ML20212D319
| ML20212D319 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1997 |
| From: | John Lubinski NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Kinder K AFFILIATION NOT ASSIGNED |
| References | |
| SSD, NUDOCS 9710310065 | |
| Download: ML20212D319 (3) | |
Text
jeway 4
UNITED STATES p-s j
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20N0001
\\...../
October 29,1997 Kerry R. Kinder HESCO, Inc.
2139 Greenville Road LaGrange, GA 30241
Dear Mr. Kinder:
This letter is in response to your application dated January 23,1997, requesting registration of the Model ML-404XX series watches and attimeters and Model ML-416XX series personal markers and amending your license for distribution of the products to persons exempt from licensing. We are in the process of evaluating your request. However, in order to continue nur evaluation, the following information is necessary:
4 1.
Your rpplication indicates that the Models ML-404XX and ML-416XX are series of products where XX is a different set of numbers for each model within the series.
Please indicate the limitations on the boundaries for the series (e.g., maximum and minimum dimensions, mounting configuration of the light sources).
2.
Please provide complete drawings, including all materials, dimensions, tolerances, and source mounting configurations for each item within the series of products.
3.
Please provide complete drawings, including all materials, dimensions, and tolerances, for each source mounting configuration, 4.
Your application indicates that the MEPROLIGHT logo is a thin, bold M (M). However, previous applications indicate that the MEPROLIGHT logo is a wide, modified M (cc).
Please verify that the logo has not L sen modified.
5.
Your application indicates that the labeling for attimeters will be applied with epoxy a
paint. Please demonstrate that the epoxy paint will maintain its integrity during the likely conditions of use for the expected usefullife of the products.
6.
Your application indicates that MEPROLIGHT has tested the watch and altimeter designs and personal marker designs in accordance with MIL-W-46374F and IDF 7-41040630-90/04, respectively. Please provide:
l copies of the referenced staridards.
details of the tests that were performed.
O i
drawing (s), including all materials, dimensions, tolerances, and source g
mounting configuration, for the design (s) that were prototype tested.
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K. Kerry 2
October 29,1997 the evaluation criteria used to demonstrate that the products passed the testing.
demonstration that each model within the series that was not tested would be expected to pass the prototype testing.
7.
With respect to watches and altimeters, your application indicates that the
- Design of the dials and hands, and their assembly methodology have been taken directly from mb-microtec and, therefore, are considered acceptable by direct comparison." Please clarify this statement. Specifically, indicate whether MEPROLIGHT tested prototypes of the products or whether HESCO is relying on the testing performed by mb-microtec. If HESCO is relying on the testing performed by mb-microtec, please indicate why the testing is applicable by providing information on the testing performed and why any differences in the designs would not effect the ability of the product to survive the testing.
8.
Section 32.25,10 CFR indicates that persons licent ed to distribute self luminous products carry out adequate quality control procedures to assure each product distributed meets the standards approved by the Commission. Your application includes details of the quality control procedures implemented by MEPROLlGHT.
However, there is not sufficient detail concerning the procedures that will be implemented by HESCO. Please verify that all products distributed will be inspected by HESCO to ensure compliance with the design specifications, including labeling requirements.
9.
Your application indicates that the instructions provided with the products will indicate that the products must be retumed to the authorized dealer for any corrective measures or disposal. Please note that this is not a regulatory requirement for users of the products and the instructions should not indicate this as a regulatory requirement. Please verify that the instructions do not misrepresent the regulations.
4 10.
Your damonstration of hov' the product design meets the safety criteria in l
10 CFR 32.23 indicates that the products will not be inadvertantly discarded and will J
l be retumed to the distributor. However, there is no regulatory requirement for the products to be retumed to the distributor nor a prohibition against discarding the products in normal trash, Therefore, please demonstrate dose commitments that may result from disposal of the products will not exceed the regulatory limits provided in 10 CFR 32.23.
11.
Your demonstration of how the personal marker design meets the safety criteria in L
10 CFR 32.23 was based on the marker _containing~2 sources. However, your i
application request approval for the markers to conto up to 3 sources. Therefore, please demonstrate that markers containing 3 sou%, "ill not exceed the regulatory limits provided in 10 CFR 32.23.
l i
... e K. K;rry 3
October 29,1997 I
12.
Your application for the personal markers indicates that during normal use the markers will be used less than 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per week. This estimate appears low since it appears reassonable that the markers would remain on hats and clothing even when not in use. Please provide justification for calculations based on 10 hours1.157407e-4 days <br />0.00278 hours <br />1.653439e-5 weeks <br />3.805e-6 months <br /> per week.
13.
Section 30.19(c),10 CFR indicates that the exemption provided in Section 30.19 does not apply for products primarily for frivolous purposes or in toys or adornments.
Please demonstrate tnat the use of tritum in personal markers should not be considered a frivolous use.
14.
Our records indicate that your possession and use license from the State of Georgia was due to expire in January 1997. Please provide a current copy of your renewed Georgia possession and use license.
15.
Since your Georgia possession and use license authorizes by model number, for possession and storage, all of the gunsight systems Hesco is authorized to distribute, it is recommerMed that Hesco contact the State of Georgia to request amendment of the possession and use license to add the new devices. Please forward a copy of the amended Georgia possession and use license for inclusion in your license file.
16.
We note that your possession and use license references a model ML-270 that is not authorized on your exempt distribution license or registration certificate. Please clarify the following: 1) what type of device is the ML-270; 2) is this device is being distributed under the exempt distribution license; and 3) should this device be deleted or added to the exempt distribution license and registration certificate.
Please provide the requested information within 45 days, if you have any questions, please contact me at (301) 415-7868 or Ms. Susan Greene at (301) 415-7846.
Sincerely, John W. Lubinski, Mechanical Engineer Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety Office of Nuclear Material Safety and Safeguards Distribution:
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SSD 97-003 NE01 SGreene
'SSD File # PENDING DOCUMENT NAME: C:\\ FILES \\SSDS\\HESCO.DEF Ts receive a copy of this document. Indicate in the boa:
'C' a copy withou attachment >enclosu.6
- E" = Copy with attachment / enclosure
'N' = No copy OFFICE IMABj d C
NAME JLubinsRi/jl DATE 10/29/97 l
OFFICIAL RECORD COPY l