The Nuclear Regulatory Commission does not have a license fee category for research and development licensees based on the amount of radioactive authorization.
Reference; 10 CFR section 170.31 Table 1.
Minnesota:
Minnesota is an agreement state with the NRC. As a result, Minnesota law in effect April 21, 2021 contains radiation protection and regulatory requirements similar to those in ch. DHS 157 and compatible with equivalent federal regulations in Titles 10 and 49, CFR. Minnesota does not have a license fee structure that differs based on the number of sites.
Minnesota does not have a license fee category for research and development licensees base the amount of radioactive authorization.
Reference: Minnesota Rules, Chapter 4731.
Summary of factual data and analytical methodologies
The department referred to all of the following to draft the proposed rules:
1. The input of an advisory committee that included stakeholders affected by the proposed rules. These included representatives of academic and medical facilities, radioactive materials users, x-ray users, and large and small businesses.
2. An agreement state rule template called the “Suggested State Regulations for the Control of Radiation” (SSRCR) developed by the Conference of Radiation Control Program Directors, Inc. (“CRCPD”). The CRCPD is a national organization of primarily state radiation control staff that supports and represents state radiation control programs. The SSRCR is developed with the involvement of federal radiation agencies, such as the NRC, FDA, and the Environmental Protection Agency. The SSRCR is also continually updated and used by most of the existing agreement states to help meet federal requirements.
3. Requirements of Titles 10, 21, and 49 CFR; 42 USC; Sections 254.31 to 254.45, Stats., and the Agreement Between The United States Nuclear Regulatory Commission and The State of Wisconsin for Discontinuance of Certain Commission Regulatory Authority and Responsibility Within the State Pursuant to Section 274 of the Atomic Energy Act of 1954, as Amended.
4. The department maintains a database of all radioactive material licensees. This data includes the number sites, quantities of radioactive material, and categories of use. The department used this information as the bases to analyze the impact of the proposed license fee changes.
5. Section 227.114 (1) (a), Stats., which defines “small business” as a business entity, including its affiliates, which is independently owned and operated and not dominant in its field, and which employs 25 or fewer full-time employees or which has gross annual sales of less than $5,000,000. Analysis and supporting documents used to determine effect on small business
The methods specified in s. 227.114 (2), Stats., for reducing a rule’s impact on small business were considered by the department, but have not been adopted in the proposed rules because they are not feasible. Adopting the methods specified in s. 227.114 (2), Stats., would be contrary to the state’s public policy on radiation control stated in s. 254.33, Stats., as well as federal requirements, and the agreement between the state and the NRC, which are the basis for the proposed rule. The department’s analysis of the effect of rulemaking on small businesses regulated by ch. DHS 157 is therefore confined to proposed revisions addressing x-ray regulatory requirements and fee changes.
The department’s x-ray registration and inspection program, and radioactive materials licensing and inspection program, are both entirely supported by the annual fees authorized under ss. 254.35 (3) and 254.365 (5), Stats. The department applied the fee changes as proposed to current licensees. The site fee equal to 25% of the applicable use category would apply to 67 of the 442 licensed sites. This would affect 42 licensees and total $48,075. There are five licensees that hold a license for research and development purposes that authorize greater than 5 curies of radioactive material. The proposed fee change for those five licensees would total $9,000. Out of the 285 current licensees, 47 would be subject to a fee change as proposed. Smaller businesses do not typically have large possession authorizations or more than two sites of use. Of the 47 licensed businesses affected by the proposed fee change, it is estimated that 23 do not meet the small business definition in s. 227.114(1) based on being a large health care provider, government entity, national company, or large publicly traded company. In the absence of further information, if it is assumed that the remaining affected business meet the small business definition, the proposed license fee changes would apply to 24 businesses and total $22,750. This analysis conservatively shows that total impact on small business would be less than $50,000.
There is expected to be little to no fiscal impact to x-ray registrants from proposed requirements. Effect on small business
Based on the foregoing analysis, the permanent rule is anticipated to have little to no economic impact on small businesses. The entities that will be affected by the proposed rule are not “small businesses” as defined in s. 227.114 (1), Stats. Agency contact person
Statement on quality of agency data
The data used by the department to prepare these proposed rules and analysis comply with ss.227.12 (2m), Stats.
Place where comments are to be submitted and deadline for submission
Comments may be submitted to the agency contact person that is listed above until the deadline given in the upcoming notice of public hearing. The notice of public hearing and deadline for submitting comments will be published in the Wisconsin Administrative Register and to the department’s website, at https://www.dhs.wisconsin.gov/rules/permanent.htm. Comments may also be submitted through the Wisconsin Administrative Rules Website, at: https://docs.legis.wisconsin.gov/code/chr/active. RULE TEXT
SECTION 1.
DHS 157.01 (10) is amended to read:DHS 157.01 (10) Subchapter IX establishes radiation safety requirements for the use of cabinet and analytical x-ray systems radiation generating devices.
SECTION 2.
DHS 157.03 (22) is amended to read:DHS 157.03 (22) Analytical x-ray system" means x-ray equipment designed to analyze the that generates ionizing radiation by electronic means for the purpose of examining the microstructure and composition of materials.
SECTION 3.
DHS 157.03 (30m), (40m), (45m), (57c), (57w), and (66m) are created to read:DHS 157.03 (30m) “Associate radiation safety officer” means an individual who meets all of the following qualifications:
(b) Is currently identified as an associate radiation safety officer for the types of use of radioactive material for which the individual has been assigned duties and tasks by the radiation safety officer on a specific medical use license issued by the department, the NRC, or another agreement state or medical use permit issued by an NRC master material licensee.
DHS 157.03 (40m) (a) “Beam port” means an opening on the x-ray apparatus designed to emit a primary beam.
(b) “Beam port” does not include accessible openings on a security screening unit.
DHS 157.03 (45m) (a) "Bomb detection radiographic equipment" means x-ray generating equipment used solely for the purpose of remotely detecting explosive devices.
(b)"Bomb detection radiographic equipment" does not include hand-held x-ray bomb detection equipment.
DHS 157.03 (57c) "Certifiable cabinet x-ray system" means an existing uncertified radiation generating device that has been modified to meet the certification requirements specified in 21 CFR 1020.40. DHS 157.03 (57w) "Certified cabinet x-ray system" means a radiation generating device certified by the manufacturer in accordance with 21 CFR 1010.2 as being manufactured and assembled pursuant to the provisions of applicable federal radiation safety performance standards 21 CFR 1010 and 1020.40. DHS 157.03 (66m) "Closed-beam x-ray equipment" means a system in which the beam path cannot be entered by any part of the body during normal operation.
SECTION 4.
DHS 157.03 (143) is amended to read:DHS 157.03 (143) “Fit test" means the use of a protocol to qualitatively ir or quantitatively evaluate the fit of a respirator on an individual.
SECTION 5.
DHS 157.03 (193e) is created to read:DHS 157.03 (193e) "Local components" means parts of a radiation generating device x-ray system and include areas that are struck by x-rays such as radiation source housings, beam port and shutter assemblies, collimators, sample holders, cameras, goniometers, detectors, and shielding, but do not include power supplies, transformers, amplifiers, readout devices, and control panels.
SECTION 6.
DHS 157.03 (204) is amended to read:DHS 157.03 (204) “Management" means the chief executive officer or other individual having the authority to manage, direct or administer the licensee’s or registrant’s activities, or those persons’ delegate or delegates.
SECTION 7.
DHS 157.03 (235m) and (239m) are created to read:DHS 157.03 (235m) "Open-beam x-ray equipment" means an open-beam x-ray system in which the beam path could be entered by any part of the body at any time.
DHS 157.03 (239m) “Ophthalmic physicist” means an individual who meets all of the following qualifications:
(b) Is identified as an ophthalmic physicist on a specific medical use license, or other equivalent permit or license issued by the department, the NRC or an agreement state, or broad scope medical use licensee.
SECTION 8.
DHS 157.03 (251m) is renumbered to DHS 157.03 (252g) and amended to read:DHS 157.03 (252g) “Personnel dosimeter" means a dosimeter, assigned to an individual, that is processed and evaluated by an accredited national voluntary laboratory accreditation program (NVLAP) processor.
SECTION 9.
DHS 157.03 (252r) is created to read:DHS 157.03 (252r) "Personnel security screening system" means any x-ray equipment used on humans for security evaluation.
SECTION 10.
DHS 157.03 (267) is amended to read:DHS 157.03 (267) “Preceptor" means an individual who provides, directs or verifies training and experience required for an individual to become an authorized user, an authorized medical physicist, an authorized nuclear pharmacist, or a radiation safety officer for medical use, or an associate radiation safety officer.
SECTION 11.
DHS 157.03 (288m) is created to read:DHS 157.03 (288m) "Radiation generating device” or “RGD" means any system, device, subsystem, or component thereof, which may generate x-rays or particle radiation between 5 keV and 1 MeV, and not intended for healing arts use for humans or animals. RGD may be fixed or portable with any of the following characteristics:
(a) Mobile-means RGD equipment mounted on a permanent base with wheels and/or casters for moving while completely assembled.
(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.
