Proposed Registration Decision PRD2025-11, Isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST

• Pest Management Regulatory Agency
• 9 October 2025
• ISSN: 1925-0886 (PDF version)
• Catalogue number: H113-9/2025-11E-PDF (PDF version)

Summary

Table of contents

• Proposed registration decision for isocycloseram
• What does Health Canada consider when making a registration decision?
• What is isocycloseram?
• Health considerations
• Environmental considerations
• Value considerations
• Measures to minimize risk
• Next steps
• Other information

Proposed registration decision for isocycloseram

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 Isocycloseram Technical, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST, containing the active ingredient isocycloseram. VANECTO Cockroach Gel Bait is for the control of cockroaches in commercial, industrial and residential buildings and other listed structures. EQUENTO is a seed treatment product for the control of insect pests on wheat, oat, barley, rye and triticale. A23128 ST, also containing active ingredients difenoconazole, sedaxane, metalaxyl-M (and S-isomer) and fludioxonil, is another seed treatment product for the control of insect pests and the control or suppression of seed-borne and soil-borne diseases on wheat, oat, barley, rye and triticale.

Difenoconazole is currently registered for the control of a wide range of fungal diseases on diverse field crops, fruits and vegetables, and turf as a foliar spray, post-harvest spray and as a seed treatment. For details, see Proposed Re-evaluation Decision PRVD2021-06, Difenoconazole and Its Associated End-use Products, and Re-evaluation Decision RVD2022-05, Difenoconazole and Its Associated End-use Products.

Sedaxane is currently registered for the control or suppression of soil- and seed-borne diseases of seedlings and mature plants. For details, see Proposed Registration Decision PRD2015-03, Sedaxane, and Registration Decision RD2015-10, Sedaxane.

Metalaxyl-M is currently registered for the control of plant diseases caused by water-mould fungi in field and greenhouse food and feed crops (including seed treatment) as well as nursery outdoor and greenhouse non-food crops (including conifers, ornamentals and turf). For details, see Proposed Re-evaluation Decision PRVD2007-10, Metalaxyl-and Metalaxyl-M, and Re-evaluation Decision RVD2008-03, Metalaxyl-and Metalaxyl-M.

Fludioxonil is currently registered as a seed treatment, a foliar spray and a post-harvest dip to control fungal pathogens on a large number of crops. For details, see Proposed Re-evaluation Decision PRVD2016-03, Fludioxonil, and Re-evaluation Decision RVD2018-04, Fludioxonil and Its Associated End-use Products.

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 in the full version of the Proposed Registration Decision PRD2025-11, Isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST provides detailed technical information on the human health, environmental and value assessments of isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST.

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 acceptable^{Footnote 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 value^{Footnote 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). They also consider the unique characteristics of 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 on how Health Canada regulates pesticides, the assessment process and risk-reduction programs, please visit the Pesticides and pest management portion of Canada.ca.

Before making a final registration decision on isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST, Health Canada's PMRA will consider any written comments received from the public directly related to the proposed decision in this consultation document.^{Footnote 3} Health Canada will then publish a Registration Decision^{Footnote 4} on isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST, 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 PRD2025-11.

What is isocycloseram?

Isocycloseram is a new conventional chemical insecticide that targets the nervous system of insects and mites on contact and through ingestion. It is effective against agricultural pests when applied as a seed treatment. When formulated as a gel bait, it is effective against cockroaches in and around commercial, industrial and residential structures.

Health considerations

Can approved uses of isocycloseram affect human health?

Products containing isocycloseram are unlikely to affect your health when used according to proposed label directions.

Potential exposure to isocycloseram may occur through the diet (food and drinking water), when handling and applying the end-use products, when coming into contact with treated surfaces, or when handling and planting treated seed. When assessing health risks, two key factors are considered:

• the levels at which no health effects occur and
• the levels to which people may be exposed.

The dose levels used to assess risks are selected 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 dose levels 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, Isocycloseram Technical, was of low acute toxicity by the oral, dermal and inhalation routes of exposure. Isocycloseram was non-irritating to the eyes and skin but caused an allergic skin reaction. Consequently, the hazard statement "POTENTIAL SKIN SENSITIZER" is required on the label.

The end-use product, VANECTO Cockroach Gel Bait, containing isocycloseram, was of low acute toxicity by the oral route of exposure. It was also classified as being of low acute toxicity by the dermal and inhalation routes. In laboratory animals, it was minimally irritating to the eyes and skin and did not cause an allergic skin reaction.

The end-use product, EQUENTO, containing isocycloseram, was of low acute toxicity by the oral, dermal and inhalation routes of exposure. It was minimally irritating to the eyes, non-irritating to the skin and did not cause an allergic skin reaction.

The end-use product, A23128 ST, containing isocycloseram, sedaxane, difenoconazole, metalaxyl-M (and S-isomer), and fludioxonil, was of low acute toxicity by the oral and inhalation routes of exposure. It was also classified as being of low acute toxicity via the dermal route. In laboratory animals, it was minimally irritating to the eyes and skin and did not cause an allergic skin reaction.

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 isocycloseram to cause neurotoxicity, immunotoxicity, chronic toxicity, cancer, reproductive and developmental toxicity, and various other potential human health hazards. The most sensitive endpoints for risk assessment were effects on body weight, altered fetal development, and reduced survival of the young. There was no evidence to suggest that isocycloseram damaged genetic material. An increase in ovarian tumours in female mice and testicular tumours in male rats could not clearly be attributed to treatment with isocycloseram. There was an indication that the young were more sensitive than the adult animal. 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 level at which these effects occurred in animal tests.

Occupational risks from handling VANECTO Cockroach Gel Bait

Occupational risks are not of health concern when VANECTO Cockroach Gel Bait is used according to the proposed label directions, which include protective measures.

Pest control operators (PCOs) applying VANECTO Cockroach Gel Bait can come in direct contact with isocycloseram residues on the skin. Therefore, the label specifies that for VANECTO Cockroach Gel Bait, workers must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during application, clean-up and repair. For PCOs re-entering areas treated with VANECTO Cockroach Gel Bait, exposure and risk is considered negligible given the short exposure durations and limited dermal contact with treated surfaces.

Taking into consideration the label statements, and the duration of exposure for handlers, the risks from exposure to VANECTO Cockroach Gel Bait are not of health concern when the end-use product is used according to the proposed label directions.

Occupational risks from handling EQUENTO and A23128 ST

Occupational risks are not of health concern when EQUENTO and A23128 ST are used according to the proposed label directions, which include protective measures.

Workers in commercial facilities (and mobile treaters) mixing, loading, calibrating and treating cereal seeds (wheat (spring/winter/durum), barley, oats, rye, and triticale) with EQUENTO and A23128 ST, and those involved in cleaning, repair, bagging, sewing and stacking bags of treated seed and driving a forklift can come in direct contact with isocycloseram residues on the skin and through inhalation. Therefore, these workers must wear the personal protective equipment and comply with the engineering controls specified in Appendix I, Tables 1a and 1b of PRD2025-11.

Farmers treating and planting cereal seeds and farmers planting commercially treated cereal seeds may also come in direct contact with isocycloseram through direct skin contact or inhalation. Therefore, farmers must also wear the personal protective equipment and comply with the engineering controls specified in Appendix I, Tables 1a and 1b of PRD2025-11.

Taking into consideration the label statements and the durations of exposure for all workers, the risks from exposure to EQUENTO and A23128 ST are not of health concern when they are used according to the proposed label directions.

Health risks in residential and other non-occupational environments

VANECTO Cockroach Gel Bait

• Risks in residential and other non-occupational environments are not of health concern when VANECTO Cockroach Gel Bait is used according to the proposed label directions.

EQUENTO and A23128 ST

• EQUENTO and A23128 ST are not domestic class products and are not permitted for use in residential settings or other non-occupational environments. Therefore, risks in residential and other non-occupational environments are not of health concern when used according to the proposed label directions.

Health Risks to bystanders

VANECTO Cockroach Gel Bait

• Bystander risks are not of health concern when VANECTO Cockroach Gel Bait is used according to the proposed label directions.

EQUENTO and A23128 ST

• Bystander risks are not of health concern when EQUENTO and A23128 ST are used according to the proposed label directions and when spray drift restrictions are observed.

Residue in food and drinking water

Dietary risks from food and drinking water are not of health concern.

Aggregate acute dietary (food plus drinking water) intake estimates indicated that all population subgroups including females 13–49 years of age are exposed to less than 10% of the acute reference doses, and therefore are not of health concern.

Aggregate chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 8% of the acceptable daily intake (ADI), and therefore are 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. Given that dietary risks from the consumption of foods are shown to be acceptable when isocycloseram is used according to the supported label directions, MRLs are being proposed as a result of this assessment (refer to PMRL2025-21, Isocycloseram).

MRLs for isocycloseram determined from the residue trials conducted throughout Canada and the United States can be found in the Science Evaluation of PRD2025-11.

One of the isocycloseram products proposed for use as a seed treatment on small grain cereals is also formulated with the active ingredients difenoconazole, fludioxonil, sedaxane, and metalaxyl-M (and S-isomer). These active ingredients are already registered for these uses in Canada, and residues in treated commodities will be covered under the existing MRLs for each active ingredient.

Environmental considerations

What happens when isocycloseram is introduced into the environment?

When isocycloseram is used according to the label directions, the risks to the environment are acceptable for use as a structural cockroach bait and as a seed treatment.

The use of isocycloseram as a cockroach bait is expected to result in limited environmental exposure. Isocycloseram enters the environment when it is applied as a seed treatment. Isocycloseram may remain in soil for long periods of time. Isocycloseram has limited ability to move downward in the soil; however, given that it may remain in the soil for long periods of time, isocycloseram may reach groundwater. Isocycloseram has the potential to runoff into aquatic habitats. In water, isocycloseram is expected to move to sediment, where it remains for short to long periods of time depending on the type of water/sediment system and environmental conditions. Isocycloseram is not expected to build-up in the tissues of plants or animals.

When used in accordance with the label directions as a cockroach bait or seed treatment, isocycloseram poses acceptable risk to terrestrial and aquatic organisms when required risk-reduction measures are applied.

Value considerations

What is the value of VANECTO Cockroach Gel Bait?

VANECTO Cockroach Gel Bait provides a new mode of action for use in controlling cockroaches indoors or outdoors via spot, crack and crevice or void space applications.

Cockroaches can infest commercial, industrial and residential areas. VANECTO Cockroach Gel Bait has been demonstrated to provide control of cockroaches and will provide a new mode of action for cockroach management, which may reduce the risk of resistance development.

What is the value of EQUENTO and A23128 ST?

The seed treatment products EQUENTO and A23128 ST control wireworms, European chafer and June beetles on wheat, oat, barley, rye and triticale seedlings. Both products provide a new mode of action for June beetles.

Wireworm, European chafer and June beetle infestations can reduce the plant stand of small grain cereal crops by destroying seedlings and, under high pest pressure, may result in crop failure. EQUENTO and A23128 ST reduced soil infestations of these pests by over 80% and significantly, and often strongly, increased plant stand, vigour and yield. A23128 ST also contains a suite of four fungicides (difenoconazole, sedaxane, metalaxyl-M (and S-isomer) and fludioxonil) that protect seedlings from common seed- and soil-borne diseases.

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 Isocycloseram Technical, VANECTO Cockroach Gel Bait, EQUENTO, and A23128 ST to address the potential risks identified in this assessment are as follows.

Key risk-reduction measures for VANECTO Cockroach Gel Bait - Human health

To reduce the potential exposure of workers to isocycloseram through direct skin contact or inhalation, workers applying VANECTO Cockroach Gel Bait must wear a long-sleeved shirt, long pants, chemical-resistant gloves, socks and shoes during application, clean-up and repair. The label also requires that VANECTO Cockroach Gel Bait only be applied by individuals holding an appropriate pesticide applicator certificate or license recognized by the provincial/territorial pesticide regulatory agency where the application occurs. In addition, the label states that care should be taken to avoid the pesticide exiting the void, and any residue deposits on non-target surfaces must be removed by the applicator.

Key risk-reduction measures for VANECTO Cockroach Gel Bait - Environment

• Precautionary label statements indicating toxicity to aquatic organisms.

Key risk-reduction measures for EQUENTO and A23128 ST - Human health

To reduce the potential exposure to isocycloseram through direct skin contact or inhalation of sprays, the EQUENTO and A23128 ST labels specify that workers in commercial facilities (and mobile treaters) mixing, loading, calibrating and treating cereal seeds (wheat (spring/winter/durum), barley, oats, rye, and triticale), and those involved in cleaning, repair, bagging, sewing and stacking bags of treated seed and driving a forklift must wear the personal protective equipment and comply with the engineering controls specified in Appendix I, Tables 1a and 1b of PRD2025-11.

Farmers treating and planting cereal seeds and farmers planting commercially treated cereal seeds may also come into contact with isocycloseram through direct skin contact or inhalation. Therefore, farmers must also wear the personal protective equipment and comply with the engineering controls specified in Appendix I, Tables 1a and 1b of PRD2025-11.

Furthermore, a standard label statement to protect against drift during application is present on the labels.

Key risk-reduction measures for EQUENTO and A23128 ST - Environment

• Precautionary label statements indicating toxicity to aquatic organisms, bees, birds and small-sized mammals.
• Label statements indicating that any spilled or exposed seeds must be incorporated into the soil or otherwise cleaned-up from the soil surface.
• Best management practice label statements to reduce runoff entering sensitive aquatic habitats.
• Best management practice label statements to minimize bee exposure to dust during planting of treated seed.
• Precautionary label statements to indicate leaching to groundwater is possible.

Next steps

Before making a final registration decision on isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST, Health Canada's PMRA will consider any written comments received from the public that are directly related to proposed decision PRD2025-11, such as comments directed to the Science Evaluation, in response to this consultation document up to 30 days from the date of publication (9 October 2025) of PRD2025-11. If more time is required to provide comments, a request for an extension of up to 15 days can be made before the end of the original 30-day consultation period. 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 PMRA Publications, through the Public Engagement Portal (Public Engagement Forms – Consultation Comment). 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 Health Canada makes its registration decision, it will publish a Registration Decision on isocycloseram, VANECTO Cockroach Gel Bait, EQUENTO and A23128 ST (based on the Science Evaluation of PRD2025-11). In addition, the test data referenced in PRD2025-11 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.