Proposed Maximum Residue Limit PMRL2022-11, Fluensulfone
Pest Management Regulatory Agency
2 June 2022
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2022-11E-PDF (PDF version)
Purpose of consultation
Maximum residue limits (MRLs)Footnote 1 for imported commodities are being proposed for the pesticide fluensulfone, as part of the following application under submission number 2020-1209, in order to permit the import and sale of food in Canada that could contain fluensulfone residues. This import MRL proposal does not result in a change of the current approved conditions of use in Canada.
Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) is proposing acceptability of the request to specify maximum residue limits (MRLs) for fluensulfone on various imported commodities, for the management of certain nematode species.
Health Canada has determined the quantity of residues that may remain in or on the imported commodities when fluensulfone is used according to the label directions of the exporting country, and that such residues will not be a concern to human health. Therefore, the 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.
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 human risk by comparing the estimated human dietary exposure to the acceptable dietary level.
Health Canada must determine the quantity of residues that could remain in or on the imported food commodities when the pesticide is used according to label directions in the exporting country, 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 label directions approved in the foreign country is not a health concern. The proposed MRL is then subject to consultation to legally specify the MRL on the corresponding imported commodity. An MRL applies to the identified raw agricultural food commodity as well as to any processed food product that contains it, except in certain instances where different MRLs are specified for the raw agricultural commodity and its processed product(s).
Consultation on the proposed MRLs for fluensulfone on imported commodities is being conducted via this document. Health Canada invites the public to submit written comments on the proposed MRLs for fluensulfone 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 Canada's Notification Authority and Enquiry Point.
The proposed MRLs, to be added to the MRLs already established for fluensulfone, are summarized in Table 1.
|Common name||Residue definition||MRL (ppm)Table 1 Footnote 1||Food commodity|
|Fluensulfone||5-chloro-2-[(3,4,4-trifluoro-3-buten-1-yl)sulfonyl]thiazole and the metabolite 5-fluoro-3,4-bis(fluoromethyl)-3-pentene-1-sulfonic acid (expressed as parent equivalents)||20||Leafy Brassica greens (crop subgroup 5B)|
|4.0||Root vegetable (except sugar beet) (crop subgroup 1B), leafy vegetables (except Brassica vegetables) (crop group 4)|
|2.0||Potato chips, potato flakes|
|1.5||Head and stem Brassica (crop subgroup 5A), raisins|
|0.8||Tuberous and corm vegetables (crop subgroup 1C), small fruits vine climbing (crop subgroup 13-07D)|
|0.5||Low growing berries (crop subgroup 13-07G)|
|0.4||Pome fruits (crop group 11-09)|
|0.3||Citrus fruits (crop group 10) (revised), sugarcane molasses|
|0.15||Stone fruits (crop group 12-09)|
|0.02||Tree nuts (crop group 14-11)|
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 geographical locations of the crop field trials used to generate residue chemistry data.
Table 2 compares the MRLs proposed for fluensulfone in Canada with corresponding US tolerances and Codex MRLs.Footnote 2 The MRLs proposed for fluensulfone in Canada are the same as corresponding American tolerances as listed in the Electronic Code of Federal Regulations, 40 CFR Part 180, by pesticide, with the exception of dried apples, where the American tolerance for pome fruit applies. A listing of established Codex MRLs is available on the Codex Alimentarius Pesticide Index webpage, by pesticide or commodity.
|Root vegetable (except sugar beet) (crop subgroup 1B)||4.0||4||4 [beetroot, carrot, celeriac, turnip-rooted chervil, horseradish, parsnip, radish, turnip (garden)]|
|Leafy vegetables (except Brassica vegetables) (crop group 4)||4.0||4||1 (leafy vegetables)
0.8 (head lettuce)
|Dried apples||0.9||0.4 (under Fruit, pome)||Not established|
|Tuberous and corm vegetables (crop subgroup 1C)||0.8||0.8||0.8 (potato, sweet potato)|
|Small fruits vine climbing (crop subgroup 13-07D)||0.8||0.8||Not established|
|Pome fruits (crop group 11-09)||0.4||0.4||Not established|
|Citrus fruits (crop group 10) (revised)||0.3||0.3||Not established|
|Sugarcane molasses||0.3||0.3||Not established|
|Stone fruits (crop group 12-09)||0.15||0.15||Not established|
|Sugarcane cane||0.06||0.06||Not established|
|Tree nuts (crop group 14-11)||0.02||0.02||Not established|
Health Canada invites the public to submit written comments on the proposed MRLs for fluensulfone up to 75 days from the date of publication of this document. Please forward your comments to Publications. 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.
Summary of field trial data used to support the proposed maximum residue limits
Residue data from field trials conducted in Canada and the United States were submitted to support the maximum residue limits (MRLs) on several imported crops/crop groups. Fluensulfone was applied to crops at rates equivalent to those on the foreign registered labels, and harvested according to label directions. In addition, processing studies in treated crops were reviewed to determine the potential for concentration of residues of fluensulfone 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 12% of the acute reference dose, and therefore are not a health concern.
Chronic dietary (food plus drinking water) intake estimates indicated that the general population and all population subgroups are exposed to less than 42% of the acceptable daily intake, and therefore are not a health concern.
Maximum residue limits
The recommendation for MRLs for fluensulfone on imported commodities was based upon the submitted field trial data, and the guidance provided in the OECD MRL Calculator. MRLs to cover total combined residues of fluensulfone and the BSA metabolite in/on crops and processed commodities are proposed as shown in Table 1. Residues in processed commodities not listed in Table 1 are covered under the proposed MRLs for the raw agricultural commodities (RACs).
|Commodity||Application method/ Total application rate
(kg a.i./ha)Table A1 Footnote 1
|Preharvest interval (days)||Lowest average field trial residues
(ppm)Table A1 Footnote 2
|Highest average field trial residues
(ppm)Table A1 Footnote 2
|Experimental processing factor|
|Radish roots||PPITable A1 Footnote 3 /4.01–4.13||34–56||0.13||3.51||Not required|
|Turnip roots||PPI or DRIPTable A1 Footnote 4/3.97–4.02||83–115||<0.02||0.58|
|Potatoes||PPI/4.0–4.3||71–148||0.08||0.60||Potato chips: 1.6×
Potato flakes: 2.4×
|Head lettuce||PPI or DRIP/3.93–4.07||53–96||<0.02||0.43||Not required|
|Leaf lettuce||PPI or DRIP/3.91–4.02||43–116||<0.02||1.36|
|Spinach||PPI or DRIP/3.97–4.13||64–88||<0.02||1.78|
|Celery||PPI or DRIP/3.95–4.18||78–104||<0.02||1.03|
|Cabbages||PPI or DRIP/3.93–4.13||66–94||0.05||1.11||Not required|
|Cauliflowers||PPI or DRIP/3.82–3.99||63–137||<0.02||0.28|
|Mustard greens||PPI or DRIP/3.97–4.19||34–71||0.12||6.49|
|Mizuna||PPI or DRIP/3.93–4.15||36–90||0.78||7.98|
Oil: <0.5 – >70×
|Apples||Chemigation/ 3.91–4.16||91–165||<0.02||0.16||Juice: 1.7×
Dried apples: 5.5×
|Sweet cherries and tart cherries||Chemigation/3.96–4.07||43–83||<0.02||0.05||Dried plums: 2.9×
Plum juice: 1.2×
Plum puree: 0.9×
|Strawberries||PPI or DRIP/3.89–4.01||62–199||<0.02||0.28||Not applicable|
|Almond nuts||Chemigation/3.96–4.02||60–90||<0.02||<0.02||Not applicable|
|Sugarcane cane||Chemigation/3.88–4.18||235–265||<0.02||0.04||Molasses: 7.3×
Refined sugar: <0.4×
Following the review of all available data, MRLs as proposed in Table 1 are recommended to cover total combined residues of fluensulfone and the metabolite BSA, expressed in parent equivalents. Dietary risks from exposure to total combined residues of fluensulfone in these imported crop 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 imported foods that contain residues as listed in Table 1 are considered safe to eat.
|3106563||2015, Magnitude of the Residue of MCW-2 in Brassica Vegetables, DACO: 7.4.1|
|3106565||2014, Magnitude of the Residue of MCW-2 in Japanese Leafy Vegetables, DACO: 7.4.1|
|3106566||2014, Magnitude of the Residue of MCW-2 in Japanese Root Vegetables, DACO: 7.4.1|
|3106567||2014, Magnitude of the Residue of MCW-2 in Strawberries, DACO: 7.4.1|
|3106568||2015, Magnitude of the Residue of MCW-2 in Leafy Vegetables, DACO: 7.4.1|
|3106569||2014, Magnitude of the Residue of MCW-2 in Radish, DACO: 7.4.1|
|3106571 & 3232678||2016, Magnitude of Residue of MCW-2 in Citrus (Orange, Lemon and Grapefruit) and Citrus Processed Commodities, DACO: 7.4.1,7.4.5|
|3106572||2016, Magnitude of the Residue of MCW-2 in Stone Fruit (Cherry, Peach and Plum), DACO: 7.4.1|
|3106573||2016, Magnitude of the Residue of MCW-2 in Pome Fruit Crops (Apples and Pears), DACO: 7.4.1|
|3106574||2016, Magnitude of the Residue of MCW-2 in Sugarcane and Sugarcane Processed Commodities, DACO: 7.4.1|
|3106575||2016, Magnitude of Residue of MCW-2 in Tree Nut Crops (Almonds and Pecans), DACO: 7.4.1|
|3106576||2015, Magnitude of the Residue of MCW-2 in Vine Crops (Grape and Kiwifruit) and Processed Commodities of Grape, DACO: 7.4.1|
|3106577||2015, Fluensulfone: Magnitude of the Residue on Carrot, DACO: 7.4.1|
|3106578||2015, Fluensulfone: Magnitude of the Residue on Potato, DACO: 7.4.1|
|3106579||2016, Fluensulfone: Stability of MCW-2 (Fluensulfone) and its Metabolites in Potato Processsing Matrices, DACO: 7.4.1,7.4.5|
|3106580||2015, Fluensulfone: Magnitude of the Residue on Radish, DACO: 7.4.1|
|3106581||2017, Magnitude of the Residue of Fluensulfone in Carrot, Potato, Sugar Beet, and Radish from Formulation Bridging with 15G and 480 EC, DACO: 7.4.1|
|3232679||2017, Freezer Storage Stability of Fluensulfone and Butene Sulfonic Acid in Citrus and Citrus Processed Commodities, DACO: 7.3|
|3232680||2016, Magnitude of Residue of MCW-2 in Peanut and Peanut Processed Commodities, DACO 7.4.1|
- Footnote 1
A maximum residue limit (MRL) is the maximum amount of residue that may remain in or on food when a pesticide is used according to label directions.
- Footnote 2
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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