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Health Canada's Regulatory Stock Review Plan, 2024 to 2027

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About the Regulatory Stock Review Plan

The Regulatory Stock Review Plan is a public list of planned reviews of regulations that Health Canada is proposing within a 3-year period. It is intended to give people in Canada, including businesses, Indigenous Peoples and international partners, greater opportunity to participate in the reviews of regulations and to plan for the future.

The plan is based on:

Health Canada adjusts and updates the plan every year to reflect our regulatory priorities and changes to how we and our stakeholders operate.

Learn more:

The stock review plan identifies a departmental contact person for the planned reviews. Those who wish to provide comments on a specific review may contact the responsible branch by using the information listed.

Completed reviews

Consumer Chemicals and Containers Regulations, 2001 (CCCR, 2001)

Enabling act(s)

Canada Consumer Product Safety Act

Rationale

The Consumer Chemicals and Containers Regulations, 2001 help protect people in Canada from certain acute health and physical hazards posed by consumer chemical products, such as cleaning products, adhesives and lubricants.

A review of the regulations revealed that they do not include requirements that help mitigate the risks of certain hazards of concern, such as carcinogens, mutagens and reproductive toxicants. Our review considered potential new requirements for hazards of concern to:

  • enhance protections for people in Canada
  • help support the Government of Canada's commitment to introduce mandatory labelling of chemicals in consumer products

Date of last review or amendment

Substantial amendments were made in 2009 to clarify requirements and correct editorial errors.

Additional amendments in 2011 account for the coming into force of the Canada Consumer Product Safety Act.

Stakeholder feedback

We issued a notice of intent to interested parties on July 11, 2023, followed by a 101-day public comment period.

A total of 40 stakeholders provided their feedback on the notice, including:

  • industry stakeholders
  • regulatory consultants
  • labour unions
  • medical professionals
  • non-governmental organizations
  • members of the public

Most stakeholders supported the need to label the identified hazards of concern on consumer chemical products.

We received a variety of comments on considering risk when determining labelling requirements. They encouraged closer alignment with the United States and supported using a risk-based globally harmonized system to classify consumer chemical products.

Most stakeholders also recommended that we consider additional protections, such as prohibitions, restrictions or child-resistant container requirements, for certain hazards of concern in consumer chemical products.

Outcomes

The review is complete.

We are reviewing stakeholder feedback on the notice of intent before developing a regulatory proposal.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Email the departmental contact for more information.

Departmental contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Tents Regulations

Enabling act(s)

Canada Consumer Product Safety Act

Rationale

A review of the Tents Regulations revealed a need to replace the flammability and labelling requirements with a national standard that the Canadian General Standards Board (CGSB) developed.

Modern tents made of synthetic materials are less flammable than traditional cotton canvas tents, but they're not fireproof. The proposed amendments to the regulations would continue to protect people in Canada from injuries and deaths caused by tent fires.

The following item from Health Canada's Forward Regulatory Plan is a result of this review:

Date of last review or amendment

Internal review completed in 2017.

No significant updates have been made since the regulations came into force in 1988.

Stakeholder feedback

We published a notice to interested parties on January 22, 2019, followed by a 60-day public comment period.

People in Canada were also invited to provide technical comments on the draft of CAN/CGSB-182.1 to the CGSB.

In general, respondents supported:

  • replacing the current fire safety labelling and flammability performance requirements in the Tents Regulations with those in the national standard
  • requiring fire safety labelling and flammability requirements for indoor play tents that do not provide outdoor shelter in the Toys Regulations

Outcomes

The review is complete.

We published the Tents Regulations in Canada Gazette, Part I on June 17, 2023, followed by a 70-day public comment period. We plan to publish the amended regulations in the Canada Gazette, Part II in fall 2024.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Email the department contact for more information.

Departmental contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Toys Regulations

Enabling act(s)

Canada Consumer Product Safety Act

Rationale

A review of the Toys Regulations revealed that there are some existing requirements that are obsolete or need to be updated, such as the prohibition of boric acid or salts of boric acid.

As a result of the review, we are proposing to amend the Toys Regulations to provide better protection to children from chemical and toxicological hazards when they play with toys.

We are also proposing to reduce or eliminate the need for animal testing in the regulations, where other methods exist.

The amendments would add new requirements for hazards that are not addressed by the regulations, such as those that:

  • set maximum allowable limits for certain harmful elements in parts of toys that are accessible to a child
  • offer greater safety in finger paints
  • concern liquids, pastes, putties, gels, powders and items containing bird feathers

The requirements will align with international standards, such as the:

The following item from our Forward Regulatory Plan is a result of this review:

Date of last review or amendment

Minor amendments for surface coating materials made in 2022.

Stakeholder feedback

We published a notice of intent to interested parties on June 2023, followed by a 90-day public comment period. A total of 12 stakeholders provided feedback, including:

  • industry stakeholders
  • regulatory consultants
  • governmental organizations
  • consumer interest groups
  • members of the public

Most stakeholders supported:

  • amending the toxicity, corrosivity, irritation and sensitization requirements to reduce or eliminate animal testing for toys
  • adding requirements for finger paints, microbiological contamination of certain toys and chemical toys (sets) other than experimental sets

They also agreed that additional requirements should align with international toy safety standards to reduce technical barriers to trade.

Outcomes

The review is complete.

We are reviewing stakeholder feedback on the notice before developing a regulatory proposal.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Email the departmental contact for more information.

Departmental contact

Geoff Barrett
Director
Consumer and Hazardous Products Safety Directorate
Healthy Environments and Consumer Safety Branch
Email: ccpsa-lcspc@hc-sc.gc.ca

Modernization of Regulations for Controlled Substances

Enabling act(s)

Controlled Drugs and Substances Act

Rationale

The Canadian legislative and regulatory framework for controlled substances has evolved over decades to address emerging issues and meet international commitments under the United Nations' drug control conventions.

The result are regulations that are similar but feature some gaps and inconsistencies. This has caused challenges for those administering and complying with these regulations and prompted us to review the regulations.

A review of the regulations for controlled substances resulted in the following item being added to our Forward Regulatory Plan:

Date of last review or amendment

We amended the regulatory provisions for licences and permits that came into force in December 2019.

Stakeholder feedback

We have consulted stakeholders on a series of notices of intent related to certain portions of this regulatory proposal since 2017. These 3 notices were published in Canada Gazette, Part I for a 60-day public comment period:

The feedback we received has generally been positive.

Stakeholders will be able to review and comment on the regulatory proposal during the 60-day consultation period once the proposal is published in Canada Gazette, Part I.

Outcomes

The review is complete. We are planning to publish the regulatory proposal in Canada Gazette, Part I in spring 2024.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Consult:

Departmental contact

Jennifer Pelley
Director
Office of Legislative and Regulatory Affairs
Controlled Substances and Overdose Response Directorate
Controlled Substances and Cannabis Branch
Email: csd.regulatory.policy-politique.reglementaire.dsc@hc-sc.gc.ca

Modernizing Clinical Trials Regulations

Enabling act(s)

Food and Drugs Act

Rationale

As part of the 2018 Targeted Regulatory Reviews, we participated in the Health and Biosciences Sector Regulatory Review Roadmap to address issues and barriers to innovation and economic growth that were identified by stakeholders. This review identified the need to modernize how clinical trials are conducted in Canada by amending the:

The proposed amendments:

  • may help ensure that Canada remains an attractive place to conduct clinical trials, while continuing to uphold high standards for protecting the health and safety of participants
  • introduce a coherent risk-based approach to the regulation of clinical trials in Canada
  • afford greater flexibility in the safe development of innovative therapies and products, and innovative clinical trials design
  • streamline regulatory processes to achieve greater efficiency and clarity
  • align with international best practices on clinical trial oversight and public access to information

This regulatory initiative will be completed in multiple phases, with the first phase focusing on amendments that concern drugs.

The following item from our Forward Regulatory Plan is a result of this review:

Dates of last review or amendment

Stakeholder feedback

We consulted stakeholders in 2019. They said a flexible framework for clinical trials would attract key companies and investments, and support research and innovation in Canada.

The proposed regulatory approach is similar to the approach in the Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. A 2020 consultation found that stakeholders generally supported the proposal to transition the interim order into regulations.

In spring 2021, we launched 2 related and parallel consultations.

For the first consultation, we sought feedback on the modernization of the clinical trial framework for drugs, devices and natural health products. Stakeholders provided 122 written submissions and close to 1,000 stakeholders participated in 8 interactive webinar sessions. We published a report on these spring and summer 2021 consultations on February 23, 2022.

For the second consultation, we sought feedback on regulations to authorize and conduct human clinical trials in Canada for foods for a special dietary purpose. Stakeholders provided 5 written responses and participated in an interactive webinar to clarify questions. We published a summary of this consultation on February 23, 2022.

In winter/spring 2023, we held a consultation to seek further stakeholder feedback on the registration of clinical trials and public disclosure of results.

Outcome

This review is complete.

The various consultations with stakeholders confirm the need to update the clinical trial regulatory framework.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Consult:

Consult:

Departmental contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Modernizing Drug Establishment Licensing Framework including the recall of drugs

Enabling act(s)

Food and Drugs Act

Rationale

As part of the 2018 Targeted Regulatory Reviews, we participated in the Health and Biosciences Sector Regulatory Review Roadmap to address issues and barriers to innovation and economic growth that were identified by stakeholders. This review identified the need to modernize our framework for drug establishment licensing (DEL) and resulted in proposed regulatory amendments. We expect the amendments would make the licensing process for DELs more efficient and predictable. This would give industry stakeholders an opportunity to streamline their compliance programs.

This work will be done in 2 phases.

Phase 1 amendments will take a more agile, risk-based approach to compliance and enforcement of drugs, and reduce regulatory and administrative burden, for:

  • items on DEL
  • good manufacturing practices
  • recall reporting

Proposed phase 1 amendments will:

  • clarify reporting requirements for voluntary recalls
  • establish reporting requirements for Minister-ordered recalls
  • replace the outdated list of regulatory authorities who participate in mutual recognition agreements with a list incorporated by reference
    • to allow industry to benefit from Canada's international cooperation efforts

Proposed phase 2 amendments would:

  • reduce the burden associated with annual licence review
  • modernize provisions for using compliance and enforcement tools, such as terms and conditions and suspensions
  • continue to modernize licensing requirements to enable access to innovative health products while maintaining oversight over health and safety risks

The following item from our Forward Regulatory Plan is a result of this review:

Additional notes

For regulatory consistency, we will make the phase 1 amendments to the Food and Drug Regulations at the same time as the phase 1 amendments to the Medical Devices Regulations. These amendments are part of the initiative to modernize medical device establishment licensing (MDEL).

Dates of last review or amendment

2018, 2021 and 2022

Stakeholder feedback

First, we consulted drug and medical device establishment licence holders between April and June 2019.

Then, we consulted industry stakeholders on this proposal between December 2021 and February 2022. We issued a 60-day notice of intent and cost-benefit analysis survey at this time.

In general, industry stakeholders supported the proposal. One industry stakeholder association was concerned about including additional reporting requirements in the regulations. They want to continue to rely on guidance when it comes to establishing timelines for submitting certain information and documents to Health Canada.

Everyone who commented supported our proposal to clarify the reporting timelines in the regulations (for instance, 24 hours from having made the decision to recall).

We also met with drug manufacturers and importers to better understand the challenges they have in complying with the finished product testing requirements.

One stakeholder wanted us to expand the conditional exemption from finished product testing to other products. This was out of scope of the current analysis and policy objective. We will, however, continue to assess how we can reduce burden and barriers and improve access to drug products.

On April 15, 2023, the proposed phase 1 amendments were pre-published in Canada Gazette, Part I, followed by a 75-day public comment period.

A total of 46 stakeholders provided feedback on the proposal. In general, they supported the proposal.

We expect that additional phase 2 consultations will begin in winter/spring 2025 with the prepublication of proposed regulations in Canada Gazette, Part I. A 75-day public comment period would follow.

Outcome

The review is complete.

We published the following regulations in Canada Gazette, Part I on April 15, 2023, followed by a 75-day public comment period:

  • Regulations Amending the Food and Drug Regulations
  • Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)

Final publication of Phase 1 amendments in Canada Gazette, Part II is anticipated for spring 2024.

We are targeting a Canada Gazette, Part I pre-publication date for phase 2 in winter/spring 2025.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Consult:

Departmental contact

Jillian Andrews
A/Associate Director, Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Modernizing Medical Device Establishment Licensing Framework including the recall of medical devices

Enabling act(s)

Food and Drugs Act

Rationale

As part of the 2018 Targeted Regulatory Reviews, we participated in the Health and Biosciences Sector Regulatory Review Roadmap to address issues and barriers to innovation and economic growth that were identified by stakeholders. This review identified the need to modernize our modernize the framework for MDELs. The work will take place in 2 phases. Our goal is to:

  • create a level playing field with other jurisdictions for Canada's medical device sector
  • improve the predictability and efficiency of recalls for industry
  • reduce the burden on industry when reporting low-risk issues for medical devices
  • extend regulatory oversight to facilities distributing safe medical devices to global markets

Phase 1 began in spring 2023. The proposed amendments to the Medical Devices Regulations would improve and modernize the regulatory oversight of medical devices in Canada.

Amendments would:

  • modernize the MDEL application requirements to reflect existing practices
  • give the Minister the ability to issue terms and conditions on a MDEL to mitigate risks to health and safety and target non-compliance
  • establish a regulatory framework for recalling medical devices ordered by the Minister
  • update the definition for recalls
  • clarify industry-reporting obligations

We are targeting phase 2 for winter/spring 2025. The proposed amendments to the Medical Devices Regulations would:

  • improve and modernize the regulatory oversight of the medical devices supply chain in Canada by
    • clarifying uncertainties around importation introduced into the regulations from the last round of amendments
    • improving the enforceability of standard operating procedure requirements to manage health and safety risks of medical devices sold in Canada

The following item from our Forward Regulatory Plan is a result of this review:

Additional notes

For regulatory consistency, we will be making the phase 1 amendments to the Medical Devices Regulations at the same time as the phase 1 amendments to the Food and Drug Regulations. These are part of the initiative to modernize the DEL framework.

Dates of last review or amendment

2018, 2021 and 2022

Targeted start for review

2020

Stakeholder feedback

We consulted:

  • industry and other stakeholders in 2016
  • DEL and MDEL holders between April and June 2019

On December 11, 2021, we informed stakeholders of the proposed policy direction by publishing a notice of intent in Canada Gazette, Part I. A 60-day public comment period followed.

We held stakeholder consultations with MDEL holders in fall 2021 and winter 2022 on phase 1 of this proposal. More than 100 stakeholders completed the cost-benefit analysis survey and participated in the consultation. In general, stakeholders supported the proposal.

On April 15, 2023, the proposed amendments were pre-published in Canada Gazette, Part I, followed by a 75-day public comment period.

A total of 46 stakeholders took part in the consultations and, in general, supported the proposal.

Outcome

The review is complete.

We published the following proposal in Canada Gazette, Part I on April 15, 2023:

  • Regulations Amending the Food and Drug Regulations and the Medical Devices Regulations (Recalls, Establishment Licences and Finished Product Testing)

Final publication of phase 1 amendments in Canada Gazette, Part II is expected for spring 2024.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Departmental contact

Jillian Andrews
A/Associate Director, Compliance Policy and Regulatory Affairs Division
Policy and Regulatory Strategies Directorate
Regulatory Operations and Enforcement Branch
Email: prsd-questionsdspr@hc-sc.gc.ca

Self-Care Framework

Enabling act(s)

Food and Drugs Act

Rationale

As part of the 2018 targeted regulatory reviews, we participated in the Health and Biosciences Sector Regulatory Review Roadmap. The goal of this review was to address issues and barriers to innovation and economic growth that were identified by stakeholders.

The review identified the need to introduce a risk-based approach to regulatory oversight for self-care products to the Natural Health Products Regulations and Food and Drug Regulations. As this regulatory proposal is significant, we will be undertaking the amendments in separate regulatory proposals.

We plan to modernize the Natural Health Products Regulations by creating a risk-based categorization structure and enhanced pre-market quality review. We would also be:

  • identifying marketed products through annual notices
  • strengthening the requirements for good manufacturing practices
  • introducing a risk-based site-licensing program

We plan to amend the Food and Drug Regulations to develop expedited pathways for lower-risk non-prescription drug products. This approach would include:

  • a class-based licensing system
  • appropriate pharmacovigilance requirements
  • establishment licensing that is in keeping with the risk of these products

These proposed amendments would address many recommendations made in the 2021 audit by the Commissioner of the Environment and Sustainable Development.

We identified this regulatory initiative in the Health and Biosciences Sector Regulatory Review Roadmap.

The following item from the Forward Regulatory Plan is a result of this review:

Date of last review or amendment

Stakeholder feedback

Since the fall of 2016, we held a series of public consultations on modernizing our approach to regulating self-care products.

For summaries of these consultations, refer to:

After publishing proposed amendments in Canada Gazette, Part I on June 26, 2021, we received 139 stakeholder submissions. These submissions represented a wide range of views on the regulatory amendments to improve the labelling of natural health products.

Outcomes

We completed the following part of the initiative:

  • published the Regulations Amending the Natural Health Products Regulations in Canada Gazette, Part II on July 6, 2022

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Consult:

Departmental contact

Bruno Rodrigue
Executive Director
Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Email: lrm.consultations-mlr@hc-sc.gc.ca

Regulations Amending the Radiation Emitting Devices Regulations (Laser Products)

Enabling act(s)

Radiation Emitting Devices Act

Rationale

A review of the Radiation Emitting Devices Regulations identified the need to amend the regulations to address health risks and injuries to people in Canada from lasers.

The amendments will align Canada's regulations with the following international standard that Canada's key trading partners use and reference:

The following item from the Forward Regulatory Plan is a result of this review:

Date of last review or amendment

The Radiation Emitting Devices Regulations are made up of a series of parts related to different devices:

Stakeholder feedback

People in Canada provided comments on the regulatory proposal during a public consultation in summer 2021 and during the Canada Gazette, Part I public comment period.

We received 23 responses during the 75-day public comment period from businesses, academia, trade associations, organizations and the public.

In general, stakeholders supported the proposal to update the regulations and to align laser product requirements with those of the IEC standard.

Some stakeholders provided comments on aspects of laser safety that were outside of the scope of the proposal or the federal mandate. Industry had concerns about the clarity of exemptions and specific aspects of labelling and information requirements.

Outcome

The review is complete.

We published the Regulations Amending the Radiation Emitting Devices Regulations (Laser Products) in Canada Gazette, Part I on July 1, 2023, followed by a 75-day public comment period.

We plan to publish the Regulations Amending the Radiation Emitting Devices Regulations (Laser Products) in Canada Gazette, Part II in fall 2024.

We will report any further regulatory proposals as a result of this review in the Forward Regulatory Plan.

For more information

Email the departmental contact for more information.

Departmental contact

Tara Bower
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Email: hc.erhsdgeneral-dssergenerale.sc@canada.ca

Ongoing reviews

Regulations Amending the Formaldehyde Emissions from Composite Wood Products Regulations

Enabling act(s)

Canadian Environmental Protection Act, 1999

Rationale

A review of the Formaldehyde Emissions from Composite Wood Products Regulations indicated the need to amend the regulations, specifically those relating to the quality control testing requirements and record-keeping provisions.

The following item from our Forward Regulatory Plan is a result of this review:

Narrative

We are proposing to amend section 17 of the formaldehyde emissions regulations to:

  • clarify the quality control testing requirements
  • review the declaration of certification record-keeping provisions

Review process

People in Canada provided comments on the proposed regulatory amendment during the 75-day Canada Gazette, Part I public comment period, which ended on August 31, 2023. We are holding discussions with key stakeholders to further clarify the comments received.

Date of last review or amendment

The Formaldehyde Emissions from Composite Wood Products Regulations have not been amended since being published in Canada Gazette, Part II on July 7, 2021.

Stakeholder feedback

After we published the Formaldehyde Emissions from Composite Wood Products Regulations, stakeholders said:

  • the requirement that manufacturer testing be conducted by an accredited laboratory is more onerous than necessary and not feasible for manufacturers
  • record-keeping requirements for declarations of certification are very complex and burdensome, especially for importers and retailers of finished goods

For more information

Email the departmental contact for more information.

Departmental contact

Andrew Beck
Director
Risk Management Bureau
Safe Environments Directorate
Healthy Environments and Consumer Safety Branch
Email: formaldehyde-formaldehyde@hc-sc.gc.ca

Pest Control Products Regulations

Enabling act(s)

Pest Control Products Act

Rationale

We are conducting the first comprehensive review of the Pest Control Products Regulations since they came into force in 2006.

We developed a multi-year plan to review the Pest Control Products Regulations in 2016. We want to:

  • ensure that the regulations are current and reflect the Pest Control Products Act, taking into account the statutory review of the act
  • ensure the regulations continue to meet policy objectives, while attempting to minimize unnecessary regulatory burden, if any, on regulatory parties
  • provide recommendations on policy, program and regulatory actions required to address identified issues

This review includes the following initiatives, which we identified in the Agri-food and Aquaculture Sector Regulatory Review Roadmap. Our goal is to modernize:

  • labels for pest control products to:
    • present information on labels consistently
    • permit the use of electronic labels and align with globally harmonized system standards
    • improve the readability of labels
  • the authorization process for certain pest control products for which registration is not required to:
    • update the current list of products that are exempt from registration under the Pest Control Products Act
  • exclusive rights and data compensation for pest control products to:
    • clarify for regulated parties how the data compensation program works in the post-market context
  • the post-market review process for pest control products to:
    • build a stronger, effective and efficient pesticide regulatory program that better protects human health and the environment
    • reduce regulatory burden on regulated parties

The following regulations from the Forward Regulatory Plan are a result of this review:

Narrative

This regulatory modernization initiative is ongoing.

For the proposal to modernize the authorization process for certain pest control products for which registration is not required, we:

  • removed sodium bromide and potassium monopersulfate from Schedule 2 of the regulations
  • will leverage the principles and policy used to come up with an approach to modernize authorization processes to ensure that any effort is in proportion to a pesticide's risk level
    • policy is a larger part of the PMRA's efforts to modernize its business approach

For the project to modernize the post-market review process for pest control products, we:

  • made policy changes
    • for example, implemented new internal processes to track key information for each pesticide active ingredient
  • planned or launched pilots, which will help us finalize our policy
    • implementing all project elements in a phased approach from 2024 to 2027
  • amended some application and importation requirements for pest control products in Canada
    • this completes certain aspects of our review of "pre-market" provisions in the regulations

We have completed our review of exclusive rights and data compensation for pest control products and amended the regulations.

Date of last review or amendment

As part of the review, we amended the regulations in 2023. We clarified for regulated parties how the data compensation program works in the post-market context.

Stakeholder feedback

We engaged stakeholders on each of these initiatives through:

We will use this feedback when we amend the regulations.

We published a regulatory proposal document outlining our proposed amendments to the Pest Control Products Regulations (Research) on December 16, 2022. The public comment period was open for 45 days.

The document proposed amendments to the research provisions in the regulations. We are reviewing the comments, which will be used when we develop the final proposal.

For the project to modernize the post-market review process for pest control products, we:

  • consulted stakeholders from across Canada on proposed changes to the pesticide evaluation program starting in February 2020
    • will use this feedback to help us modernize the post-market review process for pest control products
  • continued to consult with key stakeholders in 2023 as part of the Pest Management Regulatory Agency (PMRA) transformation agenda
    • sought feedback on plans to implement a lifecycle and proportional effort approach and to improve transparency

The draft policy on continuous oversight was published on January 3, 2024, for a 60-day consultation period.

The draft policy on proportional effort will be published in late spring/early summer 2024.

For more information

Consult:

Agency contact

Jordan Hancey
Director
Policy and Operations Directorate
Pest Management Regulatory Agency
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Radiation Emitting Devices Regulations pertaining to Ultrasound Therapy Devices

Enabling act(s)

Radiation Emitting Devices Act

Rationale

We are reviewing Schedule II, Part XIII of the regulations that concern ultrasound therapy devices to support ongoing health and safety protections for people in Canada. We also want to look at the impacts on stakeholders.

Narrative

We are reviewing the regulations to:

  • identify requirements that no longer apply due to advancement in ultrasound technologies
  • identify and mitigate any potential unintended impacts, such as barriers to trade or innovation
  • verify alignment with international equipment safety standards
    • for example, those of the International Electrotechnical Commission
  • identify opportunities to reduce regulatory burden on stakeholders

Date of last review or amendment

1984

Targeted start for review

2023

For more information

Email the departmental contact for more information.

Departmental contact

Narine Martel
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca

Proposed new reviews

Pest Control Products Fees and Charges Regulations

Enabling act(s)

Pest Control Products Act

Rationale

The Pest Control Products Fees and Charges Regulations came into force in 2017. They replaced fee regulations that came into force in 1997.

Under our cost recovery policy, we are to review fee regimes at least every 5 years. To that end, we are in the process of reviewing the fee regime set out in these regulations.

Narrative

We are using a phased approach for our review, with the first phase focusing on the post-market fees paid by registrants.

An analysis of the current post-market fee structure for pest control products indicates that fees do not reflect the costs for post-market regulatory activities. Thus, taxpayers are assuming an increasing economic burden. We anticipate that the proposed amendments would help sustain our activities and better reflect the private benefits derived from our regulatory services. We will consider feedback from the consultation period when developing a regulatory proposal.

We plan to publish a proposal in Canada Gazette, Part I for formal public consultation in fall 2024 before finalizing and implementing the fees.

For the second phase, we are reviewing pre-market fees and modernizing our business practices. This will be done when we introduce new processes in early 2024.

Our target date for consulting on the proposed fee changes is 2027 to 2028.

Date of last review or amendment

Last amended in 2018.

Targeted start for review

2023

For more information

Email the departmental contact for more information.

Agency contact

Lars Juergensen
Associate Director
Program Renewal Directorate
Pest Management Regulatory Agency
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Strengthening the Regulation of Pest Control Products in Canada

Enabling act(s)

Pest Control Products Act

Rationale

In response to the spring 2022 consultations on the targeted review of the Pest Control Products Act, we have proposed amendments to the Pest Control Products Regulations. The proposed amendments would make the federal pesticide regulatory system more transparent and protect the environment from risks posed by pesticides.

Narrative

In their feedback on the targeted legislative review, stakeholders provided feedback on:

  • accessing confidential test data
  • being transparent around maximum residue limit applications
  • considering the cumulative effects on the environment and species at risk in risk assessments

In response to the feedback we received, we published a notice of intent on June 20, 2023, and held an informational webinar on July 25, 2023. The notice was open for comments until September 8, 2023.

We held another webinar on December 11, 2023, on our:

  • proposal to implement confidential test data and
  • approach to the cost-benefit analysis

The notice of intent focused on:

  • facilitating access to confidential test data, including for research and re-analysis purposes
  • increasing transparency for maximum residue limit applications for imported food products
  • giving the Minister the explicit authority to require the submission of available information on cumulative environmental effects that have a common mechanism of toxicity
  • requiring the Minister to consider cumulative effects on the environment during risk assessments where information and methodology are available
  • strengthening consideration of species at risk by giving the Minister the explicit authority to require the submission of available information on species at risk

The objectives of the proposed amendments are to improve transparency and better protect the environment, including wildlife, from risks posed by pest control products in Canada. We will consider the feedback we receive when developing a regulatory proposal, which is targeting publication in the Canada Gazette, Part I in spring 2024.

Date of last review or amendment

2016

Targeted start for review

2022

For more information

Email the departmental contact for more information.

Agency contact

Jordan Hancey
Director
Policy and Regulatory Affairs Division
Pest Management Regulatory Agency
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

Radiation Emitting Devices Regulations pertaining to Photofluorographic X-ray Equipment and Diagnostic X-ray Equipment

Enabling act(s)

Radiation Emitting Devices Act

Rationale

We are planning to review Schedule II, Part VI (on photofluorographic x-ray equipment) and Part XII (on diagnostic X-ray equipment) of the Radiation Emitting Devices Regulations. We want to:

  • assess their ongoing effectiveness in protecting the health and safety of people in Canada
  • consider their impacts on industry stakeholders

Photofluorographic X-ray equipment is used mainly to examine the human chest and view the X-ray on a fluorescent screen. It was originally used to screen people for tuberculosis but has been replaced by more modern equipment.

Narrative

We will review the regulations to:

  • identify requirements that no longer apply due to advanced X-ray technologies
  • identify and mitigate any potential unintended impacts, such as barriers to trade or innovation
  • verify that Canada's standards align with international equipment safety standards
    • for example, those of the International Electrotechnical Commission
  • identify ways we can reduce the regulatory burden on stakeholders

We will be seeking feedback from stakeholders on the proposed regulatory option.

Date of last review or amendment

Part VI was last amended in 1979.

Part XII was last amended substantively in 2001. Minor amendments were made in 2006 through the miscellaneous amendment regulations process.

Targeted start for review

2024

For more information

Email the departmental contact for more information.

Departmental contact

Narine Martel
Director
Environmental and Radiation Health Sciences Directorate
Healthy Environments and Consumer Safety Branch
Email: erhsdgeneral-dssergenerale@hc-sc.gc.ca

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