10-144-220 Me. Code R. § C-7

Current through 2024-51, December 18, 2024

Section 144-220-C-7 - Filing application for specific licenses

A. Applications for specific license shall be filed on a form prescribed by the Agency.

B. The Agency 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 Agency to determine whether the license should be modified or revoked.

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

D. An application for a license filed pursuant to this rule will be considered also as an application for a license authorizing other activities for which licenses are required, provided that the application specifies the additional activities for which the license is requested and complies with the appropriate regulations.

E. All sections of the application must be completed, clearly and concisely, with the applicable required information and submitted with the applicable fee, if required.

F. Applications and documents submitted to the Agency may be made available for public inspection except that the Agency may withhold any document or part thereof from public inspection if disclosure of its content is not required in the public interest and would adversely affect the interest of a person concerned.

G. Except as provided in paragraphs C.7.H, I, and J, 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 must either:

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

(2) Contain the information identified in 10 CFR 32.210(c).

H. 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 applicant must provide:

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

(2) 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.

I. For sealed sources and devices allowed to be distributed without registration of safety information in accordance with C.7.G of this rule, the applicant may supply only the manufacturer, model number, and radionuclide and quantity.

J. 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.

K. An application from a medical facility, educational institution, or Federal facility to produce positron emission tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part G or equivalent Agreement State requirements shall include:

(1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under this Part, NRC requirements, or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides.

(2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in C.11.J(1)(b).

(3) Identification of 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 C.11.J(2)(b).

(4) Information identified in C.11.J(1)(c) on the PET drugs to be noncommercially transferred to members of its consortium.

L. Emergency Planning

(1) Each application to possess radioactive materials in unsealed form, on foils or plated sources, or sealed in glass in excess of the quantities in Schedule D -- Quantities of Radioactive Materials Requiring Consideration of the Need for an Emergency Plan for Responding to a Release, must contain either:

(a) An evaluation showing that the maximum dose to a person offsite due to a release of radioactive materials would not exceed 1 rem (10 mSv) effective dose equivalent or 5 rem (50 mSv) to the thyroid or an intake of 2 milligrams of soluble uranium; or

(b) An emergency plan for responding to a release of any radioactive material and to any associated chemical hazards directly incident thereto.

(2) One or more of the following factors may be used to support an evaluation submitted under paragraph L.(1)(a) of this section:

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

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

(c) The release fraction in the respirable size range would be lower than the release fraction shown in Schedule D due to the chemical or physical form of the material;

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

(e) Facility design or engineered safety features in the facility would cause the release fraction to be lower than shown in Schedule D;

(f) Operating restrictions or procedures would prevent a release fraction as large as that shown in Schedule D; or

(g) Other factors appropriate for the specific facility.

(3) An emergency plan for responding to a release of radioactive material submitted under paragraph L.(1)(a) of this section must include the following information:

(a) Facility description. A brief description of the licensee's facility and area near the site.

(b) Types of accidents. An identification of each type of radioactive materials accident for which protective actions may be needed.

(c) Classification of accidents. A classification system for classifying accidents as alerts or site area emergencies.

(d) Detection of accidents. Identification of the means of detecting each type of accident in a timely manner.

(e) 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.

(f) Assessment of releases. A brief description of the methods and equipment to assess releases of radioactive materials.

(g) 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 Agency; also responsibilities for developing, maintaining, and updating the plan.

(h) 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 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 this Agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

(i) 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 Agency.

(j) 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.

(k) Safe shutdown. A brief description of the means of restoring the facility to a safe condition after an accident.

(l) 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 shall 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 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.

(m) 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 radioactive material.

(4) The licensee shall 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 the Agency. The licensee shall provide any comments received within the 60 days to the Agency with the emergency plan.

10-144 C.M.R. ch. 220, § C-7