Proposed Registration Decision PRD2022-10, Beauveria bassiana strain R444 and Bb-Protec

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Pest Management Regulatory Agency
15 August 2022
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2022-10E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for Beauveria bassiana strain R444
• What does Health Canada consider when making a registration decision?
• What is Beauveria bassiana strain R444?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Beauveria bassiana strain R444

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 Beauveria bassiana strain R444 Technical, and Bb-Protec, containing the technical grade active ingredient Beauveria bassiana strain R444, to control twospotted spider mite and whitefly on a wide variety of greenhouse-grown ornamental and food crop plants, including plants grown for transplanting, and cannabis grown in greenhouses and enclosed structures.

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 PRD2022-10, Beauveria bassiana strain R444 and Bb-Protec provides detailed technical information on the human health, environmental and value assessments of Beauveria bassiana strain R444 and Bb-Protec.

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 Beauveria bassiana strain R444 and Bb-Protec, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-10.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Beauveria bassiana strain R444 and Bb-Protec, 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 PRD2022-10.

What is Beauveria bassiana strain R444?

Beauveria bassiana is a fungus that grows naturally in soils throughout the world. It is a generalist entomopathogenic fungus that causes a disease in many types of insects that is often fatal. Beauveria bassiana strain R444 was isolated from soil from the Clanwilliam region of South Africa. When Beauveria bassiana strain R444 spores encounter an insect, they attach to, germinate, and penetrate the insect. Once inside the insect, the fungus grows and multiplies, resulting in death of the insect by internal tissue destruction. Beauveria bassiana strain R444 is used to control twospotted spider mite and whitefly on a wide variety of greenhouse-grown ornamental and food crop plants, including plants grown for transplanting, and cannabis grown in greenhouses and enclosed structures.

Health considerations

Can approved uses of Beauveria bassiana strain R444 affect human health?

Beauveria bassiana strain R444 is unlikely to affect your health when Bb-Protec is used according to the label directions.

Potential exposure to Beauveria bassiana strain R444may occur when handling and applying Bb-Protec. 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 Beauveria bassiana strain R444 Technical and Bb-Protec were tested on laboratory animals, there was low toxicity following oral, pulmonary instillation, inhalation and dermal exposures. Bb-Protec is non-irritating to the skin. In the absence of eye irritation testing, the technical grade active ingredient and end-use product are assumed to be eye irritants. Furthermore, there was no sign that the microbial pest control agent, Beauveria bassiana strain R444, caused any disease.

All microorganisms, including Beauveria bassiana strain R444, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of Beauveria bassiana strain R444.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of Beauveria bassiana strain R444 on treated crops are possible at the time of harvest. However, no signs of infectivity or toxicity were observed when Beauveria bassiana strain R444 was tested on laboratory animals, and secondary metabolites are not expected to occur on edible portions of the crops above naturally occurring levels. In addition, the likelihood of Beauveria bassiana strain R444 contaminating drinking water is expected to be low as the label has the necessary mitigation measures to limit contamination of drinking water from the proposed uses of Bb-Protec. Consequently, dietary risks are acceptable.

Occupational risks from handling Bb-Protec

Occupational risks are acceptable when Bb-Protec is used according to label directions, which include protective measures.

Workers handling Bb-Protec can be exposed to Beauveria bassiana strain R444 through direct skin or eye contact or through inhalation. To protect workers from exposure to Bb-Protec, the label states that workers must wear personal protective equipment, including 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. The product label includes measures to restrict access to the treated area for 4 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 non-occupational exposure is acceptable.

Bb-Protec is proposed for commercial use as a diluted broadcast spray in greenhouses and enclosed structures only. Residential and non-occupational exposure to Bb-Protec 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 Beauveria bassiana strain R444 is introduced into the environment?

Environmental risks are acceptable.

Beauveria bassiana is a common microorganism that is widely distributed in the natural environment. It is an insect pathogen that causes white muscardine disease in insects. When spores of the fungus come into contact with a susceptible host insect, they germinate, enter the body of the insect and grow, eventually killing the insect. The species is typically identified as a soil microorganism. However, it can be found on insects and plants. Minimal environmental exposure to Beauveria bassiana strain R444 is expected following the proposed use in greenhouses and enclosed structures.

The applicant submitted studies designed to examine the effects of Beauveria bassiana strain R444 to birds, bees, terrestrial arthropods, fish, and aquatic arthropods. No adverse effects to birds or fish were observed during testing. Bb-Protec was toxic to bees, parasitic wasps, ladybird beetle larvae, and daphnids. Test results suggested pathogenicity to parasitic wasps, ladybird beetle larvae, and bees. As a result, the end-use product label will contain statements identifying the potential for harm to beneficial arthropods and that applications must avoid direct contact to foraging bees. The end-use product label will also contain standard statements restricting users from activities that may release Beauveria bassiana strain R444 into aquatic environments from its use in greenhouses and enclosed structures. Exposure to outdoor environments is expected to be minimal since the use is restricted to greenhouses and enclosed structures, therefore, significant adverse effects to non-target organisms are not expected.

Based on a critical review of data and published scientific literature submitted by the applicant, the risks to birds, wild mammals, fish, non-target terrestrial and aquatic arthropods, terrestrial and aquatic non-arthropod invertebrates, and plants are acceptable when Bb-Protec is applied according to directions on the label.

Value considerations

What is the value of Bb-Protec?

Bb-Protec is a biological insecticide that provides control of twospotted spider mite and whitefly on a wide variety of greenhouse-grown ornamental and food crop plants, including plants grown for transplanting, and cannabis grown in greenhouses and enclosed structures.

Bb-Protec will provide users with a new strain of Beauveria bassiana for control of two economically important greenhouse pests, twospotted spider mite and whitefly. Due to the complex mode of action of this product, resistance is unlikely to occur and therefore Bb-Protec may aid with the management of resistance of the target pests against other insecticides.

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 Beauveria bassiana strain R444 Technical and the end-use product, Bb-Protec, to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures – Human Health

The signal words "POTENTIAL SENSITIZER" and "CAUTION EYE IRRITANT" will appear on the primary display panel of the labels. Also, workers handling or applying Bb-Protec 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, all unprotected workers are restricted from entering treated areas during application and for 4 hours following application or until sprays have settled.

Key risk-reduction measures – Environment

The end-use product label will include environmental precaution statements to reduce the potential for contamination of aquatic systems from the use of Bb-Protec. The label for the end-use product will also include an environmental precaution statement to minimize the risk to beneficial insects and pollinators used in greenhouse integrated pest management programs.

Next steps

Before making a final registration decision on Beauveria bassiana strain R444 and Bb-Protec, Health Canada's PMRA will consider any comments received from the public in response to PRD2022-10. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2022-10. 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 Beauveria bassiana strain R444 and Bb-Protec (based on the Science Evaluation of PRD2022-10). 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.