total Industry Operations Benefit
Average Operations Benefit Per Site

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$87,821

$87,821
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Calculations (totals may not add because of rounding):
•
Benefits (Cost) Per Site = Product (Data Inputs)
•

Total Benefits (Cost) = Benefits (Cost) Per Site x Sites Affected

•

Total Industry Operations Cost = Sum (Total Benefits (Cost))

•

Average Operations Cost Per Site = Total Industry Operations Cost / Total Number of Sites

Assumptions (all values based on the judgement of the NRC staff):
•
In-processing personnel work 8 hours per day to complete training activities.
•

FFD drug and alcohol testing is performed on the first day of in-processing.

•

A positive drug test result is confirmed by the MRO within 3.5 days of specimen collection, on average. This means that, on
average, in-processing personnel would have completed 28 hours of training by the time the positive result was reported to the
licensee or other entity.

•

The weighted average of training time (in hours) per person during in-processing is based on the following assumptions:
(1)

All personnel require 5 days (40 hours) to complete in-process training (i.e., arrival, electronic personal history
questionnaire review and follow up if needed, general employee training (access authorization, FFD drug and alcohol
testing, emergency evacuation, site awareness, and site access badging), and site access (consent, fingerprints, personally
disqualifying information review) = 40 hours total training days

(2)

25 percent of in-processing personnel require 4 additional hours of confined space, Occupational Safety and Health
Administration (OSHA), and radiological training = 44 hours in total training time (total of 1 + 2)

(3)

25 percent of in-processing personnel require 8 additional hours of training (4 hours for confined space, OSHA, and
radiological training and 4 hours for dynamic demonstration training (e.g., in-shop demonstration training) = 48 hours in total
training time (total 1 + 2 + 3)
Weighted average of total training days per person during in-processing = (50% x 40 hours) + (25% x 44 hours) +
(25% x 48 hours) = 43 hours

•

Appendices B and D give additional information on parameters used in these calculations.

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Appendix F: Backfitting and Issue Finality
This appendix presents the evaluation by the staff of the U.S. Nuclear Regulatory Commission
(NRC) of the proposed changes to Title 10 of the Code of Federal Regulations
(10 CFR) Part 26, “Fitness for Duty Programs” (Ref. 1), in accordance with backfitting provisions
in 10 CFR 50.109, “Backfitting” (Ref. 8), and 10 CFR 70.76, “Backfitting” (Ref. 9), and the issue
finality provision in 10 CFR 52.98, “Finality of Combined Licenses; Information Requests”
(Ref. 10) (hereinafter the “Backfit Rule”). The backfitting provision of 10 CFR 70.76 is
applicable to currently licensed Category I fuel fabrication facilities. The staff has considered
these facilities in the aggregated backfit analysis.
Because some individuals seeking employment in or already working in the commercial nuclear
workforce may use illegal drugs or misuse legal drugs, or both, this proposed rule focuses on
enhancing the identification of those individuals using illegal drugs whose potential impairment
could result in unsafe or unsecure conditions at NRC-licensed facilities. Granting or maintaining
access authorization under 10 CFR Part 73 is contingent on an individual meeting the FFD
authorization requirements in 10 CFR Part 26, which in part, require the individual to have
negative test results for drugs and alcohol. An individual that uses an illegal drug or misuses a
legal drug represents a safety vulnerability because drug-induced impairment may cause or
contribute to human performance errors that may result in unplanned occupational exposure;
personal safety issues; unplanned radiological releases; or improper operation, maintenance, or
surveillance of safety- or security-related structures, systems, and components. Additionally,
granting or maintaining unescorted access authorization to these individuals also 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 exhibiting one or more of these characteristics cannot be granted
unescorted access authorization (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, “Physical Protection of Plants and Materials” (Ref. 16).
The proposed rule is projected to 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 (as compared to the 10 CFR Part 26 test results
in calendar year (CY) 2013 and CY 2014). As demonstrated in Section F.2 of this appendix, in
light of the benefits of the proposed rule, the NRC staff finds that the backfits under
10 CFR 50.109 or 10 CFR 70.76 and violations of issue finality under 10 CFR 52.98 (hereinafter
“backfits”) contained in the proposed rule, when considered in the aggregate, would constitute a
substantial increase in public health and safety or the common defense and security based on:
(1) reducing the risk that the public would be affected by an accidental offsite release of
radioactive material as a result of human performance issues associated with drug-induced
impairment, and (2) reducing security vulnerability by identifying additional individuals
demonstrating characteristics of not being trustworthy and reliable through the use of illegal
drugs, misuse of legal drugs, or attempts to subvert the drug testing process. Further, the direct
and indirect costs of implementing the proposed rule would be justified in view of this increased
protection, thereby satisfying the criteria of 10 CFR 50.109(a)(3), 70.76(a)(3), and 52.98(a) to
allow the imposition of the backfits.
The backfits would enhance the effectiveness of the NRC fitness-for-duty (FFD) testing program
to maintain reasonable assurance of a workplace free of drugs and the effects of such
substances. The staff finds that the backfits can be accomplished at a low cost—an average

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one-time cost per site33 of ($5,031) and an average annual cost per site34 of ($2,516). The
estimated net present value cost of the proposed rule over the 25-year time period of the
analysis is approximately ($2.4 million) to industry,35 assuming a 7-percent discount rate, or
approximately ($3.4 million) assuming a 3-percent discount rate.
With regard to benefits, the proposed rule is expected to enhance FFD program effectiveness
by increasing the detection of individuals using illegal drugs, misusing legal drugs, or attempting
to subvert the drug testing process, who would be identified and denied unescorted access
authorization. The proposed rule would benefit public health and safety and the common
defense and security by increasing the panel of drugs tested; increasing the timeframe (i.e., the
window of detection) in which some drugs can be detected in an individual’s body after use;
reducing the likelihood that individuals would be able to subvert the drug testing process;
improving regulatory clarity, organization, and flexibility; and enhancing program integrity and
protection of individual rights.
The backfit analysis examines the aggregation of the subset of regulatory requirements that
constitute backfits. The analysis excludes individual requirements that are not subject to the
Backfit Rule or that do not fall within the definition of “backfitting” as defined in the Backfit Rule,
which include requirements that fall into one or more of the following categories:
(1) Administrative matters are revisions that make minor administrative changes (such as
correction of typographic errors, correction of inconsistencies, relocating requirements
from one section to another, and combining existing requirements into a single section)
33

The term “site” used in this analysis corresponds to the term “facility” used by the NRC FFD performance
reports (Ref. 6). “Site” refers to a unique location at which personnel subject to an FFD program must
undergo drug and alcohol testing (e.g., a nuclear power reactor containing one or more units, a licensee
corporate office). A single FFD program may cover FFD activities at one or more sites (e.g., a corporate
office may develop one drug and alcohol testing policy for all sites).

34

The NRC staff assumes that the licensee or other entity of each site would incur an average cost per
requirement. This assumption is a simplification; some licensees and other entities would incur a higher or
lower operations cost depending on the size of the population drug tested at the site (e.g., an operating
power reactor site conducts more drug tests than a corporate office). The licensees and other entities
subject to 10 CFR Part 26 includes 57 operating power reactor sites, 2 power reactor construction sites,
5 corporate offices, 2 Category I fuel cycle facilities, and 1 contractor/vendor (C/V) (see Appendix A).
Corporate offices, Category I fuel cycle facilities, and C/Vs use much smaller workforces than operating
power reactor sites and power reactor construction sites (see Table 4-1 and Appendix A). They also do not
incur periodic workforce surges as a result of changing site conditions, unlike power reactor sites
(e.g., refueling outages, various states of site construction). An analysis of CY 2013 and CY 2014 FFD
program performance data indicated that between 23 and 25 percent of drug positive test results for
operating power reactor sites and between 33 and 40 percent of drug positive test results for power reactor
construction sites were associated with substances in the current testing panel that will be affected by the
proposed rule (i.e., amphetamine, cocaine, methamphetamine, 6-acetylmorphine (6-AM)). The proposed
rule changes would have limited impact on additional detection at other facility types given the very low
number of positive results (see Table 4-1). As a result, the NRC staff anticipates improvement in detection
at operating power reactor and power reactor construction sites. By using an average cost per site, the
analysis overestimates the operations costs for smaller workforce sites and underestimates the costs for
larger workforce sites, but on balance it provides a reasonable estimate for the incremental testing costs
associated with the proposed rule given that the majority of the sites and tested workforces (59 of 67) are at
power reactors.

35

This estimate includes one-time industry implementation costs incurred in CY 2017 and annual industry
operations costs incurred over an average of 25 years, which represents the average remaining license term
for the current power reactor operating fleet (see Section 4.2.3 for details).

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or changes in NRC administrative requirements (such as acceptable document formats,
number of copies to be submitted, or an NRC administrative process).
(2)

Information collection and reporting requirements are revisions that either amend
existing information collection and reporting requirements or impose new information
and collection and reporting requirements, as set forth in the charter for the Committee
to Review Generic Requirements (Ref. 33).

(3)

Clarifications are revisions that clarify current requirements to assure consistent
understanding and implementation of the original intent for these requirements. These
revisions remove the ambiguities that produced regulatory uncertainty without changing
the underlying requirements stated in these sections.

(4)

Permissive relaxations/voluntary alternatives are revisions that permit, but do not
require, relaxations or alternatives to current requirements (i.e., licensees or other
entities are free to either comply with current requirements or adopt the relaxed
requirements/voluntary alternatives as a binding requirement).

F.1

Rule Provisions that Constitute Backfits

The seven requirements in the proposed rule that are discussed in this section qualify as
backfits because they result in modifications to procedures required to operate the facility.
Section 5.1 of the regulatory analysis quantitatively estimates the costs and benefits of each of
these provisions, except for proposed requirements associated with the Medical Review Officer
(MRO) review of invalid validity test results due to high pH values (9.0 to 9.5), MRO
documentation of receipt of an oral request from a donor to conduct retesting of a specimen, the
requirement to conduct testing of any specimen collected during a post-event testing situation
associated with a refusal to test determination at the time of the collection, and changes to
improve the clarity, consistency, and flexibility of the 10 CFR Part 26 rule (e.g., addition and
revision of definitions and terms). As discussed in Section 4.2.3 of the regulatory analysis, the
MRO provisions would result in some incremental effort (e.g., time to perform a new review for
specimens with an invalid validity test result due to high pH values), but the cost would be
incurred only infrequently (i.e., for a subset of specimens with invalid validity test results) so the
total cost of the change would be minor. Nonetheless, these new requirements qualify as
backfits and are included in the backfit analysis.
1.

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

The proposed rule would update the cutoff levels for initial testing, listed in 10 CFR 26.133,
“Cutoff Levels for Drugs and Drug Metabolites,” and 10 CFR 26.163(a)(1), and confirmatory
testing, listed in 10 CFR 26.163(b)(1), to conform with changes to the November 25, 2008,
revisions to the U.S. Department of Health and Human Services’ (HHS) “Mandatory Guidelines
for Federal Workplace Drug Testing Programs” (Volume 72 of the Federal Register, page 1858
(73 FR 71858); Ref. 2) (hereafter referred to as the “2008 HHS Guidelines”). Section 3.4 of the
2008 HHS Guidelines describes these changes as follows:
•

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

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•

Lower the initial drug testing cutoff level for cocaine metabolites from 300 ng/mL to
150 ng/mL.

•

Lower the confirmatory drug testing cutoff level for cocaine metabolites from 150 ng/mL
to 100 ng/mL.

•

Lower the confirmatory drug testing cutoff levels for amphetamine and
methamphetamine from 500 ng/mL to 250 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 proposed rule would not require more specimen collections, but it would require each urine
specimen to be tested for 6-AM. The drug testing panel would be revised to include initial
testing for 6-AM at a cutoff level of 10 ng/mL. The proposed rule also would remove the
requirement that confirmatory testing of 6-AM only proceed when confirmatory testing shows a
morphine concentration exceeding 2,000 ng/mL (i.e., under the proposed rule, if initial testing for
6-AM is positive, confirmatory testing for 6-AM is to proceed independent of the morphine
concentration). The proposed rule would make conforming changes to the annual statistical
summary reporting requirements for HHS-certified laboratories to include the revised drug
testing panel in 10 CFR 26.169(h)(3).
3.

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

The proposed rule would not require more specimen collections, but it would require each urine
specimen to be tested for Ecstasy.36 The list of substances to be tested for would be revised to
include initial testing for MDMA and MDA at a cutoff level of 500 ng/mL. The proposed rule also
would include confirmatory testing for MDMA and MDA at a confirmatory test cutoff level of
250 ng/mL. The proposed rule would make conforming changes to the annual statistical
summary reporting requirements for HHS-certified laboratories to include the revised drug
testing panel in 10 CFR 26.169(h)(3).
4.

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

The proposed rule would require mandatory special analyses testing of specimens 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 change would increase the
number of specimens that are subject to confirmatory testing and may thereby improve the
ability of licensees to identify instances in which individuals may be attempting to subvert the
testing process.
5.

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 proposed rule would require the use of the LOQ instead of the LOD as the level at which
special analyses testing and adulterant testing would be performed. The difference between the
LOD and the LOQ for a testing assay is the ability to reliably quantify the analyte (e.g., drug,
36

Ecstasy-type drugs that would be included in the drug testing panel are methylenedioxymethamphetamine
(MDMA) and one of its derivatives methylenedioxyamphetamine (MDA).

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Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

adulterant). At the LOD, the test must meet all HHS-certified laboratory criteria for result
acceptance except quantitation. At the LOQ, the 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 special analyses and adulterant test results.
6.

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 of an aliquot of a single specimen.

The proposed rule would require additional actions by the MRO in two circumstances. First, 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 Bottle B specimen or a retest of an aliquot of a single
specimen, the MRO must document the date and time that the request was received from the
donor (this action is consistent with existing MRO practice, but this documentation requirement
was not specified in the current rule).
7.

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

The proposed rule would require the testing of any specimen collected during a post-event
testing situation when a refusal to test has been determined during the collection process.
Previously, any specimen collected would be discarded. In an effort to improve the root-cause
evaluation process associated with accidents, testing of any urine specimen collected would be
required to ensure that all available information is obtained to support the evaluation of human
performance associated with the accident.

F.2

Aggregated Backfit Analysis

The NRC staff evaluated the aggregated set of requirements that constitutes backfits to
determine whether the costs of implementing the proposed rule would be justified by a
substantial increase in public health and safety or the common defense and security. The NRC
staff considered the following nine factors:
1.

Statement of the specific objectives that the backfit is designed to achieve.

The NRC would amend certain provisions in 10 CFR Part 26 to align with the 2008 HHS
Guidelines and to reflect lessons learned from implementation of the 2008 FFD final rule
(Ref. 3) to (1) improve the effectiveness and efficiency of licensee FFD drug testing programs,
(2) improve the clarity, organization, and flexibility in the rule requirements, and (3) enhance
FFD program integrity and protection of individual rights.37

37

The majority of the requirements constituting backfits achieve at least two, and in some cases all three, of
the rule objectives, as presented in Table 5-12. As a result, disaggregation of the costs and benefits
according to the rulemaking objectives does not have meaningful implications on the cost-benefit results.

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2.

General description of the activity that would be required by the licensee or applicant in
order to complete the backfit.

The backfits would require licensees to update policies and procedures, conduct training, and
revise contracts with laboratories and blind performance test sample suppliers to reflect the new
drug testing criteria.
In addition, with regard to special analyses testing, licensees would need to conduct mandatory
limit of quantitation (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 collected
during suspected subversion attempts.
Finally, with regard to MRO reviews, licensees would need to require an updated MRO review
process for invalid validity specimen test results. Specifically, if an acceptable medical
explanation is not provided by the donor 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 requests testing of Bottle B or a retest of a single specimen and the
specimen to be tested is unavailable because of circumstances outside of the donor’s control,
licensees would need to require MROs to report a cancelled test to the licensee for the donor’s
specimen and order a second collection without prior notice to the donor.
3.

Potential change in the risk to the public from the accidental offsite release of radioactive
material.

The rulemaking would not directly affect the likelihood of core damage or spent fuel damage.
The rulemaking could reduce the risk that the public would be affected by an accidental offsite
release of radioactive material as a result of human performance issues associated with
drug-induced impairment.
4.

Potential impact on radiological exposure of facility employees.

The rulemaking would not directly affect the likelihood of core damage or spent fuel damage.
The rulemaking could reduce the risk that NRC-licensed facility employees 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 backfit, including the cost of facility
downtime or the cost of construction delay.

The estimated one-time industry cost associated with the backfits would be approximately
($337,100), and the annually recurring cost would be approximately ($168,600). Combining
these initial and annual costs, this analysis estimates that the backfits associated with the
proposed rule would cost industry approximately ($2.4 million) (present value, assuming a
7-percent discount rate) to ($3.4 million) (present value, assuming a 3-percent discount rate).
6.

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

The proposed rule would make minor changes to drug testing operations that would enhance
safety and security by identifying additional individuals using drugs and then denying their

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unescorted access authorization. This would reduce the risk of accidents and security incidents
as a result of human performance issues associated with drug-induced impairment.
7.

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

The NRC will prepare a regulatory guide and develop proposed and final rule changes. The
NRC’s implementation costs will be approximately ($273,000). The staff expects changes to the
agency’s 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 backfit.

The FFD requirements in 10 CFR Part 26 do not relate to, and are independent of, the facility
type, design, or age. Therefore, the benefits and costs attributable to the proposed rule do not
vary based upon the facility type, design, or age.
9.

Whether the backfit is interim or final and, if interim, the justification for imposing the
backfit on an interim basis.

The backfit is final.
Collectively, the individual requirements in the proposed rule that qualify as backfits would result
in an estimated present value cost of approximately ($2.4 million) to industry, assuming a
7-percent discount rate, or approximately ($3.4 million) assuming a 3-percent discount rate.
The NRC staff estimates that the backfits would result in a one-time cost of ($5,031) per site,
followed by an annual cost of ($2,516) per site.
The proposed rule is estimated to result in 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, thereby enhancing safety and security at affected facilities.
The proposed rule also would benefit public health and safety and the common 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 amphetamines, cocaine metabolites, 6-AM, and
methamphetamines would increase the timeframe (i.e., the window of detection) in
which these drugs can be detected in an individual’s body after use. This would reduce
the likelihood that individuals could subvert the testing process through temporary
abstinence from a drug. Expanding the initial drug testing panel to include 6-AM, MDMA
and MDA and the confirmatory drug testing panel to include MDMA and MDA also would
improve the ability of licensees and other entities to identifying additional persons using
illegal drugs. These changes would improve the trustworthiness and reliability of the
workforce through the identification of additional individuals using drugs who would be
denied unescorted access authorization. In addition, the improved detection of drugs is
a proactive risk-informed FFD strategy—since testing began in 1990, approximately
68 percent of individuals who test positive for drugs each year are identified before they
receive unescorted access authorization (i.e., at pre-access testing).

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•

Requiring and expanding special analyses testing. Requiring special analyses testing
on dilute specimens; and expanding special analyses testing to include specimens
collected during suspected subversion attempts, would reduce the likelihood that
individuals would be able to subvert the testing process. Additionally, using the LOQ
instead of the limit of detection as the level at which confirmatory drug testing is to be
conducted would increase the assurance provided by special analyses testing by adding
a level of precision to the testing method. These changes would further 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 physiological
characteristics, as well as enhance donor protections when special analyses testing is
conducted. These changes would improve the trustworthiness and reliability of the
workforce through the identification of individuals using illicit drugs who would be denied
unescorted access authorization.

•

Enhancing FFD program integrity and protection of individual rights. By adding MRO
review procedures for invalid validity test results due to high pH values and clarifying the
requirements for MRO actions when a donor requests the testing of a Bottle B specimen
or a retest of a single specimen, the proposed rule would enhance consistency with the
2008 HHS Guidelines, FFD program integrity, and the protection of individual rights.

•

Improving regulatory efficiency between 10 CFR Part 26 and other related Federal rules
and guidelines. The proposed rule would improve regulatory efficiency by
(1) harmonizing select 10 CFR Part 26 definitions and drug testing procedures with
those described in the 2008 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 FFD final rule,
and (3) addressing dual regulation of HHS-certified laboratories (private entities) and the
associated regulatory burden on licensees by removing select 10 CFR Part 26
requirements already included in the 2008 HHS Guidelines and verified through National
Laboratory Certification 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 current rule, if
a refusal to test is determined during the specimen collection process, any specimen(s)
obtained from the donor are discarded. The proposed rule would require the retention
and testing of any specimens collected during post-event tests for which a refusal to test
determination was made at the collection site. This change would improve the ability of
the licensee or other entity to determine if substance use could have been a contributing
factor to an accident.

In light of the direct benefit of improving the detection of drug users, as well as the efficiencies,
flexibilities, and donor protections included in the proposed rule, the NRC staff finds that the
backfits contained in the proposed rule, when considered in the aggregate, would constitute a
substantial increase in public health and safety or the common defense and security.
Tables F-1 and F-2 present information that supports the NRC staff’s determination that the
proposed rule alternative (Alternative 2) would result in a substantial increase in public health
and safety or the common defense and security.

F-8

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Table F-1 summarizes the quantified benefits and costs of each regulatory initiative under the
proposed rule alternative. It also summarizes, by regulatory initiative, the projected benefit in
the detection of additional individuals using drugs. In interpreting these results, it is important to
understand that the net present value results in Table F-1 are presented for the 25-year time
period of the analysis, while the estimated benefit, by regulatory initiative, in the detection of
additional drug users is presented on an annual basis. The broad-based improvements in
detection across the regulatory initiatives, as well as the magnitude of the total increase in
comparison to drug testing positive results in CY 2013 and CY 2014, support the NRC staff’s
determination of a substantial increase in public health and safety or the common defense and
security to be derived from the backfits and that the direct and indirect costs of implementation
are justified in view of this increased protection.

F-9

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Table F-1. Cost-Benefit Comparison of Alternative 2 (Proposed Rule)

Regulatory Initiative
Enhance detection of existing
paneled drugs by lowering
cutoff levels (amphetamine,
cocaine, methamphetamine)

7% Net Present Value
(25-year time period of the analysis)
5%
Mean
95%

($247,653)

Expand testing panel to
include initial testing of 6-AM
(and revise confirmatory
testing cutoff level)

($2,105,447)

Expand testing panel to
include testing of Ecstasy
drugs

($1,550,350)

Enhance detection of
subversion attempts by
requiring special analyses
testing of dilute specimens and
specimens collected under
direct observation
To incorporate all drug testing
program changes, sites would
incur one-time costs to change
policies, procedures, and
conduct training

($175,444)

($353,436)

($176,723)

Estimated Benefit
(Annual Basis)

43 additional positive
results (22 amphetamines
($110,715)
positives and 21 cocaine
positives)

($1,685,517) ($1,269,515)

27 additional positive
results

($931,248)

($316,821) 7 additional positive results

($123,307)

18 additional positive
results (8 positives from
($71,013) dilute specimens and
10 positives from suspect
specimens)

($338,330)

Required activities to
implement drug testing
changes at laboratories and
($324,339)
inform all subject
employees of testing
program changes
Historically, 68% of positive
test results each year are
identified at pre-access
testing.

Averted training costs
(pre-access testing)

$647,688

Total Industry Results

($3,088,766)

Average Cost per Site

($46,100)

$1,034,618

$1,492,936

Individuals testing positive
before completion of
training would result in
savings to licensees and
other entities.

95 additional positive
($2,220,507) ($1,358,859) results, and additional
non-quantified benefits
($33,142)

F-10

($20,281)

August 2019

Amend 10 CFR Part 26, “Fitness for Duty Programs,” based on provisions in the 2008 HHS Guidelines

Table F-2 summarizes the trends addressed by the proposed rule alternative. FFD program
performance data for CY 2014, a comparison of this information to previous years, and other
indicators show year-over-year increases in amphetamines positive results, a significant number
of subversion attempts that have been identified since CY 2011, and other adverse trends. This
information supports the NRC staff’s determination that the proposed rule would result in a
substantial increase in public health and safety or the common defense and security.
Table F-2. Summary of FFD Program Performance Trends and Rulemaking Options
Addressing Each Trend

Trend Addressed by Proposed Rule

Lower
Testing
Cutoff
levels

Amphetamine/Methamphetamine Positives (2010–2014)
• Year-over-year increases in positive rates
(0.032% in CY 2010; 0.067% in CY 2014)
• 6.2 to 10.6% of drug test positives each year
(use of these substances is growing in the tested population)
• High prevalence in multi-substance positives (see below)

X

Subversion Attempts (2011–2014)
• 143 to 187 individuals per year attempted to subvert the
testing process (approximately 17 to 21% of drug testing
positives each year)
• 36 to 47 sites with at least one subversion each year (site
prevalence)
• 72 to 76% of subversion attempts at pre-access testing
• 17 to 18% of subversion attempts at random testing
• Based on prevalence of subversion attempts at pre-access
testing, it is likely that some individuals are successfully
subverting the pre-access testing process (i.e., other testing
methods are relied on to identify these individuals—random,
for-cause, post-event testing)

X

Cocaine Positives
• Third most detected substance in testing panel since
CY 2008; second most detected substance in panel from
CY 1990 (first year of NRC testing) through CY 2007
• Use in critical group (i.e., two to six licensed reactor operators
and supervisors tested positive for cocaine each year from
2012 to 2014)

X

Multi-substance Positive Results (2011–2014)
• 83 to 93% of individuals with a multi-substance result tested
positive for amphetamine, methamphetamine, or cocaine, or a
combination
• 14 to 23 sites with at least one multi-substance positive each
year (site prevalence)
• 34 to 48 individuals test positive for more than one substance
each year
• Approximately 28 to 53% of individuals with a multi-substance
positive were identified by random, for-cause, post-event, or
followup testing (i.e., after unescorted access was granted)

X

F-11

Add
Drug(s) to
Testing
Panel

Revised
Testing
Method

X

X

X

August 2019