Proposed Maximum Residue Limit PMRL2019-17, Metalaxyl
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Pest Management Regulatory Agency
23 August 2019
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2019-17E-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 the new use on annual canarygrass to the product label of Insure Cereal FX4, containing technical grade pyraclostrobin, fluxapyroxad, triticonazole and metalaxyl, is acceptable. The specific uses approved in Canada are detailed on the label of Insure Cereal FX4, Pest Control Products Act Registration Number 33210.
The evaluation of this metalaxyl application indicated that the end-use product has value and the human health and environmental risks associated with the new use 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 MRL for metalaxyl is being conducted via this document (see Next Steps). MRL consultation for the other active ingredients, pyraclostrobin, triticonazole and fluxapyroxad, present in Insure Cereal FX4 is being consulted under separate actions. A summary of the field trial data used to support the proposed MRL can be found in Appendix I.
To comply with Canada's international trade obligations, consultation on the proposed MRL 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 metalaxyl, is as follows.
|Common Name||Residue Definition||MRL (ppm)Footnote 1||Food Commodity|
|Metalaxyl||methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate, including metabolites that can be converted to the 2,6-dimethylaniline moiety, each expressed as metalaxyl equivalents||0.05||Annual canarygrass seeds|
- Footnote 1
ppm = parts per million
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
Currently, there is no American tolerance for metalaxyl on annual canarygrass seeds listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide, nor is there any Codex MRLFootnote 1 listed for metalaxyl on annual canarygrass seeds on the Codex Alimentarius Pesticide Index webpage, by pesticide or commodity.
The PMRA invites the public to submit written comments on the proposed MRL for metalaxyl 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 MRL. Comments received will be addressed in a separate document linked to this PMRL. The established MRL will be legally in effect as of the date that it is entered into the Maximum Residue Limit Database.
Summary of Field Trial Data Used to Support the Proposed Maximum Residue Limit
Previously reviewed residue data from field trials conducted on wheat (translated to annual canarygrass) were reassessed in the framework of this petition. In addition, a processing study in treated wheat was also reassessed to determine the potential for concentration of residues of metalaxyl into processed commodities.
Maximum Residue Limit
The recommendation for a maximum residue limit (MRL) for metalaxyl was based upon the previously reviewed 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 annual canarygrass seeds.
|Commodity||Application Method/ Total Application Rate
(g a.i./ha)Footnote 1
|Preharvest Interval (days)||Lowest Average Field Trial Residues
|Highest Average Field Trial Residues
|Experimental Processing Factor|
|Wheat grain||Soil treatment at planting / 1120||209-259||<0.05||0.13Footnote 2||Wheat flour: 1.6×|
- Footnote 1
g a.i./ha = grams of active ingredient per hectare.
- Footnote 2
Based on the degree of exaggeration (933-fold) of a soil application, it was determined that residues resulting from a seed treatment at 1.2 g a.i./ha would not be quantifiable.
Following the review of all available data, the MRL as proposed in Table 1 is recommended to cover residues of metalaxyl. Residues of metalaxyl in annual canarygrass seeds at the proposed MRL 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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