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Import requirements for romaine lettuce from the United States

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Introduction

Romaine lettuce imported from the United States has been associated with several outbreaks of foodborne E. coli O157:H7 illnesses in Canada and the USA. Food safety investigations and trace-backs from U.S. authorities have identified a recurring geographical area as the source of the outbreaks. This area encompasses the California Salinas valley counties of Santa Cruz, Santa Clara, San Benito and Monterey.

Due to the reoccurring nature of the outbreaks in Canada the CFIA is implementing temporary import conditions for romaine lettuce originating from these growing areas. This import requirement will require importers of romaine lettuce from the implicated regions in the USA to provide a Certificate of Analysis for each shipment to demonstrate that the product does not contain detectable levels of E. coli O157:H7. This measure is in effect for all shipments arriving in Canada between October 7 and December 31, 2020.

Import requirements

The CFIA will allow the importation of romaine lettuce or products containing romaine lettuce from the USA if:

  1. the importer has a valid Safe Food for Canadians licence
  2. the importer provides a Proof of Origin indicating the state and county where the romaine lettuce was harvested if the romaine lettuce is from outside of the California counties of Santa Cruz, Santa Clara, San Benito and Monterey
  3. romaine lettuce grown in California has been handled by a certified member of the California LGMA
  4. romaine lettuce grown in Arizona has been handled by a shipper that is a certified member of the Arizona LGMA
  5. romaine lettuce or products containing romaine lettuce from the California counties of Santa Clara, Santa Cruz, San Benito and Monterey is accompanied by a certificate of analysis demonstrating that sampling was conducted according to the sampling and testing requirements and the product does not contain detectable levels of E. coli O157:H7
  6. if a Proof of Origin of the romaine lettuce is not available, a Certificate of Analysis must be provided
  7. if a Proof of Origin or Certificate of Analysis is not available at the time of import, a Conditional Release form should be provided

Scope of the import requirements

The requirements apply 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.

Proof of Origin

Shipments of romaine lettuce or products containing romaine lettuce from the USA, outside the California counties of Santa Clara, Santa Cruz, San Benito and Monterey, must be accompanied by a declaration from the exporter on official company letterhead which includes:

Conditional release for shipments that must be tested for E. coli

If you choose to have your product tested in Canada, you must submit a Conditional Release form 5078 with the import declaration. This form is also required if sampling was conducted in the USA and testing results are pending.

The conditional release form will be reviewed by the CFIA and once approved, a copy is faxed to the customs broker/importer.

The CFIA will advise the inspection staff to follow-up with the importer to verify that the Certificate of Analysis associated with the imported products meet the criteria described below.

Sampling and testing requirement

Each importer must have a sampling program in place to test for the presence of E. coli O157:H7 in romaine lettuce or products containing romaine lettuce imported from the California counties of Santa Cruz, Santa Clara, San Benito and Monterey. Sampling and testing can be conducted either in the USA or in Canada.

1. Certificate of analysis

A certificate of analysis must be provided for each type of romaine product in an import shipment, demonstrating that the test result for E. coli O157:H7 is negative. The certificate of analysis must identify:

A certificate of analysis that is compliant with the stated requirements must be provided to the CFIA before the imported product may be released for sale in Canada. However, it is possible to let the product transit from the USA to Canada while the analysis is being performed.

2. Sampling

The required number of sample units for each sampling lot is 60 units of 25 grams per lot. The sample units must be collected aseptically, be representative of the lot being tested and meet the screening methodology specifications, which in some situations may require sample units of more than 25 grams.

This sampling level is based on International Commission on Microbiological Specifications for Foods (ICMSF) recommendations for E. coli O157:H7.

2.1. Where to conduct sampling

The design of a sampling program to test for the presence of E. coli O157 is the responsibility of the importer. However, the sampling and testing can be undertaken either by a supplier in the USA or by the importer. Sampling must be conducted after all post processing and handling steps are completed (the product cannot be sampled during growing or harvesting).

Examples:

  1. Field packaged romaine hearts could be sampled after cooling and just before they are loaded into a transport truck destined for Canada
  2. Bulk romaine lettuce could be sampled just before it is loaded into a transport truck destined for Canada
  3. Mixed salad sold in bags could be sampled during the packaging process at the processor in the USA
  4. Any product can be sampled after arriving in Canada and held pending the certificate of analysis

2.2. Sampling lot

The sampling lot refers to 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).

Examples:

  1. A shipment of 800 cartons of pre-packaged romaine hearts, 50 cartons of wrapped iceberg lettuce and 169 cartons of mixed bagged salad containing romaine lettuce:

    This shipment should be considered 2 sampling lots. 1 sampling lot is 800 cartons of pre-packaged romaine hearts. The other sampling lot is 169 cartons of mixed bagged salad containing romaine lettuce

  2. A shipment of bulk romaine lettuce with a weight of 14,000 kilograms. The shipment will be delivered to numerous clients in Canada after released for sale in Canada:

    This shipment should be considered 1 sampling lot

  3. An importer purchases 1500 cartons of pre-packaged romaine hearts weighing less than 20,400 kilograms. This product will be shipped to Canada in 4 shipments headed to various distribution centers in Canada:

    This product can be considered 1 sampling lot if the importer's Preventive Control Program (PCP) includes a system for tracking all shipments that are associated with the certificate of analysis. If the importer's PCP does not have such a system, each shipment of product should be considered distinct sampling lots. Documentation explaining which import shipments correspond to a single certification of analysis must be provided with the import request documentation

All packages, cases or containers in the sampling lot must be equally represented in the sample. For example, a shipment of 800 cartons should have no more than 1 piece taken in a carton, and the 60 cartons sampled should be selected from various parts of the shipment. A shipment of 10 cartons should be sampled by collecting 6 pieces per carton. Product sampled during the packaging process should be sampled at the beginning, middle and end of the sampling lot.

3. Testing considerations and methodology

Testing with both screening and confirmation methodologies must be performed in a laboratory accredited by the Standards Council of Canada (SCC), the Canadian Association for Laboratory Accreditation (CALA), or another accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Agreement (MRA) as conforming to the requirements of ISO/IEC 17025:2017 for specific tests. The chosen method must also be on the laboratory's scope of accreditation.

For each lot, a total of 1500 g of romaine lettuce consisting of 60 individual sample units of 25 g each must be tested. Sample units may be composited for analysis to the maximum allowable analytical portion specified in the method.

A recognized test method should be used, such as methods from the Health Canada Compendium of Analytical Methods or any recognized method that is fit for the intended purpose. The most recent published version of the method should be used. The "application" section of the method chosen must be appropriate for the intended purpose.

A presumptive positive result will be considered positive (that is, to correspond to a confirmed positive test result for E. coli O157:H7/NM) unless the sample proceeds to the confirmation method. If the importer wishes to pursue cultural confirmation of a presumptive positive result in order for the CFIA to consider the sample as "not detected," then confirmation testing must be performed on the original enrichment broth within 24 hours of obtaining the presumptive result, and must be performed in an accredited laboratory by a recognized and compatible cultural confirmation method such as MFHPB-10 - Isolation of Escherichia coli O157:H7/NM from foods and environmental surface samples from the Health Canada Compendium of Analytical Methods.

Legislative authority

The import requirements are based on the following legislative authority. Failure to comply with the requirements will result in product being refused entry into Canada, destroyed or re-exported to the USA.

Section 8 of the Safe Food for Canadians Regulations and Section 4 of the Food and Drugs Act.

Section 8(1) of the Safe Food for Canadians Regulations states:

Any food that is sent or conveyed from one province to another or that is imported or exported

Section 4 of the Food and Drugs Act states: "No person shall sell an article of food that:

  1. has in or on it any poisonous or harmful substance;
  2. is unfit for human consumption;
  3. consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
  4. is adulterated; or
  5. was manufactured, prepared, preserved, packaged or stored under unsanitary conditions."
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