Proposed Registration Decision PRD2018-07, Flupyradifurone; BCS 2960 Insecticide; Altus Insecticide
Pest Management Regulatory Agency
26 April 2018
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2018-7E-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 PRD2018‑07, Flupyradifurone; BCS 2960 Insecticide; Altus 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 Flupyradifurone
- What Does Health Canada Consider When Making a Registration Decision?
- What Is Flupyradifurone?
- Health Considerations
- Environmental Considerations
- Value Considerations
- Measures to Minimize Risk
- Next Steps
- Other Information
Proposed Registration Decision for Flupyradifurone
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 Flupyradifurone TC, and the end-use products BCS 2960 Insecticide and Altus Insecticide, containing the technical grade active ingredient flupyradifurone, to control aphids, whiteflies and leafhoppers on greenhouse vegetables, ornamental crops and outdoor ornamentals, and to control aphids on Christmas trees.
Flupyradifurone is currently registered for the control of various insect pests on various fruit, vegetable and field crops, and as a seed treatment on soybeans. For further details, see Proposed Registration Decision PRD2014‑20, Flupyradifurone, and Registration Decision RD2015‑24, Flupyradifurone.
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 PRD2018‑07, Flupyradifurone; BCS 2960 Insecticide; Altus Insecticide provides detailed technical information on the human health, environmental and value assessments of flupyradifurone, BCS 2960 Insecticide and Altus 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 flupyradifurone, BCS 2960 Insecticide and Altus Insecticide, the PMRA will consider any comments received from the public in response to PRD2018‑07. The PMRA will then publish a Registration Decision on flupyradifurone, BCS 2960 Insecticide and Altus 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 PRD2018‑07.
What Is Flupyradifurone?
Flupyradifurone is an insecticide that interferes with the function of insect nerves. It is registered for use as a foliar spray on various field vegetable, fruit and nut crops or by soil application to certain field vegetable and fruit crops to control insect pests. It is the active ingredient in the new commercial class end-use products BCS 2960 Insecticide and Altus Insecticide. Control of insect pests of greenhouse-grown crops, outdoor ornamental plants and Christmas trees are new uses for this active ingredient.
Can Approved Uses of Flupyradifurone Affect Human Health?
BCS 2960 Insecticide and Altus Insecticide, containing flupyradifurone, are unlikely to affect your health when used according to label directions.
Potential exposure to flupyradifurone may occur through the diet (food and water), when handling and applying the end-use products, or when re-entering treated areas. 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, flupyradifurone was slightly acutely toxic via the oral route; therefore the signal word and hazard statement “CAUTION – POISON” are required on the label. Flupyradifurone was of low acute toxicity via the dermal and inhalation routes, non-irritating to skin, and minimally irritating to eyes. The potential for flupyradifurone to cause an allergic skin reaction could not be ruled out based on the information provided; therefore, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the label for flupyradifurone.
BCS 2960 Insecticide and Altus Insecticide, end-use products containing flupyradifurone, were considered to be of low acute toxicity via the oral, dermal and inhalation routes, as well as non-irritating to the skin and minimally irritating to the eye. The products were considered to cause an allergic skin reaction; therefore, the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the labels for these end-use products.
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 flupyradifurone to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment included general signs of toxicity as well as effects on body weight and skeletal muscle. In addition, an effect on fetal survival was also noted; however, there was no evidence to suggest that the young animal was more sensitive than the adult animal to flupyradifurone. The risk assessment protects against the effects noted above and any other potential effects by ensuring that the level of exposure to humans is well below the lowest dose at which these effects occurred in test animals.
Residues in Water and Food
Dietary risks from food and drinking water are not of health concern.
Aggregate chronic dietary intake estimates (food plus drinking water) revealed that the general population and infants less than one year old, the subpopulation which would ingest the most flupyradifurone relative to body weight, are expected to be exposed to less than 34% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from flupyradifurone is not of health concern for all population subgroups.
Acute dietary (food plus drinking water) intake estimates for females 13 to 49 years old and all population subgroups were less than 35% and 22% of the acute reference dose, respectively and are not of health concern. The highest exposed subpopulation was children 1 to 2 years old.
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 flupyradifurone on greenhouse grown tomato, cucumber, pepper, and lettuce are acceptable. The use of BCS 2960 Insecticide and Altus Insecticide on these crops will not result in residues of flupyradifurone exceeding the currently established MRLs for leafy greens (crop group 4‑13A), fruiting vegetables (crop group 8‑09) and cucurbit vegetables (crop group 9).
Risks in Residential and Other Non-Occupational Environments
Estimated risks from residential exposure are not of concern provided that directions specified on the label are followed.
The exposure assessments conducted for adults and children when contacting landscape ornamentals treated with BCS 2960 Insecticide and Altus Insecticide, including when aggregated with dietary exposure, did not identify risks of concern when the label directions are followed.
Occupational Risks From Handling BCS 2960 Insecticide and Altus Insecticide
Occupational risks are not of concern when BCS 2960 Insecticide and Altus Insecticide are used according to the proposed label directions, which include protective measures.
Farmers and custom applicators who mix and load BCS 2960 Insecticide and Altus Insecticide and apply as a foliar or soil treatment and workers re-entering treated greenhouses, nurseries and Christmas tree farms can come in direct contact with flupyradifurone residues on the skin and/or through inhalation. Therefore, the label specifies that anyone mixing/loading and applying flupyradifurone must wear long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. The label also requires that workers not enter treated fields for 12 hours after application.
Taking into consideration these label statements, precautionary measures, and the exposure duration for handlers and workers, it was determined that 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.
What Happens When Flupyradifurone Is Introduced Into the Environment?
When used according to label directions, Altus Insecticide and BCS 2960 Insecticide containing flupyradifurone are not expected to pose risks of concern to the environment.
Altus Insecticide and BCS 2960 Insecticide, containing flupyradifurone, can enter land and water habitats through spray drift and can enter water bodies through run-off when used as a foliar spray and soil drench for greenhouse vegetables, greenhouse ornamentals, outdoor ornamentals and Christmas trees. Although flupyradifurone can be broken down by microorganisms into two breakdown products, the rate of breakdown is very slow. As a consequence, flupyradifurone may build up in the soil and has the potential to move through soil to reach groundwater. In surface water, flupyradifurone mixes with water quickly and then breaks down slowly through reaction with sunlight. Breakdown by microorganisms in water is negligible. Therefore, flupyradifurone has a potential to remain in water and sediment over time. Flupyradifurone is not expected to build up in animal tissues. Flupyradifurone is not expected to move into the air and be transported long distances from where it was applied.
Flupyradifurone and its major breakdown products do not present risks of concern to plants, birds, small wild mammals, earthworms, algae, fish and amphibians when applied by foliar and soil drench applications. However, as an insecticide, flupyradifurone may pose risks to some species of non-target aquatic insects if they come in contact with high enough concentrations; therefore, preventative measures such as spray drift buffer zones, prohibiting the release of greenhouse effluent into water and advising users about the potential risk from run-off are required on the product labels. While flupyradifurone is unlikely to pose a risk to bee colonies, it may have short-term effects on adult foraging bees when applied during full bloom by foliar application. To protect bees and other non-target insects, risk reduction measures are in place and proper directions for use are outlined on product labels.
What Is the Value of BCS 2960 Insecticide and Altus Insecticide?
BCS 2960 and Altus Insecticides will provide a new active ingredient for control of insect pests on greenhouse vegetables and ornamentals, outdoor ornamentals and Christmas trees.
Both BCS 2960 Insecticide and Altus Insecticide control aphids, leafhoppers and whiteflies in greenhouse tomato, pepper, cucumber, lettuce and ornamental crops and on outdoor ornamental plants, and BCS 2960 Insecticide also controls aphids on Christmas trees. The active ingredient in these products was identified by Canadian growers as a priority to register for several of these uses.
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 labels of BCS 2960 Insecticide and Altus Insecticide to address the potential risks identified in this assessment are as follows.
Key Risk-Reduction Measures
As direct contact with flupyradifurone on the skin or through inhalation of spray mists can occur, anyone mixing, loading and applying BCS 2960 Insecticide and Altus Insecticide as a foliar or soil application through ground application equipment must wear long-sleeved shirt, long pants, chemical-resistant gloves and shoes plus socks. Any worker entering greenhouses, nurseries and farms treated with flupyradifurone must comply by the restricted-entry interval (REI) of 12 hours.
To reduce dermal contact with flupyradifurone for adults and children contacting treated plants in residential areas, statements will be included on the labels of BCS 2960 Insecticide and Altus Insecticide.
Altus Insecticide and BCS 2960 Insecticide are similar to Sivanto Prime Insecticide, a registered product. All three products contain flupyradifurone as the active ingredient. Both new products are proposed to be used in a similar manner as Sivanto Prime Insecticide, and thus, slight differences in crops and use sites between the two new products and the previously registered Sivanto Prime Insecticide do not affect the overall level of environmental exposure. The risk mitigation measures required for the previously registered Sivanto Prime Insecticide are applicable for the new products. Additional label statements are required for greenhouse uses of Altus Insecticide and BCS 2960 Insecticide for protecting pollinators and other beneficial insects used in greenhouse production and preventing the release of greenhouse effluent into aquatic systems.
Before making a final registration decision on flupyradifurone, the PMRA will consider any comments received from the public in response to PRD2018‑07. The PMRA will accept written comments on PRD2018‑07 up to 45 days from the date of publication. 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 flupyradifurone (based on the Science Evaluation of PRD2018‑07). In addition, the test data referenced in PRD2018‑07 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).
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