Questions and Answers regarding the amendments to the Food and Drugs Act for food (Bill C-38)

General
Marketing Authorization
Incorporation by Reference (IbR)

General

1. What are the proposed amendments?

The amendments propose two targeted changes to the Food and Drugs Act.

The first is a new authority called a Marketing Authorization. This allows the Minister of Health to act on certain safety decisions such as permitting the use of specific substances in foods (e.g. food additives) and allowing certain new health claims on foods. The Marketing Authorization would also allow the Minister to set specific conditions on these approvals.

The second change is to allow broader referencing of public documents as part of regulations. This is termed incorporation by reference. This amendment would also include documents developed by the department.

2. Why are they needed?

Currently, once Health Canada scientists have made a safety decision - be it about the safety of a new food additive, setting a limit for a chemical contaminant or approving a new health claim on a food, it can take many months and, sometimes, even years to implement that decision through a change in the regulations.

These delays limit access to innovative and safe products for Canadians, as well as the department's ability to respond to new scientific information that might have a beneficial impact on the health and safety of Canadians.

The amendments will reduce delays, cut red tape and make the food regulatory system more efficient and flexible, while continuing to protect the health and safety of Canadians.

3. What will be different after the amendments?

The Minister of Health will have an improved ability to act on certain safety decisions, avoiding delays in the current regulatory process. Incorporated documents including lists maintained by the department can be revised quickly. This change will permit safe new products to get to market faster and will allow government resources to be targeted where they will have the greatest impact on the health and safety of Canadians.

4. What will be the same after the amendments?

There will be no change to the scientific review and assessment - the same degree of scrutiny and rigor will be maintained so that Canadians can be assured that health and safety is not being compromised.

The Marketing Authorization will be subject to the same provisions under the Statutory Instruments Act as other regulations - ensuring such things as review by the Department of Justice and publication by the Clerk of the Privy Council.

As well, decisions will continue to be open, transparent and will continue to include public consultation. These decisions will also adhere to the Treasury Board guidance on modern regulatory reform, such as considering the impacts on small business, and they will respect all of the principles of good regulation making.

5. Why are there only targeted food amendments instead of larger changes to the food provisions in the FDA?

Modernization of the food frameworks means updating a variety of tools, policies and processes.

Currently, the biggest need is to update the tools Health Canada uses to implement safety decisions, which have not kept pace with new food safety challenges, innovation and technological advances.

A step-by-step approach is being taken, with these critical improvements moving ahead now while additional work continues on other aspects.

6. What do these targeted amendments mean for industry and Canadians?

Canadians and industry will see more timely approvals of safe, innovative products with food additives and substantiated health claims. These proposed amendments will also help keep pace with evolving scientific findings and help protect the health and safety of Canadians.

7. Why do we need these amendments so quickly?

Through the Red Tape Reduction Commission, industry stakeholders indicated to us that the way we approve food additives and other innovative ingredients is preventing economic growth and new jobs.

Further, we need to address the current delays in implementing decisions that support the health and safety, as well as, the availability of safe innovative products.

These authorities will give us modern tools to address emerging issues more efficiently.

Marketing Authorization

8. What is a marketing authorization (MA)?

Marketing authorizations will be regulations made by the Minister of Health. They will exempt products from specific prohibitions in the Food and Drugs Act and the Food and Drug Regulations. The MA will allow the Minister to make general rules permitting the sale of foods and the use of substances that are in - or on - foods. MAs will also be available to permit the use of substantiated health claims.

9. How is the MA different from what Health Canada currently does for these types of approvals?

Currently, the Minister of Health only has the authority to temporarily approve some substances in food in some situations.

The MA will allow more efficient approvals of safe foods that can address emerging safety issues, and better respond to innovation.

10. Can an MA make any type of regulation?

No - an MA is limited in what it can do. An MA can only exempt a food, or a food with a specific health claim, from a prohibition in the Food and Drugs Act or in the Food and Drug Regulations; determining classes and setting conditions as needed. An MA cannot set new prohibitions.

11. What checks and balances/oversight will there be for the MA?

The MA's will be subject to the Treasury Board directives on regulation making that require consultation and consideration of costs and benefits before a decision is made.

MAs will also be subject to the Statutory Instruments Act. This means that they must follow an open and transparent process and be reviewed by the Department of Justice to ensure that the regulation does not result in an unusual use of the authority or that it is unconstitutional.

12. Is the MA just a way to help industry?

No - The MA is a tool that will help the Government to more rapidly authorize or amend approvals of products and substances with beneficial health impacts for consumers.

These include things like food additives with antimicrobial properties to help improve safety of meat products or to allow faster specialized fortification for products like formulated liquid diets or infant formula for pre-term infants.

These products and substances provide benefits to the health and safety of Canadians, and provide the consumer with more choice.

13. Does the MA mean that there will be less scientific scrutiny?

No - the MA changes only the way the decision is implemented after the scientific assessment is completed. It does not have any impact on the scientific process or review.

Incorporation by Reference (IbR)

14. Can't Health Canada already incorporate documents by reference?

Health Canada can currently incorporate by reference certain documents into its food regulations. However, its use is generally limited to documents of a technical or explanatory nature, or developed by third parties. The new law will remove these constraints.

15. Why is the IbR with expanded scope needed?

Currently tables such as approved food additives or authorized food health claims must be written word-for-word into the Food and Drug Regulations. Consequently, if a modification is required to such a list, a regulatory amendment is needed. This regulatory process does not allow Health Canada to respond quickly to updates and advances in science and technology, market trends and/or emerging food safety risks.

The IbR authority will allow Health Canada to incorporate by reference food additive and other internally generated lists and tables into the Regulations. This will allow for changes to be adopted as soon as the scientific assessment and related consultations have been completed.

For example, instead of needing to complete time and resource consuming regulatory activities to change the level of a specific food additive or to add a new food category to which it is permitted, Health Canada will be able to edit the permitted food additive listing quickly following consultations with the Canadian public.

16. Is the incorporation provision in the FDA something new and unique?

No, there are several other federal statutes that include a similar authority for incorporation by reference.

17. How will industry and consumers know when an incorporated document has been changed?

A number of steps will help industry and Canadians to stay current.

A clear process with specific steps will be publically available to clarify exactly how changes can be made and how industry will know what rules apply to them, for example.

During the decision making, stakeholders will be consulted on the proposed changes. Also, before implementing a decision to change, a notification to the World Trade Organization (WTO) will also be issued so that both international and domestic partners are notified.

Finally, changes will be made public and the final decisions will be accessible to domestic and international partners.

18. How will incorporation by reference help Canadians?

This, for example, will help the Government put in place safety based limits on levels of contaminants in food, so that products with higher levels cannot be sold.

The current approach using Governor in Council regulations for substances in food, such as lead or melamine, is unable to keep up with the changing science, resulting in regulations that are out of date.

Updating a list on the Health Canada website, which could be incorporated by reference in a regulation, will result in a more rapid response while making sure that due process is followed to engage with stakeholders and international partners - maintaining the integrity and transparency of the decision making processes.

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