Regulatory Modernization Colleen Barnes Executive Director Food Regulatory

Regulatory Modernization Colleen Barnes, Executive Director, Food Regulatory Modernization, CFIA Canadian Meat Council May 8, 2014 © 2011 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission is prohibited.

Purpose To provide an overview of the Agency’s transformation agenda Why are we doing this? o Globalization and industry consolidation o Shifting consumer landscape – aging population and increasing expectations o Evolving production and processing technologies o Emerging pathogens and diseases o Increased knowledge of risk and systems-based approaches o Advances in science and technology o Modernization initiatives of trading partners 2

Safe Food for Canadians Act • The Safe Food for Canadians Act (SFCA) received Royal Assent in 2012, providing the legislative base to simplify and consolidate our regulations and make them outcome-based with common requirements across commodities • A discussion document entitled “A New Regulatory Framework for Federal Food Inspection” was released in June 2013 for broad consultation; the document posed a number of policy questions for consideration. The document consultation period was open until November 30, 2013 • External consultations included; – Engagement of over 1200 individual external stakeholders via webinars – Around 3400 industry and consumer representatives were engaged q 78 responses to questions posed in June 3

• The SFCA provides the legislative base to simplify and consolidate three CFIA inspection statutes and 10 corresponding regulations… Meat Inspection Act (1) Fish Inspection Act (1) Consumer Packaging and Labelling Act (1) Canada Agricultural Products Act (10) Applies to dairy, egg, fresh fruit and vegetables, maple and honey products marketed through import, export and interprovincial trade … With a single set of food inspection regulations that apply to all food imported, exported and prepared for inter-provincial trade. Meat Inspection Act (1) Fish Inspection Act (1) Consumer Packaging and Labelling Act (1) Canadian Agricultural Products Act (10) Applies to dairy, egg, fruit, vegetable, maple and honey products marketed through import, export and interprovincial trade • The Food and Drugs Act (FDA) continues to apply to all food sold in Canada, as do other CFIA statutes related to plant and animal health. 4

What we Heard • Strong support for approach: Single food regulation, licensing, preventive control plans and HACCP approach • Strong support for outcome-based regulations, provided: – guidance documents are clear, easily accessible (ideally through searchable IM/IT system) and up-to-date; and – inspectors are well trained and interpretation is consistent • Strong support that imported food having to meet the same regulatory requirements as domestic food – significant resistance to Canadian address requirement (e. g. Many importers operate based in US) • Disclosure of information - General support in the case of suspension, cancellation, recalls – concern that disclosure of inspection results and Corrective Action Requests will provide an advantage for competitors and undermine confidence in the system (consumers would not understand the nature of the non-compliance) 5

What we Heard • Strong support from Fresh Fruit and Vegetable sector for: New food safety requirements; pleased that Canada. GAP will be a model system; – Requirement for membership in the Dispute Resolution Corporation (to replace License and Arbitration Regulations; was a Canada/US Regulatory Cooperation Council priority); – Outcome-based regulations that reflect CODEX seen as a potential basis for harmonization; and – Importance of federal/provincial/territorial regulatory harmonization. – • Federal-Provincial-Territorial: – Particular interest in harmonization with respect to traceability. • Small and Medium Enterprises: – Some may still be unaware of CFIA requirements and may benefit from information on potential food safety hazards; – Developing a targeted implementation strategy, possibly including a “food safety basics” campaign; and – Some associations advocated “no exemptions” for small businesses because food risk/hazards are not dependent on size of operation. 6

Safe Food for Canadians Proposed Regulations • Elements of new the regulatory approach Safe Food for Canadians Regulations Licensing and Licensing Elements Food Safety Requirements and Elements Preventative Control Plan (PCP) Commodity Specific Requirements Target for Canada Gazette I – December 2014 and Canada Gazette II – June 2015 7

Horizontal Food Safety Requirements Licensing requirements • Everyone who imports, prepares, manufactures or packages food for inter-provincial trade will require a licence (prescribed conditions for export licence) • Most licence holders will require a preventive control plan that demonstrates how requirements are being met • Ability to suspend and cancel licenses Food Safety and Preventive Controls • Move, where possible, from prescriptive commodity-specific rules to outcome-based provisions that reflect CODEX standards, including HACCP and good manufacturing practices Ø will provide flexibility to introduce new technologies and processes that could enhance safety and/or reduce costs • Most licence holders will require a preventive control plan that demonstrates how requirements are being met 8

Food Safety Elements • Requirements would be imposed on specified regulated parties and would constitute baseline food safety requirements to be met during the manufacturing, preparing, storing, packaging and labelling of a food commodity, including: Ø Products and processes; Ø Sanitation, pest control and sanitizers, and detergents and other chemical agents; Ø Hygiene and competencies; Ø Equipment to be used in an establishment; Ø Physical structure and maintenance of the establishment; Ø Receiving, transportation and storage; Ø Investigation and notification, complaints procedure and recall procedure 9

Traceability • Anyone who imports, exports or prepares food commodities for interprovincial trade will be required to maintain traceability records • Requirements for maintaining records “One step forward, one step backwards” (Codex standard), to every stage of food supply chain under federal jurisdiction • Documents must be provided on request in a format which can be imported and manipulated for recall purposes by standard commercial software, or if in paper form, legible without external aids • It is not required that this information be kept in Canada but that it is accessible and can be provided upon request through a desktop audit • The regulations establish a minimum requirement -- CFIA continues to encourage individual businesses and sectors to enhance their traceability and record-keeping systems beyond these minimum requirements. 10

Commodity Specific Provisions - Meat • The following outlines examples of some requirements intended to be maintained in the proposed regulations: • Requirements for ante and post-mortem inspections • HACCP provisions and other requirements of the FSEP Manual, likely through continued use of incorporation by reference • Humane handling and slaughter of food animals in establishments • Provisions related to water use and re-use to cover the possibility of using safe water in lieu of potable water under specific circumstances, provided no impact on food safety and suitability • Inedible meat products (e. g. pharmaceutical, for education, for research) requirements related to identification and controls • Handling of Specified Risk Material SRM (denaturing/staining) 11

International Engagement- Meat Issues • International engagement targeting other competent authorities geared specifically to meat is a priority. • Messaging will serve to reassure trading partners that commodity specific provisions under development for meat will respect existing agreements and mandatory HACCP applies. • Engagement will be undertaken through: – Established/existing forums (e. g. RCC, QUADs, USDA-FSIS, Canada- AQSIQ Food Safety Working Group); – Canadian Posts Abroad; – Educating visiting auditors and delegations. • Engagement with US counterparts is ongoing. 12

Guidance Documents & Model Systems CFIA currently has over 250 food manuals (over 44, 000 pages). These will be replaced to align with new legislative authorities to: • Ø Provide sufficient information for industry to understand their obligations Ø Include models systems (non-binding guidance) to assist industry to comply Ø Develop verification procedures/tasks that form an integral part of the new CFIA Compliance Enforcement Strategy Ø Use a standardized format and “plain language” Ø Clearly link to regulatory provisions 13

Compliance Promotion • Compliance promotion is defined as any activity that increases awareness, informs, motivates, or changes behavior, and encourages compliance with a regulatory requirement • First step for regulated parties to achieve compliance is for them to understand their obligations and how best to meet them • As the Agency moves towards an improved inspection model and updated regulations for food, information and guidance will be key to success • There also opportunities for industry, their associations and other interested third parties (e. g. academia, non-government organizations) to play significant role in assisting regulated parties to achieve compliance • Ultimate outcome is that the food safety system is strengthened through better public health outcomes, the generation of efficiencies and the ability to target enforcement efforts 14

Additional Regulatory Modernization Initiatives Proposed Imported Food Sector Product Regulations (IFSPR) • Enhanced management of food safety issues and incidents • Greater awareness and oversight of the sector • Increased consumer trust in safety of Canadian food supply • First stage of the CFIA’s food regulatory modernization agenda Food Labelling Modernization • Develop a modern and innovative food labelling system within the context of CFIA’s priorities and vision and which aligns with the SFCA and that – Provides a better understanding of roles and responsibilities and continuous improvement as it relates to partnerships with other government departments such as Health Canada and with consumers and industry – Appropriately responds to consumer and industry needs around food labelling within CFIA’s mandate – Promotes smarter regulations and risk-based oversight by Government – Improves service delivery such as in relation to inquiries and availability of labelling information and tools 15

Outcomes Canada’s Modernization Agenda • A food safety system capable of continuous improvement based on science, global trends and best practices and be: Ø able to deliver better protection from food safety risks for Canadians; Ø focused on science-based and risk-based prevention and control of potential hazards as well as robust and responsive; Ø transparent so consumers can play their role and so industry understands obligations; Ø internationally consistent and harmonized wherever possible; Ø enabled with best available skills tools and technology to efficiently provide regulatory services to industry; and, Ø outcome-based whenever possible and assessed regularly to verify that outcomes are achieved and that systems are functioning well. 16

Next Steps Spring 2014 • Draft content of transformational SFCA food inspection regulations made available • Examples of guidance documents for industry Late Fall 2014 • Pre-publication of the SFCA regulations in Canada Gazette, Part I Mid-2015 • Target for new Food Inspection Regulations to Come into Force 17

Feedback By email: CFIA-Modernisation-ACIA@inspection. gc. ca By mail: Strategic Partnerships Division 1400 Merivale Road, Tower 1 Floor 6, Suite 218 Ottawa, ON K 1 A 0 Y 9 Canada Attn: Food Safety Regulatory Forum By fax: 613 -773 -5606 18