ML20248A134
| ML20248A134 | |
| Person / Time | |
|---|---|
| Issue date: | 11/06/1990 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kubiatowicz D MINNESOTA MINING & MANUFACTURING CO. (3M CO.) |
| Shared Package | |
| ML20247R838 | List: |
| References | |
| SSD, NUDOCS 9805290298 | |
| Download: ML20248A134 (3) | |
Text
_ _ _ - - - _ _ - _ - - - -
(
0 Medical Device sion
//
/
3M Health Care q
3M C' mer ff e
St. Paul, Minnesota 55144-1000 f
W 612/733 1110 J
November 6,1990 Steven L. Baggett, Health Physicist U.S. Nuclear Regulatory Commission Division of Fuel Cycle & Material Safety MS-6-H-3 Washingt n, DC 20555
Dear Baggett:
This letter is follow-up to our conversation of October 31, 1990 in which we discussed adding certain
" clarification" statements to the Certificates of Registration for 3M Cesium-137 sources.
As they now read, the Certificates do not specifically address distribution of cesiur sources which have undergone radioactive decay to a strength not described in the Certificates. For example, a 10 mg radium equivalent cesium source (mgRaEq) which has a green color code on the source end and which has a "10" stamped on the source body is so described, but the same i
source which has decayed to 8 mgRaEq is not described.
Distribution of such decayed sources in this decade of j
high costs and environmental concern has become important for the following reasons:
- 1) 3M has always had a certain inventory of such decayed sources which have been " scrapped" and " written off" in the past.
Presently the high costs of both source manufacture and source disposal preclude a continuance of this practice.
- 2) A decayed 8 mgRaEq source, cited in the example above, is useful to a hospital which wants to increase its current inventory of cesium sources by matching the sources with newly purchased ones of similar strength.
In our telephone discussion, you advised adding t
clarifying language to the Certificates of Registration which would allow distribution of the decayed sources by placing them in a "non-standard activity" source category. Following is suggested copy additions to the
' Certificate of Registrations:
i i
9805290298 960126 PDR RC PDR SSD l
Q $y2'ISN
Se ce g
. Steven L. Baggett, PhD November 6, 1990 i
Page 2
{
Standard Tube sources NR-460-S-137-S (Series 6500, 6520 standard Os-137 tube sources), NRC issue June 22,1990.
Page 2 in the." Description" section after the table add:
The Cs-137 tube source strengths listed above are " standard" activities. As the sources decay below the nominal activity, however, they fall into a "non-standard" activity category. The strengths of both the " standard" and "non-standard" activity sources are documented in the calibration Certificate accompanying the sources at the time of distribution.
Page 5 in the " Limitations and/or Other Considerations of Use" section, add after the first paragraph:
At time of distribution of both " standard" and "non-standard" activity Cs-137 sources, a calibration Certificate will accompany the shipment which shows for each source 4
the actual measured output activity in millicuries of Os-137 and the calculated milligram radium equivalent Os-137 activity.
Miniaturized Tube and Heyman Sources NR-460-S-169-S (Series 6510 and 6570 miniaturized Os-137 tube sources and 6550 Heyman afterloading sources), NRC issue June 22, 1990.
On page 2, replace the entire paragraph in the
" Labeling" section with:
Each miniaturized source is engraved with a
" standard" nominal activity and serial number.
The handles of the Heyman afterloading sources are engraved with a
" standard" nominal activity and serial number.
As both types of sources decay below nominal activity however, they fall into a "non-standard" activity category.
The strengths of both-the " standard" and "non-standard" sources are documented in the calibration Certificate accompanying the sources at the time of distribution.
/
Steven L. Baggett, PhD November 6,1990
-Page 3 Page 4 in the " Limitations and/or Other Considerations of Use" section, add after the first paragraph:
At time of distribution of both " standard" and "non-standard" activity miniaturized Os-137 sources and Heyman afterloading sources, a calibration Certificate will accompany the shipment which shows for each source the actual measured output activity in millicuries of Os-137 and the calculated milligram radium equivalent Os-137 activity."
I've pasted the above proposed changes in copies of the Certificates of Registration accompanying this letter.
In'our phone conversation, you indicated that these clarification additions to the source Certificates of Registration should be considered by 3M to be an
" Administrative request" and as such could by handled by you in a timely manner and without fee.
Thank you for handling these changes for us.
If you have comments about better wording of the statements or are in need of additional information, please feel free to contact Jacquelyn Bush or me by FAX or phone.
Please advise me when 3M is permitted to distribute the "non-standard" activity Cs-137 sources.
Si cerely, s
/
Day Kubia owicz Profes ional Servi Assessnent & Therapy Products Lab 3M Med:. cal Device Division 270-2A-11 3M Center St. Paul,MN 55144 Phone 612-733-9127 FAX 612-733-8293 cc: J.D. Bush, Senior Regulatory Affairs Specialist 225-3N-02 l
612-733-6421
__