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Proposed Maximum Residue Limit PMRL2024-23, Spinosad

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Pest Management Regulatory Agency
7 November 2024
ISSN: 1925-0843
Catalogue number: H113-24/2024-23E-PDF (PDF version, 238 KB)

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 and livestock. Pesticides 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). This includes regulating pesticide residues that may be present on food commodities 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.

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 a proposed MRL increase to address potential spinosad residues on cranberries grown in Canada.

Spinosad is an insecticide currently registered for use in Canada on various fruit and vegetable commodities.

A proposal was submitted by the Agriculture and Agri-Food Canada/Pest Management Centre, and supported by the registrant Corteva AgriScience Canada Company to register the post-emergent foliar use of spinosad on low growing berries (crop subgroup 13-07G) on the Success Insecticide and Entrust 80 Insecticide labels ( Pest Control Products Act Registration Numbers 26835 and 27825, respectively). This MRL increase would allow treated cranberries to be sold in Canada. The MRL for strawberries was established under EMRL2008-02. The MRLs for the remaining commodities included in this crop subgroup were established under PMRL2015-49, with the exception of cranberries which were not specified at that time.

Health Canada is proposing to accept this MRL increase. This is because Health Canada has conducted a thorough scientific assessment and found that the health risk from eating food commodities treated with spinosad 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 spinosad, 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 limit (MRL) for spinosad

Table 1 summarizes the revised MRL proposed for spinosad, and the reason for the 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 MRL is based on the following residue definition:

Spinosyn A : (2 R,3a S,5a R,5b S,9 S,13 S,14 R,16a S,16b R)-2-[(6-deoxy-2,3,4-tri- O -methyl-α-L-mannopyranosyl)oxy]-13-[[(2 R,5 S,6 R)-5-(dimethylamino)tetrahydro-6-methyl-2 H -pyran-2-yl]oxy-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14,16a,16b-tetradecahydro-14-methyl-1 H - as -indaceno[3,2- d ]oxacyclododecin-7,15-dione

And

Spinosyn D : (2 S,3a R,5a S,5b S,9 S,13 S,14 R,16a S,16b S)-2-[(6-deoxy-2,3,4-tri- O -methyl-α-L-mannopyranosyl)oxy]-13-[[(2 R,5 S,6 R)-5-(dimethylamino)tetrahydro-6-methyl-2 H -pyran-2-yl]oxy-9-ethyl-2,3,3a,5a,5b,6,9,10,11,12,13,14, 16a,16b-tetradecahydro-4,14-dimethyl-1 H - as -indaceno[3,2- d ]oxacyclododecin-7,15-dione

Table 1: Current and proposed maximum residue limit (MRL) for spinosad
Food commodity Current MRL (ppm) Table 1 footnote 1 Proposed MRL (ppm) Table 1 footnote 1 Reason for the proposed MRL
Cranberries 0.01 0.7 Increased MRL on cranberries, based on re-assessed field trial data on strawberries to address a proposed preharvest interval that is shorter than what was previously registered.
Table 1 footnote 1

ppm = parts per million

Return to table 1 footnote 1

Based on the results from the dietary risk assessment, Health Canada is proposing to accept the revised MRL request for spinosad. This is because this revised MRL meets 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 spinosad

This summary focusses 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 on How to get involved and in Appendix I.

The results from the dietary risk assessment show that when spinosad is used according to the Canadian label directions for the use on cranberries, the dietary risks from spinosad on food commodities continue to meet Health Canada's requirements for the protection of human health.

There were no acute health effects observed in the spinosad toxicology data and an ARfD was not necessary. This means that acute exposure to spinosad will not affect your health. The toxicology information for spinosad relevant to the dietary risk assessment is reported in Appendix I, Table A1-1.

The chronic dietary risk assessment results showed that exposure to spinosad is less than 77% of the ADI. This means that chronic exposure to spinosad will not affect your health. The dietary risk for each subpopulation is reported in Appendix I, Table A1-2.

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 MRL

Health Canada scientists reassessed previously reviewed residue data from field trials conducted on strawberries, as strawberry is the representative commodity for crop subgroup 13-07G (low growing berries) which includes cranberries.

Table 2 summarizes the residue data used to calculate the proposed MRL for cranberries.

Table 2: Summary of field trial data used to support the maximum residue limit (MRL)
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)
Strawberries Foliar application 397–507 1 0.04 0.51 Not applicable 0.7 (cranberries)
Table 2 footnote 1

g a.i./ha = grams of active ingredient per hectare

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Table 2 footnote 2

ppm = parts per million

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5.0 Calculating the proposed MRL

Health Canada scientists determined the proposed MRL for spinosad on cranberries using the residues observed in the field trials for strawberries. The MRL for strawberries was extended to all commodities under crop subgroup 13-07G (low growing berries), which includes cranberries.

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. Canadian MRLs are established or amended based on a robust scientific risk assessment that demonstrates safety for people in Canada. Table 3 compares the MRL proposed for spinosad on cranberries in Canada with the corresponding tolerance in the United States (U.S.) and international Codex MRL. The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.

The MRL proposed for spinosad in Canada is different than the corresponding U.S. tolerance and international Codex MRL. MRLs may vary from one country to another for a number of reasons, including differences in pesticide use patterns and the geographic locations of the crop field trials used to generate residue chemistry data.

Table 3: Comparison of the proposed Canadian MRL, U.S. tolerance and Codex MRL
Food commodity Proposed Canadian MRL (ppm) Table 3 footnote 1 Established U.S. tolerance (ppm) Table 3 footnote 1Table 3 footnote 2 Established Codex MRL (ppm) Table 3 footnote 1Table 3 footnote 2
Cranberries 0.7 0.04
(Berry, low growing, except strawberry, subgroup 13-07H)		 0.02
Table 3 footnote 1

ppm = parts per million

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Table 3 footnote 2

The established U.S. tolerance and Codex MRL are based on cranberry data at a preharvest interval (PHI) of 21 days, while the proposed Canadian MRL is based on strawberry data at a 1-day PHI. It is noted that there is a U.S. tolerance on strawberries (as part of crop subgroup 13-07G (berry, low growing, except cranberry)) at 0.9 ppm, based on strawberry data at a 1 day PHI.

Return to table 3 footnote 2

International consultation on the proposed MRL 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 revised MRL for spinosad 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 21 January 2025) before making a final science-based decision about the proposed MRL. 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 MRL, the MRL will be set and legally in effect on the date it is entered into the Maximum Residue Limit Database.

If you would like to request additional information on the supporting scientific documents for this proposed MRL, here is the information you will need to help identify the request:

Appendix I Excerpt of the dietary risk assessment

Table A1-1: Summary of toxicology information for spinosad for use in the dietary exposure assessment
Exposure scenario Toxicology reference value used in risk assessment Study Toxicological endpoint
Acute Dietary
All populations		 No ARfDTable A1-1 footnote 1 required Not applicable None
Chronic Dietary
All populations		 NOAELTable A1-1 footnote 1 = 2.7 mg/kg bw
CAFTable A1-1 footnote 1 = 300Table A1-1 footnote 2
ADITable A1-1 footnote 1 = 0.009 mg/kg bw		 1-year dog chronic dietary study LOAELTable A1-1 footnote 1 = 8.2 mg/kg bw/day
based on vacuolation in the parathyroid cell vacuolation and lymphoid tissues, increased thyroid weights (females), and increases in serum enzymes alanine aminotransferase and aspartate aminotransferase and triglyceride levels (in other words, threefold greater dose than the NOAEL)
Table A1-1 footnote 1

ARfD = Acute Reference Dose; NOAEL = No Observed Adverse Effect Level; LOAEL = Lowest Observed Adverse Effect Level; CAF = Composite Assessment Factor; ADI = Acceptable Daily Intake; bw = body weight. Reference values and endpoints cited in REG2001-10.

Return to table A1-1 footnote 1

Table A1-1 footnote 2

To account for uncertainties including inter- and intra-species variations, a CAF of 300-fold (10-fold for differences between animals and humans, 10-fold for variation between humans, and a threefold safety factor) was applied to the NOAEL for the above-mentioned toxicological effects to calculate the ADI. Therefore, NOAEL ÷ CAF = 2.7 mg/kg bw ÷ 300 = 0.009 mg/kg bw/day. This is 911-fold (LOAEL ÷ ADI) lower than the dose where toxicological effects were observed in animals (at the LOAEL = 8.2 mg/kg bw/day).

Return to table A1-1 footnote 2

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

An acute dietary exposure assessment was not required as there were no acute health effects of concern observed in the oral toxicity studies relevant to dietary exposure. This means that acute exposure to spinosad will not affect your health.

Results of the chronic dietary risk assessment

Table A1-2 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 A1-2 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 spinosad on cranberries, the estimated dietary exposure to spinosad for all population subgroups is less than 77% of the ADI. This means that chronic exposure to spinosad will not affect your health.

Table A1-2: Summary of chronic dietary risk for spinosad
Population subgroup Refined assessment Food and drinking water Table A1-2 footnote 1Table A1-2 footnote 2 – previous assessment Refined assessment Food and drinking water Table A1-2 footnote 1Table A1-2 footnote 2 – Updated to include the proposed MRL
% ADITable A1-2 footnote 3Table A1-2 footnote 4 % ADITable A1-2 footnote 3Table A1-2 footnote 5
General Population 31.1 31.6
All Infants 41.6 42.2
Children 1–2 years old 75.2 76.7
Children 3–5 years old 56.2 56.9
Children 6–12 years old 32.7 33.2
Youth 13–19 years old 20.6 21.1
Adults 20–49 years old 29.3 29.8
Adults 50+ years old 28.5 29.0
Females 13–49 years old 26.0 26.5

Bolded values indicate updated risk assessments

Table A1-2 footnote 1

"Food and Drinking Water" represents all Canadian-grown and imported foods that could be treated with spinosad, as well as the dietary contribution from consuming water that may be impacted by Canadian agricultural uses of spinosad.

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Table A1-2 footnote 2

"Estimated Environmental Concentrations" (EECs) of spinosad have been calculated for drinking water at 3.05 µg a.i./L from surface water.

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Table A1-2 footnote 3

Values are below 100% (PDI ÷ ADI × 100), therefore, there are no dietary concerns for any segment of the population.

Return to table A1-2 footnote 3

Table A1-2 footnote 4

Previous assessment conducted for submission 2014-1632 / 1633.

Return to table A1-2 footnote 4

Table A1-2 footnote 5

The updated assessment only added the chronic exposure of spinosad from cranberries to the assessment under 2014-1632 / 1633.

Return to table A1-2 footnote 5

For more information

REG2001-10, Spinosad – available through this publication request page.

PMRL2015-49, Spinosad – available through this publication request page.

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