Proposed Maximum Residue Limit PMRL2016-21, Fluopyram
Notice to the reader:
The online consultation is now closed.
Pest Management Regulatory Agency
13 May 2016
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2016-21E-PDF (PDF version)
This page is a summary of the consultation document. If you would like to comment, please request the full consultation document.
To obtain a full copy of Proposed Registration Decision PRD2016-14, Amitraz please contact our publications office.
Should you require further information please contact the Pest Management Information Service.
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 products Luna Sensation, containing technical grade fluopyram and trifloxystrobin, and Velum Prime, containing technical grade fluopyram, and the addition of new uses on various commodities to the product labels of Luna Privilege, containing technical grade fluopyram, Luna Tranquility Fungicide, containing technical grade fluopyram and pyrimethanil, and Propulse Fungicide, containing technical grade fluopyram and prothioconazole, are acceptable. The specific uses approved in Canada are detailed on the label of the new end-use products Luna Sensation and Velum Prime, and the registered end-use products Luna Privilege, Luna Tranquility Fungicide and Propulse Fungicide, Pest Control Products Act Registration Number 32107, 32108, 30509, 30510 and 30511, respectively.
The evaluation of these fluopyram applications indicated that the end-use products have value and the human health and environmental risks associated with the new uses are acceptable.
As well, under the authority of the Pest Control Products Act, Health Canada's PMRA has received applications to register technical grade fluopyram for use in greenhouses and as a seed treatment, and to register the end-use product Fluopyram Greenhouse Fungicide for use in Canada on greenhouse lettuce, tomatoes, peppers and cucumbers, and the end-use product Ilevo for use in Canada as a seed treatment on soybeans. The specific uses approved in Canada are detailed on the label of the new end-use products Fluopyram Greenhouse Fungicide and Ilevo, Pest Control Products Act Registration Number 32208 and 32207, respectively.
The evaluation of these fluopyram applications indicated that the end-use products have value, and the human health and environmental risks associated with their proposed uses are acceptable. Details regarding these applications can be found in Proposed Registration Decision PRD2016-11, Fluopyram, posted to the Health Canada website on 1 April 2016.
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.
In addition, the PMRA is proposing to establish MRLs for fluopyram on various commodities to permit the import and sale of food containing such residues. The PMRA has determined the quantity of residues that are likely to remain in or on the imported commodities when fluopyram is used according to label directions in the exporting country, and that such residues will not be a concern to human health.
Consultation on the proposed MRLs for fluopyram in/on dry soybeans, tomatoes (Crop Subgroup 8-09A), and squash/cucumbers (Crop Subgroup 9B) is being conducted via PRD2016-11, in which information regarding the proposed MRLs can be found in Sections 3.5 and 7.1, and the supporting field trial residue data are provided in Appendix I, Table 1. The PMRA invites the public to submit written comments on the proposed MRLs for fluopyram in accordance with the guidance found in PRD2016-11. Consultation on the proposed MRLs for fluopyram in/on all other commodities 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.
For the coformulant trifloxystrobin, present in Luna Sensation, the MRL consultation is being conducted under a separate action.
For the coformulant prothioconazole, present in Propulse Fungicide, the currently established MRL of 0.9 ppm for prothioconazole, including the desthio metabolite, in/on Crop Subgroup 6C (Dried shelled pea and bean, except soybean) is sufficient to cover residues resulting from the new use and is therefore unaffected by this MRL action.
For the coformulant pyrimethanil, present in Luna Tranquility Fungicide, the currently established MRLs of 15 ppm in/on Crop Subgroup 13-07A (Caneberries), 14 ppm in/on Crop Group 11 (Pome Fruits), 8.0 ppm in/on Crop Subgroup 13-07B (Bushberries), 5.0 ppm in/on grapes, 3.0 ppm in/on Crop Subgroup 13-07G (Low growing berries), 2.0 ppm in/on Crop Subgroup 3-07B (Green onions), 0.5 ppm in/on tomatoes, 0.1 ppm in/on Crop Subgroup 3-07A (Bulb onions), and 0.05 ppm in/on potatoes for pyrimethanil are sufficient to cover residues resulting from the new use and are therefore unaffected by this MRL action.
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 fluopyram, are as follows.
|Common Name||Residue Definition||MRL
(ppm)Table 1 footnote 1
|Fluopyram||N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide||400||Herbs, dried (Crop Subgroup 19A/dried)|
|70||Herbs, fresh (Crop Subgroup 19A/fresh); dill seed|
|50||Leafy Brassica greens (Crop Subgroup 5B); fresh chive leaves|
|40||Leafy greens (Crop Subgroup 4A)|
|30||Leaves of root and tuber vegetables, human food or animal feed (Crop Group 2)|
|20||Leaf petioles (Crop Subgroup 4B)|
|15||Green onions, except fresh chive leaves (Crop Subgroup 3-07B)|
|7.0||Bushberries (Crop Subgroup 13-07B)|
|5.0||Caneberries (Crop Subgroup 13-07A)|
|4.0||Head and stem Brassica (Crop Subgroup 5A); edible-podded legume vegetables (Crop Subgroup 6A); peppers/eggplants (Crop Subgroup 8-09B); globe artichokes|
|2.0||CherriesTable 1 footnote 2 (Crop Subgroup 12-09A); small fruits vine climbing, except fuzzy kiwifruit, except grapes and gooseberriesTable 1 footnote 3 (Crop Subgroup 13-07F); low growing berries, except lowbush blueberries and lingonberriesTable 1 footnote 4 (Crop Subgroup 13-07G); dried nectarines; dried peaches; wheat bran; wheat germ|
|1.8||Oilseeds, except rapeseeds (canola)Table 1 footnote 5 (Crop Subgroup 20R-A)|
|1.0||Tomatoes (Crop Subgroup 8-09A); melon, except watermelonsTable 1 footnote 6 (Crop Subgroup 9A); citrus fruits, (Crop Group 10R); peaches (Crop Subgroup 12-09B)|
|0.8||Pome fruitsTable 1 footnote 7 (Crop Group 11-09); cottonseedsTable 1 footnote 8 (Crop Subgroup 20R-C)|
|0.7||Dried shelled peas and beans, except soybeansTable 1 footnote 9 (Crop Subgroup 6C); sunflowers (Crop Subgroup 20R-B)|
|0.6||Squash/cucumber (Crop Subgroup 9B)|
|0.5||Plums (Crop Subgroup 12-09C)|
|0.4||Bulb onions (Crop Subgroup 3-07A)|
|0.3||Root vegetables, except sugar beets (Crop Subgroup 1B); dry soybeansTable 1 footnote 10|
|0.2||Succulent shelled peas and beans (Crop Subgroup 6B); peanutsTable 1 footnote 11|
|0.1||Tuberous and corm vegetablesTable 1 footnote 12 (Crop Subgroup 1C)|
|N-[2-[3-chloro-5-(trifluoromethyl)-2-pyridinyl]ethyl]-2-(trifluoromethyl)benzamide including the metabolite 2-(trifluoromethyl)benzamide (expressed as parent equivalent)||10||Meat byproducts of cattle, goats, horses and sheepTable 1 footnote 13|
|2.0||MilkTable 1 footnote 13|
|1.5||Fat and meat of cattle, goats, horses and sheepTable 1 footnote 13|
|0.15||Meat byproducts of poultryTable 1 footnote 13|
|0.06||Meat byproducts of hogsTable 1 footnote 13|
|0.05||Fat of poultryTable 1 footnote 13|
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
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. For livestock commodities, differences in MRLs can also be due to different livestock feed items and practices.
The new uses for fluopyram are being reviewed concurrently in Canada and the United States. The established American tolerances for fluopyram are listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide.
Table 2 compares the MRLs proposed for fluopyram in Canada with corresponding American tolerances and Codex MRLs.Footnote 1 A listing of established Codex MRLs is available on the Codex Alimentarius Pesticide Residues in Food website, by pesticide or commodity.
|Food Commodity||Canadian MRL
|Herbs, dried (CSG 19A/Dried)||400||40 (CSG 19A)||Not Established|
|Herbs, fresh (CSG 19A/Fresh)||70||Not Established|
|Dill seed||70||70||Not Established|
|Hops (dried)||60||60||Not Established|
|Leafy Brassica Greens (CSG 5B)||50||50||Not Established|
|Fresh chive leaves||50||15 (CSG 3-07B)||Not Established|
|Leafy Greens (CSG 4A)||40||40||Not Established|
|Leaves of Root and Tuber Vegetables, Human Food or Animal Feed (CG 2)||30||30||Not Established|
|Leaf Petioles (CSG 4B)||20||20||Not Established|
|Green onions (CSG 3-07B), except fresh chive leaves||15||15 (CSG 3-07B)||Not Established|
|Citrus oil||8.0||8.0||Not Established|
|Bushberries (CSG 13-07B)||7.0||7.0||Not Established|
|Caneberries (CSG 13-07A)||5.0||5.0||Not Established|
|Head and Stem Brassica (CSG 5A)||4.0||4.0||Not Established|
|Edible-podded legume vegetables (CSG 6A)||4.0||4.0||Not Established|
|Peppers/Eggplants (CSG 8-09B)||4.0||4.0 (CSG 8-10B)||Not Established|
|Globe artichokes||4.0||4.0||Not Established|
|Raisins||3.0||3.0||5 (Dried grapes)|
|Cherries (CSG 12-09A)||2.0||2.0 (CSG 12-12A)||0.7 (Cherries)|
|Small fruits vine climbing, except fuzzy kiwifruit, except grapes and gooseberries (CSG 13-07F)||2.0||2.0||Not Established|
|Low growing berries, except lowbush blueberries and lingonberries (CSG 13-07G)||2.0||2.0||0.4 (Strawberry)|
|Dried nectarines; Dried peaches||2.0||Not Established||Not Established|
|Wheat bran; Wheat germ||2.0||Not Established||Not Established|
|Oilseeds, except rapeseeds (canola) (CSG 20R-A)||1.8||5.0||Not Established|
|Dried tomatoes||1.5||Not Established||Not Established|
|Tomatoes (CSG 8-09A)||1.0||1.0 (CSG 8-10A)||0.4 (Tomato)|
|Melon, except watermelons (CSG 9A)||1.0||1.0||Not Established|
|Citrus Fruits (CG 10R)||1.0||1.0 (CG 10-10)||Not Established|
|Peaches (CSG 12-09B)||1.0||1.0 (CSG 12-12B)||0.4 (Peach)|
|Pome Fruits (CG 11-09)||0.8||0.80 (CG 11-10)||0.5|
|Cottonseeds (CSG 20R-C)||0.8||0.80||Not Established|
|Dried shelled peas and beans, except soybeans (CSG 6C)||0.7||0.70 (Bean, dry)||0.07 (beans, dry; chick-pea, dry; lentil, dry; lupin, dry)|
|Sunflowers (CSG 20R-B)||0.7||0.70||Not Established|
|Squash/Cucumber (CSG 9B)||0.6||0.60||0.5 (Cucumber)|
|Plums (CSG 12-09C)||0.5||0.50 (CSG 12-12C)||Not Established|
|Bulb onions (CSG 3-07A)||0.4||0.40||Not Established|
|Root Vegetables, except sugar beet (CSG 1B)||0.3||0.30||0.4 (carrots)|
|Dry soybeans||0.3||0.30||Not Established|
|Succulent shelled peas and beans (CSG 6B)||0.2||0.20||Not Established|
|Tuberous and Corm Vegetables (CSG 1C)||0.1||0.10||0.03 (Potatoes)|
|Sugarcane cane||0.08||0.08||Not Established|
|Meat byproducts of cattle, goats, horses and sheep||10||7.5||0.5 (Kidney of cattle, goats, pigs, sheep);
3 (Liver of cattle, goats, pigs, sheep)
|Meat byproducts of hogs||0.06||0.20|
|Fat and meat of cattle, goats, horses and sheep||1.5||0.70 (fat)
|0.5 (Meat from mammals other than marine mammals)|
|Meat byproducts of poultry||0.15||0.20||0.7 (Poultry, edible offal of)|
|Fat of poultry||0.05||0.04||0.7 (Poultry, edible offal of)|
The PMRA invites the public to submit written comments on the proposed MRLs for fluopyram 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.
Summary of Field Trial Data Used to Support the Proposed Maximum Residue Limits
Residue data for fluopyram from field trials conducted in Canada and the United States were submitted to support the domestic use of Luna Privilege, Luna Tranquility Fungicide, Propulse Fungicide, Luna Sensation and Velum Prime on various crops. Fluopyram was applied to carrots, radish, potatoes, dry bulb onions, green onions, leaf lettuce, head lettuce, spinach, celery, cabbage, broccoli, cauliflower, mustard greens, snap beans, snow peas, lima beans, garden peas, tomatoes, bell peppers, chili peppers, raspberries, blackberries, highbush blueberries, grass, basil, chives, dill seed, sunflowers, globe artichokes, hops and peanuts at label rates, and harvested according to label directions. Previously reviewed residue data from field trials conducted in/on potatoes, sugar beets, dry beans, dry peas, cucurbits, pome fruits, stone fruits, strawberries, grapes, tree nuts, peanuts, soybeans, cereals, canola and alfalfa were reassessed in the framework of this petition. In addition, processing studies in treated tomatoes, plums, peaches and sunflowers were reviewed, and processing data in treated potatoes, sugar beet, soybeans, apples, grapes, strawberries, wheat, field corn, canola and peanut were reassessed to determine the potential for concentration of residues of fluopyram into processed commodities.
Residue data for fluopyram from greenhouse trials conducted in Europe were submitted to support the domestic use of Fluopyram Greenhouse Fungicide on lettuce, tomatoes, peppers and cucumbers. Fluopyram was applied to lettuce, tomatoes, peppers and cucumbers at label rates, and harvested according to label directions.
Residue data for fluopyram from field trials conducted in the United States, including Canadian representative growing regions, were submitted to support the domestic use of Fluopyram ST Fungicide on soybeans as a seed treatment. Fluopyram was applied to soybeans at label rates, and harvested according to label directions.
Residue data for fluopyram from field trials conducted in the United States on orange, lemon, grapefruit, cotton seed, sugarcane and peanuts were submitted to support the maximum residue limits on imported crops. Previously reviewed residue data from field trials conducted on peanuts and cotton seed were reassessed in the framework of this petition. In addition, processing studies in treated oranges, sugarcane and cotton seed were reviewed, and processing data in treated peanuts and cotton seed were reassessed to determine the potential for concentration of residues of fluopyram into processed commodities.
Maximum Residue Limits
The recommendation for maximum residue limits (MRLs) for fluopyram 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 crops.
|Commodity||Application Method/ Total Application Rate
(g a.i./ha)Table A1 footnote 1
|Lowest Average Field Trial Residues
|Highest Average Field Trial Residues
|Experimental Processing Factor|
|Carrot roots||Foliar spray/ 487-517||0||0.017||0.088||Not required|
|Radish roots||Foliar spray/ 495-510||0||0.047||0.160||Not required|
|Sugar beet roots||Foliar spray/ 492-511||5-7||0.018||0.046||Refined sugar (1.3x)|
|Potato tubers||In furrow application to bare soil at planting/ 490-520||7||<0.01||0.069||No concentration was observed in food commodities|
|Turnip tops||Foliar spray/ 500-510||7||0.495||3.816||Not required|
|Sugar beet tops||Foliar spray/ 492-511||5-7||0.279||16.51||Not required|
|Radish tops||Foliar spray/ 495-510||0||10.53||25.31||Not required|
|Dry bulb onions||Foliar spray/ 482-501||0||0.016||0.186||Not required|
|Green onions||Foliar spray/ 488-521||0||1.745||6.182||Not required|
|Chives, whole plant w/o roots||Foliar spray/ 503-517||0||6.051||19.80||Not required|
|Head lettuce||Foliar spray/ 494-513||0||0.583||5.286||Not required|
|Leaf lettuce||Foliar spray/ 495-506||0||1.239||9.048||Not required|
|Lettuce (greenhouse)||Foliar spray/ 500||7||0.16||8.40||Not required|
|Spinach||Foliar spray/ 494-514||0||8.214||22.03||Not required|
|Celery||Foliar spray/ 492-515||0||0.024||10.58||Not required|
|Cabbage||Foliar spray/ 492-526||0||0.059||1.266||Not required|
|Broccoli||Foliar spray/ 492-526||0||1.058||1.179||Not required|
|Cauliflower||Foliar spray/ 492-526||0||0.02||0.835||Not required|
|Mustard greens||Foliar spray/ 490-509||0||8.99||25.62||Not required|
|Snap beans||Foliar spray/ 497-512||0||0.128||0.698||Not required|
|Snow peas||Foliar spray/ 500-528||0||0.784||1.240||Not required|
|Lima beans||Foliar spray/ 498-503||0||0.011||0.070||Not required|
|Garden peas||Foliar spray/ 493-511||0||<0.01||0.073||Not required|
|Dry bean seed||Foliar spray/ 494-514||13-14||<0.01||0.068||Not required|
|Dry pea seed||Foliar spray/ 494-509||14||0.03||0.350||Not required|
|Soybean seed||Foliar spray/ 485-519||12-14||<0.01||0.160||No concentration was observed in food commodities|
|Seed treatment/ 0.25 mg a.i./seed +
Foliar spray/ 370
|Tomatoes||Foliar spray/ 493-511||0||0.021||0.342||Dried tomatoes (4.3x); no concentration was observed in other food commodities|
|Tomatoes (greenhouse)||Foliar spray/ 600||0||0.15||0.81|
|Bell peppers||Foliar spray/ 494-512||0||0.035||0.359||Not required|
|Nonbell peppers||Foliar spray/ 490-503||0||0.117||1.233||Not required|
|Peppers (greenhouse)||Foliar spray/ 600||0||0.24||0.72||Not required|
|Muskmelon||Foliar spray/ 499-526||0||0.072||0.439||Not required|
|Cucumber||Foliar spray/ 485-508||0||0.051||0.144||Not required|
|Cucumber (greenhouse)||Foliar spray/ 600||0||0.10||0.40||Not required|
|Summer squash||Foliar spray/ 497-510||0||0.069||0.174||Not required|
|Apple||Foliar spray /491-517
|7||0.046||0.242||No concentration was observed in food commodities|
|Foliar spray /495-511
|Pear||Foliar spray /494-504
|Foliar spray /493-503
|Cherry||Foliar spray /501-516
|Foliar spray /498-512
|Peach||Foliar spray /489-511
|0||0.153||0.451||Dried peach (3.4x)|
|Foliar spray /494-512
|Plum||Foliar spray /481-499
|Foliar spray /495-509
|Caneberry||Foliar spray/ 499-516||0||0.427||2.392||Not required|
|Highbush blueberry||Foliar spray/ 491-505||0||0.583||4.329||Not required|
|Grape||Foliar spray/ 492-513||6-7||0.099||0.948||Raisin (2.9x)|
|Strawberry||Direct broadcast/ 491-519||0||0.196||1.012||Not required|
|Almond nutmeat||Foliar spray /481-499
|Foliar spray /495-509
|Pecan nutmeat||Foliar spray /481-499
|Foliar spray /495-509
|Field corn grain||Foliar spray/ 492-520||11-14||<0.01||0.018||Corn bran (2.6x)|
|Sweet corn K+CWHR||Foliar spray/ 495-527||0||<0.01||<0.01||Not required|
|Wheat grain||Foliar spray/ 492-514||12-15||<0.01||0.720||Wheat bran (2.7x), wheat germ (2.4x)|
|Sorghum grain||Foliar spray/ 495-518||12-14||<0.01||0.705||Not required|
|Basil, fresh leaves||Foliar spray/ 498-520||0||18.78||30.00||Not required|
|Basil, dried leaves||Foliar spray/ 498-520||0||90.61||180.8||Not required|
|Dill seed, dried||Foliar spray/ 493-513||14||9.162||29.59||Not required|
|Canola seed||Foliar spray/ 492-508||12-14||0.096||0.425||No concentration was observed in food commodities|
|Sunflower seed||Foliar spray/ 486-504||12-14||0.012||0.382||No concentration was observed in food commodities|
|Globe artichoke||Foliar spray/ 496-507||0||1.02||1.37||Not required|
|Hops, dried cones||Foliar spray/ 494-514||7||5.80||25.37||Not required|
|Peanut nutmeat||Seed treatment (250 g ai/ha) + foliar application (250 g ai/ha)||6-10||<0.01||0.128||No concentration was observed in food commodities|
|Orange||Foliar spray /490-513
|6-7||0.031||0.352||Citrus oil (16x)|
|Foliar spray /494-513
|Lemon||Foliar spray /499-511
|Foliar spray /499-511
|Grapefruit||Foliar spray /497-511
|Foliar spray /497-511
|Undelinted cotton seed||Seed treatment (72-74 g ai/ha) + in-furrow application at planting (175-182 g ai/ha) + foliar broadcast application (247-259 g ai/ha)||28-31||<0.01||0.465||No concentration was observed in food commodities|
|Sugarcane||Application to soil/ 493-506 (Rotational, plantback interval of 13-14 days)||NA||<0.01||0.043||No quantifiable residues were observed at exaggerated rates|
Based on the dietary burden and residue data, MRLs of 10 ppm in meat by-products of cattle, goats, horses and sheep, 2.0 ppm in milk, 1.5 ppm in fat and meat of cattle, goats, horses and sheep, 0.15 ppm in meat byproducts of poultry, 0.06 ppm in meat byproducts of hogs, and 0.05 ppm in fat of poultry to cover residues of fluopyram including the metabolite fluopyram-benzamide (expressed as parent equivalent) are also proposed.
Following the review of all available data, MRLs as proposed in Table 1 are recommended to cover residues of fluopyram. Residues of fluopyram in these crop and livestock 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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