Proposed Registration Decision PRD2020-01, Beauveria bassiana strain GHA, Aprehend

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Pest Management Regulatory Agency
27 January 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-1E-PDF (PDF version)

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Summary

Table of contents

Proposed registration decision for Beauveria bassiana strain GHA

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 Technical and Aprehend, containing the technical grade active ingredient Beauveria bassiana strain GHA, to kill and control bed bugs indoors.

Beauveria bassiana strain GHA is currently registered to control whitefly, aphids and thrips in greenhouse ornamentals and vegetables. For details, see Proposed Registration Decision PRD2009-03, Beauveria bassiana strain GHA, and Registration Decision RD2009-13, Beauveria bassiana strain GHA.

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 PRD2020-01, Beauveria bassiana strain GHA, Aprehend provides detailed technical information on the human health, environmental and value assessments of Beauveria bassiana strain GHA and Aprehend.

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 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 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:

Before making a final registration decision on Beauveria bassiana strain GHA and Aprehend, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-01. Health Canada will then publish a Registration Decision on Beauveria bassiana strain GHA and Aprehend, 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 Overview, please refer to the Science Evaluation of PRD2020-01.

What is Beauveria bassiana strain GHA?

Beauveria bassiana strain GHA is the active ingredient in the commercial class ready-to-use microbial product, Aprehend Insecticide, for indoor use to kill and control bed bugs. Beauveria bassiana strain GHA is a fungus that kills insects by infection and growth within the insect. It is active by contact.

Health considerations

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

Beauveria bassiana strain GHA is unlikely to affect your health when Aprehend is used according to the label directions

Potential exposure to B. bassiana strain GHA may occur when handling and applying Aprehend. 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.

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 Aprehend was tested on laboratory animals, there was low toxicity following oral, inhalation, and dermal exposures.

Aprehend was also slightly irritating to the skin and minimally irritating to the eyes. Aprehend was a dermal sensitizer. The microbial pest control agent, B. bassiana strain GHA, was not infectious or pathogenic following oral, pulmonary or intraperitoneal exposure routes.

Residues in water and food

Dietary risks from food and water are acceptable

Based on the lack of dietary exposure resulting from the proposed use of Aprehend, the health risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable

Aprehend is proposed for use in residential and commercial structures to control and prevent bed bugs. The product label will include measures to reduce bystander and residential exposures, such as not allowing people or pets into treated areas until sprays have dried, the use of low pressure sprayers to reduce aerosols and preventing applications to non-target surfaces such as furniture or upholstery where prolonged contact with humans or pets will occur and food or food processing surfaces. Residential and non-occupational exposure to Aprehend is therefore expected to be low when label directions are observed.

Consequently, the risk to residents and the general public is acceptable. Even in the event of exposure, risk to residents and the general population is acceptable since Aprehend is of low toxicity and there were no signs that B. bassiana strain GHA caused any disease in studies on laboratory animals.

Occupational risks from handling Aprehend

Occupational risks are not of concern when Aprehend is used according to label directions, which include protective measures

Workers handling Aprehend can come into direct contact with B. bassiana strain GHA on the skin, by inhalation, or in the eyes. To protect workers from exposure to Aprehend, the label states that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, goggles, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. If re-entry into treated areas is necessary before the sprays have dried, workers must wear waterproof gloves, long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, sock and shoes.

Environmental Considerations

What happens when Beauveria bassiana strain GHA is introduced into the environment?

Environmental risks are acceptable

The microbial pest control agent, B. bassiana strain GHA, is currently registered for use on greenhouse ornamentals and greenhouse food crops. The proposed use expansion of Aprehend to prevent and control bed bugs in residential and commercial structures is not expected to result in significant environmental exposure.

Based on a critical review of applicant-submitted data and information from public sources conducted during the initial registration of this microbial pest control agent, no significant effects to birds, wild mammals, fish, non-target insects, earthworms, soil microorganisms, or plants are expected when Aprehend is applied according to directions on the label.

Value Considerations

What is the value of Aprehend?

Aprehend insecticide is a new commercial class product that kills and controls bed bugs indoors

Aprehend insecticide is applied as a barrier spray. When bed bugs cross the barrier they become infected and die. Aprehend Insecticide prevents re-infestation for up to three months and is effective against strains of bed bugs resistant to chemical insecticides. Beauveria bassiana strain GHA represents a new mode of action for use against bed bugs, which is important for resistance management.

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.

Key risk-reduction measures

The key risk-reduction measures being proposed on the label of Beauveria bassiana Technical and Aprehend to address the potential risks identified in this assessment are as follows.

Human health

All microorganisms, including B. bassiana strain GHA, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to potentially large quantities of B. bassiana strain GHA. In turn, workers handling or applying Aprehend must wear waterproof gloves, goggles, long-sleeved shirt, long pants, socks with shoes, and a NIOSH-approved particulate filtering facepiece respirator.

People and pets will not be allowed to enter treated areas until sprays have dried. If re-entry into treated areas is required before the sprays have dried, workers must wear waterproof gloves, long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

The label will also instruct users to apply the product using a low pressure sprayer and prevent applications to non-target surfaces such as furniture or upholstery where prolonged contact with humans or pets will occur and to food or food processing surfaces.

Environment

The end-use product label will include an environmental precaution statement that reduces contamination of aquatic systems from the use of Aprehend. The label will also include a statement alerting users that the end-use product contains petroleum distillates that are toxic to aquatic organisms.

Next steps

Before making a final registration decision on Beauveria bassiana strain GHA and Aprehend, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-01. Health Canada will accept written comments on PRD2020-01 up to 45 days from the date of publication of this document.

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 GHA and Aprehend (based on the Science Evaluation of PRD2020-01). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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