3. Policies proposed to be included in the rule
The Department proposes to update the rule to: (1) incorporate the latest federal standards to maintain federal compatibility requirement for program rules; (2) change certain language that is ambiguous to ensure clear consistent requirements; (3) fix known grammatical and technical errors; (4) incorporate rule exemptions that are common and are routinely approved through exemption requests; (5) update documentation and retention requirements to allow for modern business practices; (6) update licensing fees for applicability to certain research and multi-site licensees; and (7) make any other corrective changes identified throughout the rule promulgation process.
4. Analysis of policy alternative
There is no acceptable alternative to the rule revision. The existing rule is outdated under the agreement between the NRC and Wisconsin, which requires periodic revision of ch. DHS 157 to remain current with comparable federal regulations.
5. Statutory authority for the rule
a. Explanation of authority to promulgate the proposed rule
Under s. 254.34 (1) (a) and (b), Stats., the department is designated as the state radiation control agency and given statutory authority to promulgate, administer and enforce rules promulgated under the subchapter, which governs radiation protection. Section 254.33, Stats., authorizes the department to advise, consult and cooperate with other agencies of the state, federal government, and other jurisdictions. Section 254.365 (4), Stats., authorizes the department to promulgate rules related to the issuance, modification, suspension, and termination of specific and general licenses for radioactive materials. Section 254.37 (3), Stats., authorizes the department to promulgate and enforce rules pertaining to ionizing radiation. The department also has rule making authority under s. 227.11 (2) (a), Stats., which states that each agency may promulgate rules interpreting the provisions of any statute enforced by the agency, if the agency considers it necessary to effectuate the purpose of the statute.
b. Statute/s that authorize/s the promulgation of the proposed rule
c. Statute/s or rule/s that will affect the proposed rule or be affected by it
6. Estimates of the amount of time that state employees will spend to develop the rule and other necessary resources
The Department will require approximately 250 hours of staff time to develop the rule. This includes the time required for research and analysis coordinating an advisory committee, drafting rule language, preparing related documents, holding a public hearing and communicating with stakeholders and other affected parties.
7. Description of all of the entities that may be affected by the rule, including any local governmental units, businesses, economic sectors, or public utility ratepayers who may reasonably be anticipated to be affected by the rule
The entities that may be affected by the proposed rule include entities that have or will apply for a radioactive materials license or x-ray machine registration. These entities include hospitals, academic institutions, medical clinics, dental facilities, chiropractic offices, veterinary facilities, facilities that perform research and development, and industrial facilities.
8. Summary and preliminary comparison of any existing or proposed federal regulation that is intended to address the activities to be regulated by the rule
The radiation protection requirements in ch. DHS 157 are based on or identical to the following federal regulations as required under state statute and the Agreement: - 10 C.F.R. pts. 19, 20, 30. 31-37, 40, 70, 71 and 150, which provide standards for notices and licensing for, packaging and transporting of, and protection from radioactive materials.
- 21 C.F.R. pts. 900, 1020, and 1040, which set quality standards for mammography, diagnostic, therapeutic, and cabinet x-ray devices.
9. Anticipated economic impact, locally or statewide
If revisions to the fee schedule are promulgated, the proposed rule is anticipated to have moderate economic impact on large facilities with multiple sites under one license and research facilities requesting larger quantities of radioactive materials. If revisions are not made to the fee schedule then little to no economic impact is anticipated. The proposed rule will have minimal effect on small businesses.
10. Agency contacts
