Proposed Registration Decision PRD2021-10, Beauveria bassiana strain CFL-A, Fraxiprotec

Pest Management Regulatory Agency
23 December 2021
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2021-10E-PDF (PDF version)

Summary

Table of contents

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

Proposed registration decision for Beauveria bassiana strain CFL-A

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 CFL-A (technical grade active ingredient (TGAI)) and Fraxiprotec, containing the active ingredient Beauveria bassiana strain CFL-A, for the reduction in emerald ash borer populations to protect ash trees from this invasive pest.

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 PRD2021-10, Beauveria bassiana strain CFL-A, Fraxiprotec provides detailed technical information on the human health, environmental and value assessments of Beauveria bassiana strain CFL-A and Fraxiprotec.

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 CFL-A and Fraxiprotec, Health Canada’s PMRA will consider any comments received from the public in response to PRD2021-10.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Beauveria bassiana strain CFL-A and Fraxiprotec, 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 PRD2021-10.

What is Beauveria bassiana strain CFL-A?

Beauveria bassiana is a common fungus that causes a lethal disease in various insects. Some strains of this fungus are already registered as active ingredients in pest control products. Beauveria bassiana strain CFL-A is a new strain that was selected for its ability to infect the emerald ash borer. It is the active ingredient in the new end-use product Fraxiprotec, which is proposed for registration to help manage the invasive pest.

Health considerations

Can approved uses of Beauveria bassiana strain CFL-A affect human health?

Beauveria bassiana strain CFL-A is unlikely to affect your health when Fraxiprotec is used according to the label directions.

Potential exposure to Beauveria bassiana strain CFL-A may occur when handling and installing Fraxiprotec in the autodissemination device and trap. When assessing health risks, several key factors are considered:

• the microorganism’s biological properties (for example, infection cycle);
• 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.

Toxicology 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 CFL-A (TGAI) was tested on laboratory animals, there was low toxicity following pulmonary instillation and there was no sign that the microbial pest control agent, Beauveria bassiana strain CFL-A, caused any disease. However, recent evidence was found that dry fungal spore preparations could be toxic via the inhalation route. In the absence of an inhalation study, dry formulations containing this microbial pest control agent were considered to be toxic via the inhalation route. Fraxiprotec was of low oral toxicity when tested on laboratory animals.

Residues in water and food

Dietary risks from food and water are acceptable.

Fraxiprotec is not proposed for food uses. In addition, the likelihood of residues of Beauveria bassiana strain CFL-A contaminating drinking water supplies from the proposed insecticidal use 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. Even in the event of dietary exposure, the health risk is acceptable since there were no signs that it caused any significant toxicity or disease in the acute oral study on laboratory animals.

Occupational risks from handling Fraxiprotec

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

Workers handling Fraxiprotec can come into direct contact with B. bassiana strain CFL-A on the skin, by inhalation, or in the eyes. To protect workers from exposure to Fraxiprotec, the label 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. 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.

Fraxiprotec is proposed for use in public and private urban forests, including parks, recreational areas and private properties. Fraxiprotec is used within the supplied autodissemination device and trap set in ash tree canopies. Residential and non-occupational exposure to Fraxiprotec 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 CFL-A is introduced into the environment?

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. This species is typically identified as a soil microorganism. However, it can be found on insects and plants. There are also reports of some isolates of Beauveria bassiana with the ability to colonize plants without causing disease.

Fraxiprotec is an insecticide intended for use exclusively within an autodissemination device and trap set in ash tree canopies only during the two month flight period of the emerald ash borer (EAB). Beauveria bassiana CFL-A (TGAI) was toxic and or pathogenic to bees at high concentrations, however, exposure to honey bees and other terrestrial invertebrates (including beneficial insects) is expected to be low and not of concern since the end-use product is to be used exclusively in the autodissemination device and trap. The end-use product is not intended for aquatic uses and its use as an insecticide in the autodissemination device and trap set in the ash tree canopy is not expected to significantly increase the levels of this microorganism in aquatic environments or in soil. The published scientific literature on the environmental fate of this species suggests that Beauveria bassiana strain CFL-A conidia are susceptible to ultraviolet (UV) light and are not expected to survive in aquatic environments and sediment. The population of Beauveria bassiana strain CFL-A on foliage in the immediate vicinity of a trap with Fraxiprotec is expected to increase slightly before returning to naturally sustainable levels following removal of the trap.

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 Fraxiprotec is used according to directions on the label.

Value considerations

What is the value of Fraxiprotec?

Fraxiprotec infects adult emerald ash borers with Beauveria bassiana strain CFL-A, which leads to a reduction in emerald ash borer populations and thus helps reduce the decline and death of ash trees caused by this invasive pest in Canada.

Fraxiprotec is used in traps that capture emerald ash borer adults. The traps used with Fraxiprotec are designed to allow the insects to escape after being exposed to the fungal spores so that they can also spread spores to other emerald ash borer adults before they die. Fraxiprotec provides a new mode of action for use against emerald ash borer and is complementary to the alternative pest control products registered for this pest, which mainly target the larval stage.

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 Beauveria bassiana CFL-A (TGAI) and Fraxiprotec to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

Dry fungal spore preparations could be toxic via the inhalation route. In the absence of an inhalation study, Fraxiprotec is considered toxic via the inhalation route. In addition, all microorganisms, including Beauveria bassiana strain CFL-A, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of Beauveria bassiana strain CFL-A. In turn, workers handling or installing Fraxiprotec must wear waterproof gloves, a long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. Signage is also required on the tree to inform the public of the treatment under progress; and on the trap, to identify the registrant or applicator with contact information, name of the end-use product (EP) contained within, including the registration number and instructions not to dismantle.

Environment

The end-use product label will include environmental precaution statements to minimize contamination of aquatic systems from the use of Fraxiprotec. The label for the end-use product will also include an environmental precaution statement to minimize the risk to beneficial insects and pollinators.

Next steps

Before making a final registration decision on Beauveria bassiana strain CFL-A and Fraxiprotec, Health Canada’s PMRA will consider any comments received from the public in response to PRD2021-10. Health Canada will accept written comments on PRD2021-10 up to 45 days from the date of publication of PRD2021-10. 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 CFL-A and Fraxiprotec (based on the Science Evaluation of PRD2021-10). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA’s Reading Room.