PROPOSED ORDER OF
DEPARTMENT OF HEALTH SERVICES
TO ADOPT PERMANENT RULES
The Wisconsin Department of Health Services proposes an order to repeal DHS 157.09 (1) (a) 8. a.; DHS 157.43 (2) (b); and DHS 157.83 (3) (b) 2. b.; to renumber DHS 157.03 (402m); DHS 157.09 (1) (a) 8. b., c., and d.; DHS 157.13 (10) (b); DHS 157.43 (2) (intro.) and (2) (a); and DHS 157.94 (5) (a); to renumber and amend DHS 157.83 (3) (b) 2. a.; and DHS 157.85 (14) (gm) (intro.); to amend DHS 157.03 (84m) and Note, (198), (200) (c), (208), (221m), (404), and (419m); DHS 157.09 (1) (a) (intro.), (1) (a) 5. a. and b., (1) (a) 10. (intro.), (2) (c) 7., (2) (d) 1. and (e) 1.; DHS 157.11 (2) (a); DHS 157.13 (1) (h) (intro.), (1) (h) 1., (1) (i), (4) (e), (4) (f), (4) (h) 2., (10) (e) 2.; DHS 157.15 (1) (a) 2. and 4., (5) (a) (intro.), (5) (a) 1., (5) (a) 3., and (5) (b); DHS 157.21 (1); DHS 157. 22 (1) (e) Note, (4) (h) 2., (5) (d) 1. and Note; DHS 157.24 (1) (b); DHS 157.25 (1) (a) 1., 2. (intro.), (1) (a) 2. b. and c., and (2) (a) 5.; DHS 157.44 (6) (a) 4.; DHS 157.61 (7) (a) 2. b, (8) (a) 1. b., and (10) (a) and (c); DHS 157.63 (2) (b) 3. and (4) (c) 2.; DHS 157.67 (11) (f) and (12) (b) 3.; DHS 157.71 (8); DHS 157.72 (1) (a) 1.; DHS 157.74 (2) (b) 2., (d) 3., (2) (f), and (h) 1. and 4. c.; DHS 157.74 (3) (b) 2. and (4) (b); DHS 157.76 (11) (a); DHS 157.77 (2) (h) 1., and (i); DHS 157.78 (4) (d) 1. and 3., (8) (title), and (9) (a); DHS 157.79 (3) (c); DHS 157.80 (1) (b), (2) (a) 1., (2) (b) 4., and (2) (c); DHS 157.83 (3) (b) 1. and 4. d.; DHS 157.85 (3) (title), (13) (em) 2. through 7., and (16) (g) 7. d.; DHS 157.87 (1) (intro.), (3) (b) 6., and (4) (a); DHS 157.92 (2) (b) and (c) 4.; DHS 157.93 (4) (b); and DHS 157.94 (5) (d), (e), and (f), and (8); to repeal and recreate DHS 157.09 (1) (a) 11. and 12.; DHS 157.10 (3); DHS 157.11 (1) (a); DHS 157.15 (5) (a) 2.; DHS 157.76 (7) (c); DHS 157.87 (1) (a); DHS 157.93 (6); DHS 157.94 (3) and (6); DHS 157 Appendix A; DHS 157 Appendix B; DHS 157 Appendix E; DHS 157 Appendix H Table V; Appendix I; Appendix M; and Appendix O; to create DHS 157.03 (6m), (12m) and Note, (25m), (36m), (56g) and Note, (56r) and Note, (77m), (108m), (109m), (124g), (139m), (143g), (150g), (166m), (189m) and Note, (193m), (215m), (219m), (221m) Note, (228m), (230m), (318m), (319g), (319r), (331g), (331r), (374m), (392m), (393m), and (402g); DHS 157.09 (1) (a) 13., (2) (c) 9. through 11., (2) (g), (3); DHS 157.13 (1) (h) 3., (4) (d) 1. h., (4) (j) 5., (4m), (10) (b) 2.; DHS 157.15 (5) (a) 1. e. and f., (5) (c); DHS 157.25 (1) (d); DHS 157.33 (3) (a) 4.; DHS 157.61 (10) (d); DHS 157.74 (2) (m); DHS 157.76 (7) (d); DHS 157.78 (10); DHS 157.80 (1) (f) 5. and 6.; DHS 157.84 (1) (b) 5.; DHS 157.85 (14)(gr); DHS 157.87 (1) (ag) and (ar), (4) (c), (d), and (e); DHS 157.93 (4) (am); DHS 157.94 (5) (a) 2.; DHS 157 Subchapter XV; and DHS 157 Appendix U; relating to radiation protection.
Explanation of agency authority
As specified under s. 254.34 (1), Stats., the department is the state radiation control agency and is required under ss. 254.34 (1) (a), 254.365 (4), and 254.37 (3), Stats., to promulgate rules pertaining to the use of radiation in Wisconsin. Specifically, the department is required to promulgate and enforce rules pertaining to sources of ionizing radiation and for registration and licensing sources of ionizing radiation, and enforcement as may be necessary to prohibit and prevent unnecessary radiation exposure. The department’s rules for by-product material, source material, and special nuclear material are required to be in accordance with 42 USC 2021 (o) and be otherwise compatible with the requirements under 42 USC 2011 to 2114 and regulations adopted under 42 USC 2011 to 2114.
Related statute or rule
Chapter NR 809 incorporates the radioactivity standards for community water systems and the exemptions and requirements established in ss. DHS 157.95 and 157.96. The department of natural resources applies these standards to community drinking water systems. Chapter DHS 163 establishes requirements for identification, removal and reduction of lead-based paint hazards. Lead in paint analysis requires use of a portable device containing radioactive material which is required to be licensed under ch. DHS 157. Section DHS 157.05 (4) also requires any person providing training for certified lead inspectors or risk assessors to meet the training requirements of s. DHS 163.24 (a) 1. and 3. and to complete an additional eight hours of radiation safety training. Chapter 462, Stats., requires radiographers to be licensed and limited x-ray machine operators to be permitted by the state. Sections DHS 157.74 (2) (m) and 157.80 (2) (a) 1. also require individuals operating x-ray equipment for diagnostic purposes to possess a current radiography license or limited x-ray machine operator’s permit from the State of Wisconsin.
Plain language analysis
Under s. 254.34 (1) (a) and (b) Stats., the department is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation, to prohibit and prevent unnecessary radiation exposure. The department is also responsible for maintaining compliance with 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 (agreement) signed by Governor Doyle and the Nuclear Regulatory Commission (NRC) in 2003. The agreement transferred regulatory authority over certain radioactive materials from the NRC to the state. Under the Agreement, the department is responsible for licensing and inspecting radioactive materials commonly used in medicine, industry, research and education. The state regulatory program is periodically evaluated by NRC staff. The Agreement provides that the state will revise the radioactive material provisions of ch. DHS 157 within three years of any applicable changes to Title10 CFR. Title 10 CFR was revised in 2013, whereas ch. DHS 157 was last revised in 2010. The department proposes to revise the radioactive material requirements in ch. DHS 157 in order to comply with the Agreement. No reasonable alternative exists to revising provisions in ch. DHS 157 pertaining to radioactive material, because the Agreement remains in effect. The proposed revisions are anticipated to bring the state into compliance with the Agreement. In addition, the department proposes to revise provisions of ch. DHS 157 pertaining to x-rays. These revisions are necessary to prohibit and prevent unnecessary radiation exposure. Revisions reflect new diagnostic and therapeutic technologies, the department’s experience with implementing and administering the current rule, changes in comparable federal regulations, suggested national standards from the Conference of Radiation Control Program Directors, and input provided to the department by an advisory group that included representatives of academic and medical facilities, radioactive materials users, x-ray users and large and small businesses. No reasonable alternative exists to revising the provisions of ch. DHS 157 pertaining to x-rays, because pursuant to s. 254.34, stats., the department must promulgate and enforce rules, including registration and licensing of sources of ionizing radiation, as may be necessary to prohibit and prevent unnecessary radiation exposure. The proposed revisions are anticipated to accomplish this purpose. 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, as required by s. 254.34 (1), Stats.
Comparison with rules in adjacent states
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 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 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.