(b) Portable-means RGD equipment designed to be hand-carried.
(c) Stationary-means RGD equipment that is installed or placed in a fixed location.
(d) Transportable-means RGD equipment to be installed in a vehicle or that may be readily disassembled for transport or use in a vehicle.
SECTION 12.
DHS 157.03 (295m) is amended to read:DHS 157.03 (295m) “Radiation safety officer for medical use" means an individual that meets the requirements of ss. DHS 157.61 (7) (a), or (c) 1. and 157.61 (11), or who is identified as a radiation safety officer on a department, NRC or another agreement state medical use license or other equivalent license or permit recognized by the department for similar types and uses of radioactive material. SECTION 13.
DHS 157.03 (331m) and (336m) are created to read:DHS 157.03 (331m) "Security screening unit" means a non-human use open-beam or cabinet x-ray system with accessible openings designed for the detection of weapons, bombs, or contraband concealed in baggage, mail, packages or other commodities or structure.
DHS 157.03 (336m) (a) "Shielded room" means a room housing a radiation generating device where, with the device at maximum technique factors, the exterior room environs meets the unrestricted area dose limits of 0.02 mSv (2 mrem) in any one hour and 1 mSv (100 mrem) in a year at 30 cm from the surface of the barrier.
(b) “Shielded room” does not include any of the following:
1. A radiation generating device that meets the definition of cabinet x-ray system.
2. A permanent radiographic installation.
3. A radiation room.
SECTION 14.
DHS 157.03 (374) (c) is amended to read:DHS 157.03 (374) (c) For CT equipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in millamperesmilliamperes (mA), x-ray pulse width in milliseconds, and the number of x-ray pulses per scan; or the product of tube current, x-ray pulse width, and the number of x-ray pulses per scan expressed as mAs.
SECTION 15.
DHS 157.03 (391) is amended to read:DHS 157.03 (391) “Transuranic waste" means waste containing elements having an atomic number greater than 92, a half-life greater than 5 years and in quantities greater than 3.7 kBq/gm (100 nCi/gm).
SECTION 16.
DHS 157.09 (2) (c) 2. a., to c. are amended to read:DHS 157.09 (2) (c) 2 a. For wrist watches, one microGymicrogray (0.1 millirad) per hour at 10 centimeters from any surface.
DHS 157.09 (2) (c) 2 b. For pocket watches, one microGymicrogray (0.1 millirad) per hour at one centimeter from any surface.
DHS 157.09 (2) (c) 2 c. For any other timepiece, 2 microGymicrogray (0.2 millirad) per hour at 10 centimeters from any surface.
SECTION 17.
DHS 157.09 (2) (c) 7. is amended to read: DHS 157.09 (2) (c) 7. Electron tubes, including spark gap tubes, power tubes, gas tubes including glow lamps, receiving tubes, microwave tubes, indicator tubes, pick-up tubes, radiation detection tubes, and any other completely sealed tube that is designed to conduct or control electrical currents, provided that the radiation dose rate from each electron tube containing radioactive material does not exceed 10 microgymicrogray (1 millirad) per hour at one centimeter from any surface when measured through 7 milligrams per square centimeter of absorber and that each tube does not contain more than one of the following specified quantities of radioactive material:
SECTION 18.
DHS 157.09 (2) (g) (title) is amended to read:DHS 157.09 (2) (g) (title) Industrial use devices containing exempt quantities or disturbed distributed under a general license.
SECTION 19.
DHS 157.10 (3) (table) is amended to read:Category | License Type | Application & Annual Fee |
1. | Special Nuclear
Material (SNM) | |
A. | License for possession and use of SNM in sealed sources contained in devices used in measuring systems | $1,000 |
B. | License for use of SNM to be used as calibration and reference sources | $300 |
C. | SNM – all other, except license authorizing special nuclear material in unsealed form that would constitute a critical mass [Fee waived if facility holds additional license category] | $1,500 |
A. | Source material processing and distribution | $4,000 |
B. | Source material in shielding [Fee waived if facility holds additional license category] | $400 |
C. | Source material – all other, excluding depleted uranium used as shielding or counterweights | $3,000 |
A. | License of broad scope for processing or manufacturing of items for commercial distribution | $20,000 |
B. | License for processing or manufacturing and commercial distribution of radiopharmaceuticals, generators, reagent kits and sources or devices | $12,000 |
C. | License for commercial distribution or redistribution of radiopharmaceuticals, generators, reagent kits and sources or devices | $3,000 |
D. | Other licenses for processing or manufacturing of items for commercial distribution | $4,000 |
E. | License for industrial radiography operations performed only in a shielded radiography installation | $3,000 |
F. | License for industrial radiography performed only at the address indicated on the license, and at temporary job sites | $5,000 |
G. | License for possession and use of less than 370 TBq (10,000 curies) of radioactive material in sealed sources for irradiation of materials where the source is not removed from the shield [Fee waived if facility holds additional irradiator license category] | $2,000 |
H. | License for possession and use of less than 370 TBq (10,000 curies) of radioactive material in sealed sources for irradiation of materials where the source is exposed for irradiation purposes. The category also includes underwater irradiators for irradiation of materials in which the source is not exposed for irradiation | $3,000 |
I. | License for possession and use of at least 370 TBq (10,000 curies) and less than 3.7 PBq (100,000 curies) of radioactive material in sealed sources for irradiation of materials | $5,000 |
J. | License for possession and use of 3.7 PBq (100,000 curies) or more of radioactive material in sealed sources for irradiation of materials | $12,000 |
K. | License to distribute items containing radioactive materials to persons under a general license | $2,000 |
L. | License to possess radioactive materials intended for distribution to persons exempt from licensing | $2,500 |
M. | License of broad scope for research and development that does not authorize commercial distribution | $6,000 |
N. | Other licenses for possession and use of less than 0.185 TBq (5 curies) of radioactive material in research and development that do not authorize commercial distribution | $1,800 |
O. | License for installation, repair, maintenance leak testing or other service of devices or items containing radioactive material, or to perform services for other persons, including testing of sealed sources for leakage or contamination, instrument calibration, and sample analysis, excluding waste transportation or broker services | $1,800 |
P. | License for portable gauges, including industrial Lixiscope | $1,400 |
Q. | License for portable x-ray fluorescence analyzer calibration flood source, dewpointer or gas chromatograph | $200 |
R. | All other byproduct, naturally - occurring or accelerator- produced material licenses, except as otherwise noted | $2,000 |
S. | Other license for possession and use of 0.185 TBq (5 curies) or more of radioactive material in research and development that do not authorize commercial distribution | $3600 |
A. | Commercial waste treatment facilities, including incineration | $200,000 |
B. | All other commercial facilities involving waste compaction, repackaging, storage or transfer | $25,000 |
C. | Waste processing – all other, including decontamination service | $5,000 |
A. | License for well logging using sealed sources or sub-surface tracer studies | $4,000 |
B. | License for well logging using sealed sources and sub-surface tracer studies | $5,000 |
A. | License for commercial collection and laundry of items contaminated with radioactive material | $16,000 |
A. | License for human use of byproduct, source, special nuclear or NARM material in sealed sources contained in teletherapy or stereotactic radiosurgery devices, including mobile therapy | $12,000 |
B. | License of broad scope for human use of byproduct, source, special nuclear or NARM materials used in medical diagnosis, treatment, research and development, excluding teletherapy, or stereotactic radiosurgery devices | $20,000 |
C. | License for mobile nuclear medicine | $2,500 |
D. | Medical – all others, including SNM pacemakers and high dose rate remote afterloading devices | $5,000 |
E. | License for veterinary use of radioactive materials | $2,000 |
A. | License for possession and use of byproduct, naturally-occurring or accelerator produced radioactive material for educational use or academic research and development that does not authorize commercial distribution, excluding broad scope or human use licenses, with a combined possession limit of 12 isotopes and 37 GBq (1 curie) total activity | $1,000 |
A. | License for accelerator production of radioisotopes with commercial distribution | $4,000 |
B. | Accelerator isotope production - all other [Fee waived if facility holds medical broad scope license with no commercial distribution] | $2,000 |
A. | Reciprocal recognition of an out-of-state specific license | 50% of annual fee of applicable category |
A. | Request to amend specific license-no license review | $0 |
Note: Examples include spelling corrections and adding or removing previously authorized users. |
B. | Request to amend specific license - license review required | $200 |
Note: Examples include new isotopes, license termination not requiring a site visit and procedural changes. |
C. | Request to amend specific license - license review and site visit required | $400 |
Note: Examples include a facility move, license termination requiring a site visit and new processes. |
A. | Each noncontiguous location listed on a license above two where licensed material is used or stored. Temporary job sites and broad scope licensees are exempt from this fee category. | 25% of annual fee of applicable category authorized at the site |
SECTION 20.
DHS 157.11(1) (a) 1. b. and c. are amended to read:DHS 157.11(1) (a) 1. b. No more than a total of 7 kg (15.4 lbs) of uranium and thorium at any one time. A person authorized to possess, use, and transfer source material under this paragraph may not receive more than a total of 70 kg (154 lb lbs) of uranium and thorium in any one calendar year. A person may not alter the chemical or physical form of the source material possessed under this subsection unless it is accounted for under the limits of subd. 1. a.
DHS 157.11(1) (a) 1. c. No more than 7 kg (15.4 lbs) of uranium, removed during the treatment of drinking water, at any one time. A person may not remove more than 70 kg (154 lb lbs) of uranium from drinking water during a calendar year under this paragraph.
SECTION 21.
DHS 157.11 (2) (b) 3. g. is amended to read:DHS 157.11(2) (b) 3. g. Except as provided in subd. 3. h. and j., transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the NRC, an agreement state or a licensing state whose specific license authorizes that person to receive the device and within 30 calendar days after transfer of a device to a specific licensee or export of the device shall furnish to the department a written report containing identification of the device by manufacturer’s or initial transferer’s transferor’s name, model and serial number, the name, address and license number of the person receiving the device, and the date of the transfer.
SECTION 22.
DHS 157.11 (2) (d) (Note) is amended to read:DHS 157.11(2) (d) (Note) A person may own radioactive material without the material being in their immediate possession. This general license does not allow the person to manufacture, produce devices containing material, transfer, receive, posses possess or use the material. A specific license is required for these activities.
SECTION 23.
DHS 157.11 (2) (h) 1. e. is amended to read:DHS 157.11(2) (h) 1. e. Small radium sources, such as discrete survey instrument check sources, sources contained in radiation measuring instruments, sources used in educational demonstrations, electron tubes, lightning rods, ionization sources or static eliminators, containing no more than 37 kBq (1 microcurie) of radium 226 radium-226.
SECTION 24.
DHS 157.11 (2) (h) 3. d. is amended to read:DHS 157.11(2)(h) 3. d. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.
SECTION 25.
DHS 157.13 (4) (i) 4. is amended to read:DHS 157.13 (4) (i) 4. The applicant commits to satisfies all of the following labeling requirements:
SECTION 26.
DHS 157.13 (4) (i) 6. d. is amended to read:DHS 157.13 (4) (i) 6. d. Measure the concentration of radionuclide contaminant in the first eluate after receipt of a molybdenum-99/technetium-99m or strontium-82/rubidium-82 generator, test the generator eluates for molybdenum-99 breakthrough or strontium-82 and strontium-85 contamination, respectively, according to s. DHS 157.63 (3), and retain a record of each measurement under s. DHS 157.71 (14). The licensee shall report the results of any test that exceeds the permissible concentration listed in s. DHS 157.63 (3) (a) at the time of generator elution, in accordance with s. DHS 157.72 (4). SECTION 27.
DHS 157.13 (4) (i) 7. is renumbered to DHS 157.13 (4) (i) 8. SECTION 28.
DHS 157.13 (4) (i) 7. is created to read:DHS 157.13 (4) (i) 7. A licensee shall satisfy the labeling requirements in subd. 4.
SECTION 29.
DHS 157.13 (5) is repealed and recreated to read:DHS 157.13 (5) Special requirements for a specific license for medical use of radioactive material.
(a) License application. The department shall approve an application for a specific license for medical use of radioactive material if all of the following conditions are satisfied:
1. The applicant satisfies the general requirements specified in sub. (2).
2. The applicant submits procedures required by s. DHS 157.67, as applicable. 3. In addition to the requirements in this paragraph and par. (b), an application for a license or amendment for medical use of radioactive material as described in s. DHS 157.70 shall also include information regarding any radiation safety aspects of the medical use of the material that is not addressed in ss. DHS 157.59 to 157.62, identification of and commitment to follow the applicable radiation safety program requirements in ss. DHS 157.63 (1) to 157.67 (1) that are appropriate for the specific s. DHS 157.70 medical use, as well as any specific information on each of the following: a. Radiation safety precautions and instructions.
b. Training and experience of proposed users.
c. Methodology for measurement of dosages or doses to be administered to patients or human research subjects.
d. Calibration, maintenance and repair of instruments and equipment necessary for radiation safety.
4. An applicant for a license for mobile services shall assure that release of individuals or human research subjects to whom radioactive drugs or implants containing radioactive material are administered will be released under s. DHS 157.62 (8). 5. The applicant or licensee shall provide any other information requested by the department in its review of the application.
(b) License amendment. An application for a license amendment shall meet all of the following requirements:
1. A licensee shall apply for and must receive a license amendment before the licensee does any of the following:
a. Receives or uses radioactive material for a type of use that is permitted under this subchapter, but that is not authorized on the licensee’s current license issued under this subchapter.
b. Permits anyone to work as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist under the license, except an individual who is certified by a specialty board appropriate to the intended use of radioactive material and recognized by the NRC; or is named as an authorized user, authorized nuclear pharmacist, ophthalmic physicist, or authorized medical physicist on a department, NRC or other agreement state license, or on a permit issued by a licensee who is authorized by a Type A license of broad scope to permit the medical use of radioactive material.
d. Permits anyone to work as an associate radiation safety officer, or before the radiation safety officer assigns duties and tasks to an associate radiation safety officer that differ from those for which the associate radiation safety officer is authorized on the license.
e. Receives radioactive material in excess of the amount or in a different form or receives a different radionuclide than is authorized on the license
f. Adds to or changes the areas identified in the application or on the license, except for areas where radioactive material is used only under ss. DHS 157.63 (1) and (2). g. Changes the address of use identified on the application or on the license.
h. Revises procedures required by ss. DHS 157.67 (4) and (10) to (12), as applicable, where such revision reduces radiation safety. i. Receives a sealed source from a different manufacturer or of a different model number than authorized by its license unless the sealed source is used for manual brachytherapy, is listed in the Sealed Source and Device Registry, and is in a quantity and for an isotope authorized by the license.
2. An application for a license amendment shall include procedures required by s. DHS 157.67, as applicable. (c) Notifications. A licensee shall make all of the following notifications:
1. Provide to the department a copy of the board certification, the NRC or agreement state license, or other equivalent permit or license for each individual no later than 30 days after the date that the licensee permits the individual to work as an authorized user, an authorized nuclear pharmacist, an ophthalmic physicist, or an authorized medical physicist under par. (b) 1. b. For individuals permitted to work under par. (b) 1. b., within the same 30 day time frame, the licensee shall also provide, as appropriate, verification of completion of all the following: b. Training in device operation, safety procedures, and clinical use for the type of use for which authorization is sought. This training requirement may be satisfied by satisfactory completion of a training program provided by the vendor for new users or by receiving training supervised by an authorized user or authorized medical physicist, as appropriate, who is authorized for the type of use for which the individual is seeking authorization as an authorized user under s. DHS 157.67 (1). c. Training for the type of use for which authorization is sought that includes hands-on device operation, safety procedures, clinical use, and the operation of a treatment planning system. This training requirement may be satisfied by satisfactorily successfully completing either a training program provided by the vendor or by training supervised by an authorized medical physicist authorized for the type of use for which the individual is seeking authorization as an authorized medical physicist.
2. Notify the department in writing no later than 30 days after any of the following occurs:
a. An authorized user, an authorized nuclear pharmacist, a radiation safety officer, an associate radiation safety officer, an authorized medical physicist, or an ophthalmic physicist permanently discontinues performance of duties under the license or has a name change.
b. The licensee’s mailing address changes.
c. The licensee’s name changes but the name change does not constitute a transfer of control of the license.
d. The licensee has added to or changed the areas where radioactive material is used under ss. DHS 157.63 (1) or (2) if the change does not include addition or relocation of either an area where PET radionuclides are produced or a PET radioactive drug delivery line from a PET radionuclide/PET radioactive drug production area. e. The licensee permits an individual qualified to be a radiation safety officer under ss. DHS 157.61 (7) and (11) to function as a temporary radiation safety officer and to perform the functions of a radiation safety officer in accordance with s. DHS 157.61 (1) (c). f. The licensee obtains a sealed source for use in manual brachytherapy from a different manufacturer or with a different model number than authorized by its license for which it did not require a license amendment as provided in par. (b) 1. i. The notification must include the manufacturer and model number of the sealed source, the isotope, and the quantity per sealed source.
(d) Exemptions for Type A broad scope licensees. A licensee possessing a Type A specific license of broad scope for medical use is exempt from all of the following requirements:
1. The provisions of par. (a) 3. regarding the need to file an amendment to the license for medical uses of radioactive material as described in s. DHS 157.70. 2. The provisions of par. (b) 1. b.
3. The provisions of par. (b) 1. f. regarding additions to or changes in the areas of use only at the addresses identified in the application or on the license.
4. The provisions of par. (c) 1.
5. The provisions of par. (c) 2. a. for an authorized user, an authorized nuclear pharmacist, an authorized medical physicist, or an ophthalmic physicist.
