Proposed Maximum Residue Limit PMRL2015-16, Spiroxamine


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Pest Management Regulatory Agency
8 May 2015
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2015-16E-PDF (PDF version)

Under the authority of the  Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has received applications to register technical grade spiroxamine and the end-use product Impulse 500 EC Fungicide for use in Canada on grapes.

The evaluation of these spiroxamine applications indicated that the end-use product has merit and value, and the human health and environmental risks associated with their proposed uses are acceptable. Details regarding these applications can be found in Proposed Registration Decision PRD2015-14, Spiroxamine, posted to the Health Canada website on 8 May 2015.

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 specified 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.

In addition, the PMRA is proposing to specify an MRL for spiroxamine on bananas to permit the import and sale of food containing such residues. The PMRA has determined the quantity of residues that are likely to remain in or on the imported commodities when spiroxamine is used according to label directions in the exporting country, and that such residues will not be a concern to human health. Details regarding the proposed MRLs on imported commodities can also be found in PRD2015-14.

Consultation on the proposed MRLs for spiroxamine is being conducted via PRD2015-14. Information regarding the proposed MRLs can be found in Sections 3.5 and 7.1. Supporting field trial residue data are provided in Appendix I, Table 6. The PMRA invites the public to submit written comments on the proposed MRLs for spiroxamine in accordance with the guidance found in PRD2015-14.

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 for spiroxamine are as follows.

Table 1 Proposed Maximum Residue Limits for Spiroxamine
Common Name Residue Definition MRL
(ppm)Table 1 footnote 1
Food Commodity

Table 1 footnotes

Table Figure 3 - Footnote 1

Specimens from NT, YT, and NU are sent to reference laboratories in other provinces.

Return to Table Figure 3 - Footnote 1 referrer

Spiroxamine 8-(1,1-dimethylethyl)-N-ethyl-N-propyl-1,4-dioxaspiro[4,5]decane-2-methanamine, including metabolites containing the N-ethyl-N-propyl-1,2-dihydroxy-3-aminopropane moiety, expressed as parent equivalents 4.0 Raisins
3.0 Bananas
2.0 Grapes

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

MRLs may vary from one country to another for a number of reasons, including differences in pesticide use patterns and the locations of the crop field trials used to generate residue chemistry data. For livestock commodities, differences in MRLs can also be due to different livestock feed items and practices.

Table 2 compares the MRLs proposed for spiroxamine in Canada with corresponding American tolerances. There are no established Codex MRLsFootnote 1 for the proposed commodities. 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 Residues in Food website, by pesticide or commodity.

Table 2 Comparison of Canadian MRLs, American Tolerances and Codex MRLs (Where Different)
Food Commodity Canadian MRL (ppm) American Tolerance (ppm)
Raisins 4.0 Not established
Bananas 3.0 3.0
Grapes 2.0 1.0

Next Steps

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

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