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 2

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 3

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 4

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 5

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 6