Proposed Maximum Residue Limit PMRL2026-04, Fluazaindolizine
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Pest Management Regulatory Agency
26 February 2026
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2026-4E-PDF (PDF version)
Table of Contents
- 1.0 Pesticides in Canada
- 2.0 Purpose of this consultation
- 3.0 Dietary risk assessment
- 4.0 Summary of residue data to support the proposed maximum residue limits (MRLs)
- 5.0 Calculating the proposed maximum residue limits (MRLs)
- 6.0 International considerations
- 7.0 How to get involved
- Appendix I Excerpt of the dietary risk assessment
- For more information
1.0 Pesticides in Canada
Pesticides provide both organic and conventional growers in Canada with a variety of options to help minimize damage to their crops and livestock from pests. The reason pesticides are used is to help protect crops from pests such as weeds, fungi, and insects. This allows people in Canada to access high-quality nutritious foods all year long.
All pesticides, for both organic and conventionally grown crops, that are approved for use in Canada are regulated by Health Canada’s Pest Management Regulatory Agency (PMRA). Pesticide residues that may be present on food commodities imported into Canada are also regulated. Health Canada reviews all new pesticide applications and re-evaluates existing pesticides on a regular basis to help ensure the protection of human health.
Maximum residue limits
A maximum residue limit (MRL) is the highest amount of a specific pesticide residue allowed on a particular food commodity when a pesticide is used according to label directions.
Health Canada scientists set (or specify) MRLs after a robust scientific review of the pesticide, provided that the risks meet Health Canada’s requirements for the protection of human health. This means that the scientists first make sure the amount of pesticide residue on or in food commodities is low enough that there are no effects on human health. Health Canada is responsible for setting MRLs on food commodities grown domestically or imported into Canada. Different food commodities can have different MRLs for the same pesticide due to differences in how the pesticide is used for each crop or food commodity.
An MRL is a scientific calculation that estimates the maximum potential concentration of residues on food commodities. It is not a measurement of pesticide toxicity or safety. It accounts for the highest potential amount of residue that may remain on a food commodity when label directions are followed. More information about these calculations is in Section 5.0 on Calculating the proposed MRL. Often, the residues that remain are much lower than the MRL under typical use conditions. If the use directions change for a given pesticide, the MRL can also change. However, before any change to an MRL is proposed, the risks must meet Health Canada’s requirements for the protection of human health.
MRLs are legal limits that are enforced by the Canadian Food Inspection Agency (CFIA). The latest National Chemical Residue Monitoring Program and Chemistry Food Safety report that uses MRLs to determine compliance rates can be requested on the Food safety testing reports and journal articles page on Canada.ca.
When setting MRLs on related food commodities, Health Canada uses crop groups. Individual crops can be allocated to a crop group based on botanical or taxonomic criteria as well as on cultivation practices. Crop groups simplify the establishment of MRLs by using residue data for crops that are representative of the whole group to extend to all crops within the crop group. Crop groups can also contain smaller and more closely related crop subgroups.
Food commodities grown in Canada
Before making any registration decision for a pesticide in Canada, Health Canada must evaluate the chemistry of a pesticide, how well a pesticide works, and the pesticide's potential impact on human health and the environment. This is the full pesticide assessment process as directed in the Pest Control Products Act. This is to ensure there are no health or environmental concerns from the potential pesticide exposure to Canadians through this use, and that the pesticide has value.
2.0 Purpose of this consultation
Health Canada is consulting the public and seeking your feedback on proposed new MRLs and revised MRLs to address potential fluazaindolizine residues on various food commodities grown in Canada.
Fluazaindolizine is a nematicide currently registered for use in Canada on carrots, potatoes (crop subgroup 1C), fruiting vegetables (crop group 8-09), cucurbit vegetables (crop group 9), and for which MRLs are established for various rotational crops.
Proposals were submitted by Corteva Agriscience Canada, to register the pre-plant and early post-emergent uses of fluazaindolizine on cherry trees (crop subgroup 12-09A) bearing fruit at the time of application, stone fruit trees (crop group 12-09) not bearing fruits at the time of application, low growing berries (crop subgroup13-07G), small fruits vine climbing, except fuzzy kiwifruit (crop subgroup13-07F) and tree nuts (crop group 14-11) on the Salibro Nematicide label Pest Control Products Act Registration Number 34182. In addition, field rotational crop studies were submitted to revise the current MRLs for leafy vegetables (crop group 4-13) and Brassica head and stem vegetables (crop group 5-13), when grown as rotational crops. These MRL changes, including new MRLs, would allow these treated commodities, or any of their derived processed commodities that may contain fluazaindolizine residues, to be sold in Canada.
Health Canada is proposing to accept these MRL changes (including new MRLs). This is because Health Canada conducted a thorough scientific assessment and found that the health risk from eating food commodities treated with fluazaindolizine meets Health Canada’s requirements for the protection of human health. The main health assessment required for this consultation was the dietary risk assessment, which was conducted in accordance with sections 10 and 11 of the Pest Control Products Act. This assessment involves a thorough evaluation of health risks that considered the toxicity and dietary exposure of fluazaindolizine, and follows strict regulatory standards. Further details on the dietary risk assessment can be found in Section 3.0 on Dietary risk assessment.
Proposed Canadian MRLs for fluazaindolizine
Table 1 summarizes the proposed new and revised MRLs for fluazaindolizine and the reason for each proposed MRL.
MRLs are based on a residue definition that typically includes the pesticide itself and may also include one or more degradation products referred to as metabolites. A searchable residue definition table is available on the Residue Definitions for Chemicals with Maximum Residue Limits Regulated Under the Pest Control Products Act page on Canada.ca.
The following MRLs are based on the following residue definition: 8-chloro-N-[(2-chloro-5- methoxyphenyl)sulfonyl]-6- (trifluoromethyl)-imidazo[1,2- alpha]pyridine-2-carboxamide.
| Food commodity | Current MRL (ppm)Table 1 Footnote 1 | Proposed MRL (ppm)Table 1 Footnote 1 | Reason for the proposed MRL |
|---|---|---|---|
| Low growing berries (crop subgroup 13-07G) | 0.01 | 0.15 | Increased MRL because of new data on strawberries (which is the representative commodity for crop subgroup 13-07G), grown as a primary crop. The current MRL is based on residues in strawberries as a rotational crop. |
| Small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F); tree nuts (crop group 14-11) | None | 0.04 | New MRL on small fruits vine climbing (crop subgroup 13-07F) and tree nuts (crop group 14-11) because of new field trial data. |
| Leafy vegetables (crop group 4-13); Brassica head and stem vegetable group (crop group 5-13) | 0.015 | 0.02 | Increased MRL because of new data on cabbages (which is the representative commodity for the OECDTable 1 Footnote 2 super crop subgroup of “Leafy vegetables and Brassicas”, in accordance with the OECD Guidance Document on Residues in Rotational Crops), grown as a rotational crop. |
| Stone fruits (crop group 12-09) | None | 0.01 | New MRL on stone fruits (crop group 12-09) because of new field trial data. |
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Based on the results from the dietary risk assessment, Health Canada is proposing to accept the new and revised MRL requests for fluazaindolizine. This is because the new and revised MRLs meet Health Canada’s requirements for the protection of human health.
3.0 Dietary risk assessment
Before an MRL can be set, Health Canada scientists make sure the amount of pesticide residue on or in food commodities is low enough that there are no effects on human health. They evaluate the relevant scientific information on the toxicity and dietary exposure of the pesticide. This process is called a dietary risk assessment.
Overview of the dietary risk assessment process
The dietary risk assessment process involves four distinct steps:
- Evaluate the relevant scientific data and information and then identify the toxicology hazards of the pesticide;
- Determine the acute reference dose (ARfD) and the acceptable daily intake (ADI), where applicable.
ARfD: the amount of a specific pesticide residue that a person can eat and drink on any given day without any negative health effects. The ARfD is used to estimate acute dietary risk, which considers the potential for health effects after a single day of exposure to the pesticide.
ADI: the amount of a specific pesticide residue a person could eat and drink every day over their entire lifetime without any negative health effects. The ADI is used to estimate chronic dietary risk, which considers the potential for health effects after a lifetime of exposure to the pesticide.
Health Canada scientists estimate both acute (single day) and chronic (lifetime) dietary intakes, where applicable, for the general population and several sub-populations such as pregnant people, infants, children and seniors.
- Estimate the potential daily intake (PDI).
PDI: the total amount of a specific pesticide residue that might be eaten. When determining the PDI for a pesticide, scientists consider all food commodities (both registered (domestic) and imported), drinking water (where applicable), and how diets can vary between people in Canada. The PDI is the potential dietary exposure to a specific pesticide.
- Characterize the acute dietary risk by comparing the PDI with the ARfD, and characterize the chronic dietary risk by comparing the PDI with the ADI, where applicable.
If the PDI is lower than both the ARfD and the ADI (where applicable), Health Canada scientists conclude that all food commodities that could be treated with this pesticide are safe to eat.
Summary of the dietary risk assessment results for fluazaindolizine
This summary is focussed on key aspects of the dietary risk assessment that are potentially of greatest interest to people in Canada. It is written to help improve the understanding of Health Canada's pesticide decisions. Further technical details and how to request additional information about the dietary risk assessment can be found in 7.0 How to get involved and in Appendix I.
The results from the dietary risk assessment show that when fluazaindolizine is used according to the Canadian label directions for the various proposed uses, the dietary risks from fluazaindolizine on food commodities continue to meet Health Canada’s requirements for the protection of human health. The toxicology information for fluazaindolizine relevant to the dietary risk assessment is reported in Table A1-1 of Appendix I.
The acute dietary risk assessment results showed that exposure to fluazaindolizine is less than 30% of the ARfD. This means that acute exposure to fluazaindolizine will not affect your health. The dietary risk for each sub-population is reported in Table A1-2 of Appendix I.
- Health Canada considers that acute risk may be of concern when exposure is greater than 100% of the ARfD. When the acute dietary risk assessment is lower than 100% of the ARfD, it means that on a given day there are no human health concerns from eating foods treated with fluazaindolizine.
The chronic dietary risk assessment results showed that exposure to fluazaindolizine is less than 74% of the ADI. This means that chronic exposure to fluazaindolizine will not affect your health. The dietary risk for each subpopulation is reported in Table A1-3 of Appendix I.
Health Canada considers that chronic risk may be of concern when exposure is greater than 100% of the ADI. When the chronic dietary risk assessment is lower than 100% of the ADI, it means that there are no human health concerns from eating foods treated with fluazaindolizine every day over a person’s lifetime.
For more information on how Health Canada assesses and manages risk from pesticides, refer to this guidance document:
- PMRA Guidance Document, A framework for risk assessment and risk management of pest control products
For more information on the MRL process, refer to Section 19 Maximum Residue Limits found within this guideline:
4.0 Summary of residue data to support the proposed maximum residue limits (MRLs)
Health Canada scientists reviewed the residue data for fluazaindolizine on the following:
- trial studies on grape vines that were submitted and reviewed to support the proposed MRL on small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F).
- data on cherry, peach and plum trees that did not bear fruit at the time of application, and data on cherry trees bearing fruit at the time of application that were submitted and reviewed to support the proposed MRL on stone fruits (crop group 12-09).
- trial studies on field-grown strawberries, as a primary crop, that were submitted and reviewed to support the proposed MRL on low growing berries (crop subgroup 13-07G).
- trial studies on almonds and pecans that were submitted and reviewed to support the proposed MRL on tree nuts (crop group 14-11).
- field crop rotational trial studies that were submitted and reviewed to support the proposed MRLs on leafy vegetables (crop group 4-13), and Brassica head and stem vegetable group (crop group 5-13), as rotational crops.
Table 2 summarizes the residue data used to calculate the proposed MRLs for the various commodities.
| Commodity | Application method | Total application rate (kg a.i./ha)Table 2 Footnote 1 |
Preharvest interval (days) | Lowest average field trial residues (ppm)Table 2 Footnote 2 |
Highest average field trial residues (ppm)Table 2 Footnote 2 |
Experimental processing factor | Proposed MRL (ppm) |
|---|---|---|---|---|---|---|---|
| Cherries | Soil application | 2.30 | 2–4 | <0.01 | <0.01 | Not required | 0.01 (stone fruits, crop group 12-09)Table 2 Footnote 3 |
| Grapes | Soil application | 2.24 | 36–42Table 2 Footnote 4 | <0.01 | 0.028 | No concentration in processed fractions | 0.04 (small fruits vine climbing except fuzzy kiwifruit, crop subgroup 13-07F) |
| Strawberries | Soil application | 2.24 | 6–8Table 2 Footnote 5 | <0.01 | 0.075 | Not required | 0.15 (low growing berries, crop subgroup 13-07G) |
| Almonds | Soil application | 2.26 | 38–41 | <0.01 | 0.021 | Not required | 0.04 (tree nuts, crop group 14-11) |
| Pecans | Soil application | 2.26 | 28–34 | <0.01 | <0.01 | Not required | |
| Cabbages | Soil application | 2.24 | 7–21 (PBI)Table 2 Footnote 6 | <0.01 | <0.01 | Not required | 0.02 (leafy vegetables (crop group 4-13), Brassica head and stem vegetable group (crop group 5-13)) |
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5.0 Calculating the proposed maximum residue limits (MRLs)
Health Canada scientists calculated the proposed MRLs for fluazaindolizine using the residues observed in the residue trials, and the guidance provided in the OECD MRL Calculator. Many international regulatory authorities use this statistical calculator to set MRLs on food commodities that are either grown domestically or imported from different countries. Full residue datasets are required to run the OECD MRL calculator, not just the highest and lowest residues reported in Table 2.
Pesticide MRLs established for each food commodity may be found using the Maximum Residue Limit Database. The database allows users to search for established MRLs, regulated under the Pest Control Products Act, for pesticides or food commodities.
6.0 International considerations
Internationally, MRLs are used to facilitate trade of food commodities between countries. Canadian MRLs are established or amended based on a robust scientific risk assessment that demonstrates safety for people in Canada. Table 3 compares the MRLs proposed for fluazaindolizine in Canada with the corresponding tolerances in the United States (U.S.) and international Codex MRLs. The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.
MRLs may vary from one country to another for a number of reasons, including differences in pesticide use patterns and the locations of the crop field trials used to generate residue chemistry data.
The U.S. tolerances and Codex MRLs for fluazaindolizine are listed in Table 3. The term “tolerance” is used in the U.S. as another name for MRLs. The tolerances in the U.S. are listed by pesticide in the Electronic Code of Federal Regulations, 40 CFR Part 180.
The Codex MRLsFootnote 1 are listed by pesticide or commodity on the Codex Alimentarius Pesticide Index webpage.
| Food commodity | Proposed Canadian MRL (ppm)Table 3 Footnote 1 | Established U.S. tolerance (ppm)Table 3 Footnote 1 | Established Codex MRL (ppm)Table 3 Footnote 1 |
|---|---|---|---|
| Low growing berries (crop subgroup 13-07G) | 0.15 | 0.01 | 0.01 (Strawberry) |
| Small fruits vine climbing, except fuzzy kiwifruit (crop subgroup 13-07F) | 0.04 | Not established | Not established |
| Tree nuts (crop group 14-11) | 0.04 | Not established | Not established |
| Leafy vegetables (crop group 4-13) |
0.02 | 0.015 | 0.04 (Leafy vegetables (group)) |
| Brassica head and stem vegetable group (crop group 5-13) |
0.02 | 0.015 | 0.02 (Brassica vegetables (except Brassica leafy vegetables) (group)) |
| Stone fruits (crop group 12-09) | 0.01 | Not established | Not established |
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7.0 How to get involved
Health Canada invites the public to submit written comments on the proposed MRL changes (including new MRLs) for fluazaindolizine up to 75 days from the date of publication of this document.
Please submit your comments to the Pest Management Regulatory Agency Publications Section.
Health Canada considers all comments received up to 75 days from the date of publication of this document (by 12 May 2026) before making a final science-based decision about the proposed MRLs. Comments received within this 75 day period will be addressed in a response to comments document found in Pesticides and pest management consultations. If no comments are received, or the comments do not result in a change to the proposed MRLs, the MRLs will be set and legally in effect on the date they are entered into the Maximum Residue Limit Database.
If you would like to request additional information on the supporting scientific documents for these proposed MRLs, here is the information you will need to identify the request:
- Active ingredient: fluazaindolizine
- Published document number: PMRL2026-04
- Submission number: 2022-1222, 2024-0395
- Related registration decisions: PRD2021-03, RD2021-06
Appendix I Excerpt of the dietary risk assessment
| Exposure scenario | Toxicology reference value used in risk assessment | Study | Toxicological endpoint |
|---|---|---|---|
| Acute Dietary All populations |
NOAELTable A1-1 Footnote 1 = 125 mg/kg bw CAFTable A1-1 Footnote 1Table A1-1 Footnote 2 = 100Table A1-1 Footnote 2 ARfDTable A1-1 Footnote 1 = 1.3 mg/kg bw |
Acute neurotoxicity in rats | LOAELTable A1-1 Footnote 1= 450 mg/kg bw Based on decreased motor activity and decreased habituation observed on the day of dosing at the LOAEL of 450 mg/kg bw/day (in other words, 3.6-fold greater dose than the NOAEL) |
| Chronic Dietary All populations |
NOAEL1 = 17 mg/kg bw/day CAFTable A1-1 Footnote 1Table A1-1 Footnote 3 = 100Table A1-1 Footnote 3 ADITable A1-1 Footnote 1 = 0.2 mg/kg bw/day |
1-year dietary toxicity in dogs | LOAELTable A1-1 Footnote 1= 36 mg/kg bw/day Based on decreased body weight and bodyweight gain, and pigmented hepatocytes observed at the LOAEL of 36 mg/kg bw/day (in other words, 2.1-fold greater dose than the NOAEL) |
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Dietary exposure assessments are conducted using a database called the Dietary Exposure Evaluation Model - Food Commodity Intake Database (DEEM-FCID) which is explained in Science Policy Note SPN2014-01, General Exposure Factor Inputs for Dietary, Occupational, and Residential Exposure Assessments. This is a food recipe and consumption database used by Canada and the U.S. for dietary exposure modelling that incorporates food consumption data from the U.S. National Health and Nutritional Examination Survey, What We Eat in America (NHANES/ WWEIA ) dietary survey. This survey is made available through the National Center for Health Statistics (NCHS), which is part of the Centers for Disease Control and Prevention (CDC). The NHANES survey, which uses interviews and physical examinations to assess the health and nutritional status of adults and children in the United States, is updated periodically and is also reflective of the large variety of food consumption patterns in the Canadian population.
Results of the acute dietary risk assessment
The results of the most recent acute dietary exposure assessment for fluazaindolizine are shown in Table A1-2 . There are no dietary risks of concern when the PDI is less than the ARfD (see Section 3.0 ). The DEEM-FCID (NHANES) analyses estimate the dietary exposure of the general population and various population subgroups. The results reported in Table A1-2 are for the general population (all ages), all infants (<1 year old), children 1–2 years old, children 3–5 years old, children 6–12 years old, youth 13–19 years old, adults 20–49 years old and adults 50+ years old. When including the use of fluazaindolizine on the various food commodities and levels of fluazaindolizine found in drinking water, the estimated dietary exposure to fluazaindolizine for all population subgroups is less than 30% of the ARfD. This means that acute exposure to fluazaindolizine will not affect your health.
| Population subgroup | Intermediate assessment food and drinking waterTable A1-2 Footnote 1Table A1-2 Footnote 2 – previous assessment | Intermediate assessment food and drinking waterTable A1-2 Footnote 1Table A1-2 Footnote 2 – Updated to include the proposed MRLs |
|---|---|---|
| % ARfDTable A1-2 Footnote 3Table A1-2 Footnote 4 | % ARfDTable A1-2 Footnote 3 | |
| General Population | 9.7 | 9.9 |
| All Infants | 29.5 | 29.5 |
| Children 1–2 years old | 16.3 | 16.4 |
| Children 3–5 years old | 12.7 | 12.7 |
| Children 6–12 years old | 9.3 | 9.5 |
| Youth 13–19 years old | 7.8 | 7.8 |
| Adults 20–49 years old | 9.0 | 9.2 |
| Adults 50+ years old | 7.9 | 8.1 |
Bolded values indicate updated risk assessments
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Results of the chronic dietary risk assessment
The results of the most recent chronic dietary exposure assessment for fluazaindolizine are shown in Table A1-3. There are no dietary risks of concern when the PDI is less than the ADI (see Section 3.0), therefore there are no chronic dietary risks of concern. The DEEM-FCID (NHANES) analyses estimate the dietary exposure of the general population and various population subgroups. The results reported in Table A1-3 are for the general population (all ages), all infants (<1 year old), children 1–2 years old, children 3–5 years old, children 6–12 years old, youth 13–19 years old, adults 20–49 years old and adults 50+ years old. When including the use of fluazaindolizine on the various food commodities, and levels of fluazaindolizine found in drinking water, the estimated dietary exposure to fluazaindolizine for all population subgroups is less than 74% of the ADI. This means that chronic exposure to fluazaindolizine will not affect your health.
| Population subgroup | Intermediate assessment food and drinking waterTable A1-3 Footnote 1Table A1-3 Footnote 2 – previous assessment | Intermediate assessment food and drinking waterTable A1-3 Footnote 1Table A1-3 Footnote 2 – Updated to include the proposed MRLs |
|---|---|---|
| % ADITable A1-3 Footnote 3Table A1-3 Footnote 4 | % ADITable A1-3 Footnote 3 | |
| General Population | 19.9 | 19.9 |
| All Infants | 73.4 | 73.5 |
| Children 1–2 years old | 28.0 | 28.1 |
| Children 3–5 years old | 22.8 | 22.8 |
| Children 6–12 years old | 16.9 | 16.8 |
| Youth 13–19 years old | 14.1 | 14.1 |
| Adults 20–49 years old | 19.7 | 19.7 |
| Adults 50+ years old | 19.1 | 19.1 |
Bolded values indicate updated risk assessments
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For more information
- PRD2021-03, Fluazaindolizine and Salibro Nematicide – available through this publication request page
- RD2021-06, Fluazaindolizine and Salibro Nematicide
Footnote
- Footnote 1
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The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.
