Agri-food and aquaculture: Targeted regulatory review - Regulatory roadmap
Published: June 2019
Last update: February 2021
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About the targeted regulatory reviews
Following the recommendations of the Advisory Council on Economic Growth, and recognizing the importance of ensuring that regulatory frameworks remain effective and relevant, the Government of Canada announced in Budget 2018 that it would fund over 3 years "targeted reviews of regulatory requirements and practices that are bottlenecks to economic growth and innovation." The first round of targeted regulatory reviews focused on 3 high-growth sectors:
- agri-food and aquaculture
- health and bio-sciences
- transport and infrastructure
A central feature of the regulatory reviews is stakeholder engagement. In partnership with departments and agencies, the Treasury Board of Canada Secretariat led national engagement efforts with businesses, Canadians, academia, and other stakeholders. This included Canada Gazette consultations, in which stakeholders were asked to provide feedback on ways to enable regulations to be more agile, transparent, and responsive resulting in benefits for all Canadians.
Background: Agri-food and Aquaculture Roadmap
Agriculture and Agri-food Canada, the Canadian Food Inspection Agency, Fisheries and Oceans Canada, Health Canada, and the Public Health Agency of Canada participated in the regulatory review focused on the agri-food and aquaculture sector. Based on feedback from stakeholder engagement, the departments and agencies drafted a sectoral regulatory roadmap to address issues raised.
The Agri-food and Aquaculture Roadmap lays out a regulatory modernization plan in support of innovation and economic growth in the agri-food and aquaculture sector. In addition to existing resources from implicated regulatory departments and agencies, the Government has identified proposed legislative and regulatory changes, as well as additional funding to move forward on the regulatory roadmaps. This includes an additional $53.6 million over 5 years, starting in 2019 to 2020, through Budget 2019, in support of the implementation of initiatives from the Agri-food and Aquaculture Roadmap.
This roadmap identifies a suite of initiatives, and proposed timelines (as of May 2019), to advance regulatory modernization in the agri-food and aquaculture sector.
Agri-food and Aquaculture Roadmap
The Agri-food and Aquaculture Roadmap is the plan developed by the participating departments and agencies (Agriculture and Agri-food Canada, the Canadian Food Inspection Agency, Fisheries and Oceans Canada, Health Canada and the Public Health Agency of Canada) to address the issues, irritants and bottlenecks, and support innovation and novel regulatory approaches in the agri-food and aquaculture sector. The Agri-food and Aquaculture Roadmap is a product of the targeted regulatory reviews. The Agri-food and Aquaculture Roadmap is divided into the following 6 sections;
- Section 1 – Sector summary
- Section 2 – Consultations undertaken
- Section 3 – Regulatory Modernization Activities
- Section 4 – Sector issues and irritants being addressed by the Department and Agencies
- Section 5 – Novel Regulatory Approaches
- Section 6 – Sector issues and irritants not being address by the Roadmap
Section 1 – Sector summary
Overview of agri-food and aquaculture sector
Canada is one of the world's most trusted and respected food suppliers – trusted to provide safe and wholesome products and respected for our commitment to global food security. The agri-food and aquaculture sector is broad and diverse, encompassing inputs, such as feeds, fertilizers, pesticides, and veterinary drugs and biologics, through to agriculture and aquaculture outputs in the form of consumer food products. Canada's strong regulatory system, combined with the supply of high quality products by Canadian industry, form the basis of this positive reputation at home and abroad.
The business environment in which the sector operates is changing at a rapid pace. Advancements in innovation all along the value chain from farm to fork, broader technological advancements (for example, machine learning, advanced data analytics, advanced laboratory techniques such as whole genome sequencing) and increasingly globalized supply chains have the potential to foster unprecedented growth, but also come with new uncertainties and risks.
The agri-food and aquaculture sector has been identified by the Advisory Council on Economic Growth as a high-potential sector for Canada's future.
In a world where water deficits, land degradation, climate change, productivity declines and energy dependency create supply side challenges for agriculture, Canada is well-placed to excel. Abundant natural resources, a robust research and development network, a diverse consumer base, a tendency to early adoption of technology, reliable access to capital and inputs, and political stability create a strong platform for growth. But some argue that the strength of this platform is tempered by underdeveloped value chains, low productivity, trade barriers, and a complex regulatory environment.
The Advisory Council on Economic Growth has made core recommendations [The Path to Prosperity: Resetting Canada's Growth Trajectory (PDF 884 KB)] about trade agreements, infrastructure, immigration and skills, and accelerating innovation. Canada's world-renowned regulatory system must remain science- and safety-based, while at the same time supporting the ongoing innovation, growth and competitiveness of the agri-food and aquaculture sector.
Overview of the evolution of the regulatory framework for agri-food and aquaculture
The sector is subject to a variety of regulations that span food safety, animal and plant health, transportation, labour, and other areas. Businesses of the 21st century cut across traditional sectoral borders, which increases the complexity of navigating the regulatory system. Additionally, sector businesses may experience a cumulative regulatory burden that is not evident if individual regulations are looked at separately.
As stakeholders seek to benefit from the increased growth potential that comes from globalization, they face challenges with a regulatory system that has not kept pace with change in the sector. Further, stakeholders emphasize the importance of a system that supports global competitiveness, including through harmonization with trading partners, shared setting of standards, and reduced regulatory barriers to trade. Regulated parties have identified opportunities to make the current system more efficient (for example, by reducing approval times), modern (for example, through changes to processes, platforms and tools) and consistent. Across the system, stakeholders underscore the importance of engaging with them throughout the regulatory process.
Canada's strong, science-based regulatory system must continue to focus on its foundation of health, safety and a sustainable plant and animal resource base, while evolving to reflect the broader operating environment (for example, rapidly evolving technology, complex business models, and global supply chains). Greater consideration of the economic impacts of the regulatory environment is necessary in order to help Canadian businesses to seize new opportunities and remain on a continued growth trajectory.
Overview of the approach to the regulatory review by federal departments and agencies
The federal regulatory reviews were announced in Budget 2018 and identified agri-food and aquaculture as one of the first sectors to be reviewed. The drivers for the regulatory review were to support economic growth and innovation, and the review was tightly linked to other Government of Canada initiatives, notably the recommendations from the Economic Strategy Tables. The targeted regulatory review provided participating departments and agencies with the opportunity to go further with modernization efforts, and to find ways to improve their understanding of the impacts of regulation on industry's ability to innovate, grow and compete.
In this effort, the Government will continue to ensure that Canada's regulatory system protects, first and foremost, the health and safety of Canadians. As noted in the 2018 Fall Economic Statement, the departments and agencies will focus on simplifying regulations and ensuring regulatory efficiency when designing and implementing regulations, while continuing to prioritize health, safety and environmental responsibilities.
The federal regulatory review provided another lens to apply to decisions regarding which actions were the most pressing or needed to be completed first – and the opportunity to use that lens of industry competitiveness, innovation and growth to adjust current plans and advance key initiatives to position both government and industry better for the future. This was not the only process for considering industry impacts – because those effects are taken into account in ongoing decision making. However, this initiative sharpened the focus on competitiveness and decisions.
Government organizations involved
The following federal departments and agencies participated in the agri-food and aquaculture regulatory review:
- Agriculture and Agri-Food Canada (AAFC)
- Canadian Food Inspection Agency (CFIA)
- Fisheries and Oceans Canada (DFO)
- Health Canada, as it relates to food, pesticides and veterinary drugs
- Public Health Agency of Canada (PHAC), as it relates to human and terrestrial animal pathogens and toxins
During the review, some of the issues that were raised related to other jurisdictions and federal departments that did not participate in the agri-food and aquaculture review. These included federal responsibilities around transportation and labour, provincial/territorial roles, and the requirements and practices of countries with which Canada trades. These issues and areas are considered to be outside the scope of this review.
All of the acts and regulations administered or enforced by the participating departments and agencies were within the scope of the review, with the exception of the following (responsible department or agency is shown in brackets after the name of the statute):
- Agricultural Products Marketing Act and the regulations and orders made under it (AAFC)
- Animal Pedigree Act and the regulations made under it (AAFC)
- Canadian Dairy Commission Act and the regulations made under it (AAFC)
- Farm Credit Canada Act and the regulations made under it (AAFC)
- Farm Products Agencies Act and the regulations and orders made under it (AAFC)
- Canadian Food Inspection Agency Act (CFIA)
The scope of the PHAC work was limited to oversight of human and terrestrial animal pathogens and toxins, under the Human Pathogens and Toxins Act and the Health of Animals Act and in collaboration with the CFIA.
Section 2 – Consultations undertaken
Stakeholders in the agri-food and aquaculture sector were consulted in a number of ways throughout the review process. These included webinars, the invitation to comment that was published in the Canada Gazette by the Treasury Board of Canada Secretariat (referred to as the Canada Gazette consultation), and meetings between departments/agencies and various industry associations and other stakeholders. Additionally, as part of regular engagement activities – such as presentations at annual general meetings, bilateral meetings and other fora – regulated parties were engaged about the regulatory review and offered opportunities to provide input. These efforts began in spring 2018 following the budget announcement of the sectoral regulatory reviews, with a peak of consultation activities during the period from July to September 2018.
The agri-food and aquaculture sector involves a broad range of stakeholders, including those responsible for agriculture inputs (for example, pesticides, veterinary drugs and biologics, feeds, seeds, and fertilizers), researchers, developers of novel products, producers, processors and sellers, and all those in between. These stakeholders, as well as non-governmental organizations, academics, and indigenous groups, were engaged on the regulatory review. Participating organizations range in size from individuals, to small and medium-sized businesses, to large multi-national companies, and include industry associations.
Approximately 70 participants, representing a range of industry associations, companies and other entities, participated in a sector-wide webinar held on July 12, 2018. A more targeted webinar focusing on pesticide regulation was held on August 23, 2018, with approximately 50 participants. Additionally, a number of bilateral meetings between stakeholders and government representatives interested in discussing the regulatory review were held during the summer and early fall of 2018.
Treasury Board of Canada Secretariat's Canada Gazette notice was published on July 28, 2018, and officially closed September 15, 2018. Review departments and agencies communicated the notice to a diverse range of stakeholders, estimated to number in the hundreds. It generated over 60 written responses related to the agri-food and aquaculture sector, raising comments on a wide variety of issues. Several responses to the Canada Gazette notice were received after the closing date.
In addition to targeted regulatory review engagement activities, departments and agencies also relied on previously collected stakeholder input from earlier consultations to inform the summary of stakeholder issues and irritants. Sources included "What we heard reports", Value Chain Roundtable discussions and recommendations, and other documentation of stakeholder consultations and engagement with respect to regulatory modernization efforts. Feedback from industry was also received from the Canada-United States Regulatory Cooperation Council (RCC), the Federal/Provincial/Territorial Regulatory Reconciliation and Cooperation Table (RCT), and the Canada-European Union Regulatory Cooperation Forum (RCF).
The recommendations of the Economic Strategy Tables also figured prominently as part of the input received. The Economic Strategy Tables were created by the Government of Canada after the Budget 2017 announcement of industry-government collaboration focused on turning Canadian economic strengths into global advantages. Reports from the Economic Strategy Tables were released in September 2018, setting ambitious growth targets and providing recommendations to achieve their goals. These reports also offered further insight into issues affecting the agri-food and aquaculture sector, as well as recommendations for change. Many of those recommendations have been addressed in the initiatives and proposals put forward in this roadmap.
The topics of discussion raised during consultation activities were varied. Some submissions included a mix of sector-wide issues that do not fall under one specific department or agency (for example, the manner in which cost benefit analyses are conducted), as well as sector specific issues. Others took the opportunity to focus on very specific issues that have been the subject of previous departmental engagement, such as guidance respecting novel plant products of biotechnology.
Section 3 – Departmental regulatory modernization activities
Prior to the launch of the regulatory reviews, the departments and agencies responsible for regulating the agri-food and aquaculture sector each had an ambitious regulatory modernization agenda that extended over several years.
Many of the regulations administered by AAFC and portfolio agencies reporting to the Minister of Agriculture and Agri-food (referred to herein as the AAF Portfolio) enable financial programs that: assist producers in managing business risks, support research and innovation through successful marketing of agricultural products, and facilitate competitiveness and trade. The AAF Portfolio organizations review and amend their regulations on an ongoing basis to ensure they continue to be timely, effective and predictable. At the time of the sector regulatory review, 2 extensive modernization efforts were underway. The Farm Products Council of Canada was reforming the regulatory framework under the Agricultural Products Marketing Act. The regulatory framework consists of 165 instruments that provide for the marketing of agricultural products in interprovincial and export trade. The Canadian Grain Commission was working to modernize the regulatory framework under the Canada Grain Act to keep pace with the evolving grain sector with the aim to enhance flexibility, improve efficiency and responsiveness, reduce inconsistencies and foster innovation. The key constraints impacting efforts to both maintain and modernize the regulations administered by the agriculture and agri-food portfolio relate to accessing limited resources throughout the regulatory development process, especially within the context of the broader Government regulatory prioritization mechanisms.
Straddling the agriculture and the health portfolios, the CFIA is pursuing regulatory modernization as part of its strategic priorities for food safety, plant protection, and animal health. A modern regulatory toolkit, that includes flexible and outcome-based regulations, will allow the industry to innovate while enabling the CFIA to adapt and respond to emerging risks. One of the major deliverables in this regulatory modernization agenda was the Safe Food for Canadians Regulations (SFCR), which replace 14 commodity-based food regulations with a single set of regulations. In force since January 2019, the SFCR applies internationally recognized food safety standards for food imported, exported, and traded inter-provincially, and enhances the reputation of Canada's system in the world. The CFIA is concurrently systematically modernizing the animal and plant health regulatory suites, starting with updated fertilizer and hatchery regulations. Additional regulatory priorities within the CFIA's modernization agenda that would address various industry irritants and issues are discussed in section 4.
In recent years, Health Canada has taken steps to modernize its regulatory framework by introducing new authorities for Marketing Authorizations and incorporation by reference to improve the efficiency and functionality of the authorization of food additives. This new approach provided the Department with a more timely way of enabling the use of food additives without requiring amendments through the Canada Gazette process, which would take several years to complete even though the additive had been deemed safe for use. The regulatory modernization plans in this roadmap build on these previous efforts and respond to the ongoing requirement to ensure that Canadians have access to safe and innovative food products in a timely manner.
There is an opportunity to modernize the regulatory framework for veterinary drugs, which was developed over a period of decades. In 2017, new regulations were published to increase Health Canada's oversight of antimicrobials used in animals and to encourage responsible use of these products. As part of these changes, Health Canada introduced a risk-based regulatory framework that facilitated access to veterinary health products such as vitamin and mineral supplements, to provide more options to support the health of companion and food-producing animals. Building on this work, Health Canada will explore options to modernize other elements of regulatory framework to ensure that it is flexible, risk-based, and keeps pace with product innovation. It will also examine ways to encourage more products such as those for minor use or minor species to seek market authorization. A modern regulatory framework would also provide the foundation for the expansion of international regulatory cooperation, including joint and simultaneous reviews that have already resulted in more treatment options available for Canadian producers. Finally, as announced in the 2018 Fall Economic Statement, Health Canada is also examining the possibility of regulatory amendments that will enable the use of foreign review decisions for certain veterinary drugs intended for unmet medical needs.
In addition, Health Canada's Pest Management Regulatory Agency (PMRA) is currently conducting a comprehensive review of the Pest Control Products Regulations (PCPR), the first such review since they were established in 2006. The review is aimed at ensuring the PCPR continues to meet program objectives (for example, of health and environmental protection) in an effective and efficient manner, while attempting to minimize regulatory burden on regulatory parties. Furthermore, in 2020, the Pest Control Products Act (PCPA) will stand referred to a committee of Parliament for review, which may provide an opportunity to implement changes to improve the efficiency and effectiveness of the regulatory program.
The Public Health Agency of Canada (PHAC) is continuously striving to improve and respond to the innovative research sector's needs while ensuring safe oversight of human and terrestrial animal pathogens and toxins. This includes seeking input from stakeholders on how to improve the regulatory framework to meet the needs of regulated parties and facilitate compliance.
Aquaculture in Canada is a shared federal-provincial-territorial jurisdiction and managed via federal-provincial regulatory frameworks. Federal regulatory activities in aquaculture currently span 7 federal organizations and 12 different pieces of legislation. Most of the many regulations overseeing aquaculture currently reside under the Fisheries Act.
As announced in the 2018 Fall Economic Statement, DFO is proposing to develop forward-looking, aquaculture-specific regulations, the General Aquaculture Regulations (GAR), which will result in one comprehensive aquaculture regulation that would consolidate aquaculture-related content and provide an opportunity to modernize DFO's regulations. As part of this proposal, DFO is planning to amend the Fishery (General) Regulations, Atlantic Fishery Regulations, the Maritime Provinces Fishery Regulations, and the Pacific Aquaculture Regulations and to further refine the Aquaculture Activities Regulations.
The proposed new regulations align with the work being undertaken by the federal-provincial-territorial working group of the Canadian Council of Fisheries and Aquaculture Ministers (CCFAM) related to the national Aquaculture Development Strategy (ADS), which seeks to improve the regulatory framework for aquaculture.
Additionally, at the CCFAM meeting on December 4 to 5, 2018, the ministers agreed to support the development of a federal aquaculture act that respects federal, provincial and territorial jurisdictions, and provides greater clarity for the sector. The new GAR would be made under the new aquaculture act.
Feedback from initial stakeholder engagement (fall 2017 to spring 2018) was positive and supportive of developing an aquaculture act. Common themes emerged, including: national consistency; a definition of "aquaculture"; disease and fish health concerns; jurisdictional concerns; environmental conservation; and Indigenous interests. It is expected that similar themes will continue, with an emphasis on environmental and Indigenous peoples' concerns, as well as the need for innovation and new technology.
Public engagement on the proposed new act and GAR commenced in early spring 2019 and will build upon feedback received through the engagement previously conducted in 2017 to 2018.
The results of the regulatory review build on this existing ambitious agenda.
Section 4 – Sector issues and irritants being addressed in the roadmap by the departments and agencies
Stakeholder input was the essential element of the federal regulatory review. Because regulatory review departments and agencies talk to stakeholders regularly, when the regulatory review began, the expectation was that the issues and irritants raised by stakeholders would be ones that had previously been raised. For the most part, that is what was found, demonstrating that agri-food and aquaculture stakeholders do generally raise challenges with regulatory departments and agencies, as they arise.
As regulatory review departments and agencies considered planned and potential activities in light of stakeholder input, it became clear that there was a sub-set of those activities that supported innovation, growth and competitiveness. Many of those activities offered the dual advantages of addressing industry issues and improving health and safety outcomes. For example, finding efficient methods of dealing with lower risks so that more attention can be paid to higher risks increases the probability of identifying and correcting significant problems early. This is a win-win situation for industry and regulators.
As participating departments and agencies assessed input and potential responses, they reviewed existing plans to advance programs, to see where those actions were aligned with an innovation, growth and competitiveness agenda, and where they were not. They also assessed how approaches or timing could be adjusted to address the issues raised. Work by federal regulatory review departments and agencies to identify actions that would contribute to agri-food and aquaculture competitiveness coincided with the work of the Economic Strategy Tables. The Economic Strategy Tables were carrying out the same type of exercise, on a broader scale, and regulatory review departments and agencies benefitted from their work.
Many of the elements that emerged from the federal regulatory review aligned with the recommendations of the Economic Strategy Tables. Review departments and agencies took on board any additional recommendations that were part of the Economic Strategy Table reports that were published in September 2018.
Issues being addressed or partially addressed
Departments and agencies working on the agri-food and aquaculture sector regulatory review have heard from stakeholders on a wide variety of issues. Comments from individual or groups of stakeholders have been consolidated into key issues, and organized along 3 principal themes:
- Clear, agile, responsive regulations
- Competitiveness in domestic and international markets
- Risk-based, efficient, predictable regulatory programs
Items that will be addressed or partially addressed are grouped together in this section. Items may be partially addressed for a number of reasons, most frequently because of dependencies on other jurisdictions, such as provincial and territorial partners, or mixed stakeholder positions. Finally, items that were not addressed in this roadmap, for a variety of reasons, are identified in Section 6.
Theme 1: Clear, agile, responsive regulations
In many areas, regulations have not kept pace with changes to industry and the environment in which they operate. As a result, parts of the regulatory framework are out of date, overly prescriptive, not sufficiently risk based, or unclear.
Stakeholders have commented that industry competitiveness does not figure prominently enough in the process for assessing regulatory options. Examples of duplication and redundancy have highlighted the need to streamline regulatory provisions or to clarify jurisdictional issues.
The desired end state is to create regulations that are clear so that they are easily understood, flexible so that they continue to be appropriate as the environment evolves, and responsive so that they can accommodate changes in the Canadian and global business environment.
With respect to this regulatory theme, the following key issues requiring action were identified:
1. Feed regulations are prescriptive and outdated, limiting the ability of industry to take advantage of the latest developments in animal nutrition
Through Canada Gazette consultations and other correspondence, stakeholders have urged the CFIA to modernize the Feeds Regulations based on principles previously consulted on, such as focusing on feed safety and by moving toward a facility-based oversight scheme (versus a product-by-product regime). Industry has indicated that the current regulations have not kept pace with developments in livestock genetics, production practices and animal nutrition. CFIA's proposed Feed regulatory modernization would introduce several benefits, including reducing the volume of products requiring pre-market assessment, which would result in improved timeliness for these services (see also Issue 18). In addition, proposed amendments would increase alignment with the feed safety oversight system of major trading partners, which would facilitate trade as well as the streamlining of new feed product approvals based on equivalency of authorizations of foreign governments. The CFIA intends to respond to these comments by proposing regulatory amendments to the Feeds Regulations for consideration for pre-publication in Canada Gazette, Part I.
Lead: Canadian Food Inspection Agency
2. Fertilizer and plant growth supplement regulations are out of date and prescriptive, affecting timely access to safe, effective and innovative products
Access to the most innovative and current fertilizers and plant growth supplements is needed in order to support efforts to meet crop production demands to fill rapidly growing global markets. Stakeholder feedback through Canada Gazette consultations and other sources indicates that regulated parties are seeking modernized Fertilizers Regulations, to provide flexibility to industry through a risk-based approach, support industry innovation, and create a more level playing field for importers and domestic manufacturers. In response to this input, the CFIA proposes to amend product definitions and compositional criteria of fertilizer and supplement materials, bringing these up to date with current science, industry trends and international norms. Streamlining the registration process and extending the validity period of the registration from 3 to 5 years will reduce the regulatory and administrative burden on stakeholders. The CFIA has developed amendments to the Fertilizers Regulations which were pre-published in the Canada Gazette, Part I on December 22, 2018. This initiative also contributes to achieving improvements in timeliness of pre-market assessment, as described in issue 18 below.
Lead: Canadian Food Inspection Agency
3. The seeds regulatory system would benefit from modernization
Canada Gazette consultations identified a number of recommendations focused on greater collaboration in the Canadian seed sector, to improve efficiency and effectiveness. The review of the regulatory framework for seeds is in its initial stages. To respond to issues raised through this process, the CFIA plans to examine the regulatory framework for seed through future consultations with stakeholders. Stakeholders would be consulted on more outcome based regulations, the use of incorporation by reference to facilitate changes, and exploring the possibility of public-private partnerships. The results of these consultations would inform the development of a regulatory package. This process is expected to take up to 3 years to complete. It is anticipated that the CFIA would advance proposed amendments to the Seeds Regulations for consideration for pre-publication in Canada Gazette, Part I, in fall 2021.
Lead: Canadian Food Inspection Agency
4. Hatchery regulations have not kept pace with industry best practices, especially for pathogen reduction
The poultry and hatching egg industry has expressed concern, through Canada Gazette consultations and other engagement, over delays in the regulatory process to update the Hatchery Regulations. The CFIA has consulted with stakeholders on amendments to the Hatchery Regulations that would reflect technological and scientific developments in disease monitoring and account for emerging risks. Completing these updates would align Canadian standards with those of its major international trading partners, thereby improving market access, while also resulting in more robust prevention and control strategies and improved risk management along the food supply chain. The CFIA intends to address concerns by moving proposed regulatory amendments forward for consideration for pre-publication in Canada Gazette, Part I.
Lead: Canadian Food Inspection Agency
5. Food regulations are out of date, limiting flexibility and industry's ability to innovate
Safe food and good nutrition are important to Canadians, and eating a safe, nutritious and balanced diet is one of the best ways to protect and promote good health. Health Canada and the CFIA share administration of federal food regulations to protect Canadians' health and safety. With respect to the food provisions of the Food and Drug Regulations, Health Canada sets the health, safety and nutrition rules, while the CFIA sets the non-health and safety provisions. The CFIA is also responsible for the compliance and enforcement of all food-related regulatory requirements. In addition, the CFIA administers the Safe Food for Canadians Regulations.
CFIA has heard concerns from industry that outdated food compositional standards and prescribed container sizes limit industry's ability to offer new products, and that labelling requirements are not streamlined or consistent across foods. Early action to address this will occur by amending the beer standard to better reflect market practices and promote industry innovation. Amendments to the beer standard were published in Canada Gazette II on May 1, 2019. The CFIA is also proposing to modernize the standard of identity for vodka, to enable product innovation, facilitate trade and enable Canadian distillers to be more competitive and grow. The CFIA will also pursue food labelling modernization regulatory amendments to create a more agile framework that can better respond to change. The CFIA anticipates bringing forward a proposed food labelling modernization regulatory package for consideration for pre-publication in spring 2019.
Lead: Canadian Food Inspection Agency
Health Canada has heard from industry stakeholders, including the Economic Strategy Table on Agri-Food, that the way in which the current food regulations are structured under the Food and Drugs Act cause impediments that prevent industry from bringing innovative products to market (for example, supplemented foods and foods that use new processes and technologies). Health Canada proposes to take incremental steps to re-design food regulations to address these concerns. Health Canada plans to undertake this work and has identified the first 3 phases. In the first phase, Health Canada proposes to make additional changes to the regulations governing food additives (such as making amendments to the marketing authorizations). Other regulatory changes will also be examined to ensure that Health Canada has the ability to rapidly update microbiological criteria and list of scientific methodologies used to determine food safety in response to emerging science; and developing a regulatory framework related to human milk fortifiers. It is anticipated that this work will be completed in the 2020 to 2021 fiscal year. In the second phase, Health Canada is proposing to make changes to the Food and Drug Regulations to establish regulations for supplemented foods (for example, food formats containing added vitamins, minerals, and herbal ingredients). This work is targeted for completion by the end of the 2021 to 2022 fiscal year and prior to expiration of existing Temporary Marketing Authorizations for such products. In the third, Health Canada is proposing to undertake a series of consultations with stakeholders to identify the next suite of regulatory modernization priorities. These discussions will take place over the coming years with specific focus during the 2022 to 2023 fiscal year.
Lead: Health Canada
6. The regulatory framework for veterinary drugs creates unnecessary barriers, is not internationally harmonized and limits therapeutic options in Canada
Health Canada undertakes a number of activities relating to veterinary drugs in order to protect human and animal health and the safety of Canada's food supply. In comments submitted through Canada Gazette consultations and the Economic Strategy Tables, stakeholder expressed concern that the framework for veterinary drugs creates unnecessary barriers, is not internationally harmonized, and limits therapeutic options. Health Canada proposes to address this issue by establishing a life-cycle and risk-based approach to the licensing of veterinary drugs. As part of these changes, Health Canada would look to create more appropriate regulatory pathways to market for a range of non-prescription products, which are currently subject to the same stringent requirements as prescription drugs.
Health Canada proposes to advance an adaptive, modern licensing scheme to effectively regulate health products throughout their lifecycles. This will enable greater alignment with international regulatory authorities to cooperate in the review of drugs, which will facilitate Canadian producers' access to the same innovative products as their international counterparts.
For further details, see the Flexible Lifecycle-Based Licensing for Drugs and Medical Devices initiative in the Health and Biosciences Regulatory Review Roadmap.
Health Canada is looking to develop the proposed amendments over a 5 year period, with pre-publication for formal consultation in 2021.
Lead: Health Canada
7. Pesticide related regulations also generated a number of comments from stakeholders, highlighting 4 key issues
Pesticide incident reporting requirements are confusing and unnecessarily complicated
Health Canada does not always receive information on pesticide incidents that is clear, consistent and timely enough to facilitate the identification of trends that may need to be addressed in order to improve health and environmental protection. Pesticide registrants also raised concerns, during Health Canada's 2015 review of the incident reporting program, that certain aspects of the incident reporting program were confusing or unnecessarily complicated (for example, provisions requiring classifications of the incident severity are difficult for registrants to follow and apply). Health Canada proposes to address this by amending the Pest Control Products Incident Reporting Regulations to modify incident reporting requirements (for example, eliminating certain severity classifications; harmonizing reporting timelines), without affecting the long-term outcome of improving health and environmental protection. The proposed regulatory amendments were pre-published in the Canada Gazette, Part I, on December 22, 2018. The proposed regulatory changes would help to reduce regulatory burden (and associated cost), by making it easier to fulfil incident reporting requirements.
Through Canada Gazette consultations, Health Canada also heard from the Canadian Animal Health Institute that adverse event reporting for veterinary pesticides needs to take a more pharmaceutical clinical risk/benefit approach. While Health Canada does not have a mandate to conduct risk/benefit analysis for pest control products, the concern underlying this comment is being addressed through the "Proposed Regulatory Changes for Pesticide Products used on Companion Animals", which is a proposed guideline published for public consultation from September 21 to November 5, 2018. Health Canada is currently reviewing the comments received and aims to finalize the document in 2019 to 2020.
Lead: Health Canada
Pesticide labelling requirements are burdensome and not aligned internationally
At present, pesticide labels are not organized or worded in a consistent manner, which makes it harder for users to find and understand the information they need to use pest control products safely and efficiently. In addition, pesticide labelling requirements were identified by stakeholders as imposing unnecessary burden and lacking international alignment. Health Canada proposes to address this issue by amending the Pest Control Products Regulations to permit use of electronic labels and internationally aligned standards, as well as to improve the readability of labels. Health Canada would propose to amend the Pest Control Products Act to give the Minister the ability to make label changes to align with changes to regulatory requirements (that is, without the registrant needing to submit an application for the change), which will save registrants both time and money. Pre-publication of proposed regulatory amendments is targeted for 2020, and the proposed statutory amendments would be pursued through the parliamentary review of the Pest Control Products Act, which could start in 2020.
Lead: Health Canada
Authorization of pest control products for which registration is not required is slow and inflexible
The process to update the list of authorized pest control products for which registration is not required is too slow and inflexible (for example, 18 to 24 months to add a single low-risk, food-grade product). Through Canada Gazette submissions, major industry stakeholders such as CropLife Canada, the Canadian Horticultural Council and Fertilizers Canada, have indicated that the current list is out of date and the process to update it is too slow to keep up with changing industry needs. The products on this list are those with low- or well-characterized risk, such as products used for organic agriculture. Stakeholders also indicated that there is duplication between Health Canada and Canadian Food Inspection Agency (CFIA) in the oversight of nitrogen stabilizers. Health Canada proposes to take a 2-stage approach to this issue. First it proposes to amend the Pest Control Products Regulations to update current authorizations (including by allowing nitrogen stabilizers to be regulated by CFIA alone, rather than by both CFIA and Health Canada). Second, Health Canada would propose statutory changes to the Minister's powers to make it easier to make risk-based authorizations and to exercise appropriate post-market oversight over the products on this list. These changes would enable industry to sell and use a wider range of products more easily, enable the regulations to keep up with changing industry needs in the future, and reduce administrative burden for Health Canada, without reducing health or environmental protections. Health Canada is targeting final publication of the regulatory amendments in 2020. Possible statutory amendments would be pursued through the parliamentary review of the Pest Control Products Act, which could start in 2020.
Lead: Health Canada
The re-evaluation process for pesticide products is lengthy and resource intensive
Health Canada had previously identified a need to examine the pest control product re-evaluation process to ensure sustainability given the increasing complexity and number of such reviews, and their resource-intensive nature. Registrants, environmental non-government organizations and grower associations have identified through Canada Gazette consultations and other fora that the re-evaluation process for pesticide products is lacking in transparency and engagement. To address this, Health Canada is conducting a review of the re-evaluation program, in order to develop recommendations to improve the re-evaluation process for pest control products to make it more efficient, effective and financially sustainable, given an increasing workload. These improvements could involve statutory, regulatory, policy and/or process changes. Improvements to the post-market review process will allow the timely consideration of new scientific knowledge and maintain protection of health and the environment. Industry will benefit from this review as it will identify opportunities for improved transparency and predictability of re-evaluations and for more effective engagement with stakeholders. Any recommended statutory changes flowing from the review would be pursued during the parliamentary review of the Pest Control Products Act, which could start in 2020. In addition, in the shorter term, Health Canada proposes statutory amendments to the Pest Control Products Act to increase the efficiency of post-market reviews on a particular issue of concern (that is, special reviews) by avoiding unnecessary special reviews that duplicate work of other post-market reviews; these statutory amendments are being sought as part of the Budget Implementation Act, 2019.
Lead: Health Canada
8. The Canadian grain regulatory framework is outdated
The Canadian grain industry has changed significantly in recent years and continues to evolve. The Canada Grain Act and Canada Grain Regulations administered by the Canadian Grain Commission do not accurately reflect current industry practices or producer needs. Calls for modernizing the structure of the Canadian Grain Commission were emphasized in the Agri-Food Economic Strategy Table Report, and through submissions as part of the regulatory review Canada Gazette portal, which underscored the importance of removal of unnecessary and/or duplicative regulations, examining service delivery changes and initiating a review of the Canada Grain Act independent of the Canadian Grain Commission. In bilateral engagement with grain stakeholders, issues related to service delivery, producer protection, governance, and others, have been raised as areas for possible reform.
Agriculture and Agri-Food Canada, with support from the Canadian Grain Commission, will address this by undertaking a review of the Canada Grain Act and Canadian Grain Commission operations. This review will identify what changes are needed to meet the needs of Canada's modern grain sector. The opportunity for comprehensive change through legislative revisions would represent tangible benefits to the sector.
Agriculture and Agri-Food Canada has initiated preliminary discussions with grain sector stakeholders to identify priority areas for the review. Analysis of these issues will be conducted through the remainder of this year (2019). AAFC intends to engage stakeholders on the results of this analysis, to be followed by proposals for potential legislative amendments.
There is also opportunity to begin modernization through specific regulatory actions ahead of any potential legislative change. While the broader review is ongoing, the Canadian Grain Commission will place early emphasis on actions to improve licensing provisions, review and promote arbitration mechanisms, and review and align the Canada Grain Regulations with other regulations (where applicable). The sector would benefit from improved transparency, clarity and simplicity of licensing provisions to reflect modern grain sector practices, ultimately reducing their compliance burden and business costs associated with regulation. Further, they would benefit from an arbitration mechanism to support producer safeguards which would increase transparency and fairness. Lastly, alignment of the Canada Grain Regulations with other government regulations (for example, Safe Food for Canadians Regulations) would reduce duplication and minimize regulatory burden on business.
With respect to stakeholder comments related to adjusting the process for grain classification, this process is not part of the Canadian Grain Commission's regulatory framework, but rather an operating policy/procedure put in place by the Commission within its current mandate. As such, industry concerns in this area will be addressed outside of the focused effort to modernize the Canadian grain legislative and regulatory framework. The implications of changing this process will also need to be discussed by the Canadian Grain Commission with its Grain Standards Committees (industry advisory groups), as well as agriculture portfolio partners to determine a potential path forward. It is estimated that, in the short term (within the next 2 years), Agriculture and Agri-food Canada and the Canadian Grain Commission will complete reviews, consultations and studies on the major requests coming from stakeholders, propose any early regulatory amendments and be in a position to support legislative changes.
Lead: Agriculture and Agri-Food Canada, with support from the Canadian Grain Commission
9. The regulatory framework for aquaculture is complex, unclear, and duplicative
Aquaculture is a growing industry with significant economic potential that supports numerous middle class jobs and international trade opportunities. Canada's Economic Strategy Table Agri-food Report identifies the potential of the aquaculture industry and calls for the Government of Canada to support its competitiveness and facilitate economic development. Also, the report recommends that the Government ensure that the Aquaculture Activities Regulations and federal-provincial license processes provide operational and economic flexibility.
As the industry evolves, DFO is looking at how its regulatory system should adapt to support responsible growth and enable Canada's sector to harness opportunities and grow. The department wants to improve regulations to better protect the environment, as well as reduce overlap and increase clarity, by streamlining regulations.
Through the Indigenous, public and stakeholder engagement sessions, many common themes emerged in terms of feedback, including: the need for an aquaculture act and a nationally consistent regulatory framework for the sector, issues concerning disease and fish health, jurisdictional concerns, pollution prevention and environmental conservation, and Indigenous interests.
The current plan to amend and consolidate aquaculture-specific regulations to create the General Aquaculture Regulations (GAR) will help to address these concerns and support responsible growth of aquaculture in Canada. A number of amendments to the regulations are being proposed as part of the GAR, including the establishment of requirements for monitoring of organic deposits in fresh water environments and post-deposit pesticide monitoring, as well as strengthening reporting requirements.
At the Canadian Council of Fisheries and Aquaculture Ministers meeting on December 4 and 5, 2018, Ministers agreed to support the development of a federal aquaculture act that respects federal, provincial and territorial jurisdictions, and provides greater clarity to the sector. Therefore, DFO, with the support of provincial-territorial partners, is also pursuing an aquaculture act to support the modernization and continuous improvement of aquaculture management in Canada. Public engagement on the proposed new act commenced in early spring 2019.
Together, the proposed act and regulations would form a new federal aquaculture management framework that would address stakeholder's concerns and support responsible growth of aquaculture in Canada.
Lead: Fisheries and Oceans Canada
10. Oversight of human pathogens and toxins is misaligned and duplicative
Feedback received from stakeholders responding to the Canada Gazette consultation as well as feedback received previously from regulated parties has cited misalignment and duplication between Canada's regulatory regimes for human and animal pathogen oversight. This makes it burdensome for entities regulated by both PHAC and the CFIA to comply with their regulatory obligations and may discourage innovative research in Canada. Researchers may have difficulty complying because of different definitions of controlled activities for human and animal pathogens, or duplicative regulatory requirements under different legislation. This can cause undue costs, unnecessary diversion of resources, and slowdowns of innovative research. To address these issues, by December 2020, PHAC and CFIA will collaborate to explore (1) alignment of different definitions in the Health of Animals Act and Human Pathogens and Toxins Act (HPTA); and (2) consider risk-based exemptions from duplicative regulatory requirements between HPTA and other authorities. Better alignment of legislative authorities would minimize regulatory burden and duplication while continuing to maintain appropriate health safeguards. Costs would be absorbed within current budgetary allotments.
To further align oversight of human and animal pathogens and toxins in Canada, PHAC has proposed legislative amendments to the HPTA to streamline the regulatory process by repealing the requirement for the Minister of Health to seek approval through both Houses of Parliament prior to making new or amended regulations, and instead allow the Minister to proceed through the standard Governor in Council process, including pre-publication in the Canada Gazette. The proposed amendments would align the HPTA with comparable legislation (for example, Health of Animals Act). Legislative amendments are being sought as part of the Budget Implementation Act, 2019.
Lead: Public Health Agency of Canada
Theme 2: Competitiveness in domestic and international markets
When it comes to the ability of our Canadian industry to innovate, grow and compete, one of the most common issues raised is that Canadian products do not have an optimal share of the market, either at home or abroad. This theme focuses on key areas of improvement in support of Canadian competitiveness and trade interests, both domestically and abroad. It also addresses opportunities for better alignment and reduction of duplication in oversight across jurisdictions, contributing to reduced regulatory burden for businesses. Key issues that hinder value creation and promotion of Canada's agri-food sector were also raised, such as the "Product of Canada" policy.
11. Competitiveness and innovation are not sufficiently considered as part of regulatory programs
Through the Economic Strategy Table reports and various Canada Gazette submissions, regulated parties emphasized the importance of an agile regulatory system that promotes competitiveness and moves at the speed of commerce. Additionally, 1 of the 6 signature initiatives of the Economic Strategy Table report is an "Own the Podium" recommendation that suggests expedited and priority government services for Own the Podium firms. The CFIA will respond to this by developing a policy that would link competitive advantages with other important outcomes, such as food safety and integrity, plant protection, animal health and environmental and resource sustainability. This policy would provide incentives to innovate and excel in risk reduction, in the form of preferred services such as for pre-market assessment. It would set risk reduction criteria to meet in order to benefit from these incentives. Feedback from stakeholders on a framework would be sought in order to shape the policy. A framework would be developed in the short term, by summer 2019, followed by engagement with stakeholders in late fall 2019 / early winter 2020, to enable the development of the policy by spring 2020. Implementation as part of CFIA programs and services would be over the medium to longer term.
Lead: Canadian Food Inspection Agency
12. Canadian influence at international standard setting bodies is limited
Stakeholders encourage federal departments to increase investment in Canadian participation at international standard setting bodies, to promote Canadian trade interests, support the consistent development of science-based international standards, and improve harmonization with international trading partners. The Economic Strategy Table Agri-food report recognizes the role of international standard setting bodies in promoting a level playing field in international trade, and recommends strong international leadership in these fora. As announced in the Fall Economic Statement, AAFC, the CFIA and Health Canada will better engage with these bodies (for example increased participation at scientific expert advisory bodies and on the committees of the Codex Alimentarius Commission) in the development of international standards that pertains to food safety and animal and plant health.
Through active engagement, Canada can further influence the development of science-based standards to the benefit of Canadian exporters while protecting health and safety of Canadians.
Lead: Agriculture and Agri-Food Canada /Health Canada/Canadian Food Inspection Agency
13. Canadian livestock producers do not have access to the same veterinary drugs as their counterparts in other countries – especially for minor uses and minor species
In order to protect Canada's food supply, Health Canada has an interest in making effective veterinary drugs available to Canadian livestock producers. However, not all veterinary drugs available internationally are available on the Canadian market, in part because the regulatory process creates a disincentive to seeking market authorization in Canada, despite the fact that there may still be a need for the drug.
This poses a particular challenge for producers whose animals have unmet medical needs that could benefit from a wider range of options for use in minor species (for example, goats, sheep, farmed fish), or for use to treat rare or life-threatening conditions in a major species (for example, cattle). As announced in the 2018 Fall Economic Statement, Health Canada is examining the possibility of proposing regulatory amendments that would create an accelerated pathway to allow certain submissions for veterinary drugs intended for unmet medical needs to be approved in Canada by relying on decisions made by specified foreign regulators. The changes would continue to ensure that these drugs meet food safety standards. The proposed changes will respond to the needs of the industry identified through Canada Gazette consultations and the Agri-Food Economic Strategy Table to increase access to drugs available to global competitors.
This project is expected to lead to regulatory amendments being published in Canada Gazette, Part I in spring 2020. The proposed changes will particularly benefit the aquaculture sector and other smaller producer groups (for example, sheep, goat).
Lead: Health Canada
14. The pre-market assessment for certain food products can be lengthy, even though these products may have already been assessed and permitted in like-minded countries
While the vast majority of foods do not require pre-market approval, the Food and Drug Regulations require that a pre-market assessment be undertaken for novel foods, infant formula and food additives. This process can take years before a product is allowed onto the market even though the same product may have been authorized or assessed in another jurisdiction. Stakeholders from different sectors (for example, biotechnology, food industry, infant formula manufacturers) have identified this issue directly with Health Canada, the Canadian Food Inspection Agency and Agriculture and Agri-Food Canada, as well as through Canada Gazette consultations and consultations for the Canada – U.S. Regulatory Cooperation Council. The Economic Strategy Table on Agri-Food also asked Health Canada to consider joint risk assessment and work sharing with like-minded countries. Stakeholders have asked Health Canada to consider acceptance of approval from other countries, permit processing aids and food additives allowed in other countries and mutually recognize infant formulas that are available in other jurisdictions. Health Canada will address this issue by exploring further collaboration with like-minded jurisdictions to use foreign reviews in pre-market assessments, where appropriate. These efforts will enable the agri-food industry to bring products to market more quickly, foster innovation, and provide business and operational efficiencies. As a first step, Health Canada will explore where it is feasible to conduct joint pre-market safety assessments or share assessments to ensure that any decision taken by Health Canada, based on this work, would not compromise the health and safety of Canadians.
Lead: Health Canada
15. Barriers to internal trade affect growth in domestic markets
There are no exemptions from federal registration/licensing based on recognition of provincial or territorial regulatory systems
Stakeholders have commented that it is costly and time consuming to meet federal requirements that apply to interprovincial trade in order to commercially move products across provincial borders, in particular for meat and meat products. This was raised through Canada Gazette consultations. In a more general sense, the Economic Strategy Table reports speak to the importance of reducing internal barriers to trade within Canada. The coming into force of the Safe Food for Canadians Act and Regulations in January 2019 has taken the initial steps to provide more flexibility in meeting federal requirements through its outcome-based approach. Additionally, in collaboration with provincial and territorial (P/T) partners, the CFIA will establish criteria to assess the equivalency of food safety programs between federal and provincial standards, followed by assessing provincial systems for recognition on a voluntary basis. A tool to assess equivalency with the provinces would be developed by summer 2019, while work to develop recognition agreements would begin in 2020. Recognition of equivalency would streamline the regulatory system for industry by reducing duplication and overlap of requirements.
Lead: Canadian Food Inspection Agency; support: PT partners
Organic, grade, labelling and packaging requirements create barriers to internal trade
The Economic Strategy Table Agri-Food Report recommends specific areas of action to address internal barriers to trade with respect to differences in the regulation of organic products between the federal and provincial levels. It was also recommended that grade, labelling and packaging requirements be reviewed to address internal barriers to trade. Early actions to address these issues occurred as a result of the coming into force of the Safe Food for Canadians Regulations in January 2019, which harmonize grade inspection requirements and introduce a federal standard for organic aquaculture.
The food labelling modernization regulatory proposal (presently called "food product innovation") would repeal certain requirements for standard weights and container sizes, and modernize this framework by incorporating by reference the list of sizes to enable further updates. This would partially address concerns about internal barriers to trade caused by packaging requirements. Food labelling modernization amendments are expected to be pre-published in spring 2019.
Issues will be further assessed for any other opportunities to reduce internal trade barriers. It should be noted that for some of these requirements, past industry consultations have revealed industry interest in maintaining status quo.
Lead: Canadian Food Inspection Agency
16. The criteria for the "Product of Canada" claim is not aligned with those used for products of provinces or trading partners
The Economic Strategy Tables recommend that the policy and criteria for the "Product of Canada" claim be reviewed. This was also heard from a variety of stakeholders as part of Canada Gazette consultations and other submissions. For example, under the current federal policy, a product that meets provincial "Aliments du Quebec" guidelines may not meet the stricter federal criteria to use the claim "Product of Canada". Stakeholders indicated that this reduces the feasibility of developing a strong Canadian branding approach. Reviewing and modifying the threshold could enable more products to use the "Product of Canada" description, which highlights Canadian content and processing. This could have the effect of elevating the profile of Canadian products and advance the "Canada Brand" initiative which is 1 of the 6 signature initiatives proposed by Canada's Economic Strategy Tables. To address this feedback, the CFIA and AAFC are reviewing the existing policy, in consultation with stakeholders and with Innovation, Science and Economic Development Canada. This work began in winter 2019.
Leads: Canadian Food Inspection Agency and Agriculture and Agri-food Canada
17. There are difficulties generating sufficient return on investment for wheat and other cereals breeding
High farm-saved seed use in cereal crops means variety developers can only capture a return on their investment on the initial sale of certified seed. Through the Agri-Food Economic Strategy Table, and regulatory review engagement, as well as through discussions with Agriculture and Agri-food Canada's Value Chain Roundtables, some grain sector stakeholders have underscored the importance of creating a new value creation mechanism to address these challenges, with the objective of stimulating greater investment and innovation. AAFC and CFIA began consulting with stakeholders on a value creation model for cereals in November 2018 to obtain stakeholder views on whether, and under what conditions a "Made for Canada" value creation model should be considered.
Leads: Agriculture and Agri-food Canada and Canadian Food Inspection Agency
Theme 3: Risk-based, efficient, predictable regulatory programs
This theme focuses on regulatory programs and services. In a number of cases, concerns have been raised that programs supporting the agri-food and aquaculture sector are not timely, predictable, sufficiently risk-based, or have not adopted efficient processes such as electronic submission platforms.
In the agri-food and aquaculture sector, a number of products require approval before they can enter the marketplace. This creates a lag in time to market that is a consistent concern for the industry that brings these products to market.
18. Pre-market assessment and authorization timelines are slow and unpredictable for feeds, seeds, fertilizers, veterinary biologics, and plants with novel traits
Through Canada Gazette consultations, stakeholders expressed concerns about the timeliness of CFIA pre-market services. Comments suggest that unpredictable and slow timelines create uncertainty in business planning and affects competitiveness. The CFIA would address these concerns using a multi-pronged approach. Proposed regulatory amendments to feeds and fertilizers outlined in the first theme would result in a lower volume of requests for approvals of fertilizer and feeds, which would improve efficiency of processes overall (see Issues 1 and 2). Approvals for new feed products would be streamlined, based on equivalency of authorizations by foreign governments, which would also result in efficiencies. The CFIA would also implement an electronic submissions process for pre-market assessment of agricultural input commodities, reducing burden by enabling online application and payment, as well as introducing automated case tracking.
This initiative has short, medium and long term elements. Proposed regulatory amendments that would have the effect of reducing the volume of pre-market submissions for fertilizer were pre-published in fall 2018, and for feed will be brought forward for consideration in the future. Onboarding of electronic submission processes is planned for the 2019 to 2020 fiscal year.
Lead: Canadian Food Inspection Agency
19. Requirements for plants with novel traits / novel feeds / novel foods are difficult to navigate and understand
Many stakeholders commented on the need for improved guidance respecting plants with novel traits, both in the Economic Strategy Table reports and through Canada Gazette consultations. This lack of clarity affects timeliness to reach market, administrative costs and investment decisions. The CFIA, in collaboration with Health Canada and AAFC, will address this by providing more clarity, through written guidance, around Canada's novelty triggers as they relate to plant breeding innovations. The first phase of improved guidance was published by the CFIA in fall 2018 in the form of questions and answers.
To further address requests for improved clarity, predictability and timeliness, the CFIA and Health Canada will also provide a well-defined process for consulting with regulatory authorities, including how to arrange a consultation, what information to provide, and the timing and format that the response from regulators will take. To support this work, AAFC is co-chairing a joint industry-government working group that will develop an industry position on improvements that should be considered in the novelty determination and pre-market assessment processes. This will be followed by options and recommendations from the working group in mid-2019 to inform the development and publication of more detailed guidance. The first suite of improvements to guidance related to Plant Breeding Innovations is anticipated to take 1 to 2 years.
There is also scope for improving the Seeds Act and Seeds Regulations, to provide better clarity around novelty determination and the oversight of environmental release and stewardship of novel products. Possible regulatory amendments providing clearer regulatory authority could help to ensure that all product developers are on a level playing field (for example, stewardship requirements), and will help to protect the interests of farmers.
Lead: Canadian Food Inspection Agency, in collaboration with: Health Canada, Agriculture and Agri-food Canada
20. CFIA uses inefficient paper-based transactional processes for its regulatory services
Many of the transactional services provided by the CFIA, such as applications for registrations, authorizations and export certifications, remain paper or email-based. These are also seen to lack transparency as stakeholders cannot easily access their profiles or CFIA-held information. The Economic Strategy Table Agri-Food report recommended that regulators increase the use of digital tools and services to streamline transactions with industry, in particular in the area of export certificates. CFIA will address this issue by incrementally rolling out digital services. Starting in January 2019, companies are able to apply and pay for licenses under the Safe Food for Canadians Regulations (SFCR) using an online portal. The SFCR requires many businesses to hold a license in order to carry out activities respecting food. Going forward in 2019 to 2020, there are plans to add additional services such as export certificates and intake of pre-market requests.
Lead: Canadian Food Inspection Agency
21. Third party oversight is not sufficiently considered in the CFIA's risk-based inspection approach
The Economic Strategy Table Agri-Food Report recommends that a panel of industry experts be established to advise regulators on various items, such as opportunities for efficiencies, including alternate service delivery, compliance strategies and third-party accreditation. The CFIA recognizes that an opportunity exists to recognize investments that industry has made in third party certification systems that often exceed regulatory requirements. The CFIA currently considers private certification of establishments as one of several mitigating factors in risk based inspection planning as part of the Establishment Risk Assessment model, which aligns well with the Economic Strategy Table recommendation. Under this initiative, third party certification systems would continue to be considered in the CFIA's Establishment Risk Assessment model and inspection oversight, and would inform things such as frequency or depth of inspections. Benefits for companies that adopt third party schemes include reduced duplication of oversight between the third party and the CFIA, and strengthened trust with the regulator. Within the next year (by fall 2019), the CFIA intends to engage with industry on how third party certification could be considered in work planning and the benefits for them. Private schemes will start to be assessed in 2019, at a rate of 1 to 2 per year.
Lead: Canadian Food Inspection Agency
22. CFIA inspection and enforcement is not always consistent over time, across product types and across the country
Through Canada Gazette consultations, some stakeholders expressed concern over inconsistencies in both inspection and enforcement by the CFIA. The CFIA has heard similar comments in the past and strives to continuously improve in this area. Specific initiatives are currently underway to address concerns, such as the implementation of Standard Inspection Process, which has been put in place to accompany the implementation of the Safe Food for Canadians Regulations (SFCR) as the food regulatory framework moved from a commodity based system to a common system across food. This work is part of ongoing modernization efforts and has been rolled out in the past year for the CFIA's food program and will continue for Plant and Animal Health Programs in the next 2 years and beyond. Other activities to address this issue include providing consistent operational guidance to inspectors on compliance and enforcement (ongoing) and training updates prompted by changes such as the implementation of the SFCR in January 2019. The adoption of digital services described in issue 20 will also improve consistency through a single digital platform for data capture.
It should be noted that while these initiatives will contribute to improved consistency, factors considered as part of compliance and enforcement decisions include not only the harm or risk associated with the violation, but also the compliance history of the regulatory party and whether or not there was intent. CFIA responses will continue to vary based on these latter 2 factors.
Lead: Canadian Food Inspection Agency
23. Duplication of oversight by multiple levels of government increases burden on industry
The Economic Strategy Table report suggests that the Canadian regulatory system needs to assign clear accountabilities with no jurisdictional overlaps. To address this, the CFIA is working with provinces to avoid duplication of oversight. This involves putting in place federal-provincial-territorial (FPT) agreements regarding food safety, animal health and plant protection in line with 4 strategic priorities: information sharing, regulatory cooperation as a move toward harmonization, emergency management and scientific collaboration. The results will be reduced burden for industry through more streamlined, efficient inspection and oversight. In addition, better alignment between federal and provincial or territorial governments will promote greater access to national and international markets for Canadian products. This work is underway and will roll out incrementally over the short to long term. The first step is the establishment of FPT agreement protocols, which will be finalized in 2019 to 2020.
Lead: Canadian Food Inspection Agency
24. Cumulative impacts of food labelling changes made by Health Canada and the Canadian Food Inspection Agency are not sufficiently considered
The food label is one of the most important and direct means of communicating product information between buyers and sellers, and it is one of the primary means by which consumers differentiate between individual foods and brands to make informed purchasing choices. Both Health Canada and the Canadian Food Inspection Agency have responsibilities with respect to federal food labelling requirements. Through Canada Gazette consultations, stakeholders have indicated that recent initiatives, including Health Canada's Healthy Eating Strategy and the Canadian Food Inspection Agency's food labelling modernization (presently called "food product innovation"), did not seem to consider the total economic impact of all proposed labelling changes, and that timelines were not sufficiently aligned to enable effective business planning.
Health Canada and the CFIA will address this issue by developing a joint strategy for future food labelling changes that would consider a formal inter-departmental coordination process, and a regularized cycle for food labelling changes. By providing for greater predictability on labelling changes, the agri-food industry may be able to decrease costs to implement the necessary changes. This would also result in enhanced economic efficiencies with respect to planning and business operations.
This project will begin with initiating stakeholder consultations starting in the 2019 to 2020 fiscal year on the intent to establish an appropriate timeline for a predictable labelling cycle. Health Canada and the Canadian Food Inspection Agency have worked together to align timelines for the proposed label changes that were recently completed (for example Nutrition Facts Table) or are in development (for example food labelling modernization, Front-of-Package Labelling). A predictable cycle for label changes will be implemented subsequent to completion of the existing initiatives.
Leads: Health Canada, Canadian Food Inspection Agency; Supported by: Agriculture and Agri-food Canada
25. Data protection requirements for pesticides are not clear enough and don't do enough to help industry reach compensation agreements
Concerns were raised by stakeholders via the 2015 Intersol Report on Data Protection under the Pest Control Products Act and Pest Control Products Regulations that rules and processes regarding the protection of pesticide innovators' data (that is, with respect to compensation for relying on such data during pre- or post-market reviews) are either unclear or don't do enough to help companies reach compensation agreements in a timely manner and this could hinder registration of and access to lower-priced, generic versions of technologies. Health Canada proposes to address this by updating the negotiation and arbitration rules to help innovators and "generic" producers to reach compensation agreements more easily and by proposing amendments to the Pest Control Products Regulations to clarify the data protection provisions applicable during post-market reviews. These changes would strengthen the existing data protection program while facilitating users' access to lower-priced, generic versions of technologies. They would also maintain compliance with international trade agreements. Rules relating to the negotiation and arbitration of pre-market compensation agreements were updated in April 2019, while final regulatory amendments relating to data protection during post-market reviews are targeted for 2020.
Lead: Health Canada
Section 5 – Novel regulatory approaches
The following novel regulatory approaches have been identified to be pursued as part of the roadmap:
1. Sector specific government-stakeholder collaboration on regulations
Stakeholders have highlighted the need to engage and work with industry in order to address the cumulative and economic impacts associated with regulations; to achieve desired outcomes; address ongoing regulatory irritants; and establish pilot projects to test new technologies.
AAFC will explore opportunities to improve government-stakeholder collaboration on regulatory issues facing the agriculture and agri-food sector.
To support efforts to create a more agile regulatory environment, further government-stakeholder collaboration will be explored. The goal is to facilitate shared solutions between government and industry regarding regulatory irritants (that is, timely, predictable solutions) and to seize opportunities to work collaboratively with industry (that is, regulatory design for new and emerging technologies), to enhance economic growth and competitiveness.
AAFC will provide a focal point for identifying and helping to solve agriculture and agri-food regulatory irritants (for example, prioritization of issues and opportunities), provide analytical capacity to better understand cumulative and economic impacts of regulations across the sector, explore ways to make the regulatory system easier to navigate, and contribute to regulatory experimentation in the agriculture and agri-food space. This initiative is intended to strengthen efforts in the following areas: supply chain regulatory burden mapping, artificial intelligence for regulatory policy and decision-making insights, designing agile regulations suited for transformative technologies and new products and processes that may not fit under current regulatory frameworks.
Any sector-specific regulatory approach would complement broader Government of Canada mechanisms to support system-wide changes and the creation of distinct spaces for regulatory experimentation and innovation.
Lead: Agriculture and Agri-food Canada
2. Reducing risk and improving trust using distributed ledger technology (blockchain)
Blockchain is a digital database that securely transmits any type of information without a central authority. In the absence of a central authority, information is transferred directly from user to user. The information is validated by the computers on the network using algorithms. Blockchain is a new tool. For regulators, it shows potential for revolutionizing the sharing of data between regulated parties and the regulator. However, it has not yet been tested in a regulatory context in Canada. The report of the Economic Strategy Tables recommends that government work with industry to pilot this technology. Distributed ledger technology could address issues of cost, quality, trust and security, which prevent wide-spread industry adoption of supply chain management platforms. It could potentially allow for more preventative risk control measures, and enable quicker and more precise interventions. The CFIA also sees real potential in using blockchain to possibly support the traceability requirements of the new Safe Food for Canadians Regulations, as well as the prevention of food fraud. As such, the CFIA will undertake a 2-year initiative involving collaboration with industry to test practical application of distributed ledger technology (blockchain) in information sharing, supply chain management and traceability. The results of the initiative will inform the next steps for harnessing the potential of blockchain technology as a regulatory tool.
Lead: Canadian Food Inspection Agency
3. Rethinking the regulatory relationship: applying innovation and behavioural science to promote compliance and improve risk management
The concept of Ethical Business Regulation is gaining favour worldwide. Ethical Business Regulation is a new regulatory oversight approach that recognizes that industry has a vested interest (by way of reputation, profits/sales, and growth) to ensure risks are well managed. The CFIA proposes to test the concept of Ethical Business Regulation with "champion" establishments/partners to explore a modified, shared risk relationship that encourages compliance and enhances information sharing. This initiative would provide champion establishments with the opportunity to promote themselves as leaders in the industry, earning greater trust and credibility with the regulator, and consumers who place value on honest business practices. In addition, working collaboratively with regulators to provide insights and intelligence such as changes in innovation and technology in the sector could position the company as a leader and influencer in the industry-regulator relationship. Thus both regulator and regulated party would stand to benefit from this new relationship. Within 2 years, the CFIA will complete a pilot, as well as the analysis of results from it, which will help it to determine next steps.
Lead: Canadian Food Inspection Agency
Section 6 – Sector issues and irritants not being addressed by the department/agency
Some of the issues that have been raised by stakeholders are not being addressed in this roadmap. The reasons why issues are not being addressed fall into 3 general categories:
- issues that are covered under other federal initiatives
- issues that are outside the mandate of the review departments and agencies or outside the scope of the regulatory review (innovation, growth, competitiveness)
- issues that cannot be considered a priority at this time, due to the need for additional assessment or misalignment with other objectives
Issues covered by other federal initiatives
Strategies to address issues that fall under the Canada-US Regulatory Cooperation Council, Regulatory Reconciliation and Cooperation Table, and Canada-European Union Regulatory Cooperation Forum are not replicated in this roadmap. However, where there are linkages, they are identified in the roadmap.
Issues outside the mandates of review departments/agencies or the scope of the review
During the regulatory review of the agri-food and aquaculture sector, a number of issues were raised that fall outside of the authorities of the departments and agencies responsible for the review but that impact the sector. These issues include:
- Labour – The administration and regulation of the Temporary Foreign Worker Program present challenges that contribute to labour shortages for the sector
- Transportation – A lack of consistency for inter-provincial transportation regulations (for example, trucking weight limits, tire weight limits, and axle configuration) as well as outdated regulations with respect to rail transportation (for example, rail performance, fluidity and rail rates) affect the ability of the sector to transport agri-food and aquaculture products
- Environment – There are questions about the evidence that carbon pricing will reduce emissions from primary agriculture and food production in Canada
- Digital Infrastructure – The adoption of precision agriculture technologies is limited by access to broadband service in rural areas
- Tariffs – Tariffs affect the ability of Canadian companies to compete on price in export markets, particularly if other countries have more favourable tariffs for the same products
In addition, through Canada Gazette submissions, some stakeholders commented that the lack of an organic standard or certification system for non-food products such as textiles and cosmetics affects this sector's growth potential. As the scope of the review was limited to the agri-food and aquaculture sector, this issue was considered to be out of scope.
Some stakeholders recommended changes to the mandates of departments and agencies involved in the review. These ranged from general recommendations, such as including competitiveness in the mandates of all of the departments and agencies, to specific recommendations to move authorities for oversight of a product or activity from one department or agency to another. This type of recommendation is beyond the purview of the review departments and agencies, and is not addressed in this roadmap.
A number of stakeholders raised issues and made recommendations directed at the regulatory process or the Cabinet Directive on Regulation (CDR) and how it is implemented by departments and agencies, including, for example, engagement and cost benefit analysis. The CDR, which came into force on September 1, 2018, sets out the Government of Canada's expectations and requirements in the development, management, and review of federal regulations. Federal departments and agencies must comply with this directive and its related policies and guidance at all stages of the regulatory life cycle. The directive is created and maintained by the Treasury Board Secretariat. As such, issues and recommendations that relate to the CDR are not addressed in this roadmap but have been provided to Treasury Board Secretariat for their consideration.
Issues not being addressed for other reasons
There is a small number of issues that were raised and that are not being addressed through actions outlined in the roadmap for a variety of reasons, other than those outlined above.
Pesticides – registration, international considerations and maximum residue limits
A small number of stakeholders raised concerns that PMRA's registration process is lengthy, unpredictable and not transparent. They also questioned whether assessment of efficacy should be part of the assessment process and whether there was too much focus on human health in risk assessments. Specific action is not being proposed in response to these concerns as the issues of length of time and predictability are already addressed by the PMRA's performance standards set out in its Management of Submissions Policy and the fact that these are generally aligned with other international regulators. Further, the PMRA's decision making process is subject to consultation and public posting, which addresses concerns of transparency. Lastly, the PMRA's mandate is to protect human health and the environment, along with other components; as such, no further action is being proposed to address the concerns that there is too much focus on human health protection.
Stakeholders also requested that PMRA conduct more international joint reviews, coordinate and align decisions and accept/recognize decisions of other regulatory authorities. The PMRA works closely with a number of foreign jurisdictions and international organizations through various fora. These efforts have resulted in harmonized requirements, routine joint reviews of many new agricultural chemicals and aligned outcomes, where possible. However, it should be noted that differences in evaluation frameworks in foreign jurisdictions, and regional differences, such as climate and product use patterns, are such that complete harmonization or alignment is not always feasible. It should likewise be noted that joint reviews of new chemicals cannot be conducted without joint submissions by pesticide manufacturers. The PMRA will continue to take opportunities to coordinate and align on an international scale where appropriate.
A number of stakeholders also raised concerns with maximum residue limits. Through the Canada Gazette submission process, stakeholders recommended greater international harmonization of maximum residue limits (MRLs). However, there was no consensus regarding with whom Canada should harmonize, as stakeholders variously recommended aligning with the U.S., the E.U. or Codex. As noted above, the PMRA already participates in international joint reviews of pesticides, which can lead to aligned outcomes on maximum residue limits. Also, while the PMRA considers risk assessments conducted in foreign jurisdictions, it cannot automatically accept foreign maximum residue limits, as these do not always consider the Canadian context, such as Canadian-specific exposure to products and use patterns.
Food safety and nutrition, including healthy eating strategy initiatives
Some stakeholders also raised issues regarding the impact of regulations on very specific product submissions or public health requirements, and issues concerning current regulatory initiatives that are in development, such as front-of-package (FOP) nutrition labelling.
For issues related to the approval of specific products or requests for exemptions or amendments to existing regulations (for example fortification requirements), Health Canada already has processes and tools in place to evaluate and determine whether these products can be allowed on the market. Stakeholders are encouraged to engage with Health Canada directly if they are unsure of how to bring their particular product onto the market.
Initiatives such as the Healthy Eating Strategy, which includes the implementation of front-of-package nutrition labelling, are meant to improve Canada's food environment. It is one of the levers that the Government of Canada has to address the growing burden of chronic disease in Canada, diseases which are largely preventable and present an overwhelming burden on our health systems. Poor diet is a primary cause of chronic diseases in Canada.
Throughout the regulatory process, Health Canada has met with industry stakeholders to discuss ways to mitigate impact on industry while still maintaining integrity of the policy objectives of the FOP initiative; Health Canada has also examined all evidence and comments submitted by industry stakeholders with the same objective. As a result, the regulatory package includes many of those measures to ensure that the costs are as limited as possible.
Fisheries and Oceans Canada received comments from 9 different organizations as part of this exercise. The majority of comments received during this review can be directly addressed by DFO's current proposals to develop a new federal aquaculture act and consolidate and amend its aquaculture regulations. Some comments, however, were linked to issues that will need to be addressed in other forums or by other federal departments.
Another issue that was raised through the Canada Gazette consultations was a desire for a Minor Use Minor Species (MUMS) program as it relates specifically to aquaculture. Health Canada, along with the Canadian Food Inspection and Agriculture and Agri-food Canada, are exploring ways to address this issue for various farmed species, including farmed fish.
Information and guidance from the CFIA
A few stakeholders raised issues or made recommendations about the information available to them from the CFIA, to help them to navigate the regulatory system or about the processes for requesting information from the CFIA. The CFIA is continuing its work to implement the AskCFIA service, to enhance guidance to regulated parties, and to promote compliance. This work is of particular importance as the CFIA works with stakeholders to prepare for the coming into force of the Safe Food for Canadians Act and the Safe Food for Canadians Regulations in January 2019, and to help them to understand and adhere to the new requirements in the months after that date. Enhanced guidance is also identified in the plans to address other issues raised in this roadmap, such as those related to plant products of biotechnology. Because of the work underway at this time on these initiatives, the CFIA has not identified additional compliance promotion or guidance activities for inclusion in this roadmap.
Issues requiring further consideration
There are several issues or recommendations that are raised stakeholders that require additional consideration. That consideration may be in relation to whether the identified issue or recommendation has the support of the broader stakeholder community, for example, or additional consideration may be required due to the complexity of the problem that needs to be solved and the lack of a clear path to address it at this time (for example, a grower compensation system for invasive plant pests). These issues and recommendations are not addressed in this roadmap.
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