Re-evaluation decision RVD2024-07, Octenol and its associated end-use products

• Pest Management Regulatory Agency
• 28 June 2024
• ISSN: 1925-1025 (PDF version)
• Catalogue number: H113-28/2024-7E-PDF (PDF version)

Summary

Table of Contents

• Re-evaluation decision for octenol and associated End-use products
• Re-evaluation decision for octenol
• Risk mitigation measures
• Implementation of the re-evaluation decision
• Next steps
• Other Information
• Appendix I Registered products containing octenol in Canada

Re-evaluation decision for octenol 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 meet current health and environmental standards and 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 to all re-evaluations.

This document presents the final re-evaluation decision^{Footnote 1} for the re-evaluation of octenol, including the response to three comments received, and the required label updates. All products containing octenol regulated under the Pest Control Products Act in Canada are subject to this re-evaluation decision.

Octenol is a naturally occurring volatile alcohol, produced and released by many species of plants, animals and mushrooms. Octenol is registered as a mosquito attractant for outdoor use only in devices which trap and kill mosquitos. Octenol is a semiochemical which mimics a component of mammalian breath and is capable of attracting mosquitoes (Canada, 2006). There are only domestic end-use products registered containing octenol.

Currently registered technical grade active ingredient, and end-use products containing octenol can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2023-05, Octenol and Its Associated End-use Products^{Footnote 2} containing the evaluation of octenol and proposed decision, underwent a 90 day consultation period ending on 4 March 2024. PRVD2023-05 proposed continued registration of octenol products in Canada, with updates to label directions and precautions to reflect the current labelling standards and to improve clarity (Appendix IV of RVD2024-07).

Health Canada received three (3) comments during the public consultation. Commenters are listed in Appendix II of RVD2024-07. The comments are summarized in Appendix III of RVD2024-07 along with the responses by Health Canada. The comment did not result in changes to the proposed re-evaluation decision as described in PRVD2023-05. A reference list of information used as the basis for the proposed re-evaluation decision is included in PRVD2023-05.

Re-evaluation decision for octenol

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

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 updated label statements, as a result of the re-evaluation of octenol, are summarized below. Refer to Appendix IV of RVD2024-07 for details.

Label improvements to meet current standards - Human health

• Addition of standard first aid statements to all product labels;

Label improvements to meet current standards - Environment

• Update the storage statement on domestic-class end-use products and disposal statement for technical grade active ingredient to current standard.

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions. When an amendment to a registration is determined to be necessary, such as the need for additional risk mitigation measures, there will be an implementation period of up to two (2) years from the date of the decision to transition to selling and using the product with the newly amended labels, if risks during this period are considered acceptable. Potential risks (human health and the environment) from the use of products containing octenol are acceptable during the implementation period under the current label use conditions. Therefore, the required label updates will be implemented within 24 months following the publication of the re-evaluation decision document.

Next steps

To comply with this decision, the required amendments (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 octenol 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 and Pest Management Section of the Canada.ca website (Public Engagement Portal - Public Engagement Forms - Notice of Objection) or contact PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2023-05) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the Pest Management Information Service.

Appendix I Registered products containing octenol in Canada