ML20035H454

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Forwards QA Program for Radioactive Matls Packages Program Manual, Rev 0,in Response to Re Usda QA Program
ML20035H454
Person / Time
Site: 07100238
Issue date: 04/29/1993
From: Jensen J
AGRICULTURE, DEPT. OF
To: Mcdonald C
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20035H455 List:
References
NUDOCS 9305050105
Download: ML20035H454 (2)


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,o United States Agricultural Radiological 6303 Ivy Lane Departnient of Research Safety Greenbelt, Maryland Agriculture Service Staff 20770-1433 APR 2 9 993 Mr. Charles Mcdonald Chief, Transponation Branch Division ofIndustrial and Medical Nuclear Safety, NMSS U.S. Nuclear Regulatory Commission Washington, DC 20555

Dear Mr. Mcdonald:

This is in reply to your letter dated March 16, 1993 concerning the USDA Quality Assurance (QA) Program.

It is our understanding that USDA is now required to apply to the NRC for a fabricators QA Program approval to cover any irradiator for which the USDA holds the NRC Certificate of Compliance.

The USDA holds the NRC Certificate of Compliance No. 9182 for the Model Husman (520, 521, and 521 A) irradiators and No. 5362 for the Model Natick irradiator.

It is our further understanding that this QA Program is applicable to these irradiators. A revised copy of USDA's QA Program for Radioactive Materials Packages is enclosed for your review. A letter from E. E. Finney, Acting Administrator, Agricultural Research Service, indicating management's support of the QA Program has been prepared, but a signed copy has not been transmitted to this office in time to meet our response deadline. A copy of this letter will be forwarded as soon as it is received.

Isomedix, Inc. began construction of a Model Husman 521 A irradiator for USDA in 1989 under the Isomedix NRC approved QA Program No. 0009. Isomedix completed all construction activities necessary for source loading prior to the termination of their QA Program in 1991. The irradiator is being stored by Isomedix while arrangements for the fabrication and loading of sealed sources are being finalized. It is our understanding that, construction activities conducted by Isomedix on the Model Husman irradiator have been performed in compliance with an NRC approved QA Program.

The USDA Radiological Safety Staff (RSS) will review the Isomedix QA procedures applied to the Model Husman irradiator for compliance with the NRC approved USDA QA Program prior to further constmetion activities by Isomedix. It is our further understanding that the QA Program review conducted by the RSS will satisfy NRC QA Program requirements for completing construction of the irradiator, source loading, and transoortation to a USDA location.

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It is our understanding that all irradiators in use by USDA have been fabricated under a manufacturer's NRC approved QA Program.

Please describe the QA Program requirements that USDA must follow for irradiators previously fabricated under a manufacturer's NRC approved QA Program and for which USDA holds the NRC Certificate of Compliance.

If our understandings are incorrect or if any additional information is required, please contact me immediately on (301) 344-0193.

Sincerely, I

Joh

.Jensen, irector, Radiological Safety Staff l

Enclosures (2) cc: w/ enclosures, H. Mabry, APHIS I

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