Pre-cooked lobster with a side order of Listeria

Greenhead Lobster Products LLC‘s (Greenhead) ready-to-eat (RTE) seafood processing facility in Bucksport, Maine, suffers from a chronic environmental contamination with Listeria monocytogenes, according to information extracted from US Food and Drug Administration’s website.

The persistent presence of the pathogen in the production environment has been known to the company and the FDA for at least the last two years.

First inspection: 2020

The FDA first visited the Bucksport facility in December 2020, issuing a list of adverse Inspectional Observations (FDA Form 483) upon completion of the inspection.

According to the agency’s inspection citations database, the FDA investigators cited four violations, including:

Failure to implement the monitoring procedures listed in the company’s HACCP plan;
Failure of the HACCP plan to list the food safety hazards that are reasonably likely to occur;
Failure to monitor the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices including prevention of cross-contamination from insanitary objects; and
A corrective action plan not in accordance with regulatory requirements to ensure that a potentially hazardous product is not entered into commerce.

Second inspection: 2021

After giving Greenhead a grace period of several months to bring its food safety programs into compliance, the FDA performed a follow-up inspection in September-October 2021.

During the 2021 inspection, FDA investigators conducted extensive environmental sampling of the facilities production areas, including food-contact surfaces, and found Listeria monocytogenes in a floor drain.

Upon reviewing the company’s environmental monitoring records, the agency noted the presence of thirteen (13) recurring L. monocytogenes positive swabs between May 2021 and August 2021 from the RTE (ready-to-eat) processing room, including eleven (11) swabs collected from food-contact surfaces.

Although the company’s records indicated that the relevant areas were cleaned and sanitized following each positive finding, Greenhead did not conduct any root cause analysis to establish and eliminate the source or sources of the contamination.

Recall #1

On October 2, 2021, while the FDA inspection was still in progress, Greenhead initiated a voluntary product recall, encompassing 5,749 lbs. of frozen cooked lobster meat. The recall cited a “…potential for contamination … noted after a routine sampling program by the company revealed the presence of Listeria monocytogenes.”

Once again, the FDA issued a Form 483 upon completion of the inspection, this time classifying the situation as “Official Action Indicated.”

Warning Letter

On January 24, 2022, after exchanges of communcations regarding the company’s plans for correcting the various deviations, the FDA issued a formal Warning Letter, giving Greenhead a deadline to respond to all outstanding issues.

The Warning Letter reiterated the list of observations included in the Form 483, providing examples to support each item. These included:

Ongoing serious concerns with the company’s HACCP plan
Ongoing concerns about the company’s inability to control Listeria monocytogenes in the production environment
Significant deviations from requirements of the Seafood HACCP plan
Insufficient monitoring of sanitation conditions and practices during processing
Inadequate control of the hazard of Clostridium botulinum in high pressure processed (HPP) lobster products.

Third inspection: 2022

In July 2022, the FDA returned to Bucksport yet again to follow up on Greenhead’s response to the Warning Letter.

And yet again, the company’s performance was found wanting.

The Form 483 issued upon completion of the July 2022 inspection listed four main concerns:

Greenhead’s HACCP plan did not list the food safety hazards that were reasonably likely to occur
The HACCP plan listed a critical limit that failed to ensure control of one or more hazards
The company did not take corrective action to prevent potentially hazardous product from entering into commerce, and did not correct the cause of the deviation
The company was not monitoring sanitation conditions and practices with sufficient frequency to ensure compliance with current Good Manufacturing Practices.

At the close of inspection, company management agreed to make the necessary corrections and the FDA classified the results of the inspection as “Voluntary Action Indicated.”

Fourth inspection: 2023?

Recall #2

Just over one year later, on October 20, 2023, Greenhead announced another voluntary product recall, this time encompassing “…all frozen and refrigerated cooked lobster meat products produced from May 9, 2023, through October 19, 2023.”

The reason given for the recall was the presence of Listeria monocytogenes in the production environment.

Although the environment was contaminated, the pathogen was not found in finished products, and there were no illnesses associated with the recalled products.

The recall encompassed eleven ready-to-eat, refrigerated or frozen lobster products. Please refer to the recall notice for a detailed list of affected products.

The recall notice made no reference to the FDA. Nor has the FDA posted information on a 2023 inspection in its Inspection Citations database.

Nevertheless, past experience suggests that another follow-up inspection is either still in progress or has been completed recently.

What next for Greenhead Lobster Products?

Although constituted as a regulatory agency, the FDA has a history and a philosophy of giving the food companies it regulates multiple chances to self-correct.

Sometimes, this works well. Other times, it does not.

Greenhead has now been inspected on at least three (and possibly four) separate occasions, and its HACCP and sanitation programs were found wanting each time.

The FDA has the power to demand compliance (via a Warning Letter), to mandate recalls (when circumstances demand), and even to shut down a facility by suspending its registration.

Except for the issuance of a Warning Letter, the agency rarely makes use of these regulatory powers.

Will Greenhead prove to be one of those rare occasions, or will the FDA sit on its hands until one or more illnesses are linked to the company’s products?

Stay tuned.

TAINTED formats 3 — “Reads like a true crime novel” – Food Safety News

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Chapter 6. Birth of a Pathogen

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A Short Excerpt

Something Rotten in the State of Iowa

The CDC first became aware of an unusual rise in Salmonella Enteritidis infections in July 2010. Epidemiological and traceback investigations pointed the finger of suspicion at two Iowa-based suppliers of shell eggs: Quality Egg, LLC (also known as Wright County Egg) and Hillandale Farms of Iowa, Inc.

Alerted by the CDC, the FDA began a detailed inspection of Quality Egg on August 12th. They encountered an egg-laying farm overrun with rodents and birds. Henhouses and buildings used to store feed grain were in a state of disrepair, with manure seeping through the concrete foundation of one of the laying houses. Uncaged chickens ambled across an eight-foot high pile of manure to access the egg-laying area.

The situation confronting inspectors when they began their inspection of Hillandale Farms on August 19th was just as bad. Uncaged hens tracked manure into the henhouses, some of which had structural damage. There was standing water adjacent to the manure pit, and liquid manure was leaking into one of the henhouses.

It surprised no one when environmental samples collected at both Quality Egg and Hillandale Farms tested positive for Salmonella Enteritidis.

Quality Egg announced a recall on August 13th, and expanded the scope of the recall on August 18th. Hillandale followed suit with its own recall notice on August 20th.

TAINTED

From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures

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TAINTED

From Farm Gate to Dinner Plate, Fifty Years of Food Safety Failures

Salmonella in eggs. Listeria in deli meats. Melamine in milk. Cyclospora in lettuce.

In a world where irrigation water is contaminated by run-off from cattle feedlots and where food processors cut corners, the food preparation skills we learned from our parents and grandparents are no longer good enough to keep us safe.

Using a variety of foodborne disease outbreaks, often illustrated with the stories of individual victims, TAINTED explores the ways in which food becomes contaminated. Some of the stories – such as the deadly 1993 Jack in the Box outbreak – will be very familiar. Others will not.

In this update to her 2007 book, Food Safety: Old Habits, New Perspectives, Phyllis Entis draws on nearly five decades of experience to explain how our regulatory systems have failed us, and to talk about what can be done to protect consumers from unsafe food.

About the Author

A graduate of McGill University and the University of Toronto, Phyllis Entis received her introduction to the field of food safety at the hands of Canada’s Health Protection Branch, where she spent the first seven years of her professional life immersed in Salmonella, Staphylococcus, E. coli and other bad actors from the microbial world.

Entis left government work to co-found (with her husband) QA Life Sciences, a company specializing in rapid testing methods for foodborne bacteria. For the next twenty-two years, she worked closely with representatives of Health Protection Branch, the US Food and Drug Administration and various state agencies to gain official sanction for the use of rapid testing methods in government and industry settings.

In 2001, Entis turned to writing. Her first book, Food Microbiology—The Laboratory, was published in 2002 by the Food Processors Institute. It was followed five years later by Food Safety: Old Habits, New Perspectives, which was released by the American Society for Microbiology Press in January 2007.

Since 2007, Entis has written about food safety issues for several publications, including Food Safety News, The Bark, and eFoodAlert. She has also found the time to write and release a 5-book mystery series, The Damien Dickens Mysteries.

In TAINTED, Entis has combined her decades of experience in food safety with the story-telling skills honed during her career as a mystery writer to revamp and update the wealth of information contained in Old Habits, and to produce a food safety narrative that is both educational and accessible.

A Short Excerpt

Chapter 3 – Betrayal

Sarah Lewis and her entire family attended a celebratory dinner at a local restaurant on May 29, 2010 to mark her sister Stacey’s college graduation. The next night, Sarah’s world turned upside down.

Already feeling unwell on the evening of May 30th, Sarah went to bed early. She awakened during the night, suffering from vomiting and severe diarrhea. The next day, Sarah’s mother, who lived nearby, took her to an urgent care facility. Twenty minutes later, she was admitted to hospital and was later diagnosed with salmonellosis.

Badly dehydrated and in enormous pain from her inflamed bowels, Sarah was moved to the hospital’s ICU. While there, she developed severe tachycardia (abnormally rapid heartbeat), and was moved to the critical care heart unit, where she spent three days.

When Sarah was finally discharged in time to attend her daughter’s preschool graduation, she thought the worst was behind her.

About 2½ weeks later, she was back in the hospital, still suffering from severe dehydration. She was released after five days.

The antibiotics Sarah took to combat her Salmonella infection stripped her digestive system of its normal population of protective bacteria, resulting in her becoming infected with Clostridium difficile (C. diff), a bacterium which causes severe diarrhea and cramping. A fourteen-day antibiotic regimen took care of the C. diff; however, the Salmonella was more resilient. Four months later, Sarah still was on five to ten different medications daily to combat the infection and control her symptoms.

Sarah Lewis was the first recorded California victim of a Salmonella Enteritidis outbreak that sickened more than 1,900 people across the United States.

The restaurant where Stacey’s graduation banquet was held had purchased custard tarts from a local bakery. Ordinarily, the bakery used a pasteurized liquid egg mixture to make the tarts. However, on the day they prepared the dessert items for the graduation dinner, the bakery ran out of pasteurized egg mix and used fresh, raw shell eggs instead. Eggs that most likely had come from Iowa.