Proposed Registration Decision PRD2021-06, Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477, Ataplan Biological Fungicide, and Arolist Biological Fungicide

Pest Management Regulatory Agency
9 July 2021
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2021-6E-PDF (PDF version)

Summary

Table of Contents

• Proposed registration decision for Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477
• What does Health Canada consider when making a registration decision?
• What Are Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Key risk-reduction measures
• Next steps
• Other information

Proposed registration decision for Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477

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 Bacillus velezensisstrain RTI301Technical, Bacillus subtilisstrain RTI477 Technical, Ataplan Biological Fungicide and Arolist Biological Fungicide, containing the technical grade active ingredients Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477 for the suppression of seed rot and seedling blight in corn (field, sweet, pop and corn grown for seed), soybean and sunflower, and for suppression of sudden death syndrome of soybean.

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 PRD2021-06, Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477, Ataplan Biological Fungicide, and Arolist Biological Fungicide provides detailed technical information on the human health, environmental and value assessments of Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477 and Ataplan Biological Fungicide and Arolist Biological 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 Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477 and Ataplan Biological Fungicide and Arolist Biological 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 Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477 and Ataplan Biological Fungicide and Arolist Biological 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 PRD2021-06.

What Are Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477?

Both Bacillus velezensis strain RTI 301 and Bacillus subtilis strain RTI 477 are new active ingredients for disease management in Canada. Both B. velezensis and B. subtilis may result in induced systemic resistance (ISR) and systemic acquired resistance (SAR) responses through the reactions to the host plant’s immune system. Combination of these two plant-associated bacteria makes them compete with the target plant pathogens in the rhizosphere, inhibit fungal growth and enhance plant growth when applied for seed treatment in corn, soybean and sunflower.

Health considerations

Can approved uses of Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477 affect human health?

Bacillus velezensis strain RTI301 and Bacillus subtilis strain RTI477 are unlikely to affect your health when Ataplan Biological Fungicide and Arolist Biological Fungicide are used according to the label directions.

Potential exposure to B. velezensis strain RTI301and B. subtilis strain RTI477may occur when handling and applying Ataplan Biological Fungicide and Arolist Biological Fungicide. 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 Bacillus velezensisstrain RTI301Technicaland Bacillus subtilisstrain RTI477 Technical were tested on laboratory animals, there was low toxicity following oral, pulmonary instillation and dermal exposures. Bacillus velezensisstrain RTI301Technicaland Bacillus subtilisstrain RTI477 Technical are irritating to the eyes and skin. Furthermore, there was no sign that the microbial pest control agents, B. velezensis strain RTI301and B. subtilis strain RTI477, caused any disease.

Residues in water and food

Dietary risks from food and water are acceptable

Residues of B. velezensis strain RTI301and B. subtilis strain RTI477 are not likely at the time of harvest. Ataplan Biological Fungicide and Arolist Biological Fungicide will not be applied to the edible portions of crops and the seed treatment applications are not expected to result any growth on the edible portions of the crops. In addition, the likelihood of residues of B. velezensis strain RTI301and B. subtilis strain RTI477 contaminating drinking water supplies from the proposed seed treatments is low and therefore not a health concern. Consequently, dietary risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Occupational risks from handling Ataplan Biological Fungicide and Arolist Biological Fungicide

Occupational risks are acceptable when Ataplan Biological Fungicide and Arolist Biological Fungicide are used according to label directions, which include protective measures.

Workers handling Ataplan Biological Fungicide and Arolist Biological Fungicide can come into direct contact with B. velezensis strain RTI301and B. subtilis strain RTI477 on the skin, by inhalation, or in the eyes. To protect workers from exposure to Ataplan Biological Fungicide and Arolist Biological Fungicide, the labels states that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable.

Ataplan Biological Fungicide and Arolist Biological Fungicide are proposed for use as commercial seed treatments on-farm and in commercial facilities. Residential and non-occupational exposure to Ataplan Biological Fungicide and Arolist Biological Fungicide is 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 velezensis strain RTI301 and Bacillus subtilis strain RTI477 are introduced into the environment?

Environmental risks are acceptable.

Bacillus velezensis and B. subtilis are common microorganisms that are widely distributed in the natural environment. Habitats are predominantly soils, including soils in water columns and bottom deposits of aquatic environments. Under adverse conditions, these microorganisms produce resilient endospores that allow them to readily survive in soils, dusts and aerosols. If protected from sunlight, endospores may survive for very long periods.

Ataplan Biological Fungicide and Arolist Biological Fungicide are intended for use as seed treatments on corn (all types), soybean, and sunflower. No adverse effects to birds or fish were observed during testing. Bacillus velezensis strain RTI301 Technical and Bacillus subtilisstrain RTI477 Technical were toxic to honey bees, springtails, and predatory mites at high concentrations, however, exposure to honey bees and other terrestrial invertebrates is expected to be low and not of concern since the end-use products are only used as seed treatments. The end-use products arenot intended for aquatic uses and their use as a seed treatment is not expected to significantly increase the levels of these microorganisms in soil. Exposure to aquatic environments is also expected to be low and limited to leaching and run-off after the seeds are sown in fields. While published scientific literature on the environmental fate of these species suggests that B. velezensis strain RTI301 and B. subtilis strain RTI477 will survive in soils and sediment under various environmental conditions, the populations of B. velezensis strain RTI301 and B. subtilis strain RTI477 in soil and sediment are expected to return to naturally sustainable levels.

Based on a critical review of studies, scientific rationales and information from public sources, the risks to birds, wild mammals, fish, terrestrial and aquatic invertebrates, and plants are acceptable when Ataplan Biological Fungicide and Arolist Biological Fungicide are applied according to directions on the labels.

Value considerations

What is the value of Ataplan Biological Fungicide and Arolist Biological Fungicide?

Bacillus velezensis strain RTI 301 and Bacillus subtilis strain RTI 477 are the active ingredients in Ataplan Biological Fungicide, and B. velezensis strain RTI 301 alone is the active ingredient in Arolist Biological Fungicide. The registrations of Ataplan Biological Fungicide and Arolist Biological Fungicide will provide Canadian users with two new products to manage these important diseases in corn, soybean and sunflower.

Ataplan Biological Fungicide and Arolist Biological Fungicide are applied as seed treatments to protect corn, soybean and sunflower against seed rot and seedling blight caused by certain soil-borne fungal pathogens, and to protect soybean against sudden death syndrome (SDS).

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 labels of Bacillus velezensis strain RTI301 Technical and Bacillus subtilis strain RTI477 Technical and the end-use products, Ataplan Biological Fungicide and Arolist Biological Fungicide to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

All microorganisms, including B. velezensis strain RTI301and B. subtilis strain RTI477, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of B. velezensis strain RTI301and B. subtilis strain RTI477. In turn, workers handling or applying Ataplan Biological Fungicide and Arolist Biological Fungicide must wear waterproof gloves, a long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

Environment

The end-use product labels will include environmental precaution statements to reduce contamination of aquatic systems from the use of Ataplan Biological Fungicide and Arolist Biological Fungicide.

Next steps

Before making a final registration decision on Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477, Ataplan Biological Fungicide and Arolist Biological Fungicide, Health Canada’s PMRA will consider any comments received from the public in response to PRD2021-06. Health Canada will accept written comments on PRD2021-06 up to 45 days from the date of it’s publication. 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 Bacillus velezensis strain RTI301, Bacillus subtilis strain RTI477, Ataplan Biological Fungicide and Arolist Biological Fungicide (based on the Science evaluation of PRD2021-06). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room.