Proposed Maximum Residue Limit PMRL2023-23, Pydiflumetofen
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Pest Management Regulatory Agency
18 April 2023
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2023-23E-PDF (PDF version)
Purpose of consultation
Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing acceptability of the requested application to add the new commodities of caneberries (crop subgroup 13-07A) to the product label of A20650 Fungicide containing technical grade pydiflumetofen and fludioxonil, to control Botrytis fruit rot. The specific uses approved in Canada are detailed on this product label, Pest Control Products Act Registration Number 33021.
The evaluation of this pydiflumetofen and fludioxonil application indicated that the end-use product has value, and the human health and environmental risks associated with the new uses are acceptable. Dietary risks from the consumption of foods listed in Table 1 were shown to be acceptable when pydiflumetofen is used according to the supported label directions. Therefore, foods containing residues resulting from this use are safe to eat, and an MRL is being proposed as a result of this assessment. A summary of the field trial data used to support the proposed MRL 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 MRL for pydiflumetofen is being conducted via this document. The currently established MRL of 7.0 ppm for fludioxonil in/on caneberries (crop subgroup 13-07A) is sufficient to cover residues resulting from this new use and is therefore unaffected by this MRL action. Health Canada invites the public to submit written comments on the proposed MRL for pydiflumetofen in accordance with the process outlined in the Next steps Section of this document.
To comply with Canada's international trade obligations, consultation on the proposed MRL is also being conducted internationally by notifying the World Trade Organization, as coordinated by the Canada's Notification Authority and Enquiry Point.
The proposed MRL, to be added to the MRLs already established for pydiflumetofen, is summarized in Table 1.
|Common name||Residue definition||MRL (ppm)Footnote 1||Food commodity|
|Pydiflumetofen||3-(difluoromethyl)-N-methoxy-1-methyl-N-[1-methyl-2-(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide||5.0||Caneberries (crop subgroup 13-07A)|
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
The MRL proposed for pydiflumetofen in Canada is the same as corresponding American tolerance as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLsFootnote 2 listed for pydiflumetofen in or on the petitioned commodities on the Codex Alimentarius Pesticide Index webpage.
Health Canada invites the public to submit written comments on the proposed MRL for pydiflumetofen up to 75 days from the date of publication of this document. 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 MRL. Comments received will be addressed in a separate document linked to this PMRL. The established MRL will be legally in effect as of the date that it is entered into the Maximum Residue Limit Database.
Summary of field trial data used to support the proposed maximum residue limit
Residue data for pydiflumetofen were submitted to support the use of A20560 Fungicide on caneberries (crop subgroup 13-07A).
Dietary risk assessment results
Acute dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 12% of the acute reference dose, and therefore there are no health concerns.
Chronic (non-cancer and cancer) dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 48% of the acceptable daily intake, and therefore there are no health concerns.
Maximum residue limit
The recommendation for the maximum residue limit (MRL) for pydiflumetofen was based upon the submitted field trial data, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data used to calculate the proposed MRL for caneberries (crop subgroup 13-07A).
|Commodity||Application method/Total application rate
(g a.i./ha)Footnote 1
|Preharvest interval (days)||Lowest average field trial residues
|Highest average field trial residues
Following the review of all available data, the MRL proposed in Table 1 is recommended to cover residues of pydiflumetofen. Dietary risks from exposure to residues of pydiflumetofen in these crop commodities at the proposed MRL were shown to be acceptable for the general population and all subpopulations, including infants, children, adults and seniors. Thus the foods that contain residues as listed in Table 1 are considered safe to eat.
|3227380||2021, Pydiflumetofen (FTH545): Magnitude of the residue on Caneberry, DACO: 7.4.1,7.4.2|
- 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
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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