Canada Gazette, Part I, Volume 158, Number 24: Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada)

June 15, 2024

Statutory authority
Pest Control Products Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Issues

Over the years, Parliament, stakeholders, independent researchers, the Commissioner of the Environment and Sustainable Development, and the public as well as Health Canada’s Pest Management Regulatory Agency (PMRA) have suggested ways to modernize the review processes for pest control products to support sustainability.

The PMRA established a transformation process following the Government of Canada’s August 4, 2021, announcement, which highlighted that Health Canada would begin a targeted review of specific provisions of the Pest Control Products Act (PCPA) to strengthen the PMRA’s oversight and protection of human health and the environment, and to increase transparency in the regulation of pesticides. This commitment aligns with the Minister of Health’s Mandate Letter. In spring 2022, Health Canada launched a targeted review of the PCPA and consulted a broad range of interested stakeholders and partners, including Indigenous organizations, through a discussion document. The feedback from the consultation, which is summarized in a What We Heard report, highlighted the following concerns related to the operation of the pesticide evaluation system in Canada and its transparency:

Health Canada determined that these concerns could be addressed through existing policy and regulatory channels and that amendments to the PCPA were not needed at this time. The PMRA is proposing amendments to the Pest Control Products Regulations (PCPR) to address these issues.

Background

The PCPA and its regulations provide the legislative framework for the regulation of pest control products federally. The Minister of Health’s primary mandate under the PCPA is to prevent unacceptable risks to human health and the environment from the use of pest control products. To meet this objective, the PCPA requires the Minister of Health to conduct premarket assessments of pest control products to determine if the risks to human health and the environment are acceptable and if the products have acceptable value. If the risks are acceptable and the product has value, the pest control product will be approved and registered for import, manufacture, distribution, and use in Canada. Once the product is registered, the PCPA also requires the Minister of Health to conduct post-market assessments, including re-evaluations and special reviews. This would determine if the pest control product continues to meet health and environmental protection standards and whether it should continue to be permitted for use in Canada.

On August 4, 2021, the Government of Canada announced that it would be investing $42 million in the PMRA over three years to further strengthen its oversight and protection of human and environmental health and safety and improve the transparency and use of independent data in the pesticide review process. To enable this work, Health Canada launched the PMRA’s Transformation Agenda, which included a targeted review in spring 2022 of specific elements of the PCPA to ensure the pesticide approval process meets the expectations of Canadians in the areas of transparency and sustainability. In response to this review, stakeholders raised key concerns in the areas of access to CTD; transparency around MRL applications; and consideration of CEE and SAR in risk assessments. A summary of each respective area is provided below.

Confidential test data

In the PCPA, “test data” means scientific and technical information respecting the health or environmental risks or the value of a pest control product. CTD is test data to which access may be refused under the Access to Information Act (ATIA); however, a person may inspect CTD under section 43 of the PCPA. This includes data used to support pesticide registration decisions (for example to register a product or maintain a registration) or proposed decisions in the case of post-market reviews (i.e. re-evaluations and special reviews). Anyone wishing to inspect CTD must submit an application form to identify the data they wish to inspect as well as an affidavit/statutory declaration stating the purpose of the inspection and attesting that the data will not be used or made available to others to register or amend a product registration. A person who inspects CTD under the PCPA is not entitled to make any copies of the CTD. The PMRA does not charge a fee to inspect CTD.

Prior to the COVID-19 pandemic, access to inspect CTD was only allowed by applying for access to a physical “reading room,” a controlled environment located at the PMRA’s offices in Ottawa, where an individual was permitted to view the documents under supervision. To prevent copying of data, electronic devices were not permitted. Note-taking was allowed if the applicant provided consent on the application form to have the notes photocopied by Health Canada. Since the COVID-19 pandemic, access to inspect CTD has been provided remotely via encrypted USB key with robust data protection software.

Without enhanced access to CTD, it is much more difficult for non-governmental organizations (NGOs) and academics to perform independent research and reanalysis of the evidence underlying the PMRA’s regulatory reviews. This limits transparency and makes it more difficult to improve Canadians’ overall confidence in the federal pesticide regulatory system.

Maximum residue limits

An MRL is the highest amount of pest control product residue that may remain on or in food when a pest control product is used according to label directions. The PCPA provides the authority for the Minister of Health to specify any necessary MRLs for a pesticide, its components, or derivatives as part of a registration application and decision. Authority also exists under the PCPA to specify MRLs for unregistered pest control products or their components or derivatives and for registered pest control products or their components or derivatives with respect to a use that is not provided for by their registration. Once an MRL application is received, the PMRA will conduct an assessment and publish a proposed MRL document for consultation.

Health Canada has implemented a public notification process for MRL applications for pest control product residues in or on imported foods that are treated with an unregistered pest control product or with a registered pest control product with respect to a use that is not provided for by its registration. Public notifications are issued once an application to specify an MRL for an imported food product has been accepted for review. The notice is published for information purposes and precedes the scientific review to help improve transparency and timely access to information for the public. The published notice describes why the MRL is being requested, the foreign regulatory authority or international standard setting organization the MRL would align with, and the types of studies conducted to support the MRL application. Public notifications took effect in spring 2024, in advance of the proposed regulatory amendments. Under this process, applicants are required to fill out and submit the form titled “Notice of application to specify/change pesticide MRLs to permit imports”. The form is available on the Health Canada website. This change aligns Health Canada with the U.S. Environmental Protection Agency (U.S. EPA) by notifying the general public of an application that has been accepted for review.

Cumulative effects on the environment

The PCPA requires the Minister of Health to apply a scientifically based approach in evaluating the health and environmental risks associated with pest control products. The purpose of the PMRA’s environmental risk assessment is to determine whether the use of pest control products may have adverse effects on organisms or the natural environment itself. The environmental risk assessment considers the exposure (environmental fate and behaviour) and hazard (toxic effects on organisms) and characterizes the risks posed by pest control products. The applicant or registrant has the burden of persuading the Minister of Health that the environmental risks are acceptable. The Minister of Health must consider information provided by the applicant or registrant, and may consider additional information obtained from other sources (interjurisdictional, literature, etc.).

A cumulative risk assessment is an analysis of the combined risks from multiple agents or stressors. For example, cumulative risk assessments could consider the combined risk from pest control products with a common mechanism of toxicity (i.e. two or more substances that cause a common toxic effect to environmental health). In the context of pesticide registration and re-evaluation, assessing cumulative effects of substances in environmental risk assessments is challenging. Cumulative effects of pest control products are not currently considered in environmental risk assessments due to a lack of information and standard methodologies (nationally and internationally).

Species at risk

Under the PCPA, “environment” encompasses biodiversity and wildlife, including SAR. In protecting SAR, the PMRA currently takes a layered approach. The environmental risk assessment is conducted as detailed in the PMRA Guidance Document, Health Canada’s Approach to Environmental Risk Assessment for Pest Control Products (and in plain language on the Health Canada website). Health Canada’s current science-based environmental risk assessments are intended to prevent unacceptable risk to non-target plant and animal species in the environment. Additionally, when there are concerns for a particular SAR through use of a pest control product, this is considered and incorporated into the environmental risk assessment and mitigation measures, such as reducing the application rate. Pest control product users are required to respect provisions of other legislation that are implicated when using pest control products, notably the Species at Risk Act (SARA) and the Fisheries Act.

While the Minister of Health does consider risks to wildlife and SAR in evaluating the environmental risks of pest control products and in determining whether those risks are acceptable under the PCPA, there is not an explicit reference to SAR in the PCPA or PCPR. Adding a reference to SAR in the PCPR would highlight the importance of protecting SAR in Canada and supports enhanced collaboration and data sharing per the Memorandum of Understanding currently being updated between the PMRA and Environment and Climate Change Canada (ECCC) with respect to SAR.

Objective

Overall, the proposed amendments would support the strategic objectives of the PMRA’s transformation initiative by improving transparency and access to information and data, and further strengthening environmental protection. Specifically, the proposed amendments would strengthen the regulation of pest control products in Canada in four ways:

Description

The proposed amendments, which complement several policy initiatives currently under way, are a key step as part of Health Canada’s initiative to strengthen the protection of human health and the environment from risks posed by pest control products while improving transparency of its decision-making process. The proposed amendments are classified under four items and are summarized below.

Item 1: Facilitate access to confidential test data

The Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada) [the proposed Regulations] would amend the PCPR to facilitate access to CTD for research and reanalysis purposes under specific conditions, without the need to submit an affidavit. The CTD would only be available for request after the final registration decision has been made, or at the proposed decision stage for post-market reviews. As per current practice, confidential business information (CBI) and private information would not be disclosed.

Requiring registrants and applicants to identify CTD

Section 17.18 of the proposed Regulations would require applicants and registrants, when they provide test data to the Minister of Health, to also provide sufficient information to enable the Minister of Health to determine whether the test data is CTD. This would include information on whether the data has been published or is otherwise publicly available, whether the data constitutes a trade secret, and whether its disclosure could reasonably be expected to prejudice the applicant, registrant, or a third party.

These requirements would apply to any test data provided to the Minister of Health, including in applications to register a pest control product, applications to amend a registration, applications to specify MRLs, and throughout the life cycle of a pest control product, including during re-evaluations, or special reviews. This would enable the PMRA to better identify CTD in advance of potential requests for access being made.

Providing access for research and reanalysis

New definitions for the terms “research” and “reanalysis” would be added as section 17.19 to the PCPR. These definitions would only apply to the amendments related to the public disclosure of CTD; research would mean any scientific or technical inquiry or experimentation that is instituted or carried out to acquire knowledge or discover new means of applying existing knowledge relating to the regulation of pest control products under the Act, and reanalysis would mean a review of CTD to verify its validity or quality, or both.

Applying for access to CTD

Section 17.2 of the PCPR would require an individual requesting access to CTD (a requester) to be a resident of Canada and submit a request to the Minister of Health. “Resident of Canada” would be defined in section 17.19 to mean an individual who ordinarily resides in Canada. A requester would not need Canadian citizenship.

Section 17.21 would describe the information the requester must submit to the Minister of Health as part of the request, including the requester’s name, residential address in Canada, email address; proof of the requester’s identity and of Canadian residency; the purpose of the research or reanalysis; a description of the CTD they are requesting access to and how it is related to the research or reanalysis; and the length of time required, up to a maximum of five years. A requester would also have to acknowledge that they have read and understood the regulatory requirements associated with access, that they are aware that the data requested may be protected by intellectual property rights, and that the information provided is accurate and complete. The amendments would also allow joint requests to be made; however, all individuals under the joint request would be required to meet the requirements mentioned above.

When access is provided or refused

Section 17.22 of the PCPR would detail how long a requester would have access to the CTD. If the requester meets the application requirements, the Minister of Health would be obliged to provide access to the CTD requested. Access would be granted for the duration of the request, or until the Minister of Health is notified that research or reanalysis has been completed or access is no longer required. The registrant who provided the CTD to the PMRA would always be notified immediately once access is granted.

Section 17.23 of the PCPR would outline under what conditions the Minister of Health would be obliged to refuse a request and under what conditions the Minister of Health would have the discretion to refuse a request. The Minister of Health would have the discretion to refuse a request where the data requested is not reasonably related to the purpose of research or reanalysis (for example an individual requests information on active ingredients that were not in the scope of their study) or where, taking into account prescribed factors, the Minister of Health determines that it would be unreasonable to respond to the request. In making such a determination, the Minister of Health would consider the scope of the request, the volume of the CTD requested, the repetitive or systematic nature of the request, and the impact on Health Canada’s operations in relation to the regulation of pest control products.

The Minister of Health would be obliged to refuse a request where the application requirements are not met or there is reason to believe the person would use the information improperly. This would include cases where the Minister of Health has reasonable grounds to believe that the requester would use the CTD to register or amend the registration of a product in Canada or elsewhere, make the information available to another individual for those purposes, or has done so in the past. It would also include cases where the Minister of Health has reasonable grounds to believe that the requester would contravene any of the requirements regarding access to CTD, or has previously done so.

Conditions of accessing CTD and for any copies made

Section 17.24 of the PCPR would require that requesters notify the Minister of Health if information changes with respect to their request; specifically, they would be required to notify the Minister of Health immediately if their Canadian residency changes, or within 15 days if their name, residential address in Canada, email address, proof of residency, purpose of access, or length of time required changes.

Section 17.25 of the PCPR would specify the requirements relating to access to the CTD, or any copies made thereof, with which any individual requesting access would need to comply, including that they could not use it for any other purpose not described in their request; not use it for the purposes of registering or amending the registration of a pest control product in Canada or elsewhere; not make the CTD available to any other person for the purposes of registering or amending the registration of a pest control product in Canada or elsewhere; and not publish or disseminate it. Furthermore, a requester would have to access the CTD in Canada and store the CTD or any copies in a secure location in Canada, as a way of exercising basic precautions to ensure the data remains secure. Lastly, the requester would be required to immediately notify the Minister of Health if they became aware of any disclosure or possible disclosure of the CTD. An individual who is found guilty of contravening the requirements relating to access specified in the PCPR would be subject to penalties under section 69 of the PCPA.

Revoking access

Section 17.26 of the PCPR would describe when and how the Minister of Health would revoke access if the requester were no longer a resident of Canada or contravened any of the requirements relating to access set out in the proposed Regulations.

Notifying the Minister

Section 17.27 of the PCPR would set out obligations for requesters once they no longer need the CTD, complete their research or reanalysis, reach the end of their access period, or where the Minister of Health has notified them that their access to the CTD is revoked. In these cases, they would be required to destroy any copies of the CTD immediately and notify the Minister of Health within 15 days that they have done so. A requester could keep copies of their research or conclusions, insofar as no CTD is included.

Compensable data

Section 17.28 of the PCPR would indicate that the disclosure of CTD under these amendments does not constitute the publication of test data that is included in a scientific study within the meaning of compensable data in section 17.01 of the PCPR (compensable data is prescribed test data provided to the PMRA by a data holder that may be used or relied upon by another applicant or registrant to support their product’s registration if compensation is paid to the data holder).

Item 2: MRL applications

Sections 12.2 and 12.3 of the PCPR would codify the applicable information requirements for applications to specify MRLs under subsection 10(2) of the PCPA. This would apply to unregistered pest control products or their components or derivatives, or to registered pest control products or their components or derivatives with respect to a use that is not provided for by their registration (i.e. MRLs for imported foods treated with a pest control product or use that is not registered in Canada). Information that would be required in an application includes information about the pest control product, a copy of the foreign label, the rationale for the request, the foreign regulatory authority or international standard setting organization that the application proposes to align with, and relevant data to allow for the evaluation of risks to human health.

For additional clarity, a definition of “foreign product” would be added to the PCPR, which would only apply to sections 12.2 and 12.3. It would specify that a foreign product is either the product for which an MRL is set by a foreign regulatory authority, or the product used by an international standard setting organization to set an MRL.

Item 3: Proposed amendments on cumulative effects on the environment

Proposed amendments to sections 8 and 17 of the PCPR would provide the Minister of Health with the explicit authority to require applicants and registrants to submit information on CEE for pest control products that have a common mechanism of toxicity. A common mechanism of toxicity exists when two or more substances cause a common toxic effect to environmental health. The PMRA will request this information upon the availability of applicable scientific methodologies. Applicants and registrants would continue to have the burden of persuading the Minister that the environmental risks of the pest control product are acceptable.

Proposed amendments would also require the Minister of Health to consider information on CEE of a pest control product provided by an applicant or registrant when an environmental risk assessment is conducted. These amendments would not prevent the PMRA from considering other information on cumulative effects (i.e. other than those related to products with a common method of toxicity) through policy in the future. For example, the Minister of Health may consider information from Environment and Climate Change Canada (ECCC) and other regulatory authorities when conducting an environmental risk assessment.

Item 4: Proposed amendments on species at risk

The proposed amendments to sections 8 and 17 of the PCPR would provide the Minister of Health with the explicit authority to require applicants and registrants to submit information on SAR, as defined in the SARA. The PMRA would not require testing on SAR. Applicants and registrants would continue to have the burden of persuading the Minister that the environmental risks of the pest control product are acceptable.

Technical issues

Separating proposed CTD provisions from research authorization provisions

The PCPR currently includes a definition of “research”, which relates to a type of authorization under the PCPR to permit the conducting of tests with certain pest control products under specified conditions. This definition would be modified to specify that it does not apply to the proposed amendments in sections 17.18 to 17.24.

Regulatory development

Consultation

Spring 2022 consultation

In spring 2022, following the announcement of the PMRA’s transformation initiative, Health Canada launched a targeted review of the PCPA and consulted a broad range of interested stakeholders and partners, including Indigenous organizations, pesticide manufacturers, pesticide users, NGOs, academia, provinces and territories, foreign jurisdictions including the United States, Australia and the European Union, and the public. A total of 121 written submissions were received. Additionally, over 40 meetings were held with partners and stakeholders, including meetings of the Transformation Steering Committee, technical working groups, public information sessions, and meetings with stakeholders. The feedback from the consultation was summarized in a What We Heard report.

Regarding the need to amend the PCPA, pesticide manufacturers and user groups felt that current legislative frameworks within the PCPA are “fit for purpose” and sufficient to enable implementation of the proposed transformation proposals, at least in the short-term, and that these should be implemented through policy and/or regulations. NGOs called for a broad review of the PCPA, and several comments and suggestions were received in support of amendments to the legislation. As a result of this review, Health Canada determined that it could address key concerns raised in the areas of access to CTD, transparency around MRL applications, and consideration of CEE and SAR in risk assessments through regulatory amendments and policy changes.

NOI2023-01

On June 20, 2023, in response to the feedback received during the spring 2022 consultation, Health Canada published notice of intent NOI2023-01, outlining general proposals to amend the PCPR. Written comments on the notice of intent (NOI) were accepted for 80 days (from June 20, 2023, to September 8, 2023). The comment period was extended 20 days from the original 60-day period at the request of stakeholders.

Health Canada sent email notifications to key stakeholders, including provincial and territorial (PT) partners, industry members, NGOs, Indigenous organizations, and stakeholder committees to invite comments on the NOI. Additionally, Health Canada pushed notifications through its RSS feed, and social media. During the consultation period, Health Canada also organized a webinar with a Q&A session.

Following the close of the consultation, Health Canada gave presentations on the NOI to its Pest Management Advisory Council (a multi-stakeholder group that provides advice to the Minister of Health on policy and issues related to the federal pesticide regulatory system) and its Federal-Provincial-Territorial Committee in September 2023. At each of these meetings, Health Canada shared its cost-benefit analysis assumptions and invited participants to provide costing clarifications. In addition, Health Canada organized a webinar on December 11, 2023, on the implementation of the CTD proposal and explained the approach to the cost-benefit analysis, including what is considered an “incremental cost,” as per the Cabinet Directive on Regulation. All stakeholders previously engaged were invited to attend. Health Canada invited participants to provide costing clarifications for consideration; however, no input was received following the webinar.

Stakeholder comments on NOI2023-01

All comments pertinent to the proposals were considered, including those received outside of the formal consultation period. Health Canada received and analyzed 165 comments pertaining to the proposals outlined in the NOI. In total, 97 comments were received from the public, 36 from national and international industries and industry associations, 28 from NGOs and academics, and 4 from provincial governments. In addition, one comment that was publicly posted on an NGO website and was not submitted directly to Health Canada was considered.

Overall, the response to the proposals was mixed. The majority of responses were opposed but had polarized reasons for their opposition (89 comments wanted further regulatory measures, 18 comments wanted fewer regulatory measures). Of the comments that were opposed, 78 were related to a letter-writing campaign, repeating similar points and format. Other responses expressed mixed opinions (31 comments) depending on the proposal, while 13 comments indicated support for the specific proposal(s) they provided comments on. Additionally, 13 comments were not in the scope of the NOI proposals.

Responses were considered with regard to whether they were consistent with the stated objectives of the PMRA’s transformation initiative and whether they could be best addressed through regulatory changes or through policy.

Comments on the instrument choice

Some NGOs and academics, as well as members of the public, requested changes that would require amendments to the PCPA. This included amendments to the definition of CTD. Additionally, some comments requested changes to the definition of third-party information in the Access to Information Act (ATIA) in order to affect the definition of CTD in the PCPA, which references the ATIA, or personal information as set out in the Privacy Act. These comments sought to achieve greater transparency. Given Health Canada’s analysis of the feedback received via the PCPA review, no act-level changes are being pursued at this time. However, Health Canada considered how the intent of these comments could be achieved through regulatory amendments or changes to the PMRA processes. The proposed amendments to the PCPR would achieve greater transparency for CTD in a manner that would meet Canada’s international treaty obligations and not result in unfair commercial use of CTD.

Conversely, most PT partners and industry and a few members of the public suggested that no changes be made to the PCPA/PCPR, or that some proposals (MRLs, CEE and SAR) were better achieved solely through policy changes. Health Canada determined that regulatory amendments would be preferable to support environmental protection, fulfill its transparency objectives, and improve alignment with federal legislation such as CEPA and SARA in a manner that is appropriate under the PCPA.

Potential costs

Generally speaking, comments from industry and PT partners expressed concerns with perceived incremental costs associated with protecting CTD, confidential business information (CBI), and privacy information; potential product losses due to increased costs to registration; incremental costs to the PMRA due to the MRL proposal; increased costs to industry as a result of submitting environmental test data for CEE and SAR; and costs to the PMRA for implementing proposed amendments generally; or they requested further costing information.

Health Canada considered these comments when conducting the cost-benefit analysis for the proposal. Most costs identified by stakeholders would not be incremental costs stemming from the regulatory proposal. This is because CTD is already accessible to the public and the Minister of Health must protect CTD, CBI and privacy information under existing legislation. In addition, the MRL notification form would make use of the existing application process to minimize costs to stakeholders and the Government. Furthermore, the Minister of Health currently has the authority to request information on CEE and SAR, so this is not an incremental cost. Overall, Health Canada’s analysis estimates the costs of the proposal to be low for the Government and stakeholders.

Expanding the scope of CTD proposal

Most NGOs, academics, and the Indigenous organization that provided comments, as well as most members of the public, requested that the scope of the CTD proposal be expanded. Examples include expanding the proposal to allow for access to CTD for review and verification purposes; ensure that joint requests can be made in the context of a research team; allow requesters to store, use and copy the data; add an appeal process for redactions or changing how redactions are applied; permit access to the PMRA evaluation reports and decisions that make use of the CTD; and permit access to CTD during regulatory activities (including pausing consultations and decisions while CTD requests were processed and CTD was inspected).

With regard to who has access to CTD, the proposal would enable all residents of Canada to access CTD insofar as it is used only for research or reanalysis and is not disseminated, published, or used to register or amend the registration of a pest control product. With regard to how the CTD could be used, the proposed amendments would permit activities such as review and verification. In addition, the proposed amendments would enable a user to store, use and copy the data to conduct research and reanalysis in a secure manner. The proposed amendments respond directly to stakeholder comments urging the PMRA to provide greater access to CTD, and to provide CTD in a format that facilitates independent research and reanalysis.

With regard to redactions and accessing the PMRA reports that use CTD, Health Canada agrees with the intent of these comments to provide greater transparency to the PMRA’s decision-making. Health Canada proposes a two-pronged approach to address these comments: through the implementation of the CTD proposal, in particular the publication of a guidance document that will provide more clarity on the PCPR, and through the PMRA’s ongoing work to improve the transparency and more timely disclosure of information and data considered in decision-making. Health Canada does not propose to include an appeal process in the proposed Regulations due to potential impacts impact on Health Canada’s operations. Health Canada will address concerns with redactions (e.g. privacy information and CBI) on a case-by-case basis.

Some of the comments were not incorporated into the proposed amendments. While a request to access CTD could be made during regulatory activities once a product is registered, it is not intended that a request to access CTD would pause the standard timeline for publication of the PMRA decisions, as there is a need for Health Canada to make timely regulatory decisions to continue to meet its mandate regarding human health and environmental protection. Individuals would still be able to file a Notice of Objection to a decision (i.e. initiate an official process to reconsider the scientific basis of a decision) under the PCPA, as appropriate.

Concerns with the CTD proposal

Industry and some PT representatives expressed concerns with the proposal to facilitate access to CTD for research or reanalysis purposes. This included concerns on how the data would be protected against unfair commercial use, concerns with the potential for misinterpretation or misinformation, and concerns around who would have access to the CTD.

The proposed amendments would incorporate measures to protect CTD against unfair commercial use with additional consideration for protection of CTD as required by international treaties to which Canada is a signatory. Health Canada will provide guidance to support the implementation of these processes, which will be available for consultation during the consultation period of the Canada Gazette, Part I.

Health Canada agrees that it is important to limit misinterpretation and misinformation, to make the PMRA decisions available in a timelier manner and easier to understand, and to provide adequate protections for CBI and privacy information. Health Canada expects that these concerns can be addressed through the following: greater CTD transparency, ongoing document disclosure initiatives to enhance access to information in the public registry, and a new approach to science communications to explain the reasoning behind regulatory decisions, found on the Health Canada website. This would be consistent with the Government of Canada’s stated priorities around accountability, transparency, and open government. Existing procedures around protection of CBI and privacy would be maintained.

Comments on the MRL setting process

Most comments from NGOs and the public, as well as those from an Indigenous organization, spoke to aspects of MRL policy that are beyond what was included in the NOI. As an example, comments from these parties touched on the setting of MRLs, such as requesting that separate MRLs be established for domestic and imported foods, and concerns regarding MRL compliance. Conversely, during the PCPA review, the PMRA heard from user groups and industry that the current process for establishing MRLs is effective in protecting health and does not require adjustment.

Health Canada has determined that the current MRL setting process protects human health and does not require changes. The Canadian Food Inspection Agency found that in the 2020/21 fiscal year, 97.5% of domestic foods and 96.1% of imported foods (including residues that are not from pesticides) sampled and tested were compliant with all Canadian regulations, limits, and guidelines. Year after year, the results show the high compliance for pesticide residues for tested fresh fruits and vegetables (they have no pesticide residues detected or have residue levels below the MRL). Health Canada maintains its commitment to improving communication and transparency with regard to why and how the PMRA specifies maximum residue limits. Health Canada expects that some of the concerns raised with regard to the MRL setting process could be addressed through scientific communications documents published on its website.

Comments on MRL transparency

NGOs, industry, and provinces provided comments on the transparency initiative for MRLs. Health Canada heard that there was broad support for increased transparency with regard to MRLs, including notifying the public when an application for an MRL for imported food products has been accepted. Stakeholders felt that this new process would improve transparency and communication on MRLs, by making available to the public the rationale for the application received as well as identifying the applicant. Industry and provinces raised concerns on potential costs; however, there were no objections to the addition of a notification process.

Comments on the CEE proposal

Most NGOs, an Indigenous organization, and some members of the public suggested broadening the CEE proposal to further strengthen environmental risk assessments with two main areas of focus. The first of these proposed expanding the assessment of CEE beyond pest control products with a common mechanism of toxicity to include synergistic and additive effects. The second area of focus proposed aligning the CEE proposal with the recent amendments to CEPA, such as adding data requirements for applicants and registrants (e.g. to obtain data through an independent third party) or considering other environmental effects of pest control products. Conversely, industry and provincial agricultural ministries thought that the changes were premature and not needed at this time as no methodologies for assessing CEE currently exist.

Health Canada considered these comments and the appropriate instrument to achieve those objectives. Health Canada agrees with the importance of protecting the environment from potential risks associated with pest control products, and with the intent to align the PCPR with CEPA where possible. The PCPA already gives wide authority to the Minister of Health to request information deemed necessary. The proposed amendments would include an explicit authority for the Minister of Health to require CEE information from applicants and registrants and for the Minister of Health to consider this information in the evaluation of the environmental risks of pest control products and determining whether those risks are acceptable.

These amendments will align with the existing PCPA requirement that cumulative effects be considered in evaluating the health risks of pest control products, which similarly requires a consideration of pest control products having a common mechanism of toxicity. The proposed amendments would not prevent Health Canada from considering other aspects of cumulative effects (e.g. other environmental or ecological variables, such as climate change) in the future when methodologies, information, and techniques evolve. Further, limiting the scope of the amendments to pest control products with a common mechanism of toxicity enables the PMRA to prioritize its work and ensures that regulatory decisions are timely. Health Canada acknowledges that the proposed amendments do not fully align with CEPA. However, alignment was achieved to the greatest extent possible recognizing that, while overlapping to a certain extent, CEPA, the PCPA and their respective regulatory frameworks serve different purposes and have different instruments for prioritizing evaluations. Nonetheless, Health Canada intends to further cooperate with ECCC, regulatory partners, and stakeholders to develop information and methods to consider CEE.

Health Canada considered comments that asked for regulatory amendments to require applicants and registrants to procure data on CEE. However, as information and methodologies on CEE are not yet available, it would be premature to require that it be procured at this time. Once it is available, applicants and registrants would be responsible to provide this information upon request. Health Canada intends to engage regulatory partners to obtain information to be used alongside what is provided by applicants and registrants. With regard to comments on requiring applicants and registrants to provide information from an independent third party, or entering into an agreement with an independent third party for the purpose of generating new information or vetting existing information, Health Canada has a number of measures to ensure data quality including submission guidelines for applicants and registrations. Additionally, the Minister of Health has the authority to gather information from third parties (such as ECCC) to consider other forms of independent information. Therefore, amendments were not necessary to achieve the objective of independent data.

Some stakeholders’ comments suggested adding more specificity regarding environmental impacts to the PCPR to strengthen the PMRA’s environmental risk assessments. Suggestions included adding a definition of “harm” and including terms such as “habitats,” “non-target species,” “food webs” and “ecosystems.” Adding these terms was not necessary, as it is clear in the PCPA that the Minister of Health already has a broad authority to consider all relevant factors in carrying out environmental risk assessments.

Industry and PT ministries indicated that the proposed amendment was premature as it precedes the development of internationally recognized methodologies for CEE. These comments touched on instrument choice, costs, and international alignment. Considering the stated objective of improving transparency and regulatory alignment, Health Canada is proposing these amendments now as a proactive approach to underline its commitment to strengthening environmental protection and to encourage efforts to develop internationally recognized methodologies on CEE.

Comments on species at risk

Most NGOs, an Indigenous organization, and some members of the public suggested broadening the SAR proposal to further strengthen environmental risk assessments. This included further data requirements for applicants and registrants (e.g. require applicants or registrants to obtain data if it is not available to them or to obtain data through an independent third party) and considering other environmental effects of pest control products. Conversely, industry and PT ministries thought that no changes were needed at this time. Health Canada currently protects SAR by being conservative in the determination of effects on organisms, including by considering the most sensitive organisms and requesting information from partners when re-evaluations and special reviews are initiated. As with the CEE proposal, Health Canada agrees that strengthening environmental protection is important and proposes to include explicit authorities to obtain information on SAR, which will align with SARA in a manner that is appropriate under the PCPA. The PMRA is committed to continuing working with its partners and stakeholders to continue to strengthen the protection of SAR.

Modern treaty obligations and Indigenous engagement and consultation

No impacts have been identified in respect of the Government’s obligations in relation to Indigenous rights protected by section 35 of the Constitution Act, 1982, or its modern treaties and international human rights obligations.

Instrument choice

Health Canada conducted thorough analysis to ascertain whether the baseline scenario (no action), a change to policy, or a regulatory amendment would be the best option. In each instance, the issue would be best addressed by a regulatory amendment, as the baseline scenario would not address the issues identified by stakeholders, and an exclusively policy-level approach would not achieve regulatory alignment, nor would it improve transparency and trust by communicating regulatory certainty to stakeholders.

Regulatory analysis

Benefits and costs

Item 1: Facilitate access to confidential test data

Under the baseline scenario, which is an ongoing pilot project, individuals requesting access to CTD are sent secure USB keys with the data they have requested. This pilot project is expected to continue indefinitely, thus most requirements on registrants/applicants are not considered as incremental costs. However, the costs to registrants/applicants to identify if data in their data submissions is CTD are considered as incremental costs. On average, applicants/registrants submitted test data for about 593 applications/evaluations per year in the past 5 years.

Cost to Government

Costs to the PMRA from the proposed Regulations would be minor and could include the costs of additional USB keys and their shipping to CTD applicants, as it is expected that there will be an increase in the number of CTD requests due to the expanded scope for research and reanalysis purposes.

Under the proposed amendments, there may be risk-based compliance and enforcement activities, to ensure that CTD is not being misused for commercial purposes. Contravention of the requirements set out in the proposed Regulations would be an offence under the PCPA and would be subject to the enforcement provisions contained in the Act. Health Canada would use its existing compliance and enforcement resources in support of the proposed Regulations.

Costs to industry

Costs to the PMRA applicants/registrants would be in the form of providing sufficient information as part of their data submission documents to help the PMRA determine whether the data is CTD (e.g. identifying whether it is publicly available, and if so, where it is published). The costs are expected to be low, as the information is readily available. Registrants/applicants should be knowledgeable about the information that will be required as it relates to their data submission. Please see the “One-for-one rule” section for further details on monetized administrative costs.

Benefits

The proposed amendments would improve the transparency of the PMRA’s regulatory decisions, support better understanding of the PMRA’s evaluation conclusions, and facilitate public participation in the regulatory process and the development of independent data on pest control products. Specifically, facilitating research and reanalysis will contribute to decision-making by the PMRA owing to the development of independent data, resulting in greater public trust in regulatory decisions, and the advancement of science around the regulation of pest control products in Canada. CBI and privacy information would continue to remain protected. Additionally, the amendments to the data submission process would help simplify and streamline the PMRA’s determination of what constitutes CTD.

Item 2: Issuing public notifications for MRL applications
Cost to Government

The PMRA implemented the MRL notification procedure in spring, 2024. Thus, any new MRL applications under subsection 10(2) PCPA for pesticide residues on imported food commodities received by the PMRA would already be subject to this new process in the baseline. Therefore, there would be no incremental costs to the Government stemming from the coming into force of this regulatory proposal.

Costs to industry

Under the PCPA, there is existing authority to require applicants under subsection 10(2) to complete and submit the notification form for online publication. Thus, industry already follows the MRL notification procedure. Therefore, there would be no incremental costs to industry after the coming into force of this regulatory proposal.

Benefits

Since the MRL notification process would already be in place, the benefit of this regulatory proposal is to ensure that the PCPR align and are consistent with current practices.

Item 3: Proposed amendments on cumulative effects on the environment
Costs to Government and industry

The Minister of Health’s authority to require information to conduct environmental risk assessments, which can include information on CEE, exists already under authorities provided by the PCPA. Since the proposed amendments to give the Minister of Health the explicit authority to require the submission of information on CEE would not result in any new obligation for regulated parties, industry and government would bear no new incremental costs. The Minister of Health would only require information when methodologies are available.

Benefits

The proposed amendments would enhance public trust in Health Canada’s scientific review process by explicitly stating in the regulation that information on CEE provided by registrants and applicants must be considered in the environmental risk assessment.

Item 4: Proposed amendments on species at risk
Costs to Government and industry

The Minister of Health’s authority to require information, including information regarding wildlife and SAR, to conduct risk environmental assessments exists already under the PCPA. Since the proposed amendments to give the Minister of Health the explicit authority would not result in any new obligation for regulated parties, industry and government will incur no new incremental costs. The Minister of Health would not require testing on species at risk.

Benefits

The proposed amendments would enhance public trust in Health Canada’s scientific review process by explicitly stating in regulation that information on SAR must be submitted to the Minister of Health for environmental risk assessments.

Small business lens

The proposal is expected to affect small businesses: item 1 (CTD) would impose minor costs to small businesses, while the proposed items 2, 3 and 4 would impose no costs. Although the number of impacted small businesses cannot be identified, it is estimated that approximately 80% of the PMRA’s registrants are small businesses (based on findings of a research project conducted in 2018 in collaboration with Statistics Canada).

One-for-one rule

The one-for-one rule applies since there is an incremental increase in administrative burden on business, and the proposal is considered a burden under the rule. The new version of the PCPR results in an additional annualized cost of $39,521 (in 2012 Canadian dollars) in administrative burden, as estimated using the Red Tape Reduction Regulations prescribed method. No regulatory titles are repealed or introduced.

Key assumptions:

Regulatory cooperation and alignment

The proposed amendments vary in alignment by item with other jurisdictions and/or international organizations.

Confidential test data

The PMRA consulted with Australia, the European Union (EU), and the United States (U.S.) to better understand their approach with respect to proprietary test data and to better understand the extent to which any new regulations regarding access to CTD in Canada would align with those approaches, bearing in mind the context created by the PCPA. All three jurisdictions provide a means for giving the public access to proprietary test data used in pesticide regulatory decisions, while protecting confidential business information and privacy information. The proposed Regulations would differ from other jurisdictions by creating a specific, and more streamlined, pathway for accessing test data for the purposes of research and reanalysis.

The key international consideration, with respect to access to CTD, would be ensuring that any changes continue to comply with the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and other international trade agreements to ensure that Canada provides sufficient protection for confidential information. The proposed regulatory provisions around protection of CTD were informed by international trade obligations and are expected to ensure that these measures meet those obligations.

Maximum residue limits

The public notification process, supported by the proposed MRL amendments, would partially align with that of the U.S. EPA.

The public notification aligns in principle with the U.S. EPA Notice of Filing a Pesticide Petition to Establish a Tolerance as required under section 408(d)(3) of the Federal Food, Drug and Cosmetic Act. The level of detail in the EPA Notice includes a verbatim summary of the application and a 30-day comment period, which is more comprehensive than the PMRA public notification. The PMRA would align with the U.S. EPA by notifying the general public of an application that has been accepted for review.

Cumulative effects on the environment

The proposed amendments would take a proactive approach to considering CEE for pest control products.

The proposal would create Canadian-specific requirements for considering CEE of pest control products, with the intent to align with CEPA where possible. Health Canada would be the first regulator to request data on CEE, and will continue to maintain and enhance cooperation with regulatory partners, including ECCC, other government departments and the provinces and territories to obtain information on CEE.

There will be future opportunities to encourage regulatory cooperation and alignment with other jurisdictions and international organizations as more methodologies and information on CEE are developed.

Species at risk

Both the PMRA and the U.S. EPA consider SAR; however, there are differences in approach.

Health Canada and the U.S. EPA have a similar approach for assessing pest control products for their environmental effects, including environmental fate and toxicity data to determine how a pesticide will move through and break down in the environment and whether potential exposure to the pesticide will result in adverse effects to wildlife and vegetation. Pesticide risk assessments and regulatory processes ensure that protections are in place for all populations of non-target species.

Health Canada considers the U.S. EPA’s approach to SAR to be comparable in the sense that both jurisdictions are committed to undertaking special consideration for any SAR when assessing a pesticide’s potential use prior to and after it becomes registered. However, both the U.S. EPA and the PMRA are looking at ways SAR considerations can be strengthened in pesticide use assessments. These considerations involve some different approaches. For example, the U.S. legislation, states, borders, and environments, and endangered species are not always a direct match to the Canadian situation. The PMRA is committed to continuing to work with the U.S. EPA, ECCC, other stakeholders, and the public to continue to strengthen the protection of SAR.

Strategic environmental assessment

In accordance with the Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a strategic environmental assessment was completed for the transformation initiative, which encompasses this regulatory proposal. The assessment concluded that the transformation initiative is expected to have both direct and indirect positive effects on the environment and human health. There are no negative environmental impacts expected from this proposal.

The proposal would authorize the Minister to require information on species at risk and cumulative environmental effects; to enhance transparency. It would be a step towards addressing some stakeholder concerns, both from environmental groups and industry and user groups.

Direct impacts in the near term would be limited; however, the proposal has the long-term potential to positively affect the environment and the health of Canadians by strengthening the review process for environmental risk assessments. Indirectly, the proposal would improve coordination within the Government of Canada on the management and regulation of pest control products, helping to reduce any negative environmental impacts, and addressing risks posed to human health and the environment, including wildlife, from the use of these products in Canada. Actions to improve science communications and transparency would also improve public confidence in the management of pest control products.

Gender-based analysis plus

It is not expected that this proposal would have any disproportionate impacts on Canadians based on factors such as gender, age, or other identify factors. Therefore, no gender-based analysis plus (GBA+) impacts have been identified for this proposal.

Implementation, compliance and enforcement, and service standards

Implementation

The proposed amendments related to MRLs, CEE and SAR would come into force on the day on which they are published in the Canada Gazette, Part II. To provide applicants and registrants with time to adjust to the CTD amendments, the proposed amendments related to CTD would come into force 180 days after the day on which they are published in the Canada Gazette, Part II.

Health Canada implemented a new public notification process applicable to MRL applications for pesticide residues on imported food commodities and made the new form available for stakeholders in the spring of 2024. The public notification would be issued once an application to specify an MRL for an imported food product has been accepted for review. The notice would be published for information purposes and precede the scientific review to help improve transparency and timely access to information for the public. The published notice would describe why the MRL is being requested, the foreign regulatory authority or international standard setting organization the MRL would align with, and the types of studies conducted to support the MRL application. The PMRA maintains a list of forms for applicants and registrants on its website.

Health Canada would continue to collaborate with ECCC on matters relating to CEE and SAR. The Memorandum of Understanding (MOU) between the two departments specific to CEE and SAR is being updated to enhance collaboration. As part of this work, a detailed workflow document has been developed as a communications tool to outline the different steps in PMRA evaluations and give details on the possible engagement points and contacts with ECCC at each step in the evaluations. This would ensure that subject matter experts at ECCC are engaged at the appropriate time points in the environmental risk assessments and that information and data relating to either CEE or SAR are included in a timely manner in the analyses.

The regulatory amendments associated with this proposal may result in changes to related policies and interpretive guidance. The PMRA would amend its guidance material to explain the new CEE provisions. Consistent with Health Canada’s obligations under the PCPA, consultation on those changes to policies and guidance would occur at the Minister’s discretion. Moreover, the PMRA’s proposed implementation approach regarding proposed amendments to facilitate access to CTD for research and reanalysis purposes is being consulted upon at the same time as these proposed Regulations with the intention to provide guidance on how the PMRA would implement these provisions before they come into force.

Compliance and enforcement

Health Canada promotes, verifies, and enforces compliance with the PCPA by providing oversight of all parties regulated by the PCPA and its regulations, including registrants, manufacturers, importers, retailers, individuals accessing CTD, and users of pesticides. Compliance promotion increases Health Canada’s reach and provides important information to regulated parties, key stakeholders, and the people of Canada to foster compliance with the PCPA and its regulations. Compliance verifications are designed to verify compliance of users, distributors, importers, and registrants of pesticides with the provisions of the PCPA and its regulations, as well as with specific terms and conditions of pesticide registration.

Health Canada uses a risk-based approach, focusing its proactive compliance verification activities to products and sectors where non-compliance could result in an unacceptable risk to human health or the environment. The same risk-based approach is also used to respond to complaints and incidents. Should non-compliance with any provisions of the PCPA or its regulations be identified, Health Canada would take enforcement action that is commensurate with risk. The PCPA provides for several enforcement tools that may be considered to address non-compliance. These may include warning letters, compliance orders, seizures, recommendations to the Public Prosecution Service of Canada for prosecution, issuance of notices of violation (NOV) under the Agriculture and Agri-Food Administrative Monetary Penalties Act (AAAMP Act) with a warning or monetary penalty, and, in partnership with the Canada Border Services Agency (CBSA), refusal of entry of unauthorized pesticides into Canada.

Compliance activities would also focus on individuals accessing CTD. All individuals seeking access to CTD would be obliged to acknowledge that they have read and understood the relevant regulatory restrictions as part of their request to access CTD. A contravention of these requirements would be an offence under the PCPA and would be subject to the enforcement provisions contained in the Act. The PMRA expects to carefully monitor access to the data, which would help ensure compliance, including identifying the sources of any potential unauthorized disclosure.

Compliance with the PCPA and its regulations is overseen through a network of designated inspectors across Canada. Health Canada also has collaborative and information-sharing agreements with provincial pesticide regulatory departments.

Health Canada’s compliance and enforcement policy on pesticides informs Health Canada’s decision making for compliance activities and enforcement actions.

Service standards

Health Canada follows established service standards or defined timelines for evaluating potential new or amended registrations, as outlined in the PMRA Guidance Document, Management of Submissions Policy.

Contact

Jordan Hancey
Director
Policy and Operations Directorate
Pest Management Regulatory Agency
Health Canada
2 Constellation Drive
Ottawa, Ontario
K1A 0K9
Email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada) under section 67footnote a of the Pest Control Products Act footnote b.

Interested persons may make representations concerning the proposed Regulations within 70 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Jordan Hancey, Director, Policy and Regulatory Affairs Division, Policy and Operations Directorate, Pest Management Regulatory Agency, Department of Health, Address Locator: 2608A, 2 Constellation Drive, Ottawa, Ontario, K1A 0K9 (email: pmra.regulatory.affairs-affaires.reglementaires.arla@hc-sc.gc.ca).

Ottawa, May 30, 2024

Wendy Nixon
Assistant Clerk of the Privy Council

Regulations Amending the Pest Control Products Regulations (Strengthening the Regulation of Pest Control Products in Canada)

Amendments

1 (1) The definition foreign product in subsection 1(1) of the Pest Control Products Regulations footnote 1 is replaced by the following:

foreign product,
other than in sections 12.2 and 12.3, means a pest control product that is registered in a country other than Canada. (produit étranger)

(2) The definition research in subsection 1(1) of the Regulations is replaced by the following:

research,
other than in sections 17.19 to 17.28, means tests that are carried out to generate test data in support of an application for registration of a pest control product or an application to amend a registration, by using a pest control product that contains an unregistered active ingredient, using an unregistered pest control product that contains a registered active ingredient or using a registered pest control product in a manner or for a use that is not specified in the conditions of registration. (recherche)

2 Section 8 of the Regulations is amended by striking out “and” at the end of paragraph (r) and by adding the following after paragraph (s):

3 The Regulations are amended by adding the following after section 8:

Minister to consider cumulative effects on environment

8.1 In evaluating the environmental risks of a pest control product and in determining whether those risks are acceptable, the Minister must consider among other relevant factors any information provided by the applicant respecting the cumulative effects on the environment of the pest control product and other pest control products that have a common mechanism of toxicity.

4 The Regulations are amended by adding the following after section 12:

Application to Specify Maximum Residue Limits

Definition of foreign product

12.1 In sections 12.2 and 12.3, foreign product means

Contents

12.2 (1) An application under subsection 10(2) of the Act to specify maximum residue limits for an unregistered pest control product or its components or derivatives, or for a registered pest control product or its components or derivatives with respect to a use that is not provided for by its registration, must include all of the following information:

Certification

(2) The applicant must include with every application to specify maximum residue limits for a pest control product a statement signed by the applicant certifying that the information in the application is accurate and complete.

Additional information — maximum residue limits

12.3 In addition to the information required under section 12.1, the applicant must provide the Minister with any other information that the Minister may require to evaluate the health risks of the pest control product, including the results of scientific investigations respecting any of the following:

5 Section 17 of the Regulations is amended by adding the following after subsection (3):

Cumulative effects on environment

(4) The registrant must, if requested by the Minister during a re-evaluation or special review under subsection 16(3) or 18(1) of the Act, provide the Minister with the results of scientific investigations respecting the cumulative effects on the environment of the pest control product and other pest control products that have a common mechanism of toxicity.

Species at risk

(5) The registrant must, if requested by the Minister during a re-evaluation or special review under subsection 16(3) or 18(1) of the Act, provide the Minister with the results of scientific investigations respecting the effect of the pest control product on species at risk, as defined in subsection 2(1) of the Species at Risk Act.

Minister to consider cumulative effects on environment

(6) In evaluating the environmental risks of a pest control product and in determining whether those risks are acceptable, the Minister must consider among other relevant factors any information provided by the registrant respecting the cumulative effects on the environment of the pest control product and other pest control products that have a common mechanism of toxicity.

6 The Regulations are amended by adding the following after section 17.17:

Determination — Confidential Test Data

Required information

17.18 If an applicant or registrant provides test data to the Minister, they must also provide sufficient information, including the following, to enable the Minister to determine whether the test data is confidential test data:

Public Disclosure of Confidential Test Data

Definitions

17.19 The following definitions apply in sections 17.2 to 17.28.

reanalysis
means a review of confidential test data to verify its validity or quality, or both. (réanalyse)
research
means any scientific or technical inquiry or experimentation that is instituted or carried out to acquire knowledge or discover new means of applying existing knowledge relating to the regulation of pest control products under the Act. (recherche)
resident of Canada
means an individual who ordinarily resides in Canada. (résident du Canada)

Access to confidential test data

17.2 An individual who wishes to access confidential test data in the Register must

Request to access

17.21 (1) The request to access confidential test data must include the following information and be submitted in the manner specified by the Minister:

Joint request

(2) The request to access confidential test data may be submitted by two or more individuals jointly, in which case the information required under subsection (1) must be provided by each of those individuals.

Disclosure

17.22 (1) Subject to section 17.23, if the individual who requests access to the confidential test data meets the requirements in section 17.2, the Minister must disclose that data to them in a secure manner in the electronic public registry.

Disclosure period

(2) The Minister must disclose the confidential test data to the individual until the earliest of

Notice to registrant

(3) If the Minister discloses the confidential test data to the individual, the Minister must make a reasonable effort to immediately notify any registrant who provided that data to the Minister.

Refusal

17.23 (1) The Minister may refuse to disclose the confidential test data to the individual who requests access to it if the Minister determines that

Factors

(2) In determining whether it is unreasonable to respond to the request, the Minister must take the following factors into account:

Refusal — other grounds

(3) The Minister must refuse to disclose the confidential test data to the individual who requests access to it if

Change of information — residency

17.24 (1) If, during the disclosure period, the individual who requested access to the confidential test data ceases to be a resident of Canada, the individual must notify the Minister immediately.

Update — other information

(2) If any of the information submitted under paragraph 17.21(1)(a), (b), (c) or (e) changes during the disclosure period, the individual must submit the updated information to the Minister as soon as practicable but in any case within 15 days after the change.

Requirements

17.25 The individual who accesses the confidential test data that is disclosed to them under subsection 17.22(1) must comply with the following requirements:

Revocation

17.26 The Minister must revoke the individual’s access to the confidential test data, and notify them of the revocation, if the Minister has reasonable grounds to believe that the individual

Destruction

17.27 (1) An individual who accesses the confidential test data that is disclosed under subsection 17.22(1) must immediately destroy any copies of that data if

Notice to Minister

(2) The individual must, within 15 days after the occurrence of either of the situations referred to in subsection (1), notify the Minister that all copies of the confidential test data have been destroyed.

Disclosure — not publication

17.28 For greater certainty, the disclosure of confidential test data by the Minister under subsection 17.22(1) does not constitute the publication of test data that is included in a scientific study within the meaning of paragraph (b) of the definition compensable data in section 17.01.

Coming into Force

7 (1) These Regulations, except subsection 1(2) and section 6, come into force on the day on which they are published in the Canada Gazette, Part II.

(2) Subsection 1(2) and section 6 come into force on the 180th day after the day on which these Regulations are published in the Canada Gazette, Part II.

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