Or. Admin. Code § 333-117-0220

Current through Register Vol. 63, No. 12, December 1, 2024

Section 333-117-0220 - 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 in accordance with these rules in such a manner as to minimize danger to public health and safety or property;

(b) The applicant's proposed equipment, facilities and procedures are adequate to minimize danger to public health and safety or property;

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

(d) The applicant satisfies any applicable special requirement in this Division.

(2) An application for a specific license to decontaminate or perform maintenance on equipment and facilities contaminated with NORM in excess of the levels set forth in Table 1 of this Division and to dispose of the resulting waste will be approved if:

(a) The applicant satisfies the general requirements specified in section (1) of this rule; and

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

(A) Procedures and equipment for 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 quality assurance of items released for unrestricted use; and

(D) Method of disposing of the radioactive material removed from contaminated equipment and facilities.

(3) An application for a specific license to manufacture and/or initially transfer products or materials containing NORM to persons exempted from these rules pursuant to OAR 333-117-0040(2) will be approved if:

(a) The applicant satisfies the general requirements specified in section (1) of this rule;

(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 OAR 333-117-0230. The information shall include:

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

(B) The type, quantity and concentration of NORM in each material or product;

(C) 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;

(D) An analysis of the solubility in water and body fluids of the NORM in the material or product;

(E) 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;

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

(G) The total quantity of NORM expected to be distributed annually in the material or product;

(H) The expected useful life of the material or product;

(I) The proposed method of labeling or marking each unit of the material or product with identification of the manufacturer and/or initial transferor of the product and the radionuclide(s) and quantity of NORM in the material or product;

(J) 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;

(K) Results of the prototype testing of the material or product, including any change in the form of the NORM contained in it, the extent to which the NORM 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 OAR 333-117-0230 and the basis for such estimates;

(M) A determination that the probabilities with respect to doses referred to in OAR 333-117-0230 meet the criteria;

(N) Quality control procedures to be followed in the production of production lots of material or product and the quality control standards the material or 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 safety of the material or product.

(4) Notwithstanding the provisions of OAR 333-117-0230(2) the Agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.

Or. Admin. Code § 333-117-0220

HD 1-1991, f. & cert. ef. 1-8-91

Tables referenced are available from the agency.

Stat. Auth.: ORS 453.605 - 453.807

Stats. Implemented: ORS 453.605 - 453.807