Proposed Registration Decision PRD2019-10, Mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and V10

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Pest Management Regulatory Agency
7 August 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-10E-PDF (PDF version)

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

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Summary

Table of Contents

Proposed Registration Decision for mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and the End-use Product V10

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 VX1 Technical, containing the active mild Pepino mosaic virus strain LP, isolate VX1, VC1 Technical, containing the active mild Pepino mosaic virus strain CH2, isolate VC1, and the end-use product V10, containing the technical grade active ingredients mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1, for use on greenhouse tomato to protect against Pepino mosaic virus (PepMV).

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 PRD2019-10, Mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and V10 provides detailed technical information on the human health, environmental and value assessments of mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and the end-use product V10.

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 mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and the end-use product V10, Health Canada's PMRA will consider any comments received from the public in response to this PRD2019-10. Health Canada will then publish a Registration Decision on mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and V10, 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 PRD2019-10.

What are mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1?

Pepino mosaic virus (PepMV) isolates VX1 and VC1 are mild forms of PepMV. These mild forms protect greenhouse tomatoes against aggressive forms of the virus through cross-protection, which is a plant defence mechanism against viral infection.

Health Considerations

Can Approved Uses of mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 Affect Human Health?

Mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 are unlikely to affect your health when V10 is used according to the label directions.

Potential exposure to mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 may occur when handling and applying V10 or by ingesting treated produce. 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 VX1 Technical and VC1 Technical were tested on laboratory animals, there was low toxicity following oral and inhalation exposures, and there was no toxicity or irritation following dermal exposure. Also, VX1 Technical and VC1 Technical were not corrosive to the skin when these products were tested in a human skin cell culture. Pepino mosaic virus is a plant virus. Plant viruses are not related to any animal or human pathogen, and there are no reports of adverse effects in published scientific literature despite the natural occurrence and prevalence of plant viruses in the environment.

Residues in Water and Food

Dietary risks from food and water are acceptable

Residues of mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 on treated food crops are possible at the time of harvest. As already noted Pepino mosaic virus is a plant virus. Plant viruses are not related to any mammalian or human pathogen, and there are no reports of adverse effects in published scientific literature despite the natural occurrence and prevalence of plant viruses in the environment. Moreover, no signs of infectivity and low toxicity were observed when mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1were tested on laboratory animals. In addition, the likelihood of residues of mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 contaminating drinking water supplies from the proposed application of V10 on greenhouse tomato crops is low. Consequently, dietary risks are acceptable.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for non-occupational exposure is acceptable

V10 is proposed for use in the greenhouse only. Consequently, it is unlikely that adults, youths and toddlers will be exposed to mild Pepino mosaic virus strain LP, isolate VX1 or mild Pepino mosaic virus strain CH2, isolate VC1. Even in the event of exposure, risk to the general population is acceptable since VX1 Technical and VC1 Technical are of low toxicity and there were no signs that they caused any disease in studies on laboratory animals.

Occupational Risks from Handling V10

Occupational risks are not of concern when V10 is used according to label directions, which include protective measures

Workers handling V10 can come into direct contact with mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 on the skin or in the eyes. For this reason, the product label will specify that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirt, long pants, goggles and socks with shoes.

Environmental Considerations

What Happens When mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 Are Introduced into the Environment?

Environmental risks are acceptable.

V10 is a new end-use product that is proposed for use on greenhouse tomato and is not intended for outdoor uses. The greenhouse use of V10 is not expected to result in sustained increases of mild Pepino mosaic virus strain LP, isolate VX1 or mild Pepino mosaic virus strain CH2, isolate VC1in terrestrial and aquatic environments beyond natural background levels.

Mild Pepino mosaic virus strain LP, isolate VX1 and mild Pepino mosaic virus strain CH2, isolate VC1 belong to the genus Potexvirus in the family Alphaflexiviridae. The Potexviruses are exclusively plant pathogens with global distribution. Contact with infected plants through tools, workers, or bumblebees is necessary for transmission to healthy plants. Infection of healthy plants occurs by contact to contaminated surfaces with damaged surfaces on the plant.

Based on a critical review of applicant-submitted information from public sources, no significant effects to birds, wild mammals, fish, terrestrial and aquatic arthropods, terrestrial and aquatic non-arthropod invertebrates, or non-target terrestrial and aquatic plants are expected when V10 is applied according to directions on the label.

Value Considerations

What Is the Value of V10?

V10 protects greenhouse tomatoes against some aggressive strains of Pepino mosaic virus.

Pepino mosaic virus is a pathogen that causes a serious disease of greenhouse-grown tomatoes, which results in reduced crop yield, quality and marketability. V10 is compatible with current greenhouse integrated pest management practices and will serve as an additional option to protect greenhouse tomato against this increasingly widespread disease problem.

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 labels of the VX1 Technical, VC1 Technical and V10 to address the potential risks identified in this assessment are as follows.

Human Health

In the absence of an eye irritation study, VX1 Technical, VC1 Technical and V10 are considered eye irritants. In addition, all microorganisms, including mild Pepino mosaic virus strain LP, isolate VX1 or mild Pepino mosaic virus strain CH2, isolate VC1, contain substances that are potential sensitizers and thus, dermal sensitivity may possibly develop in individuals exposed to potentially large quantities of mild Pepino mosaic virus strain LP, isolate VX1 or mild Pepino mosaic virus strain CH2, isolate VC1. In turn, workers handling or applying V10 must wear waterproof gloves, long-sleeved shirt, long pants, goggles, and shoes with socks.

Environment

The end-use product label will include environmental precaution statements that reduce contamination of aquatic systems from the use of V10.

Next Steps

Before making a final registration decision on mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and V10, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-10. Health Canada will accept written comments on PRD2019-10 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 mild Pepino mosaic virus strain LP, isolate VX1, mild Pepino mosaic virus strain CH2, isolate VC1, and V10 (based on the Science Evaluation of PRD2019-10). 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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