Special Review Decision SRD2024-02, Fosetyl-aluminum and its associated end-use products

Pest Management Regulatory Agency
29 August 2024
ISSN: 2561-6269 (PDF version)
Catalogue number: H113-17/2024-XE-PDF (PDF version)

Summary

Table of contents

• Special review decision for fosetyl-aluminum and associated end-use products
• Special review decision for fosetyl-aluminum
• Risk mitigation measures
• Implementation of the special review decision
• Next steps
• Other information
• Evaluation approach
• Appendix I Registered products containing fosetyl-aluminum in Canada

Special review decision for fosetyl-aluminum and associated end-use products

Under the authority of the Pest Control Products Act, pesticides are regulated by Health Canada's Pest Management Regulatory Agency (PMRA) on behalf of the Minister of Health. The Pest Control Products Act prescribes both the pre-market and post-market assessment (re-evaluations and special reviews) of pesticides to determine the acceptability or continued acceptability of human health and environmental risks, and acceptable value of a pesticide in Canada. Unlike a re-evaluation, a special review is triggered only under certain circumstances, as described in section 17 of the Pest Control Products Act, and the intent of a special review is to address specifically the identified aspect(s) of concern. The special review approach is described in the PMRA Guidance Document: Approach to Special Reviews of Pesticides. More details on the legislative framework are provided under the Legislative Framework Section of this document.

Health Canada evaluates the aspect(s) of concern that prompted the special review in accordance with subsection 18(4) of the Pest Control Products Act. The internationally accepted science-based approach is used for the assessment of the aspect(s) of concern, similar to all other scientific assessments (for example, new product registrations, re-evaluations). This step includes both risk (or value, if applicable) assessment and risk management to address the concerns identified. Health Canada's approach to risk and value assessment as well as risk management is outlined in the Framework for Risk Assessment and Risk Management of Pest Control Products.^{Footnote 1}

Fosetyl-aluminum is a systemic fungicide used for the control of various diseases on a wide range of agricultural crops, ornamentals and turf. Fosetyl-aluminum end-use products are formulated as water dispersible or wettable granules, or wettable powder. Products are applied by groundboom field sprayer, airblast sprayer, or as a drench application. All currently registered products containing fosetyl-aluminum have been considered in this special review. Currently registered pest control products containing fosetyl-aluminum are listed in Appendix I.

Pursuant to subsection 17(1) of the Pest Control Products Act, Health Canada initiated a special review of all registered pest control products containing fosetyl-aluminum, based on an amphibian metamorphosis assay study submitted through the PMRA's Incident Reporting Program (IRP). The identified aspect of concern is:

• Potential environmental risk to amphibians from exposure to fosetyl-aluminum

This document presents the final regulatory decision^{Footnote 2} for the special review of fosetyl-aluminum. All pest control products containing fosetyl-aluminum that are registered in Canada are subject to this special review decision. Prior to finalizing this decision, Health Canada published the Proposed Special Review Decision PSRD2023-02, Proposed Special Review Decision of Fosetyl-aluminum and Its Associated End-use Products,^{Footnote 3} which underwent a 45-day public consultation period ending on 29 December 2023. Comments were received from a member of the public however, these comments did not change the outcome of the proposed special review decision presented in PSRD2023-02 (Appendix II and Appendix III of SRD2024-02). Therefore, this decision is consistent with the proposed regulatory decision as described in PSRD2023-02.

A reference list of information used as the basis for the proposed special review decision is included in PSRD2023-02. No further information was provided since the publication PSRD2023-02. Therefore, the complete reference list of all information used in this final special review decision is included in PSRD2023-02.

Special review decision for fosetyl-aluminum

Health Canada has completed the special review for fosetyl-aluminum. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of fosetyl-aluminum is acceptable with additional risk mitigation measures.

The assessment of the aspect of concern from this special review indicates that potential risks to amphibians (related to the environment) from the use of fosetyl-aluminum are considered to be acceptable provided that risk mitigation measures are implemented, which includes additional label directions and updated spray buffer zones for the protection of freshwater habitats less than one metre deep.

Risk mitigation measures

Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment and must be followed by law. The required amendments, as a result of the special review of fosetyl-aluminum, are summarized below. Refer to Appendix IV of SRD2024-02 for details.

Environment

• Updated buffer zones of 1 to 25 m to protect sensitive freshwater habitats less than one metre deep (for the protection of amphibians).
• Updated label directions to prohibit releases, effluent or runoff from greenhouses containing this product to enter lakes, streams, ponds or other waters.

Implementation of the special review decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions (in other words, up to 24-month timeline for label amendments and up to 36-month timeline for cancellation), and Information Note: Update on implementation of post-market decisions provides additional information on phase-out measures for post-market decisions that include cancellations. The post-market decision considers potential health and environmental risks regarding the use of the pest control product, and its value, when establishing the implementation timelines.

With respect to fosetyl-aluminum, it is noted that the ecotoxicological effect parameter used in the risk assessment is a concentration at which no adverse effects to amphibians were observed. As such, the likelihood of the effect having an impact at the population level during a 2-year implementation period is considered to be sufficiently low and the risk is considered to be acceptable during the implementation period, when current label mitigations are followed. In addition, evidence from incident reports related to the aspect of concern was considered. There were no incidents related to the aspects of concern in the Canadian incident report database. Taking into consideration these factors, the general 2-year implementation timeline for label amendments for fosetyl-aluminum is considered appropriate.

Amendment timeframe

Based on the above consideration, the required amendments (mitigation measures and label updates) for pest control products containing fosetyl-aluminum must be implemented within 24 months from the date of this decision document.

Refer to Appendix I for details on specific products impacted by this decision.

Next steps

To comply with this decision, the required label amendments (Appendix IV of SRD2024-02) must be implemented no later than 24 months after the publication date of this decision document. Accordingly, both registrants and retailers will have up to 24 months from the date of this decision document to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of this decision document to transition to using the newly amended labels, which will be available on the Public Registry.

Other information

Any person may file a notice of objection^{Footnote 4} regarding this decision on fosetyl-aluminum within 60 days from the date of publication of this Special Review Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of Canada.ca (Public Engagement Portal – Public Engagement Forms – Notice of Objection) or the PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PSRD2023-02) are available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Evaluation approach

Legislative framework

The Minister of Health's primary objective under the Pest Control Products Act (the Act) subsection 4(1) is to prevent unacceptable risks to individuals and the environment from the use of pest control products.

As noted in the preamble of the Act, it is in the national interest that the attainment of the objectives of the federal regulatory system continue to be pursued through a scientifically-based national registration system that addresses risks to human health, the environment and value both before and after registration and applies to the regulation of pest control products throughout Canada; and that pest control products with acceptable risk and value be registered for use only if it is shown that their use would be efficacious and if conditions of registration can be established to prevent unacceptable risks to human health and the environment.

For the purposes of the Act, the health or environmental risks of a pest control product are acceptable if there is reasonable certainty that no harm to human health, future generations or the environment will result from exposure to or use of the product, taking into account its conditions of registration as per subsection 2(2) of the Pest Control Products Act.

Risk for the human health and environment, and value are defined under the Act subsection 2(1) as follows:

• Health risk, in respect of a pest control product, means the possibility of harm to human health resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
• Environmental risk, in respect of a pest control product, means the possibility of harm to the environment, including its biological diversity, resulting from exposure to or use of the product, taking into account its conditions or proposed conditions of registration.
• Value, in respect of a pest control product, means the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact.

When evaluating the health and environmental risks of a pesticide and determining whether those risks are acceptable, subsection 19(2) of the Pest Control Products Act requires Health Canada to apply a scientifically-based approach.

The science-based approach to assessing pesticides considers both the toxicity and the level of exposure of a pesticide in order to fully characterize risk. Health Canada's approach to risk and value assessment is outlined in A Framework for Risk Assessment and Risk Management of Pest Control Products.^{Footnote 5}

Appendix I Registered products containing fosetyl-aluminum in Canada