Proposed Re-evaluation Decision PRVD2021-14, p-Menthane-3,8-diol and Its Associated End-use Products

Pest Management Regulatory Agency
20 December 2021
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2021-14E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision for p-menthane-3,8-diol and associated end-use products
• Proposed re-evaluation decision for p-menthane-3,8-diol
• Risk mitigation measures
• International context
• Next steps
• Additional scientific information

Proposed re-evaluation decision for p-menthane-3,8-diol 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. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

p-Menthane-3,8-diol is a synthetic analogue of a compound derived from the lemon eucalyptus plant. Products containing p-menthane-3,8-diol are applied as personal insect repellents to repel mosquitoes, biting midges, blackflies and ticks. Currently registered products containing p-menthane-3,8-diol can be found in the Pesticide Label Search and in Appendix I of PRVD2021‑14, p-Menthane-3,8-diol and Its Associated End-use Products.

This document (PRVD2021-14) presents the proposed re-evaluation decision for p-menthane-3,8-diol, as well as the science evaluation on which the proposed decision is based. All products containing p-menthane-3,8-diol that are registered in Canada are subject to this proposed re-evaluation decision. This document is subject to a 90-day public consultation period,^{Footnote 1} during which the public (including the pesticide manufacturers and stakeholders) may submit written comments and additional information to PMRA Publications. The final re-evaluation decision will be published after taking into consideration the comments and information received during the consultation period.

Proposed re-evaluation decision for p-menthane-3,8-diol

Under the authority of the Pest Control Products Act and based on an evaluation of available scientific information, Health Canada is proposing continued registration of p-menthane-3,8-diol and associated end-use products registered for sale and use in Canada. No additional risk mitigation measures are proposed.

Human health risks from the use of p-menthane-3,8-diol and its associated end-use products were shown to be acceptable, when used according to current label directions. Therefore, Health Canada is proposing that products containing p-menthane-3,8-diol are acceptable for continued registration in Canada.

An environmental assessment is not required for the use of p-menthane-3,8-diol as a personal insect repellent.

p-Menthane-3,8-diol has value as an personal insect repellent by providing an additional choice for mosquito, biting midges, ticks and blackfly repellent users.

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. As a result of the re-evaluation of p-menthane-3,8-diol, no additional risk mitigation measures for product labels are proposed.

International context

p-Menthane-3,8-diol is currently acceptable for use in other Organisation for Economic Co-operation and Development (OECD) member countries, including the United States and Australia. No decision by an OECD member country to prohibit all uses of p-menthane-3,8-diol for health or environmental reasons has been identified.

Next steps

Upon publication of this proposed re-evaluation decision, the public, including the registrants and stakeholders are encouraged to submit additional information that could be used to refine risk assessments during the 90-day public consultation period.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of 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 PRVD2021-14 with Health Canada’s responses.

Refer to Appendix I of PRVD2021-14 for details on specific products impacted by this proposed decision.

Additional scientific information

No additional scientific data are required at this time.