Proposed Registration Decision PRD2023-02, GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP

Notice to the reader:

The online consultation is now closed.

Summary

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 PRD2023-02, GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP please contact our publications office.

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

Table of contents

Proposed registration decision for GS-omega/kappa-Hxtx-Hv1a

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 VST-006335 MP Technical, SPEAR T and SPEAR-LEP, containing the technical grade active ingredient GS-omega/kappa-Hxtx-Hv1a, to control or suppress thrips, whiteflies, mites, spotted-wing drosophila and listed Lepidopteran pests on various listed field and greenhouse crops and cannabis.

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 PRD2023-02, GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP provides detailed technical information on the human health, environmental and value assessments of GS-omega/kappa-Hxtx-Hv1a and SPEAR T and SPEAR-LEP.

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 individuals and the environment from the use of pest control products. Health or environmental risk is considered acceptableFootnote 1 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 valueFootnote 2 when used according to the label directions. Conditions of registration may include 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 GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP, Health Canada's PMRA will consider any comments received from the public in response to this consultation document.Footnote 3 Health Canada will then publish a Registration DecisionFootnote 4 on GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP, 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 PRD2023-02.

What is GS-omega/kappa-Hxtx-Hv1a?

GS-omega/kappa-Hxtx-Hv1a is a peptide derived from the venom of a species of Australian funnel spider (Hadronyche versuta). The active ingredient affects the insect nervous system.

Health considerations

Can approved uses of GS-omega/kappa-Hxtx-Hv1a affect human health?

GS-omega/kappa-Hxtx-Hv1a is unlikely to affect human health when used according to label directions.

Potential exposure to GS-omega/kappa-Hxtx-Hv1a may occur through the diet (food and water) or when handling or applying the product. When assessing health risks, two key factors are considered:

The 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 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.

In laboratory animals, VST-006335 MP Technical is considered to be of low acute toxicity by the oral, dermal, and inhalation routes, minimally irritating to the eyes, mildly irritating to the skin, and not a dermal sensitizer.

Short-term oral toxicity testing, prenatal developmental toxicity testing, and genotoxicity/mutagenicity testing on GS-omega/kappa-Hxtx-Hv1a were also assessed. Animals given repeated high doses of GS-omega/kappa-Hxtx-Hv1a exhibited changes in clinical chemistry parameters.

There was no indication that the young were more sensitive than the adult animal. GS-omega/kappa-Hxtx-Hv1a was not mutagenic in a reverse gene mutation assay in bacteria and was not clastogenic in an in vitro mammalian cell gene mutation assay.

The end-use product, SPEAR T, is considered to be of low acute toxicity by the oral, dermal and inhalation routes, minimally irritating to the eyes, mildly irritating to the skin and not a dermal sensitizer. The toxicological profile of SPEAR-LEP is equivalent to the toxicological profile of SPEAR T.

Residues in water and food

Dietary risks from food and water are acceptable.

Residues of GS-omega/kappa-Hxtx-Hv1a on treated crops are possible at the time of harvest. Due to its low toxicity profile, and the low application rate, consumer exposure to GS-omega/kappa-Hxtx-Hv1a present in SPEAR T and SPEAR-LEP is not expected to pose a health risk when the end-use products are applied as directed by the label. Similarly, the likelihood of GS-omega/kappa-Hxtx-Hv1a residues in drinking water will be low. Consequently, health risks are acceptable for all segments of the population, including infants, children, adults and seniors.

Risks in residential and other non-occupational environments

Estimated risk for residential and other non-occupational exposure is acceptable.

SPEAR T and SPEAR-LEP are proposed as commercial insecticide/acaricide end-use products. There are no residential uses proposed for SPEAR T and SPEAR-LEP. Both products are proposed for use outdoors on field grown food crops, such as fruit (orchard and field crops) and vegetable crops, whereas SPEAR T is also proposed for use indoors on greenhouse-grown food crops, ornamentals, and cannabis grown in greenhouses or other enclosed growing structures. The product labels will include measures to prevent bystander exposure such as reducing spray drift, and restricting access to the treated area until sprays have dried. Residential and non-occupational exposure to SPEAR T and SPEAR-LEP is expected to be low when label directions are observed. Consequently, the risk to residents and the general public is acceptable.

Occupational risks from handling SPEAR T and SPEAR-LEP

Occupational risks are acceptable when SPEAR T and SPEAR-LEP are used according to the label directions, which include protective measures.

Workers handling SPEAR T and SPEAR-LEP can come into direct contact with GS-omega/kappa-Hxtx-Hv1a through inhalation and contact with skin during mixing, loading, application, clean-up and repair.

To protect workers from exposure to SPEAR T and SPEAR-LEP, the labels require workers to wear long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab.

For applications using airblast equipment, workers must wear coveralls with a hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes, and a respirator with a National Institute for Occupational Safety and Health (NIOSH)-approved organic-vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved canister approved for pesticides.

A restricted-entry interval (REI) of 4 hours, or until sprays have dried, is prescribed for all uses. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate personal protective equipment (PPE) as specified by the method of application.

The occupational risks are acceptable when the precautionary statements on the label are observed.

Environmental considerations

What happens when GS-omega/kappa-Hxtx-Hv1a is introduced into the environment?

VST-006335 MP Technical contains the active substance, GS-omega/kappa-Hxtx-Hv1a. GS-omega/kappa-Hxtx-Hv1a is not expected to pose a risk to the environment when used according to product label instructions to control insect pests in greenhouse vegetable crops and fruits, outdoor fruit trees, greenhouse ornamentals, and cannabis produced commercially indoors or in greenhouses.

GS-omega/kappa-Hxtx-Hv1a is an amino acid peptide that will degrade rapidly through microbial processes and is non-persistent in terrestrial and aquatic environments. GS-omega/kappa-Hxtx-Hv1a is not expected to accumulate in plants and animals nor leach through the soil or move up into the surrounding air from where it is applied.

GS-omega/kappa-Hxtx-Hv1a does not pose a risk to birds, mammals, pollinators (bees), beneficial arthropods, terrestrial plants, fish, amphibians, aquatic invertebrates or aquatic plants.

Value considerations

What is the value of SPEAR T and SPEAR-LEP?

SPEAR T is intended for use on several agricultural field and greenhouse crops and cannabis to manage thrips, whiteflies, spider mites, and spotted wing drosophila. SPEAR-LEP is intended for use on fruit and vegetable crops to control Lepidopteran pests.

SPEAR T and SPEAR-LEP are to be used in alternation with other registered insecticides as part of an Integrated Pest Management program. SPEAR-LEP is mixed with a tank mix partner containing Bacillus thuringiensis (Bt) subspecies kurstaki or aizawai. It is thought that the activity of Bt on the insect gut assists the mode of action of SPEAR-LEP.

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 VST-006335 MP Technical, SPEAR T and SPEAR-LEP to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures - Human health

The hazard signal words "CAUTION- SKIN IRRITANT" are required on the principal display panel of the VST-006335 MP Technical, SPEAR T, and SPEAR-LEP labels. Standard precautionary statements are also required on the labels to inform of the potential to cause skin irritation and to avoid contact with skin, eyes, or clothing.

Workers are required to wear long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during handling, mixing, loading, application, clean-up and repair. Gloves are not required during application within a closed cab.

During airblast applications, workers must wear coveralls with a hood over long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes and a respirator with a NIOSH-approved organic-vapour-removing cartridge with a prefilter approved for pesticides or a NIOSH-approved canister approved for pesticides, during mixing, loading, application, clean-up and repair.

There will be a restricted-entry interval of 4 hours, or until sprays have dried. If early entry is necessary during the restricted-entry interval, workers must wear the appropriate PPE as specified for the method of application.

To limit bystander exposure, both end-use product labels require drift statements.

Key risk-reduction measures - Environment

None required following risk assessment.

Next steps

Before making a final registration decision on GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP, Health Canada's PMRA will consider any comments received from the public in response to PRD2023-02. Health Canada will accept written comments on this proposal up to 45 days from the date of publication of PRD2023-02. 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 GS-omega/kappa-Hxtx-Hv1a, SPEAR T and SPEAR-LEP (based on the Science Evaluation of PRD2023-02). In addition, the test data referenced in this consultation document will be available for public inspection, upon application, in the PMRA's Reading Room. For more information, please contact the PMRA's Pest Management Information Service.

Page details

Date modified: