Proposed Maximum Residue Limit PMRL2015-43, Clothianidin
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Pest Management Regulatory Agency
20 October 2015
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2015-43E-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 in Canada in various fruits and vegetables to the product label of Sepresto 75 WS, containing technical grade clothianidin, is acceptable. The specific uses approved in Canada are detailed on the label of Sepresto 75 WS, Pest Control Products Act Registration Number 30972.
The evaluation of this clothianidin application indicated that the end-use product has 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.
In addition, the PMRA is proposing to establish an MRL for clothianidin on wheat 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 clothianidin is used according to label directions in the exporting country, and that such residues will not be a concern to human health.
Consultation on the proposed MRLs for clothianidin is being conducted via this document (see Next Steps, the last section of this document).
Details regarding the proposed MRLs can be found in the corresponding Evaluation Report available in the Pesticides and Pest Management section of Health Canada’s website, under Public Registry, Pesticide Product Information Database. 1
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 Canada’s Notification Authority and Enquiry Point.
The proposed MRLs, to be added to the MRLs already established for clothianidin, are as follows.
|Common Name||Residue Definition||MRL (ppm)Table 1 footnote 1||Food Commodity|
|Clothianidin||[C(E)]-N-[(2-chloro-5-thiazolyl)methyl]-N'-methyl-N"-nitroguanidine||0.8||Root vegetable (except sugar beet) (Crop Subgroup 1B)|
|0.7||Leafy greens (Crop Subgroup 4A)|
|0.45||Bulb vegetables (Crop Group 3-07)|
|0.4||Brassica (cole) leafy vegetables (Crop Group 5)|
|0.35||Leaves of root and tuber vegetables (Crop Group 2)|
|0.3||Tuberous and corm vegetables (Crop Subgroup 1C)MRL (ppm)Table 1 footnote 2|
|0.02||Fat, meat and meat byproducts of cattle, goats, hogs, horses and sheep|
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 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 clothianidin in Canada with corresponding American tolerances and Codex MRLs.Table #t2_fnb2 footnote #t2_fnb2 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.
|Food Commodity||Canadian MRL (ppm)||American Tolerance
|Root vegetables, except sugar beet (Crop Subgroup 1B)||0.8||0.08||0.2 (Root and tuber vegetables)|
|Tuberous and corm vegetables (Crop Subgroup 1C)||0.3||0.3|
|Leaves of Root and Tuber vegetables (human food or animal feed) (Crop Group 2)||0.35||None||None|
|Bulb vegetables (Crop Group 3-07)||0.45||0.45||None|
|Leafy greens (Crop Subgroup 4A)||0.70||3.0 (Leafy vegetables, except Brassica (Crop Group 4))||2 (Leafy vegetables)|
|Brassica (cole) leafy vegetables (Crop Group 5)||0.40||1.9||0.2 (Brassica (cole or cabbage) vegetables, head cabbage, flowerhead Brassicas)|
|Fat, meat and meat byproducts of cattle, goats, hogs, horses and sheep||0.02||None||
0.2 (liver of cattle, goats, pigs, sheep)0.02 (mammalian fats, except milk fats, mammalian edible offal, and meat from mammals other than marine animals)
|Wheat||0.01||0.01 (cereal grain, except rice, Crop Group 15)||0.02 (wheat)|
The PMRA invites the public to submit written comments on the proposed MRLs for clothianidin 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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