Proposed Re-evaluation Decision PRVD2019-06, Tebufenozide and Its Associated End-use Products
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Pest Management Regulatory Agency
11 June 2019
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2019-5E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Tebufenozide
- 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 safety 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.
Tebufenozide is an insect growth regulator used to control Lepidoptera larvae on apples, pears, ornamental crab apple trees, cranberries, bushberries, greenhouse vegetables, greenhouse ornamentals, and forests and woodlots (restricted use). Tebufenozide is applied using ground and aerial equipment. It is registered for commercial use and can be used in residential areas by commercial applicators on ornamentals and trees.
This document (Proposed Re-evaluation Decision PRVD2019-06, Tebufenozide and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of tebufenozide 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 tebufenozide registered in Canada are subject to this proposed re-evaluation decision. This document (PRVD2019-06) 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 the PMRA. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Tebufenozide is the only active ingredient registered to manage certain moth pests on apples, berries, ornamental crab apple trees, and greenhouse ornamentals. Therefore, tebufenozide is an important component of pest management programs aimed at reducing economic damage to crops and ornamental plants from moth infestations.
With respect to human health, dietary (food and drinking water) risks from exposure to tebufenozide under the current conditions of use are shown to be acceptable. The cumulative risks from co-exposure to tebufenozide and methoxyfenozide through food and drinking water are also shown to be acceptable. The occupational risk for workers handling tebufenozide (mixing, loading, and applying) and/or entering and working in a treated site is considered acceptable. The risk to bystanders (from exposure to spray drift from commercial application), for individuals (hikers) entering treated forests and woodlots, as well as for individuals exposed to treated retail plants and residential trees is shown to be acceptable.
When used according to the proposed label directions, potential risks to the environment from tebufenozide, including risks to aquatic environments, are acceptable.
Proposed Regulatory Decision for Tebufenozide
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 tebufenozide are acceptable for continued registration in Canada, provided that the risk mitigation measures are in place.
Registered pesticide product labels include specific directions for use. Directions include risk mitigation measures to protect human health and the environment that must be followed by law. No products or uses are proposed for cancellation. As a result of the re-evaluation of tebufenozide, further risk mitigation measures for product labels are being proposed (Appendix V of PRVD2019-06).
- To meet current labelling standards and for clarity, updates to the label statements on personal protective equipment statements and restricted-entry interval are proposed.
- To meet the current labelling standard and for clarity, updates to the label statements related to spray drift and bystanders are proposed.
- Standard label statement to inform users of the potential toxic effects of tebufenozide to sediment-dwelling aquatic invertebrates.
- Spray buffer zones (up to 25 m) to protect aquatic habitats (Appendix V, Table 1 of PRVD2019-06).
- 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.
Tebufenozide is currently acceptable for use in other Organisation for Economic Co-operation and Development member countries, including Australia, the European Union, and the United States. As of 17 August 2018, no decision by an Organisation for Economic Co-operation and Development member country to prohibit all uses of tebufenozide for health or environmental reasons has been identified.
The public including the registrants and stakeholders are encouraged to submit comments during the 90-day public consultation periodFootnote 1 upon publication of this proposed re-evaluation decision (PRVD2019-06).
All comments received during the 90-day public consultation period will be taken into consideration in preparation of the 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.
Additional Scientific Information
No additional information is required at this time.
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