Response to comments received on PMRL consultation for Ethephon (PMRL2020-39)
Health Canada received comments regarding differences in regulatory outcomes when comparing to international regulatory authorities. These comments also noted the impact of the proposed changes to the maximum residue limits (MRLs) and thus, requested clarification on the enforcement date.
Response from Health Canada
The Pest Management Regulatory Agency’s (PMRA) primary mandate is to prevent unacceptable risks to Canadians and the environment from the use of pesticide products.
The PMRA acknowledges that the outcome of the risk assessment and regulatory decision from various jurisdictions can differ. In the case of ethephon, information from other regulatory authorities was considered during the re-evaluation of this active ingredient, which was also subject to consultation through the proposed re-evaluation decision document (PRVD2018-01). The dietary risk assessment was updated to incorporate comments received through this consultation, including comments on the proposal to revoke the MRLs for ethephon on apples and apple juice. The outcome of the re-evaluation decision was published in RVD2020-09.
While grower and trade implications were considered during the re-evaluation, health risks from residues of ethephon in or on apple commodities were found to pose risks of concern, and there were no feasible mitigation measures to allow ethephon use on apples produced in Canada or imported from other countries. In turn, it was determined that alignment of the MRLs was not possible in this case due to the identified health risks of concern.
With respect to the enforcement date, both registrants and retailers have up to 24 months from the date of publication of the re-evaluation decision for ethephon (RVD2020-09) to transition to selling the product with the required amendments. Similarly, users also have the same 24-month period from the date of publication of the re-evaluation decision to transition to using the newly amended labels, which will be available on the Public Registry. The revocation of MRLs will be legally in effect as of the date they are removed from the MRL database, which is 36 months from the date of publication of RVD2020-09 (published on 24 September 2020).
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