Opinion

In the world of elite meat, Dutch veal is a delicacy with its niche on the more expensive side of the scale. Yet it has a powerful footing in Europe, especially in France and Italy.  

Food Safety News this week is participating in a media tour sponsored by “Trusted Veal from Europe,” a campaign with support from the European Union.  It is  centered on the Dutch Veal region of the Amsterdam area of The Netherlands.

The kick-off event for this tour by a mix of American and Canadian journalists was a dinner at the Restaurant  Hoogheid near Apeldoom.  The five-course dinner with multiple appetizers featured veal throughout in some surprising ways.   Steak tartare of veal, broth of veal, sweetbreads, and Veal Kaibi-kimchi.  The main course was Tomahawk-liver-fall truffle.  Desserts were a tasty blend that included Jack Daniels Toffee,

I am sharing that not because Food Safety News is getting into the restaurant review business, but to demonstrate how versatile veal is in preparations by European Chefs and others around the world.

But the reason Food Safety News wanted to pay Dutch veal a visit is because of the claim by our new Dutch friends’ that their veal is the safest in the world.  The food industry always pays hommage to food safety, but few claim to be the best.  We’ll check it out as the week progresses.

We are promised a “deep dive” into the Dutch veal industry’s “expertise and commitment to the highest European food safety, quality control animal welfare standards in order to produce tasty and quality products that can be enjoyed around the world.”

We are visiting farms and production centers with the participation of the Dutch Meat Industry Association, which is excited about the opening its veal has gained in the Chinese market.

Dutch veal also adheres to the EU Standards on Animal Health and Welfare that require the animals are raised in well-lite, property ventilated space that is sufficient for them to move about. The EU regulations were designed to end veal’s bad old days of confinement.

EU regulations have also played a part in Dutch veal’s “farm to fork” system of “full traceability.”  We are looking forward to learning more about it. The EU is apparently tracing animals with more than branding and ear tags.

We’ll also be looking at the “Controlled Quality Veal (CQV” certificate, Dutch veal’s quality control program.

We are hoping the cold and rainy weather breaks with some sunshine before we have to return home. We are supposed to take a food bike tour of Amsterdam and I am not really into getting wet.

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Authorities in Germany have admitted mistakes were made as part of investigations into a Listeria outbreak that affected 37 people beginning in 2014.

One infection was recorded in 2014, three in 2016 and four in 2017 but the outbreak was only identified in 2018 by whole genome sequencing when there was an increase with 21 people sick. This year, eight more patients became ill with the last disease onset date in mid-July. Three people are reported to have died with listeriosis as a contributing factor.

The Federal Institute for Risk Assessment (BfR) and Federal Office of Consumer Protection and Food Safety (BVL) looked at supply chains and food samples. Investigations compared a Listeria isolate from the Wilke Waldecker Fleisch- und Wurstwaren company near Hesse with patient isolates from the outbreak, finding a close relationship between them.

The United States was one of more than 20 countries that may have received meat from this German company but no illnesses were recorded in other nations.

Failures at all levels
Issues were raised about the speed of communication between different authorities, scrutiny of Wilke and decision making around the timing of closing the business.

Reinhard Kubat, district administrator in Waldeck-Frankenberg, a county in Hessen, said the focus should not be on blame but on actions for the future.

“We know that there have been mistakes… and we are ready to protect consumers to jointly improve food monitoring to regain consumer confidence. As we know, there have been failures at all levels of government. All authorities must work together to prevent a repeat of the Wilke case, if possible. There cannot be 100 percent certainty. All authorities, however, collectively share the duty of learning from what happened and to do everything possible to rule out such incidents.”

A 40-page review of the Wilke case by authorities in Waldeck-Frankenberg was given to the Hessian Ministry for the Environment, Climate Protection, Agriculture and Consumer Protection.

It was agreed food monitoring would be improved with unannounced inspections in manufacturing companies to be stepped up and carried out at fixed intervals together with technical supervision. Businesses self-control systems are also going to be looked at more intensively.

What went wrong?
Priska Hinz, Hessen consumer protection minister, said the food business operator is primarily responsible at all stages of production, processing and distribution in ensuring food meets requirements of the law.

“These include in particular food safety, traceability, prevention, transparency and emergency measures, as well as cooperation with the authorities. Food inspection ensures that employers comply with their responsibilities and that only safe food comes onto the market,” she said.

“In the case of Wilke, the food business operator obviously did not fulfill his obligations. Nevertheless, it is also important in the future to recognize such cases at an early stage and to act consistently.”

Based on EU regulation, food firms are sorted into risk levels that equate to a certain frequency of checks. Wilke was classified as risk level four which should have meant the firm had to be inspected 12 times a year but a mistake saw the company reduced to quarterly inspections.

For a company the size as Wilke, a regular review of all operating rooms is necessary. However, control reports from 2018 show that inspections only took place in different areas of the site. Between 2015 and 2018 it could also not be shown that controls on self-checks at Wilke took place.

Listeria positives
Between May 2018 and May 2019, Listeria monocytogenes was found in seven of 131 product samples examined by Wilke so the company told authorities it had strengthened hygiene controls.

Despite Listeria findings by authorities from Hamburg and Baden-Württemberg no further official sampling seems to have taken place for the next four months, based on investigations in April this year.

The 31 tests from April are environmental samples of which five detected Listeria monocytogenes and two samples contained other Listeria. However, despite this there was no increase in the number of official samples.

The Hessian Ministry of Consumer Protection was informed by the BVL on Aug. 12 that Wilke had supplied food to wholesalers in six of nine health facilities where people suffering from the Listeria outbreak strain were present. But authorities in Waldeck-Frankenberg, who are responsible for food monitoring at Wilke, were not informed until Aug. 20.

After an inspection in early September, the company was told to sample all five slicers on a daily basis and thoroughly clean and disinfect all production rooms. Product samples were negative for Listeria. In mid-September a link between the company and the illness cluster was established after further analysis of the samples from April. Listeria was found in environmental samples taken this month.

Officials stopped production at the Wilke facility in early October, with the company’s inventory still at about 300 tons, and a criminal complaint was made to the public prosecutor in Kassel. The company has since filed for bankruptcy.

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Stakeholders will have additional time to give input on the Food and Drug Administration’s New Era of Smarter Food Safety, originally launched in April. 

The FDA says, “the input received at the public meeting, and in comments submitted to the accompanying Federal Register docket, will help shape an FDA blueprint for a New Era of Smarter Food Safety.” 

The original comment period was set to close on Nov. 20. But with a 15-day extension, the comment period will now last until Dec. 5.

The ‘New Era’
The FDA’s New Era of Smarter Food Safety initiative is intended to build on the FDA’s efforts to implement the FDA Food Safety Modernization. Some key point of the “New Era” initiative:

• Augment efforts implementing important FSMA requirements while also leveraging, among other things, the use of new and emerging technologies;
• Use the “Blueprint for a New Era of Smarter Food Safety.” The Blueprint will address several areas, including traceability, digital technologies, and evolving food business models;
• Review and apply tools used by other industries that are already digitally tracking the movement of planes, ride sharing, and delivery of packaged goods — these include distributed ledgers, sensors, the Internet of Things, and artificial intelligence;
• Review of the “last mile” in any given food’s trip to consumers’ homes, including a look at packaging materials, temperature control approaches, etc., to identify the appropriate standard of care in this rapidly growing sector.

The FDA plans to release the blueprint in early 2020.  It is planned to outline critical steps to protect public health and keep pace with a changing global food supply chain. It will also address public health challenges, including tracing sources of contaminated foods and using new predictive analytics tools like artificial intelligence to assess risks and prioritize the agency’s work and resources.

Comments can be submitted either electronically or written. The FDA asks that commenters please note that late submissions will not be considered. The electronic filing system will accept comments until 11:59 p.m, Dec. 5, 2019.

Full commenting instructions can be found here.

The people driving the bus
Both Yiannas and Acting Commissioner Ned Sharpless arrived at the FDA from careers in the private sector. Yiannas said that gives them a good perspective to make significant recommendations for the direction the agency needs to pursue its efforts to improve food safety.

Yiannas said it was rewarding to serve Walmart’s millions of customers worldwide, but he is even more driven to serve the 328 million people living in the United States. He considers the American public to be his employer, as does Sharpless.

“We both learned from working with the FDA, while on the other side of the fence, that there is a lot of industry and government — whether it’s the States or the Federal government — can do to advance food safety. Tackling food safety is a shared responsibility, and there’s much more we can do together and in a manner that benefits people, food companies, and the planet,” the two FDA administrators said in their announcement today.

“Ultimately, for our journey toward a new era of smarter food safety to be a success, all those involved in making food products available to consumers must walk in lockstep on this path. Whether you’re in the private or public sector, whether you’re at the state or federal level, we’re all working for the same bosses — American consumers — so let’s work together to keep their food safe. They’re counting on us to do so.” 

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More than half of Salmonella infections in Ireland last year were associated with international travel, according to a recent report.

During 2018, 363 people had salmonellosis including 349 confirmed and 14 probable compared to 414 in 2017 based on figures from the Health Protection Surveillance Centre (HPSC), Ireland’s agency for the surveillance of communicable diseases and part of the Health Service Executive (HSE).

The 363 cases in 2018 represent a 12 percent decrease on 2017; when only confirmed cases are compared, the 349 in 2018 represent an 8 percent decrease versus 2017. One large outbreak of Salmonella Brandenburg affected 71 people in 2017.

Travel-associated infections and outbreaks
Overall, notifications increased 40 percent from a low of 260 cases in 2014, but remain below levels of 2007 to 2008. The increase since 2014 is more pronounced among travel-associated infections which are up 113 percent, with an increase of 22 percent among domestically-acquired cases.

Where country of infection was reported, 51 percent, or 166 of 328 cases were travel-associated. There was a peak between July and October coinciding with the summer holiday period.

Among travel associated cases, the top countries of infection included 31 ill after going to from Spain, 27 from Bosnia and Herzegovina, 13 from Thailand, and 10 from India. The unusual high number linked with travel to Bosnia and Herzegovina was an outbreak.

This international outbreak of Salmonella monophasic Typhimurium, sequence type 19 was among members of a pilgrimage group returning from Medjugorje, Bosnia and Herzegovina in September 2018. More cases of salmonellosis in travellers returning from Medjugorje were reported from other areas in the country and another EU country, indicating it was a wider event.

In total, 29 cases were identified among Irish residents; 18 of whom were laboratory confirmed. Their age range was 42 to 83 years old. They occurred over a one month period, the earliest onset was in September and the latest in October. The source of infection was not identified but many of those ill recalled consuming eggs.

One cluster of six cases of Salmonella Enteritidis in 2018 was genetically linked to an EU outbreak associated with Polish eggs. ECDC and EFSA are currently updating this multi-country outbreak with publication expected by late January 2020.

Two apparently sporadic salmonellosis cases were genetically linked to other international outbreaks identified in Europe. One of these was part of a multi-country Salmonella Agona outbreak linked to ready-to-eat products containing cucumbers.

Number of people needing hospital treatment
There was another foodborne family outbreak with seven ill; a family meal was the suspected vehicle of transmission. Three remaining outbreaks were small with two to three cases each; two were suspected foodborne travel-related incidents and person-to-person transmission was reported for the other.

The highest age-specific incidence rate was in children under five years which is likely influenced by clinicians more readily seeking clinical samples in that age group. The next highest rate was in the 20 to 24 years old group while the lowest rate this year was in the 15 to 19 age group.

Diarrhea was the most common symptom among notified cases in 2018, followed by abdominal pain. Bloody diarrhoea occurred amongst a third of cases. Median duration of illness was eight days with a range of one to 67 days, based on 192 cases. A total of 135 people were hospitalised compared to 124 in 2017.

Salmonella Enteritidis and Typhimurium including monophasic Typhimurium were the most common serotypes followed by Newport.

Disease acquired in Ireland was more commonly caused by Salmonella Typhimurium and monophasic Typhimurium strains than by Salmonella Enteritidis strains. Illness in Europe was mostly associated with Salmonella Enteritidis, followed by Typhimurium including monophasic Typhimurium strains.

For cases from the rest of the world, non-Enteritidis, non-Typhimurium cases predominated, with Salmonella Enteritidis making up for 20 percent and Typhimurium including monophasic Typhimurium strains accounting for 23 percent of cases.

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BrucePac, based in Silverton, OR, is recalling about 55,00 pounds of ready-to-eat (RTE) chicken sausage products because of misbranding, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS).

The product contains a pork casing, which is not declared on the label. The frozen, RTE chicken sausage items were produced on various dates from Nov. 15, 2018, to June 24, 2019. The product subject to recall is:

• 30-lb. bulk pack cases containing “GRILLED SLICED ITALIAN STYLE CHICKEN SAUSAGE” with lot codes 11158S, 12058S, 03189S, 06249S and 05029S

The product has the establishment number “P-9267A” printed inside the USDA mark of inspection. These items were shipped to an institutional location in California.

Routine FSIS inspection caught the mistake.

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 product may be in institutional freezers. Institutions that have purchased these products are urged not to serve them. These products should be thrown away or returned to the place of purchase.

FSIS routinely conducts recall effectiveness checks to verify that recalling firms are notifying their customers of the recall and that actions are being taken to make certain that the product is no longer available to consumers.

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Officials say another person is among the victims of a seven-state Salmonella Dublin outbreak that is linked to ground beef. One company has initiated a recall, but federal officials say other unnamed companies also have had positive test results for the pathogen.

In an outbreak update the Centers for Disease Control and Prevention reported that 11 people have been confirmed with the outbreak strain of Salmonella Dublin. Eight have been admitted to hospitals and one has died. Illnesses started on dates ranging from Aug. 8 to Oct. 20. The agency is working with the USDA’s Food Safety and Inspection Service (FSIS). 

“USDA-FSIS and state partners traced the source of some of the ground beef eaten by one ill person in this outbreak to Central Valley Meat Co. Inc. On Nov. 15 Central Valley Meat Co. Inc. recalled 34,222 pounds of ground beef produced that may be contaminated with Salmonella Dublin,” according to the CDC update.

“At this time, a single supplier, distributor, or brand of ground beef has not been identified that can account for all the illnesses in this outbreak. The investigation is ongoing and CDC will update the public if more information becomes available.”

Some beef plants have been found by FSIS to be contaminated with the outbreak strain of Salmonella Dublin, but the government has not named them. It is not known at this time if the Central Valley recall is related to the positive findings at the unnamed plants.

About Salmonella infections
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 any recalled products or ground beef from other suppliers and developed symptoms of Salmonella infection 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 a 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.

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At least 20 people in Wisconsin have E. coli infections that could be linked to an outbreak in Maryland that has been traced to ready-to-eat romaine lettuce salads. Some officials, however, say a specific cause  of the Wisconsin outbreak has not yet been determined.

In a Twitter post the head food safety official at the Food and Drug Administration, Frank Yiannas, urged the public to not consume any of the suspect salad. The agency is assisting with the outbreak investigation.

Ready Pac, the brand of the salads involved, is owned by Bonduelle Fresh Americas. Bonduelle posted a notice on its website that says government officials notified the company of only potential connections between E. coli patients in Maryland and the salads.

However, the Maryland Department of Health is reporting that “testing of unopened salad purchased by one of the patients identified the presence of E. coli O157 in the romaine lettuce. In addition to Sam’s Club, these salad bowls are distributed to many other retailers.”

The Ready Pac statement did not identify any specific retailers, rather stating the implicated product was shipped to “a club retailer in the state of Maryland.”

Neither the state nor the company reported how many pounds or packages of salad is involved. They also did not report what other companies may have purchased the implicated lettuce for additional products.

The Maryland health department notified the public that it is investigating a cluster of E. coli O157:H7 infections among seven patients in the state. All of the patients reported eating Ready Pac Bistro Bowl Chicken Caesar Salad purchased from various Sam’s Club locations in Maryland. There has been one hospitalization but no deaths associated with these cases.

Ready Pac officials say they tested the romaine in the fields but the company statement did not indicate whether the it does any testing during the processing and packaging processes. The statement also did not include any information about whether finished product testing is conducted.

The company did not issue a recall.

“We test all of our leafy greens — including romaine — in the fields prior to harvest, including screening for E. coli O157:H7. During this time frame, we did not have any positive test results for E. coli O157:H7. We are working in partnership with the Maryland Department of Health and are working as quickly as possible to identify the possible root cause to reduce potential impacts to consumers.

“Because the products identified are already significantly past their use-by dates, we are not taking any recall action, and it does not affect any product currently on store shelves. As always, please abide by any use-by dates, and do not consume any products that have exceeded these dates.”

In the outbreak in Wisconsin, the Department of Health Services reported three of the 20 patients in that state are children. Children’s immature immune systems mean they are more likely to develop serious complications from E. coli infections. 

Dr. Larry Lutwick, an infectious disease specialist with the Mayo Clinic in Eau Claire, WI, said he’s seen three cases of E. coli at his facility and believes they may be linked to the outbreak. He thinks his patients could have contracted the bacteria from lettuce.

“In two of the three cases they suspected it was from a salad or salad ingredient,” Lutwick said.

Lutwick added that E. coli has a long incubation period, which makes it difficult to investigate.

About E. coli infections

Anyone who has eaten any of the implicated product and developed symptoms of E. coli infection should seek medical attention and tell their doctor about their possible exposure to the bacteria. Specific tests are required to diagnose the infections, which can mimic other illnesses.

Most people with an E. coli O157 infection start feeling sick three to four days after eating or drinking something that contains the bacteria. However, illnesses can start anywhere from one to 10 days after exposure.

The symptoms of E. coli infections vary for each person but often include severe stomach cramps and diarrhea, which is often bloody. Some patients may also have a fever. Most patients recover within five to seven days. Others can develop severe or life-threatening symptoms and complications, according to the Centers for Disease Control and Prevention (CDC).

About 5 to 10 percent of those diagnosed with E. coli infections develop a potentially life-threatening kidney failure complication, known as a hemolytic uremic syndrome (HUS). Symptoms of HUS include fever, abdominal pain, feeling very tired, decreased frequency of urination, small unexplained bruises or bleeding, and pallor.

Many people with HUS recover within a few weeks, but some suffer permanent injuries or death. This condition can occur among people of any age but is most common in children younger than five years old because of their immature immune systems, older adults because of deteriorating immune systems, and people with compromised immune systems such as cancer patients.

Editor’s note originally posted Nov. 3: At this time, the credibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) is not to be trusted. Both agencies have shown a reckless disregard for the public’s right to know, and their reliability going forward remains suspect. For the next six weeks, Food Safety News will publish this note above on every story involving the FDA or CDC.

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Most soft fruits exported from Serbia to Europe are not subject to official controls at primary production levels, according to a recently released audit report.

DG Sante, the European Commission’s unit for policy on food safety and health, found official controls to address potential microbiological risks at primary production are only partly risk based and carried out at a low frequency.

There are also no official controls, such as sampling of produce, after freezing to verify compliance with EU food safety standards, and there is little official verification of the controls of processors or exporters. However, risks are reportedly mitigated as most of them are third party certified against international food safety standards and receive inspections and audits from EU importers.

In response, Serbian authorities said a plan of official controls covering microbiological risk in primary production will be created by the end of January 2020. Officials also said new rules adopted in the first quarter of next year will specify a number of samples of berries to be taken after freezing.

Past issues and import volume
The audit in Serbia in July 2019 assessed the official control systems on microbial contamination of food of non-animal origin (FNAO) for export to the European Union.

After several outbreaks traced to products from Serbia and due to the volume of imports, DG Sante decided in 2013 to assess the systems to control microbiological contamination in raspberries for export to the EU. Four recommendations were made about deficiencies in the system, the labs and follow up of Rapid Alert System for Food and Feed (RASFF) notifications.

The audit this year found the control system has improved compared to 2013, and lab issues have been addressed. But, actions taken regarding the effective functioning of the system for RASFF notifications were not effective.

The 2019 visit reviewed controls on production, freezing and export, including national legislation, the organization and operation of Serbian authorities and their controls over food businesses’ compliance with hygiene rules applied during the production of raw and frozen soft berries.

The audit team visited six farms producing raspberries, blackberries, blueberries and black and red currents, three businesses freezing, packing and exporting to the EU, and one exporter and two labs.

According to the Statistical Office Republic of Serbia in 2018, around 90,000 tons of fresh and frozen raspberries were exported to the EU, 29,000 tons of blackberries and close to 2,000 tons of blueberries.

Main compliances found
Processors considered to be at high risk are inspected every nine months, at medium risk every 12 months and at low risk every 24 months. This resulted in the inspection of roughly 60 percent of freezing and collecting sites in 2018.

The audit team examined 15 reports of previous inspections of producers. Main non-compliances that led to withdrawal of produce were positive samples for norovirus and deficiencies in hygienic production, water for handwashing not available or no analytical results for water quality.

The audit team were told that in 2017, 605 inspections were conducted at freezing companies and collectors. A total of 101 had minor non-compliances and 57 were closed until evidence was provided that the deficiencies were rectified.

In 2018 inspections were reduced due to risk assessments to 490. Altogether 40 had minor non-compliances and five were shut until deficiencies were rectified. These data suggest the number of non-compliances at freezing companies dropped significantly during the last two years.

The audit team checked 15 reports of previous inspections of freezing companies not visited. Main non-compliances that led to suspension were absence of a HACCP system, use of water not fit for purpose due to non-compliant analytical reports, and absence of registration.

Significant contamination in soft berries
Reports of samples taken by food firms for auto controls are only checked randomly by inspectors regarding formal correctness such as signatures; the lab results, scope of analysis and correctness of sampling procedures are not verified.

Processors and exporters do not need special approval to export frozen soft fruits to the EU except a general provision that they must document exports meet importing countries’ requirements. However, there are no official checks on this proof.

Official samples are mainly taken at collection points from fresh produce and results indicate significant virus contamination in soft berries. Any contamination during handling and freezing will not be detected as there is no official verification of freezing activities.

Data from one lab showed in 2017, 22 official samples of fresh raspberries were positive for norovirus, which corresponds to 7.72 percent being non-compliant samples and in 2018, five non-compliant samples were taken of soft berries. So-called non-official samples were, in 2017, in 6.25 percent and in 2018 in 5.05 percent of cases contaminated with norovirus or hepatitis A virus.

In 2018, one of the two labs visited analyzed 289 samples from food firms for norovirus and 259 for hepatitis A with no positives detected. In 2019, analysis of foodborne viruses had just started with no positive findings so far.

The audit team checked follow-up of several RASFF notifications. However, in 2017 and 2018 out of three notices two were not known by the authority, showing corrective measures taken after the previous audit were not effective. However, when notifications were responded to, official controls were performed and corrective measures introduced.

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The Kraft Heinz Foods Co. is recalling some Breakstone’s brand cottage cheese following several consumer complaints about extraneous material in the product.

The company reported that bits of plastic and metal “may have been introduced during production.” The cottage cheese has expiration dates into the second week of December.

“Consumption of hard or sharp foreign material could cause injury to teeth, mouth, throat, stomach or intestine tissues if swallowed,” according to the Kraft Heinz recall notice posted by the Food and Drug Admistration. “Consumers who purchased this product should not eat it and return it to the store where purchased for an exchange or full refund.”

As of the posting of the recall notice, six consumer complaints had been received. No reports of injuries had been confirmed. Kraft Heinz reported distributing about 9,500 cases of the Breakstone’s cottage cheese that are subject to the recall. It shipped the cottage cheese to retailers and distributors in the United States and exported to Latin America, according to the recall notice. 

To determine whether they have the recalled cottage in their homes, consumers should look for the following label information:

Product Size Name of
Product Packaging Description Case Unit
Best When Used By
Code Date Single
Package
Best When
Used By
Code Date Single
Package
UPC 16 oz Breakstone’s 2%
Milkfat Lowfat Large Curd Cottage Cheese Plastic Cup, Plastic Lid, Shrink Band Dec102019 10 DEC 2019 W4 XX:XX 36-2158 0 21000
30053 2 24 oz Breakstone’s 4% Milkfat Large Curd Cottage Cheese Plastic Cup, Plastic Lid, Shrink Band Dec102019 10 DEC 2019 W4 XX:XX 36-2158 0 21000 12285 1 24 oz Breakstone’s 4% Milkfat Small Curd Cottage Cheese Plastic Cup, Plastic Lid, Shrink Band Dec102019 10 DEC 2019 W4 XX:XX 36-2158 0 21000 12284 4

Consumers with questions may contact the company at 866-572-3805.

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Farm Boy is recalling Farm Boy brand cheese balls in Ontario, Canada, due to possible Listeria monocytogenes contamination.

The product has been recalled due to Candian Food Inspection Agency (CFIA) test results. The CFIA says that consumers should not consume the recalled products.

Consumers and retailers can identify the recalled products by looking for the following label information:

Brand Product Size UPC Codes Farm Boy Cheese Ball Trio – Fiesta, Cranberry Pecan, Bacon Cheddar and/or “FB Cheese Ball Trio” 360 g

Starting with 

0 238211 All units sold up to and including November 17, 2019 Farm Boy “FB Blue Cheese & Walnut Ball” 180 g

Starting with 

0 238274 All units sold up to and including November 17, 2019 Farm Boy Cranberry Pecan Cheese Ball and/or “FB Cran Pecan Cheese Ball” 180 g

8 08912 00884 4

or Starting with 

0 232337 All units sold up to and including November 17, 2019 Farm Boy Fiesta Cheese Ball and/or Farm Boy Fiesta Cheese Ball 180 g

8 08912 00883 7

or Starting with 

0 238283 All units sold up to and including November 17, 2019 Farm Boy “FB Wht Choc Pecan Cran Ball” 180 g

Starting with

0 238275 All units sold up to and including November 17, 2019 Farm Boy Bacon Cheddar Cheese Ball and/or “FB Bacon Chedd. Cheese Ball” 180 g

8 08912 00885 1

or Starting with

0 238284 All units sold up to and including November 17, 2019

The CFIA says that as of now there have been no reported illnesses associated with the consumption of these products.

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 of the recalled products 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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The United Kingdom has been hit hardest in a multi-country outbreak of Salmonella that has affected nearly 200 people.

Five European countries are investigating 192 Salmonella Mikawasima infections identified by whole genome sequencing (WGS).

As of Nov. 12, 138 people are ill in the U.K., 33 in Sweden, 18 in France, two in Denmark and one in Ireland. Most illnesses are non-travel related. The earliest date of illness onset is late August 2019.

Portugal has also recorded an increase of Salmonella Mikawasima in 2019, with most cases identified since August. WGS data for this year are not yet available for the isolates, which are under investigation.

ECDC confirms outbreak
Infections are more common in older adults than other age groups. Slightly more females than males have been reported.

Swedish officials initially revealed the outbreak and now the European Centre for Disease Prevention and Control (ECDC) has shared the number of people sick in other countries. The number of Salmonella Mikawasima cases in Sweden is usually one or two per year. All isolates are sequence type (ST) 1815.

ECDC reported that hypothesis-generation interviews are being done with patients in all countries. However, no robust hypothesis on the vehicle of infection has been found so far.

“This appears to be a multi-country outbreak taking place in a number of EU countries. The multi-country dimension has been identified through WGS analysis. However, the outbreak was also identified through exceedance analysis in the U.K., France and Sweden,” said ECDC officials.

“The close genomic relationship between isolates in the different countries indicates association with a common source. The lack of travel history for the cases and the recent identification possibly points to a vehicle of infection simultaneously distributed in different EU countries.”

ECDC and the European Food Safety Authority (EFSA) are also working on the third update to a multi-country outbreak of Salmonella Enteritidis linked to Polish eggs. It will be published by late January 2020.

The second update listed 1,412 cases associated with the outbreak: 532 confirmed and 166 probable infections since February 2017 and 343 historical-confirmed and 367 historical-probable cases between 2012 and January 2017.

Affected countries are Belgium, Croatia, Czech Republic, Denmark, Finland, France, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Slovenia, Sweden and the U.K. The U.K. has the most illnesses with 606, followed by 287 in the Netherlands and 187 in Belgium.

Source not identified
Salmonella Mikawasima ranked 34th of the serotypes reported in The European Surveillance System (TESSy). From 2014 to 2018, 17 EU countries recorded between 142 and 210 cases per year. Spain and the U.K accounted for 31 percent and 26 percent, respectively, of all confirmed infections.

Dr. Nick Phin, deputy director, national infections service at Public Health England, said the agency identified the outbreak using WGS.

“We are working with the Food Standards Agency, Public Health Wales and Health Protection Scotland to identify the source. There are simple steps to limit the spread of Salmonella, such as hygienic handling and preparation of food including cooking food thoroughly. Salmonella can also be spread from person to person, so anyone affected should adhere to good hygiene practice such as washing your hands thoroughly after using the bathroom,” he said.

Previous increases in Salmonella Mikawasima have been in late summer or autumn. WGS analysis found the current outbreak strain is not closely genetically related to any of the available strains identified in the previous years.

Last year, about 50 people in five European countries fell ill with the rare strain of Salmonella. Salmonella Mikawasima infected 15 people in Germany, 13 in Sweden, eight in both Denmark and the Czech Republic and six in Austria.

There was also an increase in the number of Salmonella Mikawasima infections in several EU countries in 2013. There has been an upward trend in Europe since 2009.

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 need to be hospitalized.

Older adults, children, pregnant women and people with weakened immune systems, such as cancer patients, are more likely to develop a severe illness and sometimes life-threatening conditions.

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As part of its enforcements, 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.

Kwokcheng Enterprise, Inc. dba Fullei Fresh

Miami, FL

The Food and Drug Administration sent a warning letter dated Oct. 22, 2019, to Kwok-Cheng Wong, President of Kwokcheng Enterprise, Inc. dba Fullei Fresh.

During an inspection from Jan. 28 to Mar. 11, 2019, FDA inspectors collected environmental samples from Kwokcheng Enterprise, Inc. dba Fullei Fresh’s sprouting operation. The samples were tested, and the presence of Listeria monocytogenes was identified. In response to these deviations, the FDA issued an FDA-483, Inspectional Observations that lists deviations observed at the sprouting operation.

The violations noted by the FDA include:

• “After your growing, harvesting, packing, or holding environment tested positive for Listeria species or monocytogenes, you did not conduct additional sampling and testing to determine whether the Listeria species or L. monocytogenes has been eliminated, as required by 21 CFR Part 112.146(c), and you did not perform any other actions necessary to prevent recurrence of the contamination, as required by 21 CFR Part 112.146(e).  Specifically, you received results from your environmental testing on December 14, 2018; January 9, 2019; and March 1, 2019; showing that your harvesting, packing, and holding environment tested positive for L. monocytogenes.  Additionally, some of your positive environmental samples were found in the same locations or on the same surfaces over time; for example, December 14, 2018; January 9, 2019; and March 1, 2019; reports all stated that the bean sprout packing table tested positive for L. monocytogenes.  During our inspection, we also tested your growing, harvesting, packing, and holding environment and found samples positive for L. monocytogenes, including one from the bean sprout packing table.  These findings demonstrate that L. monocytogenes was not eliminated from your growing, harvesting, packing, or holding environment and demonstrate the recurrence of L. monocytogenes contamination.”
• “You did not inspect, maintain, and clean, and, when necessary and appropriate, sanitize all food contact surfaces of equipment and tools used in covered activities as frequently as reasonably necessary to protect against contamination of covered produce, as required by 21 CFR Part 112.123(d)(1).  Specifically, during the inspection, our investigator observed that white and yellow buckets used to hold and store harvested bean sprouts were cracked, with dark scores and chips on areas of the buckets that touch the bean sprouts. The surface of these buckets had dark food residues in scored crevices.  Additionally, our investigator observed cracks and rough surfaces in the plastic panels inside the bean sprout growing bins. Our investigator observed that one of the cracks in the growing bins had adhesive tape applied to the crack as a repair. Our investigator also observed that the food contact surfaces of the blue conveyor belt used to transport harvested bean sprouts from the growing room to the packaging room was in disrepair, with a cracked, peeling surface and damaged and missing sections of material along the belt.”
• “You did not aseptically collect samples of spent irrigation water, as required per 21 CFR Part 112.147(b).  Specifically, our investigator observed a laboratory employee collecting spent irrigation water samples in a white tray placed under the flow of water from the growing bins. The employee then transferred the water into glass containers with plastic lids.  The white trays and other supplies were stored in a cart as the employee traveled through the operation but were open and not protected to prevent contamination from the environment.”

At the time the warning letter was sent, Kwokcheng Enterprise, Inc. dba Fullei Fres had provided a written response dated Mar. 21, 2019, outlining the corrective actions that they took in response to the environmental and product sample findings. The FDA responded in the letter, saying, “We acknowledge that you agreed on March 8, 2019, to recall a lot of your Organic Bean Sprouts. We also acknowledge that you have stated that you will more frequently monitor the environmental samples that you collect. We are unable to evaluate from your response, however, whether you conducted any extensive sampling or testing to verify that the contamination has been removed from your operation, including food contact surfaces and non-food contact surfaces.”

A complete list of the violations in the FDA warning letter.

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 of the recalled products 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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IAFP European Symposium call for abstracts

The International Association for Food Protection is currently accepting abstracts for two conferences. The first is for IAFP’s European Symposium on Food Safety Apr. 7-9, 2020 in Munich, Germany. The deadline for abstract submissions is Jan. 14, 2020. Abstracts are required to report on results of new studies dealing with causes and control of foodborne illness, control of contamination, tracking of foodborne pathogens, or other pertinent food safety subjects.

IAFP’s European Symposium is a conference that provides a forum for food safety experts in the industry, government and academia across Europe. The Symposium provides a chance to learn about the latest in food science and safety.

IAFP Annual Meeting call for abstracts

The second conference accepting abstracts is IAFP’s Annual meeting Aug. 2-5, 2020, in Cleveland. The deadline for abstract submissions is Jan. 14, 2020. Abstracts must report on the results of original scientific research, educational subject matter, or case studies and literature reviews dealing with food protection.

IAFP’s Annual Meeting is attended by the top academic, government and industry food safety professionals. Experts speak on diverse topics, including the latest in food safety technology. At IAFP’s Annual Meeting students and professionals who have contributed exceptional work are provided with awards and scholarships.

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Central Valley Meat Co. of Hanford, CA, is recalling about 34,000 pounds of ground beef that may be contaminated with Salmonella Dublin amidst an outbreak, according to the USDA’sFood Safety and Inspection Service (FSIS).

Public health officials are concerned that some product 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.

“FSIS was notified of an investigation of Salmonella Dublin illnesses on Sept. 9. Working in conjunction with the Centers for Disease Control and Prevention (CDC), and state and local public health partners, FSIS determined that there is a link between ground beef products from Central Valley Meat Co. Inc. and this illness cluster,” according to the recall notice posted by the FSIS. 

“The traceback investigation indicated that a case-patient consumed ground beef produced by Central Valley Meat Co. Inc. Based on epidemiological investigation, 10 case-patients have been identified in 6 states with illness onset dates ranging from Aug. 8, 2019 to Sept. 22, 2019.

The recalled ground beef items were produced on July 23, 2019. The following products are subject to recall: [View Labels]

• 1-lb. chub packages of “STATER BROS. 100% PURE GROUND BEEF 96% LEAN 4% FAT” with lot 2049 on the retail label; lot 19204 on the case label; and Use By 08-14-19.
• 2-lb. chub packages of “STATER BROS. 100% PURE GROUND BEEF 93% LEAN 7% FAT” with lot 2049 on the retail label; lot 19204 on the case label; and Use By 08-14-19.
• 20-lb. cases containing “STATER BROS 93/7 Ground Beef 10# Chub 10 Lb. Chubs/ 2 Count” with lot 19204 on the case label and Use By 08-14-19.

The products subject to recall bear establishment number “EST. 6063A” printed on the retail labels next to the lot number and inside the USDA mark of inspection on the case labels. These items were shipped to retail locations in California.

Additional information may be found on the CDC website at https://www.cdc.gov/salmonella/dublin-11-19/index.html. This outbreak strain of Salmonella Dublin did not identify any antibiotic resistance. FSIS continues to work with the CDC and state and local public health partners on this investigation and will provide updated information as it becomes available.

FSIS is concerned that some product 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.

FSIS routinely conducts recall effectiveness checks to verify recalling firms notify their customers of the recall and that steps are taken to make certain that the product is no longer available to consumers. When available, the retail distribution list(s) will be posted on the FSIS website at www.fsis.usda.gov/recalls.

About Salmonella infections

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 any recalled products and developed symptoms of Salmonella infection 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 a 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.

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The Codex Committee on Food Hygiene met in Cleveland, Ohio earlier this month to talk about food allergen management, biological foodborne outbreaks and guidelines to control E. coli.

Codex Alimentarius is a collection of standards, guidelines and codes of practice adopted by the Codex Alimentarius Commission, which was established by the World Health Organization (WHO) and Food and Agriculture Organization (FAO).

Attendees discussed a draft code of practice on food allergen management, revising the General Principles of Food Hygiene (GPFH) and its HACCP annex, proposed draft guidance to manage biological foodborne outbreaks, and draft guidelines to control Shiga toxin producing E. coli (STEC) in beef, raw milk and cheese produced from raw milk, leafy greens and sprouts.

Food hygiene revision
Dr. Jose Emilio Esteban, chief scientist at the Food Safety and Inspection Service, U.S. Department of Agriculture (USDA) chaired the session, which was attended by 59 member countries, one member organization and 15 observer groups.

Revision of the GPFH were called “the most important item of the session”, by Udo Wiemer from Germany. In some countries the Codex text forms the basis of national legislation. For example, in Indonesia the GPFH are adopted to be Indonesian national standards and used as a reference by government agencies.

The update has taken several years, according to Jenny Scott, senior advisor in the Center for Food Safety and Applied Nutrition of the U.S. Food and Drug Administration and co-chair of the online working group developing the revisions.

“We have learned a lot about HACCP implementation and the importance of good hygienic practices in preventing foodborne outbreaks in the last 15 to 20 years; it is critical that this document reflect the current knowledge about food safety,” she said.

Allergens on the agenda
Food allergen controls involve labeling to ensure they are accurately identified and good hygiene practices (GHPs) to prevent transfer of an allergen from one food to another that does not contain it.

Scott said roughly 2 percent of adults and 5 percent of children in the U.S. are estimated to have food allergies.

“Food allergies are an increasing food safety issue globally, resulting in many food recalls, approximately a third of food recalls in the U.S., as well as a number of deaths, every year. The U.S. recognized that allergens pose a significant hazard to food-allergic consumers and included food allergen controls in its 2015 preventive controls requirements for food safety. With increasingly global markets for food, it is crucial to have internationally developed guidance on best practices to ensure an understanding of how to manage food allergens.”

Use of precautionary allergen labeling (PAL) is an issue the country is struggling with, said Scott.

“Many manufacturers have turned to using PAL including the expression “may contain X” on the label to advise consumers that such transfer may have occurred. Unfortunately, this practice, which seems to be growing, limits choices for food-allergic individuals and it results in some manufacturers using PAL instead of GHPs to minimize allergen cross-contact. Guidance on the controls for food allergens is important in the U.S. because of our new preventive controls requirements to protect public health and our desire to reduce allergen-related recalls.”

Future work
Dr. Mindy Brashears, deputy Under Secretary for food safety at the USDA, said that with food safety policies being constantly updated, such meetings were important.

“We have all seen in our respective nations how allergens, HACCP implementation, biological outbreaks and STEC testing can impact food safety and prevent foodborne illness. We all represent a multi-talented group of diverse and talented experts, but this is not enough. Pathogens are evolving and technology is advancing,” she said in a welcome address to delegates.

The guidance to manage biological foodborne outbreaks will next be discussed at the Codex Alimentarius Commission meeting in Rome, Italy in July 2020. Development of guidelines to control STEC in certain foods could take up to five years.

This year, the Joint FAO/WHO Expert Meeting on Microbiological Risk Assessment (JEMRA) has published meeting reports on source attributions of STEC, and safety and quality of water used in food production and processing with another document on foodborne antimicrobial resistance due anytime.

Three meetings covered methodologies for microbiological risk assessment, Vibrio parahaemolyticus and Vibrio vulnificus in seafood, and microbiological quality of water used in production and processing of fresh fruits and vegetables.

Scheduled meetings for 2020 are on STEC control and intervention, allergens and Listeria monocytogenes to provide updated synthesis of attribution and methods of analysis.

Meeting topics for 2021 could include water used in food production; microbiological safety of fresh fruits and vegetables; and follow-up on Listeria monocytogenes and allergens. A meeting on microbiological risk assessment of STEC in sprouts could happen in 2022.

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Although a single supplier has not been identified, federal officials know of a number of specific beef plants that are contaminated with a strain of Salmonella behind a deadly outbreak. But, the USDA won’t name those companies.

Seeking to force the U.S. Department of Agriculture to reveal the information, two members of Congress wrote to Agriculture Secretary Sonny Perdue Friday. The legislators played a business card in addition to citing public safety concerns.

“By disclosing this data, USDA will foster market-based incentives for safer meat and poultry,” wrote U.S. Rep. Rosa DeLauro, D-CT, and Sen. Kirsten Gillibrand, D-NY.

DeLauro and Gillibrand said increased transparency in the current outbreak investigation, and as a standard practice, would allow companies to decide whether they want to use a supplier based on actionable data.

The legislators said the current outbreak linked to ground beef, which has sickened people in 10 states and killed one person, is a case in point for increased transparency from the government agencies charged with food safety enforcement activities. 

They also want the USDA’s Food Safety and Inspection Service to make information available regarding specific strains of pathogens in its database.

“Data on samples collected by FSIS, generated using whole genome sequencing (WGS) technology, would allow companies, government researchers and members of the scientific community to identify links between pathogenic strains found in samples from FSIS-regulated establishments, and those found in samples from patients with confirmed cases of foodborne illness,” according to a joint statement from DeLauro and Gillibrand. 

“Those links provide actionable information for companies to reduce food safety risk. USDA has limited authority to require food safety interventions, but by sharing accurate information about what its testing reveals, the agency has had success in creating incentives for improved food safety.”

In their letter to the agriculture secretary, the representative and senator said the USDA has flawed reasoning regarding why it should withhold information.

“FSIS officials have suggested that they have not disclosed this genetic data because doing so could cause public confusion, or require public health authorities to focus their attention on misleading claims. We are not convinced that any such ill effects would outweigh the benefits of giving industry relevant, accurate, and timely information about contamination in food processing facilities, and creating market-based incentives for better food safety control,” the legislators wrote.

In addition to seeking a general shift toward the release of information, the legislators asked Perdue to provide answers on four key points in the investigation into the current ground beef outbreak and last year’s poultry-related outbreaks. They requested answers by Dec. 13 on the following:

1. For each sample collected by FSIS that has tested positive for the outbreak strain associated with the ongoing multistate outbreak of Salmonella Dublin infections linked to ground beef, what product was sampled, when, and at which establishment?
2. For each sample collected by FSIS that has tested positive for the outbreak strain, when and how did FSIS notify the establishment from which the positive sample was collected? If no notification has been given, why?
3. If the outbreak strain has been found in samples from more than one establishment, what is the root cause or common source of the contamination? If still not known, how is FSIS investigating to find the root cause or common source?
4. How many samples collected from turkey slaughter and processing establishments have tested positive for the outbreak strain associated with the multistate outbreak of antibiotic resistant Salmonella Infantis infections linked to raw chicken products? When, where, and from what products were these samples taken? Has FSIS notified the establishments producing these products? If not, why not? What is the root cause of this contamination, or if still not known, what is FSIS doing to find the root cause?

To read the entire letter, please click here.

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A French agency has made a number of proposals to help improve the control of microbiological hazards in powdered infant formula.

The French Agency for Food, Environmental and Occupational Health and Safety (ANSES) was asked by the Directorate General for Food (DGAL) in December 2018 to look at these products after an outbreak of salmonellosis in 2017 traced to their consumption. The agency’s opinion covers the hygiene, surveillance and control measures in the production chain.

ANSES stressed the importance of applying general hygiene measures to prevent product contamination, the need to strengthen environmental monitoring of production sites and recommended development by industry of a guide to good hygiene practices and HACCP principles for the sector.

Two recent outbreaks
Lactalis infant formula was linked to a Salmonella Agona outbreak in 2017 that sickened 38 babies in France, two in Spain and one in Greece. Recalled formula was distributed to more than 80 countries.

Since then, there was a Salmonella Poona outbreak linked to rice-based infant formula between August 2018 and February 2019. A total of 32 confirmed cases were reported: 30 in France and one each in Belgium and Luxembourg in infants aged 2 months to 28 months old. This incident was linked to products made at the Industrias Lacteas Asturianas SA (ILAS) factory in Anleo, a municipality in the Spanish province of Asturias and marketed by Sodilac under the Modilac brand.

The work updates expertise in 2008 and will be used as a basis for instructions on the focus points to be examined during inspections. Slightly more than 500,000 tons of milk powder were produced in France in 2018, including 125,862 tons of powdered infant formula by 40 factories.

ANSES used on scientific literature and analysis of technical documents describing measures taken by professionals to ensure the hygiene and safety of their products. Analysis of the manufacturing process made it possible to identify potential routes of contamination and the main preventive measures.

The agency said the outbreaks have shown microbiological analyzes on finished products are insufficient to control the risk. When microbial contamination is low, an “unrealistic” number of samples must be taken and analyzed to get relevant information.

Salmonella and Cronobacter main microbiological hazards
Salmonella is typically difficult to detect in dried products and requires sampling and testing methods with a high degree of sensitivity, according to EFSA and ECDC. They added sensitivity of the sampling procedures and analytical methods for this food warrant further evaluation.

Infant formula manufacturing steps generally include mixing the ingredients in liquid form, heat treatment such as pasteurization, drying and adding ingredients before final packaging. All these steps mean infant formula may be contaminated at different stages by bacteria in the plant environment.

The opinion advises infant formula producers to reconsider hazards after each formulation or process change and to account for new epidemiological data.

Salmonella spp. and Cronobacter spp. are the two main microbiological hazards. Products may be contaminated after pasteurization by bacteria in the plant or when adding ingredients.

From 2008 to 2019, 13 alerts for biological hazards, five each from Salmonella and Cronobacter and one for Staphylococcus in powdered infant formula were made on the Rapid Alert System for Food and Feed.

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Authorities are investigating an ongoing outbreak of scombrotoxin fish poisoning traced to yellowfin tuna. They have blocked all incoming shipments of the fish from a Vietnamese company that has refused to initiate a recall.

Public health officials have confirmed at least 47 people from unspecified states as outbreak patients. The most recent illness began Oct. 15,  according to an outbreak investigation notice posted today by the U.S. Food and Drug Administration. The first patient, known of at this time, became ill on Aug. 8.

Scombrotoxin fish poisoning occurs when fish begins to spoil and histamine levels in it increase. Histamine cannot be destroyed by freezing or cooking.

The FDA reported that all yellowfin tuna from Truong Phu Xanh Co. Ltd. of Vietnam with 2019 production dates is implicated and should be thrown away. 

Stores, restaurants and other foodservice operators are expected to pull the tuna, but the FDA wants consumers to shoulder some responsibility, too. The agency’s notice tells consumers to ask whether yellowfin tuna — also called ahi tuna — being sold is from the specific company named by the FDA.

FDA officials have not used the agency’s power to force the Vietnamese company to recall the tuna, even though the firm has been determined to have supplied the fish.

“FDA asked for the supplier of yellowfin tuna associated with most of the illnesses, Truong Phu Xanh Co. Ltd. of Vietnam, to initiate a voluntary recall of all of its imported yellowfin tuna with production dates from January 2019 to the present. At this time, the firm has not recalled any product,” the FDA reported today.

“Because scombrotoxin fish poisoning causes temporary or medically reversible adverse health consequences this incident did not meet the threshold for the use of FDA’s mandatory recall authority.”

Although the Vietnamese supplier has not issued a recall, some companies in the United States have posted recalls for the implicated tuna, the FDA reported. The agency, working with officials in unnamed states, gathered information from victims and entities in the supply chain that led to those third-party recalls. 

The FDA notice says some of the tuna could still be on the market.

“Tuna from this supplier could have been sold thawed or frozen; and could have been sold as ground tuna meat, poke cubes, steaks, or loins; this product could still be within its shelf life,” the notice states.

Because of the outbreak investigation and findings to date, the FDA placed Truong Phu Xanh Co. Ltd. of Vietnam on “Import Alert,” which means the firm’s yellowfin tuna can be detained at U.S. borders and ports of entry without physical examination.

A concurrent investigation of cases of scombroid fish poisoning by the Seattle-King County Public Health Department is not related to the FDA’s investigation of Truong Phu Xanh Co. Ltd., according to federal officials. 

Testing for the toxin
Standard tests used during enforcement activities and other kinds foodborne illness investigations are not effective for situations of suspected scombroidtoxin fish poisoning, according to the FDA’s outbreak notice. 

The samples collected thus far by federal and state investigators cannot be linked to samples from patients by Whole Genome Sequencing (WGS) or Pulsed-Field Gel Electrophoresis (PFGE) analysis. Pathogens such as specific strains of Salmonella or E. coli are generally pinpointed with WGS or PFGE processes, but the spoilage factor in the scombroid scenario makes that impossible.

“Scombrotoxin fish poisoning occurs when fish begin to spoil, resulting in increased histamine levels,” FDA’s notice says. “Multiple samples have been collected and analyzed, with positive results for decomposition or high histamine levels in products imported from Truong Phu Xanh Co. LTD.”

About scombroid poisoning
Symptoms of scombroid poisoning can become evident within minutes to two hours following consumption of contaminated fish, according to the FDA.

Initial signs can mimic an allergic response and include facial flushing, sweating, burning-peppery taste sensations about the mouth and throat, dizziness, nausea and headache. Symptoms can intensify to facial rash, hives, swelling, diarrhea and abdominal cramps. Severe reactions to the poison can include blurred vision, respiratory stress, and swelling of the tongue.

Editors’ note from FSN’s Opinion Page: At this time, the credibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) is not to be trusted. Both agencies have shown a reckless disregard for the public’s right to know, and their reliability going forward remains suspect.

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After four outbreaks in less than two years where likely contaminated romaine lettuce contained deadly E. coli O157: H7, the Food and Drug Administration has decided to turn to microbial testing for clues for the next year to try to figure out what’s happening.

Sampling and testing food is FDA’s business.

Earlier this year, the agency announced microbiological testing for frozen berries. Frozen raspberries, blackberries, and strawberries were implicated “in recent decades” for viral infection outbreaks.

But not since 2012 have raw agricultural commodities been subject to comprehensive sampling and testing. That’s when USDA’s Microbiological Data Program (MDP) ended.

The FDA reports it is now “conducting a small, focused assignment to collect samples of the raw agricultural commodity (RAC) romaine lettuce to test for Salmonella app and pathogenic Escherichia coli. . .”

The year-long testing program is set to run through November 2020. Testing for Shiga Toxin-producing E. coli or STECS includes the microbial hazards that are associated with romaine lettuce consumption.

FDA will collect raw lettuce that is trimmed or washed in its natural form before processing. No fresh-cut processed romaine will be collected or analyzed. The agency announcement explains it this way:

“Sampling of RAC romaine lettuce before it is commingled during fresh-cut processing or before preparation at point of service where it may be commingled with other produce enables FDA to quickly trace lettuce to the point of origin when samples test positive for the presence of a human pathogen.”

FDA’s question-answer information  included:

Where will the samples be collected?
The agency plans to prioritize sampling at FDA registered facilities and farms identified by traceback from 2017 to present amid foodborne illness outbreaks for which romaine lettuce was confirmed or suspected to be the food vehicle. This domestic sampling assignment may include wholesalers, foodservice distribution centers, and commercial cooling and cold storage facilities, including on-farm holding facilities. Samples will only be collected after harvest and not from growing fields.

When will FDA collect samples?
The agency plans to collect samples throughout the year from November 2019 to November 2020,  with increased frequency in March-April and October-November, the transition periods for the California Central Coast and Central Valley to/from the Imperial/Yuma Valley growing regions, when foodborne illness outbreaks associated with romaine lettuce consumption have most frequently occurred.  Samples will be collected Mondays through Thursdays, to allow time for the shipment and help forestall any delay with respect to the testing.

How many samples will FDA collect?
The FDA plans to collect 270 samples in all. Each sample will consist of 10 subsamples, with each subsample weighing a minimum of 300 grams. This approach –- the collection and testing of samples composed of multiple subsamples –- is more reflective of actual conditions, and it increases the odds of finding pathogens if present, given that microbial hazards may not be uniformly present. Accordingly, if one subsample tests positive for a target pathogen, the FDA will regard the entire sample as positive for the organism.

How will the samples be collected?
Consistent with the FDA’s standard approach, agency field staff will collect all samples aseptically to prevent contamination during the collection process. The FDA’s aseptic sampling methods, which entail the use of sterile implements and containers, and prescribed collection procedures, are published in the agency’s Investigations Operations Manual (Chapter 4; Sub- Chapter 4.3).

Samples will be held and shipped at refrigerated temperatures. Agency field staff will ship samples in insulated transport containers with cooling media. Given that romaine lettuce is highly perishable, all shipments will occur overnight via a next-day courier service.

Per the Investigations Operations Manual (Chapter 4; Sub-Chapter 4.4), FDA field staff will collect information such as the name and address of the product manufacturer and/or distributor, the collection site, photographs of the product label, the food identification code (lot codes), and supply chain information.

What test methods will the FDA use?
In testing for pathogenic E. coli, FDA analysts will follow the methods in Chapter 4A of the FDA’s Bacteriological Analytical Manual (BAM). In testing for Salmonella spp., FDA analysts will follow the methods in BAM Chapter 5.

How soon after sample collection will the FDA provide the test results?
The FDA understands that some firms may opt to hold product pending notification of test results. In all cases, the FDA will notify the firm of the test results as soon as possible following the completion of the testing.
Notification of test results generally will occur within three to four days following sample collection (i.e., for negative results and cannot-rule-out initial findings). If the agency detects a cannot-rule-out initial finding, notification of final results may take up to an additional seven days.

The FDA also will perform whole genome sequencing on the pathogens it detects and then uploads the data to the public sequence repository, which generally takes up to an additional week. The agency routinely notifies firms of the results of the bioinformatic analysis of the sequence data, which may include communicating linkages to clinical illness or other food or environmental isolates.

Follow-up and enforcement
If the FDA detects Salmonella spp. or pathogenic E. coli in a sample, the agency will notify the firm of the findings and work with the firm to take appropriate action to protect the public health. The FDA encourages voluntary corrective action and, in all cases, seeks to employ an approach of “educate before and while we regulate.”

For samples traced back to a farm in a state that holds a grant with the FDA under the State Produce Implementation Cooperative Agreement Program, the FDA will work with the state to coordinate any necessary follow-up at the farm. The agency may consider multiple compliance and enforcement actions based on the available evidence and the adequacy of the firm’s response to prevent future contamination. Enforcement activities include actions to correct and prevent violations and to remove violative food from the market, as appropriate.

MDP
From 2002-2011, the the USDA’s Microbiological Data Program (MDP) conducted tests in 42 states on 120,887 samples of fruits and vegetables, including cantaloupe, celery, green onions, hot peppers, leaf lettuce, romaine lettuce, bagged lettuce, parsley, peanut butter, spinach, bagged spinach, alfalfa sprouts and tomatoes.

MDP testing was conducted by laboratories at Land Grant universities around the country with funding from Congress that was administered by USDA.   Congress terminated the program in 2012, the year after the Food Safety Modernization Act was signed into law. No similar testing existed when the romaine outbreaks began in 2017 and 2018.

Romaine Outbreaks
An E. coli O157: H7 outbreak in late 2017 was linked to simply to leafy greens in the U.S, while it was “likely romaine” in Canada, according to investigators.

Two 2018 E.coli outbreaks were linked to romaine, as was a fourth event that FDA covered up for six weeks this fall. The four E. coli outbreaks infected a total of 320 people.  The outbreaks were notable for their high hospitalization rates. Five outbreak patients died.

The romaine outbreaks were traced to growing regions, but not the actual farms where they were grown.

OPINION

Editors’ note: At this time, the credibility of the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) is not to be trusted. Both agencies have shown a reckless disregard for the public’s right to know, and their reliability going forward remains suspect.

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Scientists are urging government officials to consider helping to develop an international database to share and analyze DNA sequences.

Such a system is a platform for storing whole genome sequencing (WGS) data on the full genomes of investigated microorganisms such as bacteria, viruses and parasites, providing quick characterization and treatment options of such organisms when they are detected in sick patients or food.

In the United States the federal Centers for Disease  Control and Prevention works with states to collect sequences of pathogens in the PulseNet database. It has been credited with helping to detect outbreaks and assisting investigations.

More than 250 scientists and experts from 40 countries met at Nanyang Technological University in June to discuss strategies to combat foodborne disease and food poisoning outbreaks. The 12th meeting of the Global Microbial Identifier (GMI) conference was organized by the NTU Food Technology Centre.

Seize the opportunity
Joergen Schlundt, professor Food Science at Nanyang Technological University Food Technology Centre (NAFTEC), said the GMI suggested such a database be created but it needs political agreement among all countries.

“I think the main takeaway is that a lot of scientists and technical people see a giant opportunity for scientists and countries to work together to build science in this microbiological area with the new technology because this is one of the first times where if we connect all our data together in one or several big databases, researchers all over the world will gain from that,” he told Food Safety News.

“If the system was functioning, public, animal and plant health would benefit because you would end up having a system that could always answer what your microorganism is, what is the name, where it comes from, how you can treat it and maybe also if it is causing foodborne outbreaks.

“It is a huge resource that we could build if we wanted to, technically it is not a big deal, but we need countries to discuss whether it makes sense, whether they want to share their data and whether they want to fund it collectively. Optimal use is dependent on policies and the willingness and ability of countries to share genomic sequences across borders and in real-time.”

Databases on DNA sequences already exist such as those run by the National Center for Biotechnology Information (NCBI) and European Nucleotide Archive (ENA) but Schlundt said these are passive.

“It would be an active system that would give you an answer as soon as you send your sequence. So you have your microorganism, you put it through the sequencer, you get a sequence so four million letters in an excel or another file, you send that off to the machine and five minutes later it will give you the answer, so it is like searching on Google. The answer is the species, subtype and resistance of the microorganism and there could be other information.”

Improve outbreak response
Sharing of sequencing results would allow early detection of emerging threats and rapid identification, investigation, and prevention of national, regional and global disease outbreaks. Equal access and implementation of such sequencing technology between countries could reduce the global burden of disease by enabling real-time surveillance of animal and human diseases and food safety risks.

Schlundt said if most countries take up the idea then there would be an almost perfect standardized real-time surveillance system for diseases.

“It could be there is a foodborne outbreak in a number of different European countries and it is the same Salmonella typhimurium subtype, the system would see the one that is in Berlin is the same strain that is in Marseille and Rome so it can link it together like that. They are starting to do something like this in the U.S. with their system so they find many more national outbreaks than before because they used this type of methodology.”

Data privacy and anonymity could be protected as there are already ways to separate metadata from the four million letters that is the sequence.

“In that system where you can go in and look you cannot see this strain number, or any details about the patient, or the animal or food this comes from. That would be hidden. You would only be able to get that metadata through a special route, for instance if there was an outbreak. So there would be safeguards against privacy concerns in relation to the single patient and so on,” said Schlundt.

Letters sent to agencies worldwide
One of the reasons GMI was founded was to include developing countries in discussions on new techniques and technology.

Schlundt said the organization sent letters in 2018 to 186 countries to push for such a database and got answers back from 15 of them.

“We sent a second round of letters at the beginning of 2019 to 30 countries, the 15 countries that answered us and some other countries we know are interested in this area. From that second round, we have received six or seven replies. They don’t go into any detail but most of them say they agree it is an important issue and there needs to be international discussions about it,” he said.

“We’re hopeful France, Germany or the U.S. might bring it up in connection with G20 Health. If you want to have big movement in things like this you need to get nation states involved. The whole thing is predicated upon an agreement that you want to share this data and that has to be an inter-governmental discussion, it cannot be only between scientists.”

GMI will keep pushing on the issue through the “friendly” countries and international organizations, said Schlundt but while he would like it to happen in the next few years it may take decades.

“In my opinion, international organizations should take their own initiative on this. The World Health Organization (WHO) especially but also the Food and Agriculture Organization (FAO). They are agreeing with us but they are not actively pursuing this. We have to rely on member states that might be interested in this as a major potential for public health and all microbiology.”

GMI 13 will take place June 8 to 11, 2020 in Vancouver, Canada.

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