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Do the FPC and FSMA have effective plans in place to prevent potential cross-border food hazards?

“The most sweeping reform of U.S. food safety laws in more than 70 years.” implemented on Jan 4, 2011, was the result of a development program launched by the FDA under the Food Safety and Modernization Act (FSMA).

Recognizing the need for information regarding new regulatory requirements, the Food Processors of Canada (FPC) held an information session for its members on the impacts of the Preventive Control Rule. The well attended session of 50 participants represented a wide variety of Canadian food manufacturers.

Dr. David Acheson (former assistant commissioner for Food at the USFDA), and Cameron Prince (former vice-president of the Canadian Food Inspection Agency) of The Acheson Group, were invited by the FPC to provide background on FSMA.

The purpose was to highlight the main impacts of the Preventive Control Rule on Canadian food producers exporting to the U.S.

Some key points that came out of the session:


FSMA focuses on preventing, rather than being reactionary, to issues that can cause food-borne illness. The safety schedules apply to firms that manufacture, process, pack or hold food for humans.

These businesses are required to have written plans that identify hazards, specify the steps they’ve put in place to prevent or minimize or those hazards. In addition, they must clearly identify monitoring procedures and record monitoring results, plus specify actions to be taken to correct problems that arise.

When compared to similar HACCP and GFSI programs, there are differences in the new FSMA Preventive Controls Rule that will require companies to re-evaluate and adjust their programs.

With the Preventive Control approach, hazards related to the process, and to plant operation, are controlled under a prerequisite program that now requires the same level of diligence in:

  • Documentation
  • Monitoring
  • Record keeping
  • Corrective actions as a CCP under HACCP

The Preventive Control approach is portrayed as “HACCP+” in which Prerequisite Programs are identified as Preventive Controls requiring the same level of control as a CCP such as:

  • Cleaning and Sanitation
  • Allergen Control
  • Recall

Products That Are “Ready-to-Eat”

Processors of Ready-to-Eat (RTE) products exporting to the U.S. may are required to implement an environmental pathogen monitoring program.

If the RTE product is open to the environment after processing and before packaging, and a kill step does not follow the packaging step, an environmental pathogen monitoring program is required.

Foreign Suppliers Verification

U.S. importers must also comply with the Foreign Suppliers Verification Rule, which means U.S. importers need to verify that Canadian Suppliers are in compliance with all U.S. Rules for FDA commodities. The verification could include an audit by the U.S. importer or a third party representing the U.S. importer.

Qualified Personnel

A qualified individual is required to develop, implement, and monitor the Preventive Controls Program by the Preventative Control Rule.

This individual is known as a Preventive Controls Qualified Individual (PCQI). Although experienced food safety managers can qualify for this position, it is strongly recommended that companies have a certified PCQI on staff.

In most cases this means a QA manager will be required to take a two-and-a-half day certified training program.