Proposed Registration Decision PRD2020-05, Fenpropathrin and Danitol EC Spray

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Pest Management Regulatory Agency
8 June 2020
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2020-5E-PDF (PDF version, 1.289 kb)

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 PRD2020-05, Fenpropathrin and Danitol EC Spray 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 fenpropathrin

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 Fenpropathrin Technical and Danitol EC Spray, containing the technical grade active ingredient fenpropathrin, to control several insect pests in various fruit and vegetable crops.

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 PRD2020-05, Fenpropathrin and Danitol EC Spray provides detailed technical information on the human health, environmental and value assessments of fenpropathrin and Danitol EC Spray.

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 acceptable0F 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 value1F 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:

For more information please refer to the following:

Before making a final registration decision on fenpropathrin and Danitol EC Spray, Health Canada's PMRA will consider any comments received from the public in response to PRD2020‑05.2F Health Canada will then publish a Registration Decision3 on fenpropathrin and Danitol EC Spray, 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 PRD2020-05.

What is fenpropathrin?

Fenpropathrin belongs to the pyrethroid class (IRAC mode of action Group 3) of insecticides. It is a broad-spectrum insecticide/miticide, which controls pests from many different orders and families of insects in the listed crops. Fenpropathrin works by contact and ingestion and modulates the sodium channels in nerves resulting in paralysis and death of the pest. It is the active ingredient in the commercial class product, Danitol EC Spray.

Health considerations

Can approved uses of fenpropathrin affect human health?

Danitol EC Spray, containing fenpropathrin, is unlikely to affect your health when used according to label directions.

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

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 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 active ingredient fenpropathrin was of high acute toxicity by the oral route; consequently, the signal word and hazard statement “DANGER – POISON” are required on the label. It was of moderate acute toxicity dermally and of slight acute toxicity through inhalation exposure. Fenpropathrin was non-irritating to the eyes and slightly irritating to the skin, and did not cause an allergic skin reaction.

The acute toxicity of the end-use product, Danitol EC Spray containing fenpropathrin, was high via the oral route; consequently, the signal word and hazard statement “DANGER – POISON” are required on the label. It was of low acute toxicity through the dermal and inhalation routes of exposure. It was severely irritating to the eyes and moderately irritating to the skin; consequently, the hazard statement “EYE AND SKIN IRRITANT” is required on the label. Danitol EC Spray has the potential to cause an allergic skin reaction; consequently, the hazard statement “POTENTIAL SKIN SENSITIZER” is 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 fenpropathrin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints used for risk assessment were mortality and effects on the nervous system. There is some concern for increased sensitivity of the young exposed to pyrethroids, such as fenpropathrin. The risk assessment protects against these and 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 water are acceptable

Aggregate chronic dietary intake estimates (food plus drinking water) revealed that the general population and infants less than one year old, the subpopulation which would ingest the most fenpropathrin relative to body weight, are expected to be exposed to less than 3%of the acceptable daily intake. Based on these estimates, the chronic dietary risk from fenpropathrin is not of health concern for all population subgroups.

Aggregate acute 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 fenpropathrin relative to body weight, are expected to be exposed to less than 58%of the acceptable reference dose. Based on these estimates, the acute dietary risk from fenpropathrin is not of health concern for all population subgroups.

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 using fenpropathrin on succulent shelled peas, Crop Group (CG) 8-09, CG 9, CG 11-09, CG 12-09, Crop Subgroup (CSG )13-07 A and B, and CG 14-11 are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of this consultation document.

Occupational risks from handling Danitol EC Spray

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

Farmers and custom applicators who mix, load or apply Danitol EC Sprayas well as field workers entering freshly treated fields can come in direct contact with fenpropathrinresidues on the skin. Therefore, the label specifies that anyone mixing/loading Danitol EC spray must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, chemical-resistant footwear and socks and protective eyewear (goggles or faceshield). Additionally, workers applying Danitol EC Spray with open-cab airblast equipment must wear coveralls, chemical-resistant footwear and chemical-resistant gloves over long-sleeved shirt, long pants, plus chemical-resistant headgear. When applying more than 39 L of Danitol EC Spray per day, open-cab airblast workers must wear chemical-resistant coveralls instead of coveralls.

The label also requires that workers do not enter treated fields up to a maximum of 23 days (depending on the crop and associated postapplication activity) after application. Taking into consideration these label statements, the number of applications and the expectation of the exposure period for handlers and postapplication workers, the risk to these individuals are not of health concern.

Risks in residential and other non-occupational environments

Risks in residential and other non-occupational environments are not of health concern when Danitol EC Spray is used according to the proposed label directions and restricted-entry intervals (REIs) are observed.

Residential exposure during pick-your-own fruit activities in treated orchards and farms are not of health concern.

Environmental considerations

What happens when fenpropathrin is introduced into the environment?

When fenpropathrin is used according to the label directions, the risks to the environment have been determined to be acceptable.

Fenpropathrin enters the environment when applied as a foliar spray to control mites on berry and orchard crops and vegetables. When fenpropathrin is released into the environment, it can enter soil and surface water where it can persist under certain conditions. In the presence of sunlight, fenpropathrin can break down quickly in shallow water. It can also break down through the action of microbes in soil. Fenpropathrin binds to soil and is not expected to move downward and enter groundwater. In surface water, fenpropathrin will move into sediments where it can persist. Fenpropathrin is not likely to accumulate in tissues of organisms. Fenpropathrin is not expected to travel long distances from where it was applied.

Fenpropathrin does not present a risk of concern to earthworms and aquatic vascular plants. When used according to labelled application rates, fenpropathrin may pose risks to pollinators, beneficial insects, birds, mammals, plants and aquatic organisms. Mitigation measures including spray buffer zones, course spray, mandatory vegetative filter strips, restriction of application during bloom for bee-attractive crops and precautionary label statements are required to reduce exposure to these organisms. When fenpropathrin is used according to the label and the required risk reduction measures are applied, the environmental risks are considered acceptable.

Value considerations

What is the value of Danitol EC Spray?

Danitol EC Spray controls or suppresses various key insects and mites affecting various vegetable, berry, tree fruit and tree nut crops.

Danitol EC Spray is a new management tool for control or suppression of important insect and mite pests in vegetable, berry, tree fruit and tree nut crops. Danitol EC Spray will aid in resistance management for several pest/crop combinations, for example, blueberry maggot on bushberries, peach twig borer on tree nuts, and spotted wing drosophila on fruiting vegetables and pome fruits.

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 Fenpropathrin Technical and Danitol EC Spray 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 fenpropathrinon the skin or through inhalation of spray mists, anyone mixing and loading Danitol EC Spray and performing cleaning and repair activitiesmust wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, chemical-resistant footwear and socks and protective eyewear (goggles or faceshield). Additionally, workers applying Danitol EC Spray with open-cab airblast equipment must wear coveralls, chemical-resistant footwear and chemical-resistant gloves over long-sleeved shirt, long pants, plus chemical-resistant headgear. When applying more than 39 L of Danitol EC Spray per day, open-cab airblast workers must wear chemical-resistant coveralls instead of coveralls. Risks to workers are not of health concern when Danitol EC Spray is used according to the label directions and restricted-entry intervals (REIs) are observed. In addition, standard label statements to protect against drift during application are found on the label.

Table of restricted-entry interval and/or pre-harvest interval (PHI) by crop and postapplication activity
Crop Postapplication activity Restricted-entry interval (REI) and/or Pre-harvest interval (PHI)
Bushberry and Caneberry Crop Subgroups Hand set irrigation 17 days
Tying/training (raspberry), hand harvesting, mechanically-assisted harvesting 15 days
Hand harvesting, scouting (lowbush blueberry) 13 days
Scouting, hand weeding, hand pruning, bird control (Saskatoon berry), frost control (Saskatoon berry) 7 days
Mechanical harvesting 3 days
All other activities 24 hours
Succulent Peas Hand set irrigation 11 days
Harvesting 7 days
All other activities 24 hours
Cucumbers Hand set irrigation 15 days
Harvesting, training 7 days
All other activities 24 hours
Cucurbit Vegetables Crop Group (except cucumbers) Hand set irrigation 20 days
Hand harvesting, mechanically-assisted harvesting, training 9 days
Mechanical harvesting 7 days
All other activities 24 hours
Tomatoes Hand set irrigation 17 days
Hand harvesting, mechanically assisted harvesting, tying/training 6 days
Mechanical harvesting 3 days
All other activities 24 hours
Fruiting Vegetables Crop Group (except tomatoes) Hand set irrigation 11 days
Hand harvesting, mechanically assisted harvesting, tying/training 7 days
Mechanical harvesting 3 days
All other activities 24 hours
Pome and Stone Fruit Crop Groups Thinning 23 days
Hand harvesting, mechanically assisted harvesting 16 days
Mechanical harvesting of pome fruit 14 days
Scouting, hand pruning 7 days
Mechanical harvesting of stone fruit 3 days
All other activities 24 hours
Tree Nuts Crop Group Scouting, hand pruning 7 days
Mechanical harvesting 3 days
All other activities 24 hours

Environment

With the following risk reduction measures on the label, the risks are considered acceptable:

Next steps

Before making a final registration decision on fenpropathrin and Danitol EC Spray, Health Canada's PMRA will consider any comments received from the public in response to PRD2020-05. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2020-05. 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 PMRA 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 fenpropathrin and Danitol EC Spray (based on the Science Evaluation of PRD2020-5). In addition, the test data referenced in PRD2020-05 will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

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