FSMA & SFCA Common Approaches to Food Safety

A Comparison of two North American Food Safety Regulations

By Sara Zborovski, LLB 

As set out in the first of this two-part series on the Food Safety Modernization Act (FSMA) and the Safe Food for Canadians Act (SFCA), similar themes run through both Acts. In this second part of the series, I will outline the common aspects of the two food safety systems.


Both Acts focus heavily on preventing problems. Part of the way they achieve this is by requiring members of the food chain to design and implement prevention plans, and by policing these plans by requiring facilities to register with or be licensed by the government.

The SFCA provides for the making of regulations respecting quality management programs, quality control programs, safety programs and preventive control plans to be implemented by persons who conduct any activity regulated under the Act (1).

Under the FSMA, food facilities are required to implement a written preventive controls plan, including evaluation of hazards that could affect food safety, identifying and monitoring preventive steps or controls to minimize or prevent hazards, and identifying an action plan in the event that problems arise (2).

In addition, the FSMA requires food production facilities to re-register with the Food & Drug Administration every two years (3). Registration is crucial, as products from non-registered facilities will be considered “misbranded,” which prohibits their sale. A facility’s registration can be suspended by the FDA if it is determined that food from the facility “has a reasonable probability of causing serious adverse health consequences or death to humans or animals (4).”

An additional aspect of the prevention program in both Acts is increased powers given to inspectors to ensure compliance. The FSMA specifically allocates more inspection-related resources to high-risk facilities (5) and the SFCA provides a number of powers to inspectors to verify compliance or prevent non-compliance with the Act (6).

(1)/SFCA, section 51(1)(g).
(2)/FSMA, section 103.
(3)/FSMA, section 102(a).
(4)/FSMA, section 102(b).
(5)/See, for example FSMA section 201.
(6)/SFCA, sections 24 to 27.
(7)/FSMA, Title III.
(8)/FSMA, sections 301 and 302.
(9)/SFCA, section 10, see too: sections 20 to 22.
(10)/FSMA, section 204.


Both Acts specifically focus on food moving across borders, and put the onus firmly on importers to verify that there are systems in place to prevent unsafe food from entering the country.

The FSMA has a chapter titled “Improving the Safety of Imported Food” (7) that includes provisions for the foreign supplier verification program and the voluntary qualified importer program. Both of these programs encourage importers to work with the FDA by offering expedited review and importation of food from compliant importers (8).

The SFCA prohibits the sending or conveying of a food commodity from one province to another, or to import or export, unless the person is authorized to do so by a registration specifically made under the Act or by a license issued under the Act (9). These registrations are non-transferable. Conditions of registration and licensing will likely be set out in regulations.

In addition to the above provisions, as part of this focus on imported food, both the Canadian and US governments have acknowledged the need to work with foreign governments to harmonize the registration and inspection of food facilities.


Finally, both Acts acknowledge that food safety issues will arise and provide for improved capacity to properly respond. As an example, the FSMA requires the FDA to establish pilot projects in coordination with the food industry to explore ways to quickly and effectively identify people who may have received tainted food in order to mitigate a foodborne illness outbreak (10). The SFCA provides for the making of regulations to provide for improved traceablity of any food commodity.


So, what does this all mean? It’s nice to see that the US and Canadian governments are taking similar approaches to ensuring the safety of food, particularly as it crosses borders. Both pieces of legislation reflect a shift in focus from being reactive to pro-active when it comes to food safety, and that can only be a good thing.

But, as with most things, the devil will be in the details. The SFCA was just adopted. As with most Acts, there is not a lot of detail in the Act itself regarding how the system will work. Rather, the regulations will provide the details. Unfortunately, as indicated by our neighbours to the south, it will likely be some time before we understand the intricacies of the SFCA. Details about the implementation of the FSMA are now becoming clear (albeit slowly) and we expect the rules to be forthcoming shortly.

For now, we watch and wait. Through my contributions to eye on Food Safety, I will keep you posted on important developments in respect to these and other developments in food safety legislation.

About the Author

Sara Zborovski is a partner at Gilbert’s LLP. She acts as legal counsel to the industries regulated by Health Canada, including the food and beverage industries. She assists companies in navigating the regulatory landscape imposed by the Food and Drugs Act and its related regulations, and advocates before all branches of Health Canada. Sara has a particular interest in food safety and advises clients on preparing and implementing compliance policies and programs. Sara works with clients to get products from idea to market and beyond, providing strategic advice on approvals, marketing strategies and compliance. www.thefoodlawyer.ca

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