The proposed revisions to ch. DHS 157 accomplish the following: • Update the radiation protection and regulatory requirements for radioactive materials to ensure compatibility with current applicable regulations of the federal Nuclear Regulatory Commission (NRC) in 10 CFR Parts 19, 20, 31-37, 39, 40, 70, 71 and 150, relating to notices, instructions and reports to workers regarding inspections and investigations; standards for protection against radiation; general domestic licenses for byproduct material, specific domestic licenses to manufacture or transfer certain items containing byproduct material; specific domestic licenses of broad scope for byproduct material; licenses for industrial radiography and radiation safety requirements for industrial radiographic operations; physical protection of byproduct material; medical use of byproduct material; licenses and radiation safety requirements for irradiators; licenses and radiation safety requirements for well logging; domestic licensing of special nuclear material; packaging and transportation of radioactive material; and exemptions and continued regulatory authority in agreement states and in offshore waters. • Compatibility with current applicable regulations of the federal Food and Drug Administration (FDA) in 21 CFR Parts 900, 1020, 1030, and 1040, relating to mammography quality standards, performance standards for ionizing radiation emitting products; microwave and radio frequency emitting products; and light-emitting products for the protection against hazards of radiation. • Codification of suggested national standards for x-ray device imaging from the Conference of Radiation Control Program Directors in the Suggested State Regulations for the Control of Radiation.
• Conformity with ch. 462, Stats., relating to licensing and the practice of radiographers and limited x-ray machine operators by removing any conflicts with ch. 462. Stats., or rules promulgated thereunder by the radiography examining board. • Correct rule language based on the Department’s experience administering the current rule.
The department had initially proposed to require recording of a patient’s radiation dose in the medical record for certain high dose medical procedures as recommended by the Food and Drug Administration. However, based on input received from an advisory group, the department determined that this requirement is not feasible at present because existing methods for estimating patient exposure are inadequate.
Entities that may be affected by the proposed revisions to ch. DHS 157 are hospitals, academic facilities, medical clinics, dental facilities, chiropractic offices, veterinary facilities and industrial facilities that use radioactive materials or x-ray devices. Summary of, and comparison with, existing or proposed federal regulations
Wisconsin’s Agreement with the Nuclear Regulatory Commission requires the department to incorporate relevant changes to federal radioactive material regulations into its radiation protection rules within three years of the effective date of the federal regulations. The proposed changes to ch. DHS 157 ensure continued compatibility with new federal radioactive material regulations in 10 CFR Pts. 19, 20, 31, 33-36, 37, 39, 40, 70, 71 and 150, and 49 CFR as required by s. 254.34 (1), Stats. Comparison with rules in adjacent states
Illinois:
Illinois is an agreement state with the Nuclear Regulatory Commission. As a result, Illinois law in effect June 1, 2016 contains radiation protection and regulatory requirements similar to those contained in ch. DHS 157 and compatible with equivalent federal regulations in Titles 10 and 49, CFR. Iowa:
Iowa is an agreement state with the Nuclear Regulatory Commission. As a result, Iowa 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. Michigan:
Michigan is not an agreement state with the Nuclear Regulatory Commission. Michigan previously declared its intent to become an agreement state but later decided to cease all activity toward pursuing the agreement. As a result, Michigan law in effect June 1, 2016 contains some regulatory requirements similar to those in ch. DHS 157. The Nuclear Regulatory Commission is currently responsible for regulating the majority of radioactive material use in Michigan under Titles 10 and 49, CFR. 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.
