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

Modernization of the Fertilizers Regulations

Compost Council of Canada

January 22, 2013

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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

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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

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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.

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Current regulatory framework

A safe and accessible food supply and plant and animal baseStrategic Outcome

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 Pre-market assessment/registration

Activities *

Safety Assessment

Efficacy/claim verification

Label Review

Marketplace monitoring

Policy development, standard setting, program design, interdepartmental collaboration, Fed/prov outreach, International harmonization, stakeholder consultations, corporate support, Label precautionary statements

Nutrient content

Compliance with EFB

Contaminant testing (pathogens, metals, pesticide residues)

Field trial inspections Inspections of imported products

Complaints Investigations and prosecutions

Surveys

Active ingredient testing

Performance claims

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Nutrient content Active ingredient testing

Post DRAP – NO EfficacyA safe and accessible food supply and plant and animal baseStrategic Outcome

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 Pre-market assessment/registration

Activities *

Safety Assessment

Efficacy/claim verification

Label Review Compliance with EFB

Marketplace monitoring

Label precautionary statements

Contaminant testing (pathogens, metals, pesticide residues)

Field trial inspections Inspections of imported products

Complaints Investigations and prosecutions

Surveys

Performance claims

Policy development, standard setting, program design, interdepartmental collaboration, Fed/prov outreach, International harmonization, stakeholder consultations, corporate support,

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Transformational agendaCurrent status FROM → → → → TO ……Modernized Framework

EFFICACYEFFICACY

Prescriptive numerical standards and quality criteria

Requirement to substantiate ALL performance/benefit claims (pre-market assessment)

Marketplace monitoring of quality

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

SAFETYSAFETY

Generic provisions – specific safety standards and requirements maintained through policy

•Maintain outcome-based approaches to safety requirements and standards

•Strengthen authority for environmental sustainability

DEFINITIONS AND EXEMPTIONSDEFINITIONS AND EXEMPTIONS

Outdated definitions that are aligned with product use patters (farm vs. home and garden)

Burdensome registration requirements for combination products

• 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

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Transformational agenda – cont. Current status FROM → → → → TO ……Modernized Framework

SCHEDULE II SCHEDULE II

Outdated definitions (over 30 years)

New safe primary materials and combinations not included

• 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)

LABELLING AND MARKET ACCESSLABELLING 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

• 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

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PO

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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 re-define major and minor amendments

Modernized Framework +

TIERED REGISTRATION

MODEL

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Product to enter Canadian Market

Exempt from registration and pre-Exempt from registration and pre-market assessment market assessment

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

RegistrationRegistration

Categorization = Pre-screening

• Text label

• 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)

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

TIER 2

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 3

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Marketplace Impact of Tiered Registration

RRII

SSKK

Tier 2 : RegistrationTier 2 : Registration

Exempt from RegistrationExempt from Registration

PRE-MODERNIZATION POST-MODERNIZATION

RegistrationRegistration

Exempt from RegistrationExempt from Registration

PRODUCTS IN THE MARKETPLACE PRODUCTS IN THE MARKETPLACE

OOVVEERRSSII

GGHHTT

RRII

SSKK

OOVVEERRSSII

GGHHTT

Tier 3: Tier 3: Reg’nReg’n

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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

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Next steps /timeline

• Present the regulatory proposal at the annual CFPF meeting (October 16-17th, 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 2012.

• 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) - 2014

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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

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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

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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

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• 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

Processed sewage

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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

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If you have any questions, please contact

Darrell Mueller

226-217-8325

Darrell.Mueller@inspection.gc.ca

Or the Crop Inputs Division in Ottawa

613-773-7189

fertilizer@inspection.gc.ca

2020© 2007 Her Majesty the Queen in right of Canada

(Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.