The Expired Sealed Source and the Unlicensed Transfer
A small industrial radiography company holds a specific license authorizing possession and use of sealed sources for industrial radiography. The license lists a maximum activity of 100 Ci for any single source. In January, the RSO discovers a 120 Ci iridium-192 source in storage that was received in error three years earlier and has been unused since. The source is now below 100 Ci due to decay, but the license still shows the original authorized maximum. The company needs to transfer the source to a licensed disposal facility. The RSO proposes to ship the source immediately under the existing license, arguing that the current activity is below the limit. The shipping clerk notes that the transfer requires a new license amendment or a specific transfer license. The RSO insists that because the source is now below the authorized limit, no amendment is needed. The company president wants to avoid delays and asks you, as the consultant, to advise.
1. Does the current license authorize the possession and transfer of the source? Explain the regulatory basis for your answer.
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No. The license authorizes possession of sealed sources up to 100 Ci at the time of receipt. The source was received at 120 Ci, which exceeded the authorized limit, so its initial possession was unauthorized. Even though the source has decayed below 100 Ci, the license does not retroactively authorize the earlier possession. Moreover, transfer of a sealed source to a disposal facility requires either a specific license amendment authorizing the transfer or a separate transfer license under 10 CFR 30.41 or equivalent Agreement State provisions. The RSO's argument fails because the license limit applies to the activity at the time of receipt and because transfers require explicit authorization. The company must apply for a license amendment to authorize the transfer and should disclose the initial receipt error to the regulator.
2. What immediate actions should the company take to come into compliance, and what are the potential enforcement consequences?
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Immediate actions: (1) Secure the source and restrict access. (2) Notify the regulator of the unauthorized possession and the receipt error. (3) Apply for a license amendment to authorize transfer to a licensed disposal facility. (4) Conduct a root-cause analysis of the receipt error and implement corrective actions, such as improved receipt procedures and license verification. (5) Document all actions. Potential enforcement consequences include a notice of violation, civil penalties, and possibly a confirmatory order. Because the company self-disclosed and took prompt corrective action, the regulator may exercise enforcement discretion and reduce penalties. However, failure to disclose could be considered a willful violation and lead to escalated enforcement. The key is to demonstrate good faith and a commitment to compliance.