| (1) A license application will be approved if the agency determines that: (A) the applicant is qualified by reason of training and experience to use the material in question for the purpose requested, according to this section, and in a manner that minimizes danger to public health and safety, property, or the environment; (B) the applicant's proposed buildings, structures, and procedures are adequate to minimize danger to public health and safety, property, or the environment; (C) the issuance of the license will not adversely affect the health and safety of the public; (D) the applicant satisfies any applicable special requirements in this section; and (E) the applicant has met the financial security requirements of subsection (v) of this section. (2) An application for a specific license to decontaminate equipment or land not otherwise exempted under the provisions of subsection (d) of this section or buildings and structures contaminated with NORM in excess of the levels set forth in subsection (w) of this section, as applicable, will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; (iii) operating and emergency procedures, and quality assurance of items released for unrestricted use; and (iv) a method of managing the NORM waste removed from contaminated equipment, buildings, structures, and land for disposal or storage. (3) An application for a specific license to perform NORM decontamination for spinning pipe gauges not otherwise exempted from the requirements of this section in accordance with subsection (d)(3) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; (iii) operating and emergency procedures, and quality assurance of items released for unrestricted use; and (iv) a method of managing the NORM waste removed from contaminated pipes for disposal or storage. (4) An application for a specific license to manufacture and/or commercially distribute products or materials containing NORM to persons exempted from the requirements of this section in accordance with subsection (d)(4) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; (B) 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 (C) 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 subsection (l) of this section. 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 human 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 type and extent of human access 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 for labeling or marking each unit of the material or product to identify the manufacturer and/or commercial distributor of the product and the radionuclide(s) and quantity of NORM in the material or product; (x) 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) results of the prototype testing of the material or product, including any change in the form of the NORM contained in it, the extent that 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 subsection (l) of this section and the basis for such estimates; (xiii) a determination that the probabilities with respect to doses referred to in subsection (l) of this section meet the criteria; (xiv) quality control procedures to be followed in assuring each production lot meets agency-approved quality control standards; and (xv) any additional information, including experimental studies and tests, required by the agency to facilitate a determination of the safety of the material or product. (5) An application for a specific license for persons who receive NORM waste from other persons for processing or persons who process NORM for other persons at temporary job sites in accordance with subsection (i)(3) of this section will be approved if: (A) the applicant satisfies the requirements specified in paragraph (1) of this subsection; and (B) the applicant has adequately addressed the following items in the application: (i) procedures and equipment for monitoring and protection of workers; (ii) an evaluation of the radiation levels and concentrations of contamination expected during normal operations; and (iii) operating and emergency procedures, including quality assurance of items released for unrestricted use. (6) Notwithstanding the provisions of paragraph (4) of this subsection, the agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen through complete technical documentation. (l) Safety criteria. An applicant for a license under subsection (k)(4) of this section shall demonstrate that the product is designed and will be manufactured so that: (1) during routine use and disposal, it is unlikely that the external radiation dose in any one year, or the dose equivalent resulting from the intake of radioactive material, excluding radon and radon decay products, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the consumer end-use material or product, will exceed the doses in column I of subsection (m) of this section; (2) during routine handling and storage of the quantities of the industrial material or product likely to accumulate in one location during marketing, commercial distribution, installation, and servicing of the material or product, it is unlikely that the external radiation dose in any one year, or the dose equivalent resulting from the intake of radioactive material, excluding radon and radon decay products, in any one year, to a suitable sample of the group of individuals expected to be most highly exposed to radiation or radioactive material from the industrial material or product, will exceed the doses in column II of subsection (m) of this section; (3) during routine use, disposal, handling, and storage, it is unlikely that the radon released from the material or product will result in an increase in the average radon concentration in air of more than 0.4 picocurie per liter (pCi/l); and Cont'd... |
