Proposed Registration Decision PRD2014-20, Flupyradifurone
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Pest Management Regulatory Agency
19 September 2014
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2014-20E-PDF (PDF version)
To obtain a full copy of Proposed Registration Decision PRD2014-20, Flupyradifurone please contact our publications office.
Table of Contents
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 BYI 02960 480 FS and Sivanto 200 SL, containing the technical grade active ingredient flupyradifurone, to control various insect pests.
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 PRD2014-20, Flupyradifurone provides detailed technical information on the human health, environmental and value assessments of Flupyradifurone TC, BYI 02960 480 FS and Sivanto 200 SL.
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 (for example, 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:
Before making a final registration decision on flupyradifurone, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2014-20, Flupyradifurone. The PMRA will then publish a Registration Decision on flupyradifurone, 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 Proposed Registration Decision PRD2014-20, Flupyradifurone.
What Is Flupyradifurone?
Flupyradifurone is an insecticide in a new Mode of Action (MoA) Subgroup (Subgroup 4D, the Butenolides), that interferes with the function of insect nerves. MoA Group 4 includes the neonicotoids (4A), nicotine (4B) and sulfoxaflor (4C). Flupyradifurone is active by ingestion and contact, but is more potent via ingestion. This active ingredient is systemic when applied as a soil treatment and has translaminar activity when applied as a foliar treatment. Formulated as BYI 02960 480 FS and used to treat soybean seeds, it controls soybean aphids and adult bean leaf beetles. Formulated as Sivanto 200 SL and sprayed on the foliage of various field, vegetable, fruit and nut crops (for example, leafy vegetables, legumes, fruiting vegetables, cucurbits, pome fruit, berries, tree nuts, corn, alfalfa, peanut and hops), flupyradifurone controls aphids, leafhoppers, scale insects, whiteflies, Colorado potato beetle, and blueberry maggot and suppresses pear psylla. When applied as a soil application to fruiting vegetables, cucurbits and berries and small fruits, Sivanto 200 SL controls aphids, leafhopper and whiteflies. This product can be applied by air to tuberous, corm, root and legume vegetables.
Can Approved Uses of Flupyradifurone Affect Human Health?
Products 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) 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.
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 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 demonstrated to be 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 the active ingredient.
Sivanto 200 SL, the end-use product for foliar and soil treatment containing flupyradifurone, was demonstrated to be of low acute toxicity via the oral, dermal and inhalation routes. It was determined to be non-irritating to the skin and minimally irritating to the eye. Sivanto 200 SL did cause an allergic skin reaction; therefore, the hazard statement "POTENTIAL SKIN SENSITIZER" is required on the label for this end-use product.
BYI 02960 480 FS, the end-use product for seed treatment containing flupyradifurone, was demonstrated to be slightly acutely toxic via the oral route; therefore the signal word and hazard statement "CAUTION - POISON" are required on the label. BYI 02960 480 FS was determined to be of low acute toxicity via the dermal and inhalation routes, minimally irritating to the skin and non-irritating to the eye, and did not cause an allergic skin reaction.
Flupyradifurone did not cause cancer in animals and did not damage genetic material. There was no indication that flupyradifurone caused damage to the immune system. Health effects in animals given repeated doses of flupyradifurone included effects on the liver, thyroid gland, kidney, and skeletal muscle. Effects on reproduction were observed at high doses.
When flupyradifurone was given to pregnant animals, an effect of a serious nature was observed in the developing fetus (death) at a dose that was toxic to the mother.
The risk assessment protects against the effects of flupyradifurone 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.
Refined aggregate dietary intake estimates (food plus drinking water) revealed that children 1 to 2 years of age, the highest exposed subpopulation, are expected to be exposed to less than 31% of the acceptable daily intake (ADI). Based on these estimates, the refined chronic dietary risk from flupyradifurone is not of health concern for all population subgroups.
Flupyradifurone is not genotoxic or carcinogenic; therefore, a cancer dietary risk assessment is not required.
Refined acute dietary (food plus drinking water) intake estimate was less than 26% of the acute reference dose for children 1 to 2 years of age, the highest exposed subpopulation. The refined aggregate exposure from food and drinking water is considered acceptable for females 13 to 49 years of age at 24% of the acute reference dose (ARfD).
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, the United States, and Brazil (coffee) using flupyradifurone on a range of representative commodities were deemed acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of Proposed Registration Decision PRD2014-20, Flupyradifurone.
Risks in Residential and Other Non-Occupational Environments
Application is limited to agricultural crops only when there is low risk of drift to areas of human habitation or activity such as houses, cottages, schools and recreational areas, taking into consideration wind speed, wind direction, temperature inversions, application equipment and sprayer settings. Therefore, bystander exposure is expected to be minimal.
The occupational re-entry worker exposure to treated crops was not of concern and is expected to address any potential exposure to bystanders in a pick-your-own (PYO) scenario.
Occupational Risks From Handling Flupyradifurone
Occupational risks are not of concern when flupyradifurone is used according to the proposed label directions, which include protective measures.
Workers in commercial seed treatment facilities (and mobile treaters) and farmers handling seed treated with BYI 02960 480 FS can come into direct contact with flupyradifurone through residues on the skin and through inhaling dust. Therefore, the label states that workers in commercial seed treatment facilities (and mobile treaters) must wear coveralls over long-sleeved shirt, long pants, chemical-resistant gloves, goggles, and shoes plus socks. Treaters and baggers/sewers/stackers must wear a NIOSH approved respirator. Soybean seeds can only be treated in closed treatment systems. Farmers planting and handling treated seed must wear long-sleeved shirt, long pants, chemical-resistant gloves, and shoes plus socks. Planters must use a closed cab tractor.
Farmers and custom applicators who mix, load and apply Sivanto 200 SL as a foliar or soil treatment and field workers re-entering treated fields 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 and shoes plus socks. The label also requires that workers not enter treated fields for 12 hours after application except for hand girdling of table grapes where workers cannot re-enter for 24 hours.
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?
Flupyradifurone may pose a risk to bees, non-target beneficial arthropods, and freshwater and saltwater invertebrates when used for foliar application. Flupyradifurone may pose a risk to birds and small wild mammals when used for soybean seed treatment.
Flupyradifurone can enter the environment when it is used as an insecticide for control of a large number of pests in a variety of crops. It can be applied as a foliar spray, as a soil drench and as a seed treatment. Flupyradifurone is systemic and, therefore, can reach pollen and nectar through its movement inside the plant.
In the terrestrial environment in Canada, flupyradifurone can persist in the environment and has a potential to carryover to the following growing season. Breakdown of the molecule is predominantly by soil microbes which produce two major transformation products, 6-chloronictinic acid (6-CNA) and difluroacetic acid (DFA). 6-CNA breaks down rapidly while DFA can persist in soil. Flupyradifurone does not readily break down by reacting with water or sunlight. Flupyradifurone is not volatile and unlikely to enter the atmosphere. Flupyradifurone and the transformation product DFA have the potential to move through the soil to enter groundwater. Flupyradifurone and DFA also have the potential to enter aquatic environment through surface run-off.
In the aquatic environment, flupyradifurone does not break down readily in the presence of microbes or by reacting with water. However, it can break down by reacting with sunlight in water where light can penetrate, producing two major transformation products: BYI 02960-succinamide and azabicyclosuccinamide. By and large, once flupyradifurone enters the aquatic environment, particularly turbid waters, it may persist for a long time.
Flupyradifurone is not expected to appreciably accumulate in fish tissues.
Overall, flupyradifurone and its major transformation products present a negligible risk to soil dwelling organisms, terrestrial and aquatic plants, freshwater algae, fish (freshwater and marine), and amphibians. However, flupyradifurone may affect some species of aquatic invertebrates from soil and foliar applications. Flupyradifurone may also affect beneficial arthropods and bees from foliar applications.
Flupyradifurone may pose a risk to birds and small wild mammals when used for soybean seed treatment.
In order to minimize the potential risk of flupyradifurone to terrestrial and aquatic organisms, precautionary label statements as well as mitigation measures are specified on the labels of the end use products (refer to the Measures to Minimize Risk Section below).
What Is the Value of BYI 02960 480 FS?
Applied to soybean seeds, BYI 02960 480 FS provides early season protection of seedlings against soybean aphids and adult bean leaf beetles.
BYI 02960 480 FS provides a new MoA Subgroup (Subgroup 4D, the Butenolides) for early season protection of soybean seedlings against soybean aphid and adult bean leaf beetles. Soybean aphids and bean leaf beetles are major pests of soybean. Other MoA Group 4 active ingredients are registered for use on soybean against these pests.
What Is the Value of Sivanto 200 SL?
Sprayed on a variety of outdoor crops, Sivanto 200 SL controls aphids, leafhoppers, scale insects, whiteflies, Colorado potato beetle, and blueberry maggot and suppresses pear psylla. Applied as a soil treatment to fruiting vegetables, cucurbits, and berries and small fruit, Sivanto 200 SL controls aphids, leafhoppers and whiteflies.
As a foliar application, Sivanto 200 SL controls several serious pests on a variety of outdoor crops. Pests which Sivanto 200 SL can be used against include whiteflies, an emerging pest of outdoor crops in Canada; aphids and leafhoppers, which are major pests of a variety of outdoor crops; scale insects, important pests of pome fruits which are considered difficult to control; blueberry maggot, an important pest of blueberries; Colorado potato beetle, an important pest of potato and fruiting vegetables; and pear psylla, an important pest of pear. Soil applications of Sivanto 200 SL to fruiting vegetables, cucurbits, and berries and small fruit control aphids, leafhoppers and whiteflies. Many of these pests have developed resistance to older chemistries. Sivanto 200 SL provides a new mode of action subgroup for use against these pests. Other MoA Group 4 active ingredients are registered for use on many of these crops and pests.
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 BYI 02960 480 FS and Sivanto 200 SL 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 BYI 02960 480 FS in commercial seed treatment facilities (and mobile treaters) must use closed treatment systems only. Workers must wear coveralls over long-sleeved shirt, long pants, chemical-resistant gloves, shoes plus socks and goggles. Treaters/applicators and baggers /sewers/stackers must wear a NIOSH approved respirator. Workers planting and handling treated soybean seed on the farm must wear long-sleeved shirt, long pants, chemical-resistant gloves, and shoes plus socks and plant using a closed cab tractor.
Workers mixing, loading and applying Sivanto 200 SL as a foliar or soil application through ground application equipment or chemigation systems must wear long-sleeved shirt, long pants, chemical-resistant gloves and shoes plus socks.
To mitigate potential exposure of aquatic organisms through spray drift, spray buffer zones of 1-10 metres are required to protect sensitive aquatic habitats and must be specified on the label of Sivanto 200 SL. Instructions for reducing run-off are required on the label of Sivanto 200 SL.
To mitigate the potential effects of flupyradifurone to bees, foliar applications are to be made in the early morning or evening when bees are not actively foraging, and measures to reduce drift are to be followed, as specified on the label of Sivanto 200 SL.
To mitigate the potential effects of flupyradifurone to beneficial arthropods, measures to reduce drift are required on the label of Sivanto 200 SL.
To minimize potential risk of flupyradifurone to birds and small wild mammals through ingestion of treated seeds, hazard statements are required on the label and on the tags of bags containing treated seeds. Guidance to reduce the availability (spills) of treated seeds and Best Management Practices are required on the label of BYI 02960 480 FS.
To minimize the potential of flupyradifurone and its transformation product difluroacetic acid to enter groundwater, a label statement informing the users of the leaching potential of this chemical is to be specified on the label of Sivanto 200 SL.
To minimize the potential of flupyradifurone to be carried over to the following growing season, label statement informing the users of the carry-over potential of this chemical is to be specified on the label of Sivanto 200 SL.
Before making a final registration decision on flupyradifurone, the PMRA will consider all comments received from the public in response to Proposed Registration Decision PRD2014-20, Flupyradifurone. The PMRA will accept written comments on Proposed Registration Decision PRD2014-20, Flupyradifurone up to 45 days from the date of publication of Proposed Registration Decision PRD2014-20, Flupyradifurone. 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 flupyradifurone (based on the Science Evaluation of Proposed Registration Decision PRD2014-20, Flupyradifurone). In addition, the test data referenced in Proposed Registration Decision PRD2014-20, Flupyradifurone will be available for public inspection, upon application, in the PMRA's Reading Room (located in Ottawa).
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