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TITLE 25HEALTH SERVICES
PART 1DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 289RADIATION CONTROL
SUBCHAPTER FLICENSE REGULATIONS
RULE §289.259Licensing of Naturally Occurring Radioactive Material (NORM)

    (C) materials being transferred are in the recycling process.

(g) Protection of workers and the general population. Each person subject to the general license in subsection (f) of this section shall conduct operations in compliance with the standards for radiation protection established in §289.202(f)-(o), (ww)-(zz) of this title, and §289.203 of this title, except for transfer for disposal, which shall be governed by subsection (h) of this section.

(h) Transfer of waste for disposal.

  (1) Each person subject to the general license in subsection (f) of this section shall manage and dispose of wastes containing NORM:

    (A) in accordance with the United States Environmental Protection Agency's (EPA) applicable requirements for disposal of such wastes;

    (B) by transfer of the wastes for disposal to a person specifically licensed to receive waste containing NORM; or

    (C) in accordance with alternate methods authorized by the agency having jurisdiction to regulate disposal of such waste.

  (2) Records of transfers for disposal shall be maintained for inspection by the agency.

(i) Specific license.

  (1) Unless otherwise exempted under the provisions of subsection (d) of this section or licensed under the provisions of §289.252 of this title, the manufacture and commercial distribution of any material or product containing NORM shall be specifically licensed in accordance with this section or in accordance with the equivalent requirements of another licensing state.

  (2) Persons conducting deliberate operations to decontaminate the following shall be specifically licensed in accordance with the requirements of this section:

    (A) buildings and structures owned, possessed, or controlled by other persons and contaminated with NORM in excess of the levels set forth in subsection (w) of this section; or

    (B) equipment or land owned, possessed, or controlled by other persons and not otherwise exempted under the provisions of subsection (d) of this section.

  (3) Unless otherwise exempted in accordance with subsection (d) of this section, persons receiving NORM waste from other persons for storage or processing or persons who process NORM for other persons at temporary job sites shall be specifically licensed in accordance with the requirements of this section.

  (4) Spinning pipe gauge licensees performing reclamation activities shall obtain specific authorization to perform NORM decontamination on pipe. Alternatively, spinning pipe gauge licensees may survey tubing before reclamation activities are performed. If the exposure rate on the outside of a pipe, measured at any accessible point, is greater than 50 µR/hr, then the spinning pipe gauge licensee shall obtain a NORM decontamination license. If the exposure rate of the pipe measures less than 50 µR/hr, a spinning pipe gauge licensee may perform the scale removal activity without additional authorization on their license.

(j) Filing application for specific licenses.

  (1) Applications for specific licenses shall be filed in duplicate on a form prescribed by the agency.

  (2) The agency may at any time after the filing of the original application, and before the expiration of the license, require further information in order to determine whether the application should be granted or denied, or whether a license should be modified or revoked.

  (3) Each application shall be signed by the applicant or licensee, or a person duly authorized to act for and on the licensee's behalf.

  (4) A license application may include a request for a license authorizing one or more activities.

  (5) Applications and documents submitted to the agency may be made available for public inspection. The agency may, however, withhold any document or part thereof from public inspection in accordance with §289.201(n) of this title.

  (6) Each application for a specific license shall be accompanied by the fee prescribed in §289.204 of this title.

(k) Requirements for the issuance of specific licenses.

  (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

  (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.

Cont'd...

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