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.