ML19343B438
| ML19343B438 | |
| Person / Time | |
|---|---|
| Issue date: | 12/03/2019 |
| From: | Harris P NRC/NSIR/DPCP/RSB |
| To: | |
| Harris P W301.287.9294 | |
| References | |
| Download: ML19343B438 (22) | |
Text
Presentation to the Drug Testing Advisory Board (HHS/SAMHSA)
NRC Update: Operating Experience in 2018 and Policy Considerations 10 CFR Part 26, Fitness-for-Duty Programs A Direct Contribution to Safety and Security December 3, 2019
Disclaimer The information in this presentation is provided as a public service and solely for informational purposes and is not, nor should be deemed as, an official NRC position, opinion or guidance, or "a written interpretation by the General Counsel" under 10 CFR 26.7, on any matter to which the information may relate. The opinions, representations, positions, interpretations, guidance or recommendations which may be expressed by the NRC technical staff during this presentation or responding to an inquiry are solely the NRC technical staff's and do not necessarily represent the same for the NRC. Accordingly, the fact that the information was obtained through the NRC technical staff will not have a precedential effect in any legal or regulatory proceeding.
Slide 2
Discussion Topics Slide 3 Fitness-for-Duty (FFD) Program Objective Individuals covered by the FFD Program Assuring Safety and Security through a Defense-in-Depth Strategy Operating Experience - 2018 Items of Interest
FFD Program Objective Provide reasonable assurance that nuclear power plant personnel are trustworthy, reliable, 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 assigned duties or be afforded unescorted access to the protected areas of nuclear power plants, sensitive information, or strategic special nuclear material (SSNM).
Slide 4 An FFD program developed under 10 CFR Part 26 is intended to create an environment which is free of drugs and alcohol, and the effects of such substances.
Individuals Covered by the FFD Program Slide 5 Security Officers Control Room Operators Maintenance & Surveillance (craft & supervisors)
Health Physics, Chemistry, & Emergency Response Construct or Direct the Construction of Reactor Plants All other persons who have unescorted access FFD Program Personnel*
Slide 5
- FFD Program Personnel include the managers, technicians, collectors, Medical Review Officers, and Substance Abuse Experts who implement the program Fit for Duty Reliable Trustworthy
Assuring Safety and Security through a Defense-in-Depth Strategy Slide 6 People Education, experience, training, qualification, etc.
Drug and Alcohol Testing (pre-access, random, for cause, follow-up, and post-event)
Behavioral Observation Fatigue Management Access Requirements (e.g., background checks, fingerprinting, psychological testing)
Physical Protection (e.g., vehicle barriers, blast walls, blast resistant enclosures, etc.)
Detection (e.g., cameras, infra-red, motion, explosive vapors, x-ray, etc.)
Programs for Insider Mitigation, Cyber Protection, and Information Controls
Slide 7 Operating Experience in 2018
Overall Industry Performance, 2018 [Draft]
145,798 Individuals drug & alcohol tested (down ~2% from 2017) 1,185 Individuals positive for drug(s), alcohol, or refused a test 69.8% identified at pre-access testing (64.3% in 2017) 17.7% identified at random testing (22.5% in 2017) 0.81%
Industry overall positive rate (0.78% in 2017) 0.28% LE positive rate (0.24% in 2017) 1.06% C/V positive rate (1.04% in 2017) 0.37%
Industry random positive rate (0.44% in 2017) 0.17% LE positive rate (0.14% in 2017) 0.68% C/V positive rate (0.89% in 2017)
LE = licensee employee; C/V = contractor/vendor All results in this presentation are MRO verified Slide 8
Results by Test and Employment Categories, 2018
[DRAFT]
Slide 9 Tested Positive Percent Positive Tested Positive Percent Positive Tested Positive Percent Positive Pre-Access 8,291 36 0.43%
72,934 791 1.08%
81,225 827 1.02%
69.8%
Random 34,676 59 0.17%
22,221 151 0.68%
56,897 210 0.37%
17.7%
For Cause 132 11 8.33%
302 65 21.52%
434 76 17.51%
6.4%
Post-Event 148 0.00%
348 2
0.57%
496 2
0.40%
0.2%
Follow-up 2,859 21 0.73%
3,887 49 1.26%
6,746 70 1.04%
5.9%
Total 46,106 127 0.28%
99,692 1,058 1.06%
145,798 1,185 0.81%
100.0%
Test Category Licensee Employees Contractor/Vendors (C/Vs)
Total
% of Total Positives Where were the most tests conducted in 2018 (>90% of tests)?
Licensee Employees Contractor/Vendors Pre-access 18.0%
Pre-access 73.2%
Random 75.2%
Random 22.3%
Follow-up 6.2%
Follow-up 3.9%
99.4%
99.3%
Where were most drug and alcohol testing violations identified in 2018 (>90% of positives)?
Licensee Employees Contractor/Vendors Pre Access 28.3%
Pre-access 74.8%
Random 46.5%
Random 14.3%
For Cause 8.7%
For Cause 6.1%
Follow-up 16.5%
95.2%
100.0%
Detection Trends 1990-2018, NRC Testing Panel Percentage of Total Positives by Substance Tested
[Draft]
Since at least 2014, this chart under reports the substances used by individuals with a drug testing violation. This is because of the high number of subversion attempts each year, and because in at least 60% of these subversion attempts, no specimens were tested.
Slide 10
Results by Employment Category, 2018
[DRAFT]
Licensee Employees (46,106 tested; 127 individuals positive)
Contractors/Vendors (99,692 tested; 1,058 individuals positive)
Alcohol 42.1%
Amphetamines 6.0%
Cocaine 9.8%
Marijuana 30.8%
Opiates 1.5%
Other 1.5%
Refusal to Test 8.3%
n = 133 Alcohol 15.3%
Amphetamines 11.1%
Cocaine 10.4%
Marijuana 42.1%
Opiates 1.6%
PCP 0.1%
Refusal to Test 19.4%
n = 1,125 Slide 11
Substances Detected by Labor Category, 2018
[DRAFT]
Slide 12
Measuring Effectiveness of Lower Cutoff Levels for Alcohol, 2018 [DRAFT]
Slide 13 42% of alcohol positives (BAC < 0.04) are the result of time-dependent cutoff levels, which have been required since 2008 32-60% of positive alcohol results per test category were BAC < 0.04
Subversion Attempt Trends [Draft]
Subversion attempt is any willful act or attempted act to cheat on a required test (e.g., refuse to provide a specimen, alter a specimen with an adulterant, provide a specimen that is not from the donors body)
Sanction for a subversion attempt is a permanent denial of unescorted access (10 CFR 26.75)
Slide 14 Subversion Attempt Trends (last 5 years) 2014 - 187 subversions (21.2% of drug testing violations) 2015 - 232 subversions (21.2% of drug testing violations) 2016 - 305 subversions (32.4% of drug testing violations) 2017 - 301 subversions (33.5% of drug testing violations) 2018 - 298 subversions (31.0% of drug testing violations)
Subversion Attempts in 2018:
70.0% facilities with at least 1 subversion attempt (50 of 71) 77.5% identified at Pre-Access testing (231 of 298) 95.6% by contractor/vendors (285 of 298)
Items of Interest Slide 15 Oral fluid testing Expanded panel testing - Prevalence testing Marijuana and Hemp 10 CFR Part 26, Fitness for Duty Programs, staff-proposed rulemaking
Oral Fluid Testing Slide 16 The commercial nuclear industry continues its support of this HHS-led testing technique Two operating reactor licensees have taken formal steps to implement a program, but subsequently deferred to wait for implementation of the HHS oral fluid guidelines o Now that the guidelines have been issued, the licensee for the Vogtle Units 3 & 4 construction site has implemented a limited program on November 1, 2019 Part 26 all the use oral fluid testing in medical situations where the donor cannot provide a sufficient urine specimen
Expanded Panel - Prevalence Testing Regulatory Problem Are we testing for the right drugs and drug metabolites in the commercial nuclear industry?
If the Part 26 panel deviates from the HHS panel, this could be a cost on the commercial nuclear industry Considerations NRC licensees are allowed to expand their drug testing panels, but few are doing so If the NRC-required a change to expand the drug panel: there must be a substantial increase in the overall protection of the public health and safety or the common defense and security and the direct and indirect costs of implementation are justified in view of this increased protection Slide 17
Expanded Panel - Prevalence Testing Possible Solutions Implement a prevalence testing program similar to that done by the U.S. Department of Defense to see what drugs are being used by individuals in the commercial nuclear workforce that are not currently being detected, but may be impairing Conduct a review of the nuclear industrys self-implemented prescription announcement program to inform NRC decisions on what drugs are being used by members of the commercial nuclear workforce Strengthen our evaluation of licensee behavioral observation programs, fitness determinations, and for-cause and post-event testing Slide 18
Marijuana and Hemp Slide 19 The commercial nuclear industry desires additional guidance be issued regarding an individuals use, sale, and possession of hemp products that may contain tetrahydrocannabinol (THC) and/or cannabidiol (CBD) (e.g., topical creams and oils, food products)
Controlled Substances Act Sec. 1308.15, Schedule V, paragraph (f)
Sec. 13008.35, Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinol (THC)
NRC-Staff Proposed Rulemaking Slide 20 Fitness for Duty Testing Requirements, NRC-2009-0225; RIN 3150-AI67 Published in the Federal Register on September 16, 2019 (84 FR 48750)
Can be viewed at Regulations.gov Public comment period closed December 2, 2019 This rulemaking propose six major provisions (next slide)
NRC-Staff Proposed Rulemaking Slide 21 Major provisions 1.
Testing for methylenedioxymethamphetamine (MDMA) and methylenedioxyamphetamine (MDA) 2.
Add initial drug testing for 6-acetylmorphine (6-AM) and update its confirmatory drug testing method 3.
Lower the drug testing cutoff levels for amphetamine, cocaine metabolite, and methamphetamine 4.
Improve the detection of subversion attempts by enhanced evaluation of dilute validity test results & specimens collected under direct observation 5.
Require Medical Review Officers to use elapsed time and/or temperature to evaluate invalid test results due to high pH 6.
Issuance of regulatory guidance
NRC Fitness for Duty Program Staff Slide 22 U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Paul Harris, Senior Program Manager Paul.Harris@nrc.gov (301-287-9294)
Brian Zaleski, Fitness-for-Duty Program Specialist Brian.Zaleski@nrc.gov (301-287-0638)