NRC Follow-up to Gamma Irradiator Service/Foss Event

1. NRC Follow-up to Gamma Irradiator Service/Foss Event Dan Collins (Deputy Director, Division of Nuclear Materials Safety, Region 1)

2. Licensees and Regulators • Gamma Irradiator Service (GIS) maintains an NRC and a PA agreement state license • GIS contracted with Foss Therapy, a California agreement state license • NJ agreement state license • Regulators involved include: NJ, PA, CA, and NRC

3. NRC Actions • NRC assisted NJ with reactive inspection at J&J on October 8, 2011 (PA assisted) • NRC issued Confirmatory Action Letter on October 20, 2011 (PA issued similar Consent Order) • NRC performed routine safety inspection at GIS on November 14 and 15, 2011 (11/15 with PA) • NRC assisted NJ with inspection of event at GIS on November 18, 2011

4. Confirmatory Action Letter Commitments • Submit copy of 30-day report • Conduct evaluation of event and revise Radiation Safety Manual, including operating and emergency procedures • Obtain the services of a third party to independently assess the Radiation Safety Manual and operating/emergency procedures

5. Confirmatory Action Letter Commitments • Submit revised Radiation Safety Manual to NRC • Obtain the services of a third party to provide comprehensive training (include review of event and corrective actions) to GIS personnel • Participate in management meeting at Region I

6. NRC Actions (Post-CAL) • NRC reviewed first individual identified by licensee for third party review and determined that nominee lacked requisite self-shielded irradiator experience • NRC reviewed and accepted second individual nominated • Reviewed and commented on NJ draft inspection report regarding Oct, 2011 event • Reviewing revised Radiation Safety Manual and operating/emergency procedures