Proposed Registration Decision PRD2019-02, BLAD Polypeptide Problad Technical Fungicide and Problad Plus Fungicide

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Pest Management Regulatory Agency
20 February 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-2E-PDF (PDF version)

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To obtain a full copy of Proposed Registration Decision PRD2019-02, BLAD Polypeptide Problad Technical Fungicide and Problad Plus Fungicide 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 BLAD polypeptide, Problad Technical Fungicide and Problad Plus Fungicide

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 Problad Technical Fungicide and Problad Plus Fungicide, containing the technical grade active ingredient BLAD polypeptide, to control grey mould on certain fruiting vegetables (field and greenhouse eggplant, peppers, tomato and pepino), suppression of powdery mildew and control of grey mould on greenhouse strawberry, and control of grey mould on greenhouse ornamentals and on lowbush blueberry.

BLAD polypeptide is currently registered to suppress or control powdery mildew and grey mould on grape, field strawberry, field tomato, stone fruit, almond and ornamental plants. For details, see the Proposed Registration Decision PRD2015-01, BLAD polypeptide and the Registration Decision RD2015-18, BLAD polypeptide.

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 PRD2019-02, BLAD Polypeptide Problad Technical Fungicide and Problad Plus Fungicide provides detailed technical information on the human health, environmental and value assessments of BLAD polypeptide, Problad Technical Fungicide, and Problad Plus Fungicide.

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 Pest Control Products 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 BLAD polypeptide, Problad Technical Fungicide, and Problad Plus Fungicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-02. Health Canada will then publish a Registration Decision on BLAD polypeptide, Problad Technical Fungicide, and Problad Plus Fungicide, 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 PRD2019-02.

What Is BLAD polypeptide?

BLAD polypeptide is a protein fragment from sweet lupine (Lupinus albus) that inhibits the growth of fungi by damaging their cell walls. BLAD stands for "Banda de Lupinus albus doce".

Health Considerations

Can Approved Uses of BLAD Polypeptide Affect Human Health?

BLAD polypeptide is unlikely to affect human health when it is used according to label directions.

Potential exposure to BLAD polypeptide may occur through the diet (food and water) or when handling and applying the product. When assessing health risks, two key factors are considered:

  • the levels where no health effects occur and
  • the levels to which people may be exposed.

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 for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Toxicology studies in laboratory animals describe potential health effects from varying levels of exposure to a chemical and identify the dose where no effects are observed.

In laboratory animals, the acute toxicity of the end-use product, Problad Plus Fungicide, containing BLAD polypeptide, was low via the oral, dermal, and inhalation routes of exposure. Problad Plus Fungicide is mildly irritating to the skin and eyes, but is not a dermal sensitizer.

A request to bridge acute toxicity data from the end-use product to the technical grade active ingredient was considered to be acceptable. The active ingredient, BLAD polypeptide, was considered to be of low acute toxicity via the oral, dermal, and inhalation routes of exposure. BLAD polypeptide was mildly irritating to the skin and eyes, but not a dermal sensitizer.

BLAD polypeptide is not expected to cause effects in developing young or to cause damage to genetic material when used according to the label instructions.

BLAD polypeptide is not expected to elicit an allergic response in individuals who are sensitive to allergens present in lupine seeds and/or other legumes.

The risk assessment protects against the effects of BLAD polypeptide by ensuring that the level of human exposure is well below the lowest dose at which effects occurred in animal tests.

Residues in Water and Food

Dietary risks from food and water are acceptable.

Dietary risks from food and drinking water are expected to be negligible given the low toxicity, the lack of quantifiable residues from the supplemental residue information, and the likelihood (most likely negligible) that exposure of individuals to Problad Plus Fungicide with lupine and/or other legume (for example, peanut) sensitivities will result in an allergic reaction.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for residential and other non-occupational exposure is acceptable.

Risk from residential exposure to individuals coming in contact with Problad Plus Fungicide, containing the active ingredient BLAD polypeptide, during application is acceptable when Problad Plus Fungicide is used according to label directions.

Occupational Risks From Handling Problad Plus Fungicide

Occupational risks are acceptable when Problad Plus Fungicide is used according to the label directions, which include protective measures.

An assessment conducted for individuals handling and applying Problad Plus Fungicide indicated that the risk is acceptable when the product is used according to label directions.

Environmental Considerations

What Happens When BLAD Polypeptide Is Introduced Into the Environment?

Problad Plus Fungicide, containing the active ingredient BLAD polypeptide, is not expected to pose risks of concern to the environment when used according to label instructions.

BLAD polypeptide may enter the environment when applied as Problad PlusFungicide to field and greenhouse fruit, vegetables, and ornamentals. Banda de Lupinus albus doce (BLAD) is a naturally-occurring seed storage protein which is expected to be broken down by microorganisms in soil and water.

Problad Technical Fungicide is expected to be non-toxic to all non-target terrestrial and aquatic organisms tested. Therefore, risk of concern to the aquatic and terrestrial environments is not expected when Problad Plus Fungicide is used according to the label directions.

Value Considerations

What Is the Value of Problad Plus Fungicide?

Problad Plus Fungicide is a broad spectrum biological fungicide with a unique mode of action that will contribute to an integrated disease management program.

Probald Plus Fungicide is effective when applied to plant foliage and has activity against powdery mildew and grey mould on greenhouse strawberry, certain fruiting vegetables, lowbush blueberry as well as greenhouse ornamental crops.

The active ingredient in Problad Plus Fungicide has a multi-site mode of action and the risk of resistance development is low.

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 Problad Technical Fungicide and Problad Plus Fungicide to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

Both Problad Technical Fungicide and Problad Plus Fungicide labels must include the statement, "CAUTION - SKIN AND EYE IRRITANT" on the principal display panel and "May irritate skin and eyes" and "Avoid contact with the skin and eyes" on the secondary display panel.

To avoid direct contact with Problad Plus Fungicide on the skin and eyes, workers involved in the mixing, loading, application, cleaning, and maintenance of machinery must wear long-sleeved shirts, long pants, chemical-resistant gloves, shoes, socks, and protective eyewear.

To avoid inadvertent bystander exposure during application on field crops, the Problad Plus Fungicide label must include the statement, "Apply only when the potential for drift to areas of human habitation or areas of human activity such as houses, cottages, schools, and recreational areas is minimal. Take into consideration wind speed, wind direction, temperature, application equipment, and sprayer settings."

Environment

No further mitigation measures are required at this time.

Next Steps

Before making a final registration decision on BLAD polypeptide, Problad Technical Fungicide and Problad Plus Fungicide, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-02. Health Canada will accept written comments on PRD2019-02 up to 45 days from the date of publication of PRD2019-02.

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 BLAD polypeptide, Problad Technical Fungicide, and Problad Plus Fungicide (based on the Science Evaluation of PRD2019-02). In addition, the test data referenced in PRD2019-02 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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