Proposed Maximum Residue Limit PMRL2019-11, Fluroxypyr-meptyl
This consultation is now closed.
Pest Management Regulatory Agency
20 August 2019
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2019-11E-PDF (PDF version)
Under the authority of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) has concluded that the registration of the new end-use product Infinity FX, containing the active ingredients pyrasulfotole, bromoxynil and fluroxypyr-meptyl, as well as the safener mefenpyr-diethyl, for use on wheat (spring, durum and winter), spring barley, triticale (spring and winter), timothy, perennial ryegrass, bromegrasses and red fescues, is acceptable. The specific uses approved in Canada are detailed on the label of Infinity FX, Pest Control Products Act Registration Number 33248.
The evaluation of this application for pyrasulfotole, bromoxynil and fluroxypyr-meptyl, as well as the safener mefenpyr-diethyl, indicated that the end-use product has value and that 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 MRL for fluroxypyr-meptyl is being conducted via this document (see Next Steps). A summary of the field trial data used to support the proposed MRL can be found in Appendix I. The currently established MRLs for pyrasulfotole, bromoxynil and the safener mefenpyr-diethyl in/on the food crops listed above are sufficient to cover residues resulting from this new use and are therefore unaffected by this MRL action.
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 fluroxypyr-meptyl, is as follows.
|Common Name||Residue Definition||MRL (ppm)Footnote 1||Food Commodity|
|Fluroxypyr-meptyl||1-methylheptyl 2-[(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy]acetate, including the metabolite [(4-amino-3,5-dichloro-6-fluoro-2-pyridinyl)oxy]acetic acid||0.5||Triticale|
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 MRL proposed for fluroxypyr-meptyl in Canada is the same as corresponding American tolerances as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide (CFR, Title 40, Part 180). Currently, there are no Codex MRLsFootnote 1 listed for fluroxypyr-meptyl in or on any commodity on the Codex Alimentarius Pesticide Index webpage.
The PMRA invites the public to submit written comments on the proposed MRL for fluroxypyr-meptyl in or on triticale 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 fluroxypyr-meptyl residue data from field trials conducted on the small grain cereals wheat, barley and oats were re-assessed in the framework of this petition. In addition, a processing study in treated wheat was also re-assessed to determine the potential for concentration of residues of fluroxypyr-meptyl into triticale processed commodities.
Maximum Residue Limit (MRL)
The recommendation for a maximum residue limit (MRL) for fluroxypyr-meptyl 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 triticale.
|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||Foliar broadcast/
|Barley grain||Foliar broadcast/
|Oat grain||Foliar broadcast/
Following the review of all available data, the MRL as proposed in Table 1 is recommended to cover residues of fluroxypyr-meptyl in/on triticale. Residues of fluroxypyr-meptyl in triticale at the proposed MRL will not pose an unacceptable risk to any segment of the population, including infants, children, adults and seniors.
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