The expression “may you live in interesting times” can be both a blessing and a curse. In North America, we are certainly living in interesting, challenging times for the food industry. The trade tariff wars and the uncertain fate of the North American Free Trade Agreement (NAFTA) may leave companies operating within the United States, Canada and Mexico with a sense of instability. However, despite the political challenges, food safety regulations within North America are evolving in positive ways.

As the U.S. continues the implementation of the Food Safety Modernization Act (FSMA), Canada recently unveiled new regulations to implement its Safe Food for Canadians Act (SFCA). Will the new Canadian rules align with the U.S. FSMA regulations to harmonize food safety requirements and streamline trade between the countries? Let’s take a closer look at the most recent developments below.

SFCR: FSMA’s Canadian Cousin

On June 13, the Canadian government published the final Safe Food for Canadians Regulations (SFCR) in order to fulfill the mandates of the 2012 SFCA legislation. The main objectives of the legislation were to streamline Canada’s food safety regulations, improve regulatory oversight and increase international regulatory alignment with key trading partners. The new regulations emphasize flexibility, rather than outlining specific processes, for the industry to achieve food safety outcomes.

The Canadian Food Inspection Agency (CFIA) regulations will come into force on January 15, 2019, but some requirements will be phased-in during a 12- to 30-month period, depending on the food commodity, type of activity and business size. See the SFCR Timetable for more information. The regulations apply to all foods imported into Canada, sold across provinces or prepared for export.

The three core elements of the new Canadian regulations are similar to those of its American relative, FSMA: preventive controls, licensing and traceability.

  • Preventive controlsUnder SFCR, all food businesses will be expected to develop and implement preventive controls to stave off food safety hazards. A preventive control plan (PCP), similar to the FSMA requirement for a food safety plan, is required for most food businesses impacted by the law. In contrast to the U.S. regulation, the Canadian mandate does not require manufacturers to employ a Preventive Controls Qualified Individual (PCQI) to oversee the plan.
  • Licensing – Canada will establish one licensing system for foods under which all food importers and businesses preparing food for export or interprovincial trade must register. The licensing requirement is similar to the U.S. Food and Drug Administration’s (FDA) bioterrorism requirement for facility registration. American companies seeking to market food in Canada will be required to have a Canadian food import license.
  • Traceability The regulations mandate an international standard for traceability, which requires information be kept in the form of electronic or paper records. The traceability requirements are aligned with the FSMA requirements for a food safety plan, recordkeeping and mandatory recalls.

Are there exemptions to the requirements?

Based on industry comments, the CFIA increased the threshold for businesses to be exempt from the requirement for a written PCP. The final regulations increased the threshold from $30,000 to $100,000 in gross annual food sales. All businesses are still required to implement preventive controls. Food industry stakeholders are advised to consult the CFIA online interactive tools listed below to determine the applicability of the key elements to their business:

Ongoing FSMA Implementation

Back in the U.S., despite the deregulatory approach of the Trump administration, the FDA is continuing to implement the requirements set forth by FSMA. While the core regulations have been published and several rules are in effect now, food businesses should be aware of additional FSMA requirements that will take effect in 2019.     

1) Intentional Adulteration

In June, the FDA issued a draft guidance for the industry to comply with the Intentional Adulteration rule, also known as the food defense rule. Under the final rule, each covered facility is required to prepare and implement a written food defense plan addressing vulnerabilities as well as actionable process steps, mitigation strategies, monitoring procedures, corrective actions and verification activities. The rule applies to the majority of domestic and foreign FDA-registered facilities that manufacture, process or pack food. The general compliance date is July 26, 2019.

2) Produce Safety

On January 26, 2018, large farms, other than sprout operations, were required to comply with the FDA’s final rule on Produce Safety, which established the first federal science-based minimum standards to ensure the safe growing, harvesting, packing and holding of raw agricultural commodities. The FDA is planning to begin routine inspections to verify industry compliance with the rule by Spring 2019, and upcoming compliance dates for certain requirements are slated for small farms and very small farms. For details, see the FDA site for FSMA Compliance Dates.

3) Foreign Supplier Verification Program

Under the Foreign Supplier Verification Program (FSVP) rule, importers are responsible for numerous food safety activities, including determining known or foreseeable hazards, evaluating their supplier’s performance and conducting supplier verification activities. For some importers, the compliance date for this rule was May 27, 2017. However, the compliance dates for importers can vary according to the following considerations:

Small businesses and “qualified facilities” should be aware of the FSVP requirements with compliance dates later this year and in 2019. For details, see the FDA site for FSVP compliance dates for importers.

Preparing for 2019

The harmonization of U.S. and Canadian regulations for food safety will support food trade both within North America and on a global scale. Overall, the new Canadian consolidated food regulatory approach will level the playing field for the food industry as both domestic and imported food are required to meet equivalent food safety standards. Moreover, the new risk-based approach to food safety should increase the efficiency and effectiveness of federal inspection and oversight activities.

Similar to the regulations laid out under FSMA, prevention is the cornerstone of the historic revision of Canada’s national food regulations. All food facilities, particularly high-risk facilities in the U.S. and Canada, should be prepared for a federal inspection to determine compliance with the new regulations.

Food manufacturers in the U.S. and Canada can prepare to comply with preventive control regulations by establishing a comprehensive environmental monitoring program for their facilities. Tracking every area within your production environment for the presence of pathogens will enable you to detect them early on and take corrective actions to prevent product contamination. EnviroMap®, Mérieux NutriSciences’ cloud-based environmental monitoring solution, automates scheduling, mapping and tracking sampling procedures to provide actionable data. Thermo Pac, one of the most reputable go-to suppliers when it comes to producing, packaging and assembling portion controlled food products, uses EnviroMap at their facilities. Download our case study to learn how EnviroMap saved them time, money and streamlined activities in their food safety supply chain.


Meet the Author

Patrick Kennedy
Information Services Manager, Mérieux NutriSciences

Patrick Kennedy is the Information Services Manager for Mérieux NutriSciences. He has over 15 years of food industry experience and has written extensively covering a wide range of food safety and regulatory subjects. He holds a MS degree in information science from the University of Illinois, and is a member of several industry organizations including AOAC, IFT and IAFP.

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