Proposed Re-evaluation Decision PRVD2021-13, Octadec-9-enoic Acid, Methyl Ester and Octadec-9-enoic Acid, Ethyl Ester

• Pest Management Regulatory Agency
• 20 December 2021
• ISSN: 1925-0967 (PDF version)
• Catalogue number: H113-27/2021-13E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision
• Next steps
• Additional scientific information

Proposed re-evaluation decision

Under 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. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

Octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester are esterified fatty acids made from vegetable oil. In Canada, these two substances are registered as adjuvants and are always co-formulated. There are currently three commercial end-use products registered containing octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester, formulated as emulsifiable concentrates (Appendix I of Proposed Re-evaluation Decision PRVD2021-13, Octadec-9-enoic Acid, Methyl Ester and Octadec-9-enoic Acid, Ethyl Ester). Octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester are also used as formulants^{Footnote 1} (List 4B) in other pesticide products and are listed as inert ingredients^{Footnote 2} by the United States Environmental Protection Agency (USEPA).

Octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester are considered activator or spray modifier adjuvants which are intended to improve the efficacy or enhance the biological performance of the pest control product with which they are tank mixed, by modifying or enhancing physical or chemical characteristics. Octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester are registered for use as a tank mix with a variety of herbicides and insecticides. Application directions of these adjuvants will vary based upon the pest control products with which they are tank-mixed. Refer to the registered adjuvant product labels for the tank mix partners. For specific details of uses, application rates and methods, precautions, restrictions, and personal protective equipment requirements, refer to the associated product label.

This document (Proposed Re-evaluation Decision PRVD2021-13, Octadec-9-enoic Acid, Methyl Ester and Octadec-9-enoic Acid, Ethyl Ester) presents the proposed regulatory decision for the re-evaluation of the following adjuvants:

When the current label directions are followed, potential risks to human health (occupational, dietary and bystander) and the environment (aquatic and terrestrial organisms) are considered to be acceptable. However, label updates are proposed to meet the current labelling standards (Appendix II of PRVD2021-13). Updates to standard label statements related to human health (wording for using the most restrictive precautions of the tank-mix labels) and environment (wording for using the most restrictive precautions and avoiding contamination of aquatic habitats and drinking water) are proposed.

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, products containing octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester listed in Appendix I of PRVD2021-13, have value and are being proposed for continued registration in Canada.

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. As a result of the re-evaluation of octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester, no further risk mitigation measures for the adjuvant product labels are being proposed.

All products containing octadec-9-enoic acid, methyl ester and octadec-9-enoic acid, ethyl ester registered in Canada are subject to this proposed re-evaluation decision. Proposed Re-evaluation Decision PRVD2021-13 is subject to a public consultation,^{Footnote 3} during which written comments and additional information may be submitted to the PMRA. The final re-evaluation decision will be published taking into consideration the comments and information received during consultation.

Next steps

The public, including the registrants and stakeholders, are encouraged to submit comments and additional information during the 90-day public consultation period upon publication of PRVD2021-13.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of re-evaluation decision document,^{Footnote 4} 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.