Category: food safety

E. coli outbreak growing; source of romaine remains unknown

One field linked to 8 illnesses; industry records complicate search for source of 90 other illnesses

The following story by Coral Beach first appeared on April 27, 2018 in Food Safety News and is reposted here with permission.

Almost 100 people have been infected in an outbreak involving romaine lettuce, and more cases are expected. Federal officials said today they have identified one grower’s romaine as the source of eight of the infections, but a tangled web of supply chain records has significantly slowed their investigation into the other illnesses.

The ongoing outbreak is the largest of its kind since the deadly 2006 E. coli outbreak traced to fresh spinach, public health officials said. There are at least two dozen romaine growers who are being reviewed as federal officials work to pinpoint the source of the current outbreak.

As of today, there are 98 confirmed cases across 22 states, up from the 84 cases reported Wednesday. All of the victims are infected with the same strain of E. coli O157:H7, and it is a particularly dangerous one, said CDC’s Robert Tauxe. Ten of the sick people have developed kidney failure, including three children.

More than half of the ill people, 46, have required hospitalization. The illness onset dates range from March 13 to April 20. 

The specific bacteria involved is referred to as an “STX2 only” form of E. coli O157:H7. It aggressively attacks blood vessels, particularly in the kidneys, digestive system and brain. 

No one should eat, serve or sell any form of romaine lettuce “under any circumstances” until further notice unless they can confirm is not from the Yuma, AZ, growing region, said Matt Wise, deputy branch chief for Outbreak Response at the Centers for Disease Control and Prevention. That warning is the same that the CDC posted April 20. Initially, only pre-chopped romaine was implicated.

Wise said the specific E. coli O157:H7 bacteria causing the illnesses is so dangerous that all people, not just the traditional high-risk groups, should avoid Yuma-grown romaine. 

Known and unknown
The CDC knows quite a bit about the confirmed victims, including the fact that 96 percent of those interviewed so far, 67 of 98, reported eating romaine during the week before they got sick. They know that all but eight of the 98 ate pre-chopped romaine from bagged or other packaged mixed salads and at restaurants.

The eight who consumed romaine from whole heads are inmates at a prison in Alaska that received the lettuce from Harrison Farm in Yuma, said Stic Harris, director of the FDA’s Coordinated Outbreak Response and Evaluation Network. However, inspectors from the Food and Drug Administration have not yet visited the farm and have not been provided details such as the specific location of the field where the implicated romaine was grown.

The FDA’s and CDC’s outbreak specialists discussed the ongoing public health threat involving romaine lettuce during a telephone news conference this afternoon.

Other than identifying the Yuma area in general and Harrison Farm in particular, FDA officials answered many of the media’s questions today with: “We don’t know yet.” That lack of knowledge is not for a lack of trying, according to FDA’s Harris.

The current federal law requires entities in the food supply chain to only maintain shipping and receiving records that are referred to as “one step forward, one step back.” That means every link, from growers to retailers and restaurants, don’t have to know where fresh produce ultimately goes or comes from.

Consequently, traceability during outbreak and recall investigations requires the FDA to contact each link in the supply chain to work its way back to the source of fresh produce commodities like romaine lettuce.

Harris said, “more descriptive” labeling would greatly help in traceback situations. Even basic requirements for uniformity of records would help. Some businesses have handwritten records and others have electronic files. Either way, the records are often incomplete. 

Many in the fresh produce industry have not implemented the labeling designed by their own industry’s Produce Traceability Initiative. A common reason is that the labels would cost more.

Questions that remain unanswered as of this afternoon’s news conference, many because of the traceability problems, include:

Q. Is the outbreak over?
A. More cases are expected to be identified because of the lag time of two to three weeks between when a person becomes sick and the time it takes for lab tests, confirmation tests, reporting to local and state officials, and finally reporting to the CDC. There may also be new infections developing from unknown and possible ongoing distribution of Yuma-area romaine.

Q. Can you guarantee that the Yuma harvest is finished and no romaine is being shipped from that area?
A. No. Industry tells us the Yuma season is over and harvest has moved to California, but we haven’t been able to confirm that yet.

Q. Are any of the two dozen other growers’ fields adjacent to the Harrison Farm romaine field?
A. We don’t have those records yet.

Q. Is there a common irrigation water source for any of the fields?
A. We don’t have those records yet.

Q. What is the specific location of the Harrison Farm field that is implicated?
A. We don’t have that information yet.

Q. Is Harrison Farm growing or shipping any other fresh produce or more romaine?
A. The FDA does not have any information at this point to suggest that any other produce in involved. Harrison Farm is currently growing grass in its romaine field.

Q. Are there any common processors or shippers among the other farms you are investigating?
A. We haven’t received all of those records yet. We are looking at all points in the supply chain, from growers to the restaurants and retailers, as is the practice for all outbreak investigations.  

This one’s for Lou

This is completely off topic, and I apologize to anyone who is annoyed, bothered or disturbed.

Nevertheless, I cannot contain my excitement at the release of my latest mystery, The Gold Dragon Caper.

Phyllis Entis's avatarPhyllis Entis

Louis Lutsky was a reader.

Newspapers, mystery novels, general fiction, whatever. My Dad read them.

It was Dad who read bedtime stories to me, over and over again, until I was old enough to read them for myself. Truth be told, I had memorized the stories long before I was able to read the words. Dad used to ‘accidentally’ skip a sentence or a page, and would laugh when I corrected him.

It was Dad who drilled me in my weekly spelling homework. His pronunciation was sometimes challenging, resulting in my shedding a few tears as I insisted on spelling ‘study’ the way he pronounced it. At last, exasperated, he corrected me. “Steady,” he said, “S-T-U-D-Y.” I believe he treasured the gold stars I received in my weekly spelling quizzes even more than I did.

It is only fitting, therefore, that I release my new novel on what would have…

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FDA gives Darwin’s pet food owners 15 days to clear up issues

Adulterated pet food, dead kitten, use of unapproved additive spur FDA warning letter

The FDA issued a formal warning letter to Arrow Reliance Inc. doing business as Darwin’s Natural Pet Products, citing pathogen problems at a production plant and saying scientific evidence shows the company’s cleaning solution is ineffective.

Darwin’s is a manufacturer of raw pet foods and is based in Tukwila, WA.

The April 2 warning letter from the Food and Drug Administration cites a history of consumer complaints and product recalls leading to the agency’s analysis of several Darwin’s products. Laboratory tests detected Salmonella, Listeria monocytogenes and E. coli O128 in one or more samples of the pet foods.

Foods under FDA jurisdiction, including pet foods, are deemed to be adulterated if they bear or contain a poisonous or deleterious substance that may render them injurious to health, according to the Federal Food, Drug, and Cosmetic Act (the Act). Introduction of an adulterated food into interstate commerce is a prosecutable violation of the Act.

Federal officials also found two Darwin’s products were also contaminated with Listeria innocua. Although it is not considered a pathogen in terms of human health, the warning letter underscored that the presence of Listeria innocua is an indicator that Listeria monocytogenes would be capable of surviving and growing in the product.

One of the consumer complaints that triggered the FDA investigation was lodged by the owner of a kitten that died as a result of a “severe systemic Salmonella infection” after being fed Darwin’s Natural Selections Duck Meals for Cats. 

Salmonella was isolated from the dead kitten’s liver and from an unopened raw pet food package. Whole Genome Sequencing (WGS) analysis, often referred to as genetic fingerprinting, confirmed that the Salmonella recovered from the dead kitten and from the pet food sample were identical.

FDA also performed WGS analysis on Salmonella recovered from various other Darwin’s samples. The identical Salmonella strain was found in two different products manufactured two weeks apart and containing two different meat sources. 

The presence of the identical Salmonella in these two products, according to the warning letter, suggests pathogen contamination in Darwin’s manufacturing facility.

In the letter, FDA also expressed its concern regarding Darwin’s use of a bacteriophage product to control pathogens in the raw pet foods, citing a lack of scientifically based validation of the controls and a change in the company’s protocol for applying the bacteriophage to the products.

The agency noted that the bacteriophage product is not “generally recognized as safe” (GRAS) nor is it the subject of a regulation describing additives permitted in animal foods.

The company was given 15 business days to reply to the warning letter, with a description of the steps taken to correct the violations and prevent these or similar violations from occurring in the future. 

This story first appeared in Food Safety News and is reposted here with permission.