Proposed Registration Decision PRD2021-09, Flutianil and GATTEN

• Pest Management Regulatory Agency
• 21 December 2021
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2021-9E-PDF (PDF version)

Summary

Table of Contents

• Proposed registration decision for flutianil
• What does Health Canada consider when making a registration decision?
• What is flutianil?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Key risk-reduction measures
• Next steps
• Other information

Proposed registration decision for flutianil

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 Flutianil Technical, and GATTEN, containing the technical grade active ingredient flutianil, for control of powdery mildew on cherries (Crop Subgroup 12-09A), cucurbit vegetables (Crop Group 9) and grape.

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 PRD2021-09, Flutianil and GATTEN provides detailed technical information on the human health, environmental and value assessments of flutianil and GATTEN.

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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program.

Before making a final registration decision on flutianil and GATTEN, Health Canada's PMRA will consider any comments received from the public in response to PRD2021-09. Health Canada will then publish a Registration Decision on flutianil and GATTEN, 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 PRD2021-09.

What is flutianil?

Flutianil is a narrow spectrum, conventional fungicide that targets certain species of powdery mildew. The exact mode of action of flutianil is not known. It is applied as a foliar spray using broadcast or airblast ground equipment against certain species of powdery mildew on cherries (Crop Subgroup 12-09A), cucurbit vegetables (Crop Group 9) and grape crops.

Health considerations

Can approved uses of flutianil affect human health?

GATTEN, containing flutianil, is unlikely to affect your health when used according to label directions.

Potential exposure to flutianil may occur through the diet (food and drinking water), when handling and applying the end-use product, or when coming into contact with treated surfaces. When assessing health risks, two key factors are considered:

• the levels at which 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). 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 level at which 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 acute toxicity of the technical grade active ingredient flutianil was low via the oral, dermal and inhalation routes of exposure. Flutianil was non-irritating to the eyes and skin. It did not cause an allergic skin reaction.

The acute toxicity of the end-use product GATTEN, containing flutianil, was low via the oral, dermal and inhalation routes of exposure. GATTEN was moderately irritating to the eyes and mildly irritating to the skin, and caused an allergic skin reaction. Consequently, the signal word "WARNING" and the hazard statements "EYE AND SKIN IRRITANT" and "POTENTIAL SKIN SENSITIZER" are required on the label.

Registrant-supplied short- and long-term (lifetime) animal toxicity tests, as well as information from the published scientific literature, were assessed for the potential of flutianil to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on the liver, delayed bone development and the respiratory tract. There was an indication that the young were more sensitive than the adult animals. The risk assessment protects against the effects noted above and 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 food and drinking water

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

Animal studies revealed no acute health effects. Consequently, a single dose of flutianil is not likely to cause acute health effects in the general population (including infants and children).

Aggregate chronic dietary (food plus drinking water) intake estimates for the general population and all population subgroups are expected to be less than 3% of the acceptable daily intake, and are not of health concern. Infants are the subpopulation expected to be subject to the highest exposure relative to body weight.

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. Given that dietary risks from the consumption of foods are shown to be acceptable when flutianil is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to PMRL2021-31, Flutianil).

MRLs for flutianil determined from the acceptable residue trials conducted throughout the United States, including growing regions representative of Canada, on summer squash, cucumbers, cantaloupe, cherries, grapes, apples, and strawberries can be found in the Science Evaluation of PRD2021-09.

Occupational risks from handling GATTEN

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

Workers mixing, loading or applying GATTEN, and workers entering recently treated fields, orchards and vineyards can come in direct contact with flutianil residues on the skin. Therefore, the label specifies that anyone mixing, loading and applying GATTEN must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and protective eyewear. The label also requires that workers do not enter or be allowed entry into treated fields, orchards or vineyards during the restricted-entry interval (REI) of 12 hours. Taking into consideration the label statements, the number of applications and the duration of exposure for handlers and postapplication workers, the risks to these individuals are not of health concern.

Health risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when GATTEN is used according to the proposed label directions and REIs are observed.

Residential risks from exposure to GATTEN during pick-your-own fruit activities in treated orchards and following commercial application to fruit trees in residential areas are not of health concern.

Health risks to bystanders

Bystander risks are not of health concern when GATTEN is used according to the proposed label directions and spray drift restrictions are observed.

A standard label statement to protect against drift during application is on the label. Therefore, health risks to bystanders are not of concern.

Environmental considerations

What happens when flutianil is introduced into the environment?

When used according to label directions, the risks associated with the use of flutianil are acceptable from the viewpoint of environmental protection.

Flutianil can enter the environment when it is applied as a foliar spray to cucurbit vegetables, cherries, and grape to control powdery mildew. Flutianil is persistent under most terrestrial and aquatic conditions, except in shallow water in the presence of sunlight, where it can break down rapidly. Flutianil is not expected to be found in the atmosphere. It binds to soil, thus, it is expected to have limited mobility to groundwater. Flutianil breaks down in the field, forming three major transformation products that are expected to have very high, slight to low, and low mobility, respectively.

Flutianil presents a negligible risk to earthworms, bees, beneficial arthropods, birds, and mammals. Flutianil may, however, present a risk to non-target terrestrial plants adjacent to treated fields, which could also affect wildlife habitat. In waterbodies, flutianil may pose a risk to aquatic organisms, such as aquatic invertebrates, fish, plants, and amphibians. Precautionary measures, such as spray buffer zones and label statements, are thus required to minimize the exposure to non-target terrestrial plants and aquatic habitats. When flutianil is used in accordance with label directions, and when the required risk reduction measures are applied, the risks to the environment are considered to be acceptable.

Value considerations

What is the value of GATTEN?

The availability of GATTEN will provide Canadian users with an additional product to control powdery mildew disease on cherries (Crop Subgroup 12-09A), cucurbit vegetables (Crop Group 9) and grape.

Crops on the GATTEN label have a high susceptibility to powdery mildew and require multiple fungicide sprays over the growing season for disease management. GATTEN, applied as a spray to leaves and fruit, effectively controls powdery mildew on these economically important 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 labels of Flutianil Technical and GATTEN to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

To reduce the potential of workers coming into direct contact with flutianilon the skin or through inhalation of sprays, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks, shoes, and protective eyewear during mixing, loading and applying GATTEN, as well as during cleaning and repair activities. The label also requires that workers do not enter or be allowed entry into treated fields, orchards and vineyards during the REI of 12 hours. Furthermore, standard label statements to protect against drift during application or to prevent the use of handheld airblast, misters and foggers are present on the label.

Rotational Crops

Cucurbit vegetables may be planted immediately after the last application.

For all other crops except for registered crops, DO NOT plant within 12 months after the last application.

Environment

Precautionary statements are required to inform users of the toxicity of flutianil to toxicity to aquatic organisms and non-target terrestrial plants.

Spray buffer zones are required to reduce the risk of spray drift to terrestrial and freshwater habitats are required.

Next steps

Before making a final registration decision on flutianil and GATTEN, Health Canada's PMRA will consider any comments received from the public in response to PRD2021-09. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2021-09. 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. 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 flutianil and GATTEN (based on the Science Evaluation of PRD2021-09). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room.