Proposed Special Review Decision PSRD2023-02, Special Review of Fosetyl-aluminum and Its Associated End-use Products: Proposed Decision for Consultation

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The online consultation is now closed.

Pest Management Regulatory Agency
14 November 2023
ISSN: 2561-636 (PDF version)
Catalogue number: H113-30/2023-2E-PDF (PDF version)

Summary

Table of contents

• Proposed special review decision for fosetyl-aluminum and associated end use products
• Proposed special review decision for fosetyl-aluminum
• Proposed risk mitigation measures
• Next steps
• Other information

Proposed 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.

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}

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 a new amphibian metamorphosis assay 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

Pursuant to subsection 18(4) of the Pest Control Products Act, Health Canada has evaluated the aspects of concern that prompted the special review of pest control products containing fosetyl-aluminum, which are relevant to the environment.

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 of PSRD2023-02.

This proposed special review decision is a consultation document.^{Footnote 2}

Health Canada will accept written comments on this proposal up to 45 days from the date of publication of this document. Please forward all comments to Publications.

Proposed special review decision for fosetyl-aluminum

Under the authority of the Pest Control Products Act and based on an evaluation of available relevant scientific information related to the aspect of concern, Health Canada is proposing 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 proposed 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.

The proposed additional mitigation measures are summarized below, and details are outlined in Appendix II of PSRD2023-02.

Proposed risk mitigation measures

Environment

Evaluation of available relevant scientific information related to the aspect of concern indicated that the registered uses of fosetyl-aluminum showed acceptable potential risk to amphibians (related to the environment) with implementation of the proposed mitigation measures outlined below and in Appendix II of PSRD2023-02.

• 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.

Next steps

Before making a special review decision on fosetyl-aluminum, Health Canada will consider all comments received from the public in response to this consultation document. A science-based approach will be applied in making a final decision on fosetyl-aluminum. Health Canada will then publish a special review decision document, which will include the decision, the reasons for it, a summary of the comments received on the proposed decision, and Health Canada's response to these comments.

Other information

The relevant confidential test data on which the proposed decision is based (see References section of this document) 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.