Information Note - Administrative Changes to the Publication Process for Maximum Residue Limits Regulated Under the Pest Control Products Act
This information note serves to advise stakeholders of the administrative changes to the current publication process for maximum residue limits (MRLs) that are regulated under the Pest Control Products Act (PCPA).
As part of the assessment process, prior to the registration of a pesticide, Health Canada’s Pest Management Regulatory Agency (PMRA) must determine whether the consumption of the maximum amount of residues, that are expected to remain on food products when a pesticide is used according to label directions, will not be a concern to human health. This maximum amount of residues expected is then legally established as an MRL and is regulated under the PCPA.
Prior to June 16, 2008, MRLs that were determined by Health Canada to be acceptable, were established by regulation under the Food and Drugs Act (FDA) via publication in Canada Gazette, Part II, following consultation in Canada Gazette, Part I. Those MRLs appeared in Table II, Part B, Division 15 of the Food and Drug Regulations (FDR). On June 16, 2008, the FDA was amended, via Bill C-28, to allow pesticide MRLs to be legally established by being specified under the PCPA, without having to be adopted by regulation under the authority of the FDA, and to deem all pesticide MRLs in Table II to have been specified under the PCPA. This change has resulted in a more efficient means of establishing, revising and revoking pesticide MRLs without adversely impacting food safety.
The current process for establishing MRLs in Canada involves the publication of a Proposed MRL (PMRL) document, which is subject to a 75 day consultation period (both domestic and international). Following the consultation, an Established MRL (EMRL) document is then posted on the Health Canada website. If comments are received, they are addressed in the Appendix of the EMRL document. All PMRLs are legally in effect as of the publication date of their corresponding EMRL document.
3.0 Administrative Changes to the Current Process
While the legislative change to the FDA allowing MRLs to be established by being specified under the PCPA, has resulted in a more efficient means of establishing, revising and revoking pesticide MRLs, delays in posting both PMRL and EMRL documents are still being encountered.
To address these delays, Health Canada has taken the following steps in facilitating how the MRL information is made available on the Health Canada website:
- All PMRL documents will now include the scientific information that was used to support the proposed MRLs. This information will be provided as an appendix to the PMRL document; and
- While the PMRL Series will continue to be published under Consultations on the Health Canada website, the EMRL Series will no longer be published. Instead, the EMRL Series will be replaced with the MRL Database, an online query application that allows users to search for established MRLs, regulated under the PCPA, both for pesticides or food commodities.
Once the consultation period for the PMRL is closed, the established MRLs will be legally in effect as of the publication date in the MRL database. Should comments be received, they will be addressed in a separate document that will be linked back to the published PMRL.
4.0 Implications for Stakeholders
The changes noted above will result in a more efficient means of establishing, revising and revoking pesticide MRLs without adversely impacting food safety as well as making available a searchable database of established Canadian MRLs.
In addition to this information note, guidance reflecting this change is provided on the Health Canada Maximum Residue Limits for Pesticides webpage and detailed instructions on how to use the MRL Database are available on the MRL Database webpage.
This information note documents and clarifies PMRA's administrative changes to the current publication process for MRLs regulated under the PCPA, which will come into effect as of the publication date of this note.
Questions concerning this information note should be directed to the Health Canada Pest Management Information Service.
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