Canada re-evaluated Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 and their associated end-use products

Re-evaluation decision for Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 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 meet current health and environmental standards and have value. The re-evaluation considers data and information from pesticide manufacturers, published scientific reports and other regulatory agencies, as well as comments received during public consultations. Health Canada applies internationally accepted risk assessment methods as well as current risk management approaches and policies.

This document (Re-evaluation Decision RVD2024-02, Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 and Their Associated End-use Products) presents the final re-evaluation decision for the re-evaluation of Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 including the required label updates. All products containing Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 regulated under the Pest Control Products Act in Canada are subject to this re-evaluation decision.

Bacillus amyloliquefaciens strain MBI 600

Bacillus amyloliquefaciens strain MBI 600 is a naturally occurring bacteria which suppresses plant diseases by preventing growth of pathogenic fungi through displacement and direct antagonistic action. Bacillus amyloliquefaciens strain MBI 600 (formerly Bacillus subtilis MBI 600) is registered in Canada 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 ornamentals, field vegetables and fruits (grape, carrot, potato, sugar beet, cucumber, caneberries, bushberries), greenhouse and field vegetables and fruits (lettuce, pepper, cucurbits, tomato and low growing berries), 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.

Bacillus subtilis strain QST 713

Bacillus subtilis strain QST 713 is registered in Canada as a microbial pest control agent to suppress a number of bacterial and fungal plant pathogens. It is registered for commercial use on a variety of crops: 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, caneberries, bushberries, small fruit, tobacco (for soil pathogens), outdoor ornamentals and turf.

Currently registered technical grade active ingredient, and end-use products containing Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 can be found in the Pesticide Product Information Database and in Appendix I. The Proposed Re-evaluation Decision PRVD2022-09, Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 and the Associated End-use Products containing the evaluation and proposed decision for these two actives, underwent a 90-day consultation period ending on 16 August 2022. PRVD2022-09 proposed continued registration of Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 and all associated registered end-use products for sale and use in Canada, with updates to label directions and precautions to reflect the current labelling standards and to improve clarity (Appendix II of the full version of RVD2024-02).

No comments were received during the consultation period. Therefore, this decision is consistent with the proposed re-evaluation decision stated in PRVD2022-09, which lists all information used as the basis for the re-evaluation decision.

Re-evaluation decision for Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713

Health Canada has completed the re-evaluation of Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713. Under the authority of the Pest Control Products Act, Health Canada has determined that continued registration of products containing Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 is acceptable. An evaluation of available scientific information found that the use of Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 products meets current standards for protection of human health and the environment and have acceptable value when used according to revised conditions of registration which includes label amendments.

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. The required label amendments, as a result of the re-evaluation of Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713, are summarized below. Refer to Appendix II of RVD2024-02 for details.

Bacillus amyloliquefaciens strain MBI 600

• General label amendments

• Add standard statements for primary display panels of labels (for example, product type, live organism)

• Add standard statements for seed treatments (for example, colouring of treated seed).

• Update storage sections on technical grade active ingredients and end-use products labels to current statements.

• Human health

• Add standard statements for seed treatments (for example, colouring of treated seed) and tank mixes.

• Update tank mix statement to current standard.

• Added standard use restrictions and precautions statements.

• Environment

• Add standard statements for seed treatments (for example, incorporating treated seed into soil).

• Add standard precaution statements.

• Update disposal statement to current standard.

Bacillus subtilisstrain QST 713

• Environment

• Updates to standard label statements (directions for use).

Implementation of the re-evaluation decision

Regulatory Directive DIR2018-01, Policy on Cancellations and Amendments Following Re-evaluation and Special Review provides general timelines for implementation of post-market decisions. When an amendment to a registration is determined to be necessary, such as the need for additional risk mitigation measures, there will be an implementation period of up to two (2) years from the date of the decision to transition to selling and using the product with the newly amended labels, if risks during this period are considered acceptable. Potential risks (human health and the environment) from the use of products containing Bacillus amyloliquefaciens strain MBI 600 or Bacillus subtilis strain QST 713 are acceptable during the implementation period under the current label use conditions. Therefore, the required label updates will be implemented within 24 months following the publication of the re-evaluation decision document.

When conducting human health risk assessments, risks from exposure to a pesticide are estimated by comparing potential exposures with the most relevant endpoint from toxicology studies, with standard protection factors incorporated to further protect human health, including the most sensitive population. These factors provide an inherent level of protection from exposures that could result in adverse effects to human health. Furthermore, Health Canada applies additional protection factors if warranted by the hazard profile of the pesticide or by the quality and completeness of the underlying data. When risks of concern are identified in the human health exposure scenarios, it does not necessarily mean that exposure will result in adverse effects, but mitigation measures to reduce potential risks would be required in order to support continued registration of the product/use.

Potential and relative health risks are thus considered acceptable during the general 2-year implementation period unless there is evidence from incident reports or other sources of real-world post-market surveillance data suggesting that there are adverse health effects occurring as a result of the use of the product(s) according to the currently approved label/use conditions. Other considerations may include how widely the product is used, the populations potentially exposed to the product and/or other factors.

The required label amendments are to update the statements to meet current labelling standards. Potential human health and environmental risks are considered acceptable based on the current use conditions for products containing Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 during the 24-month implementation timeline for label amendments.

Next steps

To comply with this decision, the required amendments (label updates) must be implemented on all product labels no later than 24 months after the publication date of RVD2024-02. Accordingly, both registrants and retailers will have up to 24 months from the date of RVD2024-02 to transition to selling the product with the newly amended labels. Similarly, users will also have the same 24-month period from the date of RVD2024-02 to transition to using the newly amended labels, which will be available on the Public Registry.

Refer to Appendix I for details on specific products impacted by this decision.

Other information

Any person may file a notice of objection regarding this decision on Bacillus amyloliquefaciens strain MBI 600 and Bacillus subtilis strain QST 713 and associated end-use products within 60 days from the date of publication of this Re-evaluation Decision. For more information regarding the basis for objecting (which must be based on scientific grounds), please refer to the Pesticides section of the Canada.ca website (Request a Reconsideration of Decision) or contact PMRA's Pest Management Information Service.

The relevant confidential test data on which the decision is based (as referenced in PRVD2022-09) are available for public inspection, upon application, in PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.