June 11, 2020 Health Canada - Pest Management Regulatory Agency - Proposed Registration Decision PRD2020-06, Broflanilide, Cimegra, Teraxxa and Teraxxa F4


BASF CIMEGRA is an insecticide that controls leafhoppers and tarnished plant bug when applied as a foliar spray.  When applied in-furrow, CIMEGRA controls wireworms.

Jan 2020, Broflanilide (trade name Vedira™) received the first registration worldwide by the Australian Pesticides and Veterinary Medicines Authority (APVMA)

BROFLANILIDE

Technical Product

BASF’s Teraxxa Insecticide Seed Treatment will be used to protect cereal crops from wireworms. It is highly effective with rapid insect mortality across all species and developmental stages without the toxicity associated with old chemistry. When wireworms attempt to damage the seed by feeding, Teraxxa protects with a unique mode of action that disrupts the wireworm nervous system (not just repelling them), resulting in wireworm mortality. By having a direct impact on wireworm mortality, Teraxxa reduces wireworm populations to give a grower’s crop the advantage needed to produce yield. This gives growers the tool they need to get control over wireworms; and it’s convenient for growers, with low use rates and multiple formulations.

Broflanilide is a compound with a novel mode of action (IRAC Group 30), demonstrating excellent efficacy in the control of many problematic chewing insect pests, including caterpillars and beetles in specialty and row crops, and non-crop pests such as termites, ants, cockroaches and flies. It has potential use applications in cereals as a seed treatment for control of wireworms, as well as for foliar use in leafy and fruiting vegetables, potato, soybean, cotton, corn and legumes.

Vedira™, Cimegra, Teraxxa and Teraxxa F4  –new insecticide based on Broflanilide, which is a Meta-diamides / GABA-gated chloride channel allosteric modulator.

BASF has co-developed Broflanilide with Mitsui Chemicals Agro, Inc. This active ingredient is a powerful and versatile new mode of action insecticide to control chewing pests. Initial market launches are expected in 2020.

June 11, 2020, Pest Management Regulatory Agency Health Canada published Proposed Registration Decision PRD2020-06, Broflanilide, Cimegra, Teraxxa and Teraxxa F4 containing the technical grade active ingredient Broflanilide, to be used as a soil treatment to control wireworm in potatoes and wireworm and corn rootworm in corn, and as a seed treatment to control wireworm in small cereal grains and wheat.

What is broflanilide?

The active ingredient broflanilide is a new non-systemic conventional insecticide with contact activity that affects the nervous system of insects. Broflanilide is used as a soil treatment to control wireworm in potatoes and wireworm and corn rootworm in corn, and as a seed treatment to control wireworm in small cereal grains and wheat. Broflanilide has value as a new mode of action for use in resistance management.

Health considerations

Can approved uses of broflanilide affect human health?

Cimegra, Teraxxa, and Teraxxa F4, containing broflanilide, are unlikely to affect your health when used according to label directions.

Potential exposure to broflanilide may occur through the diet (food and drinking water), when handling and applying the end-use products, or when coming into contact with treated surfaces. 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 level at which 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 broflanilide was of low acute toxicity via the oral, dermal and inhalation routes of exposure. It was non-irritating to the eyes and skin, and did not cause an allergic skin reaction.

The acute toxicity of the end-use products Cimegra and Teraxxa, containing broflanilide, was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and skin and did not cause an allergic skin reaction.

The acute toxicity of the end-use product Teraxxa F4 containing broflanilide was low via the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes and slightly irritating to the skin. Teraxxa F4 caused an allergic skin reaction; consequently the hazard statement “POTENTIAL SKIN SENSITIZER” is required on the product label.

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 broflanilide to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other effects. The most sensitive endpoints for risk assessment were effects on the adrenal glands and the ovaries. There was no evidence that broflanilide damaged genetic material; however, it did cause tumours of the ovaries, uterus, adrenal gland, and testes in rats. There was no evidence of increased sensitivity of the young compared to adult animals. The risk assessment protects against the effects noted above and other potential effects 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.

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

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 broflanilide relative to body weight, are expected to be exposed to less than 6% of the acceptable daily intake. Based on these estimates, the chronic dietary risk from broflanilide is not of health concern for all population subgroups.

The lifetime cancer risk from the use of broflanilide on potato, corn (all types) and small grains is not of health concern.

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 broflanilide on potatoes, corn and small cereal grains are acceptable. The MRLs for this active ingredient can be found in the Science Evaluation of PRD2020-06.

Teraxxa F4 is also formulated with the active ingredients pyraclostrobin, triticonazole, metalaxyl and fluxapyroxad. These other active ingredients are currently registered for use in Canada at rates equivalent to or greater than those proposed.

Risks in residential and other non-occupational environments

A residential assessment was not required since these products are not permitted for use by residential handlers or for use in residential areas.

Occupational risks from handling Cimegra, Teraxxa F4 and Teraxxa

Occupational risks are not of concern when broflanilide is used according to the proposed label directions for the end-use products, which include protective measures.

Workers who mix, load and apply Cimegra as an in-furrow and/or t-band treatment during planting of potato or corn can come in direct contact with broflanilide on the skin and or through inhalation. Therefore, the label specifies that anyone mixing/loading and applying broflanilide must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Gloves are not required during application within a closed cab. As Cimegra is applied to subsurface soil as an in-furrow and/or T-band, exposures to broflanilide during postapplication activities are considered negligible. As such, a restricted-entry interval is not required on the label.

Workers in commercial seed treatment facilities, mobile treaters, on-farm treaters and planters handling seed treated with Teraxxa F4 or Terraxxa can come into direct contact with broflanilide through residues on the skin and by inhaling dust. Therefore, the label states that workers in commercial seed treatment facilities and mobile treaters must wear coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, shoes, socks and a dust-mask. Workers cleaning or repairing seed treatment equipment must wear chemical-resistant coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, socks, chemical-resistant footwear and a dust-mask. Workers completing on-farm seed treatment must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Workers planting and handling treated seed must wear coveralls over a long-sleeved shirt, long pants, shoes and socks and use only a closed cab tractor. A dust-mask must be worn during the on-farm transfer of treated seed to planters/seeders.

For bystanders, exposure is considered to be negligible and are not of concern when drift statements are added to the labels.

Environmental considerations

What happens when broflanilide is introduced into the environment?

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

Broflanilide enters the environment when applied as a soil or seed treatment to potatoes, corn and small cereal grains to control insect pests. Broflanilide is persistent in soil, but is not expected to move through the soil and reach groundwater because it binds strongly to the soil surface. In water bodies, broflanilide will move to sediments where it may remain over time. Broflanilide is not expected to be found in the air or to travel long distances from where it was applied. Broflanilide is not expected to build-up in the tissues of organisms. Broflanilide is not expected to be taken up by plants and move inside plant tissues (it is not systemic) and its residues will remain mostly in the soil.

When used according to the label directions, broflanilide poses an acceptable risk to wild mammals, birds, beneficial insects, earthworms, terrestrial and aquatic plants, fish, or amphibians. Exposure to broflanilide may affect freshwater and marine invertebrates if they are exposed to high enough levels; therefore, precautionary label statements for aquatic organisms are required on product labels. Precautionary label statements and best management practices are also required for pollinators to minimize potential bee exposure to dust during the planting of treated seed; however, when used according to label directions, minimal exposure or risk to bees is expected.

Value considerations

What is the value of Cimegra?

Cimegra provides a new mode of action for controlling wireworm in potatoes and wireworm and corn rootworm in corn.

Cimegra has value for control of corn rootworm (western and northern) and wireworm, and to reduce wireworm populations in treated fields. Wireworms are major pests of potatoes and corn, and are difficult to kill with currently registered pest control products, and corn rootworms are a major pest of corn. Broflanilide has value as a new mode of action for use in resistance management; there are no reported cases of cross-resistance of broflanilide to currently registered insecticide modes of action.

What is the value of Teraxxa F4 and Teraxxa?

Teraxxa F4 and Teraxxa provide a new mode of action for controlling wireworm in small cereal grains (barley, buckwheat, pearl millet, proso millet, oats, rye, sorghum, triticale, canary seed, annual canarygrass (grown for human consumption)) and wheat (all types: winter, spring and durum).

Teraxxa F4 and Teraxxa have value for the control of wireworms and to reduce wireworm populations in treated fields. Wireworms are major pests of small cereal grains and wheat and are difficult to kill with currently registered pest control products. In addition, as Teraxxa F4 is a pre-mix formulation with pyraclostrobin, fluxapyroxad, triticonazole, and metalaxyl, it provides control or suppression of certain seed- and soil-borne diseases. Broflanilide has value as a new mode of action for use in resistance management; there are no reported cases of cross-resistance of broflanilide to currently registered insecticide modes of action.

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 Broflanilide Technical Insecticide, Cimegra, Teraxxa and Teraxxa F4 to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures

Human health

As direct contact with broflanilide on the skin or through inhalation can occur, workers mixing, loading and applying Cimegra must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Chemical-resistant gloves are not required during application within a closed cab.

Workers in commercial seed treatment facilities (and mobile treaters) must wear coveralls over a long-sleeved shirt, long pants, chemical resistant gloves, shoes and socks when applying or in contact with Teraxxa F4 or Teraxxa treated seed. Cleanout/repair personnel must wear chemical-resistant coveralls over a long-sleeved shirt, long pants, chemical-resistant gloves, chemical-resistant footwear, socks and a dust-mask. Workers treating cereal seed on farm must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Workers planting and handling treated seed must wear coveralls over a long-sleeved shirt, long pants, shoes and socks and use only a closed cab tractor. A dust-mask must be worn during the on-farm transfer of treated seed to planters/seeder.

Environment

Label statements indicating toxicity to bees and best management practices to minimize bee exposure to dust during planting of treated seed

Precautionary label statements indicating toxicity to aquatic organisms

Precautionary label statements to mitigate runoff

Next steps

Before making a final registration decision on Broflanilide, Cimegra, Teraxxa, and Teraxxa F4, Health Canada’s PMRA will consider any comments received from the public in response to PRD2020-06. Health Canada will accept written comments on PRD2020-06 up to 45 days from the date of its 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. Health Canada will then publish a Registration Decision, which will include its decision, the reasons for it, a summary of comments received on the proposed decision and Health Canada’s response to these comments.

Before this Broflanilide received the first registration worldwide by the Australian Pesticides and Veterinary Medicines Authority (APVMA). Co-developed with Mitsui Chemicals Agro, Inc. (MCAG), the active ingredient is a powerful and versatile insecticide for use in crop production as well as to control urban and rural pests.

Pest management professionals in Australia will be the first to benefit from this innovative solution, with products marketed under the Vedira™ brand. Further registrations, for uses in crop production, are anticipated in the U.S., Canada, Mexico and India, with additional registration submissions planned in upcoming years for key markets.

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