Proposed Maximum Residue Limit PMRL2024-18, Pyridate

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Table of Contents

1.0 Pesticides in Canada

Pesticides provide both organic and conventional growers in Canada with a variety of options to help minimize damage from pests to their crops or plants, and livestock. Livestock are animals that are raised on a farm or commercial facility for the purpose of providing food commodities. Pesticides help protect crops and livestock 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 livestock and organic and conventionally grown crops, that are approved for use in Canada are regulated by Health Canada's Pest Management Regulatory Agency (PMRA). This includes regulating pesticide residues that may be present on food commodities produced or grown domestically or imported into Canada. Health Canada reviews all new pesticide applications and re-evaluates existing pesticides on a regular basis to help ensure the protection of human health.

Pesticide residues in edible animal commodities

Using pesticides on crops according to label directions can leave pesticide residues on animal feeds that transfer to edible animal commodities that people may eat, such as fat, meat, meat byproducts, milk and eggs. For example, if a pesticide is used on wheat, pesticide residues can end up on animal feeds like wheat grain, forage, hay and straw. If animals eat these treated feeds, pesticide residues could transfer into edible animal commodities. Similarly, if animals are treated with pesticides directly (such as with a skin application or ear tags) or if they are exposed indirectly (such as through treated animal housing), pesticide residues could also transfer into edible animal commodities. As with crops, Health Canada conducts assessments on edible animal commodities, including a thorough evaluation of health risks that consider the toxicity and dietary exposure of pyridate, and follows strict regulatory standards. The Canadian Food Inspection Agency (CFIA) National Chemical Residue Monitoring Program monitors pesticide residues in fruits and vegetables as well as edible animal commodities like meat, dairy and eggs to make sure they comply with Canadian standards and guidelines.

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 or produced 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 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 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 crop 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 or produced in Canada

Before making any registration decision for a pesticide to be used 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 and revised MRLs to address potential pyridate residues on various food commodities grown or produced in Canada.

Pyridate is a herbicide currently registered for use in Canada on sweet and field corn, chickpeas, lentils, mint, dry peas and canola. Herbicides are chemical substances designed to control or suppress the growth of unwanted vegetation, commonly called weeds.

A proposal was submitted by Belchim Crop Protection Canada Inc. to update the label of the product BCP258H Herbicide (Registration number 34031) by adding a postemergence application option for dry peas while keeping the same maximum of two applications per season. This means that users would be able to apply the product after the growing plant has emerged out of the soil.

A second proposal was submitted by Belchim Crop Protection Canada Inc. to add the new commodity of soybeans to the BCP258H Herbicide label (Registration number 34031).

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 derived from pyridate-treated crops or from animals fed with pyridate-treated feed items 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 pyridate, and follows strict regulatory standards. Further details on the dietary risk assessment can be found in Section 3.0 Dietary risk assessment.

Proposed Canadian maximum residue limits (MRLs) for pyridate

Table 1 summarizes the proposed new and revised MRLs for pyridate, 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. Please note that recently updated residue definitions, including pyridate, will appear in the next version of the searchable residue definition table.

The MRLs presented in Table 1 are based on the following residue definition: O-(6-chloro-3-phenylpyridazin-4-yl) S-octyl carbonothioate and the metabolite 6-chloro-3-phenylpyridazin-4-ol (expressed as parent equivalents).

Table 1 Current and proposed maximum residue limits (MRLs) for pyridate
Food commodity Current MRL
(ppm)Table 1 Footnote 1
Proposed MRL
(ppm)Table 1 Footnote 1
Reason for the proposed MRL
Meat byproducts of cattle, goats, horses and sheep 0.2 0.6 Increased MRL on these animal commodities as a result of new uses on soybeans and dry peas, which can be fed to livestock.
Dry soybeans None 0.05 New MRLs on dry soybeans, because of new data on soybeans.
Pulses, dried shelled peas (crop subgroup 6-21F, except dry lentils) 0.05 (on dry chickpeas, dry field peas, dry pigeon peas) 0.05 Apply current MRL on dry chickpeas, dry field peas and dry pigeon peas to the food commodities without MRLs in crop subgroup 6-21F (pulses, dried shelled peas, except dry lentils), because of new data on peas.

Based on the results from the dietary risk assessment, Health Canada is proposing to accept the new and revised MRL requests for pyridate. This is because these 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:

  1. Evaluate the relevant scientific data and information and then identify the toxicology hazards of the pesticide;
  2. 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 subpopulations 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), drinking water (where applicable), and how diets can vary between people in Canada. The PDI is the potential dietary exposure to a specific pesticide.

  4. 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 pyridate

This summary focuses on key aspects of the dietary risk assessment that are potentially of greatest interest to people in Canada. It is intended to help improve the understanding of Health Canada's pesticide decisions. Technical details and how to request additional information about the dietary risk assessment can be found in Section 7.0 How to get involved and in Appendix I.

The results from the dietary risk assessment show that when pyridate is used according to the Canadian label directions for the various proposed uses, the dietary risks from pyridate on food commodities continue to meet Health Canada's requirements for the protection of human health. The toxicology information for pyridate relevant to the dietary risk assessment is reported in Appendix I, Table A1-1.

The acute dietary risk assessment results showed that exposure to pyridate is less than 21% of the ARfD. This means that acute exposure to pyridate will not affect your health. The dietary risk for the relevant subpopulation that may be more susceptible to potential acute effects of pyridate is reported in Appendix I, Table A1-2.

The chronic dietary risk assessment results showed that exposure to pyridate is less than 43% of the ADI. This means that chronic exposure to pyridate will not affect your health. The dietary risk for each subpopulation is reported in Appendix I, Table A1-3.

For more information on how Health Canada assesses and manages risk from pesticides, refer to this guidance document:

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 from field trial studies for pyridate on dry peas and soybeans that were submitted to support the proposed MRLs on the following commodities: pulses, dried shelled peas (crop subgroup 6-21F, except dry lentils), and dry soybeans. Health Canada scientists also reassessed previously reviewed residue data from field trial studies for pyridate on dry field peas and dry chickpeas to support the proposed label changes, as well as the new and revised MRLs on the proposed crop and edible animal commodities.

Table 2 summarizes the crop residue data used to calculate the proposed MRLs for the various commodities.

Table 2 Summary of field trial data used to support the maximum residue limits (MRLs)
Commodity Application method Total application rate
(g 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)Table 2 Footnote 2
Dry field peas Broadcast foliar 900 58–85 <0.05 <0.05 Not applicable 0.05 (Pulses, dried shelled peas, crop subgroup 6-21F, except dry lentils)
Dry chickpeas Broadcast foliar 900Table 2 Footnote 3 60–64 <0.05 0.04Table 2 Footnote 3 Not applicable 0.05 (Pulses, dried shelled peas (crop subgroup 6-21F, except dry lentils)
Dry peas Broadcast foliar 602–612 53–61 <0.05 <0.05 Not applicable 0.05 (Pulses, dried shelled peas (crop subgroup 6-21F, except dry lentils)
Dry soybeans Broadcast foliar 520–536 80–124 <0.05 <0.05 No quantifiable residues observed at proposed label rates 0.05 (dry soybeans)

5.0 Calculating the proposed maximum residue limits (MRLs)

Health Canada scientists calculated the proposed MRLs for pyridate on crops using the residues observed in the crop residue trials, and the guidance provided in the OECD MRL Calculator. Many international regulatory authorities use this statistical calculator to set MRLs on crops 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.

To calculate the proposed MRLs for pyridate in edible animal commodities, Health Canada scientists followed a 2-step process:

  1. Determine the animal dietary burden for each livestock category, such as dairy or beef cattle, poultry and swine.

    Animal dietary burden: An estimate of an animal's total exposure to a pesticide through eating treated feed items in their diet. This estimate is based on the daily intake ratios for the animal and the pesticide residue levels observed in feed items from crop residue trials and processing studies. The feed items considered are from a Canadian-specific list based on the OECD Harmonized Feedstuff Table.

  2. Calculate the anticipated residue levels for each livestock category. When rounded up, these values result in the proposed MRLs.

    Anticipated residue levels: The amounts of pesticide residues that people could be exposed to by eating food commodities derived from pyridate-treated animals or from animals fed with pyridate-treated feed items. This is calculated by combining the animal dietary burden with information from livestock feeding studies and animal metabolism studies.

    Livestock feeding studies: Measure pesticide residue levels in meat, meat byproducts, milk and eggs resulting from the animal eating treated feed items or from treating the animal directly (such as with a skin application or ear tags).

    Metabolism studies: Analyse how a pesticide is processed by an animal's body and identifies any metabolites or new chemicals that are formed as the pesticide is broken down.

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. MRLs may vary from one country to another for several reasons, including differences in pesticide use patterns and the geographic location of the residue trials. For edible animal commodities, differences in MRLs can also be due to different animal diets and feeding practices.

Table 3 compares the MRLs proposed for pyridate in Canada with the corresponding tolerance 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.

U.S. tolerances are listed by pesticide in the Electronic Code of Federal Regulations, 40 CFR Part 180. The term "tolerance" is used in the U.S. as another name for MRLs.

The Codex MRLs are listed by pesticide or commodity on the Codex Alimentarius Pesticide Index webpage.

Currently for pyridate, there is a U.S. tolerance of 0.1 ppm listed in or on chickpea seeds, but there are none listed in or on other commodities of the pulses, dried shelled pea subgroup (6-21F, except lentils), dry soybeans or meat byproducts. There are also no Codex MRLs listed for pyridate in or on any of the proposed commodities.

Table 3 Comparison of proposed Canadian maximum residue limits (MRLs), U.S. tolerances and Codex MRLs
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
Meat byproducts of cattle, goats, horses and sheep 0.6 Not Established Not established
Pulses, dried shelled peas (crop subgroup 6-21F, except dry lentils) 0.05 0.1 (chickpea, seed) Not established
Dry soybeans 0.05 Not Established Not established

International consultation on the proposed new and revised MRLs also occurs as a result of Canada notifying the World Trade Organization. This is coordinated by Canada's Notification Authority and Enquiry Point in order to comply with Canada's international trade obligations.

7.0 How to get involved

Health Canada invites the public to submit written comments on the proposed MRL changes (including new and revised MRLs) for pyridate up to 75 days from the date of publication of this document

Submit your comments to the PMRA Publications Section

Health Canada considers all comments received up to 75 days from the date of publication of this document (by 1 December 2024) 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:

Appendix I Excerpt of the dietary risk assessment

Table A1-1 Summary of toxicology information for pyridate for use in the dietary exposure assessment
Exposure scenario Toxicology reference value used in risk assessment Study Toxicological endpointTable a1-1 Footnote 1

Acute Dietary

General population

90-day oral (capsule) study in dogs Based on neurotoxic clinical signs (effects on the nervous system) following 1–2 doses at the LOAEL of 120 mg/kg bw/day (1.5-fold greater dose than the NOAEL)

Chronic Dietary

General population

3-generation dietary reproductive toxicity study in rats Based on decreased body weight in parental animals and offspring at the LOAEL of 110 mg/kg bw/day (5.8-fold greater dose than the NOAEL)

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 for pesticides 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

Table A1-2 shows that the PDI is less than 100% of the ARfD (see Section 3.0); therefore, there are no acute 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 A1-2 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, females 13–49 years old, and adults 50+ years old. When including the use of pyridate on various food commodities and drinking water, the estimated dietary exposure to pyridate for all population subgroups is less than 21% of the ARfD. This means that potential acute exposure to pyridate will not affect your health.

Table A1-2 Summary of acute dietary risk for pyridate
Population Subgroup Intermediate assessment food and drinking waterTable a1-2 Footnote 1,Table a1-2 Footnote 2, Table a1-2 Footnote 3,Table a1-2 Footnote 4 – previous assessment Intermediate assessment food and drinking waterTable a1-2 Footnote 1,Table a1-2 Footnote 2, Table a1-2 Footnote 3,Table a1-2 Footnote 4 – updated to include the proposed MRLs
(% ARfD) (% ARfD)
General Population 6.0 6.0
All Infants 20.1 20.2
Children 1–2 years old 9.2 9.2
Children 3–5 years old 7.1 7.1
Children 6–12 years old 5.5 5.5
Youth 13–19 years old 5.0 5.0
Adults 20–49 years old 5.8 5.8
Females 13–49 years old 5.8 5.9
Adults 50+ years old 5.1 5.1

Bolded values indicate updated risk assessments.

Results of the chronic dietary risk assessment

Table A1-3 shows that the PDI is less than 100% of 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, females 13–49 years old, and adults 50+ years old. When including the use of pyridate on the various food commodities and drinking water, the estimated dietary exposure to pyridate for all population subgroups is less than 43% of the ADI. This means that potential chronic exposure to pyridate will not affect your health.

Table A1-3 Summary of chronic dietary risk for pyridate
Population Subgroup Intermediate assessment food and drinking waterTable a1-3 Footnote 1,Table a1-3 Footnote 2, Table a1-3 Footnote 3,Table a1-3 Footnote 4 – previous assessment Intermediate assessment food and drinking waterTable a1-3 Footnote 1,Table a1-3 Footnote 2, Table a1-3 Footnote 3,Table a1-3 Footnote 4 – updated to include the proposed MRLs
(% ADI) (% ADI)
General Population 11.9 11.9
All Infants 42.5 42.5
Children 1–2 years old 19.5 19.6
Children 3–5 years old 15.0 15.0
Children 6–12 years old 10.7 10.7
Youth 13–19 years old 8.6 8.6
Adults 20–49 years old 11.5 11.5
Females 13–49 years old 11.3 11.3
Adults 50+ years old 11.1 11.2

Bolded values indicate updated risk assessments.

For more information

PRD2021-04, Pyridate – available through this publication request page.

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2024-12-05