Requirements for the Issuance of Specific Licenses

Requirements for the Issuance of Specific Licenses. 1. In addition to the requirements set forth in 1.3.9, and application for a specific license to decontaminate equipment, land, or facilities contaminated with NORM in excess of the levels set forth in 1.11.4(1), 1.11.10(3), or Appendix A of this section, as applicable and to dispose of the resulting waste will be approved if: a. The applicant has adequately addressed the following items in the application: i. Procedures and equipment for protection of workers; ii. An evaluation of the radiation levels and concentrations of contamination expected during normal operations; iii. Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and iv. Method of disposing of the NORM removed from contaminated equipment, facilities, and/or land. 2. An application for a specific license to manufacture and/or initially transfer products or materials containing NORM to persons exempted from these regulations pursuant to 1.11.4(2), will be approved if: a. The NORM is not contained in any food, beverage, cosmetic, drug, or other commodity designed for ingestion or inhalation by, or application to, a human being; and b. The applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, and conditions of handling, storage, use, and disposal of the NORM material or product to demonstrate that the material or product will meet the safety criteria set forth in 1.11.16. The information shall include: i. A description of the material or product and its intended use or uses; ii. The type, quantity, and concentration of NORM in each material or product; iii. The chemical and physical form of the NORM in the material or product, and changes in chemical and physical form that may occur during the useful life of the material or product; iv. An analysis of the solubility in water and body fluids of the NORM in the material or product; v. The details of manufacture and design of the material or product relating to containment and shielding of the NORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the material or product; vi. The degree of access of human beings to the material or product during normal handling, use, and disposal; vii. The total quantity of NORM expected to be distributed annually in the material or product; viii. The expected useful life of the material or product; ix. The proposed method of labeling or marking each unit of the material or product with identification of the manufacturer and/or initial transferor of the product and the radionuclide(s) and quantity of NORM in the material or product; x. The procedures for prototype testing of the material or product to demonstrate the effectiveness of the containment, shielding, and other safety features under both normal and severe conditions of handling, storage, use, reuse, and disposal; xi. The results of the prototype testing of the material or product, including any change in the form of the NORM contained in it, the extent to which the NORM may be released to the environment, any change in radiation levels, and any other changes in safety features; xii. The estimated external radiation doses and dose commitments relevant to the safety criteria in 1.11.16 and the basis for such estimates; xiii. A determination that the probabilities with respect to doses referred to 1.11.16 meet the safety criteria; xiv. The quality control procedures to be followed in the production of production lots of the material or product, and the quality control standards the material or product will be required to meet; and xv. Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the radiation safety of the material or product. 3. Notwithstanding the provisions of 1.11.16(2), the Agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.