N.D. Admin. Code 33.1-10-23-13

Current through Supplement No. 394, October, 2024

Section 33.1-10-23-13 - Requirements for the issuance of specific licenses

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

a. The applicant is qualified by reason of training and experience to use the TENORM in question for the purpose requested in accordance with article 33.1-10 in such a manner as to protect the public health and safety or property;

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

c. The issuance of the license will not constitute a significant risk to the health and safety of the public;

d. The applicant satisfied all applicable special requirements in this chapter;

e. The applicant has met the financial assurance requirements of section 33.1-10-23-25;

f. The applicant has adequately addressed the following items in the application:

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

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

(3) Operating and emergency procedures, including procedures for waste reduction and quality assurance of items released for unrestricted use; and

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

g. For each location to be listed on the license as an authorized use location, the applicant shall submit either:

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

(2) 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 department.

2. An application for a specific license to transfer or manufacture or distribute consumer or retail products containing TENORM to persons exempted from this chapter under subsection 2 of section 33.1-10-23-04 will be approved if:

a. The applicant satisfies the general requirements specified in subsection 1;

b. 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

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 TENORM product to demonstrate that the product will meet the safety criteria set forth in section 33.1-10-23-14. The information shall include:

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

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

(3) 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;

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

(5) 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;

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

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

(8) The expected useful life of the product;

(9) 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;

(10) 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;

(11) 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;

(12) The estimated external radiation doses and committed dose equivalent relevant to the safety criteria in section 33.1-10-23-14 and the basis for such estimates;

(13) A determination that the probabilities with respect to doses referred to in section 33.1-10-23-14 meet the safety criteria;

(14) 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

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

N.D. Admin Code 33.1-10-23-13

Adopted by Administrative Rules Supplement 370, October 2018, effective 1/1/2019.

General Authority: NDCC 23.1-03-04; S.L. 2017, ch. 199, § 1

Law Implemented: NDCC 23.1-03-03, 23.1-03-04; S.L. 2017, ch. 199, § 18