3.181.  The Safe Food for Canadians Act (SFCA) and the Safe Food for Canadian Regulation (SFCR) came into effect on 15 January 2019, representing the most important revision of food safety regulations in 25 years.[264] Acknowledging that Canada has one of the strongest food safety systems in the world, the authorities note that new risks and challenges need to be addressed, including new threats to food safety, changing consumer preferences, and prevention-focused international standards. The SFCA consolidates the authorities of the Canada Agricultural Products Act, the Fish Inspection Act, the Meat Inspection Act, and the food provisions of the Consumer Packaging and Labelling Act. The SFCR replaces 14 sets of regulations to reduce unnecessary administrative burdens on businesses (Box 3.4)

3.182.  Policies and national standards on food safety, nutrition quality and food-borne surveillance activities are developed, set, and enforced through the Health Portfolio. Being a member of the Codex Alimentarius Commission (Codex), the World Organization for Animal Health (OIE) and the International Plant Protection Convention (IPPC), Canada bases or aligns its SPS measures with recognized international standards, guidelines, and recommendations in accordance with the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). Implementation of food safety, animal health and plant health standards at the federal level is mainly in the hands of Health Canada and the Canadian Food Inspection Agency (CFIA). At the sub-federal level, provincial/territorial regulations are enforced by provincial/territorial authorities. Source: SFCA online information. Viewed at: https://laws-lois.justice.gc.ca/eng/acts/S-1.1/index.html; SFCR. Viewed at: http://www.gazette.gc.ca/rp-pr/p2/2018/2018-06-13/html/sor-dors108-eng.html

3.183.  Health Canada establishes standards and policies governing the safety and nutrition quality of all food sold in Canada. It also mandates and conducts food-related health risk assessments; approves and regulates pest control products, setting maximum residue limits (MRLs) for pesticides that may remain in food; and evaluates the safety of veterinary drugs used in food-producing animals, establishing the corresponding MRLs

3.184.  The CFIA enforces federally-mandated inspection, compliance, and quarantine requirements related to food, animal health and plant health. It is the lead agency for risk assessment for animal health and plant health. The CFIA has encouraged and supported the development, implementation and maintenance of Hazard Analysis Critical Control Point (HACCP) systems in all federally-registered establishments. With the SFCR, the HACCP will be a requirement for all food imported, prepared for interprovincial trade, or exported. The Food Safety Recognition Program (FSRP) is led by the CFIA with participation from provincial and territorial governments.[265] The FSRP includes the On-Farm Food Safety Recognition Program and the Post-Farm Food Safety Recognition Program, providing government recognition of food safety systems developed and implemented by national industry organizations to enhance food security, maintain the confidence of Canadian consumers, and facilitate market access. National food industry organizations that are not regulated by the CFIA may submit their food safety systems to the FSRP for technical review

3.185.  The CFIA sets policies and regulations for imports of food, agricultural input and agricultural products, live animals, animal products and by-products, and plants and plant products. The Canadian Border Service Agency (CBSA) is responsible for the initial import inspections of food, agricultural input and agricultural products at Canadian entry points. The CFIA uses an electronic system (including the Automated Import Reference System - AIRS) and a database of import requirements to assist the CBSA with the control of imported plant, animal and food products

3.186.  The Plant and Animal Health Strategy (PAHS) for Canada was adopted in 2017.[266] The PAHS is a partnership between federal government departments, provincial and territorial governments, academia, and industry stakeholders. The PAHS is designed as a comprehensive, effective and integrated system focusing on preventive risk management and partner collaboration. It provides a national vision to address evolving risks to plant and animal health in Canada. The implementation of the PAHS is being advanced under the mandates of the Canadian Plant Health Council and the National Farmed Animal Health and Welfare Council

3.187.  The Technical Barriers and Regulations Division of Global Affairs Canada is Canada's enquiry point and national notification authority under the SPS Agreement. During the period 2015-18, Canada submitted 307 notifications (excluding addenda and corrections) to the WTO related to the SPS Agreement. No new specific trade concerns (STCs) were raised regarding measures maintained by Canada in the WTO Committee on Sanitary and Phytosanitary Measures since its last Review, and Canada has not brought up any new STCs concerning measures applied by other Members. However, it has supported several STCs raised by other Members. One previous STC, import restrictions on bovine semen imposed by India, that Canada first raised jointly with the European Union in 1999, was reported by Canada as resolved in October 2017

3.188.  The revised or new FTAs Canada has concluded since its last Review all contain SPS chapters. A consistent feature of Canada's SPS chapters has been provisions aimed at avoiding and resolving trade-related SPS issues among the parties, such as the establishment of SPS Committees and/or contact points, and provisions to facilitate communications and strengthen cooperation. While affirming SPS Agreement rights and obligations, several of the FTAs (CUSMA, CETA, and CPTPP) created additional obligations subject to the dispute settlement provisions of these agreements

3.147.  The development of standards in Canada is a decentralized process. The Standards Council of Canada (SCC), which takes its mandate from the Standards Council of Canada Act, is Canada's national standardization body.[246] The SCC is a federal Crown corporation, with the mandate to promote efficient and effective standardization in Canada.[247] The SCC reports to Parliament through the Minister of Innovation, Science and Economic Development Canada and oversees Canada's national standardization network. The SCC prescribes policies and procedures for the development of national voluntary standards; it represents Canada in international standards activities and provides accreditation services for both standards development organizations and conformity assessment bodies

3.148.  The SCC also manages programmes and services designed to support the integration of standardization into regulatory practices, and coordinates and oversees the efforts of the persons and organizations involved in the National Standards System. The SCC is also charged with promoting voluntary standardization in Canada, where standardization is not expressly provided for by law, to promote the participation of Canadians in voluntary standards activities, and to ensure the effective and coordinated operation of standardization in Canada.[248] The SCC represents Canada at the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) and, nationally, sets the requirements for the development of National Standards of Canada, which are developed by SCC-accredited standards development organizations (SDOs)

3.149.  Canada's National Standards System is composed of a variety of organizations, with 3,189 members involved in international standards committees on behalf of Canada. The SCC does not develop standards but is responsible for accrediting various bodies in the system. The Technical Barriers and Regulations Division of Global Affairs Canada hosts Canada's SPS and TBT notification authority and enquiry point. The SCC and the National Research Council of Canada (NRC) share the responsibility for the Calibration Laboratory Assessment Service (CLAS) programme through an Agreement of Collaboration. The NRC is responsible for all aspects of calibration laboratory assessment, including surveillance of accredited laboratories, while the SCC is responsible for the accreditation decision

3.150.  At the national level, SCC accredits SDOs. There are currently 10 SDOs: the Air-Conditioning, Heating and Refrigeration Institute; ASTM International; the Bureau de normalisation du Qubec; the Canadian General Standards Board (CGSB); the Canadian Standards Association (CSA Group); the Health Standards Organization (HSO); the International Association of Plumbing and Mechanical Officials (IAPMO); NSF International; ULC Standards; and Underwriters' Laboratories Inc. (UL). These institutions generally operate in areas of specialty, reflecting the expertise of their technical committees, but they may develop standards in any area. Other bodies involved in standardization include: the ISED; Measurement Canada (which administers and enforces the Electricity and Gas Inspection Act and the Weights and Measures Act through the exclusive constitutional authority of the Government of Canada); the Telecommunications Standards Advisory Council of Canada (TSACC, an industry-government partnership formed to develop strategic directions for standardization in the Information Technology and Telecommunications (IT&T) sectors); the National Research Council Canada (NRC); the Institute for National Measurement Standards, which is Canada's national metrology institute; and the National Institute for Nanotechnology (NINT)

3.151.  Standards are developed through consensus by committees of interested stakeholders, and may include representation from categories such as industry, governments, authorities having jurisdiction, academia, consumers, and public interest bodies. These committees are organized and managed by an SDO. The basic process by which a standard is developed is consistent among all SDOs. The first step is the identification of the Canadian interest and strategic need for a new standard, followed by a preliminary study and the preparation of a draft outline, and the establishment of a committee, whether pre-existing or new. The committee reviews existing international and regional standards, both published and under development, first for possible adoption or adjustment; if it is not possible to use an existing standard, a new standard is developed and undergoes an approval process by the committee. Once a draft standard is developed and approved by consensus by the committee, the public is invited to review the it and provide comments. A minimum time-frame of 60 days is prescribed for the submission of comments by interested parties, which can only be shortened with appropriate rationale and action to proactively inform affected stakeholders, before the publication of the standard. All comments received, regardless of place of origin, must be considered by the technical committee and responded to, if requested

3.152.  Once a new standard is developed, it may be sent to the SCC (see below), where it is evaluated to see if it meets the criteria of a National Standard of Canada (NSC). These criteria include: a) the standard must have been developed by consensus of a balanced committee of stakeholders; b) it must have been subjected to public review; c) it must be available in both English and French (official languages) upon publication; d) it must not duplicate or overlap with the work of other SDOs, including other international or regional SDOs; and e) it must not create barriers to international trade. NSCs can be submitted to international standards development organizations for consideration and adoption as international standards

3.153.  The SCC introduced self-declaration for NSCs in 2017, allowing SDOs to meet stakeholders' needs more quickly. This facilitates SCC-accredited SDOs to self-declare compliance, through a process whereby their standards are verified for compliance on a sample basis. For SCC-accredited SDOs that have achieved this status, the SCC does not have to review and approve their NSCs prior to publication. System controls are in place to ensure the continued rigour of the development of NSCs.[249]

3.154.  NSCs must be reviewed and updated at least every five years. There were 3,096 standards developed under SCC accreditation as at 30 September 2018, of which 2,424 had NSC status. Some of the main areas where there were national standards include: information technology (977); electrical engineering (345); environment, health protection and safety (177); construction materials and building (135); health care technology (199); domestic and commercial equipment (121); metrology and measurement (27); energy and heat transfer engineering (127); and telecommunications, audio and video engineering (104)

3.155.  As noted above, the SCC facilitates Canadian participation in international standardization, including participation at the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). As the Canadian member of the ISO and the IEC, the SCC ensures effective Canadian participation in the activities of those organizations and establishes requirements and guidance for Canadian participation. Canada participates or observes on 354 ISO technical committees[250] and 115 IEC technical committees.[251]

3.156.  Cooperation Arrangements are negotiated by the SCC, which has arrangements with Brazil's Associao Brasileira de Normas Tcnicas (ABNT, signed in 2018), the British Standards Institute (BSI, signed in 2018), the Ukrainian Research and Training Center for Standardization, Certification and Quality (UkrNDNC, signed in 2018), Peru's Instituto Nacional de Calidad (INACAL, signed in 2017), the Plurinational State of Bolivia's Instituto Boliviano de Normalizacin y Calidad (IBNORCA, signed in 2017), Costa Rica's Instituto de Normas Tcnicas de Costa Rica (INTECO, signed in 2016), the American National Standards Institute (ANSI, renewed in 2018), Mexico's Direccin General de Normas (DGN, renewed in 2018), the United Kingdom Accreditation Service (UKAS, signed in 2017), the Standards Administration of China (SAC, renewed in 2016), and the Korean Agency for Technology and Standards (KATS, signed in 2018)

3.157.  The SCC also has a bilateral Cooperation Agreement with the European co-operation for Accreditation (EA) to facilitate the implementation of the Protocol on the Mutual Acceptance of the Results of Conformity Assessment within the CETA. The SCC also has a joint Cooperation Agreement with the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) and has CEN Companion Standardization Body membership.[252] In addition, the SCC is a signatory to a number of voluntary accreditation agreements, including the International Accreditation Forum (IAF), the Asia Pacific Accreditation Cooperation (APAC), and the Inter-American Accreditation Cooperation (IAAC)

3.158.  The SCC also examines standardization policy issues, both national and international in scope. This includes examining standardization and gender, such as women's rates of participation on technical committees as compared to sectoral labour rates, and the provision of policy guidance on how to effectively incorporate standards by reference in federal, provincial, and territorial regulations to achieve various public policy objectives.[253]

3.159.  The development of technical regulations in Canada is decentralized; they are established by several federal and provincial authorities. At the federal level, the development of technical regulations must follow the Cabinet Directive on Regulation and the Policy on Regulatory Development, which apply to all federal departments, agencies, and entities over which the Cabinet has either general authority or a specific authority relating to regulation making

3.160.  The Cabinet Directive on Regulation, which entered into force on 1 September 2018 and replaced the Cabinet Directive on Regulatory Management of 1 May 2012, sets out the Government of Canada's expectations and requirements in the development, management, and review of federal regulations. The Directive sets four guiding principles of federal regulatory policy: a) regulations must protect and advance the public interest and support good government; in this sense, regulations are justified in terms of protecting the health, safety, security, social and economic well‑being of Canadians, and the environment; b) the regulatory process must be modern, open, and transparent: regulations must be accessible and understandable, and must be created, maintained, and reviewed in an open, transparent, and inclusive way that engages the public and stakeholders early on; c) regulatory decision-making must be evidence-based: there must be an analysis of the costs and benefits, and the assessment of risk, while being open to public scrutiny; and d) regulations must support a fair and competitive economy: they should aim to support and promote inclusive economic growth, entrepreneurship, and innovation for the benefit of Canadians and businesses. Opportunities for regulatory cooperation and the development of aligned regulations should be considered and implemented wherever possible.[254]

3.161.  The Directive requires departments and agencies to examine and analyse regulations through all stages of their life cycle, including: the development of regulations, regulatory management, and review and results. It also requires that, during all stages of the regulatory life cycle, regulators seek opportunities to engage stakeholders (including Indigenous Peoples), pursue regulatory cooperation and regulatory alignment where appropriate, and coordinate with all levels of government to minimize cumulative and unintended impacts of regulations on Canadians, businesses, and the economy

3.162.  With respect to the development of regulations, the Directive mandates that, at the beginning of the regulatory life cycle, departments and agencies determine the approach to address an issue, set objectives, undertake consultations with stakeholders, and analyse the risks, impacts, and costs and benefits of a regulatory proposal.[255] The scope and depth of analysis required for regulatory proposals depends on the cost component of each proposal. In general, the greater the estimated cost of the proposal, the more comprehensive the analysis of benefits and costs must be, and the greater the effort required to undertake this analysis

3.163.  Departments and agencies must conduct a Regulatory Impact Analysis (RIA) on all regulatory proposals. The RIA must identify and assess the potential positive and negative effects and implications of a regulatory proposal for consideration by the public, stakeholders and the Cabinet. Regulators must demonstrate that the benefits to Canadians outweigh the costs. To this end, the departments and agencies must conduct an early assessment, known as a triage, of a regulatory proposal, to determine its expected impact level and the appropriate mix of analytical requirements. During the triage, proposals are categorized according to their expected level of impact, which is determined primarily by the anticipated cost of the proposal.[256] In the case of federal regulatory proposals, benefits and costs can be described in one of three ways: qualitative; quantitative; or monetized. An analysis of monetized benefits and costs is required for all "significant" regulatory proposals, that is, with an expected high or medium impact. If a regulatory proposal identifies environmental considerations, regulators must provide the scope and nature of the likely effects on the environment (positive and negative), describe in the Regulatory Impact Analysis Statement (RIAS) the outcomes of consultations with the public about environmental impact, and describe in the RIAS how the implementation plan would deal with issues identified. If the regulatory proposal is not likely to have environmental effects, regulators must describe in the RIAS the activities they undertook to ascertain that no environmental effects are expected.[257]

3.164.  As per the Directive, federal authorities should take into account potential opportunities for incorporation by reference of internationally-accepted standards and/or regulations or other appropriate instruments. Departments and agencies should explain in the RIAS why the technique is being used and how it achieves their regulatory objectives. Departments and agencies must submit a regulatory proposal to be considered by the Treasury Board (Governor in Council), or the relevant regulation-making authority, for pre-publication in the Canada Gazette, Part I. Pre-publication of a regulation must include the draft regulatory text as well as a RIAS. The standard comment period following pre-publication is 30 days, unless otherwise prescribed by legislative requirements and/or international obligations. A minimum comment period of 70 days may be required for consultations on proposals for new and amended technical regulations that may have a significant effect on international trade. Upon approval by the Treasury Board, the Governor General signs the regulation, and the Registrar of Statutory Instruments registers it. Regulations enter into force immediately after registration, or on a day specifically stipulated. The Regulation can only be enforced once published in the Canada Gazette Part II. Such publication must take place within 23 days of registration

3.165.  The Report to Parliament on federal regulatory management initiatives for FY2017/18 shows that 184 Governor in Council (GIC) regulations were finalized between 1 April 2017 and 31 March 2018. Of these 184 GIC regulations (compared with 189 in FY2016/17), 166 were low-impact and 18 were "significant", meaning that they had annual national costs greater than CAD 1 million. The significant regulations accounted for 9.8% of the GIC regulations finalized in FY2017-18, which is consistent with figures for previous years. Of these 18 regulations, 15 had monetized benefits and costs, 2 had monetized costs only, and 1 had quantified costs and benefits. The total monetized cost associated with significant regulations was CAD 4.4 billion, while the total monetized benefit associated with them was CAD 8.5 billion; this gave a monetized net benefit of CAD 4.1 billion. The regulatory changes that had the greatest net monetized benefits in FY2017/18 were: the Regulations Amending the Ozone-Depleting Substances, and the Halocarbon Alternatives Regulations, with a cumulative net benefit of CAD 3.725 billion (net present value) from 2018 to 2040; the Regulations Amending the Immigration and Refugee Protection Regulations, with a cumulative net benefit of CAD 115.3 million from 2017 to 2026; and the Regulations Amending the Off-Road Small Spark‑Ignition Engine Emission Regulations and Making a Consequential Amendment to Another Regulation, with an estimated net benefit of CAD 107.6 million (net present value) from 2019 to 2032. Significant proposals must demonstrate that the expected benefits are greater than the expected costs. However, this determination is based on non-monetized quantitative and qualitative analysis, in addition to monetized analysis. In FY2017/18, three significant proposals had monetized costs that were equal to monetized benefits, and another three had monetized costs that exceeded monetized benefits.[258]

3.166.  Among the technical regulations that had monetized benefits and costs identified in FY2016/17, and presented main benefits are: the Energy Efficiency Regulations, 2016, for which a cumulative net benefit associated with it was estimated at CAD 1.394 billion (net present value) to 2030, and the Multi-Sector Air Pollutants Regulations, for which a net benefit of approximately CAD 6.436 billion was estimated to 2035

3.167.  Amendment 13 to the Energy Efficiency Regulations, published in December 2016, reported a cumulative net benefit of CAD 1.46 billion through 2030. An October 2018 amendment was proposed that would bring the value up to CAD 1.80 billion by 2030.[259] The proposed amendment to the Energy Efficiency Regulations (the Amendment) would introduce or update minimum energy performance standards, testing standards, and reporting requirements to improve the energy efficiency of 12 heating and ventilation product categories. The Amendment would affect residential and commercial product categories, four of which are currently regulated federally

3.168.  Although Canada does not maintain a catalogue of technical regulations, the Canada Gazette's Consolidated Index of Federal Statutory Instruments includes (but does not specifically categorize or indicate) technical regulations

3.169.  During the period under review, Canada has continued to regularly notify its draft technical regulations, ordinances, and conformity assessment procedures to the TBT Committee. During the 2015-18 period, Canada submitted 210 notifications, including corrections and appendices. Of these, 141 were new technical regulation notifications.[260]

3.170.  Since 2015, only one specific trade concern (STC) was raised in the TBT Committee, regarding Canada's Tobacco Reduction (Flavoured Tobacco Products) Amendment Act, 2013. However, also since 2015, Canada raised 61 STCs in the TBT Committee regarding technical regulations by other Members, until end 2018.[261] The concerns raised covered a broad range of issues across multiple industry sectors

3.171.  Conformity assessment procedures to ensure compliance with technical regulations are generally specified in each technical regulation. Canada can accept first-, second- or third-party conformity assessments, depending on the product. In some cases, it is a regulatory requirement that the certifying body or person is accredited by the SCC and/or is recognized under an MRA or a multilateral agreement (MLA). The type of certification accepted also depends on factors such as risks and the particular characteristics of the sector. When third-party conformity assessment is used, regulatory authorities rely mostly on conformity assessment bodies accredited by the SCC, whose criteria are based on ISO/IEC standards, and include additional requirements to fulfil the needs of Canadian regulatory authorities. Third-party conformity assessment is used in a number of product areas, including electrical safety, and construction products. Canada uses suppliers' declaration of conformity for motor vehicles, electromagnetic compatibility, and some telecommunications products. The regulatory authorities are directly responsible for conformity assessment for certain products (e.g. pharmaceutical products and medical devices)

3.172.  According to the authorities, the underlying principles of conformity assessment in Canada, are that it: a) contributes to safeguarding public health, the environment and public safety; b) is based on international standards, agreements and protocols without undue national bias; c) upholds the WTO Agreement on Technical Barriers to Trade (TBT), and avoids creating unnecessary obstacles to trade; d) operates in an explicit, credible, and transparent manner, and is accessible, equitable and fair in its treatment of all users; e) delivers services in a timely and professional manner, in accordance with an accepted code of ethics; f) makes information regarding conformity assessment requirements, accreditation procedures and results publicly available (activities are conducted with due regard to confidentiality while ensuring full disclosure of conformity assessment results to regulatory authorities, as required); and g) is inherently voluntary; however, marketplace demands and/or government regulation may mandate specific conformity assessment requirements.[262]

3.173.  The SCC is Canada's national accreditation body. SCC accredits conformity assessment bodies (CABs), such as testing laboratories and product certification bodies, to internationally recognized standards. The SCC offers the following accreditation and recognition programmes: management systems certification bodies; product, process and service certification bodies; inspection bodies; greenhouse gas validation/verification bodies; bodies performing the certification of persons, testing and calibration laboratories; medical testing laboratories; and, proficiency testing providers. In addition, the SCC offers two non-ISO-based accreditation programmes: the SCC serves as Canada's monitoring authority for recognition of OECD good laboratory practices (GLP) and the SCC accredits standards development organizations

3.174.  The SCCs accreditation services include accrediting organizations directly, such as laboratories, as well as accrediting organizations that certify others' conformity to specific standards. Certification bodies are accredited on a fee-for-service basis. In December 2018, there were 34 accredited product, process and service certification bodies (including U.S.-based bodies), more than 350 testing organizations, and 22 management systems certification bodies (including foreign-based bodies)

3.175.  The SCC's Accreditation Services branch delivers accreditation services to Canadian customers working in Canada and abroad, and to international customers doing business in Canada. The SCC is a signatory to the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC), the Asia Pacific Accreditation Cooperation (APAC), and the Inter‑American Accreditation Co-operation (IAAC)

3.176.  The SCC accredits various types of testing laboratories, including: food testing, drinking water testing, environmental sample testing; mineral testing; and materials testing laboratories. It also accredits quality, environmental, energy, food safety, and occupational health and safety management systems. The SCC accredits electrical, fire protection, safety equipment, energy-efficient, and mobile home component product certification, as well as electrical systems, medical gas piping systems, and commercial gas-fired appliance inspections

3.177.  The accreditation of calibration laboratories is the shared responsibility of the SCC and the National Research Council Canada's (NRC) Calibration Laboratory Assessment Service (CLAS). The CLAS programme provides quality system and technical assessment services, and certification of specific measurement capabilities of calibration laboratories in support of the Canadian National Measurement System. Eligibility for CLAS certification is required for SCC accreditation of calibration laboratories. The CLAS maintains a Directory of Accredited Calibration Laboratories, providing a network of calibration laboratories to ensure clients across Canada have access to calibration services with certified traceability to national and international measurement standards. Calibration laboratories certified by the CLAS offer measurements traceable to the International System of Units (SI).[263] The calibration laboratories that are certified by the CLAS and accredited by the SCC are recognized by over 50 accreditation systems worldwide

3.178.  In its role as the national standards laboratory, the NRC maintains close ties with the Bureau International des Poids et Mesures (BIPM) and a number of other international organizations, such as the Inter-american Metrology System (SIM), the ILAC, and the IAAC, as well as the national laboratories of other countries

3.179.  In addition to the SCC, the following bodies play a role in Canada's standardization and accreditation system: the ISED; Measurement Canada; the Telecommunications Standards Advisory Council of Canada (TSACC); the NRC; the Metrology Research Center; and the National Institute for Nanotechnology (NINT)

3.180.  The SCC is a member of a number of organizations that have MRAs in place to assist with international acceptance of conformity assessment results. Canada participates in a number of conformity assessment international agreements. (Table A3.3)