Proposed Maximum Residue Limit PMRL2019-14, Fluxapyroxad

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Pest Management Regulatory Agency
23 August 2019
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2019-14E-PDF (PDF format 176 KB, 5 pages)

Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has concluded that the addition of the new use on annual canarygrass for human consumption to the product label, Insure Cereal FX4, containing technical grade pyraclostrobin, fluxapyroxad, triticonazole and metalaxyl, is acceptable. The specific uses approved in Canada are detailed on the label of Insure Cereal FX4, Pest Control Products Act Registration Number 33210.

The evaluation of this fluxapyroxad application indicated that the end-use product has value and the human health and environmental risks associated with the new use are acceptable. A revision to the MRL for rice bran is also proposed under this PMRL.

Before registering a pesticide for food use in Canada, the PMRA must determine the quantity of residues that are likely to 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. This quantity is then legally established as a maximum residue limit (MRL). An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except where separate MRLs are specified for the raw agricultural commodity and a processed product made from it.

Consultation on the proposed MRLs for fluxapyroxad is being conducted via this document (see Next Steps). MRL consultation for the other active ingredients, pyraclostrobin, triticonazole and metalaxyl, present in Insure Cereal FX4, is being consulted under separate actions. A summary of the field trial data used to support the proposed MRLs can be found in Appendix I.

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 the Canada's Notification Authority and Enquiry Point.

The proposed MRLs, to replace or be added to the MRLs already established for fluxapyroxad, are as follows.

Table 1 Proposed Maximum Residue Limits for Fluxapyroxad
Common Name Residue Definition MRL (ppm)Table 1 footnote 1 Food Commodity
Fluxapyroxad 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluoro[1,1′-biphenyl]-2-yl)-1H-pyrazole-4-carboxamide 8.5Table 1 footnote 2 Rice bran
0.01 Annual canarygrass seeds

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

Table 2 compares the MRLs proposed for fluxapyroxad in Canada with corresponding American tolerances and Codex MRLs.Footnote 1 American tolerances are listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. A listing of established Codex MRLs is available on the Codex Alimentarius Pesticide Index webpage, by pesticide or commodity.

Table 2 Comparison of Canadian MRLs, American Tolerances and Codex MRLs (where different)
Food Commodity Canadian MRL
American Tolerance
Codex MRL
Rice bran 8.5 8.5 Not Established
Annual canarygrass seeds 0.01 Not Established Not Established

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for fluxapyroxad up to 75 days from the date of publication of this document. Please forward your comments to Publications. The PMRA will consider all comments received before making a final decision on the proposed MRLs. Comments received will be addressed in a separate document linked to this PMRL. 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

Previously reviewed residue data from field trials conducted in/on wheat and barley (translated to annual canarygrass) were reassessed in the framework of this petition. In addition, processing studies in treated barley and rice were also reassessed to determine the potential for concentration of residues of fluxapyroxad into processed commodities.

Maximum Residue Limits

The recommendation for maximum residue limits (MRLs) for fluxapyroxad was based upon the previously reviewed field trial data, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data used to calculate the proposed MRLs for annual canarygrass seeds and rice bran.

Table A1 Summary of Field Trial and Processing Data Used to Support the MRLs
Commodity Application Method/ Total Application Rate
(g a.i./ha)Table A1 footnote 1
Preharvest Interval (days) Lowest Average Field Trial Residues
Highest Average Field Trial Residues
Experimental Processing Factor
Barley grain Foliar application / 200 20-27 <0.01 1.2Table A1 footnote 2 Barley flour: 0.2×
Wheat grain 0.09 0.19Table A1 footnote 2
Rice grain Ground spray / 288-309 28-29 0.22 3.84 Rice bran: 2.4×

Following the review of all available data, MRLs as proposed in Table 1 are recommended to cover residues of fluxapyroxad. Residues of fluxapyroxad in these crop commodities at the proposed MRLs will not pose an unacceptable risk to any segment of the population, including infants, children, adults and seniors.


Footnote 1

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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