Proposed Maximum Residue Limit PMRL2012-42, Saflufenacil

Notice to the reader: The online consultation is now closed. Comments and suggestions received during the public consultation period are being considered in the finalization of this document. The final report will be made available as soon as possible.

Pest Management Regulatory Agency
27 August 2012
ISSN: 1925-0843 (PDF version)
Catalogue number: H113-24/2012-42E-PDF (PDF version)

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Under the authority of the Pest Control Products Act, Health Canada's Pest Management Regulatory Agency (PMRA) has concluded that the addition of a harvest aid use on dry common beans, dry field peas, lentils, soybeans and sunflowers to the product label of Heat WG, and dry common beans and soybeans to the product label of Eragon, both containing technical grade saflufenacil, is acceptable. The specific uses approved in Canada are detailed on the labels of Heat WG and Eragon, Pest Control Products Act Registration Numbers 29368 and 29372, respectively.

The evaluation of these applications indicated that the end-use products have merit and value and the human health and environmental risks associated with the new use pattern are acceptable. Details regarding the registrations can be found in the corresponding Evaluation Reports available in the Pesticides and Pest Management section of Health Canada's website, under Public Registry, Pesticide Product Information Database.^{Footnote 1}

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 a saflufenacil MRL for undelinted cotton seeds 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 food commodities when saflufenacil is used according to label directions in the exporting country. The Agency has also determined that such residues will not be a concern to human health and is proposing to legally establish a corresponding import MRL. Details regarding the proposed import MRL are also found in the Evaluation Report.

Consultation on the proposed MRLs for saflufenacil is being conducted via this document (see Next Steps). Note that the currently established 1.0 ppm MRL for sunflower seeds is sufficient to cover residues resulting from the new harvest aid use. The currently established MRLs for all other food commodities need to be revised to accommodate the new use pattern in accordance with Table 1.

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 in Canada in or on food, to replace MRLs already legally established for saflufenacil, are as follows.

Table 1 - Proposed Maximum Residue Limits for Saflufenacil.

Common Name	Residue Definition	MRL (ppm)	Food Commodity
Table 1 footnotes Table 1 footnote 1 = parts per million Return to table 1 footnote ppm referrer Table 1 footnote 2 The residue definition in Table 1, reflecting parent chemical only, is proposed to replace the currently established residue definition for almonds, "2-methyloxirane, including the metabolites 1-bromo-2-propanol, 2-bromo-1-propanol, 1-chloro-2-propanol and 2-chloro-1-propanol". Almonds represent the only commodity currently with a Canadian MRL for propylene oxide and the 300 ppm MRL remains in effect, consistent with the tree nut crop group MRL proposed in this action. Return to table 1 footnote a referrer Table 1 footnote 2 The MRL is proposed to replace the current 0.8 ppm MRL due to the increase in livestock dietary burden resulting from the addition of the harvest aid use pattern. The MRL for liver of hogs is unaffected and remains at 0.8 ppm, consistent with the American tolerance. Return to table 1 footnote b referrer Table 1 footnote 2 The MRL is proposed to replace the current 0.02 ppm MRL due to the increase in livestock dietary burden resulting from the addition of the harvest aid use pattern. The MRL for meat byproducts, except liver, of hogs is unaffected and remains at 0.02 ppm, consistent with the American tolerance. Return to table 1 footnote b referrer
Saflufenacil	2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino] sulfonyl]benzamide, including the metabolites N'-{2-chloro-4-fluoro-5-[1,2,3,6-tetrahydro-2,6-dioxo-4-(trifluoromethyl)pyrimidin-1-yl] benzoyl}-N-isopropyl sulfamide and N-[4-chloro-2-fluoro-5-({[(isopropylamino) sulfonyl]amino}carbonyl)phenyl]urea	0.3	Dried shelled pea and bean, except soybean (Crop Subgroup 6C)Table 1 footnote a
		0.2	Undelinted cotton seedsTable 1 footnote a
		0.1	Dry soybeansTable 1 footnote a
	2-chloro-5-[3,6-dihydro-3-methyl-2,6-dioxo-4-(trifluoromethyl)-1(2H)-pyrimidinyl]-4-fluoro-N-[[methyl(1-methylethyl)amino] sulfonyl]benzamide	2.5	Liver of cattle, goats, horses and sheepTable 1 footnote b
		0.05	Meat byproducts, except liver of cattle, goats, horses and sheepTable 1 footnote c

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.

A complete list of pesticide MRLs established in Canada, as of the date indicated, can be found on the Maximum Residue Limits for Pesticides webpage in the Pesticides and Pest Management section of Health Canada's website.

International Situation and Trade Implications

The proposed Canadian MRLs for saflufenacil are the same as corresponding tolerances established in the United States (tolerances are listed in the Electronic Code of Federal Regulations, 40 CFR Part 180). Currently, there are no Codex MRLs^{Footnote 2} listed for saflufenacil in or on any commodity covered under this MRL action on the Codex Alimentarius Pesticide Residues in Food webpage.

Next Steps

The PMRA invites the public to submit written comments on the proposed import MRLs for propylene oxide 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 for propylene oxide and posting a corresponding Established Maximum Residue Limit document on the PMRA website.