Proposed Maximum Residue Limit PMRL2025-08, Florylpicoxamid
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The online consultation is now closed.
Pest Management Regulatory Agency
17 June 2025
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2025-8E-PDF (PDF version)
Table of Contents
- Purpose of consultation
- Dietary health assessment
- Proposed MRLs
- International situation and trade implications
- How to get involved
- Appendix I
- References
Purpose of consultation
A maximum residue limits (MRLs)Footnote 1 for imported commodities are being proposed for the pesticide florylpicoxamid as part of the following application submitted by Corteva AgriScience Canada Company under submission number 2023-3649, in order to permit the import and sale of food in Canada that could contain florylpicoxamid residues.
Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing acceptability of the request to specify MRLs for florylpicoxamid on the imported commodities of bananas and mangoes to control Black Sigatoka, Pseudocercospora fijiensis.
Florylpicoxamid is a fungicide currently registered in Canada for use on various commodities.
Health Canada has determined the quantity of residues that may remain in or on the imported commodities when florylpicoxamid is used according to the label directions of the exporting country, and that such residues will not be a concern to human health. Therefore, the foods containing residues resulting from this use are safe to eat, and MRLs are being proposed as a result of this assessment. A summary of the field trial data used to support the proposed MRLs can be found in Appendix I.
Dietary health assessment
In assessing the risk of a pesticide, Health Canada combines information on pesticide toxicity with information on the degree and duration of dietary exposure to the pesticide residue from food. The risk assessment process involves four distinct steps:
- Identifying the toxicology hazards posed by the pesticide;
- Determining the "acceptable dietary level" for Canadians (including all vulnerable populations), which is protective of adverse health effects;
- Estimating human dietary exposure to the pesticide from all applicable sources (domestic and imported commodities); and
- Characterizing health risk by comparing the estimated human dietary exposure to the acceptable dietary level.
Before registering a pesticide for food use in Canada, Health Canada must determine the quantity of residues that could remain in or on the food when the pesticide is used according to label directions and that such residues will not be a concern to human health (Steps 3 and 4 above). If estimated human exposure is less than or equal to the acceptable level (developed in Step 2 above), Health Canada concludes that consuming residues resulting from use according to approved label directions is not a health concern. The proposed MRL is then subject to consultation to legally specify it as an MRL.
An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except for certain instances where different MRLs are specified for the raw agricultural commodity and its processed product(s).
Consultation on the proposed MRLs for florylpicoxamid on imported commodities is being conducted via this document. Health Canada invites the public to submit written comments on the proposed MRLs for florylpicoxamid in accordance with the process outlined in the How to get involved section of this document.
To comply with Canada's international trade obligations, consultation on the proposed MRLs is also being conducted internationally by notifying the World Trade Organization, as coordinated by Canada's Notification Authority and Enquiry Point.
Proposed MRLs
The proposed MRLs, to be added to the MRLs already established for florylpicoxamid, are summarized in Table 1.
Common name | Residue definition | MRL (ppm)Footnote 1 | Food commodity |
---|---|---|---|
Florylpicoxamid | (1S)-2,2-bis(4-fluorophenyl)-1-methylethyl N-[[3-(acetyloxy)-4-methoxy-2-pyridinyl]carbonyl]-L-alaninate | 0.5 | Mangoes |
0.4 | Bananas | ||
|
MRLs established in Canada may be found using the Maximum Residue Limit Database on the Maximum Residue Limits for Pesticides webpage. The database allows users to search for established MRLs, regulated under the Pest Control Products Act, both for pesticides or for food commodities.
International situation and trade implications
As reported in Table 2, currently there are no tolerances in the United States (U.S.) for florylpicoxamid in or on the petitioned commodities listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. A listing of established Codex MRLsFootnote 2 is available on the Codex Alimentarius Pesticide Index webpage.
Food Commodity | Proposed Canadian MRL (ppm) | Established U.S. tolerance (ppm) |
Established Codex MRL (ppm) |
---|---|---|---|
Mangoes | 0.5 | Not established | 0.5 |
Bananas | 0.4 | Not established | 0.4 |
How to get involved
Health Canada invites the public to submit written comments on the proposed MRLs for florylpicoxamid up to 75 days from the date of publication of this document (by 31 August 2025). Please forward your comments to Publications. Health Canada will consider all comments received and a science-based approach will be applied in making a final decision on the proposed MRLs. Comments received will be addressed in a response to comments document found in Pesticides and pest management consultations. The established MRLs will be legally in effect as of the date that they are entered into the Maximum Residue Limit Database.
Appendix I
Summary of field trial data used to support the proposed maximum residue limits
Residue data for florylpicoxamid were submitted to support the maximum residue limits on imported bananas and mangoes.
Dietary risk assessment results
Studies in laboratory animals showed no acute health effects relative to dietary exposure. Consequently, a single dose of florylpicoxamid is not likely to cause acute health effects in the general population (including infants and children).
Chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 77% of the acceptable daily intake, and therefore there are no health concerns.
Maximum residue limits
The recommendation for maximum residue limits (MRLs) for florylpicoxamid on imported commodities was based upon the residues observed in crop commodities treated according to label directions in the exporting country, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data for florylpicoxamid used to calculate the proposed MRLs for imported bananas and mangoes.
Commodity | Application method/Total application rate (g a.i./ha)Footnote 1 |
Preharvest interval (days) | Lowest average field trial residues (ppm) |
Highest average field trial residues (ppm) |
---|---|---|---|---|
Bananas | Foliar/155–170 | 0 | <0.010 | 0.032 |
Mangoes | Foliar/465–485 | 7 | <0.010 | 0.320 |
|
Following the review of all available data, the MRLs proposed in Table 1 are recommended, in order to cover residues of florylpicoxamid. Dietary risks from exposure to residues of florylpicoxamid in these imported crop commodities at the proposed MRLs were shown to be acceptable for the general population and all subpopulations, including infants, children, adults and seniors. Thus, the imported foods that contain residues as listed in Table 1 are considered safe to eat.
References
PMRA Number | Reference |
---|---|
3489619 | 2022, 7.4.1_GF-4536 MOR of Florylpicoxamid (Adavelt) and its Metabolites in Banana Fruits, DACO: 7.4.1 |
3489620 | 2022, 7.4.1_GF-4536 MOR of Florylpicoxamid (Adavelt) and its Metabolites in Mango Fruits, DACO: 7.4.1 |
Footnotes
- Footnote 1
-
A maximum residue limit (MRL) is the maximum amount of residue that may remain in or on food when a pesticide is used according to label directions.
- Footnote 2
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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.
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