Food Safety News

All the following stem from the temporary January closure of a popular restaurant called DaVinci’s at 150 Mill Street in Lewiston, Maine:

—Tonight, the Lewiston City Council will likely notify Commissioner Jeanne M. Lambrew of Maine’s Center for Disease Control and Prevention, terminating the City’s agreement with the state for City inspection services of restaurants within the City.

—The Lewiston City Council will also likely approve a supplemental FY24 budget adjustment to rescind the funding for the Certified Sanitation Inspector/Code Enforcement Officer who did those restaurant inspections for the remainder of the fiscal year.

—The City of Lewiston has already placed Planning and Code Enforcement Director Dave Hediger on immediate administrative leave, which is part of the “continued fallout,” according to local media, over the recent temporary closure of DaVinci’s.

—The person whose position and funding are being eliminated is  Louis Lachance, the city’s long-time restaurant inspector who holds the sanitation inspector position, getting the axe tonight.

No official record explaining why DaVinci’s was closed has been made public.  Closures only occur when something is causing a severe threat to human health.

DaVinci’s co-owner Craig Tribuno told local media that someone had reported seeing a cockroach in the restaurant’s kitchen.  From Social Media posts, the closure appears to have begun on Jan. 8, and the re-opening came a week later on Jan. 15.

Tribune said the closure cost the restaurant $80,000, and he wanted assurance from the City that it wouldn’t happen again. Neither he nor City elected officials said what led to the closure or what the $80,000 bought

No restaurant inspection reports have been made available for this incident, but earlier reports for DaVinci’s are posted on the City’s code enforcement website.   And DaVinci’s failed a 2019 inspection conducted by Lachance.

A failed inspection is one with more than three critical violations or more than 10 non-critical violations.  A failing establishment gets re-inspected within 30 days or less. All critical violations must be corrected within ten days. 

DaVinci’s 2019 violations were extensive but did not require the restaurant’s closing.    Closures under the 2013 Maine Code occur only when a food service establishment is found to pose an imminent health hazard to public health. DaVinci passed its re-inspection in 2019, and the last regular inspection was in early 2022.

With a population of not more than 40,000, Lewiston has been one of three cities contracted by Maine to do restaurant inspections. It has about 175 establishments.  Ironically,  the Lewiston City Council signed its current agreement with the state only last Nov. 14.

But just 69 days later, the Lewiston City Council will likely trigger the 30-day termination clause, meaning Maine CDC is on its own.

A city building inspector, writing on Facebook, said:  “The message being received is that if I do my job well, I might no longer have a job.  Imagine going to work with that feeling.”

Immediate action by the non-partisan government could not be taken against Lachance because a union contract covered him.  However, if his position and funding Are eliminated after tonight’s council meeting, those details might not count for much.

Hediger, the planning and code enforcement director, has worked for Lewiston for 25 years.  Lachancee said Hediger is “the hardest working employee at the city.”

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The number of E. coli, Salmonella, Campylobacter, and Listeria infections has gone up in Ireland, according to 2022 data from the Health Protection Surveillance Centre (HPSC).

During the COVID-19 pandemic, reporting rates for giardiasis, listeriosis, norovirus, rotavirus, salmonellosis, shigellosis, and toxoplasmosis in Ireland decreased compared to pre-pandemic levels. Still, rates for campylobacteriosis, cryptosporidiosis, E. coli, and yersiniosis increased or remained unchanged. In 2022, most of these diseases returned to or remained at pre-pandemic levels.

A 2021 cyber-attack at the Health Service Executive (HSE) also affected data validation and collection, reporting of enhanced data variables, and outbreak notification.

Campylobacter and Salmonella stats
In 2022, 3,617 Campylobacter cases were recorded. The incidence rate increased by 13 percent compared with 2021, after a rise of 23 percent between 2020 and 2021. Rates in 2021 and 2022 were the highest recorded in recent years and remained largely unaffected by the pandemic, apart from a slight decrease in 2020. In 2022, reporting rates were above the EU average.

The highest incidence rate was among those younger than 5, with males accounting for 61 percent of cases in this age group. The rate increased across all age groups 2022 except among 5-9 and 10-14-year-olds. The highest number of notifications was reported in June, with 474.

Ireland had between zero and three outbreaks a year from 2019 to 2022. In 2022, outbreaks ranged in size from two to 11 cases, with a median of three people ill.

342 Salmonella infections were recorded in 2022, and 142 people were hospitalized. The reporting rate in Ireland remained lower than the EU average.

The incidence rate decreased in 2020 and 2021 during the pandemic. In 2022, it almost doubled from 2021 but was similar to pre-pandemic rates.

The highest incidence rate was among less than one to 4 year olds. Salmonella Typhimurium, including monophasic Salmonella Typhimurium and Salmonella Enteritidis, were the most common serotypes 2022. Other frequently seen types included Newport, Poona, Mbandaka, and Infantis. Salmonella Enteritidis was more likely among travel-associated cases, but it was Salmonella Typhimurium among domestic infections.

In 2022, 99 patients reported being infected outside Ireland. Spain, Portugal, and Turkey were the most common countries among travel-associated cases.

Seventeen outbreaks were reported in 2022, up from 11 and six in 2020 and 2021. Three were national incidents, including 16 cases that were part of the Ferrero Kinder chocolate multi-country outbreak. Another Salmonella Typhimurium outbreak affected 27 people, but the source was not found.

E. coli and Listeria figures
980 E. coli cases were recorded in 2022, and 322 people were hospitalized. The notification rate remained higher than the EU average. In 2022, only the rate in Denmark was higher than in Ireland.

Key risk factors for infection include private well water, animal/environmental exposures, and attending a childcare facility. Food and international travel play minor roles, said HPSC.

Four deaths occurred among cases in 2022; the infection did not cause two, while the cause of death was not known for the other two. All people who died were older than 60.

In 2022, the incidence rate for E. coli increased by 3 percent compared to 2021. The highest rate was among less than one to 4-year-olds, followed by those more than 65 years old.

The top serogroup among culture-confirmed cases was O26 on 232 occasions, followed by O157 164 times. Other common serogroups were O145, O146, O103, and O91. Infections caused by E. coli O26 were more common earlier in the year, peaking in June, while those caused by O157 were more common later in the year.

Twenty-four cases of hemolytic uremic syndrome (HUS) were reported. Ten were O26, and six were O157, while O103, O145, O5, and O55 caused one case each.

Seventy-eight E. coli outbreaks were notified, with 208 people ill, compared to 62 outbreaks in 2021.

There were 18 cases of listeriosis in Ireland in 2022. Notifications decreased to six in 2020 but returned to usual levels in 2021 and 2022. Notification rates in 2022 were half the average rate in Europe.

In 2022, the highest incidence occurred in people older than 65 years old. There were also two cases in the less than 1 to 4-year age group. There was one pregnancy-related listeriosis notification each year in 2022, 2021 and 2020.

Ireland also recorded three cases each of Clostridium perfringens and Bacillus cereus and two of botulism in 2022. A total of 17 Yersinia infections were reported. Hepatitis A fell from 82 cases in 2021 to 66 in 2022.

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Updated figures for antimicrobial resistant (AMR) E. coli, Campylobacter, and Salmonella on chicken and turkey meat in the United Kingdom have been released.

A survey covered 306 fresh raw chicken and 302 turkey meat samples collected at retail in the UK from January to December 2022. A report was produced by the Animal and Plant Health Agency (APHA) under contract from the Food Standards Agency (FSA). Findings continued monitoring E. coli and Campylobacter and produced new baseline prevalence data on AMR Salmonella in chicken and turkey.

The prevalence of Extended Spectrum Beta Lactamases (ESBLs) and AmpC E. coli in chicken and turkey meat was 12 percent. The prevalence of ESBLs in E. coli from chickens was similar to the 2020 survey of 13 percent. For Turkey, there was no change from the 2020-21 survey.

Mcr-1 colistin-resistant E. coli was detected in 1 percent of both meat samples. Seven of the eight positives came from imported meat. It was the second time that MCR-1 had been found in E. coli in chicken and turkey meat on retail sale in the UK.

Campylobacter and Salmonella results
The prevalence of Campylobacter in chickens was 48 percent, but only 5 percent in turkeys. High levels above 1,000 colony-forming units per gram (CFU/g) were detected in 17 chicken samples. The highest was 25,700 CFU/g in whole chicken. Campylobacter jejuni was detected in 143 chicken samples, Campylobacter coli in 17 samples, and both species were found 15 times.

Ciprofloxacin and tetracycline resistance was common in chicken and turkey Campylobacter isolates. Resistance to ciprofloxacin is a concern as it is one treatment option for campylobacteriosis in people. Resistance to chloramphenicol, erythromycin, and gentamicin was not detected.

Salmonella was found in six chicken and two turkey samples. No isolates were ESBL- or carbapenemase-producers. Salmonella Paratyphi B variant Java was isolated from a chicken breast with meat origin from the Netherlands. Other isolates were Agona four times and Infantis, London, and Mbandaka all once. Except for one Agona isolates in a turkey breast from the UK, all were from chicken of UK origin.

• Multidrug resistance (MDR) was observed in a Salmonella Agona isolate from a turkey breast, which showed resistance to ampicillin, gentamicin, and tetracycline. Another Salmonella Agona isolates from a chicken leg was resistant to ampicillin. As ampicillin, sulfamethoxazole, and tetracycline have been commonly used in veterinary medicine, the findings are not unexpected.

E. coli, Campylobacter, Salmonella, and AMR were detected in chicken and turkey samples. However, they were raw meat intended to be cooked. Proper cooking will destroy microorganisms and reduce the risk for consumers.

Food handler knowledge
Meanwhile, another survey found four in five UK food handlers had heard of antimicrobial resistance (AMR). Half of respondents said they knew at least a little about it, and over a quarter stated they knew much about AMR.

Participants were 500 workers who handled food or touched surfaces likely to be in contact with food. They completed a survey between June and July 2022. Workers were shown a list of eight statements about AMR and one about antibiotics, of which some were true and others false. 

Findings suggested that food handlers’ levels of awareness and understanding of AMR were lower than those of consumers.

“It appears that some food handlers aren’t aware of the key food handling/preparation activities that can limit the spread of AMR,” said a survey report.

Food handlers more commonly identified meat, poultry, and seafood as sources of AMR over salad and fruits. About three in 10 incorrectly believed that washing chicken before cooking can protect against the spread of AMR.

Managerial food service staff and kitchen staff had similar levels of awareness across most areas.

Women and older respondents had higher levels of knowledge in terms of correctly categorizing statements and when identifying correct sources of and ways to protect against the spread of AMR.

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The FDA’s largest reorganization in history, involving about 8,000 employees, is far more than just “moving some boxes around.”  The proposed changes and updates to an FDA-wide reorganization plan have been out for external reviews and clearances since Dec. 13, 2023, and implementation should occur sometime during 2024.

A “Unified Human Food Program(HFP)” functional risk model is at the center of the reorganization. FDA will manage public health risks  through three areas of focus:

• nutrition, microbiological food safety, and chemical safety. Its strategic management functions leverage data to better prioritize activities and resources based on risk.

• surveillance strategy, risk-informed decision framework, and resource management for HFP and related field activities. So-called cross-cutting functions are the “tools” supporting risk management priorities.

• integrated food safety system partnerships, laboratory operations and applied science, compliance and enforcement, policy, and communications and engagement.

The Reagan Udall Foundation in 2022 evaluated FDA food programs, finding outside criticisms were justified and required fixing.

FDA Commissioner Robert Califf, who took over the agency for a second time on Feb. 17, 2022, ordered work to begin that May on the FDA-wide reorganization plan.  Califf previously served as Commissioner of Food and Drugs from February 2016 to January 2017. 

The Alliance for a Stronger FDA recently gathered FDA staff who helped draft the reorganization plan. They included:

• Deputy Commissioner Janet Woodcock, 

• Chief Scientist Namandje Bumpus, 

• Deputy Commissioner for Human Food Jim Jones, 

• Acting CFSAN Director Donald Prater.

*Deputy Commissioner for Operations Jim Sing

*Commissioner for Regulatory Affairs Michael Rogers, M.S.

The reorganization was submitted for review by the Department of Health and Human Services (HHS), which houses the FDA. Others might get involved, from the Office of Management and Budget (OMB) to the various public employee unions.

Janet Woodcock, the former acting FDA Commissioner, emphasized how far-reaching the reorganization will affect nearly every FDA unit.  The authors of the plan say it not only improves the human food program but also overall efficiency.

A new Office of Inspections and Investigations (OII) is at the center of changes.

The reorganization itself was said to be “budget neutral.”

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— OPINION —

If you recall, two weeks ago, I launched my column, “The Litigated Dish,” with the goal of addressing the Internet’s most frequently asked food safety questions. I kind of veered off topic last week when I discussed the most startling recent foodborne illness outbreaks, but I’m back on track. 

We already delved into one of the top Google searches: the top foodborne pathogens. 

Another super popular question is whether foodborne illness is contagious. 

This question, however, is quite broad because – which foodborne illness? There are several bacteria, viruses, and parasites that can cause foodborne illness. I thought I would put together a neat little table of some of the pathogens I frequently encounter, their food sources, and whether they are contagious.

Hope it helps.

PathogenCommon food sourcesContagious?NorovirusProduce, shellfish, and any food contaminated by someone who is infected with the virusYes, highly contagious. Some people may be contagious for as long as two weeks after recovery. SalmonellaA wide variety of foods, including raw and undercooked eggs, undercooked meat and poultry, produce, and pet foodYes. You can get a Salmonella infection from another person or even from your pet. If you have been infected, you can spread Salmonella for as long as you carry the bacteria in your bowel, which may be months after you stop having any symptoms.E. coliUndercooked ground beef, unpasteurized milk and juices, produce and sprouts, contaminated water, animals and their environment, feces of infected peopleYes, contagious for at least as long as the person has diarrhea, and sometimes longer. E. coli bacteria can be spread from humans and animals. C. perfringensMeat, poultry, gravies, and food cooked in large batches and held at an unsafe temperatureNo.CampylobacterUndercooked poultry, raw milk, untreated waterNot usually, but it can happen if the infected person does not thoroughly wash their hands after using the bathroom. Infected people will continue to pass the bacteria in their feces for a few days to a week or more.ListeriaUnpasteurized dairy products, deli meats, smoked fish, pates or meat spreadListeria is not contagious from person to person, but the bacteria may be passed from mother to fetus during pregnancy or directly to the newborn at the time of birth.Botulism (C. botulinum)Improperly prepared home-canned foodsNo.Staphylococcus aureusCooked foods high in protein (e.g., cooked ham, salads, bakery products, dairy products) that are held too long at room temperatureNo. But people who carry Staph can contaminate food if they don’t wash their hands before touching it. If food is contaminated with Staph, the bacteria can multiply in the food and produce toxins that can make people ill.ShigellaSalads, untreated water, and any food handled by someone who is infected with the bacteriumYes, highly contagious. Shigella foodborne outbreaks are most often associated with contamination by a sick food handler.Vibrio spp.Raw or undercooked seafood, particularly shellfishNo.Hepatitis ARaw or undercooked shellfish, produce, unclean water, and any food contaminated with an infected food handlerYes, highly contagious.It can be spread from close, personal contact with an infected person, caring for someone who is ill, or using drugs with others. Hepatitis A is very contagious, and people can even spread the virus before they feel sick.CyclosporaProduceUnlikely.Cronobacter sakazakiiLow-moisture, dry foods, like powdered infant formula, powdered milks, starches, and herbal teasUnknown. Experts do not know if it spreads from person to person.

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As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems.

Lone Star Botanicals Inc.

Tyler, TX

A food firm in Texas is on notice from the FDA after an inspection at its food manufacturing facility found violations of various federal regulations, including unapproved new drugs and misbranded drugs, hazard analysis and risk-based preventive controls, and misbranded foods.

In a Nov. 6, 2023 warning letter, the FDA described an April 17-21, 2023 inspection of Lone Star Botanicals Inc.’s food manufacturing facility in Tyler, TX.

The FDA’s inspection found serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation.

They determined that the ready-to-eat (RTE) seasoning products manufactured in the firm’s facility are adulterated as they were prepared, packed, or held under insanitary conditions where they may have become contaminated with filth or rendered injurious to health. 

After the inspection, FDA investigators issued a Form 483 (FDA-483), Inspectional Observations.

Some of the significant violations are as follows:

Unapproved New Drugs and Misbranded Drugs

FDA reviewed the firm’s website at the Internet address https://drbotanicalhealth.com/ in July 2023 and Oct. 2023 and has determined that they take orders there for their Dr. Botanicals Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, Marine Collagen, Organic Cordyceps Mushroom Based Superfood Powder, Organic Acai Plant Based Superfood Powder, Organic Inulin Prebiotic Fiber Superfood Powder, Organic Chaga Mushroom Based Superfood Powder, Organic Maca Plant Based Superfood Powder, Organic Reishi Mushroom Based Superfood Powder, and Organic Rhodiola Rosea Plant Based Superfood Powder. 

In addition, FDA reviewed the firm’s product labels collected during the inspection for their Dr. Botanical Health products Organic Ashwagandha Plant Based Superfood Powder, Organic Elderberry Plant Based Superfood Powder, Organic Lion’s Mane Mushroom Based Superfood Powder, and Organic Cordyceps Mushroom Based Superfood Powder, as well as their Dr. Botanical Health Product Brochure, which directs consumers to their website https://drbotanicalhealth.com/ to purchase their products. The claims on their website, product labels, and product brochure establish that the products are drugs because they are intended for use in the cure, mitigation, treatment or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.

Examples of some of the website claims that provide evidence that their products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Anti-inflammatory”
o “It’s known to help reduce anxiety ….”
o “It…reduces anxiety and depression ….”
o “Ashwagandha powder can help reduce inflammation ….”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “Helps Fight Colds & the Flu”
o “It’s often used as a folk remedy for…the common cold and flu … helping allergies and sinus infections, treating diarrhea ….”
o “It also has anti-inflammatory properties, which makes it useful for treating allergies and sinus infections … scientifically proven to be effective at treating colds and flu, particularly at the onset of a cold or flu.”
o “Various studies have shown that it can be effective as a natural remedy for preventing and treating colds and flu … Not only can elderberry help prevent colds and flu, but it can also be used to treat allergies, including hay fever, and sinus infections. It’s thought to be particularly effective against allergies and sinus infections ….”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o From the list of hyperlinked “Tags” on the product page:
    “anxiety”
    “depression”
o “Rich in medicinal properties, Lion’s Mane mushrooms are thought to guard against dementia, reduce mild depression and anxiety, and help speed up recovery from injuries to the nervous system. Our extract powder can also help to regulate diabetes ….”
o “The lions mane mushroom contains a variety of compounds… [that] have anti-inflammatory, anti-cancer…properties.”
o “Lion’s mane mushrooms have been used medicinally for…skin diseases…reduce inflammation…. They are also used to help treat skin conditions such as psoriasis and eczema, as well as mental health conditions such as depression and anxiety.”

• Dr. Botanical Health Marine Collagen

o “Stabilizes blood sugar”
o “Reduces inflammation”
o “This powerful supplement is proven to stabilize blood sugar…reduce inflammation….”
o “[I]t can…reduce inflammation….”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o From the list of hyperlinked “Tags” on the product page:
    “anti-inflammatory”

Examples of some of the claims on their product labels that provide evidence that their products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Contains Anti-Tumor Properties”
o “Anti-Inflammatory”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “Contains Ant-Inflammatory Properties”
o “Helps Fight Infections Like Cold & Flu”
o “Fights Harmful Bacteria”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o “Helps Combats [sic] Depression, Anxiety & Stress”
o “Anti-Inflammatory”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o “Anti-Inflammatory”

Examples of some of the claims on their Dr. Botanical Health Product Brochure that provide evidence that their products are intended for use as drugs include:

• Dr. Botanical Health Organic Ashwagandha Plant Based Superfood Powder

o “Ashwagandha. …reduces anxiety and depression ….”

• Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder

o “The phytochemicals found in elderberries are known to fight infection, particularly in the respiratory system. High in antioxidants, it lowers cholesterol ….”

• Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder

o “Medicinally, Lion’s Mane mushrooms are thought to protect from dementia, reducing mild depression and anxiety, and increase recovery from nervous system injuries.”

• Dr. Botanical Health Marine Collagen

o “Marine Collagen is a powerful supplement proven to…reduce inflammation….”

• Dr. Botanical Health Organic Cordyceps Mushroom Based Superfood Powder

o “The benefits of this adaptogen also extends to fighting inflammation.”

• Dr. Botanical Health Organic Acai Plant Based Superfood Powder

o “Acai also helps lower cholesterol levels ….”

• Dr. Botanical Health Organic Inulin Prebiotic Fiber Superfood Powder

o “It is known for aiding in…constipation, diarrhea, and diabetes!”

• Dr. Botanical Health Organic Chaga Mushroom Based Superfood Powder

o “The health benefits of these mushrooms…include…lowering cholesterol, blood sugar and blood pressure…and fight unhealthy inflammation.”

• Dr. Botanical Health Organic Maca Plant Based Superfood Powder

o “Maca may also help…lower blood pressure ….”

• Dr. Botanical Health Organic Reishi Mushroom Based Superfood Powder

o “[T]hese mushrooms lower cholesterol, reduce allergic reactions ….”

• Dr. Botanical Health Organic Rhodiola Rosea Plant Based Superfood Powder

o “[T]his herb has been traditionally used to reduce anxiety, depression ….”

Hazard Analysis and Risk-Based Preventive Controls:

1. The firm did not prepare, or have prepared, and implement a food safety plan. The preparation of the food safety plan must be overseen by one or more preventive controls qualified individuals (PCQIs). Their food safety plan must also include the following:

1) The written hazard analysis;
2) The written preventive controls;
3) The written supply-chain program;
4) The written recall plan;
5) The written procedures for monitoring the implementation of the preventive controls;
6) The written corrective action procedures; and
7) The written verification procedures.

However, the firm did not have a food safety plan with any of the required elements. For example, they did not conduct a hazard analysis to identify and evaluate known or reasonably foreseeable hazards for each type of food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control. Also, they did not identify and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated or misbranded. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. Preventive controls are subject to preventive control management components (monitoring, verification, and corrective actions) as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system. The firm must also validate that the preventive controls are adequate to control the hazard as appropriate to the nature of the preventive control and its role in the facility’s food safety system. Specifically:

a. The firm did not identify and evaluate allergens as a known or reasonably foreseeable hazard to determine whether allergens are a hazard requiring a preventive control. Their facility manufactures RTE seasoning products that contain allergens (such as milk) which are processed using the same utensils on the same production day as products that do not contain milk. Therefore, allergens are a known or reasonably foreseeable hazard. A knowledgeable person manufacturing/processing food in their circumstances would identify allergens as a hazard requiring a preventive control. Food allergen controls include procedures, practices, and processes employed for ensuring protection of food from allergen cross-contact (including during storage, handling, and use) and for labeling to ensure that all food allergens required to be stated are included on the label.

The firm do not have controls in place for allergen cross-contact or perform and document the review of labels for proper declaration of allergens. For example, they do not identify ingredients used in the seasonings that contain allergens to prevent allergen cross-contact during manufacturing. The John Paine’s Steak Beast Unleashed All Purpose Rub, Net. Wt. 12oz. bears a label that contains an allergen statement that reads in part: “***Contains Dairy.***”; however, the ingredient list for this product did not include butter powder as an ingredient, which contains a major allergen, milk.

b. For their RTE seasoning products, they did not identify and evaluate contamination with environmental pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether it is hazard requiring a preventive control. The firm’s facility manufactures RTE seasoning products which are exposed to the environment during blending and filling. The packaged food does not receive any further lethal treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. A knowledgeable person manufacturing/processing food in their circumstances would identify contamination with environmental pathogens as a hazard requiring a preventive control. Sanitation controls include procedures, practices, and processes to ensure that the facility is maintained in a sanitary condition adequate to significantly minimize or prevent hazards such as environmental pathogens and biological hazards due to employee handling. In addition, note that environmental monitoring is required if contamination of an RTE food with an environmental pathogen is a hazard requiring a preventive control .

The firm does not have appropriate controls in place for contamination with environmental pathogens. They stated that they use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility. They further stated that they do not use any sanitizers at their facility, such as for food-contact surfaces.

c. The firm did not identify and evaluate bacterial pathogens, such as Salmonella, as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures RTE seasoning products made from onion powder, garlic powder, white pepper, paprika, cayenne pepper and celery powder which have been associated with vegetative bacterial pathogens such as Salmonella. A knowledgeable person manufacturing/processing food in their circumstances would identify bacterial pathogens as a hazard requiring a preventive control. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as Salmonella, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities.

The firm does not have an appropriate supply-chain program in place. For example, they do not approve suppliers or conduct appropriate supplier verification activities for the manufacturing of John Paine’s Steak Beast Unleashed All Purpose Rub (Lot: JPUL230216004), which consists of salt, brown sugar, onion powder, garlic powder, white pepper, black pepper, paprika, cayenne pepper, celery powder, and hickory smoke seasoning. Salmonella in RTE seasoning products is a hazard that can cause serious adverse health consequences or death and thus an annual onsite audit is the appropriate supplier verification activity unless there is a written determination that other verification activities and/or less frequent onsite auditing of the supplier provide adequate assurance that the hazard is controlled. The audit must be conducted before using the raw material or other ingredient from the supplier and at least annually thereafter.

d. The firm did not identify and evaluate mycotoxins as a known or reasonably foreseeable hazard to determine whether they require a preventive control. Their facility manufactures and repackages RTE seasoning products made from white pepper, cayenne pepper, and paprika. These ingredients have been associated with mycotoxins. A knowledgeable person manufacturing/ processing food in their circumstances would identify mycotoxins as a hazard requiring a preventive control in these ingredients. Further, a facility that identifies raw materials and other ingredients that require a supply-chain-applied control, such as mycotoxins, must establish and implement a risk-based supply-chain program for those raw materials and ingredients. The supply-chain program must include using approved suppliers and conducting supplier verification activities. The firm does not have this program in place.

Misbranded Foods

1. The firm’s John Paine’s Steak Beast Unleashed All Purpose Rub product is misbranded in that the finished product label fails to declare the major food allergen “milk.”

2. The firm’s John Paine’s Steak Beast Beasty Bird is misbranded in that the product label fails to bear the common or usual name of the food. The statement of identity “Beasty Bird” is not provided by law or regulation, is not the common or usual name of a food, and is not appropriately descriptive.

3. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded because the products bear or contain an artificial coloring but do not bear labeling stating that fact. Specifically, the formulation for Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub lists “color – orange” as an ingredient, and the Beasty Bird formulation lists “color – red” as an ingredient. However, none of the product labels declare the artificial color in the ingredient statements. Note that if these color additives are certified, they must be declared.

4. The firm’s John Paine’s Steak Beast Beasty Bird, Unleashed All Purpose Rub, Steak Seasoning, and Pork Rub products are misbranded in that the products are fabricated from two or more ingredients and each ingredient is not declared on the label in descending order of predominance by weight in the finished food.

5. The firm’s John Paine’s Steak Beast Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub products are misbranded in that they fail to list the name and place of business of the manufacturer, packer or distributor.

6. The firm’s John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, Unleashed All Purpose Rub), and Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products are misbranded in that the nutrition information (e.g., Nutrition Facts label, “NFL”) is not in accordance with the requirements. 

7. The firm’s John Paine’s Steak Beast products (Beasty Bird, Chop Beast Pork Rub, Steak Seasoning, and Unleashed All Purpose Rub) are misbranded because the labels fail to declare the net quantity of contents on the principal display panel.

8. Even if the firm’s Dr. Botanical Health Organic Elderberry Plant Based Superfood Powder and Dr. Botanical Health Organic Lion’s Mane Mushroom Based Superfood Powder products were not unapproved new drugs and misbranded drugs, they are misbranded because the product labels bear nutrient content claims, but the products do not meet the requirements to bear such claims. A claim that characterizes the level of a nutrient which is of the type required to be in the labeling of the food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product.

The full warning letter can be viewed here.

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The European Union has launched a campaign in the United States to promote food and beverage products.

The communication campaign highlights the safety, quality, and authenticity of European products.

The EU is the third largest supplier of agricultural and agri-food products to the United States after Mexico and Canada.

Product categories featured include cheeses, olive oil, fruits and vegetables, chocolate and confectionery products, pasta and bakery products, wine, beer, and spirits.

The EU has several quality schemes, including Protected Designation of Origin (PDO) and Protected Geographical Indication (PGI), to protect the names of specific products and to promote their features. Items are tied to these origins and cannot be reproduced elsewhere. For PDO-designated products, every part of the production, processing and preparation process must take place in the specific region, while PGI is less strict.

Use of pesticides, herbicides, additives, flavorings, and enzymes is regulated in the 27 EU member states. There are strict health and safety standards across the supply chain – from field to the consumer – covering areas from pesticides to packaging, disease prevention and hygiene.

More information can be found at events in March such as Charleston Wine + Food and South by Southwest in Texas or Vinexpo in New York in June, and the American Cheese Society conference in Buffalo in July.

State aid to Czech Republic
Meanwhile, the European Commission has approved two Czech schemes with a budget of around €1.46 billion ($1.6 billion) to help prevent the spread of certain poultry and pig diseases.

Czech Republic notified the EU Commission of plans to support farmers in preventing the diseases and adopting biosecurity measures. The aim is to stop the spread of avian influenza, Salmonella and poultry campylobacteriosis, and porcine brucellosis, porcine reproductive and respiratory syndrome, and salmonellosis.

Measures will run until December 2029 and are open to small, medium and large farmers in the Czech Republic who put in place steps for disinfection, extermination of insects and rats and other biosecurity measures.

Aid will be direct grants to support the additional costs of cleaning of farm premises and equipment, treatment of feed and water and veterinary interventions. It will cover up to 50 percent of eligible costs.

“These €1.46 billion Czech schemes will ensure the production of healthy and safe food. They will support farmers in adopting measures to prevent the spread of certain animal diseases, and will contribute to achieving the EU agricultural objective of ensuring long-term food security, without unduly distorting competition,” said Margrethe Vestager, executive vice-president in charge of competition policy.

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The Food and Drug Administration continues using import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and modifies the alerts as needed.

Recent modifications to FDA’s import alerts, as posted by the agency, are listed below. 

Click here to go to the FDA page with links to details on specific alerts.

Click on table to enlarge. Use link above to go to specific FDA page with links to specific alerts.

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— OPINION —

In the United States as of today, a total of 407 people infected with one of the outbreak strains of Salmonella were reported from 44 states (Alaska 1, Arizona 15, Arkansas 2, California 56, Colorado 11, Connecticut 2, Florida 4, Georgia 8, Illinois 22, Indiana 9, Iowa 12, Kansas 2, Kentucky 10, Maryland 9, Massachusetts 2, Michigan 7, Minnesota 29, Mississippi 1, Missouri 15, Montana 3, Nebraska 7, Nevada 8, New Hampshire 1, New Jersey 8, New Mexico 2, New York 14, North Carolina 7, North Dakota 1, Ohio 14, Oklahoma 4, Oregon 8, Pennsylvania 5, Rhode Island 1, South Carolina 10, South Dakota 2, Tennessee 7, Texas 30, Utah 12, Vermont 1, Virginia 8, Washington 4, West Virginia 3, Wisconsin 29, Wyoming 1). Illnesses started on dates ranging from October 15, 2023, to December 25, 2023. Of 362 people with information available, 158 (44%) were hospitalized. Six deaths were reported

In Canada as of December 22, there have been 164 laboratory-confirmed cases of Salmonella Soahanina, Sundsvall and Oranienburg illness linked to this outbreak in the following provinces: British Columbia (18), Alberta (4), Ontario (21), Quebec (111), Prince Edward Island (2), New Brunswick (2), Nova Scotia (4) and Newfoundland and Labrador (2). Additional Salmonella infections are under investigation and more illnesses associated with this outbreak may be confirmed. Individuals became sick between mid-October and early December 2023. Sixty-one (61) individuals have been hospitalized. Seven deaths have been reported.

The true number of sick people in this outbreak was likely much higher than the number reported, and the outbreak may not have been limited to the states with known illnesses. This is because many people recover without medical care and are not tested for Salmonella.

CDC, public health and regulatory officials in several states, and the U.S. Food and Drug Administration (FDA) investigated a multistate outbreak of Salmonella (Sundsvall and Oranienburg) infections. Epidemiologic, laboratory, and traceback data showed that cantaloupes were contaminated with Salmonella made people sick. Whole Genome Sequencing analysis shows that clinical isolates from the ill people in are genetically related to the ill people in the United States and Canada. FDA’s traceback investigation is ongoing but has identified Sofia Produce, LLC dba TruFresh of Nogales, AZ; Crown Jewels Produce of Fresno, CA; and Pacific Trellis Fruit dba Dulcinea of Fresno, CA as suppliers of the potentially contaminated “Malichita” or “Rudy” brand cantaloupes.

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That Arctic blast in Nebraska last week that caused a congressman to write the Secretary of Agriculture about whether a local Tyson pork plant was left without  USDA inspectors did prompt a response  from the Food Safety and Inspection Service (FSIS)

“All FSIS in-plant personnel understand their essential role in providing inspection services to protect public health,” an FSIS spokesman said. “However, FSIS firmly believes that the health, safety, and welfare of our inspection personnel is paramount and must be considered together with production needs during severe weather events.”

“ FSIS routinely coordinates with establishments, including in this instance, in advance of any severe weather situations to establish a plan that considers both the safety of establishment and FSIS in-plant personnel and inspection needs,” the spokesman continued. “FSIS and the establishment were in communication and agreed that on Jan. 15, FSIS would provide an inspector for the processing side of the establishment, but no slaughter operations would occur due to hazardous driving conditions.”

The Tyson pork plant in Madison, NE, returned to full operations on Jan. 16.

Local news coverage has clarified the severity and impact of the recent snowstorm in Eastern Nebraska, including the Madison area, with the storm creating “life-threatening blizzard weather conditions.” 

In response to the extreme conditions created by the storm, Nebraska Gov. Jim Pillen declared a state of emergency and urged Nebraskans to stay home. Roads in northeast Nebraska were still largely closed Monday morning, creating challenges for employees to get to work.

On Jan. 15,  U.S. Congressman Mike Flood, R-NE, wrote Secretary of Agriculture Tom Vilsack about what he said were “troubling reports” about USDA Food Safety and Inspection Service personnel not reporting for work at the Tyson Pork Plant in Madison, NE.

“Let me be clear,” Flood wrote. “This is unacceptable and must be remedied immediately.” 

Flood’s letter did not mention any complaints or communication he might have received from Tyson managers about any missing USDA inspectors — still, no pork for human consumption may be produced without  USDA inspectors being present.

Still, the weather was not bothering Flood nearly as much as shift-missing inspectors.

“If our communities can show up to work, the USDA can too,” he wrote. “Our pork producers are ready and waiting; our plant wants to operate; the USDA must step up to the plate and fulfill its mission to serve rural America.”

Flood did say the safety of Nebraskans is his “top priority,” and he understands “taking necessary steps” in light of “challenging weather.”

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Public health officials in Sweden are investigating an outbreak of Cryptosporidium infections.

The Public Health Agency of Sweden (Folkhälsomyndigheten) said it was trying to find the source of the outbreak caused by the parasite cryptosporidiosis.

Since mid-December 2023, 68 people from 14 regions have been infected. The majority of patients are from Halland and Jönköping.

Of cases, 72 percent are women, the average age is 41 and 79 percent are in the age group 21 to 60 years old. Data shows the latest case of illness onset was early January.

Typing of some samples showed that 13 of 18 belonged to the same type of Cryptosporidium, which indicates that patients have a common source of infection, said health officials.

Hoping interviews give a clue

Livsmedelsverket (the Swedish Food Agency) and affected local infection control units are also attempting to find the source, which is suspected to be some type of fresh food.

Information about what outbreak cases ate before becoming ill is gathered via interviews and the collection of questionnaires. Answers will be compared to what people in a healthy comparison group have eaten to assess whether there are foods that outbreak cases have consumed to a greater extent than the comparison group.

In October 2023, goat milk cheese was suspected to be the source of an outbreak of cryptosporidiosis in Sweden that sickened seven people. The incidents are not thought to be linked.

In 2022, 716 cryptosporidiosis cases were reported in the country. A peak in infections is usually seen in late summer and autumn. The majority of reported cases were infected in Sweden and 146 people were infected abroad.

Six cryptosporidium epidemics sickened 208 people. Epidemiological investigations in one outbreak pointed towards contaminated lettuce in ready-to-eat green leaf-mixes as the probable cause of infection.

The incubation period varies from two to 12 days. Symptoms, which normally last for up to two weeks, include moderate to severe watery diarrhea, low-grade fever, cramping abdominal pain, nausea and vomiting.

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— OPINION —

As of January 17, 2024, a total of 47 people infected with the outbreak strain of Salmonella have been reported from 22 states – Arizona 2, Colorado 1, Connecticut 1, Idaho 1, Illinois 1, Kentucky 1, Maryland 1, Michigan 1, Minnesota 1, Missouri 1, Nebraska 3, New Jersey 1, New York 4, Ohio 11, Oregon 1, Pennsylvania 3, Texas 3, Utah 1, Vermont 1, Virginia 1, Washington 5, Wisconsin 2. Illnesses started on dates ranging from November 20, 2023, to January 1, 2024. Of 38 people with information available, 10 have been hospitalized. No deaths have been reported.

State and local public health officials are interviewing people about the foods they ate in the week before they got sick. Of the 26 people interviewed, 19 (73%) reported eating a variety of charcuterie meats.

Fratelli Barretta recalled a single lot of the Busseto brand Charcuterie Sampler because of testing by Minnesota that identified Salmonella in the product.

While the outbreak is ongoing, CDC is advising not to eat, serve, or sell any lot of Busseto brand Charcuterie Sampler from Sam’s Club or Fratelli Beretta brand Antipasto Gran Beretta from Costco.

Sam’s Club and Costco have removed these products from their stores.

The Salmonella outbreak traced to cantaloupe that sickened more than 400 and killed six in the Unites States has been declared over.

The Centers for Disease Control and Prevention closed its investigation today, as did the Food and Drug Administration. The outbreak stretched across 44 states and sickened 407 people. Six deaths were reported. The CDC first reported the outbreak on Nov. 17.

Of the 362 patients with information available, 158 were hospitalized. This 44 percent hospitalization rate is higher than in most Salmonella outbreaks, suggesting a particularly virulent strain of the pathogen.

Illnesses started on dates ranging from Oct. 15, 2023, to Dec. 25, 2023. State and local public health officials interviewed people about the foods they ate in the week before they got sick. Of the 197 people interviewed, 135 reported eating cantaloupe.

The patients ranged from less than 1 year old to to 100 years, with a median age of 60. An unusually high percentage of the patients were 5 years or younger, with 26 percent of patients reported in that age group. Forty-seven percent of the patients were 65 years old or older.

The CDC reports that many more people were likely part of the outbreak but are not reflected in the official patient count. This is because many people do not seek medical attention and those who do are often not specifically tested for Salmonella infection. For every person confirmed as a patient in a Salmonella outbreak, the CDC says another 29 patients go unidentified. This means as many as 11,800 patients or more could have been part of this outbreak.

It was determined that Rudy and Malichita whole cantaloupe from Mexico were the problem. They were recalled.

Numerous cantaloupe and cantaloupe products were recalled in relation to the outbreak. There is a list of those products on FDA’s cantaloupe recall website

There is some concern that some consumers may have frozen cantaloupe pieces for future use. The CDC recommends that any cantaloup of unknown origin be thrown away.

Canadian outbreak
A simultaneous outbreak in Canada had sickened 164 people as of the most recent update on Dec. 22. Sixty-one of the patients have required hospitalization and seven have died.

The same brand of cantaloupe in Canada as in the United States has been implicated in the outbreak, Rudy and Malichita whole cantaloupe. As was the case in the United States, numerous freshcut cantaloupe products have been recalled because they were made with the recalled cantaloupe.

The outbreak strain of Salmonella from patients in Canada matches samples taken from patients in the United States. In Canada most of the patients were younger than 5 years or 65 and older.

The outbreak investigation in Canada is ongoing.

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Salmonella illnesses associated with ready-to-eat (RTE) charcuterie meat products in Busseto brand Charcuterie Sampler and Fratelli Beretta brand Antipasto Gran Beretta have the federal government out with dual alerts.

Both USDA’s Food Safety and Inspection Service (FSIS) and the Centers for Disease Control and Prevention (CDC) overnight warned about the Fratelli Beretta brand Antipasto Gran Beretta was sold at Costco in a 24-oz. twin-pack (two 12-oz. trays) and the Busseto brand Charcuterie Sampler was sold at Sam’s Club in an 18-oz. twin-pack (two 9-oz. trays). 

An investigation since Jan. 5 has identified 47 Salmonella illnesses in 22 states, with 10 reported hospitalizations associated with these products.  New additions to the report include 23 illnesses in eight more states with five new hospitalizations.

Any lot code associated with either product is potentially contaminated. The products are no longer available at Costco and Sam’s Club but could be in-home freezers.

The products of concern bear establishment numbers “EST. 7543B” and “EST. #47967” inside the USDA mark of inspection or printed on the package. FSIS is working with the CDC and state public health partners to investigate the multi-state outbreak. Onset dates ranging from November 20, 2023, through January 1, 2024, were found by the ongoing outbreak investigation, 

Minnesota identified the outbreak strain from an unopened Busseto brand charcuterie sampler, which led to recall 01-2024 on January 3, 2024. 

About Salmonella

Food contaminated with Salmonella bacteria does not usually look, smell, or taste spoiled.

Anyone can become sick with a Salmonella infection. Infants, children, seniors, and people with weakened immune systems are at higher risk of serious illness because their immune systems are fragile, according to the CDC.

Anyone who has eaten recalled products and developed symptoms of Salmonella food poisoning should seek medical attention. Sick people should tell their doctors about the possible exposure to Salmonella bacteria because special tests are necessary to diagnose salmonellosis.

 Salmonella infection symptoms can mimic other illnesses, frequently leading to misdiagnosis. Symptoms of Salmonella infection can include diarrhea, abdominal cramps, and fever within 12 to 72 hours after eating contaminated food. Otherwise, healthy adults are usually sick for four to seven days. In some cases, however, diarrhea may be so severe that patients require hospitalization.

Older adults, children, pregnant women, and people with weakened immune systems, such as cancer patients, are more likely to develop severe illness and serious, sometimes life-threatening conditions. Some people get infected without getting sick or showing any symptoms. However, they may still spread the infections to others.

 Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or send a question via email to MPHotline@usda.gov. For consumers who need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

Investigators are working to determine if any additional products may be contaminated.

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Consumer exposure to inorganic arsenic in food raises health concerns such as skin cancer, according to the European Food Safety Authority (EFSA).

In a risk assessment, EFSA considered the increase in skin cancers associated with inorganic arsenic exposure as the most relevant harmful effect. Experts concluded that ensuring protection against skin cancer will also be protective against other potential effects.

EFSA calculates a margin of exposure (MOE) for consumers when assessing genotoxic and carcinogenic substances unintentionally in the food chain. This is a ratio of the dose at which a small but measurable adverse effect is observed and the level of exposure to a substance for a given population. A low MOE represents a greater risk than a higher one.

Based on data from human studies, an MOE of 1 or less would correspond to an exposure level to inorganic arsenic that might be associated with an increased risk of skin cancer. In adults, the MOEs are low – ranging between 2 and 0.4 for average consumers and between 0.9 and 0.2 for high consumers. Experts said they were 69 percent certain that high consumers of inorganic arsenic may have an increased risk of developing skin cancer.

Arsenic is a contaminant that is present naturally and as a result of human activity. Food is the main source of exposure to inorganic arsenic for people in Europe. The main contributors to dietary exposure are rice, rice-based products, and grains and grain-based products. Drinking water also contributes, although levels are usually low in Europe.

Association with certain cancers

Findings confirm results from EFSA’s previous assessment of the risks linked to inorganic arsenic in food from 2009. EFSA’s Panel on Contaminants in the Food Chain (CONTAM) concluded the minimum amount of inorganic arsenic that produced a low-level health risk lied between 0.3 and 8 µg/kg of body weight (bw) per day.

The European Commission asked EFSA for an update considering new studies on toxic effects. EFSA consulted with stakeholders on its draft opinion and considered comments.

In the latest work, the CONTAM Panel concluded that low to moderate exposure to inorganic arsenic can cause some cancers and other issues such as stillbirth, congenital heart disease, neurodevelopmental effects, respiratory disease, chronic kidney disease, decreased birth weight, and skin lesions.

Epidemiological studies showed the chronic intake of inorganic arsenic via diet or drinking water was associated with an increased risk of cancers of the skin, bladder, and lungs. 

EFSA’s assessment established a reference point of 0.06 µg/kg bw per day based on a case-control study on skin cancer. This is an estimate of the lowest dose that could be associated with increased induction of skin cancer after exposure to inorganic arsenic and is lower than the 2009 figure.

Dietary exposure estimates for inorganic arsenic were 0.03 to 0.15 μg/kg bw per day for average and 0.07 to 0.33 μg/kg bw per day for European high-level adult consumers.

A risk assessment of combined exposure to inorganic and organic arsenic will be available by 2025.

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Health officials in Israel have sanctioned the sale of cultivated beef made by Aleph Farms.

Israel’s Ministry of Health has issued regulatory approval for Aleph Cuts in the form of a “No Questions” letter.

The first Aleph Cut to be introduced to diners in Israel — the cultivated Petit Steak — will be made of non-modified, non-immortalized cells of a Black Angus cow and a plant protein matrix from soy and wheat. Aleph Farms did not say when the product would be available.

While “cell-based,” “cultivated,” and “cultured” are preferred terminologies, other terms such as “in vitro,” “artificial,” “fake,” “clean,” and “lab-grown” have been used.

In December 2020, chicken nuggets were approved in Singapore using Eat Just’s cultivated chicken. However, Italy has banned cell-based meat. In June 2023, Upside Foods and Good Meat received backing from the USDA to sell cultivated chicken products.

The Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) published a report in 2023 on the food safety aspects of cell-based food.

First cultivated beef approval

Didier Toubia, CEO and co-founder of Aleph Farms, praised Israel’s approach to cellular agriculture.

“We believe that addressing joint challenges like food security is the best way to ensure the prosperity of the Middle East and other parts of the world that rely heavily on massive food imports, especially in Asia,” he said.

Aleph Farms said no antibiotics are used in production. A controlled and traceable process, including an aseptic production environment, increases transparency and reduces the risk of contamination. 

Yifat Gavriel, chief of regulatory affairs, quality assurance, and product safety at Aleph Farms, said 2024 could be a landmark year in regulating and commercializing cultivated meat.

“This approval grants us permission to produce and market our product in Israel, subject to specific directions for labeling and marketing provided by the Israeli Ministry of Health and the completion of a Good Manufacturing Practices (GMP) inspection for our pilot production facility.”

Cultured meat is a novel food that must be approved to protect public health. Each application is examined individually since companies have different technologies, production processes, and products.

Dr. Ziva Hamama, food risk management department director at Israel’s Ministry of Health, said the regulatory approval of bovine cell-based food boosts the country’s position in cellular agriculture.

“This regulatory milestone…reflects a comprehensive assessment of crucial factors, from toxicology and allergens to nutritional composition, microbiological safety, and chemical safety throughout the entire production process – from the initial cell isolation to processing and packaging.”

Bruce Friedrich, founder, and president of the Good Food Institute, said: “This announcement marks a critical leap in the global race to make the meat that people love in a way that’s better for our climate, biodiversity, and food security. We’re thrilled that consumers in Israel will soon be able, like those in the U.S. and Singapore, to purchase these delicious products.”

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Wayne Hsiung is a well-known California animal activist and himself a lawyer, but he won’t have a fool for a client in his appeal of a felony conviction and 90-day jail term.

That’s because Hsiung won’t be representing himself but will be represented by the University of Denver Law School attorneys involved in the Animal Activist Legal Defense Project.

Hsiung co-founded Direct Action Everywhere (DxE), the activist organization heavily involved in the events subject to the litigation.

The DU campus unit may be best known for bringing down dozens of state laws that tried to make private undercover investigations of animal abuse illegal. Their federal court victories resulted in virtually all those laws being found unconstitutional.

Hsiung was sentenced to 90 days in jail and 24 months of probation after being convicted of felony conspiracy and misdemeanor trespass charges in November, following an 8-week trial including six days of jury deliberation.

“Substantial prejudicial and reversible error occurred in Hsiung’s trial,” said Animal Activist Legal Defense Project Staff Attorney Chris Carraway, who is representing Hsiung on appeal.  “Stunningly, Judge Passaglia prohibited the jury from knowing the full scope of animal cruelty at these companies as well as the activists’ extensive efforts to obtain law enforcement of animal cruelty laws. Thus, Hsiung could not explain the intent behind his actions–a crucial element of the alleged crimes. Likewise, Judge Passaglia improperly prohibited Hsiung from mounting a necessity defense, though nothing in California law prohibits the applicability of necessity to animal rescue. We are optimistic about the reversal on appeal.”

Carraway also noted that trial participants were unconstitutionally gagged from the beginning of the trial, and press access was significantly curtailed.

California’s “Right to Rescue Act” allows anyone to enter a vehicle to rescue an animal from “circumstances that could reasonably be expected to cause suffering, disability, or death to the animal.”  DxE’s rescues and Hsiung’s defense are part of a broad effort to extend the “Right to Rescue” beyond vehicles to allow rescue from commercial industrial facilities.

Hsiung’s prosecution stemmed from two open rescues at Sonoma County farms–major egg producer Sunrise Farms and Reichardt Duck Farm, California’s largest duck farm. Activists returned with 37 chickens and 32 ducks, getting them veterinary care and “rehoming” them to sanctuaries. While both farms market themselves as “humane,” DxE did not think so and claimed systemic violations of animal cruelty laws. 

 After Hsiung’s sentencing in November,  three more activists were arrested on multiple felonies and misdemeanors while attempting to report once again evidence of unlawful animal cruelty at Sonoma County farms.

“California proudly enacted the strongest animal welfare law in the country, and its Right to Rescue Act allows literal breaking to rescue dogs,” said Hsiung. “But billions of animals suffer while animal cruelty laws go unenforced and the state prosecutes rescuers for giving aid to animals who are on the brink of death. We are working to ensure that all animals are protected from suffering and have the right to be safe, happy, and free.”

The Animal Activist Legal Defense Project at DU’s Sturm College of Law works to empower and defend animal advocates through activist defense, affirmative litigation, and training law students to join and transform the field of animal law. 

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Late Thursday, USDA’s Food Safety and Inspection Service (FSIS) issued a public health alert for the Dim Sum Factory Inc. in Flushing, N.Y., which produced and distributed raw, frozen pork dumpling products without the benefit of federal inspection.

A recall was not requested because the products are no longer available.

The raw, frozen pork wonton dumpling products were produced on various dates since September 6, 2023, and have a shelf life of 18 months. The following product is subject to the public health alert.

• 1.5-lb. vacuum-packed packages containing “GOGO DUMPLING Pork & Shepherd’s Purse Wontons (Handmade).”

The products bear the establishment number “EST. 1656” inside the USDA mark of inspection. These items were shipped to a distributor in New York and sold online nationwide.

The problem was discovered during routine FSIS surveillance activities. FSIS determined that the location where the pork wonton products were being produced was not on the official premises of the establishment and, therefore, was not inspected.

There have been no confirmed reports of adverse reactions due to consumption of these products. Anyone concerned about an injury or illness should contact a healthcare provider.

FSIS is concerned that some products may be in consumers’ freezers. Consumers who have purchased these products are urged not to consume them. These products should be thrown away or returned to the place of purchase.

Consumers with food safety questions can call the toll-free USDA Meat and Poultry Hotline at 888-MPHotline (888-674-6854) or live chat via Ask USDA from 10 a.m. to 6 p.m. (Eastern Time) Monday through Friday.

Consumers can also browse food safety messages at Ask USDA or send a question via email to MPHotline@usda.gov. For consumers who need to report a problem with a meat, poultry, or egg product, the online Electronic Consumer Complaint Monitoring System can be accessed 24 hours a day at https://foodcomplaint.fsis.usda.gov/eCCF/.

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Biery Cheese Company of Louisville, OH, is recalling Member’s Mark – Mild Cheddar Fancy (Fine) Shredded Cheese because of foreign material in the product, specifically glove remnants. 

According to the details posted by the FDA, the recall was initiated on Dec. 18, 2023, and is ongoing.

The recalled products were distributed in Illinois, Indiana, Missouri and Ohio.

Recalled products:

• Member’s Mark – Mild Cheddar Fancy (Fine) Shredded Cheese 
• Packaged in 5lbs, 8 packages per case
• Product Quantity: 320 cases
• Code Information: Run # 36699681 Lot # 0506242331218 Product # 15401 Catalog # 980225088 Manufacturer # 39-211 
• Best By 06 May 2024

Recalled products should be thrown out or returned to their place of purchase.

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The Fillo Factory Inc. of Northvale, NJ, is recalling Wellsley Farms Assorted Mini Quiches because of possible foreign material in the product, specifically aluminum.

According to the details posted by the FDA, the recall was initiated on Dec. 28, 2023, and is ongoing.

The recalled products were sent to distribution centers in Florida and Connecticut and then further distributed to retail stores in New York, Florida, Maine, South Carolina, Connecticut and Massachusetts. 

Recalled products:

• Wellsley Farms Assorted Mini Quiches NET WT 36 OZ (2LB 4 OZ) 1.02kb Keep Frozen 
• UPC: 8867002630. 
• Packaged in plastic trays in a cardboard box. 2 sealed trays in a box, 10 boxes per case
• Product Quantity: approximately 3412 retail units
• Code Information: 3483 BEST BY: 06/14/2025

Recalled products should be thrown out or returned to their place of purchase.

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