International Standards: Targeted Regulatory Review – Regulatory Roadmap

1.1 Overview

International Standards – part of an invisible infrastructure permeating our lives

Standards – the set of agreed-upon rules, guidelines or characteristics for activities or their results – make up an invisible infrastructure that touches almost every part of our lives. Together with conformity assessment – the practice of determining whether a product, service or system meets the requirements of a particular standard – standards are a common feature behind many products, services and processes that industry and Canadians use daily.

Standards play an important role in improving the health, safety, and environment of Canadians by making sure that the products and services Canadians use are safe, reliable, and consistent. They also promote an efficient Canadian economy by supporting innovation, reducing burden, and facilitating trade through promoting interchangeability and interoperability.

Research demonstrates a clear link between standardization, labour productivity and economic growth (Blind, K., Jungmittag, A., et Mangelsdort, A. (2001)^{Footnote 1}; Grimsby, G. (2018)^{Footnote 2}; Hogan, O., Sheehy, C., et Joyasuriya, R. (2015)^{Footnote 3}). In Canada, evidence shows that standards contributed to nearly $5.9 billion of the $33.7 billion increase in Canada's Gross Domestic Product in 2019 (Liao, D. (2021)^{Footnote 4}). It has been estimated that standards and technical regulations influence up to 93% of global trade (Okun-Kozlowicki, J. (2016)^{Footnote 5}). For Canada, international trade accounts for more than 60% of our Gross Domestic Product.

International standards are an essential part of the world's standardization networks and regulatory frameworks. They are developed in a broad, multi-stakeholder environment and reflect consensus among participating jurisdictions and technical experts. They give businesses and regulators a way to draw on internationally agreed-upon methods, and allow consistent products, practices, services or systems to be supplied and used across different markets. When used properly, they remove technical barriers to trade caused by differences among regulations and standards developed independently and separately by countries, national standards organizations, or industries.

International standard setting bodies, like the International Organization for Standardization and the International Electrotechnical Commission are comprised of committees of independent technical experts from around the world and therefore involve collaboration between industry, academia and governments to develop standards based on global expert opinions. Members of other organizations, such as the International Civil Aviation Organization and the International Maritime Organization are comprised predominantly of governments (though others, such as non-governmental international organizations can play a consultative role) and work to ensure the creation and use of internationally recognized regulatory frameworks, creating a universal playing field.

An effective regulatory tool supporting innovation, trade, and competitiveness

International standards support modern, agile, and responsive regulations that both keep Canadians safe and fuel the economy. When adopted strategically by regulators, these standards are a key tool to promote the innovation and competitiveness of Canadian businesses by reducing costs, duplication, and by fostering international trade.

Harmonized regulations across jurisdictions - which can be supported by adopting international standards – help to grant Canadian companies access to diverse markets all over the world. They make market access easier by reducing compliance costs and time to market, since businesses would not have to follow different regulations and standards for each jurisdiction. As a result, Canadian businesses can create single products, systems, and services that could be exported to other countries, rather than developing different versions across different countries. This helps businesses reduce costs, enhance performance and productivity, and can boost their opportunities for growth.

By establishing a common global language for new concepts and technologies, international standards can act as a launch pad for innovation. Standards are regularly updated to ensure state-of-the-art technical and safety requirements. They have a built-in review cycle that ensures that they remain relevant to the organizations and individuals they impact, while reflecting changing needs of clients and emerging technologies. They also create common, transparent performance metrics by those that adopt them, helping to provide equal access to global markets. Regulators can leverage these advantages by ensuring timely adoption of standards that remain up-to-date, relevant, and technically valid.

Taking leadership in international standards development would allow Canada to guide and influence the pathways of products in areas of key trade and strategic innovation, as well as emerging technologies. Participation in international standards-related activities offers many downstream benefits for Canadian regulators and industry, as it provides them with information on trends and best practices, which can translate into a competitive edge. Increased leadership in international standards development can support Canada in keeping pace with large international competitors; spurring economic activity following COVID-19; and responding to long standing industry stakeholder calls.

Delays in embedding international standards and obligations can have a negative impact on industry. Delays can cause misalignment, which increases compliance requirements for industry to simultaneously access Canadian and global markets. When there is not a clear regulatory purpose to the misalignment (such as, health and safety, or environmental concerns), it can unnecessarily increase the financial and administrative burden, and impede trade and economic growth. Likewise, insufficient leadership and engagement in standards setting activities increases Canada's likelihood of adopting standards that are not in Canada's best interest (for example, standards that may present unnecessary complexity, or inhibit regulatory competitiveness).

Supporting pandemic response and recovery

International standards have been essential to the Government of Canada's efforts to minimize impacts of the pandemic on public health and economic downturn, and have helped support global collaboration in response measures. For instance, the Standards Council of Canada has been coordinating with standard development organizations to compile essential standards and information on testing labs relevant to COVID-19. The Standards Council of Canada's compiled list of standards and certification laboratories is intended to help companies develop new products to respond to surging demand for medical equipment, or deal with the pressures of business continuity and crisis management related to the pandemic. These resources can be found here: Standards Council of Canada - Standardization Network Response to COVID-19.

Likewise, Health Canada has been collaborating internationally to support the response to COVID-19. Health Canada is working with international regulators, such as the International Coalition of Medicines Regulatory Authorities on a globally aligned approach for COVID-19 treatments and vaccines. Along with members of the coalition, Health Canada published a statement about the global collaboration to facilitate and expedite the development and evaluation of diagnostics and therapeutics, including possible vaccines, against SARS-CoV2. Health Canada is also working with its partners in the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium to advance the regulatory science needed to support the rapid development of diagnostic tests, as well as vaccines and treatments against COVID-19. In addition, Health Canada is working with global health organizations through contributions to the World Health Organization's R&D Blueprint vaccines plan to develop a COVID-19 vaccine, and as a member of the Pan American Health Organization's COVID-19 task group. Through continued international cooperation, Health Canada continues to develop and share best practices in response to the pandemic.

The Regulatory Roadmap on International Standards: Strategic opportunities to advance the use of international standards and advance leadership in standards development

The Regulatory Roadmap on International Standards recognizes the benefits and opportunities afforded by adopting international standards into Canada's regulatory system. The Roadmap lays out a suite of modernization plans examining the strategic use of international standards in regulations to increase regulatory cooperation through supporting regulatory harmonization, to facilitate trade, and to foster innovation.

The Roadmap contains 11 Roadmap initiatives, including 1 novel regulatory approach, that the Government of Canada will use to:

• promote the use of, and alignment of, international standards in Canadian regulations
• assume a stronger leadership role in international standards development, particularly in emerging markets, and where international standards can be used to fulfill the government's health, safety, security and environmental objectives
• make international standards used in regulations more accurate and accessible for stakeholders

These actions are primarily intended to support Canadian industry by reducing regulatory burden, facilitating international trade, and helping businesses to innovate and stay competitive in emerging and fast growing global markets. Likewise, these actions also demonstrate that international standards work can be leveraged to improve health, safety, and environmental outcomes for Canadians.

The Roadmap addresses stakeholder feedback and also includes proactive proposals identified by departments and agencies. Given the cross-cutting nature of international standards across the federal regulatory system, the stakeholder base impacted by this Roadmap is wide in scope. As articulated in the proposals, beginning in the Section titled International Standards Regulatory Roadmap initiatives, this Roadmap is intended to benefit stakeholders in the clean technology, natural resources, and transportation sectors, as well as other sectors and industries in Canada.

1.2 Regulatory framework

Although standards developed by accredited organizations are voluntary, regulators can make sure they are adhered to by incorporating standards by reference into regulations. Incorporation by reference is the mechanism that allows a standard (or another document) that is not in the text of a regulation to be made part of the regulations, turning it into a legally binding regulatory requirement. Its use has grown exponentially over the last 30 years, given its effectiveness in achieving regulatory objectives.

Incorporation by reference can be static (or fixed) or ambulatory (or dynamic). Static incorporation by reference means that only the version of the standard described in the regulation is incorporated, which means that revisions made after the date specified in the reference are not incorporated into the regulation. Ambulatory incorporation by reference incorporates a standard into a regulatory text, as it is amended from time to time, which means that subsequent editions of, or amendments to, the same standard automatically form part of the regulation.

The Cabinet Directive on Regulation, Canada's federal regulatory policy, supports the use of international standards in regulation. Section 5.2.5 of the Directive states that federal regulators should review the work undertaken by international standards development organizations for possible incorporation by reference, as part of efforts to identify potential areas for regulatory alignment or cooperation. In addition, Section 5.2.6 states that departments and agencies should take into account incorporation by reference of internationally accepted standards, as a tool to achieve regulatory outcomes.

The Standards Council of Canada is the Government of Canada's leader and voice on standards on the national and international stage. The Council encourages regulators to make sure that references to standards in regulation are accurate, up-to-date, and remain relevant and technically valid. It also encourages Canadian regulators to reference the same standards across their regulations when possible, to prevent or remove technical barriers to internal trade, and alleviate the negative economic impact that could result from a lack of standards alignment in the respective regulations.

Many international trade agreements require their members to prioritize the use of international standards in their technical regulations when these standards are aligned with regulatory objectives. In Canada, the Standards Council of Canada accredits standards development organizations. The accreditation procedures require the organizations to formally accept the World Trade Organization Technical Barriers to Trade Agreement's Code of Good Practice, which stipulates that standards bodies are to consider existing international and regional standards to the greatest extent possible. These actions help ensure that standards referenced in regulations will not introduce unnecessary barriers to trade.

The World Trade Organization Technical Barriers to Trade Agreement requires its members to use international standards, or relevant parts of them, as a basis for technical regulations whenever possible. The Technical Barriers to Trade Committee, a multi-lateral forum of World Trade Organization members formed to review trade concerns, agreed to a set of six principles aimed to provide guidance on the development of international standards:

• transparency
• openness
• impartiality and consensus
• effectiveness and relevance
• coherence
• development dimension

Through its Monitoring Standards in Regulations tool, the Standards Council of Canada raises federal departments' awareness of standards referenced in their federal regulations. The tool has identified and tracked over 5,000 standards incorporated by reference in federal, provincial, and territorial regulations. As of March 31, 2021, the Standards Council of Canada identified 1,535 references to standards in 138 Canadian federal regulations. Of these references, 328 or about 21.4% were references to international standards. In recent years there has been an increase in the use of standards and conformity assessment procedures by regulators in Canada and globally.

Since transparency is a key part of making effective policies and standards, the Statutory Instruments Act requires standards that are incorporated by reference to be accessible. Standards must also be available in both official languages, unless there is a legitimate reason for incorporating by reference in only one language.

In some situations, it may not be appropriate or in Canada's best interests to reference international standards in Canadian regulations. Factors could include, for instance, unique Canadian geographical and/or infrastructure considerations; areas where going beyond international norms may drive innovation and position Canada as a global leader in key sectors; or areas where international standards may introduce unnecessary complexity that hinders competitiveness. In discussing regulatory cooperation and alignment, including international standards, Section 5.2.5 of the Cabinet Directive on Regulation notes that when different approaches are required, federal regulators must provide a reason for Canada-specific approaches.

1.3 Government organizations involved

The following federal departments and agencies participated in this Regulatory Review. They participated in different ways, from submitting and supporting proposals, to guiding and assisting in the development of this Roadmap.

• Agriculture and Agri-Food Canada
• Environment and Climate Change Canada
• Global Affairs Canada
• Health Canada
• Canadian Food Inspection Agency
• Innovation, Science and Economic Development Canada
  • Competition Bureau
  • Measurement Canada
  • Standards Council of Canada
• Justice Canada
• Natural Resources Canada
• Transport Canada

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Given the cross-cutting nature of the international standards theme, stakeholders from many different sectors and industries provided feedback. Consultation activity included a Canada Gazette, Part I consultation led by the Treasury Board of Canada Secretariat, as well as webinars with stakeholders. A few of the Roadmap proposals address common stakeholder and industry association irritants heard during consultations outside of the Canada Gazette process.

Prior to this review, the Government of Canada's Economic Strategy Tables also provided valuable insights relevant to international standards that have helped inform development of this Roadmap. Regulators working on this review were also able to learn from Sergio Mujica, the Secretary-General of the International Organization for Standardization.

Canada Gazette, Part I Consultation on Regulatory Modernization

On June 29, 2019, the Treasury Board of Canada Secretariat published a notice on regulatory modernization in the Canada Gazette, Part I. The notice invited stakeholders to submit comments on the second round of Targeted Regulatory Reviews.

The Treasury Board of Canada Secretariat received a total of 109 written responses from businesses, industry associations, academia and Canadians, 93 of which commented on Targeted Regulatory Reviews. Of these, more than 60% were related to the Targeted Regulatory Review focused on international standards.

Stakeholders raised many specific issues, including the following (a summary of what we heard can be found here: What We Heard Report: Regulatory Modernization):

• enhancing the use of standards in regulation
• timeliness of standards adoption
• Canadian leadership in standards development
• availability and accessibility of standards
• concerns about international standards

While this Roadmap has been primarily informed by comments received during this consultation, some of the issues raised related to departments that were not included in this review. Any issues raised that related to an organization that was not involved in the review were forwarded to the relevant department or agency for review. A summary of the issues not being addressed through this Regulatory Roadmap is available in the section titled Issues not being addressed.

Webinars with Stakeholders

In August, 2019, stakeholders were invited to participate in webinars to discuss the themes of the second round of Targeted Regulatory Review. A number of different webinars were held, including one on August 14, 2019, hosted by the Treasury Board of Canada Secretariat, Innovation, Science and Economic Development Canada and the Standards Council of Canada, that included a specific focus on the international standards theme. The webinar highlighted the objectives of this review, the benefits of international standards, and key considerations, such as the value of incorporating international standards by reference to increase business competitiveness. The webinar also provided an opportunity for stakeholders to ask questions.

Economic Strategy Tables

In 2017 and 2018, the Government of Canada collaborated with industry through the Economic Strategy Tables to look at how to turn Canadian economic strengths into global advantages. The Tables recognized the need for an agile regulatory system, as well as the importance that Canada's leadership in international standards plays in reaching growth targets. For instance:

The Economic Strategy Table – Agri-Food recognized the role of international standard setting bodies in promoting a level playing field in international trade, and recommended that the Government provide resources to enhance participation and promote leadership in developing science-based international standards.

The Economic Strategy Table – Clean Technology promoted the voluntary use of technical standards to aid in the strategic application of international standards and promoted consistency and participation in Canadian and international standard setting bodies as a means to create a competitive advantage for Canadian firms. The table called for a proactive and aggressive approach to Canadian participation in the development of international standards relating to clean technology.

The Economic Strategy Table - Health/Biosciences noted that variations in the implementation and inconsistent interpretation of digital standards among other things pose significant barriers to capitalizing on data held in Canadian jurisdictions and health delivery organizations, and making sure the privacy of Canadians is upheld.

Building on the foundation of the Economic Strategy Tables, the Industry Strategy Council was established in May 2020 as a forum where Canadian business leaders could share perspectives on the impact of COVID-19 on the economy. The Council released a Report which, among other recommendations, reinforced industry support for modern and agile regulations. The Council acknowledged how COVID-19 has highlighted the importance of, and should be the impetus for, accelerated regulatory reform. This includes the work being undertaken through this Roadmap, such as seeking harmonization through incorporating international standards in regulations.

International Organization for Standardization

In November 2019, Sergio Mujica, the Secretary-General of the International Organization for Standardization, visited Canada to attend a session on the role of international standards in supporting the Government of Canada regulatory modernization agenda.

Mr. Mujica shared his views on the benefits and opportunities provided by international standards. He noted that Canada is doing well in many areas of leadership in international standards, including supporting innovation, commercialization and scale-up. The role of the Standards Council of Canada in working with innovators to design standardization strategies, supporting Canadian companies in accessing market share, and participating in standards development, was highlighted.

Some key considerations for regulators going forward were also discussed, such as the need to be strategic and prioritize Canada's engagement in standards development, and considering where Canada is well-placed to offer leadership and leverage its technical advantages. Participants also discussed Canada's role in standardization in the area of artificial intelligence, and the International Organization for Standardization Committee on Artificial Intelligence, which includes a focus on ensuring trustworthiness.

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While the Government of Canada is using this Roadmap to advance the use of international standards in Canada, this work also builds on existing work and leadership highlighted below. This work demonstrates how the Government of Canada uses international standards and has a presence in standard-setting bodies across key sectors. This includes efforts to increase the use of international standards in the federal regulatory landscape, minimize unnecessary obstacles to trade, and enhance Canadian leadership in standards development.

Agriculture and Agri-Food Canada

During the first round of Targeted Regulatory Reviews, Agriculture and Agri-food Canada committed to advancing initiatives in the Agri-food and Aquaculture Roadmap that support Canada's efforts to align and develop regulations and practices with international standards (proposal #12).

Agriculture and Agri-Food Canada works closely with the Canadian Food Inspection Agency and Health Canada to support Canada's agricultural interests at three international standard setting bodies:

• Codex Alimentarius Commission
• the World Organisation for Animal Health
• the International Plant Protection Convention

These bodies set international standards, guidelines and recommendations to protect human, animal and plant health, which helps facilitate the fair trade of agriculture and food products. These groups are also directly referenced by the World Trade Organization's Agreement on Sanitary and Phytosanitary Measures. Agriculture and Agri-Food Canada, in partnership with other federal departments and like-minded countries, promotes the work of these international standard setting bodies in support of harmonized regulations internationally, which can facilitate trade. Agriculture and Agri-Food Canada also advocates for agricultural issues of importance to Canada within the international standard setting bodies.

Funding received through the 2018 Fall Economic Statement enables Agriculture and Agri-Food Canada to advance Canadian objectives at these international standard setting bodies, which contributes to the Agri-food and Aquaculture Roadmap commitments. Agriculture and Agri-Food Canada targeted funding towards projects that help to create an international regulatory environment that will support an increase in Canadian exports, or deal with existing or possible trade barriers. Recent projects include:

• managing the risk of African Swine Fever in the Americas
• developing a group of commodity-based phytosanitary standards that promote equivalency
• training to support the development and use of maximum residue limits for Codex pesticides

Canadian Food Inspection Agency

In the Agri-food and Aquaculture Roadmap, the Canadian Food Inspection Agency committed to advancing a number of initiatives that support Canada's efforts to align and develop regulations and practices with international standards.

The first five regulatory modernization initiatives in the Agri-Food and Aquaculture Roadmap contain elements that align Canada's regulations with international standards and processes, as appropriate, in the food, animal, and plant sectors. These initiatives will help facilitate market access for food, fertilizers, feed, and seed products; strengthen animal health protections in hatcheries and feed production; and reduce barriers to innovation.

The Canadian Food Inspection Agency also participates in the three international standard setting bodies identified under the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures. These bodies are tasked with developing science-based standards for food safety, animal health, and plant health and include: the Codex Alimentarius Commission and its subsidiary bodies (for example, the Codex Committee on Food Labelling) for food safety, the World Organisation for Animal Health, and the International Plant Protection Convention.

Funding received through the 2018 Fall Economic Statement enables the Canadian Food Inspection Agency and other departments to enhance participation in these organizations to advance Canadian objectives, which contributes to Agri-food and Aquaculture Roadmap commitments.

Global Affairs Canada

Global Affairs Canada is actively working with Canadian officials and industry partners to promote at the World Trade Organization the adoption of, and compliance with, rules and procedures related to technical regulations and standards. These objectives follow the commitments taken by members under the World Trade Organization Technical Barriers to Trade Agreement and the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures.

As work moves forward on the implementation of International Standards Regulatory Roadmap, Global Affairs Canada will work with other federal departments to promote success stories and lessons learned with other World Trade Organization Members, and encourage other Members to pursue similar initiatives to increase the use of international standards in their jurisdictions.

Health Canada

International standards are essential to the work Health Canada does in protecting the health and safety of Canadians and regulating products sourced from around the world. Over the past decade, the Health Portfolio has improved its legislative and regulatory frameworks to increase the use of international standards. Using international standards makes it easier and more efficient for regulated parties to follow regulations, and allows the government to deal with challenges and threats in a cohesive manner.

Health Canada is currently working on regulatory and policy modernization commitments from the first round of Regulatory Reviews outlined in the Health and Biosciences Roadmap, and Agri-food and Aquaculture Roadmap. Through this work, Health Canada will continue its efforts to increase harmonization and collaboration with international partners with the aim of reducing unnecessary regulatory burden for the health, biosciences and agri-food industries.

Consumer and hazardous product safety

Health Canada relies on international standards to bring the safety of Canada's consumer and hazardous products safety in line with key trading partners. For example, as part of the Canada-US Regulatory Cooperation Council workplace chemicals initiative, Health Canada plans to align with the 7th revised edition of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals, a globally recognized standard for communicating the hazards associated with workplace hazardous chemicals. Canadians were provided the opportunity to comment on the proposal during the Canada Gazette, Part I public comment period. Find more information about this project in Health Canada's Forward Regulatory Plan.

An instrument choice framework is also being developed to explain how the Consumer Product Safety Program identifies and considers the tools used to help protect Canadians, and manage risks from consumer product safety hazards. The framework will provide information on how Health Canada deals with emerging risks, and how it seeks to reduce regulatory barriers through international standards and alignment with trusted regulatory partners. Health Canada undertook consultations with stakeholders on a draft of the modernized Instrument of Choice Framework in fall 2020. This project addresses stakeholder comments that were received from both rounds of Targeted Regulatory Review.

Human and veterinary drug safety

Internationally aligning the decision-making on the approval of human and veterinary drugs includes both joint and simultaneous reviews of drugs with other regulatory jurisdictions. For example, the Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium fosters regulatory cooperation to address emerging scientific and regulatory issues regarding health products, and to leverage resources and expertise. The Australia-Canada-Singapore-Switzerland-United Kingdom (Access) Consortium New Active Substance Working Sharing Initiative provides an innovative opportunity for collaborative joint review of new drugs and new indications among participating regulators.

In another example, through the Regulatory Cooperation Council, Health Canada has, along with the United States Center for Veterinary Medicine, simultaneously approved thirteen veterinary drugs. In its role overseeing regulations, Health Canada works with other countries (such as, United States, United Kingdom, European Union, and Australia) to conduct foreign on-site inspections of drug-making facilities.

Clinical trials are an important step in the development of new therapies entering the Canadian health care system and marketplace. A revised clinical trial record retention framework will seek to bring Canada's recordkeeping requirements in line with international standards, the United States, the United Kingdom, the European Union, and Australia. By changing the recordkeeping requirements, Health Canada will reduce the administrative burden on industry, help attract clinical trials to Canada, and allow the sector to grow.

Find more information about the clinical trial record retention framework in Health Canada’s Forward Regulatory Plan.

Food safety

Health Canada has a long history of collaborating with international partners. Health Canada is the Canadian contact point for Codex Alimentarius and lead the Codex Committee on food labelling. This work is key to making sure that Canada's views and ideas on food-related issues are reflected in international standards.

As part of commitments made under the November 2018 Fall Economic Statement, Health Canada is increasing its engagement with the Codex Committee on Pesticide Residues and supporting Canadian agri-food exporters. Canadian resources have helped increase capacity of the Food and Agriculture Organization/World Health Organization Joint Meeting on Pesticide Residues scientific review. These resources also support Canada's pesticide-related trade issues, like maximum residue limits.

Innovation, Science and Economic Development Canada and Portfolio Agencies

As the Government of Canada's focal point for advancing innovation and economic development policy, Innovation, Science and Economic Development Canada has a strong interest in advancing regulatory reform that supports innovation and economic growth.

Innovation Science and Economic Development Canada also supports trade negotiations and encourages standards, regulations and conformity assessment procedures to align with Canada's trading partners. Several organizations within the portfolio have worked on modernization efforts from an international standards perspective.

One such example is Innovation, Science and Economic Development Canada's Spectrum and Telecommunications Sector's use of incorporating international standards in its regulations. This sector has plans to continue to incorporate international standards as a best practice in the development of its regulations in order to reduce technical barriers to trade where possible. The group also actively participates in international and regional standards organizations, like the International Telecommunication Union and the American National Standards Institute.

The Sector helps Canadian stakeholders participate in international and regional standards setting bodies through its role as Chair of the Canadian Mirror Committee for the International Electrotechnical Commission Technical Committee on methods for the assessment of electric, magnetic and electromagnetic fields associated with human exposure. The Sector's representative as Chairperson is able to provide guidance to Canadian stakeholders on how they can become members of the Mirror Committee, identify areas of international standards development that can be of interest to their organizations, and help them understand how they can provide contributions at the international level once they become Canadian participants. In addition to the Chairperson, the Sector has other representatives that have a chairperson role within different standard development bodies, who provide similar support to Canadian stakeholders that mentioned above.

Innovation, Science and Economic Development Canada's portfolio includes the Standards Council of Canada, which is Canada's National Standards and Accreditation Body, as well as Measurement Canada, and the Competition Bureau. Each of these organizations play a role in supporting the incorporation of international standards in regulation.

In recent years, Innovation Science and Economic Development Canada has worked closely with the Standards Council of Canada to ensure that standardization strategies, which include standards and accreditation programs, support and align with federal priorities aimed to help Canadian businesses innovate and grow, and to reduce the duplication of standards, testing and certification requirements in key sectors of the economy.

Further, the Competition Bureau, an independent agency within the Innovation Science and Economic Development Canada portfolio, is currently reviewing regulations and identifying areas where Canada can harmonize domestic labelling requirements with international standards.

Measurement Canada is undertaking a review of its legislation and regulation with a focus on preparing for the future of technology and commercial practices, enabling innovation and ensuring an efficient regulatory system that supports small businesses. Measurement Canada is showing leadership by participating with international partners, such as the International Organization of Legal Metrology, on issues like measurement accuracy and international standard-setting and harmonization.

Natural Resources Canada

Natural Resources Canada's mandate includes engaging in and supporting Canadian science, technology and innovation, enhancing market access for natural resources, and promoting cooperation between domestic and international partners, including through standard-making processes. As a science-driven department with research facilities across Canada, Natural Resources Canada engages in domestic and international standard-making processes to help bring Canadian innovative technologies, processes, approaches, products and services to market.

Natural Resources Canada is engaged in the work of the International Organization for Standardization, including through the Standards Council of Canada's mirror committees, the International Electrotechnical Commission, the Open Geospatial Consortium, the International Atomic Energy Agency and ASTM International, among a long list of international and regional standard-setting bodies. Participation of technical experts and broader standards development work are supported by Natural Resources Canada through a mix of knowledge sharing and development, secretarial and work plan coordination, participation in technical committees, as well as through direct funding. To illustrate the wide scope of work:

• Natural Resources Canada's the Office of Energy Research and Development actively supports work by technical experts at CanmetENERGY labs in developing new test procedures and methods to quantify the criteria established through other related standards.
• As well, the Canadian Forest Service has supported the production of new CSA Group and International Organization for Standardization standards for cellulose nanomaterials and lignin, leading on many standards (for example, via working groups, and technical work) and participating in the development of standards led by other countries.
• The Canada Centre for Mapping and Earth Observation's GeoConnections Program works to coordinate the development of national policies, standards and mechanisms, and support their implementation – this ensures geospatial data compatibility with global standards.
• The CanmetMATERIALS research lab regularly participates in and leads pipeline standard improvements, via CSA Group and ASTM International, which contribute to understanding the strength of pipelines and how they fail.
• On critical minerals, CanmetMINING is working with Canadian experts and the Standards Council of Canada towards developing international standards for rare earth elements and lithium. Canada is also working with other countries to provide oversight on standards development for critical minerals.
• Natural Resources Canada's Low Carbon Energy Sector has been working with the Standards Council of Canada, standards development organizations (including CSA Group), and the United States Department of Energy through the auspices of Regulatory Cooperation Council to develop critical binational codes and standards for low carbon fuel technologies and infrastructure, and to work collaboratively on improving energy efficiency standards.
• International work has also been undertaken in collaboration with the International Organization for Standardization, and the International Partnership for Hydrogen and Fuel Cells in the Economy, on international codes, standards and regulations for hydrogen.

In some instances, standards in the natural resources and clean technology sectors (or methods to deploy standards, such as testing and quantification methods) are entirely new and do not already exist, which puts Natural Resources Canada experts at the forefront of standards development work.

Transport Canada

Helping to develop international standards is a key part of Transport Canada's mandate of promoting a safe, secure and environmentally responsible transportation system. Transport Canada is a long-time member of groups like the International Civil Aviation Organization and International Maritime Organization, and often plays a leadership role in both groups.

Transport Canada is actively engaged with the Permanent Mission of Canada to the International Civil Aviation Organization, contributing to consensus-led work on international civil aviation standards and the development of recommended practices in support of a safe, efficient, secure, economically sustainable and environmentally responsible civil aviation sector.

Transport Canada is the lead department for Canada's Maritime Administration and, in partnership with other federal government partners and stakeholders, is actively engaged in the work of the International Maritime Organization to, among other things, facilitate the adoption of international standards that promote maritime safety, security, and environmentally sound shipping practices, and enable international cooperation to ensure conventions are universally accepted and adopted.

Transport Canada is also working with the international community to develop standards for automated and connected vehicles. In particular, Transport Canada is working to set performance and testing requirements for specific driver assistance technologies, following a progression that also reflects other recent innovations in automotive technologies. Transport Canada also participates in the United Nations Global Forum for Road Traffic Safety (WP.1) and United Nation's World Forum for the Harmonization of Vehicle Regulations (WP.29), and represents Canada by co-chairing a sub-working group on the WP.29 that is developing test methods to validate the safety of automated vehicles.

In addition, Transport Canada vehicle safety officials are involved in a number of other international standards setting bodies and associated working groups, such as SAE International and the International Organization for Standardization.

Transport Canada also participates in various forums to make sure that Canadian views are considered when international standards reflected in its regulatory framework are created or updated. For instance, as members of the Compressed Gas Association's United States and Canadian Cylinder Specification Committees, the Transportation of Dangerous Goods program is helping to develop gas cylinder standards, which are then often adopted into Canadian standards.

As part of its ongoing regulatory modernization efforts, Transport Canada continues to seek ways to streamline practices to advance alignment with international standards. This includes reviewing current legislative tools to more efficiently adopt trusted international standards, as well as implement international obligations, with the goal of better supporting Canada's trade competitiveness, innovation and economic growth. For instance, Transport Canada proposes to update the Transportation of Dangerous Goods Regulations in late 2021, in order to include dynamic referencing of classification, tests, and criteria. These updates will also reflect changes to safety marks, classification information, shipping names, and special provisions that were introduced in the 21st edition of the United Nations Model Regulations on the Transport of Dangerous Goods, the International Maritime Dangerous Goods Code 2018, and the International Civil Aviation Organization Technical Instructions 2019-2020. More information on these proposed regulations is available on Transport Canada's Forward Regulatory Plan.

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Following consultation activities on the Targeted Regulatory Reviews in summer 2019, departments and agencies participating in the International Standards Review analyzed stakeholder feedback. During the analysis, it became evident that many stakeholders viewed the strategic use of international standards in regulation as an opportunity to enable innovation growth and competitiveness while continuing to ensure health, safety and environmental protection.

Informed by feedback received from stakeholders, participating departments and agencies are bringing forward 11 proposals (including 1 novel regulatory approach) in this Roadmap, to help ensure that international standards continue to play an important role in Canada's regulatory system, and build upon existing regulatory modernization activities. These proposals seek to address stakeholder feedback and advance the objectives of the Regulatory Review more broadly, such as supporting international standards development and use. The proposals have been grouped into four themes:

• demonstrating leadership in the development of standards
• alignment and best practices to support trade and economic growth
• supporting the accessibility and accuracy of standards
• Novel Regulatory Approaches

The remainder of this section will identify and describe these four themes, stakeholder perspectives, and actions that the Government plans to take. Finally, this section includes the benefits and impacts of these actions, as well as key milestones and associated timelines.

It is worth noting that, in addition to the 11 proposals in this Roadmap, there are efforts in the Clean Technology Regulatory Roadmap that relate to standards. This includes a proposal from Natural Resources Canada on codes and standards for clean fuels and technologies. Additional information on these efforts can be found in the Clean Technology Roadmap. For further information on other Regulatory Roadmaps, please see the Targeted Regulatory Reviews.

Theme 1: Demonstrating leadership in the development of standards

This theme focusses on advancing Canadian strategic leadership in standards development to help ensure international standards are based on science and evidence, and that input from Canadian regulators is considered. International standards drive the development, deployment and adoption of Canadian innovations, and enable trade when those standards are harmonized or recognized in key export markets. Increased Canadian leadership in international standard-setting processes can help Canada remain competitive with other countries as well as to ensure Canadian interests are being strategically represented, particularly in emerging areas.

A1 Developing a national standards strategy

Building a concrete plan for enhanced standards leadership and coordination in Canada

During the Canada Gazette consultation in summer 2019, stakeholders encouraged the Government to take a greater leadership role in the development of standards. In several cases, stakeholders called for enhanced Canadian leadership in standards development in specific sectors, products or processes, such as in hemp-based products and cannabis, food products, telecommunications, and transportation.

In response to stakeholders, the Standards Council of Canada is developing a new national standards strategy for Canada. The International Organization for Standardization defines a national standards strategy as a document that describes a country's strategic priorities and how these can be supported by national and international standards. It is developed by the national standards body and ensures that nationally beneficial standards are developed and properly implemented.

As Canada's national standards body, the Standards Council of Canada will develop this strategy by launching a national public consultation with industry and government stakeholders to identify opportunities and priorities for standards in Canada. This will include considering new conformity assessment programs and increased use of standards in regulation, according to stakeholder priorities. The strategy will also outline how Canadian standardization interests can be better represented internationally, and how the national standards system can be positioned to assist in Canada's economic recovery following the COVID-19 pandemic.

By ensuring that Canadian contributions to international standards development are strategically coordinated and aligned, the national standards strategy will enable Canada to more effectively lead in the development of international standards, so that Canadian technology and industry is best supported by standards. This is expected to bolster Canadian innovation, competitiveness, and economic growth. The strategy will also give regulators options and tools to help them use international standards as the basis for their regulations. This will also help the government meet international trade commitments under the World Trade Organization Agreement on Technical Barriers to Trade.

The development of national standards strategy will take place from 2021 to 2022. A two-phase approach will be used. Phase 1, which began in May 2021, includes rigorous engagement and background research to identify Canadian priorities that could be advanced through international and national standardization. Phase 2 will involve the drafting and publication of the final strategy in spring 2022.

Lead: Standards Council of Canada

Contact Information:

Bruce Farquhar
Director, Global Standards
Standards and International Relations Branch
Standards Council of Canada
info@scc.ca

A2 Advancing development of international standardization, interoperability and mutual support for digital credentials

Building trust and competitiveness in the digital economy through international standards

Stakeholders want the Government of Canada to harmonize international standards in the digital economy, to ensure interoperability in the use of digital tools such as digital credentials and wallets. Stakeholders have also indicated the need to use novel digital technologies to improve services to business, as well as to advance the competitiveness of Canadian businesses in international markets.

In response to this issue, Innovation, Science and Economic Development Canada proposes to enhance Canada's engagement on international standardization, interoperability and mutual support for digital credentials and related technologies, including digital wallets. This would include collaboration with domestic and international organizations to build trust and recognition for each other's digital credentials. Digital credentials are digital versions of documents, such as licences, permits, degrees and business registrations, issued by governments and trusted organizations directly to a digital wallet. They enable businesses and regulators to more easily engage in digital transactions by making it easier to share key documents and to verify the authenticity and the issuer of those documents.

Innovation, Science and Economic Development Canada is undertaking the following three initiatives as part of this proposal:

1. National Technical Specification and Prototype Conformity Assessment Program for Digital Credentials and Digital Trust Services

   In partnership with the Standards Council of Canada, Innovation, Science and Economic Development Canada will establish a National Technical Specification and prototype certification program for digital credentials and digital trust services, aligning them with international standards to enable digital credentials issued in Canada to be supported in other countries, and vice-versa. This will support the longer term objective of a National Standard of Canada and a full-scale conformity assessment program. The National Technical Specification and prototype conformity assessment program will be developed from spring 2021 to fall 2021. The prototype conformity assessment program will then be evaluated in a sandbox with Canadian companies and conformity assessment bodies from fall 2021 to spring 2022.

2. Technical and policy workshops with the European Commission

   Innovation, Science and Economic Development Canada and the European Commission are holding a series of technical and policy workshops to develop recommendations for enabling standardization, interoperability and mutual support for digital credentials and wallets across Canada and the European Union. The workshops will take place from spring 2021 to summer 2021.

3. Canada-led digital credentials dialogue through the International Association of Trusted Blockchain Applications

   Innovation, Science and Economic Development Canada will build upon the technical and policy workshops with the European Commission by leading a digital credentials dialogue through the International Association of Trusted Blockchain Applications, whose Governmental Advisory Body includes 19 countries across Europe, North America, Africa and Asia. Through the Association, there is the opportunity to identify and address best practices and challenges faced by industries and public authorities in using digital credentials across borders. The dialogue will aim to develop recommendations and best practices for enabling standardization, interoperability and mutual support for digital credentials and wallets across borders. The digital credentials dialogue will take place from summer 2021 to winter 2022, with the development and consultation of the report being completed by spring 2022.

   Increased international standardization would support adoption of these digital tools, and help to ensure mutual support for digital credentials issued in Canada and other jurisdictions. This would help to decrease the cost of transactions for activities like exporting, lower the risk of fraud and help businesses to differentiate their products, which would enable them to be more competitive internationally. Individuals and businesses can use digital credentials to conduct transactions without relying upon in‑person or paper‑based processes. The use of digital credentials also enables physical distancing, which could help limit the spread of viruses, like COVID-19.

Lead: Innovation, Science and Economic Development Canada

Contact Information:

Digital Policy and Service Innovation
Digital Design Branch
Innovation, Science and Economic Development Canada
digitaltrust-confiancenumerique@canada.ca

A3 Creating a national cyber security standard for small and medium-sized enterprises

Supporting increased consumer confidence and Canadian competitive advantage through cyber security standards

The 2016 Cyber Review, which included a public consultation on cyber security in Canada, revealed a need for enhanced federal leadership in cyber security, including the development of cyber security standards. The Review also found that small and medium-sized organizations often lack the knowledge and resources to implement cyber security regimes.

To address this issue, Budget 2018 provided resources to Innovation, Science and Economic Development Canada, in collaboration with the Communications Security Establishment, and Standards Council of Canada, to create a voluntary cyber certification program. This program, called CyberSecure Canada, is working to develop an accessible and effective national cyber security standard, to which small and medium organizations will be able to voluntarily certify.

The program aims to provide small and medium sized organizations with a means to certify to a national cyber security standard. As such, this work is expected to raise the cyber security baseline among Canadian small and medium-sized organizations, promote international standardization, reduce cyber-attacks, and better position Canadian small and medium-sized organizations to compete globally.

Many small and medium-sized enterprises are currently working towards meeting an interim standard by implementing all of the required security controls. Public consultations on a new national cyber security standard began in January 2021. The program will adopt the official standard shortly after its development is completed in fall 2021.

Lead: Innovation, Science and Economic Development Canada

Contact Information:

Spectrum and Telecommunications
Connected Canada Branch, Technology and Talent
Innovation Science and Economic Development Canada
CyberSecure: ic.cybersecurecanada-cybersecuritairecanada.ic@canada.ca

A4 Develop a framework to make Canada a leader in international standards for innovation and trade in natural resources

Using scientific and technical expertise to move forward on international standards development

During the 2019 Canada Gazette consultations, natural resources and clean technology stakeholders raised the need for the government to provide a policy and regulatory environment that enables the adoption and use of innovative technologies. This includes the development and use of domestic and international standards as tools to enhance the innovation and trade environment. Stakeholders also suggested international standards could be incorporated into regulations to enable the use of innovative technologies.

To address this, Natural Resources Canada proposes to develop a framework to better leverage and enhance technical expert engagement in standards development to support innovation and trade, and the adoption and use of innovative technologies in the natural resource sectors. In the development of this framework, Natural Resources Canada would further engage stakeholders in the natural resource sectors to identify priority areas for sustained and enhanced Canadian technical expert participation in standards development to build on ongoing activities. In addition, the framework would also include an approach to develop and build on trading partner engagement in promoting the use of relevant international standards and advancing collaboration opportunities.

While domestic initiatives in the Clean Technology Regulatory Roadmap related to standards focus on low carbon fuel technology and transportation infrastructure, including for zero-emission vehicles, this Roadmap initiative looks at increasing Canada's leadership in standards engagement internationally in all natural resources priority areas for innovation and trade.

Enhancing Natural Resources Canada's technical expert participation in international standard development would help Canada stay competitive with other countries that are using standards to promote their innovation and trade interests, including in areas such as critical minerals and batteries, forest biomaterials and low carbon fuels and clean energy technologies. This work would support Canada's economic recovery, the deployment of new clean technology, as well as the government's safety and security mandates (like critical infrastructure, nuclear energy, and accessibility).

Natural Resources Canada would undertake engagement with relevant stakeholders, starting in 2021 and ending in 2024, to determine standard-related priorities in advancing natural resources innovation and trade interests. These priorities would form the basis of standard-specific roadmaps, which NRCan would seek to establish as part of the development of the proposed framework, along with an approach to promote standards with Canada's key trading partners. The development of the framework would be completed by March 2025.

Lead: Natural Resources Canada

Contact Information:

Tara Preston
Director, Global Trade Policy Division
International and Intergovernmental Affairs
Strategic Policy and Innovation
Natural Resources Canada
Tara.preston@canada.ca

Theme 2: Alignment and best practices to support trade and economic growth

This theme focuses on aligning international standards and conformity assessment to support internal and international trade and economic growth. Through a variety of consultation opportunities, stakeholders have called for Canadian regulations to reference standards that are aligned within Canada and with other countries, and to make sure international standards are adopted into regulations in a timely manner. This helps to:

• make sure that Canada's regulatory processes and international requirements are interoperable
• reduce the cumulative burden on industry caused by differing or overlapping regulations
• improve responsiveness to changing standards based on new technology, industry innovation, and emerging risks
• support regulatory cooperation objectives

As well, harmonized regulations and aligned regulatory requirements often ensure that Canadian regulations are using global best practices. Increasing the use of international standards in Canadian regulations also better positions Canada to encourage other jurisdictions to use similar approaches.

A5 Facilitating alignment with trusted international standards and obligations in the transportation sector

Better integrate trusted international standards and obligations into Transport Canada regulations

Transportation sector stakeholders have called for the enhanced use of trusted third-party standards in Transport Canada's regulations, and, in particular, to adopt those standards in a timely manner.

Transport Canada is seeking to modernize its legislative framework in response to these concerns. Specifically, Transport Canada is looking to leverage the Annual Regulatory Modernization Bill (ARMB) to provide authority that would improve the department's ability to adeptly align its regulatory frameworks with international standards and obligations.   

The initiative would support the Government's regulatory modernization agenda, including its commitment to enhancing regulatory cooperation and harmonization. The objective, specifically, is to provide a more efficient means for Transport Canada to align its regulations with trusted international standards in order to:

• facilitate interoperability between Transport Canada's regulatory framework and international expectations and requirements
• reduce the cumulative administrative and compliance burden on Canada's transportation industry caused by divergence and overlap between Canadian and international requirements
• improve responsiveness to rapidly evolving international standards and expectations due to new technology, industry innovation, and emerging risks

The timely incorporation of international standards and obligations – where appropriate - could strengthen Canada's economic competitiveness by contributing to lower costs for businesses, increased trade and economic growth, while also improving safety, security and environmental protection outcomes for Canadians.

Specific timing for this proposal would be subject to the Annual Regulatory Modernization Bill process.

Lead: Transport Canada

Contact Information:

Legislative Modernization
Multi-Modal and Road Safety Programs
Transport Canada
TC.LegislativeModernization-Modernisationlegislative.TC@tc.gc.ca

A6 Aligning Canada's regulations with international standards on pet food

Updating the Health of Animals Regulations to bring the requirements for importing non-commercial pet food in line with recognized international standards and address long-standing traveller irritants

The Canadian Food Inspection Agency regularly receives messages from the public about importing pet food for non-commercial use under the Health of Animals Regulations. The provisions of these regulations, which regulate importing pet food for non-commercial use, are confusing and inconsistent.

Currently, the regulations allow individuals to feed their pet with pet food containing specified risk material under certain conditions. However, the World Organisation for Animal Health's international standard on specified risk material does not allow specified risk material in pet food under any circumstances.

Further to this, travellers arriving to Canada from the United States must have their pet present if they want to import pet food for non-commercial use without a zoosanitary certificate. This requirement makes it harder for the public to buy pet food in the United States, acts as a barrier to the free movement of goods between the United States and Canada, and is not science-based.

To address these issues, the Canadian Food Inspection Agency proposes to update its Health of Animals Regulations to align with the World Organisation for Animal Health's international standard. The Canadian Food Inspection Agency would also allow travellers entering Canada from the United States to import pet food for non-commercial use without needing a zoosanitary certificate or their pet present.

Aligning these requirements with the World Organisation for Animal Health's international standard would strengthen Canada's position with trading partners, increase confidence in Canada's import system, and show that Canada adheres to international agreements. These changes would also support regulatory cooperation with the United States, as the United States does not require a pet present when a person imports personal amounts of pet food from Canada into the United States.

The target date to pre-publish the proposed changes to the Health of Animals Regulations in the Canada Gazette, Part I will be winter 2023. The final publication date in Canada Gazette, Part II is expected in summer 2024.

Lead: Canadian Food Inspection Agency

Contact Information:

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

A7 Establishing an artificial intelligence standardization collaborative

Supporting the development of artificial intelligence standards in line with Canadian priorities and stakeholder needs

Industry stakeholders have expressed the need for clear, internationally aligned requirements for artificial intelligence in Canada. Stakeholders have also noted that regulators and standards development organizations are moving quickly but without the necessary forum for collaboration and coordination. There is a need for enhanced collaboration and coordination on artificial intelligence standardization-related activities in Canada to support the technology's advancement and use, and find consensus in accounting for the diverse stakeholder needs – government, industry, and consumer.

To address this need, the Standards Council of Canada, along with Innovation, Science, and Economic Development Canada, proposes to create a cross-sector group of artificial intelligence developers, users, and regulators to collaborate on the development of artificial intelligence standards and conformity assessment tools. This would include looking at opportunities to better position Canada to utilize and benefit from artificial intelligence standards being developed internationally, as well as artificial intelligence standardization efforts that could support high-growth sectors or those sectors negatively impacted by COVID-19. The group would be called the Canadian Artificial Intelligence Governance Standardization Collaborative (the Collaborative) and would be modeled after Standards Council of Canada's successful Data Governance Standardization Collaborative.

By better positioning Canada to utilize and benefit from artificial intelligence standards, the Collaborative would help to ensure artificial intelligence deployed in Canada is safe, effective, and ethical. The Collaborative would also support a more coordinated approach to artificial intelligence standardization activities in Canada, minimizing the risk of duplication of efforts among key stakeholders. Ultimately, the Collaborative would be expected to support economic growth by fostering user confidence and accelerating artificial intelligence adoption and innovation, while also potentially informing the development of future regulatory frameworks in Canada.

The Collaborative would start in 2021, with a first year of work focused on research into gaps and needs in artificial intelligence standards. Years 1 and 2 would include development of a work plan, to be completed by fall 2023, outlining the Collaborative's plans and priorities. Subsequent years (2023-2025) would be focused on delivering on the priorities outlined in the work plan. As part of support for the Pan-Canadian Artificial Intelligence Strategy, Budget 2021 proposes to provide resources to advance the development and adoption of standards related to artificial intelligence, which includes support for this initiative.

Lead: Standards Council of Canada will lead this initiative, with support from Innovation Science and Economic Development Canada.

Contact Information:

Anneke Olvera
Director, Programs and Operations
Strategy and Stakeholder Engagement Branch
Standards Council of Canada
info@scc.ca

Theme 3: Supporting the accessibility and accuracy of standards

This theme is focussed on supporting improved accessibility and accuracy of standards incorporated by reference into federal regulations.

Accessibility of standards referenced in regulations has become an important issue in recent years. Such standards must be accessible as required by the Statutory Instruments Act. Recently, standards development organizations in Canada have faced legal challenges with implications for the copyright of standards incorporated by reference in regulations.

In response to these matters, the Standards Council of Canada and the Standards Development Organizations Advisory Committee have been studying the best way to make sure that standards development organizations accredited by the Council can support accessibility requirements when standards are incorporated by reference in regulations. These groups have been examining potential policy solutions and funding opportunities to support accessibility as a key principle of Canada's standardization system. Proposal A8 below highlights and builds on the work to enhance accessibility of standards in federal regulations.

Industry stakeholders have also expressed the importance of ensuring that references to standards in federal regulations are up to date. Inaccurate and outdated references regulations can lead to marketplace obstacles and increase regulatory costs.

A8 Supporting the accessibility of standards incorporated by reference in federal regulations

Engaging across Canada's standardization network to recommend ways to enhance accessibility and protect the copyright of standards development organizations

Stakeholders have expressed the need to further explore the accessibility of standards incorporated by reference in federal regulations given the important role that standards play in Canada's regulatory frameworks. For example, the Standing Joint Committee for the Scrutiny of Regulations has recommended amending the Statutory Instrument Act to ensure the accessibility of documents incorporated by reference in federal regulations. Standards development organizations accredited by the Standards Council of Canada have also raised concerns, related to protecting and maintaining copyright for the standards that they create and publish, when these are incorporated by reference in regulations.

To address this need, the Standards Council of Canada proposes to foster discussion and collaboration on accessibility by engaging with federal departments and regulators and Standards Council of Canada-accredited standards development organizations. Ultimately, this work would result in recommendations on ways for standards in federal regulations to be more accessible, while protecting the copyright of standards development organizations.

The initiative is expected to examine ways to increase accessibility so that industry and Canadians have increased access to referenced standards. This would support good regulatory practices and provide more clarity on accessibility and copyright in cases where a federal department or regulator references a standard in a regulation. This proposal would also build upon efforts to provide access to key standards during the COVID-19 pandemic, where many standards development organizations are providing no-fee access to essential standards to help companies provide essential products and services in response to COVID-19.

This initiative began in winter 2021, with engagement with federal departments and regulators as well as standards development organizations accredited by Standards Council of Canada to occur throughout 2021. Final recommendations would be made in winter 2022.

Lead: Standards Council of Canada

Contact Information:

Stephen Head
Manager, Strategic Policy
Strategy and Stakeholder Engagement Branch
Standards Council of Canada
info@scc.ca

A9 Designing a digital tool to provide regulators with up-to-date information on references to standards in federal regulations

Helping regulators monitor references to standards in federal regulations, to support the use of up-to-date and relevant standards

In the Canada Gazette consultation, industry stakeholders noted that, in some cases, the Canadian regulatory process does not keep pace with the latest versions of international standards, which can lead to outdated references in regulations and result in technical barriers to trade. Outdated references can cause confusion and unnecessary administrative burden on industry. At the same time, regulatory stakeholders have identified a persistent challenge in accessing current information about standards, so that outdated references can be more easily analyzed.

To address these challenges, the Standards Council of Canada is proposing to design a digital tool that would give regulators tailored information about the status of references to standards in regulations. This tailored and current information would help regulators more easily identify outdated references and analyze whether references are still applicable to regulatory and policy objectives. This is expected to support regulators in keeping references up-to-date. Preliminary work has already been completed by the Canada School of Public Service. The Standards Council of Canada would work closely with the School to build on previous work to design a technically feasible solution that takes into account a wide range of design requirements.

This tool would provide the digital infrastructure to assist with monitoring and addressing references to standards in regulation. It is expected that improved and efficient monitoring of standards referenced in regulations would help regulators more quickly address outdated standards, which could help reduce confusion and regulatory burden for industry.

The work to design the tool would take place over the course of one year. In 2021, the Standards Council of Canada would complete robust stakeholder engagement to develop the design input requirements for the tool and would conduct a technical feasibility assessment on all inputs. In 2022, the Council would complete the development plan, including cost, timeline, and business case analysis.

Lead: Standards Council of Canada

Contact Information:

Alejandro Trujillo
Manager, Regulatory Affairs
Strategy and Stakeholder Engagement Branch
Standards Council of Canada
info@scc.ca

A10 Enhancing the accessibility of motor vehicle standards

Making technical standards in motor vehicle regulations easier to read and more accessible for stakeholders, while better enabling regulations to keep pace with innovation

Under the Motor Vehicle Safety Regulations, there are 72 technical standards that stakeholders must follow to be in compliance. However, stakeholders have raised they are spread across different documents, which makes them difficult to follow and interpret.

Transport Canada proposes to make technical standards for motor vehicle safety more easily readable and readily accessible for stakeholders. As a first step, Transport Canada will work towards moving the technical requirements from Canada's Motor Vehicle Safety Standards, technical standards documents and/or test methods into a single document incorporated by reference, where feasible. Going forward, Transport Canada will continue participating in the United Nations World Forum for the Harmonization of Vehicle Regulations (WP.29), including Global Technical Regulations and United Nations Regulations, with a view to aligning Canada's regulatory regime and technical standards, where appropriate. Moreover, Transport Canada will include United Nations regulations as additional compliance options when the technical requirements are substantially similar to existing Canadian or United States standards, to reduce the burden on manufacturers and allow Canadians a greater choice.

This initiative supports the Government's digital transformation and transparency agenda, and builds on work in the Transportation Sector Regulatory Roadmap to improve regulatory clarity for industry and reduce barriers to automotive innovation. A better understanding of regulatory requirements could lead to better compliance rates, and encourage trade between provinces and new investment in market. By consolidating technical requirements into a single document, Transport Canada would be better positioned to ensure regulatory requirements keep pace with emerging technologies and international best practices.

This initiative will begin in 2023, and take place alongside required regulatory amendments and updates in the years to come, in keeping with Transport Canada's Forward Regulatory Plan.

Lead: Transport Canada

Contact Information:

Ibrahima Sow
Executive Director, Road Safety and Vehicle Regulations
Multi-modal and Road Safety Programs
Transport Canada
Road Safety Regulations Clerk: RegulationsClerk-ASFB-Commisauxreglements@tc.gc.ca

Theme 4: Novel approaches to advance the use of international standards

Consistent with the first round of Reviews, this Regulatory Roadmap identifies novel regulatory approaches to advance the objective of the Review. Novel regulatory approaches are experimental or conceptual ways of regulating, such as pilot projects and regulatory co-development, which are designed to support the regulation of emerging technologies and help position the regulatory system to support innovation. The novel approach included in this Roadmap makes use of a pilot project to support collaborative efforts on artificial intelligence, as well as new tools to support changes in technology.

A11 Developing an accredited conformity assessment program for AI

Fostering artificial intelligence innovation and consumer confidence in Canada

Stakeholders have indicated that common standards and certification for artificial intelligence would support innovation and competitiveness, while helping to keep artificial intelligence users safe. People are looking for assurance that artificial intelligence decision-making is reliable, transparent, and fair. However, there are currently no accredited certification programs that could address these concerns about artificial intelligence.

In response to this need, the Standards Council of Canada, in partnership with Innovation, Science and Economic Development Canada, proposes to create an accredited conformity assessment program for artificial intelligence. The program would be based on a forthcoming international standard for artificial intelligence Management Systems, and would establish criteria to accredit conformity assessment bodies in the AI management systems area.

These efforts, alongside the forthcoming international standard, would benefit Canadians by ensuring that Canadian artificial intelligence developers and adopters have a common, internationally aligned set of verifiable metrics to guide development and procurement of artificial intelligence, including an established mechanism for certifying whether AI products, services, and systems meet the requirements of the emerging standard. This is expected to increase trust in artificial intelligence and allow for expanded adoption in sectors such as healthcare and government, where transparency, safety and reliability of artificial intelligence are vital. Furthermore, through developing this first-in-kind certification program, Canada would become a leader in safe and ethical artificial intelligence. This move would be expected to support economic activity and growth in Canada where artificial intelligence provides efficiency and cost savings for businesses of all sizes.

To deliver this work, the Standards Council of Canada and Innovation, Science, and Economic Development Canada would launch a prototype artificial intelligence conformity assessment program within a regulatory sandbox, and gather feedback from industry, government and conformity assessment stakeholders. This would then be followed by development of a full-scale program. The sandbox testing phase would be carried out in 2022 and full program development will conclude in 2024.

This project would build on financial support from the Centre for Regulatory Innovation, which is enabling the Standards Council of Canada and Innovation, Science, and Economic Development Canada to build a prototype artificial intelligence conformity assessment program. In addition, as part of support for the Pan-Canadian Artificial Intelligence Strategy, Budget 2021 proposes to provide resources to advance the development and adoption of standards related to artificial intelligence, which includes support for this initiative.

Lead: Standards Council of Canada and Innovation, Science and Economic Development Canada

Contact Information:

William O'Neill
Manager, Business and New Program Development
Accreditation Services Branch
Standards Council of Canada
info@scc.ca

Top

A central part of the Regulatory Review is addressing stakeholder feedback. While all comments provided by stakeholders were carefully considered, some of the issues are not being addressed in this Roadmap. In the interest of transparency, this section aims to summarize the types of issues raised by stakeholders that are not being addressed, which fall into four general categories.

Issues addressed by other federal initiatives

Many stakeholders raised issues that are currently or proposed to be addressed or considered through other federal efforts. For instance, some stakeholder comments were linked to recent or ongoing initiatives and processes already being undertaken by departments and agencies. In these instances, such comments have been shared with the relevant federal departments and agencies but are not addressed in this Roadmap. These include:

The Competition Bureau is conducting an internal review of the Precious Metals Marking Regulations to consider options to harmonize the regulations with international standards. Because of this, recommendations that were received during the consultation process related to precious metals marking are not included in this Roadmap.

Stakeholders commented on the lack of a common definition of “waste” and the lack of harmonized and updated laws and regulations across Canadian jurisdictions to support waste management and emerging technologies for processing of waste and wastewater. Since waste management is a shared responsibility between different levels of government, Environment and Climate Change Canada is working with provinces and territories through the Canadian Council of Ministers of the Environment to explore various solutions to waste management issues. The development of a common definition for waste could be undertaken by the Canadian Council of Ministers of the Environment should there be agreement to do so.

Some stakeholders raised concerns with Environment and Climate Change Canada's proposed Volatile Organic Compound Concentration Limits for Certain Products Regulations and misalignment with the United States.The proposed regulations were published in the Canada Gazette, Part I on July 6, 2019 for public consultation. Any comments received via the Regulatory Reviews will be considered through the existing regulatory development process, already underway. More information on these proposed regulations is available in Environment and Climate Change Canada's Forward Regulatory Plan.

Stakeholders also recommended amending the Sulphur in Gasoline Regulations to harmonize these with the United States Environmental Protection Agency Tier III rule, and eliminate duplication of reporting requirements. Environment and Climate Change Canada amended the Sulphur in Gasoline Regulations in December 2020 to extend the temporary sulphur compliance unit trading system until 2025. Amendments for a permanent system to align with the United States Environmental Protection Agency, as well as other possible amendments to these regulations, will be considered by the end of 2025.

Innovation, Science and Economic Development Canada's work to modernize international standards includes the Spectrum and Telecommunications Sector's incorporation of international standards in its regulatory standards. The Spectrum and Telecommunication Sector plans to continue to incorporate international standards as a best practice in the development of their regulatory standards to reduce technical barriers to trade. As a result, recommendations related to use the use of standards in spectrum and telecommunications are being considered as part of Innovation, Science and Economic Development Canada's ongoing modernization efforts in this area.

As well, recommendations for the Government of Canada to create cybersecurity network standards that are aligned regionally and globally are being considered as part of Innovation, Science and Economic Development Canada's ongoing modernization efforts in this domain.

Similarly, recommendations for the Minister of Innovation, Science and Economic Development to encourage Canada's national standard body to seek out alignment of standards in regulations is already addressed through work done by the Standards Council of Canada with provincial and territorial regulators to reduce barriers to trade for Canadian Businesses.

As outlined above in the section titled Regulatory modernization activities, Health Canada also heard recommendations to address stakeholder issues and irritants falling under Health Canada's regulatory oversight that are addressed by other federal initiatives.

For instance, stakeholders provided feedback on the importance of international alignment, in particular with the United States. As part of Canada's regulatory process, regulators assess opportunities for alignment with the regulatory approaches of other jurisdictions, including the United States. This includes assessing the regulatory approaches and risk management actions of other jurisdictions, while ensuring that maintaining or improving environmental protection remains the focus of domestic risk management measures.

Stakeholders emphasized that Canada could better align its Chemical Management Plan priorities with the United States. Canada considers international activities, including those in the United States, to inform its prioritization of chemical assessments and has worked with the United States through the Regulatory Cooperation Council to collaborate on activities related to chemicals management.

Budget 2021 proposed the renewal of the Chemicals Management Plan for three years. Environment and Climate Change Canada and Health Canada will continue to explore ways to improve chemicals management in a renewed program. Cooperation with other jurisdictions will remain an integral part of the program.

The Canadian Food Inspection Agency heard comments that touched on activities that already form part of current Agency practice, including the consideration of science-based rules and international standards in regulatory development as well as maintaining transparency in the consultation process.

Further to this, many issues and irritants that stakeholders have brought forward are currently being addressed through regulatory cooperation forums. For instance, a stakeholder raised the importance of harmonizing North American standards for appliances due to geographical proximity and the same electrical system with United States and Mexico. Natural Resources Canada is addressing the alignment of appliance standards within Canada through the Regulatory Reconciliation and Cooperation Table under the Canadian Free Trade Agreement. Similarly, Natural Resources Canada is leading work happening under the Canada-United States Regulatory Cooperation Council.

Stakeholders also raised issues that Transport Canada is considering to address through ongoing work through the Canada-United States Regulatory Cooperation Council's Motor Vehicle Safety Standards Workplan to align requirements and standards for Motor Vehicle Safety, and to consider self-certification approaches during the development of regulations.

Further, stakeholders raised that Transport Canada's Transportation of Dangerous Goods Regulations are misaligned with similar regulations of other jurisdictions, including the United Nations Model Regulations. These regulations provide a basic system for transport of dangerous goods provisions for the international regulatory community, and the United States. For instance, stakeholders said that there were issues with differences in regulations for the transport of medical devices, as well as for classification and safety mark requirements for dangerous goods. To address these issues, Transport Canada regularly updates the regulations to harmonize the Transportation of Dangerous Goods Regulations with international regulations. Transport Canada does the update every 24 months, called the International Harmonization Update.

Finally, stakeholders took the opportunity to express general support for the use of international standards in regulations, noting that misalignment between regulatory requirements and international standards can raise costs for industry. Building on this, some stakeholders recommended that, in cases where regulatory requirements differ from international standards, costs associated with this should be quantified through the regulatory process.

The Cabinet Directive on Regulation recognizes the value of regulatory alignment. For instance, the Directive directs departments and agencies to examine the regulatory systems of relevant jurisdictions to identify potential areas for alignment or cooperation, which should include a review of work undertaken by international standard development organizations. Further, the Directive notes that regulators must examine the potential positive and negative effects of a regulatory proposal, including the costs to businesses of complying with regulatory requirements.

Other stakeholders raised concerns about the use of international standards. This included concerns with respect to the use of international standards placing downward pressure on Canada's regulatory protections, and with costs, burden and complexity associated with the certification process for international standards, particularly for small businesses. Stakeholders also highlighted the importance of considering the suitability of international standards to the Canadian context.

The Cabinet Directive on Regulation emphasizes the importance of protecting and advancing the public interest and supporting good government through the federal regulatory system. For instance, the Directive notes that a central pillar of regulatory cooperation is the maintenance or enhancement of standards of public health and safety and environmental protection. The Directive also notes that departments and agencies are to also consider the impact of proposed regulations, including to ensure that small businesses do not unnecessarily bear a disproportionate burden when complying with regulation. Finally, it is recognized that a Canada-specific approach may be required in some cases. The Directive notes that, where differences in approaches are required, departments and agencies must provide a rationale.

Issues raised in the first round of Targeted Regulatory Reviews

The first round of Regulatory Reviews focused on agri-food and aquaculture, health and bio-sciences, and transportation. To support these Reviews, consultations with stakeholders took place in 2018 and feedback was carefully considered by participating departments and agencies. The Regulatory Roadmaps for these Reviews were published in June 2019.

In the second round of Reviews, a number of stakeholders took the opportunity to raise concerns expressed to the Government during the first round of Reviews. This included inputs related to maximum residue limits for pesticides, plant breeding innovations, regulations related to food products, improvement on international standards harmonization, leadership and engagement and others.

These submissions, like all feedback received during the second round of Reviews, were provided to relevant departments and agencies for consideration. However, as these issues were considered in the context of the first round of Reviews, and departments and agencies are working to implement the initiatives stemming from these Reviews, issues related to the first round were not reconsidered in the context of this Regulatory Roadmap.

Issues not being addressed for other reasons

Stakeholders also raised a number of issues that are not being addressed through this Regulatory Review for other different reasons. While these comments are not being addressed through this Roadmap, they were shared with the relevant departments and agencies.

For instance, Health Canada heard a number of suggestions from stakeholders about areas of regulatory oversight that were recently reviewed or modernized, or are in the process of being updated. These included:

• recent publication of the Cannabis Act and amendments to its regulations
• an agile and flexible regulatory system for health products and food
• international harmonization and cooperation of requirements for cosmetic labelling, workplace hazardous products, and consumer health products
• reducing administrative and paper burden for registered pesticide manufacturers and drug establishment licensees
• post market re-evaluation of pesticides (including water monitoring activities)

Health Canada also received stakeholder requests to amend the labelling requirements for small containers of hazardous products is not being addressed through this Roadmap. Such an amendment could have an impact on the health and safety of Canadians.

Lastly, a few stakeholders asked that specific standards be included in the Safe Food for Canadians Regulations. However, the Canadian Food Inspection Agency decided that they should not be incorporated by reference due to accessibility and consistency concerns.

Issues outside the scope of the International Standards Regulatory Review

In some cases, stakeholders also brought forward issues that did not necessarily apply to the scope of the International Standards Regulatory Review.

For instance, stakeholders noted challenges in meeting local utility requirements because of inconsistent drawings in the electricity-metering compartment and recommended harmonizing provincial and territorial electrical safety regulations. Recommendations to harmonize these regulations is a matter for provincial/territorial regulatory cooperation as CSA Group's Canadian Electrical Code is referenced by every provincial/territorial jurisdiction in Canada. The need for timely and aligned adoption of the Canadian Electrical Code amongst Provinces and Territories is currently being discussed in the Regulatory Reconciliation and Cooperation Table, which is a forum established by the Canadian Free Trade Agreement for addressing such matters.

Innovation, Science and Economic Development Canada heard a concern that it is failing to follow the proper regulatory development process. However, Innovation, Science and Economic Development Canada follows the regulatory development process in line with the Cabinet Directive on Regulation, including consulting with stakeholders to develop technical standards and making associated regulatory announcements. The approach used for comment periods for consultations on proposals is consistent with Canada's obligations under the World Trade Organization's Technical Barriers to Trade Agreement and new and updated technical standards are published in the Canada Gazette.

Health Canada received a suggestion from stakeholders for a single regulatory agency for food standards, integrity and inspection, which is outside the scope of this Targeted Regulatory Review.

Transport Canada heard that limitations in Canada's regulatory process do not allow the Government of Canada to address technological advances in the airline industry quickly enough. Although these issues do not fall within the scope of the International Standards Regulatory Review, Transport Canada has dedicated resources to modernize the Canadian Aviation Regulations to reduce the burden on industry, and harmonize with best practices.

Stakeholders also said that the current Canadian regulatory framework does not allow Transport Canada to issue certificates for new technologies that manage shipboard waste. Transport Canada has also established the Marine Technical Review Board where viable technological alternatives could be granted equivalencies or exemption.

In summary, this section of the Roadmap aims to provide a sense of the general categories of comments that are not being advanced through this Regulatory Review. As such, the list of specific examples above are not comprehensive.

Further to this, the COVID-19 pandemic has underscored the important role that international standards can play in supporting technology development and the health and safety of Canadians. During this time, new regulatory issues may have emerged, and stakeholder priorities may have shifted alongside evolving needs and circumstances. Outreach with federal regulators on further opportunities to support regulatory modernization is encouraged.

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