| (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 (4) it is unlikely that there will be a significant reduction in the effectiveness of the containment, shielding, or other safety features of the material or product from wear and abuse likely to occur in normal handling and use of the material or product during its useful life. (m) Table of allowable organ doses. The following table describes the doses allowed per specific organ. Attached Graphic (n) Issuance of specific licenses. (1) When an application meets the requirements of the Act and rules of the agency, the agency will issue a specific license authorizing the proposed activity in such form and containing appropriate or necessary conditions and limitations. (2) The agency may incorporate in a license at the time of issuance, or thereafter by amendment, any additional requirements and conditions with respect to the licensee's receipt, possession, use, and transfer of NORM subject to this section as it considers appropriate or necessary in order to: (A) minimize danger to public health and safety, property, or the environment; (B) require such reports and the keeping of such records, and to provide for such inspections of activities under the license as may be appropriate or necessary; and (C) prevent loss or theft of material subject to this section. (o) Conditions of licenses issued under subsection (k) of this section. (1) General terms and conditions. (A) Each license issued in accordance with this section shall be subject to all the provisions of the Act, now or hereafter in effect, and to all rules and orders of the agency. (B) No license issued or granted under this section and no right to possess or utilize NORM granted by any license issued in accordance with this section shall be transferred, assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person unless the agency, after securing full information, finds that the transfer is in accordance with the provisions of the Act, and gives its consent in writing. (C) Each person licensed by the agency in accordance with this section shall use and possess the licensed material at the locations and for purposes authorized in the license. (D) Each person licensed by the agency in accordance with this section is subject to the general license provisions of subsection (g) of this section. (E) Each person licensed by the agency in accordance with this section shall manage and dispose of wastes containing NORM: (i) in accordance with EPA applicable requirements for disposal of such wastes; (ii) by transfer of the wastes for disposal to a person specifically licensed to receive waste containing NORM and that is licensed under requirements equivalent to those for uranium and thorium byproduct materials in §289.260 of this title; (iii) by transfer of the wastes for disposal to a facility licensed in accordance with the requirements equivalent to those in the 10 CFR Part 61 by NRC, an agreement state, or a licensing state; or (iv) in accordance with alternate methods authorized by the agency having jurisdiction to regulate such wastes. (F) Notification to the agency. (i) Each licensee shall notify the agency, in writing, immediately following the filing of a voluntary or involuntary petition for bankruptcy by or against: (I) a licensee; (II) an entity controlling a licensee or listing the license of the licensee as property of the estate; or (III) an affiliate of the licensee. (ii) This notification shall include: (I) the bankruptcy court in which the petition for bankruptcy was filed; (II) the name of the entity in bankruptcy; and (III) the date of the filing of the petition. (2) Quality control, labeling, and reports of transfer. Each person licensed under subsection (k)(4) of this section shall: (A) carry out adequate control procedures in manufacturing the material or product to assure that each production lot meets the quality control standards approved by the agency; (B) label or mark each unit to identify the manufacturer, processor, producer, or commercial distributor of the material or product and the NORM in the material or product; and (C) maintain records identifying, by name and address, each person to whom NORM is transferred for use under subsection (d)(4) of this section or the equivalent requirements of another licensing state, and stating the kinds, quantities, and uses of NORM transferred. An annual summary report stating the total quantity of each radionuclide transferred under the specific license shall be filed with the agency. Each report shall cover the year ending December 31, and shall be filed within 30 days thereafter. If no transfers of radioactive material have been made in Cont'd... |
