Act No. 544

Public Acts of 2018

Approved by the Governor

December 27, 2018

Filed with the Secretary of State

December 28, 2018

EFFECTIVE DATE: March 28, 2019

STATE OF MICHIGAN

99TH LEGISLATURE

REGULAR SESSION OF 2018

Introduced by Reps. Frederick, Lucido, Leutheuser, Sneller, Canfield and Liberati

ENROLLED HOUSE BILL No. 5647

AN ACT to amend 1978 PA 368, entitled “An act to protect and promote the public health; to codify, revise, consolidate, classify, and add to the laws relating to public health; to provide for the prevention and control of diseases and disabilities; to provide for the classification, administration, regulation, financing, and maintenance of personal, environmental, and other health services and activities; to create or continue, and prescribe the powers and duties of, departments, boards, commissions, councils, committees, task forces, and other agencies; to prescribe the powers and duties of governmental entities and officials; to regulate occupations, facilities, and agencies affecting the public health; to regulate health maintenance organizations and certain third party administrators and insurers; to provide for the imposition of a regulatory fee; to provide for the levy of taxes against certain health facilities or agencies; to promote the efficient and economical delivery of health care services, to provide for the appropriate utilization of health care facilities and services, and to provide for the closure of hospitals or consolidation of hospitals or services; to provide for the collection and use of data and information; to provide for the transfer of property; to provide certain immunity from liability; to regulate and prohibit the sale and offering for sale of drug paraphernalia under certain circumstances; to provide for the implementation of federal law; to provide for penalties and remedies; to provide for sanctions for violations of this act and local ordinances; to provide for an appropriation and supplements; to repeal certain acts and parts of acts; to repeal certain parts of this act; and to repeal certain parts of this act on specific dates,” 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 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 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 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.

This act is ordered to take immediate effect.

Clerk of the House of Representatives

Secretary of the Senate

Approved

Governor