ML24036A330
| ML24036A330 | |
| Person / Time | |
|---|---|
| Issue date: | 02/07/2024 |
| From: | Brian Zaleski NRC/NSIR/DPCP/RSB |
| To: | |
| References | |
| RIN 3150-AJ15 | |
| Download: ML24036A330 (1) | |
Text
10 CFR Part 26, Fitness for Duty Programs Question and Answer Session on:
"Drug and Alcohol Testing: Technical Issues and Editorial Changes" Rulemaking February 7, 2024 (Webinar)
Opening Remarks The purpose of this meeting is to provide licensees and other entities with an opportunity to ask the NRC technical staff questions about key topic areas under consideration for a potential new Part 26 rulemaking effort.
This is an Information Meeting with a Question-and-Answer Session. Attendees will have an opportunity to ask questions of the NRC staff or make comments about the issues discussed throughout the meeting; however, the NRC is not actively soliciting comments towards regulatory decisions at this meeting.
Slide 2
Discussion Topics Opening Remarks and Agenda Background (overview of rulemaking process)
Key Topic Areas for Discussion
- Federal Agency Testing Program Changes (HHS, U.S. DOT)
- Petitions for Rulemaking
- Lessons Learned - Part 26 Implementation Question and Answer Session Slide 3
Agenda Slide 4 Time Topic Speaker 1:00 - 1:05 PM
Introductions
NRC 1:05 - 2:05 PM
Background
Key Topic Areas:
- Federal Agency Testing Program Changes
- Petitions for Rulemaking
- Lessons Learned - Part 26 Implementation NRC 2:05 - 2:55 PM Q&A Session Stakeholders 2:55 - 3:00 PM Closing Remarks NRC
NRC Rulemaking Information Slide 5
Title:
Drug and Alcohol Testing: Technical Issues and Editorial Changes (NRC-2012-0079; RIN 3150-AJ15)
Rulemaking Plan Regulatory Basis Proposed Rule Final Rule (were here)
Information and Schedule: NRC Planned Rulemaking Activities website https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/active/ruleindex.html Obtain Documents at Regulations.gov:
https://www.regulations.gov/search?filter=NRC-2012-0079
NRC Rulemaking Process Slide 6
Tech Issues Rulemaking Background The NRC staff committed in the SECY-21-0082, which was provided to the Commission with the 2022 Part 26 Final Rule package, that it would develop and submit a rulemaking plan to the Commission on the Tech Issues rulemaking within 1 year after publication of the final rule.
The staff stated in SECY-21-0082, that it expected to consider utilizing oral fluid testing under additional testing conditions in the future due to its potential to deter subversion attempts.
The 2022 Part 26 Final Rule, Fitness for Duty Drug Testing Requirements was published in the Federal Register on November 22, 2022.
(87 FR 71422). Compliance was required by November 22, 2023.
Slide 7
Tech Issues Rulemaking Objectives Address technical and administrative issues associated with the implementation of FFD drug and alcohol testing program requirements in three core areas:
Improve the effectiveness and efficiency of Part 26 by aligning with updates to the HHS Guidelines and DOT drug testing requirements Incorporate lessons learned in the implementation of Part 26 Resolve three petitions for rulemaking (PRM-26-4, PRM-26-7, PRM-26-8)
Slide 8
U.S. Department of Transportation (DOT), 49 CFR Part 40, Procedures for Transportation Workplace Drug and Alcohol Testing Programs 2017 Final Rule, Addition of Certain Schedule II Drugs to the Department of Transportation's Drug-Testing Panel and Certain Minor Amendments (82 FR 52229, November 13, 2017) 40.141 How does the MRO obtain information for the verification decision?
(b) If the employee asserts that the presence of a drug or drug metabolite in his or her specimen results from taking prescription medication (i.e., a legally valid prescription consistent with the Controlled Substances Act), you must review and take all reasonable and necessary steps to verify the authenticity of all medical records the employee provides.
You may contact the employees physician or other relevant medical personnel for further information. HHS certified laboratory with validate protocols (see § 40.81(c)) to conduct testing for D,L stereoisomers of amphetamine and methamphetamine or testing for tetrahydrocannabivarin (THC-V) when verifying lab results, as you determine necessary.
Federal Agency Testing Program - DOT Slide 9
Federal Agency Testing Program - DOT 2023 Final Rule Addition of Oral Fluid Specimen Testing for Drugs (84 FR 27596, May 2, 2023)
This additional methodology for drug testing will give employers a choice that will help combat employee cheating on urine drug tests and provide a less intrusive means of achieving the safety goals of the program.
Provides employers with the option to collect and test oral fluid in addition to urine testing for drugs The final rule has not been implemented yet because it requires at least two HHS-certified laboratories to test oral fluid specimens (required for split specimen testing - donor protection).
Slide 10
Federal Agency Testing Program - HHS U.S. Department of Health and Human Services, Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines) 2023 Final Revisions to Urine and Oral Fluid HHS Guidelines October 12, 2023 (Urine 88 FR 70768; Oral Fluid 88 FR 70814)
Established a process to annually review and publish the authorized drug testing panel (drugs, analytes, or cutoffs) to be used for the Federal workplace drug testing program Added biomarker testing (will annually publish with drug testing panel) -
no currently authorized biomarkers Clarified oral fluid testing procedures Revised MRO verification process for positive codeine and morphine specimens Slide 11 The Tech Issues rulemaking is not intended to address frequent panel changes.
More on this topic later in this presentation.
Petitions for Rulemaking
- 1) PRM-26-4, California Association of Marriage and Family Therapists (75 FR 51958, August 24, 2010) (Docket No. NRC-2010-0269)
Request to add marriage and family therapists to the list of acceptable credentials to serve as a substance abuse expert (26.187)
- 2) PRM-26-7, Certification of Substance Abuse Experts, American Academy of Health Care Providers in the Addictive Disorders (77 FR 33619, June 7, 2012) (Docket No. NRC-2011-0220)
Request to include the Academy as one of the organizations authorized to certify a substance abuse expert (26.187(b)(5))
- 3) PRM-26-8, Additional Synthetic Drug Testing under FFD Program (78 FR 22209, April 15, 2013) (Docket No. NRC-2012-0290)
Request to test for additional synthetic drugs (26.31(d)(1) and 26.405(d))
Slide 12 https://www.nrc.gov/reading-rm/doc-collections/rulemaking-ruleforum/petitions-by-year
Lessons Learned Topics The staff is considering lessons learned from a variety of sources such as:
Questions received on Part 26 from regulated entities Site-specific FFD program performance information NRC inspections NRC FFD technical staff identified issues 2022 Part 26 final rule (out of scope public comments)
Slide 13
Lessons Learned - Oral Fluid Testing Oral fluid drug testing (considerations) 2022 Part 26 final rule permitted oral fluid testing for limited circumstances (as an alternative to most directly observed urine collection conditions)
Continuing prevalence of identified subversion attempts of urine specimen collection process (approximately 30% of drug testing violations annually)
Consider expanding conditions when oral fluid testing is permitted:
Reasons for testing (pre-access, random, for-cause, post-event, followup)?
Shy-bladder?
Slide 14 The staff will utilize the HHS Guidelines for Oral Fluid testing (2019 and 2023) and the 2023 DOT oral fluid testing final rule to inform its oral fluid testing considerations.
Lessons Learned - Subversions Considerations Prohibit possession of subversion paraphrenia (e.g., product in backpack, product in locker - events not tied to the collection process)
- Products illegal in some states
- No legitimate reason for possession Include 26.75 permanent denial for possession of subversion paraphernalia Evaluate if more restrictive urine specimen temperature range would be beneficial in identifying additional subversion attempts (current range = 90-100oF)
Improve information on MRO test result reviews, for example:
- 1st specimen out of temperature (negative); 2nd observed specimen (positive)
- 1st specimen (invalid result); 2nd observed specimen (positive)
- Clarify that the MRO is to consider all information in making subversion determinations, such as comparison of specimen characteristics when multiple specimens are collected (temperature, creatinine, pH, specific gravity)
Slide 15
Lessons Learned - BPTS Blind Performance Test Samples (26.168) (considerations)
Contract with new laboratory, initial 90-day submittal requirements, 26.168(a)(1)
Quarterly submittal requirements, 26.168(b)-(f)
(negative, drug positive, false negative challenge, adulterated, dilute, substituted)
Industry use of a limited number of HHS-certified laboratories (presents potential efficiencies)
Fleet vs site-specimen application of BPTS requirements Why a BPTS program is needed:
Each year, NRC receives 30-day reportable events on unsatisfactory performance discovered at HHS laboratories identified by BPTS submissions, 26.719(c)
Consequences of testing violations (26.75 sanctions: 14 days, 5 years, permanent)
Special analyses testing, 26.163(a)(2)
Flexibility to use lower testing cutoff levels/expanded testing panel, 26.31(d)(1)(i)
Slide 16
Lessons Learned - Alcohol No definition in Part 26 24-hour report to the NRC under 26.719(b)(1) for consumption or presence of alcohol within a protected area (PA) 5-year minimum denial for consumption of alcohol within a PA or while performing duties - 26.75(c)
Prohibits consumption at least 5 hours5.787037e-5 days <br />0.00139 hours <br />8.267196e-6 weeks <br />1.9025e-6 months <br /> before arrival at site (a minimum but may not be sufficient to be fit for duty); during any tour of duty - 26.27(b)
Time-dependent alcohol testing violation levels (26.101)
Alcohol beverage labeling requirements do not cover all products containing impairing concentrations of alcohol Focus on potential for impairment, operating experience on:
- Very low alcohol containing products (e.g., kombucha)
- Food additives/extracts (e.g., vanilla extract is at least 35% alcohol by volume)
Slide 17
Lessons Learned - SAEs Substance Abuse Experts, 26.187 FFD program personnel involved in the day-to-day operations of the FFD program 26.4(g) and frequency of job activity performance Behavioral observation program applicability when an SAE is remote (i.e., does not have unescorted access to a site)
Initial evaluation performed after an FFD policy violation (e.g., positive result)
Face-to-face determination of fitness conducted for cause (i.e., because of observed behavior or a physical condition), 26.189(c)
Slide 18
Lessons Learned - MROs Medical Review Officers, 26.183 Legitimate medical explanation for a positive drug test result (Part 26 does not define) 26.5 defines illegal drug as any drug that is included in Schedules I to V of section 202 of the Controlled Substances Act [21 U.S.C. 812], but not when used pursuant to a valid prescription or when used as otherwise authorized by law.
(Part 26 does not define valid prescription)
Test results review (subversion attempts)
Test results review (misuse) - 26.185(j)(2)
Time to complete test result review and notify FFD program (10 business days from receipt of positive, adulterated, substituted, or invalid test result) - 26.185(p)
Retraining? An MRO is only required to receive initial training - 26.183(a)
(i.e., pass an examination administered by a nationally-recognized MRO certification board or subspecialty board for medical practitioners in the field of medical review of Federally mandated drug tests)
Slide 19
Lessons Learned - Random Testing Considerations, clarifications to:
Time to report to collection site. Report as soon as reasonably practicable after notification and within time period specified in the FFD policy) -
26.31(d)(2)(iii)
Weekend, backshift, and holiday testing. Collect specimens on an unpredictable schedule, including weekends, backshifts, and holidays -
26.31(d)(2)(i)(B) - no minimum is established by rule (e.g., is testing on one Sunday a year sufficient?)
50 percent annual random testing rate (does this apply per site or by fleet)
- 26.31(d)(2)(vii)
Random testing pool management. Part 26 is silent on the management of the random testing pool (e.g., one pool for all covered personnel at a site; one site pool for licensee employees and another for contractor/vendors) -
26.31(d)(2)(vii)
Slide 20
Lessons Learned - Laboratory Testing
- Subpart G, HHS-Certified Laboratories (HHS labs)
- 2022 Part 26 final rule eliminated 26.155 and most of 26.157, consider removing additional duplicative requirements
- Clarify requirement related to maintaining and sharing copies of HHS lab inspection report records under 26.41(g)(4)
- Subpart F, Licensee Testing Facilities (LTFs) - consider eliminating
- No licensees or other entities utilize LTFs as of 2023
- Historically, LTFs afforded licensees the ability to quickly process individuals during outages (quick turnaround on negative results), but industry has steadily moved to only using HHS labs for all testing
- Sophistication of testing required (e.g., expanded testing panels, additional specimen types)
Slide 21
Lessons Learned - FFD reporting 26.719 hour0.00832 days <br />0.2 hours <br />0.00119 weeks <br />2.735795e-4 months <br /> reports (considerations)
Establish minimum information to be provided in reports - to address reporting inconsistencies (e.g., employment category, test category)
Security officers (include in reporting criteria?)
Supervisors (another current NRC rulemaking effort is considering revising this reportability category to focus on safety and security related activities) 26.717 - Annual FFD program performance reports Consider requiring a few-risk informed data elements (right now these are optional fields in NRC Form 890, Single Positive Test Form)
- Pre-Access Testing Reason (e.g., Reinstatement (between 6 and 30 days))
- Followup testing reason (e.g., Potentially disqualifying FFD information)
Slide 22
2019 Part 26 Proposed Rule -
Out of Scope Public Comments Gender identity and observed urine collections (Comment L-1)
Post-event testing criteria (Comments F-1.1 and F-1.2)
Behavioral observation program elements (Comment G-1)
Medical evaluation (Comment N-1.1)
Alternative specimens (Comment N-1.2)
Substance abuse expert qualifications (Comment R-1)
Conditions for initiating a determination of fitness (Comment S-1)
NRC Responses to Public Comments, 2022 Part 26 Final Rule (ML22133A052)
Slide 23
Independent Staff Policy Paper on HHS Testing Panel Changes Independent of the Tech Issues rulemaking plan development, the NRC technical staff is exploring ways to make timely updates to a limited set of Part 26 requirements to align with HHS Guidelines testing panel changes (substances, cutoff levels, testing technology).
This policy paper is necessary given revisions to the HHS Guidelines published in October 2023 (i.e., annual review and possible updates to the analytes table to address societal drug use trends).
Slide 24
Question and Answer Session Slide 25
Contacts Brian Zaleski (FFD technical lead)
Specialist - Fitness for Duty / Access Authorization 301-287-0638 (Brian.Zaleski@NRC.gov)
Stewart Schneider (Rulemaking project manager)
Senior Project Manager 301-415-4123 (Stewart.Schneider@NRC.gov)
Slide 26