Proposed Registration Decision PRD2016-13, Cyantraniliprole

Pest Management Regulatory Agency
15 April 2016
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2016-13E-PDF (PDF version)

Summary

Table of Contents

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

Proposed Registration Decision for Cyantraniliprole

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 DuPont Cyazypyr Technical Insecticide (registration number 30890) and DuPont Okina Insect Control, containing the technical grade active ingredient cyantraniliprole, to control cabbage looper and whiteflies and to suppress thrips on greenhouse cucumber, eggplant, pepper and tomato.

Cyantraniliprole is currently registered in several insecticide end-use products for use on fruits and vegetables, oilseeds, greenhouse ornamentals and outdoor ornamentals. For the detailed review see the Proposed Registration Decision PRD2013-09, Cyantraniliprole and Regulatory Decision RD2013-25, Cyantraniliprole.

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

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2016-13, Cyantraniliprole provides detailed technical information on the human health, environmental and value assessments of DuPont Cyazypyr Technical Insecticide and DuPont Okina Insect Control.

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:

• Protecting Your Health and the Environment
• Pesticide Registration Process
• Pesticide Risk Reduction Program

Before making a final registration decision on cyantraniliprole, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-13, Cyantraniliprole. The PMRA will then publish a Registration Decision on cyantraniliprole, which will include the decision, the reasons for it, a summary of comments received on the proposed 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 Proposed Registration Decision PRD2016-13, Cyantraniliprole.

What Is Cyantraniliprole?

Cyantraniliprole is a member of the diamide group of insecticides, which interfere with insect muscle and nerve action causing paralysis and death to the insect. It is active by ingestion and contact. Cyantraniliprole is the active ingredient in DuPont Okina Insect Control, which is applied to the foliage of greenhouse cucumber, eggplant, pepper and tomato to control cabbage looper and whiteflies and suppress thrips. Other products that contain cyantraniliprole are applied as seed treatments, foliar sprays or soil treatments against a range of insect pests of field, fruit and tree nut crops, and greenhouse and outdoor ornamentals.

Health Considerations

Can Approved Uses of Cyantraniliprole Affect Human Health?

DuPont Okina Insect Control, containing cyantraniliprole, is unlikely to affect your health when used according to label directions.

Potential exposure to cyantraniliprole may occur through the diet (food and water) or when handling and applying the end-use 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.

The dose levels used to assess risks are established to protect the most sensitive human population (for example, children and nursing mothers). 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 using pesticide products according to label directions.

In laboratory animals, cyantraniliprole was of low acute toxicity via the oral, dermal, and inhalation routes of exposure. It was non-irritating to the skin and minimally irritating to the eyes, and did not cause an allergic skin reaction. DuPont Okina Insect Control was of low acute toxicity via the oral, dermal, and inhalation routes of exposure. Moderate irritation to the skin was identified and, consequently, the signal word and hazard statement “WARNING-SKIN IRRITANT’ are required on the label. DuPont Okina Insect Control was minimally irritating to the eyes. The potential for an allergic skin reaction was identified and, therefore, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the label.

Short-term and long-term (lifetime) animal toxicity tests were assessed for the potential of cyantraniliprole to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, genetic damage, and various other effects. The most sensitive endpoints for risk assessment included effects on the liver, thyroid and adrenal glands. When cyantraniliprole was given to the pregnant animal, reduced fetal and offspring weights were observed. However, the results indicated that the young animal did not appear to be more sensitive than the adult animal. The risk assessment protects against these effects of cyantraniliprole and other potential effects by ensuring that the level of human exposure is well below the lowest dose 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 plus drinking water) revealed that the general population and children one to two years of age, the subpopulation which would ingest the most cyantraniliprole relative to body weight, are expected to be exposed to less than 92.5%of the acceptable daily intake. Based on these estimates, the chronic dietary risk from cyantraniliprole is not of health concern for all population subgroups.

Cyantraniliprole is not carcinogenic; therefore, a cancer dietary risk assessment is not required.

Animal studies revealed no acute health effects. Consequently, a single dose of cyantraniliprole is not likely to cause acute health effects in the general population (including infants and children).

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 cyantraniliprole on greenhouse tomatoes, peppers, and cucumbers are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of Proposed Registration Decision PRD2016-13, Cyantraniliprole.

Occupational Risks From Handling DuPont Okina Insect Control

Workers who mix, load, and apply DuPont Okina Insect Control as a foliar spray, as well as greenhouse workers re-entering freshly treated crops, can come in direct contact. Therefore, the label specifies that anyone mixing, loading, and applying DuPont Okina Insect Control, and during cleanup and repair, must wear coveralls over along-sleeved shirt, long pants, chemical-resistant gloves, faceshield, socks and chemical-resistant footwear. The label also requires that workers do not enter treated greenhouses for 12 hours after application. Taking into consideration these label statements, the use pattern, and the duration of exposure for workers, risks to these individuals are not a concern.

For bystanders, exposure is expected to be negligible. Therefore, health risks to bystanders are not of concern.

Environmental Considerations

What Happens When Cyantraniliprole Is Introduced Into the Environment?

When used according to label directions, cyantraniliprole is not expected to pose an unacceptable risk to the environment.

DuPont Okina Insect Control will not be released directly into the environment when used on greenhouse tomatoes, peppers, eggplants and cucumbers. Should cyantraniliprole enter the environment, it is expected to transform quickly in both soil and water. There are a total of eight major transformation products formed in soil and/or water. The degradation of the major transformation products ranges from not persistent to persistent. Cyantraniliprole and its transformation products have the potential to leach through the soil profile to enter ground water, if it enters the environment. Cyantraniliprole is systemic and, therefore, can also reach pollen and nectar through movement inside the plant.

When cyantraniliprole is used as a foliar spray for control of pests on greenhouse tomatoes, peppers, eggplants and cucumbers, beneficial arthropods and bees, which may be used for greenhouse pest management and pollination, could be exposed to spray droplets or residues through contact or oral exposure. As such, cyantraniliprole may affect bees and beneficial arthropods from foliar applications; therefore, label statements are required to reduce exposure to bees and beneficial insects that may be used in greenhouse production.
Cyantraniliprole also is toxic to some species of aquatic invertebrates; therefore, label statements prohibiting release of greenhouse effluent into aquatic systems are required.
Environmental risk is considered to be acceptable when cyantraniliprole is used in accordance with the label and the required risk reduction measures are applied.

Value Considerations

What Is the Value of DuPont Okina Insect Control?

DuPont Okina Insect Control is a new tool for the management of cabbage looper, thrips and whiteflies on greenhouse cucumber, eggplant, pepper and tomato, and represents a new mode of action for resistance management of whiteflies and thrips on these crops.

Cabbage looper, thrips and whiteflies are important pests of greenhouse vegetable crops. DuPont Okina Insect Control represents a new mode of action for the management of whiteflies and thrips on greenhouse cucumber, eggplant, pepper and tomato; therefore, cyantraniliprole will contribute to resistance management of these crop-pest combinations.

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 DuPont Okina Insect Control to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

Because workers can come into direct contact with DuPont Okina Insect Control on the skin or through inhalation of spray mists, anyone mixing, loading and applying DuPont Okina Insect Control, and during clean-up and repair,must wear coveralls over along-sleeved shirt, long pants, chemical-resistant gloves, faceshield, socks and chemical-resistant footwear. The label also requires that workers not re-enter treated greenhouses for 12 hours after application.

Environment

Risk-based label statements are required on the label that informs users that cyantraniliprole may affect bees and some species of beneficial arthropods. Hazard-based label statements are also required to protect aquatic organisms and to prevent contamination of irrigation, drinking water supplies and aquatic habitats.

Next Steps

Before making a final registration decision on cyantraniliprole, the PMRA will consider any comments received from the public in response to Proposed Registration Decision PRD2016-13, Cyantraniliprole. The PMRA will accept written comments on PRD2016-13, Cyantraniliprole up to 45 days from the date of publication of PRD2016-13. 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 cyantraniliprole (based on the Science Evaluation of PRD2016-13, Cyantraniliprole). In addition, the test data referenced in PRD2016-13 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).