Proposed Maximum Residue Limit PMRL2018-05, Oxathiapiprolin
This consultation is now closed.
Pest Management Regulatory Agency
2 March 2018
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2018-5E-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 various commodities to the product labels of DuPontTM ZorvecTM EpicaltrinTM Fungicide, DuPontTM ZorvecTM EnicadeTM Fungicide, OrondisTM 200SC Fungicide, and OrondisTM Fungicide, containing technical grade oxathiapiprolin, is acceptable. The specific uses approved in Canada are detailed on the labels of DuPontTM ZorvecTM EnicadeTM Fungicide, DuPontTM ZorvecTM EpicaltrinTM Fungicide, OrondisTM Fungicide, and OrondisTM 200SC Fungicide, Pest Control Products Act Registration Numbers 32101, 32102, 32103, and 32104, respectively.
The PMRA has also concluded that the addition of the new in-furrow use to the product label of OrondisTM Fungicide, containing technical grade oxathiapiprolin, and registration of the new end-use product OrondisTM Gold Fungicide, containing technical grade oxathiapiprolin and metalaxyl-M and S-Isomer, is acceptable. The specific uses approved in Canada are detailed on the labels of OrondisTM Fungicide and OrondisTM Gold Fungicide, Pest Control Products Act Registration Numbers 32103 and 32806, respectively.
The evaluation of these oxathiapiprolin applications indicated that the end-use products have 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 oxathiapiprolin is being conducted via this document (see Next Steps). A summary of the field trial data used to support the proposed MRLs can be found in Appendix I.
The currently established 0.5 ppm MRL for metalaxyl in/on potatoes is sufficient to cover residues resulting from this new use and therefore unaffected by this MRL action. Furthermore, the exiting MRLs for metalaxyl are adequate to cover the uses of Orondis Gold Fungicide.
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 replace or be added to the MRLs already established for oxathiapiprolin, are as follows.
|Common Name||Residue Definition||MRL (ppm)Table 1 Footnote 1||Food Commodity|
|Oxathiapiprolin||1-[4-[4-[5-(2,6-difluorophenyl)-4,5-dihydro-3-isoxazolyl]-2-thiazolyl]-1-piperidinyl]-2-[5-methyl-3-(trifluoromethyl)-1H-pyrazol-1-yl]-ethanone||80||Dried basil leaves|
|10||Brassica leafy greens (crop subgroup 4-13B); fresh basil leaves|
|2||Stalk and stem vegetables (crop subgroup 22A)|
|0.5||Caneberries (crop subgroup 13-07A)|
|0.04||Tuberous and corm vegetables (crop subgroup 1C)Table 1 Footnote 2|
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 the Canada.ca 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 oxathiapiprolin in Canada are the same as corresponding American tolerances as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLs listed for oxathiapiprolin in or on any commodity on the Codex Alimentarius PesticideResidues in Food and Feed webpage.
The PMRA invites the public to submit written comments on the proposed MRLs for oxathiapiprolin 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 document). 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 MaximumResidue Limit Database.
Summary of Field Trial Data Used to Support the Proposed Maximum Residue Limits
Residue data for oxathiapiprolin in potatoes, raspberries/blackberries, asparagus, mustard greens and basil (field and greenhouse) were submitted to support the domestic use of OrondisTM Gold Fungicide, DuPontTM ZorvecTM EpicaltrinTM Fungicide, DuPontTM ZorvecTM EnicadeTM Fungicide, OrondisTM 200SC Fungicide, and OrondisTM Fungicide on tuberous and corm vegetables (Crop Subgroup 1C), caneberries (Crop Subgroup 13-07A), stalk and stem vegetables (Crop Subgroup 22A), Brassica leafy vegetables (Crop Subgroup 4-13B), and basil (field and greenhouse).
Maximum Residue Limits
The recommendation for maximum residue limits (MRLs) for oxathiapiprolin 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 MRLs for tuberous and corm vegetables (Crop Subgroup 1C), caneberries (Crop Subgroup 13-07A), stalk and stem vegetables (Crop Subgroup 22A), Brassica leafy vegetables (Crop Subgroup 4-13B) and basil (field and greenhouse).
|Commodity||Application Method/ Total Application Rate
(g a.i./ha)Table A1 Footnote 1
|Preharvest Interval (days)||Lowest Average Field Trial Residues
|Highest Average Field Trial Residues
|Experimental Processing Factor|
|Potato tubers||In-furrow spray at planting + soil directed spray at-hilling/
|50-124||<0.01||0.0368||Residues did not concentrate in processed commodities.|
|Raspberries and Blackberries||Soil directed/ 554 - 578||1 - 6||<0.01||0.223||Not applicable|
|Asparagus||Soil directed/ 554 - 566||0||0.275||0.745||Not applicable|
|Crown soak/ 279 - 789||19 - 43||<0.01||<0.01|
|314 - 383||<0.01||<0.01|
|Field and Greenhouse Fresh Basil Leaves||Foliar/ 141 - 148||0||1.8||5.4||Not applicable|
|Field Dried Basil leaves||Foliar/ 141 - 145||0||24||29||Not applicable|
|Mustard greens||Foliar/138 - 144||0||1.46||4.29||Not applicable|
Table A1 Footnotes
Following the review of all available data, MRLs as proposed in Table 1 are recommended to cover residues of oxathiapiprolin. Residues of oxathiapiprolin 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.
- Footnote 1
The Codex Alimentarius Commission is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.
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