Proposed Registration Decision PRD2015-01, BLAD Polypeptide

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Pest Management Regulatory Agency
6 February 2015
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2015-1E-PDF (PDF version)

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 PRD2015-01, BLAD Polypeptide 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

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act and  Regulations, is proposing full registration for the sale and use of Problad Technical Fungicide and Problad Plus, containing the technical grade active ingredient BLAD polypeptide, to be used against powdery mildew and grey mould on grape, strawberry, tomato, stone fruit, almond and ornamental plants.

An evaluation of available scientific information found that, under the approved conditions of use, the product has value and does not present an unacceptable risk to human health or the environment.

This summary describes the key points of the evaluation, while the Science Evaluation  of Proposed Registration Decision PRD2015-01, BLAD Polypeptide provides detailed technical information on the human health, environmental and value assessments of Problad Technical Fungicide and Problad Plus.

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 acceptableFootnote 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 valueFootnote 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 (for example, those most sensitive to environmental contaminants). 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, the PMRA will consider any comments received from the public in response to this consultation documentFootnote 3. The PMRA will then publish a Registration DecisionFootnote 4 on BLAD polypeptide, 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 Proposed Registration Decision PRD2015-01, BLAD Polypeptide.

What Is BLAD Polypeptide?

BLAD polypeptide is a fragment of a naturally occurring seed storage protein in sweet lupine (Lupinus albus) that serves as a nitrogen source for the germinating and developing plant. It also acts on susceptible fungal pathogens by causing damage to the fungal cell wall and disrupting the inner cell membrane. BLAD polypeptide is not yet classified by the Fungicide Resistance Action Committee, but based on the proposed mode of action, the risk of resistance is considered to be small.

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 polypeptidemay occur when handling and applying the end-use product, Problad Plus. 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 dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). Only uses for which the exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

In laboratory animals, the acute toxicity of the end-use product, Problad Plus, containing BLAD polypeptide, was low via the oral, dermal, and inhalation routes of exposure. Problad Plus is mildly irritating to the skin and eyes; consequently, the hazard signal words "CAUTION EYE AND SKIN IRRITANT" are required on the Problad Plus label. Problad Plus 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; consequently, the hazard signal words "CAUTION EYE AND SKIN IRRITANT" are required on the Problad Technical Fungicide label. BLAD polypeptide is 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. In addition, all products manufactured for import into Canada will be required to ensure the absence of primary allergen components (in other words, levels are below the level of detection).

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.

Risks in Residential and Other Non-Occupational Environments

Estimated risk for non-occupational exposure is not of concern provided that directions specified on the label are observed.

Residential exposure to individuals coming in contact with Problad Plus from drift during application is not expected to result in unacceptable risk when Problad Plus is used according to label directions.

Occupational Risks From Handling and Applying Problad Plus

Occupational risks are not of concern when Problad Plus is used according to the proposed label directions, which include protective measures.

An assessment conducted for individuals handling and applying Problad Plus indicated that the risk is not of concern when the product is used according to label directions.

Residues in Water and Food

Dietary risks from food and drinking water are not of health concern.

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 with lupine and/or other legume (for example, peanut) sensitivities will result in an allergic reaction. Consequently, the specification of a maximum residue limit under the Pest Control Products Act is not being recommended.

Environmental Considerations

What Happens When Problad Plus Is Introduced Into the Environment?

Problad Technical Fungicide will enter the environment when applied as Problad Plus to grapes, strawberries, tomatoes, stone fruit, and ornamentals. Problad Technical Fungicide will dissipate in the environment primarily through microbial degradation. The risk to non-target aquatic and terrestrial organisms in the environment is negligible.

BLAD is a naturally-occurring seed storage protein, which accumulates exclusively in the cotyledons of Lupinus species (for example, Lupinus albus), between days four and twelve after the onset of germination. It is a 20kDa polypeptide of β-conglutin, or characterized as a fragment of the amino acid sequence of β-conglutin. Th β-conglutin protein is classified as a 7S globulin which is part of the broader family of cupin proteins, which provides a major nitrogen source for germination of the developing plant.

Problad Plus is a non-systemic biofungicide with strong antifungal activities both preventive but also for control. The non-toxic mode of action is described as binding very strongly to chitin in fungal cell walls, inhibiting any fungal growth. The active ingredient degrades chitin by catalyzing the successive removal of the N-acetyl-D-glucosamine terminal chitin monomers, and destroying the fungal cells.

Problad TGAI is readily biodegradable and non-toxic to all non-target organisms tested, both terrestrial and aquatic. Therefore, the risk to non-target aquatic and terrestrial organisms in the environment is negligible when Problad Plus is used according to the label directions.

Value Considerations

What Is the Value of Problad Plus?

Problad Plus is a broad spectrum biological fungicide with a unique mode of action that will contribute to resistance management when integrated with cultural methods and chemical sprays in an Integrated Pest Management program.

Problad Plus provides non-systemic, preventative action when applied to plant foliage with activity against powdery mildew and grey mould on fruit, vegetable and ornamental crops and blossom blight on stone fruit.

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 Plus 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 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 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, the Problad Plus 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, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2015-01, BLAD Polypeptide. The PMRA will accept written comments on Proposed Registration Decision PRD2015-01, BLAD Polyeptide up to 45 days from the date of publication of Proposed Registration Decision PRD2015-01, BLAD Polypeptide. 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 BLAD polypeptide (based on the Science Evaluation of Proposed Registration Decision PRD2015-01, BLAD Polypeptide). In addition, the test data referenced in Proposed Registration Decision PRD2015-01, BLAD Polypeptide will be available for public inspection, upon application, in PMRA's Reading Room (located in Ottawa).

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