Section 440. Filing application for specific licenses

Article 4. Specific Licenses

A. Applications for specific licenses 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 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 a person duly authorized to act for and on his behalf.

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

E. Applications and documents submitted to the agency may be made available for public inspection in accordance with the Virginia Freedom of Information Act (§ 2.2-3700 et seq. of the Code of Virginia). The agency may withhold records in accordance with specific exemptions in the Virginia Freedom of Information Act or as otherwise specified by law.

F. 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 shall either:

1. Identify the source or device by manufacturer and model number as registered with the NRC under 10 CFR 32.210 or an agreement state under equivalent regulations;

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

3. For sources or devices containing radioactive material manufactured prior to 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 shall provide:

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 only the manufacturer, model number, and radionuclide and quantity; or

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.

G. Each application to possess radioactive material in unsealed form, on a foil or plated source, or sealed in glass in excess of the quantities in 12VAC5-481-3740 shall contain one of the following:

1. An evaluation showing that the projected dose to a person offsite due to a release of radioactive material would not exceed 0.01 Sv (1 rem) total effective dose equivalent or 0.05 Sv (5 rem) to the thyroid; or

2. An emergency plan, reviewed and commented on by offsite response organizations expected to respond in the event of an accident that contains the following information:

a. Facility description. A brief description of the licensee or applicant's facility and surroundings.

b. Types of accidents. An identification of each type of radioactive materials accident for which actions by licensee staff or offsite response organizations will be needed to protect members of the public.

c. Classification of accidents. A method for classifying and declaring an accident as alert or site area emergency.

d. Detection of accidents. Identification of the means for detecting each type of alert or site area emergency in a timely manner.

e. Mitigation of consequences. A brief description of the means and equipment that are available 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 available to assess releases of radioactive material.

g. Responsibilities. A brief description of the responsibilities of the licensee or applicant's personnel who will respond if an accident occurs, including identification of personnel responsible for promptly notifying offsite response organizations, including the agency.

h. Plan maintenance. A brief description of the positions assigned and methods to develop, maintain and update the plan.

i. A list of offsite response organizations, description of their responsibilities and anticipated actions, and copy of formal commitments, if any.

j. Notification and coordination. A brief description of the means to promptly notify the offsite response organizations and request offsite assistance including medical assistance for the treatment of contaminated injured onsite workers. The notification and coordination shall include alternate provisions in case key personnel, parts of the facility, or some equipment are unavailable. The licensee shall also commit to notify the agency immediately after notification of the appropriate offsite response organizations and not later than one hour after the licensee declares an emergency.

k. 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 the agency. A licensee shall allow the offsite response organizations expected to respond in case of an accident 60 days to comment on the licensees emergency plan before submitting it to the agency. A licensee shall provide any comments received within the 60 days to the agency with the emergency plan.

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

m. Drills and exercises. Provisions for conducting quarterly communications checks with offsite response organizations and biennial onsite exercises to test response to simulated emergencies. The licensee or applicant shall invite offsite response organizations to participate in biennial exercises. The exercises shall use accident scenarios postulated as the most probable for the specific site and the scenarios may not be known to most exercise participants. Critiques of exercises shall evaluate the appropriateness of the plan, emergency procedures, facilities, equipment, training of personnel and overall effectiveness of the response. Deficiencies found by the critiques shall be corrected.

n. Safe condition. A brief description of the means of restoring the facility and surroundings to a safe condition after an accident.

o. 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.

H. An application from a medical facility or educational institution to produce PET radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under Part VII (12VAC5-481-1660 et seq.) of this chapter shall include:

1. A request for authorization for the production of PET radionuclides or evidence of an existing license issued under Part III (12VAC5-481-380 et seq.) of this chapter 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 12VAC5-481-480 I.

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 ANP as specified in 12VAC5-481-480 I 2.

4. Information identified in 12VAC5-481-480 I 1 c on the PET drugs to be noncommercially transferred to members of its consortium.

I. Manufacture, preparation, or transfer for commercial distribution of drugs containing radioactive material for medical use under Part VII (12VAC5-481-1660 et seq.).

1. An application for a specific license to manufacture, prepare, or transfer for commercial distribution drugs containing radioactive material for use by persons authorized pursuant to Part VII (12VAC5-481-1660 et seq.) will be approved if:

a. The applicant satisfies the general requirements specified in 12VAC5-481-450;

b. The applicant submits evidence that the applicant is at least one of the following:

(1) Registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer;

(2) Registered or licensed with a state agency as a drug manufacturer;

(3) Licensed as a pharmacy by the Virginia Board of Pharmacy;

(4) Operating as a nuclear pharmacy within a federal medical institution; or

(5) A PET drug production facility registered with a state agency.

c. The applicant submits information on 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 storage of the radioactive drugs by medical use licensees; and

d. The applicant satisfies the following labeling requirements:

(1) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half-life greater than 100 days, the time may be omitted.

(2) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label shall include the radiation symbol as described in 12VAC5-481-850 and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.

2. A licensee authorized to manufacture, prepare or transfer for commercial distribution radioactive drugs shall ensure that any individual preparing the drugs is one of the following:

a. An authorized nuclear pharmacist (ANP) as defined in 12VAC5-481-10;

b. An individual that meets the requirements specified in 12VAC5-481-1770 and 12VAC5-481-1790, and the licensee has received an approved license amendment identifying this individual as an ANP;

c. A pharmacist, as defined in 12VAC5-481-10, designated as an ANP if:

(1) The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

(2) The individual practiced at a pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC; or

d. An individual under the supervision of an ANP as specified in 12VAC5-481-1710.

3. Shall provide to the agency no later than 30 days after the date that the licensee allows, under subdivision 2 a or c of this subsection, the individual to work as an ANP:

a. The individual's certification by a specialty board whose certification process has been recognized by the NRC with the written attestation signed by a preceptor as required by 12VAC5-481-1770;

b. An NRC or another agreement state license;

c. NRC master materials licensee permit;

d. The permit issued by a licensee or NRC master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or

e. Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a government agency or federally recognized Indian Tribe before November 30, 2007, or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and

f. The Virginia Board of Pharmacy's license.

4. A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha, beta, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall:

a. Perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and

b. Check each instrument for constancy and proper operation at the beginning of each day of use.

5. Nothing in this subsection relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radioactive drugs.

6. Each licensee preparing technetium-99m radiopharmaceuticals from molybdenum-99/technetium-99m generators or rubidium-82 from strontium-82/ryubidium-82 generators shall test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination in accordance with 12VAC5-481-1930. The licensee shall record the results of each test and retain each record for three years after the record is made.

Historical Notes

Derived from Volume 22, Issue 25, eff. September 20, 2006; amended, Virginia Register Volume 24, Issue 18, eff. June 12, 2008; Volume 32, Issue 24, eff. August 25, 2016.

Statutory Authority

§ 32.1-229 of the Code of Virginia.