Minnesota:
Minnesota is an agreement state with the Nuclear Regulatory Commission. Minnesota adopted new radiation protection regulations for radioactive materials effective January 1, 2005. As a result, Minnesota law in effect June 1, 2016 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. 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 Nuclear Regulatory Commission, the Food and Drug Administration and the Environmental Protection Agency. The SSRCR is also continually updated and used by most of the 37 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. 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, 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. 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 s. 254.35 (3) and s 254.365 (5), Stats. There are no fee increases proposed in this rule revision. Any fiscal impact to x-ray registrants may stem from proposed requirements in the following sections: DHS 157.21 (1), DHS 157.25 (2) (a) 5., DHS 157.74 (2) (m), DHS 157.77 (2) (h) and (i), DHS 157.78 (10), DHS 157.80 (1) (f) 5. and 6., DHS 157.80 (2) (a) 1., and DHS 157.85 (14) (gn). The proposed requirements and the fiscal impact on small business are as follows:
DHS 157.21 (1): The department proposes that any facility that uses an x-ray device designate a person in control who is responsible for safe operation of the radiation installation. This is already required for licensees who must designate a radiation safety officer. Since x-ray registrants may designate an existing staff person, the department anticipates minimal fiscal impact on any facility, including small businesses.
DHS 157.25 (2) (a) 5.: Fluoroscopic devices are capable of generating strong radiation fields when operational. Currently, radiation monitoring is required for any individual working within six feet of operating medical fluoroscopic equipment. This requirement does not allow any exception for individuals who may need to walk briefly past the device with minimal exposure. As a result, the department proposes to provide flexibility to medical facilities, including small businesses, by only requiring monitoring for individuals working within six feet of operating fluoroscopic equipment longer than 10 minutes per week. This is intended to reduce the radiation monitoring costs for facilities with these devices.
DHS 157.74 (2) (m): This paragraph refers to the existing requirement in s. 462.02(1) (a), Stats. that any individual who operates x-ray equipment for diagnostic medical purposes have a current radiography license or limited x-ray machine operators permit issued by the state. These licenses and permits are currently issued by the department of safety and professional services. The department anticipates no fiscal impact stemming from reference within DHS 157.74 (2) (m) to this existing requirement. DHS 157.77 (2) (h) and (i): These two paragraphs clarify the operator protection requirements for all types of x-ray systems, including veterinary systems. Specifically, DHS 157.77 (2) (h) requires the x-ray control to be permanently mounted behind a protective barrier and DHS 157.77 (2) (i) requires persons within 2.7 meters (9 feet) to wear a protective apron with at least .25 mm of lead equivalence and have lead gloves of .5 mm lead equivalence if holding the animal. There is minimal effort required to meet these requirements, as existing equipment may be used. As a result, the department anticipates minimal fiscal impact on any facility.
DHS 157.78 (10): Hand held dental x-ray units are being increasingly used in dental offices and during public dental events. These devices are capable of exposing patients and operators to substantial radiation if used inappropriately. As a result, the department proposes minimum operator training for all personnel that operate hand held dental x-ray units. This training must include manufacturer-specific training in exposure control, operation, use of safety devices, operator and patient protection, and quality control testing. Affected entities are given flexibility in how to provide training, which may include in-house (on site) training, or training limited to the entity’s particular use of x-ray units. In addition, the department proposes new radiation safety requirements specific to this technology to ensure operator and public safety during use. The requirements are drawn from the SSRCR published by the CRCPD. The department anticipates that there will be a small cost associated with the training, but little to no cost associated with the radiation safety requirements.
DHS 157.80 (1) (f) 5. and 6.: The department proposes to require that facilities using newer generation computed tomography(CT) systems ensure that two-way verbal communication exists between the patient and the operator of the device, and that a method be provided to permit continuous observation of the patient during irradiation. Although CT scans can produce a very detailed image of the body from multiple x-ray images or ‘slices,’ radiation exposure to the patient can be very high. These devices are used primarily in large medical facilities. The department anticipates no additional fiscal impact on facilities using these devices since the proposed requirements are consistent with CRCPD suggested state regulations and similar requirements that already exist in s. DHS 157.81. DHS 157.80 (2) (a) 1.: This provision refers to the existing requirement in ch. 462, Stats., that individuals operating x-ray equipment for diagnostic medical purposes have a current radiography license or limited x-ray machine permit issued by the Department of Safety and Professional Services. The department anticipates no additional fiscal impact on facilities using these devices. DHS 157.85 (14) (gn): Electronic brachytherapy is a new technology that uses small x-ray devices to treat cancer within the body. The devices are capable of producing very high levels of radiation. These devices tend to be used primarily in large medical facilities and not small businesses. Based on input from the advisory committee, the department proposes quality control requirements for these devices to ensure safe operation. The department anticipates no additional fiscal impact on facilities using these devices.
Effect on small business
Based on the foregoing analysis, the proposed rules are anticipated to have little to no economic impact on small businesses.
Agency contact person
Paul Schmidt, Chief
Radiation Protection Section
P.O. Box 2659
Madison, WI 53701-2659
Statement on quality of agency data
The department utilized the input of an advisory committee representing entities affected by the proposed rules, a rule template called the “Suggested State Regulations for the Control of Radiation” (SSRCR) developed by the CRCPD, and applicable federal regulations. Please refer to the ‘Summary of Factual Data and Analytical Methodologies’ above for more detail.
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 deadline for submitting comments and the notice of public hearing will be posted on the Wisconsin Administrative Rules Website at http://adminrules.wisconsin.gov after the hearing is scheduled. RULE TEXT
SECTION 1. DHS 157.01 (16) is created to read:
DHS 157.01 (16) Subchapter XV establishes requirements for the physical protection program for any licensee that possesses a category 1 or category 2 quantity of radioactive material listed in Appendix U.
SECTION 2. DHS 157.03 (6m), (12m) and (Note), (25m), (36m), (56g) and (Note), (56r) and (Note), and (77m) are created to read:
DHS 157.03 (6m) “Access control” means a system for allowing only approved individuals to have unescorted access to the security zone and for ensuring that all other individuals are subject to escorted access.
DHS 157.03 (12m) "Aggregated" means accessible by the breach of a single physical barrier that would allow access to radioactive material in any form, including any devices that contain the radioactive material.
Note: An aggregated total activity equal or exceeding a category 2 to quantity of radioactive material exceeds the thresholds set forth in Appendix U.
DHS 157.03 (25m) "Approved individual" means an individual whom the licensee has determined to be trustworthy and reliable for unescorted access under ss. DHS 157.100 to157.106 and who has completed the training required by s. DHS 157.108 (3). DHS 157.03 (36m) "Background investigation" means the investigation conducted by a licensee or applicant for a license to support the determination of trustworthiness and reliability.
DHS 157.03 (56g) "Category 1 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 1 threshold in Appendix U of this chapter.
Note: This is determined by calculating the ratio of the total activity of each radionuclide to the category 1 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 1 quantity. Category 1 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.Appendix U is used to determine the category 1 threshold for a category 1 quantity of radioactive material. The category 1 and category 2 thresholds in Appendix U and Appendix T are not interchangeable.
DHS 157.03 (56r) "Category 2 quantity of radioactive material" means a quantity of radioactive material meeting or exceeding the category 2 threshold, but less than the category 1 threshold in Appendix U of this chapter.
Note: This is determined by calculating the ratio of the total activity of each radionuclide to the category 2 threshold for that radionuclide and adding the ratios together. If the sum is equal to or exceeds 1, the quantity would be considered a category 2 quantity. Category 2 quantities of radioactive material do not include the radioactive material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet.Appendix U is used to determine the category 2 threshold for a category 2 quantity of radioactive material. The category 1 and category 2 thresholds in Appendix U and Appendix T are not interchangeable.
DHS 157.03 (77m) “Contamination” means the presence of a radioactive substance on a surface in quantities in excess of 0.4 Bq/cm2 (1x10-5 microCi/cm2) for beta and gamma emitters and low toxicity alpha emitters, or 0.04 Bq/cm2 (1x10-6 microCi/cm2) for all other alpha emitters.
SECTION 3. DHS 157.03 (84m) and (Note) is repealed and recreated to read:
DHS 157.03 (84m) "Criticality safety index" or "CSI" means the dimensionless number, rounded up to the next tenth, assigned to and placed on the label of a fissile material package to designate the degree of control of accumulation of packages, overpacks, or freight containers containing fissile material during transportation.
Note: Determination of the criticality safety index is described in s. DHS 157.93 (7) and (8). s. DHS 157.93 (7) and (8), and 10 CFR 71.59. The CSI for an overpack, freight container, consignment or conveyance containing fissile material packages is the arithmetic sum of the criticality safety indices of all the fissile material packages contained within the overpack freight container, consignment, or conveyance. SECTION 4. DHS 157.03 (108m), (109m), (124g), (139m), (143g), (150g), (166m), (189m) and (Note), and (193m) are created to read:
