Proposed Registration Decision PRD2019-07, Deltamethrin and Annihilator PolyZone

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Pest Management Regulatory Agency
5 July 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-7E-PDF (PDF version)

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Summary

Table of Contents

Proposed Registration Decision for Deltamethrin

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 Deltamethrin Technical Insecticide and Annihilator PolyZone, containing the technical grade active ingredient deltamethrin, to control crawling and flying insect pests by application on indoor and outdoor surfaces of agricultural buildings and structures.

Deltamethrin Technical Insecticide (Registration Number 18092) is currently registered in Canada for use on greenhouse ornamentals, greenhouse food crops, industrial oilseed crops, terrestrial feed and food crops, roadsides, shelterbelts and turf for the control of numerous insect pests and to control adult mosquitoes in residential and recreational areas. For details, see Proposed Registration Decision PRD2017-05, Deltamethrin; Registration Decision RD2017-08, Deltamethrin; PRVD2015-07, Deltamethrin; and RVD2018-27, Deltamethrin and its associated End-use Products. The use of deltamethrin on structures is a new use for this active ingredient.

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 PRD2019-07, Deltamethrin and Annihilator PolyZone provides detailed technical information on the human health, environmental and value assessments of deltamethrin and Annihilator PolyZone.

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 deltamethrin and Annihilator PolyZone, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-07. Health Canada will then publish a Registration Decision on active deltamethrin and Annihilator PolyZone, 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 PRD2019-07.

What Is Deltamethrin?

Deltamethrin is the active ingredient in the commercial class product Annihilator PolyZone Insecticide, which is used to kill various insect and tick pests in and on agricultural structures. Deltamethrin is a broad-spectrum synthetic pyrethroid insecticide which affects the insect nervous system causing paralysis and death.

Health Considerations

Can Approved Uses of Deltamethrin Affect Human Health?

Annihilator PolyZone, containing deltamethrin, is unlikely to affect your health when used according label directions.

Potential exposure to Annihilator PolyZone may occur when handling and applying the product, or through bystander exposure following application. 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, acute oral toxicity of deltamethrin ranged from low to high; consequently, the signal words and hazard statement “DANGER POISON” are required on the label. Deltamethrin is of low to moderate acute inhalation toxicity, and is of low acute dermal toxicity. Deltamethrin is not an eye or skin irritant; however, itching, tingling or burning sensations of the skin may occur as a result of its effect on nerves in the skin. Exposure to deltamethrin is not expected to cause an allergic skin reaction.

The end-use product, Annihilator PolyZone, is considered to be of low acute toxicity via the oral, dermal, and inhalation routes of exposure, minimally irritating to the eyes, and is not expected to cause an allergic skin reaction. It is considered to be mildly irritating to the skin, and consequently, the signal word and hazard statement “CAUTION SKIN IRRITANT” are required on the product 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 deltamethrin to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoint used for risk assessment was neurotoxicity, characterized by a reduced reflex response in young animals. There is some indication that the young may be more sensitive than the adult animal; this sensitivity may reflect age-dependent differences such as the maturation of key metabolic processes.

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.

Risks in Non-Occupational Environments

Estimated risks for non-occupational exposures are not of concern provided that directions specified on the label are observed.

Annihilator PolyZone is not proposed for use in residential areas. Non-occupational postapplication exposures to individuals in agricultural facilities treated with deltamethrin are not expected to result in unacceptable risk when Annihilator PolyZone is used according to label directions.

Occupational Risks from Handling Annihilator PolyZone

Occupational risks are not of concern when Annihilator PolyZone is used according to the proposed label directions, which includes protective measures.

A risk assessment was conducted for individuals handling and entering areas treated with Annihilator PolyZone.

People mixing, loading and applying Annihilator PolyZone in an occupational setting can come in direct contact with deltamethrin on the skin or through inhalation. Therefore the label will specify that a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes must be worn during mixing, loading, application, clean-up and repair activities. In addition, when treating overhead areas, it is recommended that applicators wear safety glasses, goggles or face shield and dust/mist respirator.

Occupational postapplication exposures to individuals entering agricultural facilities treated with deltamethrin are not expected to result in unacceptable risk when Annihilator PolyZone is used according to label directions.

Environmental Considerations

What Happens When Deltamethrin Is Introduced Into the Environment?

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

When used for control of crawling and flying insect pests, deltamethrin will be applied to the indoor and outdoor surfaces of buildings and structures, as a surface spray, spot treatment and as a crack and crevice spray. As a result, the amount of pesticide deposited on soil and water is expected to be minimal and will be localized to the interior and exterior surfaces of buildings and structures.

In laboratory studies, deltamethrin was found to be toxic to bees, beneficial insects, and aquatic organisms when exposed to high enough concentrations. Due to the type of application method, exposure to the environment is expected to be minimal and the use of Annihilator PolyZone is not expected to pose risks of concern to non-target terrestrial and aquatic organisms when used in accordance with the label directions.

Value Considerations

What Is the Value of Annihilator PolyZone

Annihilator PolyZone kills mosquitoes, stable flies, house flies, blue bottle flies, flesh flies, cluster flies, adult lesser mealworms and ticks in and on agricultural buildings and structures.

Mosquitoes, stable flies, house flies, blue bottle flies, flesh flies, cluster flies, adult lesser mealworms and ticks are nuisance pests for people, companion animals and livestock. Mosquitoes and ticks may transmit diseases to people and animals. Annihilator PolyZone kills these insects on contact, in and on agricultural buildings and structures such as dairy barns, poultry houses, swine barns, stables, dog kennels and storage sheds.

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 Deltamethrin Technical Insecticide and Annihilator PolyZone to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

To avoid direct contact with deltamethrin on the skin or through inhalation, long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes must be worn during mixing, loading, application, clean-up and repair activities. In addition, when treating overhead areas, it is recommended that applicators wear safety glasses, goggles or face shield and dust/mist respirator.

Environment

Label statements are required to inform users that deltamethrin is toxic to bees, beneficial insects and aquatic organisms, and to prevent contamination of irrigation, drinking water supplies and aquatic habitats.

Next Steps

Before making a final registration decision on deltamethrin and Annihilator PolyZone, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-07. Health Canada will accept written comments on PRD2019-07 up to 45 days from the date of publication of PRD2019-07.

Please forward all comments 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 deltamethrin and Annihilator PolyZone (based on the Science Evaluation of PRD2019-07). In addition, the test data referenced in PRD2019-07 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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