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Temporary import requirements for romaine lettuce from the United States (2023)

Requirements end on December 20, 2023

The temporary import licence conditions for romaine lettuce from the United States end on December 20, 2023.

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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 28 and December 20, 2023, importers of romaine lettuce and/or salad mixes containing romaine lettuce from the U.S. must:

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.

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:

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 28 to December 20, 2023.

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:

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 identify:

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).

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

When to sample:

Sampling lots:

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 lots:

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. must not be contaminated
  2. must be edible
  3. must not consist in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance; and
  4. 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. 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."

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

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