Proposed Registration Decision PRD2021-07, Cydia pomonella granulovirus isolate V-22 and Madex HP

• Pest Management Regulatory Agency
• 29 July 2021
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2021-7E-PDF (PDF version)

Summary

Table of Contents

• Proposed registration decision for Cydia pomonella granulovirus isolate V-22
• What does Health Canada consider when making a registration decision?
• What is Cydia pomonella granulovirus isolate V-22?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for Cydia pomonella granulovirus isolate V-22

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 CpGV V-22 Technical and Madex HP, containing the technical grade active ingredient Cydia pomonella granulovirus isolate V-22, to control codling moth (Cydia pomonella) and oriental fruit moth (Grapholita molesta) on stone fruits (Crop Group 12-09) and pome fruits (Crop Group 11-09).

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 PRD2021-07, Cydia pomonella granulovirus isolate V-22 and Madex HP provides detailed technical information on the human health, environmental and value assessments of Cydia pomonella granulovirus isolate V-22 and Madex HP.

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 Cydia pomonella granulovirus isolate V-22 and Madex HP, Health Canada's PMRA will consider any comments received from the public in response to PRD2021-07.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on Cydia pomonella granulovirus isolate V-22 and Madex HP, 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 PRD2021-07.

What is Cydia pomonella granulovirus isolate V-22?

Cydia pomonella granulovirus isolate V-22 is an insecticidal virus. Virus particles must be ingested by larvae to infect them. During infection, the virus replicates and disrupts feeding, resulting in death. After death, the larvae disintegrate, spreading additional virus particles where nearby larvae may become infected.

Health considerations

Can Approved uses of Cydia pomonella granulovirus isolate V-22 affect human health?

Cydia pomonella granulovirus isolate V-22 is unlikely to affect your health when Madex HP is used according to the label directions.

Potential exposure to Cydia pomonella granulovirus isolate V-22 may occur through the diet (food and water), through drift resulting from agricultural field applications, or when handling and applying Madex HP. When assessing health risks, several 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. 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. The end-use product and technical grade active ingredient are considered to be irritating to the eye.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of Cydia pomonella granulovirus isolate V-22 on various treated agricultural crops are possible at the time of harvest. Although baculoviruses, including Cydia pomonella granulovirus isolate V-22, are abundant in nature, no adverse effects from dietary exposure have been attributed to natural populations of Cydia pomonella 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 Cydia pomonella granulovirus isolate V-22 contaminating drinking water supplies from the proposed application of Madex HP to various field grown crops 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.

Risks in residential and other non-occupational environments

Estimated risk for non-occupational exposure is acceptable.

Madex HP is proposed for use as a biological insecticide on various field grown crops. There are no residential uses. The product label for Madex HP will include measures to reduce bystander and residential exposure such as reducing spray drift. Residential and non-occupational exposure to Madex HP is therefore expected to be low when the label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational risks from handling Madex HP

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

Workers handling Madex HP can come into direct contact with Cydia pomonella granulovirus isolate V-22 on the skin, in the eyes, or by inhalation. To protect workers from exposure to Madex HP, the label will specify that mixers, loader and applicators must wear waterproof gloves, protective eyewear (goggles), long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes.

A restricted-entry interval of 4 hours or until sprays are dried is required for Madex HP, and if re-entry into treated areas is necessary during this restricted-entry interval, workers must wear waterproof gloves, long-sleeved shirt, long pants, socks and shoes. The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when Cydia pomonella granulovirus isolate V-22 is introduced into the environment?

Environmental risks are acceptable.

Cydia pomonella granulovirus isolate V-22 is a naturally occurring baculovirus that specifically infects lepidopteran insects. Baculoviruses are common and persistent in aquatic and terrestrial ecosystems.

Madex HP is a new end-use product that is proposed for use as an insecticide to control codling moth and oriental fruit moth on pome and stone fruits and is not intended for aquatic applications. The field use of Madex HP is not expected to result in sustained increases of Cydia pomonella granulovirus isolate V-22 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 Madex HP is applied according to directions on the label.

Value considerations

What is the value of Madex HP?

Madex HP is a new non-conventional commercial class product that controls codling moth and oriental fruit moth on stone fruits and pome fruits. It can be used by organic growers and in integrated pest management programs.

Applications of Madex HP target early larval stages of codling moth and oriental fruit moth. Cydia pomonella granulovirus isolate V-22 represents a new non-conventional product containing a new virus isolate for use on food crops, which will contribute to 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.

The key risk-reduction measures being proposed on the label of CpGV V-22 Technical and Madex HP to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

CpGV V-22 Technical and Madex HP are considered eye irritants. In addition, all microorganisms, including Cydia pomonella granulovirus isolate V-22, contain substances that are potential sensitizers and thus, sensitivity may develop in individuals exposed repeatedly to large quantities of Cydia pomonella granulovirus isolate V-22. In turn, commercial workers handling or applying Madex HP must wear waterproof gloves, protective eyewear (goggles), long-sleeved shirt, long pants, a NIOSH-approved particulate filtering facepiece respirator, socks and shoes. Also, a restricted-entry interval of 4 hours or until sprays are dried is required for Madex HP and, if re-entry into treated areas is necessary during this restricted-entry interval, workers must wear waterproof gloves, long-sleeved shirt, long pants, socks and shoes.

A standard drift statement is required on the Madex HP label to minimize the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools and recreational areas, as well as statements to limit contamination of water supplies through cleaning or waste disposal.

Environment

The end-use product label will include environmental precaution statements that reduce contamination of aquatic systems from the use of Madex HP.

Next steps

Before making a final registration decision on Cydia pomonella granulovirus isolate V-22 and Madex HP, Health Canada's PMRA will consider any comments received from the public in response to PRD2021-07. Health Canada will accept written comments on PRD2021-07 up to 45 days from the date of its publication. 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 Cydia pomonella granulovirus isolate V-22 and Madex HP (based on the Science evaluation of PRD2021-07). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room.