10-144-220 Me. Code R. § N-13

Current through 2024-51, December 18, 2024

Section 144-220-N-13 - Requirements for the issuance of specific licenses

A. A license application will be approved if the Agency determines that:

(1) The applicant is qualified by reason of training and experience to use the TENORM in question for the purpose requested in accordance with this rule in such a manner as to protect the public health and safety or property;

(2) The applicant's proposed equipment, facilities, and procedures are adequate to protect the public health and safety or property;

(3) The issuance of the license will not be inimical to the health and safety of the public;

(4) The applicant satisfied all applicable special requirements in this Part; and

(5) The applicant has met the financial assurance requirements of N.26.

(6) The applicant has adequately addressed the following items in the application:

(a) Procedures and equipment for monitoring and protecting workers;

(b) An evaluation of the radiation levels and concentrations of contamination expected during normal operations;

(c) Operating and emergency procedures, including procedures for waste reduction and a quality assurance program designed to assess the adequacy of measurements made for the purpose of releasing items for unrestricted use; and

(d) A method for managing the radioactive material removed from contaminated equipment and facilities.

(7) For each location to be listed on the license as an authorized use location, the applicant shall submit either:

(a) A statement that the applicant owns the facility where radioactive material is to be used or stored; or

(b) A statement verifying that the facility owner has been informed, in writing, of the use or storage of radioactive material at the facility, and that the use of such material is subject to the rules of the Agency.

B. An application for a specific license to decontaminate equipment, land, or facilities contaminated with TENORM in excess of the levels set forth in N.4.A., N.7.B., or Appendix A of this Part, as applicable, and to dispose of the resulting waste will be approved if:

(1) The applicant satisfies the general requirements specified in N.13.A.; and

(2) The applicant has adequately addressed the following items in the application:

(a) Procedures and equipment for monitoring and protection of workers;

(b) An evaluation of the radiation levels and concentrations of contamination expected during normal operations;

(c) Operating and emergency procedures, including procedures for waste reduction and a quality assurance program designed to assess the adequacy of measurements made for the purpose of releasing items for unrestricted use; and

(d) Method of disposing of the TENORM removed from contaminated equipment, facilities, or land.

C. An application for a specific license to transfer or manufacture or distribute consumer or retail products containing TENORM to persons exempted from this rule pursuant to N.4.B. will be approved if:

(1) The applicant satisfies the general requirements specified in N.13.A.;

(2) The TENORM 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

(3) 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 TENORM product to demonstrate that the product will meet the safety criteria set forth in N.13. The information shall include:

(a) A description of product and its intended use or uses;

(b) The type, quantity, and concentration of TENORM in each product;

(c) The chemical and physical form of the TENORM in the product, and changes in chemical and physical form that may occur during the useful life of the product;

(d) An analysis of the solubility in water and body fluids of the radionuclides in the product;

(e) The details of manufacture and design of the product relating to containment and shielding of the TENORM and other safety features under normal and severe conditions of handling, storage, use, reuse, and disposal of the product;

(f) The degree of access of human beings to the product during normal handling, use, and disposal;

(g) The total quantity of TENORM expected to be distributed annually in the product;

(h) The expected useful life of the product;

(i) The proposed method of labeling or marking each unit of the product with identification of the manufacturer or initial transferor of the product and the radionuclides and quantity of TENORM in the product;

(j) The procedures for prototype testing of the 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;

(k) The results of the prototype testing of the product, including any change in the form of the TENORM contained in it, the extent to which the TENORM may be released to the environment, any change in radiation levels, and any other changes in safety features;

(l) The estimated external radiation doses and dose commitments relevant to the safety criteria in N.14 and the basis for such estimates;

(m) A determination that the probabilities with respect to doses referred to in N.14 meet the safety criteria;

(n) The quality control procedures to be followed in the processing of production lots of the product, and the quality control standards the product will be required to meet; and

(o) Any additional information, including experimental studies and tests, required by the Agency to facilitate a determination of the radiation safety of the product.

D. Notwithstanding the provisions of N.14.B., the Agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.

10-144 C.M.R. ch. 220, § N-13