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4th Session, 40th Legislature

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Bill 37

THE RADIATION PROTECTION ACT


Table of Contents Bilingual version (PDF) Explanatory Note

(Assented to                                         )

HER MAJESTY, by and with the advice and consent of the Legislative Assembly of Manitoba, enacts as follows:

PART 1

INTRODUCTORY PROVISIONS

Purpose

1

The purpose of this Act is

(a) to regulate the installation, operation and maintenance of equipment that emits or detects ionizing radiation;

(b) to permit authorized persons to apply ionizing radiation; and

(c) to minimize unnecessary exposure to ionizing radiation and the risk of overexposure.

Definitions

2(1)

The following definitions apply in this Act.

"approval" means an approval issued for an ionizing radiation equipment location by the director under subsection 11(1) or (2) or that is amended under subsection 13(2). (« approbation »)

"court" means the Court of Queen's Bench. (« tribunal »)

"director" means a person appointed under section 4. (« directeur »)

"dosimeter registry" means the National Dose Registry or any other prescribed centralized system for maintaining dose records for ionizing radiation workers. (« fichier dosimétrique »)

"equipment", in relation to ionizing radiation equipment, includes any structure or other thing used to support or shield the equipment and any ancillary equipment, including imaging detectors, necessary for its operation or maintenance. (« appareil »)

"health-profession specific Act" means an Act listed in Schedule 2 of The Regulated Health Professions Act. (« loi régissant une profession de la santé individuelle »)

"inspector" means a person appointed under section 30. (« inspecteur »)

"ionizing radiation" means electromagnetic radiation that is capable of ionizing atoms. (« rayonnements ionisants »)

"ionizing radiation equipment" means equipment that is described in clause 3(1)(a). (« appareil réglementé »)

"ionizing radiation equipment location" means the place where ionizing radiation equipment is installed or operated. (« emplacement d'un appareil réglementé »)

"ionizing radiation operator" means a person who operates or controls the operation of ionizing radiation equipment. (« opérateur d'un appareil réglementé »)

"ionizing radiation worker" means a person, including an ionizing radiation operator, who regularly enters into an ionizing radiation equipment location while the equipment is in operation for work or training purposes. (« travailleur soumis aux rayonnements ionisants »)

"low-emission equipment" means equipment described in clause 3(1)(b). (« appareil à faible taux d'émission »)

"maximum dose limit" means a prescribed limit for the maximum dose of ionizing radiation to which a person — other than a patient or a non-patient subject — may be exposed. (« dose maximale »)

"minister" means the minister appointed by the Lieutenant Governor in Council to administer this Act. (« ministre »)

"non-patient subject" means an individual to whom ionizing radiation is applied for an educational or research purpose. (« personne se prêtant à des études »)

"overexposure" means overexposure as described in subsection 29(1) or (2). (« surexposition »)

"owner" includes a lessee, a person in charge, a person who has care and control, and a person who holds out as having the power and authority of ownership or who for the time being exercises the power and authority of ownership. (« propriétaire »)

"person" includes a partnership and any other organization or entity, whether incorporated or not. (« personne »)

"portable", in relation to ionizing radiation equipment, means equipment that a person can carry by hand to the place where it is to be operated, but does not include equipment that is mobile. (« portatif »)

"potential exposure area" means the area adjacent to an ionizing radiation equipment location, including above or below it, where there is a potential for exposure to ionizing radiation. (« zone à risque d'exposition »)

"prescribed" means prescribed by regulation.

"proposed location" means the place where ionizing radiation equipment is to be installed or operated. (« emplacement projeté »)

"radiation safety order" means an order issued under subsection 35(1). (« ordre en matière de radioprotection »)

Reference to "Act" includes regulations

2(2)

The term "this Act" includes regulations made under this Act.

Equipment covered by Act

3(1)

This Act applies to

(a) equipment whose main function is one or both of the following:

(i) to emit ionizing radiation within a prescribed energy range,

(ii) to detect ionizing radiation from medical radionuclides or other sources; and

(b) equipment that emits ionizing radiation within a prescribed energy range but not as its main function.

Exception

3(2)

Despite subsection (1), this Act does not apply to the following:

(a) equipment that produces X-rays or other ionizing radiation capable of inducing radioactivity in matter on which the radiation falls;

(b) low-emission equipment operated at less than the prescribed voltage or less than 5kV if no voltage is prescribed;

(c) any prescribed equipment.

Appointment of directors

4

The minister may appoint one or more persons as a director for the purpose of this Act.

PART 2

IONIZING RADIATION EQUIPMENT

REGISTRATION

Registration of equipment required

5(1)

A person must not operate ionizing radiation equipment, or cause it to be operated, unless the equipment is registered under this Act or exempt from being registered.

Exception for detecting equipment

5(2)

Subsection (1) does not apply to ionizing radiation equipment that meets both of the following criteria:

1.  The main function of the equipment is to detect ionizing radiation from medical radionuclides or other sources.

2.  The equipment itself does not emit ionizing radiation.

Application

6

To register ionizing radiation equipment, an owner of ionizing radiation equipment must submit the following information to the director:

(a) the owner's name and contact information;

(b) a description of the equipment;

(c) any additional information required by the director.

Director to register equipment

7(1)

After receiving a satisfactory application, the director must register the ionizing radiation equipment and notify the owner of that fact in writing.

Affix registration sticker

7(2)

If the director requires a registration sticker to be affixed to the ionizing radiation equipment or a notice of registration to be prominently posted where the equipment is to be installed, the owner must do so.

Prohibition — tampering

7(3)

A person must not

(a) deface or tamper with a registration sticker or a notice of registration; or

(b) remove, interfere with or change a registration sticker or a notice of registration without the approval of the director.

Effect of registration

7(4)

To avoid doubt, registration relates only to the ionizing radiation equipment and does not indicate approval of a location for its installation or operation or approval of any person to operate it.

Owner must notify director

8(1)

An owner of registered ionizing radiation equipment must notify the director within 30 days after either of the following occurs:

(a) he or she ceases to be the owner;

(b) the equipment is permanently taken out of service.

Director to cancel registration

8(2)

After being notified by the owner, the director must cancel the registration.

LOCATION

Prohibition — approval of location required

9(1)

A person must not install or operate ionizing radiation equipment unless it is in a location that is approved by the director or is exempt under subsection (3).

Temporary location must be approved

9(2)

Subsection (1) applies even if the ionizing radiation equipment is to be installed or operated on a temporary basis.

Exception for detecting or portable equipment

9(3)

Subsection (1) does not apply to ionizing radiation equipment that meets either of the following criteria:

1.  The main function of the equipment is to detect ionizing radiation from medical radionuclides or other sources, and the equipment itself does not emit ionizing radiation.

2.  The ionizing radiation equipment is portable.

How to apply for approval

10

To obtain an approval, an owner of ionizing radiation equipment must submit the following information to the director for each proposed location:

(a) the owner's name and contact information;

(b) the location where the owner proposes to install or operate the equipment;

(c) the name and contact information of the location's owner;

(d) the equipment or type of equipment to be installed or operated at the location;

(e) the purpose for which each type of equipment is intended to be used;

(f) any additional information required by the director or the regulations.

Director may approve location for installation or operation

11(1)

If satisfied that the ionizing radiation equipment specified in the application can be installed and operated in a manner that is safe and appropriate for its intended purpose at the proposed location, the director may issue an approval for that location.

Director may approve location for mobile equipment

11(2)

If satisfied that the mobile ionizing radiation equipment specified in the application can be operated in a manner that is safe and appropriate for its intended purpose at the proposed location, the director may issue an approval for that location.

Director may refuse to approve location

11(3)

If not satisfied that the ionizing radiation equipment can be installed and operated at the proposed location in a manner that is safe and appropriate for its intended purpose, the director must refuse to issue an approval for that location.

Director may refuse to approve location for mobile equipment

11(4)

If not satisfied that the mobile ionizing radiation equipment can be operated at the proposed location in a manner that is safe and appropriate for its intended purpose, the director must refuse to issue an approval for that location.

Written notice

11(5)

The director must provide written notice of his or her decision to the owner.

Reasons for refusal to be provided

11(6)

If the director refuses to approve a proposed location, the director must provide written reasons for the refusal to the applicant.

Effect of approval

11(7)

To avoid doubt, an approval relates only to the location for ionizing radiation equipment and receiving approval does not satisfy the requirement to register the equipment or indicate approval of any person to operate it.

Condition imposed on approval

12(1)

As a condition of an approval, the owner of the ionizing radiation equipment must notify the director within 14 days after either of the following occurs:

(a) there is a change to the shielding — other than a change initiated by the owner and for which approval under subsection 13(1) is required — that increases or may increase the exposure to ionizing radiation of any person present in the location or the potential exposure area;

(b) the owner becomes aware of a change to the occupancy or use of the potential exposure area.

The notice must contain and be accompanied by any information required by the director.

Conditions may be imposed by regulation and director

12(2)

An approval may also be subject to terms and conditions imposed by regulation and terms and conditions imposed by the director.

Owner must comply with approval

12(3)

An owner of ionizing radiation equipment must comply with the terms and conditions of an approval.

Prior approval of changes in equipment or to location

13(1)

An owner of ionizing radiation equipment must apply to the director to amend an approval before doing any of the following:

(a) changing the equipment in a manner that

(i) affects or may affect the dose of ionizing radiation received by a patient or the quality of a patient's images, or

(ii) increases or may increase the exposure to ionizing radiation of any person present in the location or the potential exposure area;

(b) replacing the equipment;

(c) installing or operating a different type of equipment from that which was approved for the location;

(d) installing or operating additional equipment from that which was approved for the location;

(e) changing the purpose for which the use of the equipment at a location was approved;

(f) removing shielding, adding additional shielding or changing the shielding in any manner;

(g) substantially altering the approved location.

Director may amend, refuse to amend or require new approval

13(2)

The director may issue an amended approval with terms and conditions, refuse to do so for any reason referred to in section 11, or require the owner to obtain a new approval under section 10.

Reasons to be provided

13(3)

If the director refuses to amend an approval, the director must provide written reasons for the refusal to the applicant.

Suspending, Cancelling or Changing the Approval

Director may suspend, cancel or change approval

14(1)

The director may, with written notice and reasons, suspend or cancel an approval or impose new or additional terms or conditions on it

(a) for any reason for which the director may refuse to issue an approval under section 11; or

(b) for the contravention of any provision of this Act or an approval.

Reinstatement

14(2)

The director may reinstate an approval that has been suspended or cancelled, with or without conditions. The director must give written notice of the reinstated approval to the owner.

RECONSIDERATION AND APPEAL

Reconsideration

15(1)

A person who is notified of a decision under subsection 11(3), 11(4), 13(2) or 14(1) may request that the director reconsider the decision. The request must be served on the director no later than 14 days after the person is given the notice.

Form of request

15(2)

A request must take the form of a written response to the decision, setting out the reasons why the director should reconsider the decision. The person may also request the director to stay the decision pending the reconsideration.

Immediate effect

15(3)

A decision made under section 11 or subsection 13(2) or 14(1) is effective immediately.

Stay of decision

15(4)

On request, the director may stay the decision or any part of it if the director finds it appropriate to do so after considering the circumstances, the written response and any risk, including an overexposure, to the health or safety of any person.

Decision on reconsideration

15(5)

After considering the request, the director may confirm, vary or rescind the decision. The director must give the person a copy of the decision, with written reasons.

Appeal

16(1)

Within 30 days after receiving a copy of the decision under subsection 15(5), a person may appeal the decision by filing a notice of appeal with the court and serving a copy on the director.

Director is party to appeal

16(2)

The director is a party to the appeal.

Court decision

16(3)

After hearing the appeal, the court may

(a) confirm the director's decision, quash it or vary it in any manner that the court considers appropriate; and

(b) make any other order that it considers appropriate.

OPERATION

Prohibition — operation contrary to Act

17(1)

A person must not operate ionizing radiation equipment in a manner that is inappropriate or unsafe for its intended purpose or is otherwise contrary to this Act.

Prohibition — operation of equipment believed to be unsafe

17(2)

A person must not operate ionizing radiation equipment that he or she has reason to believe is inappropriate or unsafe for its intended purpose.

Prohibition — creation of unsafe conditions

17(3)

A person must not engage in any activity, practice or conduct that causes the operation of ionizing radiation equipment to be inappropriate or unsafe for its intended purpose.

MAINTENANCE

Maintaining ionizing radiation equipment

18(1)

An owner of ionizing radiation equipment must maintain the equipment in a condition that

(a) allows the equipment to properly perform its intended function in a manner that is unlikely to cause an overexposure to any person; and

(b) does not increase the risk to the health or safety of any person present in the ionizing radiation equipment location or the potential exposure area.

Complying with standards

18(2)

An owner of ionizing radiation equipment must maintain it in compliance with any prescribed maintenance standards.

QUALITY ASSURANCE

Quality assurance program

19(1)

An owner of ionizing radiation equipment must implement a quality assurance program for the equipment if it is intended to be operated for a health care purpose, such as diagnosis, imaging or therapy.

Purpose of program

19(2)

The purpose of the quality assurance program is to ensure that results of satisfactory quality are obtained when the ionizing radiation equipment is operated for its intended purpose.

Requirement

19(3)

The owner must implement the quality assurance program in compliance with any program standards set out in the regulations.

EMERGENCY USE OF IONIZING RADIATION EQUIPMENT

Exception for emergency use

20(1)

During an emergency, a person may

(a) operate ionizing radiation equipment that is not registered under section 7; and

(b) install or operate ionizing radiation equipment in a location that does not have an approval.

Director must be notified

20(2)

The person must notify the director in writing as soon as practicable after installing or operating the ionizing radiation equipment for use during the emergency.

More information may be required

20(3)

The director may require the person to provide any additional information about the ionizing radiation equipment or its location or operation that the director considers necessary.

Application

20(4)

This section applies despite subsection 5(1) or 9(1).

LOW-EMISSION EQUIPMENT

Installation or operation requirements imposed by regulation

21(1)

An owner of low-emission equipment must not install or operate it except in accordance with the regulations.

Maintenance requirements imposed by regulation

21(2)

An owner of low-emission equipment must maintain it in accordance with the regulations.

PART 3

APPLICATION OF AND EXPOSURE TO

IONIZING RADIATION

Prohibition — applying radiation to humans

22(1)

A person must not apply ionizing radiation to a human unless the person is

(a) authorized or permitted to do so by or under The Regulated Health Professions Act or a health-profession specific Act;

(b) authorized to do so by or under a regulation under this Act authorizing the application of ionizing radiation to humans for an educational or research purpose; or

(c) authorized to do so by or under any federal or other provincial enactment.

Prohibition — applying radiation to animals

22(2)

A person must not apply ionizing radiation to an animal unless the person is

(a) licensed to practise veterinary medicine under The Veterinary Medical Act;

(b) authorized to do so by or under a regulation under this Act;

(c) authorized to do so by or under any federal or other provincial enactment; or

(d) acting under the supervision of a person described in clause (a), (b) or (c).

Prohibition — requiring another person to apply radiation

23

A person must not require another person to apply ionizing radiation to a human or animal if that other person is not authorized to apply it in accordance with section 22.

Limits of exposure to persons

24(1)

An ionizing radiation operator must ensure that exposure of persons to ionizing radiation is kept as low as is reasonably practicable given the circumstances of the procedure being performed.

Limits of exposure to workers

24(2)

An owner must ensure that exposure of ionizing radiation workers to ionizing radiation does not exceed any prescribed maximum dose limit.

Dosimeters to be provided to workers

25(1)

An owner of ionizing radiation equipment must provide a personal dosimeter that meets the prescribed requirements to each ionizing radiation worker.

Function of dosimeter

25(2)

The dosimeter's function is to monitor the ionizing radiation worker's occupational exposure to ionizing radiation.

Dosimeters to be worn by workers

25(3)

An ionizing radiation worker must wear a personal dosimeter

(a) whenever present in an ionizing radiation equipment location or a potential exposure area; and

(b) while working with ionizing radiation equipment, including while receiving training on the equipment.

Maintaining dosimeters

25(4)

An owner of ionizing radiation equipment must maintain each dosimeter, or cause it to be maintained, in a condition that allows the dosimeter to properly perform its intended function.

Owner must provide protective equipment

26(1)

An owner of ionizing radiation equipment must provide protective equipment to each ionizing radiation worker.

Operator must provide protective equipment

26(2)

An ionizing radiation operator must provide protective equipment to each patient or non-patient subject to whom ionizing radiation is applied if it is appropriate to the clinical condition of that person.

Function and examples

26(3)

The function of the protective equipment is to keep exposure to ionizing radiation as low as is reasonably practicable given the circumstances of the procedure being performed and may include, without limitation, a lead apron, lead thyroid shield or protective eyewear.

Maintaining protective equipment

26(4)

An owner of ionizing radiation equipment must maintain protective equipment in a condition that allows the protective equipment to properly perform its intended function.

Complying with standards

26(5)

An owner of ionizing radiation equipment must maintain protective equipment in compliance with any maintenance standards set out in the regulations.

Records and reports of radiation exposure — workers

27(1)

An owner of ionizing radiation equipment must, in accordance with the regulations,

(a) make and maintain records of each ionizing radiation worker's exposure to ionizing radiation based on the worker's dosimeter readings; and

(b) report, or cause to be reported, the dose records for each ionizing radiation worker to a dosimeter registry.

Records and reports to be made available to a worker

27(2)

On an ionizing radiation worker's request, an owner of ionizing radiation equipment must make the records and reports relating to that worker available to the worker.

Records of radiation exposure — patients

28

An owner of ionizing radiation equipment must, in accordance with the regulations, make and maintain records of each patient's exposure to ionizing radiation or cause them to be made and maintained.

Overexposure to radiation — persons subject to maximum exposure limits

29(1)

An overexposure to ionizing radiation occurs when a person for whom there is a maximum dose limit is exposed to ionizing radiation in an amount that exceeds the maximum dose limit.

Overexposure to radiation — patients and non-patient subjects

29(2)

An overexposure to ionizing radiation occurs when a patient or non-patient subject is

(a) exposed to ionizing radiation in an amount greater than the intended dose; or

(b) exposed unintentionally to ionizing radiation.

Director to be promptly notified of overexposure

29(3)

If an overexposure occurs, the owner of the ionizing radiation equipment must promptly notify the director in the manner provided for in the regulations about the time, place and nature of the overexposure.

Director or inspector may examine records

29(4)

After notifying the director, the owner must, on request by the director or an inspector, give access to all records about the circumstances of the exposure that the director or inspector requires for the purpose of determining the potential consequences of the overexposure to the person exposed.

Inspection of equipment

29(5)

After the director receives notice, an inspector must carry out an inspection of the ionizing radiation equipment under section 31 for the purpose of verifying or testing its operation.

PART 4

COMPLIANCE AND ENFORCEMENT

INSPECTORS

Appointment of inspectors

30(1)

The minister may appoint one or more persons or classes of persons as inspectors for the purpose of this Act.

Director has powers of inspector

30(2)

The director has all the powers of an inspector under this Act.

INSPECTIONS

General inspection powers

31(1)

An inspector may, at any reasonable time and when reasonably required to administer this Act or to determine compliance with it,

(a) enter and inspect any premises that the inspector believes on reasonable grounds

(i) contains equipment to which this Act applies,

(ii) is used or may be used for operating equipment to which this Act applies, or

(iii) contains records or images to which this Act applies;

(b) use or operate any equipment in or on the premises or require it to be used, operated, disconnected or uncovered under specific conditions;

(c) require any equipment to be produced for verification, testing or other examination;

(d) conduct any test, take any images or make any other examination of the premises or any equipment;

(e) open any container that the inspector believes on reasonable grounds contains any thing relevant to the inspection;

(f) require any person to provide information or produce any record for examination or copying;

(g) use any data storage, processing or retrieval device or system in or on the premises in order to produce a record in readable form;

(h) take photographs or videos or otherwise make a record of the premises or of any equipment in or on the premises; and

(i) take any other steps the inspector considers necessary.

Removing records to make copies

31(2)

If an inspector is unable to make copies of records at the premises being inspected, he or she may remove them. But the inspector must give a receipt to the person from whom they were taken and return the originals as soon as practicable.

Electronic records

31(3)

To inspect electronic records, an inspector may require the owner or person in charge of the premises or the records to produce them in the form of a printout or in an electronically readable format, or both.

Inspector may be accompanied by others

31(4)

An inspector may be accompanied by one or more persons who may assist the inspector in carrying out the inspection.

Assistance

31(5)

The owner of the premises or the equipment being inspected, or any person found on the premises or with the equipment, must

(a) give an inspector all reasonable assistance to enable the inspector to carry out the inspection;

(b) produce any equipment or thing that the inspector requires; and

(c) provide any information that the inspector requires.

Authority to enter private dwelling

31(6)

An inspector may not enter a private dwelling except with the consent of the owner or occupant or under the authority of a warrant.

Warrant for entry and inspection

32(1)

A justice, upon being satisfied by information on oath that

(a) an inspector has been refused entry to any premises or place to carry out an inspection under section 31; or

(b) there are reasonable grounds to believe that

(i) an inspector would be refused entry to any premises to carry out an inspection under section 31, or

(ii) if an inspector were to be refused entry to any premises to carry out an inspection under section 31, delaying the inspection in order to obtain a warrant on the basis of the refusal could be detrimental to the inspection;

may at any time issue a warrant authorizing an inspector and any other person named in the warrant to enter the premises and carry out an inspection.

Application without notice

32(2)

A warrant under this section may be issued upon application without notice.

Identification to be shown

33

An inspector carrying out an inspection under this Act must show his or her identification on request.

Obstruction

34

A person must not

(a) hinder, obstruct or interfere with an inspector carrying out an inspection;

(b) refuse to answer questions on matters relevant to an inspection;

(c) provide an inspector with information on matters relevant to an inspection that the person knows to be false or misleading; or

(d) withhold from an inspector, or alter or destroy, any document, record or thing that is relevant to an inspection.

RADIATION SAFETY ORDERS

Radiation safety order by inspector

35(1)

An inspector may issue a radiation safety order if he or she has reasonable grounds to believe that

(a) a person is contravening or has contravened the requirements of this Act or the terms and conditions of an approval issued under this Act;

(b) ionizing radiation equipment is being used in a manner that increases or could increase an exposure risk to any person in an ionizing radiation equipment location or a potential exposure area, or has been used in such a manner; or

(c) actions have or have not taken place in an ionizing radiation equipment location or a potential exposure area that increase or could increase

(i) an exposure risk to any person, or

(ii) any other risk to a person's health or safety.

To whom an order may be directed

35(2)

An order may be directed to one or more of the following persons:

(a) an owner of ionizing radiation equipment;

(b) an ionizing radiation operator;

(c) an owner of an ionizing radiation equipment location.

Order requirements

35(3)

An order must be in writing and must

(a) name the person to whom the order is directed;

(b) state the reasons for the order;

(c) specify the action to be taken, stopped or modified;

(d) specify the time period within which the person must comply with the order;

(e) state that the person may request a review of the order under section 37; and

(f) be dated the day that the order is issued.

Examples of specified actions

35(4)

Without limiting clause (3)(c), an order may specify one or more of the following actions:

(a) that the ionizing radiation equipment be shut down or disconnected from energy sources, or that activities or practices involving the equipment be stopped or modified;

(b) that the person investigate the operation of the ionizing radiation equipment or undertake tests, examinations, analyses or monitoring and report the results to the inspector or director;

(c) that the person repair, adjust or calibrate the ionizing radiation equipment;

(d) that the person install or repair shielding or make modifications to the ionizing radiation equipment location;

(e) that any other action be taken, stopped or modified if necessary to prevent, avoid or reduce a health or safety risk including an overexposure.

Order may contain terms and conditions

35(5)

An order may include any terms and conditions that the inspector considers appropriate including, without limitation, ordering the person to provide the inspector with information resulting from tests or other actions required by the order.

Oral order

35(6)

If the time necessary to put the order in writing is likely to significantly increase the health or safety risk — including the risk of an overexposure — the inspector may give the order orally. But the order must be confirmed in writing within 72 hours.

Inspector must give copy of order

35(7)

The inspector must give the person to whom the order is directed a copy of it.

Immediate effect

35(8)

An order, including an oral order, is effective immediately.

Compliance

36

A person to whom an order is given under section 35 must comply with it within the time period specified in the order.

Review may be requested

37(1)

A person to whom an inspector's order is directed may request the director to review it within 14 days after the person is given the order under section 35.

Written response

37(2)

A request for a review must take the form of a written response to the order, setting out the reasons why the director should vary or rescind the order. It may also contain a request that the director suspend all or part of the order under review pending the director's review decision.

Suspending the order

37(3)

On request, the director may suspend all or any part of the order under review if, after considering the health or safety risk, including the risk of an overexposure, it is appropriate to do so.

Director's decision

37(4)

On review, the director must consider the inspector's order and the written response and may

(a) confirm, vary or rescind the order; or

(b) allow additional time for the person to comply with the order, which may include attaching conditions to that compliance.

Director must give copy of decision

37(5)

The director must give the person who requested the review a copy of the decision, with written reasons.

Appeal

38(1)

Within 30 days after receiving a copy of the decision under subsection 37(5), the person who requested the review may appeal the decision by filing a notice of appeal with the court and serving a copy on the director.

Director is party to the appeal

38(2)

The director is a party to the appeal.

Decision of the court

38(3)

After hearing the appeal, the court may

(a) confirm the director's decision, quash it or vary it in any manner that the court considers appropriate; and

(b) make any other order that it considers appropriate.

Court-ordered compliance

39(1)

If a person fails to comply with an order and the order has not been rescinded on review or quashed on appeal, the director may apply to the court for an order directing compliance. The application may be made without notice or with notice if required by the court.

Order

39(2)

The court may order compliance on any conditions that the court considers necessary and may make any other order it considers necessary to ensure compliance.

No operation in contravention of an order

40

A person must not operate, or cause or permit the operation of, ionizing radiation equipment in contravention of a radiation safety order.

INJUNCTION

Injunction

41(1)

On application by the director, and on being satisfied that there is reason to believe that a person has done, is doing or is about to do anything that contravenes this Act, including, without limitation,

(a) operating ionizing radiation equipment that is not registered; or

(b) installing or operating ionizing radiation equipment in a location that is not approved;

the court may grant an injunction ordering the person to refrain from doing that thing.

Application without notice

41(2)

An injunction may be granted only if at least 48 hours' notice is given to each person named in the application unless the urgency of the situation is such that notice would not be in the public interest.

PART 5

INFORMATION SHARING

Definitions

42

The following definitions apply in this Part.

"government agency" means a government agency as defined in The Freedom of Information and Protection of Privacy Act. (« organisme gouvernemental »)

"government department" means a department, branch or office of the executive government of Manitoba. (« ministère »)

"information" includes personal information and personal health information. (« renseignements »)

"personal health information" means personal health information as defined in The Personal Health Information Act. (« renseignements médicaux personnels »)

"personal information" means personal information as defined in The Freedom of Information and Protection of Privacy Act. (« renseignements personnels »)

Minister and director

43(1)

For the purpose of administering or determining compliance with this Act, or for planning for or dealing with health or other issues relating to the installation or operation of equipment that emits or detects ionizing radiation or the application of ionizing radiation, the minister or director may disclose information to each other and to any of the following:

(a) an inspector;

(b) a government department or government agency;

(c) a regional health authority;

(d) CancerCare Manitoba;

(e) Diagnostic Services Manitoba Inc.;

(f) an owner of an ionizing radiation equipment location;

(g) a body that has statutory authority to regulate a health profession in Manitoba;

(h) any department or agency of the Government of Canada, or the government of another jurisdiction in Canada, that deals with health or radiation issues.

Inspectors

43(2)

For the purpose of administering or determining compliance with this Act, or for planning for or dealing with health or other issues relating to the installation or operation of equipment that emits or detects ionizing radiation or the application of ionizing radiation, an inspector may disclose information to the minister, the director or any other prescribed person.

Owners of ionizing radiation equipment

43(3)

An owner of ionizing radiation equipment may disclose information

(a) to a dosimeter registry for the purpose of clause 27(1)(b);

(b) to the director or an inspector as requested by either for the purpose of administering or determining compliance with this Act; or

(c) as otherwise required by this Act.

Director or inspector may disclose to health professional

43(4)

The director or an inspector may disclose information to a physician or other health professional for the purpose of providing information about the dose amounts that a person has or may have received and their potential health impacts.

Health professional may disclose to director or inspector

43(5)

A physician or other health professional may disclose information to the director or an inspector for the purpose of providing information about the dose amounts that a person received or may have received and their potential health impacts.

Limit on disclosure of information

43(6)

When disclosing information under this section, the following rules apply:

(a) information must be disclosed only if non-identifying information will not accomplish the purpose for which the information is disclosed;

(b) any information disclosed must be limited to the minimum amount necessary to accomplish the purpose for which the information is disclosed.

PART 6

GENERAL AND OTHER MATTERS

Forms

44

The director may approve forms, including electronic forms, for use under this Act and may require them to be used.

Conflict with workplace safety and health legislation

45(1)

If there is a conflict between this Act and The Workplace Safety and Health Act or a regulation under that Act, that Act or regulation prevails.

Act does not affect other laws

45(2)

Nothing in this Act affects the powers, duties and obligations of any person or body in respect of any other enactment.

Health professionals permitted to apply radiation

46(1)

For the purpose of clause 22(1)(a), a person is authorized or permitted by or under a health-profession specific Act to apply or require another person to apply ionizing radiation to a human if he or she is otherwise enabled by a governing body under the health-profession specific Act to do so.

Regulations

46(2)

The Lieutenant Governor in Council may make regulations respecting the application of ionizing radiation by persons or classes of persons described in subsection (1).

Crown bound

47

This Act binds the Crown.

Copies as evidence

48

A document certified by the director or an inspector to be a printout or copy of a record obtained under this Act

(a) is admissible in evidence without proof of the office or signature of the person purporting to have made the certificate; and

(b) has the same probative force as the original record.

Protection from liability

49

No action or proceeding may be brought against the minister, the director, an inspector, an employer of the director or an inspector, or any other person acting under the authority of this Act for anything done or omitted to be done, in good faith, in the exercise or intended exercise of a power or duty under this Act.

PART 7

OFFENCES AND PENALTIES

False or misleading statements

50

A person must not knowingly make a false or misleading statement in any application, record or report made or maintained under this Act.

Offences

51(1)

A person who does any of the following is guilty of an offence:

(a) contravenes a provision of this Act;

(b) contravenes a term or condition of an approval;

(c) fails to comply with a radiation safety order.

Liability of corporate officers and directors

51(2)

If a corporation is guilty of an offence, a director or officer of the corporation who authorized, permitted or acquiesced in the commission of the offence is also guilty of an offence, whether or not the corporation has been prosecuted or convicted.

Separate offence for each day

51(3)

When an offence referred to in subsection (1) continues for more than one day, the person is guilty of a separate offence for each day the offence continues.

Time limit for prosecution

52

A prosecution under this Act may be commenced within two years after the day the alleged offence was committed, but not afterwards.

Penalties

53

A person who is guilty of an offence is liable on summary conviction

(a) in the case of an individual, to a fine of not more than $50,000 or imprisonment for a term not exceeding six months, or both; and

(b) in the case of a corporation, to a fine of not more than $500,000.

Additional order to comply

54

If a person is found guilty of an offence under clause 51(1)(c), the court may, in addition to imposing a fine or imprisonment, order the person to comply with the radiation safety order within the time period specified by the court.

PART 8

REGULATIONS

Regulations

55(1)

The Lieutenant Governor in Council may make regulations

(a) for the purpose of subclause 3(1)(a)(i) or clause 3(1)(b), prescribing an energy range;

(b) for the purpose of clause 3(2)(b), prescribing voltage;

(c) for the purpose of clause 3(2)(c), prescribing equipment to which this Act does not apply;

(d) governing, restricting or prohibiting the installation or operation of ionizing radiation equipment, including,

(i) for the purpose of clause 10(f), prescribing additional information to be included in an application for an approval, and

(ii) for the purpose of subsection 12(2), prescribing terms and conditions to be imposed on an approval;

(e) for the purpose of section 21, respecting installation, operation and maintenance of low-emission equipment;

(f) authorizing persons to apply ionizing radiation

(i) to humans for educational or research purposes for the purpose of clause 22(1)(b), or

(ii) to animals for the purpose of clause 22(2)(b);

(g) respecting the application of ionizing radiation to any matter or thing other than humans or animals;

(h) respecting maximum dose limits for ionizing radiation, other than ionizing radiation applied to patients or non-patient subjects;

(i) respecting limits on exposure of ionizing radiation workers to ionizing radiation in more than one occupational setting;

(j) respecting the monitoring of exposure of ionizing radiation workers to ionizing radiation, including

(i) recordkeeping, and

(ii) reporting radiation doses to a dosimeter registry;

(k) establishing and respecting standards for the maintenance of ionizing radiation equipment and protective equipment;

(l) establishing and respecting standards for quality assurance programs for ionizing radiation equipment operated for a health care purpose;

(m) exempting a person or class of persons from any or all of the requirements of sections 25 (dosimeters), 27 (worker exposure records and reports) and 28 (patient exposure records) and imposing terms and conditions on any exemption;

(n) respecting the manner of giving or serving any notice, order or other document under this Act and specifying the time at which it is deemed to have been given or served;

(o) exempting ionizing radiation equipment or locations or potential exposure areas from the application of this Act or any provision of it and imposing terms and conditions on any exemption;

(p) prescribing fees that may be charged under this Act or the manner of determining them;

(q) requiring the payment of fees and permitting the waiver and refund of fees;

(r) extending, limiting or modifying the definition "portable" in relation to ionizing radiation equipment;

(s) defining any word or expression used but not defined in this Act;

(t) prescribing anything referred to in this Act as being prescribed;

(u) respecting any matter that the Lieutenant Governor in Council considers necessary or advisable to carry out the purpose of this Act.

Application of regulations

55(2)

A regulation made under subsection (1) may be general or particular in its application and may apply to one or more classes of persons, equipment or locations, and to the whole or any part of the province.

Adopting codes, standards and other regulations

55(3)

The power to make a regulation under subsection (1) may be exercised by adopting by reference, in whole or in part, a code, standard or regulation made by any other government, or a code or standard made by a non-governmental body.

Changes

55(4)

The code, standard or regulation may be adopted as amended from time to time and subject to any changes that the Lieutenant Governor in Council considers necessary.

PART 9

TRANSITIONAL PROVISIONS AND

CONSEQUENTIAL AMENDMENT

TRANSITIONAL PROVISIONS "Former regulation" defined

56

In this Part, "former regulation" means the X-Ray Safety Regulation, Manitoba Regulation 341/88 R.

Registration of X-ray equipment continued

57

X-ray equipment for which a registration under section 12 of the former regulation was in place on the day before the coming into force of this section is deemed to be registered by the director under subsection 7(1).

Approval of permanent location continued

58

An owner of an X-ray machine installed or used in a permanent location who held an approval under section 13 of the former regulation on the day before the coming into force of this section is deemed to hold an approval for that location issued by the director under subsection 11(1).

Grace period applies for registration or approval

59

If an owner of ionizing radiation equipment that is required to be registered or that is installed or operated in a location requiring an approval submits the information required under section 6 or 10, as the case may be, within 30 days after the coming into force of this section, subsections 5(1) and 9(1) do not apply until a decision on the registration or approval is made.

CONSEQUENTIAL AMENDMENT

Consequential amendment, Manitoba Regulation 16/95

60

Section 4 of the Diagnostic Laboratories Regulation, Manitoba Regulation 16/95 made under The Health Services Insurance Act, is amended by striking out "the X-Ray Safety Regulation under The Public Health Act" and substituting "The Radiation Protection Act".

PART 10

REPEAL, C.C.S.M. REFERENCE

AND COMING INTO FORCE

Manitoba Regulation 341/88 R repealed

61

The X-Ray Safety Regulation, Manitoba Regulation 341/88 R, is repealed.

C.C.S.M. reference

62

This Act may be referred to as chapter R5 of the Continuing Consolidation of the Statutes of Manitoba.

Coming into force

63

This Act comes into force on a day to be fixed by proclamation.

Explanatory Note

This Bill regulates the installation, operation and maintenance of equipment that emits or detects ionizing radiation. Ionizing radiation equipment to which the Bill applies includes X-ray machines, PET scanners and CT scanners.

The key provisions of the Bill are as follows:

Equipment registration

Ionizing radiation equipment, other than certain equipment such as a stand-alone PET scanner, must be registered with the director appointed under the Act before it may be operated.

Location approval

Ionizing radiation equipment, other than portable equipment and certain other equipment, may be installed or operated only in locations approved by the director. In considering an approval, the director must determine whether the equipment is appropriate for its intended use at the location and can be safely operated there.

Maintenance and quality assurance

Owners of ionizing radiation equipment must maintain the equipment to specified safety standards and, if the equipment is used for health care purposes, must implement quality assurance programs.

Application and exposure

Ionizing radiation must not be applied to a human or an animal unless the person applying it is authorized to do so.

Maximum exposure limits for persons who work with ionizing radiation equipment may be set by regulation. Owners must keep records of workers' exposures and provide the records to a central registry.

If a person receives an excessive or unintended exposure to radiation, the owner of the ionizing radiation equipment must notify the director.

Inspection and enforcement powers

Inspectors may inspect ionizing radiation equipment and locations where it is used. They may also issue radiation safety orders to owners or operators of equipment if there is a health or safety risk or a failure to comply with the Act.

Other matters

Some radiation equipment, such as high-energy linear accelerators, are federally regulated and so are not regulated under the Act. As well, low-voltage equipment that emits only a small amount of radiation incidental to its main purpose, such as low-voltage vacuum tubes, is not subject to the Act's requirements.

This Bill repeals the X-Ray Safety Regulation and amends the Diagnostic Laboratories Regulation.