Proposed Registration Decision PRD2018-12, Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01

This consultation is now closed.

Pest Management Regulatory Agency
31 July 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-12E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2018-12, Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01 please contact our publications office.

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

Summary

Table of Contents

Proposed Registration Decision for Pepino Mosaic Virus, strain CH2, isolate 1906 and PMV-01

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01, containing the technical grade active ingredient Pepino mosaic virus, strain CH2, isolate 1906, to protect greenhouse tomatoes 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 PRD2018-12, Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01 provides detailed technical information on the human health, environmental and value assessments of Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01.

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 Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01, the PMRA will consider any comments received from the public in response PRD2018-12. The PMRA will then publish a Registration Decision on Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01, which will include the decision, the reasons for it, a summary of comments received on the proposed final registration decision and the PMRA’s response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2018-12.

What Is Pepino Mosaic Virus, strain CH2, isolate 1906?

Pepino mosaic virus strain CH2, isolate 1906, is a mild form of the Pepino mosaic virus (PepMV). It protects greenhouse tomatoes against aggressive forms of the virus through cross-protection, which is a plant defense mechanism against viral infection.

Health Considerations

Can Approved Uses of Pepino mosaic virus, strain CH2, isolate 1906 Affect Human Health?

Pepino mosaic virus, strain CH2, isolate 1906 is unlikely to affect your health when PMV-01 is used according to the label directions.

Potential exposure to Pepino mosaic virus, strain CH2, isolate 1906 may occur when handling and applying PMV-01 and ingesting treated produce. 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. When Pepino mosaic virus, strain CH2, isolate 1906 (technical grade active ingredient) was tested on laboratory animals, there was no sign that it caused any toxicity following oral, pulmonary or dermal exposures. Similarly, no signs of infection were observed when Pepino mosaic virus, strain CH2, isolate 1906 (technical grade active ingredient) was tested on a human cell culture. Pepino mosaic virus is a plant virus. Plant viruses are not related to any animal or human pathogen. There are no reports of adverse effects despite the natural occurrence and prevalence of plant viruses in the environment and due to the limited host range.

Residues in Water and Food

Dietary risks from food and water are not of concern.

The health risk to the general population, including infants and children, as a result of dietary exposure (food and drinking water), is not expected based on the use pattern and conditions of use.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for non-occupational exposure is not of concern.

PMV-01 is proposed for use in the greenhouse only. Consequently, it is unlikely that adults, youths and toddlers will be exposed to Pepino mosaic virus, strain CH2, isolate 1906. Even in the event of exposure, risk to the general population is not a concern since there were no signs that it caused any significant toxicity or disease in studies on laboratory animals and human cell cultures.

Occupational Risks From Handling PMV-01

Occupational risks are not of concern when PMV-01 is used according to label directions, which include protective measures.

Workers handling PMV-01 can come into direct contact with Pepino mosaic virus, strain CH2, isolate 1906 on the skin, in the eyes, or by inhalation. For this reason, the product label will specify that workers must wear personal protective equipment, including waterproof gloves, long-sleeved shirts, long pants, a mist filtering respirator, eye goggles and shoes with socks. To minimize postapplication exposure, unprotected workers are restricted from entering areas treated with PMV-01 for 4 hours following application or until sprays have dried.

Environmental Considerations

What Happens When Pepino mosaic virus, strain CH2, isolate 1906 Is Introduced Into the Environment?

Environmental risks are not of concern.

PMV-01 is proposed for use in greenhouse tomato and is not intended for outdoor uses. The greenhouse use of PMV-01 is not expected to result in sustained increases of Pepino mosaic virus, strain CH2, isolate 1906 in terrestrial and aquatic environments beyond natural background levels.

Pepino mosaic virus, strain CH2, isolate 1906 belongs 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 in the plant. The virus does not persist outside plant material and is inactivated by UV light.

Based on a critical review of an applicant-submitted aquatic plant study and information from public sources, no significant effects to birds, wild mammals, fish, terrestrial and aquatic non-target arthropods, terrestrial and aquatic non-arthropod invertebrates, or terrestrial and aquatic plants are expected when PMV-01 is applied according to directions on the label.

Value Considerations

What Is the Value of PMV-01?

PMV-01 protects greenhouse tomatoes against the aggressive forms of the Pepino Mosaic Virus.

PMV-01 provides protection against the Pepino mosaic virus, which causes a disease of greenhouse tomatoes that reduces crop yield and quality. There are no other products available to control this disease and growers rely on hygienic practices to exclude the virus and prevent infection of tomato plants. PMV-01 is compatible with current greenhouse tomato production practices.

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 the Pepino mosaic virus, strain CH2, isolate 1906 (technical grade active ingredient) and PMV-01 (end-use product) to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

In the absence of an eye irritation study, Pepino mosaic virus, strain CH2, isolate 1906 (technical grade active ingredient) and PMV-01 are considered eye irritants. In addition, all microorganisms, including Pepino mosaic virus, strain CH2, isolate 1906, contain substances that are potential sensitizers and thus, respiratory and dermal sensitivity may possibly develop in individuals exposed to potentially large quantities of Pepino mosaic virus, strain CH2, isolate 1906. In turn, workers handling or applying PMV-01 must wear waterproof gloves, long-sleeved shirts, long pants, eye goggles, a mist filtering respirator, and shoes with socks. Furthermore, all unprotected workers are restricted from entering treated areas during application and for 4 hours following application or until sprays have dried.

Environment

The end-use product label will include environmental precaution statements that limit contamination of aquatic systems from the use of PMV-01.

Next Steps

Before making a final registration decision on Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01, the PMRA will consider any comments received from the public in response to PRD2018-12. The PMRA will accept written comments on PRD2018-12 up to 45 days from the date of publication of PRD2018-12. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency’s response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on Pepino mosaic virus, strain CH2, isolate 1906 and PMV-01 (based on the Science Evaluation of PRD2018-12). In addition, the test data referenced in PRD2018-12 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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