1. Modernization of Health Canada Food Frameworks Foundations for Change Presentation to the Canadian Health Food Association June 20 2012 1

2. 2 Today’s presentation Responding to the need for change Proposed Direction How will these be implemented? Building for the future 2

3. 3 Responding to need for change Food and Drugs Act and Regulations have served Canadian consumers and industry well for over 50 years Modernization needed so that Canadian frameworks can continue to address the food safety demands of 21 st century effectively and efficiently Consider the complete suite of elements: Tools Policies Processes 3

4. 4 Responding to need for change Key area for action: Tools available to act on food safety decisions Currently, once Heath Canada scientists have made a safety decision it can take months or years to implement the decision through regulatory amendments – ex –Allowing use of a new food additive or addition of vitamin or minerals to a food –Setting a limit of chemical contaminants –Approving new health claims 4

5. 5 Responding to need for change These delays Leave some food safety standards out of date, out of step internationally Limit access to safe innovative products for Canadians Limit governments responsiveness to new science Make an unpredictable business environment for industry Identified as a priority area for food regulatory modernization by government, stakeholders, in Red Tape discussions 5

6. 6 Responding to need for change B udget 2012 (March 29 2012) pg 168 “plans to streamline and accelerate the process by which foods are regulated” Objective: new tools that will  Reduce delays,  Cut red tape and enable risk based approaches  Make the food regulatory system more efficient and flexible, responsive to emerging issues and opportunities, commensurate with risk But at the same time  Do not compromise health and safety  Provide transparent and consultative decision making 6

7. 7 Targeted FDA amendments April 26 2012, the government tabled proposed revisions to the Food and Drugs Act to meet these objectives Bill C-38, Jobs, Growth and Long Term Prosperity Act (Division 19, clauses 412, 414(2) 415 – 417, 419) Proposed targeted amendments  Marketing Authorizations: Ministerial approval for some decisions to align better with risk, international approaches  Incorporation by reference: Manage enforceable lists outside of regulations that can be amended administratively 7

8. 8 Marketing Authorization (MA) Allows the Minister of Health to act on certain food safety decisions through Ministerial regulations -  providing exemptions that permit substances in or on foods  such as food additives, residue limits agricultural chemicals or veterinary drugs, vitamins and minerals some health claims  setting specific conditions on the exemption giving flexibility to address any particular risks  establishing classes  incorporating by reference Note: Exempting authority, cannot establish new prohibitions 8

9. 9 Marketing Authorization (MA) Ministerial regulatory process has the same checks and balances as other regulations: Subject to the Statutory Instruments Act: Review by justice, registered (SOR) and publication by the Clerk, referred to the SJCSR Subject to government policies on responsible regulation (CDSR, regulatory reform initiatives such as one to one) Maintains same scientific scrutiny and review Same international notifications and consultation But Pace of the Ministerial regulatory process and challenge function can be prioritized within HC less drafting required, can incorporate lists to make amendments administratively for faster approval 9

10. 10 Incorporation by reference What is it?  Mechanism which allows a document or list that is not in the text of the regulations to be made a part of the regulations Amendments  Explicitly allow documents to be incorporated into both the Food and Drug Regulations and the MA  Includes documents developed by the government that can be amended after consultation/notification and the safety assessment  ex lists of substances with levels and foods, methods, international documents such as Food Chemicals Codex, JECFA Compendium of Food Additive Specifications  Must be accessible Updates to the list do not require regulatory amendments 10

11. 11 How would these be implemented ? What would change?  Faster implementation of certain changes to Canada’s food safety rules, such as those for food additives and food health claims, after the safety assessment completed  Increased responsiveness to emerging issues and scientific developments, safety standards keep pace What would not change?  Scientific scrutiny and rigour of analysis: will not compromise health and safety  Retain checks and balances, principles of regulatory reform  Maintain consultative and transparent processes 11

12. 12 Example: CITREM HC received a submission to approve the use of a new food additive ‘CITREM” citric acid esters of mono- and di-glycerides as an emulsifying agent in infant formula based on crystalline amino acids or protein hydrolysates, or both, at a maximum level of use of 0.155% as consumed Use to keep ingredients including nutritional components evenly dispersed in infant formula Consistent and full delivery of nutrients to newborns Helps prevent clogging when infant formula is delivered through a feeding tube 12

13. 13 Example: CITREM HC determined the safety and efficacy of CITREM in June 2008 - not eligible for Interim Marketing Approval Time between safety assessment and final approval required 41 months With the new tools An MA could be established for emulsifiers Defining a class for emulsifiers Identifying the incorporated list of approved emulsifiers kept by Health Canada on the web Exempting foods compliant with the incorporated list from the prohibitions in the Act and the food additive prohibitions in the Regulations Setting conditions 13

14. 14 Example: CITREM A “List of Permitted Emulsifying, Gelling, Stabilizing and Thickening Agents” would be published on the Health Canada Website List would include the additive, the food, the maximum level of use (i.e. look like Table IV Division 16 in the Food and Drug Regulations) After the scientific review, complete consultation/ International notification Then amend the table administratively to allow use of CITREM, possibly in as little as 6 months after the scientific decision Do not need to amend the MA or the Food and Drug Regulations 14

15. 15 How will this be implemented? Current StepsSteps After FDA Amendments – MA with incorporated lists Web and WTO consultation /notification Drafting of regulatory amendments and consequential amendments in the FDR, approved by DoJ, Health Canada to finalize list entry Development of RIAS, and approval by TBS - RAS of RIAS Approval by Health Canada Recommendation by the MinisterUpdate web listing of approved food additives that is incorporated by reference into an existing MA Seek TB recommendation to the Governor General Publication and Registration 15 Example: Updating approved Food Additives – After the Scientific Assessment is Completed

16. 16 Just a beginning – Building for the future New tools are only a starting point Sets the stage for updating other elements of the frameworks, providing more flexible and nimble tools to enable modernization Renewed Policies Streamlined Processes Ex: Food Additives Exploring risk based policy approach Developing new submission management system, performance standards

17. 17 Links Health Canada http://www.hc-sc.gc.ca/ahc-asc/media/nr-cp/_2012/2012-58-eng.php http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/c-38-eng.php Bill C-38 http://www.parl.gc.ca/LEGISInfo/BillDetails.aspx?Language=E&Mode=1&billId=5514128 Beth.Junkins@hc-sc.gc.ca 613-941-4001 Senior Advisor, Director General Food Directorate Health Canada

18. 18 Appendix 1: Summary of Amendments Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19  Clauses 412, 414(2), 415, 416, 417, 419 18 C-38 Clause FDA Provision StatusDescription 4124(2)revised-remove IMA related exemptions -retain and clarify exemption for pesticide residues from 4(1)(a) and 4(1)(d) 414(2)30(1)( r)revised-revise regulation making authority around the IMA to apply now to the MA 41530(1.1)new- Permit regulations to establish classes and distinguish among them

19. 19 Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19  Clauses 412, 414(2), 415, 416, 417, 419 19 ClauseFDA Provision StatusDescription 41630.2Replace IMA in 30.2 MA authority to allow claims prohibited in the Act and Regulations, and set conditions 30.3MA authority to allow substances in or on foods that are prohibited in the Act and Regulations, and set conditions 30.4MA authority to establish classes Appendix 1: Summary of Amendments

20. 20 Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19  Clauses 412, 414(2), 415, 416, 417, 419 20 ClauseFDA Provision StatusDescription 41630.5New-Authority for a Regulation or an MA to incorporate any document by reference from any source. -Must be accessible, does not need to be transmitted to the Clerk or published in Gazette 30.6newIbRef for food not impinge on any other existing ability to IbRef for other products in the Act Appendix 1: Summary of Amendments

21. 21 Bill C-38, Jobs, Growth and Long Term Prosperity Act - Division 19  Clauses 412, 414(2), 415, 416, 417, 419 21 ClauseFDA Provision StatusDescription 417---Transitional- Existing IMAs stay in effect until notice cancelling it, or 2 years after it was published 419---Coming into force - On day or days to be fixed by the Governor in Council Appendix 1: Summary of Amendments