64E-5.511. Registration of Radiation Machines

(1) Exemptions.

(a) Electronic equipment that produces radiation incidental to its operation for other purposes is exempt from registration registration requirements if the dose equivalent rate averaged over an area of 10 square centimeters does not exceed 0.5 mR (5 µSv) per hour at 5 centimeters from any accessible surface of the equipment. The production, testing or factory servicing of such equipment shall not be exempt.

(b) Radiation machines that are non-operational and under the control of a registered vendor prior to final installation are exempt from the registration and fee requirements of this section.

(2) Application and Fees for Registration of Radiation Machines.

(a) Each person who acquires a radiation machine or an additional radiation machine shall:

1. Apply for registration of the radiation machine with the Department within 30 days after acquisition and before use. Application for registration shall be on DH Form 1107, 10/15, “Radiation Machine Facility Registration,” which is herein incorporated by reference and available from the internet at http://www.floridahealth.gov/radiation, or at https://www.flrules.org/Gateway/reference.asp?No=Ref-06528.

2. Designate an individual who will be responsible for radiation protection.

3. Prohibit any person who is not registered with the department as a provider of services as specified in (3), below, from furnishing radiation machine servicing or services to his radiation machine.

(b) Registration fees are due within 30 days after acquiring a radiation machine. If the machine is acquired within 120 days before the October 28 annual renewal date, the registration fee will be due on or before October 28 and will be the annual renewal fee. Otherwise, the renewal fee is due annually on or before October 28.

(c) An annual fee for the registration and inspection of radiation machines shall be paid according to the following schedule:

First Tube/UnitEach Additional Tube/Unit

Medical or Chiropractic or Osteopathic$145$85

Veterinary One Tube$50$34

Educational or Industrial$47$23

Dental or Podiatry$31$11

Medical Accelerator$258$148

Non-Medical Accelerator$81$48

(3) Application for Registration of Servicing and Services.

(a) Each person who installs or offers to install radiation machines or furnishes or offers to furnish radiation machine servicing or services in Florida shall apply to the Department to register such services before furnishing or offering to furnish such services.

(b) Application for registration shall be completed on DH Form 1113, 09/14, “Radiation Machine Vendor Registration Form,” which is herein incorporated by reference and is available from the internet at http://www.floridahealth.gov/radiation, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-05442.

(c) Services include the installation or servicing of radiation machines and associated radiation machine components.

(4) Report of Changes. The registrant shall report in writing within 30 days any changes to the information in the Certificate of Registration. The report shall include name, address of installation change, receipt, sale, transfer, or disposal of any radiation machine or major component.

(5) Assembler or Transferor Obligation.

(a)1. Any registrant or person who sells, leases, transfers, relocates, lends or disposes of one or more radiation machines or major components of one or more such machines shall notify the Department within 15 days after such action. Notification shall be made on DH Form 1107, 10/15, “Radiation Machine Facility Registration.”

2. Any assembler who relocates, assembles, installs or disposes of one or more radiation machines or major components of one or more such machines shall notify the Department within 15 days after such action. Notification shall be made on DH Form 1114, 10/15, “Report of Assembly of Certified or Non-Certified X-Ray Systems,” which is herein incorporated by reference and available from the internet at http://www.floridahealth.gov/radiation and at https://www.flrules.org/Gateway/reference.asp?No=Ref-06529, or a similar form which captures all the information required on DH Form 1114, 10/15.

(b) No person shall sell, offer to sell, lease, transfer, lend or install radiation machines unless such machines meet the requirements of these regulations.

(6) Out-of-State Radiation Machines.

(a) Any person proposing to bring a radiation machine into Florida shall notify the Department in writing at least 10 days before the machine is to be used in the state. The notice shall include the type of radiation machine; the nature, duration and scope of use; and the exact location where the radiation machine will be used.

(b) Any person proposing to bring a radiation machine into Florida shall register the machine with the department and pay the registration fee.

(c) Any out-of-state person using a radiation machine in Florida shall notify the department when the use of the machine has been completed.

(7) Enforcement. The General Statement of Policy and Procedure for Radiation Machine Enforcement Actions, September 2014, which is herein incorporated by reference, will be used to determine enforcement actions to be taken. This publication can be obtained from the internet at http://www.floridahealth.gov/radiation, and at https://www.flrules.org/Gateway/reference.asp?No=Ref-05444.

Rulemaking Authority 404.051, 404.131, 404.22 FS. Law Implemented 404.071, 404.091, 404.101, 404.131, 404.141, 404.161, 404.162, 404.163, 404.22 FS. History–New 12-12-96, Formerly 10D-91.612, Amended 8-16-07, 6-3-15, 3-21-16.