ML20155B894
| ML20155B894 | |
| Person / Time | |
|---|---|
| Issue date: | 06/07/1988 |
| From: | Sjoblom G NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| To: | Cunningham R NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20155B900 | List: |
| References | |
| NUDOCS 8806140010 | |
| Download: ML20155B894 (7) | |
Text
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'07 JUN 1988 f
MEMORANDUM FOR: Richard E. Cunningham, Director Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Glen L. Sjoblom, Acting Director Division of Radiation Safety and Safeguards, RI-
SUBJECT:
REGION I MEMORANDUM DATED MARCH 23, 1988 REGARDING IMPLEMENTATION OF THE REVISED 10 CFR PART 35 Region I personnel met with you and other members of the NMSS staff on April 29, 1988 to discuss the points raised in the Region I memorandum dated March 23, 1988 and your response dated April 6, 1988.
Enclosed is a statement of each issue as contained in our March 23 memorandum, followed by the resolution or required action agreed upon at the April 29 meeting. As we also agreed at the meeting, the other regions will be polled by NMSS to assure that implementation of the revised guidance will not present unforeseen problems.
We appreciate the opportunity to have met with you to discuss _these matters.
We will be pleased to provide any required assistance in revising the written guidance following agreement by the other regions.
)
orgna$gncahy i
Glen L. Sjoblom, Acting Director Division of Radiation Safety and Safeguards, RI
Enclosure:
As stated I
cc:
Division Director, Division of Radiation Safety and Safeguards, R II-V Vandy Miller, NMSS t
John Hickey, NMSS
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Enclosure l' Specific Comments on Part 35 guidance, the Guide for Preparing Licenses, Part 35 Model Licenses and the Standard Review Plan (FC 87-2) 1.
The handling of licensee notifications when an authorized user, Radiation Safety Officer, or Teletherapy Physicist discontinues performance of duties under a license has not been clarified. A lengthy discussion at the September workshop on the processing of these notifications as amend-ments did not result in definitive guidance.
The authorized user list should be current for inspections, incident response and proof of physician training and experience. Updating this list at renewal, every 5 years, as implied by the headquarters memo dated ~ June 22, 1987, to Glenda Jackson should not be acceptable. We support amending the license'when these notifications are received. As agreed at the December Workshop, we and l
Region V will shortly provide suggested procedures regarding the handling of such notifications.
Action Item:
Region I provided a copy of the memorandum dated April 28, J
1988 from Regions I and V on a recommended policy and guidance directive for handling notifications required by 10 CFR 35.14 and reports required by 10 CFR 35.645 (attached). The NMSS staff had no objections, provided license fees could be avoided for these minor changes. The NMSS staff agreed to poll the other regions for their support'of the proposed notification handling procedure. Additionally, NMSS will confirm with the Fees Management Branch that license fees can be waived.
2.
The interpretations of "ministerial changes" (10 CFR 35.31) and changes that require amendments (10 CFR 35.13) are not clear.
10 CFR 35.13 can t
be cited to support license amendments only for the listed cases.
10 CFR 35.31 lists minor changes in radiation safety procedures but would be cited to support license amendments for all changes not listed in this part.
Region I has taken the latter interpretation, i.e., ministerial changes can be made for the examples listed in S35.31 and for adoption of regulations or regulatory guide procedures. Oral comments by headquarters personnel indicate that any changes not covered by 10 CFR 35.13 mey be considered as "ministerial changes". Wt believe it is unwise to give licensees the impression that statements made in support of an application l
may be ignored or modified based upon convenience.
Specifically, many of f
the commitments we seek are based upon Part 20 requirements. Commitments regarding personnel dosimetry, ventilation flow rates and use of protective clothing should be binding.
Resolved:
Licensees cannot ignore or modify ccmmitments made in support of an application that are important to the radiation safety program. Changes can be made which do not decrease the level of protection, j
OFFICIAL RECORD COPY MEMO CUNNINGHAM - 0003.0.0 05/26/88 l
2 Action Item:
Each region should collect examples of th
'andling of licensee questions on the ministerial char a and m
submit these examples to NMSS. These examph.. cir Se used in a future revision of Policy and Guidanct F ctive FC 87 2 and in a more comprehensive list of samt ministerial changes.
3.
We continue to be concerned about the decision not to specily model numbers for sealed sources and the devices in which they are used.
For sealed sources used for diagnosis under S35.500, the sources rust be manufactured and distributed under a 10 CFR 32.74 license.
The rule change to Part 30.22 does not address the device itself, only a device that contains a sealed source.
If the model numbers are not specified, there is potential for "approved sources" in equipment which has not been reviewed for those sources. We propose specifically listing sources and equipment per the enclosed RI license generation form. We note tFat bone mineral analyzers are usually not distributed with a source and the distr.autors may not have a Part 32 license.
Resolved:
Sealed sources used for diagnosis under S35.500 must be used in a device that has been reviewed by the NRC for compatibility with the source.
Specifically listing source and device model numbers and manufacturers would limit a licensee's flexibility in choice of equipment.
Action Item:
Region I agreed to propose appropriate wording for the authorized licensed use which would provide flexibility and source and device compatibility.
Proposed Wording:
(for use in item 9 of the license document)
Sealed sources approved in 10 CFR 35.500 in a compatible device registered pursuant to 10 CFR 30.32(g).
4.
We continue to believe that the license document would be improved in terms of communicating to the licensee if the authorizations in Item 9 were made more explicit.
This can be accomplished without significant change in the license format and length.
For example, the following standarn statements could be utilized as appropriate:
Any uptake, dilution and excretion procedure approved in 10 CFR 35.100.
Any imaging and localization procedure approved in 10 CFR 35.200.
Any cardiac uptake, dilution and excretion procedure approved in 10 CFR 35.100.
Any cardiac imaging and localization procedure approved in 10 CFR 35.200.
OFFICIAL RECORD COPY MEMO CUNNINGHAM - 0003.2.0 05/26/88 F
3 Any radiopharnaceutical therapy procedure approved in 10 CFR 35.300.
Any brachytherapy procedure approved in 10'CFR.35.400.
Resolved: The.NMSS staff agreed to revise the authorized use descriptors to include the subpart titles as illustrated above (pending input from the other Regions).
Region I believes that this minor format chance will make the license more explicit by eliminating the need to refer to the regulations for authorized use. The resulting clarity should improve licensee's under-standing of the authorizatio:
Action Item:
So'icit comments from the other Regions.
5.
The model license for a broad scope medical institution (page 2.13 of.the guide) includes, as part of Condition 12, the following statement "The licensee's Radiation Safety Committee may make case-by-case exceptions to these criteria". During the. Implementation Meeting and at the Licensing Workshop it was agreed to delete this sentence from the standard condition.
We do not support allowing licensees the authority to make' exceptions to the regulations.
Page 1 of the SRP, FC 87-2, also needs to be revised accordingly.
Resolved: Unanimous agreement with the. original NMSS response to this item in the April 6, 1988 memorandum was confirted. This response is repeated below:
Broad licensee scope of authority. The sample broad license on page 2.13 of-Policy and Guidance Directive 87-2 would allow the Radiation Safety Committee to make case-by-case exceptions to training and experience criteria.
License reviewers are not required to issue such authority to broad licensees.
Such authority may be issued if the license reviewer believes it will not negatively impact public health and safety.
6.
For broad scope medical licensees, we believe that the license docu.ent would be improved in terms of communicating with the licensee if the authorizations in Items 6, 7, 8 and 9 remained as is currently used for all broad scope programs. This is especially important for programs that have i
separated their medical use from research use. The currently used wording follows, and we propose that it be substituted for that shown on page 2.13:
6.
Any byproduct material 7.
Any 8.
50 milllicuries of with atomic numbers 1-83.
each radionuclide with a total possession limit of 2 curies 0FFICIAL RECORD COPY MEMO CUNNINGHAM - 0004.1.0
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4 9.
Medical research, diagnosis, and th'erapy; research and development-as defined in 10 CFR 30.4(q).
Resolved:
NMSS is scheduled to meet with:t'he FDA to' discuss the latter's regulation of "medical research". This will-result in the ability to define better "medical research".
The HMSS staff agreed to allow the proposed wording in items 6 and 9 (as 'above), pending further information from the NRC-FDA meeting.
Region I discussed the requirement" for a maximum or total limit in item 8-. of broad scop'e licenses to eliminate the requirement for Contingency Plans.
The NMSS staff favored a license condition to solve this problem rather than a possession limitation'.
Action Item:
Region I agreed to propose an appropriate license condition, which follows:
If only a single radionuclide specified in NUREG 0767, is possessed, the possession limit is the quantity specified in Schedule of Limiting Possession Limits, NUREG-0767.
If-two or more radionuclides are possessed, the possession limit _ for each is determined as follows:
the sum of the quotients of the quantities possessed divided by the quantities of_those radionuclides speci-fled in the Schedule of Limiting Possession Limits, NUREG-0767, shall not exceed unity.
7.
The November 20, 1987 memo stated that "when licensing the medical use of byproduct material, license reviewers should compare the application again'st the requirements of the regulations rather than reviewing the application based on the recommendations in the regulatory guide."
If a licensee commits to the regv!ations, is t'.is sufficient for license review or must we see a written procedure? We are currently requiring both a commitmer,t to the regulations and submission of procedures to cover all areas addressed in the regulatory guide.
Resolved:
The NMSS staff reiterated the necessity of reviewing a licen'see's implementing procedures.
It is not sufficient for a licensee to commit to the regulations.
The April 6, 1988 NMSS response 1
describes this policy:
Content of applications.
In its approval of the revision of 10 CFR Part 35, the Commission directed that the staff continue to review licensees' radiation safety procedures.
The reviewer should examine each submission to assure that the procedure meets the requirements of the applicable H
regulation in a' complete and technically valid way.
The l
submission does not need the extensive detail that charac-
)
terizes the procedures in Regulatory Guide 10.8; that
.l detail was provided because the guide is also used as a methods training manual for hospital radiation safety workers.
OFFICIAL RECORD COPY MEMO CUNNINGHAM - 0005.0.0 05/26/88 l
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5 8.
Item.4.2 of the "Notes on License Preparation" indicates that the staff' may make, exceptions to the
- raining and experience requirements of 10 CFR 35, Subpart J.
Please clarify who you-mean by staff.
If these exceptions can be made by license reviewers, there must be guidelines within which excaptions are permitted.
Resolved: The original NMSS response to this item-allowed license reviewers to make case-by-case exceptions from Subpart J requirements for authorized users.
This guidance was reversed by Mr. Cunningham. Any exception to the training requirements must be reviewed by headquarters staff.
9.
The new Part 35 ard Regulatory Guide 10.8, Revision 2 do.not specifically address the use of phosphorus-32. Many licensees under the oid Part 35 were specifically licensed for phosphorus-32 or have authorized users for soluble phosphate or the colloidal chromic phosphate. We propose the following format in these cases:
6.
Phosphorus-32 7.
Phosphorus-32 8.
As necessary for as included in
~ uses authorized 10 CFR 35.300 in Subitem 9 9.
Treatment of polycythemia vera, leukemia, or bone metastases.
or Intracavitary treatment of malignant effusions.
Resolved:
There was no objection to the Region I format.
- 10. Additional reviewer and inspector guidance is needed in the following areas pertaining to teletherapy; (a) Is there license review of the reports required by 35.645?
(b) Define and provide sample procedures fcr testing timer linearity, constancy and on-off error.
(This is naeded for. licensees as well).
(c) 35.645 indicates that we are only interested in the output and no longer want to receive a copy of the record of-the full calibration required in 35.632.
Action Item:
Region I emphasized the need f(* teletherapy guidance. The NMSS staff agreed.
Vandy Miller was assigned the lead for this item.
OFFICIAL RECORD COPY MEM0 CUNNINGHAM - 0006.0.0 05/26/88 E