4. The 2002 Economic Census – Wisconsin Geographic Series, which is compiled by the U.S. census bureau every 5 years for each year ending in “2" and “7". The U.S. census bureau is currently compiling the 2007 census information. This information will not become fully available until 2010. The information provided by the Economic Census includes the North American Industry Classification Codes, information on industries, business revenues, sizes, and employment. The Department used this information to approximate business size and any possible percentage increase in business costs due to the proposed revisions in x-ray regulatory requirements.
5. Criteria adopted by the Department and approved by the Wisconsin Small Business Regulatory Review Board to determine whether the Department's proposed rules have a significant economic impact on a substantial number of small businesses. Pursuant to the Department's criteria, a proposed rule will have a significant economic impact on a substantial number of small businesses if at least 10% of the businesses affected by the proposed rules are small businesses and if operating expenditures, including annualized capital expenditures, increase by more than the prior year's consumer price index (CPI) or reduce revenues by more than the prior year's CPI. For the purposes of this rulemaking, we used 2008 as the index year; the 2008 CPI is estimated to be 3.8%. The consumer price index is compiled by the U.S. Department of Labor, Bureau of Labor Statistics and measures, among other things, the rate of inflation.
6. 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 employees 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 Department is the state's 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, for registration and licensing sources of ionizing radiation, and to prohibit and prevent unnecessary radiation exposure.
The Department's x-ray registration and inspection program, and radioactive materials licensing and inspection program, are both 100% fee supported by the annual fees authorized under ss.
254.35 (3) and
254.365 (5), Stats. There are no fee increases proposed in this rule revision.
DHS 157.74 (2) (L). This new subsection requires radiation safety committee oversight of all facilities that have 2 or more therapeutic radiation machines, regardless of the type of device (external or internal) used. The requirement for a radiation safety committee already exists for radioactive materials under s.
DHS 157.61 (1) (e). The majority of therapeutic radiation machines currently being used in Wisconsin are used at large medical facilities that do not qualify as small businesses under s.
227.114 (1) (a), Stats. and have existing radiation safety committees. In the event that a facility without a radiation safety committee acquires 2 or more therapeutic radiation machines, they can utilize existing staff to form a radiation safety committee required under this section. As a result, the Department expects this new requirement to have minimal impact on any facility, including small business.
DHS 157.76 (11). Fluoroscopy devices, used to obtain continuous x-ray images of the body, produce very high radiation exposure rates with exposure time directly controlled by the device operator. The Department is aware of fluoroscopy operators receiving substantial exposure from use of fluoroscopic devices, indicating a lack of awareness of safety requirements. As a result, the Department is proposing minimum training for all personnel that operate fluoroscopy devices, regardless of the type of facility. This new requirement will impact the small percentage (less than 10%) of medical clinics, chiropractic and veterinary facilities with fluoroscopy devices, all of which are classified as a small businesses under s.
227.114 (1) (a), Stats. The proposed training requirement will also affect all large hospitals and clinics that routinely utilize fluoroscopy by requiring physicians as well as other operators to complete minimum training. The proposed training will take a minimum of 8 hours to complete. This training can be accomplished in a variety of ways, including in house (on site) training and continuing education, and can be rolled into the business' existing training infrastructure. As a result, the Department expects there will be a small cost associated with this training to all facilities using fluoroscopy devices, including small business.
DHS 157.76 (12). The Department is proposing requiring fluoroscopy units to have their radiation output measured annually by a qualified person on staff or under contract. This is consistent with the recommendations of the Conference of Radiation Control Program Directors (CRCPD) in their suggested state regulations. There is minimal effort required to meet this requirement because fluoroscopy units already have either qualified staff or contractors on hand. As a result, the Department anticipates minimal fiscal impact on any facility, including small business.
DHS 157.80 (2) (a) 2. The Department is proposing that operators of computed tomography (CT) x-ray systems for veterinary use be qualified or otherwise trained to use the device. This requirement will apply to all veterinary facilities using CT x-ray systems, which is currently a very small percentage of the total facilities statewide (approximately 4 sites). The small number of veterinary facilities impacted by this requirement are classified as a small business. The proposed training can be obtained from a device vendor or other qualified staff. To the Department's knowledge, the few veterinary facilities with CT x-ray systems already meet this requirement. Due to the very small number of impacted facilities and the access to training, the Department anticipates minimal fiscal impact to small businesses.
DHS 157.82 (2) and (5). These 2 subsections jointly require all electronic brachytherapy users to receive device specific training prior to operating this new technology. The proposed training is consistent with the requirements for other therapeutic radiation machines in ch.
DHS 157. Currently, this new technology is not being used by any facility classified as a small business under s.
227.114 (1) (a), Stats.
DHS 157.85 (13), (14), (16). These subsections establish quality assurance requirements for electronic brachytherapy devices as recommended by a national organization, the American Association of Physicists in Medicine (AAPM). Currently, this new technology is not being used by any facility classified as a small business under s.
227.114 (1) (a), Stats.
Small Business Impact
Pursuant to the foregoing analysis, the Department does not anticipate that the proposed revisions will have a significant economic impact on small businesses.
Small business regulatory coordinator
Rosie Greer
(608) 266-1279
Fiscal Estimate
Summary
Under s.
254.34 (1) (a), Stats., the Department of Health Services is responsible for developing and enforcing rules, including registration and licensing of sources of ionizing radiation. Sources of ionizing radiation include x-ray producing devices. The Department is also responsible for maintaining compliance with an agreement between Wisconsin and the federal Nuclear Regulatory Commission (NRC) that transferred regulatory authority over certain radioactive materials from the NRC to the state.
The current rule revision is intended to bring Wisconsin into compliance with the most recent changes to federal radiation protection and regulatory requirements. No fiscal effect is anticipated as a result of the incorporation of new federal standards into DHS 157.
In addition, the Department proposes to update certain radiation safety requirements. Since the last revision of DHS 157 in 2006, new x-ray technologies with potential for significant radiation exposures to operators and patients have become more prevalent in the state. This rule revision proposes operator qualification and safety requirements for these new technologies. The new x-ray technologies are primarily being used by large, medical facilities not classified as a small business under s 227.114 (1) (a), Stats. In a few cases, they are being used by a small subset of veterinary facilities that are classified as a small business. The training needed to become qualified to operate these new technologies is available and may be accomplished in-house by incorporating into existing radiation safety programs. Some facilities are already providing operator training to meet facility requirements. Any additional training cost will vary by facility, but is not expected to be significant for any facility.
The Department is also proposing new quality assurance requirements for the digital x-ray systems that are being increasingly used in medical, dental, chiropractic and podiatric offices within the state. Digital x-ray systems use a digital (i.e., electronic) image receptor that replaces the use of x-ray film. The Department does not expect a significant cost to any facility from these new requirements.
Finally, the Department is proposing minimum training for all operators of fluoroscopy devices, including physicians. Fluoroscopy devices produce a continuous x-ray image of the body with potential for significant radiation exposure to both the patient and medical personnel. Fluoroscopy devices are used by most hospitals, plus a small subset of medical clinics, chiropractic and veterinary facilities. Although there will be a cost to complete the operator qualification training, either thru formal continuing education or in-house training, it is anticipated that there will be only a minimal fiscal impact to any facility.
The proposed changes to x-ray safety requirements are not the result of the changes in federal standards, although the changes are consistent with safety standards recommended by national organizations, specifically the American Association of Physicists in Medicine (AAPM) and the Conference of Radiation Control Program Directors (CRCPD). The new standards can be incorporated into the training required of most occupations that use radiation producing devices and thus is not expected to be a significant additional cost to any facility or individual. The Department is not proposing a fee increase in this rule revision.
State fiscal effect
None.
Local government fiscal effect
None.
Private sector fiscal effect
Increase costs. Will not have significant economic impact on a substantial number of businesses.
Long-range fiscal implications
None known.
Text of Proposed Rule
SECTION 1. DHS 157.03 (5), (6), (32m) (a), (33) (a), and (50) (intro.) and (a) are amended to read:
DHS 157.03 (5) “Accelerator" means any machine capable of accelerating electrons, protons, deuterons or other charged particles in a vacuum and of discharging the resultant particle or other radiation into a medium at energies usually in excess of one MeV. Particle accelerator is considered an equivalent term.
(6) “Accelerator-produced radioactive material" means any material made radioactive by an accelerator.
(50) “Byproduct material" means eitherany of the following:
(a) Any radioactive material, except special nuclear material, yielded in or made radioactive by exposure to the radiation incident to the process of producing or utilizingusing special nuclear material.
SECTION 2. DHS 157.03 (50) (c) to (e), (75r), and (103r) are created to read:
DHS 157.03 (50) (c) Any discrete source of radium-226 that has been produced, extracted or converted after extraction, for use for a commercial, medical or research activity.
(d) Any material that has been made radioactive by use of a particle accelerator, and is produced , extracted, or converted after extraction, for use for a commercial, medical or research activity.
(e) Any discrete source of naturally occurring radioactive material, other than source material, that the NRC, in consultation with the Administrator of the Environmental Protection Agency, the Secretary of Energy, the Secretary of Homeland Security, and the head of any other appropriate federal agency, determines would pose a threat similar to the threat posed by a discrete source of radium-226 to the public health and safety or the common defense and security, and is extracted or converted after extraction for use in a commercial, medical or research activity.
(75r) “Consortium" means an association of medical use licensees and a positron emission tomography (PET) radionuclide production facility in the same geographical area that jointly own or share in the operation and maintenance cost of the PET radionuclide production facility that produces PET radionuclides for use in producing radioactive drugs within the consortium for noncommercial distributions among its associated members for medical use. The PET radionuclide production facility must be located at an educational institution, a federal facility or a medical facility.
(103r) “Discrete source" means a radionuclide that has been processed so that its concentration within a material has been purposely increased for use for commercial, medical, or research activities.
SECTION 3. DHS 157.03 (191) and (200) are amended to read:
DHS 157.03 (191) “Licensed practitioner" means a chiropractor, dentist, physician, podiatrist, physician's assistant, nurse practitioner or radiologist's assistant licensed in the state of Wisconsin.
(200)
“Low specific activity - III" or “LSA-III material" means solids, such as consolidated wastes or activated materials, excluding powders,
that satisfy the requirements of 10 CFR 71.77, for which all of the following apply:
SECTION 4. DHS 150.03 (221m) is created to read:
DHS 150.03 (221m) “Nationally tracked source" means a sealed source containing a quantity equal to or greater than Category 1 or Category 2 levels of any radioactive material listed in Appendix T. In this context a sealed source is defined as radioactive material that is sealed in a capsule or closely bonded, in a solid form and which is not exempt from regulatory control. It does not mean material encapsulated solely for disposal, or nuclear material contained in any fuel assembly, subassembly, fuel rod, or fuel pellet. Category 1 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 1 threshold. Category 2 nationally tracked sources are those containing radioactive material at a quantity equal to or greater than the Category 2 threshold but less than the Category 1 threshold.
SECTION 5. DHS 157.03 (222), (374) (a), (c) and (d), (382), (388), (402m), (407), and (413) are amended to read:
(222) “NARM" means any naturally occurring or accelerator-produced radioactive material. It does not include byproduct, source or special nuclear material.
(374) (a) For capacitor energy storage equipment, peak tube potential in kV kilovoltage and quantity of charge in mAsmillamperage-seconds (mAs).
(c) For CT x-ray systemsequipment designed for pulsed operation, peak tube potential in kV, scan time in seconds, and either tube current in mAmillamperes (mA), x-ray pulse width in milliseconds, and the number of x-ray pulses per scan; or the product of tube current, x-ray pulse width, and the number of x-ray pulses per scan expressed as mAs.
(d) For CT x-ray systemsequipment not designed for pulsed operation, peak tube potential in kV, and either tube current in mA and scan time in seconds, or the product of tube current and exposure time in mAs and the scan time when the scan time and exposure time are equivalent.
(382) “Therapeutic radiation machine" means x-ray, gamma ray or electron-producing equipment designed and used for external beam or internal radiation therapy.
(388) “Total effective dose equivalent" or “TEDE" means the sum of the deep effective dose equivalent for external exposures and the committed effective dose equivalent for internal exposures.
(402m) “Unirradiated uranium" means uranium containing not more than 2 X 103 Bq of plutonium per gram of uranium-235, not more than 9 X 106 Bq of fission products per gram of uranium- 235, and not more than 5 X 10
-3 g of uranium-236 per gram of uranium-235.
(407) “Useful beam" means the radiation emanating from which passes through the tube housing port or the radiation head and passing through and the aperture of the beam-limiting device when the exposure controls are in a mode to cause the system to produce radiationswitch or timer is activated.
(413) “Waste" means those materials having a low level of radioactivity containing that are acceptable for disposal in a land disposal facility and are not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in 42 USC 2011low-level radioactive wastes containing source, special nuclear, or byproduct material that are acceptable for disposal in a land disposal facility. For the purposes of this definition, low-level radioactive waste means radioactive waste not classified as high-level radioactive waste, transuranic waste, spent nuclear fuel, or byproduct material as defined in DHS 157.03 (50) (b) to (e).
SECTION 6. DHS 157.03 (430m) is created to read:
DHS 157.03 (430m)“X-ray control" means a device which controls input power to the x-ray high-voltage generator and/or the x-ray tube. It includes equipment such as timers, phototimers, automatic brightness stabilizers, and similar devices, which control the technique factors on an x-ray exposure.
SECTION 7. DHS 157.05 (5) title is created to read:
DHS 157.05 (5) PHYSICAL CONTROLS.
SECTION 8. DHS 157.09 (2) (a) 2., (c) 2. intro., 3., and (d) title are amended to read:
DHS 157.09 Exemptions. (2) EXEMPTIONS OF RADIOACTIVE MATERIAL OTHER THAN SOURCE MATERIAL. (a) 2. A manufacturer, processor or producer of a product or material is exempt from the requirements of subch. II if they transfer radioactive material contained in a product or material in concentrations not in excess of those in Appendix A and introduced into the product or material by a licensee holding a specific license issued by the department, the NRC or another agreement state expressly authorizing such introduction. This exemption does not apply to the transfer of radioactive material contained in any food, beverage, cosmetic, drug, or other commodity or product designed for ingestion or inhalation by, or application to, a human being.
(c) 2. Timepieces, hands or dials containing promethium-147 or radium-226, when measured through 50 milligrams per square centimeter of absorber, not exceeding the following radiation dose rate:
3. Timepieces containing up to 37 kBq (1.0 microcurie) of radium-226 per timepiece acquired prior to the effective date of August 1, 2002 the effective date of this section ….[legislative reference bureau inserts date].
(d) (title) Self-luminous products containing tritium, krypton-85, or promethium-147
or radium-226.
SECTION 9. DHS 157.09 (2) (d) 4. is repealed.
SECTION 10. DHS 157.09 (2) (f) and (g) 3. are amended to read:
DHS 157.09 (2) (f) Resins containing scandium-46 and designed for sand-consolidation in oil wells. A person is exempt from this subchapter to the extent that the person receives, possesses, uses, transfers, owns or acquires synthetic plastic resins containing scandium-46 which are designed for sand consolidation in oil wells. These resins shall have been manufactured or initially transferred for sale or distribution under a specific license issued by the NRC, or shall have been manufactured under the specifications contained in a specific license issued by the department or any agreement state to the manufacturer of the resins under licensing requirements equivalent to those in 10 CFR 32.16 and 32.17. This exemption does not authorize the manufacture or initial transfer for sale or distribution of any resins containing scandium-46.
(g) 3. Any person who desires to manufacture, prepare, process, produce, package, repackage, or transfer for commercial distribution such capsules shall apply for and receive a specific license according to s. DHS 157.13 (4) (i)10 CFR 32.21.
SECTION 11. DHS 157.11 (2) (b) 3. b., c., g. and h. are amended to read:
DHS 157.11 (2) (b) 3. b. Ensure that the device is tested for leakage of radioactive material and proper operation of the “on-off" mechanism and indicator, if any, at no longer than 6-month intervals or at such other intervals as are specified in the label, except for devices containing only krypton, tritium, not more than 3.7 MBq (100 microcuries) of other beta and gamma-emitting material, or 0.37 MBq (10 microcuries) of alpha-emitting material, and devices held in storage in the original shipping container prior to the initial installation. Devices containing only krypton need not be tested for leakage of radioactive material.
c. Ensure that the tests required by this subd. par. b. and other testing, installation, servicing and removal from installation involving the radioactive material, its shielding or containment, are performed under the instructions provided by the labels, or by a person holding an applicable specific license from the department, the NRC, an agreement state or a licensing state to perform such activities.
g. Except as provided in subd. 3.h. pars. h. and j., transfer or dispose of the device containing radioactive material only by transfer to a specific licensee of the department, the NRC, an agreement state or a licensing state whose specific license authorizes that person to receive the device and within 30 calendar days after transfer of a device to a specific licensee or export of the device shall furnish to the department a written report containing identification of the device by manufacturer's or initial transferer's name and, model and serial number and, the name and
, address and license number of the person receiving the device, and the date of the transfer. No report is required if the device is transferred to the specific licensee to obtain a replacement device.
h. Transfer the device to another general licensee only where the device is held in storage in the original shipping container at its intended location of use prior to initial use by a general licensee, or where the device remains in use at a particular location. In the latter case, the transferor shall give the transferee a copy of sub. (2) (b) and any safety documents identified in the label on the device and within 30 calendar days of the transfer. The licensee shall report to the department the manufacturer's name and, model and serial number of device transferred, the name and address of the transferee, and the name, phone number and position of an individual who may constitute a point of contact between the department and the transferee.
SECTION 12. DHS 157.11 (2) (b) 3. j. to m. are created to read:
DHS 157.11
(2)
(b) 3. j. Not export the device containing byproduct material except as allowed under
10 CFR Part 110.
k. Respond to written requests from the department to provide information relating to the general license within 30 calendar days of the date of the request, or other time specified in the request. If the general licensee cannot provide the requested information within the allotted time, it shall, within the same time period, request in writing a longer time period and provide written justification why it cannot comply.
L. Appoint an individual responsible for having knowledge of the appropriate requirements of this chapter and the authority for taking required actions to comply with these requirements. The general licensee, through this individual, shall ensure the day-to-day compliance with the appropriate requirements of this chapter. This appointment does not relieve the general licensee of any of its responsibility under this chapter.
m. May not hold devices that are not in use for longer than 2 years. If devices with shutters are not being used, the shutter shall be locked in the closed position. The testing required under this subd. par. b. need not be performed during the period of storage only. When devices are put back into service or transferred to another person, and have not been tested within the required time interval, they shall be tested for leakage before use or transfer and the shutter tested before use. Devices kept in standby for future use are excluded from the two-year time limit if the general licensee performs quarterly physical inventories of these devices while they are in standby.
SECTION 13. DHS 157.11 (2) (b) 4. is amended to read:
DHS 157.11 (2) (b) 4. The general license under this paragraph does not authorize the manufacture or import of devices containing radioactive material.
