180 Neb. Admin. Code, ch. 3, § 010

Current through September 17, 2024

Section 180-3-010 - FILING APPLICATION FOR SPECIFIC LICENSES

This section addresses filing application for specific licenses.

010.01APPLICATION FORMS. Applications for specific licenses must be filed on form NRH-7 for all medical licenses and form NRH-5 for all other licenses. Form NRH-5 is set out as Attachment 1 of this chapter.

010.02ADDITIONAL STATEMENTS. The Department may at any time after the filing of the original application 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.

010.03AUTHORIZED SIGNATURE. Each application must be signed by the applicant or licensee or a person duly authorized to act for and on their behalf.

010.04LICENSE REQUEST. An application for a license may include a request for a license authorizing one or more activities.

010.05RESERVED.

010.06RESERVED.

010.07DECOMMISIONING PLAN. As provided by 180 NAC 3-018 certain applications for specific licenses filed under 180 NAC 3, 5, and 7, must contain a proposed decommissioning funding plan or a certification of financial assurance for decommissioning.

010.08APPLICATION REQUIREMENTS. Applications must include:

(A) Other than as provided in 180 NAC 3-010.08(B) through (D), an application for a specific license to use radioactive material in the form of a sealed source or in a device that contains the sealed source must either:

(i) Identify the source or device by manufacturer and model number as registered with the U.S. Nuclear Regulatory Commission (NRC) under 10 CFR 32.210 or with an Agreement State, or for source or a device containing radium-226 or accelerator-produced radioactive material with the U.S. Nuclear Regulatory Commission (NRC) or an State under provisions comparable to 10 CFR § 32.210; or

(ii) Contain the information identified in 10 CFR 32.210(c); or

(B) For sources or devices manufactured prior to October 23, 2012 that are not registered with the U.S. Nuclear Regulatory Commission (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 applicant must provide:

(i) All available information identified in 10 CFR § 32.210(c) concerning the source, and, if applicable, the device; and

(ii) 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 must 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;

(C) For sealed sources and devices allowed to be distributed without registration of safety information per 10 CFR § 32.210(g)(1), the applicant may supply only the manufacturer, model number, and radionuclide and quantity; or

(D) 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.

010.09EMERGENCY PLANS. Emergency plans must adhere to the following:

010.09(A)EVALUATION OR EMERGENCY PLAN. Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in 180 NAC 3, Appendix 3-E "Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release" must contain either:

(i) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 0.01 sievert (Sv) (1 rem) effective dose equivalent or 0.05 sievert (Sv) (5 rem) to the thyroid; or

(ii) An emergency plan for responding to a release of radioactive material;

010.09(B)CONSIDERATIONS. One or more of the following factors may be used to support an evaluation submitted under 180 NAC 3-010.09(A):

(i) The radioactive material is physically separated so that only a portion could be involved in an accident;

(ii) All or part of the radioactive material is not subject to release during an accident because of the way it is stored or packaged;

(iii) The release fraction in the respirable size range would be lower than the release fraction shown in 180 NAC 3, Appendix 3-E due to the chemical or physical form of the material;

(iv) The solubility of the radioactive material would reduce the dose received;

(v) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in 180 NAC 3, Appendix 3-E;

(vi) Operating restrictions or procedures would prevent a release fraction as large as that shown in 180 NAC 3; or

(vii) Other factors appropriate for the specific facility;

010.09(C)EMERGENCY PLAN CONTENTS. An emergency plan for responding to a release of radioactive material submitted under 180 NAC 3-010.09 must include the following information:

(i) FACILITY DESCRIPTION. A brief description of the licensee's facility and area near the site;

(ii)TYPES OF ACCIDENTS. An identification of each type of radioactive materials accident for which protective actions may be needed;

(iii)CLASSIFICATION OF ACCIDENTS. A classification system for classifying accidents as alerts or site area emergencies;

(iv)DETECTION OF ACCIDENTS. Identification of the means of detecting each type of accident in a timely manner;

(v)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 onsite, and a description of the program for maintaining the equipment;

(vi)ASSESSMENT OF RELEASES. A brief description of the methods and equipment to assess releases of radioactive materials;

(vii) RESPONSIBILITIES. A brief description of the responsibilities of licensee personnel should an accident occur, including identification of personnel responsible for promptly notifying offsite response organizations and the Department; also responsibilities for developing, maintaining, and updating the plan;

(viii)NOTIFICATION AND COORDINATION. A commitment to and a brief description of the means to promptly notify offsite response organizations and request offsite assistance, including medical assistance for the treatment of contaminated injured onsite workers when appropriate.A control point must to 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 must also commit to notify the Department immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency. These reporting requirements do not supersede or release licensees of complying with the requirements under the Emergency Planning and Community Right-to-Know Act of 1986, Title III, P. L. 99-499 or other state or federal reporting requirements;

(ix)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 offsite response organizations and to the Department.

(x)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 must familiarize personnel with site-specific emergency procedures. Also, the training must 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.

(xi)SAFE SHUTDOWN. A brief description of the means of restoring the facility to a safe condition after an accident.

(xii)EXERCISES. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. Quarterly communications checks with offsite response organizations must include the check and update of all necessary telephone numbers. The licensee must invite offsite response organizations to participate in the biennial exercises. Participation of offsite 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 must not be known to most exercise participants. The licensee must 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.

(xiii)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, P. L. 99-499, if applicable to the applicant's activities at the proposed place of use of the radioactive material.

010.09(D)OFFSITE RESPONSE ORGANIZATIONS. The licensee must allow the offsite response organizations, expected to respond in case of an accident, 60 days to comment on the licensee's emergency plan before submitting it to the Department. The licensee must provide any comments received within the 60 days to the Department with the emergency plan.

010.11POSITRON EMISSION TOMOGRAPHY (PET) RADIOACTIVE DRUG PRODUCTION APPLICATION. An application from a medical facility, or educational institution, to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under 180 NAC 7 or equivalent Agreement State or U.S. Nuclear Regulatory Commission (NRC) requirements must include:

(A) A request for authorization for the production of Positron Emission Tomography (PET) radionuclides or evidence of an existing license issued under 180 NAC 3, U.S. Nuclear Regulatory Commission (NRC) or Agreement State requirements for a Positron Emission Tomography (PET) radionuclide production facility within its consortium from which it receives Positron Emission Tomography (PET) radionuclides.

(B) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 180 NAC 3-014.10(A)(ii),

(C) Identification of individual or individuals authorized to prepare the Positron Emission Tomography (PET) radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist accordin to 180 NAC 3-014.10(B)(ii).

(D) Information identified in 180 NAC 3-014.10(A)(iii) on the Positron Emission Tomography (PET) drugs to be noncommercially transferred to members of its consortium.

180 Neb. Admin. Code, ch. 3, § 010

Amended effective 6/15/2021