1. Detailed Description of the Objective of the Proposed Rule
The objective of this technical rule is to make technical updates to existing ETF rules, delete obsolete language in ETF rules, create consistency with provisions in 2013 Wisconsin Act 20 related to rehired annuitants, and make other minor substantive changes.
2. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
This rule is technical in nature does not contain significant changes in policy. It is designed to update ETF rules by deleting obsolete regulatory provisions, terms, and cross-references and making ETF regulations consistent with recent statutory changes. The alternative is continuing with the outdated language in ETF's current code.
3. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Wis. Stat. s. 40.03 (2) (i) The secretaryShall promulgate, with the approval of the board, all rules, except rules promulgated under par. (ig) or (ir), that are required for the efficient administration of the fund or of any of the benefit plans established by this chapter. In addition to being approved by the board, rules promulgated under this paragraph relating to teachers must be approved by the teachers retirement board and rules promulgated under this paragraph relating to participants other than teachers must be approved by the Wisconsin retirement board, except rules promulgated under s. 40.30.
Wis. Stat. s. 40.03 (2) (ig) The secretaryShall promulgate, with the approval of the group insurance board, all rules required for the administration of the group health, long-term care, income continuation or life insurance plans established under subchs. IV to VI.
Wis. Stat. s. 40.03 (2) (ir) The secretaryShall promulgate, with the approval of the deferred compensation board, all rules required for the administration of deferred compensation plans established under subch. VII.
Wis. Stat. s. 227.11 (2) Rule-making authority is expressly conferred as follows:
(a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
(b) Each agency may prescribe forms and procedures in connection with any statute enforced or administered by it, if the agency considers it necessary to effectuate the purpose of the statute, but this paragraph does not authorize the imposition of a substantive requirement in connection with a form or procedure.
(c) Each agency authorized to exercise discretion in deciding individual cases may formalize the general policies evolving from its decisions by promulgating the policies as rules which the agency shall follow until they are amended or repealed. A rule promulgated in accordance with this paragraph is valid only to the extent that the agency has discretion to base an individual decision on the policy expressed in the rule.
(d) An agency may promulgate rules implementing or interpreting a statute that it will enforce or administer after publication of the statute but prior to the statute's effective date. A rule promulgated under this paragraph may not take effect prior to the effective date of the statute that it implements or interprets.
(e) An agency may not inform a member of the public in writing that a rule is or will be in effect unless the rule has been filed under s. 227.20 or unless the member of the public requests that information.
4. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
State employees will spend an estimated 40 hours to develop these rules.
5. List with Description of all Entities that may be Affected by the Proposed Rule
The new rule will affect state and local public employers, members, subscribers, their beneficiaries and dependents who interact with ETF regarding the benefit programs administered by ETF.
6. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
No existing or proposed federal regulation addresses the contemplated rule changes.
7. Anticipated economic impact of implementing the rule (note if the rule is likely to have a significant economic impact on small businesses)
ETF anticipates that the proposed rule will have minimal or no economic impact locally or statewide and will not impact small businesses.
Contact Person
ETF General Counsel David Nispel. Phone: (608) 264-6936.
Health Services
Health, Chs. 110
This statement of scope was approved by the governor on February 24, 2014.
Rule No.
Chapter DHS 157 (revise).
Relating to
Radiation protection requirements for radiation producing machines and radioactive materials.
Rule Type
Permanent
Type of Statement of Scope
Revised
1. Finding/Nature of Emergency (Emergency Rule Only)
Not applicable.
2. Detailed Description of the Objective of the Proposed Rule
The department intends to revise ch. DHS 157 to meet the following objectives:
1. 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 source material; 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. 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.
3. Codification of recommendations from the FDA of methods designed to protect patients from radiation injuries during high dose medical procedures by requiring medical professionals to record the patient's radiation dose in the patient's medical record.
4. 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.
5. Maintenance of accurate and current rules that comply with current applicable state and federal law and nationally recognized standards.
3. a. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
The department proposes to revise ch. DHS 157 to be compatible with applicable federal regulations in Titles 10 and 21 CFR. The department is required under s. 254.34 (1) (a), 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 (Agreement) to maintain compatibility with 42 USC 2011 to 2114 and the regulations adopted thereunder by the NRC, namely Title 10 CFR relating to radioactive materials. The Agreement transferred authority over certain radioactive material from the NRC to Wisconsin. As the radiation control agency and pursuant to the policy specified in s. 254.33, Stats., the department must also maintain compatibility with rules adopted by the FDA under Title 21 CFR, relating to ionizing radiation devices such as diagnostic, therapeutic and cabinet x-ray devices. Titles 10 and 21 CFR have both been revised since the department last revised ch. DHS 157 in 2010. Revisions to Title 10 include the creation of 10 CFR 37, effective March 13, 2013, which codifies security requirements for quantities of radioactive material considered to be risk significant and warrant additional protection. These requirements were initially issued nationally by order of the NRC in 2005 and 2008 to regulated entities. The department implemented the NRC order, as a license condition. The department will codify the requirements in ch. DHS 157 and remove the license condition. Because the regulated entities have operated under these requirements beginning in 2005, codification of the requirements in ch. DHS 157 should result in no change for the regulated entities.
The FDA as a response to the multiple incidents of radiation injuries to patients during high dose medical procedures has recommended recording the patient's radiation dose in the medical record for certain procedures. Dose recording will allow physicians to better evaluate radiation risk versus treatment options. The department proposes to include these recommendations in ch. DHS 157. In order to address changes in medical x-ray technologies, including computed tomography, the department intends to propose revising ch. DHS 157 to include the updated quality control, operational, and training standards for medical x-ray imaging issued by the Conference of Radiation Control Program Directors in its publication Suggested State Regulations for the Control of Radiation.
The department further proposes to update ch. DHS 157 to correct errors and make other minor revisions to the rule, and to conform 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.
3. b. There is no acceptable alternative to the rule revision. Sections 254.34 (1), 254.33, and 254.365 (4), Stats., and the Agreement require periodic revision of ch. DHS 157 to remain compatible with comparable federal regulations.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section 227.11 (2) (a), Stats., reads: (2) Rule-making authority is expressly conferred as follows:
(a) Each agency may promulgate rules interpreting the provisions of any statute enforced or administered by the agency, if the agency considers it necessary to effectuate the purpose of the statute, but a rule is not valid if the rule exceeds the bounds of correct interpretation. All of the following apply to the promulgation of a rule interpreting the provisions of a statute enforced or administered by an agency:
1. A statutory or nonstatutory provision containing a statement or declaration of legislative intent, purpose, findings, or policy does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
2. A statutory provision describing the agency's general powers or duties does not confer rule-making authority on the agency or augment the agency's rule-making authority beyond the rule-making authority that is explicitly conferred on the agency by the legislature.
3. A statutory provision containing a specific standard, requirement, or threshold does not confer on the agency the authority to promulgate, enforce, or administer a rule that contains a standard, requirement, or threshold that is more restrictive than the standard, requirement, or threshold contained in the statutory provision.
Section 254.34 (1) (a) and (b), Stats., reads: (1) The department is the state radiation control agency and shall do all of the following:
(a) 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 rules may incorporate by reference the recommended standards of nationally recognized bodies in the field of radiation protection and other fields of atomic energy, under the procedure established by s. 227.21 (2). The rules for by-product material, source material and special nuclear material shall be in accordance with the requirements of 42 USC 2021 (o) and shall otherwise be compatible with the requirements under 42 USC 2011 to 2114 and regulations adopted under 42 USC 2011 to 2114.
(b) Administer this subchapter and the rules promulgated under this subchapter.
Section 254.33, Stats., reads: Since radiations and their sources can be instrumental in the improvement of the health and welfare of the public if properly utilized, and may be destructive or detrimental to life or health if carelessly or excessively employed or may detrimentally affect the environment of the state if improperly utilized, it is hereby declared to be the public policy of this state to encourage the constructive uses of radiation and to prohibit and prevent exposure to radiation in amounts which are or may be detrimental to health. 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.
Section 254.365 (4), Stats., reads: (4) The department shall promulgate rules for all of the following:
(a) The issuance, modification, suspension, termination and revocation of specific licenses under sub. (1) (a) under the standards specified in s. 254.34 (1) (a).
(b) The requirements for a general license under sub. (1) (b).
Section 254.37 (3), Stats., reads: The department shall promulgate and enforce the rules pertaining to ionizing radiation.
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
The department will require approximately 250 hours of staff time to develop the rule. The department will form an ad hoc advisory group consisting of representative users of radioactive materials and x-ray devices to provide input on the proposed rules. Associations representing business and hospitals will be asked to recommend members to the advisory group.
6. List with Description of all Entities that may be Affected By the Proposed Rule
Hospitals, academic facilities, medical clinics, dental facilities, chiropractic offices, veterinary facilities, and industrial facilities that use radioactive materials or x-ray devices may be affected by the proposed rules.
7. Summary and Preliminary Comparison with any Existing or Proposed Federal Regulation that is Intended to Address the Activities to be Regulated by the Proposed Rule
The radiation protection requirements in ch. DHS 157are based on or identical to the following federal regulations as required under state statute and the Agreement:
10 CFR 19, 20, 31-37, 39, 40, 70, 71, and 150 for radioactive materials.
21 CFR 900 for mammography and parts 1020, 1030, and 1040 for diagnostic, therapeutic, and cabinet x-ray devices.
8. Anticipated Economic Impact of Implementing the Rule
The proposed rules are anticipated to have no to minimal economic impact.
Contact Person
Paul Schmidt
Division of Public Health
Bureau of Environmental and Occupational Health
608 267-4792
Safety and Professional Services
Professional Services, Chs. 1—299
This statement of scope was approved by the governor on February 26 2014.
Rule No.
Chapters SPS 160 to168 (revise).
Relating to
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