Proposed Maximum Residue Limit PMRL2017-08, ethaboxam
Notice to the reader:
The online consultation is now closed.
Pest Management Regulatory Agency
11 April 2017
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2017-8E-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 for seed treatment on field peas, cowpeas and Crop Subgroup 20B (sunflower subgroup) to the product label of Intego™ Solo Fungicide, containing technical grade ethaboxam, is acceptable. The specific uses approved in Canada are detailed on the label of Intego™ Solo Fungicide, Pest Control Products Act Registration Number 31324.
The evaluation of this ethaboxam application indicated that the end-use product has value and the human health and environmental risks associated with the new uses are acceptable.
The PMRA must determine the quantity of residues that are likely to remain in or on the imported food commodities when ethaboxam is used according to label directions in the exporting country, and that such residues will not be a concern to human health. This quantity is then legally established as an MRL on the corresponding imported commodity. 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.
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 ethaboxam is being conducted via this document (see Next Steps, the last section of this summary). 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 are also being conducted internationally by notifying the World Trade Organization, as coordinated by Canada's Notification Authority and Enquiry Point.
The proposed MRLs, to be added to the MRLs already established for ethaboxam, are as follows.
|Common Name||Residue Definition||MRL (ppm)Table 1 footnote 1||Food Commodity|
|Ethaboxam||N-(cyano-2-thienylmethyl)-4-ethyl-2-(ethylamino)-5-thiazolecarboxamide||0.01||Sunflowers (crop subgroup 20B), dry cowpea seeds, dry field peas, succulent shelled cowpeas|
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
The MRLs proposed for ethaboxam in Canada do not have corresponding tolerances in the US. Ethaboxam is registered for use as a seed treatment in the US on legume vegetables, cereal grains and rapeseeds. These uses are considered “non-food” by the US, as residues are not expected in any subsequent RACs. As such, no MRLs were established on these crops. The only American tolerance for ethaboxam is for imported grapes as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLsFootnote 1.2 listed for ethaboxam in or on any commodity on the Codex Alimentarius Pesticide Residues in Food and Feed webpage.
The PMRA invites the public to submit written comments on the proposed MRLs for ethaboxam up to 75 days from the date of publication of this document. Please forward your comments to Publications (see the contact information on the cover page of this summary). 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 Maximum Residue Limits
Residue data for ethaboxam seed treatment in soybean and sunflower were submitted to support the domestic use of Intego™ Solo Fungicide on field pea, cowpea and sunflowers (crop subgroup 20B).
Maximum Residue Limits
The recommendation for maximum residue limits (MRLs) for ethaboxam was based upon the residues observed in crops treated according to label directions in the exporting country, and the guidance provided in the OECD MRL Calculator. Table A1 summarizes the residue data used to calculate the proposed MRLs for field pea, cowpea and sunflowers (crop subgroup 20B).
|Commodity||Application Method / Total Application Rate||Preharvest Interval (days)||Lowest Average Field Trial Residues (ppm)||Highest Average Field Trial Residues(ppm)||Experimental Processing Factor|
|Soybean seeds||Seed treatment
75 g a.i./100 kg seedTable 1 footnote 1.1
|130-138||<0.01||<0.01||No quantifiable residues were observed at exaggerated rates|
0.0945-0.202 mg a.i./seedTable 1 footnote 2
|105||<0.005||<0.005||No quantifiable residues were observed at exaggerated rates|
0.185-0.192 mg a.i./seedTable 1 footnote 2
Following the review of all available data, MRLs as proposed in Table 1 are recommended to cover residues of ethaboxam. Residues of ethaboxam in these crop commodities at the proposed MRLs will not pose an unacceptable risk to any segment of the population, including infants, children, adults and seniors.
- Date modified: