ML24185A212
| ML24185A212 | |
| Person / Time | |
|---|---|
| Issue date: | 07/11/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/AAFPB |
| To: | |
| References | |
| ML24185A205 | |
| Download: ML24185A212 (1) | |
Text
Presentation to the Nuclear Energy Institutes Access Authorization and Fitness for Duty Workshop Program Updates Fitness for Duty (FFD) Programs - 10 CFR Part 26 July 11, 2024 Brian Zaleski, Specialist - Fitness For Duty / Access Authorization Brian.Zaleski@nrc.gov (301-287-0638)
Discussion Topics FFD Program Performance Trends and Operating Experience Marijuana (Potential Rescheduling)
Oral Fluid Testing - HHS Laboratory Certification Status Rulemaking Updates:
- 2022 Part 26 Final Rule
- Tech Issues Rule Plan
- Decommissioning Draft Final Rule
- Part 53 Draft Proposed Rule Slide 2
FFD Program Performance, Trends, and Operating Experience Slide 3 Note: All 2023 FFD Program Performance results are DRAFT
FFD Program Performance Results, 2019-2023
- Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test Slide 4 2019 2020 2021 2022 2023 Number of Facilities Reporting 70 70 69 65 63 Individuals Tested 131,417 124,678 114,150 112,611 106,985 Individuals Testing Positive*
1,085 1,048 1,112 1,083 1,080 Identified at Pre-access Testing 67.3%
67.4%
66.5%
70.5%
72.5%
Identified at Random Testing 21.8%
22.7%
24.8%
20.3%
18.3%
Pre-Access Testing Positive Rates 1.03%
1.01%
1.17%
1.20%
1.33%
Licensee Employee 0.44%
0.38%
0.64%
0.84%
0.97%
Contractors/Vendors 1.10%
1.08%
1.17%
1.27%
1.40%
Random Testing Positive Rates 0.45%
0.49%
0.61%
0.51%
0.47%
Licensee Employees 0.19%
0.23%
0.28%
0.30%
0.31%
Contractors/Vendors 0.86%
0.92%
1.15%
0.87%
0.81%
Average Worker Population 91,954 89,205 82,512 78,472 75,782 Licensee Employees 56,152 54,190 50,094 48,103 49,434 Contractors/Vendors 35,802 35,015 31,608 30,349 26,348
FFD Program Performance Results by Test and Employment Categories, 2023 Slide 5 Test Category Tested Positive Percent Positive Pre-Access 58,948 783 1.33%
Random 41,697 198 0.47%
For Cause 223 28 12.56%
Post-Event 230 0.00%
Followup 5,887 71 1.21%
Total 106,985 1,080 1.01%
Tested Positive Percent Positive Tested Positive Percent Positive Tested Positive Percent Positive Pre-Access 9,392 91 0.97%
49,556 692 1.40%
58,948 783 1.33%
72.5%
Random 27,960 87 0.31%
13,737 111 0.81%
41,697 198 0.47%
18.3%
For Cause 100 12 12.00%
123 16 13.01%
223 28 12.56%
2.6%
Post-Event 104 0.00%
126 0.00%
230 0.00%
0.0%
Followup 3,170 17 0.54%
2,717 54 1.99%
5,887 71 1.21%
6.6%
Total 40,726 207 0.51%
66,259 873 1.32%
106,985 1,080 1.01%
100.0%
Test Category Licensee Employees Contractor/Vendors (C/Vs)
Total
% of Total Positives
Pre-Access Testing (1990-2023)
Positive Rates by Employment Category Slide 6 0.95%
Licensee Employees 0.97%
1.54%
Contractor/Vendors 1.40%
0.0%
0.2%
0.4%
0.6%
0.8%
1.0%
1.2%
1.4%
1.6%
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Percent Positive Slide 10 in this presentation provides insights on the increasing positive testing rates from 2020 through 2023.
Detection Trends - NRC Testing Panel Percentage of Total Positives by Substance Tested Slide 7 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 where no specimen is tested (at least 60% of subversion attempts each year)
Results by Employment Category, 2023 Slide 8 Licensee Employees (40,726 tested, 207 individuals positive)
Contractor/Vendors (66,259 tested, 873 individuals positive)
Marijuana 53.0%
Alcohol 11.3%
Cocaine 7.0%
Refusal to Test 20.3%
Amphetamines 6.2%
Opioids 2.2%
n = 924 Marijuana 43.0%
Alcohol 25.2%
Cocaine 9.3%
Refusal to Test 9.8%
Amphetamines 11.7%
Opioids 0.9%
n = 214
2022 Part 26 Final Rule - Is it working?
Expanded Opioid Panel Results Slide 9 Reason for Test Collection Date Employment Type Outage Worker?
Reason for Test Explanation Labor Category Substance(s)
Reason for the Action 1
Pre-Access 08/21/23 C/V Yes Reinstatement (31-365 days)
Maintenance (general facility)
Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 2
09/26/23 C/V Yes Reinstatement (31-365 days)
Maintenance (general facility)
Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 3
10/02/23 C/V Yes Reinstatement (31-365 days)
Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 4
10/17/23 C/V Yes Reinstatement (31-365 days)
Maintenance (general facility)
Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 5
10/18/23 C/V Yes Reinstatement (31-365 days)
Facility Support Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 6
10/23/23 C/V No Initial Authorization Maintenance (general facility)
Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive 7
11/27/23 C/V No Update Authorization Engineering Opioid: Oxymorphone 1st Positive 8
Random 08/17/23 C/V No Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 9
10/16/23 C/V No Facility Support Opioid: Oxycodone; Opioid: Oxymorphone 1st Positive 10 11/28/23 C/V No Maintenance (general facility)
Opioid: Oxymorphone 1st Positive 11 12/18/23 C/V Facility Support Opioid: Hydrocodone; Opioid: Hydromorphone 1st Positive
Pre-Access and Random Positive Rates - Marijuana Slide 10 Pre-Access Random 0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
0.9%
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Positive Rate Year Marijuana Positive Rates - Contractor/Vendors Pre-Access Random 0.0%
0.1%
0.2%
0.3%
0.4%
0.5%
0.6%
0.7%
0.8%
0.9%
2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 Positive Rate Year Marijuana Positive Rates - Licensee Employees
Behavioral Observation Program Effectiveness (Alcohol Detection)
What Reason for Testing identifies more alcohol positives?
For cause testing?
Random testing?
Followup testing?
Slide 11
Alcohol Positive Results, 2023 Effectiveness of Lower Cutoff Levels Slide 12 42% of alcohol positives due to time-dependent cutoff levels (BAC < 0.04)
Must abstain from alcohol use at least 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> prior to arrival for work - 10 CFR 26.27(b)(4) 0.04 or greater 92 0.03 and in work status at least 1 hr 37 0.02 and in work status at least 2 hrs 29 n = 158 44 26 11 11 15 17 5
11 12 2
4 0
10 20 30 40 50 60 70 80 Pre-Access Random For Cause Post-Event Followup 0.04 or greater 0.03 and in work status at least 1 hr 0.02 and in work status at least 2 hrs n = 158
Alcohol Positive Results, 2015-2023 Contractor/Vendors with Unescorted Access Slide 13 26 35 24 18 26 24 21 21 20 18 15 18 20 8
12 11 15 16 28 28 34 32 33 11 7
13 6
2 1
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2015 2016 2017 2018 2019 2020 2021 2022 2023 Random Followup For Cause Post-Event
Alcohol Positive Results, 2015-2023 Licensee Employees with Unescorted Access Slide 14 25 32 17 25 26 27 43 41 35 7
10 6
10 4
10 6
8 4
17 6
10 9
8 5
3 8
7 2
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
2015 2016 2017 2018 2019 2020 2021 2022 2023 Random Followup For Cause Post-Event
Random Testing -
Positive* Result by Day of Collection (2014-2023)
Slide 15
- Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test Year Mon Tues Wed Thurs Fri Sat Sun Total 2023 42 38 60 39 16 1
2 198 2022 37 56 52 49 21 4
1 220 2021 37 80 60 62 23 11 2
275 2020 47 57 54 49 30 2
239 2019 44 56 51 53 26 5
2 237 2018 44 59 40 42 21 4
1 211 2017 52 65 67 47 32 1
1 265 2016 38 63 52 67 28 8
4 260 2015 40 67 60 34 30 1
232 2014 50 46 57 44 20 3
1 221 Total 431 587 553 486 247 38 16 2,358
Subversion Attempts
- Who cheats?
- At which Reason for Testing is cheating typically identified?
- Is cheating prevalent?
- How is cheating typically identified?
Slide 16
Subversion Attempt Trends (2018-2023)
Subversion attempt: 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) 2018 2019 2020 2021 2022 2023 Number of Subversion Attempts 298 307 288 272 268 289 Percentage of Drug Testing Violations 31.0%
34.5%
34.3%
29.3%
29.7%
30.9%
Identified at Pre-access Testing 77.5%
73.3%
74.7%
72.4%
79.1%
80.3%
Committed by Contractor/Vendors 95.6%
97.4%
96.2%
94.5%
93.3%
90.7%
Percentage of Sites Reporting At Least One Subversion 70%
61%
70%
70%
74%
78%
- Draft data (2023 reporting cycle closed on February 29, 2024)
Subversion attempt sanction:
Permanent denial unescorted access, 10 CFR 26.75(b)
Slide 17
Subversion Attempts by Labor Category (2018-2023)
Slide 18 Labor Category 2018 2019 2020 2021 2022 2023 Maintenance (general facility) 226 255 245 217 211 205 Facility Support 25 18 17 26 30 41 Maintenance (safety-significant) 14 10 10 2
5 12 Security 4
6 4
9 5
8 Supervisor 7
4 1
3 3
4 FFD Program Personnel 1
Engineering 2
3 4
3 5
HP/RP 2
2 1
6 6
2 Non-Licensed Operator 2
3 Other 16 7
6 6
5 11 QA/QC 2
Total 298 307 288 272 268 289
Subversion Attempts by Labor Category and Reason for Testing, 2023 Slide 19 Labor Category Pre-Access Random For Cause Followup Total Maintenance (general facility) 172 17 3
13 205 Facility Support 34 6
1 41 FFD Program Personnel 1
1 Supervisor 3
1 4
Security 6
2 8
Maintenance (safety-significant) 10 2
12 Engineering 2
3 5
HP/RP 1
1 2
Other 6
5 11 Total 232 39 4
14 289
Substituted Specimen Test Results, 2023 Slide 20
- Operating experience demonstrates 1-3 substituted urine specimen test results received from an HHS-certified laboratory each year.
- Significant increase in 2023, with at least 13 substituted test results Reason for Testing Collection Date Reason for Test Explanation Labor Category Employment Type Outage Worker?
Pre-Access 03/01/23 Initial Authorization Maintenance (general facility)
C/V Yes 03/22/23 Initial Authorization Maintenance (general facility)
C/V Yes 04/03/23 Maintenance (general facility)
C/V Yes 04/16/23 Reinstate (31-365 days)
Facility Support C/V Yes 05/01/23 Initial Authorization Maintenance (general facility)
C/V Yes 08/28/23 Initial Authorization Maintenance (general facility)
C/V No 10/02/23 Maintenance (general facility)
C/V 10/02/23 Maintenance (general facility)
C/V Yes 10/03/23 Initial Authorization Maintenance (general facility)
C/V 10/10/23 Facility Support C/V Yes Random 04/17/23 Facility Support C/V Yes 07/18/23 Facility Support C/V No Followup 12/11/23 FFD PDI Maintenance (general facility)
C/V No
Invalid Test Results, 2023 Slide 21
- Operating experience demonstrates 5-8 invalid test results per year with the required directly observed 2nd specimen drug positive or refused
- Significant increases in 2022 (13) and in 2023 (22 invalids)
Reason for Testing Collection Date Reason for Test Explanation Labor Category Employment Type Outage Worker?
2nd Observed Specimen Result Pre-Access 01/31/23 Maintenance (general facility)
C/V Marijuana 02/07/23 Initial Authorization Facility Support C/V Yes Marijuana 02/09/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Marijuana 02/09/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 02/13/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 03/01/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 04/03/23 Initial Authorization Maintenance (general facility)
C/V Yes Testing Refusal 04/10/23 Initial Authorization Maintenance (general facility)
Employee No Marijuana 04/12/23 Initial Authorization Maintenance (general facility)
C/V Yes Marijuana 04/20/23 Initial Authorization Maintenance (general facility)
C/V No Testing Refusal 05/01/23 Initial Authorization Maintenance (general facility)
C/V Yes Marijuana 05/04/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Marijuana 05/17/23 Initial Authorization Maintenance (general facility)
Employee No Methamphetamine 08/08/23 Reinstate (31-365 days)
FFD Program Personnel C/V Yes Marijuana 08/09/23 Initial Authorization Maintenance (general facility)
C/V No Testing Refusal 08/30/23 Reinstate (31-365 days)
Maintenance (general facility)
C/V Yes Testing Refusal 11/06/23 Initial Authorization Facility Support C/V No Testing Refusal Random 02/15/23 Other (Hanger Tech)
C/V No Testing Refusal 07/31/23 Supervisor C/V No Testing Refusal Followup 03/30/23 FFD PDI Maintenance (general facility)
C/V Yes Marijuana 04/10/23 Maintenance (general facility)
C/V Yes Marijuana 09/18/23 FFD PDI Maintenance (general facility)
C/V Yes Marijuana
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 1) False negative for a blind performance test sample (BPTS) formulated to test positive for marijuana (January 2023).
When notified of the test result inconsistency, the HHS-certified laboratory:
Reviewed the initial testing data and identified that the THC screening absorbance was abnormally depressed.
Determined that a potential sampling issue occurred on the chemistry analyzer for the initial test.
Reviewed all other specimens and analytes on the load (no other abnormally depressed results were identified).
Updated its standard operating procedure to require all certifying scientists to look for abnormally depressed results. Any specimen exhibiting depressed results for any assay ( -1000) would be aliquoted for another initial test.
Slide 22
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 2) Test results for a donors specimen were not received within 5-business days after laboratory receipt of the specimen for testing, as required by 10 CFR 26.169(a) (March 2023)
- The specimen was received for testing on March 22 and confirmatory positive test results were not reported until March 29.
- The laboratory determined that the delay was due to unacceptable quality controls resulting in batch failures.
- The specimen was tested on multiple confirmation batches before final results were obtained (multiple batch failures do not routinely occur).
- The laboratory observe an increase in the failure rate for the assay during that last two weeks in March.
- A fresh bottle of reagent was placed in service on March 29 and no additional failures were observed for the assay.
Slide 23
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 3) A BPTS formulated to return a substituted validity test result was reported as negative, dilute (June 2023)
- The BPTS was prepared to measure 1.0000 for specific gravity and the absence of creatinine.
- The laboratory reported a specific gravity of 1.0023 and a creatinine concentration of 7.9 mg/dL.
- The laboratory retested the specimen and reported a substituted test result (creatinine concentration <1.0 mg/dL, specific gravity of 1.0000).
- The laboratory investigation concluded that human error during specimen aliquoting most likely caused the test result error (i.e., the specimen immediately preceding the BPTS may have splashed into the BPTS).
- The laboratory retested all other specimens in the original batch, using the original screening batch location. All retests confirmed the original test results.
- Retrained all laboratory personnel who aliquot specimens for screening batches.
Slide 24
HHS-Certified Laboratory Performance, 2023 10 CFR 26.719, 30-day event reports
- 4) Two BPTSs formulated to return adulterated validity test results were reported as invalid test results (April and May 2023)
- No notifications were made to the MRO by the laboratory certifying scientist to discuss if additional testing would be useful, as required by 10 CFR 26.169(c)(4).
For a specimen that has an invalid result, the laboratory shall contact the MRO and both will decide whether testing by another certified laboratory would be useful in being able to report a positive or adulterated test. This contact may occur through any secure electronic means (e.g., telephone, fax, e-mail).
- The MRO requested oxidizing adulterant testing, but the laboratory did not perform this type of adulterant testing.
- The laboratory provided documentation that the certifying scientist was retraining to ensure that MRO notification was be performed in the future.
- The licensee identified another HHS-certified laboratory that performs oxidizing adulterant testing if such testing is necessary in the future.
Slide 25
Marijuana (Potential Rescheduling)
Slide 26
Marijuana (Potential Rescheduling)
The U.S. Department of Justice, Drug Enforcement Administration, published a notice of proposed rulemaking in the Federal Register on May 21, 2024 (89 FR 44597)
The notice proposes to transfer marijuana from schedule I of the Controlled Substances Act (CSA) to schedule III of the CSA.
This proposal is consistent with the view of HHS that marijuana has a currently accepted medical use as well as HHSs views about marijuanas abuse potential and level of physical or psychological dependence.
If the transfer to schedule III is finalized, the regulatory controls applicable to schedule III controlled substances would apply, as appropriate, along with existing marijuana-specific requirements and any additional controls that might be implemented, including those that might be implemented to meet U.S. treaty obligations.
The public comment period closes July 22, 2024.
Slide 27
Marijuana (Potential Rescheduling)
Potential impacts on federal drug testing programs Federal workplace drug testing programs (HHS Guidelines):
- Executive Order 12564, Drug-Free Federal Workplace only permits the testing of Schedule I and II drugs.
- National Laboratory Certification Program (NLCP) inspections only verify the testing of drugs specified in the HHS Guidelines.
U.S. Department of Transportation is required by federal law (i.e., The Omnibus Transportation Employee Testing Act of 1991) to implement the testing panel specified in the HHS Guidelines and to test specimens at HHS-certified laboratories.
The NRC drug testing panel in 10 CFR 26.31(d)(1) specifies the minimum substances that must be tested in each specimen collected under 10 CFR Part 26.
The NRC is not required to change its testing panel based on revisions to the HHS Guidelines.
Slide 28
Oral Fluid Testing -
HHS Laboratory Certification Status Slide 29
Oral Fluid Testing -
HHS laboratory certification status The 2022 Part 26 final rule in 10 CFR 26.83(b) enabled the option to collect and drug test oral fluid specimens under four observed specimen collection conditions (i.e., 10 CFR 26.115(a)(1) through (a) (3) and (a)(5)).
An HHS-certified laboratory must be used to conducted oral fluid testing (10 CFR 26.153(a) and 10 CFR 26.31(d)(3)(i)).
No laboratory has yet to apply for certification by HHS to test oral fluid specimens under Mandatory Guidelines for Federal Workplace Drug Testing Program.
Considerations:
Waiting on FDA 510(k) approval of immunoassays (initial drug tests)
(only 3 FDA 510(k) cleared oral fluid immunoassays)
FDA clears immunoassay test systems with a specified collection device
[take a look at Dr. Barry Samples Status of Availability of FDA 510(k) Cleared Assays presentation made at the June 2024, HHS Drug Testing Advisory Board meeting]
Slide 30
Part 26 Rulemaking Updates Slide 31
2022 Part 26 Final Rule (RIN 3150-AI67; Docket NRC-2009-0225)
Slide 32 Aligned Part 26 drug testing requirements more closely with the U.S. Department of Health and Human Services 2008 and 2017 Mandatory Guidelines for Federal Workplace Drug Testing of urine specimens. Also incorporated lessons learned from implementing Part 26.
Published: November 22, 2022 (87 FR 71422)
Compliance Required by: November 22, 2023 Substantive changes:
Added testing for MDMA, MDA, hydrocodone, hydromorphone, oxycodone, oxymorphone
Lowered drug testing cutoff levels for amphetamine, methamphetamine, cocaine
Improved testing method to identify heroin metabolite (6-acetylmorphine)
Strengthened methods to detect donor subversion attempts (special analyses testing)
Included option to collect and drug test oral fluid for most observed collection conditions
Tech Issues Rulemaking Plan Development Drugs and Alcohol: Technical Issues and Editorial Changes (RIN 3150-AJ15, Docket: NRC-2012-0079)
Slide 33 Effectiveness and efficiency improvements in three topic areas:
1)
Incorporating 15 years of lessons learned from implementing Part 26 2)
Aligning with updates to HHS and DOT testing program requirements 3)
Resolving three petitions for rulemaking accepted by the NRC Why now? A key driver for rulemaking is the continuing prevalence of subversion attempts of the urine drug testing process (~30 percent of drug testing violations annually).
Public meeting to discuss plan - held on February 7, 2024 (NRC slides: ML24036A330; Meeting transcript: ML24116A143)
Rulemaking Plan Regulatory Basis Proposed Rule Final Rule (were here)
Other Rulemakings Decommissioning Rulemaking (i.e., Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning)
Final rule package to Commission (Jan. 31, 2024)
Final rule package publicly available (ML23258A200)
Part 53 Risk-Informed, Technology-Inclusive Regulatory Framework for Advanced Reactors The Commission approved the draft proposed rule, in part, on March 4, 2024, in the Staff Requirements Memorandum SRM-SECY-23-0021 (ML24064A039)
The staff is currently revising the draft proposed rule to address Commission direction in the SRM Slide 34
Slide 35 Questions?