Proposed Registration Decision PRD2022-13, Bacillus amyloliquefaciens strain F727 and Stargus Biofungicide

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• Pest Management Regulatory Agency
• 25 October 2022
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2022-13E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for Bacillus amyloliquefaciens strain F727
• What does Health Canada consider when making a registration decision?
• What is Bacillus amyloliquefaciens strain F727?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Bacillus amyloliquefaciens strain F727

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of MBI-110 TGAI and Stargus Biofungicide (previously known as MBI-110 EP Biofungicide), containing the technical grade active ingredient Bacillus amyloliquefaciens strain F727, to partially suppress grey mould on indoor-grown cannabis and to suppress or partially suppress certain economically important diseases on field-grown hemp, grape, tomato, potato, red (garden) beet, sugar beet, cabbage and Brussels sprouts.

Bacillus amyloliquefaciens strain F727 is currently registered for suppression or partial suppression of listed diseases on various terrestrial food crops. For details, see Proposed Registration Decision PRD2018-17, Bacillus amyloliquefaciens strain F727 and MBI-110 EP Biofungicide and Registration Decision RD2018-20, Bacillus amyloliquefaciens strain F727 and MBI-110 EP Biofungicide.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2022-13, Bacillus amyloliquefaciens strain F727 and Stargus Biofungicide provides detailed technical information on the human health, environmental and value assessments of B. amyloliquefaciens strain F727 and Stargus Fungicide.

What does Health Canada consider when making a registration decision?

The key objective of the Pest Control Products Act is to prevent unacceptable risks to people and the environment from the use of pest control products. Health or environmental risk is considered acceptable^{Footnote 1} if there is reasonable certainty that no harm to human health, future generations or the environment will result from use or exposure to the product under its proposed conditions of registration. The Act also requires that products have value^{Footnote 2} when used according to the label directions. Conditions of registration may include special precautionary measures on the product label to further reduce risk.

To reach its decisions, the PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children) as well as organisms in the environment. These methods and policies also consider the nature of the effects observed and the uncertainties when predicting the impact of pesticides. For more information please refer to the following:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on B. amyloliquefaciens strain F727 and Stargus Fungicide, Health Canada's PMRA will consider any comments received from the public in response to this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on B. amyloliquefaciens strain F727 and Stargus Fungicide, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada's response to these comments.

For more details on the information presented in this Summary, please refer to the Science Evaluation of PRD2022-13.

What is Bacillus amyloliquefaciens strain F727?

Bacillus amyloliquefaciens strain F727 is a bacterium used to manage certain plant diseases by reducing the establishment of causal pathogens, mycelial growth and spore germination.

Health considerations

Can approved uses of Bacillus amyloliquefaciens strain F727 affect human health?

Bacillus amyloliquefaciens strain F727 is unlikely to affect your health when Stargus Biofungicide is used according to the label directions.

Potential exposure to Bacillus amyloliquefaciens strain F727 may occur when handling and applying Stargus Biofungicide and when ingesting treated produce. When assessing health risks, several key factors are considered:

• the microorganism's biological properties (for example, production of toxic by-products);
• reports of any adverse incidents;
• its potential to cause disease or toxicity as determined in toxicological studies; and
• the level to which people may be exposed relative to exposures already encountered in nature to other isolates of this microorganism.

The levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). As such, sex and gender are taken into account in the risk assessment. Only uses that are determined as having no health risks of concern are considered acceptable for registration.

Studies in laboratory animals describe potential health effects from large doses of exposure to a microorganism and identify any pathogenicity, infectivity and toxicity concerns.

When MBI-110 TGAI was tested on laboratory animals, there was low toxicity following oral, inhalation and dermal exposures, and no infectivity when injected (intravenous). MBI-110 TGAI was not irritating to the skin or eyes. Stargus Biofungicide is not expected to be irritating to the skin but may be irritating to the eyes.

Furthermore, there was no sign that the microbial pest control agent Bacillus amyloliquefaciens strain F727 caused any disease.

The end-use product Stargus Biofungicide and technical grade active ingredient MBI-110 TGAI are considered potential sensitizers.

Residues in water and food

Dietary risks from food and water are acceptable.

Stargus Biofungicide is already approved for use on various food crops, and residues of Bacillus amyloliquefaciens strain F727 on treated crops are possible at the time of harvest. While Bacillus amyloliquefaciens and its close relative, Bacillus subtilis, are abundant in nature, only a few cases involving foodborne illness in people have been reported and only with isolates that are able to produce a toxin which is not known to be produced by Bacillus amyloliquefaciens strain F727. Since its registration on food crops in 2016 in the United States and since 2018 in Canada, there have been no foodborne illnesses reported for Bacillus amyloliquefaciens strain F727, and no signs of infectivity or toxicity were observed when Bacillus amyloliquefaciens strain F727 was tested on laboratory animals.

Occupational risks from handling Stargus Biofungicide

Occupational risks are acceptable when Stargus Biofungicide is used according to label directions, which include protective measures.

Workers handling Stargus Biofungicide can come into direct contact with Bacillus amyloliquefaciens strain F727 on the skin, by inhalation, or in the eyes. To protect workers from exposure to Stargus Biofungicide, the label states that workers must wear personal protective equipment, including a long-sleeved shirt, long pants, protective eyewear (goggles), waterproof gloves, socks and shoes, and a National Institute for Occupational Safety & Health (NIOSH)-approved particulate filtering facepiece respirator with any N, R or P filter.

The product label includes measures to restrict access to the treated area for four hours or until sprays have settled. The occupational risks are acceptable when the precautionary statements on the label are observed.

Risks in residential and other non-occupational environments

Estimated risk for residential and other non-occupational exposure is acceptable.

Stargus Biofungicide is currently registered for use as a commercial fungicide on various outdoor food crops. Stargus Biofungicide is being proposed for use on additional terrestrial food crops and industrial hemp. There are no residential uses. The product label includes mitigation measures to prevent bystander exposure such as reducing spray drift. Stargus Biofungicide is also being proposed for use on cannabis grown in greenhouses and enclosed structures. This use is not expected to result in significant residential and bystander exposure due to drift. Residential and non-occupational exposure to Stargus Biofungicide is therefore expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Environmental considerations

What happens when Bacillus amyloliquefaciens strain F727 is introduced into the environment?

Environmental risks are acceptable.

Stargus Biofungicide is approved for use on various terrestrial food crops. Information on the environmental fate of Bacillus amyloliquefaciens strain F727 suggests that, as a soil microorganism, it is likely to readily survive after applications of Stargus Biofungicide to agricultural field crops, but that over time its population should return to naturally sustainable levels.

Based on a critical review of previously submitted studies and information from public sources, the risks to birds, wild mammals, fish, terrestrial and aquatic arthropods, terrestrial or aquatic non-arthropod invertebrates and plants expected from the use expansion of Stargus Biofungicide are acceptable when Stargus Biofungicide is applied according to directions on the label.

Value considerations

What is the value of Stargus Biofungicide?

Stargus Biofungicide is applied to indoor-grown cannabis to partially suppress grey mould and to suppress or partially suppress certain economically important diseases on field-grown hemp, grape, tomato, potato, red (garden) beet, sugar beet, cabbage and Brussels sprouts.

Stargus Biofungicide is a biological fungicide that will serve as an alternative disease management product option for use on these crops. This product may reduce the risk of resistance development to conventional fungicides as well as provide organic growers with an additional tool for disease management.

Measures to minimize risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human and environmental health. These directions must be followed by law.

Key risk-reduction measures

Based on the revision to the product guarantee, and on the proposed use expansion to additional outdoor crops and on cannabis grown in greenhouses and enclosed structures, no additional risk-reduction measures are necessary. Risk-reduction measures already present on the registered labels of MBI-110 TGAI and Stargus Biofungicide are described below.

Key risk-reduction measures - Human health

The principal display panel of MBI-110 TGAI and Stargus Biofungicide includes the signal words signal "POTENTIAL SENSITIZER". The signal words "WARNING - EYE IRRITANT" appears on the principal display panel for Stargus Biofungicide.

The end-use product and technical grade active ingredient are considered potential sensitizers. In turn, workers handling or applying Stargus Biofungicide as a foliar application outdoors or in greenhouses and enclosed structures must wear a long-sleeved shirt, long pants, protective eyewear (goggles), waterproof gloves, socks and shoes, and a NIOSH-approved particulate filtering facepiece respirator with any N, R or P filter. Furthermore, when applied as a foliar treatment, all unprotected workers are restricted from entering treated areas during application and for four hours following application or until sprays have dried.

Key risk-reduction measures - Environment

The end-use product label includes standard environmental precaution statements to prohibit aerial application, limit drift and reduce contamination of aquatic systems from the use of Stargus Biofungicide.

Next steps

Before making a final registration decision on B. amyloliquefaciens strain F727 and Stargus Fungicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-13. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-13. Please forward all comments to Publications. Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada's response to these comments.

Other information

When the Health Canada makes its registration decision, it will publish a Registration Decision on B. amyloliquefaciens strain F727 and Stargus Fungicide (based on the Science Evaluation of PRD2022-13). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.