June 6, 2008
ISBN: 978-0-662-48985-6 (978-0-662-48986-3)
Cat. No.: H113-24/2008-25E (H113-24/2008-25E-PDF)
(PMRL2008-25)

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Health Canada's Pest Management Regulatory Agency (PMRA), under the authority of the  Pest Control Products Act, has received applications for the conversion of the conditional registrations of Pyraclostrobin Technical Fungicide, Headline EC Fungicide and Cabrio EG Fungicide to full registrations (Pest Control Products Act Registration Numbers 27321, 27322 and 27323, respectively).

The evaluation of these pyraclostrobin applications indicated that the end-use products have merit and value and that the human health and environmental risks associated with their use are acceptable. Details on these applications can be found in Proposed Registration Decision PRD2008-04, Pyraclostrobin.

Pyraclostrobin is conditionally registered for use in Canada to control fungal diseases on labelled root vegetables, bulb vegetables, legume vegetables, fruiting vegetables, cucurbit vegetables, stone fruits, berries, cereal grains (barley, oats, rye and wheat), corn and strawberries.

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 pose an unacceptable health risk. 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.

Currently, MRLs are legally established under the Food and Drug Regulations (FDR) after consultation through the Canada Gazette. Amendments to the Food and Drugs Act via  Bill C-28, anticipated to come into force in 2008, will allow pesticide MRLs to be legally established under the Pest Control Products Act without having to adopt MRLs by regulation under the Food and Drugs Act. This will result in a more efficient means of establishing, revising and revoking pesticide MRLs.

There are no legally established Canadian MRLs for pyraclostrobin. However, 192 MRLs were proposed and consulted upon in Proposed Maximum Residue Limit document PMRL2006-01, Transitioning the Legal Establishment of Maximum Residue Limits (MRLs) for Pesticides from the Food and Drugs Act to the Pest Control Products Act: Consultation on Proposed MRLs, including MRLs for bulb vegetables and berries. However, further residue trials were conducted on a number of fruit and vegetable commodities in representative Canadian zones in accordance with the labelled use pattern to support the conversion to full registration. Based on these trials, higher MRLs are required for bulb vegetables (Crop Group 3) and berries (Crop Group 13) than were previously proposed in PMRL2006-01. See Appendix I for a list of crop group commodities. In addition, new MRLs are being proposed for poultry commodities.

Consultation on the new MRLs for poultry and the revised MRLs for berries and bulb vegetables is being conducted via this document (see Next Steps). Information regarding the proposed MRLs can be found in Sections 3.4.4 and 7.1, Tables 9 and 10 of Appendix I, and Appendix II of PRD2008-04. This action is being taken in advance of Bill C-28 coming into force to allow the MRLs to be legally established as soon as possible after the Food and Drugs Act is amended.

The proposed new and revised MRLs for pyraclostrobin in Canada in or on food are as follows.

Table 1 Proposed Maximum Residue Limits for Pyraclostrobin

Common Chemical Name	Chemical Name of Substance	MRL (ppm)	Food Commodities
Pyraclostrobin	methyl [2-[[[1- (4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl]phenyl] methoxycarbamate, including the metabolite [2-[[[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxy]methyl] phenyl]carbamate	3.5 0.9	Berries (Crop Group 13)* Bulb vegetables (Crop Group 3)**
	methyl [2-[[[1- (4-chlorophenyl)-1H -pyrazol-3-yl]oxy]methyl]phenyl] methoxycarbamate, including the metabolites convertible to 1-(4-chlorophenyl)-1H-pyrazol-3-ol and 1-(3-chloro-4-hydroxyphenyl)-1H-pyrazol-3-ol	0.1	Eggs, meat and meat byproducts of poultry

* PMRL2006-01 proposed an MRL of 1.0 ppm for berry commodities but a higher MRL is required to accommodate residues found in additional supervised residue trials conducted to support the conversion from conditional to full registration (see PRD2008-04, Appendix I, Table 9).
** PMRL2006-01 proposed an MRL of 0.65 ppm for bulb vegetable commodities but a higher MRL is required to accommodate residues found in additional supervised residue trials conducted to support the conversion from conditional to full registration (see PRD2008-04, Appendix I, Table 9).

A complete list of all MRLs established in Canada can be found in  Table II, Division 15 of the Food and Drug Regulations. Once the amendments to the Food and Drugs Act via Bill C-28 are in force, the list of legally established Canadian MRLs will be available on the PMRA's MRL webpage, which will be updated to include the MRLs listed in this document.

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 field crop trials used to generate residue chemistry data. For animal commodities, differences in MRLs can also be due to different livestock feed items and practices.

Table 2 compares the proposed MRLs in Canada, tolerances in the United States (listed in  40 CFR Part 180 by pesticide) and Codex¹ MRLs ( Codex MRLs searchable by pesticide or commodity).

Table 2 Comparison of Canadian MRLs, American Tolerances and Codex MRLs

Food Commodity	Canadian MRL (ppm)	American Tolerance (ppm)	Codex MRL (ppm)
Berries (Crop Group 13)	3.5	4	1.0 (Blueberries)
Bulb vegetables (Crop Group 3)	0.9	0.9	0.2 (Onion, bulb) 0.05 (Garlic)
Meat of poultry	0.1	No poultry tolerances established	0.05
Meat byproducts of poultry	0.1	No poultry tolerances established	0.05 (Edible offal)
Eggs	0.1	No poultry tolerances established	0.05

Next Steps

The PMRA invites the public to submit written comments on the proposed MRLs for pyraclostrobin up to 75 days from the date of publication of this document. Please forward your comments to Publications (see contact information on the cover page of this document). The PMRA will consider all comments received before making a final decision on the proposed MRLs for pyraclostrobin and posting an Established Maximum Residue Limit (EMRL) document on the PMRA's website once the amendments to the Food and Drugs Act are in force.

Appendix I

Crop Groups: Numbers and Definitions

Crop Group Number	Name of the Crop Group	Food Commodities Included in the Crop Group
3	Bulb vegetables	Dry bulb onions Garlic Great headed garlic Green onions Leeks Potato onions Rakkyo Shallots Tree onion tops Welsh onion tops
13	Berries	Blackberries Blueberries Currants Elderberries Gooseberries Huckleberries Loganberries Raspberries

¹ Codex is an international organization under the auspices of the United Nations that develops international food standards, including MRLs.