ML20210V021

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Summary of 990811 Meeting with Graystar,Inc in Rockville,Md Re Classification of Graystar,Inc Irradiator Design, Submitted to NRC for Approval as Sealed Source & Device
ML20210V021
Person / Time
Issue date: 08/13/1999
From: Jankovich J
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To: Sturz F
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
References
SSD, NUDOCS 9908230038
Download: ML20210V021 (3)


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,o August 13,1999 MEMORANDUM TO:

Frederick Sturz, Section Leader Materials Safety and Inspection Branch, IMNS b

FROM:

John Jankovich Senior QA Engi er Materials Safety and Inspection Branch, IMNS

SUBJECT:

MINUTES OF MEETING WITH GRAYSTAR, Inc.

AUGUST 11,1999 Representatives of GrayStar, Inc., requested a meeting with NRC management to discuss the l

classification of their irradiator design, submitted to NRC for approval as a sealed source and device. The meeting was held on August 11,1999, at NRC headquarters in Rockville, Md.

Mssrs. Martin Stein, President /CEO and Russell Stein. VP represented GrayStar and presented the following issues for discussion:

1. Sealed Source and Device issues GrayStar received and understands the questions in the NRC deficiency letter dated July 26,1999; they stated that the design may not fit the classification of 10 CFR 36 as " panoramic" l

irradiator; GrayStar would prefer a classification of ANSI Category 1 in order to simplify the emergency response systems and the operator training requirements; human entry is limited to maintenance and cleaning; a number of generic issues (e.g. operating manual, operating procedures, personnel dose rates) contained in the NRC deficiency letter, should not be in the SSD registration but should be addressed in the site specific materials license.

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2. Environmental Assessment issues i

GrayStar needs additional information why the " categorical exclusion" from environmental reports (10 CFR 51.22) would not apply to their design; they would like to receive a copy of the generic (original) study which gave categorical exclusion to other irradiator designs; they will study the comparability of the GrayStar design to the ones in the generic report; GrayStar stated that approximately 600 irradiators are in use with Cs-137 as source material. Consequently, if GrayStar was to be required to prepare an environmental report, it would set a precedent.

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D NRC participants discussed the technical details of the issues presented by GrayStar.

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F. Sturz 2

In conclusion, the GrayStar representatives stated that they will wr:te a letter to NRC asking for (1) classification as a non-panoramic irradiator; (2) delineation why they must prepare an environmental report; and (3) extension of the response period to NRC's deficiency letter.

NRC oartici9 ants:

l John Hickey /IMNS Seung Lee /IMNS Charlotte Abrams/NMSS Markley Au/IMNS Frederick Sturz/IMNS John Jankovich/IMNS l

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- v F. Sturz 2

In conclusion, the GrayStar representatives stated that they will write a letter to NRC asking for (1) classification as a non-panoramic irradiator; (2) delineation why they must prepare an environmental report; and (3) extension of the response period to NRC's deficiency letter.

NRC oarticipants:

John Hickey /IMNS Seung Lee /IMNS Charlotte Abrams/NMSS Markley Au/IMNS Frederick Sturz/IMNS John Jankovich/IMNS l

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. hdM DISTRIBUTION Ep\\(gb NRC Central File IMNS r/f NMSS r/f Participants J. Piccone/IMNS SSD-99-27 g:i

{gItcuje, D. Cool /IMNS PDR OFFICE MSIB J/

khs NAME JJank DATE 8/ ($'/99 OFFICIAL RECORD COPY

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