Proposed Maximum Residue Limit PMRL2013-09, Tembotrione

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Pest Management Regulatory Agency
21 March 2013
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2013-9E-PDF (PDF version)

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Under the authority of the  Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has granted conditional registration to technical grade tembotrione and the end-use product VIOS G3 Suspension Herbicide, containing technical grade tembotrione and thiencarbazone-methyl, for use in Canada on field corn. The specific uses approved in Canada are detailed on the product label of VIOS G3, Pest Control Products Act Registration Number 29643.

The evaluation of this application indicated that the end-use product has merit and value and the human health and environmental risks associated with the new uses are acceptable. Details regarding these registrations can be found in Evaluation Report ERC2012-02, Tembotrione , posted to the Health Canada website on 2 October 2012.

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 when separate MRLs are specified for the raw agricultural commodity and a processed product made from it.

Consultation on the proposed livestock MRLs for tembotrione is being conducted via this document (see Next Steps). Note that MRLs for tembotrione in or on corn (field, pop and sweet) are to be proposed under a separate MRL action. Corresponding corn and livestock MRLs for thiencarbazone-methyl are currently established.

ERC2012-02 includes information regarding the livestock MRLs for tembotrione in Sections 3.5.4 and 7.1. Appendix II addresses the international situation and trade implications. Supporting field trial residue data are provided in Appendix I, Table 8 of the Evaluation Report.

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  Standards Council of Canada.

The proposed MRLs for tembotrione in Canada in or on food are as follows.

Table 1 - Proposed Maximum Residue Limits for Tembotrione

Common Name	Residue Definition	MRL (Table 1 footnote ppm)	Food Commodity
Table 1 footnotes Table 1 footnote 1 = parts per million Return to table 1 footnote ppm referrer
Tembotrione	2-[2-chloro-4-(methylsulfonyl)-3-[(2,2,2-trifluoroethoxy)methyl] benzoyl]-1,3-cyclohexanedione, including the metabolite 2-[2-chloro-4-(methylsulfonyl)-3-[2,2,2-trifluoroethoxy)methyl]benzoyl]-4,6-dihydroxycyclohexane-1,3-dione	0.4	Liver of cattle, goats, horses and sheep
		0.07	Liver of poultry; meat byproducts (except liver) of cattle, goats, horses and sheep
		0.02	Eggs; fat and meat of cattle, goats, hogs, horses, poultry and sheep; meat byproducts of hogs; meat byproducts (except liver) of poultry; milk

Pesticide MRLs established in Canada may be accessed using the  Maximum Residue Limit Database, accessible via the Maximum Residue Limits for Pesticides webpage in the Pesticides and Pest Management section of Health Canada's website, and searchable by pesticide or commodity.

International Situation and Trade Implications

Table 2 compares the MRLs proposed for tembotrione in Canada with corresponding American tolerances as listed in the  Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLs^{Footnote 1} listed for tembotrione in or on any commodity on the Codex Alimentarius  Pesticide Residues in Food webpage.

Table 2 - Comparison of Canadian MRLs and American Tolerances

Food Commodity	Canadian MRL (ppm)	American Tolerance (ppm)
Liver of cattle, goats, horses and sheep	0.4	0.4
Meat byproducts (except liver) of cattle, goats, horses and sheep	0.07	0.07
Liver of poultry	0.07	0.07
Fat and meat of cattle, goats, hogs, horses, poultry and sheep	0.02	Not established
Meat byproducts of hogs	0.02	Not established
Meat byproducts (except liver) of poultry	0.02	Not established
Eggs, milk	0.02	Not established

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for tembotrione 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 MRLs will take legal effect as of the date posted to the  Maximum Residue Limit Database in the Pesticides and Pest Management section of Health Canada's website.