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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 481. Virginia Radiation Protection Regulations
7/11/2020

12VAC5-481-3560. 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 these rules 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;

5. The applicant has met the financial surety requirements of 12VAC5-481-450 C; and

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 quality assurance of items released for unrestricted use; and

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

B. An application for a specific license to decontaminate equipment, land, or facilities contaminated with TENORM in excess of the levels set forth in 12VAC5-481-3480 A, 12VAC5-481-3510 2, or Table 6, as applicable, and to dispose of the resulting waste will be approved if:

1. The applicant satisfies the general requirements specified in subsection A of this section; 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 quality assurance of items released for unrestricted use; and

d. Method of disposing of the TENORM removed from contaminated equipment, facilities, and/or land.

C. An application for a specific license to transfer materials or manufacture or distribute products containing TENORM to persons exempted from these regulations pursuant to 12VAC5-481-3530 B will be approved if:

1. The applicant satisfies the general requirements specified in subsection A of this section;

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 material or product to demonstrate that the material or product will meet the safety criteria set forth in 12VAC5-481-3570. 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 TENORM in each material or product;

c. The chemical and physical form of the TENORM 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 TENORM in the material or product;

e. The details of manufacture and design of the material or 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 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 TENORM 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 or initial transferor of the product and the radionuclides and quantity of TENORM in the material or product;

j. The 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. The results of the prototype testing of the material or 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 12VAC5-481-3570 and the basis for such estimates;

m. A determination that the probabilities with respect to doses referred to in 12VAC5-481-3570 meet the safety criteria;

n. The quality control procedures to be followed in the production of production lots of the 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 radiation safety of the material or product.

D. Notwithstanding the provisions of subdivision 2 of 12VAC5-481-3570, the agency may deny an application for a specific license if the end uses of the product are frivolous or cannot be reasonably foreseen.

Statutory Authority

§ 32.1-229 of the Code of Virginia.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008.

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