ML20149G917
| ML20149G917 | |
| Person / Time | |
|---|---|
| Issue date: | 07/17/1997 |
| From: | Steven Baggett NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Camper L, Combs F, Piccone J NRC |
| References | |
| SSD, NUDOCS 9707240125 | |
| Download: ML20149G917 (4) | |
Text
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4 UNITED STATES j
g NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 20555-0001 i
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July 17, 1997 NOTE TO:
Generic Assessment Panel Fred C. Combs Larry W. Camper Josephine M. Piccone Kevin M. Ramsey
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FROM:
Steven L. Baggett, Section Leader i
Sealed Source Safety Section i
Medical, Academic, and Commercial Use Safety Branch Division of Industnal and Medical Nuclear Safety, NMSS
SUBJECT:
RECOMMENDATIONS REGARDING REVISION OF GUIDANCE DOCUMENTS TO ENSURE THAT STAFF REVIEW THE ENVIRONMENTAL AND USE CONDITIONS The following is provided in response to GAP's request to develop specific wording regardits revision of registration, licensing and inspection guidance documents to ensure that staff review the environmental and use conditions proposed by the applicant with respect to any information contained in the registration certificate, and to identify those guidance documents to be considered.
Reaistration Certificate and Safety Evaluation Guidance j
The Sealed Source Safety Section has discussed any changes that are necessary in draft NUREG-1556, Vol. 5 (which consolidates NUREG-1550, Regulatory Guides 10.10 and 10.11, and assorted P& gds). Although the safety evaluation process already includes an evaluation of vibration and other environmental and potentially limiting conditions, draft NUREG-1556, Vol. 5 va'l stress the importance of fully considering these issues during the safety evaluation m
and including more complete information listing the environmental and use conditions that the product was evaluated to.
1 Licensino Guidance Recommendations regarding changes to licensing procedures are to include a provision that, i
during license review, staff should consider the environmental and use conditions proposed by the applicant with respect to any information contained in the registration certificate. Of primary importance would be those documents developed under the NUREG-1556 series in conjunction with the Consolidated Guidance Document effort.
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.i Generic Assessment Panel Suggested wording for the recommended changes to licensing guidance documents for licensing categories that require the licensee to identify the sources and devices to be used is as follows:
During licensing, staff should consider the actual environmental and use conditions under which the source or devices is operated or is subjected to and compare this to.
any information contained in the registration certificate. Examples of environmental and use conditions to look for are pressure, vibration, mounting height / method, temperature, humidity, poor air quality, corrosive atmospheres, corrosive chemicals including process materials and cleaning agents, possible impact or puncture conditions, and any fire, explosion and flooding potential. If the applicant wishes to use the source or device under conditions which exceed those limits described in the registration certificate, the applicant must either:
(1) arrange to have the registration certificate amended by the source or device distributor to include the new conditions, or (2) provide sufficient information so that a custom review can be performed. Any instances where the proposed conditions exceed any conditions listed in the registration certificate should be addressed. The applicant should provide sufficient information and justification to demonstrate that the use conditions do not impact the safety or integrity of the source or device. If the applicant is approved to use the source or device in conditions which exceed any listed in the registration certificate, this should be noted on the license.
Suggested wording for the recommended changes to licensing guidance documents for licensing categories that allows the applicant to commit to using only registered devices in accordance with the registration certificate is as follows:
If the applicant commits to using only registered devices in accordance with the registration certificate, then the license reviewer need not consider the environmental and use conditions. If the applicant wishes to use the source or device under conditions which exceed those limits described in the registration certificate, the applicant must do one of the following:
(1) Arrange to have the registration certificate amended by the source or device distributor to include the new conditions.
(2)
Provide sufficient information so that a custom review can be performed. The licensing reviewer should consider the actual environmental and use conditions J
under which the source or devices is operated or is subjected to and compare this to any information contained in'the regie,ation certificate. Examples of
. environmental and use conditions to look for are pressure, vibration, mounting height / method, temperature, humidity, poor air quality, corrosive atmospheres,
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corrosive chemicals including process materials and cleaning agents, possible 1
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e-Generic Assessment Panel July 17, 1997 impact or puncture conditions, and any fire, explosion and flooding potential.
Any instances where the proposed conditions exceed any conditions listed in the registration certificate should be addressed. The applicant should provide sufficient information and justificatior h demonstrate that the use conditions do not impact the safety or integrity of the source or device. If the applicant is approved to use the source or device in conditions which exceed any listed in the registration certificate, this should be noted on the license.
insoection Guidance It is recommended that the following wording be considered for all inspection procedure documents included in the current format revision effort currently being performed by IMOB:
During inspection, staff should consider the actual environmental and use conditions under which the source or devices is operated or is subjected to and compare this to any information contained in the registration certificate, and in the license. Examples of environmental and use conditions to look for are pressure, vibration, mounting height / method, temperature, humidity, poor air quality, corrosive atmospheres, corrosive chemicals including process materials and cleaning agents, possible impact or puncture conditions, and any fire, explosion and flooding potential.
This should close action on ticket # IMNS-5749.
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Distribution:
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SSSS staff [.
ticket #'IMNS-5745 OFk;&, l MOB-SMerchant, IMAB
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' DOCUMENT NAME: C:\\SSSS\\ TICKETS \\lMNS5749. GAP -
Ta receive e copy of this doeurnent, Indicate in the box: "C" a Copy without attachment / enclosure
- E' = Copy with attachment / enclosure
- N" = No copy OFFICE IMAB C IMAB h l(L.
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~F NAME MBurgess/mtuh46 SBaggett DATE 07/ lG /97 07/ 17 /97
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.c' Generic Assessment Panel 4 impact or puncture conditions, and any fire, explosion and flooding potential.
Any instances where the proposed conditions exceed any conditions listed in the registration certificate should be addressed. The applicant should provide sufficient information and justification to demonstrate that the use conditions do not impact the safety or integrity of the source or device. If the applit 2:* is approved to use the source or device in conditions which exceed any li J in the registration certificate, this should be noted on the license.
Insoection Guidance It is recommended that the following wording be considered for all inspection procedure documents included in the current format revision effort currently being perforrrma by IMOB:
During inspection, staff should consider the actual environmental and use conditions under which the source or devices is operated or is subjected to and compare this to any information contained in the registration certificate, and in the license. Examples of environmental and use conditions to look for are pressure, vibration, mounting height / method, temperature, humidity, poor air quality, corrosive atmospheres, corrosive chemicals including process materials and cleaning agents, possible impact or puncture conditions, and any fire, explosion and flooding potential.
This should close action on ticket # IMNS-5749.