Consultation on Flg22-Bt Peptide, Vismax Seed Treatment, and Vismax Row Crop, Proposed Registration Decision PRD2025-01

Pest Management Regulatory Agency
12 February 2025
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2025-1E-PDF (PDF version)

Summary

Table of contents

• Proposed Registration Decision for Flg22-Bt Peptide
• What does Health Canada consider when making a registration decision?
• What Is Flg22-Bt Peptide?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other Information

Proposed Registration Decision for Flg22-Bt Peptide

Health Canada's Pest Management Regulatory Agency (PMRA), pursuant to subsection 28(1) of the Pest Control Products Act, is proposing registration for the sale and use of Flg22-Bt Peptide Technical, Vismax Seed Treatment, and Vismax Row Crop, containing the active ingredient Flg22-Bt peptide, to control fungal plant disease caused by Fusarium species in soybean and wheat.

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 PRD2025-01, Flg22-Bt Peptide, Vismax Seed Treatment, and Vismax Row Crop provides detailed technical information on the human health, environmental and value assessments of Flg22-Bt peptide, Vismax Seed Treatment, and Vismax Row Crop.

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 individuals 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 precautionary measures on the product label to further reduce risk.

To reach its decisions, Health Canada's PMRA applies modern, rigorous risk-assessment methods and policies. These methods consider the unique characteristics of sensitive subpopulations in humans (for example, children). They also consider the unique characteristics of 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 on how the Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and Pest Management portion of Canada.ca.

Before making a final registration decision on Flg22-Bt peptide, Vismax Seed Treatment, and Vismax Row Crop, Health Canada's PMRA will consider any written comments received from the public in response to PRD2025-01.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Flg22-Bt peptide, Vismax Seed Treatment, and Vismax Row Crop, 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 PRD2025-01.

What Is Flg22-Bt Peptide?

Flg22-Bt peptide is a synthetic 22 amino acid peptide that is also commonly found in nature as a component of the swimming appendage (flagellum) of Bacillus thuringiensis, a species of bacterium also called Bt. When Flg22-Bt peptide is applied to the surface of soybean seeds or wheat flowers, it stimulates the plant's natural immune response to prevent infection from certain fungal plant pathogens.

Health considerations

Can approved uses of Flg22-Bt peptide affect human health?

Flg22-Bt peptide is unlikely to affect human health when it is used according to label directions.

Potential exposure to Flg22-Bt peptide may occur through the diet (food and water), when handling the product, or when handling and planting treated seeds. When assessing health risks, two key factors are considered: the levels where no health effects occur and the levels to which people may be exposed. 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 for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed. In laboratory animals, Flg22-Bt peptide was considered to be of low acute toxicity by the oral and dermal routes, of slight acute toxicity by the inhalation route, non-irritating to the eyes and the skin, and not a dermal sensitizer.

Rationales to waive testing for short-term oral toxicity and prenatal developmental toxicity were accepted based on an in vitro digestion study and an allergenicity assessment.

Results from testing indicate that Flg22-Bt peptide is not mutagenic.

In laboratory animals, the end-use product, Vismax Row Crop, was considered to be of low acute toxicity by the oral and inhalation routes, non-irritating to the eyes, minimally irritating to the skin, and not a dermal sensitizer.

The toxicological profile of Vismax Seed Treatment is equivalent to the toxicological profile of Vismax Row Crop.

Residues in water and food

Dietary risks from food and water are acceptable.

When Vismax Row Crop is applied as directed by the label, residues of Flg22-Bt peptide on treated crops (wheat) are not anticipated at the time of harvest, based on the timing of foliar applications.

There is no direct application of Vismax Seed Treatment to the edible portions of the crops. Based on the proposed use pattern as a seed treatment for soybean, residues of Flg22-Bt peptide are expected to be low on the harvested crops.

Similarly, the likelihood of Flg22-Bt peptide residues in drinking water will be low. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

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

Vismax Row Crop and Vismax Seed Treatment are proposed as commercial fungicide end-use products. There are no residential uses for Vismax Row Crop and Vismax Seed Treatment.

The label for Vismax Row Crop will include measures to prevent bystander and residential exposure, such as reducing spray drift and restricting access to the treated area until sprays have dried.

Vismax Seed Treatment will only be applied to seed in commercial seed treatment facilities; therefore, bystander exposure is not expected to occur.

Residential and non-occupational exposure to Vismax Row Crop and Vismax Seed Treatment is expected to be low when label directions are observed. Consequently, the health risk to residents and the general public is acceptable.

Occupational risks from handling Vismax Row Crop and Vismax Seed Treatment

Occupational risks are acceptable when Vismax Row Crop and Vismax Seed Treatment are used according to the label directions, which include protective measures.

Workers handling Vismax Row Crop can come into direct contact with Flg22-Bt peptide through inhalation and contact with skin during mixing, loading, application, clean-up and repair.

To protect workers from exposure to Vismax Row Crop, the label requires workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab.

In addition, the Vismax Row Crop label requires a restricted-entry interval of four (4) hours, or until sprays have dried, and includes a spray advisory statement to minimize spray drift. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate personal protective equipment (PPE).

Workers handling Vismax Seed Treatment can come into direct contact with Flg22-Bt peptide through inhalation and contact with the skin during mixing, loading, treating, clean-up and repair, bagging, sewing, stacking, as well as during handling and planting of treated seeds. To protect workers from exposure to Vismax Seed Treatment, the label requires workers to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, treating, clean-up and repair, bagging, sewing, stacking, as well as during handling and planting of treated seeds.

Treated seed must be labelled or tagged with instructions for workers handling seed outside of the seed treatment facility.

The occupational risks are acceptable when the precautionary statements on the labels are observed.

Environmental considerations

What happens when Flg22-Bt Peptide is introduced into the environment?

When used according to label directions, risks associated with Flg22-Bt peptide and associated end-use products are acceptable from the viewpoint of environmental protection.

Flg22-Bt peptide can enter the environment when applied as a foliar spray or as seed treatment. It is a synthetic substance derived from a natural bacterial protein and has a non-toxic mode of action. It is very soluble in water and is expected to be broken down quickly by reaction with water and by microorganisms in the environment. As such, Flg22-Bt peptide is not likely to build up in the tissue of organisms. Peptides are expected to have low volatility in general, and thus, significant dissipation of Flg22-Bt peptide into the air is not expected under field conditions.

Flg22-Bt peptide has relatively low toxicity to non-target organisms in the environment. The environmental risks from the proposed uses of Flg22-Bt peptide are acceptable when its end-use products are used according to the label directions.

Value considerations

What is the value of Vismax Seed Treatment?

Vismax Seed Treatment is a non-conventional, commercial fungicide that provides a new mode of action to suppress seed rot, damping-off, seedling blight and root rot caused by Fusarium spp. when applied as a seed treatment on soybean.

By reducing early plant stand, Fusarium seed and seedling diseases have a considerable impact on crop yield. Vismax Seed Treatment is a new non-conventional fungicide that suppresses these diseases. It will benefit soybean growers who may not wish to use conventional pesticides. It may also be used in a tank mix with conventional seed treatment fungicides. As Vismax Seed Treatment contains a new active ingredient for use against Fusarium seed and seedling diseases, it may delay the development of fungicide resistance to other registered active ingredients.

What is the value of Vismax Row Crop?

Vismax Row Crop is a non-conventional, commercial fungicide that provides a new mode of action to suppress a major disease of wheat, fusarium head blight, when applied as a foliar spray.

Active ingredients that are effective against fusarium head blight (FHB) are few in number. Vismax Row Crop provides a new disease management option to wheat growers who prefer to use non-conventional fungicides in combination with integrated disease management practices. Vismax Row Crop may be used in alternation or in a tank mix with conventional fungicides. By providing a new mode of action against FHB, Vismax Row Crop may delay the development of fungicide resistance to other registered active ingredients.

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.

The key risk-reduction measures being proposed on the label of Flg22-Bt Peptide Technical, Vismax Seed Treatment, and Vismax Row Crop to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

For Vismax Row Crop, workers are required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab.

For Vismax Row Crop, there will be a restricted-entry interval of four (4) hours, or until sprays have dried. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate PPE.

To limit bystander exposure, the label for Vismax Row Crop includes a drift statement.

For Vismax Seed Treatment, workers mixing, loading, treating, and performing clean-up and repair, and during all other activities involving the handling of treated seeds will be required to wear a long-sleeved shirt, long pants, chemical-resistant gloves, and socks and shoes.

To limit worker and residential bystander exposure, Vismax Seed Treatment and treated seed must be handled in a way that both do not come in contact with workers or residential bystanders. Additionally, only workers wearing PPE may be in the area where treating, bagging, sewing, stacking or loading for transport is occurring.

Treated seed must be labelled or tagged with instructions for workers handling seed outside of the seed treatment facility.

Next steps

Before making a final registration decision on Flg22-Bt peptide, Vismax Seed Treatment, and Vismax Row Crop, Health Canada's PMRA will consider any written comments received from the public in response to PRD2025-01 up to 45 days from the date of publication (by the 29 March 2025) of PRD2025-01.Please forward all comments to PMRA Publications, through the Public Engagement Portal (Public Engagement Forms – Consultation Comment). 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 Health Canada's PMRA makes its registration decision, it will publish a Registration Decision on Flg22-Bt peptide, Vismax Seed Treatment, and Vismax Row Crop (based on the Science Evaluation of PRD2025-01). 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 or if you have questions, please contact the PMRA's Pest Management Information Service.

Footnotes