ARCHIVED - Information Note: Progress on Minimizing Reliance on the 0.1 Parts per Million as a General Maximum Residue Limit for Food Pesticide Residue
The purpose of this note is to provide stakeholders an update on the progress to minimize reliance on the 0.1 parts per million (ppm) General Maximum Residue Limit (GMRL) for food pesticide residues. The note also summarizes and responds to issues raised by those who commented on the 2006 Discussion document.
Health Canada's Pest Management Regulatory Agency (PMRA) is responsible for determining the maximum amount of pesticide residues that might be expected on a food commodity when a pesticide is used according to approved label directions. These residues are referred to as Maximum Residue Limits (MRLs) and are calculated using internationally accepted statistical principles and methods. MRLs are established only if the dietary exposure assessment confirms that the consumption of food containing these residue levels does not pose a human health concern. In Canada, specific MRLs are established for each crop and pesticide combination and apply to both domestically-grown and imported foods.
Existing regulation under the Food and Drug Regulations (FDR) provides for a general maximum residue limit (GMRL) of 0.1 ppm for residues of agricultural chemicals, and pesticides, on domestically grown and imported food, unless specific MRLs are established. Historically, Health Canada relied on the use of the GMRL more frequently when pesticide residues were at or below 0.1 ppm. However, over the past 10 years Health Canada has taken steps to establish specific MRLs for new pesticides or new uses of registered pesticides where the use of a pesticide may result in residues at or below 0.1 ppm in/on food commodities.
Establishing pesticide specific, food-specific MRLs results in a more accurate representation of the actual residues, potentially reduces dietary exposure to pesticides and reduces the reliance on the GMRL.
In 2006, Health Canada sought comments on a regulatory proposal to eventually revoke the 0.1 ppm as a GMRL for pesticide residues on food. The establishment of specific MRLs would strengthen health protection of Canadians and is part of ongoing efforts to modernize pesticide regulation in Canada.
Current Approach to Minimizing Reliance on the GMRL
Following further analysis and consideration of stakeholder's comments, Health Canada has decided that a stepwise approach to reduce reliance on the GMRL will be undertaken before determining a timeframe for the GMRL revocation.
A stepwise approach will efficiently manage the workload for both Health Canada and stakeholders and help to identify areas of concern and avoid potential interruptions in trade in food.
Process for the Establishment of Replacement MRLs
Establishment of specific MRLs to replace the 0.1 ppm GMRL
Following the publication of the 2006 discussion document, amendments to the Food and Drugs Act (FDA) via Bill C-28 in 2008 now permit pesticide MRLs to be established solely under the authority of the PCPA. Although the process for establishing pesticide MRLs in law has changed, the GMRL of 0.1 ppm for pesticide residues on domestically grown and imported food still exists unless specific MRLs are established.
For pesticide/commodity combinations that are currently registered in Canada but have historically been addressed by the 0.1 ppm GMRL, Health Canada will begin consultation on the use of U.S. tolerances at or below 0.1 ppm where these are current and meet Canadian standards.
Consultation on stakeholder needs
Before determining a timeframe for the GMRL revocation, specific MRLs will also need to be established to allow new uses or continued uses of pesticides in Canada and facilitate access to many imported food products. Health Canada will consult with stakeholders to prioritize the establishment of MRLs for pesticide/commodity combinations using modern scientific risk assessment methodologies.
Health Canada will seek the input from Canadian grower groups through activities such as the Grower Priority Database to identify priorities for the establishment of MRLs for commodities grown in Canada and the registration of pesticides and pesticide uses to help bridge the gap in availability of products between Canada and the U.S.
Health Canada will seek input from importers of commodities to identify priorities for the establishment of MRLs for imported commodities. Health Canada will continue to accept and review submissions for an import MRL but will give priority to those requests for an import MRL that are accompanied by a request for registration where Canadian growers have identified the need.
Health Canada will also consider modifying or revoking an import MRL that would contribute significantly to the overall exposure or may pose a human health concern, if domestic use is precluded as a result of an import MRL.
Following establishment of priorities, an analysis will be conducted to identify the required data for an initial list of priorities, and Health Canada will explore options for obtaining the data with registrants, growers and NAFTA partners.
Experience gained through an initial phase of implementation with the time required to set MRLs based on scientific data will allow Health Canada to better identify a future target for revocation of the GMRL.
Other Issues to be Addressed to Reduce Reliance on the GMRL
In the 2006 discussion document, Health Canada provided further clarification and guidance on several issues relating to the revocation of the GMRL. Health Canada received several comments on the proposals for the Canadian research authorization and emergency use. Health Canada recognizes the continued challenges and concerns expressed about the possible impact of the 0.1 ppm revocation on research and emergency use in Canada. Health Canada continues to analyze the issues and consideration will be given to the different comments provided. No final decision has been made on the overall approach for research authorizations and emergency registration. Health Canada will consult with the Canadian public and stakeholders on any proposed changes.
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