Proposed Registration Decision PRD2019-01, Dinotefuran and Related End-Use Products

! Notice to the reader:

This consultation is now closed.

Pest Management Regulatory Agency
5 February 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: h513-9/2019-1E-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 PRD2019-01, Dinotefuran and Related End-Use Products 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 Dinotefuran

Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act and Regulations, is proposing registration for the sale and use of Dinotefuran Technical and the following three end-use products, Vectra 3D for Dogs Weighing 25.1 to 43 kg, Vectra 3D for Dogs and Puppies Over 7 Weeks of Age Weighing 9.1 to 25 kg and Vectra 3D for Dogs and Puppies Over 7 Weeks of Age Weighing 4.6 to 9 kg, containing the technical grade active ingredient dinotefuran, to repel and/or kill ticks and specific insect and mite pests on dogs and puppies. In addition, the PMRA is proposing registration for the sale and use of the following three end-use products, Prescription Treatment Brand Alpine Pressurized Insecticide, Prescription Treatment Brand Alpine Dust Insecticide and Prescription Treatment Brand Alpine Cockroach Gel Bait Reservoir, containing the technical grade active ingredient dinotefuran, to kill several structural pests found inside and/or on the exterior surfaces of commercial, industrial and residential structures and inside transportation vehicles.

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 PRD2019-01, Dinotefuran and Related End-Use Products provides detailed technical information on the human health, environmental and value assessments of dinotefuran and Vectra 3D for Dogs Weighing 25.1 to 43 kg, Vectra 3D for Dogs and Puppies Over 7 Weeks of Age Weighing 9.1 to 25 kg, Vectra 3D for Dogs and Puppies Over 7 Weeks of Age Weighing 4.6 to 9 kg (the three end-use products hereinafter referred to as Vectra 3D products) and Prescription Treatment Brand Alpine Pressurized Insecticide, Prescription Treatment Brand Alpine Dust Insecticide, Prescription Treatment Brand Alpine Cockroach Gel Bait Reservoir (the three end-use products hereinafter referred to as Prescription Treatment Brand Alpine products).

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 Pest Control Products 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 dinotefuran, Vectra 3D products and Prescription Treatment Brand Alpine products, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-01. Health Canada will then publish a Registration Decision on Dinotefuran and Related End-Use Products, 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 PRD2019-01.

What Is Dinotefuran?

Dinotefuran is an insecticide which kills insects by contact or ingestion. It is one of the active ingredients in the Vectra 3D domestic class products, which repel and/or kill ticks, specific insect and mite pests on dogs and puppies. It is also the active ingredient or one of the active ingredients in the Prescription Treatment Brand Alpine commercial class products used to kill several structural pests found inside and/or on the exterior surfaces of commercial, industrial and residential structures and inside transportation vehicles.

Health Considerations

Can Approved Uses of Dinotefuran Affect Human Health?

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

Potential exposure to products containing dinotefuran may occur when handling and applying the end-use products, or when coming in contact with treated surfaces or pets. 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). 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 technical grade active ingredient dinotefuran was of low acute toxicity by the oral, dermal and inhalation routes of exposure. Dinotefuran was minimally irritating to the eyes and skin, and did not cause an allergic skin reaction.

The Vectra 3D products, which are intended for use on dogs of various weight ranges, were of low acute toxicity via the oral and dermal routes of exposure, moderately irritating to the eyes and mildly irritating to the skin, and did not cause an allergic skin reaction.

The Prescription Treatment Brand Alpine products were of low acute toxicity via the oral, dermal and inhalation routes of exposure. Prescription Treatment Brand Alpine Pressurized Insecticide and Prescription Treatment Brand Alpine Cockroach Gel Bait Reservoir were minimally to non-irritating to the eyes. However, Prescription Treatment Brand Alpine Dust Insecticide was mildly irritating to the eyes, and consequently the signal word and hazard statement "CAUTION POISON" are required on the label. All three of the products were minimally to non- irritating to the skin, and did not cause an allergic skin reaction.

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 dinotefuran 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 nervous system and body weight. There was no evidence of sensitivity of the young. There was no evidence to suggest that dinotefuran damaged genetic material. Dinotefuran did, however, cause benign thyroid tumours in rats at very high-dose levels. 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 Water and Food

Dietary risks from dinotefuran on food and water are not a concern.

The end-use products are not intended for application to food. In addition, the Prescription Treatment Brand Alpine product labels instruct not to contaminate food and water with the end-use products; therefore, exposure to dinotefuran through food from the end-use product uses is anticipated to be negligible.

Risks in Residential and Other Non-Occupational Environments

Residential risks are not of concern when Vectra 3D products are used according to label directions and instructions.

Exposure to dinotefuran can occur when adults handle these end-use products, and come in direct contact with dinotefuran residue on the skin. Adults, youth, and children can come in direct contact with dinotefuran residue on the skin when contacting treated pets. In addition, children may ingest residues by hand-to-mouth activity after contacting treated dogs. Inhalation exposure was considered negligible.

Residential exposures (application and postapplication) to the Vectra 3D products are not expected to result in unacceptable risks when used according to label directions. No concern was identified for adults, youth, and children who dermally contacted treated dogs, and for young children who engage in hand-to-mouth activity after touching dogs treated with the end-use products.

For bystanders, exposures are considered to be addressed by the residential postapplication exposure assessments. Therefore, health risks to bystanders are not of concern.

Estimated risks from residential exposure are not of concern provided that directions specified on the Prescription Treatment Brand Alpine products labels are followed.

Residential exposure to individuals contacting treated indoor and outdoor surfaces is not expected to result in risks of concern when dinotefuran is used according to label directions.

Occupational Risks from Handling Vectra 3D products

Vectra 3D products are domestic products; therefore, no quantitative occupational assessments were conducted.

No quantitative occupational assessments were conducted. However, commercial workers (for example, veterinary, kennel, and pet care) may wear personal protective equipment (PPE) including gloves and laboratory coat/apron, when applying pet products. Applying pet products is only one of many tasks that workers would do. There is sufficient evidence to indicate that their exposures will not result in risks of concern.

Occupational risks are not of concern when the Prescription Treatment Brand Alpine products are used according to the label directions, which include protective measures.

Applicators loading and applying Prescription Treatment Brand Alpine products can come into direct contact with dinotefuran on the skin or through inhalation. Therefore, the labels will specify that anyone loading and/or applying an end-use product containing dinotefuran must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. A respirator is required when Prescription Treatment Brand Alpine Dust Insecticide is loaded and applied.

Environmental Considerations

What Happens When Dinotefuran Is Introduced Into the Environment?

When Prescription Treatment Brand Alpine products are used according to label directions, dinotefuran is not expected to pose risks of concern to the environment.

Prescription Treatment Brand Alpine products containing dinotefuran are proposed to be used as a crack and crevice, void, spot, and perimeter treatment for flying and crawling insects indoors. Other proposed uses include the localized treatment of the exterior surface of structures and direct treatment of the nests of stinging insects, such as bees, hornets and wasps (including paper wasps and yellow jackets). For outdoor treatment of stinging insect nests, dinotefuran is to be applied directly into voids (above- and below-ground) where nests are located. As such, environmental releases are expected to be minimal and a quantitative risk assessment was not conducted. The Prescription Treatment Brand Alpine products, containing dinotefuran, are not expected to pose risks of concern to the environment.

It should be noted that an environmental risk assessment for the registration of Vectra 3D Domestic class products is not required. These proposed Domestic class products are spot-on products for use on companion animals. Because of the use pattern, dinotefuran is not expected to result in environmental exposure.

Value Considerations

What Is the Value of the Vectra 3D Products?

They are spot-on products which combine dinotefuran (4.95%) with two other active ingredients, permethrin (36.08%) and pyriproxyfen (0.44%), for use against fleas, ticks, stable flies, mosquitoes, dog biting lice and walking dandruff mites on dogs and puppies weighing 4.6-43 kg and over seven weeks of age.

These products are new tools for use on dogs against labelled pests. They are the first pesticide product registered for use against walking dandruff mites on dogs, and have acceptable value.

What Is the Value of:

Prescription Treatment Brand Alpine Pressurized Insecticide (0.5% dinotefuran), Prescription Treatment Brand Alpine Dust Insecticide (0.25 % dinotefuran and 77.4% silicon dioxide present as diatomaceous earth), and Prescription Treatment Brand Alpine Cockroach Gel Bait Reservoir (0.5% dinotefuran)?

They are pressurized, dust and gel products, respectively, that are registered to kill a variety of structural pests (for example, ants, bed bugs, cockroaches, stored product pests, wasps) inside and/or on the exterior surfaces of structures and inside transport vehicles.

These products are new tools that kill labelled structural pests and have acceptable value. Some of these pests, such as cockroaches and bed bugs, impact the health and well-being of people. The Prescription Treatment Brand Alpine Dust Insecticide kills nests of stinging insects and can be applied in locations where a spray cannot be applied, such as around electrical fittings.

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 the technical grade active ingredient and end-use products to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

To avoid direct contact with dinotefuran, bystanders and residents must not be present during loading and/or application of the Prescription Treatment Brand Alpine products and cannot re-enter treated areas until residues have dried or dusts have settled.

Applicators loading and applying Prescription Treatment Brand Alpine products can come into direct contact with dinotefuran on the skin or through inhalation. Therefore, the labels will specify that anyone loading and/or applying an end-use product containing dinotefuran must wear a long-sleeved shirt, long pants, chemical-resistant gloves, and shoes plus socks. A respirator is required when Prescription Treatment Brand Alpine Dust Insecticide is loaded and applied.

Environment

Label statements are required to limit the outdoor use of Prescription Treatment Brand Alpine dinotefuran-containing products to crack and crevice, void or spot treatments, and to indicate that direct application of dinotefuran to water is not allowed.

Next Steps

Before making a final registration decision on dinotefuran, Vectra 3D products and Prescription Treatment Brand Alpine products, Health Canada's PMRA will consider any comments received from the public in response to PRD2019-01. Health Canada will accept written comments on PRD2019-01 up to 45 days from the date of publication of PRD2019-01. 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 Health Canada makes its registration decision, it will publish a Registration Decision on Dinotefuran and Related End-Use Products (based on the Science Evaluation of PRD2019-01). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).

Report a problem or mistake on this page
Please select all that apply:

Thank you for your help!

You will not receive a reply. For enquiries, contact us.

Date modified: