ML20199J945
| ML20199J945 | |
| Person / Time | |
|---|---|
| Issue date: | 11/26/1997 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Houillion P OHMART CORP. |
| References | |
| SSD, NUDOCS 9711280275 | |
| Download: ML20199J945 (10) | |
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NUCLEAR REGULATORY COMMISSION -
t WASHINGTON, D.C,306M4001 November 26, 1997 7,,
1 Mr. Paul L. Houillion Ohmart Corporation i
Nuclear Service Group 4241 Allendorf Dr.
Cincinnati, OH 45209
Dear Mr. Houillion:
This letter is in reference to Ohmart Corporation's lequests to consolidate a number of registration certificates for your density, level, weight scale and moisture gauges, in your letter dated April 3,1996, and in the two supplc.,ents, both dated March 11,1997, you requested to consolidate the Model SHLG and SHN series of gauges under one registration certificate. In your letter dated February 7,1996, and in the supplements dated December 6,1996, and February 12,1997, you requested to consolidate the Model SH F, SH and SR series of gauges under another registration certificate.
This letter addresses these requests as well as the additionalinformation that we need to complete our evaluation of your applications.
Regarding the consolidation of registration certificates, please note the following policy issued to determine whether to group similav devices on a single registration certificate:
[O)nly products which are essentially identical in detign, function, construction, and which vary only in a dimensional capacity, in the sources used or in their application, may be grouped together on a single registration certificate (NUREG-1556, Vol. 3, Section 13.3).
Based upon this policy and the representations made in your letters, it has been determined that these models cannot be combined in the o anner requested.
Specifically, in our review we noted that the design, construction, and the source holders are different in the SH series and the SR series devices. The similarities between them extend only to their Industrial application (e.g. density or level measurements) and to the sources that are used in them. With regard to the SHLG and the SHN series, we also found that the design, construction, shleid materials, and source holders are different; and the sources, that you intend to use, show an overlap only.-
Consequently, we intend to continue our evaluation of these devices with separate regirtration certificates in the following manner:
l SH series:
NR 522 D-899 B, J
. SR series:
(presently registered as NR 522 D-881 B and NR 522 D 895 B, to be combined into one)
NR 522 D-881 B,
.SHLG series: NR 522 D-892 B, SHN series:
(presently registered as NR 522-D-846-S and NR 522 D 867 S, to be combined into one)
NR 522 D-846.
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't Mr. Houillion 2-An initial evaluation of applications has been cornpleted. We have identified areas where additional information or clarification is needed as described in Enclosures 1 and 2. In order to continue our evaluation, you must address these issues.
We look forward to receiving the requested information. Please provide the information within 30 days so we could continua our review. If you have any questions, please contact me at (301) 415 7904 or Mr. Steven Baggett at (301) 415 7273.
Sincerely,
- John P. Jankovich, Ph.D., Sr. Engineer Sealed Source Safety Section Division of Industrial and Medical Nucleat Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated.
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. An initial evaluation o app ications as een comp e e.l t d ~ We have identified areas where f
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b additionalintnernation or clarification is needed as described in Enclosures 1 and 2. In order to continue our eiduation, you must address these issues.
We look forward to receiving the requested information. Please provide the information within 30 days so we could continue our review, if you have any questions, please contact me at (301) 415 7904 or Mr. Steven Baggett at (301) 415 7273.-
i Sincerely,
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-John P. Jankovich, Ph.D., Sr. Engineer Sealed Source Safety Section Division of Industrial and Medical Nucleer Safety Office of Nuclear Material Safety and Safeguards
Enclosures:
As stated.
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Request for Additionalinformation for SHLG and SHN Series To complete our evaluation of your application dated April 3,1996, and your two supplements both dated March 11,1997, we need the following additional information.
Device Model Designations 1.
The current inactive registration certificate (NR 522 D 892 S) and active Kentucky registration certificate (KY 512 D 102 S) also list the Model SHLG 3A, but you did not list this model in your application. Do you wish to register this device with the SHLG series gauges 1 If so, please provide complete information on this model.
Sealed Source Model Designations,lootopes, and Maximum Activities 2.
Your application lists the U.S. Nuclear Co. Type 2102/#3280 sealed source for use in the source holders. No listing of this source can be found in our records. Please provide a copy of the source specifications, including appropriate test results.
- 3., Drawing No. A 2102, lists an Amersham Model CDC.7001 sealed source.
This model is not included on an ! ctive registration certificate. Please either provide Information that verifies that the source has been evaluated and is registered with NRC or an Agreement State or provide the information necessary to register the source.
Information necessary for a source registration is included in Regulatory Guide 10.11
" Guide for the Preparation of Applications for Radiation Safety Evaluation and Registration of Sealed Sources Containing Byproduct Material."
4.
In your application, Amersham source Models CDC.700, CDC.800, and CDC.93 are listed as having activities greater than what is permitted on their respective registration certificates. Either. Amersham Corporation would need to amend these registration certificates prior to use of these sources in your gauges, or Ohmart needs to modify the application to limit to the currently authorized maximum activity. Please advise us of your plans.
- 5.. Drawing No. B 57148 !ists the source as having an activity of 702.95 mCl.
Please explain why such a high activity was used for the survey when the maximum activity requested for the SHLG 3 source holder is 500 mCl.
6.
Leak test intervals of longer than six months require sufficient justification that the longer intervalis warranted. Please provide a determination that the sources are acceptable for
. an extended leak test interval. The provisions of 10 CFR 32.51(b) describe the information that you must supply.
Design 7.
The application states that a thin steel or aluminum plate is attached to the device to cover the beam port for protection. A weather strip compound is also used to attach the 1
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. gasket to the aetent/ bearing block. Drawing No. B 33132 specifies bath tub caulk (RTV) for the SHN source assembly. Please provide udditional;,Jormation for alllocations where sealing is used that the compounds that are specified can perform their intended function under their environmental conditions (e.g. in a radiation environment) for the expected life of the devices.
8.
Please address the potential for galvanic corrosion for the Model SHLG 1 and the possible effects on the sealed source; this model contains a stainless steel source attached to an aluminum rod which is then attached to a stainless steel rod. Regarding galvanic interaction, please also address the compatibility of the beam port cover plate, made of aluminum (referred to in item 7 above), with the materials of the other o;mponents that it is in contact with.
9.
Please provide engineering drawings for source holder which is designed to hold the Model A 57878 sealed source.
10.
Your application states that the devices may be used in highly corrosive conditions.
What effect will this have on these devices during the expected life of the devices?
11.
Section " Potential Hazards" of your application states that optional equipment may be L
added to the source shutter handle to permit remote on/off operation of the source shutter. Please provide additionalinformation on this equipment.
Labeling 12.
Drawing No. A 33739 in Tab 3 includes on the label a field entitled 'DATE'. Please confirm that this is the assay date of isotope in the sealed source.
13.
Drawing Nos. A 536's, and A 53678 indicate that the material for these labels will be vinyl with pressure sensitive backing Please demonstrate that such a label materialis permanent in the environment (e.g. temperature, humidity, splashed Industrial materials, radiation) for the expected useful hfe of the devices.
Conditions of Normal Use 14.
Please provide the expected useful life for the both the SHLG and RHN devices.
15.
Section
- Conditions of Normal Use" of your sample registration certificate states that the SHLG series source holders may experience a maximum temperature of 60'C. In Tab 5 of the application, Drawings Nos. C 49792, C-49796, and C-49800 indicate a maximum temperature of 116'C Please clarify the maximum temperature.
16.
Section
- Conditions of Normal Use" of your samplo registration certificate states that the SHLG series source housings are used as components of the Densart and Levelart gauges. Do these two gauges contain source housings other than the SHLG source housings? If so, please provide details.
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.l Prototype Testing 17.
Your sample registry lists the Model SHLG 3 as being subjected to prototype testing.
Please provide further details regarding the test procedures and results. Also, please provide information that verifies the Models SHLG 1 and SHLG 2 will withstand representative testing as required by the applicable standards. An engineering analysis or comparison to a similar device is permitted in place of actual testing.
External Rediation Levels 18.
All of the radiation survey drawings in Tab 5 of your application, in which the source is in the 'ON' position, include the following statement: " X mR/hr output at Y feet in open position', where X and Y are variables. Please explain this statement. If these statements represent the dose rate in the beam, the dose rates do not seem to be proportional to source activity; e.g., the dose rate for the 2.4 Ci source at 20 ft is 17.5 mR/hr, the 9 Ci source at 20 ft is 22 mR/hr, and the 10 Ci at 20 ft is 42 mR/hr. These dose rates should be able to be calculated using the same method used for calculating the dose rates around the devices with the maximum activity. Please explain.
19.
Several radiation survey drawings in Tab 5 show an "x" at some designated measurement points. Please provide completed information for these drawings.
20.
Your sample registration certificate has listed some dose rates which are different from that found on the drawings in Tab 5 of your application. Please provide the appropriate values.
Field Use of the Devices 21.
Please provide a list of all documentation that will be shipped with the source holders, in addition, please indicate who will receive the information in Tabs A, B, C, and D (i.e., the licensee, field service engineer, etc.),
22.
There is a discrepancy between two of your Safety Manuals for the k-value of Cs 137:
specifically, in Radiation Safety Manual RS 305, Section 4.2, the k value for Cs-137 is 3.5; in Radiation Safety Manual RS 306, Section 4.2, the k value for Cs 137 is 504. Both sections refer to an unshielded dose rate calculation, with the dose rate given in mrem /hr, activity given in mCl, and distance from source given in inches. Please provide the correct value in both manuals.
23.
In the example in RS 305, the dose rate is calculated using a distance in units of feet, not inches as indleated. Please revise so that all units are in agreement.
24.
-In Tab A, page 4 7, and Tab B, page 411, you recommend placing absorbers between the source and the detector to reduce the number of counts. Are the absorbers attached to the gauge? If so, please provide further information such as drawings, material specifications, methods of attachment, and whether the absorbers are routinely shipped
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with your devices? Is this procedure expected to be performed by generallicensees? If so, please provide a dose assessment for the individuals involved.
25.
Please verify that each general licensee will be provided a copy of 10 CFR 31.5, or applicable agreemrint state requirements, in accordance with 10 CFR 32.51a.
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Enclosuro 2 Roquest for AdditionalInformation for SH and SR series To complete our evaluation of your application dated February 7,1996 and the suppfoments dated December 6,1996, and February 12,1997, we nood the following additionalinformation.
Device Model Designation 1.
The curront inactive registration cortificate (NR 522 D 881 B) and the activo Kentucky registration cortificato (KY 512 D 1118) list the Model SR 1 gauge which was not included in your application. Do you wish to register this device with the SR series gaugos? If so, please provido complete information on this model.
Scaled Source Model Designations, Isotopes, and Maximum Activities 2.
Please provido a table for each modelin the SR Series which contains the manufactutor's source model number, corresponding Ohmart source model number, isotopo, and maximum activity.
3.
Your application lists the U.S. Nuclear Co. Type 2102/#3280 sealed sourco for uso in the sourco holdars. No listing of this source can be found in our records. Pbaso provido a copy of the source specifications, including appropriate test results.
4.
Your applicanon and sample registration cortificato list the maximum activity for the Model A 2100 scaled sourco, when used in the SR A sourco holder, to bo 3.0 Curios. In the inactive registration cortificato NR 522 D 895 B and activo Kentucky registration certificato KY 512-D 110 B, the value is listed as 3.5 Curies. Pleaso provido the desired maximum activity value.
- 5., Drawing No. A 2102, does not list Amersham Models CDC.700 and CDC.800 sealed sources as being acceptable for the Ohmart designation as scaled source Model A 2102. Please clarify.
6.
Leak test intervals of longer than six months require sufficient justification that the longer intervslis warranted. Please provido a dotormination that the sources are acceptable for an extended leak test interval. Tho rovisions of 10 CFR 32.51.(b) describe the information that you must supply.
Design 7.
Please provide the material of construction for the positioning screws that hold the hand!o in the "on" and *std" positions. In addition, please provido any details of instances where the screw became frozen, leaving the soutco in the "on" position, 8.
Section "Potontial Hazards" of your application states that optional equipment may be added to the sourco shutter handle to permit remoto on/off operation of the source shuttor. Please provido additionalinformation on this equipment.
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9-Conflicting pipe diameter ranges are given in the two registration certificates and application for the Model SR 1 A when it is used as a density gauge. Please provide the proper range of pipe diameters.
10.
Please provide information for the SH series that no corrosion potential exists between l
the materials of the shutter, shutter shaft, bearings ar.d source holder body (for reference, for example, see Drawing No. D 55000). Please also indicate that the lubricant used, if any, is suitable for the environmental conditions (including radiation i
environment) for the expected usefullife of the devices.
l Labeling 11.
Drawing A 33739 in Tab 3 includes on the label a field *DATE". Please confirm that this is the assay date of the identified isotope.
= 12.
Drawing Nos. A 53677 and A 53678 indicate that the material for these labels will be vinyl with pressurs sensitive backing. Please demonstrate that such a label materialis permanent in the environment (e.g. temperature, humlaity, splashed industrial materials, radiation) for the expected usefullife of the devices.
Conditions of Normal Use 13.
Please provide the expected usefullife for the SR series source holders and the basis for this determination.
14.
Section
- Conditions of Normal Use" of your sample registration certificate states that the SR series source holders may experience a maximum temperature of 60'C. In Tab 5 of the application, drawing C 44701 Indicates a maximum temperature of 315'C, Please provide the appropriate maximum temperature.
Prototype Testing 15.
Your sample registry lists th9 model SR series source holders as being subjected to 7
prototype testing, Please provide further details regarding the test procedures and results. An engineering analysis or comparison to a similar device is permitted in place of actualtesting.
External Radiation Levels 16.-
Please provide complete radiation profiles for each modelin the SR Series source holders.' The devices should contain the maximum activity for each source selected for that device. Radiation profiles for devices in typicalinstalled orientations should also be provided. Indicate whether the radiation profiles are derived from calculation or from surveying the device, if they are derived from surveying the device, p! ease provide a description of the instruments used to perform the surveys. The radiation profiles must be provided at 5,30, and 100 centimeters from the external surface of the device.
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17.
In your supplement, dated December 6,1996, for the Model SR 1 gaugo you show *."
at 100 cm with a Cs 137 source of 1000 mCl activity (p. 7 of the proposed registration cortificato). Pleaso provide the missing data.
l Field Use of Devices 18.
Please provido a list of all documentation that will be shipped with the source holders.
19.
In Tab A, pago 4 7, and Tab 8, pago 411, you recommend placing absorbors betwoon the source and the detector to reduce the number of counts. Are the absorbers attached to tho gaugo? Is so, please provido further information such as drawings, material specifications, methods of attachment, and whether the absorbers are routinely shipped with your devicos? Is this proceduro expected to be performed by generallicenseos? If so, please provide a doso assessment for the individuals involved.
20.
Please verify that each generallicensee will be provided a copy of 10 CFR 5i.5, or applicable agrooment stato requirements, in accordanco with 10 CFR 32.51a.
21, is thoro any guidanco provided to users of the devices for situations where the vossols are empty and radiation fields exceed limits specified in 10 CFR 20? Specifically, regarding your statomont that in tanks containing two liquids of different densities, the radiation field may exceed 5 mrom/hr (P 4, p. 7. Part 1 Section " Maximum Distance from Density Lovel or Interfaco Gaugo Model SHLG Series Sourco Holder to Radiation Detector"), please describo your provisions that apply for generallicensoos to assure radiation safety.
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