Summary of public comments received on Regulatory Proposal PRO2025-03

• Pesticides Regulatory Directorate
• Healthy Environments and Consumer Safety Branch
• Health Canada

15 October 2025

Comments received in response to Regulatory Proposal PRO2025-03, Consultation on revised procedures for the registration of pesticides for emergency use, published on 16 July 2025, are summarized below and followed by Health Canada's responses. These comments were taken into consideration to prepare the Pesticides Guidance Document, Procedures for the Registration of Pesticides for Emergency Use.

1. Comment

Information was requested on the responsibilities of the entity requesting an emergency registration on behalf of the sponsor and how to differentiate those entities on the application form.

Health Canada response

The sponsor is the entity submitting the application for an emergency registration, typically on behalf of another entity (for example, grower group). On the application form, the sponsor is the submission contact, as indicated in the guidance document in Section 6.0. Responsibilities of the sponsor of an emergency registration application are outlined in Section 2.0.

2. Comment

Comments were received related to the scope of emergency registration applications qualifying for multi-year emergency registrations. Comments indicated that expanding the scope of multi-year emergency registrations would reduce regulatory and financial burden, ensuring equitable access, and noted that the majority of emergency issues are not solved within the default 1-year timeline.

Health Canada response

PRO2025-03 proposed the following criteria for multi-year emergency registrations: "Multi-year validity periods will be considered by Health Canada only when the registration is intended to prevent the establishment of a new invasive species (for example, as a component of an Early Detection Rapid Response program) or control a pest posing other environmental concerns (for example, threat to biodiversity, species-at-risk)."

The feedback received during the consultation for PRO2025-03 established a clear need to extend consideration of multi-year emergency registrations to include uses outside the proposed criteria. With a focus on eliminating unnecessary regulatory burden, Health Canada will consider multi-year validity periods for any emergency situation for which the sponsor establishes a reasonable expectation that it will require multiple years to manage and the extended validity will have no foreseeable impact on the environmental or health risks. Not all emergency situations are suitable for a multi-year validity period; however, the expansion of the eligibility criteria will reduce regulatory and financial burden for applicants and sponsors, while ensuring equitable access for emergency situations that will require multiple years to manage.

3. Comment

A comment was received requesting clarity on annual updates for multi-year emergency registrations and questioned the importance of the added step.

Health Canada response

To remove unnecessary regulatory burden associated with emergency registrations, Health Canada will not proceed with a requirement for annual updates over the validity period of multi-year emergency registrations. While Health Canada may request updates from sponsors as additional information under certain circumstances (for example, information on developing pest severity, manufacturing capacity), these will be submitted on a voluntary basis and not part of the standard multi-year emergency registration process. Note that the type of information requested as part of a voluntary update will not be related to any information required by Health Canada for the determination of acceptable risk. Progress towards registration through normal regulatory channels is still expected to be made during the validity period of a multi-year emergency registration and will be considered in any future repeat request. The timely submission of updates requested in the course of a multi-year validity period may facilitate the processing of information required to support any subsequent requests for the emergency use in question.

4. Comment

Comments were received concerning emergency registration applications that are rejected on Health Canada's determination that the sponsor failed to demonstrate that existing registered alternative products and cultural controls were insufficient to mitigate the pest situation. These included requests for additional viewpoints to be considered for alternatives and requests for greater clarity (for example, established criteria) in how the viability of alternatives is assessed.

Health Canada response

The diverse range of pest situations that emergency use applications encompass complicates the establishment of general criteria to determine if existing control measures are sufficient. Such criteria may also be unnecessarily prescriptive. In cases where alternative solutions exist but are regarded as insufficient by growers, the sponsor is encouraged to contact Health Canada before formally submitting their emergency registration application to discuss the viability of the alternative control measures. It should be noted that very few emergency registrations are refused on the basis of existing alternatives; over the last five years, emergency registration requests for only two situations have been rejected on this basis.

5. Comment

Comments were received regarding emergency registration fees as an economic barrier.

Health Canada response

While application fees are subject to separate regulations and outside the scope of this consultation, the expansion of consideration for multi-year emergency registrations, addressed above, will reduce the financial burden associated with yearly emergency registration submissions for pest situations requiring multiple years to manage. The fees associated with emergency registrations are limited to those set out in section 3 of the Pest Control Products Fees and Charges Regulations for processing applications and exclude any additional review fees charged in the assessment of regular submissions.

6. Comment

Comments were received requesting much shorter timelines for emergency registration decisions (for example, as little as 24–48 hours).

Health Canada response

While Health Canada completes the review of emergency registration applications as quickly as possible and with the highest level of prioritization, time is required to conduct the necessary risk assessments. The timeline for the review will vary depending on the subject use and the complexity of issues surrounding the request. Under certain circumstances, requests may be processed in a matter of days after submission of a formal application. To facilitate rapid reviews, sponsors must ensure submission packages are complete and that any clarification requests from Health Canada are addressed in a timely manner. It is noted that emergency requests typically submitted to Health Canada would rarely have necessitated such short timelines and that requested dates for first applications are generally met.

7. Comment

Comments were received indicating that declaration forms (for example, statements of no-objection) represent a barrier to obtaining an emergency registration.

Health Canada response

Given the high resource requirement associated with the processing and review of emergency registration requests, Health Canada must obtain beforehand assurance of support from provincial partners involved in the regulation of pesticide use. Declaration forms from provincial environmental ministries, for example, help ensure that emergency registrations, once issued, will be available to users for their intended purpose.

8. Comment

A comment was received requesting flexibility in the number of crops accepted under an emergency registration application for pest situations that affect multiple crops and that multi-crop applications shouldn't have to have identical use patterns between the subject crops, but instead "similar" use patterns.

Health Canada response

Different use patterns may require different risk assessments, which may result in extending the review timeline for an emergency registration and thus reduce Health Canada's ability to rapidly respond to an emergency pest situation. The sponsor should communicate directly with Health Canada ahead of submitting the application to determine if a multi-crop emergency registration is appropriate, or if separate submissions for each crop are advisable to ensure timely completion.

9. Comment

A comment was received requesting that the risk of resistance development to currently registered products be included in the eligibility criteria for emergency registration applications.

Health Canada response

While resistance to registered alternatives may help satisfy the emergency criteria by rendering these insufficient to manage a seriously detrimental pest situation, the potential risk of resistance developing to current pesticides does not constitute an emergency situation in itself. Registrations of products and uses providing new modes of action to reduce the risk of pesticide resistance should be processed through the normal regulatory channels.

10. Comment

A comment was received requesting that sponsor-led evidence of the insufficiency of alternative control measures for pest situations (including field data, academic trials and economic impact analyses) substitute for registrant-led User Request Minor Use Label Expansion (URMULE) submissions in demonstrating ongoing need.

Health Canada response

Sponsors are encouraged to submit evidence of insufficiency; however, emergency registrations are not a permanent solution, and therefore cannot replace regular registrations (for example, those registered through the URMULE program). The sponsor is advised to work with the registrant towards developing the required information.

11. Comment

A comment was received requesting that leniency be provided concerning evidence of progress toward full registration for repeat emergency application requests for minor-use/niche crops, as the registrant incentives for pursuing URMULEs are low.

Health Canada response

While Health Canada recognizes challenges in developing the required information package to support the registration of a claim through normal regulatory channels, the emergency registration pathway cannot be relied on as a permanent solution. Nevertheless, While the sponsor is advised to continue working with the registrant towards developing the required information, Health Canada will continue to take into account crop- and use-specific factors that may delay progress towards full registration.

12. Comment

A comment was received requesting that industry associations be explicitly allowed as sponsors of emergency registration applications.

Health Canada response

While provincial, territorial or federal authorities are best positioned to fulfil all the responsibilities of a sponsor for an emergency registration application, agricultural industry associations are encouraged to partner with representatives from these authorities to prepare and develop the emergency registration submission package. Sponsorship through these authorities is the most efficient means to ensure the support needed from other levels of government is provided (for example, declaration forms stating no objection).

13. Comment

A comment was received requesting clarity on what constitutes an emergency situation.

Health Canada response

Emergency situations encompass a wide variety of scenarios, and the applicant should justify why the pest situation satisfies the criteria outlined in Section 1.0 of Procedures for the Registration of Pesticides for Emergency Use.

14. Comment

A comment was received requesting the prioritization of pre-market submissions addressing emergency registration uses.

Health Canada response

While this comment largely pertains to processes overseen by the Minor Use program more than to the subject of the PRO2025-03 consultation, Health Canada is committed to continue engaging with stakeholders with the goal of further improving the efficiency and responsiveness of its regulatory processes, which may include additional considerations in the prioritization of minor uses. It should also be noted that value assessments conducted as part of a full review for a normal registration consider any emergency registrations previously granted for the subject use and that ongoing reviews for normal registrations that could address the situation at the time of the emergency use request are preferably expedited whenever possible to avoid the need for emergency registration.

15. Comment

A comment was received indicating support for the revised procedures for the registration of pesticides for emergency use.

16. Comments outside of the scope of the guidance document

Health Canada received other comments that were not directly related to the revised Procedures for the Registration of Pesticides for Emergency Use (PRO2025-03) and are not addressed in this document.