Proposed Maximum Residue Limit PMRL2016-08, Fludioxonil

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Pest Management Regulatory Agency
29 March 2016
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2016-8E-PDF (PDF version)

Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing to establish maximum residue limits (MRLs )for fludioxonil on leaf petioles (CSG 4B), pomegranates, black sapotes, canistels, papayas and star apples to permit the import and sale of foods containing such residues.

Fludioxonil is a fungicide currently registered in Canada for use on various commodities.

The PMRA must determine the quantity of residues that are likely to remain in or on the imported food commodities when fludioxonil is used according to label directions in the exporting country, and that such residues will not be a concern to human health. This quantity is then legally established as an MRL on the corresponding imported commodity. 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 MRL for fludioxonil is being conducted via this document (see Next Steps, the last section of this document). A summary of the field trial data used to support the proposed MRL can be found in Appendix I.

To comply with Canada's international trade obligations, consultation on the proposed MRLs are also being conducted internationally by notifying the World Trade Organization, as coordinated by Canada's Notification Authority and Enquiry Point.

The proposed MRLs, to be added to the MRLs already established for fludioxonil, is as follows.

Table 1 - Proposed Maximum Residue Limits for Fludioxonil
Common Name Residue Definition MRL (ppm)Table 1 footnote 1 Food Commodity
fludioxonil 4-(2,2-difluoro-1,3-benzodioxol-4-yl)-1H-pyrrole-3-carbonitrile 15Table 1 footnote 2 Leaf petioles (Crop Subgroup 4B)
5.0Table 1 footnote 3 Pomegranates, black sapotes, canistels, papayas, star apples
Table 1 footnote 1

ppm = parts per million

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Table 1 footnote 2

This proposed MRL will replace the currently established MRL of 0.01 ppm on CSG 4B

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Table 1 footnote 3

This proposed MRL will replace the currently established MRL of 1.7 ppm on pomegranates, and of 0.45 ppm

Return to table 1 footnote 3 referrer

MRLs are proposed for each commodity included in the listed crop groupings in accordance with the Residue Chemistry Crop Groups webpage in the Pesticides and Pest Management section of Health Canada's website.

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 MRLs proposed for fludioxonil in Canada are the same as corresponding tolerances in the United States, in accordance with American tolerances listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide.

Table 2 compares the MRLs proposed for fludioxonil in Canada with corresponding Codex MRLFootnote1listed on the Codex Alimentarius Pesticide Residues in Food webpage. Currently there are no Codex MRLs listed for fludioxonil in or on celery or other leaf petiole commodities, black sapotes, canistels, papayas and star apples.

Table 2 Comparison of Canadian MRLs and Codex MRLs (where different)
Food Commodity Canadian MRL (ppm) Codex MRL (ppm)
Pomegranates 5.0 2.0

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for fludioxonil 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 it is 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 fludioxonil in celery and pomegranate were submitted to support the maximum residue limits on imported leaf petioles (CSG 4B), pomegranates, black sapotes, canistels, papayas, and star apples.

Maximum Residue Limits

The recommendation for maximum residue limits (MRLs) for fludioxonil 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 used to calculate the proposed MRLs for imported leaf petioles (CSG 4B), pomegranates, black sapotes, canistels, papayas, and star apples.

Table A1 Summary of Field Trial and Processing Data Used to Support MRLs
Commodity Application Method/Total Application Rate Preharvest Interval (days) Lowest Average Field Trial Residues (ppm) Highest Average Field Trial Residues (ppm) Experimental Processing Factor
Celery Broadcast foliar; 1.00 kg ai/haTable 3 footnote 1 0 2.0 8.5 None
Pomegranates 74 g ai/100 LTable 3 footnote 2 (double dip) 0 1.3 2.0 None
Table A1 footnote 1

kg a.i./ha = kilograms of fludioxonil ingredient per hectare

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Table A1 footnote 2

g ai/100 L = grams of fludioxonil per 100 L of water.

Return to table A1 footnote 2 referrer

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

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