Proposed Registration Decision PRD2024-01, Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir

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Pest Management Regulatory Agency
26 February 2024
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2024-1E-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 PRD2024-01, Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir please contact our publications office.

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

Table of contents

• Proposed registration decision for Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir
• What does Health Canada consider when making a registration decision?
• What is Phthorimaea operculella granulovirus isolate GV-0019?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir

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 PhopGV Technical and Tutavir, containing the technical grade active ingredient Phthorimaea operculella granulovirus isolate GV-0019, for control of tomato leafminer (Tuta absoluta) on greenhouse fruiting vegetables.

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 PRD2024-01, Phthorimaea operculella granulovirus isolate GV-0019 provides detailed technical information on the human health, environmental and value assessments of Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir.

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, Health Canada's 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 Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir, 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 Decision^{Footnote 4} on Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir, 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 the full version of PRD2024-01.

What is Phthorimaea operculella granulovirus isolate GV-0019?

Phthorimaea operculella granulovirus isolate GV-0019 is an insect-specific baculovirus and is the active ingredient in the insecticide product, Tutavir. Tutavir infects only larvae of certain Lepidopteran species (for example, moths) and acts only on ingestion by larvae, not by contact.

Health considerations

Can approved uses of Phthorimaea operculella granulovirus isolate GV-0019affect human health?

Phthorimaea operculella granulovirus isolate GV-0019is unlikely to affect your health when Tutavir is used according to the label directions.

Potential exposure to Phthorimaea operculella granulovirus isolate GV-0019may occur through the diet (food and water) or when handling and applying Tutavir. 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.

Studies in laboratory animals describe potential health effects from large doses of exposure to a microorganism and identify any pathogenicity, infectivity and toxicity concerns.

Granuloviruses belong to the baculovirus group of insect viruses. When other baculoviruses were tested on laboratory animals and in tissue cultures, there were no signs of significant toxicity or disease. Furthermore, there have been no reported adverse effects despite the natural occurrence and prevalence of baculoviruses in the environment, and the limited host range associated with baculoviruses has been well documented. 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 Phthorimaea operculella granulovirus isolate GV-0019, contain substances that are potential sensitizers and thus, sensitivity may possibly develop in individuals exposed to large quantities of Phthorimaea operculella granulovirus isolate GV-0019.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of Phthorimaea operculella granulovirus isolate GV-0019on treated agricultural crops are possible at the time of harvest. Although baculoviruses, including Phthorimaea operculella granulovirus, are abundant in nature, no adverse effects from dietary exposure have been attributed to natural populations of Phthorimaea operculella granulovirus. Furthermore, no signs of infectivity or toxicity were observed when baculoviruses were tested on laboratory animals and in tissue culture studies. In addition, the likelihood of residues of Phthorimaea operculella granulovirus isolate GV-0019contaminating 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 Tutavir. Consequently, health risks from dietary exposure are acceptable for all segments of the population, including infants, children, adults and seniors.

Occupational risks from handling Tutavir

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

Workers handling Tutavir can be exposed to Phthorimaea operculella granulovirus isolate GV-0019through direct skin or eye contact or through inhalation. To protect workers from exposure to Tutavir, 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 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 is acceptable.

Tutavir is being proposed for commercial use in greenhouses only and there are no residential uses. Residential and non-occupational exposure to Tutavir 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 Phthorimaea operculella granulovirus isolate GV-0019 is introduced into the environment?

Environmental risks are acceptable.

Phthorimaea operculella granulovirus isolate GV-0019 is a naturally occurring baculovirus that specifically infects Lepidopteran insects. Baculoviruses are common and persistent in aquatic and terrestrial ecosystems. Tutavir is a new end-use product that is proposed for use as an insecticide to control tomato leafminer larvae on greenhouse Solanaceous crops (for example, tomato or eggplant), and is not intended for outdoor uses. Phthorimaea operculella granulovirus isolate GV-0019 may be introduced to the environment through disposal of treated plant material. However, the greenhouse use of Tutavir is not expected to result in sustained increases of Phthorimaea operculella granulovirus isolate GV-0019 in terrestrial and aquatic environments beyond natural background levels.

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

Value considerations

What is the value of Tutavir?

Tutavir can be used as a foliar spray to control tomato leafminer (Tuta absoluta), which has the potential to become a major economic pest within Canada on greenhouse fruiting vegetables.

The registration of Tutavir will provide Canadian greenhouse fruiting vegetable growers, including organic growers, a new alternative microbial product with a novel mode of action to combat the greenhouse pest, tomato leafminer (Tuta absoluta). The narrow host range of the active ingredient makes the product a suitable component in integrated pest 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.

The key risk-reduction measures being proposed on the labels of PhopGV Technical and Tutavir 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. In turn, workers handling or applying Tutavir 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 Tutavir.

Next steps

Before making a final registration decision on Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir, Health Canada's PMRA will consider any written comments received from the public in response to PRD2024-01 up to 45 days from the date of publication (26 February 2024) of PRD2024-01. 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 Phthorimaea operculella granulovirus isolate GV-0019 and Tutavir (based on the Science Evaluation of PRD2024-01). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.