ML042380145
| ML042380145 | |
| Person / Time | |
|---|---|
| Issue date: | 09/22/2004 |
| From: | Nader Mamish NRC/NSIR/DPR |
| To: | Alexis Nelson Nuclear Energy Institute |
| williams K nsir/dpr/epd 415-1104 | |
| References | |
| Download: ML042380145 (9) | |
Text
September 22, 2004 Mr. Alan Nelson Chief, Emergency Preparedness Regulatory Affairs 1776 I Street NW, Suite 400 Washington, D.C. 20006-3708
Dear Mr. Nelson:
Thank you for sending the 10 CFR 50.54(q) guidance document, 10 CFR 50.54(q) Guidance, NEI 50.54(q) Task Force, July 2004. The Nuclear Regulatory Commission (NRC) appreciates the Nuclear Energy Institutes (NEIs) determination and initiatives regarding 10 CFR 50.54(q).
The NRC understands the magnitude of the issue and the need to establish clear, concise, and informative guidance regarding 10 CFR 50.54(q). The combined efforts of NEI and the NRC will ensure that this project continues to move forward.
On July 15, 2004, we received NEIs revised guidance document along with NEIs comments regarding the development of the NRCs Regulatory Issue Summary Clarifying the Process for Making Emergency Plan Changes. We understand that NEI would like NRC to endorse the guidance. The staff has reviewed the revised guidance document and has identified concerns that need to be addressed before the NRC endorses the guidance. We shared a number of these concerns with you during a conference call on Monday, August 16, 2004. This letter is a follow-up to our call on August 16, 2004, and it includes a detailed documentation of our comments in Enclosure 1, Major Comments and Enclosure 2, Minor Comments.
The comments provided are also applicable to the NEI guidance document attachments that implement the NEI 50.54(q) guidance. We look forward to reviewing the revision to the NEI 50.54(q) guidance. If you have any questions or comments please contact Kevin Williams of my staff at (301) 415-1104.
Enclosures:
As stated Sincerely,
/RA/
Nader Mamish, Director Emergency Preparedness Directorate Division of Preparedness and Response Office of Nuclear Security and Incident Response
Major Comments
Section 4, the definition of a decrease in effectiveness (DIE).
The NEI Guidance document defines decrease in effectiveness to an emergency plan (EP) as a change to an EP commitment which, if implemented, would not meet the standards of 10 CFR 50.47(B) (sic.) and the requirements of Appendix E to 10 CFR Part 50... The NEI Guidance document also provides that an EP commitment which exceeds a regulatory requirement may be changed without prior NRC review and approval under 50.54(q) so long as the EP continues to meet the applicable NRC requirements.
The NRC staff views the NEI Guidance document to be inconsistent with the decrease the effectiveness criterion in § 50.54(q). Whether an EP commitment change would decrease the effectiveness of an EP must be determined with regard to whether there is a reduction in the licensees capability to perform EP functions, and reductions in the timeliness of performing those functions and requirements. A decrease in effectiveness of an EP commitment change is not determined by assessing whether NRC regulatory requirements continue to be met after the EP commitment change.
The use of exceeds the baseline standard As discussed above, a determination whether the § 50.54(q) decrease the effectiveness threshold is exceeded is not determined by whether a proposed change to a commitment that exceeds the NRC standards meets the applicable NRC regulatory requirement after the change.
The terms, regulatory commitment and for information only.
The NRC staff fundamentally disagrees with the NEI Guidance documents categorization scheme for EP commitments, using the terms, regulatory commitment and for information only, as defined in the NEI Guidance document. In the NRC staffs view, EP commitments fall into two categories for purposes of determining whether prior NRC review and approval of a change in the commitment is required under § 50.54(q):
(1) commitments addressing compliance with legally-binding NRC requirements such as regulations, license conditions, technical specifications, and orders, which may either be at the minimum necessary, or may be greater than the regulatory minimum; and (2) commitments which do not address compliance, but have been included in the EP for information or otherwise voluntarily agreed to by the licensee. Commitments in the first category are subject to the § 50.54(q) criterion in determining whether prior NRC review and approval of a change in the commitment is required. By contrast, commitments in the second category are not subject to the § 50.54(q) change requirement and may be changed or entirely removed from the EP without consideration of § 50.54(q).
Minor Comments
Section 1, third paragraph and Note 3, the difference between Commission and NRC.
The regulations are written such that the Commission rather than the NRC staff, must approve changes under 50.54(q). As of this time, the Commission has not delegated this authority to the staff.
Therefore, the last sentence in the third paragraph and note 3 should be revised to reflect that under 10 CFR 50.54(q), licensees may make changes, which decrease the effectiveness of the emergency plan, but must submit these to the Commission for approval prior to implementing the changes.
Section 2 letter (b), the use of restore the original intent of the rule.
The rule and its intent are clear. What we are clarifying is the implementation of the rule. We are not operating outside the "original intent" of the rule.
Section 2 letter (b), the use of overly restrictive.
The Regulations are written to ensure compliance. Characterizing them as overly restrictive implies the rule must be changed. The NRC staff has not made such a determination at this time. Accordingly, the sentence should be revised to remove these words.
Section 2 letter (d), the use of While latitude has always existed to allow improvements in one area of the plan to offset reductions in other areas, evaluation of the appropriateness of these determinations has been a subject of much discussion and concern. It is the intent of this guidance to reduce or eliminate these inconsistencies and ambiguities. Use of this guidance should allow a licensee to add to, delete from, or modify the current emergency plan, without NRC prior approval, provided that the 10 CFR 50.54(q) evaluation clearly demonstrates that there is no reduction in effectiveness of the plan and that the result of the proposed change will provide required protection.
This guidance also clarifies the provision to properly evaluate and reduce commitments where a licensee may have exceeded regulatory requirements and where such commitments were not agreed to between the licensee and the regulator to address a site-specific need.
The staff has two issues: (1) the first sentence erroneously implies an overall effectiveness concept, which is not defined in Emergency Preparedness and (2) the last sentence erroneously implies that commitments in excess of the regulatory minimum may be changed under 50.54(q) without prior NRC approval.
Section 2 letter (e), the use of "judicious determinations."
The expectation should be for licensees to thoroughly document why they are making the change and have a 10 CFR 50.54(q) change process. The licensee should use sound judgement through a documented process.
Section 4, the use of current plan.
The definition of current plan represents the definition of an approved plan. The NEI guidance should be revised to eliminate the distinction between current plan and approved plan and define the approved plan as follows:
Approved Emergency Plan:
1.
The initial/original NRC approved emergency plan for the issuance of an operating license.
2.
The initial/original NRC approved emergency plan that has been maintained in accordance with 50.54(q) and submitted in accordance with 10 CFR 50.4.
Section 4 under Change, the use of adversely impact and Attachment 2, the use of impact on in the flowchart, Attachment 2.
It is not clear what is meant by adversely impact or an impact on. The staff reviewed NEI 96-07 Guidelines for 10 CFR 50.59 Implementation. The NEI 96-07 document uses adverse impact as a screening tool prior to the formal evaluation. The staff has determined that adversely impact could imply; (1) a function is not performed; or (2) relaxing the manner of how 10 CFR requirements are met; or (3) an alternative method for compliance is proposed. The 10 CFR 50.54(q) process which uses decrease in effectiveness as a means of non-compliance is the appropriate term. It should be clear that the process for making changes addresses the standards and requirements and the change is subject to 10 CFR 50.54(q). There is not a need to introduce a term that is not defined or understood in Emergency Preparedness.
With regard to impact on this should clearly state whether the change meets a standard and/or a requirement. In addition, the change should be subject to the language of decrease the effectiveness. The term impact on is not defined and the implementation and use of the term is not clear.
Section 5 step 4 first paragraph, the statement... changes that affect information but were not derived from 10 CFR 50.47 or Appendix E are also reviewed.
It is difficult to determine what is meant by not derived from. This is open to interpretation and does not indicate what the change is being reviewed against. The purpose of this statement and what standard, guidance, etc, the change being reviewed against should be clear.
, the use of Emergency Action Level (EAL) in the flowchart, does not accurately capture the process of making changes.
Regulatory Issue Summary (RIS) 2003-18 Use of NEI 99-01, Methodology for Development of Emergency Action Levels, Revision 4, dated January 2003" and Supplement 1 to RIS 2003-18 dated, July 13, 2004, provide clear guidance on how changes to EALs are to be processed. If the EALs are to be a part of the flowchart, the process for changing EALs should be reflected. In addition, the use of an alternative method for complying with the regulations is not addressed in the flowchart.
Mr. Alan Nelson Chief, Emergency Preparedness Regulatory Affairs 1776 I Street NW, Suite 400 Washington, D.C. 20006-3708
Dear Mr. Nelson:
Thank you for sending the 10 CFR 50.54(q) guidance document, 10 CFR 50.54(q) Guidance, NEI 50.54(q) Task Force, July 2004. The Nuclear Regulatory Commission (NRC) appreciates the Nuclear Energy Institutes(NEIs) determination and initiatives regarding 10 CFR 50.54(q).
The NRC understands the magnitude of the issue and the need to establish clear, concise, and informative guidance regarding 10 CFR 50.54(q). The combined efforts of NEI and the NRC will ensure that this project continues to move forward.
On July 15, 2004, we received NEIs revised guidance document along with NEIs comments regarding the development of the NRCs Regulatory Issue Summary Clarifying the Process for Making Emergency Plan Changes. We understand that NEI would like NRC to endorse the guidance. The staff has reviewed the revised guidance document and has identified concerns to the extent that NRC cannot endorse the guidance in its current form. We shared a number of these concerns with you during a conference call on Monday, August 16, 2004. This letter is a follow-up to our call on August 16, 2004, and it includes a detailed documentation of our comments in Enclosure 1, Major Comments and Enclosure 2, Minor Comments.
The comments provided are also applicable to the NEI guidance document attachments that implement the NEI 50.54(q) guidance. We look forward to reviewing the revision to the NEI 50.54(q) guidance. If you have any questions or comments please contact Kevin Williams of my staff at (301) 415-1104.
Enclosures:
As stated Sincerely,
/RA/
Nader Mamish, Director Emergency Preparedness Directorate Division of Preparedness and Response Office of Nuclear Security and Incident Response DISTRIBUTION:
K. Williams W. Lanning, Rgn I C. Casto, Rgn II C. Pederson, Rgn III D. Chamberlain, Rgn IV EPD R/F ADAMS Accession Number: ML042380145 OFFICE NSIR/EPD NSIR/EPD NSIR/EPD OGC NSIR/EPD NAME K. Williams S. Rosenburg E. Weiss S. Treby N. Mamish DATE 08/26/04 09/21/04 08/31/04 09/21/04 09/22/04 OFFICIAL DOCUMENT COPY