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HPPOS-127 PDR-9111210299

Transfer and/or Disposal of Spent Generators

See IE Information Notice No. 81-32 entitled as above and dated October 23, 1981. This notice states that spent radiopharmaceutical generators may be stored for decay to background and, after surveys, disposed of in any manner. Spent generators with residual activity may be transferred only to a person licensed to receive the material. The health physics position was written in the context of 10 CFR 20.201 and 20.207, but it also applies to the “new” 10 CFR Part 20, Sections 20.1301, 20.1801, and 20.1902. HPPOS- 045 contains a related topic.

It was reported to NRC that drivers of transporting companies with contracts from suppliers to deliver new generators and to pick up spent generators from medical institutions were storing the generators at their residence and/or removing the generator lead shielding for resale. In one incidence, police found eleven used Mo-99 / Tc-99m generators from a major radiopharmaceutical supplier inside a box labeled radioactive materials in the driveway of a driver. The average exposure rates measured from these generators were approximately 25 mR/hr at contact and 2 mR/hr at 3 feet; sufficient to deliver a dose of 25 mrem to the hands during dismantling.

NRC licenses contain specific procedures for the disposal of spent generators (e.g., return to supplier, etc.). In a letter dated June 4, 1981, the NRC Material Licensing Branch stated the conditions for authorizing decay-in-storage of certain radioactive materials, including generators. (A copy is enclosed with this document.) These conditions would be automatically added to new licenses or to existing licenses upon request. The proper way to store spent generators for decay and subsequent disposal is to segregate the generator columns and monitor them separately prior to disposal. There are no special requirements on disposal except for appropriate surveys to verify total decay, records of the surveys, and defacing or removal of labels on the devices. Any surveys should include the lead shielding. The generators may be disposed in non-radioactive trash when the activity has decayed to background levels. When spent generators are stored for decay, the requirements of 10 CFR 20.105 (permissible levels of radiation in unrestricted areas), 10 CFR 20.207 (storage and control of licensed materials in unrestricted areas), and 10 CFR 20.203 (posting and labeling requirements) must be complied with. [Note: The equivalent requirements are now found in 10 CFR 20.1301 (dose limits for individuals members of the public), 10 CFR 20.1801 (security of stored material), and 10 CFR 20.1902 (posting of areas or rooms in which licensed material is used or stored).] Until surveys indicate that no radioactivity remains, the generators must be treated as licensed material. None of the exemptions of Part 30 apply. Any person possessing these items (e.g., for lead recovery or waste disposal) is required to have an NRC license. The only exception would be the delivery of properly packaged and labeled items to a common or contract carrier for transport to an authorized recipient.

10 CFR 30.41 (b) (5) requires that licensed material be transferred only to a person who is licensed by NRC or one of the Agreement States. Therefore, when transferring spent generators back to the supplier, the common or contract carrier transporting the generators should be made fully aware that any operations with or use of the material, other than the actual transport or storage, is not authorized. Following delivery of the generators to the carrier, licensees are urged to provide specific instructions on the shipping papers indicating that the generators are to be delivered to the consignee without any unnecessary delay or unauthorized storage, and that the generators are not to be disassembled. It would be judicious to establish a routine point-of-contact with the supplier to inform him of the carriers being used, and to ask for the supplier’s cooperation in reporting any instances of improper actions.

The generator supplier may have provided instructions in package inserts regarding proper, safe and legal packaging and transport of generators. If licensees do not have these instructions or are unfamiliar with them, they are urged to contact the supplier.

Regulatory references: 10 CFR 20.201, 10 CFR 20.207, 10 CFR 20.1301, 10 CFR 20.1801, 10 CFR 20.1902, 10 CFR 30.41

Subject codes: 3.4, 3.5, 9.7

Applicability: Byproduct Material