Bacterial Pathogens and Indicators in Imported Romaine Lettuce - April 1, 2019, to March 31, 2024

Food microbiology - Targeted surveys - Final report

Summary

A targeted surveyFootnote 1 analyzed 4450 samples of imported fresh romaine lettuce (whole [n=1258], hearts [n=1822], fresh-cut or salads [n=1370]) over a 5-year period from April 1, 2019, to March 31, 2024. Samples were tested for the presence of the pathogens E. coli O157:H7/Non-Motile (NM), and Salmonella species (spp.). All samples were tested for generic E. coli which is an indicator of the overall hygienic and sanitary conditions throughout the food supply chain from production to the point of sale.

Almost all (99.98%) of the samples tested were found to be satisfactory. E. coli O157:H7/NM and Salmonella spp. were not found in any of the samples (0/4432 and 0/2795 samples, respectively). Generic E. coli at elevated levels was found in 1 of the 4450 (0.02%) samples. The Canadian Food Inspection Agency (CFIA) conducted appropriate follow-up activities, as necessary.

Overall, our survey results indicate that imported fresh romaine lettuce sold in Canada is generally safe for consumption. However, as with all foods, and especially those that are ready-to-eat (RTE), good hygienic practices are recommended for producers, retailers, and consumers.

Why the survey was conducted

The survey was conducted to provide enhanced oversight of imported romaine lettuce sold at retail in Canada. Romaine lettuce is popular among CanadiansFootnote 2 as part of a healthy diet including plenty of fruits and vegetables. Unfortunately, leafy green vegetables (including romaine lettuce) have been associated with foodborne illness outbreaks of bacterial pathogens such as E. coli O157:H7, and Salmonella spp.Footnote 3Footnote 4. Between 2017 and 2020, romaine lettuce imported from the United States (US) were associated with several foodborne illness outbreaks of E. coli O157:H7 in the USFootnote 5Footnote 6Footnote 7Footnote 8, and CanadaFootnote 9Footnote 10Footnote 11. This survey was initiated in response to these reoccurring outbreaks. Additionally, the CFIA implemented import requirements for products containing romaine lettuce harvested from the affected US growing regionsFootnote 12Footnote 13.

Food safety investigations, and traceback studies into the outbreaks revealed that the contamination was associated with the close proximity of the lettuce growing fields to concentrated animal feeding operationsFootnote 14Footnote 15. Lettuce in growing fields could have been contaminated with E. coli O157:H7 from cattle feces via irrigation water, wind and other meansFootnote 14Footnote 15. Food safety action plans and control measures were implemented in the implicated US growing regions in 2020Footnote 16.

When the survey was conducted

The survey was conducted over a 5-year period from April 1, 2019, to March 31, 2024.

Where the samples were collected from

Samples were collected from national retail chains and local/regional grocery stores located in the following 11 major cities across Canada:

  • Halifax
  • Moncton
  • Quebec City
  • Montreal
  • Toronto
  • Ottawa
  • Vancouver
  • Victoria
  • Calgary
  • Saskatoon
  • Winnipeg

The planned number of samples to be collected from each city was based on the population of the province in which the city was located relative to the total population of Canada.

Total number and description of samples collected

A total of 4450 imported fresh romaine lettuce samples including whole (1258), hearts (1822), and fresh-cut romaine or romaine lettuce-based salads (1370) were collected over the 5-year survey period. A sample consisted of a single or multiple consumer sized packages of the same lot weighing at least 250 g.

What the samples were tested for

The imported fresh romaine lettuce samples (whole, hearts, and fresh-cut or salads) were tested for the presence of E. coli O157:H7/NM, Salmonella spp., and generic E. coli (table 1). E. coli O157:H7/NM, and Salmonella spp. are pathogenic bacteria while generic E. coli is an indicator of the overall hygienic and sanitary conditions under which the samples have been produced, processed, stored, and transported.

Table 1 - Bacterial analyses by romaine lettuce type
Fiscal year Bacteria Whole romaine lettuce Whole romaine lettuce hearts Fresh-cut romaine lettuce or romaine lettuce-based salads Total number of samples tested
2019 to 2020
2020 to 2021
E. coli O157:H7/NM
generic E. coli
457 682 516 1655
2021 to 2022
2022 to 2023
2023 to 2024
E. coli O157:H7/NM
Salmonella spp.
generic E. coli
801 (5Footnote a) 1140 (9Footnote a) 854 (4Footnote a) 2795 (18Footnote a)

Methods used to test the samples

Samples were analyzed using analytical methods published in Health Canada's Compendium of Analytical Methods for the Microbiological Analysis of FoodsFootnote 17 that were suitable for the testing of romaine lettuce.

How the samples were assessed

The samples were assessed using criteria based on the principles of the following Health Canada documents: Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Foods – An Interpretive SummaryFootnote 18, and the Food and Drugs Act (Section 4(1)a)Footnote 19. See table 2.

Table 2 - Assessment criteria
Bacteria Satisfactory Investigative Unsatisfactory
E. coli O157:H7/NM Not detected/25 g Not applicable Detected/25 g
Salmonella spp. Not detected/25 g Not applicable Detected/25 g
Generic E. coli ≤ 102 Colony Forming Unit (CFU)/g 102 < x < 103 CFU/g > 103 CFU/g

At the time of writing this report, no assessment guidelines had been established in Canada for the presence of Salmonella spp. in fresh vegetables. As Salmonella spp. is considered pathogenic to humans, its presence was assessed as unsatisfactory and might be considered a violation of the Food and Drugs Act Section 4(1)aFootnote 19.

Survey results

Almost all (99.98%) of the samples tested were found to be satisfactory. E. coli O157:H7/NM and Salmonella spp. were not found in any of the (0/4432) and (0/2795) samples, respectively. Generic E. coli at elevated levels was found in one of the 4450 samples (table 3).

Table 3 - Analysis assessment results
Bacterial analysis Number of samples tested Satisfactory Investigative Unsatisfactory
E. coli O157:H7/NM 4432 4432 0 0
Salmonella spp. 2795 2795 0 0
Generic E. coli 4450 4449 1Footnote b 0
Total (%) 4450 (100.00) 4449 (99.98) 1 (0.02) 0 (0.00)

Survey samples are also presented by product type (table 4), by fresh-cut romaine lettuce or romaine lettuce-based salad product sub-types (table 5), origin (table 6), and production practice (table 7).

Table 4 - Assessment results by product type
Product type Number of samples tested (%) Satisfactory Investigative Unsatisfactory
Whole romaine lettuce 1258 (28.3) 1258 0 0
Whole romaine lettuce hearts 1822 (40.9) 1821 1Footnote b 0
Fresh-cut romaine lettuce or romaine lettuce-based salads 1370 (30.8) 1370 0 0
Total (%) 4450 (100.00) 4449 (99.98) 1 (0.02) 0 (0.00)
Table 5 - Product sub-types of fresh-cut romaine lettuce and romaine lettuce-based salads
Product sub-types of fresh-cut romaine lettuce and romaine lettuce-based salads Number of samples tested
Fresh-cut romaine lettuce 283
Salad blend 75
Caesar salad 888
Romaine lettuce salad 74
Romaine lettuce heart salad 50
Total (%) 1370 (100.0)

The majority of the romaine lettuce samples were imported from the US (92.1%) with the remainder from Mexico (6.9%), and other countries (1%) (table 6).

Table 6 - Country of origin of imported romaine lettuce samples
Country of origin Number of samples tested (%) Whole romaine lettuce Whole romaine lettuce hearts Fresh-cut romaine lettuce or romaine lettuce-based salads
Mexico 305 (6.9) 26 166 113
Spain 1 (0.02) 0 1 0
US 4102 (92.2) 1225 1655 (1Footnote b) 1222
US and Mexico 41 (0.9) 6 0 35
UnknownFootnote c 1 (0.02) 1 0 0
Total (%) 4450 (100.0) 1258 1822 1370

Country of origin could not be assigned from the product label, or available sample information.

Most of the romaine lettuce samples tested in this survey were conventionally produced (81.9%) (table 7).

Table 7 - Production practice of imported romaine lettuce samples
Production practice Number of samples tested (%) Whole romaine lettuce Whole romaine lettuce hearts Fresh-cut romaine lettuce or romaine lettuce-based salads
Conventional 3645 (81.9) 1140 1178 (1Footnote b) 1327
Organic 805 (18.1) 118 644 43
Total (%) 4450 (100.0) 1258 1822 1370

What the survey results mean

The result of the current study has shown results approximating those from a previous Canadian studyFootnote 20 on the microbial quality, and safety of leafy vegetables including imported romaine lettuce (whole and fresh-cut).

This 5-year survey was one of several collaborative actions of Canadian food safety authorities in response to the reoccurring E. coli O157:H7 outbreaks in the period 2017 to 2020Footnote 12Footnote 13 to verify the safety of produce available to Canadians.

Overall, our survey results indicate that imported romaine lettuce products (whole, hearts and fresh-cut or salads) sold in Canada are generally safe for consumption. However, as with all foods, and especially those that are RTE, good hygienic practices are recommended for producers, retailers, and consumers.

What is done with the survey results

All results are used to:

  • inform risk management decisions
  • support program design and re-design

The investigative sample triggered appropriate follow-up activities, as necessary.

Where to access the survey data

The data will be accessible on the Open Government Portal.

References

Footnote 1

Canadian Food Inspection Agency, Food chemistry and microbiology.

Return to footnote 1 referrer

Footnote 2

Public Health Agency of Canada, Foodbook Report. 2015 [cited 2024 May 29].

Return to footnote 2 referrer

Footnote 3

Yang, X. and R. Scharff, Foodborne Illnesses from Leafy Greens in the United States: Attribution, Burden, and Cost. Journal of Food Protection, 2024. 87(6): p. 100275.

Return to footnote 3 referrer

Footnote 4

Marshall, K.E., et al., Lessons Learned from a Decade of Investigations of Shiga Toxin--Producing Escherichia coli Outbreaks Linked to Leafy Greens United States and Canada. Emerging Infectious Diseases, 2020. 26(10): p. 2319-2328.

Return to footnote 4 referrer

Footnote 5

Centers for Disease Control and Prevention, 2017 E. coli Outbreak Linked to Leafy Greens. 2018 [cited 2024 May 17].

Return to footnote 5 referrer

Footnote 6

Centers for Disease Control and Prevention, 2018 E. coli Outbreak Linked to Romaine Lettuce A. 2019 [cited 2024 May 17].

Return to footnote 6 referrer

Footnote 7

Centers for Disease Control and Prevention, 2019 E. coli Outbreak Linked to Romaine Lettuce. 2020 [cited 2024 May 17].

Return to footnote 7 referrer

Footnote 8

Centers for Disease Control and Prevention, 2020 E. coli Outbreak Linked to Leafy Greens. 2020 [cited 2024 May 17].

Return to footnote 8 referrer

Footnote 9

Public Health Agency of Canada, Public Health Notice - Outbreak of E. coli infections linked to romaine lettuce. 2018 [cited 2024 May 17].

Return to footnote 9 referrer

Footnote 10

Public Health Agency of Canada, Public Health Notice - Outbreak of E. coli infections linked to romaine lettuce. 2019.

Return to footnote 10 referrer

Footnote 11

Public Health Agency of Canada, Public Health Notice - United States outbreak of E. coli infections linked to romaine lettuce with implications for Canadians. 2020 [cited 2024 May 17].

Return to footnote 11 referrer

Footnote 12

Canadian Food Inspection Agency, Food safety investigation: outbreak of E. coli infections linked to romaine lettuce. 2018 [cited 2024 May 17].

Return to footnote 12 referrer

Footnote 13

Canadian Food Inspection Agency, Government of Canada actions in response to the food safety alerts concerning E. coli O157:H7 in romaine lettuce issued by the United States' Centers for Disease Control and Prevention and the Food and Drug Administration. 2019 [cited 2024 May 17].

Return to footnote 13 referrer

Footnote 14

US Food and Drug Administration, FDA Releases Investigation Report Following Fall 2020 Outbreak of E. coli O157:H7 Illnesses Linked to Leafy Greens. 2021 [cited 2024 May 17].

Return to footnote 14 referrer

Footnote 15

Waltenburg, M.A., et al., Two multistate outbreaks of a reoccurring Shiga toxin-producing Escherichia coli strain associated with romaine lettuce: USA, 2018-2019. Epidemiol Infect, 2021. 150: p. e16.

Return to footnote 15 referrer

Footnote 16

US Food and Drug Administration, Leafy Greens STEC Action Plan. 2020 [cited 2024 May 17].

Return to footnote 16 referrer

Footnote 17

Health Canada, The Compendium of Analytical Methods. 2018.

Return to footnote 18 referrer

Footnote 18

Health Canada, Health Products and Food Branch Standards and Guidelines for the Microbiological Safety of Food - An Interpretive Summary. 2008.

Return to footnote 18 referrer

Footnote 19

Health Canada, Food and Drugs Act, RSC 1985, c F-27. 1985.

Return to footnote 19 referrer

Footnote 20

Denis, N., et al., Prevalence and trends of bacterial contamination in fresh fruits and vegetables sold at retail in Canada. Food Control, 2016. 67: p. 225-234.

Return to footnote 20 referrer