DepartmenT of Health Services Office of Legal Counsel F-02318 (12/2018) | STATE OF WISCONSIN |
WISCONSIN DEPARTMENT OF HEALTH SERVICES PROPOSED ORDER TO ADOPT PERMANENT RULES |
The Wisconsin Department of Health Services (“the department”) proposes an order to repeal DHS 157.44 (6) (a) 4., and 157.74 (2) (e); renumber DHS 157.13 (4) (i) 7., and 157.9719 (1) (Note 1); renumber and amend DHS 157.03 (251m), 157.67 (1) (b), (18); amend DHS 157.01 (10), 157.03 (22), (143), (204), (267), (295m), (374) (c), and (391), 157.09 (2) (c) 2. a. to c., (2) (c) 7., and (2) (g) (title), 157.10 (3) (table), 157.11 (1) (a) 1. b. and c., (2) (b) 3. g., (2) (d) (Note), (2) (h) 1. e., and (2) (h) 3. d., 157.13 (4) (i) 4., (4) (i) 6. d., and (8) (d), 157.15 (3) (d), 157.21 (3), 157.35, 157.44 (6) (a), (a) 3., (6) (d) and (f), 157.45 (11) (c), 157.51 (1) (a) 2., 157.52 (4) (a), 157.53 (3) (a), 157.61 (1) (b) and (c), (4) (a) 1., (5) (b) 3. and 4., (7) (intro.), (a), (b) 2., and (c) 1. and 2., (9) (intro.), (a), (a) 1. and (12) (a) to (c), 157.62 (2) (b) 3. (Note), 157.63 (4) (intro.), (a), (b), (c) 2., (5) (intro.), (a) (intro.), (b), and (c) 2., 157.64 (1), (4) (intro.), (b) 1., 2. and 2. g., (5) (intro.), (b), (c) (intro.) and (c) 2., (6) (intro.), (b) and (c) (intro.) and (c) 2., and (7) (intro.), (a) to (c), (c) 1. and 2., and (c) 2. f., 157.65 (1) (a) and (b), 157.65 (8) (intro.), (a), (a) 1., (b) 2. and 3., and (10) (a) and (b), 157.66 (2) (intro.) 157.67 (1) (intro.) and (1) (a), (4) (d) and (e), (15) (title) and (a), and (17) (intro.), (a) (intro) and 1., (b) 2. and 3., 157.68 (2) (a), 157.71 (4) (b) 3, and (5) (c), 157.72 (1) (a) (intro.) and (a) 3., and (2) (f) 1. b., 157.73 (12) (d) (intro.), (e) and (g), (14) (a), (c), (18) (b), and (22) (e), 157.74 (2) (f) 1., 157.76 (intro.), (8), and (2) (b), 157.80 (1) (c) 2., 157.81 (4), 157.93 (4) (am) and (b) 1. and 2., 157.94 (5) (a) (Note), (am) (Note), and (d), (6) (c), (f) 1., 1. a. and b., and (f) (2) and (2) a., 157.9701 (6) (b), 157.9702 (2) (b) 1., 157.9706 (1), 157.9708 (4) (b), (4) (c) (intro.) and (c) 1., (e), (f), (g) and (h) 2., 157.9714 (1), 157.9719 (1) (a), Appendix B, and Appendix D; repeal and recreate DHS 157.13 (5), 157.61 (4) (b), (8), and (10), 157.62 (4), 157.63 (3) (b) 1., 157.63 (6), 157.64 (8), 157.65 (6), 157.65 (9), 157.66 (1), Table DHS 157.75, Subchapter IX (title), 157.87. 157.9703 (3), Appendix A, Appendix F, Appendix H, Appendix L, Appendix O, Appendix T; and to create DHS 157.03 (30m), (40m), (45m), (57c), (57w), (66m), (193e), (235m), (239m), (252r), (288m), (331m), and (336m), 157.13 (4) (i) 7., 157.61 (5) (b) 5. and 6., (7) (b) 3., (c) 3., and (9) (b) 3., 157.62 (5) (b) 3., 157.63 (3) (b) 3. and (d),157.63 (4) (c) 3. and (5) (c) 3., 157.64 (4) (b) 3., (5) (c) 3., (6) (c) 3., and (7) (c) 3., 157.65 (6m), (8) (b) 4., and (10) (a) 1. and 2., 157.66 (2) (c), 157.67 (1) (a) 1., (1) (b) (intro.), (1) (b) 1. and 2. , (4) (g) and (e), (17) (b) 4., and (18) (a) and (b), 157.71 (1) (c), 157.72 (1) (am) and (4), 157.74 (2) (fm) and (5), 157.9719 (1) (Note 1), relating to radiation protection requirements for radiation-producing machines and radioactive materials.
RULE SUMMARY
Statute interpreted
Statutory authority
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. As specified under s. 254.33, Stats., it is further the policy for the department to advise, consult and cooperate with other agencies of the state, the federal government, other states and interstate agencies and with affected groups, political subdivisions and industries; and, in general, to conform as nearly as possible to nationally accepted standards in the promulgation and enforcement of rules. 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 or x-ray tube which is required to be licensed or registered 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. Section 254.33, Stats., further directs the department to “conform as nearly as possible to nationally accepted standards in the promulgation and enforcement of rules.” 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(“the 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 Title 10 CFR. Title 10 CFR was revised as recently as 2019, whereas ch. DHS 157 was last revised in 2016. 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, and to conform to nationally accepted standards for technologies employing x-rays. 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 ss. 254.33 and 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.
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.
The proposed revisions to ch. DHS 157 would accomplish the following:
1. 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 pp. 19, 20, 31-37, 39, 40, 70, 71, and 150 and 49 CFR, 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.
2. Add one radioactive material license fee category and modify one fee category to reflect the difference in program effort and cost for licensees that use large amounts vs smaller amount of radioactive material in research and development.
3. Add one additional fee category for radioactive materials licenses that are authorized for three or more sites of locations of use or storage. There have been no fee increases or category changes since 2003. The number of licensees authorized for multiple sites under the same license has increased since 2003. This site fee category reflects the additional operating revenue needed for the radioactive materials program to sufficiently license and inspect licensees with multiple sites.
4. Achieve compatibility with current applicable regulations of the federal Food and Drug Administration (FDA) in 21 CFR pp. 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.
5. Codify 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.
6. Correct outdated, imprecise, and inconsistent rule language based on the department’s experience administering the current rule.
The proposed revision to ch. DHS 157 will have the following economic impact on radioactive material regulated entities:
1. Increase the annual and application fee from $1800 to $3600 for licensees that are authorized to use a total of 5 curies or more of radioactive material for research and development.
2. The annual fee for each noncontiguous site listed on a license, starting at three, has a fee equal to 25% of the applicable fee category of use per each additional site. For example:
-licensee A has 2 sites with an applicable fee category of $1000, there is no change and the total fee is $1000;
-licensee B has 3 sites with an applicable fee category of $1000, the fee increases 25% per site greater than 2 and the total fee is $1250;
-licensee C has 3 sites with an applicable fee category of $1000 and 1 site with an applicable fee category of $500, a total of 4 sites and two different applicable fee categories. The total fee is $1750 ($1000 for sites one and two + $250 for site three + $500 for site four).
These fee changes apply to a small percentage of current licensees and is proportional to their operations.
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 pp.. 19, 20, 31, 33-36, 37, 39, 40, 70, 71 and 150, and 49 CFR as required by s. 254.34 (1), Stats.
The proposed changed to ch. DHS 157 are equivalent to 21 CFR pp. 900, 1020, and 1040, which set quality standards for mammography, diagnostic, therapeutic, and cabinet x-ray devices. Comparison with rules in adjacent states
Illinois:
Illinois is an agreement state with the NRC. As a result, Illinois law in effect April 21, 2021 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. Illinois’s annual fee structure for radioactive materials licenses includes an additional site fee for every site that isn’t the main location of the licensee. The site fee is based on the category authorized at the site and ranges from 20-55% of the full cost of the fee category.
Illinois does not have a fee category for research and development licensees based on the amount of radioactive authorization.
Reference: Illinois Regulation Title 32: Energy chapter II: Illinois emergency management agency Subchapter b: radiation protection Part 331 fees for radioactive material licensees
Iowa:
Iowa is an agreement state with the NRC. As a result, Iowa 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. Iowa’s annual fee structure for radioactive materials licenses includes and additional site fee for every additional license site. Licensees with more than two authorized locations of are charged an additional 10% of the annual fee per location.
Iowa does not have a license fee category for research and development licensees based on the amount of radioactive authorization.
Reference: Iowa Administrative Code 641-38.8(2)
Michigan:
Michigan is not an agreement state with the NRC. Michigan law in effect April 21, 2021 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. The Nuclear Regulatory Commission determines license fees within Michigan. There are specific fee categories that limit the number of sites authorized under the license. The ranges are 1-5 locations, 6-20 locations, more than 20 locations. The fee for 6-20 locations and more than 20 locations is an additional 32% and 65% of the 1-5 location fee, respectively.
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.
