Disclaimer

This document is intended to assist regulated parties in understanding requirements under the Animals for Research Act (ARA) and its regulations. It is provided for information purposes only and does not constitute legal advice. In the event of any conflict between this document and applicable legislation, the legislation prevails. Regulated parties are responsible for ensuring compliance with all applicable legal requirements.

Why research and supply facilities are inspected

There are 2 main types of facilities overseen by the Ministry of Agriculture, Food and Agribusiness (OMAFA) related to the use of animals in research.

Research facilities are premises on which animals are used in research and includes institutions such as universities, hospitals or private research facilities that use animals for scientific, educational or testing purposes. They must be registered under the Act unless they fit within specific exemptions.

Supply facilities are premises, other than a research facility, that are used for the breeding and rearing of animals pursuant to a contract between the operator thereof and the operator of a research facility. They must be licensed under the Act.

Both facility types can be inspected to ensure that they are operated and maintained such that animals are sourced, cared for and used in accordance with provincial requirements. OMAFA administers the ARA and associated regulations through its inspection and compliance program.

Inspections and oversight:

  • monitors the humane care and use of animals in research
  • helps support facilities in improving already high standards of animal care
  • promotes compliance with legislation, guidelines and approved protocols
  • maintains public confidence in the ethical use of animals in science

Under this legislation, OMAFA-appointed inspectors, including a veterinarian appointed as chief inspector, are authorized to enter either facility type and assess compliance with the legislation and its regulations.

Guiding frameworks

OMAFA delivers inspection services in line with its Compliance Policy and Ontario’s Regulators’ Code of Practice. These frameworks guide how inspections are planned, carried out and communicated in a fair, consistent and risk‑based manner.

Inspectors are appointed under legislation which enables them to act in an official capacity. In addition to following the Regulators’ Code of Practice they adhere to the Public Service of Ontario Act, the Anti-Racism Act, 2017, the Ontario Human Rights Code, their oath of office, and relevant Ontario Public Service Directives.

This is how we ensure fair treatment, promote diversity and inclusion, and maintain a safe environment. The government has a leading role to play in eliminating systemic racism and ensuring a healthy and safe work environment for all Ontarians, including ministry staff. When a ministry staff member is working anywhere onsite, that location becomes their workplace where they must be safe and respected, free from racism, harassment and discrimination.

We are committed to promoting interactions that are inclusive and support dignity and respect. We expect that OMAFA staff will receive the same treatment from the businesses we regulate. Working together, we can build professional and respectful relationships and maintain positive outcomes for everyone.

Research facilities are responsible for maintaining a safe workplace in accordance with Ontario’s Occupational Health and Safety Act. While on site, inspectors must follow applicable workplace health and safety requirements to help ensure inspections are conducted safely.

Working together we can build professional and respectful relationships and maintain positive outcomes for everyone.

Animal care committees

The operator of every registered research facility must establish an animal care committee, as required under the Act. Animal care committees are responsible for the oversight of research at registered research facilities and for upholding high standards of care required under the legislation and will also have a formal approval requirement effective January 1, 2027. Every animal care committee must have at least 1 member who is a veterinarian.

The animal care committee’s role is to coordinate and review the registered research facility’s:

  • standards of care and facilities, equipment and materials for animals
  • training and qualifications of the personnel engaged in the care of animals at the facility
  • protocols for how animals will be used in research (added as a standalone requirement effective January 1, 2027)
  • procedures for the prevention of unnecessary pain including the use of anesthetics and analgesics
  • procedures related to the care of animals

Proposals for new research projects must be submitted to, reviewed and, effective January 1, 2027, approved by animal care committees before any research projects can be undertaken. The goal is to ensure alignment with legislative requirements as well as the facility’s own standards and protocols.

If the animal care committee believes any research may contravene section 16 of the ARA, it has the authority to make an order. Section 16 contains provisions related to requirements for anesthetics and analgesics. Effective January 1, 2027, the committee’s authority also applies to potential contraventions of section 15.1, which prohibits certain types of research unless the research is in compliance with requirements set out in subsection 14(1) of Regulation 22. In these circumstances, the committee may order that:

  • any research in connection with the offence or potential offence be stopped or does not proceed
  • an animal be humanely euthanized if the research has caused severe pain or illness that cannot be alleviated

Animal care committees are not a requirement for supply facilities, but standards of care and the humane treatment of animals is a requirement, and these and other requirements are reviewed by inspectors. Refer to the types of inspection section for greater detail on the types of things that are looked at during the course of inspection.

Prepare for inspections

Understand requirements and expectations

The ARA or its regulations set out the requirements for the lawful operation of animal research and supply facilities in Ontario.

OMAFA has tools, resources and support available to help the regulated community understand what it means to comply.

Research and supply facilities remain responsible for their own compliance and should review the Act and its regulations thoroughly and seek independent legal advice and support where needed to ensure all requirements are met.

For more information contact ARA.OMAFA@ontario.ca.

Maintain facility readiness and records

To support ongoing inspection activities, research and supply facility operators are expected to:

  • maintain a strong understanding of all aspects of facility operations (such as sanitation requirements, pest control, animal care and housing standards)
  • ensure applicable documentation such as animal use protocols, animal care committee meeting minutes or other relevant standard operating procedures are kept current and readily available if requested
  • always keep records organized, up to date, and accessible to support ongoing inspection activities

During the inspection

Inspectors appointed under the Act carry out inspections on behalf of OMAFA and are responsible for verifying compliance with regulatory requirements. Upon arrival, the inspector will identify themselves and provide proof of appointment, if requested. Failure to grant or deny entry to the facility or access to any information can be considered an obstruction of inspection, an offence under the Act.

During inspections, inspectors may:

  • monitor and assess compliance with applicable legislation and regulations
  • provide regulatory guidance and information
  • take appropriate compliance and enforcement actions to address risk and with an aim to prevent recurrence of future non-compliance
  • document inspection activities (which can include photographs or videos), findings and follow‑up actions

During an inspection, an inspector may examine any area of the registered research facility. The inspector may also review any documentation related to research that is being conducted or proposed to be conducted at a the facility. In addition, any documentation related to animals at a research facility or supply facility may be subject to inspection.

Effective January 1, 2027, regulatory changes clarified that inspectors can review documentation related to the research being conducted or proposed at a research facility. The specifics of the facility and the type of research activities and animals being used in research may influence areas of focus, as inspections are done using a risk-based approach tailored to the facility and the facility’s compliance history.

During inspections, operators of research and supply facilities should:

  • provide accurate and complete information to the inspector
  • seek clarification if anything is unclear
  • inform inspectors of any site-specific safety procedures

If an operator is unsure of an answer, they should do one of the following:

  • obtain and share the information from an appropriate source of documentation
  • indicate when and how a response will be provided

Types of inspections a facility may receive

OMAFA conducts different types of inspections depending on the facility type and circumstances, including:

  • planned general inspections scheduled using a risk‑based approach
  • unscheduled and unannounced general inspections using a risk-based approach 
  • inspections related to recent facility-based improvements such as renovations, or the construction of a new research or supply facility
  • inspections triggered by complaints, or referrals from other regulators

During any inspection, inspectors may address any observed non‑compliance within the scope of the legislation. Key areas of focus for the inspection may include, but are not limited to:

  • administration of the facility including:
    • training of personnel
    • documentation and records
    • animal care committee composition (research facility only)
  • research activities (research facility only) including:
    • standard operating procedures
    • animal sourcing requirements and records
    • ongoing documentation and monitoring
    • procedures and practices used during research including the appropriate use of analgesics and anesthetics, condition of animals, humane euthanasia practices
  • animal care including:
    • standard operating procedures
    • transportation of animals
    • animal health and health management
    • housing
    • ongoing observation and care of animals in the facility’s care
    • infection control programs
    • suitable ambient environment (temperature, humidity, lighting)
  • facility environment and maintenance including:
    • standard operating procedures and records
    • infrastructure and building materials
    • state of general repair and upkeep of the facility and where animals are housed and have access to
    • cleaning and sanitation practices
    • pest and vermin control

How OMAFA responds to non-compliance

When a non‑compliance is identified at a research or supply facility, inspectors use a progressive, risk‑based approach to address the issue. This approach prioritizes protection of animal welfare, while supporting compliance in a fair and proportionate way.

Inspectors may explain inspection findings that require corrective actions to the research and supply facility operators and document them through inspection reports or corrective action plans. The compliance response depends on factors such as:

  • the level of risk the non-compliance poses
  • the impact the non‑compliance has had on animal health and welfare
  • the facility’s compliance history

Inspectors apply compliance tools in a consistent, risk‑based manner to address issues, verify corrective actions, and prevent repeated non‑compliance.

Communication during the inspection

When non-compliance is identified, the inspector may:

  • discuss the inspection findings with the research or supply facility manager and/or animal care committee veterinarian where appropriate
  • explain the non-compliance and the required corrective actions
  • work with the research or supply facility operator to assign a corrective action date based on risk (for example, a high-risk non-compliance that may impact animal health and welfare could require remedy immediately or within a single business day, whereas a more minor infraction with a negligible impact on animal health and welfare may have a longer timeframe for corrective action)
  • explain next steps, potential consequences if compliance is not achieved, and appeal options (if applicable)

Research and supply facility operators are encouraged to ask questions or seek clarification at any time during the inspection.

The inspector shares the inspection report with the research or supply facility operator and includes the identified instances of non-compliance and the corrective action plan. They will document and link all instances of non-compliance identified during an inspection to the applicable legislative requirement and the compliance tool used to address the issue.

Clear and respectful communication between inspectors and operators is important. Open communication helps ensure expectations are understood, corrective actions are addressed and risks are managed effectively.

Animal care committee interventions

Registered research facilities in Ontario are overseen by animal care committees which include veterinary oversight and ensure that the use of animals in research projects is done in alignment with high standards for animal care.

Animal care committees play an important role in reducing risks due to non-compliance with legislative or regulatory requirements. The need to employ direct interventions during a well-planned and thoroughly reviewed and approved research project is rare due to the ongoing oversight of the animal care committees.

Animal care committees can:

  • review animal use protocols and research proposals and proposing amendments to the proposal to safeguard animal care and welfare prior to authorizing the project
  • order any research project to halt or be paused if non-compliance with section 16 or effective January 1, 2027 s.15.1 is seen or anticipated
  • order the euthanasia of animals, where necessary to humanely end undue suffering and pain

Compliance tools

Compliance tools are applied throughout the inspection process, documented in inspection reports and used progressively. OMAFA’s regulatory compliance toolbox includes both voluntary and mandatory compliance tools.

Voluntary compliance tools

Voluntary tools are often the first step when issues are identified and are used to support operators in achieving compliance.

These may include:

  • guidance and education to help operators understand and meet regulatory requirements
  • advisory or warning letters to formally document and bring attention to an issue that needs to be corrected within a specified time period

Mandatory compliance tools

OMAFA may decide to use mandatory tools set out in legislation when immediate action is needed due to a higher risk to animal care or welfare, or if issues are not corrected.

These may include a suspension or revocation of registration or licence. After a hearing, the director under the ARA may temporarily suspend or permanently revoke a research facilities registration or a supply facilities licence under the act when legal requirements are not met.

A suspension requires activities to stop while issues are being corrected, or further steps are taken.

A revocation or non-renewal ends the authority to operate a registered research facility until a new registration or licence is obtained.

Enforcement tools

If compliance is not achieved after available compliance tools have been used or if circumstances warrant it (for example, obstruction of an inspector, high risk non-compliance), the inspector may refer the matter for further enforcement action.

OMAFA’s Provincial Offences Officers may conduct inspections to verify compliance and/or investigations to determine if provincial offence charges are warranted as a mandatory enforcement tool.

Penalties under the ARA vary. Effective January 1, 2027, penalties for:

  • individuals found liable for specified offences include fines up to $75,000–$260,000 and/or imprisonment for a term of up to 6–24 months depending on if the offence is minor or major, and whether or not the offence is the first or a subsequent offence
  • corporations found liable of specified offences include fines up to $100,000–$1,000,000 depending on if the offence is minor or major and whether or not the offence is the first or a subsequent offence

Enforcement is key to building and maintaining a culture of compliance.