Proposed Maximum Residue Limit PMRL2021-12, Oxathiapiprolin

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Pest Management Regulatory Agency
13 May 2021
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2021-12E-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 label of Orondis Gold Fungicide, containing technical grade metalaxyl-M and S-isomer and oxathiapiprolin, is acceptable. The specific uses approved in Canada are detailed on the label of Orondis Gold Fungicide, Pest Control Products Act Registration Number 33508.

The evaluation of this oxathiapiprolin 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.

Consultation on the proposed MRLs for oxathiapiprolin is being conducted via this document (see Next steps). MRL consultation for the other active ingredient, metalaxyl-M and S-isomer, present in Orondis Gold Fungicide is being conducted under a separate action. 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 Canada's Notification Authority and Enquiry Point.

The proposed MRL, to be added to the MRLs already established for pendimethalin, is as follows.

Table 1 Proposed maximum residue limits for oxathiapiprolin
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	0.5	Bushberries (crop subgroup 13-07B, except lowbush blueberries)^{Table 1 Footnote 2}
		0.4	Low growing berries (crop subgroup 13-07G, except lingonberries and cranberries)^{Table 1 Footnote 3},^{Table 1 Footnote 4}
		0.01	Tree nuts (crop group 14-11)
Table 1 Footnote 1 ppm = parts per million Return to table 1 footnote 1 referrer Table 1 Footnote 2 Lowbush blueberries is in multiple crop subgroups and is included in crop subgroup 13-07G for this MRL action. Return to table 1 footnote 2 referrer Table 1 Footnote 3 Lingonberries is in multiple crop subgroups and is included in crop subgroup 13-07B for this MRL action. Return to table 1 footnote 3 referrer Table 1 Footnote 4 Cranberries are excluded from this MRL action since cranberries are not included on the product label of Orondis Gold Fungicide. Return to table 1 footnote 4 referrer

MRLs are proposed for each commodity included in the listed crop groupings in accordance with the Residue Chemistry Crop Groups webpage in the Pesticides 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

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.

Table 2 compares the MRLs proposed for oxathiapiprolin in Canada with corresponding American tolerances and Codex MRLs.^{Footnote 1} American 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 Index webpage, by pesticide or commodity.

Table 2 Comparison of Canadian MRLs, American tolerances and Codex MRLs (where different)
Food commodity	Canadian MRL (ppm)	American Tolerance (ppm)	Codex MRL (ppm)
Bushberries (crop subgroup 13-07B, except lowbush blueberries)	0.5	0.5	1.3 (dried grapes = currants,^{Table 2 Footnote 1} raisins and sultanas)
Low growing berries (crop subgroup 13-07G, except lingonberries and cranberries)	0.4	0.4 (Berry, low growing, subgroup 13-07G, except cranberry)	Not established
Tree nuts (crop group 14-11)	0.01	0.2 (Nut, tree, group 14-12)	Not established
Table 2 Footnote 1 Currants are included in Crop subgroup 13-07B. Return to table 2 footnote 1 referrer

Next steps

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. 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.

Appendix I

Summary of field trial data used to support the proposed maximum residue limits

Residue data for oxathiapiprolin in highbush blueberries, strawberries, almonds and pecans were submitted to support the domestic use of oxathiapiprolin on bushberries (crop subgroup 13-07B, except lowbush blueberries), low growing berries (crop subgroup 13-07G, except lingonberries and cranberries), and tree nuts (crop group 14-11).

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 bushberries (crop subgroup 13-07B, except lowbush blueberries), low growing berries (crop subgroup 13-07G, except lingonberries and cranberries), and tree nuts (crop group 14-11).

Table A1 Summary of field trial data used to support the MRLs
Commodity	Application method/Total application rate (g a.i./ha)^{Table A1 Footnote 1}	Preharvest interval (days)	Lowest average field trial residues (ppm)	Highest average field trial residues (ppm)
Highbush blueberries	Soil drench/ 553–577	1	<0.01	0.27
Strawberries	Soil-directed + foliar/ 393–398	0	0.051	0.207
Almonds	Soil-directed/ 268–-283	27-31	<0.01	<0.01
Pecans	Soil-directed/ 279–280	26-30	<0.01	<0.01
Table A1 Footnote 1 g a.i./ha = grams of active ingredient per hectare Return to table A1 footnote 1 referrer

Following the review of all available data, the MRL 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.

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Date modified:: 2021-07-29

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