ML20128J102
| ML20128J102 | |
| Person / Time | |
|---|---|
| Issue date: | 09/30/1996 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Frame J SCIENTIFIC TECHNICAL, INC. |
| References | |
| SSD, NUDOCS 9610100185 | |
| Download: ML20128J102 (4) | |
Text
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k UNITED STATES 2!
j NUCLEAR REGULATORY COMMISSION s
WASHINGTON. D.C. 20555-0001
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September 30, 1996 John M. Frame, President ScienTech, Inc.
P.O. Box 118 N.E.1230 Hickman Ct.
Pullman, WA 99163
Dear Mr. Frame:
This is in response to your facsimile dated April 19,1996, requesting clarification of several issues concerning the requirements for the manufacture, distribution, and possession of certain devices containing tritium foil sources manufactured by Rydock Scientific and ScienTech incorporated. From your letter, it is our understanding that the device that ScienTech is distributing is listed on registration certificate WA-667-D-101-G and is intended for use by persons generally licensed. In addition, based on information contained ~in your letter, and information obtained from the State of Arizona and Safety Light Corporation, we have determined that the devices marketed by Rydock Scientific are intended for use by persons under a specific !icense who have specific authorization to use tritium in foil form. The intended i
use and user of these devices are an important distinction that will become apparent later in this letter.
NRC and Agreement State regulations concerning the use of licensed radioactive material are
" user" based. This means that persons who possess and use licensed material are responsible for the safe use and control of the material, and their license authorizing possession and use of the material is written accordingly. In addition, persons who wish to use licensed material under a specific license are responsible for demonstrating that the intended uses of the licensed material are safe. However, NRC and Agreement State regulations include a provision by which users of a sealed source or a device containing a sealed source may reference a safety evaluation that has previously been performed for the sealed source or device based on information supplied by the manufacturer or initial distributor of the product. This provision is contained in 10 CFR section 30.32(g), or the equivalent Agreement State regulation. In general, this provision only applies to sealed sources or devices that are commercially distributed and which will be used by persons who intend to rely on the safety features of the sealed source or device to ensure the safe use of the product. Licensees who do not intend to rely on the safety features of the product to ensure its safe use must demonstrate that they a:
have adequate qualifications and procedures in place to ensure the safe use of the material, 8$
neglecting the safety features of the product.
o
$o Since ScienTech's device listed on registration certificate WA-667-D-101-G is intended for use by persons generally licensed, its use is govemed by the requirements in 10 CFR Part 31 ng (specifically, section 31.5), or equivalent Agreement State regulation. In addition, the
'ou manufacture of the device is subject to the requirements contained in Washington State's 3*
regulation equivalent to 10 CFR 32.51. This section requires a safety evaluation be performed See for devices covered by this section, prior to the granting of approval for their manufacture and transfer. It is our understanding that the State of Washington issued registration certificate g
WA-667-D-101-G based on their safety hvaluation performed in accordance with their MECg g
equivalent regulation.
h h
h 550-1
J. Frame,
Conversely, devices marketed by Rydock are intended for use by persons who possess a specific license that authorizes the use of tritium in the form of a foil, without restriction on the j
use of the material and neglecting the safety features of any device into which the source may be installed. The Safety Light brand sources used in the Rydock devices are in foil form.
Therefore, a licensee who is authorized to possess tritium in foil form would be authorized to receive the Safety Light source, up to the activity limit listed on their license, regardless, of whether or not it was incorporated into the Rydock device. In addition, since the use of the material by these licensees is, in general, not restricted, the licensees would be authorized to install (or remove) the source into (or from) the Rydock device. This is due to the fact that the license for the use of the material has been issued based on the qualifications and approved procedures of the licensee to safely use the materialin foil form. For this reason, the manufacturer and transfer of the Rydock device, containing the Safety Light foil source, is not subject to the requirements in 10 CFR Part 32, or equivalent Agreement State regulation.
Therefore, a safety evaluation would not need to be performed for the product and neither Rydock nor Safety Light would need to obtain a registration certificate for the device. In addition, since the manufacture and transfer of the Rydock device are not subject to the requirements in 10 CFR Part 32, or equivalent Agreement State regulation, the distinction of who is the manufacturer of the device is not relevant.
Your letter also referred to the transfer of a Rydock device to a company located in Canada.
NRC and Agreement State regulations governing the possession and use of licensed material apply only to activities within the US. Therefore, a person who distributes a product containing 3
licensed material to a person in a foreign country would not be subject to the requirements in 10 CFR Part 32, or equivalent Agreement State regulations, for the manufacture and transfer of certain products, and would not be required to have a safety evaluation performed for the product, prior to its transfer. However, persons who import or export certain licensed material into or from the US are subject to the licensing requirements under 10 CFR Part 110 for import and export activities, and 10 CFR Part 30 for their possession and use of the material.
Based on the information contained in your letter, and additional information obtained from the State of Arizona and Safety Light, the current method used by Rydock and Safety Light to supply electron capture detectors containing tritium foil sources to persons authorized by license to possess and use tritium in the form of foil sources, is in accordance with NRC regulations.
If you have any questions concerning this matter, do not hesitate to call me at (301) 415-7273.
Sincerely, Sl Steven L. Baggett, Section Chief Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS Distribution:
i SSSS Staff SSSS r/f NE02-SSD-1/A RLO'Connell BDSpitzberg, RIV PASCIENTEC.lSS To receive a copy of th6s document. Indicate in the tion: *C" = Copy without attachment / enclosure
- E" = Copy with attachment / enclosure
- N* = No copy OFFICE IMABG l
j l
l NAME SLBaghett DATE 09h/96 j
'O "0 0g f
'%[kj NUCLEAR REGULATORY COMMISSION UNITED STATES C
WASHINGTON. D.C. 20555-0001 g
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...,e September 30, 1996 John M. Frame, President ScienTech, Inc.
P.O. Box 118 N.E.1230 Hickman Ct.
Pullman, WA 99163
Dear Mr. Frame:
This is in response to your facsimile dated April 19,1996, requesting clarification of several issues concerning the requirements for the manufacture, distribution, and possession of certair.
devices containing tritium foil sources manufactured by Rydock Scientific and ScienTech Incorporated. From your letter, it is our understanding that the device that ScienTech is distributing is listed on registration certificate WA-667-D-101-G and is intended for use by persons generally licensed. In addition, based on information contained in your letter, and information obtained from the State of Arizona and Safety Light Corporation, we have determined that the devices marketed by Rydock Scientific are intended for use by persons under a specific license who have specific authorization to use tritium in foil form. The intended use and user of these devices are an important distinction that will become apparent later in this letter.
NRC and Agreement State regulations concerning the use of licensed radioactive material are
" user" based. This means that persons who possess and use licensed material are responsible for the safe use and control of the material, and their license authorizing possession and use of '
the material is written accordingly. In addition, persons who wish to use licensed material under a specific license are responsible for demonstrating that the intended uses of the licensed material are safe. However, NRC and Agreement State regulations include a provision by which users of a sealed source or a device containing a sealed source may reference a safety evaluation that has previously been performed for the sealed source or device based on information supplied by the manufacturer or initial distributor of the product. This provision is contained in 10 CFR section 30.32(g), or the equivalent Agreement State regulation. In general, this provision only applies to sealed sources or devices that are commercially distributed and which will be used by persons who intend to rely on the safety features of the sealed source or device to ensure the safe use of the product. Licensees who do not intend to rely on the safety features of the product to ensure its safe use must demonstrate that they have adequate qualifications and procedures in place to ensure the safe use of the material, neglecting the safety features of the product.
Since ScienTech's device listed on registration certificate WA-667-D-101-G is intended for use by persons generally licensed, its use is governed by the requirements in 10 CFR Part 31 (specifically, section 31.5), or equivalent Agreement State regulation. In addition, the manufacture of the device is subject to the requirements contained in Washington State's regulation equivalent to 10 CFR 32.51. This section requires a safety evaluation be performed for devices covered by this section, prior to the granting of approval for their manufacture and transfer. It is our understanding that the, State of Washington issued registration certificate WA-667-D-101-G based on their safety evaluation performed in accordance with their equivalent regulation.
J. Frame,
3 Conversely, devices marketed by Rydock are intended for use by persons who possess a specific license that authorizes the use of tritium in the form of a foil, without restriction on the use of the material and neglecting the safety features of any device into which the source may
{
be installed. The Safety Light brand sources used in the Rydock devices are in foil form.
{
Therefore, a licensee who is authorized to possess tritium in foil form would be authorized to receive the Safety Light source, up to the activity limit listed on their license, regardless of whether or not it was incorporated into the Rydock device. In addition, since the use of the material by these licensees is, in general, not restricted, the licensees would be authorized to install (or remove) the source into (or from) the Rydock device. This is due to the fact that the license for the use of the material has been issued based on the qualifications and approved procedures of the licensee to safely use the material in foil form. For this reason, the manufacturer and transfer of the Rydock device, containing the Safety Light foil source, is not subject to the requirements in 10 CFR Part 32, or equivalent Agreement State regulation.
Therefore, a safety evaluation would not need to be performed for the product and neither Rydock nor Safety Light would need to obtain a registration certificate for the device. In addition, since the manufacture and transfer of the Rydock device are not subject to the 4
requirements in 10 CFR Part 32, or equivalent Agreement State regulation, the distinction of who is the manufacturer of the device is not relevant.
Your letter also referred to the transfer of a Rydock device to a company located in Canada.
NRC and Agreement State regulations governing the possession and use oflicensed material apply only to activities within the US. Therefore, a person who distributes a product containing licensed material to a person in a foreign country would not be subject to the requirements in 10 CFR Part 32, or equivalent Agreement State regulations, for the manufacture and transfer of certain products, and would not be required to have a safety evaluation performed for the product, prior to its transfer. However, persons who import or export certain licensed material
^
into or from the US are subject to the licensing requirements under 10 CFR Part 110 for import i
and export activities, and 10 CFR Part 30 for their possession and use of the material.
J Based on the information contained in your letter, and additional information obtained from the State of Arizona and Safety Light, the current method used by Rydock and Safety Light to supply electron capture detectors containing tritium foil sources to persons authorized by license to possess and use tritium in the form of foil sources, is in accordance with NRC regulations.
If you have any questions concerning this matter, do not hesitate to call me at (301) 415-7273.
Sincerely, Steven L. Baggett, Section Chief Sealed Source Safety Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS Distribution:
SSSS Staff SSSS r/f NE02-SSD-1 RLO'Connell BDSpitzberg, RIV PASCIENTEC.lSS To receive a copy of this document, indicate in the boa:
'C' = Copy without attachment / enclosure "E* = Copy with ettachment/ enclosure
- N* = No copy OFFICE IMAEG l
l l
l NAME SLBalgiett DATE 094 /96