Proposed Registration Decision PRD2016-03, Mandestrobin

Pest Management Regulatory Agency
29 January 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-3E-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 PRD2016-03, Mandestrobin 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 Mandestrobin

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 Mandestrobin Technical (previously known as S-2200 Fungicide Technical) and the associated end-use products: S-2200 4 SC Fungicide, Intuity Fungicide (previously known as S-2200 4 SC Ag Fungicide), Pinpoint Fungicide (previously known as S-2200 4 SC VPP Fungicide), and S-2200 3.2 FS Fungicide, containing the technical grade active ingredient mandestrobin, for the management of various fungal diseases in canola and other oilseed crops, corn, grape, legume vegetables, strawberry and other low growing berries, as well as turfgrass.

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 PRD2016-03, Mandestrobin provides detailed technical information on the human health, environmental and value assessments of S-2200 Fungicide Technical, S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, S-2200 4 SC VPP Fungicide, and S-2200 3.2 FS 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 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 mandestrobin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-03, Mandestrobin. The PMRA will then publish a Registration Decision on mandestrobin, which will include the decision, the reasons for it, a summary of comments received on the proposed 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 PRD2016-03, Mandestrobin.

What Is Mandestrobin?

Mandestrobin is the active ingredient in the following fungicide products that are being proposed for registration in Canada: S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, S-2200 4 SC VPP Fungicide, and S-2200 3.2 FS Fungicide. These products are formulated for either foliar or seed applications and are intended for the management of various fungal diseases in canola and other oilseed crops, corn, grape, legume vegetables, strawberry and other low growing berries, as well as turfgrass. Mandestrobin has preventative and systemic properties and acts by interfering with the cellular mechanisms in susceptible fungal pathogens.

Health Considerations

Can Approved Uses of Mandestrobin Affect Human Health?

Products containing mandestrobin are unlikely to affect your health when used according to label directions.

Potential exposure to mandestrobin may occur through the diet (food and water) or when handling and applying the products. 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.

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. The health effects noted in animals occur at doses more than 100-times higher (and often much higher) than levels to which humans are normally exposed when pesticide products are used according to label directions.

In laboratory animals, the technical grade active ingredient mandestrobin was of low acute toxicity by the oral, dermal and inhalation routes. Mandestrobin was minimally irritating to the eye and non-irritating to the skin. Mandestrobin did not cause allergic skin reactions.

The acute toxicity of the end-use products was low via the oral, dermal and inhalation routes of exposure. The products were non-irritating to the skin and minimally irritating to the eyes. They did not cause allergic skin reactions. Consequently, no hazard signal words are required on their labels.

Applicant-supplied short- and long-term (lifetime) animal toxicity tests were assessed for the potential of mandestrobin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were adverse effects noted on growth and in the liver, bile duct, and kidneys. There was a low level of concern for sensitivity of the young animal. The risk assessment protects against the finding noted above as well as any other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in animal tests.

Residues in Water and Food

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

Aggregate dietary intake estimates (food plus drinking water) revealed that the general population and children 1-2 years old, the subpopulation which would ingest the most mandestrobin relative to body weight, are expected to be exposed to less than 10%of the acceptable daily intake. Based on these estimates, the chronic dietary risk from mandestrobin is not of health concern for all population subgroups.
Animal studies revealed no acute health effects. Consequently, a single dose of mandestrobin is not likely to cause acute health effects in the general population (including infants and children). Mandestrobin is not carcinogenic; therefore, a cancer dietary risk assessment is not required.

The Food and Drugs Act prohibits the sale of adulterated food, that is, food containing a pesticide residue that exceeds the established maximum residue limit (MRL). Pesticide MRLs are established for Food and Drugs Act purposes through the evaluation of scientific data under the Pest Control Products Act. Food containing a pesticide residue that does not exceed the established MRL does not pose an unacceptable health risk.

Residue trials conducted throughout Canada (and the United States) using mandestrobin on rapeseed, corn, grapes, strawberries, and soybeans are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of Proposed Registration Decision PRD2016-03, Mandestrobin.

Occupational Risks From Handling S-2200 4 SC Fungicide, S-2200 3.2 FS Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicide

Occupational risks are not of concern when S-2200 4 SC Fungicide, S-2200 3.2 FS Fungicide, S-2200 4 SC Ag Fungicide and S-2200 4 SC VPP Fungicide are used according to the label directions, which include protective measures.

Farmers, custom applicators, seed treaters and planters who mix, load, apply or treat seeds with S-2200 4 SC Fungicide, S-2200 3.2 FS Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicide, as well as field workers re-entering freshly treated fields, can come in direct contact with residues on the skin. Therefore, the label specifies that anyone mixing/loading and applying S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicidemust wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. The field crew and the mixer/loaders for aerial applications of S-2200 4 SC Ag Fungicide must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks, and goggles or face shield during mixing/loading, cleanup and repair. The label also requires that workers do not enter treated fields for 12 hours after application. Workers treating seeds with S-2200 3.2 FS Fungicide must use closed transfer systems in commercial facilities (excluding mobile treaters), and must wearlong pants, a long-sleeved shirt and chemical-resistant gloves, shoes and socks during mixing, loading, treating, bagging, sewing or stacking of bagged treated seed, handling treated seed, and planting treated seed. In addition, seed treatment workers performing cleaning, maintenance, and repair of seed treatment equipment must wear chemical-resistant coveralls. As well, standard label statements to protect against drift during application are on the labels. Taking into consideration these label statements, the use pattern, and the duration of exposure for handlers and workers, risks to these individuals are not a concern.

For bystanders, exposure is expected to be much less than that for workers and is considered negligible. Therefore, health risks to bystanders are not of concern.

Environmental Considerations

What Happens When Mandestrobin Is Introduced Into the Environment?

When used according to label directions mandestrobin is not expected to pose an unacceptable risk to the environment.

Mandestrobin enters the environment when applied as a foliar spray, seed treatment or chemigation. Mandestrobin can break down in the presence of microbes in terrestrial systems. Laboratory studies indicate mandestrobin has the potential to be persistent in certain soils, whereas field studies indicate that mandestrobin is less likely to persist in the environment. The properties of mandestrobin and its transformation products, 5-COOH-S-2200 and 2-COOH-S-2200, indicate some potential for downward movement through the soil. However, field studies and modelling indicate that levels of mandestrobin and its transformation products that may reach groundwater are low. In aquatic systems, mandestrobin will move out of the water column and into sediments where it has the potential to persist.

Mandestrobin does not break down by reacting with water, but it can break down rapidly in the presence of sunlight, especially in clear shallow waters. It is not expected to accumulate in the tissues of aquatic organisms. Mandestrobin is not expected to enter the atmosphere nor be transported long distances from where it was applied.

When used according to label directions, mandestrobin is expected to pose a negligible risk to earthworms, bees, beneficial arthropods, birds and small mammals. If exposed to high enough concentrations, mandestrobin may pose a risk to non-target aquatic organisms and terrestrial plants. Risks to non-target aquatic organisms and terrestrial plants can be mitigated with label statements and spray buffer zones to protect sensitive aquatic and terrestrial habitats. Label statements are required on the product labels to inform the users of the potential risks.

Value Considerations

What Is the Value of S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, S-2200 4 SC VPP Fungicide, and S-2200 3.2 FS Fungicide?

These products have demonstrated good efficacy and will provide growers with additional product options for the management of a broad range of common diseases in economically important crops in Canada.

S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 VPP Fungicide are formulated for foliar spray applications to control or suppress a range of diseases on oil seed crops, grape, low growing berries including strawberry, and turfgrass. S-2200 3.2 FS Fungicide is applied as a seed treatment to control various common fungi that cause seed rots in corn, legume vegetables, and oil seed crops. Mandestrobin is most effective when applied preventatively or at the early stages of disease development. Appropriate use of these products will help growers maximize the quality and yield of their crops.

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 S-2200 4 SC Fungicide, S-2200 3.2 FS Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicide to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

Because there is a concern with users coming into direct contact with S-2200 4 SC Fungicide, S-2200 3.2 FS Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicide on the skin or through inhalation of spray mists, anyone mixing, loading and applying S-2200 4 SC Fungicide, S-2200 4 SC Ag Fungicide, and S-2200 4 SC VPP Fungicidemust wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. The field crew and the mixer/loaders for aerial applications of S-2200 4 SC Ag Fungicide must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks, and goggles or face shield during mixing/loading, cleanup and repair. The label also requires that workers do not enter treated fields for 12 hours after application.

Workers treating seeds with S-2200 3.2 FS Fungicide must use closed transfer systems in commercial facilities (excluding mobile treaters), and must wearlong pants, a long-sleeved shirt and chemical-resistant gloves, shoes and socks during mixing, loading, treating, bagging, sewing or stacking of bagged treated seed, handling treated seed, and planting treated seed. In addition, seed treatment workers performing cleaning, maintenance, and repair of seed treatment equipment must wear chemical-resistant coveralls. Standard label statements to protect against drift during application are also on the labels.

Environment

Mandestrobin can pose a risk to non-target aquatic organisms and terrestrial plants. To mitigate potential exposures to mandestrobin via spray drift, spray buffer zones of 0 to 15 metres are required to protect sensitive terrestrial and aquatic habitats, depending on the method of application. These spray buffer zones are to be specified on the product labels.

Next Steps

Before making a final registration decision on mandestrobin, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-03, Mandestrobin. The PMRA will accept written comments on PRD2016-03, Mandestrobin up to 45 days from the date of publication of PRD2016-03. Please note that, to comply with Canada's international trade obligations, consultation on the proposed MRLs will also be conducted internationally via a notification to the World Trade Organization. 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 mandestrobin (based on the Science Evaluation of Proposed Registration Decision PRD2016-03, Mandestrobin). In addition, the test data referenced in PRD2016-03 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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