Section 0400-20-10-.24 - REGISTRATION(1) The owner or person having possession of any radiation machine or accelerator, except those specifically exempted in Rule 0400-20-10-.07, shall register such sources within 10 days after acquisition of such machine. Prior to processing a request for registration, the FDA Clearance 510K number specific to the particular device must be provided to the Division. The owner or possessor of any accelerator shall substitute an application for certified registration required in Chapter 0400-20-09. The application for certified registration must be received by the Department within 10 days after acquisition of the accelerator; however, an accelerator may not be energized until registered pursuant to Chapter 0400-20-09. In addition, every person who provides inspections as provided for in paragraph (4) of Rule 0400-20-10-.27 and every person who assembles, installs, or services radiation machines shall register with the Division of Radiological Health, Tennessee Department of Environment and Conservation. Registration under this rule shall be on Department Form RHS 8-4, Form RHS 8-4a or Form RHS 8-4b, as appropriate, as furnished by the Department and may be obtained from the Division of Radiological Health, at the address given in Rule 0400-20-04-.07. A registration fee in accordance with the Classification and Fee Schedule in paragraph (3) of this rule shall be due upon receipt of an invoice from the Division of Radiological Health following the submittal of the completed registration form. The check for the fee shall be made payable to "Treasurer, State of Tennessee."(2) An annual registration fee will be required each year as long as the radiation machine or service is subject to registration. Each registrant shall submit the annual fee payable to, "Treasurer, State of Tennessee," in the appropriate dollar amount in accordance with the Classification and Fee Schedule in paragraph (3) of this rule to the Division of Radiological Health. Payment shall be accompanied by a copy of the fee invoice properly completed. The invoice for the annual fee will be dated May 1st and will require payment by June 15th of the indicated year. The annual registration fee shall be due within 45 days of issuance of an invoice. At the time of the annual payment, a registrant of only Class II radiation machines may request specific times or list restricted hours during normal work hours for inspections pursuant to Rule 0400-20-10-.27 by personnel of the Division of Radiological Health, Tennessee Department of Environment and Conservation.(3) Classification and fee schedule. For purposes of inspections and payment of fees the classification and fee schedule shall be as follows: (a) Radiation Machines CLASS I | |
Dental Radiation Machines: | $85.00 per tube |
All diagnostic equipment used exclusively for dental diagnostic procedures. | |
CLASS II | |
Priority Two Medical Radiation Machines: | $195.00 per tube |
All medical diagnostic x-ray equipment, not in Class III, used exclusively for medical or veterinary diagnostic procedures. | |
CLASS III | |
Priority One Medical Radiation Machines: | $286.00 per tube |
All diagnostic x-ray equipment used in radiologists' offices, orthopedic surgeon's offices or hospitals exclusively for medical diagnostic procedures. | |
CLASS IV | |
Therapy Medical Radiation Machines: | $390.00 per tube |
All x-ray equipment with energies less than 0.9 MeV used for the purpose of medical or veterinary radiation therapy. | |
CLASS V | |
Priority Two Industrial and Educational Radiation Machines: | $780.00 per tube |
Closed-beam analytical radiation machines, gauges or industrial radiation machines used in shielded room or cabinet radiography. | |
CLASS VI | |
Priority One Industrial and Educational Radiation Machines: | $1,170.00 per tube |
All x-ray machines used for industrial radiography and all open-beam analytical x-ray machines and all radiation machines not specifically included in Class I, II, III, IV, V, VII. | |
CLASS VII | |
Accelerators: All devices defined as accelerators as per "State Regulations for Protection Against Radiation." | $2,600.00 annual fee, plus an initial fee of $375.00 per maximum nominal rated MeV for initial certified registration review initial review fee not to exceed $150,000.00) |
(b) A person providing inspection services as permitted by paragraph (4) Rule 0400-20-10-.27 shall pay of an annual registration fee of eight hundred fifty dollars. | $850.00 |
(c) A person providing assembly/installation/servicing shall pay an annual registration fee of eight hundred fifty dollars. | $850.00 |
(d) A registrant may qualify to pay a registration fee equal to 18 percent of that listed in this paragraph, subject to the following conditions: 1. All tubes subject to registration are inspected in accordance with paragraphs (3), (4) and (5) of Rule 0400-20-10-.27. (i) For purposes of the 18 percent fee, the first inspection performed on an x-ray tube on or after December 6, 2011, will establish a new baseline date for that tube. Previous baseline dates will be reset to the last day of the month of performance of the previous inspections. (I) Each subsequent inspection of a tube shall be performed during the same month as the preceding inspection or the month immediately following resulting in "baseline periods" of from 59 days to 62 days, depending upon applicable new 2 month periods, according to the schedule set out in subparagraph (3)(a) of Rule 0400-20-10-.27.(II) An inspection performed prior to or after the applicable new 2 month period shall establish a new baseline date for that tube.(III) An inspection performed after the applicable new 2 month period shall not qualify the registrant for the 18 percent fee.(IV) An inspection performed prior to the applicable new 2 month period and meeting all other requirements found in paragraphs (3), (4) and (5) of Rule 0400-20-10-.27 shall qualify the registrant for the 18 percent fee.2. Each newly acquired tube subject to registration is inspected within 3 months of ownership or possession.3. An individual who satisfies the requirements in paragraph (4) of Rule 0400-20-10-.27 performs all inspections.4. The registrant submits to the Division, at the address given in Rule 0400-20-04-.07: (i) Copies of the appropriate State evaluation forms within 60 days after the inspection.(ii) Copies of applicable service reports to document correction of any deficiencies noted within 60 days after the inspection.(iii) A signed "X-Ray Inspection Notification and Certification of Compliance" form within 60 days of the inspection.5. Inspections found by the Division to be unsatisfactory under this subparagraph or under paragraph (4) or (5) of Rule 0400-20-10-.27 shall not qualify for the 18 percent.(i) The registrant shall correct and re-submit the report(s) and documentation of an inspection found to be unsatisfactory within 30 days of the date of notification by the Division. Failure to correct and re-submit the report(s) and documentation of an unsatisfactory inspection will subject the registrant to the Division's normal enforcement actions, penalties and assessments.(ii) The 30-day correction period shall not establish a new baseline. It shall not:(I) Qualify an existing tube for reduced fee for the following calendar year, or(II) Qualify a newly acquired tube for reduced fee for the current calendar year. (4) Any failure to pay an invoiced amount by the date specified on the invoice, unless qualified by subparagraph (3)(d) of this rule, shall be deemed to constitute a violation of T.C.A. §§ 68-203-101 et seq.(5) Whenever there is a change in information such as address, ownership, possessor, or location of use from that declared on the last previous registration, the completion of a new Form RHS 8-4 shall be required within 10 days of the change.(6) Each registrant, or his estate, who permanently discontinues the use of or transfers all of his radiation machines at an installation shall notify the Division in writing within 60 days of such action. In the event of a transfer, the notification shall include the name and address of the transferee.(7) No person shall state or imply that any activity under such a registration has been approved by the Division.Tenn. Comp. R. & Regs. 0400-20-10-.24
Original rule filed February 22, 2012; effective May 22, 2012. Amendment filed February 13, 2013; effective May 14, 2013. Amendments filed September 25, 2014; effective December 24, 2014. Amendments filed March 3, 2015; effective June 1, 2015. Amendments filed February 28, 2024; effective 5/28/2024.Authority: T.C.A. §§ 4-5-201, et seq.; 68-202-101, et seq.; and 68-202-201, et seq.