Proposed Maximum Residue Limit PMRL2016-28, Tebuconazole

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Pest Management Regulatory Agency
30 May 2016
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2016-28E-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 limit (MRLs) for tebuconazole on imported oranges from Spain (Crop Subgroup 10A - revised) and citrus oil to permit the import and sale of foods containing such residues.

Tebuconazole is a fungicide currently registered in Canada for use on wheat, barley, oats, corn, nuts, cucurbits, and soybeans.

The PMRA must determine the quantity of residues that are likely to remain in or on the imported food commodities when tebuconazole 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 MRLs for tebuconazole 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 MRLs can be found in Appendix I.

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 Canada's Notification Authority and Enquiry Point.

The proposed MRLs, to be added to the MRLs already established for tebuconazole, are as follows.

Table 1 Proposed Maximum Residue Limits for Tebuconazole
Common Name Residue Definition MRL
(ppm)Table 1 footnote 1
Food Commodity
Tebuconazole a-[2-(4-chlorophenyl)ethyl]-a-(1,1-dimethylethyl)-1H-1,2,4-triazole-1-ethanol 10 Citrus oil
1.0 Oranges (Crop Subgroup 10A revised)
Table 1 Footnote 1

ppm = parts per million

Return to Table 1 footnote 1 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 tebuconazole in Canada are the same as corresponding American tolerances as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLsFootnote 1 listed for tebuconazole in or on orange commodities on the Codex Alimentarius Pesticide Residues in Food webpage.

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for tebuconazole 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

Residue data for tebuconazole in oranges and mandarins were submitted to support the maximum residue limits on imported oranges (Crop Subgroup 10A revised). In addition, processing studies in treated oranges were reviewed to determine the potential for concentration of residues of tebuconazole into processed commodities.

Maximum Residue Limits

The recommendation for maximum residue limits (MRLs) for tebuconazole 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 oranges (Crop Subgroup 10A revised) and citrus oil.

Following the review of all available data, MRLs as proposed in Table 1 are recommended to

Table A1 Summary of Field Trial and Processing Data Used to Support MRLs
Commodity Application Method/ Total Application Rate
(g a.i./ha)Table A1 footnote 1
Preharvest Interval (days) Lowest Average Field Trial Residues
(ppm)
Highest Average Field Trial Residues
(ppm)
Experimental Processing Factor
Mandarins 240 0 0.38 0.48 --
Oranges 0.20 0.28 24.5
(orange oil)
Table A1 Footnote 1

ppm = parts per million

Return to Table A1 footnote 1 referrer

cover residues of tebuconazole. Residues of tebuconazole 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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