Proposed re-evaluation decision PRVD2020-01, Fenhexamid and its associated end-use products
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Pest Management Regulatory Agency
7 January 2020
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2020-01E-PDF (PDF version)
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Table of contents
- Proposed re-evaluation decision
- Outcome of science evaluation
- Proposed regulatory decision for Fenhexamid
- Proposed risk mitigation measures
- International context
- Next steps
- Additional scientific information
Proposed re-evaluation decision
Under the authority of the Pest Control Products Act, all registered pesticides must be regularly 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.
Fenhexamid is a foliar fungicide registered for use on greenhouse vegetables and ornamentals, as well as outdoor fruit trees, berries, ginseng, grapes, stone fruits and ornamentals. Currently registered products containing fenhexamid can be found in Appendix I of PRVD2020-01.
This document (Proposed Re-evaluation Decision PRVD2020-01, Fenhexamid and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of fenhexamid including the proposed risk mitigation measures to further protect human health and the environment, as well as the science evaluation on which the proposed decision was based. All products containing fenhexamid registered in Canada are subject to this proposed re-evaluation decision. PRVD2020-01 is subject to a 90-day public consultation period, 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 taking into consideration the comments and information received.
Outcome of science evaluation
Fenhexamid controls gray mold on a wide variety of crops and ornamentals. It is an important rotational fungicide as it is the only Group 17 mode of action registered on several agricultural commodities for managing Botrytis cinerea, which is susceptible to developing fungicide resistance.
With respect to human health, risks have been shown to be acceptable with mitigation measures required for greenhouse and outdoor ornamentals grown for cut flowers. Exposure from the remaining uses is unlikely to affect human health when used according to the proposed label directions.
Fenhexamid enters the environment when used to control molds in a variety of agricultural food and feed crops and outdoor ornamentals or when it is present in discharge water from use in greenhouses. Based on available scientific information, potential risks to the environment have been shown to be acceptable when fenhexamid is used according to the proposed label directions.
Proposed regulatory decision for fenhexamid
Under the authority of the Pest Control Products Act, and based on the evaluation of currently available scientific information, Health Canada is proposing that products containing fenhexamid are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place.
Proposed 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. As a result of the re-evaluation of fenhexamid, further risk mitigation measures, as summarized below, are being proposed for product labels. Refer to Appendix IX of PRVD2020-01 for details.
To protect mixer/loader/applicators:
- Require that workers wear a minimum level of protective clothing, including chemical-resistant gloves;
- Require that workers wear additional personal protective equipment (PPE) when applying using handheld air blast/mistblower equipment.
To protect workers entering treated sites:
- Increase the minimum restricted entry interval (REI) from 4 to 12 hours;
- Increase the REIs for some postapplication activities in some crops;
- Reduce the number of applications for greenhouse and outdoor ornamentals grown for cut flower production
To protect bystanders from spray drift:
Require a statement on end-use product labels to promote best management practices to minimize human exposure from spray drift or spray residues resulting from drift.
To protect the environment:
- Standard label statements to inform users of the potential toxic effect of fenhexamid to small mammals, fish and amphibians;
- Spray buffer zones up to 20 m to protect sensitive aquatic habitats;
- Precautionary label statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted to reduce the potential for runoff of fenhexamid into adjacent aquatic habitats;
- A label statement directing users not to discharge fenhexamid-contaminated effluent from greenhouses into aquatic environments.
Fenhexamid is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States, the EU, and Australia. No decision by an OECD member country to prohibit all uses of fenhexamid for health or environmental reasons has been identified.
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 periodFootnote 1 upon publication of PRVD2020-01.
All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision documentFootnote 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.
Additional scientific information
No additional data are required at this time.
For the uses where changes to the use pattern are proposed as mitigation measures, Health Canada is asking stakeholders if these measures are considered to be agronomically feasible for the management of the pest in the production of the crop across Canada. Stakeholders are specifically asked to provide comment regarding the feasibility of the proposed new 3-day restricted entry interval for fruit thinning by hand in stone fruit (cherries, peaches and nectarines).
Stakeholders should also note that for the control of Botrytis, the registrant has requested to reduce the number of applications from 3 to 1 for grapes, and from 3 to 2 per crop cycle for greenhouse tomatoes and greenhouse peppers.
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