ML21165A058
| ML21165A058 | |
| Person / Time | |
|---|---|
| Issue date: | 06/15/2021 |
| From: | NRC/NRR/DANU |
| To: | |
| Wagner K | |
| Shared Package | |
| ML21165A052 | List: |
| References | |
| Download: ML21165A058 (22) | |
Text
The NRCs public meeting to discuss risk-informing medical exam requirements for Research and Test Reactor (RTR) licensees will begin shortly.
Please ensure you have connected to MS Teams audio either through your computer or by phone.
Discussion of Risk-informing Medical Exam Requirements for Research and Test Reactor (RTR) Licensees June 15, 2021 Non-Power Production and Utilization Facilities Oversight Branch Division of Advanced Reactors and Non-Power Production and Utilization Facilities Office of Nuclear Reactor Regulation ADAMS Accession No. ML21165A058
Todays Meeting The purpose of this public meeting is to discuss with the research and test reactor (RTR) community the NEI comment received regarding requirements for medical exams for licensing of RTR operators and possible options to move forward with risk-informing the medical exam requirement for RTR operators.
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Todays Agenda
- NRC Staff Presentation
- TRTR Remarks
- NRC and TRTR Panel Discussion
- Short Break
- Open Discussion for Feedback and Questions
- Submit questions and comments via Chat at any time (we will address them during the Open Discussion portion of the meeting).
- During the Open Discussion, raise your hand so we can enable your microphone.
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NRC Presentation Agenda
- Current legislative authority and regulatory framework
- Retrospective Review of Administrative Requirements (RROAR) process
- NEI letter with recommendation/comments
- NRC response
- Feedback and questions 5
Current Legislative Authority
- Atomic Energy Act, Sec. 107, Operators Licenses The Commission shall-
- a. prescribe uniform conditions for licensing individuals as operators of any of the various classes of production and utilization facilities licensed in this Act;
- b. determine the qualifications of such individuals;
- c. issue licenses to such individuals in such form as the Commission may prescribe; and
- d. suspend such licenses for violations of any provision of this Act or any rule or regulation issued thereunder whenever the Commission deems such action desirable 6
Current Regulatory Framework (Slide 1 of 7)
- § 55.33 Disposition of an initial application.
- (a)(1) Health. The applicants medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety. The Commission will base its finding upon the certification by the facility licensee as detailed in § 55.23.
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Current Regulatory Framework (Slide 2 of 7)
- § 55.23 Certification.
- To certify the medical fitness of the applicant, an authorized representative of the facility licensee shall complete and sign NRC Form 396, "Certification of Medical Examination by Facility Licensee," which can be obtained by . . . visiting the NRC's Web site at http://www.nrc.gov and selecting forms from the index found on the home page.
- (a) Form NRC-396 must certify that a physician has conducted the medical examination of the applicant as required in § 55.21.
- (b) When the certification requests a conditional license based on medical evidence, the medical evidence must be submitted on NRC Form 396 to the Commission and the Commission then makes a determination in accordance with § 55.33.
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Current Regulatory Framework (Slide 3 of 7)
- § 55.21 Medical examination.
- An applicant for a license shall have a medical examination by a physician. A licensee shall have a medical examination by a physician every two years. The physician shall determine that the applicant or licensee meets the requirements of
§ 55.33(a)(1).
- § 55.33(a)(1): ... applicants medical condition and general health will not adversely affect the performance of assigned operator job duties or cause operational errors endangering public health and safety.
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Current Regulatory Framework (Slide 4 of 7)
- § 55.33 Disposition of an initial application.
- (b) Conditional license. If an applicant's general medical condition does not meet the minimum standards under § 55.33(a)(1) of this part, the Commission may approve the application and include conditions in the license to accommodate the medical defect. The Commission will consider the recommendations and supporting evidence of the facility licensee and of the examining physician (provided on Form NRC-396) in arriving at its decision.
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Current Regulatory Framework (Slide 5 of 7)
- NRC Form 396:
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Current Regulatory Framework (Slide 6 of 7)
- Summary of Public Comments and Final Actions from Final Rule affecting 10 CFR Parts 50 and 55 (selected excerpts)1:
- The intent is to prevent the manipulation of the controls by an operator whose medical condition and general health would cause operational errors endangering public health and safety.
- The NRC has the responsibility for making an assessment of the applicant for a license, including the applicants medical fitness. Neither the facility nor the NRC staff will make medical judgments.
1 - Nuclear Regulatory Commission; Operators' Licenses and Conforming Amendments; Final Rule, 52 FR 9453 (March 25, 1987).
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Current Regulatory Framework (Slide 7 of 7)
- Existing regulatory process and flexibilities:
- 10 CFR 55.33(b) provides a process for conditional license if an applicants general medical condition does not meet minimum standards.
- NRC Form 396 identifies multiple versions of industry-developed consensus standards as guidance for medical exams.
- NRC Form 396 identifies the potential to use an Other alternative guidance document for medical exams.
- NRC Form 396 could be revised if industry opts to revise ANSI/ANS 15.4 or develop a new consensus standard for medical exams.
- There may be additional flexibilities not considered here.
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What is Retrospective Review of Administrative Requirements (RROAR)?
Purpose:
- Identify outdated or duplicative administrative requirements (recordkeeping or reporting) that may be eliminated or modified.
- Method:
- Collect suggestions from the NRC staff, industry, and members of the public.
- Apply a set of five Commission-approved evaluation criteria.
- For more information see: RIC 2020 Digital Exhibit 14
Important Documents
- February 4, 2020 Federal Register notice regarding request for comments applicable to RROAR (85 FR 6103)
- NEI letter dated May 6, 2020 (ML20128J340) submitted in response to Federal Register notice 15
Partial Text of NEI Comment on 10 CFR 55.33(a) (Slide 1 of 2)
- This requirement should be modified to allow for alternate means for operator medical qualification at non-power utilization facilities (NPUFs), in order to 1) better align with the Atomic Energy Act of 1954, as amended, which dictates minimum regulations be imposed upon NPUFs and 2) align with their inherently low risk-profile.
- One alternative is to incorporate ANSI/ANS Standard 15.4, Section 7.3, which NRC has previously endorsed. It permits in 7.3.1(3), Certification from Level 2 indicating that the individual can safely perform his or her assigned duties.
- Source: ML20128J340
[see next slide]
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Partial Text of NEI Comment on 10 CFR 55.33(a) (Slide 2 of 2)
- 10 CFR 55.33 could incorporate a new part (c), which states, Medical qualification for facilities licensed under 104(a), (b), or (c) of this part may be justified at the time of initial application and subsequent renewal by having a valid U.S. drivers license, by consent of the Level 2 individual, or in accordance with the established Requalification Plan. An operator shall obtain written statement from a licensed physician, physicians assistant, or nurse practitioner stating the individual can reasonably be expected to perform operations consistent with those necessary to operate a commercial motor vehicle (NEI Table 18: Medical Requirements for Research and Test Reactor Operators).
- Source: ML20128J340 17
NRC Response to NEI Comment
- NRC staff have prepared a response as part of a forthcoming SECY paper.
- The SECY paper is expected to be made publicly available soon.
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Discussion
- The NRC is interested in any feedback regarding the medical exam component of the operator licensing process, such as:
- Does the current process meet your needs?
- Hurdles encountered?
- Other concerns?
- Ideas for possible flexibilities or improvements to the current approach?
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And now we will hear from the National Organization of Test, Research, and Training Reactors Ayman I. Hawari, Ph.D.
Director, Nuclear Reactor Program North Carolina State University
How to Comment
- Submit questions or comments via Chat and we will read them aloud.
- Click on the hand icon at the top of your Teams screen to raise your hand.
- We will enable your microphone.
- You must then unmute yourself to speak.
- You can mute yourself when you are finished (or we can mute you).
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We are taking a short break.
We will resume at 3:15 p.m. EDT.