On September 7, 2017, the Pest Management Regulatory Agency (PMRA) published in the Canada Gazette a set of amendments to the Pest Control Products Regulations (PCPR) for implementation of the Canada-European Union Comprehensive Economic and Trade Agreement (CETA). A key objective of CETA is to eliminate trade barriers between Canada and the European Union (EU) on most goods. The recently published amendments have an effective date of September 21, 2017 and seek to align the PCPR with Article 20.30 of CETA which requires Canada to promulgate regulations aimed at avoiding duplicative animal testing. Under the amendments, an applicant or registrant of a pest control product will be allowed to rely on a previous study involving animals rather than completing a new, duplicative study in support of an application, re-evaluation or special review of a chemical. PMRA states, “Health Canada is engaged in ongoing efforts to develop and implement testing methods that avoid the use of live animals and adhere to the ‘Three Rs’ (reduce, refine, replace), which are the guiding principles for more ethical use of animals in testing.” PMRA provides as an example Health Canada’s implementation of guidance and criteria that allow for data waivers and bridging or extrapolation of data from one pesticide product to another.
Prior to the promulgation of the amendments to the PCPR, Health Canada consulted with affected stakeholders, including generic pesticide product manufacturers, in early May 2017. As part of this outreach effort, Health Canada invited interested parties to engage in a May 4, 2017 conference call and webinar that had 40 participants. During this event, several stakeholders representing the generic pesticide manufacturing industry urged Health Canada to create an online accessible database of existing test data which would identify the protection status of such data. Generic registrants also called upon Health Canada to specify in the database which data have already received compensation in the EU. Health Canada noted that it is working on the establishment of an online database that would be available to applicants and registrants for purposes of viewing the status of protected data. However, with regard to tagging that data for which compensation has already been made in the EU, Health Canada maintained that this information would be disclosed during the normal course of data compensation negotiation and/or arbitration proceedings.
The amendments to the PCPR as published in the Canada Gazette may be accessed by clicking here.