Modernization of the Fertilizers Regulations

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1 Modernization of the Fertilizers Regulations Compost Council of Canada January 22, Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.

2 Purpose To introduce the modernization of the Fertilizers Regulations initiated by the Canadian Food Inspection Agency To outline the regulatory proposal including the objectives and desired outcomes of the regulatory amendments DRAFT 2 2

3 3 Context In December 2011, the Agency announced a systematic review of all of its regulatory frameworks - the Fertilizers Regulations have been identified as a short term priority (1-3 years). The CFIA is committed to finalizing the technical review of the Regulations by December 2012, with the regulatory amendment and gazetting process to commence the following year Changes to Fertilizer Program administration (as per the Budget 2012 decision) include discontinuation of all efficacy and quality related activities Consultations to date: ongoing collaboration with the Canadian Fertilizer Products Forum and Industry Working Groups : Efficacy Safety Definitions and Exemptions, List of materials exempt from registration - Schedule II Labelling and Market Access

4 4 Guiding Principles Protection of public safety and confidence in the inspection framework; Enabling an environment of improved business opportunity and consumer choice by facilitating innovation and competitiveness; Clear policy objectives established in consultation with partners; Appropriate balance between administrative costs and benefits derived from regulatory intervention; Consistent, transparent and where appropriate, outcomes-based regulations with performance measurements; Vital importance of science and risk management approaches in decision making; To the extent possible, harmonization with international, provincial and trading partners standards.

5 5 Current regulatory framework Strategic Outcome A safe and accessible food supply and plant and animal base Immediate Outcome Fertilizers and supplements sold and imported into Canada are SAFE (plant, animal, human health and the environment), EFFICACIOUS (for the intended purpose) and PROPERLY LABELLED (to avoid product misrepresentation and protect consumers) Program Elements Activities * Safety Assessment Pre-market assessment/registration Efficacy/claim verification Label Review Policy development, standard setting, program design, interdepartmental collaboration, Fed/prov outreach, International harmonization, stakeholder consultations, corporate support, Marketplace monitoring Contaminant testing (pathogens, metals, pesticide residues) Nutrient content Active ingredient testing Field trial inspections Inspections of imported products Compliance with EFB Surveys Complaints Investigations and prosecutions Performance claims Label precautionary statements

6 6 Post DRAP NO Efficacy Strategic Outcome A safe and accessible food supply and plant and animal base Immediate Outcome Fertilizers and supplements sold and imported into Canada are SAFE (plant, animal, human health and the environment), EFFICACIOUS (for the intended purpose) and PROPERLY LABELLED (to avoid product misrepresentation and protect consumers) Program Elements Activities * Safety Assessment Pre-market assessment/registration Efficacy/claim verification Label Review Policy development, standard setting, program design, interdepartmental collaboration, Fed/prov outreach, International harmonization, stakeholder consultations, corporate support, Marketplace monitoring Contaminant testing (pathogens, metals, pesticide residues) Nutrient content Active ingredient testing Field trial inspections Inspections of imported products Compliance with EFB Surveys Complaints Investigations and prosecutions Performance claims Label precautionary statements

7 7 Transformational agenda Current status FROM EFFICACY Prescriptive numerical standards and quality criteria Requirement to substantiate ALL performance/benefit claims (pre-market assessment) Marketplace monitoring of quality SAFETY Generic provisions specific safety standards and requirements maintained through policy DEFINITIONS AND EXEMPTIONS Outdated definitions that are aligned with product use patters (farm vs. home and garden) Burdensome registration requirements for combination products TO Modernized Framework Removal of all quality provisions- Buyer-beware marketplace Based on feedback from the CFPF working groups only a few sectors are contemplating self-regulatory initiatives Maintain outcome-based approaches to safety requirements and standards Strengthen authority for environmental sustainability Align definitions with current science and market trends Support new exemption scheme Maintain consistency with other relevant legislation Align exemptions with the risk profile of the product, ingredients and their sources

8 8 Transformational agenda cont. Current status FROM SCHEDULE II Outdated definitions (over 30 years) New safe primary materials and combinations not included LABELLING AND MARKET ACCESS Prescriptive labelling provisions Prescriptive submission format requirements (application form, label etc) Two-tiered rigid registration scheme exempt from registration or subject to full pre-market assessment Three year registration period TO Modernized Framework Amend existing definitions to reflect current science and modern manufacturing practises Add materials to be exempt from registration (based on history of safe use and relevance to the marketplace)- risk based approach to regulation Remove materials no longer used (e.g. garbage-tankage) Outcome-base approach removal of prescriptive provisions - mandatory labelling of core information ONLY Flexibility (placement of information, units etc) Less Prescriptive submission format -removal of application form from Schedule IV of the regulations Three tiered registration scheme + 5 year registration period blend of regulatory and policy instruments Support innovation and facilitate/ expedite market access

9 9 Key elements of change REGULATORY AMENDMENTS Removal of efficacy and quality provisions Amend definitions Clarify general exemptions Revise exemptions from registration Modernize Schedule II (add primary materials exempt from registration) Streamline labelling requirements Simplify submission format Extend the registration period and redefine major and minor amendments POLICY INSTRUMENTS Modernized Framework + TIERED REGISTRATION MODEL

10 10 Product to enter Canadian Market Exempt from registration and pre- market assessment Registration EXEMPTIONS IN THE REGULATIONS Mixed fertilizers (mineral form) Secondary nutrients (Ca, Mg, S) Schedule II materials (single ingredient) Combinations/mixtures of exempt products Exempt products + registered products Potting soils + registered products Seeds + registered products TIER 1 Text label Rapid Screening (safety and label) Registration number May request additions to the label to ensure safe use 5 year re-registration period Reduced service delivery standard Categorization = Pre-screening Complete list of ingredients and sources Method of manufacture and QA/QC procedures Results of analysis (metals, pathogens, dioxins and furans, solubility and nutrient content when applicable to determine safe use) Full assessment (safety and label) Registration number Full safety assessments, data and rationale if applicable 5 year re-registration period 3-step review process, current service delivery standards TIER 2 TIER 3

11 11 Marketplace Impact of Tiered Registration PRE-MODERNIZATION POST-MODERNIZATION R I S K Registration Exempt from Registration O V E R S I G H T R I S K Tier 3: Reg n Tier 2 : Registration Exempt from Registration O V E R S I G H T PRODUCTS IN THE MARKETPLACE PRODUCTS IN THE MARKETPLACE

12 12 Alignment with Modernization Principles Increased focus on product safety: safeguarding the food production continuum, protection of consumer safety and environmental sustainability Reduced burden on the regulated sector balancing cost of regulation with benefit of risk management Streamlined approvals and expedited time to market for safe and well established products Reduced number of products requiring comprehensive assessments Science-based alignment of regulatory framework with the risk profile of the product, its ingredients, sources and level of treatment Outcome-based regulations; removal of prescriptive provisions (numerical criteria and standards, labelling, sampling procedures etc.) Strengthened international alignment of safety standards, precautionary labelling and environmental sustainability criteria

13 13 Next steps /timeline Present the regulatory proposal at the annual CFPF meeting (October th, 2012); discuss placement of Schedule II regulatory vs. administrative listing Collect input from the broader stakeholder group on the regulatory proposal/analyze input - November 2012 Finalize regulatory amendment proposal -December Post the proposal on CFIA external Website for pre-consultation (60 days)- February, 2013 Prepare drafting instructions, review by Legal February- March, 2013 User fee consultation April June 2013 Treasury Board documents (Triage, Cost/Benefit analysis, RIAS) April August, 2013 Gazette I publication Fall, 2013 Regional meetings to communicate program changes to producers and consumers and CFIA field staff (5 regional meetings 2 days each)

14 14 Review of Schedule II Purpose and objective of the Schedule: Part of the Fertilizers Regulations Listing of primary fertilizer and supplement materials (chemical or organically derived) exempt from registration and pre-market assessment Outlines definition, name and compositional criteria for each material In order for a material to meet the exemption it must adhere to the standards provided in the definition Reserved for materials with history of safe use, consistent performance and agronomic relevance Facilitates timely market access and reduces regulatory burden on well established, low risk fertilizer and supplements Materials on SII represent a significant portion of the fertilizer and supplement market share

15 15 Drivers for change Schedule II has not been reviewed or amended for over 30 years It no longer reflects current science, modern manufacturing practices or products available in the marketplace Motion-460 (passed in the House of Commons in 2010) to facilitate farmers access to agricultural production tools and inputs (feed, fertilizer, pesticides, etc.) available in other jurisdictions One of the CFIA s implementation/response strategies to M-460 was a comprehensive review of Schedule II Scope and anticipated results of the review included: additions, deletions and amendments to the definition and compositional criteria of fertilizer and supplement materials Schedule II review continued as part of the regulatory modernization of the Fertilizers Regulations

16 16 Desired outcomes of the review Align with scientific advances, modern technologies and current fertilizer/supplement manufacturing practices Reduce regulatory and administrative burden Promote international harmonization (where and when applicable) including the US Association of American Plant Food Control Officials (AAPFCO) Reduce time to market for well established, safe and agronomically relevant products Facilitate timely access of Canadian producers to fertilizers and supplements available in other jurisdictions Allow CFIA to focus on higher risk fertilizer materials/production technologies

17 17 Processed sewage Definition: (Specify grade) Products made from sewage freed from grit and coarse solids that are dried, ground and screened Processed sewage is exempt from registration but must meet the composition and naming designation in Schedule II Processed sewage is defined as a fertilizer and is required to be represented as such a grade and nutrient guarantees are required The product must meet all safety standards (metals, pathogens and dioxins and furans) Information required on the label includes: brand, name of product, grade, guaranteed analysis, weight, directions for use, name and address of the packager/manufacturer

18 18 Processed sewage and Schedule II review The definition and compositional criteria for processed sewage products is under review as part of the Schedule II review Considerations Highly variable quality and safety depending on the inputs and level of treatment and processing Emerging substances of concern (pharmaceuticals, personal care products etc) Definition of biosolids as opposed to processed sewage Stricter compositional criteria so that only highly processed materials are exempt from registration and pre-market assessment Interaction with the Provinces CCME s beneficial use policy and spread on agricultural land A survey was developed and distributed by the Canadian Fertilizer Products Forum to seek stakeholder feedback on the definition of biosolids

19 19 If you have any questions, please contact Darrell Mueller Or the Crop Inputs Division in Ottawa

20 2007 Her Majesty the Queen in right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited