ARCHIVED - Exploring the Future of the Food Regulatory Framework Under the Food and Drugs Act

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Purpose and Scope

  • To stimulate a discussion about how to modernize Canada's regulatory framework for food under the Food and Drugs Act
  • Focus is on the possible framework for a future regulatory structure, including:
    • Health Canada's role in food safety and how best to operationalize that role
    • Points of alignment with CFIA regulatory modernization
    • Potential vision and principles
    • The ways in which modernized regulations may be developed
    • An overview of a phased plan
  • Intended to:
    • Be part of a multi-stage engagement with stakeholders on food regulatory modernization
    • Help shape a discussion paper that would serve as the basis for structured consultations

A new framework for foods established in its own set of regulations would introduce significant revision to the existing Part B to streamline and render more efficient and transparent the regulation of such things as food additives, contaminants, and the fortification of foods. Given the mixed provisions between safety oversight and the standardization of foods, consideration will be given to untangling the two in the standard food provisions.

Regulatory Roadmap for Health Products and Food

Context: A Time of Significant Change

  • Evolving regulatory landscape, domestic and global:
    • Health and safety issues, threats
    • Product innovation, technology, globalization
    • Evolving science
    • Consumer trends
    • Actions taken by other jurisdictions, trade/market access issues
  • GoC Regulatory Reform agenda:
    • Red tape reduction initiatives
    • Regulatory Cooperation Council
    • Cabinet Directive on Regulatory Management

Health Portfolio Initiatives:

  • HPFB Regulatory Roadmap
  • New FDA legislative authorities - Marketing Authorization (MA) and Incorporation by Reference (IbR):
    • Modernized food additive and veterinary drug residue systems
  • Transition of foods formerly marketed as NHPs
    • Supplemented foods, energy drinks
  • The CFIA change agenda (agency transformation, inspection modernization, etc.)
  • Safe Foods for Canadians Act, Food Labelling Modernization initiative
  • The CFIA joins the Health Portfolio
  • Healthy and Safe Foods for Canadians Framework
  • Speech from the Throne, October 2013 – nutrition labelling
  • Budget 2014 – food safety investments and modernize food standards

Health Canada's Role in Food Safety

  • Health Canada's mandate: help Canadians maintain and improve their health
  • In fulfilling this mission, as the federal standard-setting body, Health Canada:
    • sets standards related to food safety and nutritional quality;
    • conducts risk assessments and other scientific assessments; and
    • provides information and advice to the public and others.
  • Compliance and enforcement of federal standards is the responsibility of the CFIA
  • To support its standard-setting, risk assessment, and informational roles, Health Canada also conducts:
    • scientific research; and
    • post-market surveillance.

Food and Drugs Act's Food Regulatory Framework

  • Most food products are considered safe, can go directly to market
  • Requirements set out in FDA/FDR with rules of general application:
    • Rules apply to entire food industry – manufacturers know what can be added to, said about, or done to foods:
      • In this sense, federal oversight occurs mostly after foods are on market
      • "Post market" surveillance and enforcement based upon FDA/FDR, policy and guidance
  • Many rules are "enabling". However:
    • Prescriptive/mandatory rules are also established in regulations (e.g., compositional standards, mandatory fortification rules, nutrition labelling for prepackaged foods)
    • Prohibitive frameworks/rules used in some cases (e.g., contaminants/adulterants)
  • Two types of pre-market review:
    • Leading to enabling rules of general application (e.g., additives)
    • Leading to letters of no objection (e.g., novel foods), TMALs, or voluntary opinions (e.g., some health claims)

From Mandate to Practice, Evolving Over Time

  • Health Canada's role is generally well-defined and stable over time, but it is important to consider, on a regular basis, the operationalization of that role
    • Relative level of focus/effort in different areas
    • Decisions about level of oversight on specific issues; and
    • Instrument choice
  • Stakeholders regularly engage Health Canada on its role; for example:
    • Advocating for a greater reliance on international standards in setting our own;
    • Seeking increased or decreased oversight over health claims;
    • Considering the federal role in evaluating efficacy (vs. safety); or
    • Calling for a more active federal role in food safety and nutrition "myth-busting".
  • HC continually assessing activities/operations against role, environment, resources
    • Business transformation must go hand-in-hand with regulatory modernization
    • Critical to align capacity/tools with mandate/priorities, with a view to establishing a sustainable operating position well-aligned to the evolving landscape and future needs

Regulatory Challenges

  • The food regulatory structure has been developed over the past 50 years, accounting for the various needs and shifting priorities of the population over that period
  • The subject matter and scope of the regulations is broad, including:
    • what substances can be in/on food
    • what you can say about food
    • elements of food production/processing/treatment; and
    • formulation/composition/identity of foods
  • FDR have served Canadians well; however, having been built incrementally:
    • have become challenging to interpret and understand
    • are increasingly out of date
    • are generally not constructed/drafted as regulations would be today

Moving Forward

Click on image for larger view
Image - Translating the regulatory roadmap into a food context. Description follows.

Description for Image - Translating the regulatory roadmap into a food context

A large image illustrating the objectives, principles and possible critical elements for moving forward with the modernization of the food regulations current under the Food and Drug Regulations. The image consists of a combination of two squares and two rectangles. A rectangle at the top and bottom with two squares in between.

The top rectangle is blue and titled "Translating the regulatory roadmap into a food context". Within it is the following text: A sustainable, internationally aligned food regulatory framework – built on rules of general application – that protects Canadians and is responsive to new science, emerging issues, and innovation. Immediately below the blue rectangle are two squares, the one on the left titled "Objectives" and the one to its right titled "Principles". The "Objectives" square includes four bullets which read: Enhance protection and promotion of human health; Be flexible and responsive to emerging food safety and nutrition challenges; Support industry innovation; and Reduce red tape and minimize unnecessary delays in bringing safe food to the marketplace.

The "Principles" square includes four bullets which read: Based on the best available science; Proportional risk-based oversight that balances benefits, harm, and uncertainty; Efficient; and Consumer focused, supporting informed choice.

The last rectangle is green and is located at the very bottom of the image, below the Objectives and Principles squares. It is titled "Possible Critical Elements" and includes three sub-themes which are: Efficient, flexible, and responsive; Clear and Coherent; and Transparent, Open and Accountable.

The "efficient, flexible and responsive" sub-theme includes five bullets which read: Use of rules of general application; Efficient, timely creation and maintenance of rules; Outcome based / less prescriptive; Modernize standards of composition and identity; and International alignment/regulatory cooperation. The "clear and coherent" sub-theme includes two bullets which read: Simplify - regulate like things in like ways; and Eliminate duplication and inconsistencies.

The final sub-theme - "transparent, open, and accountable" - includes three bullets which read: Open, transparent decision-making processes; Guidance and policy clarity (regulatory status); and Gaps between actual and perceived oversight

Efficient, Flexible and Responsive

  • Use of rules of general application
    • Most foods governed by rules of general application, with post-market oversight
    • Avoids need for time-intensive and burdensome approval processes
    • Scope for greater use of rules of general application, positive/negative lists
  • Efficient, timely creation and maintenance of rules
    • Regulatory process has not always allowed for timely updates to reflect advances in science, innovation, or emerging risks
    • MA and IbR can, where appropriate, render rule-making more efficient (e.g., IbR of low-discretion, scientific information requiring frequent or regular updates)
  • Outcome-based / less prescriptive
    • Prescriptiveness sometimes necessary/appropriate, but can also create undue burden and lead to more frequent regulatory changes than necessary
    • Less prescriptive, outcome-based rules increase flexibility, but maintaining clear, reliable information (and consistent interpretation, together with CFIA) critical
  • Modernize standards of composition and identity
    • Standards increasingly out of date, difficult to update, and – in some cases – duplicative with other parts of FDR/SFCA-associated regulations
    • Makes it difficult for companies to keep pace with global market developments and can restrict consumer access to product choice and even health benefits
    • Will work closely with CFIA to modernize, giving strong consideration to alternative models, use of IbR, and untangling health/safety vs. other provisions
  • International alignment and regulatory cooperation
    • Considering diet/exposure critical in standard-setting for Canadian population
    • But better use could be made of collective international resources, and lack of alignment can lead to trade impediments, missed health/safety opportunities
    • Scope for increased cooperation – based on science – including through mutual recognition, greater adoption/use of trusted standards, joint processes

Clear and Coherent Regulatory Structure

  • Simplify – regulate like things in like ways:
    • Scope of FDR is broad; requirements are interrelated, complicated, and contain (unnecessary) inconsistencies
    • Often challenging to interpret and understand, leading to increased industry burden and legal complexity and risk
    • Will be important to simplify the structure of regulations, consolidating related subject matter and regulating "like" things in "like" ways, wherever appropriate
  • Eliminate duplications and inconsistencies
    • Over time, duplication and inconsistency have progressively appeared across FDR
    • Duplication and inconsistency lead to lack of clarity regarding provisions and their enforcement, administrative burden for industry
    • Work required within FDR and between FDR and SFCA regulations, with the CFIA

Transparent, Open and Accountable

  • Open, transparent (O&T) decision-making processes
    • O&T a priority for government, portfolio, department
    • Measures will include O&T frameworks/policies, guidance on new authorities (some joint with CFIA), expanded publication of scientific rationales supporting regulatory decisions, plain language/consumer-friendly approaches
  • Guidance and policy clarity (regulatory status)
    • Some requirements for sale of foods in Canada found in policies/guidance
    • Policies and guidance documents do not necessarily have the force of law
    • Greater clarity required regarding regulatory status of decisions/advice, using new authorities where appropriate
  • Gaps between actual and perceived oversight
    • Gaps between the actual level of government oversight and the perceived level of oversight by consumers (and potentially stakeholders) require management

What Comes Next?

  • Continued engagement, expanded/formalized guidance
  • Parallel, interconnected work on operations/business transformation, sustainability, O&T
  • Structured consultation on discussion paper
  • Phased, multi-year regulatory modernization as per the broader Roadmap:
    • Building on food additives modernization, scope to use new authorities for other substances and health/nutrition claims
    • Align with CFIA efforts and, to extent possible, with other Health Products and Food Branch product line plans
    • Subject to evolving priorities, capacity, and other factors

Regulatory reform as a large and comprehensive change to the health products and food regulatory systems […] cannot be accomplished all at once. A well-planned approach separated into several phases is necessary to achieve the objectives and minimize the impact to current operations while making best use of the finite resources available […] Consideration must also be given to the transition required by all stakeholders […]

Regulatory Roadmap for Health Products and Food

Modernized Food Framework: A Phased Plan

Click on image for larger view
Image - Modernized Food Framework: A Phased Plan. Description follows.

Description for Image - Modernized Food Framework: A Phased Plan

Large image illustrating Health Canada's phased plan for the modernization of the food framework. The image consists of three blue columns, titled from left to right: "Early 2014-15"; "Medium 2016-17"; and "Late 2018".

Each blue column contains a number of golden boxes. Four under the "Early 2014-15" column, three in the form of arrows under the "Medium 2016-17" column column and one large text box under the "Late 2018 -" column.

Under the "Early 2014-15" column, there are four golden boxes titled in descending order: SFT/Budget Commitments; Modernization/New Tools; Specific Food Safety Measures; and Interim Positions. Each box contains text relevant to the title of the box.

In the SFT/Budget Commitments text box, there are two bullets which read: Improving nutrition labelling*; and standards modernization*. In the Modernization/New Tools text box, there are also two bullets which read: Additives (regulatory "clean up", Marketing Authorization for Food Additives With Other Generally Accepted Uses); and Fortification (address loss of IMA)

In the Specific Food Safety Measures text box, there is a single bullet which reads: Such as Mechanically tenderized beef* labelling regulations

The last box under the "Early 2014-15" column, titled Interim Positions, reads as follows: Interim Positions on topics such as supplemented foods

Under the second "Mid 2016-17" column, there are three boxes in the shape of arrows pointing to the right. The first box, which is adjacent to the golden box titled SFT/Budget Commitments in the first column, includes two bullets which read: Evaluate Temporary Marketing Authorization data/research; and Develop supplement foods regulatory proposal.

The second box immediately below the first is adjacent to the golden box in the first column titled Modernization/New Tools. This box reads: Ongoing modernization initiatives and implementation. The final box in the second column is titled "Policy Reviews" and reads as follows: Policy Reviews in such areas as packaging, incidental additives, and processing aids*; novel foods; methods*; and special dietary foods.

The third and final blue column titled "Late (2018-)" includes a single large golden text box. This text box is titled "Modernized Framework*" and in it are three bullets which read: Consolidated food regulations (one "Part"); Convergence of changes; and Sustainable tools/capacity to address specific regulatory issues on an ongoing basis.

* = particularly strong CFIA linkage / imperative for alignment

Discussion Questions

  • Are there ways in which you feel Health Canada could more effectively carry out its food safety mandate or operationalize and balance its various roles in this area?
  • Have we accurately characterized the challenges and opportunities associated with the current regulatory framework?
  • Have we identified the correct "critical elements" of a future regulatory structure ? Did we miss any?
  • Which component(s) of our regulatory modernization efforts do you consider to be the most urgent / highest priority?

Annex 1: New Authorities – MA Fundamentals

  • Enables the Minister to implement certain food safety decisions through a streamlined ministerial regulatory process
  • Scope of MAs clearly defined in the Act:
    • MAs can exempt from the FDA and associated regulations
      • Cannot be used to set prohibitions
      • Subject matter: claims, substances
    • MAs can establish classes
    • MAs can set conditions; and
    • MAs can incorporate documents by reference
  • Subject to provisions of the Statutory Instruments Act (SIA) and to principles of the Cabinet Directive on Regulatory Management (CDRM)

Notes:

  • Interim Marketing Authorization (IMA) replaced
  • TMAL remains (distinct purpose and application)

Annex 2: New Authorities – IbR Fundamentals

  • Enables the incorporation by reference of documents maintained by GoC or other parties
    • May include documents that are amended "from time to time" (ambulatory incorporation)
    • Documents must be accessible
  • Documents can be incorporated via an MA or GiC regulation
    • They may then be amended administratively, as needed, as opposed to requiring regulatory amendments
    • But establishing an incorporation always requires a regulatory decision and associated checks and balances
  • Incorporated documents have the force of law
  • Due process remains (e.g., science, consultation/notification)

Annex 3: TMAL Fundamentals

  • TMAL is a letter issued by Health Canada which allows for:
    • the temporary sale of a non-compliant food in Canada
    • for a limited period of time
    • under specified conditions
    • for the purposes of collecting data in support of a regulatory amendment (GIC or MA) to the FDR
  • In order to obtain a TMAL, a manufacturer or distributor must provide the requested information (B.01.054 of the FDR)
  • MA vs. TMAL
    • The MA is a regulatory tool that may be used by the Minister to implement certain food decisions.
    • A TMAL is a letter issued by Health Canada to a food company granting it temporary market access.

Acronyms

  • CFIA: Canadian Food Inspection Agency
  • FD: Food Directorate
  • FDA: Food and Drugs Act
  • FDR: Food and Drug Regulations
  • GoC: Government of Canada
  • HC: Health Canada
  • HPFB: Health Products and Food Branch
  • IbR: Incorporation by Reference
  • MA: Marketing Authorization
  • NHP: Natural health product
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