Proposed Re-evaluation Decision PRVD2018-02, Soybean Oil and Its Associated End-use Products
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Pest Management Regulatory Agency
31 January 2018
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2018-2E-PDF (PDF version)
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Table of Contents
- Proposed Re-evaluation Decision
- Outcome of Science Evaluation
- Proposed Regulatory Decision for Soybean Oil
- 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. The PMRA applies internationally accepted risk assessment methods as well as current risk management approaches and policies to all re-evaluations.
Soybean oil is registered as an indoor insecticide for domestic use to kill several household pests (for example, ants, cockroaches, and spiders). It is also registered as a personal insect repellent for mosquitoes and black flies. Soybean oil is manufactured from a naturally occurring plant, has a long history of use as a food, and can be found incorporated into various cosmetics and natural health products. The indoor domestic insecticide products are sprayed directly onto target pests as a household crack and crevice spot treatment, and the personal insect repellent products are applied directly to the skin. Soybean oil end-use products are formulated as ready-to-use products.
This proposed re-evaluation decision (PRVD2018-02) presents the proposed regulatory decision for the re-evaluation of soybean oil and includes the proposed label updates to meet the current standards, as well as the science evaluation on which the proposed decision was based. All products containing soybean oil registered as an insecticide in Canada are subject to this proposed re-evaluation decision. Proposed Re-evaluation Decision PRVD2018-02, Soybean Oil and Its Associated End-use Products 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 Publications Section. The final re-evaluation decision will be published taking into consideration the comments and information received.
Outcome of Science Evaluation
Soybean oil has value in providing non-conventional solutions for insect control. As an indoor domestic insecticide, soybean oil can play an important part in resistance management, and as a personal insect repellent, soybean oil has value in offering Canadians access to a plant-based personal repellent.
Soybean oil is manufactured from a naturally occurring plant, has a long history of use as a food, and can be found incorporated into various cosmetics and natural health products. In laboratory animals, the active ingredient was of low acute toxicity via the oral, dermal, and inhalation routes of exposure. It was not a skin or eye irritant, and was not a skin sensitizer. Since soybean oil contains soy, a priority allergen, adequate warning statements (for example, “Warning, contains the allergen soy”) appear on the technical grade active ingredient and end-use product labels.
When current label directions on pesticide products containing soybean oil are observed, exposures to all populations (including applicators and bystanders) are not of concern from the use of soybean oil as an indoor insecticide and personal insect repellent. Soybean oil is not registered for use on food or outdoor sites; therefore, risks from dietary (food and drinking water) exposure to soybean oil is not of concern for all populations.
When used under the current label directions, environmental exposure to soybean oil is expected to be minimal. The potential environmental risks from these uses are not expected to be of concern.
Proposed Regulatory Decision for Soybean Oil
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 soybean oil (used as an insecticide) are acceptable for continued registration for use and sale in Canada, provided that the proposed updates to label directions are in place.
Registered pesticide product labels include specific instructions 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 soybean oil, no additional risk mitigation measures are proposed by the PMRA. To meet current labelling standards, the following label updates are proposed (Refer to the details in Appendix II of PRVD2018-02, Soybean Oil and Its Associated End-use Products):
- Storage and disposal label statements.
Soybean oil is currently acceptable for use in other Organization for Economic Co-operation and Development (OECD) member countries, including the United States of America, Mexico, and Chile. As of 30 October 2017, no decision by an OECD member country to prohibit all uses of soybean oil 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 Proposed Re-evaluation Decision PRVD2018-02, Soybean Oil and Its Associated End-use Products.
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 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 along with the PMRA’s responses.
Additional Scientific Information
No additional data are required.
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