Proposed Registration Decision PRD2019-14, Tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino

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Pest Management Regulatory Agency
30 December 2019
ISSN: 1925-0886 (PDF version)
Catalogue number: H113-9/2019-14E-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 PRD2019-14, Tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino please contact our publications office.

Should you require further information please contact the Pest Management Information Service.

Summary

Table of Contents

Proposed Registration Decision for Tetraniliprole

Health Canada’s Pest Management Regulatory Agency (PMRA), under the authority of the Pest Control Products Act, is proposing registration for the sale and use of Tetraniliprole Technical, Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, containing the technical grade active ingredient tetraniliprole, to control a wide range of insect pests on labelled fruit and vegetable crops and turf.

An evaluation of available scientific information found that, under the approved conditions of use, the health and environmental risks and the value of the pest control products are acceptable.

This summary describes the key points of the evaluation, while the Science Evaluation of Proposed Registration Decision PRD2019-14, Tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino provides detailed technical information on the human health, environmental and value assessments of tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino.

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:

Before making a final registration decision on tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480 FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, Health Canada’s PMRA will consider any comments received from the public in response to this PRD2019-14. Health Canada will then publish a Registration Decision on tetraniliprole and Tetraniliprole 200SC Insecticide, Tetraniliprole 480 FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, which will include the decision, the reasons for it, a summary of comments received on the proposed registration decision and Health Canada’s response to these comments.

For more details on the information presented in this summary, please refer to the Science Evaluation of PRD2019-14.

What Is Tetraniliprole?

Tetraniliprole is an insecticide that is active by ingestion and contact. It is the active ingredient in the commercial class products Tetraniliprole 200SC Insecticide, Tetraniliprole 480 FS, Tetraniliprole 200SC Turf Insecticide and Tetrino.

Health Considerations

Can Approved Uses of Tetraniliprole Affect Human Health?

Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, containing tetraniliprole, are unlikely to affect your health when used according to label directions.

Potential exposure to tetraniliprole may occur through the diet (food and drinking 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 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 tetraniliprole was of low acute toxicity via the oral, dermal and inhalation routes. It was minimally irritating to the eyes and skin, but did cause an allergic skin reaction. Consequently, the hazard signal words “POTENTIAL SKIN SENSITIZER” are required on the label.

The end-use products Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, containing tetraniliprole, were of low acute toxicity via the oral, dermal and inhalation routes. They were non-irritating to the eyes and skin, and did not cause an allergic skin reaction.

Registrant-supplied short-term and long-term (lifetime) animal toxicity tests were assessed for the potential of tetraniliprole 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 body weight. The overall evidence suggests low concern for young animals and their sensitivity to tetraniliprole when compared to adult animals. There was no evidence that tetraniliprole damaged genetic material; however, there was equivocal evidence that it caused uterine tumours in rats.

The risk assessment protects against the effects noted above, and other potential effects, by ensuring that the level of human exposure is well below the lowest dose level 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 all population subgroups are expected to be exposed to less than 59% of the acceptable daily intake. Children 1 to 2 years old are the subpopulation expected to be subject to the highest exposures relative to body weight. Based on these estimates, the chronic dietary risk from tetraniliprole is not of health concern for all population subgroups.

On the strength of the overall information, it was determined that a threshold approach was appropriate for the cancer risk assessment based on the observed tumours (equivocal increase of uterine tumours in rats). Overall, the endpoints selected for non-cancer dietary risk assessment are considered to be protective of these findings.

Animal studies revealed no acute health effects. Consequently, a single dose of tetraniliprole 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.

MRLs for tetraniliprole determined from the acceptable residue trials conducted throughout Canada and the United States on Crop Subgroup 1C, Crop Group 4-13, Crop Group 5-13, Crop Group 8-09, dry soybeans, Crop Group 10 (revised), Crop Group 11-09, Crop Group 12-09, Crop Subgroup 13-07F, Crop Group 14-11, field corn, sweet corn, and Crop Subgroup 20R-C can be found in the Science Evaluation section of this Consultation Document.

Occupational Risks From Handling Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide, and Tetrino

Risks in Residential and Other Non-Occupational Environments

Residential and non-occupational risks are not of concern when tetraniliprole is used according to the proposed label directions.

Tetraniliprole 200SC Insecticide can be applied as a foliar spray to fruit trees in residential areas and Tetraniliprole 200SC Turf Insecticide and Tetrino can be applied to recreational areas such as golf courses and turf in residential areas. Therefore, there is the potential for adults, youth and children to be exposed via the dermal route as well as via the incidental oral route for children.

The exposure assessments conducted for adults, youth and children when contacting foliage and turf treated with tetraniliprole did not identify risks of concern when the label directions are followed.

Occupational Risks from Handling Tetraniliprole

Occupational risks are not of concern when Maxtima is used according to the proposed label directions, which include protective measures.

Workers in commercial seed treatment facilities (and mobile treaters) and those planting and handling seed treated with Tetraniliprole 480FS can come into direct contact with tetraniliprole through residues on the skin. Therefore, the label states that treaters/applicators, baggers/sewers/stackers and forklift drivers in commercial seed treatment facilities (and mobile treaters) must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Cleanout/repair personnel must wear coveralls over long-sleeved shirt and long pants, chemical-resistant gloves, shoes and socks. Corn and soybean seed can be treated using closed transfer systems only. Workers planting and handling treated seed must wear long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks.

Farmers and custom applicators who mix, load and apply Tetraniliprole 200SC Insecticide as a foliar or soil treatment can come in direct contact with tetraniliprole residues on the skin and or through inhalation and workers entering treated fields can come in direct contact with tetraniliprole residues on the skin. Therefore, the label specifies that anyone mixing/loading and applying tetraniliprole 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.

Applicators who mix, load and apply Tetraniliprole 200SC Turf Insecticide or Tetrino to turf, including sod farms, golf courses and residential areas, and workers entering treated turf can come in direct contact with tetraniliprole residues on the skin and/or through inhalation. Therefore, the label specifies that anyone mixing/loading and applying tetraniliprole must wear long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. The label also requires that workers not enter treated sod fields for 12 hours after application and all other treated turf areas until sprays have dried.

Taking into consideration label statements and precautionary measures, 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.

Environmental Considerations

What Happens When Tetraniliprole Is Introduced Into the Environment?.

When used according to label directions, the risks associated with tetraniliprole are acceptable from the viewpoint of environmental protection.

When tetraniliprole is used as a foliar application, in-furrow application or seed treatment to control insects, it can remain in the soil for a number of months depending on the soil type and conditions. It will not move from the treatment area to the air and, therefore, will not move to another area by movement through air. Tetraniliprole and its by-products can move downward in the soil, and, therefore, may reach groundwater. It can also move off the treatment area to reach surface waters such as ponds, streams and rivers. Once in water, tetraniliprole will not remain for a long period of time. Tetraniliprole is not expected to accumulate in plant or animal tissue.

Tetraniliprole can affect pollinators and beneficial insects following application. Because it is possible that tetraniliprole may enter ponds, streams and rivers after it is sprayed, it can affect aquatic life. Without precautions in place on how tetraniliprole should be used, the terrestrial and aquatic organisms listed above may be affected. Therefore, precautions are required to reduce the environmental exposure to tetraniliprole, thereby reducing the environmental risks. When tetraniliprole is used in accordance with the label and the required precautions, the resulting environmental risk is considered to be acceptable.

Value Considerations

What Is the Value of Tetraniliprole 200SC Insecticide?

Tetraniliprole 200SC Insecticide contains the new active ingredient tetraniliprole (200 g/L) and controls or suppresses numerous insect pests of field, fruit, tree nut and vegetable crops by foliar or in-furrow application.

Tetraniliprole 200SC Insecticide is a new commercial class product that is applied by foliar application by ground equipment to all listed crops, and also by aerial equipment to potato. It also can be applied in-furrow to tuberous and corm vegetables. It controls or suppresses important pests including aphids, Colorado potato beetle and grape berry moth. The product provides a new mode of action for mullein bug on pome fruit, aphids on tree nuts, and aphids and flea beetles on corn. Therefore, it may aid in resistance management of these pests on these crops.

What Is the Value of Tetraniliprole 480FS?

Tetraniliprole 480FS contains the new active ingredient tetraniliprole (480 g/L) and is a seed treatment that protects corn and soybean from certain soil-dwelling insects.

Tetraniliprole 480FS is a new commercial class seed treatment that protects corn and soybean from feeding damage by seedcorn maggot, wireworms and the larvae of European chafer, Japanese beetle and June beetles. These are important pests of corn and soybean. The product provides a new mode of action for use on soybean against these pests and may aid in resistance management.

What Is the Value of Tetraniliprole 200SC Turf Insecticide and Tetrino?

Tetraniliprole 200SC Turf Insecticide and Tetrino contain the new active ingredient tetraniliprole at 200 and 43 g/L, respectively, and control various insect pests of turf.

Tetraniliprole 200SC Turf Insecticide and Tetrino are new commercial class products that control annual bluegrass weevil, billbugs, chinch bugs and sod webworms, and control or suppress larvae of certain beetles on turf. These products provide a new mode of action against larvae of Asiatic garden beetle, northern masked chafer and oriental beetle on turf. Therefore, they may aid in resistance management of these turf 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 Tetraniliprole Technical, Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino to address the potential risks identified in this assessment are as follows.

Key Risk-Reduction Measures

Human Health

As direct contact with tetraniliprole on the skin or through inhalation can occur, anyone applying Tetraniliprole 480FS in commercial seed treatment facilities (and mobile treaters) must use closed transfer systems only. Also, treaters/applicators, baggers/sewers/stackers and forklift drivers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Cleanout/repair personnel must wear coveralls over long-sleeved shirt and long pants, chemical-resistant gloves, shoes and socks. Workers planting and handling treated corn or soybean seed on farm must wear a long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks.

Workers mixing, loading and applying Tetraniliprole 200SC Insecticide using ground application equipment and aerial applicators must wear long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Chemical-resistant gloves are not required during application within a closed cab or cockpit. For aerial application, the field crew and the mixer/loaders must wear chemical-resistant gloves, coveralls and goggles or face shield during mixing/loading, clean-up and repair.

Workers mixing, loading and applying Tetraniliprole 200SC Turf Insecticide and Tetrino to turf using ground application equipment, including handheld equipment, must wear long-sleeved shirt, long pants, chemical-resistant gloves, shoes and socks. Chemical-resistant gloves are not required during application within a closed cab.

Environment

Next Steps

Before making a final registration decision on tetraniliprole, Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino, Health Canada’s PMRA will consider any comments received from the public in response to PRD2019-14. Health Canada will accept written comments on PRD2019-14 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.

Other Information

When the Health Canada makes its registration decision, it will publish a Registration Decision on tetraniliprole, Tetraniliprole 200SC Insecticide, Tetraniliprole 480FS, Tetraniliprole 200SC Turf Insecticide and Tetrino (based on the Science Evaluation of PRD2019-14). In addition, the test data referenced in PRD2019-14 will be available for public inspection, upon application, in the PMRA’s Reading Room (located in Ottawa).

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