ML20209D034

Responds to 971223 & 1230 Ltrs Requesting Amend of Device Registry NR-587-D-104-S.Listed Addl Info Needed to Continue Review of Application Requested

ML20209D034
Person / Time
Issue date:	04/16/1998
From:	John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:	Seaman S SEAMAN NUCLEAR CORP.
Shared Package
ML20209C963	List: ML20209C961 ML20209C967 ML20209D034
References
SSD, NUDOCS 9907130013
Download: ML20209D034 (4)

Text

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                          %                                 UNITED STATES
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    J                                  ' NUCLEAR REGULATORY COMMISSION f                           WASHINGTON, D.C. 20066 4001
             %......o                                   April 16, 1998 Scott Seaman, President Seaman Nuclear Corporation 7315 South First Street Oak Creek, WI 53154

Dear Mr. Seaman:

This letter is in response to your letters dated December 23,1997, and December 30,1997, requesting amendment of device registry NR-587-D-104-S. We are in the process of reviewing N application. However, in order to continue our review, we need the following information:

1. Your application requests amending the registry to include the C-N00 series, where N is an integer. Further, it is indicated that the series will include 3 designs, the 1 C-100, C-200, and C-300. However, the information provided in the application only addresses the C-300._ Therefore, please provide complete details of the Models C-100 and C-200. The remainder of this letter only addresses the Model C-300.

2. Please provide a copy of Seaman Nuclear's drawing 450-0000 that is referenced on page 2 of your application.

3. Please note that the maximum activity for the Model AMN. PES, as indicated on the registry for the source, is 37.5 mCl. Therefore, this is the maximum activity that will be authorized for this source model.

4. Please demonstrate that the Amersham Model AMNV.997 is registered with NRC or an Agreement State or provide sufficient information for registration of the source design.

5. The first two sentences on page 9 of the application seem to be out of place. Please explain the applicability of these sentences.

6. 10 CFR 32.51 Indicates that the labeling must include the following wording (or i substantially similar wording): "This labeling shall be maintained on the device in a legible condition. Removal of this labelis prohibited." This information is not included in the labeling described on page 11 of the application. Please indicate how the j device labeling will be modified to meet this requirement.

l -7. Please indicate the location of the general license labeling indicated on page 11 of the i application and verify that it will be visible to users of the device.

8. Please indicate how the device will be labeled to indicate the On/Off status of the shielding of the cesium-137 source.

9. You have indicate that a prototype device was tested to verify that it will maintain its integrity when subje'c ted to likely vibrations during use. Please verify and explain how 9907130013 990607 / ( ') ~

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I S. Seaman 2 this testing dernonstrates that the device will maintain its integrity when subjected to likely vibrations during transportation. ~

        .10.      Please verify that the radiation levels in the first column (Contact) of the table on page 24 of the application are the dose rates on contact, except for those with the

• which are calculated values at 5 cm. In addition, please verify that the units for the dose rates in the table are mrem / hour.

11.  !

The fourth bullet on page 25 of the applications indicates that "... top of base neutron I exposures are calculated using the inverse square law." Please provide justification for the applicability of the inverse square law to neutron exposures.

12. Please provide the calculations for radiation doses provided on pages 20 and 23 of -

the application, and provide justification for the times and distances used in the calculations.

13. Please provide' additional justification for the applicability of customer exposures.

Specifically, explain why the listed exposures are considered representative and indicate the number of years upon which the exposures are based, j

14. On page 22 of the application, it is indicated that "NW HW D1" had 3 users with l

annual exposures in the range of 100- mrem /yr. .Please explain 100- mrem /yr. Does -l this mean greater than 100 mrem /yr? -If so, what was the maximum exposure? Did any individual exceed 500 mrem /yr?

15. In your letter dated December 30,1997, your indicate that "... an example C-300 Operators Manual"is provided. Please note that the Operator's Manual is considered part of your application and changes to the manual must be approved by NRC.

16. On page 49 of the Operators Manual, it is indicated that "A general license to possess and use Seaman gauges is issued in the regulations of NRC or an agreement state without application or fees, .. " Please note that this statement would only apply to the Model C-300 gauge. In addition, note that this statement may not be true for some agreement states that have more stringent regulations for general licensees. Please indicate how Seaman Nuclear will address these concems.

17. On page 50 of the Operators Manual, it is indicated that general licensees need to establish a Radiation Safety Program. Please note that while the aspects of the program, as defined in your manual, are required for general licensees, there is no regulatory requirement for the establishment of a Radiation Safety Program. Please indicate how Seaman Nuclear will address this concem.

       .18. On page 50 of the Operators Manual, it is indicated that "A current leak test is not required during periods of long term storage." While this is true for specific licensees, there is no provision for this in the general license. Please indicate how Seaman Nuclear will address this'concem.

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                 .S.Stamin                                                           3

'~ ' 19/ We'have concems about the drawings submitted with the application and Seaman Nuclear's' proposed definitions of critical and non-critical specifications. Specifically, , we have concems about the dimensions that Seaman Nuclear has indicated are ' critical dimensions. In addition, we believe the following are acceptable definitions of l critical and non-critical specifications: l --

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l ' Critical Specifications - dimensions, tolerances, and materials of constructions that are important to shleiding, durability, and safety and have been identified . on the drawings, with stars. The criteria for selection of critical specifications were: (a) thicknesses and locations of the shielding which effects radiation levels; and, (b) thicknesses of the base and other components which effect drop test durability and strength of the operating mechanism. These specifications cannot be changed without the prior approval of NRC and an amendment to the registration certificate. Non-Critical Specifications - dimensions, tolerances, and materials of constructions that have less significant effect on strength, durability, and safety and, therefore, alterations may be made to these parameters without prior approval from NRC. However, the applicant will perform and document an  ; analysis'that there is no reduction in the degree of shielding, as verified by no  ! increase in the measured radiation levels around the device, and that the change will not adversely effect gauge durability and performance. We believe that the details of these concems should be discussed during a meeting between NRC and Seaman Nuclear. We will need to set up the date, time, and location of the meeting. Once the concems are adequately addressed, Seaman Nuclear will need to provide NRC will updated copies of drawings and procedures, including a revised quality assurance program. Please note that this letter only addresses technical issues associated with'the device design and specific requirements of 10 CFR 32.51. Licensing conditions and difficulties associated with ensuring accountability and security of devices will be addressed under separate cover. During our meeting concerning the application and the drawings provided, we also can discuss a schedule submittal of the information requested in this letter. If you have any questions, please contact me at (301) 415-7868 or Mr. Steven Baggett at (301) 415-7273. Sincerely IS [, John W. Lubinski, Mechanical Engineer Materials Safety Branch Division of Industrial and Medical Nuclear Safety _ Office of Nuclear Material Safety and Safeguards Distribution: IMNS r/f SSD-98-02 SSD-98-05 NE01 SSD File # NR-587-D-104-S DOCUMENT NAME: C:\ FILES \SSDS\ SEAMAN.DEF ' Ta receive a espy of this documentf indioete in the bos: 'C' = Copy vdthout attachment / enclosure *E' - Copy with attachment / enclosure 'N' = No copy OFFICE IMSBA -{ 6 l l NAME JLubin#ki/jl DATE 04/16/98-OFFICIAL RECORD COPY m

CONVERSATION RECORD TYPE: Outgoing Telephone NAME OF PERSON CONTACTED: ORGANIZATION: TIME: DATE: Todd Seaman Seaman Nuclear 07/15/98

SUBJECT:

Application for GL Registration - Model 300 series

SUMMARY

Requested the following information: j

1. Letter referenced in item 12. '

2. Clarification of the maximum effect on dose rates and likely doses based on 50 vs 40 mci of Am, and assurance that it will not exceed the 91 dose limits.

ACTION REQUIRED: Await response PLACE THIS RECORD IN: Pending Registration jy i

                                           //                          l PERSON DOCUMENTING THE        SIGNATUR '/                   DATE:

CONVERSATION: 7

                                               ..g j John W. Lubinski              /    /  ,

g 07/15/98 1 l i L}}