La. Admin. Code tit. 33 § XV-324

Current through Register Vol. 50, No. 11, November 20, 2024

Section XV-324 - Filing Application for Specific Licenses

A. Applications for specific licenses shall be filed on a form prescribed by the Office of Environmental Compliance or in any other manner specified by the department.

B. The department may at any time after the filing of the original application, and before the expiration of the license, require further statements in order to enable the department to determine whether the application should be granted or denied or whether a license should be modified or revoked.

C. Each application shall be signed by the applicant or licensee or by a person duly authorized to act for and on his or her behalf.

D. An application for a license may include a request for a license authorizing one or more activities.

1. An application from a medical facility, educational institution, or a federal facility to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Chapter 7 or the equivalent regulations in 10 CFR 35 of the U.S. Nuclear Regulatory Commission requirements shall include:

a. a request authorizing the production of PET radionuclides, or evidence of an existing license issued under LAC 33:XV.324 or 10 CFR 30 of the U.S. Nuclear Regulatory Commission requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides;

b. evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in LAC 33:XV.328.J or 10 CFR 32.72(a)(2);

c. identification of the individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in LAC 33:XV.763.K or 10 CFR 32.72(b)(2); and

d. information on the PET drugs to be noncommercially transferred to members of its consortium, including the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for the safe handling and the storage of the radioactive drugs by medical use licensees.

2. Except as provided in Paragraphs D.3, 4, and 5 of this Section, an application for a specific license to use byproduct material in the form of a sealed source or in a device that contains the sealed source shall:

a. identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR 32.210, with an agreement state, or for a source or a device containing radium-226 or accelerator-produced radioactive material with a state under provisions comparable to 10 CFR 32.210; or

b. contain the information identified in 10 CFR 32.210(c).

3. For sources or devices manufactured before October 23, 2012, that are not registered with the NRC under 10 CFR 32.210 or with an agreement state, and for which the applicant is unable to provide all categories of information specified in 10 CFR 32.210(c), the application shall include:

a. all available information identified in 10 CFR 32.210(c) concerning the source, and, if applicable, the device; and

b. sufficient additional information to demonstrate that there is reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. Such information shall include a description of the source or device, a description of radiation safety features, the intended use and associated operating experience, and the results of a recent leak test.

4. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with 10 CFR 32.210(g)(1), the applicant may supply the manufacturer, model number, radionuclide, and quantity.

5. If it is not feasible to identify each sealed source and device individually, the applicant may propose constraints on the number and type of sealed sources and devices to be used and the conditions under which they will be used, in lieu of identifying each sealed source and device.

E. In the application, the applicant may incorporate by reference information contained in previous applications, statements, or reports filed with the department, provided such references are clear and specific.

F Applications and documents submitted to the department shall be available for public inspection unless the administrative authority makes a written determination of confidentiality in accordance with LAC 33:1. Chapter 5.

G If the department determines that any material should not be afforded confidentiality, a written denial of the request will be issued to the requestor in accordance with LAC33:I. Chapter 5.

H. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in LAC 33:XV.399. Appendix C (Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release) must contain either:

1. an evaluation showing that the maximum dose to a person off-site due to a release of radioactive materials would not exceed 1 rem effective dose equivalent or 5 rems to the thyroid; or

2. an emergency plan for responding to a release of radioactive material.

I. One or more of the following factors may be used to support an evaluation submitted under LAC 33:XV.324.H. 1:

1. the radioactive material is physically separated so that only a portion could be involved in an accident;

2. all or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

3. the release fraction in the respirable size range would be lower than the release fraction shown in LAC 33:XV.399. Appendix C due to the chemical or physical form of the material;

4. the solubility of the radioactive material would reduce the dose received;

5. facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in LAC 33:XV.399. Appendix C;

6. operating restrictions or procedures would prevent a release fraction as large as that shown in LAC 33:XV.399. Appendix C; or

7. other factors appropriate for the specific facility.

J. An emergency plan for responding to a release of radioactive material submitted under LAC 33:XV.324.H.2 must include the following information:

1. Facility Description. A brief description of the licensee's facility and area near the site;

2. Types of Accidents. An identification of each type of radioactive materials accident for which protective actions may be needed;

3. Classification of Accidents. A classification system for classifying accidents as alerts or site area emergencies;

4. Detection of Accidents. Identification of the means of detecting each type of accident in a timely manner;

5. Mitigation of Consequences. A brief description of the means and equipment for mitigating the consequences of each type of accident, including those provided to protect workers on-site, and description of the program for maintaining the equipment;

6. Assessment of Releases. A brief description of the methods and equipment to assess releases of radioactive materials;

7. Responsibilities. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying off-site response organizations and the department. Also, responsibilities for developing, maintaining, and updating the plan will be included;

8. Notification and Coordination. A commitment to and a brief description of the means to promptly notify off-site response organizations and request off-site assistance, including medical assistance for the treatment of contaminated injured on-site workers when appropriate. A control point must be established. The notification and coordination must be planned so that unavailability of some personnel, parts of the facility, and some equipment will not prevent the notification and coordination. The licensee shall also commit to notify the Office of Environmental Compliance by telephone at (225) 765-0160 immediately after notification of the appropriate off-site response organizations and not later than one hour after the licensee declares an emergency¹ ;

9. Information to be Communicated. A brief description of the types of information on facility status, radioactive releases, and recommended protective actions, if necessary, to be given to off-site response organizations and to the department;

10. Training. A brief description of the frequency, performance objectives and plans for the training that the licensee will provide workers on how to respond to an emergency including any special instructions and orientation tours the licensee would offer to fire, police, medical, and other emergency personnel. The training shall familiarize personnel with site-specific emergency procedures. Also, the training shall thoroughly prepare site personnel for their responsibilities in the event of accident scenarios postulated as most probable for the specific site, including the use of team training for such scenarios;

11. Safe Shutdown. A brief description of the means of restoring the facility to a safe condition after an accident;

12. Exercises. Provisions for conducting quarterly communications checks with off-site response organizations and biennial on-site exercises to test response to simulated emergencies. Quarterly communications checks with off-site response organizations must include the check and update of all necessary telephone numbers. The licensee shall invite off-site response organizations to participate in the biennial exercises. Participation of off-site response organizations in biennial exercises, although recommended, is not required. Exercises must use accident scenarios postulated as most probable for the specific site, and the scenarios shall not be known to most exercise participants. The licensee shall critique each exercise using individuals not having direct implementation responsibility for the plan. Critiques of exercises must evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall effectiveness of the response. Deficiencies found by the critiques must be corrected; and

13. Hazardous Chemicals. A certification that the applicant has met its responsibilities under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the byproduct material.

K. The licensee shall allow the off-site response organizations expected to respond in case of accident 60 days to comment on the licensee's emergency plan before submitting it to the Office of Environmental Compliance. The licensee shall provide any comments received within the 60 days to the Office of Environmental Compliance with the emergency plan.

¹These reporting requirements do not supersede or release licensees of complying with requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, Pub. L. 99499 or other state or federal reporting requirements.

La. Admin. Code tit. 33, § XV-324

Promulgated by the Department of Environmental Quality, Nuclear Energy Division, LR 13:569 (October 1987), amended by the Office of Air Quality and Radiation Protection, Radiation Protection Division, LR 18:34 (January 1992), LR I): 179 (February 1994), amended by the Office of the Secretary, LR 22:345 (May 1996), amended by the Office of Environmental Assessment, Environmental Planning Division, LR 26:2567 (November 2000), LR 27:1227 (August 2001), amended by the Office of the Secretary, Legal Affairs Division, LR 31:2525 (October 2005), LR 33:2178 (October 2007), amended by the Office of the Secretary, Legal Division, LR 40:286 (February 2014), LR4L1277 (July 2015).

AUTHORITY NOTE: Promulgated in accordance with R.S. 30:2001 etseq., and 2104(B)1.