ML19154A547

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SRM-SECY-17-0027: Enclosure 2 - Draft Regulatory Analysis and Backfitting and Issue Finality 10 CFR Part 26 Fitness for Duty Drug Testing Requirments
ML19154A547
Person / Time
Issue date: 06/03/2019
From: Annette Vietti-Cook
NRC/SECY
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Shared Package
ML19154A539 List:
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Download: ML19154A547 (112)
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Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review i February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review ii February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review iii February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review iv February 2017

Code of Federal Regulations

Federal Register

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review v February 2017 Code of Federal Regulations

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review vi February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review vii February 2017 Code of Federal Regulations

Federal Register***

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review viii February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review ix February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review x February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review xi February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review xii February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review xiii February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review xv February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review xvi February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 1 February 2017 Code of Federal RegulationsFederal Register1.1 Background

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 2 February 2017

NRC FFD Program and the HHS Guidelines

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 3 February 2017

1.2 Statement of the Problem and U.S. Nuclear Regulatory Commission Objectives for the Rulemaking

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 4 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 5 February 2017

      • 2.1 Alternative 1: Take No Action

only Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 6 February 2017

2.2 Alternative 2: Amend 10 CFR Part 26 Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 7 February 2017

2.3 Alternative 3: Address Issues through Means Other than Rulemaking

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 8 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 9 February 2017 Federal Register

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 10 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 11 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 12 February 2017

4.1 Identification of Affected Attributes

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 13 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 14 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 15 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 16 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 17 February 2017 4.2 Analytical Methodology

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 18 February 2017

  • FFD Programs*Drug Testing Laboratories**Total Industry Cost or Benefit Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 20 February 2017
  • Average Cost per SiteTotal Industry Cost or Benefit Average Cost or Benefit per Site Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 21 February 2017
  • Testing Data by Facility Type

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 22 February 2017

  • Analysis Horizon
  • Base Year*Discounting of Costs and Savings*Cost/Benefit Inflators Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 23 February 2017
  • Sign conventions*Labor rates(1) Lowered initial and confirmatory drug testing cutoff levels for amphetamines and cocaine metabolites. ****

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 24 February 2017 (2) Expanded initial drug testing panel to include 6-acetylmorphine (6-AM) and revised confirmatory drug testing cutoff level for 6-AM.

    • (3) Expanded initial and confirmatory drug testing panels to include Ecstasy.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 25 February 2017

    • (4) Required special analyses testing of dilute specimens and specimens collected during suspected subversion attempts.

option

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 26 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 27 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 28 February 2017

  • Affected entities*Site-specific drug and alcohol testing data *Workforce to receive training on policy changes*NRC drug testing information
  • Reactors under construction (test results)*Percent change in positive rates (amphetamines and cocaine)

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 29 February 2017

  • Expected positive rates for the new drugs included in the testing panel (6-AM and Ecstasy drugs)
  • Specimen testing costs*Special analyses testing of specimens collected under direct observation (suspect specimens)

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 30 February 2017

  • Special analyses testing of dilute specimens:

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 32 February 2017

5.1 Benefits and Costs of the Proposed Rule

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 33 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 34 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 35 February 2017 1 Average cost per site calculated by dividing the total industrywide cost by the number of sites (67).

2 In addition to these industry costs, the NRC implementation costs as a result of the final rule are estimated to be ($273,000).

3 Results stated in 2017 dollars.

TOTAL ($168,594)

($2,439,343)

($3,360,912)

($2,516) 1 Average cost per site is calculated by dividing the total industrywide cost by the number of sites (67).

2 Results stated in 2017 dollars.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 36 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 37 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 38 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 39 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 40 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 41 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 42 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 43 February 2017

.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 44 February 2017

5.2 Uncertainty Analysis

most likely Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 45 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 46 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 47 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 48 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 49 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 50 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 51 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 52 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 53 February 2017

5.3 Disaggregation

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 54 February 2017 5.4 Backfitting and Issue Finality 5.5 Results for the Committee to Review Generic Requirements Federal Register Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 55 February 2017 Federal RegisterFederal Register Federal Register

Federal Register Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 56 February 20176.1 Regulatory Analysis

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 57 February 2017***Expanding the drug testing panel and lowering the testing cutoff levels for select drugs.Requiring and expanding special analyses testing Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 58 February 2017Enhancing FFD program integrity and protection of individual rights.Improving regulatory efficiency between 10 CFR Part 26 and other related Federal rules and guidelines.Enhancing root-cause analysis in post-event testing situations associated with a refusal to test determination at the collection site6.2 Backfitting and Issue Finality Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 59 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 60 February 2017Federal Register***

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 61 February 2017U.S. Code of Federal Regulations

Federal RegisterFederal Register Controlled Substances Act, Federal Register

U.S. Code of Federal Regulations U.S. Code of Federal Regulations U.S. Code of Federal Regulations

Title 10 Code of Federal Regulations

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 62 February 2017 Code of Federal RegulationsCode of Federal Regulations U.S. Code of Federal Regulations

U.S. Code of Federal Regulations

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 63 February 2017

Federal Register

Federal Register Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review 64 February 2017

Federal Register

Federal Register Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review A-1 February 2017 Appendix A: Site-Specific Fitness-for-Duty Program Performance Data (Calendar Years 2009-2014) (Table sorted by Facility Type, then FFD Program, and then Units)

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review A-2 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review A-3 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review B-1 February 2017 Appendix B: General Inputs

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review B-2 February 2017

6-Acetylmorphine (6-AM) Amphetamines Cocaine

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review B-3 February 2017 Dilute Specimens (Special Analyses Testing)

Subversion Attempts (Special Analyses Testing of Suspect Specimens)

Averted Training Costs-Pre-Access Testing

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-1 February 2017 Appendix C: Assumptions and R esults by Regulatory Initiative C.1 Policy, Procedure, and Training Costs Activity Labor Category Wage Rate or Unit Cost Quantity Benefits (Cost) Entities Affected Total Benefits (Costs)

Total Industry Implementation Cost ($337,090) Average Implementation Cost Per Site ($5,031)

- - Total NRC Implementation Cost **

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-2 February 2017 C.2 Lower Initial and Confirmatory Testing Cutoff Levels for Amphetamines and Cocaine Activity Parameter Value Benefits (Cost) Sites Affected Total Benefits (Costs)

Total Industry Operations Cost ($13,733) Average Operations Cost Per Site ($205)

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-3 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-4 February 2017 C.3 Expand Initial Drug Testing Panel to Include 6-AM and Revise Confirmatory Testing Cutoff Level for 6-AM Activity Parameter Value Benefits (Cost) Sites Affected Total Benefits (Costs)

Total Industry Operations Cost ($136,555) Average Operations Cost Per Site ($2,038) ********

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-5 February 2017 C.4 Expand the Initial and Confirmatory Drug Testing Panels to Include Ecstasy **Activity Parameter Value Benefits (Cost) Sites Affected Total Benefits (Costs)

Total Industry Operations Cost ($94,871) Average Operations Cost Per Site ($1,416) ********

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-6 February 2017 C.5 Special Analyses Testing of Dilute Specimens and Specimens Collected during Suspected Subversion Attempts Activity Parameter Value Benefits (Cost) Sites Affected Total Benefits (Costs)

Total Industry Operations Cost ($11,256) Average Operations Cost Per Site ($168)

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review C-7 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review D-1 February 2017 Appendix D: Costs of Subsequent Actions

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review E-1 February 2017 Appendix E: Averted Costs Averted Training Costs-Pre-Access Testing Activity Parameter Value Positives Per Site Sites Affected Total Positives Total Additional Positive Test Results Projected from Proposed Rule Changes

Total Additional Positive Test Results Projected from Proposed Rule Changes 95 Averted Training Costs-Pre-Access Testing

Total Industry Operations Benefit $87,821 Average Operations Benefit Per Site $1,311 Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review E-2 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-1 February 2017 Appendix F: Backfitti ng and Issue Finality Code of Federal Regulations

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-2 February 2017

Administrative matters Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-3 February 2017 Information collection and reporting requirements Clarifications Permissive relaxations/voluntary alternatives

1. Lower initial and confirmatory testing cutoff levels for amphetamines and cocaine metabolites. Federal Register
2. Expand initial drug testing panel to include heroin metabolite, 6-acetylmorphine (6-AM), and revise confirmatory testing cutoff level for 6-AM.
3. Expand initial and confirmatory drug testing panels to include Ecstasy-type drugs. 4. Require special analyses testing of dilute specimens and specimens collected during suspected subversion attempts.
5. Require the use of the limit of quantitation (LOQ) instead of the limit of detection (LOD) as the decision point for special analyses testing and adulterant testing of specimens.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-5 February 2017

6. Additional MRO review for specimens with invalid validity test results due to high pH values (9.0 to 9.5)and MRO actions when a donor requests testing a Bottle B specimen or retesting of an aliquot of a single specimen.

Testing of any specimen(s) collected during post-event testing when a refusal to test has been determined during the collection process

1. Statement of the specific objectives that the backfit is designed to achieve.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-6 February 2017

2. General description of the activity that would be required by the licensee or applicant in order to complete the backfit.
3. Potential change in the risk to the public from the accidental offsite release of radioactive material.
4. Potential impact on radiological exposure of facility employees.
5. Installation and continuing costs associated with the backfit, including the cost of facility downtime or the cost of construction delay. 6. The potential safety impact of changes in plant or operational complexity, including the relationship to final and existing regulatory requirements.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-7 February 2017

7. The estimated resource burden on the NRC associated with the backfit and the availability of such resources.
8. The potential impact of differences in facility type, design, or age on the relevancy and practicality of the backfit.
9. Whether the backfit is interim or final and, if interim, the justification for imposing the backfit on an interim basis.
  • Expanding the drug testing panel and lowering the testing cutoff levels for select drugs Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-8 February 2017
  • Requiring and expanding special analyses testing.*Enhancing FFD program integrity and protection of individual rights. *Improving regulatory efficiency between 10 CFR Part 26 and other related Federal rules and guidelines. *Improving root-cause analysis by testing any specimen(s) collected during a post-event test when a refusal to test has been made at the collection site.

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-9 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-10 February 2017

Amend 10 CFR Part 26, "Fitness for Duty Programs," based on provisions in the 2008 HHS Guidelines Draft for Commission review F-11 February 2017

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