N.J. Admin. Code § 7:28-4.8

Current through Register Vol. 56, No. 21, November 4, 2024

Section 7:28-4.8 - Special requirements for approval of an application for an initial specific license or renewal of a specific license for use of diffuse naturally occurring or diffuse accelerator produced radioactive materials

(a) If the Department determines that an applicant meets the requirements of this subchapter and the Act, an initial specific license or renewal of a specific license may be issued for use of multiple quantities or types of radioactive material provided:

1. The applicant satisfies the general requirements for approval of specific license applications in 7:28-4.7;

2. The applicant's staff has had substantial training and experience with a variety of radioisotopes for various research and development uses;

3. The applicant has established an isotope committee, composed of a radiological safety officer, a representative of management and one or more persons trained or experienced in the safe use of radioactive materials, which will review and approve or disapprove proposals for use of radioactive materials in the advance of purchase of such materials; and

4. The applicant has appointed a radiological safety officer who shall be responsible for rendering advice and assistance on radiological safety.

(b) No license to possess or utilize radioactive material pursuant to this subchapter shall be transferred or assigned, or in any manner disposed of, either voluntarily or involuntarily, directly or indirectly, through transfer of control of any license to any person, unless the Department shall, after securing full information, find that the transfer is in accordance with the provisions of the Act and shall give its consent in writing.

(c) If the Department determines that an applicant meets the requirements of this subchapter and the Act, an initial specific license or renewal of a specific license may be issued to distribute certain devices to persons generally licensed under 7:28-4.5(a) and (e) provided:

1. The applicant satisfies the general requirements for approval of specific license applications in 7:28-4.7;

2. The applicant submits sufficient information relating to the design, manufacturer prototype testing, quality control procedures, labeling, proposed uses and potential hazards of the device to provide reasonable assurance that:

i. The radioactive material contained in the device cannot be easily removed from the device;

ii. No person possessing, using, transporting or exposed to the device will receive a radiation dose to a major portion of his body in excess of 0.1 rem in any one year under ordinary circumstances of use;

iii. The device can be safely operated by persons not having training in radiological protection; and

iv. The radioactive material within the device would not be accessible to unauthorized persons; and

3. In describing the label or labels and contents thereon to be affixed to the device, the applicant shall separately indicate those instructions and precautions which are necessary to assure safe operation of the device. Such instructions and precautions shall be contained on labels as described in 7:28-4.5(e).

(d) The Department may incorporate in any license at the time of issuance, or thereafter, all such additional requirements and conditions with respect to the licensees distribution or arrangement for the distribution, sale, lease, receipt, possession, use, ownership, or transfer of radioactive material as it deems appropriate or necessary in order to assure compliance with this chapter and the Act.

N.J. Admin. Code § 7:28-4.8

Amended by 46 N.J.R. 768(a), effective 5/5/2014.