Re-evaluation Decision RVD2021-01, Tebufenozide and Its Associated End-use Products

Pest Management Regulatory Agency
21 January 2021
ISSN: 1925-1025 (PDF version)
Catalogue number: H113-28/2021-01-PDF (PDF version)

Summary

Table of contents

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

Re-evaluation decision for tebufenozide 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.

Tebufenozide is an insect growth regulator used to control Lepidoptera larvae on apples, pears, ornamental crab apple trees, berries, greenhouse vegetables, greenhouse ornamentals, and forests and woodlots (restricted use). Tebufenozide is applied using ground and aerial equipment. Tebufenozide is registered for commercial use and can be used in residential areas by commercial applicators on trees. Currently registered products containing tebufenozide can be found in the Pesticide Label Search and in Appendix I. The Proposed Re-evaluation Decision PRVD2019-06, Tebufenozide and its Associated End-Use products^Footnote 1 containing the evaluation of tebufenozide and proposed decision, underwent a 90-day consultation period ending on 9 September 2019. PRVD2019-06 proposed that products containing tebufenozide are acceptable for continued registration in Canada, provided that the risk mitigation measures are in place.

Health Canada received comments and information relating to the health and environmental assessments. Commenters are listed in Appendix II of RVD2021-01. These comments are summarized in Appendix III along with the responses by Health Canada. These comments and new data did result in revisions to the environmental risk assessments (see Science evaluation update), and did result in changes to the proposed re-evaluation decision as described in PRVD2019-06.

A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2019-06, and further information used in the re-evaluation decision is listed in Appendix VI of RVD2021-01. Therefore, the complete reference list of all information used in this final re-evaluation decision includes both the information set out in the Reference List of the PRVD2019-06 and the information set out in Appendix VI of RVD2021-01.

This document (Re-evaluation Decision RVD2021-01, Tebufenozide and Its Associated End-use Products) presents the final re-evaluation decision^Footnote 2 for the re-evaluation of tebufenozide, including the required amendments (risk mitigation measures) to protect human health and the environment, and any label amendments required to bring labels to current standards. All products containing tebufenozide that are registered in Canada are subject to this re-evaluation decision.

Re-evaluation decision for tebufenozide

Health Canada has completed the re-evaluation of tebufenozide. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing tebufenozide is acceptable. An evaluation of available scientific information found that uses of tebufenozide products meet current standards for protection of human health and the environment when used according to revised label directions, which include mitigation measures. Label amendments, as summarized below and listed in Appendix V, are required.

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/updated label statements and/or mitigation measures, as a result of the re-evaluation of tebufenozide, are summarized below. Refer to Appendix V of RVD2021-01 for details.

Human health

Label improvements to meet current standards:

• Updated label statements for personal protective equipment, restricted-entry intervals and those related to spray drift and bystanders.

Environment

Risk mitigation:

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

• Standard label statement to inform users of the potential toxic effects of tebufenozide to sediment-dwelling aquatic invertebrates.
• Spray buffer zones (up to 15 m) to protect aquatic habitats (Appendix V, Table 1 of RVD2021-01).
• To reduce the potential for runoff of tebufenozide to adjacent aquatic habitats, precautionary label statements for sites with characteristics that may be conducive to runoff and when heavy rain is forecasted.

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 RVD2021-01. 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 RVD2021-01 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 tebufenozide and its associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. 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.

The relevant test data on which the decision is based (as referenced in PRD2019-06 and in Appendix VI of RVD2021-01) 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 by phone (1-800-267-6315) or by e-mail (pmra.info-arla@hc-sc.gc.ca).

Appendix I Registered tebufenozide products in Canada