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Response to comments received on the consultation for proposed maximum residue limits for chlorantraniliprole (PMRL2025-11)

Health Canada
Pesticides Regulatory Directorate
Healthy Environments and Consumer Safety Branch
3 September 2026

Health Canada published the Proposed Maximum Residue Limit PMRL2025-11, Chlorantraniliprole, for a 75-day public consultation period ending on 5 October 2025. Health Canada proposed four new maximum residue limits (MRLs) for chlorantraniliprole on tea, avocado, oil palm fruits and palm oil imported into Canada. Comments were received from the public and non-government organizations.

Some of the comments received claimed chlorantraniliprole was killing pollinators and objected to animal testing. Other comments questioned the Canadian regulatory framework for setting MRLs for imported food commodities and claimed that there has been an increase in chlorantraniliprole residues in the environment and drinking water. One commenter also questioned the hazard characterization and selection of Toxicology Reference Values (TRVs) and the lack of a cumulative risk assessment.

Health Canada acknowledges receipt of these comments. Please note that Health Canada's PMRL consultation process is intended to obtain comments on the scientific information which form the basis of the proposed MRL decisions. As these are based on residue chemistry data and dietary exposure assessments, all comments not related to this information are considered out of scope and will not be addressed. Responses to all MRL and dietary exposure assessment-related comments are presented below. The comments received do not change the scientific basis of the proposed MRLs, in turn these MRLs will be specified in the MRL database. More information on MRLs can also be found on the Maximum residue limits, human health, and food safety webpage.

1. Comment

A commenter expressed concern that Health Canada was inflating the Canadian MRL to align with the higher import MRL, thereby removing the Canadian standard for pesticide residues, leaving no measure for pesticide residue that may remain on or in food grown in Canada when a pesticide is used according to Canadian label directions.

Health Canada Response:

As noted in PMRL2025-11, no increase in MRLs are being proposed, as these are new proposed MRLs for avocado, tea, oil palm fruits and palm oil that will allow importation of these crops, which are not grown in Canada.

2. Comment

A commenter expressed concern with the uncertainties and problems with the dietary risk assessment, as it did not consider palm oil and as such, this commodity was not assessed using a scientifically based approach.

Health Canda Response:

Dietary risk assessment results for chlorantraniliprole

Before an MRL can be set, scientists from Health Canada make sure the amount of pesticide residue on or in food commodities is low enough that there would be no effects on human health. Scientists evaluate the relevant scientific information on the toxicity and dietary exposure of the pesticide. This process is called a dietary risk assessment, which involves four distinct steps:

  1. Evaluate the relevant scientific data and information and then identify the toxicology hazards of the pesticide.
  2. Determine the acceptable daily intake (ADI) and the acute reference dose (ARfD), when applicable.

    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. This is set considering all vulnerable people such as pregnant people, infants, children, and seniors.

    ARfD: the amount of a specific pesticide residue that a person can eat and drink on any given day without any negative health effects. This is set considering all vulnerable people such as pregnant people, infants, children, and seniors.

  3. 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) and how diets can vary between people in Canada. The PDI is the potential amount of dietary exposure to a specific pesticide.

  4. Characterize the human health risk by comparing the PDI with the ADI and ARfD, if applicable.

If the PDI is lower than the ADI and the ARfD, the scientists at Health Canada conclude that all food commodities that could be treated with this pesticide based on the label directions are safe to eat.

In the case of chlorantraniliprole, studies in laboratory animals showed no acute health effects relevant to dietary exposure. Consequently, an ARfD was not established as a single dose of chlorantraniliprole is not likely to cause acute health effects in the general population (including infants and children).

Repeat dose studies with chlorantraniliprole in laboratory animals did show health effects relevant to dietary exposure. Therefore, an ADI has been established. The unrefined chronic dietary exposure assessment for chlorantraniliprole, conducted in 2021, included all established Canadian MRLs, U.S. tolerances and default processing factors. The chronic dietary exposure from all supported domestic and imported food uses and drinking water for the representative population subgroups were less than 8% of the ADI. Health Canada conducted a dietary risk assessment considering using the Dietary Exposure Evaluation Model – Food Commodity Intake Database™ program (DEEM-FCID™, Version 4.02, 05-10-c) and considering palm oil only. Palm oil was shown to account for less than or equal to 0.1% of the ADI for all population subgroups including infants and children. Therefore, the dietary contribution of palm oil to the overall diet is expected to be minimal.

3. Comment

One commenter noted that the OECD MRL Calculator can yield misleadingly high values when limited or heterogeneous residue trials are used. For the commodities avocado and palm fruit, the OECD MRL Calculator Output is clear there is "high uncertainty of MRL estimate due to small dataset". The values from the field trials are much lower than those in the Calculator Output, demonstrating that the MRL was inflated by the calculator's algorithmic rounding or statistical treatment of small datasets.

Health Canada Response:

An MRL is not a measure of the toxicity of a pesticide. It is a scientifically-based calculation that estimates the maximum potential concentration of residues on food commodities, when a pesticide is used according to approved label directions. Health Canada establishes MRLs only when there are no health risks of concern to consumers.

Health Canada uses a statistical MRL calculation tool, adopted internationally by Organisation for Economic Co-operation and Development (OECD) countries and regulatory authorities, such as the European Union, to calculate MRLs, also referred to as the OECD MRL calculator. Health Canada scientists collaborated with other OECD scientists to develop this OECD MRL calculator. The calculator is also used by the Joint Food and Agriculture Organization (FAO)/World Health Organization (WHO) Meeting on Pesticide Residues (JMPR) to recommend MRLs for adoption by the Codex Committee on Pesticide Residues (CCPR) to protect consumer health and promote fair practices in food trade.

MRLs are based on the highest potential amount of residue that may remain on crops when a pesticide is used according to label directions. The calculator compares the lowest residue with the highest residue in the crop field trials; the larger that range is, the greater the difference present in the data. This difference is taken into account when computing the MRL and may lead, in some cases, to MRL proposals considerably greater than the highest residue observed in the trials. This helps ensure MRLs are not underestimated when the product is used in different regions or growing conditions.

The OECD White Paper, which explains this Calculator, notes that for smaller datasets (i.e., less than 10 points), the MRL proposed is typically greater than the highest residue in the data set to ensure that the MRL is not underestimated. For such residue datasets, this outcome is expected, especially when there is a great deal of variability within the data set.

Conclusion

Dietary risks from the consumption of chlorantraniliprole residues in or on the imported crops were shown to be acceptable when chlorantraniliprole is used according to the supported foreign label directions. As such, the foods containing these residues are safe to eat, and the MRLs will be specified in the MRL Database as proposed in PMRL2025-11.

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2026-09-03

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