Proposed Maximum Residue Limit PMRL2014-41, Spirodiclofen
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Pest Management Regulatory Agency
28 July 2014
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2014-41E-PDF (PDF version)
Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has concluded that the addition of new uses on highbush and lowbush blueberries to the product label of Envidor® 240 SC Miticide, containing technical grade Spirodiclofen, is acceptable. The specific uses approved in Canada are detailed on the label of Envidor® 240 SC Miticide, Pest Control Products Act Registration Number 28051.
The evaluation of this Spirodiclofen 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.
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.
Consultation on the proposed MRLs for Spirodiclofen 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 MRLs is also being conducted internationally by notifying the World Trade Organization, as coordinated by the Standards Council of Canada.
The proposed MRLs, to be added to the MRLs already established for Spirodiclofen, are as follows.
|Common Name||Residue Definition||MRL (ppm)Table 1 footnote 1||Food Commodity|
Table 1 footnotes
|Spirodiclofen||3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate||4.0||Bushberry subgroup (Crop subgroup 13-07B)|
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
MRLs may vary from one country to another for a number of reasons, including differences in pesticide use patterns and the locations of the field crop trials used to generate residue chemistry data.
Table 2 compares the MRLs proposed for Spirodiclofen in Canada with corresponding American tolerances and Codex MRLs.Footnote 1American tolerances are listed inthe 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.
|Food Commodity||Canadian MRL (ppm)||American Tolerance (ppm)||Codex MRL (ppm)|
|Bushberry subgroup (Crop subgroup 13-07B)||4.0||Not established||1
(Currants, Black, Red, White)
The PMRA invites the public to submit written comments on the proposed MRLs for Spirodiclofen 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.
Summary of Field Trial Data Used to Support the Proposed MRL
Residue data from field trials conducted in Canada and the United States were submitted to support the domestic use of Envidor® 240 SC Miticide on blueberries. Spirodiclofen was applied to blueberries at the proposed rate, and the crop was harvested according to the proposed label directions.
Maximum Residue Limit
The recommendation for the maximum residue limit (MRL) for Spirodiclofen was based upon the submitted field trial data, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data used to calculate the proposed MRL for bushberry subgroup (Crop subgroup 13-07B).
Total Application Rate
|Preharvest Interval (days)||Residues (ppm)|
|Blueberries||Foliar broadcast/ 304-344||6-7||<0.05||1.10|
Following the review of all available data, an MRL of 4.0 ppm is recommended to cover residues of Spirodiclofen. Residues of Spirodiclofen in Bushberry subgroup (Crop subgroup 13-07B) at the proposed MRL will not pose an unacceptable risk to any segment of the population, including infants, children, adults and seniors.
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