Proposed Re-evaluation Decision PRVD2022-13, Bacillus sphaericus Strain 2362 and Its Associated End-use Products

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Pest Management Regulatory Agency
5 July 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-13E-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 regularly by Health Canada's Pest Management Regulatory Agency (PMRA) to ensure that they continue to meet health and environmental safety standards and continue to have value. The re-evaluation considers data and information from various sources such as information from pesticide manufacturers, incident reports, and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods, risk management approaches and policies to all re-evaluations.

This document (Proposed Re-evaluation Decision PRVD2022-13, Bacillus sphaericus Strain 2362 and Its Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of Bacillus sphaericus strain 2362.

Bacillus sphaericus strain 2362 is a microbial insecticide registered for control of mosquito larvae in various aquatic habitats. In Bacillus sphaericus strain 2362, insecticidal activity is attributed to two distinct toxin types: the mosquitocidal toxin (Mtx) and the binary toxin (Btx). Btx is produced during sporulation and contributes to the primary toxic activity of commercial insecticidal strains after ingestion by mosquito larvae. Mtx exhibits lower insecticidal activity. As production batches of B. sphaericus strain 2362 are produced in a manner to permit sporulation and formation of Btx, little Mtx is expected to remain and additional processing into the end-use products further inactivates the toxin.

End-use products are classified as Restricted Class and formulated as wettable granules, a granular, or as a granular packaged in water soluble pouches. These products are applied to catch basins, water bodies and to waste tires. Depending on the site of application, these products are applied by hand or using ground or aerial application equipment. Currently registered products containing Bacillus sphaericus strain 2362 are listed in Appendix I of PRVD2022-13.

Bacillus sphaericus strain 2362 is of value for mosquito control targeting mosquito larvae. As a biological insecticide, Bacillus sphaericus strain 2362 provides a unique alternative to conventional chemical methods for mosquito control. The potential risks to human health (occupational, residential, bystander and dietary) and the environment are considered to be acceptable when products containing Bacillus sphaericus strain 2362 are used according to label directions. 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. In order to meet current standards, label updates to clarify use directions for products containing Bacillus sphaericus strain 2362 are proposed in Appendix II of PRVD2022-13. The proposed label updates as a result of the re-evaluation of products containing Bacillus sphaericus strain are summarized below:

• Update warning statement on primary principle panel and Notice to User statement for all products.
• Add drift statement for products with aerial and ground applications.
• Update personal protection equipment (PPE) for Vectolex CG.
• Clarify application rate and include aerial application directions for Vectolex WDG.
• Add storage and handling instructions for Vectolex WSP.

Under the authority of the Pest Control Products Act and based on an evaluation of currently available scientific information, products containing Bacillus sphaericus strain 2362 (Appendix I of PRVD2022-13) are being proposed for continued registration in Canada, with the proposed updates to label directions (Appendix II of PRVD2022-13).

All products containing Bacillus sphaericus strain 2362 registered in Canada are subject to this proposed re-evaluation decision. This document (PRVD2022-13) is subject to a public consultation^{Footnote 1}, during which written comments and additional information may be submitted to PMRA Publications. The final re-evaluation decision will be published taking into consideration the comments and information received during the consultation period.

Next steps

The public, including the registrant and stakeholders, are encouraged to submit written comments and additional information during the 90-day public consultation period upon publication of PRVD2022-13.

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

Additional scientific data are not required.