ARCHIVED - Proposed Changes to Fertilizer Program Administration in Canada
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Modernization of the Fertilizers Regulations
The consultation closed 2013-09-17
This document is intended to outline the proposed direction, objectives and principles of the modernized Fertilizers Regulations and to seek broad stakeholder comments and input on the regulatory proposal.
The Fertilizer Program of the Canadian Food Inspection Agency (CFIA) has been modernizing its policies and requirements since 2006. More recently (December 2011), the CFIA has initiated a systematic review of its regulatory frameworks and modernization of the Fertilizers Regulations was identified as a short term priority.
In addition, as of April 26th, 2013 the CFIA no longer regulates the quality and efficacy of products regulated under the Fertilizers Act. This included discontinuation of pre-market efficacy assessments and verifications of performance/benefit claims as well cessation of marketplace monitoring for product quality. The amendments to the Fertilizers Regulations associated with this decision came into force April 26th, 2013, and were published in the Canada Gazette, Part II, on May 8th, 2013. Please note that these changes are independent of the regulatory modernization initiative and are not subject to this consultation.
The regulatory modernization initiative builds on the recent changes to the Fertilizers Regulations and represents an opportunity for additional changes to program administration; with a further shift towards risk-based approaches and outcome-based regulations whenever appropriate or applicable. It aims to lessen regulatory burden on products that are deemed safe and have a well-established history of use and to remove prescriptive provisions from the regulations, thus providing for greater flexibility and less red tape on the regulated sector.
The regulatory modernization proposal was developed in consultation with the stakeholder community, namely the Canadian Fertilizer Products Forum (CFPF). The CFIA anticipates that this initiative will bring benefits to the fertilizer and supplement industry, regulated parties, small business owners, users, producers and consumers. The added flexibility is intended to support innovation, reduce regulatory burden, and expedite time to market for safe fertilizers and supplements thus facilitating farmers' access to innovative agricultural inputs.
This document is intended to outline the proposed direction, objectives and principles of the modernized Fertilizers Regulations and to seek broad stakeholder comments and input on the regulatory proposal.
2.1 Industry Structure
Canada's fertilizer industry plays an essential role in ensuring that the world's food needs are met in a sustainable and economical manner. The regulated sector consists of manufacturers, retailers, importers and exporters of a wide range of product categories and types. This includes traditional Nitrogen, Phosphorous and Potassium (N, P, K) fertilizers, micronutrients, plant growth regulators, microbial supplements, as well as waste-derived materials (such as composts, municipal biosolids, paper sludges, anaerobic digestates, etc.) used as recyclable sources of plant nutrients and organic matter. The industry consists of both well-established multinational corporations and small businesses.
2.2 Changes to the Fertilizers Regulations effective as of April 26th, 2013
As of April 26th, 2013 the CFIA no longer regulates the quality and efficacy of products regulated under the Fertilizers Act. This change to the Fertilizer Program required amendments to the Fertilizers Regulations, namely the removal of all provisions pertaining to efficacy substantiation, numerical quality standards and tolerances for fertilizers and supplements. These changes came into force April 26th, 2013 and were published in Canada Gazette, Part II, on May 8th, 2013. They resulted in the cessation of: 1) pre-market efficacy assessments; 2) verification of performance/benefit claims; as well as 3) marketplace monitoring of product quality. In effect, the CFIA no longer plays a role in the verification of fertilizer quality and performance and will focus its efforts on its mandate to ensure the safety of fertilizers and supplements. The decision to discontinue the regulation of efficacy and quality is not open for consideration as part of this consultation.
2.3 Safety of Fertilizers and Supplements
While the CFIA is no longer regulating product quality and efficacy a number of labelling provisions will remain in the modernized regulatory framework to ensure producers and consumers have access to safe products and to enable safe and sustainable use. This includes requiring guaranteed analysis on fertilizer and supplement labels (active ingredient and nutrient guarantees), directions for use (including application rates, frequencies and target crops) and all applicable precautionary statements.
2.4 Changing Environment
Regulatory modernization offers opportunities to strengthen safety focus of the regulatory framework and mitigate against potential risks.
The fertilizer world is changing in response to the global demand for yield increases, the rapid pace of innovation, significant improvements to manufacturing practices, as well as growing pressures to recycle waste materials as fertilizers. The Canadian fertilizer industry is sourcing primary materials from different parts of the world (with varying levels of regulatory oversight), and from different waste streams with the potential for dangerous contaminants.
Further, the pace of innovation itself is altering the fertilizer landscape in Canada and internationally with the introduction of innovative technologies and product types (e.g. microbial inoculants, signalling compounds, nanomaterials etc.). Albeit beneficial to the economic profitability of the agricultural sector this complexity demands a continued commitment and focus on the safety of these new technologies.
Finally the increasing public focus on the protection of the environment and Canada's food production continuum (from farm gate to plate) continues to challenge governments to strengthen the effectiveness of their regulatory frameworks and to protect citizens from health threats associated with the food supply, and more broadly, protect the environment by ensuring the sustainability of agricultural practises.
2.5 CFIA Transformational Agenda
The CFIA has embarked on an extensive plan to modernize its legislative, regulatory and program frameworks over the coming years.
In many respects, the CFIA seeks to align the level of Agency oversight with the risk associated with the commodity or activity. For example, the CFIA is proposing to license all regulated parties that import, export or prepare food domestically for sale inter-provincially or for export. Regulated parties will be required to maintain preventive control plans to mitigate sources of risk and meet regulatory requirements. Requirements will be less prescriptive where possible and focused on safeguarding the food supply and protecting Canada's plant and animal resource base.
As described in this document, the proposed changes to the CFIA's fertilizer program administration were designed with the Agency's broader agenda in mind. While the Fertilizer Act does not currently contain the authorities to allow all aspects of that agenda, such as licensing, to be implemented, modernizing Fertilizer Regulations intends to add flexibility to the existing framework and allow it be further improved should additional authorities be gained in the future.
2.6 CFIA Regulatory Modernization
In December 2011, the CFIA initiated a systematic review of its regulatory frameworks for food safety, plant health and animal health. Through this structured and comprehensive review, the Agency intends to update its regulatory frameworks to reduce overlap and redundancy, increase responsiveness to industry changes, address gaps, weaknesses and inconsistencies, while providing clarity and flexibility to assist regulated parties in fulfilling their obligations. The modernization of the Fertilizers Regulations is part of the multi-year regulatory review plan and has been identified as a short-term priority (one to three years).
2.7 Principles of CFIA Regulatory Modernization
The following principles guide the overall CFIA regulatory modernization process:
- 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 - including industry, consumers, small business, other departments and provinces;
- 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 trading partners' and provincial standards.
2.8 Opportunities for Modernization of the Fertilizers Regulations
The review and modernization of the Fertilizers Regulations builds on the recent changes and offers further opportunity to examine regulatory instruments to achieve optimal results including outcome-based regulations when appropriate and applicable. The Fertilizer Program is focusing its regulatory renewal initiative on removing prescriptive standards and requirements from the regulations, while strengthening regulatory controls for product safety, environmental sustainability and consumer protection. As such, the regulatory framework will shift towards risk-based approaches where regulatory intervention and oversight is commensurate with the potential health and safety risks associated with the product and its use. This approach adds flexibility that intends to better align the regulatory framework with stakeholder expectations as well as small business needs. In addition, it aims to support innovation and expedite time to market for safe fertilizers and supplements thus promoting profitability in the agricultural sector, and effective choice for consumers.
2.9 Consultative Process to Date
The Canadian Fertilizer Products Forum (CFPF) is a permanent consultative body for the fertilizer and supplement sectors and a highly effective vehicle for active stakeholder engagement in regulatory renewal process. The Fertilizer program and the CFPF have been working collaboratively on modernizing the Fertilizer Program since the establishment of the CFPF in 2006. On March 14th, 2012 a preliminary stakeholder panel meeting, including members of the CFPF, was held to describe the Agency's regulatory modernization initiative and to discuss considerations and objectives of the review. In response to the regulatory modernization initiative, the CFPF established four new thematic working groups (WG) to facilitate dialogue and provide CFIA with consensus based recommendations:
- Safety WG;
- Efficacy WG;
- Labelling and Market Access WG; and
- Definitions and Exemptions WG.
A fifth WG devoted to the review of Schedule II (a listing of primary fertilizer and supplement materials exempt from registration), was first formed in 2010, and agreed to continue its work and provide their recommendations as part of the regulatory modernization process.
Each WG consisted of 15 to 30 self-identified participants, including representatives from various industry sectors (NPK fertilizers, micronutrients, microbial inoculants, chemical supplements, waste derived materials, organics, etc.), retail and wholesale chains, producer/farmer organizations, Provincial Ministries of Environment (MOE), US regulatory bodies and US-based companies. Representatives of the CFIA were assigned to each WG to participate in an advisory capacity. To structure stakeholder input, a three-step process was adopted, which included:
- problem identification phase,
- articulation of desired outcomes and,
- implementation options.
At the end of each phase, stakeholder comments and feedback was collated by the WG chairs and forwarded to CFIA in the form of consensus-based recommendations.
The CFIA held its annual regulatory workshop on October 16 and 17, 2012, in conjunction with the annual general meeting of the CFPF. Close to 100 participants representing government departments, fertilizer industry associations, and producers were present. The objectives of the workshop were:
- to inform stakeholders of the various regulatory initiatives that impact the CFIA Fertilizer Program;
- to provide a progress update on the regulatory modernization of the Fertilizers Regulations and related CFPF WG recommendations;
- to offer a venue for dialogue and stakeholder feedback on the direction and outcomes of regulatory modernization; and
- to discuss the regulatory proposal in preparation for broader public consultation.
The session featured a series of presentations and discussions on a number of key issues related to the future regulatory framework. Presentations were given by federal government representatives as well as industry representatives from the Canadian Fertilizer Institute (CFI) and the CFPF. Throughout the event, a variety of perspectives were discussed and participants provided detailed feedback on a range of regulatory issues. The Workshop proceedings are available upon request.
Following the workshop, the CFIA compiled the input received from participants, conducted additional analysis of outstanding regulatory issues, particularly in areas where consensus was not reached at the workshop, and developed this comprehensive proposal.
The CFIA also conducted a scan of international jurisdictions and their approaches to regulation of fertilizers and supplements with a particular focus on 1) Safety provisions and requirements; 2) Labelling and 3) Product registrations and approvals. The intent of the review was to determine the spectrum of regulations used internationally, the level of regulatory intervention employed by other federal and state regulatory bodies and how they compare to the regulatory framework in Canada. The review is available from the CFIA upon request.
3. Proposed Regulatory Amendments:
The following sections represent the CFIA's regulatory proposal taking into account the recommendations provided by the CFPF WGsand the feedback received during the October workshop. The key change elements (including both amendments to the Regulations and supporting policy instruments) have been grouped into thematic areas that correspond to the provisions in the Regulations. Provided below is a synopsis of the proposed amendments for the modernized regulatory framework.
As part of the regulatory modernization initiative, the CFIA is proposing to amend/add/remove certain product definitions to align them with current science, industry trends, and international norms and to support a new, revised exemption scheme (see section 3.3 below). This includes the introduction of definitions for "micronutrient", "secondary nutrient" and "microbial consortium", and the removal of "lesser nutrients", in order to better reflect the modern and commonly accepted terminology. In addition, the definitions for "specialty fertilizer" and "farm fertilizer" would be removed as the distinction between the two categories would become unnecessary given the proposed amendments to the exemptions. This is further intended to ensure proper oversight for products intended for home and garden applicators where the use patterns and exposure scenarios are very different than in agricultural settings. The other definitions in the Regulations are proposed to remain unchanged to ensure ongoing consistency with the Fertilizers Act and other relevant legislation (e.g. the Canadian Environmental Protection Act (CEPA), Pest Control Products Act (PCPA), and other Government of Canada documentation).
3.2 General Exemptions
The current Fertilizers Regulations exempt certain products from all provisions of the Act and Regulations – these products are not subject to regulation by the CFIA. The regulatory modernization proposal intends to:
- align these provisions with other relevant pieces of legislation such as the Health of Animals Act and Regulations in the case of animal manures
- broaden the exemption for products intended for export to include imported products as opposed to only those manufactured domestically with the intent to export
- clarify the exemption for fertilizers and supplements sold for manufacturing purposes. This would entail exempting products both imported and manufactured domestically that require and/or are subject to further processing and treatment other than blending, mixing, re-packaging or application to seed and
- remove the exemption for fertilizers imported for direct application to the soil by the importer and not for sale in CanadaFootnote 1.
These changes collectively are intended to ensure a level playing field between importers and domestic fertilizer and supplement producers and facilitate regulatory oversight over final product formulations, as opposed to individual chemicals/primary materials that can be used in other commodities or commercial products as well as protect consumers from potential contaminants and associated health risks.
3.3 Exemptions from Registration
The delineation between products subject to registration and those exempt from registration was historically aligned with their respective safety and performance risks. Accordingly, products with a history of safe use and consistent performance were exempt from registration. However, the exemptions have not been reviewed in over 30 years and no longer reflect current science, modern product types, technologies and manufacturing practices. There is an increasing interest in the recycling of by-products, industrial and organic waste materials for land application as fertilizers and supplements (e.g., soil amendments). The benefits of this practice include the return of nutrients to soil and the improvement of soil physical condition. However, these benefits must be carefully balanced against the potential safety hazards associated with such materials including biological and chemical contaminants. Consideration of the source of waste-derived materials and the level of processing and treatment used during their manufacture are essential in determining risks, since concerns over plant, animal, human health and the environment can be effectively alleviated with adequate treatment.
The proposed regulatory amendments include revision of the exemptions from registration and mandatory pre-market assessment in accordance with the risk profile of the guaranteed active ingredients contained in a fertilizer or supplement. In addition, the proposal includes a comprehensive review of materials found on Schedule II (Sch II) of the Fertilizers Regulations. The following points describe the results of the proposed exemption scheme:
- Mixed fertilizers that contain nutrients in mineral form (and do not contain pesticides or micronutrients) will continue to be exempt from registration. In addition, the regulations will only exempt mixed fertilizers that are not modified with other non-fertilizer materials (e.g. polymers, nanomaterials, biological mixtures, etc.), if the material is registered or approved for that use/purpose. Materials that are innocuous or inert, such as anti-caking agents or dust control additives, will be exempt from this requirement. This is intended to ensure safety oversight for novel technologies which may pose health and safety risks.
- Products containing micronutrients, either alone or in combination with other nutrients such as N, P and K, are proposed to be subject to pre-market registration, irrespective of their target market (farm vs. specialty). This is intended to reflect the health and safety risks associated with these products (metal contamination, dioxins and furans, radioactive compounds etc.) which may appear in some sources of primary materials especially if they are derived from industrial wastes or mined from contaminated areas. This is also intended to address the exposure pathways routinely faced by the general public (home and garden owners, children and pets).
- Waste-derived materials used in fertilizers and supplements (including pH adjusters), other than those otherwise exempted, would require pre-market registration to verify compliance with safety standards.
- The proposed exemption scheme will allow mixtures of products that are either exempt from registration or registered and approved for a given use, to enter the marketplace without prior CFIA approval (e.g. combinations of Schedule II materials, seeds inoculated with registered supplements, potting soils with registered supplements, N, P, K fertilizers with registered supplements or registered micronutrients etc). This exemption will not, however, apply to mixtures of registered supplements containing viable microorganisms as active ingredients, due to the potential for cross-reactivity and sensitization.
- Secondary nutrients (Ca, Mg, S) would continue to be exempt from registration.
- The blanket exemption for all specialty fertilizers is proposed to be removed (along with the definition for specialty fertilizers). Many of these products will continue to be exempt from registration under the exemption described in 1) above.
3.4 Schedule II
Schedule II (Sch II) of the Fertilizers Regulations is a listing of primary fertilizer and supplement materials that serves two distinct roles: 1) exempts materials from registration and pre-market assessment, and 2) provides a repository of acceptable material names and compositional criteria. Sch II does not list final products or brands – it is reserved for primary generic fertilizer and supplement materials (e.g. urea, compost, bone meal, etc.)
Sch II had not been updated in over 30 years, and hence was subjected to a rigorous and comprehensive review in the context of Fertilizer Program modernization which first began in October, 2010 with the creation of a stakeholder/CFIA WG (S2WG). The intent of the review was to ensure that Sch II reflects current science and facilitates unimpeded market access for well established and safe fertilizers and supplements. More specifically, the objectives included alignment of the compositional criteria with modern manufacturing practices, reduction in regulatory and administrative burden, promotion of international harmonization and reduction in time to market for safe fertilizers and supplement materials, while maintaining Sch II's status as a repository of materials exempt from registration (together with their compositional criteria) that is enforceable by the regulations.
The review focussed on the following technical components: validation of material names and definitions, establishment of agronomic relevance and ongoing demand in the marketplace as well as determination of material safety. Rigorous and comprehensive safety evaluations considered risks to human health, as well as impacts on mammalian, avian, aquatic, soil and sediment species. The evaluations were completed by December, 2012. In total, 91 materials were assessed. 35 new materials were proposed for addition and 7 for removal, replacement or re-assignment to different classes. Prior to the review, Sch II contained 56 materials. Following the review, Sch II is proposed to include 84 materials. This represents a 50% increase in the number of materials exempt from registration. The materials proposed for addition are currently subject to registration, but will become exempt; thus facilitating their unimpeded access to the marketplace. Conversely, those removed from Sch II, will require additional regulatory oversight and scrutiny to mitigate against contamination risks. A complete listing of changes proposed to Sch II is available from the CFIA upon request.
The advantage of Sch II is that products with a well-established history of safe use and acceptance in the Canadian marketplace are not subject to mandatory pre-market assessments. This in turn allows the Agency to focus on new and emerging technologies and/or areas of potential safety concern (e.g. due to contamination). The CFIA continues to seek the most appropriate venues to administer Sch II to be more responsive and easier to amend while preserving its enforceability, consistency in interpretation and effective implementation. Some of these venues require additional authorities in the Fertilizers Act (e.g. incorporation by reference) and until such time as these authorities are gained the CFIA is proposing to maintain the updated Schedule II in the Fertilizers Regulations.
3.5 Labelling Requirements
The current Fertilizers Regulations contain a number of highly prescriptive labelling requirements (weight declaration, placement, size, font of information on the label etc.) that do not directly impact the safe use of the product. In addition, as the CFIA no longer verifies product effectiveness or regulate performance/benefit claims, there is a need to review and amend mandatory labelling information that would be subject to CFIA review.
3.5.1 Core Mandatory Information
The proposal calls for requiring only core mandatory information. This is proposed to include: product name; address of manufacturer/packager; net contents (volume or weight); guaranteed analysis, registration number (if applicable); directions for use (if applicable); and precautionary statements (if required). Product ingredients will not need to be displayed/listed on the label, however, the active ingredients would have to be guaranteed (and thus displayed) as they determine whether the product requires registration or is exempt. If the product is exempt from registration, the ingredient(s) that qualify it for the exemption must be listed on the label e.g.: the mineral source of the nutrient in N, P, K fertilizers, Sch II material(s), other exempt materials, all registered products used as ingredients in the final formulation and the registration number.
In accordance with the renewed focus on safety, the CFIA will continue to examine product guarantees and application rates to ensure that the product, when used as directed, does not pose environmental safety/sustainability concerns. The proposal also continues to require precautionary statements on labels that instruct the user/consumer as to the potential hazards and risk mitigation measures such as protective equipment, application directions and/or restrictions etc., to ensure safe and sustainable product use.
This proposal maintains safety provisions in the Regulations while repealing sections that are overly prescriptive or do not directly impact the consumer. It is anticipated that these changes will effectively reduce burden on businesses while still protecting the consumers and the environment.
3.5.2 Guaranteed Analysis
The requirement for guaranteed analysis would be maintained in the modernized Fertilizers Regulations as it is essential in determining and enabling the safe and sustainable use of the product (particularly under site-specific or variable rate applications). The guaranteed analysis and the directions for use are essential in assisting the farmers and other users in applying the product at appropriate rates to meet the needs of the crop while protecting against any potential adverse effects on consumers, bystanders and the environment. The proposal also calls for a certain level of prescription regarding the format of the guaranteed analysis on the label. This is required to ensure international norms and standards are upheld on Canadian products thus facilitating exports and promoting global market alignment and harmonization. Fertilizers would require the following guarantees of nutrients:
- Nitrogen (N) - total N/weight basis
- Phosphorus (P) - available phosphoric acid (P2O5) basis
- Potassium (K) - a soluble potash (K2O) basis
- Calcium (Ca), Magnesium (Mg), Sulphur (S) - in percent elemental basis.
- Micronutrients: Boron (B), Chloride (Cl), Copper (Cu), Iron (Fe) Manganese (Mn) Molybdenum (Mo) Zinc (Zn) - in percent elemental basis.
- If organic matter is guaranteed, the amount expressed in percent and moisture expressed in percent.(when appropriate)
For supplements the guaranteed analysis section must include one of the following or combination thereof:
- The amount of the active ingredient as a percentage
- The number of viable cells of the active microorganism per gram of product (including the genus and, where known, the species of microorganism in the product) unless the product consist of microbial consortium in which case total microbial biomass (viable cells per gram) will be required
- For liming materials, the neutralizing value expressed in per cent of the acid neutralizing capacity of calcium carbonate and the per cent passing through a sieve with openings of a specified width (if applicable)
- For acidifying materials, the acidifying value expressed in per cent of the basic neutralizing capacity of hydrochloric acid and the per cent passing through a sieve with openings of a specified width (if applicable)
- For products represented to contain pesticides the amount of active ingredient (pesticide) expressed in a percent by weight basis
3.5.3 Bilingual Labelling
The Fertilizers Regulations currently allow for labels to be in French or English or both languages which is not in compliance with the requirements of the Official Languages Act (OLA). The OLA requires that regulated parties provide information related to the health, safety or security of members of the public (in this case via the product label) in both official languages. To reflect this requirement, core mandatory label information (outlined in section 3.7.1 of the proposal) as well as safety-related information will be required to appear in both official languages.
3.5.4 Incorrect or Misleading Information
The Fertilizers Regulations include provisions against the inclusion of incorrect, misleading or deceptive information on a product label. However, given the decision to discontinue oversight for the efficacy and quality of fertilizers and supplements, the relevant provisions will be clarified to pertain to product safety information only to align with the Agency's focus on the safety of fertilizers and supplements.
3.6 Registration Submission Format
The Fertilizers Regulations are highly prescriptive as to the required format of applications for registration. These requirements are based on a "paper submission format" and do not easily support electronic interfaces with the stakeholder community.
This proposal would amend the Regulations so that the submission requirements will become largely outcome based (e.g. adequate information to substantiate product safety etc.). Furthermore, the CFIA is proposing to remove the application form from the Regulations to add flexibility and support future electronic submissions, as well as accept text labels to streamline the required format. The CFIA is cognizant that appropriate reference and guidance documentation will be essential in assisting applicants in providing complete and comprehensive packages and thus avoiding delays in approvals. These reference materials will be housed in policy documents rather than Regulations themselves to facilitate frequent updates and to enable transition to an electronic user interface in the future.
Repealing Schedule IV (application form) and other prescriptive requirements will provide the industry with greater flexibility, reduced costs and lessen red tape. This is aligned with stakeholder expectations and will significantly reduce administrative burden on the regulated parties and the Agency. It will further create efficiencies in submission processing, tracking and reporting thereby alleviating resource demands on the system and the CFIA long term.
3.7 Registration Period and Definition of Major and Minor Amendments
Currently, a registration is valid for a period of 36 months. In order to continue to import or sell a product that has been registered under the Fertilizers Act, the registration must remain valid by re-registering the product every 3 years. To re-register and continue the sale or importation of a fertilizer or supplement, an application for re-registration must first be reviewed and approved by the Fertilizer Program.
The proposal will extend the registration period to 5 years and simplify the registration amendment process. In addition to the extended registration period, the CFIA would re-define minor and major amendments that require notification and approval from the CFIA (changes to Fees Notice) so that minor changes to the product that do not impact its safety or sustainable use will either be fast-tracked or can be made without prior approval from the CFIA. Similarly, re-registrations of products that were not altered during the registration period (no changes to the formulation, active ingredients, their sources, directions for use, manufacturing process, etc.) will be subject to expedited review times.
It is anticipated that these changes will streamline approvals and expedite time to market thus giving Canadian farmers and consumers faster access to innovative fertilizers and supplement products.
3.8 Compendium of Fertilizer-Use Pesticides and Uncoupling
The Pest Management Regulatory Agency (PMRA) approves and registers pesticides under the Pest Control Products Act (PCPA) including pesticides intended for combination with fertilizers, and sold as fertilizer-pesticides combination products. These combination products are registered by the CFIA in accordance with the requirements of the PCPA as prescribed in the Compendium of Fertilizer-Use Pesticides (CFUP) (in the form of application rates, precautionary statements, etc.). Compliance with the PCPA is a regulatory obligation explicitly stated in the Fertilizers Regulations. Similarly, the CFUP is also referenced in the regulations. In February 2010, the PMRA concluded that fertilizer-pesticide combination products for lawn and turf uses do no support the goals of best practices for pest management in turf. As such, the PMRA made the decision to uncouple fertilizer-pesticides combination products intended for lawn and turf uses. The decision was effective as of January 1, 2013 and registrations of all affected fertilizer-pesticide combination products have been cancelled by the CFIA. These decisions highlighted the need to streamline approvals of the CFUP, thus the CFIA proposes to remove all reference to the CFUP from the Fertilizers Regulations. Fertilizer-pesticides combination products regulated under the Fertilizers Act and Regulations will continue to be subject to the PCPA. As such, fertilizer-pesticides combination products that are exempt from the uncoupling decision would need to obtain a "letter of no-objection" to the combination of the pesticide with a fertilizer from the PMRA.
3.9 Implementation Strategies
The CFIA will consider "phase-in" periods to allow sufficient time for the implementation of some of the new or amended regulatory requirements in order to minimize the burden and cost incurred on the regulated parties while balancing safety considerations and protection of the public.
4. Policy Instruments
To maximize and support the benefits of the regulatory amendments, the CFIA is also considering policy/administrative refinements and changes as part of the overall modernized regulatory framework for fertilizers and supplements. A fundamental component of the proposed framework and the Fertilizer Program administration is a "tiered registration system".
4.1 Tiered Registration
This concept supports a risk-based regulatory model whereby products that are deemed safe and have a well-established history of use and marketplace acceptance are subject to reduced regulatory scrutiny. This includes exemptions from registrations (in the Regulations) and a two tiered assessment process for products that are subject to mandatory registration (Tier II and III). The categorization of products into their respective assessment tiers would be based on pre-screening evaluation of the risk profile of the ingredients (both active and inert), their sources, method of manufacture and, where applicable, results of analysis for biological and/or chemical contaminants and/or nutrient loading into the environment. As only active ingredients will have to be guaranteed, the listing of all ingredients on the product label will remain at the discretion of the product proponent. In accordance with this model, products that are deemed to pose negligible risks receive expedited registration based on minimum evidence and data. Products that do not meet these criteria would be subject to a comprehensive review, submission of additional data and/or scientific rationales. The tiered registration process is anticipated to improve timeliness of product approvals (new registrations and re-registrations) and ongoing compliance with the safety requirements and standards. Delineation between Tier II and III will be administered through policy instruments allowing for changes and refinements as new science comes to light. In effect, the number of products subject to rigorous requirements and scrutiny will be reduced while still maintaining human, animal, plant and environmental protection objectives.
5. User Fee Review
The CFIA is currently reviewing its service delivery costs and fees within the Fertilizer Program as part of an Agency-wide User Fee modernization initiative. Objectives for the User Fee initiative include the promotion of effective and responsive service delivery; establishing a consistent and robust approach to user fee development; and fostering an understanding that user fees may be charged for services, products, rights and privileges provided by the Agency. For more details, see the Cost Recovery Policy and Framework.
The Agency will hold public consultations later this year on user fees related to services provided by the Fertilizer Program. Service recipients will have an opportunity to comment on the detailed user fee proposal once it is made public.
5.1 Current Services/Fees
The Fertilizer Program's current fees are found in Part 5 of the Canadian Food Inspection Fees Notice. There are currently 6 user fees related to the registration of fertilizers and supplements, and 3 user fees related to the release of novel supplements for research purposes. A registration fee is charged for the assessment of a fertilizer or supplement for:
- registration ($350);
- renewal of registration ($250);
- minor amendment of a registration (e.g. change in colour or format of the label, product name, name and address of manufacturer, net weight) ($50);
- a major amendment (any other changes not defined as minor) ($350);
- a safety assessment ($500); or
- an efficacy assessment ($250).
The maximum fee payable for the consideration of an application is $1,000 plus applicable taxes.
Fees associated with the release of novel supplements for research purposes include:
- an evaluation of a novel supplement, if no safety assessment is needed ($250);
- an evaluation with a safety assessment ($500); or
- a renewal of authorization to release ($100).
The current Fees Notice was implemented in 1997 and is not representative of the costs incurred by the CFIA in providing the services. This can be partially attributed to the varying scope and duration of the assessments which depend on the complexity of the data/information required to substantiate product safety. There is no flexibility in applying the fee. In addition, fees are only applicable for registration-related submissions and do not cover the wide range of submissions processed by the Agency. Furthermore, as the CFIA no longer regulates the efficacy and quality of fertilizers and supplements, the fees for efficacy data assessments will no longer be applicable. This change in program administration will have to be reflected in the User Fee Notice to align it with the renewed focus on product safety.
5.2 Future User Fees
The CFIA will continue to conduct safety data reviews, offer pre-submission consultations and label review services; it will also register fertilizers and supplements, approve regulated products through the Letter of No Objection (LONO) process, issue research authorizations, and certificates of free sale. Future user fees will also reflect the Fertilizer Program's proposed tiered registration model. It is intended to more accurately reflect the costs of delivering a given service as well as the public vs. private benefit derived from the service. In addition, new user fees will have clearly stated service delivery standards, which will be developed concurrently with the amended user fees.
5.3 Next Steps
A user fee proposal related to services provided by the Fertilizer Program is currently being developed and will be subject to stakeholder and public consultation prior to implementation. The proposal will contain details on the fee structure, service delivery standards and the rationale for both.
6. Timeline and Next Steps
The technical review of the regulations was completed in December 2012 which considered recommendations of the CFPF WGs as well as the feedback received at the October, 2012 workshop. The regulatory amendment process including drafting and gazetting process is targeted to commence in the Fall of 2013 after public pre-consultation is complete.
7. Contact Information
Your input and feedback is critically important to the success of the regulatory modernization initiative and we strongly encourage you to provide your input.
The consultation closes September 17, 2013.
Appendix A – Proposed Tiered Registration Model
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