Proposed Registration Decision PRD2017-12, Cyclaniliprole and Cyclaniliprole 50SL Insecticide
Notice to the reader:
The online consultation is now closed.
Pest Management Regulatory Agency
28 July 2017
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2017-12E-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 PRD2017-12, Cyclaniliprole and Cyclaniliprole 50SL Insecticide please contact our publications office.
Should you require further information please contact the Pest Management Information Service
Table of Contents
- Proposed Registration Decision for Cyclaniliprole
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Cyclaniliprole?
- Health Considerations
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- Next Steps
- Other Information
- What Additional Scientific Information is Being Requested?
Proposed Registration Decision for Cyclaniliprole
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 Technical Cyclaniliprole Insecticide and Cyclaniliprole 50SL Insecticide, containing the technical grade active ingredient cyclaniliprole, as a foliar insecticide to suppress or control various insect pests on a variety of vegetable, tree nut and fruit crops.
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 PRD2017-12, Cyclaniliprole and Cyclaniliprole 50SL Insecticide provides detailed technical information on the human health, environmental and value assessments of Technical Cyclaniliprole Insecticide and Cyclaniliprole 50SL 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 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 cyclaniliprole and Cyclaniliprole 50SL Insecticide, the PMRA will consider any comments received from the public in response to PRD2017-12. The PMRA will then publish a Registration Decision on cyclaniliprole and Cyclaniliprole 50SL 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 PRD2017-12.
What Is Cyclaniliprole?
Cyclaniliprole is a member of the diamide group of insecticides. Other insecticides in the same group registered in Canada are chlorantraniliprole and cyantraniliprole. Cyclaniliprole is the active ingredient in the end-use product Cyclaniliprole 50SL Insecticide, which suppresses or controls various insect pests on a variety of vegetable, tree nut and fruit crops.
Can Approved Uses of Cyclaniliprole Affect Human Health?
Cyclaniliprole 50SL Insecticide, containing cyclaniliprole, is unlikely to affect your health when used according to label directions.
Potential exposure to cyclaniliprole may occur through the diet (food and water), when handling and applying the product, or when entering an area that has been treated with 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.
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 (TGAI) cyclaniliprole was of low acute toxicity via the oral, dermal and inhalation routes. It was non-irritating to the skin and eyes and did not cause an allergic skin reaction. Based on these findings, hazard statements for acute toxicity are not required on the label.
The end-use product, Cyclaniliprole 50SL Insecticide, was of low acute toxicity via the oral, dermal, and inhalation routes of exposure. It was minimally irritating to the eyes and not irritating to the skin. It did not cause an allergic skin reaction. Based on these findings, hazard statements for acute toxicity are not required on the label.
Registrant-supplied short-term and long-term (lifetime) animal toxicity tests were assessed for the potential of cyclaniliprole 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 marginal effects on the liver. There was no evidence that the young were more sensitive to cyclaniliprole than the adult animal.
The risk assessment protects against the effects noted above 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 food and drinking water are not of health concern.
Aggregate dietary intake estimates (food plus drinking water) revealed that the general population and children 1-2 years old, the subpopulation which would ingest the most cyclaniliprole relative to body weight, are expected to be exposed to a maximum of 5%of the acceptable daily intake (ADI). Based on these estimates, the chronic dietary risk from cyclaniliprole is not of health concern for all population subgroups.
Animal studies revealed no acute health effects. Consequently, a single dose of cyclaniliprole 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 Canada and the United States using cyclaniliprole on representative crops of leafy vegetables (crop group 4-13), brassica head and stem vegetables (crop group 5-13), fruiting vegetables (crop group 8-09), cucurbit vegetables (crop group 9), pome fruit (crop group 11-09), stone fruit (crop group 12-09), small fruits vine climbing crop subgroup, except fuzzy kiwifruit (crop subgroup 13-07f) and tree nuts (crop group 14-11) are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of PRD2017-12.
Risks in Residential and Other Non-Occupational Environments
Residential and non-occupational risks are not of concern when Cyclaniliprole 50SL Insecticide is used according to the proposed label directions.
Given that fruits and berries can be treated with cyclaniliprole, there is potential for exposure from pick-your-own activities. Health risks from these activities have been evaluated and are not of concern.
Occupational Risks From Handling Cyclaniliprole 50SL Insecticide
Occupational risks are not of concern when Cyclaniliprole 50SL Insecticide is used according to the approved label directions, which include protective measures.
Farmers and custom applicators who mix, load or apply Cyclaniliprole 50SL Insecticideas well as field workers re-entering freshly treated fields and orchards can come in direct contact with cyclaniliproleresidues on the skin. Therefore, the label specifies that anyone mixing/loading and applying Cyclaniliprole 50SL Insecticidemust wear a long-sleeved shirt, long pants, shoes, socks and chemical-resistant gloves (chemical-resistant gloves are not required during groundboom or aerial application). The label also requires that workers do not enter treated fields for 12 hours after application. Taking into consideration these label statements, the number of applications and the expectation of the exposure period for handlers and workers, the health risk to these individuals are not 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.
What Happens When Cyclaniliprole Is Introduced Into the Environment?
When used according to label directions, cyclaniliprole is not expected to pose risks of concern to the environment.
Cyclaniliprole enters the environment when applied to control or suppress insect pests on certain vegetable, tree nut or fruit crops. It can remain in the environment for a long time as it does not break down in the presence of water or soil. In the presence of sunlight, it can break down to form several breakdown products, but these are not expected to persist in the environment. Cyclaniliprole is not expected to move into the air from water or moist soils. It is not expected to accumulate in the tissues of organisms. Cyclaniliprole is not expected to move inside plants and its residues will remain mostly on leaves; spray application during bloom may result in residues on the flowers.
Cyclaniliprole does not present a risk of concern to wild mammals, birds, fish and amphibians. Cyclaniliprole may affect bees and beneficial insects if these are exposed to high enough levels. Freshwater and marine invertebrates may also be affected by exposure in surface water as a result of spray drift. To minimize exposure and reduce risks to these organisms, use restrictions, spray buffer zones and precautionary label statements are required.
Some cyclaniliprole can still be found in the soil the next growing season after it is applied and it has the potential to move through soil to reach groundwater; therefore, precautionary label statements are required to inform users that cyclaniliprole can persist in soil and reach groundwater.
What Is the Value of Cyclaniliprole 50SL Insecticide?
Cyclaniliprole 50SL Insecticide is a new tool to control or suppress various insect pests on many outdoor crops and represents a new mode of action for resistance management on certain crop-pest combinations.
Cyclaniliprole 50SL Insecticide is a new product which is applied as a foliar spray to control or suppress various insect pests on labelled vegetable, tree nut and fruit crops. It can be applied by ground application to all listed crops, and by aerial application to the vegetable crops. While other diamide products are registered for most of the uses of Cyclaniliprole 50SL Insecticide, it is the first insecticide proposed for registration in Canada to control walnut husk fly on stone fruits, and omnivorous leafroller on stone fruits and small fruits (vine climbing) other than grapes. Cyclaniliprole also represents a new mode of action for certain crop-pest combinations including use on small fruits (vine climbing) against spotted wing drosophila, an invasive pest which is difficult to control, and will therefore be useful for resistance management on 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 Cyclaniliprole 50SL Insecticide to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
Because there is a concern with users coming into direct contact with cyclaniliproleon the skin or through inhalation of spray mists, anyone mixing, loading and applying Cyclaniliprole 50SL Insecticidemust wear a long-sleeved shirt, long pants, shoes, socks and chemical-resistant gloves (chemical-resistant gloves are not required during groundboom or aerial application). In addition, standard label statements to protect against drift during application were added to the label. The label also requires that workers do not enter treat ed fields for 12 hours after application.
Precautionary label statements are required to inform users of the potential risks of carry-over and leaching of cyclaniliprole.
To minimize exposure and reduce risks to bees, beneficial arthropods and aquatic invertebrates, use restrictions, spray buffer zones and precautionary label statements are required. Application is restricted to periods when most bees are not actively foraging, and/or when flowers are closed. In addition, application is restricted during the blooming period of crops that are highly attractive to bees such as pome fruits and stone fruits, or when managed bees are used for pollination services.
Before making a final registration decision on cyclaniliprole and Cyclaniliprole 50SL Insecticide, the PMRA will consider any comments received from the public in response to PRD2017-12. The PMRA will accept written comments on PRD2017-12 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.
When the PMRA makes its registration decision, it will publish a Registration Decision on cyclaniliprole (based on the Science Evaluation of PRD2017-12). In addition, the test data referenced in PRD2017-12 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
What Additional Scientific Information is Being Requested?
Since this technical product is only manufactured at pilot scale before registration, five-batch data representing commercial-scale production at all listed manufacturing sites will be required as post-market information after registration.
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