ML18344A103

IMC 0303 Health Physics Positions (Hppos)

ML18344A103
Person / Time
Issue date:	07/10/2019
From:	Garmon D NRC/NRR/DRA/ARCB
To:
Garmon D
Shared Package
ML18247A002, ML19191A072	List:
References
DC 19-001; CN 19-023
Download: ML18344A103 (10)

Text

NRC INSPECTION MANUAL ARCB INSPECTION MANUAL CHAPTER 0303 HEALTH PHYSICS POSITIONS (HPPOS)

Effective Date: 07/10/2019 0303-01 PURPOSE This Inspection Manual Chapter (IMC) describes the NRCs Health Physics Positions (HPPOS) program; provides instructions on how the HPPOS program is to be administered; and how HPPOS are developed and maintained. The guidance in this IMC ensures that HPPOS are not used to interpret regulations or inadvertently impose generic requirements on NRC licensees.

Finally, this guidance explains that as a knowledge management tool, HPPOS are not to be used to establish new agency regulatory positions.

0303-02 OBJECTIVE 02.01 To describe the HPPOS program 02.02 To provide guidance and a protocol for the development of new HPPOS 02.03 To establish a change control and document management process for HPPOS 0303-03 APPLICABILITY This IMC applies to those organizations within the NRC responsible for oversight, licensing and enforcement in the area of radiation protection.

0303-04 DEFINITIONS 04.01 General Health Physics Positions. HPPOS are summaries and clarifications of NRC positions, policies and requirements applicable to radiation protection. In general, NRC positions, policies and requirements are documented in official agency records and vetted through formal agency processes (e.g., Committee to Review Generic Requirements [CRGR], generic communications, Task Interface Agreements [TIA], rulemaking, licensing etc.). HPPOS exist primarily for knowledge management purposes; however, they can facilitate efficiency and consistency within regulatory processes, as it applies to radiation protection, by serving as a catalog of vetted staff positions on various regulatory issues.

Issue Date: 07/10/19 1 0303

0303-05 RESPONSIBILITIES AND AUTHORITIES 05.01 Chief, Radiation Protection and Consequence Branch (ARCB), Division of Risk Assessment (DRA), Office of Nuclear Reactor Regulation (NRR)

a. Manages the overall HPPOS program and ensures adequate staff resources are provided to maintain and develop HPPOS

b. Develops and approves HPPOS that are applicable to reactor (commercial and research) licensees

c. Coordinates development of HPPOS with the Office of Nuclear Security and Incident Response (NSIR), the Office of Nuclear Regulatory Research (RES) and the Office of Nuclear Material Safety and Safeguards (NMSS)

d. Assigns a staff member to serve as the HPPOS Coordinator 05.02 Senior Level Advisor for Emergency Preparedness, Division of Preparedness and Response (DPR), Office of Nuclear Security and Incident Response (NSIR)

a. Serves as the NSIR point of contact to direct HPPO-related questions to the appropriate branch(es) within NSIR

b. Facilitates development of HPPOS that are within the NSIR scope of responsibility 05.03 Senior Level Advisor for Health Physics, Division of Materials Safety, State, Tribal and Rulemaking Programs (MSTR), Office of Nuclear Material Safety and Safeguards (NMSS)

a. Serves as the NMSS point of contact to direct HPPO-related questions to the appropriate branch(es) within NMSS

b. Facilitates development of HPPOS that are within the NMSS scope of responsibility 05.04 Regional Branch Chiefs Responsible for Oversight of Radiation Protection

a. Ensure Regional inspectors are familiar with the HPPOS program and how it fits within the regulatory framework

b. Review and approve their staffs requests for the development of new HPPOS and or changes to existing HPPOS 05.05 Chief, Radiation Protection Branch, RES/DSA/RPB

a. Supports development and maintenance of HPPOS through staff reviews and feedback Issue Date: 07/10/19 2 0303

0303-06 HEALTH PHYSICS POSITION PROGRAM 06.01 Description HPPOS1 provide summaries or clarifications of NRC positions that are applicable to radiation protection. For the purposes of this procedure, NRC positions are regulatory decisions, or methodologies for making regulatory decisions, that have been approved by the appropriate NRC authority and documented in official agency records. The terminology NRC position includes NRC policies, procedures and requirements. In and of themselves HPPOS cannot be used to establish new NRC positions, they can only be used to summarize or clarify an existing NRC position. Additionally, any HPPOS may be subject to review by the CRGR and the Office of General Counsel (OGC) to ensure they are consistent with the adopted NRC position. These provisions are important because agency programs that are used to establish and/or communicate new or revised NRC positions contain protections against inadvertent regulatory backfits, and these programs provide frameworks for coordination among NRC offices, management and other stakeholders (e.g., public, OGC, CRGR, Commission), as necessary.

HPPOS are formatted, white paper-type documents that are stored in the Agencywide Documents Access and Management System (ADAMS) and made available via the NRCs public webpage.

The HPPOS program aims to conveniently provide information that is pertinent to radiation protection programs for knowledge management purposes and to facilitate efficiency and consistency within the regulatory process. Since HPPOS provide summaries or clarifications of NRC positions, they should not be considered standalone references. The positions described in HPPOS can only be fully understood within the context of the underlying reference they are summarizing or clarifying. Therefore, NRC staff should only use HPPOS to elucidate discussions concerning NRC positions. When referencing the NRC positions in NRC documents (e.g., inspection reports or correspondence with licensees), the document containing the actual NRC position should be referenced, not the HPPOS. For example, the proper way to reference HPPOS-001, Proposed Guidance for Calibration and Surveillance Requirements to Meet Item II.F.1 of NUREG-0737, in an NRC document would be to reference the underlying memorandum from D.G. Eisenhut to the Regional Administrators, the document where this position was articulated.

The overall HPPOS program is managed by NRR; however, individual HPPOS may be developed and maintained by other headquarters offices who have oversight of radiation protection within their scope of responsibilities.

06.02 Decision Basis and Authority The decision to develop a HPPOS is made by the headquarters organization in charge of the technical area to which the HPPOS applies. This decision is based primarily on the judgement of the headquarters lead office with advice from other NRC offices and staff. This decision must 1

The HPPOS program was used in the 1980s and 1990s to provide supplementary guidance to NRC staff in the area of radiation protection. HPPOS were especially useful following the implementation of a major change to 10 CFR Part 20 in the early 1990s.

The program, then described in Inspection Procedure 99100 - Health Physics Positions, Issue Date 10/30/1992, consisted of a desktop database with individual positions cataloged according to subject-codes, applicability and regulations. The previous HPPOS program was retired in an effort to increase efficiency by using other agency programs with similar functions; however, staff later identified a continuing need for a formalized knowledge management process specific to the area of radiation protection. The HPPOS program was reestablished in 2019.

Issue Date: 07/10/19 3 0303

consider the significance of the subject matter, the applicability of the subject matter to the area of radiation protectionincluding the general applicability of the information versus information that is potentially licensee-specificand the likelihood that a HPPOS will endure and improve understanding of the subject matter over an appreciable period of time. These qualitative criteria are in place to ensure the integrity and continued usefulness of the HPPOS program.

Interaction with regional organizations and counterpart headquarters organizations is encouraged in this decisionmaking process; however, only one headquarters office will be designated and accountable as the lead for each HPPOS. Section 05 of this IMC provides amplifying guidance on the approval authority for each of the headquarters lead offices.

As the overall manager of the HPPOS program, the Chief of NRR/DRA/ARCB will ensure adherence to this procedure. If NRR is not the headquarters lead office for a HPPOS that is being developed or revised, then the headquarters lead office should coordinate its efforts with the NRR/DRA/ARCB.

The following subject matters shall not be discussed in HPPOS:

• Unresolved inspection issues, enforcement actions and allegation material

• Safeguards and sensitive unclassified non-safeguards information (SUNSI)

• On-going rulemaking activities

• Industry or trade standards not formally endorsed by the NRC 06.03 Recommending the Development or Modification/Withdrawal of a HPPOS Before recommending the development or modification of a HPPOS, staff is encouraged to consult with agency subject matter experts and the appropriate headquarters lead office to develop a sound basis for the recommendation. Supervisors approving requests to develop HPPOS do so with the understanding that they are requesting the expenditure of staff resources to address the request; therefore, these requests should be judicious in their proposed use of agency resources.

Regional staff, and headquarters staff not responsible for the technical area to which a HPPOS applies, can recommend the development or modification of a HPPOS through an Inspection Program Feedback Form (FBF). IMC 0801, Inspection Program Feedback Process, provides guidance on how to develop and submit a FBF. HPPOS recommendations will normally be treated as long-term feedback (LTF), as described in IMC 0801, and the Chief of NRR/DRA/ARCB will review all HPPOS-related FBFs during the FBF Review Panels. Staff recommending the development of HPPOS, and headquarters staff responding to requests, shall follow IMC 0801 with the following additions/amplifications:

a. The request should clearly state the topic, or question, to which the HPPOS would apply in Section C (Summary of Issue) of the FBF

b. The request should include, if known, any documented NRC policies, positions and requirements that are relevant to the request in Section D (Comment(s)/

Recommendation(s)) of the FBF Issue Date: 07/10/19 4 0303

c. The approving supervisor (Branch Chief or above) should specifically recommend the development of a HPPOS in Section F (Supervisors Review) of the FBF

d. If the recommendation is accepted by the headquarters lead office:

1. The headquarters lead office will follow the procedures in Section 06.04 of this IMC.

2. Once the new HPPOS is developed, the lead office will include the HPPOS Number and the Agencywide Documents Access and Management System (ADAMS) Accession Number in Section H (Lead Reviewers Response) of the closed-out FBF.

e. If the recommendation is rejected by the lead office, the headquarters lead office will follow IMC 0801 process for a rejected FBF Headquarters staff wishing to recommend a new HPPOS, or modifying an existing HPPOS, in the area to which they are the technical lead can address their recommendations to their supervisor, or the appropriate authority as listed in Section 05. The format of that recommendation is left to the discretion of the approving authority.

06.04 Developing a New HPPOS or Modifying/Withdrawing an Existing HPPOS To maintain the integrity and transparency of NRC processes, it is important that HPPOS only be used to document and clarify existing NRC positions. When developing or modifying a HPPOS, staff should conduct a thorough search of the NRR/DRA/ARCB Knowledge Management SharePoint site, ADAMS, the NRC public website, the NRC Technical Library and other sources that provide access to NRC positions that are pertinent to the issue of interest.

Once the lead office identifies the NRC position(s) to be addressed in a HPPOS, the lead office should develop a HPPOS summary statement. The HPPOS summary statement should adequately characterize the underlying regulatory issue and provide appropriate citations (e.g.,

title, date, and ADAMS accession number(s)) to the applicable documents. HPPOS summary statements should be of sufficient length to effectively communicate the relevant content; however, they should be no longer than about one page. To the extent practicable, the supporting documentation that is referenced in a HPPOS should be publicly available and linked through the HPPOS summary sheet. Referencing documentation that is not publicly available should be specifically justified and documented in the HPPOS summary statement. Note, Section 06.02 prohibits the discussion of safeguards and SUNSI information in HPPOS. The lead office will coordinate with other headquarters organizations as described in Section 05 of this IMC to develop the HPPOS summary statement. This coordination should occur early and throughout the process as it is important to ensure the summary statement is consistent with practical applications of agency positions across NRC offices. Regional staff are encouraged to participate throughout the process. The designated lead office will approve the final HPPOS summary statement at the Branch Chief level.

When the HPPOS summary statement is finalized, the lead office will email the summary statement to the HPPOS Program Lead for publishing. The HPPOS Program Lead ensures the HPPOS summary statement is published as described in the HPPOS Desktop Guide.

The HPPOS Desktop Guide is a local procedure maintained by NRR/DRA/ARCB that provides detailed instructions on how to publish and communicate the release of new HPPOS and how to Issue Date: 07/10/19 5 0303

maintain a list of active HPPOS on the NRC public website. The HPPOS Desktop Guide also contains instructions on how to manage revisions and withdrawals of HPPOS. These detailed instructions are beyond the scope of this IMC.

The development of a HPPOS is guided by IMC 0801. Normally, a HPPOS would be treated as a LTF item and the Feedback Form Review Panel would provide oversight and determine the deadline for completion. The timeliness goal for closure of a LTF item is 12 months from the time the FBF is received but it can be greater than 12 months; based on the issue.

06.05 Special Case: No Existing NRC Position that is Responsive to the HPPOS Request In the event the lead office determines that there is no existing NRC position that is responsive to the HPPOS request, the lead office will have to determine the appropriate method for documenting the staffs position on the issue. It is expected that most of the inquiries and requests for new HPPOS will concern NRC oversight activities and thus will fall within the scope of IMC 0801. The Inspection Program Feedback process provides a formal, flexible and responsive process for addressing requests for new staff positions concerning oversight activities. This approach is preferred over the more resource intensive approaches described below. Once an NRC position is documented in a response to a FBF (e.g., via a memo from an NRC headquarters organization to the Regions), a HPPOS can be developed that references this position as described in Section 06.03 of this IMC.

Occasionally, the development of a new NRC position may require a higher level of coordination, resources or authority, or it can be determined that the audience for the position will include many NRC licensees. In these cases, the lead office should determine the appropriate NRC process to use to resolve the underlying issue of interest (e.g., Rulemaking, Generic Communication, Regulatory Guide, TIA etc.). Detailed discussion of these processes is beyond the scope of this IMC. However, once the NRC position is documented using the appropriate process, a HPPOS can be developed that references this position as described in Section 06.03 of this IMC.

06.06 Change Control and Document Management HPPOS will be documented in a standardized form and made publicly available through ADAMS as described in the HPPOS Desktop Guide. Revisions to HPPOS will be documented and tracked in the HPPOS forms and the HPPOS listing that is published on the NRC public website.

At the reintroduction of the HPPOS program, there were several hundred legacy HPPOS in place. NUREG/CR-5569, Health Physics Positions Data Base, (ADAMS Accession No. ML093220108) contains HPPOS in effect as of 1994; a complete listing of HPPOS is available through the NRCs public website (https://www.nrc.gov/about-nrc/radiation/protects-you/hppos/hppos.html). A wholesale review of the existing HPPOS prior to launching the new program was not performed. Instead, the headquarters lead offices will incrementally review HPPOS through the course of their routine activities and update or retire HPPOS as appropriate. Headquarters and regional staff can recommend updating or retiring legacy HPPOS by following a process similar to that described in Section 06.03.

It is important that staff is attentive to the possibility of inadvertently introducing a backfit when retiring or modifying legacy HPPOS. Legacy HPPOS may reflect long-standing NRC positions.

In accordance with NRC practices at the time, these positions were typically established by a Issue Date: 07/10/19 6 0303

letter from the NRC headquarters office to the NRC region. In all cases these letters communicated NRC radiation protection staffs understanding of applicable NRC policies, positions and requirements in the area of interest and as such serve as documentation of the NRCs approach toward regulating in the area of interest at the time. In cases where these letters provide staff positions regarding NRC regulations, unless these letters were specifically approved by the NRCs General Counsel or the Commission, the positions they contain are not binding upon the Commission. This is because, except as specifically authorized by the Commission in writing, no interpretation of the meaning of a regulation by an officer or employee of the Commission, other than a written interpretation by the General Counsel, will be recognized to be binding upon the Commission. However, where NRC radiation protection staff has applied the guidance contained in these letters to conduct regulatory activities for a substantial period of time, or made regulatory decisions based upon these positions, modifications to these letters (or associated HPPOS) could be subject to backfitting provisions and will be evaluated appropriately upon the proposed modification of the agency position. In all cases, staff should ensure that, as applicable, the NRCs backfitting policies are properly applied.

0303-07 REFERENCES MD 8.18, NRC Generic Communications Program LIC-400, Procedures for Controlling the Development of New and Revised Generic Requirements for Power Reactor Licensees (non-public)

COM-106, Control of Task Interface Agreements IMC 0801, Inspection Program Feedback Process NUREG/CR-5569, Health Physics Positions Data Base END : Revision History for IMC 0303 Issue Date: 07/10/19 7 0303

ATTACHMENT 1 Revision History for IMC 0303 Commitment Accession Description of Change Description of Comment Resolution and Tracking Number Training Closed Feedback Form Number Issue Date Required and Accession Number (Pre-Change Notice Completion Date Decisional, Non-Public Information)

N/A ML18344A103 First issuance as an inspection manual Webinar-based ML18347A005 07/10/19 chapter. This is a complete re-write of training provided CN 19-023 TG9900, which was deleted from the to HP inspection program on March 9, 2007 counterparts because it was no longer applicable to the current inspection program. Researched commitments for the last four years and found none.

Issue Date: 07/10/19 Att1-1 0303