Category Archives: FDA

FDA

Image CDC

Recommendation

FDA, CDC, and state health authorities are investigating an outbreak of illnesses caused by E. coli O157:H7 in the United States. Epidemiologic, laboratory, and traceback evidence indicates that romaine lettuce from the Salinas, California growing region is a likely source of this outbreak. According to CDC, there have been 102 cases reported in 23 states.  The latest date that one of these patients reports becoming ill was on November 18, 2019.

 

Consumers: Consumers should not eat romaine lettuce harvested from Salinas, California. Additionally, consumers should not eat products identified in the recall announced by the USDA on November 21, 2019.

Romaine lettuce may be voluntarily labeled with a harvest region. If this voluntary label indicates that the romaine lettuce was grown in “Salinas” (whether alone or with the name of another location) do not eat it. Throw it away or return it to the place of purchase.  If romaine lettuce does not have information about harvest region or does not indicate that it has been grown indoors (i.e., hydroponically- and greenhouse-grown), throw it away or return it to the place of purchase. Consumers ordering salad containing romaine at a restaurant or at a salad bar should ask the staff whether the romaine came from Salinas.  If it did, or they do not know, do not eat it.

At this time, romaine lettuce that was harvested outside of the Salinas region has not been implicated in this outbreak investigation. Hydroponically- and greenhouse-grown romaine, which is voluntarily labeled as “indoor grown,” from any region does not appear to be related to the current outbreak. There is no recommendation for consumers to avoid using romaine harvested from these other sources.

Restaurants and Retailers: Restaurants and retailers should not serve or sell romaine harvested from Salinas, California.  If you do not know the source of your romaine lettuce, and if you cannot obtain that information from your supplier, you should not serve, nor sell it.

Suppliers and Distributors: Suppliers, distributors and others in the supply chain should not ship or sell romaine harvested in Salinas, California. If the source of the romaine lettuce is unknown, you should not ship, nor sell the product.

For Restaurants, Retailers, Suppliers and Distributors: Currently, the FDA does not have enough traceback information to identify the specific source of the contamination that would allow us to request a targeted recall from specific growers.

FDA requested that industry voluntarily withdraw romaine grown in Salinas from the market and is requesting that industry withhold distribution of Salinas romaine for the remainder of the growing season in Salinas. Without more specific traceback information, this was the most efficient way to ensure that contaminated romaine was off the market.

At this time, romaine lettuce that was harvested outside of the Salinas region has not been implicated in this outbreak investigation. Hydroponically- and greenhouse-grown romaine, which is voluntarily labeled as “indoor grown,” from any region does not appear to be related to the current outbreak. There is no recommendation for consumers or retailers to avoid using romaine harvested from these other sources.

Update

According to the CDC, as of December 2, 2019, 102 people infected with the outbreak strain of E. coli O157:H7 have been reported from 23 states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 18, 2019. Illness onset dates reported to date are prior to the public warning issued on November 22.

Based on available traceback data, FDA requested that industry voluntarily withdraw romaine grown in Salinas from the market and is requesting that industry  withhold distribution of Salinas romaine for the remainder of the growing season in Salinas. This was the most efficient way to ensure that contaminated romaine was off the market.

Products that were part of the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced recall related to this outbreak investigation had a “Best By” of Nov. 1 or earlier, more than one month ago, and should no longer be on the market.

FDA continues to actively investigate the cause of this outbreak. FDA, with the assistance of staff from the California Department of Public Health and the California Department of Food and Agriculture, immediately deployed investigators to three farms in the Salinas area that were identified based on the traceback investigation. On the farms, investigators sampled soil and animal droppings, compost, water, and other potential environmental sources. The samples and information collected during the farm investigations are currently being analyzed. Investigators are attempting to identify any factors that could have led to contamination. Additionally, state partners are testing romaine lettuce samples for E. coli that they have collected from stores and from case patients’ homes.

The FDA and state partners are conducting a traceback investigation to determine whether a common supplier or source of contamination can be identified.  This investigation involves collecting and analyzing potentially hundreds of distribution records to trace the romaine that may have been available at points of exposure reported by ill people to their source. We are continuing to collect these records.

This remains an evolving and fluid situation. Information about our findings will be forthcoming as the investigation proceeds.

The Salinas region as defined by the United Fresh Produce Association and the Produce Marketing Association Romaine Taskforce ReportExternal Link Disclaimer includes: Santa Cruz, Santa Clara, San Benito, and Monterey counties in California.

Case Counts

Total Illnesses: 102
Hospitalizations: 58
Deaths: 0
Last illness onset: November 18, 2019
States with Cases:  AZ (3), CA (4), CO (6), FL (1), IA (1), ID (3), IL (1), MD (4), MI (1), MN (3), MT (1), NE (1), NJ (7), NC (1), NM (2), OH (12), OR (1), PA (8), SD (1), TX (4), VA (4), WA (2), WI (31)

FDA

November 20, 2019

Recommendation

Consumers are advised not to eat Ready Pac Bistro® Chicken Caesar Salad, lot #255406963, UPC  0 77745 27249 8, “Best By” date Oct. 31, 2019, purchased from Sam’s Club stores in Maryland. State testing of unopened salad purchased by an ill person identified the presence of E. coli O157 in the romaine lettuce.  It should be noted that the “Best By” date was almost 3 weeks ago, so this product is not likely in stores. Consumers should not eat this specific product, regardless of where it was purchased.

Background

FDA, CDC and state health authorities are investigating an outbreak of illnesses caused by E. coli O157:H7  in the U.S.

According to the CDC, as of November 18, 2019, 17 people infected with the outbreak strain of E. coli O157:H7 have been reported from eight states. The case patients report that illnesses started on dates ranging from September 24, 2019 to November 8, 2019.

Two cases reported from Maryland have been linked to this outbreak by Whole Genome Sequencing (WGS), through analysis of clinical samples taken from those patients. The Maryland Department of Health identified E. coli O157 in an unopened package of Ready Pac Bistro® Chicken Caesar Salad collected from a ill person’s home in Maryland which was purchased from a Sam’s Club in that state. Preliminary information indicates that romaine lettuce used in the product that tested positive was harvested in mid-October and is no longer within current expiration dates. To date, the food sample has not yet been definitively linked to the Maryland cases or other E. coli O157 illnesses in the multi-state outbreak. WGS analysis is currently underway for this sample to determine if it is closely related genetically to the E. coli found in people in this outbreak.

As analysis is underway, FDA is tracing back the supply of the romaine lettuce in the Caesar salad. FDA has identified possible farms in Salinas, California. FDA is deploying investigators to the farms in question to determine the source and extent of the contamination. More information will be forthcoming as the investigation proceeds.

Although the ill people interviewed in Maryland reported eating Ready Pac Bistro® Chicken Caesar Salad, at this time, ill people in other states have not reported eating this particular salad. Therefore, exposure to this product alone does not fully explain other cases in the outbreak.

State and local public health officials are interviewing ill people to determine what they ate and other exposures of interest in the week before their illness started.