ML21096A010

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NRC Presentation for Fitness for Duty Drug Testing Requirements Final Rule; Part 26, Comulative Effects of Regulation Public Meeting
ML21096A010
Person / Time
Issue date: 04/13/2021
From: Stewart Schneider
NRC/NMSS/DREFS/RRPB
To:
Schneider, Stewart
References
10 CFR Part 26, NRC-2009-0225, RIN 3150-AI67
Download: ML21096A010 (22)
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Text

Public Meeting April 13, 2021 ADAMS Accession No. ML21096A010 Fitness for Duty Drug Testing Requirements Final Rule Cumulative Effects of Regulation

Announcements

  • Information Meeting with a Question and Answer Session
  • Teleconference Number (for audio) 1-800-857-4880 passcode: 9110579

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Meeting Guidelines

  • Identify yourself when speaking

- Please state your name, organization, and question

- Feedback during the meeting can only be provided using the bridge line 3

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Agenda 9:00-9:10 AM Welcome/Introductions/Logistics 9:10-9:30 AM Substantive Changes to Final Rule 9:30-9:40 AM Effective Date of Final Rule (Cumulative Effects of Regulation) 9:40-10:00 AM Public Feedback and Questions, Closing NRC Remarks, and Adjourn 4

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Providing Feedback

  • Feedback received today on cumulative effects of regulation (CER) issues will be captured in the meeting transcript
  • Feedback on this meeting can submitted in two ways, discussed at the end of the presentation 5

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Meeting Purpose

  • Discuss proposed effective date of final rule
  • Obtain public feedback on the effective date as it pertains to CER
  • Discuss substantive changes to final rule
  • NRC will not provide written responses to any comments made at this meeting 6

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Background-Schedule Sept. 16, 2019 Proposed rule published (84 FR 48750) to align Part 26 with select drug testing provisions in the 2008 HHS Guidelines Dec. 2, 2019 Public comment period closed (22 public comment submissions)

Sept. 15, 2021 NRC staff submits the final rule package to the Commission to obtain approval to publish the final rule 7

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Cumulative Effects of Regulation 8

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021 CER is a term used by the NRC to refer to the challenges that licensees and other entities face while implementing multiple regulatory actions within a limited implementation period and with limited available resources This CER public meeting is intended to obtain feedback during the final rule development to inform the implementation schedule

CER Considerations 9

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

  • Substantive changes to the final rule
  • NRC staffs expectations for rule implementation date
  • Public feedback

Drug Testing Panel Proposed Rule Changes

  • Lower testing cutoff levels:

- Amphetamine

- Methamphetamine

- Cocaine metabolite

  • Add two amphetamine-based drugs:

- Methylenedioxymethamphetamine (MDMA)

- Methylenedioxyamphetamine (MDA)

  • Revise testing approach for 6-Acetylemorphine (6-AM) 10 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Subversion Attempt Detection Proposed Rule Changes Revise special analyses testing provisions in § 26.163(a)(2):

  • Require special analyses testing when a specimen with a dilute validity test result has a drug or drug metabolite concentration at least 40 percent of initial test cutoff
  • Change confirmatory test cutoff from the Limit of Detection (LOD) to the Limit of Quantitative (LOQ) 11 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Subversion Attempt Detection Proposed Rule Changes Add special analyses testing for four direct observation collection conditions:

  • Donor provided a urine specimen with a substituted, adulterated, or invalid test result with no adequate medical explanation
  • Donors specimen outside acceptable temperature range (90-100oF)
  • Donors conduct indicates possible subversion attempt
  • Specimen unavailable for retesting (Bottle B or single specimen) 12 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Shy-Bladder Process Proposed Rule Change Permit a member of the FFD program personnel to observe a donor during the hydration process. Change would permit the initial collector to perform other activities (e.g., other collections) 13 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021 Final rule eliminates proposed requirement that hydration monitor be FFD program personnel

Questions in Proposed Rule Substantive Comment Received

  • Direct Observation of Specimen Collection Any effective alternatives to direct observation that will assist in preventing subversion of the drug testing process?

14 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Substantive Rule Changes Due to Public Comment

  • Expand drug testing panel to include four additional opioids (hydrocodone, hydromorphone, oxycodone, oxymorphone) in the 2017 HHS Guidelines
  • Provide option to collect an oral fluid specimen for direct observation conditions 15 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Question in Proposed Rule on Effective Date 16 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021 One commenter recommended 120 days (to understand and communicate changes to all departments and sections)

Another commenter recommended 1 year (to implement the new program utilizing established procedures and will need to evaluate change management plan items to include procedures, union/lab contracts, computer systems, and training)

NRC Staff Expectations 17 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021 Proposed 60-day implementation schedule is not expected to result in a cumulative impact on affected licensees and other entities because:

  • No other pending 10 CFR Part 26 regulatory actions exist that would impact the site professionals responsible for implementing the rule requirements
  • Changes to FFD policy, procedures, contracts, and training are minimal
  • Implementation guidance will be issued with the rule

Open Discussion and Questions 18 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021

Where to Find Information 19 Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting April 13, 2021 Search for docket ID NRC-2009-0225

How did we do?

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting Use this QR code April 13, 2021 20 OR Use Meeting Feedback Form link available in the NRC meeting notice OR

NRC Contacts Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting Stewart Schneider Rulemaking Project Manger 301-415-4123 Stewart.Schneider@nrc.gov Brian Zaleski Technical Lead 301-287-0638 Brian.Zaleski@nrc.gov April 13, 2021 21

Fitness for Duty Drug Testing Requirements Final RuleCER Public Meeting Thank You April 13, 2021 22

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