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To amend existing rules to allow for the routine use of handheld devices. The rule would prohibit
the use of a handheld dental X-ray system to perform dental radiography unless the machine is
registered and the system, personnel operating the system, and facility in which the system is
being used to meet all of the following requirements:
-The system has been approved for human use by the U.S. Food and Drug Administration (FDA)
and is used consistently with the approval.
-The system has a backscatter shield that meets all of the following requirements:
-The shield is composed of a leaded polymer or a lead-equivalent substance that has a
substantially equivalent protective capacity.
-The shield is permanently affixed to the system.
-The system is certified by its manufacturer before its first use and is calibrated at least every 24
months after the date of the last certification.
-When not in use, the system is stored in a manner that restricts access to the system, such as by
storing the system in a locked area of the facility.
(An individual using the machine need not use a lead apron or other personal monitoring
equipment, but that equipment must be available for use.)
-The equipment may not be used if the backscatter shield described above is broken.
The proposed changes are a result of legislative change.
8. Please cite the specific promulgation authority for the rules (i.e. department director,
commission, board, etc.).
The department has the authority to promulgate rules, The Public Health Code 368 PA 1978, MCL
333.13521.
A. Please list all applicable statutory references (MCLs, Executive Orders, etc.).
The Public Health Code, 1978 PA 368, Part 135, MCL 333.13515, MCL 333.13521, MCL
333.13522, and MCL 333.13527. Executive Reorganization Order Nos. 1996-1, 1996-2, 2003-1,
and 2019-3, being MCL 330.3101, MCL 445.2001, MCL 445.2011, MCL 445.2030, and MCL
125.1998.
B. Are the rules mandated by any applicable constitutional or statutory provision? If so, please
explain.
The Public Health Code, 1978 PA 368, MCL 333.13521.
9. Please describe the extent to which the rules conflict with or duplicate similar rules,
compliance requirements, or other standards adopted at the state, regional, or federal level.
MIOSHA is not aware of any conflict or duplication.
10. Is the subject matter of the rules currently contained in any guideline, handbook, manual,
instructional bulletin, form with instructions, or operational memoranda?
None that MIOSHA is aware of.
11. Are the rules listed on the department’s annual regulatory plan as rules to be processed
for the current year?
Yes
12. Will the proposed rules be promulgated under Section 44 of the Administrative Procedures
Act, 1969 PA 306, MCL 24.244, or under the full rulemaking process?
MCL 24.244 (1)
A. Explain why the rules are being promulgated under 24.244.
MCL 24.239