Proposed Registration Decision PRD2016-11, Fluopyram

 

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Pest Management Regulatory Agency
1 April 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-11E-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 PRD2016-11, Fluopyram 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 Fluopyram

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 Fluopyram Technical Fungicide and three end-use products, FLU+tfs 1:1 SC Fungicide containing the technical grade active ingredients fluopyram and trifloxystrobin, and Fluopyram ST and Fluopyram Greenhouse Fungicide, both containing the technical grade active ingredient fluopyram. All three end-use products are used to control several fungal diseases on turfgrass, soybean seeds or food crops.

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 PRD2016-11, Fluopyram provides detailed technical information on the human health, environmental and value assessments of Fluopyram Technical Fungicide, FLU+tfs 1:1 SC Fungicide, Fluopyram ST, and Fluopyram Greenhouse 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 fluopyram, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-11, Fluopyram. The PMRA will then publish a Registration Decision on fluopyram, 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 PRD2016-11, Fluopyram.

What Is Fluopyram?

Fluopyram is a conventional active ingredient with fungicidal properties. It acts on pathogen cells by inhibiting their normal respiration process. Fungicide products containing fluopyram are applied as foliar spray, drip irrigation or drench, and seed treatment on various greenhouse crops, turfgrass and soybeans to manage economically important plant diseases.

Health Considerations

Can Approved Uses of Fluopyram Affect Human Health?

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

Potential exposure to fluopyram may occur through the diet (food and water), when handling and applying the products or when entering treated sites. 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 acute toxicity of fluopyram was low via the oral, dermal and inhalation routes of exposure. Fluopyram was minimally irritating to the eyes and non-irritating to the skin and did not cause an allergic skin reaction.

The acute toxicity of the end-use product FLU+TFS 1:1 SC Fungicide was low via the oral, dermal and inhalation routes of exposure. The product was minimally irritating to the eyes and skin. It caused allergic skin reactions; consequently, the hazard statement "POTENTIAL SKIN SENSITIZER" is required on the label.

The acute toxicity of the end-use product Fluopyram ST was slight via the oral route of exposure and low via the dermal and inhalation routes of exposure. It was non-irritating to the eyes and skin and did not cause an allergic skin reaction. The hazard statement "CAUTION - POISON" is required on the label.

The acute toxicity of the end-use product Fluopyram Greenhouse Fungicide was low via the oral, dermal and inhalation routes of exposure. The product was minimally irritating to the eyes and non-irritating to the skin. It did not cause an allergic skin reaction.

Registrant-supplied short- and long-term (lifetime) animal toxicity tests were assessed for the potential of fluopyram to cause neurotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, genetic damage and various other effects. The most sensitive endpoints used for risk assessment were decreased activity and effects on the liver, thyroid and kidneys. There were no indications that the young were more sensitive to fluopyram than the adult animal. Fluopyram caused liver tumours in rats and thyroid tumours in mice. These tumours were observed at high dose levels.

The risk assessment protects against these and any other potential effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests.

Risks in Residential and Other Non-Occupational Environments

Residential and non-occupational risks are not of concern when FLU+TFS 1:1 SC Fungicide is used according to the label directions.

Adults, youth and children may be exposed to fluopyram while golfing on courses treated with FLU+TFS 1:1 SC Fungicide. Based on the expected short-term duration of this activity, risk to children, youth and adults is not a concern.

Occupational Risks from Handling Fluopyram Greenhouse Fungicide, Fluopyram ST and FLU+TFS 1:1 SC Fungicide

Occupational risks are not of concern when the products containing fluopyram are used according to the label directions, which include protective measures.

Farmers and custom applicators who mix, load or apply fluopyram, as well as workers re-entering freshly treated greenhouses and turf or treating seeds can come in direct contact with fluopyram residues on the skin. Therefore, the labels specify that anyone mixing/loading and applying Fluopyram Greenhouse Fungicide and FLU+TFS 1:1 SC Fungicide must wear a long-sleeved shirt, long pants, shoes plus socks, and chemical-resistant gloves. In addition, the Fluopyram ST label specifies that treaters must wear a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. When cleaning seed treatment equipment, workers must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. Workers bagging, sewing, stacking or fork lifting treated seed must wear a long-sleeved shirt, long pants, and shoes and socks; gloves are recommended for good hygiene practices. Anyone involved with the handling of treated seeds (including planting) must also wear a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. Workers planting more than 2900 kg of treated soybean seeds must also use closed-cab tractors. The Fluopyram Greenhouse Fungicide label also requires that workers do not enter treated greenhouses for 12 hours after application. The FLU+TFS 1:1 SC Fungicide requires that workers do not enter sod farms for 12 hours after application and golf courses until sprays have dried. Taking into consideration these label statements, the number of applications and the anticipated exposure period for handlers and workers, health risks to these individuals are not a concern. Furthermore, the endpoints selected for worker risk assessment are also protective of any potential cancer findings and there are no health risks of concern.

FLU+TFS 1:1 SC Fungicide is a co-formulation with trifloxystrobin. Trifloxystrobin is registered for use on sod farms and golf courses. The precautions required to mitigate risk from the exposure of fluopyram are also adequate for the co-formulated active ingredient.

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.

Residues in Water and Food

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

Aggregate chronic (cancer and non-cancer) dietary intake estimates (food plus water) revealed that the general population and children 1-2 years old, the subpopulation which would ingest the most fluopyram relative to body weight, are expected to be exposed to less than 98% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from fluopyram is not of health concern for all population subgroups. The lifetime cancer risk from the use of fluopyram is not of health concern.

Aggregate acute dietary intake estimates (food and water) for the general population and all population subgroups were less than 38% of the acute reference dose, and are not of health concern. The highest exposed subpopulation was children 1-2 years old.

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 the United States, including Canadian representative growing regions, using fluopyram on soybeans, and in greenhouses in Europe using fluopyram on tomatoes, peppers, cucumbers and lettuce are acceptable. The MRLs for this active ingredient in/on dry soybeans, tomatoes and cucumbers can be found in the Science Evaluation section of this Consultation Document. MRLs to cover residues of fluopyram in/on lettuce and peppers are under promulgation, based on crop grouping principles and residue data generated following foliar field applications. The use of fluopyram in greenhouses on these crops is not expected to result in residues exceeding these MRLs.

Environmental Considerations

What Happens When Fluopyram Is Introduced Into the Environment?

When used according to label directions, fluopyram is not expected to pose risks of concern to the environment.

Fluopyram can enter the environment when it is applied as a fungicide on turf and seed. Fluopyram does not breakdown readily in soils and therefore has the potential for residue carry over to the following crop season. It is moderately mobile in soils and has a potential to move downward through the soil and enter groundwater. Fluopyram is unlikely to enter the atmosphere and be transported to areas far removed from where it was applied. Fluopyram is not expected to accumulate in the tissues of organisms.

When used according to the label directions, fluopyram does not present risks of concern to birds, small mammals, fish, algae, earthworms, bees, invertebrates and aquatic plants. The use of the end-use product, Fluopyram ST may pose a risk to small mammals and birds. The use of the end-use product, FLU+TFS 1:1 SC Fungicide, may pose a risk to non-target terrestrial plants and amphibians. The use of the end-use product Fluopyram Greenhouse Fungicide is not anticipated to present an unacceptable risk to non-target terrestrial and non-target aquatic organisms. Spray buffer zones are specified on the product label of FLU+TFS 1:1 SC Fungicide to protect terrestrial and freshwater habitats adjacent to treated areas and specific instructions are provided to prevent runoff into aquatic habitats. Precaution statements are also specified on the product label to inform users that fluopyram can be toxic to terrestrial plants and amphibians. Precaution statements and seed labeling requirements are specified on the product label of Fluopyram ST to inform users that fluopyram can be toxic to small mammals and birds.

Value Considerations

What Is The Value of FLU+TFS 1:1 SC Fungicide, Fluopyram ST, and Fluopyram Greenhouse Fungicide?

Fluopyram and tryfloxystrobin, the active ingredients in FLU+TFS 1:1 SC Fungicide, control important summer diseases on turfgrass.

FLU + TFS 1:1 SC Fungicide controls dollar spot, brown patch and leaf spot on turfgrass. The addition of the active ingredient, fluopyram with trifloxystrobin, will offer an additional chemistry to control dollar spot on turfgrass and help manage resistance development since the dollar spot pathogen has developed resistance to other commonly used active ingredients.

Fluopyram, the active ingredient in Fluopyram ST, controls sudden death syndrome in soybean.

Currently, very few fungicide products are registered to control sudden death syndrome (SDS) of soybean in Canada. SDS was first identified in Ontario in 1998. Since then, it has become a prominent and economically important disease in southwestern Ontario. In some areas, SDS now ranks among the top-tier of yield-reducing diseases of soybean.

Fluopyram, the active ingredient in Fluopyram Greenhouse Fungicide, also controls prevalent diseases, including grey mould, powdery mildew, and blights in major greenhouse crops.

In addition to providing Canadian greenhouse vegetable producers with a new and effective option for the management of major diseases in tomato, cucumbers, peppers, and lettuce, registration of this product also offers a new method of application for this group of fungicides with either drip or drench treatments to control botrytis in tomato. This application method is particularly suitable to greenhouse vegetable production in Canada given the common use of hydroponic technologies and drip irrigation in most commercial operations.

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 FLU+tfs 1:1 SC Fungicide, Fluopyram ST, and Fluopyram Greenhouse 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 fluopyram residues on the skin or through inhalation of spray mist, anyone mixing, loading and applying Fluopyram Greenhouse Fungicide and FLU+TFS 1:1 SC Fungicide must wear a long-sleeved shirt, long pants, shoes plus socks, and chemical resistant gloves. In addition, the Fluopyram ST label specifies that treaters must wear a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. When cleaning seed treatment equipment, workers must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. Workers bagging, sewing, stacking or fork lifting treated seed must wear a long-sleeved shirt, long pants, and shoes and socks; gloves are recommended for good hygiene practices. Anyone involved with the handling of treated seeds (including planting) must also wear a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes and socks. Workers planting more than 2900 kg of treated soybean seeds must also use closed-cab tractors.

The Fluopyram Greenhouse Fungicide label also requires that workers do not enter treated greenhouses for 12 hours after application. The FLU+TFS 1:1 SC Fungicide requires that workers do not enter sod farms for 12 hours after application and golf courses until sprays have dried.

Environment

To minimize potential risks to non-target terrestrial plants, small mammals, birds and amphibians, label statements, seed labeling statements and no-spray buffer zones to protect sensitive terrestrial and aquatic habitats are specified on the end-use product labels for Fluopyram ST and FLU+TFS 1:1 SC Fungicide.

Next Steps

Before making a final registration decision on fluopyram, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-11, Fluopyram. The PMRA will accept written comments on PRD2016-11, Fluopyram up to 45 days from the date of publication of PRD2016-11, Fluopyram. Please forward all comments to Publications.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on fluopyram (based on the Science Evaluation of PRD2016-11, Fluopyram). In addition, the test data referenced in PRD2016-11 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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