HB-5647, As Passed House, December 20, 2018
HB-5647, As Passed Senate, December 19, 2018
SUBSTITUTE FOR
HOUSE BILL NO. 5647
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 13521 (MCL 333.13521), as amended by 1989 PA
56, and by adding section 13527.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec. 13521. (1) The department shall promulgate rules
providing for general or specific licenses or registration, or
exemption from licensing or registration, for radioactive materials
and
other sources of ionizing radiation. The rules shall must
provide for amendment, suspension, or revocation of licenses. In
connection with those rules, subject to section 13527, the
department may promulgate rules to establish requirements for
record keeping, permissible levels of exposure, notification and
reports of accidents, protective measures, technical qualifications
of personnel, handling, transportation, storage, waste disposal,
posting and labeling of hazardous sources and areas, surveys, and
monitoring.
(2)
The rules shall must not limit the intentional exposure of
patients to radiation for the purpose of lawful therapy or research
conducted by licensed health professionals.
(3) The department shall promulgate rules specifying the
minimum training and performance standards for an individual using
a radiation machine for mammography as set forth in section 13523.
Sec. 13527. (1) A person shall not use a handheld dental X-ray
system to perform dental radiography unless the machine is
registered with the department under department rules for
registration of radiation machines and the system, the personnel
operating the system, and the facility in which the system is used
meet all of the following requirements:
(a) The system has been approved for human use by the United
States Food and Drug Administration and is used in a manner
consistent with that approval.
(b) The system has a backscatter shield that meets all of the
following requirements:
(i) The shield is composed of a leaded polymer or a lead-
equivalent substance that has a substantially equivalent protective
capacity.
(ii) The shield has at least 0.5 millimeters of lead or lead-
equivalent shielding, as determined by the department.
(iii) The shield is permanently affixed to the system.
(c) The system is calibrated by its manufacturer before its
House Bill No. 5647 as amended September 5, 2018
first use and is recalibrated at least every 24 months after the
date of the last calibration.
(d) 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.
(e) Each individual who operates the system is an individual
who is authorized to operate a dental radiography machine pursuant
to rules promulgated under part 166. An individual operating the
system is not required to wear a lead apron or other personal
monitoring equipment while operating the system if it is determined
that the use of the system is in compliance with part 381 of the
Michigan occupational safety and health administration occupational
health standards, R 325.60601a to R 325.60618 of the Michigan
Administrative Code[, or equivalent federal occupational safety and
health standards]; part 33 of the Michigan occupational safety
and health administration general industry safety and health
standard, R 408.13301 to R 408.13395g of the Michigan
Administrative Code[, or equivalent federal occupational safety and
health standards]; R 333.5057 of the Michigan Administrative
Code; and R 333.5063 to R 333.5065 of the Michigan Administrative
Code. Upon request, a registrant shall make a lead apron or other
personal monitoring equipment available to an individual who
operates the system.
(f) The system is not used if the backscatter shield described
in subdivision (b) is broken, missing, or malfunctioning.
(2) A handheld dental X-ray system that meets the requirements
described in this section may be used for routine dental
radiography in a dental office or a situation in which it is
impractical to transfer a patient to a radiation machine that is
stationary.
(3) As used in this section, "handheld dental X-ray system" or
"system" means an X-ray system that is used to take radiographs, is
designed to be handheld during its operation, and is portable.
Enacting section 1. This amendatory act takes effect 90 days
after the date it is enacted into law.