ML19193A071: Difference between revisions

From kanterella
Jump to navigation Jump to search
(Created page by program invented by StriderTol)
(StriderTol Bot change)
 
(One intermediate revision by the same user not shown)
Line 18: Line 18:


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.
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
Slide2


Operating Experience in 2018 Slide 3
Slide3 Operating Experience in 2018


Overall Industry Performance [Draft]
Overall Industry Performance [Draft]
2018               2017             Change Individuals Tested                                             145,798           148,741             2,943 Individuals Testing Positive*                                     1,186             1,165                 21 Identified at Pre-access Testing                         69.8%             64.3%             5.5%
*Positive=Positivedrugandalcoholtests,adulteratedandsubstitutedvaliditytestresults,andrefusalstotest AllresultsinthispresentationareMROverified Slide4 2018 2017 Change Individuals Tested 145,798 148,741 2,943 Individuals Testing Positive*
Identified at Random Testing                             17.7%             22.5%             4.8%
1,186 1,165
Industry Positive Rate - All Tests                               0.81%             0.78%             0.03%
 
Licensee Employee (LE)                                   0.28%             0.24%             0.04%
21 Identified at Pre-access Testing 69.8%
Contractor/Vendors (CVs)                                 1.06%             1.04%             0.02%
64.3%
Industry Positive Rate - Random Tests                             0.37%             0.44%             0.07%
 
LE Positive Rate                                         0.17%             0.14%             0.03%
5.5%
CV Positive Rate                                         0.68%             0.89%             0.21%
Identified at Random Testing 17.7%
* Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test All results in this presentation are MRO verified Slide 4
22.5%
 
4.8%
Industry Positive Rate - All Tests 0.81%
0.78%
0.03%
Licensee Employee (LE) 0.28%
0.24%
0.04%
Contractor/Vendors (CVs) 1.06%
1.04%
0.02%
Industry Positive Rate - Random Tests 0.37%
0.44%
0.07%
LE Positive Rate 0.17%
0.14%
0.03%
CV Positive Rate 0.68%
0.89%
0.21%


Results by Test and Employment Categories, 2018
Results by Test and Employment Categories, 2018
[DRAFT]
[DRAFT]
Licensee Employees              Contractor/Vendors (C/Vs)                    Total
Slide5 Tested Positive Percent Positive Tested Positive Percent Positive Tested Positive Percent Positive Pre-Access 8,291 36 0.43%
                                                                                                                  % of Total Test Category                          Percent                            Percent                        Percent Tested   Positive                 Tested    Positive               Tested   Positive           Positives Positive                             Positive                       Positive Pre-Access         8,291         36       0.43%     72,934         791       1.08%   81,225       827   1.02%   69.8%
72,934 791 1.08%
Random           34,676         59       0.17%     22,221         151       0.68%   56,897       210   0.37%   17.7%
81,225 827 1.02%
For Cause           132         11       8.33%       302           65     21.52%       434         76   17.51%   6.4%
69.8%
Post-Event           148       -          0.00%       348           2       0.57%       496         2   0.40%   0.2%
Random 34,676 59 0.17%
Follow-up         2,859         21       0.73%     3,887           49       1.26%     6,746         70   1.04%   5.9%
22,221 151 0.68%
Total   46,106       127       0.28%     99,692       1,058       1.06%   145,798     1,185   0.81% 100.0%
56,897 210 0.37%
Where were the most tests conducted in 2018 (>90% of tests)?
17.7%
Licensee Employees                         Contractor/Vendors Pre-access   18.0%                     Pre-access   73.2%
For Cause 132 11 8.33%
Random     75.2%                         Random     22.3%
302 65 21.52%
Follow-up   6.2%                       Follow-up   3.9%
434 76 17.51%
99.4%                                   99.3%
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)?
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%
Licensee Employees Contractor/Vendors Pre Access 28.3%
Random     46.5%                         Random     14.3%
Pre-access 74.8%
For Cause     8.7%                       For Cause     6.1%
Random 46.5%
Follow-up   16.5%                                   95.2%
Random 14.3%
For Cause 8.7%
For Cause 6.1%
Follow-up 16.5%
95.2%
100.0%
100.0%
Slide 5


Detection Trends 1990-2018, NRC Testing Panel Percentage of Total Positives by Substance Tested
Detection Trends 1990-2018, NRC Testing Panel Percentage of Total Positives by Substance Tested
[Draft]
[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.
Sinceatleast2014,thischartunderreportsthesubstancesusedbyindividualswithadrugtesting violation.Thisisbecauseofthehighnumberofsubversionattemptseachyear,andbecauseinat least60%ofthesesubversionattempts,nospecimensweretested.
Slide 6
Slide6


Results       by Employment Category, 2018
Results by Employment Category, 2018
[DRAFT]
[DRAFT]
Licensee Employees                                    Contractors/Vendors (46,113 tested; 127 individuals positive)               (99,685 tested; 1,059 individuals positive)
LicenseeEmployees (46,113tested;127individualspositive)
PCP                        Alcohol Alcohol 0.1%                        15.3%
Contractors/Vendors (99,685tested;1,059individualspositive)
Other                        42.1%                                    Refusal to Test 1.5%                                                                      19.4%
Alcohol 42.1%
Refusal to Test 8.3%                                      Opiates 1.6%
Amphetamines 6.0%
Amphetamines Opiates                                                                                            11.1%
Cocaine 9.8%
1.5%
Amphetamines                                              Cocaine 6.0%                                                  10.4%
Marijuana 30.8%
Marijuana 30.8%
Cocaine                               Marijuana 9.8%                                   42.2%
Opiates 1.5%
n = 133 n = 1,126 Slide 7
Other 1.5%
Refusal to Test 8.3%
n = 133 Slide7 Alcohol 15.3%
Amphetamines 11.1%
Cocaine 10.4%
Marijuana 42.2%
Opiates 1.6%
PCP 0.1%
Refusal to Test 19.4%
n = 1,126


Substances Detected by Labor Category, 2018
Substances Detected by Labor Category, 2018
[DRAFT]
[DRAFT]
Slide 8
Slide8


Measuring Effectiveness of Lower Cutoff Levels for Alcohol, 2018 [DRAFT]
Measuring Effectiveness of Lower Cutoff Levels for Alcohol, 2018 [DRAFT]
* 42% of alcohol positives (BAC < 0.04) are the result of time dependent cutoff levels, which have been required since 2008
Slide9 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
* 32-60% of positive alcohol results per test category were BAC < 0.04 Slide 9


Testing for Additional Substances In 2018, eight facilities conducted expanded panel testing in two ways:
Testing for Additional Substances In 2018, eight facilities conducted expanded panel testing in two ways:
* Tested all specimens collected for barbiturates, benzodiazepines, methadone, and propoxyphene (four facilities, one FFD program)
Tested all specimens collected for barbiturates, benzodiazepines, methadone, and propoxyphene (four facilities, one FFD program)
* Tested follow-up, for cause, and post-event testing specimens for benzodiazepines (i.e., alprazolam, clonazepam, and lorazepam), and hydromorphone, hydrocodone, and oxycodone (four facilities, one FFD program)
Tested follow-up, for cause, and post-event testing specimens for benzodiazepines (i.e., alprazolam, clonazepam, and lorazepam), and hydromorphone, hydrocodone, and oxycodone (four facilities, one FFD program)
Typically, a few facilities each year conduct testing for one or more additional substances when ordered by the MRO (e.g., for-cause or follow-up test).
Typically, a few facilities each year conduct testing for one or more additional substances when ordered by the MRO (e.g., for-cause or follow-up test).
Slide 10
Slide10


Additional Substance Test Results, 2011-2018
Additional Substance Test Results, 2011-2018
[Draft]
[Draft]
Substance                         2011 2012 2013 2014 2015 2016 2017 2018   Total Benzodiazepines                   1       2       1     1     1   1       7 Buprenorphine                             1                     1     1     3 Fentanyl                                                       1           1 Hydrocodone                                               1     1     1     3 Hydromorphone                                             1           1     2 Methadone                         1       1       1     1                 4 Norbuprenorphine                                                     1     1 Oxycodone                                 1       1     1     1       1   5 Oxymorphone                               1       1     1     1       1   5 Propoxyphene                                             1                 1 Tramadol                                                       1           1 Total     2       6       4     7     7   1 4 2 33 The 33 test results in this table reflect positive results for 25 individuals (see next slide). That is, some individuals test positive for more than one substance in the same testing event Slide 11
The33testresultsinthistablereflectpositiveresultsfor25 individuals(seenextslide).Thatis,someindividualstestpositive formorethanonesubstanceinthesametestingevent Substance 2011 2012 2013 2014 2015 2016 2017 2018 Total Benzodiazepines 1
2 1
1 1
1 7
Buprenorphine 1
1 1
3 Fentanyl 1
1 Hydrocodone 1
1 1
3 Hydromorphone 1
1 2
Methadone 1
1 1
1 4
Norbuprenorphine 1
1 Oxycodone 1
1 1
1 1
5 Oxymorphone 1
1 1
1 1
5 Propoxyphene 1
1 Tramadol 1
1 Total 2
6 4
7 7
1 4
2 33 Slide11


Additional Substance Results by Test Category (2011-2018) [Draft]
Additional Substance Results by Test Category (2011-2018) [Draft]
Substances                                                   Pre-Access Random For Cause Follow-up Total Benzodiazepines                                                           1       1         2     4 Benzodiazepines; Amphetamine; Methamphetamine                                     2               2 Benzodiazepines; Amphetamine; Methamphetamine; Marijuana                           1               1 Benzodiazepines; Cocaine                                                           1               1 Benzodiazepines; Marijuana;                                                       1               1 Benzodiazepines; Methadone; Marijuana                             1                                 1 Buprenorphine                                                     1                                 1 Buprenorphine; Norbuprenorphine                                                   1               1 Hydrocodone                                                                       1               1 Hydrocodone; Hydromorphone; Amphetamine; Marijuana               1                                 1 Hydrocodone; Hydromorphone; Amphetamine; Methamphetamine                           1               1 Hydrocodone; Oxycodone; Oxymorphone                                               1               1 Methadone                                                                 1       1               2 Oxycodone; Oxymorphone                                                             3               3 Oxycodone; Oxymorphone; Fentanyl                                                   1               1 Propoxyphene; Marijuana                                           1                                 1 Tramadol                                                                           2               2 Total     4       2       17         2     25
68%ofindividuals(17of25)testedpositiveonforcausetesting 36%ofindividuals(9of25)alsotestedpositiveforasubstanceintheNRCrequiredtestingpanel Substances Pre-Access Random For Cause Follow-up Total Benzodiazepines 1
* 68% of individuals (17 of 25) tested positive on for cause testing
1 2
* 36% of individuals (9 of 25) also tested positive for a substance in the NRCrequired testing panel Slide 12
4 Benzodiazepines; Amphetamine; Methamphetamine 2
2 Benzodiazepines; Amphetamine; Methamphetamine; Marijuana 1
1 Benzodiazepines; Cocaine 1
1 Benzodiazepines; Marijuana; 1
1 Benzodiazepines; Methadone; Marijuana 1
1 Buprenorphine 1
1 Buprenorphine; Norbuprenorphine 1
1 Hydrocodone 1
1 Hydrocodone; Hydromorphone; Amphetamine; Marijuana 1
1 Hydrocodone; Hydromorphone; Amphetamine; Methamphetamine 1
1 Hydrocodone; Oxycodone; Oxymorphone 1
1 Methadone 1
1 2
Oxycodone; Oxymorphone 3
3 Oxycodone; Oxymorphone; Fentanyl 1
1 Propoxyphene; Marijuana 1
1 Tramadol 2
2 Total 4
2 17 2
25 Slide12


Subversion Attempt Trends [Draft]
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)
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)
Sanction for a subversion attempt is a permanent denial of unescorted access (10 CFR 26.75)
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)
Slide13 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:
Subversion Attempts in 2018:
* 70.0% facilities with at least 1 subversion attempt (50 of 71)
70.0% facilities with at least 1 subversion attempt (50of71) 77.5% identified at Pre-Access testing (231 of 298) 95.6% by contractor/vendors (285 of 298)
* 77.5% identified at Pre-Access testing (231 of 298)
* 95.6% by contractor/vendors (285 of 298)
Slide 13


Subversion Attempts, 2018 (draft)
Subversion Attempts, 2018 (draft)
Positive Results for Specimens Collected under Direct Observation Test Result                                 Pre-Access   Random For Cause Follow-up Total Marijuana                                       39       5       2         1     47 Cocaine                                           3               1         2     6 Amphetamine; Methamphetamine                     3                                 3 Cocaine; Marijuana                               3                                 3 Amphetamine; Marijuana                           1       1                         2 Amphetamine; Methamphetamine; Marijuana           2                                 2 Amphetamine                                       1                                 1 Amphetamine; Methamphetamine; Cocaine             1                                 1 Cocaine; 6-AM; Codeine; Morphine; PCP             1                                 1 Methamphetamine                                           1                       1 Morphine                                                           1                 1 Total       54       7       4         3     68
Positive Results for Specimens Collected under Direct Observation 298 individuals identified as subverting a test in 2018 68 provided specimens under direct observation (68/298 = 22.8%)
* 298 individuals identified as subverting a test in 2018
Test Result Pre-Access Random For Cause Follow-up Total Marijuana 39 5
* 68 provided specimens under direct observation (68/298 = 22.8%)
2 1
Slide 14
47 Cocaine 3
1 2
6 Amphetamine; Methamphetamine 3
3 Cocaine; Marijuana 3
3 Amphetamine; Marijuana 1
1 2
Amphetamine; Methamphetamine; Marijuana 2
2 Amphetamine 1
1 Amphetamine; Methamphetamine; Cocaine 1
1 Cocaine; 6-AM; Codeine; Morphine; PCP 1
1 Methamphetamine 1
1 Morphine 1
1 Total 54 7
4 3
68 Test Result Pre-Access Random For Cause Follow-up Total Marijuana 39 5
2 1
47 Cocaine 3
1 2
6 Amphetamine; Methamphetamine 3
3 Cocaine; Marijuana 3
3 Amphetamine; Marijuana 1
1 2
Amphetamine; Methamphetamine; Marijuana 2
2 Amphetamine 1
1 Amphetamine; Methamphetamine; Cocaine 1
1 Cocaine; 6-AM; Codeine; Morphine; PCP 1
1 Methamphetamine 1
1 Morphine 1
1 Total 54 7
4 3
68 Slide14


Limit of Detection (LOD) Testing of Dilute Specimens 10 CFR 26.163(a)(2) permits a licensee to require the HHS-certified laboratory to conduct confirmatory drug testing to LOD for a substance if:
Limit of Detection (LOD) Testing of Dilute Specimens 10 CFR 26.163(a)(2) permits a licensee to require the HHS-certified laboratory to conduct confirmatory drug testing to LOD for a substance if:
: 1. Validity test result = Dilute, and
: 1. Validity test result = Dilute, and
: 2. Immunoassay response is equal to or greater than 50% of cutoff
: 2. Immunoassay response is equal to or greater than 50% of cutoff 66 of 71 sites maintained the optional LOD testing policy in 2018 422 dilute specimens were tested to LOD in 2018, with 17 individuals testing positive 35% sites (23 of 66) conducted at least one 26.163(a)(2) test in 2018 Slide15
* 66 of 71 sites maintained the optional LOD testing policy in 2018
* 422 dilute specimens were tested to LOD in 2018, with 17 individuals testing positive
* 35% sites (23 of 66) conducted at least one 26.163(a)(2) test in 2018 Slide 15


LOD Testing of Dilute Specimens (2010-2018) - 10 CFR 26.163(a)(2)
LOD Testing of Dilute Specimens (2010-2018) - 10 CFR 26.163(a)(2)
Slide 16
Slide16


HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
: 1) A blind performance test sample (BPTS) formulated to return an adulterated validity test result (due to low pH) was reported with negative drug test results. The forensic processing technician did not properly aliquot all of the original specimen to the correct sample cup, which caused the incorrect result.
: 1) A blind performance test sample (BPTS) formulated to return an adulterated validity test result (due to low pH) was reported with negative drug test results. The forensic processing technician did not properly aliquot all of the original specimen to the correct sample cup, which caused the incorrect result.
: 2) A donor specimen was reported as negative dilute. Two days later, the laboratory updated the result to negative. It was determined that the Screening Technician did not load the specimen on the refractometer consistent with the Standard Operating Procedure, which resulted in an incorrect specific gravity value. A second aliquot of the sample consistent with the applicable procedure determined the specimen was not dilute.
: 2) A donor specimen was reported as negative dilute. Two days later, the laboratory updated the result to negative. It was determined that the Screening Technician did not load the specimen on the refractometer consistent with the Standard Operating Procedure, which resulted in an incorrect specific gravity value. A second aliquot of the sample consistent with the applicable procedure determined the specimen was not dilute.
Slide 17
Slide17


HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
: 3) A BPTS formulated to return an adulterated validity test result was submitted for testing. Initial validity testing indicated general oxidants were above normal and required confirmation. However, the laboratorys confirmatory oxidant testing equipment (ion chromatograph instrument) was out of service. The laboratory sent the specimen to a second HHScertified laboratory for additional adulterant testing, but that laboratory was not the licensees authorized backup laboratory. That specimen was then sent to the licensees authorized backup laboratory, but the specimen was empty upon receipt and was reported as invalid.
: 3) ABPTSformulatedtoreturnanadulteratedvaliditytestresultwassubmittedfor testing.Initialvaliditytestingindicatedgeneraloxidantswereabovenormaland requiredconfirmation.However,thelaboratorysconfirmatoryoxidanttesting equipment(ionchromatographinstrument)wasoutofservice.Thelaboratorysentthe specimentoasecondHHScertifiedlaboratoryforadditionaladulteranttesting,but thatlaboratorywasnotthelicenseesauthorizedbackuplaboratory.Thatspecimen wasthensenttothelicenseesauthorizedbackuplaboratory,butthespecimenwas emptyuponreceiptandwasreportedasinvalid.
: 4) A BPTS formulated to test positive for marijuana was reported by the HHS-certified laboratory as negative. The BPTS was a false negative challenge sample formulated at between 130 and 155 percent of the initial testing cutoff concentration for marijuana). The licensee determined the unexpected results were related to the BPTS supplier's preparation and/or preservation of the samples.
: 4) A BPTS formulated to test positive for marijuana was reported by the HHS-certified laboratory as negative. The BPTS was a false negative challenge sample formulated at between 130 and 155 percent of the initial testing cutoff concentration for marijuana). The licensee determined the unexpected results were related to the BPTS supplier's preparation and/or preservation of the samples.
Slide 18
Slide18


HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)
: 5) A licensee sent two donor specimens for testing to the HHScertified laboratory, and both specimens were reported as "rejected for testing" due to the Bottle B specimens being switched. The licensee and the laboratory conducted investigations, with conflicting conclusions reached.
: 5) AlicenseesenttwodonorspecimensfortestingtotheHHScertifiedlaboratory,and bothspecimenswerereportedas"rejectedfortesting"duetotheBottleBspecimens beingswitched.Thelicenseeandthelaboratoryconductedinvestigations,with conflictingconclusionsreached.
* The laboratory reported the accessioner identified a switch in the bottle B specimens for the two donors and the accessioner's supervisor verified the bottle switch.
ThelaboratoryreportedtheaccessioneridentifiedaswitchinthebottleB specimensforthetwodonorsandtheaccessioner's supervisorverifiedthebottle switch.
* The licensee concluded that it was likely that the Bottle B specimens were switched at the laboratory because the licensee only allows for one collection to be performed at a time and that the donor certifies the Bottle A and B specimens and observes the sealing of the specimens in the tamperevident bag. In addition, in one of the two cases, the specimen was monitored by another member of management that observed the process from beginning to end, including sealing of the tamper evident bag.
ThelicenseeconcludedthatitwaslikelythattheBottleBspecimenswere switchedatthelaboratorybecausethelicenseeonlyallowsforonecollectionto beperformedatatimeandthatthedonorcertifiestheBottleAandBspecimens andobservesthesealingofthespecimensinthetamperevidentbag.Inaddition, inoneofthetwocases,thespecimenwasmonitoredbyanothermemberof managementthatobservedtheprocessfrombeginningtoend,including sealingofthetamperevidentbag.
Slide 19
Slide19


Status of Regulatory Issues Slide 20
Slide20 Status of Regulatory Issues


Status of Regulatory Issues
Status of Regulatory Issues Slide21 Staff-proposed Part 26 / 2008 HHS Guidelines rulemaking HHS Guidelines (Oral Fluid & Hair)
* Staff-proposed Part 26 / 2008 HHS Guidelines rulemaking
Cannabidiol, Hemp, and Marijuana Enforcement on Individuals Reporting of Alcohol-related Events Submission of FFD Forms containing PII
* HHS Guidelines (Oral Fluid & Hair)
* Cannabidiol, Hemp, and Marijuana
* Enforcement on Individuals
* Reporting of Alcohol-related Events
* Submission of FFD Forms containing PII Slide 21


Part 26 Proposed Rule 2019
Part 26 Proposed Rule 2019 SRM-SECY-17-0027: Proposed Rulemaking: Fitness-for-Duty Drug Testing Requirements (RIN 3510-AI67), ADAMS No. ML19154A539 (June 3, 2019)
* SRM-SECY-17-0027: Proposed Rulemaking: Fitness-for-Duty Drug Testing Requirements (RIN 3510-AI67), ADAMS No. ML19154A539 (June 3, 2019)
Key highlights:  
* Key highlights:
- Testing panel changes
    - Testing panel changes
- Subversion attempt detection enhancements
    - Subversion attempt detection enhancements
- Donor protections and process improvements Slide22
    - Donor protections and process improvements Slide 22


Part 26 Proposed Rule 2019 NRC Standard Drug Testing Panel Changes Testing Cutoff Levels (ng/mL)
Part 26 Proposed Rule 2019 NRC Standard Drug Testing Panel Changes Drugs or drug metabolites Testing Cutoff Levels (ng/mL)
Drugs or drug metabolites Initial         Confirmatory Marijuana metabolites                                               50                   15 Cocaine metabolites                                           300150               150100 Opiate metabolites:                                             2000 Codeine                                                                         2000 Morphine                                                                        2000 6-acetylmorphine (6-AM)1                                       10                   10 Phencyclidine                                                       25                   25 Amphetamines:                                               1000500 Amphetamine                                                                   500250 Methamphetamine                                                             5002502 MDMA3                                                         500                 250 MDA4                                                         500                 250 1 Confirmatory testing for 6-AM performed only when morphine concentration exceeds 2,000 ng/mL 2 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 200100 ng/mL 3 Methylenedioxymethamphetamine 4 Methylenedioxyamphetamine Slide 23
Initial Confirmatory Marijuana metabolites 50 15 Cocaine metabolites 300150 150100 Opiate metabolites:
2000 Codeine Morphine 2000 2000 6-acetylmorphine (6-AM)1 10 10 Phencyclidine 25 25 Amphetamines:
1000500 Amphetamine 500250 Methamphetamine 5002502 MDMA3 500 250 MDA4 500 250 Slide23 1 Confirmatory testing for 6-AM performed only when morphine concentration exceeds 2,000 ng/mL 2 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 200100 ng/mL 3 Methylenedioxymethamphetamine 4 Methylenedioxyamphetamine


Proposed Rule Information:
Proposed Rule Information:
Subversion Attempt Enhancements Special analyses testing under 26.163(a)(2):
Subversion Attempt Enhancements Slide24 Special analyses testing under 26.163(a)(2):
* Require testing of dilutes (before optional)
Require testing of dilutes (before optional)
* Add specimens collected under direct observation when indications of a subversion attempt on initial collection
Add specimens collected under direct observation when indications of a subversion attempt on initial collection Change drug concentration on initial test that triggers special analyses testing (from 50% of cutoff to 40% of cutoff)
* Change drug concentration on initial test that triggers special analyses testing (from 50% of cutoff to 40% of cutoff)
Change confirmatory testing to Limit of Quantitation (LOQ) from the Limit of Detection (LOD)
* Change confirmatory testing to Limit of Quantitation (LOQ) from the Limit of Detection (LOD)
Slide 24


Proposed Rule Information:
Proposed Rule Information:
Other Notable Changes
Other Notable Changes Donor protections:
* Donor protections:
- Verbal request for retest (MRO document request)  
  - Verbal request for retest (MRO document request)
- MRO review of invalid specimens 9.0 to 9.5 (handling conditions)
  - MRO review of invalid specimens 9.0 to 9.5 (handling conditions)
Hydration monitor: permit FFD program personal to monitor donor hydrating (currently, the collector who started the collection process must stay with donor)
* Hydration monitor: permit FFD program personal to monitor donor hydrating (currently, the collector who started the collection process must stay with donor)
Will concurrently publish a draft regulatory guide (limited information specific to current rulemaking)
* Will concurrently publish a draft regulatory guide (limited information specific to current rulemaking)
Will include a question on 2017 HHS Guidelines in proposed rule Slide25
* Will include a question on 2017 HHS Guidelines in proposed rule Slide 25


Cannabidiol, Hemp, and Marijuana 10 CFR 26.185(j) - Review of opiates, prescription and OTC medications (4)(ii) There can be a legitimate medical explanation only with respect to a drug that has a legitimate medical use.
Cannabidiol, Hemp, and Marijuana Slide26 10 CFR 26.185(j) - Review of opiates, prescription and OTC medications (4)(ii) There can be a legitimate medical explanation only with respect to a drug that has a legitimate medical use.
(5)     The MRO may not consider consumption of food products, supplements, or other preparations containing substances that may result in a positive confirmatory drug test result, including, but not limited to supplements containing hemp products or coca leaf tea, as a legitimate medical explanation for the presence of drugs or drug metabolites in the urine specimen above the cutoff levels specified in &sect; 26.163 or a licensees or other entitys more stringent cutoff levels.
(5)
Marijuana = Cannabis sativa L. = Cannabis Indica = Hemp Slide 26
The MRO may not consider consumption of food products, supplements, or other preparations containing substances that may result in a positive confirmatory drug test result, including, but not limited to supplements containing hemp products or coca leaf tea, as a legitimate medical explanation for the presence of drugs or drug metabolites in the urine specimen above the cutoff levels specified in &sect; 26.163 or a licensees or other entitys more stringent cutoff levels.
Marijuana=Cannabissativa L.=CannabisIndica=Hemp


Cannabidiol, Hemp, and Marijuana Date:     May 26, 2015 From:     Katherine Archuleta, Director, U.S. Office of Personnel Management
Cannabidiol, Hemp, and Marijuana Slide27 Date:
May 26, 2015 From:
Katherine Archuleta, Director, U.S. Office of Personnel Management


==Subject:==
==Subject:==
Federal Laws and Policies Prohibiting Marijuana Use Federal law on marijuana remains unchanged. Marijuana is categorized as a controlled substance under Schedule I of the Controlled substance Act.
Federal Laws and Policies Prohibiting Marijuana Use Federal law on marijuana remains unchanged. Marijuana is categorized as a controlled substance under Schedule I of the Controlled substance Act.
Thus knowing or intentional marijuana possession is illegal, even if an individual has no intent to manufacture, distribute, or dispense marijuana. In addition, Executive Order 12564, Drug-Free Federal Workplace, mandates that (a) Federal employees are required to refrain from use of illegal drugs; (b) the use of illegal drugs by Federal employees, whether on or off duty, is contrary to the efficiency of the service Slide 27
Thus knowing or intentional marijuana possession is illegal, even if an individual has no intent to manufacture, distribute, or dispense marijuana. In addition, Executive Order 12564, Drug-Free Federal Workplace, mandates that (a) Federal employees are required to refrain from use of illegal drugs; (b) the use of illegal drugs by Federal employees, whether on or off duty, is contrary to the efficiency of the service  


Cannabidiol, Hemp, and Marijuana Date:       November 22, 2017 From:       Ron Flegal, B.S., MT (ASSCP), M.S., Director, HHS/SAMHSA/DWP
Cannabidiol, Hemp, and Marijuana Slide28 Date:
November 22, 2017 From:
Ron Flegal, B.S., MT (ASSCP), M.S., Director, HHS/SAMHSA/DWP


==Subject:==
==Subject:==
Line 191: Line 313:
CBD is chemically distinguishable from THC and will not cause a positive drug test result under the current drug testing panel but is a Schedule I drug.
CBD is chemically distinguishable from THC and will not cause a positive drug test result under the current drug testing panel but is a Schedule I drug.
However, CBD products may contain other cannabinoids such as THC, therefore, use of CBD oils and marijuana-derived products may result in a positive urine drug test for THCA.
However, CBD products may contain other cannabinoids such as THC, therefore, use of CBD oils and marijuana-derived products may result in a positive urine drug test for THCA.
Slide 28


Sec 7606 of the Agricultural Act of 2018 (Farm Bill)
Slide29 Sec 7606 of the Agricultural Act of 2018 (Farm Bill)
* Permits agricultural research pilot programs to grow industrial hemp
Permits agricultural research pilot programs to grow industrial hemp The term industrial hemp includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis The term tetrahydrocannabinols includes all isomers (CBD), acids, salts, and salts of isomers of tetrahydrocannabinols
* The term industrial hemp includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis
* The term tetrahydrocannabinols includes all isomers (CBD), acids, salts, and salts of isomers of tetrahydrocannabinols Slide 29


Enforcement Policy Revision SRM-SECY-17-0059 Proposed Enforcement Policy Revision for Processing Fitness-For-Duty Cases Resulting from Site Fitness-For-Duty Drug and Alcohol Violations by Individuals (ADAMS Accession Nos. ML16355A048 and ML19108A476)
Slide30 Enforcement Policy Revision SRM-SECY-17-0059 Proposed Enforcement Policy Revision for Processing Fitness-For-Duty Cases Resulting from Site Fitness-For-Duty Drug and Alcohol Violations by Individuals (ADAMS Accession Nos. ML16355A048 and ML19108A476)
Federal Register Notice Processing Fitness-for-Duty Drug and Alcohol Cases 84 FR 34363; May 28, 2019; Office of Enforcement Revision to the NRC Enforcement Policy, Section 4.1, Considerations in Determining Enforcement Actions Involving Individuals:
Federal Register Notice Processing Fitness-for-Duty Drug and Alcohol Cases 84 FR 34363; May 28, 2019; Office of Enforcement Revision to the NRC Enforcement Policy, Section 4.1, Considerations in Determining Enforcement Actions Involving Individuals:
For FFD violations involving non-licensed individuals who violate drug and alcohol provisions of site FFD programs, which are explicitly described in &sect; 26.75, Sanctions, the NRC will not typically consider FFD drug and alcohol-related violations for enforcement action unless there is an apparent deficiency in the licensees FFD program to take the required sanctions against the individual(s) or deficiencies in implementation of the licensee FFD program.
For FFD violations involving non-licensed individuals who violate drug and alcohol provisions of site FFD programs, which are explicitly described in &sect; 26.75, Sanctions, the NRC will not typically consider FFD drug and alcohol-related violations for enforcement action unless there is an apparent deficiency in the licensees FFD program to take the required sanctions against the individual(s) or deficiencies in implementation of the licensee FFD program.
Slide 30


Reporting of Alcohol-related Events 10 CFR 26.719 (b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers the violation:
Reporting of Alcohol-related Events Slide31 10 CFR 26.719 (b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours after the licensee or other entity discovers the violation:
(1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area (2) Any acts by any person licensed under 10 CFR parts 52 and/or 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts (iii) Involve the consumption of alcohol within a protected area or while performing the duties that require the individual to be subject to the FFD program Slide 31
(1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area (2) Any acts by any person licensed under 10 CFR parts 52 and/or 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts (iii) Involve the consumption of alcohol within a protected area or while performing the duties that require the individual to be subject to the FFD program


Reporting of Alcohol-related Events Response to NEI question on the reporting of alcohol-related occurrences to the NRC Headquarters Operation Center (HOC) pursuant to 10 CFR 26.719(b)(1) and (b)(2)(iii):
Reporting of Alcohol-related Events Slide32 Response to NEI question on the reporting of alcohol-related occurrences to the NRC Headquarters Operation Center (HOC) pursuant to 10 CFR 26.719(b)(1) and (b)(2)(iii):
Licensees should report to the NRC HOC alcohol-related events when they involve a liquid having an alcohol concentration equal to or greater than 0.5 percent alcohol by volume (ABV), as measured by the licensee or other entity, or a container labeled pursuant to the United States Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau under 27 CFR Part 16, Alcoholic Beverage Health Warning Label.
Licensees should report to the NRC HOC alcohol-related events when they involve a liquid having an alcohol concentration equal to or greater than 0.5 percent alcohol by volume (ABV), as measured by the licensee or other entity, or a container labeled pursuant to the United States Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau under 27 CFR Part 16, Alcoholic Beverage Health Warning Label.
Posted on the FAQ website on June 13, 2019 (https://www.nrc.gov/docs/ML1908/ML19084A144.html)
Posted on the FAQ website on June 13, 2019 (https://www.nrc.gov/docs/ML1908/ML19084A144.html)
Slide 32


Reporting of Alcohol-related Events Additional Guidance
Reporting of Alcohol-related Events Slide33 Additional Guidance
: 1. Alcohol is a substance intended for human consumption with a molecular formula of C2H5OH. Alcohol is typically in a liquid form (e.g., liquor, beer, wine) but can come in many forms (used as an ingredient in a marinade, sauce, or extract; infused into a solid such as a cake; converted to a powder form; vaporized; prescription and over-the-counter medications).
: 1. Alcohol is a substance intended for human consumption with a molecular formula of C2H5OH. Alcohol is typically in a liquid form (e.g., liquor, beer, wine) but can come in many forms (used as an ingredient in a marinade, sauce, or extract; infused into a solid such as a cake; converted to a powder form; vaporized; prescription and over-the-counter medications).
: 2. An empty can, bottle, box with a label indicating at least 0.5 percent ABV alcohol that is identified in a PA should be reported to the HOC. If the licensee or other entity determines the product was not recently used (e.g.,
: 2. An empty can, bottle, box with a label indicating at least 0.5 percent ABV alcohol that is identified in a PA should be reported to the HOC. If the licensee or other entity determines the product was not recently used (e.g.,
container was covered with dust, cobwebs, etc.) the event should not be reported.
container was covered with dust, cobwebs, etc.) the event should not be reported.
Slide 33


Reporting of Alcohol-related Events Additional Guidance
Reporting of Alcohol-related Events Slide34 Additional Guidance
: 3. For consumable products, including over-the-counter and prescription medications, that list alcohol as an ingredient, but do not have a Federal alcohol label, licensees and other entities should use their site processes and procedures to determine if a report to the NRC HOC is needed.
: 3. For consumable products, including over-the-counter and prescription medications, that list alcohol as an ingredient, but do not have a Federal alcohol label, licensees and other entities should use their site processes and procedures to determine if a report to the NRC HOC is needed.
: 4. Products with denatured alcohol such as Listerine, Purell hand sanitizer, or cosmetics, are not alcohol under 10 CFR Part 26.
: 4. Products with denatured alcohol such as Listerine, Purell hand sanitizer, or cosmetics, are not alcohol under 10 CFR Part 26.  
Slide 34


Submission of FFD Forms containing PII Be aware when submitting FFD program performance reports (Single Positive Test Forms) the NRC using the NRCs Electronic Information Exchange (EIE)
Slide35 Submission of FFD Forms containing PII Be aware when submitting FFD program performance reports (Single Positive Test Forms) the NRC using the NRCs Electronic Information Exchange (EIE)
EIE saves both the licensee-designated "File Name" and "Document Title" entered for each FFD form uploaded and submitted to the NRC.
EIE saves both the licensee-designated "File Name" and "Document Title" entered for each FFD form uploaded and submitted to the NRC.
DO NOT include any personally identifying information or medical information in the File Name" or "Document Title" fields, such as a person's name, initials, social security number, or site badge number.
DONOTincludeanypersonallyidentifyinginformationormedicalinformationintheFileName" or"DocumentTitle"fields,suchasaperson's name, initials, social security number, or site badge number.
Slide 35


Operational Experience Slide 36
Slide36 Operational Experience


Operational Experience (OpE) Topics Topic 1: Follow-up testing Topic 2: Testing of remote location personnel Topic 3: Alternative specimens Topic 4: Gender identity and observed collections Topic 5: Random testing Slide 37
Operational Experience (OpE) Topics Topic 1: Follow-up testing Topic 2: Testing of remote location personnel Topic 3: Alternative specimens Topic 4:
Gender identity and observed collections Topic 5: Random testing Slide37


OpE Topic 1 -
OpE Topic 1 -
Follow-up testing 26.31(c)(4)
Follow-up testing 26.31(c)(4)
Performed because of:
Performed because of:
* A prior positive 10 CFR Part 26 drug/alcohol test Did you know?
A prior positive 10 CFR Part 26 drug/alcohol test Potentially disqualifying FFD information
* Potentially disqualifying FFD information 20142018 results Purpose:                                             Positive rate for
 
* Detection (confirms continued abstinence)         followup testing is
==Purpose:==
* Deterrence                                           double that for random testing Operational issues impacting:
Detection (confirms continued abstinence)
* Not onsite on a regular basis (e.g., contractor)     ~6,800 - 8,400
Deterrence Operational issues impacting:
* Meeting testing schedule                         followup tests were
Not onsite on a regular basis (e.g., contractor)
* Transfers from licensee programs                 performed annually
Meeting testing schedule Transfers from licensee programs Testing plan information Slide38 Didyouknow?
* Testing plan information Slide 38
20142018results Positiveratefor followuptestingis doublethatfor randomtesting
~6,800- 8,400 followuptestswere performedannually


OpE Topic 2 -
OpE Topic 2 -
Line 249: Line 365:
AND
AND
: 2) whose duties require access OR who perform activities listed in 26.4(g)
: 2) whose duties require access OR who perform activities listed in 26.4(g)
Note: Subpart K (construction sites also can utilize 49 CFR Part 40 collection sites)
Slide39 Note:SubpartK(constructionsitesalso canutilize49CFRPart40collectionsites)
Slide 39


OpE Topic 3 -
OpE Topic 3 -
Alternate Specimen Collections Licensees and other entities can collect an alternate specimen in three circumstances:
Alternate Specimen Collections Licensees and other entities can collect an alternate specimen in three circumstances:
: 1) Shy-bladder medication condition highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period - 26.119(g)(3)
1)
: 2) Invalid specimen with an acceptable medical explanation and an invalid result similarly would affect the testing of another urine specimen - 26.185(f)(2)
Shy-bladder medication condition highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period - 26.119(g)(3) 2)
: 3) Medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous - 26.31(d)(5)(i)
Invalid specimen with an acceptable medical explanation and an invalid result similarly would affect the testing of another urine specimen - 26.185(f)(2) 3)
Slide 40
Medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous - 26.31(d)(5)(i)
Slide40


OpE Topic 4 -
OpE Topic 4 -
Line 265: Line 381:
HHS --Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs (pages 26-27, 10/01/2017)
HHS --Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs (pages 26-27, 10/01/2017)
The observers gender must be the same as the donors gender, which is determined by the donors gender identity.The donors gender identity may be the same as or different from the donors sex assigned at birth.
The observers gender must be the same as the donors gender, which is determined by the donors gender identity.The donors gender identity may be the same as or different from the donors sex assigned at birth.
Slide 41
Slide41


OpE Topic 5 -
OpE Topic 5 -
Random Testing 26.31(c)
Random Testing 26.31(c)
* Random number generator, equal probability of selection
Random number generator, equal probability of selection Random testing pool incomplete Testing on weekends limited Slide42
* Random testing pool incomplete
* Testing on weekends limited Slide 42


Random Testing Positive Rates [Draft]
Random Testing Positive Rates [Draft]
Site-Specific Distributions, 2018 Slide 43
Site-Specific Distributions, 2018 Slide43


Random Testing Positive Rates [Draft]
Random Testing Positive Rates [Draft]
Site-Specific Distributions, 2014-2018 Licensee Employee                C/V Positive Rate Range (%)
Site-Specific Distributions, 2014-2018 Slide44 2014 2015 2016 2017 2018 2014 2015 2016 2017 2018 0
2014   2015 2016 2017 2018 2014 2015 2016 2017 2018 0                               39     35   34     37 29 23   32   32   32   28
39 35 34 37 29 23 32 32 32 28
> 0% - 0.25%                     20     21   19     20 22 2   4   2   1   4
> 0% - 0.25%
> 0.25% - 0.5%                   11     15   15     12 16 17   12   10   10   14
20 21 19 20 22 2
> 0.5% - 0.75%                   3       1     3     2 4 18   13   10   13   6
4 2
> 0.75% - 1%                                                 4   3   8   6   10
1 4
> 1% - 1.25%                     1             1           3   4   2   4   5
> 0.25% - 0.5%
> 1.25% - 1.5%                                               4   2   2   1   1
11 15 15 12 16 17 12 10 10 14
> 1.5% - 1.75%                                               3   3   4   2   2
> 0.5% - 0.75%
> 1.75% - 2%                                                 1         3   1
3 1
> 2%                                                                         2   1 Sites (with at least 1 test)   74     72   72     71 71 75   73   73   72   71 Sites (no tests performed)       1       1     1     1 0 0   0   0   0   0 Total Sites     75     73   73     72 71 75   73   73   72   71 Slide 44
3 2
4 18 13 10 13 6
> 0.75% - 1%
4 3
8 6
10
> 1% - 1.25%
1 1
3 4
2 4
5
> 1.25% - 1.5%
4 2
2 1
1
> 1.5% - 1.75%
3 3
4 2
2
> 1.75% - 2%
1 3
1
> 2%
2 1
Sites (with at least 1 test) 74 72 72 71 71 75 73 73 72 71 Sites (no tests performed) 1 1
1 1
0 0
0 0
0 0
Total Sites 75 73 73 72 71 75 73 73 72 71 Positive Rate Range (%)
Licensee Employee C/V


Random Testing (Days of the Week) 10 CFR 26.31(c)(2)(i)(B) requires random testing to be conducted on an unpredictable schedule, including weekends, backshifts, and holidays. . .
Random Testing (Days of the Week)
Percentage of Positive* Tests Results by Day of Collection Year       Mon.         Tues.       Wed.           Thur.       Fri.         Sat.         Sun.
Slide45 10 CFR 26.31(c)(2)(i)(B) requires random testing to be conducted on an unpredictable schedule, including weekends, backshifts, and holidays...
2018         21.0%       28.1%       18.6%         20.0%     10.0%         1.9%         0.5%
PercentageofPositive*TestsResultsbyDayofCollection Year Mon.
2017         19.8%       24.4%       25.2%         17.6%     12.2%         0.4%         0.4%
Tues.
2016         14.6%       24.2%       20.0%         25.8%     10.8%         3.1%         1.5%
Wed.
2015         17.2%       28.9%       25.9%         14.7%     12.9%         0.4%         0.0%
Thur.
2014         22.6%       20.8%       25.8%         19.9%       9.0%         1.4%         0.5%
Fri.
* Positive = Positive drug and alcohol tests, adulterated and substituted validity test results, and refusals to test Slide 45
Sat.
Sun.
2018 21.0%
28.1%
18.6%
20.0%
10.0%
1.9%
0.5%
2017 19.8%
24.4%
25.2%
17.6%
12.2%
0.4%
0.4%
2016 14.6%
24.2%
20.0%
25.8%
10.8%
3.1%
1.5%
2015 17.2%
28.9%
25.9%
14.7%
12.9%
0.4%
0.0%
2014 22.6%
20.8%
25.8%
19.9%
9.0%
1.4%
0.5%
*Positive=Positivedrugandalcoholtests,adulteratedandsubstitutedvaliditytestresults, andrefusalstotest


NRC Fitness for Duty Program Staff U.S. Nuclear Regulatory Commission Office of Nuclear Security and Incident Response Paul Harris, Senior Program Manager Paul.Harris@nrc.gov (301-287-9294)
NRC Fitness for Duty Program Staff Slide46 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)
Brian Zaleski, Fitness-for-Duty Program Specialist Brian.Zaleski@nrc.gov (301-287-0638)}}
Slide 46}}

Latest revision as of 01:21, 5 January 2025

NRC Presentation on 10 CFR Part 26 FFD Program Operating Experience in 2018, NEI Access Authorization-FFD Workshop (July 10-11, 2019)
ML19193A071
Person / Time
Issue date: 07/10/2019
From: Harris P, Brian Zaleski
NRC/NSIR/DPCP/FCTSB
To:
Brian Zaleski 301-287-0638
References
Download: ML19193A071 (46)


Text

Presentation to the Nuclear Energy Institutes Annual Access Authorization/Fitness For Duty Conference Operating Experience in 2018 and Status of Regulatory Issues 10 CFR Part 26, Fitness-for-Duty Programs A Direct Contribution to Safety and Security July 10-11, 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.

Slide2

Slide3 Operating Experience in 2018

Overall Industry Performance [Draft]

  • Positive=Positivedrugandalcoholtests,adulteratedandsubstitutedvaliditytestresults,andrefusalstotest AllresultsinthispresentationareMROverified Slide4 2018 2017 Change Individuals Tested 145,798 148,741 2,943 Individuals Testing Positive*

1,186 1,165

21 Identified at Pre-access Testing 69.8%

64.3%

5.5%

Identified at Random Testing 17.7%

22.5%

4.8%

Industry Positive Rate - All Tests 0.81%

0.78%

0.03%

Licensee Employee (LE) 0.28%

0.24%

0.04%

Contractor/Vendors (CVs) 1.06%

1.04%

0.02%

Industry Positive Rate - Random Tests 0.37%

0.44%

0.07%

LE Positive Rate 0.17%

0.14%

0.03%

CV Positive Rate 0.68%

0.89%

0.21%

Results by Test and Employment Categories, 2018

[DRAFT]

Slide5 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]

Sinceatleast2014,thischartunderreportsthesubstancesusedbyindividualswithadrugtesting violation.Thisisbecauseofthehighnumberofsubversionattemptseachyear,andbecauseinat least60%ofthesesubversionattempts,nospecimensweretested.

Slide6

Results by Employment Category, 2018

[DRAFT]

LicenseeEmployees (46,113tested;127individualspositive)

Contractors/Vendors (99,685tested;1,059individualspositive)

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 Slide7 Alcohol 15.3%

Amphetamines 11.1%

Cocaine 10.4%

Marijuana 42.2%

Opiates 1.6%

PCP 0.1%

Refusal to Test 19.4%

n = 1,126

Substances Detected by Labor Category, 2018

[DRAFT]

Slide8

Measuring Effectiveness of Lower Cutoff Levels for Alcohol, 2018 [DRAFT]

Slide9 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

Testing for Additional Substances In 2018, eight facilities conducted expanded panel testing in two ways:

Tested all specimens collected for barbiturates, benzodiazepines, methadone, and propoxyphene (four facilities, one FFD program)

Tested follow-up, for cause, and post-event testing specimens for benzodiazepines (i.e., alprazolam, clonazepam, and lorazepam), and hydromorphone, hydrocodone, and oxycodone (four facilities, one FFD program)

Typically, a few facilities each year conduct testing for one or more additional substances when ordered by the MRO (e.g., for-cause or follow-up test).

Slide10

Additional Substance Test Results, 2011-2018

[Draft]

The33testresultsinthistablereflectpositiveresultsfor25 individuals(seenextslide).Thatis,someindividualstestpositive formorethanonesubstanceinthesametestingevent Substance 2011 2012 2013 2014 2015 2016 2017 2018 Total Benzodiazepines 1

2 1

1 1

1 7

Buprenorphine 1

1 1

3 Fentanyl 1

1 Hydrocodone 1

1 1

3 Hydromorphone 1

1 2

Methadone 1

1 1

1 4

Norbuprenorphine 1

1 Oxycodone 1

1 1

1 1

5 Oxymorphone 1

1 1

1 1

5 Propoxyphene 1

1 Tramadol 1

1 Total 2

6 4

7 7

1 4

2 33 Slide11

Additional Substance Results by Test Category (2011-2018) [Draft]

68%ofindividuals(17of25)testedpositiveonforcausetesting 36%ofindividuals(9of25)alsotestedpositiveforasubstanceintheNRCrequiredtestingpanel Substances Pre-Access Random For Cause Follow-up Total Benzodiazepines 1

1 2

4 Benzodiazepines; Amphetamine; Methamphetamine 2

2 Benzodiazepines; Amphetamine; Methamphetamine; Marijuana 1

1 Benzodiazepines; Cocaine 1

1 Benzodiazepines; Marijuana; 1

1 Benzodiazepines; Methadone; Marijuana 1

1 Buprenorphine 1

1 Buprenorphine; Norbuprenorphine 1

1 Hydrocodone 1

1 Hydrocodone; Hydromorphone; Amphetamine; Marijuana 1

1 Hydrocodone; Hydromorphone; Amphetamine; Methamphetamine 1

1 Hydrocodone; Oxycodone; Oxymorphone 1

1 Methadone 1

1 2

Oxycodone; Oxymorphone 3

3 Oxycodone; Oxymorphone; Fentanyl 1

1 Propoxyphene; Marijuana 1

1 Tramadol 2

2 Total 4

2 17 2

25 Slide12

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)

Slide13 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 (50of71) 77.5% identified at Pre-Access testing (231 of 298) 95.6% by contractor/vendors (285 of 298)

Subversion Attempts, 2018 (draft)

Positive Results for Specimens Collected under Direct Observation 298 individuals identified as subverting a test in 2018 68 provided specimens under direct observation (68/298 = 22.8%)

Test Result Pre-Access Random For Cause Follow-up Total Marijuana 39 5

2 1

47 Cocaine 3

1 2

6 Amphetamine; Methamphetamine 3

3 Cocaine; Marijuana 3

3 Amphetamine; Marijuana 1

1 2

Amphetamine; Methamphetamine; Marijuana 2

2 Amphetamine 1

1 Amphetamine; Methamphetamine; Cocaine 1

1 Cocaine; 6-AM; Codeine; Morphine; PCP 1

1 Methamphetamine 1

1 Morphine 1

1 Total 54 7

4 3

68 Test Result Pre-Access Random For Cause Follow-up Total Marijuana 39 5

2 1

47 Cocaine 3

1 2

6 Amphetamine; Methamphetamine 3

3 Cocaine; Marijuana 3

3 Amphetamine; Marijuana 1

1 2

Amphetamine; Methamphetamine; Marijuana 2

2 Amphetamine 1

1 Amphetamine; Methamphetamine; Cocaine 1

1 Cocaine; 6-AM; Codeine; Morphine; PCP 1

1 Methamphetamine 1

1 Morphine 1

1 Total 54 7

4 3

68 Slide14

Limit of Detection (LOD) Testing of Dilute Specimens 10 CFR 26.163(a)(2) permits a licensee to require the HHS-certified laboratory to conduct confirmatory drug testing to LOD for a substance if:

1. Validity test result = Dilute, and
2. Immunoassay response is equal to or greater than 50% of cutoff 66 of 71 sites maintained the optional LOD testing policy in 2018 422 dilute specimens were tested to LOD in 2018, with 17 individuals testing positive 35% sites (23 of 66) conducted at least one 26.163(a)(2) test in 2018 Slide15

LOD Testing of Dilute Specimens (2010-2018) - 10 CFR 26.163(a)(2)

Slide16

HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)

1) A blind performance test sample (BPTS) formulated to return an adulterated validity test result (due to low pH) was reported with negative drug test results. The forensic processing technician did not properly aliquot all of the original specimen to the correct sample cup, which caused the incorrect result.
2) A donor specimen was reported as negative dilute. Two days later, the laboratory updated the result to negative. It was determined that the Screening Technician did not load the specimen on the refractometer consistent with the Standard Operating Procedure, which resulted in an incorrect specific gravity value. A second aliquot of the sample consistent with the applicable procedure determined the specimen was not dilute.

Slide17

HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)

3) ABPTSformulatedtoreturnanadulteratedvaliditytestresultwassubmittedfor testing.Initialvaliditytestingindicatedgeneraloxidantswereabovenormaland requiredconfirmation.However,thelaboratorysconfirmatoryoxidanttesting equipment(ionchromatographinstrument)wasoutofservice.Thelaboratorysentthe specimentoasecondHHScertifiedlaboratoryforadditionaladulteranttesting,but thatlaboratorywasnotthelicenseesauthorizedbackuplaboratory.Thatspecimen wasthensenttothelicenseesauthorizedbackuplaboratory,butthespecimenwas emptyuponreceiptandwasreportedasinvalid.
4) A BPTS formulated to test positive for marijuana was reported by the HHS-certified laboratory as negative. The BPTS was a false negative challenge sample formulated at between 130 and 155 percent of the initial testing cutoff concentration for marijuana). The licensee determined the unexpected results were related to the BPTS supplier's preparation and/or preservation of the samples.

Slide18

HHS-Certified Laboratory Testing Errors, 2018 10 CFR 26.719 (30-day event reports)

5) AlicenseesenttwodonorspecimensfortestingtotheHHScertifiedlaboratory,and bothspecimenswerereportedas"rejectedfortesting"duetotheBottleBspecimens beingswitched.Thelicenseeandthelaboratoryconductedinvestigations,with conflictingconclusionsreached.

ThelaboratoryreportedtheaccessioneridentifiedaswitchinthebottleB specimensforthetwodonorsandtheaccessioner's supervisorverifiedthebottle switch.

ThelicenseeconcludedthatitwaslikelythattheBottleBspecimenswere switchedatthelaboratorybecausethelicenseeonlyallowsforonecollectionto beperformedatatimeandthatthedonorcertifiestheBottleAandBspecimens andobservesthesealingofthespecimensinthetamperevidentbag.Inaddition, inoneofthetwocases,thespecimenwasmonitoredbyanothermemberof managementthatobservedtheprocessfrombeginningtoend,including sealingofthetamperevidentbag.

Slide19

Slide20 Status of Regulatory Issues

Status of Regulatory Issues Slide21 Staff-proposed Part 26 / 2008 HHS Guidelines rulemaking HHS Guidelines (Oral Fluid & Hair)

Cannabidiol, Hemp, and Marijuana Enforcement on Individuals Reporting of Alcohol-related Events Submission of FFD Forms containing PII

Part 26 Proposed Rule 2019 SRM-SECY-17-0027: Proposed Rulemaking: Fitness-for-Duty Drug Testing Requirements (RIN 3510-AI67), ADAMS No. ML19154A539 (June 3, 2019)

Key highlights:

- Testing panel changes

- Subversion attempt detection enhancements

- Donor protections and process improvements Slide22

Part 26 Proposed Rule 2019 NRC Standard Drug Testing Panel Changes Drugs or drug metabolites Testing Cutoff Levels (ng/mL)

Initial Confirmatory Marijuana metabolites 50 15 Cocaine metabolites 300150 150100 Opiate metabolites:

2000 Codeine Morphine 2000 2000 6-acetylmorphine (6-AM)1 10 10 Phencyclidine 25 25 Amphetamines:

1000500 Amphetamine 500250 Methamphetamine 5002502 MDMA3 500 250 MDA4 500 250 Slide23 1 Confirmatory testing for 6-AM performed only when morphine concentration exceeds 2,000 ng/mL 2 To be reported positive for methamphetamine, a specimen must also contain amphetamine at a concentration equal to or greater than 200100 ng/mL 3 Methylenedioxymethamphetamine 4 Methylenedioxyamphetamine

Proposed Rule Information:

Subversion Attempt Enhancements Slide24 Special analyses testing under 26.163(a)(2):

Require testing of dilutes (before optional)

Add specimens collected under direct observation when indications of a subversion attempt on initial collection Change drug concentration on initial test that triggers special analyses testing (from 50% of cutoff to 40% of cutoff)

Change confirmatory testing to Limit of Quantitation (LOQ) from the Limit of Detection (LOD)

Proposed Rule Information:

Other Notable Changes Donor protections:

- Verbal request for retest (MRO document request)

- MRO review of invalid specimens 9.0 to 9.5 (handling conditions)

Hydration monitor: permit FFD program personal to monitor donor hydrating (currently, the collector who started the collection process must stay with donor)

Will concurrently publish a draft regulatory guide (limited information specific to current rulemaking)

Will include a question on 2017 HHS Guidelines in proposed rule Slide25

Cannabidiol, Hemp, and Marijuana Slide26 10 CFR 26.185(j) - Review of opiates, prescription and OTC medications (4)(ii) There can be a legitimate medical explanation only with respect to a drug that has a legitimate medical use.

(5)

The MRO may not consider consumption of food products, supplements, or other preparations containing substances that may result in a positive confirmatory drug test result, including, but not limited to supplements containing hemp products or coca leaf tea, as a legitimate medical explanation for the presence of drugs or drug metabolites in the urine specimen above the cutoff levels specified in § 26.163 or a licensees or other entitys more stringent cutoff levels.

Marijuana=Cannabissativa L.=CannabisIndica=Hemp

Cannabidiol, Hemp, and Marijuana Slide27 Date:

May 26, 2015 From:

Katherine Archuleta, Director, U.S. Office of Personnel Management

Subject:

Federal Laws and Policies Prohibiting Marijuana Use Federal law on marijuana remains unchanged. Marijuana is categorized as a controlled substance under Schedule I of the Controlled substance Act.

Thus knowing or intentional marijuana possession is illegal, even if an individual has no intent to manufacture, distribute, or dispense marijuana. In addition, Executive Order 12564, Drug-Free Federal Workplace, mandates that (a) Federal employees are required to refrain from use of illegal drugs; (b) the use of illegal drugs by Federal employees, whether on or off duty, is contrary to the efficiency of the service

Cannabidiol, Hemp, and Marijuana Slide28 Date:

November 22, 2017 From:

Ron Flegal, B.S., MT (ASSCP), M.S., Director, HHS/SAMHSA/DWP

Subject:

Use of Marijuana Oils or Marijuana Infused Commercial Products Marijuana products, including CBD, are classified as Schedule I controlled substances under the Controlled Substances Act and, thus, are illegal under federal law.

CBD is chemically distinguishable from THC and will not cause a positive drug test result under the current drug testing panel but is a Schedule I drug.

However, CBD products may contain other cannabinoids such as THC, therefore, use of CBD oils and marijuana-derived products may result in a positive urine drug test for THCA.

Slide29 Sec 7606 of the Agricultural Act of 2018 (Farm Bill)

Permits agricultural research pilot programs to grow industrial hemp The term industrial hemp includes the plant Cannabis sativa L. and any part or derivative of such plant, including seeds of such plant, whether growing or not, that is used exclusively for industrial purposes (fiber and seed) with a tetrahydrocannabinols concentration of not more than 0.3 percent on a dry weight basis The term tetrahydrocannabinols includes all isomers (CBD), acids, salts, and salts of isomers of tetrahydrocannabinols

Slide30 Enforcement Policy Revision SRM-SECY-17-0059 Proposed Enforcement Policy Revision for Processing Fitness-For-Duty Cases Resulting from Site Fitness-For-Duty Drug and Alcohol Violations by Individuals (ADAMS Accession Nos. ML16355A048 and ML19108A476)

Federal Register Notice Processing Fitness-for-Duty Drug and Alcohol Cases 84 FR 34363; May 28, 2019; Office of Enforcement Revision to the NRC Enforcement Policy, Section 4.1, Considerations in Determining Enforcement Actions Involving Individuals:

For FFD violations involving non-licensed individuals who violate drug and alcohol provisions of site FFD programs, which are explicitly described in § 26.75, Sanctions, the NRC will not typically consider FFD drug and alcohol-related violations for enforcement action unless there is an apparent deficiency in the licensees FFD program to take the required sanctions against the individual(s) or deficiencies in implementation of the licensee FFD program.

Reporting of Alcohol-related Events Slide31 10 CFR 26.719 (b) Significant FFD policy violations or programmatic failures. The following significant FFD policy violations and programmatic failures must be reported to the NRC Operations Center by telephone within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> after the licensee or other entity discovers the violation:

(1) The use, sale, distribution, possession, or presence of illegal drugs, or the consumption or presence of alcohol within a protected area (2) Any acts by any person licensed under 10 CFR parts 52 and/or 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel who are authorized under this part, if such acts (iii) Involve the consumption of alcohol within a protected area or while performing the duties that require the individual to be subject to the FFD program

Reporting of Alcohol-related Events Slide32 Response to NEI question on the reporting of alcohol-related occurrences to the NRC Headquarters Operation Center (HOC) pursuant to 10 CFR 26.719(b)(1) and (b)(2)(iii):

Licensees should report to the NRC HOC alcohol-related events when they involve a liquid having an alcohol concentration equal to or greater than 0.5 percent alcohol by volume (ABV), as measured by the licensee or other entity, or a container labeled pursuant to the United States Department of the Treasury, Alcohol and Tobacco Tax and Trade Bureau under 27 CFR Part 16, Alcoholic Beverage Health Warning Label.

Posted on the FAQ website on June 13, 2019 (https://www.nrc.gov/docs/ML1908/ML19084A144.html)

Reporting of Alcohol-related Events Slide33 Additional Guidance

1. Alcohol is a substance intended for human consumption with a molecular formula of C2H5OH. Alcohol is typically in a liquid form (e.g., liquor, beer, wine) but can come in many forms (used as an ingredient in a marinade, sauce, or extract; infused into a solid such as a cake; converted to a powder form; vaporized; prescription and over-the-counter medications).
2. An empty can, bottle, box with a label indicating at least 0.5 percent ABV alcohol that is identified in a PA should be reported to the HOC. If the licensee or other entity determines the product was not recently used (e.g.,

container was covered with dust, cobwebs, etc.) the event should not be reported.

Reporting of Alcohol-related Events Slide34 Additional Guidance

3. For consumable products, including over-the-counter and prescription medications, that list alcohol as an ingredient, but do not have a Federal alcohol label, licensees and other entities should use their site processes and procedures to determine if a report to the NRC HOC is needed.
4. Products with denatured alcohol such as Listerine, Purell hand sanitizer, or cosmetics, are not alcohol under 10 CFR Part 26.

Slide35 Submission of FFD Forms containing PII Be aware when submitting FFD program performance reports (Single Positive Test Forms) the NRC using the NRCs Electronic Information Exchange (EIE)

EIE saves both the licensee-designated "File Name" and "Document Title" entered for each FFD form uploaded and submitted to the NRC.

DONOTincludeanypersonallyidentifyinginformationormedicalinformationintheFileName" or"DocumentTitle"fields,suchasaperson's name, initials, social security number, or site badge number.

Slide36 Operational Experience

Operational Experience (OpE) Topics Topic 1: Follow-up testing Topic 2: Testing of remote location personnel Topic 3: Alternative specimens Topic 4:

Gender identity and observed collections Topic 5: Random testing Slide37

OpE Topic 1 -

Follow-up testing 26.31(c)(4)

Performed because of:

A prior positive 10 CFR Part 26 drug/alcohol test Potentially disqualifying FFD information

Purpose:

Detection (confirms continued abstinence)

Deterrence Operational issues impacting:

Not onsite on a regular basis (e.g., contractor)

Meeting testing schedule Transfers from licensee programs Testing plan information Slide38 Didyouknow?

20142018results Positiveratefor followuptestingis doublethatfor randomtesting

~6,800- 8,400 followuptestswere performedannually

OpE Topic 2 -

Testing of Remote Location Personnel Can a hospital or other location meeting U.S. DOT 49 CFR Part 40 requirements collect specimens for a 10 CFR Part 26 FFD program?

Yes, but only for FFD program personnel and only under limited circumstances. Section 26.31(b) permits use of a 49 CFR Part 40 compliant location to collect alcohol and drug testing specimens from FFD program personnel who are:

1) involved in day-to-day operations (as defined in licensee procedures)

AND

2) whose duties require access OR who perform activities listed in 26.4(g)

Slide39 Note:SubpartK(constructionsitesalso canutilize49CFRPart40collectionsites)

OpE Topic 3 -

Alternate Specimen Collections Licensees and other entities can collect an alternate specimen in three circumstances:

1)

Shy-bladder medication condition highly likely to prevent the donor from providing a sufficient amount of urine for a very long or indefinite period - 26.119(g)(3) 2)

Invalid specimen with an acceptable medical explanation and an invalid result similarly would affect the testing of another urine specimen - 26.185(f)(2) 3)

Medical condition that makes collection of breath, oral fluids, or urine specimens difficult or hazardous - 26.31(d)(5)(i)

Slide40

OpE Topic 4 -

Gender Identity and Observed Collections 26.115 Collecting a urine specimen under direct observation.

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

Part 26 is silent on how the gender of an individual is to be determined.

HHS --Urine Specimen Collection Handbook for Federal Agency Workplace Drug Testing Programs (pages 26-27, 10/01/2017)

The observers gender must be the same as the donors gender, which is determined by the donors gender identity.The donors gender identity may be the same as or different from the donors sex assigned at birth.

Slide41

OpE Topic 5 -

Random Testing 26.31(c)

Random number generator, equal probability of selection Random testing pool incomplete Testing on weekends limited Slide42

Random Testing Positive Rates [Draft]

Site-Specific Distributions, 2018 Slide43

Random Testing Positive Rates [Draft]

Site-Specific Distributions, 2014-2018 Slide44 2014 2015 2016 2017 2018 2014 2015 2016 2017 2018 0

39 35 34 37 29 23 32 32 32 28

> 0% - 0.25%

20 21 19 20 22 2

4 2

1 4

> 0.25% - 0.5%

11 15 15 12 16 17 12 10 10 14

> 0.5% - 0.75%

3 1

3 2

4 18 13 10 13 6

> 0.75% - 1%

4 3

8 6

10

> 1% - 1.25%

1 1

3 4

2 4

5

> 1.25% - 1.5%

4 2

2 1

1

> 1.5% - 1.75%

3 3

4 2

2

> 1.75% - 2%

1 3

1

> 2%

2 1

Sites (with at least 1 test) 74 72 72 71 71 75 73 73 72 71 Sites (no tests performed) 1 1

1 1

0 0

0 0

0 0

Total Sites 75 73 73 72 71 75 73 73 72 71 Positive Rate Range (%)

Licensee Employee C/V

Random Testing (Days of the Week)

Slide45 10 CFR 26.31(c)(2)(i)(B) requires random testing to be conducted on an unpredictable schedule, including weekends, backshifts, and holidays...

PercentageofPositive*TestsResultsbyDayofCollection Year Mon.

Tues.

Wed.

Thur.

Fri.

Sat.

Sun.

2018 21.0%

28.1%

18.6%

20.0%

10.0%

1.9%

0.5%

2017 19.8%

24.4%

25.2%

17.6%

12.2%

0.4%

0.4%

2016 14.6%

24.2%

20.0%

25.8%

10.8%

3.1%

1.5%

2015 17.2%

28.9%

25.9%

14.7%

12.9%

0.4%

0.0%

2014 22.6%

20.8%

25.8%

19.9%

9.0%

1.4%

0.5%

  • Positive=Positivedrugandalcoholtests,adulteratedandsubstitutedvaliditytestresults, andrefusalstotest

NRC Fitness for Duty Program Staff Slide46 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)