Canadian Seed Trade Association Semi-Annual Meeting PMRA Opening - - PowerPoint PPT Presentation

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

• 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

Overview

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.

• 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 Status of Neonic Reviews: Clothianidin and Thiamethoxam

Update on the Re-evaluation of Thiram

• Proposed Re-evaluation Decision (PRVD2016-07):

– Proposed decision published February 29th 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

• f the program.
• The current and anticipated Re-evaluation Program workload is exceeding available

PMRA resources.

• 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.

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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.

Engagement Approach

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Fall

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Domestic

Late Fall

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International

Winter

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New Models Proposal

PHASE 1

Information Gathering

PHASE 2

Engagement

• Raise awareness and understanding of the Post-

Market Pesticide Program Review initiative.

• Solicit input from stakeholders on current post-

market program and areas for improvement.

• Collect information to inform potential new models

and identify opportunities to improve post-market program.

• Present proposed

models/changes to re- evaluation processes.

• Gather feedback and

recommendations on proposed improvements.

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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

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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

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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

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.

• Any member of the Canadian public can use the Public Engagement

Portal.

Who can benefit from this 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

How can the public access the portal?

• Already deployed – ready for use

When will it be available?

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

• 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: Regulatory Framework

• 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

Pesticide Treated Seeds: Legislative Requirements

• Importers of seeds are also required under the PCPR registration

exemption (paragraph 4(1)(b) and Schedule 2, item 3 of the PCPR) to ensure that the pesticide-treated seed being imported into Canada is properly labelled (whether it be packaged (bagged) or bulk shipments

• f treated seed).
• In addition, importers should be aware that there are also labelling

requirements as per the Seeds Act as administered by CFIA.

– e.g.,

• the Seeds Regulations require that any seed treated with a pest control product

be stained with a conspicuous colour to show that the seed has been treated.

• the following labelling statement is required: Do not use for food or feed. This

seed has been treated with (common or chemical name of pest control product).

Pesticide Treated Seeds: Legislative Requirements (cont’d)

• As previously presented, importers and brokers of treated seed can

comply with the PCPR import declaration requirements by using the Goods Description field when they submit an electronic release request via the Electronic Data Interchange (EDI) to the Canada Border Services Agency (CBSA).

• However, CBSA administrative data show that between Jan-April of

2018 only 0.03% of total seed shipments were declared by importers/brokers to be treated seeds in the ‘Goods Description’ field.

• The following is an example of how the PMRA would like to see the

required information captured in the Goods Description field:

– Product (indicate “treated” and seed type): e.g., “Treated corn seed for sowing” – Treated: Yes – Common name of the active ingredient: {insert active ingredient name} (Note: a list of common names of the pesticide active ingredients likely to be found in seed treatments is listed in Appendix 1). – Quantity being imported: {insert amount in kilograms}

Pesticide Treated Seed: Importation Obligations

• NOTE: Using the “goods description” field approach is only an interim /

transitional solution until CBSA’s Integrated Import Declaration (IID) system becomes the new system for use by all customs brokers, import service providers, and anyone who declares imports to CBSA (target date for implementation: Spring 2019).

• More information about becoming an EDI client or to certify for the SWI IID can

be found on CBSA’s website: http://www.cbsa-asfc.gc.ca/trade-commerce/facil- eng.html

• Note: If the treated seed being imported is for research purposes only, refer

to the webpage on “Research Authorizations and Notifications” (https://www.canada.ca/en/health-canada/services/consumer-product- safety/pesticides-pest-management/registrants-applicants/research- authorizations-notifications.html) for further information on requirements for research authorizations, notifications, exemptions etc.

Pesticide Treated Seeds: Importation Obligations (cont’d)

All importers of pesticide-treated seed should be aware of their legal

• bligations under the PCPA, i.e.,
• Ensuring all imported seed is treated only with pesticides registered under

the PCPA for the purposes of treating that seed;

• Declaring all imports of pesticide-treated seed as per s.36 of the PCPRs

(including: pesticide product name, active ingredient name, amount being imported); and

• Ensuring that any pesticide-treated seed coming into Canada is labelled

appropriately as per Schedule 2 of the PCPRs.

NOTE: If an importer has questions about their obligations under the PCPA, they can contact PMRA’s Pest Management Information Service (E-mail: pmra.infoserv@hc-sc.gc.ca, Telephone: 613-736- 3799) or their local Regional Pesticide Officer.

Pesticide Treated Seeds: Key Points

• Although there are no end-use products currently registered with the

subject active ingredients (Clothianidin and Bacillus firmus strain I-1582) for treatment of corn and soybean seeds, the labels for Votivo 247FS Nematicide (PCP Reg. No. 30279) and Votivo 240FS Nematicide (PCP

• Reg. No. 31996) allow for tank mixing with Poncho 600FS (PCP Reg. No.

27453; Clothianidin 600g/L) for treatment of corn seed only.

• Provided that the treatment product to be used in the US to treat the corn

seed is the same as the Canadian registered product, the treated corn seed is exempted from registration and the importation would be acceptable.

• The onus is on the importer to ensure that all imported seed is treated only

with pesticides registered under the Pest Control Products Act (PCPA) for the purposes of treating that seed. In this regard, the seed treating company should be able to determine (in consultation with the registrant of the seed treatment product if need be) if the US product is the same as the Canadian product. This information is to be kept on record should it be required upon inspection.

Pesticide Treated Seed: Poncho/Votivo Combination

Thank you…any questions?

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