If your workplace owns or is about to acquire an X-ray device in Ontario, you will likely need to register it with the Ministry of Labour, Immigration, Training, and Skills Development (MLITSD) under Regulation 861 (X-Ray Safety) of the Occupational Health and Safety Act. The registration is done through form on00057, submitted along with a floor plan of the X-ray location.
The application is not complicated, but it leaves little room for error. Mistakes can mean delays, requests for clarification from the reviewer, or even an invalid registration. This post outlines common errors and how to avoid them.
First, does this apply to you?
A quick note on jurisdiction. X-ray sources operating above 1 MeV fall under the Canadian Nuclear Safety Commission, not the province. If the maximum photon energy of the device is below 5,000 electron volts, it does not meet Ontario’s definition of X-rays and Regulation 861 does not apply. In Ontario, registration for devices under 1 MeV used in the diagnosis or treatment of human beings is with the Ministry of Health, as specified in the Healing Arts Radiation Protection (HARP) Act. For other applications of X-rays under 1 MeV in Ontario, including industrial, research, veterinary, security, and training uses, registration with the MLITSD is required.
Treat Form ON00057 like a legal document
Because it is one. Every piece of information you enter should be as accurate as possible, and this mindset prevents most of the errors below.
Get the names right, and in the right boxes. Ensure names are spelled correctly.Also, the form asks for last name first, then first name. People often do not notice, so it is common to accidentally reverse them. If errors such as these happen, the approval will be issued to someone with names that are incorrect, which means the business does not have proper approval for its X-ray source.
Write names out in full. Do not use short forms or abbreviations for the employer, business, or responsible person, even if the full name is long. A name discrepancy between the application and the actual business identity could put the validity of the approval in dispute. The same names should match exactly across the form and the floor plan.
Know the difference between the business address and the X-ray facility address. The applicant information in Section 1 reflects ownership of the registration. The facility address, entered later in the form, is where the X-ray source will actually be located. A head office registering a device for a satellite site would enter two different addresses. The form has a checkbox for if they are one and the same.
Check the attestation box. This is the smallest error on this list and possibly the most common. The e-signature section includes a checkbox confirming that you are the employer or authorized to submit on the employer’s behalf. If the box is missed, the form is not considered signed, and an unsigned form is an unfinished one.
Answer every required field. Every entry box marked with a red star needs a response. If an exact value is not known, provide a reasonable estimate, making protective assumptions where there is uncertainty.
Make the most of the form’s helpful features
A few sections deserve special attention because they can work in your favour.
Applicant notes to reviewer. This optional section is a good place to give context: a special setup, a minor revision to an existing approval, or anything else that helps a reviewer understand the situation. A couple of sentences here can prevent a round of questions later.
Occupancy tables. The form provides default occupancy rates for typical adjacent spaces. An occupancy rate is how often a space is occupied during operating hours, averaged over a year. You might spend a whole afternoon in a parking lot once, but averaged across the year, the default is 2.5%. If an adjacent space does not match its default rate, whether higher or lower, note it in the alternate occupancy section. These rates feed directly into dose estimates for the people around the X-ray room, so accuracy here is important.
Workload. The form asks for the anticipated maximum workload in milliampere-minutes per week: maximum current multiplied by time per exposure multiplied by exposures per week, divided by 60. Think ahead here. Operation of the equipment is only permitted up to the workload stated in the form, so if the facility is expected to grow, consider stating a workload with some leeway built in. If the approved workload for your application is lower than a possible future workload, a full re-application will be required. Do note that a structural change in the x-ray room construction itself, such as a renovation, will require a re-application regardless.
Attachments. The floor plan can be attached directly to the form, along with anything else that helps: equipment manuals, control procedures, or an expanded layout of the facility. Reviewers only have these documents to work from, and anything that clarifies the picture helps them review properly.
The floor plan: where most applications stumble
Regulation 861 sets minimum requirements for the plan drawings, and every one of them matters. The floor plan must:
- Be a legible scale drawing at 1:100 or greater (between 1:1 and 1:100, not 1:200)
- Bear the name of the applicant and the address of the X-ray location
- Accurately indicate the direction north
- Show the proposed location of the X-ray source and, where applicable, its range of motion
- Show the location of the control panel, if separate from the source
- Indicate the use of all adjacent rooms and areas, both horizontally and vertically
- Indicate the type and thickness of shielding on the boundaries of the location
- Indicate safety devices such as warning lights, interlocks, and cut-off switches
These are minimum requirements. Submitters are encouraged to go beyond them with any additional information that may help a reviewer understand the setup. Errors to avoid include:
Vague or missing adjacent spaces. All adjacent spaces need to be specified: north, east, south, west, above, and below, even when the answer is as simple as “roof above” or “ground below.” Above and below are the ones most often forgotten. You may know there is nothing up there, and the reviewer may suspect it too, but if it is not on the plan, the plan is incomplete.
Missing units and unspecified materials. A wall labelled “25 drywall” is a problem: 25 what? A reviewer cannot assume it means millimetres just because another wall says so. Similarly, a door labelled “metal” is not enough, because steel, aluminum, and lead behave very differently as shielding. Every barrier needs a material and a thickness with units: walls, doors, windows, ceiling, and floor. If the contents of a barrier are unknown, they can be left out, but understand that the reviewer will then assume the barrier contains no useful shielding at all.
Ambiguous drawings. A single dot in the middle of a room will not be assumed to be a fixed X-ray source. An unlabelled blue line on a wall could be a window or a door. A “switch” could be a light switch, a power switch, or the exposure switch. Reviewers are not on site, and they will not assume anything. It is up to the submitter to make everything explicit. Label the exposure switch as an exposure switch, mark the source and its travel limits clearly, and identify every opening.
Inaccurate north arrows. The north direction should match compass north as closely as possible. If an inspector later cannot map the X-ray room against the plan because of a wrong north arrow, the application may need to be updated or resubmitted.
No dimensions or scale reference. Room dimensions and a scale reference line are not explicitly required. Without them, however, a reviewer may need to request additional information to confirm that the drawing is properly to scale.
Hand-drawn plans. We advise against them. If a hand drawing is the only option, be extra meticulous with scale descriptions and proper formatting. A sketch on the back of a napkin is not acceptable for review.
Exposure switch placement. Where the operator does not need to be inside the room during exposure, the switch should be positioned so the operator is shielded: behind a wall or barrier, and outside the room where possible. The switch operator should never be directly exposed to the source.
Room access control. For dental X-ray machines in particular, the Ministry’s policy is that all entryways to the X-ray room should be controlled by interlock or by visual control from the switch operator. More broadly, think through how each opening to the X-ray room is safely controlled. Where a control procedure is relied on to limit occupancy of an adjacent space, outline clearly how that is achieved. A procedurally controlled area depends on a human factor, which is more prone to failure than engineered shielding that would have to be physically removed to cause a problem.
A note on portable and mobile X-rays
If the source is portable or mobile and used that way, floor plans are not applicable. Instead, written notice must be given to the Ministry including the employer’s name, address, and registration number (if any); where the device will be stored; the purpose for which it will be used; and the make, model, serial number, maximum operating voltage, and maximum operating current. Mobile setups often require a solution tailored to the specific case, so have detailed information ready about every room where the machine may be used, because the Ministry will likely request it.
Four habits of a clean submission
Review your work. Ten minutes spent checking the form and floor plan before submission can save days of revisions during review, or even a future reapplication.
Provide detail. The Ministry evaluates the X-ray source based on the form and floor plan alone. Reviewers are not on site and do not run the machine. Anything vague invites clarification requests, delay, or rejection that a clear picture would have avoided.
Plan ahead. Even a perfect application takes time to process, as the Ministry handles a very large volume of applications each year. Apply well before the installation date so any required changes can be made before construction starts or at least before it finishes. Nobody wants to rip out an installed wall because it was found to be lacking. Also, if there is any later change to the installation or use of the X-ray source, the use of adjacent rooms or areas, or the shielding that may increase a worker’s exposure to X-rays, the X-ray source cannot be used until the change has been reviewed by and is acceptable to an inspector. Planning ahead can prevent headaches later.
Respond to everything. If a reviewer reaches out with questions, answer all of them to the best of your ability, even those that seem unusual or unnecessary. They are usually asking because something in the application is unclear or could indicate a violation, and unanswered questions only stall the approval.
Resources
The Government of Ontario provides information on registration and guidance for the application form on its website, with form on00057 linked from that page. The Radiation Safety Institute of Canada also offers detailed application support on our website, including a guidance document, training video, a free learning course, and free X-ray safety templates for Regulation 861.
For questions on this or any radiation safety topic, our toll-free information service supports employers, workers, and the public on both ionizing and non-ionizing radiation safety: 1-800-263-5803 or info@radiationsafety.ca.
The material provided here is general information, not legal advice. We take no responsibility or liability in the application of this content. The content is correct for Ontario, Canada at the time of writing.
