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Evaluation: Evaluation of the Fertilizer Program

Evaluator: CFIA Corporate Evaluation

CFIA Program Area: Fertilizer program

Report Approved by Evaluation Committee

The action plan is developed around the two themes within the recommendation; first, the integration of systematic and pro-active identification and consideration of risks into program design and delivery, and second, reduction of administrative burden and increased flexibility in the regulatory framework and its administration. A number of activities identified in the MRAP are ongoing in nature and will become a part of the "normalized" administration and operation of the Program.

Evaluation Recommendation

Recommendation 1:

"The Fertilizer Program should implement a mechanism to align its pre-market assessment and marketplace monitoring activities (inspection and analytical testing) with areas that pose the greatest risk to Canada's food, plants, animals and the environment. Emerging risks should be identified proactively to allow adequate risk mitigation …

**Management Response and Action Plan (MRAP) – Recommendation 1**
Management Response (Agree or Disagree and if Disagree, reason why)	Action Plan	Lead (position) Target Date
Agree Please note the following considerations: 1) There are deliverables and dependencies for Branches other than PPB such as Operations, Science and IM/IT that are essential to the response to the evaluation. 2) Seasonal nature of the industry sector and the program creates operational constraints in terms of even distribution of inspections and samples throughout the year due to narrow window of product availability in the marketplace prior to the growing season which is outside the control of the CFIA. 3) The planned gazetting of the modernized Fertilizers Regulations in the winter of 2013 is an ambitious timeline and will depend on the TB regulatory amendment process and timing of publication in Canada Gazette part I and II. 4) Furthermore passing of legislative changes is dependent on parliamentary priorities	A) Systematic and pro-active identification and consideration of risks is integrated into program design, priorities and plans. To ensure this alignment, the following key elements are planned: 1. To properly integrate proactive risk consideration into program design and delivery, the section must first invest in mechanisms that allow for identification of areas of risk/trends. This will be achieved by developing a common understanding (stakeholders and the Plant Business Line) of emerging issues, associated risks and resulting implications by ensuring that staff remain knowledgeable of emerging issues and priorities (as these are associated with risks) domestically and internationally through engagement with stakeholders, international partners and international standard setting bodies, and that there is access to relevant internal data that can assist in identifying risk areas. Planned activities include: Domestically, continued active engagement with the industry (Canadian Fertilizer Products Forum and industry events/conferences) to understand emerging issues, monitor trends and work towards a common understanding of associated risks, how they should be prioritized and what the resulting implications are on the program Internationally: Engagement with international regulatory bodies (OECD, CEC, AAPFCO, ISO, AOAC etc) in standard setting, monitoring scientific and program developments internationally and encouraging collaborative partnerships in areas where the CFIA lacks expertise so that staff are in a position to identify international trends, emerging risks and associated program and scientific implications, Internally: Work through existing governance mechanisms to improve information management and transfer across the business line to ensure a common understanding of emerging issues, associated risks and development of responsive measures such as new science regulatory research and method development, program policy adjustment, better compliance data and operational alignment to highest risks.	Planned for Fall 2013 Plant Business Line co-chairs (ED-Level)
	2. Once the risk considerations/trends are identified, to ensure they are fully integrated into plans and priorities, the Agency'spre-market assessment and registration process will align priorities with areas that pose the greatest risk to Canada's food, plants animals and the environment by: Having pre-market assessments (registrations and product approvals) focussed on product safety (rather than performance data reviews and verification of benefit claims) Providing a modernized Fertilizer Regulatory framework including the Fertilizers Regulations and associated policies, including: Proposing a revised exemptions scheme - products with well-established history of safe use and agronomic relevance are exempt from mandatory registration Proposing updates to Schedule II to include additional materials exempt from registration Tiered registration system where only products posing substantial or unknown safety risks are subject to comprehensive safety assessments (tier 3), and approvals of products posing lesser risks are expedited requiring submission of only core safety data (tier 2) Updating AIRS	Planned for Fall 2014 ED PHPD
	3. With the proactive identification of risks, modernized program design and aligned into priority setting, the integration will be delivered with focused planned marketplace monitoring activities. The program delivery will be focussed on areas of greatest risk: Inspection quota will be allocated to safety related programs (e.g. pathogen testing, heavy metal analysis, pesticide residues, verification of imports, field trial inspections etc) and away from quality verification The workplan priorities will be clearly identified through business line decision making; inspector training will be routinely conducted and the delivery of the plan will reported on quarterly basis. Additional enforcement options (suite of sanctions) will be implemented (when possible and feasible)	Plant Business Line Co-chairs (ED Level)
…while enabling flexibility in the regulatory framework and reducing administrative burden whenever possible and appropriate."	B) Administrative burden is reduced and the flexibility in program delivery is enhanced: With the delivery of the Fertilizer Regulatory Modernization framework, flexibility is expected to be increased through implementation of proposed outcome-based regulations (where appropriate) and the proposed removal of prescriptive provisions for labelling and guaranteed analysis. Administrative burden is proposed to be reduced by: Removal of the application form from the Regulations Expedited product review process for tier 2 submissions Extension of registration period from 3 to 5 years Revising definitions for major and minor amendments Ongoing dialogue with PMRA regarding dual registrations Availability of modern IM/IT tools including improved file tracking database, and an electronic database of labels and progress is being made on E-submissions	Planned for Fall 2014 PPB ED PHPD IM/IT (ED BIM)