Proposed Re-evaluation Decision PRVD2021-06, Difenoconazole and Its Associated End-use Products

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Proposed re-evaluation decision for difenoconazole and associated end use products

Under the authority of the Pest Control Products Act, all registered pesticides must be re-evaluated by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet current health and environmental standards and continue to have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Difenoconazole is a systemic fungicide registered for the control of a wide range of fungal diseases on diverse field crops, fruits and vegetables, and turf. Currently registered products containing difenoconazole can be found in the Pesticide Label Search and in Appendix I of PRVD2021-06.

This document (Proposed Re-evaluation Decision PRVD2021-06, Difenoconazole and Its Associated End-use Products) presents the proposed re-evaluation decision for difenoconazole, including the proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based. All products containing difenoconazole that are registered in Canada are subject to this proposed re-evaluation decision. PRVD2021-06 is subject to a 90-day public consultation periodFootnote 1, during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for difenoconazole

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of difenoconazole and all associated end-use products registered for sale and use in Canada.

With respect to human health, occupational and postapplication risks were shown to be acceptable when difenoconazole is used according to proposed conditions of registration, which include new mitigation measures, such as updated engineering controls, personal protective equipment, statements reducing potential drift and hazard statements on seed tags. Dietary risks were shown to be acceptable when used according to current conditions of registration.

Based on available scientific information, potential risks to the environment were shown to be acceptable when difenoconazole is used according to the proposed conditions of registration, which includes new mitigation measures such as additional precautionary label statements and spray buffer zones.

Difenoconazole controls a wide range of fungal diseases on different field crops, fruits, vegetables and turf as a foliar spray, post-harvest spray and as a seed treatment. It is of particular importance for the control of Fusarium dry rot in potato as there are few registered alternative active ingredients to manage this storage pathogen.

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 proposed label amendments including any revised/updated label statements and/or mitigation measures, as a result of the re-evaluation of difenoconazole, are summarized below. Refer to Appendix VIII of PRVD2021-06 for details.

Human health

As a result of the re-evaluation of difenoconazole, the PMRA is proposing additional risk-reduction measures to minimize the potential human health risks. Additional revisions to the difenoconazole labels are proposed to update label statements to current policies and language.

Risk mitigation:

To protect workers, the general population and animals, the following risk-reduction measures are proposed:

Environment

Risk mitigation:

To protect the environment, the following risk-reduction measures are proposed:

International context

Difenoconazole is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States and the European Union. No decision by an OECD member country to prohibit all uses of difenoconazole for health or environmental reasons has been identified as of 6 November 2020.

Next steps

Upon publication of this proposed re-evaluation decision, the public, including the registrants and stakeholders are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document,Footnote 2 which could result in revised risk mitigation measures. The re-evaluation decision document will include the final re-evaluation decision, the reasons for it and a summary of comments received on the proposed re-evaluation decision with Health Canada's responses.

Refer to Appendix I of PRVD2021-06 for details on products impacted by this proposed decision.

Additional scientific information

No additional scientific data are required at this time.

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