Feed aggregator

A Norwegian company has revealed that it sold frozen salmon for several years, which was not suitable for human consumption.

Findings come from an internal investigation by the board of Pure Norwegian Seafood (PNS) into suspected irregularities in the sale of frozen salmon. Prior regulatory inspections, controls, and audits had not discovered the issues.

The board of PNS said it first suspected something at the end of October 2023. The sale of frozen salmon was halted, affected products were recalled, and the frozen salmon storage was sealed. Two individuals in the company were suspended. 

There are no reports of related illness

PNS was found to have sold frozen salmon that, according to Norwegian regulations, is not suitable for human consumption. This includes self-dead fish, floor fish, and sexually mature fish. The sale of these categories is illegal. Affected fish should have been discarded or subject to secondary processing before export.

Experts commissioned by PNS thawed frozen salmon of the types sold from the warehouse and examined them. No samples tested positive for Salmonella. The percentage of samples with Listeria monocytogenes was higher than what was expected. Listeria was only detected on the outside of fish. There are no reports that anyone’s health has been affected. 

Sales occurred to around 20 customers, especially in Eastern Europe. Findings from the investigation suggest these firms were aware of what they were buying and asked for frozen salmon in these categories. It has not been possible to determine what happened to the final products.

Estimates suggest that sales of salmon not fit for human consumption constituted just under 1 percent of the total volume of fish in PNS between 2020 and 2023, amounting to around 500 tons.

PNS also exported fish without it being processed domestically according to regulations. This kind of salmon is not unfit to eat but has external damages that must be corrected in Norway before export. The investigation indicated that between 300 and 400 tons of production fish had been exported in the past four years.

Findings ‘serious and disappointing’
The Norwegian Food Safety Authority (Mattilsynet) was notified early in November. Authorities have also been informed about the findings and conclusions.

“This is a very serious matter. The investigation is not a verdict and does not give final answers, but it documents surprising and disappointing activities. Considerable work has been done to address these issues, and we are continuing those efforts,” said Helge Kvalvik, chair of the board at PNS.

“The most severe issue, in our opinion, is that the investigation uncovers systematic and concealed sales of salmon that should not have gone to human consumption. Upon request, specific customers can purchase frozen salmon that is self-dead, damaged, sexually mature, or so-called floor fish.

“In addition, production fish has been exported. This category of salmon is suited for human consumption but must be processed and corrected in Norway before export, according to Norwegian regulations.”

Måsøval acquired 65 percent of PNS in June 2021. Kvalvik is also the CEO of Måsøval, which has been a supplier of salmon to PNS. 

“These activities have been kept concealed. Neither the board of PNS, Måsøval as a supplier, nor the auditors have discovered it until now. There have been inspections and controls from the Norwegian authorities in recent years, but the activities have not been possible to uncover.”

Remy Strømskag, acting CEO of PNS since October 2023, said it had been a hard few months for everyone working there.

“It is tough to acknowledge that the company has exported frozen salmon that does not meet our standards. This should have been reported and addressed earlier. We are working together to ensure that something like this will never happen again.”

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Nam & Son of MD of Jessup, MD, has expanded a recall of one-pound bags of soybean sprouts, with the sell-by date of Dec. 21, 2023, because testing has shown contamination with Listeria monocytogenes.

The product was distributed to retail stores in Maryland on Dec. 14, 2023, according to the company’s recall notice posted by the FDA on Feb. 1, 2024.

The affected product is packaged in 1-pound plastic bags labeled under the Nam & Son of MD DBA Sam Sung S & M Food and have a “Sell By” date of Dec. 21, 2023.

No illness has been reported to date in relation to the product. However, it can take up to 70 days after exposure for symptoms of Listeria infection to develop.

The recall was initiated after a random sample was collected and analyzed by the state of Maryland, which resulted in confirmation of presence Listeria Monocytogenes in the product. The company has actively started investigating the root cause of the problem. 

All retail stores who have this “Sell By” date on the packaging should remove this product from their shelves. Consumers should not consume the products and should discard this product or return them to the place of purchase for a full refund.

Consumers should contact their health provider with any illness concerns. Consumers with questions about the warning may contact Nam & Son at 443-896-6738.

Link to First Recall

About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled product and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.

Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop. 

Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses. 

Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.

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A bipartisan pair of U.S. Senators have introduced legislation banning the National School Lunch Program (NSLP) from including cell-cultivated meat products on its menu.

The NSLP is the federally assisted meal program in public and nonprofit private schools and residential childcare institutions. It serves more than 4,9 billion lunches annually to more than 30 million children in about 100,000 schools.

U.S. Senators Mike Rounds, R-SD, and Jon Tester, D-MT, are sponsoring The School Lunch Integrity Act of 2024 to prevent lab-grown protein from being served in the School Lunch and Breakfast Programs.

Cell-grown meat has been in the active research and development stage since around 2013 but is not yet available in any commercial sense.

Rounds and Tester want to ban NSLP from offering lab-grown meat because USDA has not published any guidance on cell-cultivated protein. In addition, they argue that there is a lack of demonstrated studies showing the safety of lab-grown meat.

“Our students should not be test subjects for cell-cultivated ‘meat’ experiments,” said Rounds. “South Dakota farmers and ranchers work hard to produce high-quality beef products. These products are often sold to South Dakota schools, where they provide the necessary nutrition to our students. With high-quality, local beef readily available for our students, there’s no reason to serve fake, lab-grown meat products in the cafeteria. I’m pleased to introduce this bipartisan legislation that benefits South Dakota producers and protects students from the unknown effects of cell-cultivated ‘meat’ products.”

“Montana ranchers grow the best meat in the world, that’s a fact – and our students ought to be getting the best in their school breakfasts and lunches daily,” said Tester. “This commonsense bill will ensure our schools can serve real meat from our ranchers, not a fake substitute grown in a lab.”  

The two “cattle-country” Senators have successfully united the Top 3 associations behind the bill.  The legislation is endorsed by the U.S. Cattlemen’s Association, R-CALF USA, and the National Cattlemen’s Beef Association.

“The federal government should not allow lab-grown protein in school lunch and breakfast programs without knowing the long-term health effects on children,” said Ethan Lane, Vice President of Government Affairs at the National Cattlemen’s Beef Association. “The lack of nutrition and allergen research related to lab-grown proteins creates unnecessary risks for children, while traditional beef provides essential nutrients that benefit children. School cafeterias are not test labs, and we appreciate Senator Rounds and Senator Tester for standing up for our children and cattle producers.”

As the Senate’s only working farmer, Tester has led the charge to support Montana ranchers and increase competition for American family farms and ranches. Last year, Tester introduced bipartisan legislation to ban Paraguayan beef imports and suspend Brazilian beef imports until experts can systematically review the commodity’s impact on food safety and animal health. Tester has repeatedly pressed USDA Secretary Tom Vilsack on suspending Brazilian beef imports to the U.S. and addressing consolidation in the ag industry, citing that JBS – one of the four big packers controlling more than 80 percent of the beef industry – is based in Brazil. 

Tester has also introduced his bipartisan Cattle Price Discovery and Transparency Act to increase market transparency by establishing minimums for negotiated sales and requiring transparent reporting of marketing contracts. His Meatpacking Special Investigator Act to combat anticompetitive practices in the meat processing industry by appointing a USDA special investigator with subpoena power to enforce the nation’s anti-trust laws. Last January, Tester introduced his bipartisan American Beef Labeling Act to reinstate mandatory country of original labeling (MCOOL) for beef.

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A multi-year outbreak of Listeria infections traced to peaches, nectarines, and plums has been declared over by the Centers for Disease Control and Prevention.

In its final update, the CDC reported that the seven-state outbreak had sickened 11 people and killed one. One of the patients was pregnant and went into pre-term labor.

All of the patients except one were hospitalized. The CDC says many more people were likely sickened in the outbreak but were not reported because they did not seek medical attention or were not tested explicitly for Listeria.

Listeria infection can be challenging to diagnose, and it can be hard to identify outbreaks because symptoms can take up to 70 days after exposure to develop. Patients are generally identified through testing because of symptoms. They are interviewed about the foods they ate before becoming ill.

Analysis showed that people in this outbreak were 18 times more likely to eat peaches, nectarines, or plums than sick people not in this outbreak. Sick people’s samples were collected from Aug. 22, 2018, to Aug. 16, 2023.

“On Oct. 23, 2023, the FDA collected a sample of HMC Farms peaches for testing and found Listeria. On Nov. 6, 2023, whole genome sequencing showed that the Listeria in the peaches were closely related to bacteria from sick people. This means that people likely got sick from eating those peaches,” according to the CDC’s final outbreak report. 

On November 17, 2023, HMC Farms recalled whole peaches, plums, and nectarines sold in stores between May 1 and November 15 in 2022 and 2023.

This outbreak is an example of how whole genome sequencing can identify outbreak patients separated by long periods. Using the technique, investigators can match new cases with previous ones by comparing samples in a database. Then, finding a match between contaminated food and a patient sample reveals the source of an outbreak.

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The European Commission has extended restrictions on imports of bivalve mollusks from Turkey.

The measures for bivalve mollusks, such as clams, oysters, and mussels, will now apply until the end of December 2026.

The short shelf life of live and chilled bivalve mollusks effectively rules out testing at the border. This means imports are banned. Consignments of frozen and processed bivalve mollusks are tested for marine biotoxins, and shipments of frozen mollusks are tested for E. coli.

Measures were introduced following DG Sante audits, which identified problems in implementing official controls by Turkish authorities on the production of bivalve mollusks sent to Europe and member states’ reports of non-compliant consignments from Turkey due to microbiological concerns.

Onsite audits in 2022 and 2023 identified persistent deficiencies in the official control system for bivalve mollusks. Checks revealed structural food safety shortcomings within Turkish establishments approved for exporting these products to the EU.

If existing protective measures were lifted, these unresolved issues would pose significant food safety risks for products exported from these premises, said the EU Commission.

In January 2020, Turkish authorities sent information on corrective measures to address the problems found in a 2015 audit. These had been assessed favorably on paper.

An extension of the measures for three years aims to allow Turkey to address the recommendations from previous audits and for these actions to be assessed by the EU Commission.

Approved control plans and import changes
Several changes have also been made to the list of countries with approved control plans, allowing them to export various products of animal origin to Europe.

Israel told the Commission that it is no longer interested in sending eggs to the EU, so the legislation needed updating.

Jamaica has not submitted a control plan for honey, but Morocco and Rwanda have done so. As these plans provide sufficient guarantees, they should be approved, but Jamaica’s entry has been removed.

Following a DG Sante audit in July and August 2023, it was found that Colombia couldn’t guarantee oestradiol 17-beta is not used in heifers and cows. As Colombia already exports composite products to the EU containing processed milk from another country with control plans for pharmacologically active substances, pesticides, and contaminants, the country’s listing for milk will be changed.

A two-month transition period allows entry to the EU for consignments of shelf-stable composite items manufactured from processed milk products of Colombian origin dispatched before the regulation comes into force on Feb. 11, 2024.

South Africa’s control plan for some products, which covers mollusks and marine gastropods from aquaculture, is also set to be approved as it guarantees food safety.

Bangladesh, Chile, the Falkland Islands, Guernsey, New Caledonia, Nicaragua, and Uruguay have informed the EU Commission they are not interested in exporting composite products manufactured using processed aquaculture products or processed milk and processed egg products. So a marking indicating their intention to export will be removed.

Kenya and Mozambique intend to export composite products made using processed milk or processed egg products from a member state or another country with the relevant control plans. However, they have failed to submit evidence and guarantees of compliance with EU rules so that the marking will be deleted.

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A spike in hepatitis E infections was recorded in Finland this past month.

The National Institute of Health and Welfare (THL) is investigating the reasons for the increase.

In January, 19 people fell ill due to a hepatitis E infection in different parts of the country.

In 2023, only one hepatitis E infection was reported to the Infectious Disease Register during the same period.

THL has requested hepatitis E-positive samples from clinical laboratories for genotyping. This information on the virus is used to identify a potential outbreak.

So far, six infected people have been interviewed by THL, but no specific common factor has yet been found.

Between 20 and 60 hepatitis E cases are reported to the Infectious Disease Register each year. In 2023, there were 30 cases.

In mid-2023, health officials in Jersey revealed an undisclosed number of hepatitis E infections linked to undercooked pork, based on patient interviews. Some people needed hospital treatment.

Hepatitis E infection is a liver disease caused by the hepatitis E virus (HEV). People usually get infected through food or water. Advice to avoid infection includes thoroughly cooking all meat, especially pork, before eating it and washing hands after touching uncooked meat or meat products.

Symptoms include fatigue, poor appetite, stomach pain, nausea, and jaundice. However, many people, especially young children, have no symptoms. Symptoms usually appear from two to six weeks after exposure to the virus and last from one to four weeks.

Latest zoonoses data for Finland
Meanwhile, the Finnish Food Authority (Ruokavirasto) has shared that Campylobacter and Salmonella were behind the most infections in Finland in 2022, reflecting the situation in Europe.

Salmonella Mbandaka caused the largest epidemic in Finland, with nearly 100 people falling ill.

While the third most common agent in Europe was Yersinia, in Finland, it was Cryptosporidium. The incidence of Shiga toxin-producing E. coli (STEC) infections and listeriosis has remained at the same level in Finland from 2018 to 2022.

Salmonella was found in two poultry establishments in 2022. Salmonella Typhimurium was detected in two flocks of broilers reared on the same establishment, and Salmonella Enteritidis was detected in laying hens. Based on stool samples, Salmonella infections were detected in cattle at 23 establishments. The pathogen was also found in pigs at two sites.

Presence in animals and meat remained within the target set by the National Salmonella Control Program of less than 1 percent in slaughter animals and less than 0.5 percent in meat. 

Of broilers examined in Finland, Campylobacter occurred in just over 4 percent in summer and less than half a percent in winter. No neck skin samples examined by operators had a level above 1,000 colony-forming units per gram (CFU/g).

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Legislators in West Virginia are considering allowing expanded raw milk sales in their state.

Two bills have been introduced so far this session. The first, House Bill 4911, would allow the sale of unpasteurized, raw milk as long as containers were clearly labeled as being ungraded raw milk. The bill, introduced by Delegate Michael Hornby, would also give raw milk producers immunity from civil liability related to consuming their unpasteurized products.

The other bill before West Virginia legislators, House Bill 4736, is the West Virginia Farm Fresh Dairy Act. It would “allow for the sale and consumption of homemade and farm fresh raw milk and raw milk products and to encourage the expansion of raw milk dairy sales by small farm producers and accessibility of their products to informed end consumers.”

House Bill 4736 would allow sales of unpasteurized, raw milk directly between the producer and consumer. It would allow the West Virginia Department of Agriculture to register and inspect small dairies for compliance.

Regulatory items include milking practices, cleaning, testing, and storage.

The bill would make it illegal for municipalities to have their regulations about raw milk: “Notwithstanding any other provisions of law or specific requirements of the West Virginia Farm Fresh Dairy Act, there shall be no licensure, permitting, or certification required by any agency of any political subdivision of the state which pertains to the preparation, serving, use, consumption or storage of raw milk or raw milk products under the West Virginia Farm Fresh Dairy Act.”

Both bills were referred to the House Agriculture and Natural Resources Committee. The bills must be scheduled for hearings to continue in the legislative process.

The transportation and sale of raw milk across state lines is prohibited by federal law. Most local and state health and agriculture departments advise against drinking raw, unpasteurized milk because bacteria and viruses can contaminate it. 

The U.S. Food and Drug Administration, Centers for Disease Control and Prevention, and the U.S. Department of Agriculture advise against drinking raw milk. It can be especially dangerous for children, adults older than 65, pregnant women, and people with compromised immune systems.

Many states have laws against the sale of raw, unpasteurized milk. Some allow it only within herd share operations and others allow it to be sold by farmers directly to individual consumers. A few states, such as California, allow raw milk to be sold at retail stores, but it must have warning labels.

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The two non-governmental organizations, with a joint project to trim the number of food additives in candy, soda, and other food items, are moving into a second year in a second state.

The two nationally-known consumer and environmental organizations, Consumer Reports (CR) and the Environmental Working Group (EWG), in 2023 guided Assembly Bill 418 to become law in California.

The California project successfully banned bacterial vegetable oil, potassium bromate, propylparaben, titanium dioxide, and red dye No. 3 from food. 

It failed to put titanium dioxide on the banned list because it did not fly in the California Senate. Banning all five food additives, however, remains the project goal as the activists move across the country to the Illinois Legislature

In Springfield, IL, State Senator Willie Preston, D-Chicago, has introduced  Senate Bill 2637 to ban the five ingredients.

“This legislation, in its simplest form, increases food safety for Illinoisans,” said Preston. “These substances have been used in food for decades, and new evidence shows they can pose serious threats to our health and the health of our kids.”

SB 2637 – the Illinois Food Safety Act – will ban specific, dangerous food additives from manufacturing, delivering, distributing, holding, or selling food products. 

These banned additives include brominated vegetable oil, potassium bromate, Propylparaben, and red dye no. 3.

“Illinois families deserve access to the healthiest food options,” Preston said. “This legislation does not seek to ban products or take away our favorite foods. This measure sets a precedent for consumer health and safety to encourage food manufacturers to update their recipes to use safer alternative ingredients.”

Preston intends to work alongside his colleagues this legislative season to include additional additives like titanium dioxide. Additionally, his proposed legislation will call for studies on the potential health risks of BHA and BHT.

If Illinois joins California, other areas of the U.S. might have difficulty operating around the bans.

Titanium dioxide, which escaped the banned list in California, is often added to foods to enhance white coloring or opacity.  Chewing gum, candy, pastries, chocolates, coffee creamers, and cake decorations are among food items that may contain titanium.

The FDA continues to view titanium dioxide as safe, as does the California Senate.

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Canadian officials have posted their final update on a Salmonella outbreak traced to cantaloupe, adding two deaths to the toll.

There were 190 laboratory-confirmed cases of Salmonella Soahanina, Sundsvall, Oranienburg, and Newport illnesses associated with the nationwide outbreak. Sixty-eight patients were hospitalized, and nine died.

Recalls for Malichita and Rudy brand cantaloupe from Mexico began in November. Several secondary recalls of fresh-cut products made with the cantaloupes were initiated. Investigators found the outbreak strain of Salmonella on Malichita brand cantaloupe.

Individuals who became ill were less than 1 to 100 years of age. Most of the patients were children five years or younger, 33 percent, or adults 65 years or older, 45 percent. About half of the cases were female.

The Canadian outbreak coincided with an outbreak in the United States that was traced to the same cantaloupe as was implicated in Canada.

In the United States, the outbreak stretched across 44 states and sickened 407 people. Six deaths were reported. The Centers for Disease Control and Prevention 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 particularly virulent pathogen strains.

Illnesses started from Oct. 15, 2023, to Dec. 25, 2023.

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 five 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 to 40 patients go unidentified, according to researchers. This means as many as 11,800 patients could have been part of this outbreak.

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According to recently published figures, mushroom poisoning remains a significant problem in China.

In 2023, the Chinese Center for Disease Control and Prevention (CDC) investigated 505 reports of mushroom poisoning, resulting in 1,303 patients and 16 deaths.

Incidents increased compared to 2022, but the number of patients was lower, according to the study published in China CDC Weekly journal.

Mushroom poisoning in China is a significant food safety concern. Following an incident, CDC staff and hospital professionals collect mushroom specimens and photos, which are then sent to mycologists for identification. In parallel, toxin detection is performed on mushrooms and biological samples from patients, such as blood and urine.

97 poisonous mushroom species, including 12 newly recorded ones, were identified, leading to six distinct clinical manifestations. This brings the cumulative number of species involved in poisoning incidents in China to 220.

Newly discovered dangers
The number of patients per incident ranged from 1 to 15, with an average of 2—only six involved more than ten patients. Among the cases, 23 patients from 11 incidents consumed poisonous mushrooms purchased from markets, while 23 patients from nine incidents were poisoned after eating dried mushrooms. Also, 217 patients and five deaths resulted from 70 incidents where individuals consumed mixed wild mushrooms either self-collected or purchased from markets.

Between May and October, 461 incidents, 1,207 patients, and 15 deaths were reported, with a peak in June. May had the most deaths, with seven. Hunan, Yunnan, Guizhou, Sichuan, and Hubei were the top affected regions.

A total of 97 species of poisonous mushrooms were identified in poisoning cases, leading to six clinical syndromes. Among these species, 12 were newly discovered as poisonous in China.

Collybia subtropica, Russula brevispora, Russula flavescens, and Russula pseudojaponica were newly described species in 2023. Coprinopsis strossmayeri, Gymnopus dysodes, and Gymnopus similis were three newly recorded poisonous varieties that caused gastroenteritis.

The most deadly mushroom was Amanita fuligineoides with seven deaths. Amanita subpallidorosea and Russula subnigricans both caused two deaths. Chlorophyllum molybdites was associated with the most poisonings, appearing in 150 incidents and affecting 303 patients.

While some species caused acute liver or renal failure, others led to gastroenteritis or psycho-neurological disorders.

Scientists said in many incidents, no mushroom specimens or photos were obtained, making it challenging to confirm the species of poisonous mushrooms and provide targeted treatment for patients.

Example incident
Another study published in the same journal reported on poisoning from a toxin in mushrooms. Wild mushrooms containing amanita toxins induce gastrointestinal symptoms initially, which are followed by potentially life-threatening acute liver damage.

In September 2023, five people in Xingtai City, Hebei Province, fell sick. All experienced different levels of liver damage, but none died.

Patients were members of the same family and had symptoms including nausea, vomiting, abdominal pain, and diarrhea. They had a history of consuming self-forged wild mushrooms before the onset of symptoms. The group consisted of three males and two females, ages 34 to 45.

One patient, who had previous experience identifying and consuming wild mushrooms in Guizhou, said collected mushrooms were edible. Patients harvested the mushrooms themselves from a pine forest. They were later identified as Amanita subjunquillea. Health officials said the identification of toxic and non-toxic mushrooms should not solely rely on personal experience or appearance.

Local authorities initiated public education programs to raise awareness of the risks of consuming wild mushrooms and prohibited residents from foraging for and eating them.

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According to two UK food agencies, the likelihood of vulnerable people contracting listeriosis from blue cheese is very low.

A Food Standards Agency (FSA) and Food Standards Scotland (FSS) risk assessment found the severity of Listeria monocytogenes infection in vulnerable people is high. However, the frequency of listeriosis in these groups from consumption of blue cheese is considered very low.  

Vulnerable people include pregnant women, people over 65 years of age, infants, and those with weakened immune systems.

Vulnerable people do not frequently consume blue cheese. When eaten, it is usually in low amounts. UK data suggests the prevalence of Listeria in blue cheese is around 1 to 3 percent of samples at retail. Blue cheeses include Stilton, Roquefort, Gorgonzola, and Danish Blue. The majority of blue cheeses for sale at retail in the UK are made from pasteurized milk.

The findings mean there will be no change to FSA and FSS advice. However, NHS websites listed Stilton as an example as a safe food for pregnant women, which has now been changed.

Listeria risk from blue cheese
Blue cheese can become contaminated at different stages of the cheesemaking process. Listeria monocytogenes could be present in the raw milk and in the brine used in cheesemaking, or it may contaminate cheese during processing, handling, cutting, and packaging.

A search found two listeriosis outbreaks and one case that may have been caused by blue cheese, but none were in the UK. The first, in 2011, was in the United States, with 15 cases and one death. The second was in 1989 and 1990 in Denmark, with 26 cases and six deaths. In 2003, a 63-year-old man was sickened in Italy.

Most semi-soft cheeses do not let Listeria monocytogenes grow, but blue cheeses may be an exception. This is because the mold in them makes the interior less acidic, which helps Listeria growth. Blue cheese is needed to allow air into the center for mold growth. Such cheese can have different acidity, moisture content, and salt levels.

Data from the Scottish Food Sampling Database for 2014 to 2021 showed that of 1,085 tests for Listeria monocytogenes on cheese products, 13 were deemed unsatisfactory. Non-compliant products included two pasteurized blue cheese wheels and two small pasteurized blue cheeses.

In the same period, 1,192 tests for generic Listeria species were carried out on cheese products, and ten were unsatisfactory. Three of these were Gorgonzola samples.

A search of the FSA incidents and alerts system 2000 resulted in 17 notifications of Listeria spp. in blue cheese products for the UK market, three of which were Stilton. A search of EU signals from 2019 to 2023 identified 39 recalls of blue cheese, mostly Gorgonzola, due to Listeria spp. The number of samples positive for Listeria spp. in Stilton in 2023 was six of 106, according to Dairy UK.

A survey of unpasteurized milk cheeses at retail in England between 2019 and 2020 sampled 77 blue cheeses, of which two were positive for Listeria monocytogenes. Researchers found a significant correlation between storage at high temperatures and poor microbiological results.

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The Pennsylvania Department of Agriculture is warning consumers to immediately discard all Conoco View Dairy raw milk sold or dropped off in certain counties because of reports of campylobacter infections.

The unpasteurized, raw milk was sold in Cumberland, Juniata, Perry, Snyder, and York Counties, and delivered direct to homes or drop-off points in Cumberland, Dauphin, Juniata, and Perry Counties. 

The agriculture department ran tests after 11 reports of campylobacteriosis illnesses in December and January and confirmed Campylobacter contamination in the dairy’s products.

While the source of the bacteria is clear, every specific production date could not be pinpointed. All products, including those in consumers’ freezers, should be discarded, according to the outbreak announcement from the state.

People with Campylobacter infections usually have diarrhea which is often bloody, fever, and stomach cramps, and may have nausea and vomiting. Symptoms usually start two to five days after infection and last about one week. Anyone who consumed the milk should consult their physicians if they become ill. 

Information about drinking raw milk can be found on the Centers for Disease Control website.

Conoco View Dairy raw milk was sold in plastic pints, quart, and gallons, as well as glass quarts. Products were sold at the dairy’s retail outlet at 410 Clarks Run Road in Blain, Perry County, and the retail locations listed below. The dairy also delivers their products directly to homes in Dauphin, Perry, and Juniata County and at drop-off points in Harrisburg, Carlisle, Enola, and Mechanicsburg. 

Cumberland County

Maple Lane Farm, Carlisle

Spring Garden Greenhouse Carlisle

Juniata County

Pallet Grocery, McAlisterville

Perry County

Blain Market, Blain

Leids Market, Loysville

Lighthouse Health Foods, Newport

Skyline Bargains, Newport

Snyder County

Whispering Pines Fruit Farm, Mount Pleasant Mills

York County

Castle Creek, 

Dillsburg

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Without naming his company or town, Mr. Chris Jenkins became the first to ask USDA’s Food Safety and Inspection Service to “strike down” Petition 23-07 from Animal Partisan last week.

“I feel these requests would only add greater confusion to an industry that has become riddled with gray areas and misinterpretations due to these requests,” Jenkins wrote.

Animal Partisan, one of the nation’s many animal activist organizations, last September petitioned  FSIS to issue a notice to convey that: 

1) State government officials are not categorically preempted from enforcing state anti-cruelty laws by the Federal Meat Inspection Act, the Humane Methods of Slaughter Act, or the Poultry Products Inspection Act, and 

2) FSIS personnel should cooperate with state government officials to enforce state anti-cruelty laws and improve clarity and frequency of communication with those officials.

Jenkins, however, points out that FSIS regulations already exist for cooperation between state and Federal in meat and poultry processing.

“I feel there is plenty of clarity already, “ he added. “Any additional notices or directives could create greater confusion or misinterpretation.”

The petition has been pending since it was filed on September 2, 2023. It mainly asks FSIS to publish a notice clarifying that federal law does not necessarily prevent state government officials from bringing animal cruelty charges when farmed animals are abused in slaughter plants.

The Animal Welfare Institute filed comments in support of the petition just ahead of Jenkins.     It said the Animal Partisan petition “ is a  simple request and would require relatively little of the agency; yet, it could significantly improve the welfare of animals at slaughter.”

Petition 23-07 is pending at the FSIS Office of Policy and Program Development for review.

Meanwhile, the Animal Legal Defense Fund (ALDF), another animal activist organization,  submitted comments in support of an Environmental Working Group’s (EWG) petition to prohibit the use of “climate-friendly” claims or similar claims on beef products or in the

alternative, to require independent third-party verification of such claims and a numerical carbon disclosure whenever such claims are made on beef product packaging.

In Petition 23-04, EWG asks FSIS to:

●  Prohibit the “Low-Carbon Beef” Claim recently approved by USDA. 

●  Require third-party verification for similar carbon claims. 

●  Require a numerical on-pack carbon disclosure when such claims are made. 

ALDF comments run 154 pages.

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— COMMENTARY —

Three weeks ago, I introduced my column, “The Litigated Dish,” to answer the internet’s most frequently asked food safety questions. One particularly popular question, according to AnswerThePublic.com (a website that tracks the top Google searches), is “What are the symptoms of food poisoning?”

Much like my answer to last week’s question, this question elicits a lawyer’s favorite response: “It depends.” Which foodborne illness are we talking about? Various bacteria, viruses, and parasites can be responsible for causing food poisoning.

But despite the diversity among the pathogens responsible for food poisoning, there are common symptoms shared by many, if not all, of these maladies. Primary among them is gastroenteritis — a short-term illness triggered by the infection and inflammation of the digestive system — characterized by abdominal cramps, diarrhea, and nausea and/or vomiting. TMI warning: if one contracts Salmonella, Shigella, or Campylobacter, the diarrhea may contain blood. E. coli, another bacterium, can induce hemorrhagic colitis, characterized by minimal stool and large amounts of blood.

Fever, chills, fatigue, and loss of appetite are additional symptoms common to many foodborne illnesses. While many symptoms overlap, however, some distinct signs may be linked to specific pathogens. For instance, in severe cases, Listeria (especially affecting pregnant women, older adults, and individuals with compromised immune systems) can present with headache, stiff neck, confusion, loss of balance, and other classic signs of meningitis. Botulism can manifest as difficulty in speaking or swallowing, dry mouth, facial weakness or paralysis, blurred or double vision, and respiratory failure. Hepatitis A, a highly contagious liver infection, can result in jaundice — yellowing of the skin and eyes.

Additionally, infection by different pathogens can lead to diverse long-term consequences—but I think I will save that for my next post.

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A food safety barometer in Belgium has found improvements in the country during the past decade.

The purpose is to measure food safety and enable evidence-based risk management and policy decisions. It consists of 30 indicators that cover various aspects of food safety from farm to fork.

It relies on data collected from the Belgian Federal Agency for the Safety of the Food Chain (FASFC) control programs and the National Reference Center for Disease data. Indicators are expressed as positive or negative changes compared to the previous year and compared to a reference year to assess long-term progress.

Barometer benefits
The indicators describe the presence of chemical and microbial hazards, inspection outcomes, compliance of food businesses’ self-checking, zoonotic agents, and the number of reported foodborne outbreaks. They are weighted based on their importance and displayed as percentages. However, the weight assigned to each indicator is based on expert opinion and not risk assessment.

The method has been used for over a decade and helps show stakeholders, consumers, and trade partners the state of food safety in Belgium.

It enables trend analyses and provides insights into the food safety system. However, the dynamic nature of the food chain means a flexible system is needed to adapt to risks and incorporate new indicators.

By 2021, the barometer results increased by 25.3 percent compared to the reference year of 2010, according to FASFC, also known as AFSCA and FAVV.

Involving stakeholders representing the whole food chain was a strength in terms of participation and getting the best knowledge, but a challenge because of the different emphasis on food safety risks.

FASFC said interpretation of results can be difficult. The number of foodborne outbreaks highlights this issue: a low number of outbreaks can be due to a good food safety situation or a poor reporting system, as well as external constraints such as measures implemented in the early days of the COVID-19 pandemic.

The agency also warned that inconsistent procedures may lead to biased results, hampering the development of control strategies.

Upcoming meetings
Meanwhile, the U.S. Food and Drug Administration (FDA) and the UN Food and Agriculture Organization (FAO) have organized a workshop on the use of whole genome sequencing (WGS) in water and foodborne disease outbreaks in Peru this week.

Presentations will highlight the benefits and potential drawbacks of WGS, and discussions will focus on summarizing the state of technology implementation at the global level and options for using WGS for food safety in Peru.

The workshop is a closed meeting with invited government officials, public health professionals, researchers, and stakeholders involved in food safety, water, and foodborne disease surveillance and response. A report on the event will be published in the future.

Another workshop, in Bogota, Colombia, from Feb. 12 to 16, will focus on the prevention and control of Campylobacter.

The event is for professionals from the PulseNet Latin America and Caribbean Network (PNALC). It is in response to increased Guillain-Barre Syndrome (GBS) cases in Peru from 2018 to 2023 and reinforced genomic surveillance of Campylobacter.

On the same dates, a second meeting on foodborne viruses is held in Geneva, Switzerland.

In 2022, a Codex committee asked for scientific advice from the Joint FAO/WHO Expert Meetings on Microbiological Risk Assessment (JEMRA) as part of work to update guidelines on controlling viruses in food. The document covers all foods, focusing on ready-to-eat food, Hepatitis A, and norovirus.

FAO and WHO held an initial meeting to work on food attribution, analytical methods, and indicators of viruses in foods in September 2023.

The second meeting will gather and evaluate recent data, evidence, and scientific opinions on the prevention and intervention measures and the efficacy of interventions in the food chain for foodborne viruses. 

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Researchers in Denmark have shared lessons learned as part of work on national burden of disease estimates.

The Danish burden of foodborne disease study ranks pathogens and chemicals. Results from 2019 showed the top hazards were Campylobacter, lead, peanut allergy, methylmercury, and Salmonella.

National studies are helpful for risk ranking and identifying priorities for food safety resource allocation, found the study published in the journal Food Control.

The National Food Institute launched an initiative to rank foodborne diseases in Denmark in 2015. The study highlights things learned over more than seven years and has recommendations for other countries planning such work.

Danish experience
In total, 14 hazards are included: Salmonella, Campylobacter, norovirus, Toxoplasma gondii, Listeria monocytogenes, Yersinia enterocolitica, Shiga toxin-producing E. coli (STEC), Hepatitis A virus, Methylmercury, lead, cadmium, inorganic arsenic, acrylamide, and peanut allergy.

The first step in estimating the disease burden of any hazard is to calculate the attributable incidence of disease in the population. Based on this, the burden of disease due to a given hazard can be estimated in terms of disability-adjusted life years (DALYs). 

The 14 hazards caused 133,388 cases, 90 deaths, and 5,928 DALYs in 2019.

Campylobacter caused 5,389 registered cases and 58,983 estimated cases. Total costs were €124 million ($134 million). This included direct costs in the health sector, indirect costs of lost productivity, and estimates of the value of unpaid time lost to morbidity and premature deaths. STEC led to the highest direct health costs, which is due to the larger number of complicated hospitalizations associated with infections.

Lead was linked to an estimated 996 cases, peanut allergy 252 cases, methylmercury 417 cases, and Salmonella 8,657 cases. 

Norovirus was estimated to cause many cases but few DALYs. Toxoplasma gondii and Listeria monocytogenes led to few cases and many DALYs. Hazards causing the lowest burden were hepatitis A virus and cadmium.

Possible interventions
Chemical hazards vary regarding food sources and vulnerable groups, as well as the duration and severity of associated health outcomes.

Intervention strategies are very different. Food safety interventions to control pathogens in foods include pre-harvest control, post-harvest measures, monitoring of foods at retail, investigation of outbreaks to prevent further cases, and raising awareness on food handling practices. Those to prevent exposure to chemical hazards will involve control measures to limit contamination of foods and maximum levels to keep highly contaminated foods off the market.

Actions to control pathogens should have a shorter time from intervention to effect than those needed to control exposures to chemical hazards, which will usually not be measurable for several years due to a long time from exposure to the onset of a health effect.

According to researchers, Ranking foodborne diseases is essential to inform evidence-based food safety priorities and monitor the effect of interventions. If hazards are ranked low, this may indicate current measures are effective and not that resources should be allocated elsewhere.

Plans include expanding the study with more hazards and developing digital platforms for visualization and interaction with the burden of disease estimates.

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The 9-day closure of a popular Lewiston, ME, restaurant has created such a kerfuffle that Food Safety News has looked deeper into what happened.  Dialing back to last year, it seems an emerging cockroach infestation concerned restaurant staff who tried working with their pest control contractor but found it necessary to report the health hazard to health authorities shortly after the first of the year.

Staff reported on Jan. 6 to Maine health officials that there was a cockroach infestation at the restaurant. 

In mid-2023, staff had reported the roach sightings to Pine State Pest Solutions, the restaurant’s contractor, for handling infestations. The DaVinci’s staff members said they were stepping on cockroaches at the restaurant. 

Their official complaint went to the City of Lewiston Sanitarian Louis Lachance, who found an imminent health hazard for cockroach infestation and asked for DaVinci’s voluntary closure to correct the hazard.  

DaVinci’s representative, Craig Tribuno, voluntarily agreed to close the restaurant on Jan. 6. It would re-open on Jan. 15.

First, a word about cockroach infestations.

Cockroaches are harbingers of disease and pathogens. Their shed exoskeletons and feces can trigger asthma in otherwise healthy people, and a significant cockroach infestation can be incredibly unhealthy for people.

Roaches also leave behind stains and bad smells. If they, or their waste, come into contact with food, humans can develop food poisoning-like symptoms that may become severe enough to require hospitalization.

Under Maine’s Freedom of Access Act, the City of Lewiston has provided Food Safety News with documents that show Davinci’s cockroach issue was a problem by at least last August.  Then, its pest control contractor said the “amount and location” of cockroach infestation meant an “after-hours” spray was required.

It is not clear from the documents if that was ever done.

Pine State’s Parker Adams is a technician for the pest control company servicing Davinci’s.  He spent just over one hour at the restaurant on Oct. 17, 2023, after restaurant staff reported cockroaches. Adams found two pests “in the glue boards” and applied insecticide.  He said the live cockroaches were “physically deformed,” which is a sign the spray is working.

Keith Ellsworth, another Pine Street tech, visited Davinci’s two days later and found no “no activity in the bait stations.”  One roach was caught on a glue board in the pizza area.  

Adams returned on Oct. 23, 2023, finding no signs of roach activity.  He promised to “stay on top of this until there are no new sightings  by staff for an extended time.”

Ellsworth was back on Oct.31, finding that “1 nymph “ was captured on a glue board.  On Nov. 8,  Ellsworth reported finding one “deformed adult roach” in a glue board near the pizza oven.  He also added bait in various “cracks and crevices”

In a checkup on Nov. 16, Ellsworth found two “juveniles”  in basement glue boards.  He applied a gel-based bit and aerosol pesticide.

A third Pine State tech named Evan Thompson was at the restaurant on Dec. 15, finding three dead cockroaches but said, “Things are looking very good” and showing “no cockroach activity.”

Ellsworth returned on Dec. 26, finding two roaches, one near a pizza oven and one under a sink. He said there were some signs of “light feeding.”

On Jan. 5, 2024 — one day before the voluntary closure — Ellsworth found no roaches but did say a DaVinci staff member reported seeing one on the bar.  

Ten days later, another Pine Street tech, Ethan Nadeau, looked for cockroaches in the building for 16 minutes, ”observing no live or dead activity anywhere.”  It was re-opening day for DaVinci’s. He returned on Jan. 17 for 30 minutes, finding no pest activity.

Louis Lachance, the city’s restaurant inspector,  followed up on the Jan. 6 complaint on Jan. 11, with inspection notes.  He reported no Person in Charge for DaVinci’s was present for the follow-up inspection, at which no live or dead cockroaches were observed.

LaChance said there would be a re-inspection within 30 days of the re-opening and another follow-up within three months.  On Jan. 11, LaChance said he could approve the re-opening once professional cleaning and disinfection is completed.

The DaVinci’s cockroach infestation and subsequent short-term closure were routine events for any restaurant inspection program, but they’ve been anything but routine for the City of Lewiston.   

The Lewiston City Council on March 19 is still looking at firing its veteran restaurant inspector and letting the state take over restaurant inspections in the city.  

Those actions were to have occurred at the Jan. 23 meeting. Still, public comments overwhelmingly supported LaChance and his boss, Dave Hediger, the City’s Planning and Code Enforcement Director, who was putatively on administrative leave.

The Lewiston City Council has drafted a letter to 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.

Also drafted is 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.

That supplemental would punish Lachance, the city’s long-time restaurant inspector who holds the sanitation inspector position, by eliminating his position and its funding.

Tribuno, DaVinci’s co-owner, acknowledged a cockroach issue but not infestation or how concerned some of his staff were about it.  

DaVinci’s failed a 2019 inspection conducted by Lachance.  It was not inspected in 2023 but did pass inspection early in 2022.

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Clostridium perfringens and Salmonella were the agents responsible for the most foodborne outbreaks in Singapore from 2018 to 2021, according to a study.

A total of 171 outbreaks involving 7,538 cases were investigated from January 2018 to December 2021. The number of outbreaks ranged from 12 in 2020 to 59 in 2019.

For the 121 foodborne outbreaks, more than 42 percent were traced to food prepared by caterers, 14.9 percent by restaurants, and 12.4 percent by in-house kitchens. Of the 50 non-foodborne outbreaks, 48 were at schools, found the study published in the International Journal of Environmental Research and Public Health.

The Singapore Food Agency (SFA) and Ministry of Health, together with other relevant public agencies, conduct outbreak investigations.

Stool samples of 1,050 patients were collected for laboratory identification of causative pathogens. A total of 1,024 food samples were selected for microbiological analysis based on the food consumption history of cases and epidemiological information from outbreaks, while 917 environmental swabs were taken based on kitchen operations via interviews with food handlers.

Data on pathogens
Clostridium perfringens with 20 and Salmonella with 18 outbreaks were the most common pathogens. Salmonella outbreaks involved Salmonella Enteritidis, Weltevreden, Typhimurium, and Salmonella Kirkee. Other causative pathogens included E. coli, Vibrio parahaemolyticus, Bacillus cereus, and Staphylococcus aureus.

Food samples and environmental swabs collected were mostly positive for Bacillus cereus. Only 100 of the 1,024 food samples were positive. The top 3 bacterial pathogens were Bacillus cereus, Staphylococcus aureus, and E. coli. In total, 17.3 percent of food samples had more than one type of pathogen.

Only 134 of 917 environmental swabs collected were positive for pathogens. The top three were Bacillus cereus, norovirus, and Salmonella Enteritidis.

Bacillus cereus was detected in a variety of food samples such as ready-to-eat fish, chicken, milk powder, vegetables, rice, noodles, and sauces and environmental swabs including on a knife, chopping board, utensils, preparation table, door handle, and kitchen appliances.

It is important to ensure good temperature control, proper food handling practices, and the routine disinfection of food contact surfaces during food preparation, as once food is contaminated, cooking may kill the bacteria but not remove the toxins produced, said scientists.

COVID impact and caterers role
Based on national disease surveillance statistics for Singapore, there was an increase in the number of food poisoning notifications from 4.8 to 7.5 per 100,000 population from 2013 to 2019. In 2020 and 2021, notifications decreased to 3.9 and 4.7 per 100,000 population, respectively. Similar reductions were observed in other countries, likely due to COVID-19 control measures.

The relaxation of Coronavirus measures, such as the gradual reopening of schools, workplaces, and food establishments for dining-in, saw the number of outbreaks climb in 2021.

A large proportion of outbreaks could be attributed to transmission from food prepared by licensed caterers for events and gatherings and dining in at restaurants. While caterers were linked to 51 outbreaks, unlicensed premises and home-based businesses both caused two each.

Common foods associated with Clostridium perfringens include meat, poultry products, soups, sauces such as gravy, and other precooked food and are typically associated with improper cooking or the inadequate heating of products. Caterers usually have to cook in bulk to serve larger groups of customers, and it is crucial for them to rapidly cool food products, said scientists.

In outbreaks were the causative agents could not be determined, many had findings of poor personal hygiene, environmental hygiene and/or poor food preparation practices.

“Mitigation measures such as implementing stricter food hygiene protocols and the re-training of food handlers would help to improve overall food hygiene and handling standards and consequently reduce the number of pathogens found in food and the environment. This would ultimately reduce the risk of gastroenteritis outbreaks in Singapore.”

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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.

Reconserve Inc.
Santa Monica, CA

A California food firm with a facility in Maryland is on notice from the FDA for unsanitary storing of ingredients that could contaminate food products. A Jan. 3, 2024, warning letter serves as a reminder that pet food products can contain dangerous pathogens and should be handled as carefully as other products.

In the warning letter, the FDA described a May 23 through June 29, 2023, inspection of Reconserve Inc.’s animal food manufacturing facility in Baltimore, MD.

The FDA’s inspection was in response to a complaint from a state regulatory partner about ingredient storage conditions.

During the inspection, an FDA Investigator found evidence of significant violations of the Current Good Manufacturing Practice, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, which caused the firm’s products to be adulterated. Additionally, this inspection found evidence that their product is adulterated in whole or in part because of a filthy, putrid or decomposed substance.

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

Some of the significant violations are as follows:

Current Good Manufacturing Practice (CGMP) Requirements for Animal Food

The firm’s animal food facility is subject to the CGMP requirements. During the inspection of their facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:

1. The firm did not examine their raw materials and other ingredients to ensure they were suitable for manufacturing and processing into animal food, and they did not handle them under conditions that will protect against contamination and minimize deterioration as required.

Specifically, on May 23, 2023, the FDA Investigator observed human food bakery by-products intended for use as an ingredient in their (redacted) outside, piled on a gravel ground and uncovered. They stated that they started storing these received ingredients there around February 2023, after a fire occurred at their facility. The FDA Investigator observed the visual state of these ingredients to be deteriorated and containing foreign material such as: gravel, rocks, soil, mud, unidentifiable substances and unknown man-made foreign materials. The FDA Investigator also observed wild birds flying around, landing and feeding on the pile, and insects flying around and crawling on the pile. The pile is exposed to contaminations from weather conditions including rainfall, and rainwater runoff with chemicals from nearby trucks and industrial equipment. The firm’s Vice President of Environmental Health and Safety estimated this outdoor storage pile of ingredients to be (redacted) and the facility (redacted) of ingredients from this storage pile with newly received ingredients to manufacture animal food.

2. The firm did not effectively protect the animal food stored outdoors in bulk from contamination, including by (1) using protective coverings where necessary and appropriate; (2) controlling areas over and around the bulk animal food to eliminate harborages for pests; and (3) checking on a regular basis for pests, pest infestation, and product condition related to safety of the animal food, as required.

Specifically, on May 23, 2023, and June 7, 2023, the FDA Investigator observed an uncovered pile of human food bakery by-products intended for use in their (redacted) being stored outside directly on an uncovered gravel driveway at their facility. The FDA Investigator observed wild birds flying, landing, and feeding upon the pile; flying and crawling insects; deteriorated packaging materials and foreign objects such as gravel, rocks, soil, mud, and other unknown man-made materials mixed in the pile. In addition, the uncovered bakery by-products were exposed to contamination since Feb. 2023 from weather conditions such as rainfall and rainwater runoff and excreta from birds, insects, and rodents. The pile was approximately three feet high and (redacted) in size and consisted of (redacted) of bakery by-products.

3. The frim did not keep the grounds around their animal food plant under their control in a condition that would protect against the contamination of animal food, including maintenance of grounds to properly store equipment and remove litter and waste within the immediate vicinity of the plant that may constitute an attractant, breeding place, or harborage for pests, as require.

Specifically, on May 24, 2023, and June 7, 2023, the FDA Investigator observed discarded metal equipment, burned metal barrels, wood pallets, plastic packaging materials, and other trash stored against the outside wall of the manufacturing facility that may constitute an attractant, breeding place, or harborage for pests.

Hazard Analysis and Risk-Based Preventive Controls Requirements

The firm’s animal food facility is subject to the hazard analysis and risk-based preventive controls requirements. During the inspection of their facility, the FDA Investigator observed evidence of significant violations of these requirements, which included:

4. The firm did not conduct a hazard analysis to identify and evaluate, based on experience, illness data, scientific reports, and other information, known or reasonably foreseeable hazards for each type of animal food manufactured, processed, packed, or held at their facility to determine whether there are any hazards requiring a preventive control, as required.

Specifically, in February 2023, the firm began storing human food bakery by-products intended for use as an ingredient in their (redacted) outside, piled directly on a gravel ground and uncovered. They did not identify or evaluate hazards associated with the change in their process of storing these materials outside and exposed to the environment. Known or reasonably foreseeable hazards include, but are not limited to:

A. Pests such as wild birds, rodents, and insects
B. Packaging materials (plastic and cardboard)
C. Foreign objects, including but not limited to, gravel, rocks, soil, mud, metal, and unknown man-made foreign materials
D. Chemicals such as lubricants and coolants from trucks parked adjacent to the pile and from nearby vehicle traffic
E. Nutrient deficiencies
F. Unknown industrial chemicals from this and neighboring facilities

In addition, they did not identify and evaluate the known or reasonably foreseeable hazard of recontamination with environmental pathogens in the processing steps following the dryer, which they have identified as their control for pathogens in their ingredients.

5. The firm did not validate that the process preventive control they identified and implemented is adequate to control the hazard as appropriate to the nature of the preventive control and its role in their facility’s food safety system, as required.

The firm’s hazard analysis for (redacted) documents a CCP (critical control point) at the dryer step to control pathogens, which they determined are a hazard requiring a preventive control. Their hazard analysis states that they operate the dryer at an “average temperature of (redacted)” for a minimum of (redacted). However, they failed to validate the use of their dryer as a preventive control to significantly minimize or eliminate pathogens in their (redacted). For example, they were unable to provide any scientific or technical evidence or studies that determined whether the dryer operating at (redacted) at a minimum of (redacted) would be adequate to control pathogens, as required.

6. The firm failed to establish and implement written procedures for monitoring their preventive controls, as required. In addition, they failed to document the monitoring of preventive controls, as required. “Monitoring” means to conduct a planned sequence of observations or measurements to assess whether control measures are operating as intended.

The firm’s hazard analysis for (redacted) identifies a process preventive control at the “Dryer” step. They do not have written procedures for monitoring the preventive control that outline the parameters that must be controlled at the dryer step (e.g., temperature and time), the maximum and minimum values for the parameters, and the frequency with which these parameters must be monitored. Additionally, they did not provide documentation of any monitoring activities related to their preventive control at the dryer step, such as temperature records, to demonstrate that these activities consistently took place.

The full warning letter can be viewed here.

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