Proposed Maximum Residue Limit PMRL2023-41, Mefentrifluconazole

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Pest Management Regulatory Agency
7 September 2023
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2023-41E-PDF (PDF version)

Purpose of consultation

Maximum residue limits (MRLs)^{Footnote 1} are being proposed for the pesticide mefentrifluconazole, as part of the following applications under submission number 2021-1865 for Canadian use, and submission number 2021-2499 for imported commodities.

Under the authority of the Pest Control Products Act, Health Canada’s Pest Management Regulatory Agency (PMRA) is proposing acceptability of the requested application to add new commodities [certain commodities within bulb and green onions (crop subgroups 3-07A and 3-07B), leafy vegetables (crop group 4-13), fruiting vegetables (crop group 8-09), melon and squash/cucumber (crop subgroups 9A and 9B), bushberries (except gooseberries) (crop subgroup 13-07B) and low growing berries (crop subgroup 13-07G)] to the product label of Cevya containing technical grade mefentrifluconazole, to control or suppress certain fungal diseases. The specific uses approved in Canada are detailed on this product label, Pest Control Products Act Registration Number 33405.

The evaluation of this mefentrifluconazole application indicated that the end-use product has value, and the human health and environmental risks associated with the new uses are acceptable. Dietary risks from the consumption of foods listed in Table 1 were shown to be acceptable when mefentrifluconazole is used according to the supported label directions. Therefore, foods containing residues resulting from this use are safe to eat, and MRLs are being proposed as a result of this assessment. A summary of the field trial data used to support the proposed MRLs can be found in Appendix I.

In addition, Health Canada is proposing acceptability of the request to specify MRLs for mefentrifluconazole on imported commodities (root vegetables (except sugar beet) (crop subgroup 1B), leaves of root and tuber vegetables (crop group 2), bulb and green onions (crop subgroups 3-07A and 3-07B), leafy vegetables (except head lettuce) (crop group 4-13), fruiting vegetables (crop group 8-09), sunflowers (crop subgroup 20B), dried tomatoes, bananas, sugarcane cane, green coffee beans and undelinted cotton seeds) to control or suppress certain fungal diseases, in order to permit the import and sale of food that could contain such residues. Health Canada has determined the quantity of residues that may remain in or on the imported commodities when mefentrifluconazole is used according to the label directions of the exporting country, and that such residues will not be a concern to human health. These import MRL proposals do not result in a change of the current approved conditions of use in Canada.

Dietary health assessment

In assessing the risk of a pesticide, Health Canada combines information on pesticide toxicity with information on the degree and duration of dietary exposure to the pesticide residue from food. The risk assessment process involves four distinct steps:

Identifying the toxicology hazards posed by the pesticide;
Determining the “acceptable dietary level” for Canadians (including all vulnerable populations), which is protective of adverse health effects;
Estimating human dietary exposure to the pesticide from all applicable sources (domestic and imported commodities); and
Characterizing health risk by comparing the estimated human dietary exposure to the acceptable dietary level.

Before registering a pesticide for food use in Canada, Health Canada must determine the quantity of residues that could 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 (Steps 3 and 4 above). If estimated human exposure is less than or equal to the acceptable level (developed in Step 2 above), Health Canada concludes that consuming residues resulting from use according to approved label directions is not a health concern. The proposed MRL is then subject to consultation to legally specify it as an MRL. An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except for certain instances where different MRLs are specified for the raw agricultural commodity and its processed product(s).

Consultation on the proposed MRLs for mefentrifluconazole is being conducted via this document. Health Canada invites the public to submit written comments on the proposed MRLs for mefentrifluconazole in accordance with the process outlined in the Next steps Section of this document.

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.

Proposed MRLs

The proposed MRLs, to be added to the MRLs already established for mefentrifluconazole, are summarized in Table 1.

Table 1 Proposed maximum residue limits for mefentrifluconazole
Common name	Residue definition	MRL (ppm)^{Table 1 Footnote 1}	Food commodity
Mefentrifluconazole	α-[4-(4-chlorophenoxy)-2-(trifluoromethyl)phenyl]-α-methyl-1H-1,2,4-triazole-1-ethanol	30	Leafy vegetables (crop group 4-13, except head lettuce)
		20	Leaves of root and tuber vegetables(human food or animal feed) (crop group 2)
		5.0	Bushberries (crop subgroup 13-07B, except gooseberries^{Table 1 Footnote 2}); head lettuce
		4.0	Green onions (crop subgroup 3-07B); dried tomatoes
		2.0	Low growing berries (crop subgroup 13-07G)
		1.5	Bananas; sugarcane cane
		0.9	Fruiting vegetables (crop group 8-09)
		0.7	Root vegetable (except sugar beet) (crop subgroup 1B)
		0.5	Melon (crop subgroup 9A); green coffee beans
		0.2	Bulb onions (crop subgroup 3-07A); squash/cucumber (crop subgroup 9B); undelinted cotton seeds
		0.15	Sunflowers (crop subgroup 20B, revised)
Table 1 Footnote 1 ppm = parts per million Return to table 1 footnote 1 referrer Table 1 Footnote 2 An MRL of 1.5 ppm is already established for gooseberries under crop subgroup 13-07F (Small fruits vine climbing, except fuzzy kiwifruit) Return to table 1 footnote 2 referrer

The commodities included in the listed crop groups/subgroups can be found on the Residue Chemistry Crop Groups webpage in the Pesticides section of Canada.ca.

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 geographic locations of the crop field trials used to generate residue chemistry data.

Table 2 compares the MRLs proposed for mefentrifluconazole in Canada with corresponding American tolerances. American tolerances are listed inthe Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide. Currently, there are no Codex MRLs^{Footnote 2} listed for mefentrifluconazole in or on the petitioned commodities on the Codex Alimentarius Pesticide Index webpage.

Table 2 Comparison of proposed Canadian MRLs, American tolerances and codex MRLs
Food commodity	Canadian MRL (ppm)	American tolerance (ppm)	Codex MRL (ppm)
Green coffee beans	0.5	0.4	Not established
Bushberries (crop subgroup 13-07B, except gooseberries)	5.0	5 (bushberry, subgroup 13-07B), including gooseberries
Leafy vegetables (crop group 4-13, except head lettuce)	30	30
Head lettuce	5.0	5
Leaves of root and tuber vegetables (crop group 2)	20	20
Green onions (crop subgroup 3-07B)	4.0	4
Dried tomatoes	4.0	4
Low growing berries (crop subgroup 13-07G)	2.0	2
Bananas	1.5	1.5
Sugarcane cane	1.5	1.5
Fruiting vegetables (crop group 8-09)	0.9	0.9
Root vegetables (except sugar beet) (crop subgroup 1B)	0.7	0.7
Melon (crop subgroup 9A)	0.5	0.5
Bulb onions (crop subgroup 3-07A)	0.2	0.2
Squash/cucumber (crop subgroup 9B)	0.2	0.2
Undelinted cotton seeds	0.2	0.2 (cottonseed, crop subgroup 20C)
Sunflowers (crop subgroup 20B, revised)	0.15	0.15

Next steps

Health Canada invites the public to submit written comments on the proposed MRLs for mefentrifluconazole up to 75 days from the date of publication of this document. Please forward your comments to Publications (see the contact information on the cover page of this document). Health Canada will consider all comments received and a science-based approach will be applied in 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 mefentrifluconazole in carrot roots, radish roots, radish leaves, turnip greens, dry bulb onions, green onions, head lettuce, leaf lettuce, spinach, mustard greens, tomatoes, peppers, cucumbers, summer squash, muskmelons, blueberries, strawberries, sunflowers, bananas, coffee, cotton, and sugarcane were submitted and reviewed to:

support the use of Cevya (Reg. No. 33405) on selected crops from bulb and green onions (crop subgroups 3-07A and 3-07B), leafy vegetables (crop group 4-13), fruiting vegetables (crop group 8-09), melon and squash/cucumber (crop subgroups 9A and 9B), bushberries (except gooseberries) (crop subgroup 13-07B) and low growing berries (crop subgroup 13-07G).
support the maximum residue limits on imported commodities of root vegetables (except sugar beet) (crop subgroup 1B), leaves of root and tuber vegetables (crop group 2), bulb and green onions (crop subgroups 3-07A and 3-07B), leafy vegetables (except head lettuce) (crop group 4-13), fruiting vegetables (crop group 8-09), sunflowers (crop subgroup 20B, revised), dried tomatoes, bananas, coffee, cotton and sugarcane.

Previously reviewed residue data on sugar beet roots and tops were reassessed. In addition, processing studies in treated tomatoes, sugar beets, soybeans, cotton, and coffee were reviewed or reassessed to determine the potential for concentration of residues of mefentrifluconazole into processed commodities.

Dietary risk assessment results

Acute dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 8% of the acute reference dose, and therefore there are no health concerns.

Chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 19% of the acceptable daily intake, and therefore there are no health concerns.

Maximum residue limits

The recommendation for maximum residue limits (MRLs) for mefentrifluconazole 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 the food commodities listed above.

Table A1 Summary of field trial and processing 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)	Experimental processing factor
Carrot roots	Foliar application/ 450–466	6–7^{Table a1 Footnote 5}	<0.01	0.215	Not applicable
Radish roots	Foliar application/ 438–457	7–8	<0.01	0.380	Not applicable
Radish leaves	Foliar application/ 438–457	7–8	0.37	7.95	Not applicable
Turnip greens	Foliar application/ 452–457	7	3.15	10.0	Not applicable
Dry bulb onions	Foliar application/ 447–465	6–8	<0.01	0.108	Not applicable
Green onions	Foliar application/ 448–498	7	0.11	2.05	Not applicable
Head lettuce	Foliar application/ 447–466	0	0.12	2.15	Not applicable
Leaf lettuce	Foliar application/ 447–466	0	2.25	7.20	Not applicable
Spinach	Foliar application/ 449–458	0	3.75	17.0	Not applicable
Mustard greens	Foliar application/ 437–455	0	4.10	12.0	Not applicable
Cherry tomatoes	Foliar application/ 372–398	0	0.125	0.405	Dried tomato: 9.2× Juice: 0.1× Paste: 0.5× Puree: 0.3×
Tomatoes	Foliar application/ 395–417	0	0.026	0.370	Dried tomato: 9.2× Juice: 0.1× Paste: 0.5× Puree: 0.3×
Bell peppers	Foliar application/ 397–405	0	0.044	0.729	Not applicable
Non-bell peppers	Foliar application/ 397–398	0^{Table a1 Footnote 6}	0.188	0.602	Not applicable
Muskmelons	Foliar application/ 447–457	0	0.105	0.217	Not applicable
Cucumbers	Foliar application/ 446–467	0	0.013	0.096	Not applicable
Summer squash	Foliar application/ 449–460	0	<0.01	0.088	Not applicable
Blueberries	Foliar application/ 437–464	0	0.055	3.155	Not applicable
Strawberries	Foliar application/ 445–469	0	<0.01	1.050	Not applicable
Sunflowers	Foliar application/ 295–308	18–22	<0.01	0.062	Refined oil: <0.8×^{Table a1 Footnote 2} <0.1×^{Table a1 Footnote 3}
Bananas	Foliar application/ 700	0^{Table a1 Footnote 7}	0.026	0.605	Not applicable
Coffee	Foliar application/ 407–520	9–15^{Table a1 Footnote 8}	<0.01	0.435	Concentrated liquor: <0.1× Instant: 0.2× Roasted and ground: 0.6×
Cotton	Foliar application/ 438–458	28–33	0.01	0.118	Refined oil: <0.1×
Sugarcane	Foliar application/ 298–324	13–14	0.097	0.97	Refined sugar: <0.1×^{Table a1 Footnote 4}
Table A1 Footnote 1 g a.i./ha = grams of active ingredient per hectare Return to table A1 footnote 1 referrer Table A1 Footnote 2 Processing factor taken from processing data for soybean. Return to table A1 footnote 2 referrer Table A1 Footnote 3 Processing factor taken from processing data for cotton. Return to table A1 footnote 3 referrer Table A1 Footnote 4 Processing factor taken from processing data for sugar beet. Return to table A1 footnote 4 referrer Table A1 Footnote 5 Residues from a 14-day decline trial sample was used in the OECD calculator for carrot root, to account for higher residues at the longer PHI. Return to table A1 footnote 5 referrer Table A1 Footnote 6 Residues from a 3-day decline trial sample was used in the OECD calculator for non-bell pepper, to account for higher residues at the longer PHI. Return to table A1 footnote 6 referrer Table A1 Footnote 7 Residues from 1, 3, and 7-day decline trial samples were used in the OECD calculator for banana, to account for higher residues at the longer PHIs. Return to table A1 footnote 7 referrer Table A1 Footnote 8 Residues from 30, 45, and 60-day decline trial samples were used in the OECD calculator for coffee, to account for higher residues at the longer PHIs. Return to table A1 footnote 8 referrer

Following the review of all available data, the MRLs proposed in Table 1 are recommended in order to cover residues of mefentrifluconazole. Dietary risks from exposure to residues of mefentrifluconazole in these crops and livestock commodities at the proposed MRLs were shown to be acceptable for the general population and all subpopulations, including infants, children, adults and seniors. Thus, the foods that contain residues as listed in Table 1 are considered safe to eat.

References


PMRA Number	Citation
3226181	2015, Validation of BASF Method Number L0076/09 for the determination of BAS 750 F in citrus (whole fruit), coffee (grain), dry beans (seed), soybeans (grain), tomato (whole fruit), wheat (grain) and wheat (straw) using LC-MS/MS, DACO: 7.2.1,7.2.2
3226183	2018, Magnitude of the Residue of BAS 750 F in Carrot and Radish Following Applications of BAS 750 03 F, DACO: 7.4.1,7.4.2
3226185	2018, Magnitude of the Residue of BAS 750 F in/on Turnip Tops Following Applications of BAS 750 03 F, DACO: 7.4.1,7.4.2
3226187	2019, Magnitude of the Residue of BAS 750 F in Sunflower Seeds Following Applications of BAS 750 03 F, DACO: 7.4.1,7.4.2
3226189	2018, Magnitude of the Residue of BAS 750 F in or on Berries and Small Fruits Raw Agricultural Commodities, DACO: 7.4.1,7.4.2
3226191	2018, Magnitude and Decline of BAS 750 F Residues Following Applications of BAS 750 03 F to Fruiting Vegetables (Crop Group 8), DACO: 7.4.1,7.4.2
3226193	2018, Magnitude of the Residue of BAS 750 F in/on Bulb Vegetables Following Applications of BAS 750 02 F, DACO: 7.4.1,7.4.2
3226195	2017, Magnitude of the Residues of BAS 750 F in Cucurbit Vegetables Raw Agricultural Commodities Following Applications of BAS 750 02 F, DACO: 7.4.1,7.4.2
3226197	2019, Magnitude and decline of the residues of BAS 750 F and metabolites in sugarcane following treatment with BAS 750 03 F., DACO: 7.4.1,7.4.2
3226199	2019, Magnitude of BAS 750 F residues following applications of BAS 750 03 F to cotton., DACO: 7.4.1,7.4.2
3226204	2019, Magnitude of the Residues of BAS 750 F in Leafy Vegetables Raw Agricultural Commodities Following Applications of BAS 750 02 F, DACO: 7.4.1,7.4.2
3226209	2019, Residue Study of mefentrifluconazole in banana bagged and unbagged (whole fruit, pulp and peel) after treatment with BAS 750 02 F under field conditions in Brazil, Columbia and Ecuador, DACO: 7.4.1,7.4.2
3226212	2017, Residue study of BAS 750 F and Pyraclostrobin in coffee (beans) after treatment with BAS 750 01 F, under field conditions in Brazil, DACO: 7.4.1,7.4.2
3226214	2018, Residue study of mefentrifluconazole and fluxapyroxad in coffee (beans), after treatment with BAS 752 01 F, under field conditions in Brazil, DACO: 7.4.1,7.4.2
3226217	2016, Residue study of BAS 750 F, fluxapyroxad and pyraclostrobin in coffee (beans), after treatment with BAS 753 03 F, under field conditions in Brazil, DACO: 7.4.1,7.4.2
3226219	2019, Residue study of mefentrifluconazole in coffee (beans), after treatment with BAS 751 01 F under field conditions in Ecuador and Columbia, DACO: 7.4.1,7.4.2
3226220	2018, Magnitude of BAS 750 F Residues in Tomato Processed Fractions, DACO: 7.4.5
3226222	2019, Magnitude of BAS 750 F residues in cotton processed fractions following applications of BAS 750 03 F to cotton., DACO: 7.4.5
3325158	2019, Residue Study of mefentrifluconazole in coffee (dried coffee cherry, beans and processed fractions) after treatment with BAS 751 01 F under field conditions in Brazil, DACO: 7.4.5

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Date modified:: 2023-11-30

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