Targeted Regulatory Review: Agri-food and Aquaculture Roadmap

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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 three 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 three 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 Regulatory Review 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 five years, starting in 2019-20, through Budget 2019, in support of the implementation of initiatives from the Agri-food and Aquaculture Regulatory 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.

For further details and the latest information on proposed regulatory changes, please go to the following Forward Regulatory Plans:

For further details and the latest information on proposed policy, program and novel approaches, go to the Agri-food and Aquaculture Roadmap Policy and Program Initiatives and Novel Approaches

Agri-food and Aquaculture Roadmap

The Agri-food and Aquaculture Sector Regulatory Review 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 Sector Regulatory Review Roadmap is a product of the Targeted Regulatory Reviews. The Agri-food and Aquaculture Sector Regulatory Review Roadmap is divided into the following six sections;

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:

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 the spring of 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, two 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

Aquaculture in Canada is a shared federal-provincial-territorial jurisdiction and managed via federal-provincial regulatory frameworks. Federal regulatory activities in aquaculture currently span seven 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 4-5, 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 2017/18.

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 three principal themes:

  1. Clear, Agile, Responsive Regulations
  2. Competitiveness in Domestic and International Markets
  3. 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 three 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.

  1. 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 01, 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 three 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 HC 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 FY 2020/21. 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 FY 2021/22 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 FY 2022/23.

    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 five 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 four key issues:
  1. 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 05, 2018. Health Canada is currently reviewing the comments received and aims to finalize the document in 2019-20.

    Lead: Health Canada

  2. 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 (i.e., 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

  3. 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, 18-24 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 two-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

  4. 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 (i.e., 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 (e.g. 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 two 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 4-5, 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, one of the six 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 HC 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
  1. 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

  2. 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 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 one of the six 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 2019-20 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 HC 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 the fall of 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 1-2 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 2019-20, 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 1-2 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 Procedures, which have 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 two 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 two 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 four 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 2019-20.

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, 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 FY 2019-2020 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 (i.e., 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 (i.e., timely, predictable solutions) and to seize opportunities to work collaboratively with industry (i.e., 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 (e.g., 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 two 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 three 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.

Aquaculture

Fisheries and Oceans Canada received comments from nine 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.

The Agri-food and Aquaculture Roadmap Policy and Program Initiatives and Novel Approaches

Label Modernization for Pest Control Products

Description of Issue

The Pest Control Products Regulations do not allow use of electronic labels or, in most circumstances, labels based on the Globally Harmonized System of Classification and Labelling of Chemicals. As such, registrants have to bear the costs of paper-based labels rather than using an electronic label, and they don't have the option of aligning their Canadian label to a European one, for example. Additionally, labels are not currently structured or worded in a consistent manner, making it harder for users to understand and find the information they need to use pest control products safely and efficiently.

The Pest Control Products Act also does not allow the Minister to amend registrants' approved product label content without receiving an application for each. As a result, registrants must spend time and resources submitting applications even to implement simple required changes (for example, as a result of a regulatory amendment). This creates avoidable administrative burden for industry.

Description of Approach

Health Canada proposes to address this issue by proposing amendments to the Pest Control Products Regulations to modernize pesticide labels, including to permit use of electronic labels and international formats (i.e., the Globally Harmonized System of Classification and Labelling of Chemicals), and to improve the readability of labels.

Health Canada also proposes to amend the Pest Control Products Act to give the Minister the ability to make label changes to align with changes to regulatory requirements (i.e., without the registrant needing to submit an application for the change).

Key Milestones

With respect to amending the Pest Control Products Regulations, pre-publication of the proposed regulatory amendments in the Canada Gazette, Part I is targeted for 2020.

The proposed statutory amendments would be pursued via the legislated Parliamentary review of the Pest Control Products Act, which could commence in 2020.

Department Contact Information

Policy and Regulatory Affairs Divisions
PMRA, Health Canada
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Modernize Authorization Process for Certain Pest Control Products for which Registration is Not Required

Description of Issue

Industry stakeholders have indicated that the current list of authorized pest control products for which registration is not required is out of date. The products on this list are products with low- or well-characterized risk, such as products used for organic agriculture. Further, the process for updating the list via the Governor in Council is too slow and inflexible to keep up with changing industry needs. An 18-24 month process is required to add even a single low-risk product (for example, a food-grade substance), which is not reflective of the low risk presented by such a product.

Stakeholders also indicated that there is duplication between Health Canada and Canadian Food Inspection Agency in the oversight of nitrogen stabilizers.

Description of Approach

In the short term, the Pest Control Products Regulations would be amended to update the list of authorized pesticides to include more products (for example, products used for agriculture, pool and spa products and treated articles). Amendments would also be made to allow nitrogen stabilizers to be regulated by the Canadian Food Inspection Agency alone, rather than also requiring duplicative oversight by Health Canada. See HC's Forward Regulatory Plan.

In the longer term, statutory changes would be proposed to grant the Minister power to add certain types of pest control products to the list of authorized products not requiring registration. This would enable products with low- or well-characterized risk to be added to the list without going through the Governor in Council process. Statutory changes would also be proposed to grant the Minister power to strengthen post-market regulatory oversight, including to manage any potential health or environmental risks arising from an increased number of authorized products not requiring registration. These products would be made subject to the same post-market requirements as registered products. This would include, for example, incident reporting and sales reporting, and allowing Health Canada to require recalls and stop-sales of non-compliant authorized products.

Key Milestones

A public pre-consultation document on the proposed regulatory amendments was published online on 30 November 2018, with written comments being accepted for 90 days.

With respect to amendment of the Pest Control Products Regulations, pre-publication of the proposed regulatory amendments in the Canada Gazette, Part I, is targeted for winter / spring 2020. Final publication of regulations in the Canada Gazette, Part II, is targeted for fall 2020.

The proposed statutory amendments would be pursued via the legislated Parliamentary review of the Pest Control Products Act, which could commence in 2020.

Department Contact Information

Policy and Regulatory Affairs Divisions
PMRA, Health Canada
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Modernize the Post-Market Review Process for Pest Control Products

Description of Issue

While consistent with international standards, the re-evaluation process for pesticide products is resource intensive, and has been criticized as taking too long and lacking transparency/engagement. In addition, the Pest Control Products Act requires Health Canada to initiate a new post-market review of a particular issue of concern, even if doing so duplicates the work of another post-market review.

Description of Approach

In 2018, Health Canada began a review of the Re-evaluation Program for pesticide products and will be considering opportunities for improvements to address challenges been identified by stakeholders.

As part of this review, Health Canada has consulted and will continue to consult its stakeholders and key partners to develop a plan to achieve a sustainable post-market pesticide review program that continues to protect health and the environment.

The review will result in recommendations to improve the re-evaluation process for pest control products to make it more efficient, effective and financially sustainable. These recommended improvements could involve possible statutory, regulatory, policy and/or process changes. 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

Some operational changes to process may be possible under current legislation, and would be implemented as soon as practicable, such as enhancing the opportunity for stakeholder engagement.

In the short term, Health Canada proposes to amend the Pest Control Products Act to eliminate duplicative or unnecessary work by allowing the Minister of Health to: expand the scope of an existing post-market review rather than initiating a new special review; and, decide not to initiate a new special review if the issue of concern is being or has been addressed in another post-market review, and, in the latter case, that there is no additional information that would warrant initiating a special review. The Minister would retain the option to proceed with special reviews where it is in the best interest of health and environmental protection.

In the longer term, statutory changes may be proposed to more comprehensively amend or restructure all post-market reviews to increase efficiencies, avoid duplication of efforts, and increase clarity, coherence and predictability between currently parallel processes for re-evaluations and special reviews. Such proposals could be considered as part of the Parliamentary review of the Pest Control Products Act, which could start in 2020.

Key Milestones

Health Canada consulted its stakeholders and key partners in fall 2018/Winter 2019 to inform development of a plan to achieve an efficient, effective and sustainable post-market pesticide review program that continues to protect health and the environment.

Short term: 1-2 years

Seek amendments to s. 17 of the Pest Control Products Act (re: special reviews), to eliminate duplicative and unnecessary work, as described above. These proposed amendments are set out in the Budget Implementation Act, 2019.

Complete the review and seek approval to implement non-statutory components.

Medium term: 3-5 years

Pursue implementation through statutory or regulatory changes as required, as well as amendments resulting from the Parliamentary review of the Act (as early as 2020).

Develop a business case to support the long-term sustainability of the re-evaluation program.

Department Contact Information

Policy and Regulatory Affairs Divisions
PMRA, Health Canada
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Modernizing Federal Aquaculture Regulations through the Development of the General Aquaculture Regulations

Description of the issue

Concerns have been expressed about Canada's aquaculture regulatory regime for being too complex, overlapping and lacking transparency. There are concerns that these challenges hinder both competitiveness and responsible growth of the industry.

DFO is the primary federal regulator for aquaculture in Canada; however, some aspects of aquaculture also involve other federal organizations. While aquaculture is a shared regulatory jurisdiction between federal and provincial and territorial governments, and is generally viewed as a strong, robust regulatory regime for effective management of aquaculture, stakeholders have expressed concern about varying requirements in different provinces, which can lead to complexities and inconsistency, and the need for consolidated regulations that recognize and meet the specific needs of aquaculture management.

Description of the Approach

Stakeholders have provided both specific and general feedback on how DFO can improve how it regulates aquaculture in Canada. As a way to address many of these concerns, DFO is developing the General Aquaculture Regulations (GAR). This initiative would consolidate DFO's diverse regulatory provisions pertaining to aquaculture into one comprehensive set of regulations under the Fisheries Act, which will enhance regulatory clarity and understanding and provide the opportunity to deliver a suite of amendments that will improve many aspects of aquaculture management.

For example, subject to further consultation, the GAR will address stakeholders concerns on the following:

  • better clarify regulatory requirements by consolidating DFO's diverse aquaculture regulatory provisions into a single set of regulations;
  • increase transparency through enhanced reporting authorities and requirements; and
  • anticipate and allow for industry innovation (e.g. via national standards).

The GAR will continue to respect provincial and territorial jurisdictions. DFO will continue to regularly engage and consult with its regulatory partners and stakeholders as the GAR is developed and implemented.

In December 2018, provincial Ministers agreed to support the development of a federal aquaculture act with limited scope that respects federal, provincial and territorial jurisdictions, and provides greater clarity to the sector. Though the development of federal aquaculture act is not being developed in response to the TBS Regulatory Review process, the legislative authorities in the Act will need to be established before the GAR can be finalized. The proposed Act, together with the GAR, will support industry growth and investment by providing clarity and certainty to the sector while enhancing environmental protection and overall sustainability.

Cooperation Implications

Given that aquaculture in Canada is a shared federal-provincial-territorial jurisdiction and managed via complex federal and provincial regulatory frameworks, DFO will continue to engage provincial and territorial partners as well as Indigenous groups as it moves forward with the GAR and the proposed aquaculture act.

Key Milestones

Regarding the act, DFO will engage with Canadians Spring/Summer 2019 and in 2020. At present, it expected that drafting of a new bill will begin in late 2020 with ongoing engagement with Indigenous groups, stakeholders, and provincial and territorial partners. Royal assent could be expected as early as fall 2022. It is expected that the department will be in a position to finalize the GAR once the act has received royal assent.

Department Contact Information

Aquaculture Management Directorate
Fisheries and Oceans Canada
Aquatic Ecosystems Sector
Fisheries and Oceans Canada
Email: AquacultureConsultations.XMAR@dfo-mpo.gc.ca

Create Clear, Agile, Responsive Regulatory Structure for Pathogens and Toxins; Streamlined and Coordinated Regulatory Oversight

Description of Issue

The Public Health Agency of Canada (PHAC) regulates human pathogens under the Human Pathogens and Toxins Act (HPTA) and the importation of certain animal pathogens under the Health of Animals Act (HAA). The Canadian Food Inspection Agency (CFIA) regulates certain animal pathogens under the HAA.

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 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.

Description of Approach

Description and Rationale/explanation:

To address these issues, PHAC and CFIA would collaborate to explore:

  • Alignment of HAA and HPTA definitional differences identified by our shared stakeholders; and
  • Opportunities to align, clarify for regulated parties and cooperate on oversight of human and terrestrial animal pathogens.

Furthermore, PHAC would:

Propose to streamline regulation-making authorities in the HPTA to follow the standard Canada Gazette consultation process, rather than needing prior approval through both Houses of Parliament, to enable a more nimble and responsive regulatory framework for human pathogens and toxins while maintaining existing health safeguards.

  • 1) Increased collaboration between PHAC and CFIA:

    There may be opportunities to increase clarity and decrease administrative burden on parties regulated by both PHAC and CFIA. 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) 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.

  • 2) Regulation-making authorities:

    Current Governor in Council regulation-making authorities under the HPTA require the Minister to lay proposed regulations before both Houses of Parliament, except those to update schedules of human pathogens and toxins. The proposed legislative amendments to the HPTA would 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. This would align the HPTA with similar legislation (for example, the Health of Animals Act).

Key Milestones

Two separate timelines will be followed to address the identified areas for improvement:

  • Explore alignment of HAA and HPTA definitions and risk-based exemptions: 2020
  • Proposed legislative amendments to streamline HPTA regulation-making authorities from approval by both Houses of Parliament to standard Governor in Council process: legislative amendment is being sought as part of the Budget Implementation Act, 2019.

Agency Contact Information

Office of Stakeholder Engagement and Regulatory Affairs
Health Security and Infrastructure Branch
Public Health Agency of Canada
Email: phac.pathogen-pathogene.aspc@canada.ca

Competitiveness and Innovation Policy

Description of Issue

Stakeholders have commented that industry competitiveness and innovation need to be more prominently considered as part of Departmental and Agency mandates and activities.

Description of Approach

The CFIA has a broad mandate, focused primarily on mitigation of food safety, plant and animal health risks, while also responsible for market access related activities. Industry stakeholders seek increased consideration of competitiveness in the delivery of regulatory programs. To promote all of these interests, the CFIA proposes to develop a policy that links innovation and best practices in risk reduction with competitive advantages in the delivery of CFIA services.

The policy would outline how the CFIA would provide competitive advantages in the delivery of CFIA services by incentivizing innovation and best practices in risk reduction. Regulated parties are required to comply with regulatory requirements; however, there are those that voluntarily go above and beyond legal requirements. This policy would outline criteria for this differentiating advantage that would include such things as: improving food safety and authenticity; enhancing plant protection; improving animal health and welfare; increasing environmental and sustainability benefits; lowering costs or providing other benefits for consumers/businesses; and surpassing federal and international standards and approaches. It would also outline how this differentiation would enable categorization of those businesses, through a tiered approach, for the receipt of preferred CFIA services (e.g. fast lane for pre-market assessment, streamlined inspection regime, etc.).

A framework document will be developed to engage stakeholders, prior to the development of the policy. Feedback received during the consultations will help the CFIA in shaping its Competitiveness and Innovation Policy

Cooperation Implications

Stakeholders will be engaged early in the policy development process to assess which CFIA services are of greatest interest to them in this context. Engagement will continue through to policy finalization and implementation.

Key Milestones

The framework would be developed in the short term, i.e. by summer 2019, followed by external consultations with stakeholders in late fall 2019 / early winter 2020.

This would be followed by the development of a policy, targeting late spring 2020.

Implementation of the policy would be in the medium to long term, through integration in existing CFIA programs and services.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Increased Canadian Participation/Influence in International Standards Setting Bodies

Description of Issue

Stakeholders encourage federal departments to increase investment in Canadian participation at international standard setting bodies, to promote Canadian trade interests, and improve harmonization with international trading partners. Maintaining and strengthening the integrity of the international rules-based trading system through strong international leadership is important to help Canada achieve export growth targets.

Description of Approach

Agriculture and Agri-food Canada (AAFC), Health Canada (HC) and the Canadian Food Inspection Agency (CFIA) will enhance their engagement in the development of international standards.

This would be carried out in areas within the respective department's mandates (for example sanitary and phytosanitary measures, human health, technical barriers to trade, etc.). This initiative includes enhancing engagement in the work of the Codex Alimentarius Commission's to help develop standards, guidelines and recommendations that protect consumer health and promote fair practices in food trade, the World Organization for Animal Health (OIE), and the International Plant Protection Convention for plant health.

To support this enhanced engagement, AAFC, HC and CFIA will also build capacity to provide expertise to inform Canadian positions and facilitate international standard development process (for example increase the ability to provide expertise to international scientific expert advisory bodies).

Cooperation Implications

Participation as part of international standard setting bodies contributes to alignment of Canadian standards with international standards and helps address non-tariff barriers to trade.

Key Milestones

The benefits and results will be realized over the long term since the development of trade rules and international standards are negotiated over several years between member countries of the relevant international organizations.

Department / Agency Contact Information

Regulatory Policy Coordination Office
Strategic Policy Branch, Agriculture and Agri-Food Canada
Email: aafc.regulation-reglementation.aac@canada.ca

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Food Directorate
Health Products and Food Branch
Health Canada
Email: hc.food-aliment.sc@canada.ca

Use of Foreign Reviews and Joint Risk Assessments to Bring Innovative Food Products to Market for Canadians

Description of Issue

Health Canada (HC) undertakes a pre-market assessment for various food products (for example food additives, infant formula, packaging materials and processing aids) to ensure they are safe for Canadians. However, the pre-market assessment process can be lengthy, even though these products may have already been assessed and permitted in like-minded countries. This prevents industry from marketing safe and innovative food products to Canadians in a timely manner.

Description of Approach

HC will address this issue by exploring the feasibility of using foreign reviews and conducting joint risk assessments with like-minded countries to bring innovative food products to market in a timely manner.

HC has cooperation mechanisms in place with various like-minded countries such as United States, Australia, New Zealand as well as the European Union. These arrangements enable the Department to leverage scientific and technical capacity, undertake joint assessments and facilitate regulatory alignment in areas of mutual interest.

In the short term, HC will complete a feasibility study to identify potential product lines and conditions for which foreign reviews and joint risk assessments can be undertaken. Health Canada will explore how the existing agreements can be leveraged for joint safety assessments or sharing assessments. Following this, HC will establish potential conditions, product lines and criteria, under which Health Canada can consider using foreign reviews. HC will also need to conduct a thorough comparability analysis (both in terms of regulatory frameworks and safety assessments) to determine the suitability of using foreign reviews. This will lay the foundation for HC to proceed with establishing a process for working with foreign regulators for pre-market approvals and joint risk assessments.

Any new approach to support the use of foreign reviews and joint risk assessments will maintain the primacy of health and safety and the integrity of the science-based decision-making process, while also supporting the economic and innovation interests of the agri-food industry.

Cooperation Implications

This initiative will allow Canada to enhance alignment of regulatory approaches with trusted foreign regulators (for example, United States, European Union, Australia, New Zealand).

Key Milestones

HC is expected to complete its feasibility study by summer 2020, following which HC will initiate work to establish a process for use of foreign reviews and joint risk assessment in fall 2020. Health Canada is expected to have processes in place by the end of Fiscal Year 2021-2022.

Department Contact Information

Food Directorate
Health Products and Food Branch
Health Canada
Email: hc.food-aliment.sc@canada.ca

Food Safety Oversight: Domestic Equivalence

Description of Issue

Federal regulations apply to businesses that trade across provincial/territorial or international borders, while provincial/territorial regulations apply to those that sell only within their province/territory.

To trade inter-provincially, businesses must meet all the applicable federal requirements to get a federal license. The example most often cited by industry is that requirements specify that meat and meat products can only be commercially moved across provincial borders if they are derived from the federal meat inspection system.

The requirements for obtaining a federal registration or license were often more rigorous and, consequently, more costly and time consuming. The former Meat Inspection Act/Regulations, which were replaced by the Safe Food for Canadians Act and Regulations on January 15, 2019, were prescriptive in nature. There were no provisions for exemptions based on recognition of provincial or territorial regulatory systems.

Description of Approach

On January 15, 2019, the Safe Food for Canadians Act (SFCA) and Safe Food for Canadians Regulations (SFCR) came into force. The SFCR apply international food safety standards established by Codex Alimentarius to all food that is imported, exported or traded between provinces, and requires that all food products traded across Canada meet the same food safety outcomes.

The Regulatory Reconciliation and Cooperation Table (RCT) has tasked the Federal/Provincial/Territorial (FPT) Food Safety Committee to work on the development of a domestic food safety recognition framework, similar to the CFIA's Foreign Food Safety Systems Recognition Framework. Once completed, this framework will enable provinces and territories to self-assess against federal criteria to determine if there are any gaps or areas where they may wish to align their food safety system.

For provinces and territories that choose to assess their food safety systems against the federal regime, the shift to outcome based requirements under SFCR will facilitate PTs assessment of their food safety legislation which is an essential component of the overall food safety systems assessment.

Once a province or territory undertakes a self-assessment of their food safety system against the federal regime, this will serve to determine if there are any gaps or areas that can be better aligned. At this point a determination can be made that a PT food inspection system is equivalent to, or exceeds, federal standards, leading to recognition agreements to formalize equivalence.

Cooperation Implications

Provinces and territories will play a role in self-assessing systems against federal criteria, as well as making any necessary adjustments to achieve equivalence.

Key Milestones

A tool to assess the equivalency of food safety systems is expected to be complete in spring 2019.

The development of the first recognition agreement to formalize equivalence of a provincial food safety system is anticipated no sooner than 2020.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Internal Trade Issues Relating to Food Grades, Food Packaging, Food Labelling and Organic Products

Description of Issue

The Economic Strategy Table (EST) report on the agri-food sector recommended that internal trade barriers on certification of organic standards, packaging, labelling and grading requirements be addressed in order to improve interprovincial commerce within Canada.

Specifically, actions were recommended in the following priority areas:

Certification of organic standards

There are national standards for labelling organic agriculture and organic aquaculture developed by the Canadian General Standards Board (CGSB). The Safe Food for Canadian Regulations (SFCR) incorporates both of these standards into the federal organic regime. Some provinces have organic regimes that make use of the CGSB labelling standards, but others do not. As a result, some manufacturers of organic food may face uncertainty when trying to label their products for different markets within Canada. The EST report recommends a consistent approach to the use of these standards across jurisdictions in Canada to create a level playing field.

Packaging and grade requirements

There are packaging and grade requirements that must be met in order for certain foods to move from one province to another or to be imported, while such requirements do not apply to foods shipped within a province. For example, there are limits on the size of shipment of fresh graded produce that can move across a provincial border before seeking a Ministerial exemption. The EST report has identified these as issues that affect productivity and efficiency.

Food Labelling

The Economic Strategy Tables did not highlight a specific federal labelling requirement that is creating a barrier to internal trade. However, there may be certain provincial requirements that differ from federal requirements.

Description of Approach

The Safe Food for Canadians Regulations (SFCR), which came into force on January 15, 2019, harmonized grade inspection requirements such that grade verification inspections will be applied consistently across Canada. Incorporation by Reference of grades in the SFCR will facilitate future updates, based on industry consensus. Additionally, the SFCR introduce provisions that enable foods with certain non-compliances, including with respect to grades, to be moved from one province to another on condition that the food is brought into compliance within three months.

With respect to organic, the CGSB standards are available for adoption by provinces and territories that may be interested in applying them within those jurisdictions. CFIA is available to provide information on the federal regime upon request.

With respect to packaging, the Food Labelling Modernization initiative proposed to 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 remove some of the current limitations on the movement of food across provincial borders due to prescribed package size requirements. Pre-regulatory proposals to this effect were consulted on in 2017, and a regulatory package to implement the Food Labelling Modernization proposals is part of the CFIA's Forward Regulatory Plan.

The majority of federal food labelling requirements apply at all levels of trade in Canada and do not restrict trade between provinces. However, there are a limited number of trade and commerce related federal labelling requirements that apply only to specific commodities in international and interprovincial trade. These are referred to as commodity-specific labelling requirements. The CFIA's Food Labelling Modernization initiative will streamline commodity-specific labelling requirements and reduce the number of these provisions. In some cases there may be differences in labelling requirements between provinces due to provincial requirements that are outside of the authorities of the departments and agencies involved in the federal regulatory review.

Cooperation Implications

The grades and organic aquaculture issues were included in the work plan for the Regulatory Reconciliation and Cooperation Table that was created as part of the Canada Free Trade Agreement.

Issues related to consistency of organic standards for products traded intra-provincially rely on provincial and territorial adoption of the federal standard.

Key Milestones

For food grades and organic aquaculture, these items were addressed (to the extent possibly at the federal level) when the SFCR came into force on January 15, 2019.

Food packaging changes will be made as part of Food Labelling Modernization amendments. Pre-publication of these regulations is anticipated in spring 2019.

Further Information

The CFIA's Industry Labelling Tool provides additional information on grades and organic labelling.

Information on Organic Aquaculture is also accessible on the CFIA website.

More information on the Food Labelling Modernization regulatory initiative can be found in the CFIA's Forward Regulatory Plan.

Agency Contact Information

Reviewing the Policy for "Product of Canada" Label Claims for Foods

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Reviewing the Policy for "Product of Canada" Label Claims for Foods

Description of Issue

The current "Product of Canada" guidelines allow this claim to be used on food when all or virtually all ingredients, processing, and labour are Canadian. All or virtually all is considered to mean greater than 98%. Some industry stakeholders believe that this high threshold reduces their ability to offer products identified as Canadian to consumers. Industry stakeholders have also noted that this level does not align with "Product of" claims for Canadian provinces or trading partners. For example, a food can be called a product of Quebec ("Aliments du Québec") with 85% Quebec content, but that same food would not be considered "Product of Canada.

The "Made in Canada" guidelines were also referenced in the Economic Strategy Table reports but were subject to fewer comments. "Made in Canada" claims can be made on a food when the last substantial transformation of the product occurred in Canada (e.g., baking ingredients into a cookie), even if some ingredients are from other countries. If the "Made in Canada" claim is used, it must also include a qualifying statement to indicate that the food product is made in Canada from imported ingredients or a combination of imported and domestic ingredients. The qualifying statements that can be used include "Made in Canada from domestic and imported ingredients" or "Made in Canada from imported ingredients".

Description of Approach

Based on feedback, the CFIA and AAFC will collaborate to review these guidelines.

AAFC will facilitate discussions with industry stakeholders aimed to achieve general agreement on potential new criteria for using the Product of Canada and Made in Canada claims on food, with CFIA support.

The CFIA and AAFC will also undertake work to validate any proposed changes to the policy with industry stakeholders and the public. Once validated, a revised policy would be implemented.

Any modifications to the guidelines on "Product of Canada" and "Made in Canada" claims would be intended to better reflect consumer and industry expectations and better reflect the reality of Canadian food production. Changes that enable more products to use the "Product of Canada" claim to highlight Canadian content could elevate the profile of Canadian products and may also help to advance the "Canada Brand" initiative, which is one of the six signature initiatives proposed by Canada's Economic Strategy Tables. Furthermore, revised guidelines may provide an incentive for Canadian companies to increase their use of the "Product of Canada" claim, which in turn could support increased demand for Canadian agricultural inputs.

Cooperation Implications

Reviewing these guidelines will provide an opportunity to bring Canadian and provincial origin claims into closer alignment.

Innovation, Science and Economic Development Canada (ISED) maintains a similar policy on Product of Canada for consumer products other than food. The CFIA and AAFC will communicate with ISED on any potential changes to the "Product of Canada" and "Made in Canada" guidelines for food.

Key Milestones

This work is planned to be completed in a medium term timeline (i.e., up to three years.

The overall breakdown of the timelines is as follows:

Fiscal year 2019-20: AAFC will conduct industry engagement aimed at achieving general agreement on a new policy. AAFC and CFIA will then validate any proposed change to the guidelines with a broader group of industry stakeholders and the public. Following the consultations, recommendations will be provided to the Minister of Agriculture and Agri-Food Canada for consideration.

Fiscal year: 2020-21: Implementation of new policy

Further Information

The current Product of Canada and Made in Canada guidelines are accessible on the CFIA website.

Department / Agency Contact Information

Regulatory Policy Coordination Office
Strategic Policy Branch
Agriculture and Agri-Food Canada
Email: aafc.regulation-reglementation.aac@canada.ca

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Enhancing the Competitiveness of the Cereals Sector

Description of Issue

Grain sector stakeholders have asked the Government of Canada to launch consultations regarding a value creation mechanism to stimulate greater investment and innovation in Canadian cereal variety development.

Description of Approach

Currently, due to the widespread use of farm-saved seed by producers, cereal variety developers are unable to generate sufficient revenue through initial sales of certified seed to recoup their R&D investment. A new value creation model could lead to increased funding in Canadian cereals research and variety development, benefitting farmers and other members of the value chain.

A new model could help to attract new sources of investment in Canadian cereals research and development of improved varieties, ultimately supporting greater profitability and competitiveness in Canada's cereals sector, including farmers.

Key Milestones

Short term: AAFC/CFIA consultations will be completed prior to any regulatory proposals being drafted. These consultations began in November 2018 and are ongoing. No decision has been made at this time.

Medium term: If a decision is made to proceed after the consultations, proposed regulatory changes to support a new value creation model would be expected for pre-publication in Canada Gazette Part 1 for fall 2020.

Long term: Monitoring and reporting would be required to ensure that the value creation mechanism was benefitting producers and other industry stakeholders.

Department/Agency Contact Information

Regulatory Policy Coordination Office
Strategic Policy Branch, Agriculture and Agri-Food Canada
Email: aafc.regulation-reglementation.aac@canada.ca

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Pre-Market Assessment of Agricultural Inputs

Description of Issue

Stakeholders have indicated that the process and timelines for pre-market assessments for agricultural inputs (feed, seed, fertilizer, veterinary biologics, plants with novel traits) are lengthy and unpredictable, which compromises efficient access to markets.

Description of Approach

In response to the above issue, the CFIA proposes to:

  1. Implement amendments to the Fertilizers Regulations, which would reduce the volume of products requiring pre-market assessment and increase the validity of the registration period in order to decrease burden. [See Section 4, key issue 2. – Fertilizers Regulations]
  2. Implement amendments to Feeds Regulations, which would reduce the volume of products requiring pre-market assessment. [See Section 4, key issue 1. – Feeds Regulations]
  3. Streamline approval of new feed products, based on equivalency of authorizations by foreign governments. [See also Section 4, key issue 1. – Feeds Regulations].
  4. Implement an electronic submission process for pre-market assessment of agricultural input commodities, reducing burden by enabling online application and payment, as well as automated case tracking. See Digital CFIA Services.

Key Milestones

Short term: Fit gap analysis (pre-market program review) and options analysis to determine current vs. required solution functionality (Fiscal 2018/19).

Medium term: Internal and external change management activities (i.e., business process re-engineering, communications) in support of the upcoming change to submission, review and issuance process. Industry enrolment in MY CFIA. IT system development, testing and deployment. Business continues to offer and support legacy processes (paper-submission) for those stakeholders unwilling or unable to submit applications electronically (Fiscal 2019/20).

Long term: Information management, archiving disposal of paper documents, and setting rules related to document retention based on program requirements.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Approach to Novel Products of Biotechnology (Plant Breeding Innovation)

Description of Issue

Plant Breeding Innovations (PBI), also known as gene editing or new plant breeding techniques, refer to a suite of new technologies that can be used to efficiently introduce genetic changes. The seed and grain industry has identified that Canada's outcome-focused approach to determining which new varieties are subject to pre-market assessments causes uncertainty for the plant breeding community and that this may be a disincentive to investment and limit producer access to products developed using plant breeding innovation techniques.

Canada has a regulatory framework that effectively covers new technologies, but this flexibility does not lend itself to simple answers around whether or not a product may be regulated, particularly when the product is in the early stages of development. The industry states that, as a result, plant breeders do not make their best efforts to innovate, and Canada misses opportunities to nurture the development of innovative small businesses. To make investment and commercialization decisions that take advantage of new technologies, developers, as well as producers who wish to use and export those products, have indicated they require clearer and more predictable regulatory requirements around authorization prior to commercialization.

Many jurisdictions do not have the flexibility to capture these new technologies and are examining their frameworks, which add to the challenge of regulatory uncertainty for product developers in the global marketplace.

Description of Approach

Canada's outcome-focused approach to novel products of biotechnology is unique. Consequently, since this framework was established (roughly 25 years ago), Canada has had the ability to regulate products of biotechnology that other regulatory frameworks do not capture. This flexible approach provides many advantages for ensuring appropriate stewardship, and can seamlessly accommodate new technologies without the uncertainty that other jurisdictions are currently working through. However, because the triggers are outcome-focused, product developers are less certain as to whether a specific product will be regulated.

Based on input from industry, the CFIA and Health Canada are working together to address issues raised by:

  1. Providing more clarity around Canada's novelty triggers as they related to Plant Breeding Innovations, through written guidance.
  2. Providing a well-defined process for consulting with regulatory authorities on whether a product is novel, including how to arrange a consultation, what information to provide, and the timing and format that the response from regulators will take. This will address the need for clarity and timeliness to help developers determine whether their product is regulated.
  3. Considering opportunities to provide improved guidance on information requirements when a regulated product is submitted for pre-market assessment, and continue to find efficiencies in the pre-market assessment process, while ensuring safety. Canada already takes a flexible approach to information requirements, and allows the case for safety to be made using bridging to past submissions or published literature. Whether a more formalized tiered approach to information requirements, as requested by industry, is feasible is being considered as part of this work towards continuous improvement.

Furthermore, to support the above initiatives, Agriculture and Agri-food Canada (AAFC) is co-chairing an industry-government working group (the Biotech Working Group under the Grains Roundtable), which has been given the renewed mandate as of August 2018 to focus intensively on the PBI issue. The group worked to clearly define the problem and presented a draft work plan for consideration by the Grains Roundtable in March 2019. Options/solutions will be further developed with regulatory groups and AAFC. These discussions will provide a clear industry perspective to inform the CFIA and Health Canada actions identified above.

This action plan will address many of the points heard from industry around clarity and predictability. However, some points raised by industry will not be addressed, or may not be addressed to the extent that industry is seeking, as follows:

  1. Providing certainty in advance through written guidance on what types of products are or are not novel, and being prescriptive about information requirements isn't feasible, as there will always be marginal cases or new developments that will require case-by-case consideration. However, Canada's approach in this regard allows developers the opportunity to present a logical case to justify why their specific product is not novel, and allows flexibility in what information is sufficient to demonstrate that a novel product is as safe as its counterparts.
  2. Joint file review coordination between the CFIA and Health Canada. Industry is of the opinion that a co-ordinated file review between the three assessment groups (for use as food, as feed, and for environmental release) would be more efficient. The CFIA and Health Canada are interested in exploring all opportunities for improved efficiency, and have initiated pilot projects to determine whether certain joint review processes are feasible or result in efficiencies. If these pilot projects indicate that a joint review is more efficient, then joint review will be adopted. However, considering the different assessment endpoints and other complexities of safety assessments, this irritant may not be addressed to the extent that the industry would like, and any impacts on program efficiencies may be much smaller than industry appears to be anticipating.
  3. Alignment with trading partners. The industry has also indicated an interest in seeing mutual recognition or aligned data requirements between like-minded countries. As described above, Canada's outcome-focused regulatory framework provides many advantages that would be lost if Canada were to undertake the complex work of adjusting our approach to be similar to more process-oriented jurisdictions. Globally, there is a great deal of variation in which products are subject to pre-market assessment. Canada will continue to work collaboratively with our international counterparts as we have done for many years in a variety of fora, with the goal of establishing areas of mutual agreement and harmonizing our systems where possible. While work-sharing and joint review is being explored in a very limited fashion between Canada and like-minded countries, the current global environment and diverse regulatory frameworks mean that this request will not be fully addressed. Obtaining authorizations in all major markets will remain an important step in the commercialization of novel products.
  4. Data requirements for other product categories (for example crop protection products and animal health products) are not the same as data requirements for pre-market assessment of novel agricultural products. The assessment endpoints, and therefore the data used to meet those endpoints, are different. As outlined in the response plan above, the CFIA and Health Canada take a flexible approach to data requirements for novel products, and are committed to seeking opportunities to minimize regulatory burden, which could include a more formalized tiered approach, if feasible. This may partially address the request for streamlined data requirements, but extending this approach to different product categories is outside of the scope of this work.

Cooperation Implications

Canada's safety assessment process for food is based upon principles developed through international expert consultations carried out by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO) of the United Nations, the Codex Alimentarius Commission and the Organisation for Economic Co-operation and Development (OECD).

Key Milestones

Questions and Answers on whether products of PBI are plants with novel traits were posted online in fall 2018. Additional improvements to guidance related to Plant Breeding Innovations are anticipated in 1-2 years (medium term) for some earlier outcomes, and longer-term for the more complex projects, with the following milestones:

  • Options/Recommendations from the Biotech Working Group (mid 2019)
  • Published guidance on Canada's novelty triggers in the context of PBI (within 1-2 years)
  • Development of a better-defined process for consulting with regulators on novelty (within 1-2 years) Where feasible, explore further efficiencies around assessment processes and information requirements (longer term)

Improvements to the Seeds Act and Seeds Regulations to create clearer authorities for oversight of seed and release of novel plants may also be pursued as a separate but related initiative; this work will have a longer-term implementation timeline (3+ years).

Department/Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Food Directorate
Health Products and Food Branch
Health Canada
Email: hc.food-aliment.sc@canada.ca

Digital CFIA Services

Description of Issue

Stakeholders have indicated that the process and timelines for CFIA services are cumbersome, paper based, lengthy and unpredictable, which creates complexity and additional cost, compromising competitiveness.

Description of Approach

Enabling new processes for permissions, export certification, and inspections through the use of technology, the Digital Service Delivery Platform (DSDP) project, is an essential component of CFIA's transformation strategy.

DSDP will standardize and automate processes, provide services on-line, support planning, tracking, and assignment of activities; and provide improved business reporting capabilities. The platform provides a set of technologies and tools for citizens, industry, international trading partners, and CFIA inspectors to more readily carry out their respective roles and conduct regular business transactions.

Key Milestones

Full implementation of the Digital Service Platform will be carried out over a three-year period sequenced as follows:

FY18-19 – Full Regulatory Lifecycle – Food Business Line

Licensing, Inspections in support of Safe Food for Canadians Regulations – which came into force January 2019.

FY19-20 – Enabling Market Access

Export Certificates – Dairy (June 2019); Additional Commodities; Plants, Seafood, Live Animals

Digital Exchange of Export Certificates (Phytosanitary Hubs)

Pre-market approvals (Seeds, Feeds, Fertilizers, Veterinary Biologics, Plant Breeder Rights Registrations).

Import Permits – Food and Plant Business Lines

FY20-21 – Full Regulatory Lifecycle – ALL Business Lines

Export Certificates – Remaining Commodities

Digital Exchange of Export Certificates – Strategic Trading Partners

Inspections – Plants and Animals

Emergency Response

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Recognition of Third Party Oversight

Description of Issue

The Canadian Food Inspection Agency's risk-based approach to inspection oversight and frequencies has not fully integrated third party oversight into overall risk assessment and the inspection model. Often the standards set by these third party oversight regimes exceed regulatory requirements. An opportunity exists to better recognize investments that industry has made in third party certification systems through the application of a risk-based approach to oversight that gives industry "credit" for implementing such programs. This may include fewer or faster inspections, consideration of third party audits in the application of inspection oversight, etc.

The Economic Strategy Table (EST) Report recommended that a panel of industry experts advise regulators on various items, including opportunities for efficiencies, including alternate service delivery, compliance strategies and third party accreditation. This proposal would position the CFIA to discuss third party oversight and seek advice from such a panel.

Description of Approach

The CFIA developed a Private Certification Policy for food safety in 2015. This policy provides direction on how industry's investment in an appropriate private certification scheme would be considered within the CFIA risk-based regulatory framework.

As part of this model, the CFIA assesses the requirements of private certification against food safety regulatory requirements. For example, in 2017, the CFIA's Food Safety Recognition Program recognized the Canada GAP program for fresh fruit and vegetables.

The CFIA has also started considering private certification of establishments as one of several factors in risk based planning. For example, as a result of risk-based prioritization, Canada GAP certified establishments are subject to fewer inspections than non-certified establishments.

In addition, the CFIA's Establishment Risk Assessment (ERA) Model recognizes 3rd party certification as a risk mitigation factor in its algorithm. A lower risk result means that an establishment will not be inspected as frequently and the scope of the inspection is reduced.

Going forward, the CFIA plans to:

  1. Communicate to industry how the CFIA is using 3rd party certification for work planning
  2. Assess more private certification programs against Canadian food safety requirements

Benefits of this approach include reduced duplication of oversight between third parties and the CFIA, as well as strengthened trust. Overall, food safety oversight is improved as it is a tool that enables the CFIA to focus inspection on higher risk establishments.

Cooperation Implications

The United States Food Safety Modernization Act recognizes accreditation of third-party certification bodies to conduct food safety audits. The program was implemented in 2017.

Key Milestones

Short term (within the next year):

  • The CFIA will continue its work on taking 3rd party certification into account in risk-based inspection planning.
  • The CFIA will continue to assess private schemes. It is expected that 1-2 schemes will be assessed per year.

Further Information

The Agency's ERA model's algorithm considers third party audits and international certification schemes as a mitigation factors, the measures or strategies that a food establishment is using, to reduce the inherent risk and therefore reduce the risk of a food safety issue. Further information about the ERA model can be found in The science behind it: The Establishment-based Risk Assessment (ERA) model and The CFIA Chronicle.

The Food Safety Recognition Program (FSRP) includes the On-Farm Food Safety Recognition Program and the Post-Farm Food Safety Recognition Program, which provides government recognition of on-farm and post-farm food safety systems developed and implemented by national industry organizations on a voluntary basis. This program acknowledges that a food safety program has been developed in line with a systematic and preventive approach to food safety based on international accepted standards.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Consistent Inspection

Description of Issue

Regulated parties have expressed some concerns around the consistency of inspection and/or enforcement activities by the Canadian Food Inspection Agency.

Description of Approach

The CFIA is in the process of implementing a number of internal initiatives to improve consistency of delivery, including:

  1. Implementation of Standard Inspection Procedures – Inspectors use a combination of onsite inspection and evaluation techniques for assessing compliance and evaluating the impact of non-compliance of regulated parties. Verification activities can include making visual observations, evaluating documentation, interviewing personnel, sampling, measuring, testing, and commodity inspection. Ensuring that we have a Standard Inspection Procedure (SIP) for the use of these techniques will provide inspectors with the flexibility to adapt to different situations that may arise during an inspection within a consistent framework. CFIA has rolled out this standardization exercise initially in the food sector with the implementation of the Safe Food for Canadians Regulations and will continue into the Plant and Animal Health sectors. Using the same approach for inspection through standardized procedures will enhance consistent outcomes and predictability for regulated parties.

    Time line – Plant and Animal Health (2019 and beyond)

  2. Provision and implementation of updated operational guidance. Operational guidance (also referred to as operational policy) is the instrument or practice by which the CFIA Operations Branch ensures consistent delivery of programs for inspectors and investigators (which will also be available to the regulated parties). An exercise to ensure this guidance is up to date and consistent will result in consistent decision making, consistent regulatory outcomes, and transparent and predictable enforcement actions for regulated parties. Operational inspection guidance updates have been made for inspections of food commodities as this was a key success factor in the implementation of the SFCR.

    Time line – Compliance and enforcement guidance, including guidance in using various enforcement tools (such as AAMPs) is ongoing. It is also expected that incremental changes will occur in the longer term for Animal and Plant Health inspections (2020 and beyond).

  3. Provision of updated training for inspectors and investigators. Updating guidance to our inspectors will necessitate updates to the training we give our staff. Training already occurs, but as changes to operational guidance are incrementally implemented, inspectors and investigators are receiving updated training. This will ensure that updates to our procedures are well implemented resulting in clear and consistent application by our inspectors in the field.

    Time line – This activity has started in support of SFCR implementation, and is ongoing as we continue the incremental changes to our guidance.

  4. Adoption of the Digital Service Delivery Platform. The Agency is investing in a single digital platform for the capture of inspection activities and to provide as better on line tools for inspection staff and regulated parties. This system will result in improving data quality and trends analyses. This improved data availability will inform the inspectorate in a more rigorous way when doing their inspections, resulting in more focussed inspections based on risk and more consistent delivery of inspections. For more information, see Digital CFIA Services.

    Timeline – Medium term to longer term. (2019 and beyond)

Key Milestones

Has been implemented for Food. Will be implemented in the next two years and beyond for Plant and Animal Health, aligned to associate regulatory initiatives in these business lines.

Data capture platforms development is in progress using an incremental approach, so completion and roll out across all sectors is expected to be medium to longer term (i.e. 1 to 2 years and beyond). See the Digital CFIA Services initiative (above) for more information.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Potential Duplication of Oversight

Description of Issue

Duplication of federal or federal/provincial oversight increases regulatory burden for businesses, and can impede the competitiveness of Canadian businesses.

Description of Approach

The CFIA is working with the provinces to avoid duplicating food oversight as the Safe Food for Canadians Regulations (SFCR) have taken effect, and is taking part in developing inspection information sharing protocols.

To that end, the CFIA has undertaken a number of initiatives with the provincial authorities, including:

  1. New FPT agreements between the CFIA and the provincial departments have been signed (or are being negotiated) to ensure food safety, animal health and plant protection in Canada (FPT "Umbrella Memorandum of Understanding (MOU)"), in line with four strategic priorities: information sharing, regulatory collaboration as a move toward harmonization, emergency management and scientific collaboration.

    Timeline: Signed in five provinces (as of May 29, 2019). To be finalized in 2019-2020 (1 year)

  2. The CFIA is working with Quebec's Ministère de l'Agriculture, des Pêcheries et de l'Alimentation du Québec (MAPAQ) on a new inspection agreement for the regulated parties targeted by the new Safe Food for Canadians Regulations (SFCR). The goal is to have a single point of contact carrying out inspections. The industry will deal with a single inspection authority (CFIA or MAPAQ).

    Timeline: 2019-2022 (3 years)

  3. Cooperation on the development of tailored inspection tools, which takes into account the fact that in some provinces, the designated provincial inspectors enforce federal regulations administered by the CFIA. This includes:
    • Developing inspection directives and joint training designed to qualify the designated inspection staff and ensure consistent enforcement.
    • Digital Service Delivery Platform project with MAPAQ to provide access to information on shared regulated parties under CFIA and MAPAQ inspection agreements. This includes provincial and federal licensing and certification in the food, animal health and plant protection sectors.

    Timeline: 2019-2024 (5 years)

  4. Planning of joint inspection and surveillance activities, particularly with regard to testing for chemical residues in food. Elimination of surveillance program duplication and recognition of partner testing whenever possible.

    Timeline: Ongoing.

  5. Integrated risk management: Sharing of the CFIA's integrated risk management models with the provinces. Work on this has begun with MAPAQ with a view to possible harmonization. This would make it possible to engage in similar inspection activity planning and prioritization for fair treatment of regulated parties.

    Timeline: 2019-2024 (5 years)

Key Milestones

The timeline for each initiative is indicated above and is shown as short-term (1 year) or medium/long-term (3 to 5 years). The priority is the food sector (SFCR inspection agreements), but it takes into account the tools to be put in place and rolled out across all sectors, including animal and plant health.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Food Labelling Coordination Strategy

Description of Issue

Stakeholders have indicated that the Government of Canada does not seem to consider the cumulative impacts of regulatory changes made across federal departments as they relate to food labelling. These changes can have a significant economic impact on the industry. If coming into force timelines are misaligned, industry may need to adjust labels on food products more frequently than is practical.

Consumers use food labels to make more informed choices about the food they purchase. Both Health Canada and the CFIA are responsible for labelling policies in Canada. Health Canada is responsible for labelling requirements with respect to health, safety and nutritional quality of food sold in Canada (for example nutrition facts table, allergen labelling, nutrient content claims) while the CFIA sets out non-health and safety related labelling requirements (for example organic claim, net quantity, date labelling).

Description of Approach

Health Canada and the CFIA will address this issue by developing a strategy to coordinate timelines for food labelling changes.

Through the recent changes to nutrition labelling, labelling changes being developed through Health Canada's Healthy Eating Strategy and the CFIA's Food Labelling Modernization, Health Canada and the CFIA have made concerted efforts to align the timelines for the changes being proposed and provide a transition period to minimise economic impact on the industry. However, there is an opportunity to develop a more formalized approach to ensure that both departments coordinate timelines for future labelling changes in a manner that can provide industry with greater clarity and predictability.

In any formal or informal process, the Government of Canada will need to maintain the flexibility to implement labelling changes related to health and safety, especially in response to health needs.

Cooperation Implications

Health Canada and the CFIA will look to labelling alignment timing practices in other international jurisdictions to inform the development of a strategy in Canada.

Key Milestones

Health Canada and the CFIA will work together to continue to align timelines for the labelling changes proposed in the Healthy Eating Strategy and the Food Labelling modernization initiatives. A predictable cycle for label changes will be implemented subsequent to these proposed changes coming into force.

Consultations with stakeholders will begin in fiscal year 2019-2020 to establish appropriate timeline for a predictable cycle.

Health Canada and the CFIA will establish the timelines in consultation with various stakeholders.

Department/Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Food Directorate
Health Products and Food Branch
Health Canada
Email: hc.food-aliment.sc@canada.ca

Data Protection Modernization for Pest Control Products

Description of Issue

Some stakeholders have expressed concern that the negotiation and arbitration process relating to compensation for relying on data on pest control products belonging to other parties during pre-market reviews is insufficient to help parties to reach compensation agreements in a timely manner in all cases. Further, the requirements of the post-market data protection program for pest control products are unclear to regulated parties.

Description of Approach

Health Canada will address the process for settling data protection compensation for pre-market reviews of pest control products by updating the "Ministerial Agreement" (a document issued by the Minister under s. 66 of the Pest Control Products Act that sets out the details of the negotiation and arbitration process for pre-market data protection compensation).

Health Canada is also proposing to amend the Pest Control Products Regulations to clarify the data-protection provisions that apply during post-market reviews of pest control products.

Key Milestones

Health Canada published the updated "Ministerial Agreement" for consultation in fall 2018, and published the final version in April 2019. A draft update was previously consulted with stakeholders in Winter 2016/17, and industry comments were used to develop the fall 2018 consultation draft.

With respect to amending the Pest Control Products Regulations, Health Canada recently concluded industry consultations on the proposed approach to data protection during post-market reviews. Health Canada is targeting the pre-publication of draft regulations in the Canada Gazette, Part I in fall 2019 / winter 2020. Publication in the Canada Gazette, Part II is targeted for 2020.

Department Contact Information

Policy and Regulatory Affairs Divisions
PMRA, Health Canada
Email: hc.pmra.regulatory.affairs-affaires.reglementaires.arla.sc@canada.ca

Sector Specific Government-Stakeholder Collaboration on Regulations

Description of Issue

The Federal Regulatory Review consultations in the Canada Gazette, as well as recommendations from the Agri-Food Economic Strategy Table and other recent regulatory modernization efforts have pointed to the opportunity to improve Canada's regulatory environment to foster innovation, growth and competitiveness for the agriculture and agri-food sector while maintaining health and safety objectives.

Stakeholder submissions as part of the Regulatory Review process echoed recommendations from the Agri-Food Economic Strategy Table and stressed the need to: take immediate action on tackling ongoing irritants; address the cumulative economic impact of regulations; and, test new technologies through regulatory experimentation.

In addition, stakeholders re-iterated concerns over the clarity of regulations, the need for earlier and more meaningful engagement in regulatory development, an opportunity to better consider cumulative and economic impacts of regulations; and difficulty navigating the regulatory system.

Description of Approach

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 in order to facilitate shared solutions between government and industry regarding regulatory irritants (i.e., timely, predictable solutions) and to seize opportunities to work collaboratively with industry (i.e., regulatory design for new and emerging technologies), to enhance economic growth and competitiveness.

AAFC will look to provide a focal point for identifying and helping to solve agriculture and agri-food regulatory irritants, 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.

Cooperation Implications

AAFC plans to work with relevant departments and agencies to facilitate collaboration between government and stakeholders regarding regulatory irritants and opportunities that are impacting economic growth and competitiveness.

Key Milestones

AAFC is planning to have discussions with relevant departments and agencies in 2019.

Department/Agency Contact Information

Regulatory Policy Coordination Office
Strategic Policy Branch
Agriculture and Agri-Food Canada
Email: aafc.regulation-reglementation.aac@canada.ca

Reducing Risk and Improving Trust using Distributed Ledger Technology (Blockchain)

Description of Issue

Due to the complexity of globalized food supply chains, processing technologies, food fraud and international trade, the transparency and electronic enablement of food supply chains and the information associated with them have never been so important to the safety, integrity and value of what Canadians eat and produce.

The agri-food and agriculture industry is currently undergoing a supply chain digital transformation. A digital supply chain means that the series of activities that are connected like the movement of raw materials, goods and parts from the supplier to consumer and the associated financial, material and information are enabled with digital technology.

Regulated parties create and manage data through industry-based digital supply chain platforms that would assist the CFIA in its risk management and service delivery capacity. This includes compliance data on the regulated party derived from other jurisdictions as well as product history, origin and other relevant supply chain information. Historically, the CFIA and regulated parties do not voluntarily share data.

Legacy technologies related to data storage and management have also contributed to the challenges associated with the transmission and storage of the data across supply chain participants and between the regulator and regulated parties.

To date other international counterparts have already indicated their intention to further explore the use of blockchain technology in the regulatory space. That is because blockchain allows for flexibility in the type of data that is shared between regulator and regulated party which could include traceability, firm identity, production and supply information, laboratory analysis results, or third party certifications or permissions among others. Based on the type of information that is shared, the performance of multiple regulatory functions, like issuing permissions or response, could be sped-up and streamlined.

The Economic Strategy Tables specifically recommended undertaking a pilot in this area.

Despite evidence that distributed ledger technologies could enable the desired secure, transparent and confidential sharing of information between parties, it is still relatively new and the implications of the deployment of the technology and as a regulatory tool are not well understood. It thus requires further research and experimentation, which will be enabled by this sandbox approach.

Description of Approach

The CFIA is proposing to create a regulatory sandbox with the aim to reduce risk to food safety/plant/animal health by increasing collaboration and trust between regulator and regulated parties through improved information and data sharing. This sandbox would include the adoption of a data-exchange platform using distributed ledger technology ("blockchain").

Distributed ledger technology ("blockchain") is a disruptive technology changing the way buyers and sellers transfer assets without the involvement of a third party administrator. Blockchain is a digital database that securely transmits any type of information without a central authority. In 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. Distributed ledger technology could address issues of cost, quality, trust, and security.

This sandbox project will look to assess the feasibility of the blockchain technology at the CFIA by engaging with technical and industry experts to a) develop a detailed description of how the technology could be used at the CFIA in order to assess the feasibility of the technology to perform the intended functions; b) identify legal and policy implications of adopting this type of approach; c) recommend a potential strategy for future development.

Relative to food safety, the CFIA is interested in the application of blockchain for supply chain management. It could potentially allow for more preventative risk control measures, and enable quicker and more precise interventions to preserve human health and safety. There may also be 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.

Cooperation Implications

For the purposes of the pilot, CFIA would seek collaboration with other Agencies/Departments as well as potentially industry to deliver on the project.

Key Milestones

Short Term (Year 1): The objective of the short term work will be to build capacity, engage with and create a network of key stakeholders as well as to collaboratively design and implement the sandbox project.

  • Experiment with an actual blockchain (or prototype) with the regulator and regulated party to test a number of assumptions as well as ascertain real evidence as to the complexity, value, challenges and costs associated with the use of blockchain technologies for regulatory oversight.
  • The project will be sufficiently complex to test various aspects of regulatory application to identify and evaluate numerous implications, but will also look to leverage supply chains and technologies that are already advancing. The results and analysis of the pilot will inform policy decisions for the CFIA and reference findings for other regulatory agencies on the usefulness and adoption of ledger technologies in a regulatory context.

Medium Term (Year 2): The objective of this second phase of work will be to analyze the results of the previous project, and further consultation and engagement with stakeholders to identify key opportunities and challenges. Given the outcomes of these analyses, a decision will be required to determine the feasibility of advancing work under this initiative including broader external consultation and engagement.

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

Rethinking the Regulatory Relationship: Applying Innovation and Behavioural Science to Promote Compliance and Improve Risk Management

Description of Issue

Regulators in Canada are exploring a new approach to providing oversight and enforcing regulation to better align with industry commitment to complying with regulatory requirements. The approach recognizes that most businesses want to meet regulatory requirements and keep their customers safe, and that they are more likely to be readily and actively compliant when they are part of a system, which encourages them to do so.

This new type of regulatory relationship enables regulators to deepen collaboration with businesses that create and maintain trust with customers and regulators (for example, through consistent application of compliance systems and audits, high number of satisfied customers, transparency and commitment to core values). This type of relationship encourages trust and open sharing of information, while mitigating fear of reprisal when regulated parties self-identify risk or non-compliance. It leverages industry's vested interest (by way of reduced costs, reputation, profits/sales, and growth) to ensure risks are well managed and provides a new opportunity for regulators to explore innovation in regulatory delivery and compliance.

This new approach will explore when and how a regulator can place greater trust in an operator's ability to control risk and to provide data and information on their performance. This could allow strong performers to be monitored offsite and inspected less frequently, and regulator efforts to be redirected instead to weaker performers with repeat compliance issues, or to focus on other key areas of risk. The enhanced information sharing enables the regulated party to signal any emerging issues or trends with implications for the broader sector to the regulator, who can in turn adjust its oversight and reach out to the sector to better understand and manage risks.

Description of Approach

The CFIA proposes a pilot approach with a willing industry partner to explore a relationship that encourages compliance and enhanced information sharing in support of shared risk mitigation goals.

The proposed pilot involves a company, facility, establishment or industry association who can be considered a leader in their sector, exemplifying qualities and business practices that other businesses could model themselves after. The chosen partner should:

  • have a positive working relationship with the CFIA
  • be willing to be open and transparent about their business practices
  • be agreeable to sharing information on their activities
  • provide, where possible, useful insights and intelligence that could help the CFIA take a proactive approach to mitigating risk

The CFIA would develop a proposal to scope the pilot, along with terms and conditions including how industry information will be used. The data collected from pilot companies will point to new, collaborative and intuitive ways of identifying and addressing non-compliance. The approach will also encompass best practices for forging and maintaining relationships with companies and businesses who effectively and efficiently comply with CFIA requirements. Following the pilot, a report would be developed that summarizes the findings, along with best practices and areas requiring further refinement or adjustment should there be interest to expand the pilot.

Cooperation Implications

This pilot explores a cultural shift between regulator and industry by developing trusting relationships that serve to benefit both parties by way of improved data exchange and enhanced transparency.

In the medium-longer term other government departments that carry out inspection activities may be implicated as there is likely to be a larger interest in this pilot from other members of the regulatory community, including the Community of Federal Regulators.

Key Milestones

In the short term (within 1 year), the CFIA would demonstrate the feasibility and benefits/risks of using deeper industry collaboration and data-sharing as an effective approach to improving compliance. The Agency would establish the necessary supports to launch the pilot including data sharing, information management/technology support, governance agreement and clear articulation of pilot deliverables including replication analysis and recommendations.

In the Medium Term (1-2 years), the CFIA would conclude delivery of the pilot and would finalize the result analysis including recommendations for continuation, further refinement, feasibility for adoption and recommendations including any on-going costs or additional resourcing required for expansion (if the pilot is deemed successful).

Agency Contact Information

Regulatory, Legislative and Economic Affairs Division
Policy and Programs Branch
Canadian Food Inspection Agency
Email: cfia.legislation-legislation.acia@canada.ca

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