Proposed Registration Decision PRD2018-15, Afidopyropen; Sefina Insecticide; Versys Insecticide

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Pest Management Regulatory Agency
15 August 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-15E-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 PRD2018-15, Afidopyropen; Sefina Insecticide; Versys Insecticide 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 Afidopyropen

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 Inscalis Technical Insecticide, Sefina Insecticide and Versys Insecticide, containing the technical grade active ingredient afidopyropen, to control aphids and whiteflies on various vegetables and tree fruits, soybeans, hazelnuts, and greenhouse and outdoor ornamentals.

An evaluation of the 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 PRD2018-15, Afidopyropen; Sefina Insecticide; Versys Insecticide provides detailed technical information on the human health, environmental and value assessments of Inscalis Technical Insecticide, Sefina Insecticide and Versys Insecticide.

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 afidopyropen, Sefina Insecticide and Versys Insecticide, the PMRA will consider any comments received from the public in response to PRD2018-15. The PMRA will then publish a Registration Decision on afidopyropen, Sefina Insecticide and Versys Insecticide, 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 PRD2018-15.

What Is Afidopyropen?

Afidopyropen affects the nerves of aphids and whiteflies and stops the target insects from feeding on treated plants. It is the active ingredient in two commercial class products, Sefina Insecticide and Versys Insecticide.

Health Considerations

Can Approved Uses of Afidopyropen Affect Human Health?

Sefina Insecticide and Versys Insecticide, containing afidopyropen, are unlikely to affect your health when used according to label directions.

Potential exposure to afidopyropen may occur through the diet (food and water), when handling and applying the end-use products, or through bystander exposure following application. 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 afidopyropen was of low acute toxicity via the oral, dermal and inhalation routes of exposure. It was not irritating to the eyes or skin, and did not cause an allergic skin reaction.

Sefina Insecticide was of low acute toxicity via the oral and dermal routes of exposure. It was slightly acutely toxic via the inhalation route of exposure and mildly irritating to the skin; consequently, the signal word and hazard statements “POISON” and “CAUTION – SKIN IRRITANT” are required on the product label. Sefina Insecticide was minimally irritating to the eye and did not cause an allergic skin reaction.

Versys Insecticide was of low acute toxicity via the oral and dermal routes of exposure. It was slightly acutely toxic via the inhalation route of exposure and moderately irritating to the skin; consequently, the signal word and hazard statements “POISON” and “WARNING – SKIN IRRITANT” are required on the product label. Versys Insecticide was minimally irritating to the eye 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 afidopyropen to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints used for risk assessment included effects on the brain and an alteration in the sex ratio. There was some evidence suggesting that the young animal may be more sensitive to afidopyropen than the adult animals. There was no evidence that afidopyropen damaged genetic material; however, it did cause uterine tumours in rats. The risk assessment protects against the effects noted above, and other potential effects, by ensuring that the level of human exposure is well below the lowest dose level at which these effects occurred in animal tests.

Residues in Water and Food

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

Aggregate dietary intake estimates (food and drinking water) revealed that all population subgroups, including children 1 to 2 years of age, the subpopulation that would ingest the most afidopyropen relative to body weight, are expected to be exposed to less than 3%of the acceptable daily intake. Based on these estimates, the intermediate chronic dietary risk from afidopyropen is not of health concern for all population subgroups.

Chronic non-cancer exposure to the metabolite cyclopropane carboxylic acid (CPCA) from drinking water was estimated to be less than 1% of the acceptable daily intake for all population subgroups, including females 13 to 49 years of age, which is not of health concern.

The lifetime cancer risk from exposure to afidopyropen in food and drinking water was estimated to be 9 × 10-7 to 2 × 10-6 for the general population, which is below the PMRA’s level of concern. The lifetime cancer risk from exposure of CPCA in drinking water was estimated to be 1 × 10-6 for the general population, which is below the PMRA’s level of concern.

An acute reference dose was not required for the general population. Acute dietary intake (food plus drinking water) estimates for females 13 to 49 years of age were less than 21% of the acute reference dose, and are not of health concern. The acute exposure of CPCA from drinking water for females 13 to 49 years of age was estimated to be less than 3% of the acute reference dose, which is not of health concern.

When combining the exposure estimates from residues of afidopyropen (food and drinking water) with those of CPCA (drinking water) for all population subgroups, the cumulative exposure assessment does not exceed 1% of the afidopyropen or CPCA cumulative reference values.

Occupational Risks From Handling Sefina Insecticide and Versys Insecticide

Occupational risks are not of concern when Sefina Insecticide and Versys Insecticide are used according to the label directions, which include protective measures.

Farmers and custom applicators who mix, load or apply Sefina Insecticide and Versys Insecticide as well as field workers re-entering freshly treated fields, nurseries and greenhouses can come in direct contact with afidopyropen residues on the skin. Therefore, the labels specify that a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks must be worn. Additionally, Versys Insecticide requires that chemical handlers wear coveralls over a long-sleeved shirt and long pants and chemical-resistant headgear for airblast application. The labels also require that workers do not enter treated fields for 12 hours after application. Taking into consideration these label statements, the number of applications and the exposure period for handlers and workers, the risks to these individuals are not a 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 Afidopyropen Is Introduced Into the Environment?

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

Afidopyropen enters the environment when applied to control insect pests on ornamentals, vegetables, and tree fruit crops. On land, afidopyropen breaks down relatively quickly and its breakdown products are not expected to move through the soil and reach groundwater. In water bodies, afidopyropen and its breakdown products will move to sediments where they may remain over time. Afidopyropen is not expected to be found in the air or to travel long distances from where it was applied. Afidopyropen is not expected to build-up in the tissues of organisms. Afidopyropen is not expected to move inside plants and its residues will remain mostly on the surface of leaves and flowers.

When used according to the label directions, afidopyropen does not present a risk of concern to wild mammals, birds, beneficial insects, earthworms, or terrestrial and aquatic plants. Afidopyropen may pose risks of concern to freshwater and marine invertebrates, freshwater fish, amphibians, and bees; therefore, preventative measures and use restrictions to reduce exposure to animals and insects that are not pests are required.

Value Considerations

What Is the Value of Sefina Insecticide and Versys Insecticide?

Sefina Insecticide controls potato aphid, green peach aphid, sweet potato whitefly and silverleaf whitefly in potato and controls soybean aphid in soybean.

Versys Insecticide controls various aphids and whiteflies in tuberous and corm vegetables, leafy vegetables, brassica head and stem vegetables, fruiting vegetables, cucurbit vegetables, leaf petioles vegetables, pome fruits, stone fruits, hazelnuts, and greenhouse and outdoor ornamentals (except conifers).

Sefina Insecticide and Versys Insecticides are new management tools for control of aphids, which are widespread pests of horticultural crops, and whiteflies, which are prevalent pests in the ornamental greenhouse industry. Both products will aid in resistance management for crops where no other insecticides with the same mode of action are registered, which include hazelnuts, labelled tree fruit crops and most of the vegetable crops.

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 outlined on the labels of Sefina Insecticide and Versys Insecticide 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 afidopyropenon the skin or through inhalation of spray mists, anyone mixing, loading and applying afidopyropenmust wear a long-sleeved shirt, long pants, chemical-resistant gloves and shoes plus socks. Additionally, Versys Insecticide requires that all chemical handlers wear coveralls over a long-sleeved shirt and long pants, and chemical-resistant headgear for open cab airblast application. Furthermore, standard label statements to protect against drift during application are present on the label.

Environment

  • To minimize exposure and reduce risks to bees, aquatic invertebrates, fish and amphibians, use restrictions, vegetative filter strips, spray buffer zones and precautionary label statements are required. Application is restricted to periods when most bees are not actively foraging, for crops that are highly attractive to bees, or when managed bees are used for pollination services.

Next Steps

  • Before making a final registration decision on afidopyropen, Sefina Insecticide and Versys Insecticide, the PMRA will consider any comments received from the public in response to PRD2018-15. The PMRA will accept written comments on PRD2018-15 up to 45 days from the date of publication. 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 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 afidopyropen, Sefina Insecticide and Versys Insecticide (based on the Science Evaluation of PRD2018-15). In addition, the test data referenced in PRD2018-15 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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