ML20147C423
| ML20147C423 | |
| Person / Time | |
|---|---|
| Issue date: | 02/05/1997 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Spell W LOUISIANA, STATE OF |
| References | |
| SSD, NUDOCS 9702060193 | |
| Download: ML20147C423 (2) | |
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NUCLEAR REGULATORY COMMISSION S
WASHINGTON, D.C. 2066tM001 February 5, 1997 Mr. William H. Spell, Administrator Radiation Protection Division j
Office of Air Quality and Radiation Protection 7720 Bluebonnet Road Post Office Box 82315 Baton Rouge, LA 70884-2135
Dear Mr. Spell:
I am responding to your E-mail received on January 31,1997, regarding Amersham field testing of a new pipeliner design in the State of Louisiana. Your basic question is why doesn't NRC oversee the field trial with an NRC licensee. NRC typically does not dictate where field testing is conducted. The vendor typically chooses a field test location that simulates the environment for which the device is designed. In this case, Amersham was approached by firms in Imuisiana to build a pipeliner that meets the 10 CFR Part 34 equipment requirements. These firms also offered to assist at the ground level in the development and testing of the device. Because of the amount of pipeline work done by the Louisiana firm and the fact that Amersham has a full service center located in Baton Rouge j
to allow immediate response to equipment problems or users questions, Amersham decided to field test this device in IAuisiana. The State of Iouisiana may need to amend the louisiana j
firms license to authorize the research and development of prototype devices.
I understand from a discussion with Amersham that they have submitted you a draft test plan and draft users manual for your review and comment. I further understand that the test plan has user reporting requirements at completion of each site use. Amersham will assemble these reports and provide a summary of its findings and corrective actions as appropriate to NRC, and the States of Louisiana and Massachusetts. This procedure is similar to how the 660 lock field test was authorized by NRC. It should be noted that the products that will be tested in Imuisiana, as was the case that NRC previously authorized, was a field trial of devices and components that had already been tested to 10 CFR 34 requirements. This gave some assurance that the product would maintain integrity during the field trial, and focused on the operation and function of the device. I would suggest that you review the plan and draft users manual and determine if the content addresses Imuisiana's radiation program requirements.
I agree with your assumption that the 3 month time frame may not be adequate. However, Amersham assures me that the use conditions proposed by the Louisiana license should be enough to address any operational and functional concerns by then. The 3 month time frame also does not consider Amersham going back to the drawing board if the field test reveal problems.
9702060193 970205 PDR RC SSD PDR
Mr. William F. Spell The activity of allowing field trails of prototype devices under research and development is not a new approach. This activity is often done in the gauging industry, especially in the area of analytical equipment to determine if a device is acceptable to a class of users before the product goes into production. It is not used as frequent in the radiography industry because of the few changes in equipment designs that have occurreA over the years.
Sincerely, Reinal signea by Steven L. Baggett, Chief 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 cc: Paul Imhaus, OSP Kate Roughan, Amersham Corp.
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