STATEMENT OF SCOPE
WISCONSIN DEPARTMENT OF HEALTH SERVICES
CHAPTER: DHS 157
RELATING TO: RADIATION PROTECTION REQUIREMENTS FOR RADIATION PRODUCING MACHINES AND RADIOACTIVE MATERIALS.
RULE TYPE: PERMANENT
SCOPE TYPE: ORIGINAL
FINDINGS OF EMERGENCY: NOT APPLICABLE
SUMMARY
1. Description of rule objective/s
The Department of Health Services proposes to amend ch. DHS 157 relating to radiation producing machines and radioactive materials. The proposed rule revision will accomplish the following: - Incorporate the newest federal radioactive material regulations in 10 C.F.R. pts 19, 20, 31-37, 39, 40, 70, 71 and 150.
- Update the x-ray requirements to reflect changes in 21 C.F.R. pts 900, 1020 and 1040 and other nationally recognized standards.
- Revise the fee structure in s. DHS 157.10 to require that specific radioactive material licenses which authorize research and development are subject to fees based on the possession limits, and that licenses which authorize multiple facilities are subject to fees based on the number of facilities that are licensed. - In order to reduce the regulatory burden on licensees and registrants, incorporate alternatives to rule requirements that are routinely accepted by the department.
- Incorporate minor corrections and clarification to rule definitions and language based on the department’s experience administering the current rule and the input of an advisory group.
- Correct grammatical and other technical errors that have been identified.
2. Existing policies relevant to the rule
The department proposes to revise ch. DHS 157 to comply with applicable federal regulations in 10 and 21 C.F.R. Under s. 254.34 (1) Stats., the department is required to promulgate and enforce rules. Including the registration and licensing of sources of ionizing radiation, that are necessary to prevent unnecessary radiation exposure. Under the 2003 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), the department’s rules must remain compatible with 42 U.S.C. 2011-2014 and the regulations adopted thereunder by the United States Nuclear Regulatory Commission (NRC) relating to radioactive materials, namely 10 C.F.R. In order to maintain compliance with the 2003 agreement, the requirements in ch. DHS 157 pertaining to radioactive materials must be updated within 3 years of any applicable changes to 10 C.F.R. 10 C.F.R is revised frequently. Each revision to 10 C.F.R. has a separate effective date, which requires the department to revise DHS 157 approximately every 3 years to meet the NRC requirement. The department further proposes to revise the fee schedule in s. DHS 157.10 to better align the fee schedule with regulatory workload. The radioactive materials program is funded by licensing fees that are proportional to the work hours for a given license type. Changes in licensee business practices have resulted in licensees combining multiple locations under the same license. These changes in business practices are not reflected in the current fee category structure. In addition, research licensees are requesting to use larger quantities of radioactive materials that require increased regulatory review and inspection. With input from a dedicated advisory committee, the rule revision will modify the fee schedule in s. DHS 157.10 to account for multiple-site licenses, licenses authorizing larger quantities of radioactive materials for research purposes, multisite tiers set at a percent of the base fee category, and licenses for research and development based on possession limit. Minor revision of DHS 157 is also needed to address changes in x-ray technology, rule variances and exemptions that are routinely granted by the department, editorial errors, changes in comparable federal regulation in 21 C.F.R. and other changes in nationally recognized quality control standards for x-ray device imaging.
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
