Proposed Maximum Residue Limit PMRL2014-74, Fenamidone

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Pest Management Regulatory Agency
30 September 2014
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2014-74E-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 ginseng and succulent beans, except cowpeas, to the product label of Reason 500 SC Fungicide, containing technical grade fenamidone, is acceptable. The specific uses approved in Canada are detailed on the label of Reason 500 SC Fungicide, Pest Control Products Act Registration Number 27462.

The evaluation of this fenamidone application indicated that the end-use product has merit and 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 fenamidone is being conducted via this document (see Next Steps, the last section of this document). 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  Standards Council of Canada.

The proposed MRLs, to replace or be added to the MRLs already established for fenamidone, are as follows.

Table 1 Proposed Maximum Residue Limits for Fenamidone
Common Name Residue Definition MRL (ppm)Table 1 footnote 1 Food Commodity

Table 1 footnotes

Table 1 footnote 1

ppm = parts per million

Return to table 1 footnote 1 referrer

Table 1 footnote 2

This MRL is proposed to replace the established MRL of 0.15 ppm for residues of fenamidone in/on ginseng roots

Return to table 1 footnote 2 referrer

Fenamidone (5S)-3,5-dihydro-5-methyl-2-(methylthio)-5-phenyl-3-(phenylamino)-4H-imidazol-4-one 0.8 Ginseng roots,Table 1 footnote 2 Edible-podded legume vegetables (Crop Subgroup 6A) and Succulent shelled pea and bean group (Crop Subgroup 6B), except cowpea

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 fenamidone 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 MRLsFootnote 1 listed for fenamidone in or on any commodity on the Codex Alimentarius  Pesticide Residues in Food webpage.

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for fenamidone 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 MRL

Residue data from field trials conducted in Canada and the United States were submitted to support the domestic use of Reason 500 SC Fungicide on ginseng and residue data from field trials conducted in the United States were submitted to support the domestic use of Reason 500 SC Fungicide on succulent beans. Fenamidone was applied to ginseng, snap beans and succulent shelled lima beans at exaggerated rates, which were harvested according to the proposed label directions.

Maximum Residue Limits

The recommendation for maximum residue limits (MRLs) for fenamidone 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 ginseng, Edible-podded legume vegetables (Crop Subgroup 6A) and Succulent shelled pea and bean group (Crop Subgroup 6B), except cowpea.

Table A1 Summary of Field Trial Used to Support Maximum Residue Limits (MRLs)
Commodity Application Method / Total Application Rate
(kg a.i./ha)
Preharvest Interval (days) Residues (ppm)
Min Max
Dried ginseng roots Foliar/2.72-2.78 12-15 0.05 0.53
Snap bean pods with seeds Foliar/1.18-1.24 3-4 0.084 0.46
Lima bean seeds without pods Foliar/1.17-1.23 2-4 <0.02 0.08

Following the review of all available data, MRLs of 0.8 ppm are recommended to cover residues of fenamidone in/on ginseng, Edible-podded legume vegetables (Crop Subgroup 6A) and Succulent shelled pea and bean group (Crop Subgroup 6B), except cowpea. Residues of fenamidone 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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