31 January 2008
ISBN: 978-0-662-47735-8 (978-0-662-47736-5)
Cat. No.: H113-5/2008-2E (H113-5/2008-2E-PDF)
(REV2008-02)
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Health Canada's Pest Management Regulatory Agency (PMRA) is reviewing the continued acceptability of older active ingredients and their associated end-use products under the current re-evaluation program. Since the initiation of the re-evaluation program, registrants have chosen to discontinue a number of active ingredients and their associated end-use products. In such cases, the PMRA does no further review of the pesticide and a schedule, including last dates of sale and use (i.e. expiry date) is established for existing products. Furthermore, for agricultural products, the PMRA recommends that maximum residue limits (MRLs) be amended, unless additional data to support residues in imported foods are provided.
The purpose of this document is to inform interested parties of the discontinuation of such active ingredients and the revocation of the corresponding MRLs. Parties interested in supporting import MRLs should submit their requests with sufficient time to allow the PMRA to make a decision regarding the petition, prior to the revocation of the corresponding MRLs. In addition, some interim mitigation measures to be implemented prior to expiry are outlined for certain active ingredients.
The purpose of this document is as follows:
Currently, MRLs are legally established under the Food and Drug Regulations after consultation through the Canada Gazette. Amendments to the Food and Drugs Act, via
Bill C-28, anticipated to come into force in the near future, 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, resulting in a more efficient means of establishing, revising and revoking pesticide MRLs. Once the amendments to the Food and Drugs Act are in force, the list of legally established Canadian MRLs will be available on the PMRA's MRL webpage.
In general, when the use of an agricultural pesticide is discontinued in Canada, the PMRA will recommend that all existing MRLs be revoked, unless there is reason to believe that those MRLs will be needed for imported commodities. In such cases, data must be provided to evaluate the continued acceptability of food residues of that active ingredient using current approaches. This requirement is to enable the PMRA to assess the continued acceptability of MRLs currently listed in Table II, Division 15 of the Food and Drug Regulations. Examples of such situations include the following:
If no supporting information is provided regarding American tolerances or other indications of the need to maintain import MRLs, proposed amendments to the MRLs will be addressed under the Pest Control Products Act.
The timing of the amendments to the MRLs will be adjusted for each active ingredient to reflect the discontinuation schedule of the products. When the registration of an agricultural chemical is discontinued, existing products may be applied to crops following the label instructions until the product expiry date, which is determined when the product is discontinued. The PMRA proposes that, under normal circumstances, the existing MRLs remain in place for at least an additional year after the last expiry date of all end-use products containing that pesticide. This is to ensure that food treated legally in Canada is able to clear the channels of trade.
Table 1 includes recently discontinued pesticide active ingredients that have MRLs currently listed in Table II, Division 15 of the Food and Drug Regulations. Table 1 also presents the last date that any product containing the active ingredients may be applied to any crop in Canada and the earliest date when proposed MRL changes could take effect.
Table 2 lists recently discontinued pesticide active ingredients that could be used on food in Canada until the expiry date, for which there are currently no specific MRLs in Canada. This document informs stakeholders of the registration change of these products.
Where no specific MRL is established for a pest control product under the Food and Drug Regulations, subsection B.15.002(1) applies. This requires that residues do not exceed 0.1 ppm, which is considered a general MRL for enforcement purposes. However, changes to this general MRL may be implemented in the future, as indicated in Discussion Document DIS2006-01, Revocation of 0.1 ppm as a General Maximum Residue Limit for Food Pesticide Residues [Regulation B.15.002(1)]. If and when the general MRL is revoked, a transition strategy will be established to allow permanent MRLs to be promulgated.
| Active Ingredient | Product Type | Marketing Type | Reg. No. | Product Name | Canadaian-Labelled Uses | Last Date of Application (expiry date)Table 1 footnote 1 | Earliest Date the MRL Change Would Take EffectTable 1 footnote 2 |
|---|---|---|---|---|---|---|---|
Table 1 footnotes
|
|||||||
| Phosalone |
Insecticide; Acaricide | Domestic | 15416 | Wilson Fruit Plus | Apple, pear, cherry, grape, peach, plum/prune | 31 December 2009 | 30 September 2013 |
| Insecticide; Acaricide | Domestic | 24092 | Wilson Fruit Plus 1 | 31 December 2009 | |||
| Insecticide; Acaricide | Commercial | 17983 | Zolone Flo Insecticide | 30 September 2012 | |||
| Vinclozolin |
Fungicide | Commercial | 24894 | Ronilan EG Contact Fungicide | Canola, beans, lettuce, strawberries | 31 December 2010 | 31 December 2011 |
| Zineb | Fungicide | Commercial | 9318 | Zineb 80W | Asparagus, broccoli, Brussels sprouts, cabbage, carrots, cauliflower, celery, cucumbers, eggplant, lettuce, melons, onions (dry), onions (green), peppers, potatoes, pumpkins, squash, tomatoes | 31 December 2010 | 31 December 2011 |
| Insecticide; Fungicide | Domestic | 10644 | Co-op Bug & Blight Control Insecticide-fungicide Dust | Potatoes | 31 December 2008 | ||
| Insecticide; Fungicide | Domestic | 11515 | Manchester 2 In 1 Bug Killer Dust | 31 December 2010 | |||
| Insecticide; Fungicide | Domestic | 10711 | King PTV Potato Dust | 31 December 2010 | |||
| Active Ingredient | Product Type | Marketing Type | Reg. No. | Product Name | Uses | Last Date of Application (expiry date)Table 1 footnote 1 |
|---|---|---|---|---|---|---|
Table 1 footnotes
|
||||||
| Oxine Benzoate | Fungicide | Commercial | 3794 | No-damp Fungicide for Damping-off | Ornamental seedlings and cuttings; vegetable seedlings and cuttings | 31 December 2011 |
| Fungicide | Domestic | 11880 | No-damp Fungicide for Damping-off | Seedlings and cuttings | ||
| Dinocap | Fungicide; Acaricide; | Commercial | 10495 | Dikar Wettable Powder Fungicide-miticide | Apples, pears, grapes | 31 December 2012 |
For commercial phosalone products, label changes will be implemented in time for the 2008 use season. These include changes to crops (remove use on grapes), preharvest intervals, restricted-entry intervals, additional worker protection measures and label statements for bystander protection from spray drift.
For the commercial vinclozolin product, the registrant will communicate additional protective measures to users in order to further protect human health. These measures include advising against the use of human flaggers, the addition of restricted-entry intervals, label statements for bystander protection from spray drift, as well as communicating to users that vinclozolin should no longer be used on strawberries.
Parties interested in supporting an MRL to allow imports of specific commodities treated with pesticides specified in this proposal should submit their requests with sufficient time to allow the PMRA to review the supporting data package and make a decision regarding the petition, prior to the revocation of the corresponding MRLs.