Proposed Registration Decision PRD2024-09, Beauveria bassiana strain ANT-03 and BioTitan WP

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The online consultation is now closed.

Pest Management Regulatory Agency
5 December 2024
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2024-9E-PDF (PDF version)

Summary

This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.

To obtain a full copy of Proposed Registration Decision PRD2024-09, Beauveria bassiana strain ANT-03 and BioTitan WP please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Table of contents

Proposed registration decision for Beauveria bassiana strain ANT-03

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 ANT-03 and BioTitan WP, containing the active ingredient Beauveria bassiana strain ANT-03, for reduction in numbers of tarnished plant bug on industrial hemp grown outdoors; and for the reduction in numbers of whiteflies, aphids, and thrips on outdoor ornamentals, including transplants.

Beauveria bassiana strain ANT-03 is currently registered for use on a variety of field crops as well as in turf. For details, see Proposed Registration Decision PRD2020-16, Beauveria bassiana strain ANT-03, BioCeres F WP, BioCeres F GR, and BioCeres D GR; and Registration Decision RD2021-02, Beauveria bassiana strain ANT-03, BioCeres F WP, BioCeres F GR, and BioCeres D GR.

Beauveria bassiana strain ANT-03 is also currently registered for use on a variety of greenhouse food crops and ornamentals. For details, see Proposed Registration Decision PRD2014-06, Beauveria bassiana strain ANT-03, and Registration Decision RD2014-16, Beauveria bassiana strain ANT-03.

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 the full version of the Proposed Registration Decision PRD2024-09, Beauveria bassiana strain ANT-03 and BioTitan WP provides detailed technical information on the human health, environmental and value assessments of Beauveria bassiana strain ANT-03 and BioTitan WP.

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 acceptableFootnote 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 valueFootnote 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, the 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 Beauveria bassiana strain ANT-03 and BioTitan WP, Health Canada's PMRA will consider any written comments received from the public in response to this consultation document.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on Beauveria bassiana strain ANT-03 and BioTitan WP, 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 PRD2024-09.

What is Beauveria bassiana strain ANT-03?

Beauveria bassiana strain ANT-03 is a fungus that infects and kills insects. It is the active ingredient in the biological insecticide BioTitan WP, which is a commercial class product registered for use in certain agricultural products and in turf.

Health considerations

Can approved uses of Beauveria bassiana strain ANT-03affect human health?

Beauveria bassiana strain ANT-03is unlikely to affect your health when BioTitan WP is used according to the label directions.

Potential exposure to Beauveria bassiana strain ANT-03may occur through the diet (food and water) or when handling and applying BioTitan WP. When assessing health risks, several key factors are considered:

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 ANT-03 was tested on laboratory animals, there was low toxicity following oral, pulmonary and dermal exposures, and no infectivity following oral, pulmonary or intravenous exposures. Furthermore, there was no sign that the microbial pest control agent (MPCA), Beauveria bassiana strain ANT-03, caused any disease. The technical grade of the active ingredient, Beauveria bassiana strain ANT-03, is of moderate acute toxicity by the inhalation route of exposure. Beauveria bassiana strain ANT-03 is also moderately irritating to the eye.

All microorganisms, including Beauveria bassiana strain ANT-03, contain substances that are potential sensitizers and thus, sensitivity may develop in individuals exposed to potentially large quantities of Beauveria bassiana strain ANT-03.

Residues in water and food

Dietary risks from food and water are acceptable.

Similar to currently registered uses of BioTitan WP on various food crops, the proposed new uses may result in residues of Beauveria bassiana strain ANT-03 on treated agricultural crops at the time of harvest. However, no signs of infectivity or toxicity were observed when Beauveria bassiana strain ANT-03 was tested on laboratory animals by the oral route, and metabolites of toxicological significance are not expected to occur on edible portions of the crops above naturally occurring levels. In addition, the likelihood of residues of Beauveria bassiana strain ANT-03 contaminating drinking water supplies is expected to be low as the label has the necessary mitigation measures to limit contamination of drinking water from the proposed uses of BioTitan WP. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Occupational risks from handling BioTitan WP

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

BioTitan WP is currently registered as a commercial insecticide for terrestrial food crops and turf. Workers handling BioTitan WP can be exposed to Beauveria bassiana strain ANT-03 through direct skin or eye contact or through inhalation. While the technical grade active ingredient was of moderate acute toxicity by the inhalation route of exposure, BioTitan WP is applied as a spray suspension and no inhalation toxicity is anticipated for aqueous suspensions. To protect workers from exposure to BioTitan WP, 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 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 dried. The proposed new uses do not pose any additional occupational exposure concerns.

The health risks to workers 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 acceptable.

BioTitan WP is currently registered as a commercial insecticide for terrestrial food crops and turf. The new uses for BioTitan WP include commercially-grown outdoor ornamentals and industrial hemp grown outdoors. There are no residential uses. The existing label includes mitigation measures to prevent bystander exposure such as reducing spray drift. The proposed new uses do not pose any additional residential and non-occupational exposure concerns. Residential and non-occupational exposure to BioTitan WP is therefore expected to be low when the label directions are observed. Consequently, the health risk to residents and the general public is acceptable.

Environmental considerations

What happens when Beauveria bassiana strain ANT-03 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. There are also reports of some isolates of Beauveria bassiana with the ability to colonize plants without causing disease.

The proposed use expansion of Beauveria bassiana strain ANT-03 to include outdoor ornamentals and industrial hemp grown outdoors is expected to increase environmental exposure to this microorganism. While information suggests that Beauveria bassiana strain ANT-03 will survive under field conditions, over time the populations should return to naturally occurring levels. The spores of this species are hydrophobic and are not expected to be readily transferred to groundwater by leaching. However, the species could enter aquatic environments via run-off from treated areas. Beauveria bassiana is not expected to grow in aquatic environments.

No overt adverse effects to birds and to an insect species were observed during testing. Acute testing on honey bees with spores of Beauveria bassiana strain ANT-03 demonstrated significant toxicity/pathogenicity following contact and dietary exposures. However, no such effects were observed in semi-field trials with BioTitan WP. No evidence of significant adverse effects on birds, fish, non-arthropod invertebrates and plants were found in the published scientific literature. Also, Beauveria bassiana strain ANT-03 was not toxic or pathogenic to laboratory mammals through oral, pulmonary, and dermal routes. While the technical grade active ingredient is moderately acutely toxic by the inhalation route of exposure, BioTitan WP is applied as a spray suspension and no inhalation toxicity is anticipated for aqueous suspensions.

Based on a critical review of studies, scientific rationales and information from public sources, the risks to birds, wild mammals, fish, non-target terrestrial and aquatic arthropods, and plants are acceptable when BioTitan WP is applied according to directions on the label. Since acute studies on beneficial arthropods (including honey bees) previously demonstrated toxic and/or pathogenic effects, the BioTitan WP label already includes statements identifying the potential harm to beneficial insects and bees and instructs applicators to limit exposure to beneficial insects.

Value considerations

What is the value of BioTitan WP?

BioTitan WP is suitable for use in organic production of crops.

BioTitan WP reduces numbers of tarnished plant bug in industrial hemp grown outdoors, which has been identified as a priority for Canadian growers, and also reduces numbers of whiteflies, aphids and thrips in outdoor ornamental plants, including transplants. BioTitan WP provides a new mode of action for these uses.

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 bassianastrain ANT-03 (technical grade of the active ingredient) and BioTitan WP to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The end-use product and technical grade active ingredient are considered to be irritating to the eyes, and are considered potential sensitizers. The signal words "POTENTIAL SENSITIZER" and "WARNING EYE IRRITANT" appear on the primary display panel of the labels. The technical grade active ingredient, Beauveria bassiana strain ANT-03, is moderately acutely toxic by the inhalation route of exposure, and the end-use product, BioTitan WP, is considered slightly acutely toxic by inhalation. Therefore, "WARNING POISON" and "CAUTION POISON" are required on the principal display panels of the technical grade active ingredient and end-use product labels, respectively.

Workers handling or applying BioTitan WP 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 four hours following application or until sprays have dried.

Key risk-reduction measures - Environment

The end-use product label already includes standard environmental precaution statements to prohibit aerial application, limit drift, and reduce contamination of aquatic systems from the use of BioTitan WP. The label for the end-use product also includes environmental precaution statements to minimize the risk to beneficial insects and pollinators.

Next steps

Before making a final registration decision on Beauveria bassiana strain ANT-03 and BioTitan WP, Health Canada's PMRA will consider any written comments received from the public in response to PRD2024-09 up to 45 days from the date of publication (5 December, 2024) of PRD2024-09. 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 ANT-03 and BioTitan WP (based on the Science evaluation of PRD2024-09). 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 Pest Management Information Service.

Footnotes

Footnote 1

"Acceptable risks" as defined by subsection 2(2) of the Pest Control Products Act.

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Footnote 2

"Value" as defined by subsection 2(1) of the Pest Control Products Act: "the product's actual or potential contribution to pest management, taking into account its conditions or proposed conditions of registration, and includes the product's (a) efficacy; (b) effect on host organisms in connection with which it is intended to be used; and (c) health, safety and environmental benefits and social and economic impact."

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Footnote 3

"Consultation statement" as required by subsection 28(2) of the Pest Control Products Act.

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Footnote 4

"Decision statement" as required by subsection 28(5) of the Pest Control Products Act.

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