ML20155B909
| ML20155B909 | |
| Person / Time | |
|---|---|
| Issue date: | 04/28/1988 |
| From: | Joyner J, Jonathan Montgomery NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Miller V NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20155B900 | List: |
| References | |
| NUDOCS 8806140015 | |
| Download: ML20155B909 (4) | |
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UNITED STATES NUCLEAR REGULATORY COMMISSION
- o REGION I U # 475 ALLENDALE ROAD KING OF PRUSSIA, PENNSYLVANIA 19408 APR. 2 81988 MEMORANDUM FOR: Vandy Miller, Chief i Medical, Academic and Commercial Use l Safety Branch, NMSS FROM: James H. Joyner, Chief Nuclear Materials Safety Branch, RI James L. Montgomery, Liief Nuclear Materials Safety and Safeguards Branch, RV
SUBJECT:
RECOMMENDED POLICY AND GUIDANCE DIRECTIVE FOR HANDLING NOTIFICATIONS REQUIRED BY 10 CFR.35.14 AND REPORTS REQUIRED BY 10 CFR 35.645.
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Regions I and V agreed to propose procedures for handling notifications now required by Sections of Part 35 cited above and we have coordinated on this memorandum. The requirement to provide these notifications is unique to medical regulation and thus requires coordination to assure unifonn handling among the Regions and Headquarters.
Our goals in fonnulating the attached proposal are as follows:
- 1. Provide for appropriate and timely review of and response to the required notifications.
- 2. Utilize existing systems (with minimal changes) to track review of l notifications and the labor expended.
- 3. Provide a mechanism to assure official documentation of notification review without creating a new records system. The documentation l should be quickly available to both reviewers and inspectors.
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- 4. Provide a basis for determining if either a licensing fee or an inspection fee should be charged for reviewing a notification.
We believe a very simple mechanism exists for achieving goals 1 through 3. If notifications are treated administratively as a sixth type of licensing action, then LMS can be used to track actions, RITS to track labor, and license amend-ments to document the review. LMS could be easily modified to accept an action type "6 ' and RITS to accept a new planned accomplish.nent r. umber. Implementa-tion is simple and requires extremely little retraining of staff.
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. APR. 2 81988 Vandy Hiller 2 The only problem with this mechanism occurs because the notifications can be l construed as an amendment to the license, which requires a fee pursuant to !
Part 170. However, we do not believ1 that this was the intent when Part 35 was I revised. We believe that persuasive arguments can be made to conclude that a fee is not required for each of the various types of notifications required by 10 CFR 35.14 and 35.645. We believe that situations in which the fee issue arises fall into three categories.
- 1. The notifications do not authorize new activities and do not reduce the effectivenest ' the existing ;afety program.
We feel that dropping a named user, changing the name of an already authorized user or changing the mailing address of the licensee clearly fall within this description. The reasons for amending the license are to assure that the NRC can contact appropriate licensee personnel when necessary and to assure that the license accurately reflects the licensee's facility and staff. We believe that not charging a fee for this type of change is consistent with past practice for all types of licensees.
- 2. The notifications reflect temporary changes to the radiation safety program, pending establishment of permanent solutions that require an amendment pursuant to 10 CFR 35.13.
Licensees are required to obtain a license amendment prior to changing a Radiation Safety Officer or Teletherapy Physicist. The notifica-tion of a temporary change provides the NRC the opportunity to review interim measures and to solicit and document comitments to restrict programs when changes occur in critical staff. A fee will eventually be paid before the required personnel changes are incorporated by amendment.
- 3. The notifications are submitted as the confirmation of implementation of an arrendment to modify facilities or equipment.
Most of the notifications (reports) required by 10 CFR 35.645 are submitted as evidence that required programs have been implemented, or that facilities and equipment operata as designed. The programs, facilities and equipment were reviewed as part of an amendment.
Therefore the report should be considered as a continuation of an amendment, and requires no additional fee. ;
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Vandy Miller 3 If your staff has questions regarding our proposal, please have them contact John Glenn (FTS 346-5260).
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W mes H. Joyne hief Nuclear Materials Safety Branch Region I N w ames L. Montg ry, Chief Nuclear Materials Safety and Safeguards Branch Region V
Enclosures:
As stated cc:
W. Cline, RII B. Mallett, RIII W. Fisher, RIV J. Montgomery, RV J. Glenn J. Kinneman J. White G. Jackson, LFMB I
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SUBJECT:
POLICY AND GUIDANCE DIRECTIVE FC88- ; PROCESSING 0F NOTIFICATIONS REQUIRED BY 10 CFR 35.14 AND 10 CFR 35.645 Part 35 now requires that licensees make notifications when certain changes occur in their programs. These notifications are not event reports in the same sense as those required by Part 20. In many instances, the notification concerns changes that will eventually require amendment to the license. This guide describes the administrative procedures and technical requirements for the review of these notifications.
Notifications will be processed and tracked as a sixth type of licensing action.
Control numbers will be assigned, fee sheets completed, and milestones entered as for any other type of licensing action. The action type within the LMS system will be "6".
Fees will not be charged for notifications. However, a fee review will be required and a revised copy of the license will not be issued until the fee review is complete. Notwi:hstanding fee review, notifications should be screened by the Section Chief or designee as soon as possible after receipt.
The technical review should be expeditious. Review of notifications should receive first priority in assignment of licensing actions. The technical review should (1) establish the likely impact of the change upon the licensed program, (2) determine any interim measures instituted by the licensee, and (3) evaluate the adequacy of the interim measures to maintain an acceptable licensed program. Inadequacies should be identified immediately to the licensee and adequate procedures negotiated. Depending upon the nature of the inadequacy, l the negotiated interim procedures may be documented in a letter from the licensee or a Confirmatory Action Letter from the NRC.
Completion of the review will be documented by amending the license. These amendments nust be limited to changing the mailing address, deleting names or referencing the notification and any negotiated interim procedures. If the licensee requests any other action, the issuing of the amendment will require the payment of a fee. !
l Time spent processing or reviewing Part 35 notifications will be charged in the l Regulatory Information Tracking System (RITS) to TACS # " . <
l If you have any questions on this directive, please contact l at (FTS) ,
l Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety
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