New Rules Effective May 25, 2016

The Legislative Service Bureau submitted the proposed rules to the Joint Committee on Administration Rules (JCAR) on March 23, 2016, along with a report summarizing the changes made following the public hearing. The JCAR had 15 legislative session days to meet and object. The JCAR did not object to the rules and they were filed with the Great Seal on May 25, 2016.and became effective immediately.

Public Hearing

A public hearing on the proposed rules was held on September 17, 2015. Verbal comments were received from five attendees. Written comments were received prior to and during the public hearing. A summary of the comments including the Department's responses is available in the Summary of Public Comment.

Subsequent to the public hearing the rules promulgation proceeded as follows:

  • The department created a new draft of the rules to address the comments received. The new draft was submitted to the Office of Regulatory Reinvention (ORR).
  • The ORR reviewed all the changes and certified the new draft.
  • The ORR submitted the draft to the Legislative Service Bureau (LSB) who certified the rules for form, classification, and arrangement.

The Department has prepared a table providing a rule by rule comparison of the previous rules and the new rules governing radiation machines.

Background
Executive Reorganization Orders 1996-1 and 1996-2 split the authority for the regulation of radioactive materials and the regulation of radiation machines between the Department of Environmental Quality (DEQ) and the Department of Consumer and Industry Services, which now is the Department of Licensing and Regulatory Affairs (LARA). The administrative rules which governed the use of these two ionizing radiation sources, however, was contained in a single rule set with the machine and material rules intertwined (R 325.5001 - 325.5721).

The previous rule set was promulgated in 1975 and had not been significantly changed since that time, except for registration changes made in 1979 and the subsequent additions of Part 14 - Mammography in 1993 (later revised in 2013) and Part 15 - Computed Tomography Installations in 2011. This rulemaking was intended to create a separate rule set for radiation machines (R 333.5001 - 333.5721).

Highlights of Changes
Since the main point of this rulemaking was to establish a rule set governing radiation machines only, most of the rules were simply translated to the new rule space (i.e. R 325.5xxx to R 333.5xxx) with little or no change. Rule parts dealing with general topics radiation safety are the most revised. The previously applicable parts 1 (General Provisions), 4 (Registration of Radiation Machines), and 5 (Standards For Protection Against Radiation) have been replaced by parts 1 (General Provisions For the Use of Radiations Machines), 2 (Registration of Radiation Machines), 3 (Standards For Protection Against Radiation for Users of Radiation Machines), and 4 (Notices, Instructions and Reports To Workers; Inspections For Users of Radiation Machines). The draft versions of these rules received stakeholder input during the agreement state effort of 2007 to 2009. Much of the requirements and language of the new rules had an equivalent in the old rules, although there have been changes. The new standards for protection and registration rules were founded on the Suggested State Regulations of the Conference of Radiation Control Program Directors and received input from an advisory committee of interested stakeholders. Some of the major differences in these parts include:

  • Removal of language referring to radioactive material
  • Removal of many definitions
  • Use of SI units
  • Low power electron microscopes are exempted from registration
  • A rule was added requiring shielding plan reviews
  • Dose limits are changed to be consistent with current national standards, including a separate dose limit for the lens of the eye and the elimination of quarterly limits
  • The dose limit for members of the public is reduced to 1 mSv

Part 6 (Industrial Radiographic Operations and Installations) contains the same requirements as the prior set however the order of the rules has been changed to more clearly distinguish the requirements for class D installations from the other classes of industrial radiographic installations. The definitions of "radiographer" and "radiographer's assistant" now clearly apply to only class D operations. Some of the language has been modified to match the current State of Michigan style guide and references to radioactive material are gone.

Parts 7 through 15 are essentially the same as the previous rules. Most of the requirements are unchanged other than an update of language. Some notable differences from these parts are:

  • Removal of references to the NFPA and national electric codes
  • Allowances for lower standards for machines manufactured prior to 1975 are removed
  • The requirement for measurement of cineradiography rates is changed from quarterly to annually
  • The appendices in part 7 providing recommended shielding are removed and the reader is referred to the Department's web page
  • There are no requirements pertinent to the control of radioactive material in part 11
  • There is a new subrule exempting low power electron microscopes from the rules
  • The most recent medical physicist's report is added to the list of items to be included in a mammography machine authorization application
  • A new rule states that stereotactic breast biopsy machines shall be maintained in compliance with the FDA performance standards

Questions or comments concerning this information should be sent to T.R. Wentworth at wentwortht@michigan.gov.

Last update: 6/6/2016



Related Documents
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