Canadian Seed Trade Association Semi-Annual Meeting PMRA Opening Remarks to the CSTA Seed Applied Technologies Committee Peter Brander Chief Registrar and Director General Pest Management Regulatory Agency November 26, 2018
Overview • Update on the Status of the Neonic Reviews • Update on the Re-evaluation of Thiram • Post-Market Pesticide Program Review Project • IT Update – Public Engagement Portal – Public Registry • Pesticide Treated Seeds – Regulatory Framework – Legislative Requirements – Importer Obligations – Poncho/Votivo seed treatment combination
Update on the Status of Neonic Reviews: Imidacloprid • Full Cyclical Re-evaluation (excluding Pollinators): – Proposed decision published in November 2016 for public comment (PRVD2016-20). • Proposed decision: Phase out all agricultural uses, including seed treatments, and a majority of other outdoor uses for the protection of the environment. • Extensive comments and data were received and are currently under review. • Pollinator Re-evaluation: – Proposed decision published in May 2018 for public comment (PRVD2018-12). • Proposed decision: Phase out many uses of imidacloprid on crops that bees find attractive and to restrict when these products can be applied. Seed treatment uses were found to be acceptable. • Extensive comments were received and are currently under review. • A final decision that includes pollinators, human health, value and a full environmental assessment is anticipated in December 2018: – Will consider comments received on the two consultations of November 2016 and May 2018.
Update on the Status of Neonic Reviews: Clothianidin and Thiamethoxam • Special Reviews on Aquatic Invertebrates : – Proposed decisions published August 15 (PSRD2018-01 and PSRD2018-02). • Proposed decision: Phase out all outdoor agricultural and turf uses of clothianidin and, Phase out all outdoor agricultural and ornamental uses of thiamethoxam. – Consultation ended on November 13th, 2018. Extensive comments and data were received will be reviewed. – Final special review decisions are expected in January 2020. • Pollinator Re-evaluations: – Proposed decisions published December 2017 (PRVD2017-23 and PRVD2017-24). • Proposed decisions: Phase out many of the uses on crops that bees find attractive and to restrict when these products can be applied. Seed treatment uses were found to be acceptable. • Extensive comments were received and are currently under review. – Final decisions are expected in December 2018. • Full Cyclical Re-evaluations (excluding Pollinators and aquatic invertebrates): – Initiated in 2016, currently underway. – Proposed decisions are expected in December 2019.
Update on the Re-evaluation of Thiram • Proposed Re-evaluation Decision (PRVD2016-07) : Proposed decision published February 29 th 2016. – • Proposal to phase out all thiram uses, based on risks of concerns to human health and the environment. – Comments received from the registrants and other stakeholders, including the seed sector. – Comments have been considered and assessments are being revised, where warranted. – A final re-evaluation decision expected in December 2018. – As per current practice, stakeholders will be informed of the document’s release prior to its publication.
Post-Market Pesticide Program Review Project • PMRA is conducting a review of activities relating to the Post-Market Pesticide Re- Evaluation Program, with a view to increasing both the efficiency and the effectiveness of the program. • The current and anticipated Re-evaluation Program workload is exceeding available PMRA resources. To create a sustainable post-market review program that first and foremost continues to protect health and the environment, but is also efficient and streamlined from a stakeholder and regulator perspective. • The review of the post-market pesticide program, will build on the improvements that were implemented in 2016. • PMRA is actively engaging with pesticide stakeholders to identify: 1. areas for improvement with current process and, 2. to inform the development of new re-evaluation models. 6
Engagement Approach PHASE 1 PHASE 2 Information Gathering Engagement Late Fall Winter Fall 18 18 19 Domestic International New Models Proposal • Raise awareness and understanding of the Post- • Present proposed Market Pesticide Program Review initiative. models/changes to re- evaluation processes. • Solicit input from stakeholders on current post- market program and areas for improvement. • Gather feedback and recommendations on • Collect information to inform potential new models proposed improvements. and identify opportunities to improve post-market program. 7 7
International Comparison – Regulatory Partners A detailed analysis was carried out on seven compatible international jurisdictions to compare and contrast pesticide re-evaluation programs with the Canadian model to review best-practices, taking into account the global perspective. 8 8
Key Themes Regulatory Landscape • Legislation and Regulations • Governing Organization Funding Profile/Cost Recovery • Program costs and funding sources • Post-market costs and funding sources • Cost Recovery Post-Market Review • Process • Engagement and Consultation Key Elements • Unique Features • Challenges 9 9
Post-Market Pesticide Program Review: Next Steps Complete Phase 1 Stakeholder Engagement Sessions Draft “What was heard” Report Post “ What was heard” Report for comments Use information provided in Phase 1 to inform the development of new models for Phase 2 Consult Stakeholders on options for New Models Gather information and develop recommendations for Senior Management 10
IT Update: Public Engagement Portal • The Public Engagement Portal (PEP) is a central web portal for the public to interact with HC’s PMRA in six different business areas: 1. Info. Services Inquiry 4. Complaint and Violation Report 2. Consultation Comments 5. Application for Inspection of Confidential Test Data (Reading Room) 3. Voluntary Incident Reports 6. Notice of Objection • The portal provides ease of use to send questions, comments, concerns; • Information is appropriately protected to ensure security and privacy: • To allow PMRA to meet the Government of Canada’s ‘Openness and Transparency’ and ‘Service Excellence’ initiatives.
Who can benefit from this portal? • Any member of the Canadian public can use the Public Engagement Portal. How can the public access the portal? • Available from Health Canada’s PMRA web page • Six forms are available online to complete and submit • A confirmation number is issued upon receipt for tracking, follow-up When will it be available? • Already deployed – ready for use
The Portal
IT Update: Public Registry • It is a collection of non-confidential information on pesticides and the pesticide regulatory system. • It automatically publishes non-confidential information from the PMRA’s internal e-PRS database based on internally established business rules and system processes. Why change the current Pesticide Registry? • To modernise the interface and underlying technology • To improve our transparency; increased availability of information related to submissions, products, actives, data protection status • To improve search capability with advanced search features and provide an API (Application Programming Interface) • To meet user interface accessibility standards (WCAG 2.0) • To integrate mobile computing technology.
The Pesticide Registry
Pesticide Treated Seeds: Regulatory Framework • It is recognized that seed used for planting crops is produced and marketed worldwide. – In Canada, seeds used for planting are both produced domestically and imported. • According to Statistics Canada, in 2014, approximately 163 million kilograms of seed (not just for sowing/planting) was imported into Canada (e.g., corn, canola seed, soybean seed). • In some cases (e.g., canola), demand for seed for commercial production in Canada is mainly met domestically; for others (e.g., vegetable crops), there is limited domestic product and demand is met through imported seed. – Often, seed is pre-treated with pesticides.
Pesticide Treated Seeds: Legislative Requirements • Seeds pre-treated with pesticides are pest control products under the Pest Control Products Act (PCPA) and Regulations (PCPR). – As such, it is prohibited to manufacture, import, or use treated seeds unless certain conditions are met. • To be exempt from registration (but still subject to regulation under the PCPA), both the active ingredient and the seed treatment product must be registered in Canada for the purpose of treating the seed (i.e., to benefit from the registration exemption as per paragraph 4(1)(b) and Schedule 2, item 3 of the PCPR). • Alternatively, the seed itself could be registered as a pesticide although this has not been done to date. • Importers of pesticides, including importers of pesticide-treated seeds, are required under the PCPR (section 36) to provide an import declaration including: • Name of the pest control product • Name of the active ingredient • Amount of pest control product (treated seed) being imported
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