8 February 2010
HC Pub: 091208
ISBN: 978-1-100-14564-8 (print version)
ISBN: 978-1-100-14565-5 (PDF version)
Catalogue number: H113-9/2010-2E (print version)
Catalogue number: H113-9/2010-2E-PDF (PDF version)

Summary

Table of Contents

• Registration Decision for Acetamiprid
• What Does Health Canada Consider When Making a Registration Decision?
• What Is Acetamiprid?
• Health Considerations
• Environmental Considerations
• Value Considerations
• Measures to Minimize Risk
• Next Steps
• Other Information

Registration Decision for Acetamiprid

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 Acetamiprid Technical Insecticide, Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, Acetamiprid RTU Insecticide and Vault 50 FS Insecticide Seed Treatment containing the technical grade active ingredient acetamiprid to control a variety of insect pests in various fruit, vegetable, ornamental and oilseed crops.

Acetamiprid Technical Insecticide (Registration Number 27125), Assail 70 WP Insecticide (Registration Number 27128; previously known as Assail Brand 70 WP Insecticide), Tristar 70 WSP Insecticide (Registration Number 27127; previously known as Chipco Brand Tristar 70 WSP Insecticide), Acetamiprid RTU Insecticide (Registration Number 27126; previously known as Pristine Brand RTU Insecticide) and Vault 50 FS Insecticide Seed Treatment (Registration Number 28119) are conditionally registered in Canada. The detailed review for Acetamiprid Technical Insecticide, Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, and Acetamiprid RTU Insecticide can be found in Regulatory Note REG2002-05, Acetamiprid, Assail Brand 70 WP Insecticide, Chipco Brand Tristar 70 WSP Insecticide and Pristine Brand RTU Insecticide.

Subsequent to the original applications, an application to register Vault 50 FS Insecticide Seed Treatment was reviewed and conditionally approved. The current applications were submitted to convert Acetamiprid Technical Insecticide, Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, Acetamiprid RTU Insecticide and Vault 50 FS Insecticide Seed Treatment from conditional registration to full registration.

An evaluation of available scientific information found that, under the approved conditions of use, the products have value and do not present an unacceptable risk to human health or the environment.

This overview describes the key points of the evaluation, while the Science Evaluation section of Proposed Registration Decision PRD2010-02, Acetamiprid, provides detailed technical information on the human health, environmental and value assessments of Acetamiprid Technical Insecticide, Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, Acetamiprid RTU Insecticide and Vault 50 FS Insecticide Seed Treatment.

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 acceptable¹ 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 have² 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 (such as children) as well as organisms in the environment (such as those most sensitive to environmental contaminants). 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 acetamiprid, the PMRA will consider all comments received from the public in response to this consultation document. The PMRA will then publish a Registration Decision on acetamiprid, 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 section of Proposed Registration Decision PRD2010-02, Acetamiprid.

What Is Acetamiprid?

Acetamiprid is a neonicotinoid insecticide that is active against insects on contact as well as through ingestion, and it is distributed systemically within plants. End-use products containing acetamiprid are registered for use on a variety of food crops and ornamentals by conventional ground application and for use as a seed treatment on canola and mustard seed.

Health Considerations

Can Approved Uses of Acetamiprid Affect Human Health?

Acetamiprid is unlikely to affect your health when used according to label directions.

Exposure to acetamiprid may occur through diet (food and water) or when handling and applying the product. 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.

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 using acetamiprid products according to label directions.

The technical grade active ingredient acetamiprid showed high acute toxicity to rats when ingested. Consequently, the statement "Danger Poison" is required on the label for the technical grade active ingredient. The end-use products Assail 70 WP Insecticide and Tristar 70 WSP Insecticide caused moderate acute toxicity in animals when ingested. Consequently, the statement "Warning Poison" is required on the labels for these end-use products.

Acetamiprid does not cause cancer in animals and does not damage genetic material such as DNA. Health effects in animals given daily doses of acetamiprid over long periods of time included generalized toxicity manifested as effects on body weight and food consumption as well as mild, non-adverse effects on the liver as it adapted to an increased demand to metabolize acetamiprid.

Acetamiprid does not cause birth defects in animals. There was evidence in animals that the young are more sensitive to the effects of acetamiprid than adults. Effects on the young animal were considered more serious than those observed in parental animals at the same dose level. In addition, signs suggestive of neurotoxicity were observed in young animals at doses lower than those that caused effects in parental animals.

The risk assessment protects against these effects by ensuring that the level of human exposure is well below the lowest dose at which these effects occurred in animal tests. The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing infants). Only those uses where exposure is well below levels that cause no effects in animal testing are considered acceptable for registration.

Residues in Water and Food

Dietary risks from food and water are not of concern

Aggregate dietary intake estimates (food plus water) revealed that children less than two years of age, the population group that would ingest the most acetamiprid relative to body weight, are expected to be exposed to less than 8.4% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from acetamiprid is not of concern for all population groups. A cancer potency factor (Q1*) has not been established for acetamiprid. Therefore, a cancer dietary risk assessment is not required.

An aggregate (food plus water) dietary intake estimate for the highest exposed population (children one to two years old) used less than 95% of the acute reference dose, which is below the level of concern. Therefore, the acute dietary risk from acetamiprid is below the level of concern for all population groups.

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.

Confirmatory residue trials conducted throughout Canada using acetamiprid on leafy vegetables, cole crops, field tomatoes, pome fruit and grapes were acceptable. MRLs will not be revised as a result of this evaluation. As such, please refer to Health Canada's List of Maximum Residue Limits Regulated Under the Pest Control Products Act for this active ingredient.

Risks in Residential and Other Non-Occupational Environments

All uses currently registered for the domestic ready-to-use product are not of concern, and entry by the public into treated commercial areas is considered acceptable.

Exposure of the general population to residues of acetamiprid from orchards treated with Assail 70 WP Insecticide could occur by participating in pick-your-own (U-pick) activities for apples and pears. The exposure from such activities was considered acceptable for adults, youths and children.

Exposure could also occur from homeowners spraying Acetamiprid RTU Insecticide, and subsequently entering treated residential areas. Both the use and postapplication exposures to adults, youth and children were considered acceptable.

Occupational Risks From Handling Assail 70 WP Insecticide, Tristar 70 WSP Insecticide and Vault 50 FS Insecticide Seed Treatment

Occupational risks are not of concern when Assail 70 WP Insecticide, Tristar 70WSP Insecticide and Vault 50 FS Insecticide Seed Treatment are used according to the proposed label directions, which include protective measures.

Farmers and custom applicators who mix, load or apply Assail 70 WP Insecticide, Tristar 70 WSP Insecticide and Vault 50 FS Insecticide Seed Treatment as well as field workers entering treated fields, nurseries, greenhouses, shadehouses and lathhouses can come in direct contact with acetamiprid residues on the skin or by inhalation.

Therefore, the labels specify that anyone mixing, loading and applying these products must wear a long-sleeved-shirt, long pants, socks and shoes, and chemical-resistant gloves. In addition, depending on the product, workers may require chemical-resistant coveralls and/or a respirator. The labels also require that workers do not enter treated fields or other treated sites for at least 12 hours after application, or longer, depending on the tasks to be performed. Taking into consideration these label statements, the number of applications and the expectation of the exposure period for handlers and workers, the risks to these individuals are determined not to be of concern.

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.

Environmental Considerations

What Happens When Acetamiprid Is Introduced Into the Environment?

Acetamiprid poses a potential risk to non-target organisms including terrestrial plants, marine-estuarine invertebrates (such as the mysid shrimp) and honeybees. Therefore, risk-reduction measures including precautionary label statements and buffer zones must be observed.

The environmental fate and environmental toxicology of acetamiprid is described in REG2002-05.

The environmental transformation products of acetamiprid, IM-1-5 in soil, IM-1-4 in sediment, and IB-1-1 in water, are not expected to accumulate or move in the environment, nor pose a risk to non-target organisms.

Acetamiprid will pose negligible risk to earthworms under conditions of field use. The risk to avian reproduction is also negligible. It will, however, pose a potential risk to aquatic invertebrates, non-target terrestrial plants and honey bees exposed to direct treatment. These risks can be mitigated by precautionary label statements and the establishment of terrestrial and aquatic buffer zones to protect these habitats.

Value Considerations

What is the Value of Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, Acetamiprid RTU Insecticide, and Vault 50 FS Insecticide Seed Treatment?

Pest control products containing acetamiprid control a variety of insect pests in various fruit, vegetable, ornamental, and oilseed crops.

Assail 70 WP Insecticide is registered for commercial use to control aphids, whitefly, Colorado potato beetle, tentiform leafminer, leafhoppers, codling moth, pear psylla, swede midge, oriental fruit moth and pea leafminer on leafy vegetables, cole crops, certain fruiting vegetables, pome fruits, grapes, potato and tobacco.

Tristar 70 WSP Insecticide is registered for commercial use to control European pine sawfly, aphids, tentiform leafminer, leafhoppers and whiteflies on ornamentals, including trees, potted flowering plants, foliage plants, bedding plants, and flowers grown for cuttings, outdoors and in greenhouses, lathhouses and shadehouses.

Acetamiprid RTU Insecticide is registered for domestic use to control aphids, European pine sawfly, leafhoppers, whiteflies, tentiform leafminer, and Colorado potato beetle on flowers and ornamental plants, leafy vegetables, cole crops, field tomatoes and pome fruits.

Vault 50 FS Insecticide Seed Treatment is registered for commercial use as a seed treatment to control flea beetles on canola and mustard.

Please see the registered product labels on the Pesticide Label Search page for complete details of the registered uses.

Acetamiprid is an alternative to other insecticides currently registered for use on the pests and crops previously listed. Alternatives such as acetamiprid are needed to help prevent the development of resistance to registered insecticides and to provide replacements for older insecticides that may become unavailable as a result of re-evaluation.

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 Acetamiprid Technical Insecticide, Assail 70 WP Insecticide, Tristar 70 WSP Insecticide, Acetamiprid RTU Insecticide, and Vault 50 FS Insecticide Seed Treatment to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

There is a concern for users coming into direct contact with acetamiprid on the skin or through inhalation of spray mists. Therefore, anyone mixing, loading or applying Assail 70 WP Insecticide must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes. In addition, when mixing or loading certain amounts of product for application to potatoes, they must also wear chemical-resistant coveralls and a respirator.

When mixing, loading or applying Tristar 70 WSP Insecticide for outdoor use, handlers and applicators must wear a long-sleeved shirt, long pants, socks and shoes, and chemical-resistant gloves. When applying indoors, handlers and applicators must wear chemical-resistant coveralls over a long-sleeved shirt and long pants, chemical-resistant gloves, rubber boots, goggles or faceshield, and a respirator.

For all tasks relating to treating seed (including mixing, loading, or treating) using Vault 50 FS Insecticide Seed Treatment, workers must wear chemical-resistant coveralls over long-sleeved shirt and long pants, chemical-resistant gloves, socks and shoes, and a respirator. Planters of treated seed must wear coveralls over long-sleeved shirt, long pants, socks and shoes, and chemical-resistant gloves.

A 12-hour restricted-entry interval for the agricultural products encompasses most postapplication tasks. However, it is necessary for longer restricted-entry intervals for some tasks on several crops, including cole crops, pome fruits and grapes. Other mitigation measures include the reduction of application rate, increased time interval between sprays and restrictions on the amount of product that can be handled in a day. Exposure concerns could not be reconciled for aerial use on potato crops. Therefore, this use can not be supported. Standard label statements to protect against drift during application are on the label.

All use statements on the currently registered label of Acetamiprid RTU Insecticide are acceptable.

Environment

Key risk-reduction measures for the protection of the environment include precautionary label directions and sparay buffer zones. These measures were originally described in REG2002-05 and are summarized here for the current end-use products and the technical active ingredient.

Assail 70 WP Insecticide and Tristar 70 WSP Insecticide

• Toxicity statements for aquatic organisms, non-target terrestrial plants and bees
• Restriction of use when bees are in the area
• Terrestrial spray buffer zones of 2 m and 10 m for field sprayer and airblast application, respectively
• Aquatic spray buffer zones of 20 m and 30 m for field sprayer and airblast application, respectively

Vault 50 FS Insecticide Seed Treatment

• Toxicity statements for aquatic organisms, non-target terrestrial plants, bees and birds
• Directions to remove any seeds left on soil surface

Acetamiprid RTU Insecticide

• Toxicity statements for aquatic organisms, non-target terrestrial plants and bees
• Restriction of use when bees are in the area
• No application to bodies of water and no application during gusty winds

Acetampirid Technical

• Toxicity statement for aquatic organisms, non-target terrestrial plants and bees
• Precaution statement for discharge of effluent into bodies of water

Next Steps

Before making a final registration decision on acetamiprid, the PMRA will consider all comments received from the public in response to this consultation document. The PMRA will accept written comments on this proposal up to 45 days from the date of publication of Proposed Registration Decision PRD2010-02, Acetamiprid. Please forward all comments to Publications. The PMRA will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed final decision and the Agency's response to these comments.

Other Information

When the PMRA makes its registration decision, it will publish a Registration Decision on acetamiprid (based on the Science Evaluation of Proposed Registration Decision PRD2010-02, Acetamiprid). In addition, the test data referenced in Proposed Registration Decision PRD2010-02, Acetamiprid, will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).