• New CFIA requirements
  • What falls under these new requirements
  • Sampling and testing requirements

The Canadian Food Inspection Agency (CFIA) has recently added new requirements for romaine lettuce that has taken the food industry by surprise and has producers and importers scrambling for answers on how to comply with the new regulation. Since 2016 there have been numerous outbreaks in Canada caused by E. coli O157:H7 linked to the consumption of romaine lettuce imported from the US, especially product that originated from the Salinas Valley of California. The new regulation was put in place very quickly (draft published Sept. 28, rule enforced as of Oct. 7), and without the industry input that is typical for these types of regulations.

The new regulation is entitled “Import Regulations for Romaine Lettuce from the United States” and applies to all shipments of romaine lettuce arriving in Canada from Oct. 7 to Dec. 31, 2020. Specifically, the regulation applies to “all US shipments of romaine lettuce or products containing romaine lettuce, sold in bags, in bulk, or combined with other food items, in a fresh state.  It applies to all varieties of mature and baby romaine.” If the romaine lettuce originates from areas of the US outside of the specific California counties of Santa Cruz, Santa Clara, San Benito or Monterey, the importer must provide a Proof of Origin (a declaration signed by the exporter).  If it does originate from one of these counties, or a Proof of Origin is not available, there must be a Certificate of Analysis (COA) accompanying each lot, indicating that sampling and testing was conducted demonstrating non-detectable levels of E. coli O157:H7. If the testing is not completed in the US, or the testing is done in Canada, the importer must submit a Conditional Release form 5078.  These regulations are in addition to the regulations that were already in place for produce in the Safe Food for Canadians Regulations.

The sampling and testing requirements are the part of the new regulation that industry is finding to be most difficult.  The sampling and testing needs to be done on finished product (not field or raw product samples).  The lot is defined as “a shipment or load of 1 type of product that is no more than the equivalent of 1 truckload of product (no more than 20,400 kilograms/45,000 pounds).”  The sampling needs to be representative of the lot, meaning samples need to be taken equally from throughout the lot (a single large “grab sample” would not suffice) using an N60 sampling.  In other words, for each lot 60 samples of 25 g each must be tested. A validated compositing scheme can also be used (e.g., 4 x 375g composite samples containing 15 X 25g each).  The testing must be conducted at an accredited laboratory using methods from the Health Canada Compendium of Analytical Methods or other methods that have been validated as fit for the intended use.



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