Temporary import requirements for romaine lettuce from the United States

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1. Introduction

Romaine lettuce imported from the United States (U.S.) have been associated with several outbreaks of foodborne E. coli O157:H7 illnesses in Canada and the U.S. Food safety investigations 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.

To decrease the risk associated with E. coli O157:H7 in romaine lettuce, the Canadian Food Inspection Agency (CFIA) is implementing temporary Safe Food for Canadians (SFC) licence conditions for the importation of romaine lettuce originating from the U.S. Between September 26 and December 18, 2024, importers of romaine lettuce and/or salad mixes containing romaine lettuce from the U.S. must:

  • declare that the product does not originate from counties of Santa Cruz, Santa Clara, San Benito and Monterey in the Salinas Valley, California, U.S., or
  • submit an attestation form and Certificates of Analysis for each shipment to demonstrate that the romaine lettuce does not contain detectable levels of E. coli O157:H7

The complete details on the temporary SFC licence conditions and other existing import requirements are outlined in this document.

The temporary SFC licence conditions are in addition to other existing import requirements and preventive control plan requirements.

2. Requirements at time of import

If importers and the products they import comply with other Canadian legislation, the CFIA will allow the importation of romaine lettuce and/or salad mixes containing romaine lettuce from the U.S. if they comply with the temporary SFC licence conditions and other import requirements, as follows:

  • 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
  • romaine lettuce and/or salad mixes containing romaine lettuce from the California counties of Santa Clara, Santa Cruz, San Benito and Monterey is accompanied by an attestation (using form Importer's attestation for romaine lettuce products from the Salinas Valley, California, United States (CFIA/ACIA 5961; 2024/08)) that sampling was conducted according to the temporary SFC licence conditions and by the Certificate of Analysis demonstrating that the product does not contain detectable levels of E. coli O157:H7
  • if a Proof of Origin of the romaine lettuce is not available, the attestation and Certificate of Analysis must be provided
  • romaine lettuce grown in California has been handled by a certified member of the California Leafy Greens Marketing Agreement (LGMA)
  • romaine lettuce grown in Arizona has been handled by a shipper that is a certified member of the Arizona LGMA

3. Temporary SFC licence conditions

Temporary licence conditions pursuant to section 20 (3) of the Safe Food for Canadians Act will be in effect for the period from September 26 to December 18, 2024.

During this period, the conditions for import will require importers of leafy greens to provide proof that romaine lettuce and/or salad mixes containing romaine lettuce do not originate from counties of Santa Cruz, Santa Clara, San Benito, and Monterey in the Salinas Valley of California, U.S.

Alternatively, importers who import romaine lettuce and/or salad mixes containing romaine lettuce from the counties of Santa Cruz, Santa Clara, San Benito, and Monterey in the Salinas Valley of California, U.S., or who import such products without a valid Proof of Origin, must conform with the following:

  1. the licence holder's preventive control plan includes a written procedure describing how the sampling and testing requirement outlined below is implemented
  2. each shipment is accompanied by an attestation by the importer, in the form provided by the CFIA (CFIA/ACIA 5961), attesting that: they have an official Certificate of Analysis for each romaine-lettuce product in the shipment; sampling and testing was conducted according to the temporary SFC licence conditions (points d., e., and f. below); and E. coli O157:H7 was not detected
  3. each shipment is accompanied by the Certificates of Analysis issued for the romaine products in the shipment

  4. the imported product was sampled and tested for E. coli O157:H7 according to 1 of the 2 sampling options described below and the testing conditions outlined in points e. and f. below:

    Option 1: Finished-product sampling

    • sampling and testing is conducted after all post processing and handling steps are completed, but before the product is imported into Canada
    • a sampling lot is 1 type of romaine-lettuce product and a size no larger than the equivalent of 1 truckload of product (no more than 20,400 kilograms/45,000 pounds)
    • for each sampling lot, the minimum sampling and testing requirement is a total sample weight of 1,500 g consisting of 60 individual random sample units of 25 g each

    Option 2: Pre-harvest sampling

    • sampling of romaine lettuce in the field is conducted no more than 7 days before harvest
    • a sampling lot is a 2 acre field or less of homogeneous romaine lettuce crop that has been exposed to homogeneous agricultural conditions
    • for each sampling lot, the minimum sampling and testing requirement is a total sample weight of 1,500 g consisting of 60 individual random sample units (grab specimens) of 25 g each

    • this sampling option can be used for romaine lettuce that will be field-packed at the time of harvest

      This option is also acceptable for romaine lettuce destined for further processing before export (for example, chopped or mixed with other products) if the product is to be processed in separate batches, and a link can be established and documented between the Certificate of Analysis of the product sampled in the field and the finished product at the time of import

  5. testing with both screening and confirmation methodologies must be performed in a laboratory accredited by an 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 be on the laboratory's scope of accreditation

    The "application" section of the method chosen must be appropriate for the intended purpose, including that it is intended for testing romaine lettuce, leafy greens, or fresh fruits and vegetables

  6. a presumptive positive result from a screening method is treated as a positive result for E. coli O157:H7 unless a confirmation test is performed on the original enrichment broth within 24 hours of the first test and produces a negative result (that is, not detected)

    The confirmation test is a cultural method that is compatible with the screening method

4. Guidance on the temporary SFC licence conditions

a. Scope

The temporary SFC licence conditions apply to all U.S. import shipments of romaine lettuce and/or salad mixes 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.

b. Proof of Origin

Shipments of romaine lettuce and/or salad mixes containing romaine lettuce from the U.S. but outside the California counties of Santa Clara, Santa Cruz, San Benito, and Monterey, must be accompanied by a declaration from the exporter on an official company letterhead which includes:

  • the signature of the exporter
  • the date the letter was signed by the exporter
  • the state and county where the romaine lettuce was harvested

c. Certificate of Analysis

A Certificate of Analysis issued by the laboratory that conducted the test must be provided for each romaine product in an import shipment, demonstrating that the test result for E. coli O157:H7 is negative. The Certificate of Analysis must include:

  • the date of sample collection
  • the certificate number
  • the laboratory that analysed the sample
  • the client
  • a product description and lot identifier(s)
  • the methodology
  • the sample weight and number of units
  • the test result
  • the test date

Importers must be able to demonstrate how the Certificate of Analysis links to the specific type of romaine product in the shipment.

d. Sampling

The sampling level is based on International Commission on Microbiological Specifications for Foods (ICMSF) recommendations for E. coli O157:H7. The 2 sampling options are considered of similar value in achieving the required sampling level. The sample units must be collected aseptically and be representative of the lot being tested.

For option 2, additional guidance on how to take representative samples from a field is available on the California LGMA website (see Appendix C (PDF)).

Examples of appropriate sampling for option 1: Finished-product sampling

When to sample:

  • field packaged romaine hearts can be sampled after cooling and just before they are loaded into a transport truck destined for Canada
  • bulk romaine lettuce can be sampled just before it is loaded into a transport truck destined for Canada
  • mixed salad sold in bags can be sampled during the packaging process at the processing facility or before it is loaded into a transport truck destined for Canada

Sampling lots:

  • Example 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

    • when romaine-lettuce products in a shipment have different bar codes or Price Look-Up (PLU) codes, they should be treated as separate sampling lots

  • Example 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 import to Canada:

    • this shipment should be considered 1 sampling lot

  • Example 3 – An importer purchases 1,500 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
    • the importer's preventive control plan must include a system for tracking all shipments that are associated with the Certificate of Analysis

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 lot.

Examples of appropriate sampling for option 2: Pre-harvest sampling

When to sample:

  • sampling is conducted as close as possible to harvest day, but not more than 7 days before harvest
  • if the 7-day window is exceeded, the sampling lot can be re-sampled before harvest or the finished product can be sampled later according to option 1: Finished-product sampling

Sampling lots:

  • Example 1 – A 3-acre plot of romaine lettuce intended for packaged romaine hearts:

    • 2 sampling lots must be taken as the field size from which the romaine lettuce was harvested exceeds the maximum 2-acre sampling size
  • Example 2 – A shipment of bulk romaine lettuce with a weight of 14,000 kilograms
    • The bulk romaine is from 2 farms:
      • this shipment should originate from at least 2 pre-harvest sampling lots (at least 1 from each farm)
      • the number of sampling lots from each farm depends on field size from which romaine lettuce was harvested (maximum 2-acre sampling size)
  • Example 3 – A shipment of 169 cartons of mixed bagged salad containing romaine lettuce:
    • this shipment could originate from 1 pre-harvest sampling lot provided all of the romaine lettuce was harvested from 1 homogeneous field not exceeding 2 acres
    • the product must be processed in batches separate from other product with a clear break between production lots
    • a link must be established and documented between the Certificate of Analysis of the product sampled in the field and the finished product at the time of import
    • if the processing facility handles tested and untested products (or products not tested according to the temporary SFC licence conditions), the break between production lots requires a full sanitation of the production line
  • Example 4 – Pre-harvest sampling and testing is conducted on a sampling block that is subsequently harvested over multiple days:
    • the gap between the sampling date and the last harvest date must not exceed 7 days

5. Legislative authority

The licence conditions are based on the following legislative authority.

Section 20(3) of the Safe Food for Canadians Act states: "The Minister may make a registration or licence subject to any additional conditions that the Minister considers appropriate."

The import requirements are based on the following legislative authority.

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 1 province to another or that is imported or exported

  1. (a) must not be contaminated
  2. (b) must be edible
  3. (c) must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and
  4. (d) must have been manufactured, prepared, stored, packaged and labelled under sanitary conditions"

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

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

Failure to comply with the temporary licence conditions and import requirements may result in enforcement action taken by the CFIA.

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