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Consultation Document on Flucarbazone-sodium - Proposed Maximum Residue Limit - PMRL2008-47

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.

25 November 2008
ISBN: 978-1-100-11020-2 (978-1-100-11021-9)
Cat. No.: H113-24/2008-47E (H113-24/2008-47E-PDF)

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Under the authority of the Next link will take you to another Web site Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has received applications to convert the conditional registrations of Everest Technical Herbicide and the end-use products Everest 70 WDG Herbicide and Everest Solupak 70 DF, all containing technical grade flucarbazone-sodium, to full registrations. The specific uses on wheat approved in Canada are detailed on the product labels of Everest 70 WDG Herbicide and Everest Solupak 70DF, Pest Control Products Act Registration Numbers 26447 and 26448, respectively.

The evaluation of these flucarbazone-sodium applications indicated that the end-use products have merit and value and that the human health and environmental risks associated with the products are acceptable. Details regarding these applications can be found in Proposed Registration Decision PRD2008-13, Flucarbazone-sodium.

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.

A Canadian MRL of 0.01 ppm has been established for flucarbazone-sodium on wheat but MRLs for livestock commodities were not previously established (see Regulatory Note REG2000-09). Consultation on the proposed livestock MRLs for flucarbazone-sodium listed herein was conducted domestically through PRD2008-13. Information regarding the proposed MRLs is found in Sections 3.3 and 7.1 and in Appendix I and II of the PRD. The PMRA received no comments in response to this consultation.

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 flucarbazone-sodium in Canada in or on food, to be added to the MRL already legally established, is as follows.

Table 1 Proposed Maximum Residue Limits for Flucarbazone-sodium
Common Name Residue Definition MRL (ppm) Food Commodity
Flucarbazone-sodium 4,5-dihydro-3-methoxy-4-methyl-5-oxo-N-[[2-(trifluoromethoxy) phenyl]sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt1 0.05 Liver of cattle, goats, hogs, horses and sheep
0.01 Eggs; meat and meat byproducts (except liver) of cattle, goats, hogs, horses and sheep; meat and meat byproducts of poultry
0.0025 Milk

A complete list of all MRLs established in Canada can be found on the PMRA's MRL webpage.

International Situation and Trade Implications

MRLs may vary from one country to another for a number of reasons, including differences in pesticide use patterns. For animal commodities, differences in MRLs can also be due to different livestock feed items and practices. As per Table 2, the Canadian MRLs proposed for six commodities differ from corresponding tolerances established in the United States (tolerances listed in Next link will take you to another Web site 40 CFR Part 180 by pesticide) and there are no American tolerances established for poultry commodities. Currently, Codex2 MRLs have not been established for flucarbazone-sodium on any commodity (Next link will take you to another Web site Codex MRLs searchable by pesticide or commodity).

Comparison of Canadian MRLs, American Tolerances and Codex MRLs (where different)
Food Commodity Canadian MRL(ppm) American Tolerance (ppm) Codex MRL (ppm)
Liver of cattle, goats, hogs, horses, sheep 0.05 1.5 No MRL established
Milk 0.0025 0.005 No MRL established
Eggs 0.01 No tolerance established No MRL established
Meat and meat byproducts of poultry 0.01 No tolerance established No MRL established

References

1 The residue definition for the established MRL on wheat includes the metabolite 4,5-dihydro-3-methoxy-5-oxo-N-[[2-(trifluoromethoxy)phenyl]sulfonyl]-1H-1,2,4-triazole-1-carboxamide, sodium salt but the metabolite is not found in human food commodities. Therefore, the Canadian residue definition for all commodities is to be modified to reflect flucarbazone-sodium only in accordance with the above table.

2Codex is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.