Proposed Registration Decision PRD2023-09, Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide

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• Pest Management Regulatory Agency
• 25 October 2023
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2023-9E-PDF (PDF version)

Summary

Table of contents

• Proposed Registration Decision for Lecanicillium muscarium strain Ve6
• What does Health Canada consider when making a registration decision?
• What is Lecanicillium muscarium strain Ve6?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed Registration Decision for Lecanicillium muscarium strain Ve6

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 Mycotal Technical Biological Insecticide and Mycotal Biological Insecticide, containing the technical grade active ingredient Lecanicillium muscarium strain Ve6, for suppression of whiteflies on greenhouse ornamentals, cucumbers and peppers.

Lecanicillium muscarium strain Ve6 is currently registered for suppression of whiteflies on greenhouse tomatoes. For details, see Proposed Registration Decision PRD2020-14, Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide, and Registration Decision RD2020-18, Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide. The preharvest interval and number of applications on greenhouse tomatoes is being revised in accordance with the proposed use on greenhouse ornamentals, cucumbers and peppers.

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 PRD2023-09, Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide provides detailed technical information on the human health, environmental and value assessments of Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide.

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, 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 Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides section of Canada.ca.

Before making a final registration decision on Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide, 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 Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide, 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 PRD2023-09.

What is Lecanicillium muscarium strain Ve6?

Lecanicillium muscarium strain Ve6 is a naturally occurring fungus that infects insects, growing into the insect's body and destroying tissues, thus causing death. It is the active ingredient in Mycotal Biological Insecticide, which is a pest control product for use on greenhouse crops.

Health considerations

Can approved uses of Lecanicillium muscarium strain Ve6 affect human health?

Lecanicillium muscarium strain Ve6 is unlikely to affect your health when Mycotal Biological Insecticide is used according to the label directions.

Potential exposure to Lecanicillium muscarium strain Ve6 may occur when handling and applying Mycotal Biological Insecticide and when ingesting treated produce. 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 age 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 Lecanicillium muscarium strain Ve6 was tested on laboratory animals, there was low toxicity following oral, inhalation and dermal exposures, and no infectivity when injected (intravenous). Furthermore, there was no sign that the microbial pest control agent (MPCA) Lecanicillium muscarium strain Ve6 caused any disease or genotoxic effects. In the absence of eye irritation testing, the technical grade active ingredient and end-use product are assumed to be eye irritants.

All microorganisms, including Lecanicillium muscarium strain Ve6, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to large quantities of Lecanicillium muscarium strain Ve6.

Residues in water and food

Dietary risks from food and water are acceptable.

Mycotal Biological Insecticide is already approved for use on greenhouse grown tomatoes, and residues of Lecanicillium muscarium strain Ve6 on treated produce are possible at the time of harvest. Metabolites of toxicological significance are not known to be produced by Lecanicillium muscarium strain Ve6. Furthermore, no signs of infectivity or toxicity were observed when Lecanicillium muscarium strain Ve6 was tested on laboratory animals. In addition, the likelihood of residues of Lecanicillium muscarium strain Ve6 contaminating drinking water supplies from the proposed applications of Mycotal Biological Insecticide to the new greenhouse grown crops (cucumbers, peppers and ornamentals) is expected to be low as the label has the necessary mitigation measures to limit contamination of drinking water. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Occupational risks from handling Mycotal Biological Insecticide

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

Workers handling Mycotal Biological Insecticide can be exposed to Lecanicillium muscarium strain Ve6 through direct skin or eye contact or through inhalation. To protect workers from exposure to Mycotal Biological Insecticide, 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 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.

Mycotal Biological Insecticide is proposed for commercial use as a diluted broadcast spray in greenhouses only. Residential and non-occupational exposure to Mycotal Biological Insecticide 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 Lecanicillium muscarium strain Ve6 is introduced into the environment?

Environmental risks are acceptable.

Lecanicillium muscarium is a common microorganism that is widely distributed in the natural terrestrial environment. It has been isolated from numerous species of insects, mites and spiders in the tropics and in temperate regions. It has also been found on decaying food and organic material and is often isolated from soil and wood.

Mycotal Biological Insecticide is currently registered for use on greenhouse tomatoes and is not intended for outdoor uses. The proposed greenhouse uses of Mycotal Biological Insecticide are not expected to result in sustained increases in Lecanicillium muscarium in terrestrial and aquatic environments beyond natural background levels. Lecanicillium muscarium strain Ve6 may be introduced to the environment through disposal of treated plant waste and growth media. The spores of Lecanicillium muscarium strain Ve6 are not easily dispersed by air and are highly sensitive to UV light and desiccation.

Any spores that are transferred to soil by rainwater have limited long-term persistence in this environment and do not leach into ground water. While Lecanicillium muscarium strain Ve6 could enter aquatic environments through run-off from soil or treated plants, this microorganism should not become established in non-aerated or deep waters.

No overt adverse effects to birds, freshwater fish or honey bees were observed during testing. No evidence of significant adverse effects on birds, freshwater fish, non-target terrestrial arthropods, aquatic arthropods and terrestrial and aquatic plants were found in the published scientific literature. Also, Lecanicillium muscarium strain Ve6 was not toxic or pathogenic to laboratory mammals through a variety of exposure routes.

Based on a critical review of studies, scientific rationales and information from public sources, no significant effects to birds, wild mammals, fish, non-target terrestrial and aquatic arthropods, and plants are expected when Mycotal Biological Insecticide is applied according to directions on the label.

Value considerations

What is the value of Mycotal Biological Insecticide?

Mycotal Biological Insecticide provides a new active ingredient for suppression of whiteflies on greenhouse crops.

Whiteflies are important pests of greenhouse crops, both vegetables and ornamentals. Mycotal Biological Insecticide provides a new alternative, containing a new biological active ingredient, for the suppression of whiteflies on greenhouse cucumber, pepper and tomato, and greenhouse ornamental crops.

Measures to minimize risk

Labels of registered pesticide products include specific instructions for use. Directions include risk-reduction measures to protect human health and the environment. These directions must be followed by law.

The key risk-reduction measures being proposed on the label of Mycotal Technical Biological Insecticide and Mycotal Biological Insecticide 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. The end-use product and technical grade active ingredient are considered potential sensitizers, and the end-use product contains the allergens milk and soy. In turn, "Contains the Allergens Milk and Soy" will appear on the primary display panel of the updated end-use product label, and workers handling or applying Mycotal Biological Insecticide 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 will include environmental precaution statements that prevent the runoff and contamination of aquatic systems from the use of Mycotal Biological Insecticide. The label for the end-use product also includes 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 Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide, Health Canada's PMRA will consider any comments received from the public in response to PRD2023-09. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2023-09. 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 Health Canada makes its registration decision, it will publish a Registration Decision on Lecanicillium muscarium strain Ve6 and Mycotal Biological Insecticide (based on the Science Evaluation of PRD2023-09). 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 PMRA's Pest Management Information Service.