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
This statement of scope was approved by the governor on February 24, 2014.
Rule No.
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:
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.
Relating to
Substance abuse professionals.
1. Finding/Nature of Emergency (Emergency Rule Only)
N/A
2. Detailed Description of the Objective of the Proposed Rule
The proposed rulemaking project is intended to update the administrative rules relating to substance abuse professionals by incorporating current industry standards and technological advances and to reorganize pertinent administrative rules for clarity, consistency, and greater ease of use. The proposed rules also would address policy problems facing the substance abuse professional industry including workforce shortage issues.
3. Description of the Existing Policies Relevant to the Rule, New Policies Proposed to be Included in the Rule, and an Analysis of Policy Alternatives
Current department administrative rules relating to substance abuse professionals resulted from an initial, large-scale rule-writing effort. Since initial promulgation, a number of areas of the code have been identified as redundant, confusing, and/or outdated. Proposed modifications would revise existing rules for greater clarity and update credential requirements to incorporate current industry standards and technological advances. The proposed rule would address credential requirements that exacerbate workforce shortage issues including modifying restrictions on internet-based coursework and establishing alternative education options.
4. Detailed Explanation of Statutory Authority for the Rule (Including the Statutory Citation and Language)
Section 227.11 (2) (a), Wis. Stats. 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.
Section 440.88 (3) (a) and (b), Wis. Stats. Subject to pars. (b) and (c) and except as provided in sub. (3m), the department shall promulgate rules that establish minimum standards and qualifications for the certification of all of the following, including substance abuse counselors and clinical supervisors described under s.
HFS 75.02 (11) and
(84), Wis. Adm. Code, in effect on December 15, 2006: 1. Substance abuse counselors-in-training., 2. Substance abuse counselors., 3. Clinical substance abuse counselors., 4m. Clinical supervisors-in-training., 5. Intermediate clinical supervisors., 6. Independent clinical supervisors., 7. Prevention specialists-in-training., and 8. Prevention specialists. (b) Rules promulgated under par. (a) shall include standards based on demonstrated requisite competency, knowledge, skills, and attitudes of professional practice that are culturally competent and evidence-based.
Section 440.88 (9), Wis. Stats. The department may do all of the following: (a) Establish the minimum number of hours of continuing education required for renewal of certification under this section and the topic areas that the continuing education must cover. (b) Require continuing education as part of any disciplinary process for an individual.
Section 440.88 (10), Wis. Stats. Continuing education course approval. The department shall establish the criteria for the approval of continuing education programs and courses required for renewal of certification of a substance abuse counselor, clinical supervisor, or prevention specialist and the criteria for the approval of the sponsors and cosponsors of those continuing education programs and courses. The department shall approve continuing education programs and courses in accordance with the criteria established under this subsection.
Section 440.88 (11), Wis. Stats. Scope of practice. The department shall promulgate rules establishing minimum standards for the practice of substance abuse counseling, supervision, and prevention.
5. Estimate of Amount of Time that State Employees Will Spend Developing the Rule and of Other Resources Necessary to Develop the Rule
200 hours.
6. List with Description of all Entities that may be Affected by the Proposed Rule
Individuals certified, or attempting to obtain certification, under s.
440.88, Stats., as any level of prevention specialist, substance abuse counselor, or clinical supervisor.
