Re-evaluation Decision RVD2021-02, Fenhexamid and Its Associated End-use Products

Pest Management Regulatory Agency
26 February 2021
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2021-2E-PDF (PDF version)

Summary

Table of contents

• Re-evaluation decision for fenhexamid and associated end-use products
• Re-evaluation decision for fenhexamid
• Risk mitigation measures
• Next steps
• Other information
• Appendix I - Registered fenhexamid products in Canada

Re-evaluation decision for fenhexamid 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, as well as comments received during public consultations. 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 the Pesticide Label Search and in Appendix I.

The Proposed Re-evaluation Decision PRVD2020-01, Fenhexamid and Its Associated End-use Products^Footnote 1containing the evaluation of fenhexamid and the proposed decision underwent a 90 day consultation period ending on 6 April 2020. PRVD2020-01 proposed that products containing fenhexamid are acceptable for continued registration in Canada, provided that the additional proposed risk mitigation measures are in place. The proposed risk mitigation measures included: additional personal protective equipment (PPE), increased restricted-entry intervals (REIs), reduction in number of applications for some crops, environmental hazard statements including terrestrial spray buffer zones, and standard runoff statements.

Health Canada received comments relating to the value and occupational assessments. Commenters are listed in Appendix II of RVD2021-02. The comments are summarized in Appendix III of RVD2021-02 along with the responses by Health Canada. The comments did not result in revisions to the risk assessments, and did not result in changes to the proposed re-evaluation decision as described in PRVD2020-01.

This document (Re-evaluation Decision RVD2021-02, Fenhexamid and Its Associated End-use Products) presents the final regulatory decision^Footnote 2 for the re-evaluation of fenhexamid, including the required amendments (risk mitigation measures) to protect human health and the environment, as well as the label amendments required to bring labels to current standards. All products containing fenhexamid that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for fenhexamid

Health Canada has completed the re-evaluation of fenhexamid. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing fenhexamid is acceptable. An evaluation of available scientific information found that the use of fenhexamid products meet current standards for protection of human health and the environment when used according to revised conditions of registration, which includes new mitigation measures.

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, including any revised label statements and mitigation measures, as a result of the re-evaluation of fenhexamid, are summarized below. Refer to Appendix IV of RVD2021-02 for details.

Human health

To protect human health, the following risk-reduction measures are required for continued registration of fenhexamid in Canada:

• For mixers/loaders and applicators:
  • Wear long-sleeved shirt, long pants and chemical-resistant gloves.
  • When applying using handheld airblast/mistblower equipment, wear chemical resistant coveralls with a chemical resistant hood over long-sleeved shirt, long pants, and chemical-resistant gloves, and a respirator.

• For postapplication workers:
  • Increase the current label REI of 4 hours to 12 hours. Longer REIs are also required for some specific crops and activities (Appendix IV of RVD2021-02).
  • Decrease the number of applications for ornamentals grown for cut flowers from 6 applications/year or crop cycle to 1 per crop cycle (greenhouse) and 4 per year (outdoor).

Environment

To protect the environment, the following risk-reduction measures are required for continued
registration of fenhexamid in Canada:

• Standard hazard statements are required to inform users of the potential for toxic effects to mammals, fish and amphibians.
• To reduce the potential for runoff of fenhexamid to adjacent aquatic habitats, precautionary statements are required for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted.
• To mitigate the potential impact of spray drift on non-target organisms, spray buffer zones of 1–20 m are required to protect sensitive aquatic habitats.
• A label statement directing users not to discharge fenhexamid-contaminated effluent from greenhouses into aquatic environments is also required.

Next steps

To comply with this decision, the required amendments (mitigation measures and label updates) must be implemented on all product labels 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. Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection^Footnote 3 regarding this decision on fenhexamid within 60 days from the date of publication of RVD2021-02. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact the PMRA's Pest Management Information Service by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca).

The relevant test data on which the decision is based (as referenced in PRVD2020-01) are available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa). For more information, please contact the PMRA's Pest Management Information Service

Appendix I Registered fenhexamid products in Canada