Proposed Re-evaluation Decision PRVD2022-09, Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713 and the Associated End-use Products

Pest Management Regulatory Agency
20 May 2022
ISSN: 1925-0967 (PDF version)
Catalogue number: H113-27/2022-9E-PDF (PDF version)

Table of contents

• Proposed re-evaluation decision
• Bacillus amyloliquefaciens strain MBI600:
• Bacillus subtilis strain QST 713
• Next steps for Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713
• Other information
• 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 current health and environmental safety standards and continue to have value. The re- evaluation considers data and information from pesticide manufacturers and other regulatory agencies. Health Canada applies internationally accepted risk assessment methods, risk management approaches and policies to all re-evaluations.

This document (PRVD2022-09, Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713 and the Associated End-use Products) presents the proposed regulatory decision for the re-evaluation of Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713, including any proposed amendments (risk mitigation measures) to protect human health and the environment, as well as the science evaluation on which the proposed decision is based.

Bacillus amyloliquefaciens strain MBI600

Bacillus amyloliquefaciens strain MBI600 is a naturally occurring bacteria which suppresses plant diseases by preventing growth of pathogenic fungi through displacement and direct antagonistic action. Bacillus amyloliquefaciens strain MBI600 (formerly Bacillus subtilis MBI600) has been registered in Canada since 2004 as a treatment of plant growing media such as soil and peat moss-based mixtures to suppress seedling and root diseases caused by various fungal pathogens. It is also registered for foliar use on greenhouse and/or field vegetables and fruits, in-furrow application on potatoes, as a soil drench to greenhouse cucurbits, fruiting vegetables and ornamentals, and as a seed treatment on canola, corn, soybean, dried shelled peas and beans. Currently registered products containing Bacillus amyloliquefaciens strain MBI600 are listed in Appendix I, Table 1 of PRVD2022-09.

Bacillus amyloliquefaciens strain MBI600 has a non-toxic mode of action and has value in providing pest management solutions. Based on the current use pattern of Bacillus amyloliquefaciens strain MBI600 the potential health (occupational, dietary, residential, and bystander) and environmental (aquatic and terrestrial) risks are considered to be acceptable when products are used according to label directions. As a result of re-evaluation, no additional mitigation measures are proposed, however, updates to product labels as per current labelling standards are proposed (Appendix II, Table 2 of PRVD2022-09).

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, products containing Bacillus amyloliquefaciens strain MBI600 (Appendix I, Table 1 of PRVD2022-09) are being proposed for continued registration in Canada, with the proposed updates to label directions (Appendix II of PRVD2022-09).

All products containing Bacillus amyloliquefaciens strain MBI600 registered in Canada are subject to this proposed re-evaluation decision. This document 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.

Bacillus subtilis strain QST 713

Bacillus subtilis strain QST 713 has been registered in Canada since 2007. Bacillus subtilis strain QST 713, is antagonistic toward fungal and bacterial plant pathogens and is a microbial pest control agent for agricultural use, as well as for home garden use on ornamentals, fruits and vegetables. It is used to suppress a number of bacterial and fungal plant pathogens. It is registered for commercial use on a variety of crops, including greenhouse vegetables/herbs (including wasabi), greenhouse ornamentals, corn (for soil pathogens only), herbs and spices, canola and oilseeds, mushroom production, vegetables (asparagus, Brassica, bulb, cucurbits, fruiting, leafy, root and tuber, stem and petiole), potato, pulses (beans, chickpeas, lentils, peas), peanut, soybean, sugarbeet, grape, pome fruit, stone fruit, cane berries, bush berries, small fruit, tobacco (for soil pathogens), outdoor ornamentals and turf. Currently registered products containing Bacillus subtilis strain QST 713 are listed in Appendix I, Table 2 of PRVD2022-09.

Bacillus subtilis strain QST 713 has a non-toxic mode of action and has value in providing pest management solutions. Based on the current use patterns of Bacillus subtilis strain QST 713 the potential health (occupational, dietary, residential, and bystander) and environmental (aquatic and terrestrial) risks are considered to be acceptable when products are used according to label directions. As a result of re-evaluation, no additional mitigation measures are proposed; however, updates to product labels as per current labelling standards are proposed (Appendix II of PRVD2022-09).

Under the authority of the Pest Control Products Act and based on the evaluation of currently available scientific information, products containing Bacillus subtilis strain QST 713 (Appendix I, Table 2 of PRVD2022-09) are being proposed for continued registration in Canada, with the proposed updates to label directions (Appendix II of PRVD2022-09).

All products containing Bacillus subtilis strain QST 713 registered in Canada are subject to this proposed re-evaluation decision. This document is subject to a public consultation,^{Footnote 2} 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 for Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713

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 these proposed re-evaluation decisions.

All comments received during the 90-day public consultation period will be taken into consideration in preparation of the re-evaluation decision document,^{Footnote 3} 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.

Other information

When Health Canada makes its re-evaluation decision, it will publish a Re-evaluation Decision on Bacillus amyloliquefaciens strain MBI600 and Bacillus subtilis strain QST 713 (based on the Science Evaluation of this consultation document). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room.

Additional scientific information

Additional scientific data are not required at this time.